AB725 - Source plasma donation.

Amended IN Assembly May 01, 2025 CALIFORNIA LEGISLATURE— 2025–2026 REGULAR SESSION Assembly Bill No. 725 Introduced by Assembly Member Solache (Coauthors: Assembly Members Carrillo, Castillo, Nguyen, and Tangipa) February 18, 2025 An act to amend Section 1302 of the Business and Professions Code, and to amend Section 1605 of the Health and Safety Code, of, and to add Chapter 4.05 (commencing with Section 1631) to Division 2 of of, the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGEST AB 725, as amended, Solache. Source plasma donation. Existing law requires a person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the state, and requires licensed blood banks and blood transfusion services to meet specified standards. Existing law authorizes the State Department of Public Health to establish and require compliance with additional requirements, as specified. This bill, the California Source Plasma Donation Centers Act, would authorize a person to operate a source plasma donation center for the purpose of collecting source plasma, as defined. The bill would, among other things, authorize a source plasma donation center to offer payment to a donor of money or other valuable consideration. The bill would require the operator of a source plasma donation center to obtain a license from the State Department of Public Health, as specified. The bill would authorize the department to regulate source plasma donation centers, including to inspect the property or records of the center and to suspend or revoke a license for violation of specified law or regulation. The bill would authorize the department to promulgate any regulations it deems necessary to implement the bill’s provisions. The bill would make a violation of the bill’s provisions a misdemeanor, and would authorize a district or city attorney to prosecute a violation of the bill’s provisions. By creating a new crime, the bill would impose a state-mandated local program. This bill would require a local health officer, if they obtained records from a source plasma donation center of a plasma donor who had a reactive result to HIV antibody testing, upon completion of the officer’s efforts to locate and notify the plasma donor, to expunge all of the individual’s records. By imposing additional duties on local health officials, this bill would impose a state-mandated local program. Existing law establishes the Clinical Laboratory Improvement Fund and requires specified fees collected from the licensing and regulation of blood banks and blood transfusion services to be deposited in the fund, available upon appropriation, for the purpose of regulating blood banks and blood transfusion services. This bill would additionally require fees collected from the licensing and regulation of source plasma donation centers to be deposited in the fund for the purpose of regulating source plasma donation centers, upon appropriation by the Legislature. Existing law requires specified establishments that receive specified human whole blood and derivatives to be considered blood bank depositories and require specified procedures on blood for transfusion to be the sole responsibility of the blood bank depository. This bill would exempt source plasma donation centers from these provisions. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that with regard to certain mandates no reimbursement is required by this act for a specified reason. With regard to any other mandates, this bill would provide that, if the Commission on State Mandates determines that the bill contains costs so mandated by the state, reimbursement for those costs shall be made pursuant to the statutory provisions noted above. Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill Text The people of the State of California do enact as follows: SECTION 1. This act shall be known, and may be cited as, the California Source Plasma Donation Centers Act. SEC. 2. Section 1302 of the Business and Professions Code is amended to read: 1302. (a) There is hereby established in the State Treasury, the Clinical Laboratory Improvement Fund. (b) All fees established under this chapter and Chapters 4 (commencing with Section 1600) and 4.05 (commencing with Section 1631) of Division 2 of the Health and Safety Code shall be collected by and paid to the department, and shall be deposited by the department in the Clinical Laboratory Improvement Fund, along with any other moneys received by the department for the purpose of licensing, certification, inspection, proficiency testing, or other regulation of clinical laboratories, blood banks, or clinical laboratory personnel. Notwithstanding Section 16305.7 of the Government Code, all interest earned on moneys deposited in the fund shall be maintained in the fund. (c) Moneys deposited in the Clinical Laboratory Improvement Fund that are appropriated in the annual Budget Act, or any other appropriation, for support of, or expenditure by, the state department shall, upon appropriation, be expended by the state department to administer this chapter and Chapters 4 (commencing with Section 1600) and 4.05 (commencing with Section 1631) of Division 2 of the Health and Safety Code. All fees collected pursuant to this chapter shall, upon appropriation, be expended to administer this chapter and shall not be redirected for any other purpose. All fees collected pursuant to Chapters 4 (commencing with Section 1600) and 4.05 (commencing with Section 1631) of Division 2 of the Health and Safety Code shall, upon appropriation, be expended to administer its respective chapter and shall not be redirected for any other purpose. SEC. 3. Section 1605 of the Health and Safety Code is amended to read: 1605. Establishments which receive human whole blood and human whole blood derivatives specified by regulation and are not subject to license in accordance with this chapter shall be considered as blood bank depositories. Laboratory tests and other procedures with respect to the preparation of blood for transfusion shall be the sole responsibility of the blood bank depository. This section does not apply to source plasma donation centers licensed pursuant to Chapter 4.05 (commencing with Section 1631). SEC. 4. Chapter 4.05 (commencing with Section 1631) is added to Division 2 of the Health and Safety Code, to read: CHAPTER 4.05. Source Plasma Article 1. Definitions 1631. For the purposes of this chapter, the following terms have the following meanings: (a) “Department” means the State Department of Public Health. (b) “Medical director” or “permanent medical director” means the California licensed physician and surgeon designated by the licensee to direct and control personnel and relevant procedures concerning the determination of donor eligibility, collection of source plasma, the immunization of a donor, and the return of red blood cells or other blood components to the donor during collection of source plasma by plasmapheresis. (c) “National Donor Deferral Registry” means the database of deferred plasma donors in North America owned by the Plasma Protein Therapeutics Association. (d) “Person” means any individual, blood bank, source plasma donation center, hospital, firm, corporation, or any other entity. (e) “Plasmapheresis” means a procedure in which, during a single visit to a source plasma donation center, blood is removed from a donor, the plasma separated from the formed elements, and at least the red blood cells are returned to the donor. (f) “Source plasma” means the fluid portion of human blood collected by plasmapheresis that is intended as source material for further manufacturing use. “Source plasma” does not mean single donor plasma products intended for intravenous use. (g) “Source plasma donation center” means a facility, other than a licensed blood bank, where source plasma is collected by plasmapheresis. (h) “Source plasma donor phlebotomist” means a suitably qualified individual who has received appropriate training on venipuncture, blood sample collection, and collection of source plasma via automated plasmapheresis which has been approved by the medical director of the donation center. (i) “Substitute medical director” means the California licensed physician and surgeon designated by the licensee to temporarily direct and control personnel and procedures in the stead of the permanent medical director if a permanent medical director dissociates from a source plasma donation center. Article 2. Donations 1632. (a) (1) Notwithstanding any other provision of law, a person may operate a source plasma donation center for the purpose of collecting source plasma if they are licensed under this chapter and the source plasma is collected in accordance with this chapter. (2) A source plasma donation center that is licensed pursuant to this chapter is exempt from licensure as described in Chapter 4 (commencing with Section 1600). (b) A source plasma donation center may offer payment to a donor of money or any other valuable consideration that can be converted to money by the recipient in return for the donation of source plasma. 1632.1. A source plasma donation center shall require a donor of source plasma who receives payment in exchange for the donation of source plasma to provide photographic driver’s license or other photographic identification that is issued by the Department of Motor Vehicles, pursuant to Division 6 (commencing with Section 12500) of the Vehicle Code, or other acceptable identification issued by any other state or federal government agency, or tribal government, as specified in regulation. 1632.2. Before a donor donates source plasma for the first time, a source plasma donation center shall do all of the following: (a) Require the donor to complete a donor history questionnaire recognized by the United States Food and Drug Administration. (b) Advise the donor of the risks and hazards of plasmapheresis and obtain informed consent from the donor. (c) Notify the donor in writing and obtain a written statement confirming the notification that each donation shall be tested for evidence of relevant transfusion-transmitted infections. (d) Notify the donor in writing that the test results may result in the donor being deferred from future donations and being placed on the National Donor Deferral Registry. (e) Require a registered nurse to conduct a donor screening examination of the donor. 1632.3. (a) A source plasma donation center shall prominently display at each of its donation sites a notice that provides the addresses and telephone numbers of sites, within the proximate area of the source plasma donation center, where anonymous HIV antibody testing provided pursuant to Chapter 3 (commencing with Section 120885) of Part 4 of Division 105 may be administered without charge. (b) (1) Notwithstanding any other provision of law, civil liability or criminal sanction shall not be imposed for disclosure of test results to a local health officer if the disclosure is necessary to locate and notify a plasma donor of a reactive result to HIV antibody testing if reasonable efforts by the source plasma donation center to locate the donor have failed. (2) Upon completion of the local health officer’s efforts to locate and notify a source plasma donor of a reactive result to HIV antibody testing, all records obtained from the source plasma donation center pursuant to this subdivision, or maintained pursuant to this subdivision, including, but not limited to, any individual identifying information or test results, shall be expunged by the local health officer. 1632.4. (a) (1) Notwithstanding Chapter 7 (commencing with Section 120975) of Part 4 of Division 105, or any other provision of law, no public entity or any private source plasma donation center shall be liable for an inadvertent, accidental, or otherwise unintentional disclosure of the results of an HIV test. (2) As used in this section, “public entity” includes, but is not limited to, any publicly owned or operated source plasma donation center, local health officer, and the department. (b) Neither the department nor any source plasma donation center, including a source plasma donation center owned or operated by a public entity or a local health officer, shall be held liable for any damage resulting from the disclosure of test results obtained pursuant to subdivision (a). 1632.5. The procurement, processing, distribution, or use of source plasma is the provision of a service by a person, firm, or corporation rather than a sale of source plasma. Article 3. Administration of Source Plasma Donation Centers 1632.6. (a) (1) Notwithstanding any other law, personnel who are explicitly authorized by the source plasma donation center and who meet the education, training, and competency standards of the source plasma donation center may obtain a predonation health history and perform predonation screening, including nondiagnostic general health assessments for which blood collection is performed by skin puncture. (2) When unlicensed personnel perform the duties described in paragraph (1), the review of work required by federal regulations relating to good manufacturing practices, as described in Parts 211 and 606 of Title 21 of the Code of Federal Regulations, shall be performed by a staff member who is a licensed health care professional. (b) Notwithstanding any other law, a licensed clinical laboratory bioanalyst, as described in Section 1203 of the Business and Professions Code, a licensed clinical laboratory technologist, a registered clinical laboratory technologist trainee, a licensed vocational nurse, as described in Section 2859 of the Business and Professions Code, a registered nurse, as described in Section 2725 of the Business and Professions Code, a blood donor phlebotomist, as defined by the American Association of Blood Banks, or a source plasma donor phlebotomist may perform skin puncture and venipuncture for the purposes of collecting human source plasma. (c) The acts described in subdivisions (a) and (b) shall be performed under both of the following conditions: (1) In a source plasma donation center licensed pursuant to this chapter and according to standard operating procedures approved by the United States Food and Drug Administration. (2) Under the general supervision of a licensed physician and surgeon. The licensing and registration described in this section shall be licensing and registration pursuant to the Business and Professions Code. (d) Notwithstanding paragraph (2) of subdivision (a), source plasma may be collected at a source plasma donation center when a physician or surgeon is not physically present on the premises. The physician [Text truncated for display. Full text available on Congress.gov.]