California AB 2009

(1) 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. A violation of these licensing provisions is a misdemeanor. Existing law requires a license to be automatically revoked when there is a change of address, ownership, or person in charge of biologics production. Existing law authorizes a new license to be secured for the new location, owner, or person in charge prior to the actual change, as specified. This bill would prohibit the department from automatically revoking the plasma collection center's license when there is a change of the person in charge of biologics production if the owner or the owner's representative provides written notification of the change to the department within 5 days of the change, as specified, and the licensee submits, within 30 days of the change, the application for a new person in charge of biologics production. The bill would prohibit a licensee from operating without the supervision of a medical director. The bill would authorize a licensee to designate an interim person in charge of biologics production for a period not to exceed 30 calendar days if certain conditions are met. The bill would require plasma centers and their auxiliaries to be under the direction of a medical director or person in charge of biologics production who meets specified qualifications, including being a physician and surgeon and having a minimum of 3 months of experience or training in plasma center methods. Existing law requires each blood bank or plasma center to require as identification either a photographic driver's license or other photographic identification that is issued by the Department of Motor Vehicles from all donors of human whole blood or blood components who receive payment in return for the donation of the blood or blood components. The bill would instead require each blood bank or plasma center to require identification issued by the Department of Motor Vehicles, as described above, or photographic identification issued by another state, federal agency, or tribal government from all donors of human whole blood or blood components who receive payment in return for the donation of the blood or blood components. By creating new crimes, this bill would impose a state-mandated local program. (2) Existing law requires certain establishments that receive specified human whole blood and derivatives to be considered blood bank depositories and requires specified procedures on blood for transfusion to be the sole responsibility of the blood bank depository. This bill would specify that source plasma donation centers, as defined, that are licensed pursuant to the above-described provisions are not blood bank depositories. (3) Existing law authorizes a person to perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the State Department of Public Health determines several conditions are met, including, among others, that the person meets specified training and education requirements, and performs the total protein test under supervision and using standard operating procedures, as specified. This bill would also require the department to determine that the licensed plasma collection center's supervising medical director has sufficient proficiency and knowledge with the use and supervision of digital refractometers in performing total protein tests. The bill would authorize a licensed plasma collection center's medical director to delegate to other licensed health care professionals, as approved by the department, the performance of health services duties, including donor screenings, predonation health screenings, and donor suitability assessments. (4) 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 no reimbursement is required by this act for a specified reason.