(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 delete the requirement to automatically revoke a license if there is a change of the person in charge of biologics production. The bill would instead require a license to be revoked if a replacement person in charge of biologics production is not designated within 45 days, unless the period of time is extended by the department, as specified. If a person in charge of biologics production disassociates with the licensed facility, the bill would require the licensee to provide written notification to the department within 24 hours of the date of the disassociation. The bill would prohibit a licensee from operating without the supervision of a duly appointed person in charge of biologics production. The bill would authorize a licensee to designate an interim person in charge of biologics production for a period not to exceed 45 calendar days if certain conditions are met.

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 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.

(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. The bill would exempt licensed source plasma donation centers performing only a total protein test, as specified, from clinical laboratory licensure requirements.

(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 physician and surgeon or licensed clinical laboratory 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 supervising physician and surgeon to delegate to other licensed health care professionals the performance of health services duties, including donor screenings, predonation health screenings, and donor suitability assessments.