Blood banks and plasma centers

The law gives plasma centers limited continuity when their biologics-production lead changes while maintaining medical supervision and state oversight. It also broadens acceptable identification for paid donors.

What the law does ​

• Lets plasma centers avoid automatic license revocation after a change in the person in charge of biologics production if they notify the State Department of Public Health within five days and apply for a replacement within 30 days.
• Allows a qualified interim biologics-production lead for up to 30 days and requires centers to operate under a medical director.
• Requires plasma centers and auxiliaries to be directed by a physician and surgeon with at least three months of plasma-center training or experience.
• Permits paid donors to use photo identification issued by another state, a federal agency, or a tribal government, in addition to California Department of Motor Vehicles identification.
• Allows medical directors, under department-approved protocols, to delegate donor screenings, predonation health screenings, suitability assessments, and other authorized health duties to licensed health professionals acting within their scopes of practice.
• Requires supervising medical directors to be proficient in using and supervising digital refractometers for total-protein testing, while retaining training, onsite supervision, documentation, and recordkeeping safeguards.
• Clarifies that licensed source plasma donation centers are not blood bank depositories.

Who it affects ​

• Licensed plasma collection centers, their owners, medical directors, and biologics-production leads.
• Licensed health care professionals performing delegated donor-screening and health-service duties.
• Workers performing donor total-protein tests using digital refractometers.
• People paid to donate blood components or source plasma.

Context ​

The State Department of Public Health may revoke a center's license if it does not timely apply for a replacement biologics-production lead, subject to a possible 30-day extension for good cause.

Breakdown ​

Plasma Center Licensing and Donor ID ​

AB 2009 changes the rules for plasma collection centers when their biologics-production supervisor changes. A center can keep its license during that transition if it promptly notifies the state and applies for approval of a new person in charge, while remaining under medical supervision. The bill also broadens the photo identification that paid blood or plasma donors may use.

Key takeaways

• A plasma collection center’s license will not be automatically revoked solely because its person in charge of biologics production changes if the owner gives written notice within five days and applies for a new person in charge within 30 days.
• A licensee may not operate without supervision from a medical director.
• A licensee may appoint an interim person in charge of biologics production for up to 30 calendar days when the bill’s conditions are met.
• Plasma centers and their auxiliaries must be directed by a qualified medical director or person in charge who is a physician and surgeon with at least three months of relevant plasma-center experience or training.
• Paid donors may use qualifying photo identification from another state, a federal agency, or a tribal government, in addition to California Department of Motor Vehicles identification.
• The bill creates new offenses, which can result in local enforcement responsibilities.

Source Plasma Centers ​

The bill clarifies that licensed source plasma donation centers are not treated as blood bank depositories. As a result, the rules that apply specifically to blood bank depositories do not apply to those centers on that basis.

Key takeaways

• Licensed source plasma donation centers are expressly excluded from the definition of blood bank depositories.
• The change applies to source plasma donation centers as defined by the bill.
• The bill distinguishes source plasma donation centers from facilities that receive certain human blood and derivatives as blood bank depositories.

Plasma Center Medical Oversight ​

The bill adds a requirement that a plasma collection center’s supervising medical director must be proficient and knowledgeable in using and supervising digital refractometers for total protein tests. It also allows a center’s medical director to delegate certain health-service duties to other department-approved licensed health professionals.

Key takeaways

• The Department of Public Health must determine that the supervising medical director is proficient and knowledgeable in using and supervising digital refractometers for total protein testing.
• The new requirement applies to licensed plasma collection centers that perform total protein tests with digital refractometers.
• A medical director may delegate health-service duties to other licensed health professionals if the department approves them.
• Delegable duties include donor screenings, predonation health screenings, and assessments of whether a donor is suitable to donate.

No State Reimbursement Required ​

The bill states that the state does not have to reimburse local agencies or school districts for costs connected with this act. It gives a specified reason for that conclusion under California’s rules on state-mandated local costs.

Key takeaways

• The bill declares that no state reimbursement is required for costs resulting from this act.
• California normally reimburses local agencies and school districts for certain state-mandated costs.
• The bill relies on a specified reason to conclude that reimbursement is not required.