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Patient care & rightsNew in this edition

AB 2009 revises plasma center personnel and donor controls

AB 2009 creates a conditional personnel-change pathway for plasma centers, preserving medical-director supervision and a 30-day replacement application. It also changes director qualifications, delegated screening, paid-donor identification and digital-refractometer oversight while keeping professional-scope limits.

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What happened

California enacted AB 2009 on September 27, revising plasma-center licensing and personnel rules. A change in the person in charge of biologics production need not automatically revoke a plasma collection center’s license if the owner or representative gives CDPH written notice within five days and the licensee files the replacement application within 30 days. The notice must identify the departed person, departure date, interim designee’s name and qualifications, anticipated duration and owner or representative signature. A qualified interim designee may serve no more than 30 calendar days, and the center may not operate without medical-director supervision. Failure to file the replacement application within 30 days requires revocation, subject to an additional 30-day extension CDPH may grant for good cause. The enactment is the event reported here; the applicable commencement of these provisions must be confirmed separately.

Plasma centers and auxiliaries must be directed by a licensed physician and surgeon with at least three months of plasma-center methods experience or training and other applicable qualifications. Medical directors may establish screening and donor-suitability protocols and delegate health-service duties to other licensed professionals under the department-approval, scope and supervision conditions; the provision does not expand professional scope. For paid whole-blood or component donors, identification may include photographic identification from another state, a federal agency or tribal government as well as the specified DMV identification. The law also adds supervising medical-director proficiency in digital refractometers to the testing framework and clarifies that licensed source-plasma donation centers are not blood bank depositories.

Scope and timing

Authority status
Final
Applicability
Potentially applicable
Audience
Health systems, Provider networks, Health-tech
Jurisdiction
California

Why it matters

The personnel-change exception prevents an automatic licensing consequence only when the filing and coverage conditions are met. It does not permit an unsupervised center or an indefinite interim appointment. Donation, screening and laboratory workflows also have distinct identification and qualification requirements.

Sources

Complete edition and supplemental material

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