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AB 2009 revises plasma center personnel and donor controls

AB 2009 allows a conditional plasma-center personnel transition without automatic license revocation and broadens qualifying paid-donor identification. Medical-director coverage, timely notice and replacement applications, interim qualifications, and testing and delegation controls remain material safeguards.

What happened

California enacted AB 2009 on September 27 as Chapter 570. A plasma collection center avoids automatic revocation for a change in its biologics-production lead only if the owner or representative provides the specified signed written notice within five days and submits the replacement application within 30 days. A qualified interim lead may serve no more than 30 calendar days with notice, and the licensee may not operate without medical-director supervision. Failure to submit the replacement application requires revocation, subject to a department-granted additional 30-day good-cause extension. The exception does not generally excuse address or ownership changes.

Paid-donor identification can include qualifying photographs issued by another state, a federal agency, or tribal government as well as DMV identification. Medical directors may authorize and supervise specified screenings and health services by department-approved licensed professionals within their scope, without expanding that scope. The refractometer provisions retain training, physically onsite supervision, quality control, and competency evaluation, while requiring medical-director proficiency and limiting unrelated experience demands for plasma-only services. The law also distinguishes licensed source-plasma donation centers from blood-bank depositories and specifies physician licensure and experience for the identified leadership roles.

Scope and timing

Authority status
Final
Applicability
Potentially applicable
Audience
Health systems, Provider networks, Health-tech
Jurisdiction
California
Recorded date
2027-01-01
Date type
effective

Why it matters

A personnel-change exception does not authorize unsupervised operation.

Sources

Complete edition and supplemental material

This finding in the complete approved report →

Regulatory horizons, CIA trends and implementation trackers remain in the full report.

Read the entire Compliance Sweep report →

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