Blood centers rely on blood collected at more than 800 donation sites across the country.
Each time a new donation site is opened, a blood center must go through an extensive licensure process to add the new site to their existing Blood License Application (BLA). This process can take more than a year, despite the blood center using the same Standard Operating Procedures (SOPs), devices, and staff as their primary licensed facility.
The Problem
- Outdated regulations are creating significant bottlenecks in the U.S. blood supply chain.
- Current rules require redundant reviews for new apheresis collection sites, despite prior FDA approval. This unnecessary duplication delays blood availability to patients and impedes blood centers' ability to adapt to changing needs.
- As new donation locations open nationwide, these regulations pose a critical challenge. They not only slow down the process of establishing new collection sites but also create inefficiencies in an already complex healthcare system.
Take Action
Representatives Wied (R-WI-8) and Schrier (D-WA-8) introduced H.R. 5791, the Boosting Lifesaving Operations, Opening Donation (BLOOD) Centers Act. This bipartisan legislation would streamline the licensure process for blood centers by creating an expedited pathway to add new apheresis collection sites under an existing license. This marks a significant advancement on a key priority in our 2025 ABC Advocacy Agenda.
Urge your members of Congress to support this bill by sending prewritten messages - it takes only minutes but could have a lasting impact.
Latest Developments
America’s Blood Centers Honors Reps. Tony Wied and Kim Schrier as 2026 Congressional Champions
Washington, D.C. — America’s Blood Centers (ABC), the national organization of community-based, independent blood centers that supply 60 percent of the nation’s blood supply, today announced the recipients of…
ABC Applauds Introduction of Bipartisan BLOOD Center Act to Advance Access, Streamline Licensure for Blood Centers
Legislation would help improve the quantity of our nation’s blood supply and streamline the opening of new blood centers Washington, DC – America’s Blood Centers…
Resources
Apheresis Collections Licensure Routes & Validation Data
Presentation by America's Blood Centers featuring flowcharts detailing the apheresis collections licensure routes and validation data.
Over 100 organizations launch Blood Advocacy Week Urging Congress to Make the Blood Supply a National Priority
Over 100 leading organizations from across the nation have united to kick off Blood Advocacy Week 2026, calling on Members of Congress to take decisive…