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Full Consensus Recommendations 15-16

Advisory Council on Blood Stem Cell Transplantation (ACBSCT) Consensus Recommendations to the Secretary of Heath and Human Services (HHS)

The ACBSCT met on May 11, 2011, in Washington, DC, and unanimously agreed on its fifteenth and sixteenth recommendations.

On this page:

Recommendation 15

Consistent with Congressional mandates and strategic efforts to expand collection site participation, ACBSCT recommends that the Secretary recognize public cord blood bank oversight of the collection process as sufficient means to ensure safe manufacturing practices, and oppose the requirement for hospitals to register with the FDA as the establishment responsible for recovery.

Recommendation 16

Based on data from nearly two decades of practice controlled by public cord blood banks to ensure safe collection processes and protect product integrity, ACBSCT recommends that the Secretary support the collection of cord blood from uncomplicated deliveries in accredited hospitals without environmental monitoring of delivery rooms.