Source plasma donation centers are facilities where source plasma is collected by plasmapheresis. "Source plasma" means the fluid portion of human blood collected by plasmapheresis and intended as source material for plasma protein therapies. This term does not apply to facilities where single donor plasma is collected for the purpose of intravenous use.
Source plasma donation centers are required to comply with federal regulations for source plasma collection and donor eligibility testing specifically for hematocrit and total protein. Facilities that perform plasma collection for intravenous use, collect any other blood components, or perform any other testing must obtain a blood bank or clinical laboratory permit from the Clinical Laboratory Evaluation Program.
Source plasma donation centers must employ both a responsible physician, who oversees all plasma collection activities, and a laboratory director, who oversees the donor eligibility testing.
Source plasma donation centers must participate in CMS-approved commercially available proficiency testing for total protein. Results of proficiency testing must be authorized for release to the Clinical Laboratory Evaluation Program.
Registration forms for source plasma donation centers are forthcoming. Questions can be directed to plasma@health.ny.gov.