CBER U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

CBER Medical Oversight in Source Plasma Centers Leslie Holness, MD Chief, Blood & Plasma Branch Division of Blood Applications FDA, Center for Biologics Evaluation & Research

CBER 3 FDA’s Mission is to Protect and Promote

CBER 4 Medical oversight in SP centers

CBER 5 SP Center Medical Director Must have a current state license (640.62) Must be trained on FDA regulations, cGMPs, recommendations, and center SOPs (606.20(b)) Must supervise the physician substitutes (640.63(a)) Should evaluate physicians substitutes’ performance of assigned duties Must select and schedule immunizations and evaluate clinical response (640.66) Must evaluate abnormal test results and determine whether donors may continue in the program (640.65(b)(2)(i))

CBER 6 Medical Supervision of RBC Immunization Program  Medical Director must: (640.66) – Certify the donor’s health to participate – Approve injection schedule – Select the antigen to be injected – Perform at least weekly evaluation and review of the donor immunization record – Evaluate clinical response (including monitoring reactions)  Medical Director must be on premises during RBC immunizations (640.62)

CBER 7 Physician Substitute A physician substitute program is approved by CBER to allow trained individuals to perform some of the duties of a physician provided the physician substitute is under the direct supervision of the on- site Center Physician/Medical Director

CBER 8 Physician Substitute Blood Memorandum: Physician Substitutes (August 15, 1988) Physician substitute program approved by CBER as alternative procedure to Submitted as a Prior Approval Supplement (601.12(b)) CBER approves program, not individual PS Physician substitute program should define the limits of authority and duties and provide specific instructions concerning handling medical emergencies & consulting the Medical Director Nursing (RN/LPN), EMT, physician assistant graduate Current state licensure or certification

CBER 9 Physician Substitute Maintains current CPR certification Has completed minimum 5 week training program Undergoes additional training if participates in immunization program Must be trained on FDA regulations, cGMPs, recommendations, and center SOPs [ (b)] May evaluate normal healthy donors, including donors in a pre-existing disease-associated antibody program

CBER 10 Physician Substitute Must be on premises during donor suitability determinations and collections (640.62) Not authorized to substitute for Medical Director in vaccine/RBC immunization, disease state, high risk and therapeutic exchange plasma programs Routinely they are not authorized to select or schedule immunizations Some physician substitutes are approved to do this as alternative procedure to Approval applies to vaccine immunization program using licensed vaccines according to the package insert Should not re-enter donors after an abnormal test result

CBER 11 Physician Substitute Duties Authorized to:  perform medical examinations and administer informed consents  Explain the plasmapheresis procedure  Determine donor suitability for normal healthy donors  Review SPEs (can accept normal SPEs, reject abnormal SPEs)  Give RBC immunization & vaccine injections  Manage medical emergencies and donor reactions  Counsel deferred donors  Communicate with Medical Director

CBER 12 Documentation  Evidence that Medical Director and physician substitute have received training required in (b)  Their evaluation of the donor’s suitability to donate and continue participation in donation programs ( (a & b(1))  Evidence they evaluated the records of adverse reactions that are required in (b)(1)(iii) – Records of adverse reactions related to immunization should be kept in a format that permits easy retrieval and analysis

CBER 13 Medical Oversight Summary  Medical Director must be active in plasma center donor programs – Physician substitute is not authorized to replace physician in some special plasma center donor programs  Medical Director is responsible for supervising physician substitute  Trained physician substitutes may perform some of the Medical Director duties – Physician substitute program is approved as a alternative procedure to under the provisions of

CBER 14 Medical Oversight Summary  Trained physician substitutes may perform some of the Medical Director duties – Normal Source Plasma donors – Pre-existing disease-associated antibody donors – Licensed vaccine immunization program, with additional training  Additional physician substitute training – Procedures relevant to the approved immunizing agents – Knowledge of hazards of immunizations to obtain appropriate informed consent – Details of how to handle unexpected adverse donor reactions by the immunizing agents

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