Medical Oversight in Source Plasma Centers

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Medical Oversight in Source Plasma Centers

• Leslie Holness, MD
• Chief, Blood Plasma Branch
• Division of Blood Applications
• FDA, Center for Biologics Evaluation Research

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FDAs Mission is to Protect and Promote
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Medical oversight in SP centers
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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))

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Medical Supervision of RBC Immunization Program

• Medical Director must (640.66)
• Certify the donors 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)

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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

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Physician Substitute

• Blood Memorandum Physician Substitutes
• (August 15, 1988)
• Physician substitute program approved by CBER as
  640.120 alternative procedure to 640.62
• 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

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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 606.20(b)
• May evaluate normal healthy donors, including
  donors in a pre-existing disease-associated
  antibody program

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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 640.120 alternative procedure to 640.66
• Approval applies to vaccine immunization program
  using licensed vaccines according to the package
  insert
• Should not re-enter donors after an abnormal test
  result

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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

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Documentation

• Evidence that Medical Director and physician
  substitute have received training required in
  606.20(b)
• Their evaluation of the donors suitability to
  donate and continue participation in donation
  programs (606.160(a b(1))
• Evidence they evaluated the records of adverse
  reactions that are required in 606.160(b)(1)(iii)
• Records of adverse reactions related to
  immunization should be kept in a format that
  permits easy retrieval and analysis

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Medical OversightSummary

• 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 640.62 under the
  provisions of 640.120

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Medical OversightSummary

• 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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