Physician Substitutes (8/15/88)


DATE:     15 August 1988

FROM:     Director, Center for Biologics Evaluation and Research

SUBJECT:  Physician Substitutes

TO:       All Licensed Manufacturers of Source Plasma


This memo updates recommendations of 14 December 1984, for the
duties performed by adequately trained physician substitutes
approved under provisions of 21 CFR 660.75.  Adequately trained
physician substitutes may perform some of the routine functions
of a physician provided the following requirements are met:

1.  The physician substitute must be a graduate of a recognized
educational program such as nursing, emergency technician or
physician assistant and be currently licensed or certified in the
state. The physician substitute must maintain current
certification in cardiopulmonary resuscitation (CPR).

2.  The establishment must have a training program of at least 5
weeks duration and a job description or statement of
responsibilities for the physician substitute.  The description
of duties should clearly define the limits of authority and
provide specific instructions concerning handling medical
emergencies and directions for consulting the medical director or
plasma center physician.  Descriptions of the training program
and the job responsibilities must be submitted in writing to the
FDA for review and approval prior to the initiation of any person
in the training program.

3.  After completion of training, the physician who is
responsible for the training must evaluate the individual's
performance of assigned duties in the plasma center.  A copy of
the physician's evaluation, and the physician substitute's
curriculum vitae, license or certificate, and signed statement of
understanding should be submitted to the FDA for approval.

4.  The physician substitute's function may include evaluation of
normal healthy donors for both manual and automated apheresis
procedures, and "disease state donors" when such donors meet the
criteria for normal plasma donors.  Physician substitutes are not
authorized to replace physicians in programs that collect
Therapeutic Exchange Plasma (TEP) or plasma from donors who test
reactive for HBsAg or positive for antibody to HIV.

5.  Physician substitutes may administer or supervise all
approved immunizations except red blood cell immunizations,
provided they satisfactorily undergo an additional week of
training.  This training should include procedures relevant to
the approved immunizing agents, knowledge of the hazards of
immunizations, so as to obtain appropriate informed donor
consent, and details of unexpected adverse donor reactions by the
immunizing agents and how to handle them.  The plasma center
physician continues to be responsible for at least weekly
evaluation and review of the donor immunization record and
approval of scheduled injections.  To facilitate evaluation of
specific programs, we recommend keeping the required records of
all adverse reactions related to immunization in a format that
permits easy retrieval and analysis.

For further information or certification of the procedure,
contact Andrea Casper, Division of Blood and Blood Products at
(301) 456-0952.


                             Paul D. Parkman, M.D.