Physician Substitute – LVN/LPN: Licensed LVN or LPN

Physician Substitute – LVN/LPN: Licensed LVN or LPN

Ensure suitability of plasmapheresis donors, through the use of the SOP, current FDA and State guidelines, OSHA, CLIA, cGMP, and all internal company procedures.

General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.

Perform History and Physical Exams on all applicant donors to assess donor suitability.
• Perform Repeat History and Physical exams on an annual basis of qualified donors.
• Explain process of Plasmapheresis.
• Obtain signed consent for Plasmapheresis.
• Explain all risk involved in Plasmapheresis.
• Evaluate donor reactions and initiate appropriate therapy.
• Initiate emergency medical procedures as needed, per standing orders of the physician.
• Notify physician of all emergencies.
• Serve as a liaison between the center and medical facilities and physician.
• Review the donor’s accumulated lab data/test result and collection records as required to
determine the donor’s continued suitability.
• Provide appropriate and confidential counseling to ineligible donor candidates.
• Counsel donors with positive test results and confirmed positive test results.
• Maintain both donor and personnel confidentiality.
• Review normal SPE test results.
• Review and check donors with weight loss as needed.
• Perform periodic checks of donor floor to observe donors during plasmapheresis process.
• Function as a member of Quality Assurance team which monitors employee performance of screening
and collection procedures.
• Participate in employee safety, education and training programs.
• Provide first aid for employee injuries.
• Monitor emergency medical supplies on a monthly basis.
• Must be trained at minimum in donor screening after 3 months from Physician Substitute certification.
• Once certified, assist in reception area, donor floor and plasma processing as needed or directed by the
center manager.
• Assist with management and administration of employee counseling, testing and follow-up of
employee exposures to plasma or blood.
• Determine Hematocrit (HCT) and Protein (CA Centers RN only performs) via finger stick and use
of the hematastat and refractometer.
• Perform Proficiency Testing - (CA Centers RN only performs).
• Perform Statistical Analysis of Total Protein Results (CA Centers RN only performs).
• Perform daily controls.
• Perform monthly statistical analysis.
• Perform periodic Accu-Test (CA Centers RN only performs).
• Perform Calibration of machines as needed.
Reporting and Accountability
• Consult with Medical Director as necessary regarding donor suitability and treatment of donor
reactions.
• Consult with Medical Director as necessary regarding medications not listed in Medication Handbook.
• Unusual medical problems, especially those involving donor selection and health, and both donor
and employee safety, are to be brought to the attention of the Medical Director as soon as possible.
• Duties and performance are subject to periodic review by Medical Director, QA Manager, and Corporate QA department.
• Responsible for product safety by selecting only healthy donors, and for donor safety assuring that procedures are correctly performed.
• Responsible for providing coverage for all the hours of operation that they are scheduled. This individual is responsible for finding an appropriate substitute if they cannot cover the hours.
• Must read, understand and comply with all federal, state and local regulations. Other Responsibilities
• Will make decisions regarding donor suitability, based on broad medical knowledge, familiarity
with the current SOP and all applicable regulations to plasmapheresis.
• Will evaluate donor reaction regarding type, severity, and appropriate treatment methods.
• Consult with the medical director whenever an unusual problem occurs.
• Will notify management if the center is operating outside of the standard operating procedures to
prevent a detrimental impact on the donor, employees or product.
• Will appraise new procedures and equipment for impact on donor, employee and product safety.
• Provide oversight for Reception area.
• Perform ancillary duties and act as a support person for the reception area, donor floor or plasma area.
• Review SOP, cGMP regulations, and company policies on annual basis.
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as
otherwise posted or communicated.
• Any other duties as assigned.