Physician Substitute

PURPOSE

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. 

ESSENTIAL RESPONSIBILITIES & DUTIES

• 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 the 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 the Medical Director as necessary regarding donor suitability and treatment of donor reactions.
• Consult with the 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 dono