Position Summary
Under the direction of the Medical Director and/or Center Licensed Physician(s), the Physician Substitute determines the acceptability of all first-time donors and return applicant donors. The Physician Substitute determines the suitability of donors by following Standard Operating Procedures (SOPs) designed to ensure the donor meets suitability criteria in accordance with FDA guidance and regulations. The Physician Substitute also reviews normal donor laboratory test and refers abnormal test to the Physician for review.
The Physician Substitute works closely with the Medical Director or Licensed Center Physician(s) while making any decisions which directly impact donor suitability. The Physician Substitute also provides medical oversight in screening, phlebotomy, and the plasma processing areas.
Essential Functions (ES) and Responsibilities
Key Duties (ES):
- Performs new and returning donor physicals, and annual donor physicals. The Physician Substitute may not perform physical examinations for donors receiving red blood cell immunizations.
- Administers and answers donor questions about the Plasmapheresis Informed Consent, RSV Plasmapheresis Informed Consent and the informed consent for any other applicable donation program.
- Administers the AIDS Bulletin and assesses the donors understanding of high-risk activities.
- Keeps accurate, legible, and complete donor records in accordance with cGMP.
- Reviews normal donor laboratory work within time requirements as outlines in the SOPs and refers abnormal lab work to the Licensed Center Physician(s).
- Observes and approves staff training in medically related areas.
- Ensures donor reviews are executed in accordance with SOPs.
- Provides immediate care and assessment of all donor reactions.
Job Responsibilities or Job Requirements
Competencies
Experience Requirements
- Education Requirements: High school diploma or equivalent required.
- Experience Requirements: None.
- Certification(s): CPR certified or the ability to obtain certification.
- License(s): Current RN, LPN, or Advanced EMT license in the state the Donor Center operates.
Preferred Experience
Compliance Requirements (ES)
As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.
- Job Limitations:
The Physician Substitute may not:
- Prescribe immunization orders or evaluate the clinical response to donor immunizations.
- Authorize Donor Center staff to administer drugs from the emergency kit.
- Fulfill the Licensed Physician’s responsibilities for:
-Therapeutic Exchange Plasma
-RBC Immunization
-Plasmapheresis of HBsAg reactive Donors
-Plasmapheresis of HIV antibody positive Donors
-Disease State Donor Programs
- Review abnormal lab results.
- Re-instate Donors who have been deferred due to an abnormal Serum Protein Electrophoresis (SPE). Licensed Center Physician approval is required for the reinstatements of deferred donors. Physician Substitute may only review steps with Licensed Center Physician to re-establish suitability of a Donor.