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.
The Physician Substitute plays a critical role in ensuring donor safety and compliance with medical standards while overseeing various aspects of donor screening and care.
Essential Functions (ES) and Responsibilities
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.
Reviews all medical incidents and records the appropriate DAE in the applicable donor center system, and takes the appropriate actions to manage the incident when necessary.
Completes and manages all Medical Incident Reports and conducts follow-up with donor in accordance with SOPs.
Licensed Nursing staff administers employee Hepatitis B immunizations in accordance with protocol.
Licensed Nursing staff administers donor immunizations as applicable.
Communicates all compliance or risk areas to the Center Director and Quality Manager.
Provides confidential counseling to donors who are ineligible for donation.
Confirms donor identification.
Teaches the donor to use the self-administered questionnaire and assist as needed.
Performs donor arm checks.
Determines donor vital signs and weight and properly records results in applicable donor center system.
Determines donor suitability by reviewing donor responses to questionnaire and confirming the donor has provided the correct answers to donor suitability questions.
Defer donors based on knowledge of donor acceptance and deferral criteria.
Explains deferrals and associated time frames to donors.
Respects and maintains donor confidentiality regarding donor deferrals.
Performs donor total protein readings using a refractometer and records the results in applicable donor center system.
Performs donor hematocrit readings and records the results in applicable donor center system.
Operates and cleans as necessary screening equipment per operating manual.
Enters required information into the applicable donor center system.
Confirms all required donor suitability criteria and associated records are complete and accurate before determining donor acceptance.
Maintains knowledge with all donation programs.
Sets-up and readies the collection device correctly.
Collects and labels the required samples at the donor bedside.
Inspects soft goods prior to use to confirm there is no breakage, kinks in the line, contamination, or particles in the solutions.
Correctly maintains, handles, and cleans equipment in accordance with manufacturer’s recommendations.
Operates the automated collection device as determined in the user manual.
Monitors the donor for any sign of reaction before, during, and after plasmapheresis.
Disconnects the donor from the automated collection device and ensures the donor is in good physical condition prior to release.
Records information in the collection device as prompted. Records medical incidents as applicable. Records equipment incident information as prompted.
Restocks supplies as necessary.
Maintains an organized and clean work environment.
Reports all unsafe situations or conditions to supervisor.
Maintains a professional appearance and demeanor when interacting with peers and donors.
Attends staff meetings and staff training sessions.
Obtains assistance from the center physician for any matters outside of the defined areas of responsibility and authority.
Maintains competence with all position required tasks.
Ability to train others as required.
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).
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.
Physical Requirements (ES)
Available to work extended shifts and weekends.
Occupational Exposure to blood borne pathogens.
Ability to lift, pull, or tug up to 40lbs.
Ability to work within a cold environment, -30°C, for short periods of time.
Work requires extended periods of standing and bending.
Travel Requirements
Travel required on an as needed basis.
Job 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.
Required Skills
Strong organizational skills.
Strong communication skills, both verbal and written.
Ability to interpret medical information to formulate appropriate actions.
In addition to competitive compensation, we offer a comprehensive benefits package including :
ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov / E-Verify.
ADMA Biologics is an Equal Opportunity Employer
Lpn Rn • Myrtle Beach, SC, United States