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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 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.

REQUIREMENTS

• Must be a graduate of a recognized educational program and be currently licensed in the state they are employed.

• Physician Substitute – EMT: Must be EMT basic or above
• Physician Substitute – RN: Only RN’s or Licensed Physician Assistants may hold this position
• Physician Substitute – LVN/LPN: Licensed LVN or LPN

• Individuals must meet and maintain current licensing requirements in the state they are employed and company with federal, state, and local regulations.
• Must maintain current certification in CPR
• Must complete our training program for Physician’s Substitute/Physician Assistant under the supervision of the Center’s Medical Director, and additional programs when deemed necessary
• Proficient with computer entry
• Minimum requirement is additionally certified in Donor Screening. Phlebotomy and Plasma Processing certification may be required by management
• May be required to travel for training
• Must be proficient in English (Read, Write, Speak).
• Bilingual (English/Spanish) required

PHYSICAL DEMANDS

Performing the responsibilities of the job requires the ability to talk and hear. Regularly required to use hands and fingers, handle, or feel objects, tools or controls, and reach with the hands and arms. Frequently required to stand, for extended periods (2–3-hour intervals), walk, climb, or balance; and stoop, kneel, or crouch. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. Ability to lift tug and pull up to 50 pounds.

WORK ENVIRONMENT

This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment is required such as eyewear, lab coats, and gloves.