Job Description:

This position reviews and approves all policies and procedures related to donor suitability, donor collection, and donor safety. Assists the Medical Director as assigned with the oversight of the medical staff regarding determination of donor suitability, donor collection and the review of donor test results. Provides guidance on a day-to-day basis regarding donor safety issues. The Alternate Medical Director may act as the center’s CLIA Technical Consultant. The Alternate Medical Director must be on-site as needed based on the needs of the center.

The Alternate Medical Director follows all FDA, CLIA and OSHA policies and procedures and maintains confidentiality of all personnel, donor, and company information. They assist with the administrative duties to support the Donor Center and maintain compliance with procedures and regulations while following current Good Manufacturing Practices.

Job Functions:

The functions of this position include but are not limited to:

• Performs new, return applicant and annual donor physicals for all donation programs including donor immunization programs and disease state programs.
• Administers informed consents for all donation programs including donor immunization programs and disease state programs.
• Orders immunizations and evaluates the clinical response to immunizations for donors on immunization programs.
• Orders immunizations and evaluates clinical response to employees Hepatitis B Immunizations.
• Administers the HIV Bulletin and assesses donor understanding of high-risk behaviors.
• Maintains medical records in accordance with SOPs and cGMP.
• Trains physician substitutes in accordance with physician substitute training program.
• Assesses the performance of new physician substitutes and gives final approval for the new physician substitutes to work independently.
• Assists with assessing the competence of physician substitutes on an annual basis.
• Completes donor reviews in accordance with the timelines established in the SOPs and reviews and enters the 14 Day SPE results into the applicable donor center system in accordance with SOPs.
• Reviews all Level 2 and 3 Medical Incident Reports and abnormal test results and takes appropriate follow-up actions.
• Communicates any compliance or risk areas to the Center Director and Quality Assurance
• Participates in monthly QA meetings.
• Provides confidential counseling to ineligible donors when necessary.
• Reports all unsafe situations or conditions to Center Director.
• All other duties as assigned by management.

CLIA Technical Consultant Responsibilities:

• • Establish and maintain QA/QC programs, including taking remedial action when performance deviates from established standards.
  • Enroll the laboratory in a CMS (Centers for Medicare & Medicaid Services) approved proficiency testing (PT) program, ensure PT is performed per CLIA requirements, submit results on time, and ensure staff review PT reports and implement corrective actions when needed.
  • Ensure personnel are properly trained and competent before performing patient testing; maintain ongoing competency assessment; and identify, provide and document remedial training as necessary.

Job Requirements, Qualifications, and/or Experience Requirements:

• Current MD or DO license in the state the Donor Center operates.
• For CLIA Technical Consultant: MD certified in Pathology or Hematology or have at least one year of experience directing or supervising non-waived laboratory testing, or completion of an approved training course with at least 20 continuing medical education (CME) credit hours in laboratory practice.
• CPR BLS Certification
• Annual GMP training.
• Strong organizational skills.
• Strict adherence to current good manufacturing procedures.
• Strong communication skills, both verbal and written.
• Ability to interpret medical information to formulate appropriate actions.
• Occupational Exposure to blood borne pathogens.
• Work requires extended periods of standing and bending.
• Ability to train others is required.