Description
General Summary of Position
The Histocompatibility Lab Assistant Director plays an active role in pre- and post-transplant anti-HLA antibody testing, HLA typing, flow cytometric crossmatching, chimerism review, and transplant-related clinical consultation, including on-call virtual assessments. The incumbent is involved in short- and long-term laboratory planning and direction, quality assurance and quality improvement activities, and resident teaching.
The Assistant Director works in the Histocompatibility Laboratory, which supports kidney, pancreas, heart, lung, liver, small bowel, and bone marrow transplant programs. Combined, these programs perform more than 600 transplants annually.
Primary Duties and Responsibilities
Establishes department goals and objectives and adheres to departmental policies, procedures, quality standards, and safety standards. Complies with governmental and accreditation regulations.
Maintains the Histocompatibility Laboratory Quality Plan and recommends improvements.
Ensures all laboratory sections follow standard operating procedures (SOPs) and meet federal, state, and licensure requirements.
Reviews SOPs and training documents related to quality assurance processes and systems to ensure regulatory compliance.
Develops, performs, and reviews personnel training and initiates retraining programs. Evaluates all competency assessments as part of the formal competency evaluation process. Maintains sufficient technical competency to ensure effective training and competency evaluation.
Ensures validation plans are established and executed in accordance with internal SOPs and external regulations.
Oversees monthly audits in all sections to ensure compliance with regulatory requirements. Supervises comprehensive annual internal audits of the entire quality system in preparation for inspections.
Participates in quality improvement and corrective action teams within and across operational areas.
Assists with hosting and coordinating CAP, ASHI, OSHA, CLIA, and other inspections, as necessary. Ensures licensure is accurate and up to date.
Participates in multidisciplinary clinical meetings.
Oversees and establishes technical protocols for clinical testing, including HLA molecular testing (by RSSO and/or NGS), crossmatching (by flow cytometry), HLA antibody testing (by flow cytometry and/or Luminex), and post-transplant chimerism testing.
Performs immunologic assessments to evaluate donor and recipient compatibility.
Communicates with clinical providers regarding test interpretation and evolving program needs.
Assists in the training of clinical pathology residents, nephrology fellows, and medical students.
Requirements
Minimum Qualifications
Education
Doctoral degree in immunology, genetics, or a related biological science required.
Experience
1–2 years of full-time postdoctoral laboratory training; or
1–2 years of experience in histocompatibility or immunogenetics; or
Residency in clinical and/or anatomic pathology or another related medical specialty; or
Supervisory experience with high-complexity testing in human histocompatibility and immunogenetics in an accredited laboratory.
Licenses and Certifications
American College of Histocompatibility and Immunogenetics (ACHI) certification as a Fellow (F(ACHI)) or Associate (A(ACHI)) within one year is required.
Knowledge, Skills, and Abilities
Excellent verbal and written communication skills.
