On-Site HCLD Director - Reproductive Medicine Clinic

General Description: The Director will provide leadership and oversight to the day to day operation of the Embryology, Andrology and Endocrine Reproductive laboratories. The Director will be responsible for the implementation of an in-depth Quality Management Plan spanning all of the Reproductive Laboratories. The Director will also insure compliance with all applicable regulations and institutional standards (CLIA. CAP/SART and FDA) pertaining to the Reproductive Laboratories.

Essential Responsibilities:

Responsibilities listed in this section are core to the position. Inability to perform these responsibilities with or without an accommodation may result in disqualification from the position.

• Responsible for formulating laboratory policies, SOP's .and protocols necessary for the daily operation of the Laboratories. The Laboratory Director shall be responsible for overall operation, administration, technical and scientific oversight of the laboratories which includes the employment of personnel who are qualified to perform assisted reproductive technology (ART) laboratory procedures. In conjunction with Sr. Embryologists, provide training and guidance to these individuals. , Document procedural outcomes promptly, accurately and proficiently. The Laboratory Director shall be the individual whose name appears on all licensing and accreditation certificates.
• The Laboratory Director will serve as the Chief Clinical Embryologist and is expected to be expert in all of the techniques practiced in the ART laboratory to include ICSI, Blastocyst TE biopsy, and Assisted Hatching using a laser. The Director shall be experienced in the vitrification and warming of oocytes and blastocysts. This position is for a working Laboratory Director, therefore the Director is expected to participate in laboratory activities inclusive of weekend and holiday rotation.
• The Laboratory Director will insure that performance metrics are documented and reviewed on a regular basis for all the laboratories, which will be a major part of the Quality Management Plan (QC,QA and QI).
• It is incumbent upon the Laboratory Director to insure that all lab personnel are appropriately trained in ART laboratory and Andrology procedures. The Director will insure that all personnel have the required number of annual continuing education hours for any required certifications. Competency evaluations will be conducted on all laboratory personnel annually by the Laboratory Director.
• The Director will oversee and insure that the laboratory is enrolled in a proficiency testing (PT) system that covers all testing being performed by the laboratories. The Director will review the results of all proficiency testing and insure that all proficiency testing is properly performed. Corrective actions will be taken and documented when applicable.
• The Laboratory Director will be responsible for the selection of all equipment, testing methodology, and culture reagents and will ensure that testing and treatment methods chosen are scientifically valid-
• The Laboratory Director will develop effective working relationships with the medical and clinical staff and physicians and will provide consultation to physicians and patients as required regarding laboratory aspects of treatment.
• It is imperative that patient confidentiality is maintained throughout the laboratory process and that HIPPA rules are followed. The Laboratory Director shall develop a reliable record management systems for the ART and Andrology laboratories. As part of the QM system the Director will insure accurate and timely documentation of laboratory results and communication of laboratory data
  
• The Laboratory Director shall have the primary responsibility for all laboratory inspections including CLIA, CAP/SART and the FDA. It is required that the Laboratory Director to be on-site during the inspections. The Director will be responsible for addressing and documenting any corrective actions required by the regulatory agencies such that the actions taken are acceptable.
• The Director insures that all laboratories conform to the requirements the American Board of Bioanalysis (requirements and certification for High-complexity Clinical Lab Director (HCLD) and the requirements of the American Society for Reproductive Medicine. requirements. The Director will also comply with Clinical Laboratory Improvement Amendment of 1988,(CLIA), College of American Pathologists Reproductive Laboratory Accreditation Program (CAP) and SART Guidelines .
  

General Responsibilities:

• Performs other duties as assigned

Minimum Qualifications:

Education: The laboratory director shall hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution with training in Reproductive Biology.

Experience: Candidate must have at least three years of documented pertinent experience directing a program performing IVF-and Andrology related procedures. People management experience preferred.

License(s)/Certification(s)/Registration(s) Required: The incumbent shall meet the qualifications for a high complexity laboratory director (HCLD) under the CLIA '88 regulations, 42 CFR 493.1443(b)(3)(i).

Knowledge, Skills and Abilities: