Director Responsibilities and Qualifications

PURPOSE

To describe responsibilities of the director of the Neuropathology Biorepository.

QUALIFICATIONS

The laboratory director must meet the qualifications defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). The director should hold an earned doctoral degree in biological science from an accredited institution and be/eligible to be certified in Clinical Cytogenetics by the American Board of Medical Genetics. The laboratory director must be experienced in day-to-day supervision of a laboratory to provide state-of-the-art clinical service. (Reference: Fed Register. 1992(Feb28):7177-7180[42CFR493.1449], additional requirement for clinical cytogenetics)

GENERAL RESPONSIBILITIES

Ensure that adequate testing procedures are used for all tests performed in the Biorepository to provide accurate results and quality patient care.
Ensure that the physical condition and the working environment of the laboratory are safe and appropriate for employees to perform their duties.
Ensure that the laboratory is enrolled in an approved proficiency testing program (ISBER proficiency testing in Biorepository) and that corrective actions are taken when any proficiency testing results are unacceptable.
Ensure that policies and procedures are established to monitor all tests and testing of personnel. Responsible of establishing and monitoring on a routine basis the Quality Control(QC), Quality Assurance (QA) and Performance Improvement (PI) programs. Responsible for the supervision of changes in laboratory procedures, technical verification and maintenance of equipment functions, and training of personnel in cases of failure to comply with standards.
Ensure that the laboratory personnel have the appropriate education, experience and training to perform testing. Responsible for the annual job performance evaluation and appraisals of all personnel in accordance with the policies of Thomas Jefferson University Hospital.
Prepare annual reports summarizing the clinical activities of the laboratory.
Develop the business plan in conjunction with the Chairman of the Department of Pathology, Anatomy and Cell Biology and the Lab Administrator.
Develop, evaluate, and implement new technologies and supervise the purchase of equipment to maintain the standard of care and provide state-of-the-art service.
Carry out scholarly activities, including publications in peer-reviewed journals, research and teaching.
Recommend, as appropriate, an evaluation by a clinical geneticist and genetic counseling by a genetic counselor in cases of an abnormal cytogenetic result.

Revisions

POL ID	Date Revised	Author	Summary of Changes
POL 06.001	08/05/2016	Patel, Miraj	Policy finalized.

Version & Approval

POL ID	Category	Approval	Date
06.001	Administration	Stephen Peiper, MD	08/05/2016