Clinical Pathology

Clinical Pathology

The Division of Clinical Pathology and the DUHS Clinical Laboratories

The Clinical Pathology Division of the Department of Pathology is an integrated and integral part of the department that consists of 11 full time PhD laboratory directors with either primary or joint appointments in our department, 14 part time medical directors who are part of the academic or community pathology practice, and 3 fellows.  This group supports the three part mission of the school of medicine and health system as follows below.

DUHS Clinical Laboratories

DUHS Lab Manual

Clinical Mission

The Department of Pathology has operational and medical oversight and sets direction for our DUHS Clinical Laboratories.  In this role, we (1) oversee clinical testing and reporting to ensure the highest quality clinical services, (2) develop quality management systems and proficiency testing programs, (3) provide consultation with ordering physicians, (4) ensure educational programs for our staff, and (5) develop strategic plans that are in line with the needs of our patient population, physicians and health system leadership. Our laboratories consist of approximately 40 individual work centers including labs at DUH, DRH, and DRAH. Laboratories services include but are not limited to; clinical chemistry, hematology, urinalysis, coagulation, microbiology, molecular pathology, cytogenetics, biochemical genetics, point of care testing and transfusion services.  These laboratories employ state of the art technologies to provide the best clinical care for our Duke patients (eg. NGS in the Molecular Diagnostics laboratory for acquired and inherited mutation detection, MALDI-TOF mass spectrometry in the microbiology laboratory for rapid micro-organism identification and a variety of mass spectrometry approaches for metabolite identification in the Biochemical Genetics Laboratory) All practices of Clinical Pathology are represented within our laboratories and nearly all clinical laboratories within our health system are under this oversight umbrella.  The laboratories are staff by approximately 720 employees and have an annual testing volume of approximately 7-8 million reportables / year.

Educational Mission

The Clinical Pathology division within our department is home to the CP component of our resident education program. Residents have the opportunity to rotate through all of laboratories.  They spend at least two months in molecular diagnostics/molecular pathology and one month in cytogenetics to ensure that they have a strong working knowledge of the largest growth area in Clinical Pathology.  Residents also participate in a yearlong apprenticeship program in which they are paired with a laboratory director so that they can see and be part of large projects from start to finish (new test validation, new instrument implementation, etc).  We currently have 3 fellows in the Molecular Diagnostics and Cytogenetics Laboratories and 1 fellow position in the Clinical Microbiology Laboratory.  The molecular/cytogenetics fellows are part of the ABMG fellowship program which is joint effort between the Department of Pathology and the Medical Genetics Division within the Department of Pediatrics.  The microbiology fellowship is an ACGME accredited program through the department of Pathology. These fellows are training to be laboratory directors.  They also are central to our research and new test development within our labs.

Research Mission

The CP division of the our department supports research in three ways; (1) by offering our routine clinical services and activities to Duke investigators in support of clinical trials or basic research, (2) through the translations and validation of clinical tests that stem from the efforts of our Duke investigators, (3) through the individual research interests and activities of our directors.  At any one time, there are many trials that use the routine testing services of our laboratories.  Efforts range for simple research blood draws supported by phlebotomy to the validation of instruments or devices through partnerships with industry to the development and validation of molecular assays to support clinical research studies.  In addition, the clinical laboratories serves serve as the end point translational portal for discoveries made within the health system including the translation of a variety of discoveries into diagnostic tests now used in the care of our patients.