Quality Assurance

In addition to the rigorous Quality Management (QM) programs run by all of the DUHS Clinical Laboratories on the technical side, the Department of Pathology has an extensive QM Plan governing the professional practice of credentialed DUHS Department of Pathology physician-pathologists.

Credentialed Duke pathologists provide Anatomic Pathology Services (such as Surgical Pathology, Cytopathology, Autopsy Pathology) and Clinical Pathology Services (Molecular Diagnostics, Image Cytometry, Transfusion Medicine consultations, and serum electrophoresis interpretations). The professional practice of providing these services, including generating and maintaining the quality of these result reports in the patient’s medical record, is tightly monitored. Quality management of these activities is the purview of the Division Directors with assistance from the Quality Assurance Representative for the Department of Pathology. Ultimately, all of this activity is under the leadership of the Chairman of the Department of Pathology.

Duke University Health System (DUHS) Clinical Laboratories also contracts with the Duke Department of Pathology to provide separate medical directorship services to the many anatomic and clinical pathology laboratories in the DUHS. These medical directors perform essential laboratory leadership and management roles as required for continuous College of American Pathologists’ Accreditation. This includes implementation of specific laboratory quality management plans, oversight of proficiency testing, oversight of employee competency assessment and evaluations, and any other duties listed on their Laboratory Director Letter of Delegation. Delegation and oversight for these responsibilities is provided by the Medical Director of DUHS Clinical Laboratories. If a credentialed Duke Pathologist serves in one of these contracted roles, their professional practice includes providing these services to DUHS Clinical Laboratories.

Oversight of the professional practice of Pathology is part of the ongoing quality improvement, peer review, and re-credentialing process that takes place within DUHS and the Duke Department of Pathology. Execution of our plan assures continuous improvement in patient services, alignment with the Health System’s and DUHS Clinical Laboratories’ mission and vision, and departmental compliance with accreditation and regulatory requirements defined by governmental and professional agencies e.g. College of American Pathologists (CAP), The Joint Commission (TJC), and Center for Medicare and Medicaid Services (CMS).

John Madden MD PHD
John Madden, MD PhD

John Madden, MD PhD

Quality Assurance Officer

DUMC 3712

Durham, NC 27710

Office Phone: 919-681-6671