Quality Management System in Clinical Digital Pathology Operations at a Tertiary Cancer Center.

Digital pathology workflows can improve pathology operations by allowing reliable and fast retrieval of digital images, digitally reviewing pathology slides, enabling remote work and telepathology, use of computer aided tools, and sharing of digital images for research and educational purposes. The need for quality systems is a prerequisite for successful clinical grade digital pathology adoption and patient safety. In this work, we describe the development of a structured digital pathology laboratory quality management system (QMS) for the clinical digital pathology operations at Memorial Sloan Kettering Cancer Center (MSK). This digital pathology specific QMS development stemmed from the gaps that were identified when MSK integrated digital pathology into its clinical practice. The Digital Scan Team in conjunction with the Department of Pathology and Laboratory Medicine Quality Team developed a QMS tailored to the scanning operation to support departmental and institutional needs. As a first step, systemic mapping of the digital pathology operations identified the pre-scan, scan, and post-scan processes, instrumentation, and staffing involved in the digital pathology operation. Next, gaps identified in quality control and quality assurance measures led to the development of standard operating procedures and training material for the different roles and workflows in the process. All digital pathology related documents were subject to regulatory review and approval by Departmental leadership. The quality essentials were developed into an extensive Digital Pathology Quality Essentials (DPQE) framework to specifically address the needs of the growing clinical use of digital pathology technologies. Using the unique digital experience gained at MSK, we present our recommendations for QMS for large scale digital pathology operations in clinical settings.