Synapse - Quality management system in clinical digital pathology operations at a tertiary cancer center

Quality management system in clinical digital pathology operations at a tertiary cancer center Journal Article

Authors:	Ardon, O.; Labasin, M.; Friedlander, M.; Manzo, A.; Corsale, L.; Ntiamoah, P.; Wright, J.; Elenitoba-Johnson, K.; Reuter, V. E.; Hameed, M. R.; Hanna, M. G.
Article Title:	Quality management system in clinical digital pathology operations at a tertiary cancer center
Abstract:	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 article, we describe the development of a structured digital pathology laboratory quality management system (QMS) for 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 prescan, scan, and postscan 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 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 largescale digital pathology operations in clinical settings.(c) 2023 THE AUTHORS. Published by Elsevier Inc. on behalf of the United States & Canadian Academy of Pathology. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords:	management; quality; clinical implementation; digital pathology operations
Journal Title:	Laboratory Investigation
Volume:	103
Issue:	11
ISSN:	0023-6837
Publisher:	Nature Publishing Group
Date Published:	2023-11-01
Start Page:	100246
Language:	English
ACCESSION:	WOS:001082240400001
DOI:	10.1016/j.labinv.2023.100246
PROVIDER:	wos
PUBMED:	37659445
PMCID:	PMC10841911
Notes:	The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in PubMed and PDF. Corresponding MSK author is Orly Ardon -- Source: Wos