Clinical Operations for Laboratory of Pathology

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The Laboratory of Pathology (LP) supports the clinical and research missions of the NIH and the NCI by providing anatomic pathology and tissue processing services to the Clinical Center and to all of the categorical institutes. LP is CLIA-certified with a Certificate of Accreditation and is inspected every two years for compliance with regulatory standards by the College of American Pathologists. LP's clinical services provide services in surgical pathology, autopsy pathology, hematopathology, cytopathology, chromosome pathology, pediatric pathology, flow cytometry and molecular/special diagnostics. Clinical Operations is the administrative and technical core of the clinical component of the Laboratory of Pathology. It oversees the Quality Management program, the core laboratory services, human resource management for clinical and technical staff, the Laboratory Information System (LIS) and manages the clinical diagnostic tissue archives of the laboratory. As a service to investigators throughout the NIH, scientists may request tissues for research from the archive following appropriate ethical approval (from their IRB or from the OHSR). In this fiscal year through the end of July, we processed about 250 new and ongoing requests for tissue samples. This resulted in approximately 10,500 individual biospecimens (unstained slides, special stains, tissue shavings, and tissue slides processed with RNAse precautions) provided to researchers from our tissue archive. The Clinical Operations section also processed approximately 125 medical-legal requests, which involved retrieving and processing approximately 1,000 clinical slides and/or blocks that were forwarded to other healthcare or research facilities at the request of clinicians or patients. A relatively new function within LP's Clinical Operations section has been the addition of whole slide scanning of stained tissue slides. Whole slide scanning allows the indefinite storage and electronic access of patient case material, without the risk of slide loss or deterioration of stain intensity over time. Newer technologies in slide scanning also provides a platform that employs image algorithms that can accurately and reproducibly analyze immunohistochemical stains. In fiscal year 2016, LP residents and staff scanned approximately 2,800 stained whole tissue slides of: unique and interesting pathology cases; cases submitted to LP clinical pathologists which required the slides be returned to the submitting facility; clinical cases shared with staff pathologists or clinical consultants electronically rather than risking the loss of glass slides; and cases scanned for resident study sets, research or to present at conferences on and off campus. As of July, 2017, there have been more than 4,200 while slide scans performed or supported by Clinical Operations staff. In total since inception of whole slide scanning, over 20,000 slides have been scanned. The Clinical Operations section also includes oversight of the Laboratory Information System (LIS) and collection and reporting of quality management (QM) data to LP's leadership and QM Committee monthly. The LIS is part of the SoftLab system used by the Clinical Center and it interfaces with the hospital information system so that anatomic pathology results are available online. As part of the tissue request process and to support requests for pathology reports from patients and clinicians, we conduct searches of the pathology database and provide lists of cases that match the requested criteria. We currently have reports scanned from 2008 to the present and are maintaining the report archive in real-time. The LIS is also used by Clinical Operations to generate benchmark data and quality assurance statistics for managing and continuously improving the clinical diagnostic services. The quality management program monitors LP's performance with key benchmarks, such as: cytology, surgical and biopsy turnaround times; specimen adequacy, labeling and identification compliance; and quality control of special stains. Annual QM reports are provided to LP's clinical leadership to identify areas that have demonstrated improvements, but also shows areas that need continuous improvement and monitoring. Annual QM reports are provided to the NIH Clinical Center's Office of Patient Safety and Clinical Quality as one element needed to demonstrate an ongoing quality assurance and process improvement program for clinical services that is required for Joint Commission accreditation. Clinical operations also oversees pathologist-supervised tissue division for research. Patients who undergo surgery at the NIH Clinical Center frequently have tissue divided between research and diagnostic purposes, as dictated by IRB-approved protocols.The Technical Laboratory Manager maintains the lab, and Pathologists Assistants (PAs) assist in procurements, dissection, documentation of specimen accountability, and distribution of tissues to researchers and clinical sections. The TLM also serves as contract officer technical representative for LP and assists the Clinical Manager in property management, equipment procurement, and maintenance activities for the clinical and research sections of LP.