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 NIH institutes. 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. The Clinical Operations section: oversees the regulatory compliance and accreditation of all clinical sections; manages the Quality Management program; provides core laboratory services in tissue procurement, processing, and gross analysis of clinical specimens; manages the clinical administrative functions; supports human resource management for clinical and technical staff; supports operations of the Laboratory Information System (LIS); and maintains the clinical diagnostic tissue archives of the laboratory. LP is CLIA-certified and maintains a Certificate of Accreditation. LP's regulatory compliance and accreditation are managed by the Clinical Operations section. LP is inspected every two years for compliance with regulatory standards by the College of American Pathologists, with our most recent onsite accreditation inspection in January 2018. During this inspection, six laboratory specialists evaluated more than 1,500 standards in all of LP's clinical services and cited only one minor deficiency. Continued accreditation is required for CLIA compliance, but also demonstrates that the department's quality in patient care is of the highest standards. Clinical Operations' pathologists assistants perform tissue division for clinical and research tissue sections, and perform gross analysis, dissection and processing of clinical biopsy and resected tissues from NIH patients for anatomic pathology diagnosis. Patients who undergo surgery at the NIH Clinical Center frequently have tissue divided between research and diagnostic purposes, as dictated by IRB-approved protocols. For clinical cases, the diagnostic material is processed and special stains are performed by the Histopathology section and distributed to LP's pathologists for diagnostic interpretation. After pathology diagnoses are rendered, Clinical Operations staff provide pathology reports to requesting clinicians internal and external to the NIH. Tissues that are collected for research purposes are processed in the Tissue Procurement Facility where Clinical Operations staff document, collect, process, preserve and transfer the biomaterial to research investigators. The Technical Laboratory Manager (TLM) maintains the procurement lab, and Pathologists Assistants (PAs) assist in procurement, 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 and Scientific Manager in property management, equipment procurement, and maintenance activities for the clinical and research sections of LP. 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 375 new and ongoing requests for tissue samples. This resulted in approximately 16,500 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 833 medical-legal requests, which involved retrieving and processing approximately 2,850 clinical slides and/or blocks that were forwarded to other healthcare or research facilities at the request of clinicians or patients.LP's Clinical Operations section also performs whole slide scanning of tissue slides, which 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 provide a platform that employs image algorithms that can accurately and reproducibly analyze immunohistochemical stains. LP residents and staff scanned approximately 3,150 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. 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, molecular, surgical and biopsy turnaround times; specimen adequacy, labeling and identification compliance; and quality control performance of special stains. Annual QM reports are provided to LP's leadership to identify areas that have demonstrated improvements, but also show 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.
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