Clinical Operations for Laboratory of Pathology

Division Of Basic Sciences - Nci

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Abstract

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 sections provide services in surgical pathology, autopsy pathology, hematopathology, cytopathology, chromosome pathology, pediatric pathology, flow cytometry and a dynamic and growing genomic pathology service. 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); whole slide imaging; and maintains the clinical diagnostic tissue archives of the laboratory. ACCREDITATION AND REGULATORY COMPLIANCE: LP is CLIA-certified and maintains a Certificate of Accreditation. LP is inspected every two years for compliance with regulatory standards by the College of American Pathologists, with our last onsite accreditation inspection in March 2022. During that onsite inspection, seven laboratory specialists evaluated more than 1,200 standards in all of LP's clinical services with minimal recommendations. Continued accreditation is required for CLIA compliance, but also demonstrates that the department's quality in patient care is of the highest standards. TISSUE PROCUREMENT, HISTOLOGY and SURGICAL PATHOLOGY Support: 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. TISSUE RESOURCE REQUESTS: Clinical Operations staff manage the Tissue Processing and Procurement Facility and have oversight of the Tissue Resource Requests. As a service to investigators throughout the NIH, Clinical Operations staff process requests from scientists for tissues to be used for research from the clinical archives while ensuring appropriate ethical approval (from their IRB or from the OHSR). During the fiscal year, approximately 16,988 individual biospecimens (unstained slides, special stains, tissue shavings, whole mount slides, and tissue slides processed with RNAse precautions) were provided to researchers from 2,323 blocks our tissue archive. The TRC program facilitated the sendout of $44,766 tissue processing requests to support non-LP investigators' TRC requests. The Clinical Operations section also processed approximately 850 medical-legal requests, which involved retrieving and processing approximately clinical slides and/or blocks that were forwarded to other healthcare or research facilities at the request of clinicians or patients. LABORATORY INFORMATION SYSTEM (LIS): 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. The LIS is used by Clinical Operations to generate benchmark data and quality assurance statistics for managing and continuously improving the clinical diagnostic services. QUALITY MANAGEMENT: The LP 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. In support of the training program, the QM program ensures active participating by clinical fellows and residents. Fellows and residents participate with the preparation of monthly QM reports with providing investigative findings to quality outliers; participate in monthly QM meetings and are engaged in discussions about the quality indicators; and participate with six performance improvement projects aimed at addressing administrative, processing, technical and reporting outliers. WHOLE SLIDE IMAGING: The Clinical Operations staff performed whole slide imaging for more than 1,500 clinical cases with 15,112 H&E, IHC, and special stained slides scanned. The whole slide imaging program provides telepathology capability for LP's pathologists, and collaborative projects with NCI investigators working with whole slide imaging and analyses. In addition, a new file-sharing research image repository, Halo-link, has been implemented and actively used to manage whole slide images across all NIH Institutes from cases scanned in by the Clinical Operations service.