Clinical Operations for Laboratory of Pathology

Division Of Basic Sciences - Nci

Investigators

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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 services 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); 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 last onsite accreditation inspection in January 2020. During that onsite inspection, eight laboratory specialists evaluated more than 1,200 standards in all of LP's clinical services and cited only five minor deficiencies which were resolved during the inspection. 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. Clinical Operations also includes management of the Tissue Processing and Procurement Facility and maintenance services and capital procurements for all LP sections. The TLM oversees the operational and technical services for the procurement laboratory, while also serving 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 request tissues for research from the archive following appropriate ethical approval (from their IRB or from the OHSR). During the fiscal year, This resulted in approximately 19,325 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 1,150 medical-legal requests, which involved retrieving and processing approximately 3,200 clinical slides and/or blocks that were forwarded to other healthcare or research facilities at the request of clinicians or patients. With an increase in volumes for the Comprehensive Oncologic Molecular Pathology and Sequencing Service (COMPASS) program, specifically in our Molecular Diagnostics section, Clinical Operations has taken an active role in the coordination of the cases. Clinical Operations oversees the clinical and research case load from submission to ordering clinical Next-Generation Sequencing to hosting an integrated conference with the clinical team to producing a report that will support clinical decisions. We work very closely with the clinicians and research teams to provide support in ordering NGS testing and receiving the clinical reports. Within the last fiscal year, there have been over 2,500 cases for Molecular testing and 700 cases for Methylation Sequencing. 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. The LIS is 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.