Clinical Operations for Laboratory of Pathology

病理学实验室（LP）通过向临床中心和所有分类研究所提供解剖病理学和组织处理服务，支持NIH和NCI的临床和研究任务。LP通过CLIA认证，并获得认证证书，每两年由美国病理学家学会检查是否符合监管标准。LP的临床服务提供外科病理学、尸检病理学、血液病理学、细胞病理学、染色体病理学、儿科病理学、流式细胞术和分子/特殊诊断学方面的服务。临床操作是病理学实验室临床部分的行政和技术核心。它监督质量管理计划，核心实验室服务，临床和技术人员的人力资源管理，实验室信息系统（LIS），并管理实验室的临床诊断组织档案。作为对整个NIH研究者的一项服务，科学家可以在获得适当的伦理批准（来自IRB或OHSR）后，从档案中请求组织用于研究。在截至7月底的本财政年度，我们处理了大约250个新的和正在进行的组织样本请求。这导致从我们的组织档案中向研究人员提供了大约10，500份个体生物标本（未染色的载玻片、特殊染色剂、组织切片和经过RNA酶预防处理的组织载玻片）。临床操作科还处理了约125项医疗法律请求，其中涉及检索和处理约1，000份临床载玻片和/或组织块，这些载玻片和/或组织块应临床医生或患者的请求转发给其他医疗保健或研究机构。LP临床操作部分中的一个相对较新的功能是添加染色组织载玻片的全载玻片扫描。整个载玻片扫描允许无限期存储和电子访问患者病例材料，而不会出现载玻片丢失或染色强度随时间推移而恶化的风险。载玻片扫描中的新技术还提供了一个平台，该平台采用图像算法，可以准确和可重复地分析免疫组织化学染色。在2016财政年度，LP居民和工作人员扫描了大约2，800个染色的全组织载玻片：独特和有趣的病理学病例;提交给LP临床病理学家的病例，要求将载玻片返还给提交机构;与工作人员病理学家或临床顾问电子共享临床病例，而不是冒丢失载玻片的风险;以及为住院研究集、研究或在校内校外会议上展示而扫描的病例。截至2017年7月，临床运营人员已执行或支持超过4，200次切片扫描。自全载玻片扫描开始以来，共扫描了20，000多张载玻片。临床操作部分还包括监督实验室信息系统（LIS）以及每月向LP领导层和质量管理委员会收集和报告质量管理（QM）数据。LIS是临床中心使用的SoftLab系统的一部分，它与医院信息系统连接，以便在线获得解剖病理学结果。作为组织请求流程的一部分，为了支持患者和临床医生对病理报告的请求，我们对病理数据库进行搜索，并提供符合所需标准的病例列表。我们目前有从2008年至今的扫描报告，并实时维护报告档案。临床运营部门还使用LIS生成基准数据和质量保证统计数据，以管理和持续改进临床诊断服务。质量管理计划通过关键基准监控LP的绩效，例如：细胞学、手术和活检周转时间;标本充足性、标签和识别合规性;以及特殊染色的质量控制。向LP的临床领导层提供年度质量管理报告，以确定已证明改进的领域，但也显示需要持续改进和监测的领域。年度质量管理报告提供给NIH临床中心的患者安全和临床质量办公室，作为证明联合委员会认证所需的临床服务的持续质量保证和流程改进计划所需的一个要素。临床操作还监督病理学家监督的组织部门进行研究。根据IRB批准的方案，在NIH临床中心接受手术的患者通常将组织分为研究和诊断目的。技术实验室经理负责维护实验室，病理学家助理（PA）协助采集、解剖、记录标本清点以及将组织分发给研究人员和临床部门。TLM还担任LP的合同官技术代表，并协助临床经理进行LP临床和研究部门的财产管理、设备采购和维护活动。

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.