Clinical Operations for Laboratory of Pathology

病理实验室临床操作

• 批准号: 9556867
• 负责人: Frederic Barr
• 金额: $ 66.83万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9556867
• 关键词: Accountability; Accreditation; Algorithms; American; Anatomy; Archives; Area; Autopsy; Benchmarking; Biopsy; CLIA certified; Categories; Certification; Childhood; Chromosomes; Clinical; Clinical Laboratory Information Systems; Clinical Management; Clinical Pathology; Clinical Research; Clinical Services; Collection; Contracts; Cytology; Cytopathology; Data Quality; Databases; Deterioration; Diagnostic; Diagnostic Services; Dissection; Documentation; Drug or chemical Tissue Distribution; Elements; Ethics; Flow Cytometry; Glass; Goals; Health care facility; Hematopathology; Hospital Information Systems; Human Resources; Image; Individual; Institutes; Joints; Label; Laboratories; Leadership; Legal; Maintenance; Medical; Mission; Molecular; Monitor; Operative Surgical Procedures; Pathologist; Pathology; Pathology Report; Patients; Performance; Process; Property; Protocols documentation; Quality Control; Reporting; Research; Research Personnel; Research Support; Ribonucleases; Risk; Scanning; Scientist; Services; Slide; Specimen; Staining method; Stains; Supervision; Surgical Pathology; System; Time; Tissue Sample; Tissue Stains; Tissues; United States National Institutes of Health; clinical diagnostics; college; data management; equipment acquisition; improved; new technology; operation; patient safety; programs; quality assurance; research facility; statistics; symposium; tissue processing

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.

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是clia认证的认证证书，每两年由美国病理学家学院检查是否符合监管标准。LP的临床服务提供手术病理学、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。临床操作是病理实验室临床部分的行政和技术核心。它监督质量管理程序，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）和管理实验室的临床诊断组织档案。作为对整个NIH调查人员的服务，科学家可以在适当的伦理批准后（从他们的IRB或OHSR）从档案中请求用于研究的组织。在截至7月底的本财政年度，我们处理了大约250份新的和正在进行的组织样本申请。这产生了大约10,500个个体生物标本（未染色的载玻片，特殊染色，组织切片和用RNAse预防措施处理的组织载玻片）从我们的组织档案中提供给研究人员。临床业务科还处理了约125项医疗法律请求，其中涉及检索和处理应临床医生或患者的要求转交给其他保健或研究设施的约1 000张临床载玻片和/或切片。在LP的临床操作部门中，一个相对较新的功能是增加了对染色组织切片的整片扫描。整个玻片扫描允许无限期存储和患者病例材料的电子访问，没有玻片丢失或染色强度随时间恶化的风险。幻灯片扫描的新技术也提供了一个使用图像算法的平台，可以准确和可重复地分析免疫组织化学染色。在2016财年，LP住院医生和工作人员扫描了大约2800张染色的组织切片：独特而有趣的病理病例；提交给LP临床病理学家的病例需要将载玻片送回提交机构；以电子方式与工作人员病理学家或临床顾问分享临床病例，而不是冒着丢失玻片的风险；并扫描病例，以进行常驻学习、研究或在校园内外的会议上展示。截至2017年7月，临床操作人员进行或支持的切片扫描已超过4200次。自全片扫描开始以来，共扫描了2万多张幻灯片。临床操作组还包括监督实验室信息系统（LIS），收集质量管理（QM）数据并每月向LP领导层和质量管理委员会报告。LIS是临床中心使用的SoftLab系统的一部分，它与医院信息系统接口，以便在线提供解剖病理结果。作为组织请求过程的一部分，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，并提供符合要求标准的病例列表。我们目前有从2008年到现在的报告扫描，并实时维护报告存档。临床手术部亦会使用资讯系统编制基准数据和质素保证统计数字，以管理和持续改善临床诊断服务。质量管理程序通过关键基准来监控LP的表现，例如：细胞学、手术和活检的周转时间；标本充足性、标签和鉴定符合性；并对特殊污渍进行质量控制。年度质量管理报告提供给LP的临床领导，以确定已经证明改进的领域，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美国国立卫生研究院临床中心患者安全和临床质量办公室，作为联合委员会认证所需的临床服务持续质量保证和过程改进计划的一个要素。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批准的协议，在NIH临床中心接受手术的患者经常将组织分为研究和诊断目的。技术实验室经理维护实验室，病理学助理（PAs）协助采购，解剖，记录标本责任，并将组织分发给研究人员和临床部门。TLM还担任LP的合同官员技术代表，并协助临床经理进行LP的临床和研究部门的物业管理、设备采购和维护活动。