Blank Gary E, Virji Mohamed A
Department of Pathology, University of Pittsburgh Medical Center and the School of Medicine, Pittsburgh, PA, USA.
J Pathol Inform. 2011 Jan 26;2:14. doi: 10.4103/2153-3539.77176.
Clinical pathology laboratories increasingly use complex instruments that incorporate chromatographic separation, e.g. liquid chromatography, with mass detection for rapid identification and quantification of biochemicals, biomolecules, or pharmaceuticals. Electronic data management for these instruments through interfaces with laboratory information systems (LIS) is not generally available from the instrument manufacturers or LIS vendors. Unavailability of a data management interface is a limiting factor in the use of these instruments in clinical laboratories where there is a demand for high-throughput assays with turn-around times that meet patient care needs.
Professional society guidelines for design and transfer of data between instruments and LIS were used in the development and implementation of the interface. File transfer protocols and support utilities were written to facilitate transfer of information between the instruments and the LIS. An interface was created for liquid chromatography-tandem mass spectroscopy and inductively coupled plasma-mass spectroscopy instruments to manage data in the Sunquest(®) LIS.
Interface validation, implementation and data transfer fidelity as well as training of technologists for use of the interface was performed by the LIS group. The technologists were familiarized with the data verification process as a part of the data management protocol. The total time for the technologists for patient/control sample data entry, assay results data transfer, and results verification was reduced from approximately 20 s per sample to <1 s per sample. Sample identification, results data entry errors, and omissions were eliminated. There was electronic record of the technologist performing the assay runs and data management.
Development of a data management interface for complex, chromatography instruments in clinical laboratories has resulted in rapid, accurate, verifiable information transfers between instruments and LIS. This has eliminated manual data entry that is prone to errors and enabled technologists to focus on analytical applications on the instruments.
临床病理实验室越来越多地使用结合了色谱分离技术（如液相色谱）与质谱检测功能的复杂仪器，用于快速鉴定和定量生化物质、生物分子或药物。仪器制造商或实验室信息系统（LIS）供应商通常无法通过与LIS的接口对这些仪器进行电子数据管理。在临床实验室中，由于需要进行高通量检测并满足患者护理需求的周转时间，数据管理接口的缺失成为使用这些仪器的一个限制因素。
在接口的开发和实施过程中，采用了专业协会关于仪器与LIS之间数据设计和传输的指南。编写了文件传输协议和支持实用程序，以促进仪器与LIS之间的信息传输。为液相色谱 - 串联质谱仪和电感耦合等离子体质谱仪创建了一个接口，用于在Sunquest（®）LIS中管理数据。
LIS团队进行了接口验证、实施和数据传输保真度测试，以及技术人员使用该接口的培训。技术人员熟悉了作为数据管理协议一部分的数据验证过程。技术人员输入患者/对照样本数据、传输检测结果数据和验证结果的总时间从每个样本约20秒减少到每个样本<1秒。消除了样本识别、结果数据输入错误和遗漏。有技术人员进行检测运行和数据管理的电子记录。
临床实验室为复杂的色谱仪器开发数据管理接口，实现了仪器与LIS之间快速、准确、可验证的信息传输。这消除了容易出错的手动数据输入，使技术人员能够专注于仪器上的分析应用。
