Laboratory information system

The clerk enters patient and specimen information in the Laboratory Information System. 

The clerk enters the site of brushing, number of slides submitted, and the patient s information in the laboratory information system. 

Specific guidelines for laboratory information systems include regulahons for computer conhgurahon, procedure manuals, system security, data entry/reports/ retrieval, hardware and software, and system maintenance. 

Facility Audit The facility audit includes all aspects of the facility that are listed in the GLP regulations. These include the personnel (Subpart B) as well as the laboratory itself (Subpart C), the equipment used in the laboratory (Subpart D), the test substances, reagents, and samples used (Subpart F), and the laboratory information systems. 

In addition to developing reference methods and establishing the LSP, CDC has sponsored two conferences focusing on standardization and traceability. The first was the Conference on a National Understanding for the Development of Reference Methods and Materials, in 1977 [12], This conference led to the formation of the Council of the National Reference System for Clinical Chemistry, which subsequently became the Reference System for the Clinical Laboratory, within the NCCLS (formerly the National Committee of Clinical Laboratory Standards). The second, in 1983, was the Second International Conference on Biomedical Laboratory Standardization. This conference led to the formation of the International Medical Laboratory Information System... 

Computerized Information System. The Project SEARCH Criminalistics Laboratory Information System (CLIS) Committee is another LEAA funded project. Approximately fifteen criminalists are serving on the CLIS Committee which is conducting a requirements analysis for a nationwide computerized crime laboratory information system. With the assistance of a technical subcontractor, PRC Public Management Services, Inc., the committee has determined the "user needs" for such a data system, a conceptual design of a computer system to meet these requirements, and an assessment of different organizational and equipment alternatives for the system. The most recent task reports and implementation plan have been completed and submitted to the advisory committee for final review. Copies of the final reports should be ready for dissemination in the very near future. 

Integral to the automation of the clinical laboratory was the development of the laboratory information system (LIS) that first appeared in laboratories in the latter part of the... 

In many laboratory information systems, electronic entry either in the laboratory or at a nursing station of a test order for a uniquely identified patient generates a specimen label bearing a unique laboratory accession number. A record is established that remains incomplete until a result (or set of results) is entered into the computer against the accession number. The unique label is affixed to the specimen collection container when the blood is drawn. Proper alignment of the label on the collection container is critical for subsequent specimen processing when using bar coded labels. Arrival of the specimen in the laboratory is recorded by a manual or computerized log-in procedure. In other systems, the specimen is labeled at the patient s bedside with the patient identification and collection information and enters... 

A major advance in the automation of specimen identification in the clinical laboratory has been the incorporation of bar coding technology into analytical systems.In practice, a bar coded label (often generated by the laboratory information system and bearing the specimen accession number) is placed onto the specimen container and is subsequently read by one or more bar code readers that have been strategically placed at key positions in the analytical train. The resultant identifying and ancillary information is then transferred to and processed by the system software. 

Computers and computer telecommunications are integral components of the entire analytical and reporting process and control the data input, operation, monitoring, and data reporting functions in automated analyzers. Also, workstations have been used to integrate the operation of one or more laboratory analyzers. Individual analyzers and/or their workstations are electronically interfaced with large central data repositories on laboratory information systems (LIS) and/or laboratory automation systems (LAS) (see Chapter 18). 

The NCCLS has an Area Committee on Automation and Informatics, which oversees the above standards and initiates new standards development projects. Current standards development projects include Data Content for Specimen Identification, Protocols to Vafidate Laboratory Information Systems, and Remote Access to Hospital Diagnostic Devices via tihe internet. In 2002, ASTM transferred to NCCLS the ownership and copyright of aU nine standards in its E31.13 group, including the two standards referenced above. These standards all relate to the clinical laboratory, with some of them simply preceding or overlapping the NCCLS automation standards. NCCLS is now in the process of evaluating which of these standards will be maintained and updated and which may be abandoned. 

Most analytical devices used in clinical laboratories are directly linked or connected via an electronic interface to a laboratory information system (LIS). In this progression, many different informatic functions (see Chapter 18) are used, including the electronic transfer of data from the analyzers to the LIS and ultimately into a patient s electronic medical record. This provides healthcare professionals with quick, accurate, and appropriate access to the patient s medical history and information. 

Computer platforms and interfacing to the laboratory information system... 

One of the first functions supported by laboratory information systems (LISs) was the printing of summary laboratory data for inclusion in the patient s chart. This replaced the labor-intensive and error-prone process of manually writing or typing results on individual slips of paper. Other important intralaboratory functions included assigning accession numbers and tracking specimens and workload. Information system functions have expanded to include virtually every area of laboratory operation. ... 

To understand the way laboratory information systems work, it is helpful to think about laboratory workflow and the lands of information required at each step. Box 18-1 lists a set of workflow steps usually followed by a laboratory test. 

Brannigan VM. Regulation of clinical laboratory information systems after the 1990 amendments to the Food and Drug Act Chn Lab Man Rev 1992 6 49-57. 

Elevitch FR, AUer RD. The ABCs of LIS Computerizing your laboratory information system. Chicago ASCP Press, 1989. 

Integrating ERMS with automated laboratory information systems and clinical and nonclinical trials databases is a critical issue. Records and documents can come from laboratory devices as well as word processing, spreadsheet, database, e-mail, and web-based applications. An ERMS must integrate all of these functions into a cohesive workflow that prevents unauthorized access and logs all activity in an FDA compliant audit trail. 

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