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CLSI Publishes New Automation and Informatics Document (AUTO15)


Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute (CLSI) has published AUTO15—Autoverification of Medical Laboratory Results for Specific Disciplines provides general guidance, as well as discipline-specific direction, on design and validation of an autoverification system. Autoverification is the process by which laboratory analyte results are accepted or rejected for automatic delivery to a patient data repository. This process uses a predetermined set of criteria applied at one or more points during the electronic flow of information. This guideline is provided for use by laboratorians, personnel responsible for information systems, and vendors for medical informatics and in vitro diagnostics.

William Marquardt, Chairholder of AUTO15, said, “The laboratory testing process has never been more automated than in today’s clinical laboratory. Many laboratories have yet to significantly automate the results review process, which can consume the majority of time and skilled labor within the laboratory.   With vacancy rates for medical laboratorians on the rise,  as well a constant increase in the depth and breadth of clinical testing, a high rate (>90%) of automatic verification (autoverification) should be of formidable concern for any laboratory;  yet most labs either choose not to implement autoverification or to stop at rates <60%.  Until now, comprehensive guidelines have not been established to provide direction on how to create and implement a robust autoverification solution at an individual departmental level and clinical guidelines have not been provided to laboratory equipment vendors, regulating agencies, and information systems providers to provide adequate direction and tools to reach high autoverification rates.  In 2006, Auto10-A set the stage for laboratorians to understand the basics of autoverification and considerations for various conditions.  Auto15 now provides a granular framework that can be used as a cornerstone for laboratorians, regulating agencies, instrumentation and automation vendors, and information systems providers alike to provide direction on exactly how a robust autoverification system should function so that high levels of autoverification can be achieved.” 

For more information about AUTO15, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.   

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.   For over 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.    

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency. 


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