CLSI AUTO10
Autoverification of Clinical Laboratory Test Results
Streamline and enhance your laboratory workflow with CLSI document AUTO10. This guideline provides a comprehensive framework for designing, implementing, validating, and customizing autoverification (automated verification) rules. By leveraging advanced algorithms, AUTO10 optimizes test result verification, improving efficiency, accuracy, and consistency. Tailor autoverification to meet the specific needs of your patient population and medical philosophy with this essential resource.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document AUTO10-A—Autoverification of Clinical Laboratory Test Results; Approved Guideline provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population. The goal is to provide a new set of guidelines that will take us beyond traditional autoverification to the next generation that allows the use of more sophisticated algorithms to meet laboratory needs, as well as accurately reflect the medical philosophy of the laboratory. In addition, important supporting sections are provided that deal with the different aspects of regulatory compliance and validation of algorithms that are essential to establishing and maintaining a modern autoverification program. Through utilization of this structured approach, the end users will be able to ensure compliance with regulatory agencies (where acceptable by law), yet effectively develop and establish monitors to ensure that all aspects related to quality are maintained. Guidelines are provided for the automated delivery of high priority results that can be customized to meet a provider’s specific needs, along with a confirmation process that results have been received.
This guideline specifies recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results.
The intended users of this guideline are information system vendors; hospital, reference, independent, and physician office laboratories; data management vendors; instrument manufacturers; and those involved in point-of-care testing.
This guideline is not intended to provide test parameter rules or limits for practicing medicine or methods for confirmation of result delivery. This guideline does not address hardware specifications, interface specifications, connectivity, or software configuration. Security measures are beyond the scope of this document and are assumed to be covered by country-specific policies. For additional information, refer to the current edition of CLSI document AUTO11—IT Security of In Vitro Diagnostic Instruments and Software Systems.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute document AUTO10-A—Autoverification of Clinical Laboratory Test Results; Approved Guideline provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population. The goal is to provide a new set of guidelines that will take us beyond traditional autoverification to the next generation that allows the use of more sophisticated algorithms to meet laboratory needs, as well as accurately reflect the medical philosophy of the laboratory. In addition, important supporting sections are provided that deal with the different aspects of regulatory compliance and validation of algorithms that are essential to establishing and maintaining a modern autoverification program. Through utilization of this structured approach, the end users will be able to ensure compliance with regulatory agencies (where acceptable by law), yet effectively develop and establish monitors to ensure that all aspects related to quality are maintained. Guidelines are provided for the automated delivery of high priority results that can be customized to meet a provider’s specific needs, along with a confirmation process that results have been received.
This guideline specifies recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results.
The intended users of this guideline are information system vendors; hospital, reference, independent, and physician office laboratories; data management vendors; instrument manufacturers; and those involved in point-of-care testing.
This guideline is not intended to provide test parameter rules or limits for practicing medicine or methods for confirmation of result delivery. This guideline does not address hardware specifications, interface specifications, connectivity, or software configuration. Security measures are beyond the scope of this document and are assumed to be covered by country-specific policies. For additional information, refer to the current edition of CLSI document AUTO11—IT Security of In Vitro Diagnostic Instruments and Software Systems.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.