CLSI AUTO13
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring
Ensure seamless laboratory operations with AUTO13, which provides best practices for designing user-friendly software interfaces and guidance on validating laboratory data management systems. This standard helps laboratories select, implement, and validate software for data collection, interpretation, and reporting, whether purchased, custom-built, or developed in-house. By following AUTO13, laboratories can enhance workflow efficiency, reduce errors, and improve compliance with industry standards, ensuring that software systems are intuitive, reliable, and easy to use.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document AUTO13-A2—Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition provides user interface design recommendations that make new software programs easier for laboratory personnel to learn and use. Additionally, the guideline addresses the preparation and execution of validation plans for software purchased from manufacturers; custom software commissioned by the laboratory; or in-house applications developed to collect, interpret, or report laboratory, patient, or quality control information.
The scope of this document is limited to issues that affect ease of learning and the ease of use of software user interfaces. Although there is a need to improve the hardware interface between operators and instruments (e.g., keyboard, mouse, touch screen, printer, reports, voice, and light pens used when adding or removing patient samples, reagents, and waste), these topics are not within the scope of this guideline. AUTO13-A2 is not intended as a tool to be used in the selection, recommendation, or judgment of the suitability of specific input/output technologies, since these may change rapidly. Since it is described elsewhere, the transfer of electronic information between information and/or automation systems (such as between a laboratory information system or laboratory automation system software and an instrument) is not the subject of this document.
This document identifies the most important factors that designers and laboratory managers should consider during the development of a new software-actuated system and when selecting a software user interface intended to improve the ease of learning and use within the clinical laboratory. Without attempting to provide a comprehensive or exhaustive discussion of software user interfaces or trying to define an identical appearance for user interfaces by describing a single, detailed design solution, this document addresses some common design elements. This discussion is intended to encourage manufacturers of laboratory instruments and specimen handling devices to develop more uniform software user interfaces within their product lines.
The primary focus of this document is the software user interface within the centralized laboratory environment. The guidelines presented in this document are not directly constructed for point-of-care, physician-office, or over-the-counter devices, although many of the principles discussed apply to these devices as well. The primary focus of this document is software user interfaces on instruments, although the guidelines also apply to interfaces on laboratory systems and other associated information systems used in the laboratory.
These design guidelines and examples are not, however, universally applicable to all laboratory systems. Implementation of a specific design depends on the size, complexity, and cost of a device, as justified by its intended use.
This document provides some simple rules to help laboratory personnel prepare validation protocols that fulfill the laboratory's obligation to test and verify the functionality and dependability of its software. This document does not advocate relieving software developers of their duty to validate the software products that they develop; AUTO13 offers assistance to the purchaser when no other means of validation is available. Developers should refer to sources such as IEEE sources for specific guidelines for software system validation.
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 AUTO13-A2—Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition provides user interface design recommendations that make new software programs easier for laboratory personnel to learn and use. Additionally, the guideline addresses the preparation and execution of validation plans for software purchased from manufacturers; custom software commissioned by the laboratory; or in-house applications developed to collect, interpret, or report laboratory, patient, or quality control information.
The scope of this document is limited to issues that affect ease of learning and the ease of use of software user interfaces. Although there is a need to improve the hardware interface between operators and instruments (e.g., keyboard, mouse, touch screen, printer, reports, voice, and light pens used when adding or removing patient samples, reagents, and waste), these topics are not within the scope of this guideline. AUTO13-A2 is not intended as a tool to be used in the selection, recommendation, or judgment of the suitability of specific input/output technologies, since these may change rapidly. Since it is described elsewhere, the transfer of electronic information between information and/or automation systems (such as between a laboratory information system or laboratory automation system software and an instrument) is not the subject of this document.
This document identifies the most important factors that designers and laboratory managers should consider during the development of a new software-actuated system and when selecting a software user interface intended to improve the ease of learning and use within the clinical laboratory. Without attempting to provide a comprehensive or exhaustive discussion of software user interfaces or trying to define an identical appearance for user interfaces by describing a single, detailed design solution, this document addresses some common design elements. This discussion is intended to encourage manufacturers of laboratory instruments and specimen handling devices to develop more uniform software user interfaces within their product lines.
The primary focus of this document is the software user interface within the centralized laboratory environment. The guidelines presented in this document are not directly constructed for point-of-care, physician-office, or over-the-counter devices, although many of the principles discussed apply to these devices as well. The primary focus of this document is software user interfaces on instruments, although the guidelines also apply to interfaces on laboratory systems and other associated information systems used in the laboratory.
These design guidelines and examples are not, however, universally applicable to all laboratory systems. Implementation of a specific design depends on the size, complexity, and cost of a device, as justified by its intended use.
This document provides some simple rules to help laboratory personnel prepare validation protocols that fulfill the laboratory's obligation to test and verify the functionality and dependability of its software. This document does not advocate relieving software developers of their duty to validate the software products that they develop; AUTO13 offers assistance to the purchaser when no other means of validation is available. Developers should refer to sources such as IEEE sources for specific guidelines for software system validation.
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.