CLSI AUTO09
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet
The CLSI AUTO09 standard provides essential guidance for managing, validating, and ensuring the integrity of laboratory test data efficiently. Designed for laboratory professionals, IT specialists, and regulatory compliance teams, this standard outlines best practices for data handling and system validation to ensure seamless, reliable, and standardized handling of laboratory test data. Key features include: Best practices for data management and security Guidance on validation and verification of test results Standardized approaches for data exchange between systems Recommendations to enhance accuracy and efficiency.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document AUTO09-A—Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard provides a standard communication protocol that will allow remote connections to laboratory devices. It establishes a means to leverage the existing infrastructure provided by the hospital’s Local Area Network (LAN) and the Internet to achieve remote connectivity. These remote connections can be used to monitor instruments’ subsystems to determine proper operation; collect diagnostic data for remote system troubleshooting; and collect data that would allow for electronic inventory management.
This document will address connections by public networks, but not direct point-to-point connections. It will also address information protection issues, and remote operation of instruments from both intranets and the Internet. Requirements for patient privacy and information security are addressed, for example, HIPAA (the Health Insurance Portability and Accountability Act of 1996) and the European Union Privacy Directive 95/46/EC.
This document has been developed for instrument system vendors, device manufacturers, and healthcare administrators as a standard for communication protocols to allow remote connections to diagnostic devices. This standard is not intended to address remote access to the healthcare organization’s information system. It establishes a means to leverage the existing infrastructure provided by the healthcare facility’s local area network (LAN) and the Internet to achieve the remote connectivity. This standard discusses which characteristics of communication protocols (Internet and others) are required.
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 AUTO09-A—Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard provides a standard communication protocol that will allow remote connections to laboratory devices. It establishes a means to leverage the existing infrastructure provided by the hospital’s Local Area Network (LAN) and the Internet to achieve remote connectivity. These remote connections can be used to monitor instruments’ subsystems to determine proper operation; collect diagnostic data for remote system troubleshooting; and collect data that would allow for electronic inventory management.
This document will address connections by public networks, but not direct point-to-point connections. It will also address information protection issues, and remote operation of instruments from both intranets and the Internet. Requirements for patient privacy and information security are addressed, for example, HIPAA (the Health Insurance Portability and Accountability Act of 1996) and the European Union Privacy Directive 95/46/EC.
This document has been developed for instrument system vendors, device manufacturers, and healthcare administrators as a standard for communication protocols to allow remote connections to diagnostic devices. This standard is not intended to address remote access to the healthcare organization’s information system. It establishes a means to leverage the existing infrastructure provided by the healthcare facility’s local area network (LAN) and the Internet to achieve the remote connectivity. This standard discusses which characteristics of communication protocols (Internet and others) are required.
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.