CLSI AUTO04
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements
CLSI AUTO04-A serves as a comprehensive guide for clinical laboratories aiming to implement or enhance automation systems. This document delineates the operational requirements, characteristics, and essential information elements necessary for clinical laboratory automation systems to function successfully and seamlessly with minimal human intervention.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI document AUTO04-A—Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard defines operational requirements, characteristics, and required information elements of clinical laboratory automation systems to support continuous, uninterrupted operation with appropriate human intervention. The standard is divided into two parts. The first part of this document was developed to serve as a standard describing elements which will facilitate the rapid determination of the status of a clinical specimen within a clinical laboratory automation system. The second part of this document was developed to serve as a standard describing elements which will facilitate the rapid determination of the status of the components of a clinical laboratory automation system.
Laboratory automation involves the complex interaction of a process control component of the LAS; instruments and/or specimen processing/handling devices; information systems; and other components, such as specimen containers and carriers, docking systems, bar-code devices, and the patient’s specimen. There is a need for a uniform approach among instruments and/or specimen processing/handling devices and LAS manufacturers to monitor the status of these components. This standard identifies and suggests uniform ways of communicating essential data elements that describe the status, location, integrity, quality control, and other relevant characteristics of the components of the LAS. These standard formats are meant to inform and guide manufacturers in the development of LAS status monitoring. This standard has been developed through a consensus process that includes people who collectively possess a broad range of knowledge in the manufacture and use of laboratory automation.
This standard fits into the series of interrelated NCCLS automation standards AUTO1—Laboratory Automation: Specimen Container/Specimen Carrier; AUTO2—Laboratory Automation: Bar Codes for Specimen Container Identification; AUTO3—Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; and AUTO5—Laboratory Automation: Electromechanical Interfaces.
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.
CLSI document AUTO04-A—Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard defines operational requirements, characteristics, and required information elements of clinical laboratory automation systems to support continuous, uninterrupted operation with appropriate human intervention. The standard is divided into two parts. The first part of this document was developed to serve as a standard describing elements which will facilitate the rapid determination of the status of a clinical specimen within a clinical laboratory automation system. The second part of this document was developed to serve as a standard describing elements which will facilitate the rapid determination of the status of the components of a clinical laboratory automation system.
Laboratory automation involves the complex interaction of a process control component of the LAS; instruments and/or specimen processing/handling devices; information systems; and other components, such as specimen containers and carriers, docking systems, bar-code devices, and the patient’s specimen. There is a need for a uniform approach among instruments and/or specimen processing/handling devices and LAS manufacturers to monitor the status of these components. This standard identifies and suggests uniform ways of communicating essential data elements that describe the status, location, integrity, quality control, and other relevant characteristics of the components of the LAS. These standard formats are meant to inform and guide manufacturers in the development of LAS status monitoring. This standard has been developed through a consensus process that includes people who collectively possess a broad range of knowledge in the manufacture and use of laboratory automation.
This standard fits into the series of interrelated NCCLS automation standards AUTO1—Laboratory Automation: Specimen Container/Specimen Carrier; AUTO2—Laboratory Automation: Bar Codes for Specimen Container Identification; AUTO3—Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; and AUTO5—Laboratory Automation: Electromechanical Interfaces.
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.