Standard Document
Second Edition
Automation and Informatics

CLSI AUTO03

Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems

The second edition of CLSI AUTO03-A2 has been recognized by the US Food and Drug Administration (FDA) as a consensus standard suitable for use in satisfying regulatory requirements. This document provides essential guidelines to facilitate accurate and timely electronic data exchange among clinical laboratory systems, instruments, devices, and information systems.

September 30, 2009
David Chou, MD

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Abstract

Clinical and Laboratory Standards Institute document AUTO03-A2—Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition provides standards to facilitate accurate and timely electronic exchange of data and information between the automated laboratory elements. This will allow and encourage scalable, open systems, and extendibility and interoperability of the automated laboratory elements. Implementation of this standard will contribute to the development of a shared vision of future clinical laboratory automation communications.

Overview of Changes

This document replaces the first approved edition, AUTO03-A, which was published in 2000. Several changes were made in this edition; chief among them is incorporation of Chapter 13 of Health Level 7 (HL7) 2.6 that includes major changes resulting from the introduction of new segments SFT (software segment defined in Chapter 2 of HL7) and SPM (specimen segment defined in Chapter 7 of HL7). Appendix B from the first version was removed.

Scope

This standard provides a protocol for communications between Laboratory Automation Systems (LASs), Laboratory Information Systems (LISs), automated instruments (analyzers), and pre- and postanalytical (pre- and postexamination) automated devices. The primary audience for this standard is health care providers in the clinical laboratory implementing laboratory automation, vendors of laboratory automation, instrumentation, and LISs. However, in the future, elements of this standard may be applicable to the anatomic pathology, cytology, and related laboratories, as well as to nonclinical (analytical) laboratories. Additionally, although the focus of this standard is clinical laboratory automation, elements of the standard may apply to related (nonautomated) areas such as small analyzers or point-of-care devices. 

This standard fits into the series of interrelated CLSI automation standards (AUTO01, AUTO02, AUTO04, and AUTO05).

Product Details
AUTO03A2E
1-56238-707-3
116
Additional Details

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.

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 document is available in electronic format only.

Authors
David Chou, MD
Andrzej J. Knafel, PhD
Ed Heierman, PhD
David A. Lacher, MD, Med
William Neeley, MD, FACP, DABCC
Jeff Quint, PhD
Eugene T. Reilly
Richard S. Seaberg, MT(ASCP)
Abstract

Clinical and Laboratory Standards Institute document AUTO03-A2—Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition provides standards to facilitate accurate and timely electronic exchange of data and information between the automated laboratory elements. This will allow and encourage scalable, open systems, and extendibility and interoperability of the automated laboratory elements. Implementation of this standard will contribute to the development of a shared vision of future clinical laboratory automation communications.

Overview of Changes

This document replaces the first approved edition, AUTO03-A, which was published in 2000. Several changes were made in this edition; chief among them is incorporation of Chapter 13 of Health Level 7 (HL7) 2.6 that includes major changes resulting from the introduction of new segments SFT (software segment defined in Chapter 2 of HL7) and SPM (specimen segment defined in Chapter 7 of HL7). Appendix B from the first version was removed.

Scope

This standard provides a protocol for communications between Laboratory Automation Systems (LASs), Laboratory Information Systems (LISs), automated instruments (analyzers), and pre- and postanalytical (pre- and postexamination) automated devices. The primary audience for this standard is health care providers in the clinical laboratory implementing laboratory automation, vendors of laboratory automation, instrumentation, and LISs. However, in the future, elements of this standard may be applicable to the anatomic pathology, cytology, and related laboratories, as well as to nonclinical (analytical) laboratories. Additionally, although the focus of this standard is clinical laboratory automation, elements of the standard may apply to related (nonautomated) areas such as small analyzers or point-of-care devices. 

This standard fits into the series of interrelated CLSI automation standards (AUTO01, AUTO02, AUTO04, and AUTO05).

Additional Details

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.

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 document is available in electronic format only.

Authors
David Chou, MD
Andrzej J. Knafel, PhD
Ed Heierman, PhD
David A. Lacher, MD, Med
William Neeley, MD, FACP, DABCC
Jeff Quint, PhD
Eugene T. Reilly
Richard S. Seaberg, MT(ASCP)