Standard Document
Second Edition
Automation and Informatics

CLSI LIS01

Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

CLSI LIS01 provides essential specifications for the electronic transmission of digital information between medical laboratory instruments and computer systems. It ensures seamless data exchange, enabling efficient processing, storage, reporting, and analysis of laboratory results.

April 28, 2008
David Chou, MD and Andrzej J. Knafel, PhD

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Abstract

CLSI document LIS01-A2—Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition describes the electronic transmission of digital information between clinical laboratory instruments (those that measure one or more parameters from one or multiple samples) and computer systems (those that are configured to accept instrument results for further processing, storage, reporting, or manipulation).

Overview of Changes

Several changes were made in this edition: Transmission Control Protocol/Internet Protocol (TCP/IP) communication is now included (Sections 4.4 and 4.5) and the state diagram was replaced (see Appendix A) so it is consistent with the text of the document. The revisions in this edition of the LIS01 standard are intended to delineate this document from its former ASTM edition. The title and text have been revised throughout to indicate that this standard applies to clinical laboratory instruments. The term computer has been replaced with the term information to better reflect the current terminology (ie, Laboratory Information System or LIS) and the headings of Sections 6 and 8 have been changed to make them more specific.

Scope

This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. This specification addresses the low-level protocol used for both serial binary data exchange and TCP/IP data exchange. For message content in the interface between clinical instruments and computer systems, reference CLSI/NCCLS document LIS2.1.

Product Details
LIS01A2E
1-56238-665-4
40
Additional Details

This document is available in electronic format only.

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.

Authors
David Chou, MD
Andrzej J. Knafel, PhD
Charles D. Hawker, PhD, MBA, FACB
Ed Heierman, PhD
David A. Lacher, MD, MEd
William Neeley, MD, FACP
Eugene T. Reilly
Richard S. Seaberg, MT(ASCP)
Abstract

CLSI document LIS01-A2—Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition describes the electronic transmission of digital information between clinical laboratory instruments (those that measure one or more parameters from one or multiple samples) and computer systems (those that are configured to accept instrument results for further processing, storage, reporting, or manipulation).

Overview of Changes

Several changes were made in this edition: Transmission Control Protocol/Internet Protocol (TCP/IP) communication is now included (Sections 4.4 and 4.5) and the state diagram was replaced (see Appendix A) so it is consistent with the text of the document. The revisions in this edition of the LIS01 standard are intended to delineate this document from its former ASTM edition. The title and text have been revised throughout to indicate that this standard applies to clinical laboratory instruments. The term computer has been replaced with the term information to better reflect the current terminology (ie, Laboratory Information System or LIS) and the headings of Sections 6 and 8 have been changed to make them more specific.

Scope

This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. This specification addresses the low-level protocol used for both serial binary data exchange and TCP/IP data exchange. For message content in the interface between clinical instruments and computer systems, reference CLSI/NCCLS document LIS2.1.

Additional Details

This document is available in electronic format only.

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.

Authors
David Chou, MD
Andrzej J. Knafel, PhD
Charles D. Hawker, PhD, MBA, FACB
Ed Heierman, PhD
David A. Lacher, MD, MEd
William Neeley, MD, FACP
Eugene T. Reilly
Richard S. Seaberg, MT(ASCP)