AUTO03-A2
Vol. 29 No. 21
Replaces AUTO03-A
Vol. 20 No. 30
Laboratory Automation: Communications
With Automated Clinical Laboratory
Systems, Instruments, Devices, and
Information Systems; Approved Standard—
Second Edition
This document provides standards to facilitate accurate and timely electronic exchange of
data and information between the automated laboratory elements.
A standard for global application developed through the Clinical and Laboratory
Standards Institute consensus process.
AUTO03-A2
ISBN 1-56238-707-3
Volume 29 Number 21 ISSN 0273-3099
Laboratory Automation: Communications With Automated Clinical
Laboratory Systems, Instruments, Devices, and Information Systems;
Approved Standard—Second Edition
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.
Clinical and Laboratory Standards Institute (CLSI). Laboratory Automation: Communications With Automated Clinical
Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition. CLSI document
AUTO03-A2 (ISBN 1-56238-707-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2009.
The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any
given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or
guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are
listed in the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to
become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:
customerservice@clsi.org; Website: www.clsi.org
Volume 29 AUTO03-A2
Contents
Abstract ....................................................................................................................................................i
Committee Membership........................................................................................................................ iii
Matrix of CLSI Laboratory Automation Standards ............................................................................. vii
Foreword ................................................................................................................................................ix
1 Scope .......................................................................................................................................... 1
1.1 Limitations .................................................................................................................... 1
2 Introduction ................................................................................................................................ 1
2.1 Elements of an Automation System .............................................................................. 1
3 Standard Precautions.................................................................................................................. 3
4 Terminology............................................................................................................................... 3
4.1 Definitions .................................................................................................................... 4
4.2 Abbreviations and Acronyms ....................................................................................... 8
5 Laboratory Automation Architectures/Models .......................................................................... 8
5.1 Overview of Architectures ............................................................................................ 8
5.2 Functional Control Model ............................................................................................. 8
5.3 Information Among Elements..................................................................................... 10
6 Communication Standard......................................................................................................... 11
6.1 Introduction and Overview ......................................................................................... 11
6.2 Relationship Among Existing Communications Standards and the CLSI Standard... 11
7 HL7 Communication Standard for Laboratory Automation .................................................... 14
7.1 Background and Introduction ..................................................................................... 15
7.2 Trigger Events and Message Definitions .................................................................... 28
7.3 Message Segments ...................................................................................................... 35
7.4 Notes regarding usage ................................................................................................. 69
7.5 Outstanding issues ...................................................................................................... 73
8 Low-Level Protocol Considerations ........................................................................................ 73
8.1 Requirements to Low-Level Protocol ......................................................................... 73
8.2 Recommendations for the Low-Level Communication Protocol ............................... 74
9 Implementation Considerations ............................................................................................... 75
9.1 Admission, Discharge, and Transfer; Patient; Episode-of-Care Functions ................ 76
9.2 Order Entry Function .................................................................................................. 77
9.3 Results Function ......................................................................................................... 78
9.4 Query Function ........................................................................................................... 78
9.5 Network Management Function ................................................................................. 79
9.6 Analyzer/Instrument Functions................................................................................... 79
9.7 Timing and Throughput Considerations ..................................................................... 79
9.8 Recommended Character Set Support ........................................................................ 79
9.9 Example Transactions ................................................................................................. 79
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Number 21 AUTO03-A2
Contents (Continued)
References ............................................................................................................................................. 80
Appendix A. Laboratory Automation Architectures/Models................................................................ 81
Appendix B. History of Laboratory Automation Standards ................................................................. 84
Summary of Delegate Comments and Committee Responses .............................................................. 88
The Quality Management System Approach ........................................................................................ 96
Related CLSI Reference Materials ....................................................................................................... 97
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Volume 29 AUTO03-A2
Matrix of CLSI Laboratory Automation Standards
The CLSI laboratory automation standards AUTO01,1 AUTO02,2 AUTO03, AUTO04,3 and AUTO054
are interdependent with respect to their implementation in automated laboratory systems. The matrix
describes the engineering relationships between the standards elements in each of the five documents.
This matrix is provided so designers and engineers, as well as users and customers, understand the
relationships between the different standards’ components in an automated system. The matrix format
allows the users of one document to easily identify other standard elements, which relate to the standard
elements in the document or documents from which they may be working, to design a system correctly.
How to Read the Matrix (See the matrix on the next page.)
The numbers listed on the horizontal (X) and vertical (Y) axes contain multiple-digit numbers [eg, (1)5.4,
(5)5.4.1.3].
The ‘first digit’ (in parentheses) represents one of the five automation documents [eg, (1)5.4 is from
AUTO01; (5)5.4.1.3 is from AUTO05].
The ‘remaining digits’ represent the specific section of that document.
The symbol XX represents the direct ‘engineering relationship’ between two sections.
The symbol ## represents the section’s ‘self’; when it has been lined up with itself on the other axis.
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Number 21
Matrix of CLSI Laboratory Automation Standards
viii
This matrix cross-links sections from CLSI documents AUTO01,1 AUTO02,2 AUTO03, AUTO04,3 and AUTO05.4
AUTO03-A2
Volume 29 AUTO03-A2
Foreword
Clinical laboratory automation is defined as the integration of laboratory personnel and analytical
(examination), preanalytical (preexamination), postanalytical (postexamination), and computer systems to
positively benefit the health care system, patient, and the laboratory’s quality, economics, reliability,
speed, and safety.
This standard addresses the communication of data between systems and provides information that is
needed for developing automated laboratory systems. Recent standards developments have addressed
messaging and data interchange, and test/result naming. Although some are used by a few instrument and
Laboratory Information System (LIS) vendors, they have not been universally adopted; are only a small
part of what will eventually be needed for true standard, compatible device interconnectability; and lack a
mechanism for validating vendor conformance.
These specifications are also intended to complement the following interrelated CLSI standards
developed by other automation subcommittees and support overall operational goals for future
development in laboratory instrumentation and automation: AUTO01,1 AUTO02,2 AUTO04,3 and
AUTO05.4
Any standard dealing with laboratory automation will continually evolve. Open communication and
exchange of ideas and information can be used to modify the standard through the consensus process.
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.
Because future editions of this AUTO03 standard may not necessarily coincide with the revision of HL7,
readers will be referred to the current version 2.x of HL7.
Key Words
Analytical instruments, automation, clinical laboratory automation, Laboratory Automation System
(LAS), Laboratory Information System (LIS), process instruments
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Volume 29 AUTO03-A2
Laboratory Automation: Communications With Automated Clinical
Laboratory Systems, Instruments, Devices, and Information Systems;
Approved Standard—Second Edition
1 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 (AUTO01,1 AUTO02,2
AUTO04,3 and AUTO054).
1.1 Limitations
This standard focuses on the characteristics of the communications (low-level protocol) and the data to be
transferred (high-level protocol). The low-level protocol was developed to meet the bandwidth and time
characteristics required by automation. The high-level protocol defines specific messages and data to be
transferred in automated communications.
It is recognized that there are old protocols in use in clinical laboratories that are not supported by this
standard. The overall intent of this standard is to be prospective in nature and meet anticipated future
needs for automation. Of necessity, therefore, the standard focuses on protocols that can meet the time
and data characteristics for automation systems. Older (legacy) systems are not necessarily excluded but
are also not supported.
2 Introduction
Clinical laboratory automation is defined as the integration of laboratory personnel and analytical
(examination), pre- and postanalytical (pre- and postexamination), and computer systems to positively
benefit the health care system, patient, and the laboratory’s quality, economics, reliability, speed, and
safety. The goal of this document is to facilitate accurate and timely electronic exchange of 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.
2.1 Elements of an Automation System
This section describes the essential requirements for information transfer by all elements in an automation
system. This document structures the discussion in three levels, as described in the next section.
(1) Define at a macro level the elements of an automation system and their properties.
(2) Define the automation architectures/models (in theory or realized).
©
Clinical and Laboratory Standards Institute. All rights reserved.
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Number 21 AUTO03-A2
The Quality Management System Approach
Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the
development of standards and guidelines, which facilitates project management; defines a document structure via a
template; and provides a process to identify needed documents. The approach is based on the model presented in the
most current edition of CLSI/NCCLS document HS01—A Quality Management System Model for Health Care. The
quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any
organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how
a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or
service, serving as a manager’s guide. The QSEs are
Documents and Records Equipment Information Management Process Improvement
Organization Purchasing and Inventory Occurrence Management Customer Service
Personnel Process Control Assessment—External and Facilities and Safety
Internal
AUTO03-A2 addresses the QSEs indicated by an “X.” For a description of the other documents listed in the grid,
please refer to the Related CLSI Reference Materials section on the following page.
and Inventory
Improvement
Facilities and
Organization
Management
Management
Assessments
and Records
and Internal
Information
Occurrence
Documents
Purchasing
Equipment
—External
Personnel
Customer
Control
Process
Process
Service
Safety
X
AUTO01
AUTO02 AUTO02
AUTO04 AUTO04
AUTO05
GP19 GP19 GP19 GP19 GP19 GP19 GP19 GP19 GP19 GP19 GP19
LIS01 LIS01
LIS02 LIS02
M29 M29
Adapted from CLSI/NCCLS document HS01—A Quality Management System Model for Health Care.
Path of Workflow
A path of workflow is the description of the necessary steps to deliver the particular product or service that the
organization or entity provides. For example, CLSI/NCCLS document GP26⎯Application of a Quality
Management System Model for Laboratory Services defines a clinical laboratory path of workflow, which consists
of three sequential processes: preexamination, examination, and postexamination. All clinical laboratories follow
these processes to deliver the laboratory’s services, namely quality laboratory information.
AUTO03-A2 addresses the clinical laboratory path of workflow steps indicated by an “X.” For a description of the
other documents listed in the grid, please refer to the Related CLSI Reference Materials section on the following page.
Preexamination Examination Postexamination
receipt/processing
Sample collection
Results reporting
Sample transport
Results review
and follow-up
and archiving
Interpretation
Examination
Examination
management
ordering
Sample
Sample
X
LIS01
LIS02
Adapted from CLSI/NCCLS document HS01—A Quality Management System Model for Health Care.
©
96 Clinical and Laboratory Standards Institute. All rights reserved.
Volume 29 AUTO03-A2
Related CLSI Reference Materials∗
AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (2000). This
document provides standards for the design and manufacture of specimen containers and carriers used for
collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory
automation systems.
AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—
Second Edition (2005). This document provides specifications for use of linear bar codes on specimen
container tubes in the clinical laboratory and for use on laboratory automation systems.
AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information
Elements; Approved Standard (2001). This document describes operational requirements, characteristics,
and required information elements of clinical laboratory automation systems. This information is used to
determine the status of a clinical specimen within the clinical laboratory automation system, as well as the
status of the actual components of the clinical laboratory automation system.
AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard (2001). This document
provides standards for the development of an electromechanical interface between instruments and specimen
processing and handling devices used in automated laboratory testing procedures.
GP19-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
(2003). This document identifies important factors that designers and laboratory managers should consider
when developing new software-driven systems and selecting software user interfaces. Also included are
simple rules to help prepare validation protocols for assessing the functionality and dependability of software.
LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments
and Computer Systems; Approved Standard—Second Edition (2008). This document describes the
electronic transmission of digital information between clinical laboratory instruments and computer systems.
LIS02-A2 Specification for Transferring Information Between Clinical Laboratory Instruments and Information
Systems; Approved Standard—Second Edition (2004). This document covers the two-way digital
transmission of remote requests and results between clinical laboratory instruments and information systems.
M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—
Third Edition (2005). Based on US regulations, this document provides guidance on the risk of transmission
of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific
precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and
materials; and recommendations for the management of exposure to infectious agents.
∗
CLSI documents are continually reviewed and revised through the CLSI consensus process; therefore, readers should refer to
the most current editions.
©
Clinical and Laboratory Standards Institute. All rights reserved. 97
