LIS2-A2

ISBN 1-56238-550-X
Volume 24 Number 33 ISSN 0273-3099
Specification for Transferring Information Between Clinical Laboratory
Instruments and Information Systems; Approved Standard—Second
Edition
Paul J. Mountain, M.Sc., M.T.(ASCP)
David Chou, M.D.
James V. Callaghan, M.T.(ASCP)

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Randall R. Davis
Charles D. Hawker, Ph.D., MBA, FACB
David A. Herold, M.D., Ph.D.
Andrzej J. Knafel, Ph.D.
Gary W. Kramer, Ph.D.
Rodney S. Markin, M.D., Ph.D.

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Abstract
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NCCLS document LIS2-A2—Specification for Transferring Information Between Clinical Laboratory Instruments and
Information Systems; Approved Standard—Second Edition addresses the two-way digital transmission of remote requests and
results between clinical laboratory instruments and information systems. It enables any two such systems to establish a logical
link for communicating text to send result, request, or demographic information in a standardized and interpretable form.

NCCLS. Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems;
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Approved Standard—Second Edition. NCCLS document LIS2-A2 (ISBN 1-56238-550-X). NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

THE NCCLS consensus process, which is the mechanism for moving a document through two or more levels of review by the
healthcare 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outdated editions with the current editions of NCCLS documents. Current editions are listed in the NCCLS Catalog, which is
distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to
become one, and to request a copy of the NCCLS Catalog, contact the NCCLS Executive Offices. Telephone: 610.688.0100;
Fax: 610.688.0700; E-Mail: [email protected]; Website: www.nccls.org
Volume 24 LIS2-A2

Contents

Abstract ....................................................................................................................................................i

Committee Membership........................................................................................................................ iii

Foreword ................................................................................................................................................ix

1 Scope..........................................................................................................................................1

2 Definitions .................................................................................................................................1

3 Significance and Use..................................................................................................................2

4 Information Requirements in Clinical Testing...........................................................................3

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4.1 General Approach .........................................................................................................3
4.2 Logical Structure of the Message Level Protocol.........................................................4
5 Message Content—General Considerations ..............................................................................5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
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Character Codes............................................................................................................5
Maximum Field Lengths...............................................................................................5
Maximum Record Length .............................................................................................6
Delimiters......................................................................................................................6
Data Record Usage Overview.......................................................................................8
Common Field Types....................................................................................................9
Examples of Basic Record Types ...............................................................................11
6 Message Header Record ..........................................................................................................11
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6.1 Record Type ID ..........................................................................................................11
6.2 Delimiter Definition....................................................................................................11
6.3 Message Control ID ....................................................................................................11
6.4 Access Password.........................................................................................................12
6.5 Sender Name or ID .....................................................................................................12
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6.6 Sender Street Address .................................................................................................12

6.7 Reserved Field ............................................................................................................12
6.8 Sender Telephone Number .........................................................................................12
6.9 Characteristics of Sender ............................................................................................12
6.10 Receiver ID .................................................................................................................12
6.11 Comment or Special Instructions................................................................................12
6.12 Processing ID..............................................................................................................12
6.13 Version Number..........................................................................................................13
6.14 Date and Time of Message .........................................................................................13
7 Patient Information Record......................................................................................................13
7.1 Record Type................................................................................................................13
7.2 Sequence Number .......................................................................................................13
7.3 Practice-Assigned Patient ID ......................................................................................13
7.4 Laboratory-Assigned Patient ID .................................................................................13
7.5 Patient ID Number 3 ...................................................................................................13
7.6 Patient Name...............................................................................................................13
7.7 Mother’s Maiden Name ..............................................................................................13
7.8 Birthdate......................................................................................................................13
7.9 Patient Sex ..................................................................................................................14
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Contents (Continued)
7.10 Patient Race-Ethnic Origin .........................................................................................14
7.11 Patient Address ...........................................................................................................14
7.12 Reserved Field ............................................................................................................14
7.13 Patient Telephone Number .........................................................................................14
7.14 Attending Physician ID...............................................................................................14
7.15 Special Field 1 ............................................................................................................14
7.16 Special Field 2 ............................................................................................................14
7.17 Patient Height .............................................................................................................14
7.18 Patient Weight.............................................................................................................15
7.19 Patient’s Known or Suspected Diagnosis ...................................................................15
7.20 Patient Active Medications .........................................................................................15
7.21 Patient’s Diet...............................................................................................................15
7.22 Practice Field Number 1 .............................................................................................15

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7.23 Practice Field Number 2 .............................................................................................15
7.24 Admission and Discharge Dates .................................................................................15
7.25 Admission Status ........................................................................................................15
7.26 Location ......................................................................................................................15
7.27
7.28
7.29
7.30
7.31
7.32
7.33
7.34
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Nature of Alternative Diagnostic Code and Classifiers ..............................................15
Alternative Diagnostic Code and Classification .........................................................16
Patient Religion...........................................................................................................16
Marital Status..............................................................................................................16
Isolation Status............................................................................................................16
Language.....................................................................................................................16
Hospital Service..........................................................................................................17
Hospital Institution .....................................................................................................17
7.35 Dosage Category.........................................................................................................17
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8 Test Order Record....................................................................................................................17
8.1 General........................................................................................................................17
8.2 Multiple Orders...........................................................................................................17
8.3 General Applications ..................................................................................................18
8.4 Field Definitions .........................................................................................................18
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9 Result Record...........................................................................................................................22
9.1 Record Type ID ..........................................................................................................22
9.2 Sequence Number .......................................................................................................22
9.3 Universal Test ID........................................................................................................22
9.4 Data or Measurement Value .......................................................................................22
9.5 Units............................................................................................................................23
9.6 Reference Ranges .......................................................................................................23
9.7 Result Abnormal Flags ...............................................................................................23
9.8 Nature of Abnormality Testing...................................................................................23
9.9 Result Status ...............................................................................................................23
9.10 Date of Change in Instrument Normative Values or Units .........................................24
9.11 Operator Identification................................................................................................24
9.12 Date/Time Test Started ...............................................................................................24
9.13 Date/Time Test Completed .........................................................................................24
9.14 Instrument Identification.............................................................................................24
10 Comment Record .....................................................................................................................24
10.1 Record Type ID ..........................................................................................................24

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Contents (Continued)
10.2 Sequence Number .......................................................................................................25
10.3 Comment Source.........................................................................................................25
10.4 Comment Text ............................................................................................................25
10.5 Comment Type ...........................................................................................................25
11 Request Information Record ....................................................................................................25
11.1 Record Type ID ..........................................................................................................25
11.2 Sequence Number .......................................................................................................25
11.3 Starting Range ID Number .........................................................................................25
11.4 Ending Range ID Number ..........................................................................................26
11.5 Universal Test ID........................................................................................................26
11.6 Nature of Request Time Limits...................................................................................26
11.7 Beginning Request Results Date and Time.................................................................26

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11.8 Ending Request Results Date and Time......................................................................26
11.9 Requesting Physician Name .......................................................................................26
11.10 Requesting Physician Telephone Number ..................................................................27
11.11 User Field Number 1...................................................................................................27

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11.12
11.13

12.1
12.2
12.3
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User Field Number 2...................................................................................................27
Request Information Status Codes..............................................................................27
Message Terminator Record ....................................................................................................27
Record Type ID ..........................................................................................................27
Sequence Number .......................................................................................................27
Termination Code .......................................................................................................27
Scientific Record......................................................................................................................28
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13.1 Record Type ID ..........................................................................................................28
13.2 Sequence Number .......................................................................................................28
13.3 Analytical Method ......................................................................................................28
13.4 Instrumentation ...........................................................................................................28
13.5 Reagents......................................................................................................................28
13.6 Units of Measure.........................................................................................................28
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13.7 Quality Control ...........................................................................................................28

13.8 Specimen Descriptor...................................................................................................28
13.9 Reserved Field ............................................................................................................28
13.10 Container.....................................................................................................................29
13.11 Specimen ID ...............................................................................................................29
13.12 Analyte........................................................................................................................29
13.13 Result ..........................................................................................................................29
13.14 Result Units.................................................................................................................29
13.15 Collection Date and Time ...........................................................................................29
13.16 Result Date and Time .................................................................................................29
13.17 Analytical Preprocessing Steps...................................................................................29
13.18 Patient Diagnosis ........................................................................................................29
13.19 Patient Birthdate .........................................................................................................29
13.20 Patient Sex ..................................................................................................................29
13.21 Patient Race ................................................................................................................29
14 Manufacturer Information Record ...........................................................................................30

References.............................................................................................................................................34

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Contents (Continued)
Appendix. Comparison of LIS2 and LIS5 ...........................................................................................35

Summary of Delegate Comments and Area Committee Responses .....................................................36

The Quality System Approach..............................................................................................................38

Related NCCLS Publications................................................................................................................39

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Foreword
In 2001, ASTM Committee E31 decided to restructure its operations, with the intent of focusing on
standards-development issues such as security, privacy, and the electronic health record. Part of the
reorganization plan was to transfer responsibility for E31.13 standards to NCCLS.

Following this transfer, nine standards (formerly ASTM E792; E1029; E1238; E1246; E1381; E1394;
E1466; E1639; and E2118) were redesignated as NCCLS standards LIS1 through LIS9. This collection of
former ASTM standards provides a wide variety of information relating to clinical laboratory computer
systems. Some included documents are of general interest as reference sources; others represent
specifications of primary importance to instrument manufacturers. LIS2 is a revision of the former ASTM
E1394-97.

The Area Committee on Automation and Informatics has assumed responsibility for maintaining the
documents and will revise or update each document in accord with the NCCLS Administrative

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Procedures. The area committee prioritized LIS2-A as the first standard from this collection to be
updated, incorporated into the NCCLS document template, and advanced through the NCCLS consensus
process. The area committee will revise other documents in the series in a similar manner.

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With the transfer of the former ASTM standards, the Area Committee on Automation and Informatics has
expanded its Mission Statement to include laboratory information systems. In the future, the area
committee will develop additional standards addressing informatics issues as well as issues related to the
integration of patient clinical data.

The revisions in this version of the LIS2 standard are intended to delineate this document from the former
ASTM version of this standard. 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 (i.e., LIS).
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Key Words

Component field, delimiter, field, message, record, repeat field

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Volume 24 LIS2-A2

Specification for Transferring Information Between Clinical Laboratory

Instruments and Information Systems; Approved Standard—Second Edition

1 Scope
This standard covers the two-way digital transmission of remote requests and results between clinical
laboratory instruments and information systems. It is intended to document the common conventions
required for the interchange of clinical results and patient data between clinical laboratory instruments
and information systems. This standard specifies the message content for transferring information
between a clinical laboratory instrument and an information system. It enables any two such systems to
establish a logical link for communicating text to send result, request, or demographic information in a
standardized and interpretable form. This standard does not necessarily apply to general analytical
instruments in an industrial analytical setting, or to a research and development setting.

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This standard is intended to apply to the structure of messages exchanged between clinical laboratory
instruments and information systems by means of defined communications protocols. Low-level
communications protocols and data transfer requirements are beyond the scope of this standard. A
separate specification is available detailing a standard for low-level data transfer communications (see

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NCCLS document LIS1—Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems).

This standard specifies the conventions for structuring the content of the message and for representing the
data elements contained within those structures. It is applicable to all text-oriented clinical
instrumentation. It has been specifically created to provide common conventions for interfacing
computers and instruments in a clinical setting. It would also be applicable to interfacing instruments in
clinical practice settings, such as physicians’ offices, clinics, and satellite laboratories. The intended users
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of this standard are developers of clinical laboratory information systems and clinical laboratory
managers.

2 Definitions
Battery – A group of tests ordered together, for example, an admitting battery; NOTES: a) The term
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battery is used in the document synonymously with the term profile or panel; b) The test elements within
a battery may be characteristic of a single physiologic system, for example, liver function tests, or many
different physiologic systems; c) The battery is simply a convention by which a user can order multiple
tests by specifying a single name.

Component field – A single data element or data elements which express a finer aggregate or extension
of data elements which precede it, for example, parts of a field or repeat field entry; NOTES: a) As an
example, the patient’s name is recorded as last name, first name, and middle initial, each of which is
separated by a component delimiter; b) Components cannot contain repeat fields.

Download – Data transmitted from an information system to a clinical instrument.

Field – One specific attribute of a record which may contain aggregates of data elements further refining
the basic attribute.

Message – A textual body of information consisting of a header (H) record through a message terminator
(L) record.

Record – An aggregate of fields describing one aspect of the complete message.

An NCCLS global consensus standard. ©NCCLS. All rights reserved. 1