Lis Vendor Interface - L-005933-Document-Rev-2017

LIS Vendor Interface Document
LIS
Vendor Interface
Document
BECTON, DICKINSON AND COMPANY

7 Loveton Circle
Sparks, MD 21152 USA
L–005933(19) 2017-04
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Change History
Revision Date Pages/Sections Reason
(A) 10/99 All New manual release
(B) 3/00 All New fields added to EpiCenter interface to support

Phoenix ID/AST instrument data. Added Isolate
results reporting for EpiCenter. Added additional
results for tests. And changed Patient and Specimen
user defined fields 4 & 5 to free text fields.
(C) 3/01 All Added BD Phoenix 100 section. Updated list of

antibiotic and organism codes. EpiCenter uploads
chartable rules and special messages. EpiCenter
allows blanking of a field. EpiCenter adds fields for
excluding isolates from statistics and test complete
DT.
(D) 5/01 2, 17, 18, 22, 28, Updated orders record to incorporate critical panel
61-63, 65 specification. Updated result record to include
resistance markers 4 – 10. Changed ‘resistance
mechanism’ to ‘resistance marker’ throughout.
Changed “BACTEC9000” to “BT9000” in instrument
type result field. Fix Phoenix resistance marker result
upload example.
(E) 10/01 All Formatting changes
(F) 3/02 All Various updates throughout the document to cleanup

references/definitions and lists of information.
(G) 12/03 All Updates for EpiCenter Version 4 Features
(H) 12/03 18,31,63,65-76 Updates for Phoenix Version 4
(I) - - Skipped
(J) 4/14/04 All Phoenix Version 4.01Z and EpiCenter 4.10A updates,
BD ProbeTec ET and Viper SP updates for new
configuration options, status, and assay type list.
(K) 03/14/05 All Various updates throughout the document to cleanup

examples.
(L) 04/28/08 13, 16, 22, 25, Updates for FX , Emulating BACTEC 9000, addition of
28, 31, 32, 38, ID test source field, addition of isolate upload
39, 41, 42 examples
(M) 9/11/2008 83-98 Added section 14.4 describing BACTEC FX

standalone
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(N) 2/25/2009 22, 30, 66-69 Added new Viper XTR assay codes for HSV1 and
HSV2
(O) 7/02/2010 25, 27, 37 Add additional value to Time Qualifier field, add note
to Admission Date/Time, Collection Date/Time and
Received Date/Time fields
06/06/2011 23, 30, 33-35,
Updates for Innova instrument
41,47, 101-109
(P) 07/27/2012 72 Added new Viper XTR assay codes for HPV and
TVQx
(Q)(17) 10/24/2013 69-75 Added additional information for Viper LT
18 10/2016 Preface; sections Added information for BD Phoenix M50

8, 12, 13, 14
19 04/2017 Section 14.6 Added information for BD MAX
© 2017 BD. BD and the BD logo are trademarks of Becton, Dickinson and Company.
All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in
retrieval systems, or translated into any language or computer language, in any form or by any means,
electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written
permission of BD, 7 Loveton Circle, Sparks, MD, 21152, USA.
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Table of Contents
1. Purpose ................................................................................................................................. 8
2. Scope ..................................................................................................................................... 8
3. Definitions ............................................................................................................................ 8
4. Overview ............................................................................................................................... 8
4.1. Physical Cable Interface .............................................................................................................. 8
4.2. Communication Protocols............................................................................................................ 9
4.3. System Configurations ................................................................................................................. 9
4.4. EpiCenter- LIS Communication ............................................................................................... 11
5. Workflow ............................................................................................................................ 11
5.1. Uploaded Test Results ................................................................................................................ 11
5.2. Uploaded Isolate Results ............................................................................................................ 12
5.3. Unsolicited Downloads ............................................................................................................... 14
5.4. File Import .................................................................................................................................. 14
5.5. Queries......................................................................................................................................... 15
5.6. Error Reporting .......................................................................................................................... 15
6. Protocol Specifications ...................................................................................................... 15
6.1. Physical Protocols ....................................................................................................................... 15
6.1.1. Memory limitations.............................................................................................................................. 15
6.1.2. Unpacked Frames ................................................................................................................................ 16
6.1.3. BDMODEM ........................................................................................................................................ 16
Emulate BACTEC 9000 LIS Interface ........................................................................................ 16
6.2. Logical Protocols ........................................................................................................................ 17
6.2.1. Unprocessed Records ........................................................................................................................... 17
6.2.2. Download Only Fields ......................................................................................................................... 17
6.2.3. Communication Errors ......................................................................................................................... 17
6.2.4. LIS Codes ............................................................................................................................................ 18
6.2.5. Blanking fields ..................................................................................................................................... 18
7. Configurable Options ......................................................................................................... 18
7.1. Port parameters .......................................................................................................................... 18
7.2. Auto-Populating Lists ................................................................................................................ 19
7.3. Logical Protocol Parameters ..................................................................................................... 19
7.4. ASTM Field Mapping ................................................................................................................ 19
7.5. User Defined Fields..................................................................................................................... 19
8. Message Content ................................................................................................................ 20
8.1. Field List ...................................................................................................................................... 20
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8.2. Field Descriptions ....................................................................................................................... 23

8.2.1. Header Fields ....................................................................................................................................... 23
8.2.2. Patient Fields ....................................................................................................................................... 24
8.2.3. Order Fields ......................................................................................................................................... 25
8.2.4. Result Fields ........................................................................................................................................ 27
8.2.5. Comment Fields ................................................................................................................................... 33
8.2.6. Request Fields ...................................................................................................................................... 34
8.2.7. Terminator Fields ................................................................................................................................. 36
9. Simulator ............................................................................................................................ 37
10. Appendix A - Sample EpiCenter Messages ....................................................................... 38
10.1. LIS Order .................................................................................................................................. 38
10.2. Host Query ................................................................................................................................ 38
10.3. LIS Requests Results ................................................................................................................ 38
10.4. Results....................................................................................................................................... 39
10.4.1. BACTEC G&D Test results ................................................................................................................ 39
10.4.2. MGIT 960 G&D Test results: .............................................................................................................. 39
10.4.3. MGIT AST Test Results ...................................................................................................................... 39
10.4.4. Innova Results ..................................................................................................................................... 40
10.4.5. Isolate Results ...................................................................................................................................... 40
Isolate with Expert system changes - Blank MIC, modified SIR ................................................ 40
Isolate with Resistance Markers .................................................................................................. 41
Isolate with Expert Comments ..................................................................................................... 42
Isolate with inferred results .......................................................................................................... 42
Isolate with multiple test sources ................................................................................................. 43
Isolate with multiple instruments ................................................................................................. 43
11. Appendix B – Tests and Results ........................................................................................ 45
12. Appendix C – Antibiotic Abbreviations ............................................................................. 48
13. Appendix D – Organism Abbreviations............................................................................. 51
14. Appendix E – BD Instrument Specifics ............................................................................ 61
14.1. BACTEC MGIT 960............................................................................................................... 61
14.1.1. Configurable Options ........................................................................................................................... 61
14.1.2. Message Content .................................................................................................................................. 61
Field List .............................................................................................................................................................. 61
Field Descriptions ................................................................................................................................................ 63
Header Fields ................................................................................................................................................... 63
Patient Fields ................................................................................................................................................... 63
Order Fields ..................................................................................................................................................... 63
Result Fields .................................................................................................................................................... 63
Request Fields.................................................................................................................................................. 64
Terminator Fields............................................................................................................................................. 65
14.1.3. Example ASTM 1394 Protocol ............................................................................................................ 66
14.2. BD ProbeTec ET, Viper XTR, & Viper LT.......................................................................... 68
14.2.2. Message Content .................................................................................................................................. 69
Field List .............................................................................................................................................................. 69
Field Descriptions ................................................................................................................................................ 70
Header Fields ................................................................................................................................................... 70
Patient Fields ................................................................................................................................................... 70
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Order Fields ..................................................................................................................................................... 70

Result Fields .................................................................................................................................................... 70
Request Fields.................................................................................................................................................. 72
Terminator Field .............................................................................................................................................. 72
14.2.4. Unsolicited Demographics Download (Viper LT) ............................................................................... 73
Patient Fields ............................................................................................................................... 73
Order Fields ................................................................................................................................. 74
14.3. BD Phoenix 100 and BD Phoenix M50 .................................................................................. 74
General Options ........................................................................................................................... 74
Results Upload Options ............................................................................................................... 74
Communications Setup ................................................................................................................ 75
Organism and Antimicrobial Configuration Screens ................................................................... 76
14.3.2. Modes of Communications .................................................................................................................. 76
14.3.3. Message Content .................................................................................................................................. 77
Field List .............................................................................................................................................................. 77
Field Descriptions ............................................................................................................................................ 78
Patient Fields ................................................................................................................................................... 78
Order Fields ..................................................................................................................................................... 78
Result Fields .................................................................................................................................................... 79
Comment Fields ............................................................................................................................................... 82
Terminator Field .............................................................................................................................................. 82
14.4. BACTEC FX ........................................................................................................................... 85
14.4.1. BACTEC FX LIS Configuration Screen ............................................................................................. 85
14.4.2. BACTEC FX Configurable Options .................................................................................................... 85
LIS ENABLE Group ................................................................................................................... 85
Port Parameters Group ................................................................................................................. 85
Physical Layer Group .................................................................................................................. 86
LIS Options Group....................................................................................................................... 86
ASTM 1381 Group ...................................................................................................................... 88
BD Modem Group ....................................................................................................................... 89
Send Button ................................................................................................................................. 90
Print Button .................................................................................................................................. 90
14.4.3. Message Content .................................................................................................................................. 91
Field List ...................................................................................................................................... 91
Field Descriptions ........................................................................................................................ 92
14.5. Innova ...................................................................................................................................... 97
14.5.1. LIS Connection .................................................................................................................................... 97
14.5.2. BD ASTM Interface............................................................................................................................. 98
Overview...................................................................................................................................... 98
Valid Characters .......................................................................................................................... 98
Invalid Characters ........................................................................................................................ 98
Message Content .......................................................................................................................... 98
Field List ...................................................................................................................................... 99
Field Descriptions ...................................................................................................................... 101
Examples.................................................................................................................................... 105
CONTAINER_BC_INSTEAD_OF_ACC Barcode ................................................................... 107
14.6. BD MAX ................................................................................................................................ 107
14.6.1. Additional definitions applicable to the BD MAX Section ............................................................... 107
14.6.2. Valid and Invalid characters for BD MAX ........................................................................................ 107
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14.6.3. Unresolved (UNR)/Indeterminate (IND)/Incomplete (INC) Results Handling ................................. 108

14.6.4. Overview of the BD MAX LIS Interface ........................................................................................... 108
14.6.5. General information about Default settings ....................................................................................... 108
14.6.6. Uploading Results to the LIS - “Unsolicited” vs “Solicited mode” ................................................... 108
LIS Retransmit Feature .............................................................................................................. 108
14.6.7. General information about the “Confirming positive results” feature ............................................... 109
14.6.8. Results queries from the LIS.............................................................................................................. 109
14.6.9. Communication Protocols.................................................................................................................. 109
Logical Protocols (ASTM E 1394) ............................................................................................ 109
Physical Protocols (ASTM E 1381) ........................................................................................... 111
14.6.10. Physical Cable Interface ................................................................................................................ 111
14.6.11. BD MAX LIS Configuration Screen ............................................................................................. 112
14.6.12. BD MAX LIS Configurable Options ............................................................................................. 113
Enable LIS ................................................................................................................................. 113
Parameters Group: Physical....................................................................................................... 114
LIS Options Group: Logical ...................................................................................................... 115
14.6.13. Message Content ............................................................................................................................ 116
Field content .............................................................................................................................. 116
Field Descriptions ...................................................................................................................... 118
Details for Bi-directional connection (worklist upload to BD MAX) ....................................... 123
14.6.14. Guidelines for setting up a connection ........................................................................................... 125
Tools and Information required ................................................................................................. 125
Required Cables and Adapters .................................................................................................. 125
Setting the connection to LIS .................................................................................................... 125
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1. Purpose
This document is intended to provide the information necessary for an LIS to exchange medical data with
Becton Dickinson instruments. This document was written to include the specifications for the BD data
management system as well as all future BD instruments. Any differences between instrument and data
management communication are outlined in this document’s appendices.
2. Scope
This document details the interface between a Laboratory Information System and Becton Dickinson
instruments and the Becton Dickinson data management system. The interface uses the ASTM E_1381
protocol at the physical layer and the ASTM E_1394 protocol at the logical layer.
3. Definitions
LIS – Laboratory Information System; Computer system present in most microbiology labs responsible for
collecting patient and test data.
ASTM – American Society for Testing and Materials; Committee responsible for publishing specification
on communication between lab instruments and lab computer systems.
ASTM E_1381 – Protocol published by ASTM describing low-level data exchange across a serial port.
ASTM E_1394 – Protocol published by ASTM describing the logical level formatting of patient and test
data.
EpiCenter – Data Management System produced by Becton Dickinson that collects microbiology test
results.
LIS Interface Library – Common module responsible for implementing communication protocols. This
module is used by both the BD instruments and the EpiCenter for LIS
communication.
Date/Time – All times will be represented in local time unless otherwise specified.
4. Overview
Becton Dickinson (BD) has released several instruments that perform automated microbiology testing. BD
has also released a data management workstation that communicates with these instruments and collects
test results. It is BD’s intention to communicate these results up to the LIS, if one is present in the
microbiology lab. The protocols and specifications for exchanging data between BD instruments and an
LIS are described in this and subsequent sections.
It is Becton Dickinson’s expectation that an LIS vendor will implement the specifications in this
document in their entirety. The proper functioning of the EpiCenter and BD instruments is dependent
on the proper exchange of information with an LIS. An agreement to support LIS communication with
BD instruments should be considered an agreement to implement all aspects of this specification.
4.1. Physical Cable Interface

The BD instruments and data management system communicate to the LIS using an
RS232 serial port interface. The serial port interface used by the instruments uses only 3
signals in the interface cable, Transmit Data (Pin 2), Receive Data (Pin 3), and Signal
Ground (Pin 5). Becton Dickinson does not believe that the inclusion of additional
signals will cause any problems for the interface; however, Becton Dickinson has not
tested this case.
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4.2. Communication Protocols

The American Society for Testing and Materials (ASTM) has published standards for how
information should be exchanged between a clinical instrument and lab computer system. BD has
implemented communication software to adhere to these specifications. In system configurations
that include the BD data management system, the EpiCenter plays the role of the instrument.
The ASTM committee has produced standards describing both the logical level formatting and the
physical exchange of data across a serial port. The logical level formatting describes how to place
individual pieces of medical information into a record string, and how to combine record strings
into a properly formatted message string. The physical level protocol describes how logical level
message strings can be partitioned and passed across an RS232 line to an LIS.
ASTM E_1394 is the publication that outlines the logical formatting of medical information. This
is the logical protocol BD uses to read/write data exchanged with the LIS. The ASTM E_1394
publication should be referred to for implementation details. A later section in this document
discusses any deviations from that specification.
ASTM E_1381 is the publication that outlines the physical communication of medical
information. This is the physical protocol BD uses to read/write data exchanged with the LIS. A
later section in this document discusses any deviations from that specification.
4.3. System Configurations

The BD data management system is designed to communicate with several different
types of BD instruments. The system configuration of these instruments is outlined in
figure 1. New generation BD instruments have a TCP/IP network capability and use a
local network to communicate to the EpiCenter. These results are then passed up to an
LIS via the protocols described in this document.
Since the BD EpiCenter collects results from several different types of BD instruments, it
passes several types of test results up to the LIS. This document specifies several
different types of result records (per ASTM E_1394) for handling all of the various types
of result data.
BD also has implemented LIS interface software in each of its new generation
instruments. This allows the instruments to pass results directly up to the LIS, when a
BD EpiCenter is not present in the lab. This configuration is illustrated in figure 2. Each
of the instruments sends up the results that they acquire. The types of result messages
that they produce (per ASTM E_1394) are expected to be the same as those for the
EpiCenter.
Any specifications that relate only to a BD instrument are included in an appendix to this
document.
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4.4. EpiCenter- LIS Communication

The BD EpiCenter is designed to handle results from several different types of microbiology tests.
BD instruments produce a varied set of results including growth and detection, ID, and AST
results. In addition, manual off-line tests are often required to supplement the instrumented
results. The BD EpiCenter is designed to manage these off-line test results as well as
instrumented results.
The BD EpiCenter expects to upload test results, both instrumented and manual, to the LIS.
The BD EpiCenter also expects to receive downloaded patient demographics and supplemental
test information from the LIS. The test information that is exchanged with an LIS is configurable
by the user, as is described in a later section of this document.
The BD EpiCenter is designed to use coded values for communicating data with an LIS. Most
fields in the BD database are associated with an “LIS Code” that is configurable at the
BD EpiCenter. This is a 20-character string that contains an LIS defined value that uniquely
identifies that item. “LIS Codes” are used to represent patient demographic fields, tests, and test
results in LIS communications. Later sections of this document outline the fields represented by
LIS codes and how they are mapped in an LIS communication.
The most efficient way to implement this interface would be an exchange of configuration
information between BD and the LIS vendor. The LIS vendor can provide BD with the LIS Codes
necessary to translate message data. The list of tests and results currently defined in the EpiCenter
database is included in Appendix B of this document. The BD EpiCenter can also import coded
list information (Body site, Hospital Service, Ordering Physician, etc.) The BD EpiCenter can
accept this information as a text based comma separated value file or other similar format.
However, most BD instruments are not able to change their LIS codes for LIS vendor
convenience. Instead they pass hard coded literal strings for test id’s, test status values, etc. The
literal values passed by the instruments are restricted to fields related to that instrument. These
literal strings used by the instruments are outlined in later sections of this document.
5. Workflow
The BD EpiCenter has a more sophisticated workflow with regard to an LIS than any instrument.
Therefore this section concentrates more heavily on BD EpiCenter workflow. Details about BD instrument
workflow are provided in an appendix in this document.
5.1. Uploaded Test Results

Each test in the BD EpiCenter database, both manual and instrumented, has a set of results defined
for that test. Each test result has a configurable field determining if that status is reportable to the
LIS. This field can be set to one of three values, always report to LIS, never report to LIS and
report only when finalized. When a test result is changed to a new value, the BD EpiCenter
checks this field to determine if the result should be uploaded to the LIS. A status configured to
be “Auto Upload only when finalized” is only uploaded when the user has finalized the test. By
using the “Auto Upload to LIS” field, the user can tailor the LIS interface to upload only the tests
and results the LIS has defined. This configuration option also allows the BD EpiCenter to mimic
any LIS workflow defined by a particular instrument.
Test results can be forced over these upload restrictions by first enabling the LIS Forced
Upload feature of the BD EpiCenter. Then initiating a manual upload of the test results
via the BD EpiCenter user interface, or querying for the associated specimen or test will
result in the test results being uploaded to the LIS despite the upload restrictions. The
BD EpiCenter can be configured to enable or disable unsolicited uploads from the
BD EpiCenter. If unsolicited uploads are enabled, then when a test is assigned an
uploadable status, an upload message is generated to the LIS. If the unsolicited upload
option is disabled, then test status changes do not generate upload messages. Instead, the
LIS has to query the EpiCenter for test information, and only those tests with an
uploadable status are included in the response message. If LIS Forced Uploads is
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enabled at the BD EpiCenter, all test results matching the query will be uploaded
regardless of whether their status is uploadable.
5.2. Uploaded Isolate Results

In an attempt to characterize an organism, a lab may run more than one ID/AST test on a
particular isolate. Multiple ID/AST tests may produce conflicting results for either an
organism id or antibiotic susceptibility. The BD EpiCenter identifies when two or more
tests produce conflicting results and alerts the user that they must select the appropriate
results for that isolate. Once the conflict has been resolved, the BD EpiCenter saves the
ID and AST results for that isolate separate from the test results. On the BD EpiCenter,
these are called Isolate Level Results.
Figure 3 depicts the basic record structures within the BD EpiCenter.
Figure 3
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The relationships and hierarchy of the finalization scheme in the BD EpiCenter is

depicted in Figure 4.
Figure 4
The BD EpiCenter also includes an expert system, which evaluates ID/AST results. The
input to the expert system is the results from any ID/AST test. The output of the expert
system may be a different isolate AST result. Any expert system changes to AST results
are maintained as a separate field, but are included as part of the isolate results. So
isolate results provide both the test result and the expert system result, as described in a
later section.
Isolate results may be a compilation of several ID/AST results. They are also free of any
conflicts. Expert system evaluations are also available with isolate level results. For
these reasons, some LIS sites may find isolate level results more valuable than test level
results. The BD EpiCenter therefore provides a mechanism for uploading isolate level
results, test level results, or both.
The configuration section of the BD EpiCenter allows the user to set an LIS Auto
Uploadable field for isolates. This field can be set to Always “Auto Upload” to LIS,
“Never Auto Upload” to LIS, “Auto Upload When Specimen Finalized” or “Auto Upload
When Isolate Finalized”. This works in a similar way as test status results do for tests.
When the isolate Auto Upload field is set to “Auto Upload When Specimen Finalized”,
isolate level results are only uploaded once the specimen has been finalized by the user.
When the isolate Auto Upload field is set to “Auto Upload When Isolate Finalized”,
isolate level results are only uploaded once the isolate has been finalized by the user.
Isolate results can be forced over these upload restrictions by first enabling the LIS
Forced Upload feature of the BD EpiCenter. Then initiating a manual upload of isolate
results via the BD EpiCenter user interface, or querying for the associated specimen will
result in the isolate results being uploaded to the LIS despite the upload restrictions.
Isolate results are differentiated from test results as follows:
x The Test Id in Order field (O, 5, 1, 4) is set to “ISOLATE RESULT” instead of
a real test id.
x The first result record of an isolate result is always an ID record regardless of
test types.
x The ID record will contain the ID test source in field (R, 4, 1, 9).
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x Unlike test uploads which have a fixed number of results, the number of results included
in an isolate can fluctuate until the isolate is finalized.
x Isolate level AST result records will contain Interpreted (R, 4, 1, 4), Expert (R, 4, 1, 5)
and Final (R, 4, 1, 3) AST susceptibility values whereas test level results only contain
Interpreted (R, 4, 1, 4) AST susceptibility values.
x Isolate level AST result records will contain the AST test source in field
(R, 4, 1, 6).
It is possible to dictate the upload order of individual antimicrobial isolate results from
the BD EpiCenter through the use of Antimicrobial Ordering feature.
5.3. Unsolicited Downloads

The BD EpiCenter accepts unsolicited download data from the LIS containing patient
demographics and supplemental test information. The fields that the BD EpiCenter are
interested in receiving are outlined in section 8 (Message Content) of this document.
Supplemental tests and results are expected to be transmitted in the same logical
placement as tests and results that are uploaded. The time/date fields for test results are
used to identify LIS test results more recent than BD EpiCenter test results. Also a
test/consumable sequence number field can be used as an identifier for a test. This allows
the LIS or BD EpiCenter to distinguish between two tests of the same type ordered
against a specimen.
An LIS Test Order can also be accepted via unsolicited download without a
test/consumable sequence number. In this way the LIS can order tests on specific
specimens and isolates without having to format a valid BD instrumented sequence
number. These orders will be automatically associated with matching tests in the
BD EpiCenter database as they are detected. These orders can also be manually
associated with orphan tests by the BD EpiCenter user.
The BD EpiCenter does not accept edits from the LIS to key fields used to identify
patients and specimen. A patient ID is the key field identifying a patient. An accession
number is the key field identifying a specimen. If either of these fields is received in a
download message to the BD EpiCenter, and these values are not matched in the
BD EpiCenter database, they are considered new entries. Re-association of a test to a
new specimen, or re-association of a specimen to a new patient, must be done at the
BD EpiCenter.
For test order and result information, the BD EpiCenter evaluates the time stamps
associated with that data to determine which results are more current. If the LIS
information is more current, than it is used to override the BD EpiCenter information.
For all other data downloaded from the LIS, which does not include a time stamp, the LIS
data is considered correct and overrides any BD EpiCenter data.
Isolate level results are not accepted in a download from the LIS.
5.4. File Import

The BD EpiCenter has the ability to import LIS files containing downloaded information.
The user can access a screen in the BD EpiCenter to manually select files to import.
Import files must be text files that follow the ASTM 1394 protocol, which describes the
serial line interface. The import file text is sent through the same message parser that
regular serial communications go through, processing the same fields that are configured
for the serial interface.
Currently the BD EpiCenter does not export any upload information to a file.
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5.5. Queries
The BD EpiCenter is able to generate request messages (or queries) to the LIS for
information. When the BD EpiCenter sees a new accession number, either from user
entry or an instrument, the BD EpiCenter uploads a request message. BD EpiCenter
request messages, (as outlined in section 8 - Message Content), are sent for only a single
specimen at a time. Requests for information from the BD EpiCenter should be
interpreted as requests for both patient demographics and supplemental test information
for that specimen.
The BD EpiCenter can be configured to enable or disable queries sent to the LIS. If
BD EpiCenter queries are enabled then the BD EpiCenter generates request messages to
the LIS for information. If LIS queries are disabled, then no request messages are
uploaded to the LIS.
The BD EpiCenter is also able to respond to a request generated by the LIS. The ASTM
E_1394 specification describes several qualifying fields that can be included in the
request for a particular set of results. The qualifying fields that the BD EpiCenter can
process are a subset of those and are outlined in section 8 (Message Content) of this
document.
The fields that are included in an uploaded response message are the same fields that are
included in an n unsolicited upload message.
The BD EpiCenter only requests information from the LIS one specimen at a time. The
BD EpiCenter does not use many of the qualifying fields provided for in the ASTM
specifications. An example of a request from the BD EpiCenter is provided in section
8.2.6, outlining request record fields.
5.6. Error Reporting

The LIS interface implemented by Becton Dickinson adheres to all of the error detection and
recovery outlined in the physical level protocol. The ASTM E_1381 protocol defines the use of
check sums, time outs, etc., for the proper exchange of information. The rules described in that
specification should be used to indicate whether or not data was properly sent between the LIS and
the BD instruments. In the BD EpiCenter, any errors detected at the physical protocol level are
also reported to the user and recorded in an error log.
Information transfers can also contain logical level formatting problems, or errors in message
content. These logical errors may be determined after the physical receipt of the message has been
acknowledged. The ASTM protocols do not describe a mechanism for reporting logical level
errors. Instead any logical level errors are reported to the user by the BD EpiCenter. The
BD Epicenter has an error log that contains any problems that occurred during the processing of an
LIS download. It is the user’s responsibility to recognize and resolve logical level problems.
6. Protocol Specifications
Most of the specifications needed for implementing the communication protocols are contained in the
published documents referred to Overview Section of this document. The following sections contain any
clarifications or deviations to those specifications.
6.1. Physical Protocols

The BD LIS interface implements the ASTM E_1381 physical level protocol as outlined
in the published specification except for the deviations described below.
6.1.1. Memory limitations
The ASTM E_1381 protocol does not place a limit on the total size of the
message that can be received by the instrument. Since the BD EpiCenter is
software resident on a standard PC, it does not have any significant restrictions
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on download message sizes. The BD EpiCenter expects to be able to handle

any reasonably sized messages downloaded from the LIS. Should any
download message exceed the maximum capacity of the EpiCenter, the
message is rejected during transmission and an error notification is displayed to
the user.
6.1.2. Unpacked Frames
Becton Dickinson interprets the ASTM E_1381 specification to imply that an
intermediate frame of a message should be packed to be 240 characters in
length. The only frame that should be less than 240 bytes in size is the last
frame of a message.
However BD has had feedback from several LIS vendors who interpreted the
ASTM E_1381 specification differently. These vendors have requested that
the BD LIS interface be able to send and receive frames that contain only a
single logical record. (i.e. Header, Patient, Order, Result and Terminator
records all are sent in separate frames). This implies that most frames are less
than 240 bytes in length. However it is still possible that a single logical record
could be longer than the 240 bytes limit for a frame. In this case a single
logical record is sent in several consecutive intermediate frames. All but the
last frame are packed to 240 bytes and the last frame containing that logical
record is less than 240 bytes.
The BD LIS interface is configurable to send either packed frames or unpacked
frames, which contain a single record per frame. (The BD simulator described
in a later section also has this configurable option).
6.1.3. BDMODEM
The BD LIS Interface can be configured to use the BDMODEM physical layer protocol.
This customized protocol has been implemented by BD instrumentation already out in the
field. In order to maintain backwards compatibility, the data management system
supports this protocol. However, this protocol is not intended to be used for any new LIS
connections. BD strongly suggests implementing the industry standard ASTM 1381
protocol for all new LIS connections. A full description of the BDMODEM protocol is
provided in other BD documentation. If needed, please contact Becton Dickinson for
more information.
Emulate BACTEC 9000 LIS Interface
The Emulate BACTEC 9000 LIS Interface option is available when
BDMODEM is the selected physical protocol.
This option provides backwards compatibility when an EpiCenter is being
installed where a BD BACTEC instrument is currently connected directly to an
LIS per the BACTEC 9000 LIS Vendor Interface Specification.
Field Map Changes
The following field mappings are changed when the Emulate BACTEC 9000
LIS Interface option is enabled.
EpiCenter Default Value Corresponding BDModem/Emulate 9000 Value
Test Code to O, 5, 1, 4 Test Sequence Number to O, 5, 1, 4
Used for Vial Sequence Number 1
Isolate Source Test 1 to O, 14, 1, 1 Isolate Source Test 1 to O, 5, 2, 4
Isolate Source Test 2 to O, 14, 2, 1 Isolate Source Test 2 to O, 5, 3, 4
Specimen User Text 1 to O, 19, 4, 1 Specimen User Text 1 to O, 5, 4, 4
16
EpiCenter Default Value Corresponding BDModem/Emulate 9000 Value

Specimen User Text 2 to O, 19, 5, 1 Specimen User Text 2 to O, 5, 5, 4
Result Type to R, 3, 1, 4 and enabled Result Type to R, 3, 1, 3 and disabled
Sequence Number to R, 3, 1, 5 Sequence Number to R, 3, 1, 4
Media Type to R, 14, 1, 2 Media Type to R, 3, 1, 5
Instrument Type to R, 14, 1, 1 Instrument Type to R, 14, 1, 5
Instrument Location to R, 14, 1, 5 Instrument Location to R, 14, 1, 1
Request Test Status Code to Q, 5, 1, 2 Request Test Status Code to Q, 5, 1, 4
Request Instrument Number Q, 5, 1, 4 Request Instrument Number to Q, 5, 1, 2
Comment Text C, 4, 1, 1 Comment Text C, 3, 1, 1
Test Status LIS Codes

Duplicate LIS Codes are permitted for BACTEC and FX tests when the Emulate
BACTEC 9000 LIS Interface option is enabled.
6.2. Logical Protocols

The BD LIS interface implements the ASTM E_1394 logical level protocol as outlined in
the published specification except for the deviations described below.
6.2.1. Unprocessed Records
The ASTM E_1394 logical level specification describes the use of Scientific and
Manufacturer records. The BD LIS interface accepts these records in a download
message, however it does not evaluate the content of these record types. These records
are extracted from any messages downloaded from the LIS. Messages generated by a
BD LIS interface do not contain any of these records.
6.2.2. Download Only Fields
The ASTM E_1394 specification describes several fields that are divided into
components, such as patient address field and patient name. For example, the address
field is defined to have the street address, city, state, country, and zip code all separated
by component delimiters. However these fields are saved as a single string in the
EpiCenter database. The BD LIS interface reads those individual components from a
download message and concatenate them for storage.
The BD LIS interface does parse these fields into their components for upload messages.
If a concatenated field is selected for upload, the entire string is placed in the first
component of the field. For example, a Patient’s address, including city, state and zip
code, are all included in the string in the Street Address field of the Patient record.
Currently the only two fields that are handled this way are Patient Name and Patient
Address.
6.2.3. Communication Errors
The ASTM E_1394 protocol defines a hierarchical relationship to logical records. This
protocol states that if a complete message is not successfully transmitted, then only the
logical records that complete the hierarchical relationship must be resent. For example, if
a message containing several patient records is not received by the instrument properly,
17
then only the logical records from the latest Patient record on must be resent in a new
message.
However the ASTM E_1381 protocol, in section 6.5.2.3, states that if a message is not
received properly, the complete message is resent. The BD LIS interface follows the
specification as outlined in the ASTM E_1381 physical level protocol. If a message is
not transmitted successfully the BD LIS interface expects the whole message to be resent.
6.2.4. LIS Codes
The BD EpiCenter uses “LIS Codes” to represent many fields in an LIS communication.
“LIS Codes” are values defined by the LIS that uniquely identify a field. BD uses these
codes for any information that can be configured by the user. These fields include many
patient demographic fields, such as Hospital Service. “LIS Codes” are also used as test
ID values, and as test status values, as described in the overview section.
“LIS Codes” are used for field values instead of full names, as described in the ASTM
E_1394 specification. If an LIS does not have abbreviated codes for these fields, then the
“LIS Codes” can be configured to be the same as the field name text. A complete list of
fields associated with an LIS code can be found in section 8 (Message Content) of this
document.
Again, instruments generally do not communicate using LIS Codes. They send pre-
defined literal strings in their ASTM messages. The strings used by the instruments
when reporting their results are outlined in the instrument specific Appendices of this
document.
LIS codes are NOT case sensitive and have a maximum length of 20 characters, except
resistance markers that have a maximum length of 16 characters.
6.2.5. Blanking fields
As per the ASTM 1394 specification, the BD EpiCenter will accept the “” string as an
indication that the value of a field should be blanked. Key fields, like Patient Id and
Accession Number do not support this feature. When any coded list field in the
BD EpiCenter, for example Hospital Service, gets blanked by the LIS, its value will
change to the default value of “Unspecified”.
The BD EpiCenter can exchange fields with an LIS that include a list of possible values,
for example Resistance Markers. When the BD EpiCenter receives data in a download it
will replace its entire list with the list provided in the download. And in order to blank
out all entries of that list, the “” string should be placed in the first field designated for
that data.
7. Configurable Options
There are several aspects of the BD LIS interface that are configurable by the user. This allows the BD
instruments to tailor their connection to the local LIS. The configurable parts of the BD LIS interface are
described below.
In some cases, configuration options are specific to the EpiCenter. An appendix at the end of this
document lists configuration options specific to each instrument.
7.1. Port parameters

The BD LIS interface is based on serial port communication. The parameters for
initializing the serial port are configurable by the user to allow for proper communication.
The configurable parameters include the following fields.
Comm Port Number – acceptable values range from 1 to 4.
Baud Rate – acceptable values include 300, 600, 1200, 2400, 4800, 9600,
14400, 19200, 28800, 38400, 57600, and 115200.
18
Data Bits – acceptable values range from 5 to 8.

Stop Bits – acceptable values include 1 and 2.
Parity – acceptable values include ODD, EVEN, and NONE.
7.2. Auto-Populating Lists

The BD EpiCenter has a configurable option to allow new entries detected in a
downloaded message to be automatically added to the BD database. If an unrecognized
“LIS Code” is found in a download field, a new entry is made to the database containing
that translation code. A notification is then presented to the user suggesting that they
complete the proper name, and other fields, for that list entry. This is designed to provide
a mechanism for initializing the BD EpiCenter database with all of the relevant values
needed for proper LIS communication.
Antibiotics and organisms are considered coded list fields by the BD EpiCenter and have
an LIS translation code associated with them. For antibiotics and organisms the LIS
codes are defaulted to Becton Dickinson defined abbreviations. The user has the ability
to modify these codes if they do not agree with codes used by the LIS, however the
Organism and Antimicrobial coded lists do not support the auto-populate feature. A
listing of antibiotics and corresponding BD abbreviations can be found in Appendix C. A
listing of organisms and corresponding BD abbreviations can be found in Appendix D.
7.3. Logical Protocol Parameters

The ASTM E_1394 protocol specifies four types of characters to be used to delimit fields
in a record, (field, repeat, component, and escape delimiters). The user is able to
configure which characters are used as delimiter characters. These characters are
defaulted to the ones used in the ASTM E_1394 publication, ‘|’, ‘\’, ‘^’, and ‘&’
respectively.
The user is able to configure whether packed or unpacked frames are uploaded to the LIS.
Unpacked frames contain a single logical record per frame.
At the BD EpiCenter, the user is able to configure whether or not a logical record is
terminated by a CR character only, or both a CR – LF character sequence.
7.4. ASTM Field Mapping

There are a number of fields contained in the BD EpiCenter database that need to be
exchanged with the LIS. BD has made an effort to properly map these fields, per the
ASTM E_1394 specification, to a field position in an appropriate record. However, some
LIS vendors may interpret the meaning of these ASTM fields differently. The BD LIS
interface allows the user to update the location of any field. This should allow the user to
compensate for any inconsistencies between BD and LIS interfaces.
The user is able to identify each field in the BD database as an upload or download field. Fields
enabled for upload messages are included in result messages passed up to the LIS. Fields enabled
for download messages are parsed from any download messages from the LIS. This allows the
BD LIS interface to be tailored to the specific needs of the LIS environment.
Several fields appear to be mapped into multiple locations, including test/consumable sequence
number and Organism Code. These fields are mapped into the Order record because they may be
needed to define a specific ordered test. These fields are also mapped into the Result record
because they may be considered a result of an ID test. These fields are looked for and extracted
from either location.
7.5. User Defined Fields

The BD EpiCenter contains 5 patient and 5 specimen fields that can be defined by the
user. The BD EpiCenter makes no assumptions about what type of information is
19
maintained in these fields. The user is able to use these fields to contain any data that the
BD EpiCenter did account for with its other fields.
Three patient fields and three specimen fields are managed as coded list fields. These are
fields whose value is one from a pre-configured list. For example the Specimen Type
field can be set to a value from a determined list. The user is able to configure the entries
listed in each field and define a label for that field.
Two more patient and 2 more specimen fields are free text fields that need not come from
a pre-defined list of values. For example, these fields could be used for data such as a
patient’s Social Security Number. The user can also define a label for these fields.
Since the BD EpiCenter has no knowledge of the type of information being maintained in
these fields, it cannot assign a meaningful default mapping in an ASTM record. These
fields are mapped by default to an unused ASTM location. They are also disabled by
default for both upload and download messages. The user can populate these fields and
re-map them to an ASTM location agreed upon with the local LIS.
8. Message Content
The following sections describe which fields are exchanged with each instrument and the BD EpiCenter.
8.1. Field List

This section lists all of the fields by name BD EpiCenter can exchange with the LIS.
Each field is displayed with its default mapping in the ASTM E_1394 records. This position
consists of a record type (Patient, Order, Result, Query, or Comment), a field delimiter counter,
repeat delimiter counter, and component delimiter counter. The fields are grouped according to the
ASTM E_1394 record type they are mapped to.
The field list also indicates if that field is defaulted as an upload (U) or download (D) field, or
both (U/D). A blank column indicates that the field is not to be exchanged with an LIS. Fields
not configured to be exchanged with the LIS are ignored in a download message.
The first two fields of every record include the Record Type indicator and a record index value.
These fields are considered part of every record but are not listed in these tables. The following
section describes these fields in more detail, including the expected values for each field.
Result records have data fields with multiple definitions, such as Result Data 1, Result Data 2, etc.
The data contained in these fields depends on the type of results being reported. ID tests may have
organism data in those fields, while AST tests have antibiotic data in those fields. The following
sections describe in more detail what data can be expected in a result record.
Header Record Field Name ASTM Pos. Direction

Sender Name H, 5, 1, 1 U
Version Number H, 13, 1, 1 U
Message Date/Time H 14, 1, 1 U
Patient Record Field Name ASTM Pos. Direction

Patient ID P, 4, 1, 1 U/D
Patient Name (Last) P, 6, 1, 1 U/D
Patient Name (First) P, 6, 1, 2 D
Patient Name (Middle) P, 6, 1, 3 D
Patient Name (Suffix) P, 6, 1, 4 D
Patient Name (Title) P, 6, 1, 5 D
Date of Birth P, 8, 1, 1 U/D
Patient Sex P, 9, 1, 1 U/D
20

Address (Street) P, 11, 1, 1 U/D
Address (City) P, 11, 1, 2 D
Address (State) P, 11, 1, 3 D
Address (Zip Code) P, 11, 1, 4 D
Address (Country) P, 11, 1, 5 D
Patient Phone Number P, 13, 1, 1 U/D
Admitting Physician P, 14, 1, 1 U/D
Patient User Field 1 P, 15, 1, 1
Patient Diagnosis P, 19, 1, 1 U/D
Patient Therapy (1-5) P, 20, 1-5,1 U/D
Admit Date/Time P, 24, 1, 1 U/D
Room Number P, 26, 1, 1 U/D
Hospital Service P, 33, 1, 1 U/D
Hospital Client P, 34, 1, 1 U/D
Order Record Field Name ASTM Pos. Direction

Accession Number O, 3, 1, 1 U/D
Isolate Number O, 3, 1, 2 U/D
Organism O, 3, 1, 3 U/D
Exclude Isolate from Statistics O, 3, 1, 4 U/D
Test ID O, 5, 1, 4 U/D
Test/Consumable Sequence Number O, 5, 1, 5 U/D
Priority O, 6, 1, 1 U/D
Collection Date/Time O, 8, 1, 1 U/D
Collected By O, 11, 1, 1 U/D
Received By O, 11, 1, 2 U/D
Specimen Action Code O, 12, 1, 1 U
Isolate Source Test (1-3) O, 14,1-3,1 U/D
Isolate Source Test Start Time (1-3) O, 14,1-3,2 U/D
Receipt Date/Time O, 15, 1, 1 U/D
Specimen Type O, 16, 1, 1 U/D
Body Site O, 16, 1, 2 U/D
Ordering Physician O, 17, 1, 1 U/D
Ordering Physician Phone O, 18, 1, 1 U
Ordering Physician Fax O, 18, 1, 2 U
Ordering Physician Pager O, 18, 1, 3 U
Specimen User Field 1 O, 19, 1, 1
Finalized Date/Time* O, 23, 1, 1 U/D
Specimen Reimbursement Value O, 24, 1, 1 U
Test Reimbursement Value O, 24, 2, 1 U
Isolate Classification/Nosocomial O, 29, 1, 1 U/D
Result Record Field Name ASTM Pos. Direction

Result Type Code R, 3, 1, 4 U/D
Test/Consumable Sequence Number R, 3, 1, 5 U/D
21

Antibiotic R, 3, 1, 6 U/D
Antibiotic Concentration R, 3, 1, 7 U/D
Antibiotic Concentration Units R, 3, 1, 8 U/D
Test Status R, 4, 1, 1 U/D
Result Data 1
BACTEC MGIT 960 R, 4, 1, 2 U
Growth Units
ProbeTecET/Viper XTR R, 4, 1, 2
Alg.Results
AST MIC for AST MIC test R, 4, 1, 2 U/D
AST Diameter for AST Dia. test R, 4, 1, 2 U/D
Organism ID for ID test R, 4, 1, 2 U/D
Result Data 2
AST susceptibility (Final) R, 4, 1, 3 U/D
Profile Number for ID Test R, 4, 1, 3 U/D
Profile Number for Isolate ID R, 4, 1, 3 U/D
Result Data 3
AST susceptibility (Interpreted) R, 4, 1, 4 U
Resistance Marker 1 R, 4, 1, 4 U
Result Data 4
AST susceptibility (Expert) R, 4, 1, 5 U
Result Data 5
AST Source test R, 4, 1, 6 U
Result Data 6
Result Data 7
Result Data 8
ID Source Test R, 4, 1, 9 U
Preliminary/Final Status R, 9, 1, 1 U/D
Test Start Date/Time R, 12, 1, 1 U/D
Result/Status Date/Time R, 13, 1, 1 U/D
Test Complete Date/Time R, 13, 2, 1 U
Media Setup Date/Time R, 13, 1, 2 U
Instrument Type R, 14, 1, 1 U
Media/Assay Type R, 14, 1, 2 U
Protocol Length R, 14, 1, 3 U
Instrument Number R, 14, 1, 4 U
Instrument Location R, 14, 1, 5 U
Protocol Name R, 14, 1, 8 U
Additional Result Quantity (1-5) R, 15, 1-5,1 U/D
Additional Result (1-5) R, 15,1-5,2 U/D
Comment Record Field Name ASTM Pos. Direction

Comment Text C, 4, 1, 1 U/D
Comment Type C, 5, 1, 1 U/D
Request Record Field Name ASTM Pos. Direction
22
Request Starting Patient Id Q, 3, 1, 1 D

Request Starting Accession Number Q, 3, 1, 2 U/D
Request Starting Sequence Number Q, 3, 1, 3 D
Request Ending Patient Id Q, 4, 1, 1 D
Request Ending Accession Number Q, 4, 1, 2 D
Request Ending Sequence Number Q, 4, 1, 3 D
Request Test Id Q, 5, 1, 1 D
Request Test Status Q, 5, 1, 2 D
Request Instrument Type Q, 5, 1, 3 D
Request Instrument Number Q, 5, 1, 4 D
Request Result Qualifier Q, 5, 1, 5 D
Request Time Qualifier Q, 6, 1, 1 D
Starting Date/Time Q, 7, 1, 1 D
Ending Date/Time Q, 8, 1, 1 D
Request Information Status Code Q, 13, 1, 1 U/D
Terminator Record Field Name ASTM Pos. Direction

Termination Code L, 3, 1, 1 U/D
8.2. Field Descriptions

This section provides detailed information for each field listed in the previous section.
8.2.1. Header Fields
The header records that start each logical message are the same from all BD instruments.
An example record is provided below. For examples of Header records used in the
context of a message, please refer to Appendix A of this document.
H|\^&| | |Becton Dickinson| | | | | | | |V1.00|19981019184200
Delimiter Fields (H, 2, 1, 1) – These single characters can be used to process the
remainder of the message. These characters denote the field, repeat, component and
escape delimiters as described in the ASTM E_1394 specification. These fields are
defaulted to “|”, “\”, “^”, and “&” respectively, as shown above.
Sender Name (H, 5, 1, 1) – Messages coming from a Becton Dickinson instrument have
the BD identifier in this field as shown above.
Version Number (H, 13, 1, 1) – This version number represents the version of the
BD LIS interface used for communications.
Message Date/Time (H, 14, 1, 1) – BD includes the current time and date when
constructing his message, formatted as described in the ASTM E_1394 specification in
section 6.6.2.
23
8.2.2. Patient Fields

A full patient record is shown below. The fields used in this example are referred to in
the field explanations. For examples of Patient records used in the context of a message,
please refer to Appendix A of this document.
P|1| |PatId123| |Doe^John^R^Jr.^Dr.| |19651029|M| |2 Main

St.^Baltimore^ MD^21211ÛSA| |(410) 316 - 4000|JSMITH| | |
| |PNEU|P\AM\AMX| | | |19981015120000| |324| | | | | | |ER|St.
Josephs Hospital
Patient ID (P, 4, 1, 1) - Identifier that uniquely identifies a patient. This is a required

field for patient demographic downloads. This field can be up to 16 characters long.
(e.g. PatId123)
Patient Name (P, 6, 1, 1-5) – Patient name is divided into 5 components in the ASTM
E_1394 specification. The BD EpiCenter stores these fields as a single string in its
database. Therefore the BD LIS Interface concatenates these fields from a download
message. The patient name can be up to 40 characters long. If these fields are selected
for upload on the EpiCenter the whole name is placed in the first component of this field
(P, 6, 1, 1). Patient name shown in the sample record is Dr. John R Doe Jr.
Date of Birth (P, 8, 1, 1) – Patient date of birth formatted as described in ASTM E_1394
section 6.6.2. The date shown in the sample record is Oct. 29, 1965.
Patient Sex (P, 9, 1, 1) – There are 3 predefined values accepted for this field in the
BD EpiCenter database, Male, Female, and Unspecified. If the value does not match the
code for either Male or Female then the sex is set to Unspecified. (This is an LIS coded
field for the EpiCenter).
Patient Address (P, 11, 1, 1-5) – The ASTM E_1394 specification suggests that the
address field be divided into 5 separate components. The BD EpiCenter concatenates all
5 address fields into one before saving it in the database. The patient address can be up
to 255 characters long. If this field is selected for upload on the EpiCenter, the whole
address is placed in the first component of this field (P, 11, 1, 1).
Patient Phone Number (P, 13, 1, 1) – This field is defined as a free text field that can be
up to 25 characters long.
Admitting Physician (P, 14, 1, 1) – The physician admitting the patient into the hospital.
In the example above “JSMITH” could be used as an LIS defined abbreviation for Dr.
Jane T. Smith, who may work in the hospital. (This is an LIS coded field for the
BD EpiCenter).
Patient Diagnosis (P, 19, 1, 1) – The diagnosis assigned to the patient for the current
visit. In the example above “PNEU” could be used as an LIS defined abbreviation for
Pneumonia. (This is an LIS coded field for the EpiCenter).
Patient Therapy (P, 20, 1-5, 1) – This field contains up to 5 antibiotics that the patient
may be receiving at the time the specimen is being processed. A repeat delimiter as per
ASTM E_1394 specifications separates each antibiotic. The above example indicates
that the patient is currently receiving Penicillin (P), Ampicillin (AM), and Amoxicillin
(AMX). (This is an LIS coded field for the EpiCenter).
Admission Date/Time (P, 24, 1, 1) – This is the time and date that the patient was
admitted to the hospital. This field is formatted as specified in the ASTM E_1394
specification, in section 6.6.2. The time portion of this field is assumed to be local time.
The optional time zone is deemed unnecessary and is not evaluated.
24
Note: If the Date/Time string is less than fourteen-characters, the time shall be set to
12:00:00 AM.
Room Number (P, 26, 1, 1) – This is a text field containing the patient’s room number
and can be up to 10 characters long.
Hospital Service (P, 33, 1, 1) – The ward or hospital service involved in caring for this
patient. (This is an LIS coded field for the BD EpiCenter). (e.g. ER may represent the
Emergency Room).
Hospital Client (P, 34, 1, 1) – This field is used by reference laboratories that accept
specimens from client hospitals. (This is an LIS coded field for the BD EpiCenter).
User Defined Patient Fields 1-3 (P, 15, 1-3, 1) – In the BD EpiCenter, the user has the
ability to configure the values for 3 coded lists related to patient fields. These fields are
mapped to unused fields in the patient record by default. The user may fill these fields
and remap them to a field agreed upon by the local LIS. (These are LIS coded fields for
the BD EpiCenter).
User Defined Patient Fields 4-5 (P, 15, 4-5, 1) – In the BD EpiCenter, the user has 2
free text fields that can hold any alpha-numeric information. These fields are mapped to
unused fields in the patient record by default. The user may fill these fields and remap
them to a field agreed upon by the local LIS.
8.2.3. Order Fields
A full order record is shown below to provide examples for the content of each field. For
examples of Order records used in the context of a message, please refer to Appendix A
of this document.
O|1|Acc123^1^MYCBTUB | | ^ ^ ^ MGIT_960_GND ^Seq123|

| |19981019023300| | |SJB^MMF|A| | |19981019045200
|BloodÂrm|MJones|(410) 555 – 1234^(410) 555 – 9876^(410)
555 – 7777| | | | |19981020053400|62| |O| | |Nos
Accession Number (O, 3, 1, 1) – The unique alphanumeric string that identifies a

specimen. This field can be up to 20 characters long. (e.g. Acc123) This is a required
field for processing specimen and test information.
Isolate Number (O, 3, 1, 2) – The number associated with an isolate that the test should
be performed on.. This field should only be used when ordering isolate based tests,
otherwise this field should be left blank. Isolate numbers can range from 1 to 20.
Organism (O, 3, 1, 3) – The organism assigned to a particular isolate. The organism
code shown in the example above, MYCBTUB, is the code for Mycobacterium
tuberculosis. (This is an LIS coded field for the BD EpiCenter).
If an organism is indicated when ordering a BD Phoenix 100 or BD Phoenix
M50 ID/AST combo panel, then the ID portion of the panel will automatically
be disabled. As a result, only the AST portion of the panel will report results.
Exclude Isolate from Statistics (O, 3, 1, 4) – This field will explicitly indicate if this
isolate should be included or excluded from statistic reporting. If this field contains an
“I”, then the isolate will be included in statistical reporting. If this field contains an “E”,
then the isolate will be excluded from statistical reporting. If this field is left empty, then
the BD EpiCenter will use its internal logic to make this decision.
25
Test Id (O, 5, 1, 4) – The unique code used to represent a particular test. This is an LIS
coded field for the BD EpiCenter. For BD instrumented tests, the test ID is the pre-
defined test name provided in appendix B. (e.g. MGIT_960_GND)
For isolate level results coming from the BD EpiCenter, this field will
contain the string “ISOLATE RESULT”.
As noted in Appendix B, tests common to the BD BACTEC 9000 and
BD BACTEC FX have the same LIS code.
Test/Consumable Sequence Number (O, 5, 1, 5) – The value that identifies a test ordered.
For tests originating from an instrument, this field is set with the consumable id value.
For manual tests ordered at the BD EpiCenter, this field contains any test id entered by
the user at test order time. In downloads from the LIS, this field is used to distinguish
between multiple tests (of the same type) ordered against a specimen. If this field is
blank, the BD EpiCenter assumes that this is an LIS Test Order and creates a blank test
in the BD EpiCenter database. These orders will be automatically associated with
matching tests in the EpiCenter database as they are detected. These orders can also be
manually associated with orphan tests by the BD EpiCenter user.
This value can be up to 17 characters long.
Priority (O, 6, 1, 1) – This field is defined in the ASTM E_1394 specification. Currently
only the values ‘A’ for Critical, ‘R’ for Normal and blank for default normal or no
change are supported.
Collection Date/Time (O, 8, 1, 1) – Date and time that the specimen was collected from
the patient, formatted as described in ASTM E_1394 section 6.6.2. The date/time shown
in the sample record is 2:33 am on Oct. 19, 1998.
12:00:00 AM.
Collected By (O, 11, 1, 1) – The hospital personnel that collected the specimen from the
patient. The example above shows that the specimen was collected by SJB which could
be the initials for Sarah J Baker. (This is an LIS coded field for the BD EpiCenter).
Received By (O, 11, 1, 2) – The lab technician that received the specimen. The example
above shows that the specimen was received by MMF, which could be the initials for
Mike M Ferris. (This is an LIS coded field for the BD EpiCenter).
Specimen Action Code (O, 12, 1, 1) – This field is defined in the ASTM E_1394
specification. Currently only the value Q is supported, for QC tests. Normal tests leave
this field blank.
Isolate Source Test (1-3) (O, 14, 1-3, 1) – The isolate source test is the specimen level
test that produced the isolate. Often growth and detection tests are sub-cultured to
produce several isolates. This field will contain test ids for up to 3 tests that yielded an
isolate. This field only applies to Order records containing isolate information.
Isolate Source Test Start Time (1-3) (O, 14, 1-3, 2) – This is the start date and time of
the isolate source test described above. It is possible that two of the same test type will
be run on a specimen. This field is used to uniquely identify the isolate source test. This
field only applies to Order records containing isolate information. This field is formatted
as described in ASTM E_1394 section 6.6.2.
Receipt Date/Time (O, 15, 1, 1) – Date and time that the specimen was received into the
lab, formatted as described in ASTM E_1394 section 6.6.2. The date/time shown in the
sample record is 2:33 am on Oct. 19, 1998.
12:00:00 AM.
26
Specimen Type (O, 16, 1, 1) – The type of specimen collected from the patient. (This is
an LIS coded field for the BD EpiCenter). (e.g. Blood)
Body Site (O, 16, 1, 2) – The body area that the specimen was taken from. (This is an
LIS coded field for the BD EpiCenter). (e.g. Arm)
Ordering Physician (O, 17, 1, 1) – The physician that ordered this test. (This is an LIS
coded field for the BD EpiCenter). (e.g. MJones could represent Mark Jones).
Ordering Physician Phone Numbers (O, 18, 1, 1-3) – The phone numbers that can be
used to reach the ordering physician. Three numbers are accepted in this field, phone
number, fax number and pager number. A component delimiter separates each phone
number. These fields are free text fields that can be up to 25 characters in length.
User Defined Specimen Fields 1-3 (O, 19, 1-3, 1) – In the BD EpiCenter, the user has
the ability to configure the values for 3 coded lists related to specimen fields. These fields
are mapped to unused fields in the patient record by default. The user may fill these
fields and remap them to a field agreed upon by the local LIS. (This is an LIS coded field
for the BD EpiCenter).
User Defined Specimen Fields 4-5 (O, 19, 4-5, 1) – In the BD EpiCenter, the user has 2
free text fields that can hold any alphanumeric information. These fields are mapped to
unused fields in the order record by default. The user may fill these fields and remap
them to a field agreed upon by the local LIS.
Finalized Date/Time (O, 23, 1, 1) – The ASTM specification describes this field as
containing the time the results were last modified. The BD EpiCenter places this
information in the result record to be evaluated for each result. This field contains the
date/time, formatted as described in ASTM E_1394 section 6.6.2, that the results for this
test were finalized.. This field is blank if the test results are not yet finalized. The time
shown in the example record is 5:34 am on Oct 20, 1998.
For isolate level results, this field contains the date/time the specimen was finalized.
Specimen Reimbursement Value (O, 24, 1, 1) – The value used for insurance
reimbursement based on the specimen type. This number can be between 0 and 10,000.
The value of 62 is used in the example record above.
Test Reimbursement Value (O, 24, 2, 1) – The value used for insurance reimbursement
based on this test type. This number can be between 0 and 10,000. The example record
above does not have a test reimbursement value.
Report Type (O, 26, 1, 1) – This field is defined in the ASTM E_1394 specification.
When a cancelled order is sent back to the LIS the report type is ‘X’.
Isolate Classification/Nosocomial (O, 29, 1, 1) – This field contains the BD EpiCenter
LIS code for the isolate classification. The BD EpiCenter has a pre-defined list of
classifications for an isolate. The complete list is as follows (Significant/Nosocomial,
Significant/Community Acquired, Significant/Unknown, Contaminate, Not Determined).
If a downloaded code is not recognized, then the Isolate Classification is set as
Significant/Unknown.
8.2.4. Result Fields
The BD EpiCenter uploads results from several different types of tests. This causes
several different types of result records to be passed to the LIS. The information
contained in the generic “Data Fields” depends on the type of result being reported. AST
Result records contain antibiotic and susceptibility information. ID Result records
contain organism and Resistance Marker information. Growth and Detection result
records contain a Positive or Negative status. Below are several different examples of
result records, each one passing up a different type of result.
27
For AST sets, several result records may be sent to the LIS in a single message. Each
result record would report the results for a single drug in the AST set. For ID/AST
combo tests, an ID result record is sent as the first result record, and the AST result
records follow. An example AST set result message is shown in the Appendix A of this
document.
Isolate results are also exchanged using these records. Isolate results are exchanged using
the same format as an ID/AST combo tests with an ID record first, then followed by
several AST result records. Since isolate results are not associated with a particular
test, the test code field in the Order record is replaced with the literal string
“ISOLATE_RESULT”.
For examples of Results records used in the context of a message, please refer to
Appendix A of this document.
BACTEC MGIT 960 growth and detection test level result example
R|1| ^ ^ ^GND_MGIT^430100001234|INST_POSITIVE
^87| | | | |P| | |19981019153400|19981020145000|
MGIT960^^42^3^B/A12
BACTEC MGIT 960 AST test level result example:
R|1| ^ ^ ÂST_MGIT^439400005678^P^0.5ûg/ml|
INST_COMPLETE^105^^S| | | | |P| | |19981019153400|
19981020145000|MGIT960^^42^3^ B/A12
Phoenix AST MIC test level result example:
R|1| ^ ^ ÂST_MIC^429530000002^P|
INST_COMPLETE^0.5^^S| | | | | F| | |19981019153400|
19981020145000
Diameter based AST test level result example:
R|1|^^ÂST_DIA^Seq123^P^0.5|COMPLETE^15^^S| | |
| |F| | |19981019153400| 19981020145000
Identification test level result example:
R|1| ^ ^
ÎD^Seq123|Complete^MYCBTUB^45678^RM_VRE| | |
| |F| | |19981019153400|19981020145000
For all other tests:
R|1| ^ ^ ÔTHER^Seq123|Complete| | | | |F| |

|19981019153400|19981020145000|
|Many^GPOS_Bac\Few^GNEG_Rods
Isolate level result example:
R|1| ^^ÂST^^P^100.0ûg/mL|
^^R^R^^MGIT_960_AST92| | | | |F
28
“Universal Test ID” ASTM E_1394 Result field 3

Result ID Code (R, 3, 1, 4) – This is a BD defined code that indicates the type of
information being exchanged in the result record. The interpretation of several fields
may vary depending on which type of result is being passed. The possible values for this
field include the following.
GND – indicates results for a BD BACTEC FX, BD BACTEC 9000, or generic
growth and detection test.
GND_MGIT – indicates results for a BD BACTEC MGIT 960 growth and
detection test.
GND_PROBETEC – indicates results for a BD ProbeTec ET test.
AST – indicates results for a generic AST test not included in the other AST
categories.
AST_MGIT – indicates results for a BD BACTEC MGIT 960 Antibiotic
Susceptibility Test.
AST_MIC – indicates results for an MIC based Antibiotic Susceptibility Test.
AST_DIA – indicates results for a diameter based Antibiotic Susceptibility Test.
(e.g. Kirby Bauer tests).
ID – indicates identification results.
STREAK – indicates Innova Protocol results
OTHER – indicates test results not included in the above categories.
Test/Consumable Sequence Number (R, 3, 1, 5) – The value that identifies the
media/consumable used for generating these results. This field may be blank for manual
test results where a sequence number is not known. This value can be up to 17 characters
long. The example records above show the results being reported for sequence number
“Seq123”.
A test/consumable sequence number is required for all instrumented test
results downloaded to the BD EpiCenter. For manual or supplemental test
results downloaded to the BD EpiCenter this field is optional. If no sequence
number is included with the results the BD EpiCenter searches on the current
access number for any test matching the test code provided in the order record.
If a match is found, the BD EpiCenter updates the results for that test. If no test
match is found, then the BD EpiCenter orders a new test. Be aware that
unwanted consequences could occur if more than one of a particular test
type are ordered for an access number and test sequence numbers are not
used.
Antibiotic (R, 3, 1, 6) (AST Results) – The antibiotic tested in this AST test. The
antibiotic code shown in the above AST examples is “P” for Penicillin. (This is an LIS
coded field for the EpiCenter).
Concentration (R, 3, 1, 7) (AST Results) – Several AST tests, such as Kirby Bauer tests,
are done with antibiotics at a specific concentration. For these tests the antibiotic
concentration is needed to define the test that results are being provided for. When no
concentration units are provided it is assumed to be in ug/ml. This field can be up to 15
characters long. The antibiotic concentration shown in the AST (MGIT960) example
above is “0.5”.
Concentration Units (R, 3, 1, 8) (AST Results) – The BD BACTEC MGIT 960 results
include the concentration units of the concentration provided in the previous field. This
field can be up 15 characters long. The concentration units shown in the AST example
29
above is “ug/ml” for micrograms per milliliter. This is also assumed to be the default if
no other value is provided.
“Data or Measurement Values” ASTM E_1394 Result field 4
The contents of the Result Data fields vary depending on the type of test result being
reported, as described below.
Test Status (R, 4, 1, 1) – The status value for a particular test. This field is filled for all
test results. This is an LIS coded field for the BD EpiCenter. For BD instrumented tests,
the status code is one of the pre-defined values listed in Appendix B of this document.
The GND example record shown above has a test status value of INST_POSITIVE.
Result Data Field 1
Growth Units (R, 4, 1, 2) (BACTEC MGIT 960 Results Only) – See Appendix E for
instrument specific information. The Positive GND tube listed above indicates 87 growth
units. The AST example record shows a growth value of 105. This field is never more
than 5 characters long.
ProbeTecET Algorithmic Result (R, 4, 1, 2) (BD ProbeTec ET/Viper XTR Result
Only) – See Appendix E for instrument specific information. (future)
Minimum Inhibitory Concentration (R, 4, 1, 2) (MIC based AST Result) – For AST
tests that produce MIC values, this field contains the minimum antibiotic concentration
that inhibits growth of the tested organism. The example above for an MIC based AST
test contains an MIC value of “0.5”. This field can be up to 20 characters long and is
assumed to contain a number in ug/ml.
This field may contain signed MIC values such as “<=4” or “>8”, MIC values
for compound antimicrobials such as “0.5/4”or “<=0.5/16” as well as the
following:
“?” - Ongoing
“C” - Antimicrobial is Rapid Completed (For nonQC tests in EpiCenter V4
and later)
“X” - Error
Diameter (R, 4, 1, 2) (Diameter based AST Results) – For Kirby Bauer type tests, this
field contains the diameter of the inhibited growth region caused by the antibiotic. The
diameter based AST example above shows a diameter value of 15. This number is
assumed to be in millimeters.
Organism (R, 4, 1, 2) (ID Results Only) – The organism assigned to a particular isolate.
The organism code shown in the example above, MYCBTUB, is the code for
Mycobacterium tuberculosis. (This is an LIS coded field for the BD EpiCenter).
Result Data Field 2
AST Susceptibility, Final (R, 4, 1, 3) (Isolate AST results only) – This is a code that
indicates is the organism is susceptible to the antibiotic specified in this record. The
acceptable values for this field are S, I, R, N, and X, representing susceptible,
intermediate, resistant, not-susceptible and error respectively. This field is only uploaded
by the BD EpiCenter as part of an isolate level result (see earlier section). The isolate
AST example record shows that the user decided to override the expert system results and
say that the organism was susceptible to the antibiotic, indicated by “S” in the Final field.
Profile Number (R, 4, 1, 3) (ID results and Isolate ID results) – This is a text field that
holds the profile number associated with an ID test. This value can be up to 16 characters
long. The ID result record example above indicates a profile number of 45678.
30
Result Data Field 3

AST Susceptibility, Interpreted (R, 4, 1, 4) ( All AST results) – This is a code that
indicates is the organism is susceptible to the antibiotic specified in this record. The
intermediate, resistant, not-susceptible and error respectively. This field contains the
AST interpretation from the instrument or user before being processed by the Expert
System. The isolate AST example record shows that the organism has intermediate
susceptibility to the specified antibiotic, indicated by “I”.
Resistance Marker 1 (R, 4, 1, 4) (Isolate ID results) – This represents a Resistance
Marker associated with the organism identified in the ID result record. The BD EpiCenter
generates this data as part of the expert system and are only included for Isolate uploads.
The first Resistance Marker in the ID example above is RM_VRE, which may be an LIS
code used for Vancomycin resistant Enterococci. (This is an LIS coded field for the
BD EpiCenter).
Result Data Field 4
AST Susceptibility, Expert (R, 4, 1, 5) (Isolate AST results only) – This is a code that
indicates if the organism is susceptible to the antibiotic specified in this record. The
intermediate, resistant, not-susceptible and error respectively. This field is only uploaded
by the BD EpiCenter as part of an isolate level result (see earlier section). The
BD Phoenix 100, the BD Phoenix M50, and the BD EpiCenter have an expert system that
can produce a secondary evaluation of susceptibility. The isolate AST example record
shows that the expert system decided that the organism is resistant to the specified
antibiotic, indicated by “R”.
The example record above contains only one Resistance Marker. (This is an LIS coded
field for the BD EpiCenter).
Result Data Field 5
AST Source Test (R, 4, 1, 6) (Isolate AST results) – This represents the Test Id for the
source test that included this AST result. This is included because Isolate results may be
compiled from several different AST tests. The example Isolate upload record above
contains the Test Id of MGIT_960_AST. (This is an LIS coded field for the
BD EpiCenter).
It is possible that there can be results on the isolate upload that have been inferred by the
BD EpiCenter BDXpert system and are not associated with a test. When this
condition occurs, BD EpiCenter uploads a “blank”, or an empty field in the
AST Source Test field(R, 4, 1, 6) as well as the MIC field(R, 4, 1, 2).
Results example with AST Source Test:
R|2|^^ÂST^^CTX|^<=1^S^S^^NMICID4 | | | | |F
Inferred results example without AST Source Test:
R|3|^^ÂST^^CZ|^^R^^R| | | | |F
31
Result Data Field 6

Result Data Field 7
Result Data Field 8
ID Source Test (R, 4, 1, 9) (Isolate ID results) – This represents the Test Id for the
source test that produced this ID result. (This is an LIS coded field for the
BD EpiCenter).Preliminary/Final Status (R, 9, 1, 1) – This field contains either a “P” or
an “F” as defined in the ASTM E_1394 specification. The result status shown in the
examples above are final. For isolate level results, this indicates the status of the isolate.
Start Date/Time (R, 12, 1, 1) – This is the date and time that the test was first started or
entered into an instrument. This field is formatted as described in the ASTM E_1394
specification in section 6.6.2. The test start time shown above is 3:34 pm on Oct 19,
1998. This field has special significance for BACTEC MGIT 960 AST tests. Please
read the instrument specific section for more details.
Result/Status Date/Time (R, 13, 1, 1) – This is the date and time that the test received
the status being reported in this record. This is a required field and is used to identify
when results downloaded from the LIS are more recent than those contained in the
BD EpiCenter. This field is formatted as described in the ASTM E_1394 specification in
section 6.6.2. The test status time shown above is 2:50 p.m. on Oct 20, 1998.
Test Complete Date/Time (R, 13, 2, 1) – This is the date and time that an instrumented
test finished its results. This is different than the Result Date/Time in that this time will
not change if the user assigns a new status to a test. For a growth and detection result
record, this field will hold the Positivity Date/Time. For an ID result record, this field
will hold the time that the Id portion of a BD Phoenix 100 or BD Phoenix M50 panel
completed. For an AST result from a BD Phoenix 100 or BD Phoenix M50 panel, this
field will hold the time that a valid MIC was produced. This field is formatted as
described in the ASTM E_1394 specification in section 6.6.2.
Media Setup Date/Time (R, 13, 1, 2) – For Innova tests this field indicates the time that
the specimen was successfully streaked. If the specimen was not successfully streaked,
this field will be blank.
Instrument Type (R, 14, 1, 1) (Instrumented Results Only) – This field indicates which
BD instrument produced the result. This field is filled with one of several BD defined
values listed below.
“BT9000” – BD BACTEC 9000 series instrument
“MGIT960” – BD BACTEC MGIT 960 instrument
“PHOENIX” – BD BD ID/AST instrument
“PROBETEC” – BD ProbeTec ET instrument
32
“BACTECFX” - BD BACTEC FX instrument

“INNOVA” – BD Innova instrument
Media Type (R, 14, 1, 2) (Instrumented Results Only) – This field indicates the type of
media or consumable used to perform this test. See Appendix E for instrument specific
information.
Protocol Length (R, 14, 1, 3) (Instrumented Results Only) – this field indicates the
length of time (in hours or days) required to complete the test. For growth and detection
tests, this number represents the number of days before a tube can be considered
negative.
Instrument Number (R, 14, 1, 4) (Instrumented Results Only) – This is the user
number assigned to the instrument that ran the test. This value can be between 1 and 99.
Instrument Location (R, 14, 1, 5) (Instrumented Results Only) – This value indicates
the position inside of the instrument where the test was performed.
For BD BACTEC MGIT 960 tests this value indicates a drawer number, row number
and well number. In the GND example above, the location B/A12 indicates that the test
was performed in drawer B, row A well number 12.
For Innova tests this value indicates a drawer number, canoe number, and position in
canoe and is represented as 3-1-8.
BD ProbeTec ET QC Type (R, 14, 1, 6) (BD ProbeTec ET Result Only) – See
Appendix E for instrument specific information.
Test Protocol (R, 14, 1, 8) - This value indicates the name of the protocol with which the
specimen was processed on the Innova instrument.
BD ProbeTec ET QC Kit Lot Number (R, 14, 1, 7) (BD ProbeTec ET Result Only) –
See Appendix E for instrument specific information.
Additional Results Quantity 1-5 (R, 15, 1-5, 1) (BD EpiCenter Additional Results
Only) – This field contains a text value that associates a quantity to the additional result
reported in the next ASTM component field. The quantities Many and Few are used in
the example record for other tests. See the Additional Results field description for more
detail. (This is an LIS coded field for the BD EpiCenter).
Additional Results (R, 15, 1-5, 2) (BD EpiCenter Additional Results Only) – There are
several tests that can be assigned multiple results at one time. An example of such a test
is a Gram Stain test, which can be assigned results such as “Gram Negative Rod Seen”
AND “Gram Positive Bacillus Seen”. These results differ from GnD test results of
simply Positive or Negative. The BD EpiCenter maintains a user configurable list of
additional test results that can apply to a test. Each additional result can also be
associated with a quantity value, which precedes the additional result in the record. In
the example above for other tests, the additional results and quantities reported are Many
GP_BAC and Few GN_RODS. (These are LIS coded fields for the BD EpiCenter).
8.2.5. Comment Fields
The BD EpiCenter accepts and sends comment strings for patients, specimen, and
isolates. Patient comments are exchanged in a comment record following a patient
record, and include the patient type identifier. Specimen and isolate comments are
exchanged in a comment record following the order record, and include either the
specimen or isolate type identifier. An order record with both a specimen and isolate
comment is shown below.
If multiple comment records are received for a patient, specimen, or isolate, then all
comments of the same type are appended together and saved in the BD EpiCenter.
33
The BD EpiCenter can upload the description for chartable rules. This is the descriptive
text for expert system rules that have been run against an isolate. The user has the ability
to configure individual rules as reportable on a patient’s chart report. If a rule is
configured to be chartable, the rule description will be included in an upload Comment
record. These comment records will follow after an Order record. Since the
BD EpiCenter expert system rules only apply to isolates, these types of comments will
only be part of Isolate Uploads as described in section 5.2.
The following is an example of a comment record containing a rule where <310> is the
rule number and (AMX, ATM, CAZ) is a list of the affected antimicrobials.
C|1| |<310> BDXpert Rule 310 text.( AMX, ATM, CAZ )|E
Special Messages are messages that indicate a special condition for a BD Phoenix 100 or
BD Phoenix M50 panel. These will be uploaded in a Comment record as part of the test
results for the panel. The following is an example of a comment record containing a
special message with a list of the affected antimicrobials.
C|1| | Special message text. (AM, CAZ)|T

Comment records not appearing after the Patient or Order records are ignored.
Comments not containing the appropriate type indicator are ignored.
O|1|Acc123^1^MYCBTUB|
C|1| |This is a specimen comment |S
C|2| |This is an isolate comment |I
Comment Text (C, 4, 1, 1) – The text to be used for the patient, specimen or isolate
comment. This field can be up to 1600 characters long.
Comment Type (C, 5, 1, 1) – The type of comment record. This field should be a P, S,
I, E, T or R for patient, specimen, isolate, chartable rule, special message or result
comment respectively.
8.2.6. Request Fields
The ASTM E_1394 defines a Request record with several fields for qualifying the
requested data. Data requests can be made by specifying ranges of patient IDs, accession
numbers, or sequence numbers. Data requests can also be qualified by date/time ranges.
All of these fields are supported by the BD EpiCenter interface for requests originating
FROM the LIS.The field mapping table on the previous pages correctly indicates the
support query fields. Examples can also be found in the Sample Messages section of this
document.
Q|1|Âcc123||MGIT_960_GNDÎNST_POSITIVE^MGIT_960
^2|R|19981019120000|19981020120000
The sample record shown above is evaluated to request the result information for positive
MGIT_960_GND tests, on instrument 2, for the specimen with an accession number of
Acc123 between the dates specified. Note that all query criteria are ANDed together, so
that only records that meet ALL criteria will be uploaded in response to a query from the
LIS.
The BD EpiCenter only requests information from the LIS on a per specimen basis. The
request records generated by the BD EpiCenter contains only the accession number as a
qualifying field as shown below. The BD EpiCenter request should be interpreted as
requesting both patient demographics and all ordered tests for that specimen.
34
Q|1|Âcc123| | |R
Starting Patient ID (Q, 3, 1, 1) – A patient ID value. This field should be filled if the
data request is for either a single patient or for a range of patients. If patient ID is not to
be used as a search criterion for requested data, then this field can be left blank. This
field can be up to 16 characters long. In the example above, a range of patients is
specified, beginning with patient ID “Pat123”.
Starting Access Number (Q, 3, 1, 2) – A specimen ID value. This field should be filled
if the data request is for either a single specimen or for a range of specimen. If accession
number is not to be used as a search criterion for requested data, then this field can be left
blank. This field can be up to 20 characters long. In the example above, a range of
specimen is specified, beginning with Accession number “Acc123”.
Starting Sequence Number (Q, 3, 1, 3) – A consumable ID value. This field should be
filled if the data request is for either a single test or for a range of tests. If sequence
blank. This field can be up to 17 characters long. In the example above, no specific
sequence numbers are requested.
Ending Patient ID (Q, 4, 1, 1) – The patient ID that ends the alphanumeric range of ID
values requested. If only data for a single patient ID is requested, then this field can be
left blank. This field can be up to 16 characters long. This field contains “Pat456” in the
example shown above.
Ending Accession Number (Q, 4, 1, 2) – The specimen ID that ends the alphanumeric
range of ID values requested. If only data for a single accession number is requested,
then this field can be left blank. This field can be up to 20 characters long. This field
contains “Acc456” in the example shown above.
Ending Sequence Number (Q, 4, 1, 3) – The consumable ID that ends the alphanumeric
range of ID values requested. If only data for a single test is requested, then this field can
be left blank. This field can be up to 17 characters long. In the example above, no
specific sequence numbers are requested.
Test ID (Q, 5, 1, 1) – This is the code used to represent a particular test, and is used to
request the results for this test type. This is an LIS coded field for the BD EpiCenter.
For BD instrumented tests, the test id is the pre-defined test name listed in appendix B.
Test Status (Q, 5, 1, 2) – The status for a particular test. This field is only evaluated if
the Test ID field contains valid data. This is an LIS coded field for the BD EpiCenter.
For BD instrumented tests the status value is one of the pre-defined values listed in
Appendix B. The example record requests result information for XXX tests with a status
of INST_POSITIVE.
Instrument Type (Q, 5, 1, 3) – This field indicates the type of instrumented test
requested by the LIS. The BD EpiCenter may be connected to several instruments of
different types. This field allows the LIS to request all tests run in a particular instrument
type. The appropriate values for this field are listed for the Instrument Type in the result
record (R, 14, 1, 1). If the value MGIT960 is used in this field, all MGIT_960_GND and
all MGIT_960_AST tests are returned.
Instrument Number (Q, 5, 1, 4) – This field allows the LIS to request results for a
particular instrument number. This field is only evaluated if the instrument type field is
also set.
Result Qualifier (Q, 5, 1, 5) – This field allows the LIS to request results that have been
modified since the last request. The only acceptable value for this field is MOD, to
indicate modified results. If this field is left blank, all results that meet the remaining
35
criteria are included. The BD EpiCenter will not accept other criteria in a query
containing the MOD result qualifier.
Time Qualifier (Q, 6, 1, 1) – The use of this field is described in the ASTM E_1394
specification. The acceptable values for this field are S, R, and T which identify the
content in the Starting and Ending Date/Time fields as follows:.
(S) - Specimen Collection Time
(R) – Result Time
(T) – Test Start Time
EpiCenter NOTE: If no Time Qualifier is specified, the Starting and Ending
Times will, by default, refer to Result times.
In the example record times refer to result dates.
Starting Date/Time (Q, 7, 1, 1) – The starting date/time (inclusive) of the data
requested. This field is formatted as specified in ASTM E_1394 specifications section
6.6.2. The date/time requested in example above is 12 pm on Oct 19, 1998.
EpiCenter NOTE: If a Starting Date/Time is specified and no Ending
Date/Time is specified, data will be delivered whose Collection or Result Time
is since the specified Starting Date/Time.
EpiCenter NOTE: If a Starting Date/Time specifies only the Date portion, the
time will default to midnight 00:00:00.
Ending Date/Time (Q, 8, 1, 1) – The ending date/time (inclusive) of the data requested.
This field is formatted as specified in ASTM E_1394 specifications section 6.6.2. The
date/time requested in example above is 12 pm on Oct 20, 1998.
EpiCenter NOTE: If an Ending Date/Time specifies only the Date portion, the
time will default to 23:59:59.
Request Information Status Code (Q, 13, 1, 1) – This field cancels an outstanding
query. The only acceptable value for this field is ‘A’. The BD EpiCenter will ignore any
other Request criteria fields when they appear in the same query record as a Query
Cancel command.
If the string ‘ALL” appears in any Request Field, and no other Criteria are present, the
BD EpiCenter will attempt to upload all test data in its database to the LIS.
If the string ‘ALL” appears in any Request Field, and any other Criteria are present, the
BD EpiCenter will ignore it because an empty criteria field is an implied ‘ALL’.
8.2.7. Terminator Fields
Below is an example terminator record.
L|1|N
Termination Code (L, 3, 1, 1) – The termination code provides an explanation of the
end of session as described in the ASTM E_1394 specification. The BD EpiCenter
supports codes of N, Q, F and I in request responses downloaded from the LIS, as
described in the ASTM specifications. However the EpiCenter and all of the BD
instruments upload either N, Q or F. All other codes are ignored and treated as a normal
message. Normal result uploads are indicated with N and request response uploads are
indicated by F. Requests that contain an error are replied to with an empty message
containing the code ‘Q’ in the terminator record. Requests that have no data satisfying
the request, are responded to with a message containing only a Header and Terminator
record.
36
The BD interface sends the results for a single test in a message. However there may be
several tests that satisfy a data request downloaded by the LIS. In this instance, the BD
interface uploads all tests but the last as single tests in separate messages marked as
normal uploads (N). Only the last test that satisfies the request is marked as query
response (F). Once the LIS receives the query response indicator (F), it has received all
of the data it requested.
9. Simulator
Becton Dickinson has developed a simulator for testing the physical level LIS interface. This simulator can
be configured to emulate either the LIS or instrument in the ASTM E_1381 protocol.
The simulator accepts ASTM E_1394 message strings from a file and transmit them across the serial port
interface. The simulator also receives messages across the serial port interface and save the message text
into a file. A full description of the simulators specifications can be found in a separate document.
Becton Dickinson intends to make the simulator and supporting document available to LIS vendors to help
facilitate interface development.
37
10. Appendix A - Sample BD EpiCenter Messages

10.1. LIS Order
BD BACTEC MGIT 960 GND tube ordered at the LIS for a new patient. Patient and test
information is downloaded to the BD EpiCenter.
H|\^&||||||||||||19981019184200
P|1||PatId123||Doe^John^R^Jr.^Dr.||19651029|M||2 Main
St.^Baltimore^ MD^21211ÛSA||(410) 316 - 4000|JSMITH|||||
|P\AM\AMX||||19981015120000||324|||||||ER|St. Josephs
Hospital
O|1|Acc123^ ^ ^Seq123|| ^ ^ ^MGIT_960_GND||
|19981019023300|||SJB^MMF|A|||19981019045200
|BloodÂrm|MJones|(410)555-
-1234^(410)555-
-9876^(410)555-
-
7777|||||19981020053400|62||O||Nos
L|1|N
10.2. Host Query

The BD EpiCenter can receive a new accession number from a barcode on an
instrumented test. The BD EpiCenter requests information from the LIS about that
specimen.
H|\^&|||Becton Dickinson||||||||V1.00|19981019184200
Q|1|Âcc123|||R
L|1|N
The LIS should respond to this request with patient demographics and ordered test
information. Patient Demographics may not be included if they are not yet known. The
terminator record should indicate that this is a message in response to a request.
H|\^&||||||||||||19981019184200
P|1||PatId123||Doe^John^R^Jr.^Dr.||19651029|M||2 Main
St.^Baltimore^ MD^21211ÛSA||(410) 316 - 4000|JSMITH|||||
|P\AM\AMX||||19981015120000||324|||||||ER|St. Josephs
Hospital
O|1|Acc123^ ^ ^Seq123|| ^ ^ ^MGIT_960_GND||
|19981019023300|||SJB^MMF|A|||19981019045200
|BloodÂrm|MJones|410)555-
-1234^410)555-
-9876^(410)555-
-
7777|||||19981020053400|62||O||Nos
L|1|F
10.3. LIS Requests Results

The LIS can request result information from the BD EpiCenter.
H|\^&||||||||||||19981019184200
Q|1|Âcc123|Âcc125|MGIT_960_GNDÎNST_POSITIVE^MGIT960^2|R
L|1|N
38
10.4. Results
BD EpiCenter will report results to the LIS in response to a request for results or as an
unsolicited upload message. When results are uploaded in response to a request, the
termination code in the terminator record will indicate that this is a message in response
to a request.
H|\^&|||Becton Dickinson|||||||| V1.00 |19981019184200
P|1||PatId123
O|1|Acc123||^^^MGIT_960_GND^430100065178
R|1|^^^GND^430100065178|INST_POSITIVE^87|||||P||
|19981019153400|19981020145000|MGIT960^^42^3^B/A12
L|1|F
10.4.1. BACTEC G&D Test results

P|1||P0001||Patient
Name||20040229|M|||||ADMIT_PHYS||||||||||20060221092800||||
|||||HOSP_SERV|CLIENT
O|1|20060223001||^^^PLUSAEF^449200917642|R||20060222092300|
||COLL_BY^RECD_BY||||20060223092300|SAMP_TYPE^BODY|ORD_PHYS
||||||20060223105527
R|1|^^^GND^449200917642|INST_NEGATIVE|||||F|||2005020112304
6|20050208124106|BT9000^92^32^7Â1
L|1|N
10.4.2. MGIT 960 G&D Test results:

P|1||PatXYZ||Mr. Fred A. Stare
O|1| Acc456||^^^MGIT_960_GND^430100065177|R||
20041104082700|||||||20041104082750||||||||20050316152949
R|1|^^^GND_MGIT^430100065177|INST_NEGATIVE^0|||||F|
||20041029112243|20041103110237|MGIT960^^5^1^B/C17
L|1|N
10.4.3. MGIT AST Test Results
H|\^&|||Becton Dickinson|||||||| V1.00 |19981019184200

P|1||PatId123
O|1|Acc123||^^^MGIT_960_AST
R|1|^^ÂST_MGIT^439400001234^P^0.5ûg/ml|
INST_COMPLETE^105^^S||||||||19981019153400|19981020145000|
MGIT960^^42^3^ B/A13
R|2|^^ÂST_MGIT^439400001234ÂMX^0.5ûg/ml|
INST_COMPLETE^142^Î||||||||19981019153400|19981020145000|
MGIT960^^42^3^ B/A14
R|3|^^ÂST_MGIT^439400001234ÂM^0.5ûg/ml|
INST_COMPLETE^130^^R||||||||19981019153400|19981020145000|
MGIT960^^42^3^B/A15
L|1|N
39
10.4.4. Innova Results

P|1||PatID1||Smith Billy Bob
B||20110405|M||||||||||||||||||||||||ER|Client
O|1|Acc055||^^ÎNNOVA|R||20110422010000|||collecby^recby|||
|20110423102935|RESP^bdysite|phys||||||20110512113329
R|1|^^^STREAK|INST_COMPLETE|||||F|||20110512113327|
20110512113329|INNOVA^^^^1-1-1^^^Protocol 2_1
L|1|N
10.4.5. Isolate Results

Isolate results are different from test results as follows:
x The Test Id in Order field (O, 5, 1, 4) is set to “ISOLATE RESULT” instead of
a real test id.
x The first result record of an isolate result is always an ID record regardless of
test types.
x The ID record will contain the ID test source in field (R, 4, 1, 9).
x Unlike test uploads which have a fixed number of results, the number of results included
in an isolate can fluctuate until the isolate is finalized.
x Isolate level AST result records will contain Interpreted (R, 4, 1, 4), Expert (R, 4, 1, 5)
and Final (R, 4, 1, 3) AST susceptibility values whereas test level results only contain
Interpreted (R, 4, 1, 4) AST susceptibility values.
x Isolate level AST result records will contain the AST test source in field (R, 4, 1,
6).
P|1||P0001||Patient Name||20040229|M|||||ADMIT_PHYS|||
|||||||20060221092800|||||||||HOSP_SERV|CLIENT
O|1|20060223001^1ÊSCCOL||^^ÎSOLATE RESULT|
||20060222092300|||COLL_BY^RECD_BY|||
|20060223092300|SAMP_TYPE^BODY|ORD_PHYS|
|||||20060223105534||||||UNK
R|1|^^ÎD|ÊSCCOL^0000031BF0000021^^^^^^NMIC/ID-14|||||F
R|2|^^ÂST^ÂM|^8^S^S^^NMIC/ID-14|||||F
R|3|^^ÂST^ÂMC|^8/4^S^S^^NMIC/ID-14|||||F
R|4|^^ÂST^ÂN|^<=2^S^S^^NMIC/ID-14|||||F
R|5|^^ÂST^ÂTM|^<=2^S^S^^NMIC/ID-14|||||F
R|6|^^ÂST^^CAZ|^<=1^S^S^^NMIC/ID-14|||||F
R|7|^^ÂST^^CIP|^<=0.25^S^S^^NMIC/ID-14|||||F
R|8|^^ÂST^^CTX|^<=2^S^S^^NMIC/ID-14|||||F
R|9|^^ÂST^^CXM|^8^S^S^^NMIC/ID-14|||||F
L|1|N
Isolate with Expert system changes - Blank MIC, modified SIR

The BDXpert system may change either the MIC value or the SIR value calculated on the
instrument based on rules that implement generally accepted microbiology principles or
suppressed reporting requirements. In the example below, 4 result values have been
impacted.
40
Result record 2 and 14 have had the MIC removed and the SIR value set to “R” due to
intrinsic resistance of this organism to the drugs. Note that the MIC field is empty. A
blank value should be posted in the LIS system for this MIC.
Result record 5 has had the SIR value modified from S to X indicating that the drug result
cannot be reported.
Result record 17 has had the SIR value modified from S to R, indicating the drug should
be reported as resistant even though it appeared susceptible in vitro.
P|1||P0001||Patient Name||20040229|M|||||ADMIT_PHYS
||||||||||20060221105100||Room|||||||HOSP_SERV|CLIENT
O|1|20060223002^2^STAWAR||^^ÎSOLATE RESULT|||
20060222105100|||COLL_BY^RECD_BY||||20060223105100|
SAMP_TYPE^BODY|ORD_PHYS||||||20060223105622||||||UNK
R|1|^^ÎD|^STAWAR^00000010002DD000^^^^^^PMIC/ID-14|||||F
R|2|^^ÂST^ÂM|^^R^^R^PMIC/ID-14|||||F
R|3|^^ÂST^ÂMC|^8/4^R^R^^PMIC/ID-14|||||F
R|4|^^ÂST^^C|^4^S^S^^PMIC/ID-14|||||F
R|5|^^ÂST^^CC|^<=0.25^X^S^X^PMIC/ID-14|||||F
R|6|^^ÂST^^CIP|^<=0.5^S^S^^PMIC/ID-14|||||F
R|7|^^ÂST^Ê|^>4^R^R^^PMIC/ID-14|||||F
R|8|^^ÂST^^FM|^<=16^S^S^^PMIC/ID-14|||||F
R|9|^^ÂST^^GM|^<=2^S^S^^PMIC/ID-14|||||F
R|10|^^ÂST^^LVX|^<=1^S^S^^PMIC/ID-14|||||F
R|11|^^ÂST^^LZD|^2^S^S^^PMIC/ID-14|||||F
R|12|^^ÂST^^MXF|^<=1^S^S^^PMIC/ID-14|||||F
R|13|^^ÂST^ÔX|^>2^R^R^^PMIC/ID-14|||||F
R|14|^^ÂST^^P|^^R^^R^PMIC/ID-14|||||F
R|15|^^ÂST^^RA|^<=0.5^S^S^^PMIC/ID-14|||||F
R|16|^^ÂST^^SXT|^<=0.5/9.5^S^S^^PMIC/ID-14|||||F
R|17|^^ÂST^^VA|^2^R^S^R^PMIC/ID-14|||||F
L|1|N
Isolate with Resistance Markers

If an organism is identified with resistance mechanism, then the resistance mechanism
code is reported as part of the identification result. Up to 5 resistance marker codes can
be sent.
P|1||P0001||Patient Name
||20040229|M|||||ADMIT_PHYS||||||||||20060221105100||Room||
O|1|20060223002^2^STAWAR||^^ÎSOLATE RESULT
|||20060222105100|||COLL_BY^RECD_BY||||20060223105100|
SAMP_TYPE^BODY|ORD_PHYS||||||20060223105622||||||UNK
R|1|^^ÎD|^STAWAR^00000010002DD000^RM_MRSA^RM_GP_BL^^^^
PMIC/ID-14 |||||F
R|4|^^ÂST^^C|^4^S^S^^PMIC/ID-14|||||F
L|1|N
41
Isolate with Expert Comments

Certain rules in BD EpiCenter can produce chartable comments. These comments appear
after the Order record and have a Comment Type of “E””.
There is no limit to the number of comments that could be
reported.
||20040229|M|||||ADMIT_PHYS||||||||||20060221105100||Room||
||||| HOSP_SERV|CLIENT
O|1|20060223002^2^STAWAR||^^ÎSOLATE
RESULT|||20060222105100|||COLL_BY^RECD_BY||||20060223105100
| SAMP_TYPE^BODY|ORD_PHYS||||||20060223112842||||||UNK
C|1||<132>Staphylococcal isolates that are resistant to
oxacillin (MRS) should not be treated with penicillins,
beta-lactam/beta-lactamase inhibitor combinations,
cephalosporins and carbapenems.( AM, P )|E
C|2||<335>Macrolide-resistant staphylococci with an
interpretation of susceptible or intermediate for
clindamycin may have inducible resistance to clindamycin
(MLSb resistance) or may be resistant only to macrolides
(efflux-mechanism). User must perform a clindamycin
induction test (disk approximation test). If positive,
isolate should be reported as clindamycin resistant.
However, clindamycin may still be effective in some
patients. If "D" zone is not observed, isolate should be
reported as susceptible.( CC )|E
R|1|^^ÎD|^STAWAR^00000010002DD000^RM_MRSA^^^^^
PMIC/ID-14|||||F
R|4|^^ÂST^^C|^4^S^S^^PMIC/ID-14|||||F
R|5|^^ÂST^^CC|^<=0.25^X^S^X^PMIC/ID-14|||||F
R|6|^^ÂST^^CIP|^<=0.5^S^S^^PMIC/ID-14|||||F
R|7|^^ÂST^^P|^^R^^R^PMIC/ID-14|||||F
L|1|N
Isolate with inferred results

The Expert system is able report results for drugs that were not actually tested on the
instrument. This may be used where the drug on the test is not commonly prescribed, but
is used as an indicator for drugs available in the pharmacy.
In this case, because the drug was not rested in the instrument, the inferred result records
do not have MIC or test source values. In this case a blank should be posted for the MIC.
Result record 6 is an inferred result in the example below.
||20040229|M|||||ADMIT_PHYS||||||||||20060221105100||Room||
O|1|20060223002^1ÊNTCFAA||^^ÎSOLATE
|SAMP_TYPE^BODY|ORD_PHYS||||||20060223112842||||||UNK
42
R|1|^^ÎD|ÊNTCFAA^000017F82CD064C0^^^^^^PMIC/ID-14|||||F
R|2|^^ÂST^ÂM|^<=2^S^S^^PMIC/ID-14|||||F
R|3|^^ÂST^^C|^8^S^S^^PMIC/ID-14|||||F
R|4|^^ÂST^Ê|^2ÎÎ^^PMIC/ID-14|||||F
R|5|^^ÂST^^GMS|^<=500^S^S^^PMIC/ID-14|||||F
R|6|^^ÂST^ÎPM|^^S^^S|||||F
R|7|^^ÂST^^LVX|^<=1^S^S^^PMIC/ID-14|||||F
R|8|^^ÂST^^LZD|^2^S^S^^PMIC/ID-14|||||F
R|9|^^ÂST^^MXF|^<=1^S^S^^PMIC/ID-14|||||F
L|1|N
Isolate with multiple test sources

The Isolate results in BD EpiCenter are a consolidation of all AST results for an
organism. As a result, if more than one test is used to generate these susceptibility
results, more than one test source code could be reported back to the LIS system.
In the example below, the result record 16 is a drug not available on the panels tested,
and was thus a supplemental test with test code “KB”.
||20040229|M|||||ADMIT_PHYS||||||||||20060221092800||||||||
|HOSP_SERV|CLIENT
O|1|20060223003^1^KLEPNEP||^^ÎSOLATE
|SAMP_TYPE^BODY|ORD_PHYS||||||20060223120336||||||UNK
R|1|^^ÎD|^KLEPNEP^000012DFF9412020^^^^^^ NMIC/ID-14|||||F
R|2|^^ÂST^ÂM|^>16^R^R^^NMIC/ID-14|||||F
R|3|^^ÂST^ÂMC|^16/8ÎÎ^^NMIC/ID-14|||||F
R|4|^^ÂST^ÂN|^32ÎÎ^^NMIC/ID-14|||||F
R|5|^^ÂST^ÂTM|^<=2^S^S^^NMIC/ID-14|||||F
R|6|^^ÂST^^CF|^<=1^S^S^^NMIC-2|||||F
R|7|^^ÂST^^CIP|^2ÎÎ^^NMIC/ID-14|||||F
R|8|^^ÂST^^CTX|^<=2^S^S^^NMIC/ID-14|||||F
R|9|^^ÂST^^CXM|^16ÎÎ^^NMIC/ID-14|||||F
R|10|^^ÂST^^CZ|^16ÎÎ^^NMIC/ID-14|||||F
R|11|^^ÂST^^FOX|^<=1^S^S^^NMIC-2|||||F
R|12|^^ÂST^^FM|^64ÎÎ^^NMIC/ID-14|||||F
R|13|^^ÂST^^LVX|^2^S^S^^NMIC/ID-14|||||F
R|14|^^ÂST^^MEM|^<=1^S^S^^NMIC/ID-14|||||F
R|15|^^ÂST^^NN|^8ÎÎ^^NMIC-2|||||F
R|16|^^ÂST^ÔX|^4^R^R^^KB|||||F
R|17|^^ÂST^^PIP|^>64^R^R^^NMIC/ID-14|||||F
L|1|N
Isolate with multiple instruments

An BD EpiCenter is configured with mixed instruments, BD Phoenix and
BD BACTEC MGIT 960.
P|1||PatXYZ||Mr. Fred A. Stare
O|1|Acc456^2^STACOH||^^ÎSOLATE RESULT|||
20041104082700||||||| 20041104082750||||||||||||||UNK
R|1|^^ÎD|^STACOH^00001C71C71C71C7^^^^^^GPIDAST 954|||||F
43
R|2|^^ÂST^ÂM|^^X^^X^GPIDAST 954|||||F
R|3|^^ÂST^ÂMC|^>16/8^X^R^X^GPIDAST 954|||||F
R|4|^^ÂST^^CF|^>0.125^X^R^X^GPIDAST 954|||||F
R|5|^^ÂST^^CIP|^<=2^S^S^^GPIDAST 954|||||F
R|6|^^ÂST^^CRO|^>1^X^X^^GPIDAST 954|||||F
R|7|^^ÂST^^FEP|^<=4^X^S^X^GPIDAST 954|||||F
R|8|^^ÂST^^GM|^>32^R^R^^GPIDAST 954|||||F
R|9|^^ÂST^ÎNH^0.10 ug/mL|^^R^R^^MGIT_960_AST94|||||F
R|10|^^ÂST^ÎNH^0.40 ug/mL|^^S^S^^MGIT_960_AST94|||||F
R|11|^^ÂST^ÎPM|^4^X^S^X^GPIDAST 954|||||F
R|12|^^ÂST^^LVX|^^S^^S|||||F
R|13|^^ÂST^^MEM|^<=1^X^S^X^GPIDAST 954|||||F
R|14|^^ÂST^ÔFX|^^S^^S|||||F
R|15|^^ÂST^^P|^>1^X^X^^GPIDAST 954|||||F
R|16|^^ÂST^^RA^1.0 ug/mL|^ÎÎ^^MGIT_960_AST94|||||F
R|17|^^ÂST^^SXT|^^^^^GPIDAST 954|||||F
R|18|^^ÂST^^TE|^^^^^GPIDAST 954|||||F
R|19|^^ÂST^^TZP^0.5|^^R^R^ÂSTDIA1|||||F
L|1|N
44
11. Appendix B – Tests and Results

The following appendix lists test names and test status values. If the LIS code for a test name or test status
is different than the name, it is in parenthesis next to the name. Instrumented tests and their status values
appear in bold. At the BD EpiCenter the non-instrumented tests can be reconfigured by the user. Note:
This list is not intended to be an exhaustive list, for example only some of the Test Names are listed for the
Phoenix Gram Negative and Gram Positive panel types.
Test Type Test Name (LIS Code) Test Status (LIS Code)
False Positive
Incomplete
30 degree MGIT 960 G&D Tube (30MGT)
Negative
Positive
Incomplete
Acid Fast Bacilli Seen (AFB Seen)
Acid Fast Smear (AFS)
No Acid Fast Bacilli Seen (No AFB
Seen)
Positive (INST_POSITIVE)
Negative (INST_NEGATIVE)
Indeterminate (INST_INDETERMINATE)
ProbeTec ET Assay (BD_PROBETEC_GND)
Equivocal (INST_EQUIVOCAL)
QC Pass (INST_QC_PASS)
QC Fail (INST_QC_FAIL)
Colistin (COLIS)
Incomplete
Growth and Gram Stain (GRMSTN)
Negative
Detection Lowenstein-Jensen Medium (LJ)
Positive
Tests Myco/F Lytic (MYFLTC)
Pending (Pending)
False Positive (False Positive)
Manual Negative (Manual Negative)
Manual Positive (Manual Positive)
Threshold Positive (Threshold
MGIT 960 G&D Tube (MGIT_960_GND) Positive)
Negative (INST_NEGATIVE)
Ongoing (INST_ONGOING)
Removed Ongoing (INST_REMOVED)
Positive (INST_POSITIVE)
Complete (INST_COMPLETE)
Contaminate
Incomplete
Middlebrook 7H11 Medium (7H11)
Negative
Positive
Indirect Acid Fast Smear (INDAFS)
Indirect Gram Stain (INDGRMSTN) Complete
ID Tests
ProbeTec ET MAC (ETMAC) Incomplete
ProbeTec ET Mtb (ETMTB)
Ampicillin Disk (AMDISK)
AST –
Cephalothin Disk (CFDISK) Complete
Diameter
Gentamicin Disk (GMDISK) Incomplete
Tests
Penicillin Disk (PDISK)
45
Test
Test Name (LIS Code) Test Status LIS Code
Type
Pending (Pending)
Manual Complete (Manual Complete)
AST – MGIT 960 AST Carrier Set
AST Error (INST_ERROR)
MGIT 960 (MGIT_960_AST)
Complete (INST_COMPLETE)
Ongoing (INST_ONGOING)
460TB AST (460TB)
Ethambutol AST Test (ETHM)
AST-MIC Isoniazid AST Test (INH) Complete
Tests Pyrazinmide AST Test (PZA) Incomplete
Rifampin AST Test (RIF)
Streptomycin AST Test (STREPM)
NID Complete (INST_COMPLETE)
Rapid Complete (INST_RAPID_COMPLETE)
NQC01 Ongoing (INST_ONGOING)
Phoenix NMIC/ID-1 Partially Complete
Gram NMIC/ID-13 (INST_PARTIAL_COMPLETE)
NMIC/ID-14 In Attention Complete
Negative (INST_ATTN_COMPLETE)
NMIC/ID-15 In Attention Ignored (INST_ATTN_IGNORED)
Pending (INST_PENDING)
QC Status see section 14.3.3
PID Complete (INST_COMPLETE)
Rapid Complete (INST_RAPID_COMPLETE)
PQC01 Ongoing (INST_ONGOING)
Phoenix PMIC/ID-1 Partially Complete
Gram PMIC/ID-17 (INST_PARTIAL_COMPLETE)
PMIC/ID-18 In Attention Complete
Positive (INST_ATTN_COMPLETE)
PMIC/ID-20 In Attention Ignored (INST_ATTN_IGNORED)
Pending (INST_PENDING)
QC Status see section 14.3.3
BD
Sceptor Complete (COMPLETE)
Panels
BACTEC DVE PLUS Aerobic/F (96AER)
9000 DVE PLUS Anaerobic/F (97ANA)
Lytic/10 Anaerobic/F (LYTIC10ANF)
Myco/F Lytic (MYCFLYTIC)
Mycosis-IC/F (MYCOSISIC)
PEDS Plus/F (PEDPLUSF) Confirmed Positive(Confirmed Positive)
Manual Negative(Manual Negative)
PLUS Aerobic/F (PLUSAEF) Manual Positive(Manual Positive)
Plus Aerobic/F (82) (PLUS_A) Negative(INST_NEGATIVE)
Plus Aerobic/F(DVE)(80) (DVE_A) Ongoing (INST_ONGOING)
Plus Anaerobic/F (PLUSANF) Pending (Pending)
Positive(INST_POSITIVE)
Plus Anaerobic/F(83) (PLUS_N) Removed Ongoing(INST_REMOVED)
Plus Anaerobic/F(DVE)(81) (DVE_N)
Standard 10 Aerobic/F (STD10AEF)
Standard Aerobic/F(90) (STDAER)
Standard Anaerobic/F (STDANF)
BACTEC Lytic/10 Anaerobic/F (LYTIC10ANF)

FX Myco/F Lytic (MYCFLYTIC) Confirmed Positive(Confirmed Positive)
Manual Negative(Manual Negative)
Mycosis-IC/F (MYCOSISIC) Manual Positive(Manual Positive)
PEDS Plus/F (PEDPLUSF) Negative(INST_NEGATIVE)
PLUS Aerobic/F (PLUSAEF) Ongoing (INST_ONGOING)
Plus Anaerobic/F (PLUSANF) Pending (Pending)
Positive(INST_POSITIVE)
Standard 10 Aerobic/F (STD10AEF) Removed Ongoing(INST_REMOVED)
Standard Anaerobic/F (STDANF)
46
Test
Test Name (LIS Code) Test Status LIS Code
Type
Innova Protocol (INNOVA) Complete (INST_COMPLETE)

Innova
Error (INST_ERROR)
Blood Agar Plate (TSA)
Blood Agar Plate Anaerobic (BAPANA)
CDC Anaerobe 5% Sheep Blood Agar (CDC)
CDC Anaerobe Laked Sheep Blood Agar
Other Complete
with KV (KV)
Tests Incomplete
Cefinase (CEFINASE)
Choc Plate (CHOC)
Indole (INDOLE)
MacConkey II Agar (MAC)
47
12. Appendix C – Antibiotic Abbreviations

The following is a list of the antibiotics in the BD database, with the associated LIS Code. On the
BD EpiCenter, BD Phoenix 100, and BD Phoenix M50, these codes are configurable by the user. However
on the BD BACTEC MGIT and BD ProbeTec ET instruments these values are not configurable. Therefore
a direct instrument interface sends these values as AST results.
1st gen cephalosporin CEFG1 Framycetin SO

1st gen cephalosporins CEF_G1 Furazolidone FX
1st gen cephalosporins w/ anti-pseudomonaCEF_H1AP Fusidic Acid FA
2nd gen cephalosporin; grp 1 GRP1 Gatifloxacin GAT
2nd gen cephalosporin; grp 2 (cephamycinsGRP2 Gemifloxacin GEM
2nd gen cephalosporin; grp 3 GRP3 Gentamicin GM
2nd gen cephalosporins CEF_G2 Gentamicin -Syn GMS
3rd gen cephalosporin w/ aerobic GNR actiCEF_MAP Glycopeptides GLYCPEP
3rd gen cephalosporin w/ anti-pseudomonalCEF_AP Grepafloxacin GRX
3rd gen cephalosporins CEF_G3 High level amino glycosides HLAR
4th gen cephalosporin CEFG4 Hydrolyzable Penicillins PEN_GRP
4th gen cephalosporins CEF_G4 Imidazole IMIDAZ
6' methoxypenicillin MO_PEN Imipenem IPM
Amdinocillin AMD Isepamicin ISP
amdinopenicillins AMDINO_PEN Isoniazid INH
Amikacin AN Josamycin JM
Aminocyclitols AMNCYC Kanamycin K
Aminoglycosides AMNGLY Kanamycin Synergy KS
aminopenicillins AM_PEN Levofloxacin LVX
aminopenicillins w/ Beta-lact. Inhib. AM_PEN_BLI Lincomycin L
Amoxicillin AMX Lincosamides LINCO
Amoxicillin/Clavulanate AMC Linezolid LZD
Amoxicillin/Clavulanate (f) AXC Lividomycin LV
Ampicillin AM Lomefloxacin LOM
Ampicillin/Sulbactam SAM Loracarbef LOR
Ampicillin/Sulbactam (f) SXA Lymecycline LYM
Antimycobacterial drugs AMYCOB Macrolides MACRO
Apalcillin APL Macrolides Lincosam. StreptoMLS
Apramycin AP Mecillinam MEC
Arbekacin ARB Meropenem MEM
Aspoxicillin APX Methacycline MC
Astromycin AST Methicillin DP
Azithromycin AZM Metronidazole MET
Azlocillin AZ Mezlocillin MZ
Aztreonam ATM Mezlocillin/Sulbactam MZS
Bacitracin B Micronomycin MCR
Benzylpenicillin BZP Midecamycin MID
Beta-lactams BETA_LAC Minocycline MI
Biapenem BPM Monobactams MONOBAC
Capreomycin CAP Moxalactam MOX
Carbacephem CARBACEF Moxifloxacin MXF
Carbenicillin CB Mupirocin MUP
Carbepenems CARBAPEN Nafcillin NF
carboxypenicillins CO_PEN Nalidixic Acid NA
carboxypenicillins w/ Beta-lact. Inhib. CO_PEN_BLI Neomycin N
Carumonam CAR Netilmicin NET
Cefaclor CEC Nifuroazide NFX
Cefadroxil CFR Nifurzide NZD
Cefamandole MA Nitrofurantoin FM
Cefatrizine FAT Nitroxoline NIT
Cefazolin CZ Non-hydrolyzable PenicillinsPEN_M
Cefbuperazone CFB Norfloxacin NOR
Cefdinir CDR Novobiocin NB
Cefditoren CDN Nystatin NY
Cefditoren pivoxil CDNp Ofloxacin OFX
Cefepime FEP Olandeomycin OL
Cefepime/Sulbactam SFP Ornidazole ORN
Cefetamet-pivoxil CAT Others OTHER
48
Cefixime CFM Oxacillin OX

Cefmenoxime CMX Oxolinic Acid OA
Cefmetazole CMZ Oxytetracycline T
Cefminox CNX p -Aminosalicylic acid PAS
Cefodizime CDZ Panipenem PAN
Cefonicid CID Paromomycin PAR
Cefoperazone CFP Pefloxacin PEF
Cefoperazone/Sulbactam SCP Penamycin PENAMYCIN
Ceforanide CND Penicillin G P
Cefotaxime CTX Penicillin V PV
Cefotaxime/Clavulanate CCX Penicillin w/ Beta -lact. inhPEN_BLI
Cefotaxime/Sulbactam SCT Penicillins PENS
Cefotetan CTT Penicill ins w/ Beta-lact. inPENS_BLI
Cefotiam CFT Phenoxymethylpenicillin PXM
Cefotiam-hexiteil CFTh Pipemidic Acid PI
Cefoxitin FOX Piperacillin PIP
Cefozopran CFZ Piperacillin/Sulbactam SPI
Cefpimazole CPZ Piperacillin/Tazobactam TZP
Cefpiramide CPM Pirlimycin PRL
Cefpirome CPO Piromidic Acid PIR
Cefpirome/Sulbactam SCO Pivampicillim PAM
Cefpodoxime-proxetil CPD Pivmecillinam PMC
Cefpodoxime/Clavulanate CCP Polymyxin B PB
Cefprozil CPR Primary aminoglycosides PRI_AMN
Cefroxadine CFX Primary penicillin PRI_PEN
Cefsulodin CFS Primary quinolones PRI_QUIN
Ceftazadime/Sulbactam SCZ Pristinamycin PR
Ceftazidime CAZ Pyrazinamide PZA
Ceftazidime/Clavulanate CCZ Quinolones QUIN
Cefteram CEM Quinupristin/dalfopristin SYN
Ceftibuten CTB Rifabutin RBN
Ceftiofur XNL Rifampin RA
Ceftizoxime ZOX Rifamycin RF
Ceftriaxone CRO Rifamycins RIFAMYC
Ceftriaxone/Clavulanate CCR Rokitamycin ROK
Cefuroxime sodium CXM Rosoxacin R
Cefuroxime-axetil CXMa Roxithromycin RXT
Cefuzonam CZN Sarafloxacin SRF
Cephalexin CN Sisomyci n SIS
Cephaloridine CD Sparfloxacin SPX
Cephalosporins CEPHEM Spectinomycin SPT
Cephalosporins w/ Beta-lactamase inhib. CEPHEM_BLI Spiramycin SP
Cephalosporins w/ Beta-lactamse inhib. CEF_BLI Streptogramins STREPTO
Cephalothin CF Streptomycin S
Cephapirin CP Streptomycin-Syn STS
Cephradine CH Sulbenicillin SBC
Chloramphenicol C Sulfadiazine SD
Chlortetracycline A Sulfamethizole TH
Cinoxacin CIN Sulfamethoxazole SMZ
Ciprofloxacin CIP sulfapenicillin SU_PEN
Clarithromycin CLR Sulfathiazole ST
Clinafloxacin CLX Sulfisoxazole G
Clindamycin CC Systemic fluoroquinilones SYS_FQUIN
Clofazimine CLO Teicoplanin TEC
Cloxacillin CX Telithromycin TEL
Colistin CL Temafloxacin TMA
Cyclic peptides CYC_PEP Temocillin TEM
Cycloserine CS Tetracycline TE
Daptomycin DAP Tetracyclines TET
Dibekacin DKB Thiacetazone TB1
Dicloxacillin DX Thiamphenicol TP
Difloxacin DFX Ticarcillin T IC
Dihydrofolate reductase inhibitor DHFR_INH Ticarcillin/Clavulanate TIM
Dihydrofolate reduct./Dihydropteroate synDHFR_DHPS_INH Tilmicosin TIL
Dihydropteroate synthetase inhibitor DHPS_INH Tobramycin NN
Dirithromycin DTM Tosufloxacin TFX
Doxycycline D Trimeth/Sulfa (DIN) STG
49
Enoxacin ENX Trimethoprim TMP

Enrofloxacin EFX Trimethoprim/Sulfadiazine SDT
Epicillin EP Trimethoprim/SulfamethoxazolSXT
Erythromycin E Triple Sulfa SSS
Ethambutol EM Trospectinomycin TRP
Ethionamide EA Trovafloxacin TVA
Fleroxacin FLE Tylosin TYL
Flomoxef FLO Unspecified UNS
Flucloxacillin FO ureidopenicillins UR_PEN
Flumequine FLQ ureidopenicillins w/ B-lact.UR_PEN_BLI
Fluoroquinilones FQUIN Urinary fluoroquinilones UR_FQUIN
Folate antagonists FOL_ANT Vancomycin VA
Fosfomycin w/G6PD FF Virginiamycin VRG
50
13. Appendix D – Organism Abbreviations

The following is a list of the organisms in the BD database, with the associated LIS Code. On the
BD EpiCenter, BD Phoenix 100, and BD Phoenix M50, these codes are configurable by the user. However
on the BD BACTEC MGIT and BD ProbeTec ET instruments these values are not configurable. Therefore
a direct instrument interface sends these values as AST results.
51
52
53
54
55
56
57
58
59
60
14. Appendix E – BD Instrument Specifics

14.1. BD BACTEC MGIT 960
BD BACTEC MGIT 960 supports ASTM E_1394 Logical Protocol and ASTM E_1381
Physical Protocol.
14.1.1. Configurable Options
LIS Enable –acceptable values are ENABLE or DISABLE. Used to enable the LIS
interface within the instruments. The instrument defaults to DISABLE.
Baud Rate – acceptable values are 1200, 2400, 4800, 9600, 19200. The instrument
defaults to 9600.
Data Bits – acceptable values are 7 and 8. The instrument defaults to 8.
Stop Bits – acceptable values are 1 and 2. The instrument defaults to 1.
Parity - acceptable values are ODD, EVEN, and NONE. The instrument defaults to
NONE.
Upload Results – acceptable values are SOLICITED and UNSOLICITED. The
instrument defaults to UNSOLICITED. In unsolicited mode the instrument
automatically uploads results as tests are completed. The instrument in solicited
mode waits for LIS to request the results.
Consumable Tracking – acceptable values include ENABLE or DISABLE. The
instrument defaults to DISABLE. Enabling this option causes the instrument to
automatically send a specimen’s test status to the LIS when a specimen has been
scanned-in the instrument for the first time (ONGOING) or scanned-out of the
instrument (REMOVED) (automatic transfer when UPLOAD_RESULT option
set to UNSOLICITED).
Orphan Result – acceptable values include ENABLE and DISABLE. The instrument
defaults to DISABLE. Enabling this option causes the instrument to report results
for tests that do NOT have an accession number associated with them.
Packed Frames – acceptable values include ENABLE and DISABLE. The instrument
defaults to ENABLE. Enabling this option allows message frames sent to the LIS
to support multiple records per frame (“packed”). When Disabled, only one record
is tranmitted per frame.
14.1.2. Message Content
Field List
The BD BACTEC MGIT 960 shall exchange fields with the LIS per the following table:


Accession Number O, 3, 1, 1 U
Isolate Number O, 3, 1, 2 U
Test ID O, 5, 1, 4 U
61

Result Type Code R, 3, 1, 4 U
Test/Consumable Sequence R, 3, 1, 5 U
Number
Antibiotic R, 3, 1, 6 U
Antibiotic Concentration R, 3, 1, 7 U
Antibiotic Concentration Units R, 3, 1, 8 U
Test Status R, 4, 1, 1 U
Result Data 1
BACTEC MGIT 960 R, 4, 1, 2 U
Growth Units
Result Data 3
AST susceptibility (Interpreted) R, 4, 1, 4 U
Preliminary/Final Status R, 9, 1, 1 U
Test Start Date/Time R, 12, 1, 1 U
Result/Status Date/Time R, 13, 1, 1 U

Request Starting Patient Id Q, 3, 1, 1
Request Starting Accession Q, 3, 1, 2 D
Number
Request Starting Sequence Q, 3, 1, 3 D
Number
Request Ending Patient Id Q, 4, 1, 1
Request Ending Accession Q, 4, 1, 2
Number
Request Ending Sequence Q, 4, 1, 3
Number
Request Instrument Type Q, 5, 1, 3
Request Instrument Number Q, 5, 1, 4
Request Time Qualifier Q, 6, 1, 1
Request Information Status Q, 13, 1, 1
Code

62
Field Descriptions
Header Fields
General
Patient Fields
BD BACTEC MGIT 960 does not support patient information and therefore always
transmits an empty Patient record.
Order Fields
specimen. This field can be up to 20 characters long. (e.g. Acc123).
Isolate Number (O, 3, 1, 2) – Specimen’s assigned isolate number.
Test Id (O, 5, 1, 4) – BD BACTEC MGIT 960 transmits MGIT_960_GND for Growth
and Detection specimens or MGIT_960_AST for AST sets.
Result Fields
Result Id Code (R, 3, 1, 4) – transmits GND_MGIT for growth and Detection
specimens or AST_MGIT for AST sets.
Test Sequence Number (R, 3, 1, 5) – specimen’s assigned sequence number (barcode)
that is always be 12 digits.
Drug Abbreviation (R, 3, 1, 6) – Antibiotic abbreviation used for a drug within an AST
set.
Drug Concentration (R, 3, 1, 7) – Drug concentration used for a drug within an AST
set.
Drug Units of Measurement (R, 3, 1, 8) – Drug units of measurement used for a drug
within an AST set.
Test Status LIS Code (R, 4, 1, 1) – BD BACTEC MGIT 960 transmits the following
specimen status:
INST_ONGOING
INST_POSITIVE
INST_NEGATIVE
INST_COMPLETE
INST_REMOVED (for Ongoing Removed only)
INST_ERROR
It should be noted that Result records are not transmitted for G&D specimens
that are in error. However, Result records are transmitted for AST set
specimens that are in error because an AST set in error is considered a
completed status. An AST set in error cannot return to an Ongoing state. A
G&D specimen in error requires the users to resolve the before it returns to an
Ongoing or Completed state.
Result Data (R, 4, 1, 2) – The BD BACTEC MGIT 960 instrument measures
Mycobacterial growth. The instrument assigns a numerical value to quantify the amount
of growth in a tube. This growth value is placed in the second component for any results
generated by this instrument, one of either GND_MGIT or AST_MGIT tests. This field
is never more than 5 characters long.
AST SIR Status (R, 4, 1, 4) – The BD BACTEC MGIT 960 instrument transmits an ‘S’
for susceptible, ‘I’ for Indeterminate (not currently used), or an ‘R’ for resistant.
Result Status Code (R, 9, 1, 1) – Always a ‘P’ for Premliminary result.
63
Start Date/Time (R, 12, 1, 1) – This is the date and time that the test was first started or
entered into an instrument. This field is formatted as described in the ASTM E_1394
specification in section 6.6.2.
The BD BACTEC MGIT 960 AST tests are run in reusable plastic carriers. The
plastic carrier contains a sequence number that uniquely identifies the tube
carrier. This is the sequence number transmitted with results up to the LIS.
However, it is possible that a single plastic carrier could be used more than once
for a particular access number. If the LIS intends to allow these carriers to be
used more than once for the same access number, then the LIS should take note
of the test start date/time. The test start date/time, with the sequence number,
uniquely identifies a test and its result.
MGIT AST test information downloaded from the LIS is checked for this start
date/time. If this field is filled, meaning that existing results are being copied
back to the EpiCenter, the EpiCenter tries to use it to match an existing test in its
database. New test orders should not fill this field. If the test sequence number
and entry date/time don’t match an existing test, or are blank, then the EpiCenter
considers it a new test order.
Test Result Date/Time (R, 13, 1, 1) – The instrument’s date and time that the specimen
completed its test.
x For an INST_ONGOING specimen this field is empty.

x For an INST_POSITIVE specimen this is the time the specimen went
positive.
x For an INST_NEGATIVE specimen this is the time the specimen went
negative (calculated by adding the protocol length with the start time).
x For an INST_REMOVED specimen, this is the time the specimen was
removed from the instrument.
x For an INST_COMPLETE specimen this is the time the AST set completed.
x For an INST_ERROR specimen this is the time the AST set went into error
(this is considered a completed status).
Instrument Type (R, 14, 1, 1) – transmits a ‘MGIT960’.
Protocol Length (R, 14, 1, 3) – the specimen’s assigned protocol length.
Instrument Number (R, 14, 1, 4) –the user configured instrument number that ranges
from 1 to 99.
Instrument Location (R, 14, 1, 5) – the specimen’s location within the instrument. For
example, Drawer A, Row D, Column 12 would be represented as “A/D12”.
Request Fields
The ASTM 1394 protocol defines this as a Request Information Record message. A
download Request record is also known as a “Query”. The only type of download
“Query” request that the Firefly instrument accepts is a request for test results. A
Terminator record with a termination code of “F” or “Q” is used to signal the last packet
of a query response. If a query request was invalid, the instrument interface responds
with only the Terminator record with a termination code of “Q”. If the instrument
interface can not locate any specimens in the active or history databases that meet the
query criteria, it responds with only the Terminator record with a termination code of
“F”. Note, that the BD BACTEC MGIT 960 instrument does NOT request data
from an LIS.
64
A query contains a set of request parameters that are used to determine which
specimen(s) to access. The following tables define the ASTM 1394 Request record fields
that are transmitted from the LIS in an Download message and the MGIT 960 statuses
that correspond to the StatusId field.
Accession Number (Q, 3, 1, 2) – The unique alphanumeric string that identifies a

specimen. This field can be up to 20 characters long. (e.g. Acc123). The use of “ALL”
or no definition indicates that the Accession # is not used as a search parameter in the
query.
Sequence Number (Q, 3, 1, 3) – specimen’s assigned sequence number (barcode) that is
always be 12 digits. The use of “ALL” or no definition indicates that the Sequence # is
not used as a search parameter in the query.
Test ID (Q, 5, 1, 1) – The BD BACTEC MGIT 960 instrument accepts the test ids
MGIT_960_GND, MGIT_960_AST, or ALL and return the test results for those test
types currently in the instrument. The keyword ALL returns both GND and AST test
results that are currently in the instrument.
Test Status Id (Q, 5, 1, 2) – The status of the specimens being requested. This field is
only evaluated if the Test ID field contains valid data. No definition indicates that the
specimen status is not used as a search parameter.
The following Test Statuses are used when requesting test results for specimens:
INST_ONGOING (G&D and AST)
INST_POSITIVE
INST_NEGATIVE
INST_COMPLETE (G&D and AST)
Qualifier (Q, 5, 1, 5) – optional qualifier ‘MOD’ that indicates that the request is for
specimen results that have been modified/changed since last request.
Beginning Time (Q, 7, 1, 1) – the beginning time and date used when requesting data
that occurred within a specified time range.
End Time (Q, 8, 1, 1) – the ending time and date used when requesting data that
occurred within a specified time range.
When a "Time Range" has been specified in a Query (Begin Time and/or End
Time fields), the time field from the instrument's database that is used for
comparison is dependent upon the Query's "TestId" field as follows,
INST_ONGOING - Time the specimen was scanned into instrument.
INST_POSITIVE - Time the specimen went positive.
INST_NEGATIVE - Time the specimen went negative.
INST_REMOVED - Time the specimen was removed.
INST_COMPLETE - Time the AST set specimen completed.
INST_ERROR - Time the AST set specimen went into error.
Terminator Fields
General
65
14.1.3. Example ASTM 1394 Protocol

The following are examples of various instrument message transmissions that conform to
the Becton Dickinson Common LIS Interface using the ASTM 1394 protocol.
MGIT960 G&D specimen that has been entered into an instrument, but has NOT been tested:
H|\^&|||Becton Dickinson|7 Loveton Circle^Sparks^MD^21152||410 316 -
4000||||P|V1.00|19981019184200
P|1
O|1|0970038018||^^^MGIT_ 960_GND
R|1|^^^GND_MGIT^430109967349|INST_ONGOING^0|||||P|||||MGIT960^^42^1^B/A01
L|1|N
MGIT960 G&D specimen that has been tested and is still active in the instrument:
H|\^&|||Becton Dickinson|7 Loveton Circle^Sparks^MD^21152||
410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018||^^^MGIT_960_GND
R|1|^^^GND_MGIT^430109967349|INST_ONGOING^123|||||P|||19960502115414|
19960507115414|MGIT960^^42^1^B/A01
L|1|N
MGIT960 G&D specimen that has been tested POSITIVE:

410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018||^^^MGIT_960_GND
R|1|^^^GND_MGIT^430109967349|INST_POSITIVE^1234|||||P|||19960502115414|
19960509123456|MGIT960^^42^1^B/A01
L|1|N
MGIT960 G&D specimen that has been tested NEGATIVE:

410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018||^^^MGIT_960_GND
R|1|^^^GND_MGIT^430109967349|INST_NEGATIVE^12|||||P|||19960502115414|
19960509123456|MGIT960^^42^1^1B/A01
L|1|N
MGIT960 AST specimens that have been entered into an instrument, but has NOT been tested:
410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018^1||^^^MGIT_960_AST
R|1|^^ÂST_MGIT^439309967349ÊMB^5.0ûg/ml|INST_ONGOING^0|||||P|||||
MGIT960^^^13^B/A02
R|2|^^ÂST_MGIT^439309967349^RIF^1.0ûg/ml|INST_ONGOING^0|||||P|||||
MGIT960^^^13^B/A03
L|1|N
66
MGIT960 AST specimens from an AST set that have been tested and are still active in the instrument:
410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018^1||^^^MGIT_960_AST
R|1|^^ÂST_MGIT^439309967349ÊMB^5.0ûg/ml|INST_ONGOING^1 23|||||P|||
19960502115414|19960502115414|MGIT960^^^13^B/A02
R|2|^^ÂST_MGIT^439309967349^RIF^1.0ûg/ml|INST_ONGOING^12|||||P|||
19960502115414|19960502115414|MGIT960^^^13^B/A03
L|1|N
MGIT960 AST specimens that have completed testing:

410 316-4000||||P|V1.00|19981019184200
P|1
O|1|0970038018^1||^^^MGIT_960_AST
R|1|^^ÂST_MGIT^439309967349ÊMB^5.0ûg/ml|INST_COMPLETE^1234^R|||||P|||
19960502115414|19960502115414|MGIT960^^^13^B/A02
R|2|^^ÂST_MGIT^439309967349^RIF^1.0ûg/ml|INST_COMPLETE^12^S|||||P|||
19960502115414|19960502115414|MGIT960^^^13^B/A03
L|1|N
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting all specimen results for a
period of time.
H|\^&||||||||||||19990208000001
Q|1|ÂLLÂLL||ALL||19980502123000|19980613123000
L|1|N
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting only ONGOING specimen
results for a period of time.
H|\^&||||||||||||19990208000001
Q|1|ÂLLÂLL||INST_ONGING||19980502123000|19980613123000
L|1|N
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting all specimen results which have
been assigned the specified Accession #.
H|\^&||||||||||||19990208000001
Q|1|Âccess1234||ALL
L|1|N
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting a specimen result which has
been assigned the specified Sequence #.
H|\^&||||||||||||19990208000001
Q|1|^^430109967349||ALL
L|1|N
67
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting all specimen results which have
been modified/changed since the last request.
H|\^&||||||||||||19990208000001
Q|1|||ALL^^^^MOD
L|1|N
A Request Record (Query) sent from an LIS to a MGIT960 instrument requesting all G&D specimen results that
went Positive between January 2, 1999 at 15:34:00 and January 3, 1999 at 15:34:00.
H|\^&||||||||||||19990208000001
Q|1|||MGIT_GNDÎNST_POSITIVE||19990102123400|19990103123400
L|1|N
14.2. BD ProbeTec ET, BD Viper XTR, & BD Viper LT

BD ProbeTec ET supports ASTM E_1394 Logical Protocol and ASTM E_1381 Physical
Protocol.
BD ProbeTec ET does not send results for specimens without accession or specimen
numbers. As such the instrument does not allow LIS communication to be enabled
unless the instrument Specimen Tracking/Accession Barcoding feature is enabled. The
feature is enabled from a configuration screen.
Comm Port Number – is a dedicated communication port on the instrument and therefore
is not configurable.
Baud Rate – acceptable values are 2400, 4800, 9600, 14400, 19200, 38400. The
instrument defaults to 9600. Viper LT will support Baud Rates of 300, 600, 1200,
1800, 2000, 2400, 3600, 4800, 7200, 9600, 14400, 19200, 28800, 38400, 57600,
115200.
Data Bits – acceptable values are 7 and 8. The instrument defaults to 8.
Stop Bits – acceptable values are 1 and 2. The instrument defaults to 1.
Parity - acceptable values are ODD, EVEN, and NONE. The instrument defaults to
NONE.
Upload Mode – acceptable values are SOLICITED and UNSOLICITED. The instrument
defaults to UNSOLICITED. The instrument in unsolicited mode uploads results as
tests are completed. The instrument in solicited mode waits for the LIS to request
the results.
Low Positive Status Upload – select 1 to enable the option or 0 to disable the option on
BD ProbeTec ET. Check to enable the option on Viper XTR. If the option is
enabled, a MOTA value greater than or equal to 2,000 and less than 10,000 will
produce an INST_LOW_POS Test Status LIS Code (R,4,1,1). Disabled is the
default.
This feature is not supported for Viper LT.
Upload Algorithm Results – (BD Viper XTR & BD Viper LT ) – Select check box to
upload calculated algorithm value to the LIS.
Packed/Unpacked Frames – (BD Viper XTR & BD Viper LT ) – Select checkbox to
upload frames in Packed format.
68

Field List
Header Record Field Name ASTM Direction

Pos.
Order Record Field Name ASTM Direction

Pos.
Accession Number O, 3, 1, 1 U
Specimen Action Code O, 12, 1, 1 U
Result Record Field Name ASTM Direction

Pos.
Test/Consumable Sequence Number R, 3, 1, 5 U
Result Data 1
ProbeTecET/Viper XTR/Viper LT R, 4, 1, 2 U
Alg.Results
Media/Assay Type R, 14, 1, 2 U
QC Type R, 14, 1, 6 U
QC Kit Lot Number R, 14, 1, 7 U
Request Record Field Name ASTM Direction

Pos.
Request Starting Patient Id Q, 3, 1, 1
Request Starting Accession Number Q, 3, 1, 2
Request Starting Sequence Number Q, 3, 1, 3
Request Ending Patient Id Q, 4, 1, 1
Request Ending Accession Number Q, 4, 1, 2
Request Ending Sequence Number Q, 4, 1, 3
Request Test Status Q, 5, 1, 2
Request Instrument Type Q, 5, 1, 3
Request Instrument Number Q, 5, 1, 4
Request Time Qualifier Q, 6, 1, 1
Starting Date/Time Q, 7, 1, 1
Ending Date/Time Q, 8, 1, 1
Request Information Status Code Q, 13, 1, 1
Terminator Record Field Name ASTM Direction

Pos.
69
Field Descriptions
Header Fields
General
Patient Fields
BD ProbeTec ET does not support patient information and therefore always transmits an
empty Patient record.
P|1
Order Fields
specimen. This field can be up to 20 characters long. (e.g. Acc123) This is a required
field for processing specimen and test information. The instrument excludes the
following special characters from being entered in the accession / specimen number field
and therefore never transmits them: * ? [ ] #. Viper LT excludes the following additional
characters: !|.
Test Id (O, 5, 1, 4) –BD ProbeTec ET transmits BD_PROBETEC_GND for the test id
code field.
Specimen Action Code (O, 12, 1, 1) - In the special case when no accession /
specimen number is transmitted then the Specimen Action Code is designated ‘Q’ as an
indicator to treat the result as a QC result.
P|1
O|1|Accession_789 | | ^ ^ ^BD_PROBETEC_GND
P|1
O|1| | | ^ ^ ^BD_PROBETEC_GND| | | | | | |Q
Result Fields
Result Id Code (R, 3, 1, 4) – BD ProbeTec ET always transmits ‘GND_PROBETEC’
for the result id code.
Test Sequence Number (R, 3, 1, 5) – Designates the assay kit lot number and is always
7 digits.
Test Status LIS Code (R, 4, 1, 1) – BD ProbeTec ET transmits the following specimen
status:
INST_POSITIVE
INST_LOW_POS (If enabled, see Configurable Options. Not sent by
BD Viper LT)
INST_NEGATIVE
INST_INDETERMINATE
INST_EQUIVOCAL (Not sent for BD Viper LT)
The instrument transmits the following QC status:
INST_QC_PASS
INST_QC_FAIL
Algorithmic Results (R, 4, 1, 2) – If enabled, see Configurable Options.
Test Start Date/Time (R, 12, 1, 1) – BD ProbeTec ET transmits the instrument’s date
and time that the specimen started its test. Time zone is not included.
Test Result Date/Time (R, 13, 1, 1) – BD ProbeTec ET transmits the instrument’s date
and time that the specimen ended its test. Time zone is not included. Typically, the test
result date and time are 1 hour after the test start date and time.
70
Instrument Type (R, 14, 1, 1) – BD ProbeTec ET transmits a ‘PROBETEC’ for its

instrument type.
Media (Assay) Type (R, 14, 1, 2) – BD ProbeTec ET transmits the following assay types:
1 – CT assay (Viper XTR)

2 – GC assay (Viper XTR)
3 – Intentionally skipped
4 – DTB assay
5 – ctb assay
6 – mac assay
7 – kan assay
8 – Intentionally skipped
9 – CF assay
10 – LP assay
11 – MP assay
12 – tCF assay
13 – tMP assay
14 – dCT assay (Viper XTR, Viper LT)
15 – dGC assay (Viper XTR, Viper LT)
16 – SCV assay
17 – HSV1 assay (Viper XTR)
18 – HSV2 assay (Viper XTR)
19 – HPV assay (Viper XTR – HR for Viper LT)
20 – TV assay (Viper XTR)
200 – HPV 16 (Viper LT)
206 – HPV 33/58 (Viper LT)
207 – HPV 56/59/66 (Viper LT)
208 – HPV 35/39/68 (Viper LT)
209 – GT (Viper LT)
The list of assay types will expand as further assays are supported on the
BD ProbeTec ET instrument.
Protocol Length (R, 14, 1, 3) – BD ProbeTec ET currently has a 1 hour test time and
therefore does not transmit a protocol length.
Instrument Number (R, 14, 1, 4) – BD ProbeTec ET transmits the user configured
instrument number that ranges from 1 to 99.
Instrument Location (R, 14, 1, 5) – BD ProbeTec ET transmits a plate number from 1
to 30, followed by a 96 microwell location of row (A-H), then column (1-12)
Viper XTR transmits a plate number from 1 to 60, followed by a 96 microwell location of
row (A-H), then column (1-12).
Viper LT transmits a rack number from 1 to 30, followed by a 96 microwell location of
row (A-H), then column (1-12).
QC Type (R, 14, 1, 6) – BD ProbeTec ET transmits a ‘+’ or ‘-‘ if the parent Order record
designates a QC result to indicate what type of QC, positive or negative QC.
71
QC Kit Lot Number (R, 14, 1, 7) – BD ProbeTec ET transmits a value only if parent
order record is designated as a QC test.
P|1
O|1|Accession_789 | | ^ ^ ^BD_PROBETEC_GND
R|1| ^ ^ ^ GND_PROBETEC ^000120299|INST_NEGATIVE| | | | | | |
|19981019153400|19981019163400| PROBETEC ^1^^3^14A10
P|1
O|1| | | ^ ^ ^BD_PROBETEC_GND| | | | | | |Q
R|1| ^ ^ ^ GND_PROBETEC ^000120299|INST_QC_PASS| | | | | | |
|19981019153400|19981019163400| PROBETEC ^1^^3^14H12^+^000031500
Request Fields
The ASTM 1394 protocol defines this as a Request Information Record message. A
download Request record is also known as a “Query”. The only type of download
“Query” request that the BD ProbeTec ET instrument accepts is a request for test results.
The BD Probetec ET instrument will accept "query" requests in either the SOLICITED or
UNSOLICITED settings for the Upload Mode as described above under Configurable
Options. Note, that the BD PROBETEC ET instrument does NOT request data from
an LIS.
For an ALL request, BD Viper LT will send up to 30 of the most recently completed
racks.
Test ID (Q, 5, 1, 1) – BD ProbeTec ET accepts the following test name:
BD_PROBETEC_GND. The keyword ALL can also be used to return all of the test
results currently in the instrument.
Q|1| | |BD_PROBETEC_GND
Q|1| | |ALL
Result Qualifier (Q, 5, 1, 5) – BD ProbeTec ET accepts the following result qualifiers:
MOD – All available results that have not been previously transmitted to the LIS.
Q|1| | |BD_PROBETEC_GND^^^^MOD
Terminator Field
General
The following are examples of valid requests for test results from the LIS to the
BD ProbeTec ET instrument that conform to the Becton Dickinson Common LIS
Interface using the ASTM 1394 protocol:
A Request Record (Query) sent from an LIS to a BD ProbeTec ET instrument requesting
all test results currently in the instrument.
For an ALL request, Viper LT will send up to 30 of the most recently completed
racks.
H|\^&
Q|1|||ALL
L|1|N
72
A Request Record (Query) sent from an LIS to a BD ProbeTec ET instrument requesting

all available test results that have not been previously transmitted to the LIS.
H|\^&
Q|1||| BD_PROBETEC_GND^^^^MOD
L|1|N
14.2.4. Unsolicited Demographics Download (Viper LT)

Viper LT shall accept patient demographic fields from the LIS per the following tables:

Sender Name H, 5, 1, 1 U/D
Version Number H, 13, 1, 1 U/D
Message Date/Time H 14, 1, 1 U/D

Patient ID P, 4, 1, 1 D
Date of Birth P, 8, 1, 1 D
Patient Sex P, 9, 1, 1 D
Hospital Service P, 33, 1, 1 D
Hospital Client P, 34, 1, 1 D

Accession Number O, 3, 1, 1 D
Collection Date Time O, 8, 1, 1 D

Patient Fields
Patient ID (P, 4, 1, 1) - Identifier that uniquely identifies a patient. This is a required
field for patient demographic downloads. This field can be up to 16 characters long
(e.g. PatId123). If the field is blank, the record is ignored.
Date of Birth (P, 8, 1, 1) – patient date of birth formatted as described in ASTM E_1394
section 6.6.2. This field is optional.
Patient Sex (P, 9, 1, 1) – There are 3 predefined values accepted for this (M)ale,
(F)emale, and (U)nspecified. If the value does not match the code for either Male or
Female then the sex is set to Unspecified. This field is optional.
Hospital Service (P, 33, 1, 1) – An acronym or abbreviation for the ward or hospital
department involved in caring for this patient (e.g. ER may represent the Emergency
Room). This field can be up to 20 characters long.
Hospital Client (P, 34, 1, 1) – This is the facility that the specimen came from, for
instance Smith Radiology or Central Labs. This field is optional. This field can be up to
20 characters long.
73
Order Fields
Accession Number (O, 3, 1, 1) - Maximum field length: 20 characters. A unique
alphanumeric string that identifies a specimen. If the field is blank, the record is ignored.
Collection Date Time (O, 8, 1, 1) Date and time that the specimen was collected from
the patient, formatted as described in ASTM E_1394 section 6.6.2.
H|\^&||||||||||||20130215184200
P|1||PatId123||^^^^||19651029|M||^^^^||||||
||||||||||||||ER|St. Josephs Hospital
O|1|Acc123||^^^^|||20130214023300||||||| |^||^^||||||||||
L|1|N
14.3. BD Phoenix 100 and BD Phoenix M50

BD Phoenix 100 and BD Phoenix M50 support ASTM E_1394 Logical Protocol and
ASTM E_1381 Physical Protocol.
The BD Phoenix 100 and BD Phoenix M50 provide 3 groups of Configurable Options
for customizing the LIS Interface.
General Options
Results Upload Options
Communications Setup
The instruments also provide an Organism Configuration Screen and an Antimicrobial
Configuration Screen for editing LIS Codes.
General Options
Send Interpretation Results
Acceptable values are CHECKED and UNCHECKED. When CHECKED, final
SIR values are included in the AST result record. The instrument defaults to
CHECKED.
Unsolicited Queries
Acceptable values are CHECKED and UNCHECKED. When CHECKED, the
instrument shall issue a query to the LIS at the time the panel is physically
placed in the instrument if the panel is missing an organism id. The instrument
defaults to UNCHECKED.
Send When Placed In Instrument
Acceptable values are CHECKED and UNCHECKED. When CHECKED, the
instrument shall send a result upload to the LIS at the time the panel is
physically placed in the instrument. The instrument defaults to CHECKED.
Results Upload Options
There are five results upload options, only one of which can be CHECKED at a
time. The BD Phoenix M50 makes use of radio buttons which are SELECTED
instead of CHECKED.
Solicited
Acceptable values are CHECKED and UNCHECKED. When CHECKED the
instrument waits for the LIS to request the results The instrument defaults to
UNCHECKED.
74
Send On Finalization
instrument shall send results to the LIS when the panel is finalized or a
modification has been made to a finalized panel. The instrument defaults to
UNCHECKED.
Send On Completion
instrument shall send results to the LIS when the panel’s status transitions to
COMPLETE or a modification has been made to a COMPLETE panel . The
instrument defaults to CHECKED.
Send as Available
COMPLETE or the panel has partial results. Partial results are when at least one
MIC value is determined for an AST or ID/AST panel or the organism ID is
determined for an ID/AST panel. The instrument defaults to UNCHECKED.
Send at Fixed Time
COMPLETE and send panels with partial results to the LIS at the Fixed Time.
When the Fixed Time is reached, any panel that is ONGOING and has partial
results shall be uploaded to the LIS with a Test Status of
INST_PARTIAL_COMPLETE. The instrument defaults to UNCHECKED.
Communications Setup
NOTE: Modifying any of the following options will result in the
BD Phoenix 100 or BD Phoenix M50 rebooting.
Baud Rate
Acceptable values are 2400, 4800, 9600, 14400,19200,38400. The
BD Phoenix 100 and BD Phoenix M50 default to 9600. The BD Phoenix M50
also supports 57600 and 115200 baud rates.
Data Bits
Acceptable values are 7 and 8. The instrument defaults to 8.
Parity
Acceptable values are ODD, EVEN, and NONE. The instrument defaults to
NONE.
Stop Bits
Acceptable values are 1 and 2. The instrument defaults to 1.
Packed Frames
Acceptable values for BD Phoenix 100 are YES and NO. Acceptable values for
BD Phoenix M50 are CHECKED for YES and UNCHECKED for NO.
Selecting YES allows message frames sent to the LIS to support multiple
records per frame (“packed”). When NO is selected, only one record is
transmitted per frame. The instrument defaults to YES.
75
Organism and Antimicrobial Configuration Screens

Except for antimicrobials listed in special messages and BDXpert Rules within
comment fields, all referrals to organism IDs and antimicrobials in LIS
communications use the LIS Codes stored in the instrument which are set to
default values per Appendix C and Appendix D. These codes can be edited to a
different value. The values in Appendix C and Appendix D represent most
organisms and antimicrobials. The currently supported lists that can be edited
are found on the BD EpiCenter, BD Phoenix 100, and BD Phoenix M50
configuration screens.
14.3.2. Modes of Communications
Download refers to communications from the LIS to the instrument and upload refers to
communications from the instrument to the LIS. NOTE: The total size of a message
downloaded to the instrument should not exceed 100k characters.
Note: New in version V5.02, results for orphan panels and QC panels are not uploaded to
the LIS unless the panels satisfy the criteria of an LIS query.
The BD Phoenix 100 and BD Phoenix M50 shall support the following modes of
communications with an LIS:
Result Uploads
The BD Phoenix 100 and BD Phoenix M50 shall upload results according to the
CHECKED Results Upload Option. For AST sets, several result records shall be sent in
a single message. Each result record shall report the results for a single drug in the AST
set. For ID/AST combo tests, an ID result record is sent as the first result record, and the
AST result records follow.
Query Uploads
The BD Phoenix 100 and BD Phoenix M50 shall upload queries if the Unsolicited
Queries Option is CHECKED.
Order Downloads
The BD Phoenix 100 and BD Phoenix M50 shall accept order downloads. All orders
must include either a Test ID or a Sequence Number, a valid Accession number and a
valid Isolate Number. An order consisting of a valid Consumable Sequence Number and
valid Accession\Isolate Number shall be saved to the instrument database as a
PENDING panel. Orders without the Consumable Sequence Number shall be saved in
the instrument, BUT must be associated to a Consumable Sequence Number via the LIS
Login Screen prior to being saved to the instrument database on the BD Phoenix 100.
Orders without the Consumable Sequence Number on the BD Phoenix M50 shall be
ignored. Orders with invalid data shall be rejected by the instrument. See the Phoenix
User Manual (RE: LIS Order Cancelled Messages) for more information regarding
cancelled LIS orders.
If an order is received with an organism ID that is either unknown to the instrument or is
an unclaimed organism, the order will still be saved to the database or saved for future
association with a Consumable Sequence Number, BUT the organism ID will be replaced
with Invalid Organism Received.
If an order is downloaded with a sequence number that already exists in the instrument
and all populated order fields are valid, the panel record is populated/overwritten with the
order fields. Modifications shall not be accepted for Finalized panels.
An order field with all spaces will be treated as “missing”. Leading or trailing spaces are
trimmed.
76
Query Downloads
The BD Phoenix 100 and BD Phoenix M50 shall accept download queries. The
instrument shall accept queries on the following fields: Result Qualifier, Start Time, End
Time, Request Time Qualifier, Sequence Number, Test ID, Status and Accession.
Queries with invalid data shall be rejected by the instrument. See the Phoenix User
Manual (RE: LIS Query Assembly Messages) for more information regarding invalid
queries.
The BD Phoenix 100 and BD Phoenix M50 shall exchange fields with the LIS per the
following table:
Field List
The BD Phoenix 100 and BD Phoenix M50 shall exchange fields with the LIS per the
following table:


Isolate Number O, 3, 1, 2 U/D
Organism O, 3, 1, 3 U/D
Test/Consumable Sequence Number O, 5, 1, 5 U/D
Priority O, 6, 1, 1 U/D
Report Type O, 26, 1, 1 U

Test/Consumable Sequence Number R, 3, 1, 5 U
Antibiotic R, 3, 1, 6 U
Result Data 1
AST MIC for AST MIC R, 4, 1, 2 U
Result
Organism ID for ID Result R, 4, 1, 2 U
Result Data 2
AST susceptibility (Final) R, 4, 1, 3 U
Profile Number for ID Test R, 4, 1, 3 U
Result Data 3
Result Data 4
Result Data 5
Result Data 6
Result Data 7
77

Test Complete Date/Time R, 13, 2, 1 U

Comment Text C, 4, 1, 1 U
Comment Type C, 5, 1, 1 U

Request Starting Accession Number Q, 3, 1, 2 U/D
Request Starting Sequence Number Q, 3, 1, 3 U/D
Request Time Qualifier Q, 6, 1, 1 D

Field Descriptions
Patient Fields
BD Phoenix 100 and BD Phoenix M50 do not support patient demographics and
therefore shall send an empty Patient record.
Order Fields
Accession Number (O, 3, 1, 1) - Maximum field length: 20 characters. A unique
alphanumeric string that identifies a specimen.
Isolate Number (O, 3, 1, 2) - Maximum field length: 2 characters. Allowable range:
1-20. The number associated with an isolate.
Organism (O, 3, 1, 3) - Maximum field length: 20 characters. LIS code of the organism
ID. The organism ID for an ID panel or an ID/AST panel is the User ID if it exists or if a
User ID does not exist and the panel has a single Instrument ID it is the Instrument
Organism ID. The organism ID for an AST panel is the User ID if it exists or if a User ID
does not exist and the panel has been auto associated it is the Instrument Organism ID.
Organism IDs and their corresponding LIS codes can be viewed/edited in the
instrument’s Organism Configuration Screen
For QC Panels the organism ID shall be the Test Strain.
78
Test ID (O, 5, 1, 4) - Maximum field length: 20 characters. Populated with the panel
format abbreviation as shown on the panel’s barcode label. Appendix B contains a
sample list.
Test/Consumable Sequence Number (O, 5, 1, 5) - 12 digit numeric string identifying
the instrument consumable.
Priority (O, 6, 1, 1) - Maximum field length: 1 character. This field is defined in the
ASTM E_1394 specification. Currently only the values ‘A’ for Critical, ‘R’ for Normal
and blank for default normal or no change are supported.
Report Type (O, 26, 1, 1) – This field is defined in the ASTM E_1394 specification.
When a cancelled order is sent back to the LIS the report type is ‘X’.
Result Fields
The BD Phoenix 100 and BD Phoenix M50 uploads shall consist of AST results and ID
results. The information contained in the generic “Data Fields” depends on the type of
result being reported. AST Result records contain antimicrobial and susceptibility
information. ID Result records contain organism and Resistance Marker information.
Result ID Code (R, 3, 1, 4) A BD defined code that indicates the type of information in
the result record. The keyword AST_MIC indicates results for a MIC based
Antimicrobial Susceptibility Test and the keyword ID indicates identification results.
Test/Consumable Sequence Number (R, 3, 1, 5) – 12 digit numeric string identifying
the instrument consumable. Antimicrobial (R, 3, 1, 6) (AST Results) Populated with the
LIS code corresponding to the antimicrobial. Antimicrobials and their corresponding LIS
codes can be viewed/edited in the instrument’s Antimicrobial Configuration Screen. This
field can be up to 20 characters long.
Test Status LIS Code (R, 4, 1, 1) For non QC panels this field is populated with one of
the statuses listed in Appendix B. For QC panels that are ONGOING or PENDING , the
status is reported as for non QC panels, however, for COMPLETED panels the status is
INST_QC_PASS or INST_QC_FAIL.
Result Data Field 1
The contents of the Result Data fields vary depending on the type of result being
reported, as described below.
Minimum Inhibitory Concentration (R, 4, 1, 2) (MIC based AST Result) For AST
tests that produce MIC values; this field contains the minimum antibiotic concentration
that inhibits growth of the tested organism. This field can be up to 20 characters long and
is assumed to contain a number in ug/ml.
This field may contain signed MIC values such as “<=4” or “>8”, MIC values for
compound antimicrobials such as “0.5/4”or “<=0.5/16” as well as the following:
“?” - Ongoing
“C” - Antimicrobial is Rapid Completed (For nonQC tests in V4.01 and later)
“X” - Error
Note: For QC panels, MIC values of X will be uploaded to the LIS for V4.01. The
uploaded MIC values for QC panels are ‘blank’ in previous software versions.
Organism (R, 4, 1, 2) (ID Results Only) LIS code of the organism ID. The organism ID
for an ID panel or an ID/AST panel is the User ID if it exists or if a User ID does not
exist and the panel has a single Instrument ID it is the Instrument Organism ID. The
organism ID for an AST panel containing a resistance marker, otherwise the organism ID
is only included in the order record. Organism IDs and their corresponding LIS codes
can be viewed/edited in the instrument’s Organism Configuration Screen. This field can
be up to 20 characters long.
79
Result Data Field 2

AST Susceptibility, Final (R, 4, 1, 3) ( AST results only) This is a code that indicates
the organism’s susceptibility to the antibiotic specified in this record. The acceptable
values for this field are, blank, S, I, R, N, X representing MIC is pending, susceptible,
intermediate, resistant, not susceptible and error respectively.
Result Data Field 3
Resistance Marker 1 (R, 4, 1, 4) (ID results) This represents a Resistance Marker
associated with the organism identified in the ID result record. This field can be up to 8
characters long. Examples of Resistance Markers and their corresponding LIS codes are
listed below.
Extended Spectrum B-Lactamase RM_ESBL

Methicillin Resistant Staphylococcus RM_MRSA
Streptomycin HLAR RM_HLSR
B-Lactamase in Gram Positive Cocci RM_GP_BL
Vancomycin Resistant Enterococci RM_VRE
Gentamicin HLAR RM_HLGR
High Level Kanamycin Resistant RM_HLKR
Streptococcus MLSb Phenotype RM_MLSB
Streptococcus Macrolide Efflux Phenotype RM_MEFF
High Level Penicillin Resistant S. Pneumoniae RM_HLPRSP
Low Level Penicillin Resistant S. Pneumoniae RM_LLPRSP
High Level Mupiricin Resistant Staphylococcus RM_HLMUP
Result Data Field 4

characters long. Examples of Resistance Markers and their corresponding LIS codes are
listed under Result Data Field 3.
Result Data Field 5
characters long. . Examples of Resistance Markers and their corresponding LIS codes are
Resistance Marker 4-10 (R, 4, 1, 7-13) (ID results) This represents a Resistance Marker
characters long. . Examples of Resistance Markers and their corresponding LIS codes are
Preliminary/Final Status (R, 9, 1, 1) This field contains either a “P” for preliminary
status or an “F” for final status, which occurs when the panel is finalized at the
instrument.
Start Date/Time (R, 12, 1, 1) This is the date and time that the panel was physically
placed in the instrument. This field is represented in the YYYYMMDDHHMMSS
format.
Result/Status Date/Time (R, 13, 1, 1) This is the date and time that the panel’s status
transitioned to COMPLETE. This field is represented in the YYYYMMDDHHMMSS
format.
80
Test Complete Date/Time (R, 13, 2, 1) (ID results) This is the date and time that the ID
panel obtained an ID. (AST results) This is the date & time that a drug obtained a valid
MIC. This field is represented in the YYYYMMDDHHMMSS format.
Instrument Type (R, 14, 1, 1) Identifies the instrument with the keyword PHOENIX.
Instrument Number (R, 14, 1, 4) Instrument number between 1 and 99.
Instrument Location (R, 14, 1, 5) Indicates the panel position inside the instrument as a
3 character string represented in TierStation format. Tier values are A-D and station
values are 1-25. This field is empty for PENDING panels.
Request FieldsStarting Access Number (Q, 3, 1, 2) - Maximum field length: 20
characters. This field should be populated if the request is for either a single specimen or
for a range of specimens. If accession number is not to be used as a search criterion for
requested data, then this field can be left blank. Populating this field with the keyword
ALL queries for all panels in the instrument database that meet the remaining criteria.
Starting Sequence Number (Q, 3, 1, 3) - Required field length: 12 digit consumable ID
value. This field should be populated if the request is for a single panel. If sequence
blank. Populating this field with the keyword ALL queries for all panels in the instrument
database that meet the remaining criteria.
Test ID (Q, 5, 1, 1) - Maximum field length: 20 characters. This field should be
populated with the test type (ID, AST_MIC). The BD Phoenix 100 and BD Phoenix M50
accept the keywords ID and AST_MIC as valid test types as well as the pre-defined test
names. See appendix B for examples. Populating this field with the keyword ALL
queries for all panels in the instrument database that meet the remaining criteria.
Test Status (Q, 5, 1, 2) The BD Phoenix 100 and BD Phoenix M50 accept queries for
panels with a status as follows:
x INST_ONGOING, panels with an onging status that may or may not yet
contain results.
x INST_COMPLETE, panels with a complete, rapid complete, in attention
ignored, in attention complete, QC pass, or QC fail status
x INST_RAPID_COMPLETE, panels with a rapid complete status
x INST_PARTIAL_COMPLETE, panels with an onging status that have
obtained results.
x INST_QC_PASS, QC panels with a passed QC status
x INST_QC_FAIL, QC panels with a failed QC status
Result Qualifier (Q, 5, 1, 5) The only acceptable value for this field is the keyword
MOD to request only results that have been modified since the last request.
Time Qualifier (Q, 6, 1, 1) - Maximum field lenth: 1 character. The acceptable values
for this field are ‘S’ which indicate the following date time fields refer to test start times
or ‘R’ which indicate the following date time fields can refer to result/status times.
Starting Date/Time (Q, 7, 1, 1) The starting date/time (inclusive) of the data requested
represented in the YYYYMMDDHHMMSS format.
Ending Date/Time (Q, 8, 1, 1) The ending date/time (inclusive) of the data requested
represented in the YYYYMMDDHHMMSS format.
81
Comment Fields
The BD Phoenix 100 and BD Phoenix M50 send comment strings for BDXpert rule text
and special messages.
The following is an example of a comment record containing a rule where <310> is the
rule number and (AMX, ATM, CAZ) is a list of the affected antimicrobials.
C|1| |<310> BDXpert Rule 310 text.(AMX, ATM, CAZ)|E

Special Messages are messages that indicate a special condition for a BD Phoenix 100
panel.
The following is an example of a comment record containing a special message with a
list of the affected antimicrobials.
C|1| | Special message text.(AM, CAZ)|T

Comment Text (C, 4, 1, 1) – The text to be used for the patient, specimen or isolate
comment. This field can be up to 1600 characters long.
Comment Type (C, 5, 1, 1) – The type of comment record. This field should be an E, or
T for BDXpert rule, or special message comments respectively.
Terminator Field
General
Result Upload Examples
Example of a rejected order
P|1
O|1|~!@#$^1||^^^CT04N|||||||||||||||||||||X
C|1||LIS Order Cancelled: Invalid Accession Number Field|T
L|1|N
Example of a “Send When Placed in Instrument” result upload
P|1
O|1|IDAST 1^1||^^^GNIDAST 951^429510000001|R
R|1|^^ÎD^429510000001|INST_ONGOING|||||P|||20031110101102||PHOENIX^^^1^C7
R|2|^^ÂST_MIC^429510000001ÂM|INST_ONGOING^?^ |||||P|||
20031110101102||PHOENIX^^^1^C7
R|3|^^ÂST_MIC^429510000001ÂN|INST_ONGOING^?^ |||||P|||
20031110101102||PHOENIX^^^1^C7
R|4|^^ÂST_MIC^429510000001ÂMC|INST_ONGOING^?^ |||||P|||
20031110101102||PHOENIX^^^1^C7
L|1|N
82
Example of a result upload for an ID panel
P|1
O|1|ID 1^1ÂLCPIE||^^^GNID 952^429520000001|R
R|1|^^ÎD^429520000001|INST_COMPLETEÂLCPIE|||||P|||20031110101102|
20031110102747\20031110102747|PHOENIX^^^1^D7
L|1|N
Example of result uploaded to an LIS with the Send Interpretation Results option
UNCHECKED
P|1
O|1|IDAST 1^1^SHISPE||^^^GNIDAST 951^429510000001|R
R|1|^^ÎD^429510000001|INST_COMPLETE^SHISPE|||||P|||20031110112648|
20031110114736\20031110114735|PHOENIX^^^1Â7
R|2|^^ÂST_MIC^429510000001ÂM|INST_COMPLETE^<=4^S|||||P|||
20031110112648|20031110114736\20031110114735|PHOENIX^^^1Â7
R|3|^^ÂST_MIC^429510000001ÂN|INST_COMPLETE^<=4^S|||||P|||
20031110112648|20031110114736\20031110114735|PHOENIX^^^1Â7
R|4|^^ÂST_MIC^429510000001ÂMC|INST_COMPLETE^<=4/2^S|||||P|||
20031110112648|20031110114736\20031110114735|PHOENIX^^^1Â7
L|1|N
Example of a result upload for an ID/AST panel with special messages, resistance
markers and the Send Interpretation Results option UNCHECKED
P|1
O|1|ABC^1ÊNTCFAA||^^^CT01P^424940000029|R
C|1||The MICs for this antibiotic and species combination are not reported by the Phoenix
system. An alternate method should be utilized.(RA)|T
C|2||Fill failures were detected with this antibiotic and no MIC can be determined. The
isolate should be retested.(CF)|T
R|1|^^ÎD^424940000029|INST_IN_ATTN_COMPLETEÊNTCFAA^^RM_VRE^RM
_HLSR^RM_HLGR|||||P|||20031110145645|20031110150803|PHOENIX^^^1^C5
R|2|^^ÂST_MIC^424940000029ÂM|INST_IN_ATTN_COMPLETE^>32|||||P|||200311
10145645|20031110150803\20031110150802|PHOENIX^^^1^C5
R|3|^^ÂST_MIC^424940000029ÂZM|INST_IN_ATTN_COMPLETE^>8|||||P|||20031
110145645|20031110150803\20031110150802|PHOENIX^^^1^C5
R|4|^^ÂST_MIC^424940000029^CAZ|INST_IN_ATTN_COMPLETE^>64|||||P|||20031
110145645|20031110150803\20031110150802|PHOENIX^^^1^C5
83
R|5|^^ÂST_MIC^424940000029^CC|INST_IN_ATTN_COMPLETE^>8|||||P|||2003111
0145645|20031110150803\20031110150802|PHOENIX^^^1^C5
L|1|N
Query Upload Examples
Example of an Unsolitcited Query uploaded due to a missing organism id
Q|1|ÎnvOrg^429530000072
L|1|N
Order Download Examples
Example of a download order for a critical panel
H|\^&|||
P|1
O|1|Critical^1||^^^GNID 952|A
L|1|N
Query Download Examples
For test start times between Nov 10,2003 at 09:00:00 and Nov 10,2003 at 16:00:00
H|\^&
Q|1||||S|20031110090000|20031110160000
L|1|N
For test result times after Nov 10,2003 at 09:00:00
H|\^&
Q|1||||S|20031110090000||
L|1|N
For panels that have partial results and have been modded since the last request
H|\^&
Q|1|||ÎNST_PARTIAL_COMPLETE^^^MOD
L|1|N
For the panel with 429530000072 sequence number
H|\^&
Q|1|^^429530000072||
L|1|N
For ALL accession numbers
H|\^&
Q|1|||ALL|||
L|1|N
84
14.4. BD BACTEC FX
14.4.1. BD BACTEC FX LIS Configuration Screen
The BD BACTEC FX LIS Configuration Screen allows the user to specify the
configurable behavior of the LIS interface. To navigate to the BD BACTEC FX LIS
Configuration Screen select the Configuration Tab then the LIS Tab. The configurable
options on the BD BACTEC FX LIS Configuration Screen are somewhat different than
the parameters specified within the BD BACTEC 9000 Configuration File but are
intended to give the user most of the same LIS interface functionality.
The BD BACTEC FX LIS interface is configured by enabling and defining fields within
the LIS tab on the BD BACTEC FX Configuration screen. If parameters are changed on
the LIS configuration screen, the new configuration will take effect immediately after the
SAVE button is pressed. The BD BACTEC FX doesn’t need to and will not restart after
the LIS configuration parameters are changed (BD BACTEC 9000 requires reboot after
configuration changes). However BD recommends that the host LIS be inactive during
the reconfiguration period. An LIS download transaction could be lost during the
reconfiguration of the BD BACTEC FX LIS interface. In addition the BD BACTEC FX’s
response to an active LIS query will not be transmitted or cancelled.
14.4.2. BD BACTEC FX Configurable Options
LIS ENABLE Group
The options for this group are mutually exclusive.
Possible parameters:
ENABLED
DISABLED
Default: DISABLED
Port Parameters Group

Parameters defined in this group control the communication parameters
assign to the serial communications port on the BD BACTEC FX that is
connected to the LIS
BAUD
The BAUD parameter allows the adjustment of the speed of the communications
link between the LIS system and the BD BACTEC FX.
1200
2400
4800
9600
19.2K
Default: 9600
85
PARITY
The PARITY parameter allows for the adjustment of the error check that can be
performed on every character that is received and transmitted.
NONE
ODD
EVEN
Default: NONE
DataBits
The Databits parameter allow for the adjustment of the size of the character that
is transmitted and received by the Physical Protocol Layer.
7 DataBits
8 DataBits
Default: 8 DataBits
STOPBits
The STOPS parameter allow for the adjustment of the number of stop bits that
are appended to the characters that are transmitted by the Physical Protocol
Layer.
1 StopBit
2 StopBits
Default: 1 StopBit
Physical Layer Group
This group allows the user to select between the physical communications
protocols that the LIS interface will use.
The options for this group are mutually exclusive.
ASTM 1381
BDMODEM
Default: BDMODEM
NOTE: If the ASTM physical layer is to be used for LIS communication, refer
to the BD LIS interface specification for ASTM interfaces, document number
L–005933.
LIS Options Group
This group allows the user to define the LIS/LAB specific workflow(dictating
when data is sent to the LIS) and the types of data that will be sent to the
LIS.
86
Upload Pos Result

When this checkbox is enabled (checked), Positive results will be uploaded to
the LIS, whenever a Results Upload to the LIS occurs (see LIS Solicit Results
section 6.3.1.4.2)
Default: Disabled
LIS Solicited Results
If LIS Solicit Results is enabled (checked) Negative Results will be sent only
when the LIS requests results. If Upload Positive Results is enabled Positive
results will also be sent to the LIS when solicited.
If LIS Solicit Results is disabled (unchecked) Negative results will be sent
automatically when the vial goes out of protocol. If Upload Positive Results is
enabled Positive results will also be sent to the LIS when the vial turns Positive.
If Vial Tracking is enabled then Vial Tracking information will also be sent
automatically to the LIS when the vial’s location changes.
Default: Solicit
Vial Tracking
When this function is enabled (checked) Vial Tracking information will be sent
to the LIS when the vial location changes (INST_NEW, INST_REMOVED,
INST_REENTERED). This function is disabled when the LIS solicited Results
checkbox is enabled (checked) so therefore, Vial Tracking information will only
be sent unsolicited. The BD BACTEC FX will report INST_REENTERED for
all vials that have been removed and reentered. The workflow for
BD BACTEC FX allows the operator to remove an ongoing vial and reenter it.
Default: Disabled
Host Query Mode
The BD BACTEC FX will perform a Host Query to request patient
demographics information from the LIS for any vial without a patient name/id
that has an associated accession number. This option only works if Accession
Barcoding is enabled on the Configuration screen and the LIS Solicited Results
(is not selected) is operating in the Unsolicited mode.
MANUAL
User initiated Batch Host Query. When this option is selected the user can
initiate a Batch Host Query via the Maintenance\Test tab by pressing the LIS
button. A Batch Host Query consists of multiple individual SINGLE Host
Queries for all vials in the BD BACTEC FX database without Patient
Demographics. When this option is selected the parameter Query Timeout can
also be adjusted within the LIS Options Group. The Query Timeout dictates how
long the BD BACTEC FX will wait for the LIS to respond to a Host Query
before sending the next Host Query requesting Patient data for the next vial.
SINGLE
A Single Host Query is initiated when a new vial with an accession number is
entered. When this option is selected the parameter Query Timeout can also be
adjusted within the LIS Options Group. The Query Timeout dictates how long
the BD BACTEC FX will wait for the LIS to respond to a Host Query before
sending the next Single Host Query requesting Patient data for the next newly
entered vial.
87
AUTO
In Auto Mode the BD BACTEC FX will perform a Single Host Query when a
new vial with an accession number is entered. It will also initiate a Batch Host
Query based on the frequency defined in the Auto HQ Interval field. So if the
LIS doesn’t respond to the Single Host Query when a vial is loaded, the
BD BACTEC FX will automatically gather the missing patient information via a
Batch Host Query sent at the next Auto HQ Interval. In AUTO mode the
parameter Query Timeout can also be adjusted within the LIS Options Group.
The Query Timeout dictates how long the BD BACTEC FX will wait for the
LIS to respond to a Single Host Query before sending the next Single Host
Query requesting the demographic for the next vial.
DISABLED
Do not initiate a Host Query of any kind due to instrument workflow.
Default: AUTO
Query Timeout
Query Timeout is enabled for AUTO, SINGLE and MANUAL Host Query
modes. It can be set from 1 – 99 seconds. The Query Timeout dictates how long
the BD BACTEC FX will wait for the LIS to respond to a Single Host Query
before sending the next Single Host Query requesting the demographic
associated with the next vial.
Auto HQ Interval
Auto HQ Interval can be set for AUTO mode. It can be set from 1–999 minutes.
This parameter dictates the frequency the BD BACTEC FX will perform an
AUTO Batch Host Query.
Log Comms Checkbox
The Log Comms checkbox is used as a tool for BD personnel in order to assist
in troubleshooting LIS communication issues. When enabled and a USB key is
present, additional low-level messages are logged to a file on the USB key.
These messages, when used in tandem with the LIS messages from the event
log, will assist in deciphering any communications issues.
Force Upload Checkbox
The Force Upload checkbox is to be used as a troubleshooting mechanism for
LIS communication issues. When checked (and saved via the <Save> button on
the LIS configuration tab) the Save button on the Culture Screen Vial Tab shall
be disabled and the ‘Send’ button shall be displayed and enabled in its place
when non-modified vial data is recalled into the Vial Tab. Pressing the ‘Send’
button will transmit a Result record of the recalled vial on the Culture screen to
the LIS
ASTM 1381 Group
Not applicable for the BDModem Protocol. This group allows the user to
specify Packed Frames or Unpacked Frames.
Packed Frames ON/OFF
Default: ON
88
BD Modem Group
The parameters defined within this group are used to determine where
specific data is located in the LIS records. and to define the expected
characters in a message to determine specific information.
New Sequence Position
To ensure backwards-compatibility with LIS interfaces written prior to this
specification, this option indicates where barcodes would be found in an Order
record, regardless if they are downloaded or not. The NEW parameter should
only be used if an LIS interface is being written or updated to this specification.
OLD
NEW
Default: NEW
Hospital Service Field (33)
This parameter allows the selection of the field for placement of the Hospital
Service Code in the Patient Record, for both download and upload. This
parameter allows vendors who have implemented the old BD DMC LIS
interface to use code that they already have. The DMC LIS (OLD interface)
interface calls for the Hospital Service Code to be placed in field 26 of the
record. The BD BACTEC 9000 LIS (NEW interface) interface calls for the
Hospital Service Code to be placed in field 33 of the record. This option should
be set to match the location that the LIS vendor will be using to provide the
Hospital Service Code. If the dialog box is checked the Hospital Service Code is
in field 33. If it is not checked the Hospital Service Code will be in field 26
Possible parameters: 26 or 33
Default: 33
SOH
The SOH parameter allows the selection of the character that will be used to
indicate the Start Of Header for a message. The values are specified in hex.
Possible parameters: 00hex..FFhex
Default: 01hex
EOT
The EOT parameter allows the selection of the character that will be used to
indicate the End Of Text for a message. The values are specified in hex. The
value that is used by the LIS vendors could be one of two possible values. The
protocol has been implemented with EOT set to 2 or 4. When the LIS system is
configured the LIS vendor should indicate the value that they are using for EOT.
The EOT value in the configuration file should be set accordingly.
Default: 04hex
ACK
The ACK parameter allows the selection of the character that will be used to
indicate the Acknowledgement for a message. The values are specified in hex.
Default: 06hex
89
NAK
The NAK parameter allows the selection of the character that will be used to
indicate the Negative Acknowledgement for a message. The values are specified
in hex.
Default: 15hex
CAN
The CAN parameter allows the selection of the character that will be used to
indicate the Cancellation for a message. The values are specified in hex.
Default: 18hex
SYN
The SYN parameter allows the selection of the character that will be used to
indicate the Synchronization request for the start of a message. This control
character has been implemented using two different values. The LIS vendor
should be queried as to the value they used in the implementation and the option
set accordingly. The two values that have been used are 26 and 16 hex. The
values are specified in hex.
Default: 16hex
Send Button
When vial information for a non-pending, non-orphan sequenced vial is recalled onto
the Culture screen, the <Send> button shall become enabled – when the Force
Upload Checkbox is enabled (see section 14.4.2.4.7).
Touching the <Send> button shall cause the displayed vial data to be transmitted as
an LIS message immediately. Since this is used as a troubleshooting mechanism, the
information will be formulated into the appropriate LIS message format and the LIS
message to be transferred to the attached LIS.
Once any data on the Culture Screen Vial Tab has been modified, the ‘Send’ button
shall be removed from the display and the ‘Save’ button shall be displayed and
disabled.
Print Button
The Print button on the Maintenance/Configuration/Lis tab shall be displayed
and enabled when the LIS interface is enabled.
When enabled, the Print button shall be accessible by all users; no password
or enabling of the Log Comm checkbox is required in order for this button to
be operational.
Touching the Print button shall cause all of the LIS messages that are
contained in the event log to be printed to the selected printer in the selected
language. This will include the messages time stamp in order for the timing of
these messages as well as the low-level messages being saved on the USB
key to be coordinated.
90

Field List
The BD BACTEC FX shall exchange fields with the LIS per the following table:


Patient Last Name P, 6, 1, 1 U/D
Patient First Name P, 6, 1, 2 D
Patient Middle Name P, 6. 1, 3 D
Patient Name Suffix P, 6, 1, 4 D
Patient Name Title P, 6, 1, 5 D
Old Hospital Service P, 26, 1, 1 U/D

Old Sequence 1 O, 3, 1, 3 D
Sequence 1 O, 5, 1, 5 D
Collection Date Time O, 8, 1, 1 U/D

Result ID Code R, 3, 1, 4 U
Result Sequence Number R, 3, 1, 5 U
Prelim Status R, 9, 1, 1 U
Start Date Time R, 12, 1, 1 U
End Date Time R, 13, 1, 1 U
91

Media Type R, 14, 1, 2 U
Request Record Field Name ASTM Direction

Pos.
Request Starting Accession Q, 3, 1, 2 U
Number
Request Information Status Q, 13, 1, 1 U/D
Code

Field Descriptions
Header Fields
General – Same as BD EpiCenter (see section 8.2.1)
Patient Fields
Patient ID (P, 4, 1, 1) - Identifier that uniquely identifies a patient. This is a
required field for patient demographic downloads. This field can be up to 16
characters long. (e.g. PatId123)
Patient Name (P, 6, 1, 1-5) – Patient name is divided into 5 components in the
ASTM E_1394 specification. The BD BACTEC FX stores these fields as a
single string in its database. Therefore the BD LIS Interface concatenates these
fields from a download message. The patient name can be up to 40 characters
long. If these fields are selected for upload on the BD BACTEC FX the whole
name is placed in the first component of this field (P, 6, 1, 1). Patient name
shown in the sample record is Dr. John R Doe Jr.
Patient Last Name (P, 6, 1, 1)
Patient First Name (P, 6, 1, 2)
Patient Middle Name (P, 6, 1, 3)
Patient Name Suffix (P, 6, 1, 4)
Patient Name Title (P, 6, 1, 5)
Old Hospital Service (P, 26, 1, 1) – (Do Not Use unless the LIS vendor has
previously implemented the old BD DMC LIS interface and that code is reused)
An acronym or abbreviation for the ward or hospital department involved in
caring for this patient. (e.g. ER may represent the Emergency Room). (Old
Hospital Service field only for compatibility with older BD BACTEC 9000 LIS
interfaces).
Hospital Service (P, 33, 1, 1) – An acronym or abbreviation for the ward or
hospital department involved in caring for this patient. (e.g. ER may represent
the Emergency Room).
92
Accession Number (O, 3, 1, 1) - Maximum field length: 20 characters. A

unique alphanumeric string that identifies a specimen.
Old Sequence1 (O, 3, 1, 3) –(Do Not Use unless the LIS vendor has previously
implemented the old BD DMC LIS interface and that code is reused) 12 digit
numeric string identifying the instrument consumable.
numeric string identifying the instrument consumable..
Old Sequence10 (O, 3, 10, 3) –(Do Not Use unless the LIS vendor has
previously implemented the old BD DMC LIS interface and that code is reused)
12 digit numeric string identifying the instrument consumable.
Test Id (O, 5, 1, 4) –BACTEC FX transmits “BACTECFX_GND” for the Test
ID.
Sequence1 (O, 5, 1, 5) -- 12 digit numeric string identifying the instrument
(BD BACTEC FX) consumable.
93

Collection Date Time (O, 8, 1, 1) Date and time that the specimen was
collected from the patient, formatted as described in ASTM E_1394 section
6.6.2.
Result Fields
Result ID Code (R, 3, 1, 4) The BD BACTEC FX transmits a “GND” as the
Result ID Code.
Result Sequence Number (R, 3, 1, 5) – 12 digit numeric string identifying the
instrument (BD BACTEC FX) consumable.
Test Status LIS Code (R, 4, 1, 1) -- This describes the Status of a
BD BACTEC FX vial. The possible values are:
x INST_NEW
x INST_POSITIVE
x INST_NEGATIVE
x INST_REMOVED
x INST_REENTERED
x INST_ONGOING
Preliminary Status (R, 9, 1, 1) -- We always put a P in this field, because all
results from BD BACTEC FX are preliminary.
Start Date/Time (R, 12, 1, 1) This is the date and time that the vial was
physically placed in the instrument. This field is represented in the
YYYYMMDDHHMMSS format.
End Date/Time (R, 13, 1, 1) This is the date and time that the panel’s status
transitioned to POSITIVE or OUT OF PROTOCOL. This field is represented in
the YYYYMMDDHHMMSS format.
Instrument Type (R, 14, 1, 1) The BD BACTEC FX transmits BACTECFX
for the instrument Type.
Media Type(R, 14, 1, 2) 2 digit code representing the type of media contained
within a BACTEC vial.
Protocol Length(R, 14, 1, 3) this field indicates the length of time required to
complete the BACTEC GND test. For BD BACTEC FX (a growth and
detection test), this number represents the number of days before a vial can be
considered negative.
Instrument Number (R, 14, 1, 4) Instrument number between 1 and 99.
Instrument Location (R, 14, 1, 5) Indicates the vial position inside the
instrument as an 8 character string = ii-d-rcc
where:
94
ii = instrument number(1–99)
d = drawer letter(A–D)
r = row letter(A–K with no I)
cc= column number (1–10)
Request Fields
The ASTM 1394 protocol defines this as a Request Information Record
message. A download Request record is also known as a “Query”. The only
type of download “Query” request that the BD BACTEC FX instrument accepts
is a request for test results. A Terminator record with a termination code of
“F”(processed) or “Q”(error) is used to signal the last packet of a query
response. If a query request was invalid, the instrument interface responds with
only the Terminator record with a termination code of “Q”. If the instrument
interface cannot locate any specimens in the active or history databases that
meet the query criteria, it responds with only the Terminator record with a
termination code of “F”.
specimen(s) to access. The following tables define the ASTM 1394 Request
record fields that can be transmitted from the LIS in a Download message and
are accepted and acted upon by the BD BACTEC FX.
Test Status (Q, 5, 1, 2) The BD BACTEC FX instrument accepts queries for
vials with a status as follows:
INST_POSITIVE = POSITIVE & Manual Positive vials
INST_NEGATIVE = NEGATIVE & Manual Negative vials
ALL = POSTIVE & NEGATIVE & ONGOING & Manuals Positive & Manual
Negative vials
AWL = (Do Not Use unless the LIS vendor has previously implemented the
BD DMC LIS interface and that code is reused) POSTIVE & NEGATIVE &
ONGOING & Manuals Positive & Manual Negative vials
Starting Date\Time (Q, 7, 1, 1) – Requested starting time for query -- the

beginning of the Date/Time range to gather data for. If it is null the
BD BACTEC FX will use the Date 1/1/1970.
End Date\Time (Q, 8, 1, 1) – Requested Ending time for the query -- the ending
of the Date \Time range to gather data for. It must be greater than the Starting
Date\Time or the query will be rejected. If it is null, the BD BACTEC FX will
use the current date time.
When a "Time Range" has been specified in a Query (Begin Time and/or End
Time fields), the time field from the instrument's database that is used for
comparison is dependent upon the Query's "Test Status" field as follows,
INST_POSITIVE -- Time the specimen went positive.
INST_NEGATIVE -- Time the specimen went out of protocol.
INST_ONGOING – The time the specimen was entered into the
BD BACTEC FX.
MANUAL vials – Time the user set the Status.
Terminator Fields
General – Same as EpiCenter (see section 8.2.7)
95

The following are examples of various BD BACTEC FX message transmissions that
conform to the Becton Dickinson Common LIS Interface using the ASTM 1394 protocol.
BACTEC FX G&D specimen that has been entered into an instrument as a new vial: (note: whether the vial has
received a first test or not is not relevant in the BD BACTEC FX instrument.) – sent from the BD BACTEC FX
instrument to the LIS.
P|1
O|1|ACC-001||^^^BACTECFX_GND|||19700101000000
R|1|^^^GND^446500000000|INST_NEW|||||P|||20081017105508||BACTECFX^65^5^01Â -
G01
L|1|N
BACTEC FX G&D specimen that has been tested POSITIVE – sent from the BD BACTEC FX
instrument to the LIS:
P|1||PATID||LastName FirstName
O|1|ACC-001||^^^BACTECFX_GND|||19700101000000
R|1|^^^GND^446500000000|INST_POSITIVE|||||P|||20081017105508|20081017110031|B
ACTECFX^65^5^01Â-G01
L|1|N
BACTEC FX G&D specimen that has been tested NEGATIVE – sent from the BD BACTEC FX
instrument to the LIS:
P|1||PATID2||LastName2 FirstName2
O|1|DAG||^^^BACTECFX_GND|||19700101000000
R|1|^^^GND^446504178134|INST_NEGATIVE|||||P|||20080918155201|20080923160143|B
ACTECFX^65^28^01Â-A02
L|1|N
A Request Record (Query) sent from an LIS to a BD BACTEC FX instrument requesting all specimen results (all
positive, negative, and ongoing vials records will be sent).
H|\^&
C|1|This is a request for POSITIVE, NEGATIVE AND ONGOING vials from the LIS
Q|1|ALLÂLL||ÂLL||||||||P
L|1
A Request Record (Query) sent from an LIS to a BD BACTEC FX instrument requesting only POSITIVE
specimen results for a period of time (vials that had a positive result called between 9/23/2008 4:01:43 p.m.
and 10/17/2008 10:55:08 a.m.)
H|\^&
C|1|This is a request for POSITIVE vials from the LIS
Q|1|ALLÂLL||ÎNST_POSITIVE||20080923160143|20081017105508|||||P
L|1
96
A Patient Record sent from an LIS to a BD BACTEC FX instrument
H|\^&
C|1|L|Patient information from LIS to BACTEC FX
P|1||PATID3||LastName^FirstName^Middle^Suffix^Title||||||||||||||||||||||||||
|HosSer|
O|1|Acc-003| |^^^\^^^\^^^\^^^\^^^\^^^\^^^\^^^\^^^\^^^\^^^|||20081025120000
L|1
14.5. BD Innova
14.5.1. LIS Connection
The instrument attempts to connect to an LIS server when processing of a batch begins. If
a connection to the LIS server has not yet been established or has been disconnected, the
instrument will attempt to establish a connection when processing of subsequent batches
begin.
The instrument connects to the LIS via Ethernet TCP/IP using a configurable IP address
and port. Configuring the IP address and port is done via a CSV file.
The instrument exchanges data with the LIS per the protocol specified in the Data Link
Section of ASTM E_1381.
The instrument formats the content of the data exchanged as messages containing a
collection of records per ASTM E_1394.
The instrument will send and receive frames that contain only a single logical record (i.e.
Header, Patient, Order, Result and Terminator records all are sent in separate frames).
The instrument will not respond to queries generated by the LIS.
The instrument will not accept unsolicited data sent from the LIS.
The implemented LIS Interface specification is selectable to be either the legacy interface
or the preferred BD ASTM interface. The interface is configurable via a CSV file.
Selecting the BD ASTM Interface will result in the following changes:
x Queries to the LIS will not contain a confirmation record.
x Specimen plating status will be sent separately formatted as an H/P/O/R/L
message.
The instrument will expect a query response from the LIS within a configurable amount
of time. The timeout value is configurable via a CSV file. The default time is 15 seconds.
97
14.5.2. BD ASTM Interface

Overview
The instrument will default to the BD ASTM Interface.
When the instrument reads a new container ID barcode from a container, a query
for patient demographics and test orders is sent to the LIS.
When processing has successfully completed for a container, the instrument will
send a result message to the LIS containing H/P/O/R/L records.
Sending of the result message can be enabled or disabled via a CSV file. The
default setting is enabled.
Valid Characters
The following characters are valid at the Innova instrument.
A–Z, a–z, 0–9,; : , . / @ $ % ( ) _ + - ` =
Invalid Characters
The following characters are invalid at the Innova instrument.
"*?[]!#|'&<>{}~^\
These characters cannot be entered at the BD Innova instrument but could be
supplied by an LIS/ BD EpiCenter Server download.
If these characters are encountered in the Patient Information record that has
been received from the LIS/ BD EpiCenter server, the following will occur :
If an illegal character is contained in the container barcode field (O, 3,
1, 1), the illegal character will be replaced with a “$”. The barcode will
be passed on for further validation. When the “Mismatched barcode”
check is performed, the check will fail and the container will be
rejected.
If an illegal character is contained in any other field of the record, the field will
be “nulled out.” This will result in several potential scenarios:
If the BD Innova is operating in LIS/ BD EpiCenter Protocol Defined
Source mode and if the Specimen Type/Body Site field has been nulled
out, the specimen will be rejected with a protocol not found.
If the field that has been nulled out is contained in the label
configuration, this field will be null on the plate label.
If the field is not printed on the plate label and it is not the barcode field
or the Specimen Type/Body Site field in LIS/ BD EpiCenter Protocol
Defined Source mode, then the user will never see this nulled - out
field.
The result record that is echoed back to the LIS will contain the nulled -
out field. This should cause no issues in either the LIS or the
BD EpiCenter Server sites.
Message Content
The following sections describe which fields are exchanged with the BD Innova
instrument.
98
Field List
Each field is displayed with its default mapping in the ASTM E_1394 records.
This position consists of a record type (Patient, Order, Result, Query, or
Comment), a field delimiter counter, repeat delimiter counter, and component
delimiter counter. The fields are grouped according to the ASTM E_1394 record
type they are mapped to.
The field list also indicates if that field is defaulted as an upload (U) field,
download (D) field, or both (U/D).
The first two fields of every record include the Record Type indicator and a
record index value. These fields are considered part of every record but are not
listed in these tables.

Delimiter Field H, 2, 1, 1 U/D
Processing ID H, 12, 1, 1 U/D

Patient Name (Last) P, 6, 1, 1 U/D
Patient Name (First) P, 6, 1, 2 U/D
Patient Name (Middle) P, 6, 1, 3 U/D
Date of Birth P, 8, 1, 1 U/D
Patient Sex P, 9, 1, 1 U/D
Hospital Client P, 34, 1, 1 U/D

Accession Number / O, 3, 1, 1 U/D
Container ID*
Culture ID O, 3, 1, 2 U/D
Barcode Number / O, 5, 1, 5 U/D
Accession Number*
Collection Date/Time O, 8, 1, 1 U/D
Specimen Type O, 16, 1, 1 U/D
Body Site O, 16, 1, 2 U/D
Ordering Physician O, 17, 1, 1 U/D
99

Server Free Text O, 19, 5, 1 U/D
Report Type O, 26, 1, 1 U/D
*See Field Descriptions - Order Fields Subsection

Mode R, 4, 1, 9 U
Media Setup Date/Time R, 13, 1, 2 U
Machine Instrument Number R, 14, 1, 4 U
Protocol Name R, 14, 1, 8 U
Accession Number Q, 3, 1, 2 U
Container Barcode Number Q, 3, 1, 3 U
Request Instrument Number Q, 5, 1, 4 U
Request Information Status Code Q, 13, 1, 1 U

Comment Text C, 4, 1, 1 U
Comment Type C, 5, 1, 1 U

100
Field Descriptions
This section provides detailed information for each field listed in the previous
section.
Header Fields
The header record that starts each logical message is the same from all BD
instruments. An example record is provided below.
H|\^&| | |Becton Dickinson| | | | | | |P |X1.00|20100901184200
Delimiter Fields (H, 2, 1, 1) – These single characters can be used to process

the remainder of the message. These characters denote the field, repeat,
component and escape delimiters as described in the ASTM E_1394
specification.
These fields are defaulted to “|”, “\”, “^”, and “&” respectively, as shown above.
Sender Name (H, 5, 1, 1) – Messages coming from a Becton Dickinson
instrument have the BD identifier in this field as shown above.
Processing ID (H, 12, 1, 1) – Indicates how this message is to be processed.
The following codes will be used:
P – Treat message as an active message to be completed according to
standard processing.
Version Number (H, 13, 1, 1) – This version number represents the version of
the LIS interface used for communications. For the Innova instrument, the
version number will begin with X1.00.
constructing his message, formatted as described in the ASTM E_1394
specification in section 6.6.2.
Patient Fields
P | 1 | | PatId123 | | Last Name ^ First Name^ MI| |19651029
|M||||||||||||||||||||||||Hospital Service|Hospital Client
Patient ID (P, 4, 1, 1) - Identifier that uniquely identifies a patient. This field

can be up to 16 characters long (e.g. PatId123). This field is optional.
Patient Name (P, 6, 1, 1-3) – Patient name is divided into 5 components in the
ASTM E_1394 specification. The Innova instrument will accept the first 3
components of this field. The instrument stores these fields as a single string in
its database. The patient name can be up to 40 characters long. When uploaded,
the whole name is placed in the first component of this field (P, 6, 1, 1). This
field is optional.
Date of Birth (P, 8, 1, 1) – Patient date of birth formatted as described in
ASTM E_1394 section 6.6.2. The date shown in the sample record is Oct. 29,
1965. This field is optional.
Patient Sex (P, 9, 1, 1) – There are 3 predefined values accepted for this (M)ale,
(F)emale, and (U)nspecified. If the value does not match the code for either
Male or Female then the sex is set to Unspecified. This field is optional.
Hospital Service (P, 33, 1, 1) – This is the location within the hospital that the
specimen came from, for instance ER (emergency room), OR1 (operating room
1). This field is optional.
101
Hospital Client (P, 34, 1, 1) – This is the facility that the specimen came from,
for instance Smith Radiology or Central Labs. This field is optional.
Order Fields
O | 1 | Access1^331316ÂCC123| | ^^^^ | | | 20090108080510 | | | |
| | | | URINE^CleanCatch | Dr. Ameigh | | \ \ \ \Server Free Text
|||||||O
Accession Number (O, 3, 1, 1) – A unique alphanumeric string that identifies a

specimen. This field can be up to 16 characters long. This field is required.
NOTE: if “CONTAINER_BC_INSTEAD_OF_ACC” flag is set to 1 (one –
CID Mode 1), this field will contain the container barcode that was queried for
to obtain the accession number.
Culture ID (O, 3, 1, 2) – An alphanumeric string that identifies a culture. This
field is optional.
Barcode Number (O, 5, 1, 5) – An alphanumeric string to be included on the
printed plate label. This field is optional.
NOTE: if “CONTAINER_BC_INSTEAD_OF_ACC” flag is set to 1 (one – CID
Mode 1), this field will contain the accession that is to be associated to the CID
that was queried for in Q, 3, 1, 3 field.
For additional information on “CONTAINER_BC_INSTEAD_OF_ACC”
functionality, see the CONTAINER_BC_INSTEAD_OF_ACC section.
Collection Date/Time (O, 8, 1, 1) – Date and time that the specimen was
collected from the patient, formatted as described in ASTM E_1394 section
6.6.2. This field is optional.
Specimen Type (O, 16, 1, 1) – The type of specimen collected from the patient.
This field is optional.
For LIS/ BD EpiCenter Defined Protocol Source, this field must exactly match
the field at the Innova associated to a protocol. This field is a maximum of 14
characters at the Innova.
Body Site (O, 16, 1, 2) – The body site for the source of the specimen collected
from the patient. This field is optional.
For LIS/ BD EpiCenter Defined Protocol Source, this field must exactly match
the field at the Innova associated to a protocol. This field is a maximum of 14
characters at the Innova.
Ordering Physician (O, 17, 1, 1) – The physician that has ordered the test. This
field is optional. This field has a maximum of 16 characters when it is printed on
the label at the Innova.
Server Free Text (O, 19, 5, 1) – This field contains free text that can hold any
alphanumeric information (such as special instructions to look for fungi on the
plate, etc.). This field will have a maximum of 16 characters when printed on the
label. This field is optional.
102
Report Types (O, 26, 1, 1) – If the Report Types field contains an “X”, “Y”, or
“Z”, the specimen is rejected. Any other value will be ignored. This field is
optional. (From ASTM 1384 specifications)
X – request cancelled
Y – no order on record for this test (in response to query)
Z – no record of this patient (in response to query)
Result Fields
R | 1 | ^^^STREAK|INST_COMPLETE^^^^^^^^MANAGED | | | |
| P | | | |^20110817130534 | INNOVA^^^1^1-1-1^^Ûrine
Result ID Code (R, 3, 1, 4) – This is a BD defined code that indicates the type
of information being exchanged in the result record. This field contains the
value, “STREAK”, to indicate the results are from an automated plate streaking
instrument.
Test Status (R, 4, 1, 1) – The status value for a particular specimen. This field is
the pre-defined value INST_COMPLETE for specimens that have completed
successfully. For specimens that have not completed successfully, the value is
INST_ERROR.
Mode (R, 4, 1, 9) – The mode indicates whether the specimen was run with the
“User Defined Protocol” mode of operation (UD) or the LIS Defined Protocol
mode of operation (LD).
This field will contain the following values:
“MANAGED” – specimen processed in LD mode.
“BATCH” - specimen processed in UD mode
Preliminary/Final Status (R, 9, 1, 1) – This field contains a “P” to indicate the
results should be considered Preliminary Results.
Media Setup Date/Time (R, 13, 1, 2) – This field indicates the time the
specimen was successfully streaked. If the specimen was not successfully
streaked, this field will be blank.
Instrument Type (R, 14, 1, 1) – This field indicates which BD instrument
produced the result. This field contains the value, “INNOVA”.
Machine Instrument Number (R, 14, 1, 4) – This is the number assigned to
the instrument.
Instrument Location (R, 14, 1, 5) – Indicates the location of the container in
the instrument. Represented as drawer number - canoe number - position in
canoe.
Protocol Name (R, 14, 1, 8) – This is the protocol used to plate the specimen.
It is derived from the Specimen Type/Body Site supplied by the LIS or selected
by the user for a User Defined specimen.
103
Request Fields
Standard Query
Q | 1 | ^0123456| |^^^1 | | | | | | | |O|
CID Mode 1 Query
Q | 1 | ^^0123456| |^^^1 | | | | | | | |O|
Accession Number (Q, 3, 1, 2) – The unique alphanumeric string that identifies

a specimen. This field can be up to 16 characters long. In the example above,
the Accession number is “0123456”.
Container Barcode Number (Q, 3, 1, 3) – The unique alphanumeric string that
identifies a container. This field can be up to 16 characters long.
This field will ONLY be populated when the Innova has its
“CONTAINER_BC_INSTEAD_OF_ACC” flag set to 1 (one – CID Mode 1).
NOTE: when this field is used, its value MUST be returned in O, 3, 1, 1 so that
the Innova can verify the accession number that is returned is intended for the
container barcode that was queried.
Request Information Status Code (Q, 13, 1, 1) – The following codes will be
used:
O – Requesting test orders and demographics only (no results)
A – abort/cancel last request criteria (allows a new request to follow,
sent from Innova if query result not received before timeout)
Comment Fields
The comment record in the Innova will immediately follow the result record if
the result is INST_ERROR. It will contain the enum value associated to the
specimen’s result and the associated string that is displayed to the user on the
DB Log screen and on the Batch Results screen. If there is more than one result
enum value associated to the Specimen, then more than one comment record
will be sent to the LIS/EpiCenter, one for each result enum value and string.
C | 1 | |<4> No Barcode | R
C | 2 | |<28> Low Liquid Level | R
Comment Text (C, 4, 1, 1) – The text to be used for the patient, specimen or
isolate comment. This field can be up to 1600 characters long.
The number between the < > will be the enum value that is associated to the
Innova ContainerProcessingStatusMask. The text that follows in this field will
be the string that is displayed to the user at the Innova and that is associated to
the ContainerProcessingStatusMask enum value.
Comment Type (C, 5, 1, 1) – The type of comment record. This field should be
a P, S, I, E, T, or R for patient, specimen, isolate, chartables rule, special
message comments, or result comment respectively.
For the Innova, this field will contain an “R”.
104
Examples
Query - Standard
H|\^&|||Becton Dickinson|||||||P|X1.00|20100816171740
Q|1|^10467||^^ÂLL||||||||O
L|1|N
LIS Query Response - Standard

H|\^&|||LIS|||||||P|1|20100806093245
P|1||PatID1||Clark^John| |19800806 |M||||||||||||||||||||||||ER|Universal Labs
O|1|10467|||||20100805093245| | | | | | | |URINE^Clean Catch|
L|1|F
Query - CID Mode 1

Q|1|^^10467||^^ÂLL||||||||O
L|1|N
LIS Query Response – CID Mode 1

H|\^&|||LIS|||||||P|1|20100806093245
P|1||PatID1||Clark^John| |19800806 |M||||||||||||||||||||||||ER|Universal Labs
O|1|10467 ||^^^^PatAccession|||20100805093245| | | | | | | |URINE^Clean Catch|
L|1|F
LIS Query Response with no information

H|\^&|||LIS|||||||P|1|20100806093245
L|1|I
Confirmation Message Upload

P|1||PatID1||John Clark| |19800806 | M ||||||||||||||||||||||||ER|Universal Labs
O|1|10467||^|||20100805093245||||||||URINE ^ Clean Catch
R|1|^^^STREAK|INST_COMPLETE| | | | |P| | | | |INNOVA^^^1^3-2-
6^^^Plate Protocol
L|1|N
105
Confirmation Message Upload Error Status

P|1||PatID1||John Clark| |19800806 | M ||||||||||||||||||||||||ER|Universal Labs
O|1|10467||^|||20100805093245||||||||URINE ^ Clean Catch
R|1|^^^STREAK|INST_ERROR| | | | |P| | | | |INNOVA^^^1^3-2-6^^^Plate
Protocol
C | 1 | |<4> No Barcode | R
C | 2 | |<28> Low Liquid Level | R
L|1|N
Host Reject Messages

14.5.2.7.8.1. Report Type X
Test was deleted do not plate.
H | \ ^ & | | | HOST | | | | | | | P | 1 | 20090109100400

P | 1 | | 13099844202 | |^| | |
O | 1 | 13099844202 ^ ^ | | ^ ^ ^ | | | | | | | | | | | | | | | | | | | | X
L | 1|N
14.5.2.7.8.2. Report Type Y
No specimen information found – if this is LIS Driven mode, do not
plate no protocol information available.
H | \ ^ & | | | HOST | | | | | | | P | 1 | 20090109100400

P | 1 | | 13099844202 | |^| | |
O | 1 | 13099844202 ^ ^ | | ^ ^ ^ | | | | | | | | | | | | | | | | | | | | Y
L | 1|N
14.5.2.7.8.3. Report Type Z
No patient information found – if this is LIS Driven mode and there is
no associated Specimen information, do not plate no protocol
information available.
H | \ ^ & | | | HOST | | | | | | | P | 1 | 20090109100400

P | 1 | | 13099844202 | |^| | |
O | 1 | 13099844202 ^ ^ | | ^ ^ ^ | | | | | | | | | | | | | | | | | | | | Z
L | 1|N
106
CONTAINER_BC_INSTEAD_OF_ACC Barcode
This section describes the CONTAINER_BC_INSTEAD_OF_ACC barcode
functionality that will be available in a Post-V3.10 release. This functionality gives the
user the ability to read a barcode on the specimen container and query the LIS for the
associated Accession barcode.
A new parameter will be added to the MachineGeneralAttributes.csv file. This parameter
will be named CONTAINER_BC_INSTEAD_OF_ACC. Its default value will be “0” for
standard container barcode query. If the barcode on the container is not the accession and
the user desires to have the accession returned, this parameter should be configured to
have a value of 1 (one).
Standard Container Barcode is Accession Functionality
If the barcode that is on the container IS the Accession barcode, the
LIS/BD EpiCenter will be queried for Patient Information by sending the
container barcode that was read in Q, 3,1, 2. When the LIS/BD EpiCenter
returns the Patient Information, it must return the same barcode that was queried
for in O, 3, 1, 1. If the same barcode is not returned in this O, 3, 1, 1; the Patient
Information will be rejected with a “Mismatched Barcode” error.
CONTAINER_BC_INSTEAD_OF_ACC Functionality – CID
Mode 1
If the barcode that is on the container IS the Container barcode and NOT the
Accession barcode, the LIS (and in a future BD EpiCenter release), will be
queried for Patient Information by sending the container barcode that was read
in Q, 3, 1, 3. When the Patient Information is returned, the barcode that was
queried for must be returned in O, 3, 1, 1 and the associated accession must be
returned in O, 5, 1, 5. If the same barcode is not returned in this O, 3, 1, 1; the
Patient Information will be rejected with a “Mismatched Barcode” error.
14.6. BD MAX
This section describes the configuration of the interface between an LIS and the BD MAX instrument, and
is a complement to the information included in the BD MAX User’s Manual (REF: 8089570 International
Windows Version / 8089571 US Open System Windows Version / 8089572 US IVD Windows Version).
14.6.1. Additional definitions applicable to the BD MAX Section
This list of definitions is a complement to the list provided in Section 3 of this document.
Confirmed Positive – This is a positive result that has been confirmed as a positive by the user on
the Results > Run Details > PCR Analysis screen. This status is only used in the LIS Result
record.
Instrument Positive (Preliminary Positive) – This is the positive result that is determined by the
instrument software. It is reported to the LIS, should this option be configured via the MAX User
Interface, as an instrument positive until it is confirmed as a positive by the user on the Results >
Run Details > PCR Analysis screen. This status is only used in the LIS Result record.
14.6.2. Valid and Invalid characters for BD MAX
Invalid characters – The following list of characters will not be accepted by the BD MAX:
“*?[]!#|‘&<>{}~^\
Valid Characters – The following characters are acceptable for entry on the BD MAX
instrument: A – Z, a – z, 0 – 9, ; : , . / @ $ % ( ) _ + - ` =
107
14.6.3. Unresolved (UNR)/Indeterminate (IND)/Incomplete (INC) Results Handling

On the BD MAX, Unresolved, Indeterminate, and Incomplete results are not reported across the
LIS. Only Instrument Positive (Preliminary Positive), Confirmed Positive and Negative results are
reported.
14.6.4. Overview of the BD MAX LIS Interface
The BD MAX communicates with the LIS via a serial interface. The physical interface is provided
through the D89 serial connection on the BD MAX All-In-One computer. The logical interface
follows the ASTM 1934 protocol. If the LIS is enabled on the BD MAX, the application will
create an LIS interface thread at start up. The BD MAX will communicate results to the LIS based
on the user selected configuration options. The protocols and specifications for exchanging data
are described in subsequent sections.
14.6.5. General information about Default settings
The BD MAX default will be LIS Interface disabled. The LIS Vendor/BD Field Service Engineer
must enter various laboratory specific configuration parameters to enable the LIS interface when
required for laboratory operations.
The configuration settings have to be selected based on the LIS vendors parameters.
There is no standard configuration for a LIS- connection.
Comprehensive information about available settings on the BD MAX can be found in Section
14.6.11.
14.6.6. Uploading Results to the LIS - “Unsolicited” vs “Solicited mode”
When the BD MAX completes a run, if the LIS is enabled and “unsolicited” mode is configured,
the configuration settings for the result upload will be checked. If the user has configured the LIS
to upload instrument negative results, the negative final calls will be uploaded to the LIS. If the
user has configured the LIS to upload instrument positive results, the instrument positive final
calls will be uploaded to the LIS.
If “solicited” mode is selected, results will be uploaded upon request from the LIS.
Sending results for solicited or unsolicited mode can be enabled or disabled via the
Configuration/LIS screen. The default setting for all upload types is disabled. The default setting
for solicited uploads is enabled. This screen will only be accessible to users that have ADMIN
permission level.
Detailed information can be found in Section 14.6.11.
LIS Retransmit Feature
The current BD MAX System Software sends results to the LIS when certain conditions
are met. On occasion, results must be re-transmitted from the instrument to the LIS. This
feature will allow a user to re-transmit results that have been previously sent from the
instrument to the LIS system (the instrument is required to be in unsolicited mode). A
user shall be able to re-transmit a result to the LIS system if this result was previously
sent. Comprehensive information about the LIS Retransmit Feature can be found in the
BD MAX User’s Manual (REF: 8089570 International Windows Version / 8089571 US
Open System Windows Version).
108
14.6.7. General information about the “Confirming positive results” feature

If the user does not desire to have the instrument positive results sent to the LIS without being
confirmed first, a feature will be provided that gives the user the ability to confirm the positive
result and then send the confirmed positive final call to the LIS.
When one run is opened with results, the user can select Positives from the Group By combo box.
Only the positions with positive results will be displayed, and each graph will gain a check-box,
allowing the user to confirm the positive results displayed.
If the user has configured the LIS to upload confirmed positive results in unsolicited mode, the
confirmed positive results will be sent to the LIS as soon as possible.
NOTE: To have the uploading of negative and positive final calls and confirmed positives
available with Open System Testing, the Result Logic needs to be enabled and programmed.
Detailed information can be found in Section 14.6.11.
14.6.8. Results queries from the LIS
The BD MAX will accept result request queries from the LIS when the LIS is enabled in solicited
mode. The result information that will be sent to the LIS will be based on the date range specified
in the query and the types of results that have been configured to be sent to the LIS (instrument
positive, instrument negative, and/or confirmed positives).
When configured to send a result record to the LIS, the instrument will send a result message to
the LIS containing H/P/O/R/L records. For a result to be sent to the LIS, the test must have an
Accession.
Detailed information about message content can be found in Section 14.6.12.
14.6.9. Communication Protocols
Logical Protocols (ASTM E 1394)
Basic information about the logical protocol used by BD (ASTM E 1394) can be found in
Section 4.2.
The logical protocol describes where to place individual pieces of information
into a record string and how to combine the record strings into a properly
formatted message. The combination of logically grouped records is called a
data packet. Data packets are composed of records, which contains the data
that is transferred between an LIS and the BD MAX instrument. The data within
the record is separated into fields by delimiters (|). Within a field, a caret (^)
can be present to split the field into a subfield (component) for additional
information.
Records contain logical subdivisions of information identifying the sender of the
message, patient, test order, test results, requests for information, comments and
end of the data packet. A letter in the first field of the record always identifies
the record type.
109
General information related to Record types and fields can be found in

Section 8.2.
Logical Protocol - ASTM transmission control characters
In addition to the information described in Section 8.2, the following
information can help understand the nomenclature used in the logical
protocol and help understand the LIS connection on the BD MAX.
In order to “wrap” the logical data, certain identifying characters are
required by the logical protocol to control the low level functions.
These characters are called control characters. To avoid
misinterpretation, control characters are never values that are part of the
logical message; instead they are represented by ASCII values that are
not printable characters. Many of the ASCII control codes are to mark
data packets, or to control a data transmission protocol: ACKnowledge,
Negative AcKnowledge, Start Of Header, Start of TeXt, End of TeXt,
etc...
ASTM Control Characters
Decimal Hex Abbreviation Name/Meaning
2 02 STX Start of text
3 03 ETX End of text
4 04 EOT End of
Transmission
5 05 ENQ Enquiry
6 06 ACK Acknowledgement
10 0A LF Line feed
13 0D CR Carriage return
21 15 NAK Negative
Acknowledgement
23 17 ETB End of Transmit

Block
An example of ASTM Control Characters codes application during

communication between the BD MAX and the LIS:
a) BD MAX informs the LIS it wants to send a message, using
(ENQ)
b) LIS responds (ACK) if it is ready or (NAK) if it not.
c) If it is ready, then the BD MAX starts the transmission, using
(STX/….data…../ETX)
d) After receiving the transmission, the LIS responds (ACK) if it has
received the data or (NAK) if it did not.
e) After transmission is complete, the BD MAX will end the
transmission, using (EOT).
110
Physical Protocols (ASTM E 1381)

Basic information about the physical protocol used by BD (ASTM E 1381) can be found
in Section 4.2.
The physical protocol describes how logical level message strings can be
partitioned and transmitted to the LIS. The ASTM E 1381, low-level protocol
defines how the logical data record is separated into data packets, or “frames”.
The protocol also controls the sequencing of message transmission and error
checking on the frames that ensures the integrity and correctness of the
transmission, ensuring that no data is lost during transmission.
Unpacked/packed Frames
The BD LIS interface is configurable to send either packed frames or
unpacked frames. This settings needs to be adapted to the strategy used
by the LIS Vendor.
See Section 6.1.2. on additional details regarding the BD interpretation
of Packed/Unpacked frame.
14.6.10.Physical Cable Interface
On the BD MAX, the connection to the LIS must be made using a RS232 COM-Port.
No other type of connection can be used. In some cases, specific adapters could be
required.
111
NOTE: The serial port interface used by the instruments uses only 3 signals in the
interface cable, Transmit Data (Pin 2), Receive Data (Pin 3), and Signal Ground (Pin 5).
BD does not believe that the inclusion of additional signals will cause any problems for
the interface, however BD has not tested this case.
On the BD MAX, COM 1 must be used. The typical physical cable used is a NULL
modem serial cable (female-to-female). NULL modem serial cables are normally used
to connect DTE-to-DTE devices (PC-to-PC).
Example of a BD MAX to LIS physical connection:
NOTE: In some cases, specific adapters will have to be used. A USB to COM-port
adapter may have to be installed.
14.6.11.BD MAX LIS Configuration Screen

This section is a complement to the information included in the BD MAX User manual (REF:
8089570 International Windows Version / 8089571 US Open System Windows Version 8089572
US IVD Windows Version).
The BD MAX LIS Configuration Screen lets the user specify the configurable behavior
of the LIS interface. To navigate to the BD MAX LIS Configuration Screen, select the
Configuration Tab then the External Devices Tab (when logged in as ADMIN).
112
The LIS Configuration Group will be displayed. The BD MAX LIS interface is
configured by enabling and defining fields within the LIS Tab at the BD MAX
instrument. If parameters are changed for the LIS configuration, the new configuration
takes effect immediately.
14.6.12.BD MAX LIS Configurable Options
There are several aspects of the BD MAX LIS interface that are configurable by the user.
The configurable parts of the interface are described below.
NOTE: The configuration settings have to be selected based on the LIS vendor’s
parameters and end-user selections. There is no standard configuration for a LIS-
connection. Settings may vary between LIS vendors. When working in the LIS
configuration screen, it is recommend to note the existing parameters (for example, by
performing a print screen of the existing parameters). This information could be used to
restore the parameters if they are lost for any reason.
Enable LIS
The options for this choice are mutually exclusive.

Possible Parameters:
ENABLED
DISABLE
Default: Disabled
113
Parameters Group: Physical

Parameters defined in this group control the communication parameters assigned to the
serial communications port that is connected to the LIS.
Serial communication using RS-232 requires that four parameters are specified: the baud
rate of the transmission, the number of data bits encoding a character, the sense of the
optional parity bit, and the number of stop bits.
Each transmitted character is packaged in a character frame that consists of a
single start bit followed by the data bits, the optional parity bit, and the stop bit
or bits.
Example: A typical character frame encoding the letter "m" (hexadecimal 0x6d)
with 7 data bits, 1 parity bit, and 2 stop bits):
BAUD
The BAUD parameter allows the adjustment of the speed of the communications
link between the LIS system and the BD MAX.
Possible Choices:
1200
2400
4800
9600
19200
Default: 9600
PARITY
The PARITY parameter allows for the adjustment of the error check that can be
performed on every character that is received and transmitted.
Possible Parameters:
NONE
ODD
EVEN
Default: ODD
NOTE: Many LIS vendors will require that the “NONE” setting is selected.
114
DataBits
The DataBits parameter allows for the adjustment of the size of the character
that is transmitted and received by the Physical Protocol Layer.
Possible Values:
7 Databits
8 Databits
Default: 8 DataBits
STOPBits
The STOPBits parameter allows for the adjustment of the number of stop bits
that are appended to the characters that are transmitted by the Physical Protocol
Layer.
Possible Parameters
1 StopBit
2 StopBits
Default: 1 StopBit
LIS Options Group: Logical
This group allows the user to define the LIS/LAB specific workflow (dictating when data
is sent to the LIS) and the types of data that will be sent to the LIS.
LIS Solicited Results
If LIS Solicited Results is enabled (checked), results will be sent only when the
LIS requests results. If this Option is selected the LIS must actively ask for
new results. This option needs to be determined with the LIS vendor.
Default: Solicited
Upload Instrument Negatives
When this checkbox is enabled (checked), Negative results will be uploaded to

the LIS, whenever a Results Upload to the LIS occurs. This could occur when
the result is called for the test, if so configured, or when a request from the LIS
is received for INST_NEGATIVES results and the test has not already been
transmitted to the LIS.
Default: Disabled
115
Upload Instrument Positives
When this checkbox is enabled (checked), PRELIMINARY Positive (meaning

Positive results determined by the instruments – not confirmed by the user)
results will be uploaded to the LIS, whenever a Results Upload to the LIS
occurs. This could occur when the result is called for the test, if so configured,
or when a request from the LIS is received for INST_POSITIVE results.
Default: Disabled
Upload Confirmed Positives
When this checkbox is enabled (checked), CONFIRMED Positive results will be

uploaded to the LIS, whenever a Results Upload to the LIS occurs. This could
occur when the user selects the Save Confirmed Positives button on the
Results > Run Details > PCR Analysis screen, if so configured, or when a
request from the LIS is received for CONFIRMED_POSITIVE results.
Default: Disabled
Packed frames
If selected BD MAX will send frames packed with multiple records.

If unselected (unchecked), BD MAX will send frames that contain only a single
record.
This setting needs to be discuss with the LIS vendor.
Default: Enabled
14.6.13.Message Content
The following sections describe which fields are exchanged between the BD MAX and the LIS.
Field content
This section lists all of the fields by name BD MAX can exchange with the LIS.
Each field is displayed with its default mapping in the ASTM E_1394 records. This
position consists of a record type (Header, Result, Query, Terminator, etc.), a field
delimiter counter, repeat delimiter counter, and component delimiter counter. The fields
are grouped according to the ASTM E_1394 record type to which they are mapped.
The field list also indicates if that field is defaulted as an upload (U) or download (D)
field, or both (U/D). A blank column indicates that the field is not to be exchanged with
an LIS. Fields not configured to be exchanged with the LIS are ignored in a download
message.
The first two fields of every record include the Record Type indicator and a record index
value. These fields are considered part of every record but are not listed in these tables.
The following section describes these fields in more detail, including the expected values
for each field.
116



Test/Assay Name O, 16.1.1 U/D

User Result Identifier R, 4, 1, 2 U
Test Start Date Time R, 12, 1, 1 U
Instrument Position (specimen location) R, 14, 1, 5 U
Test Name (Analyte) R, 14, 1, 8 U
Confirmed Positive indicator R, 15, 1, 2 U

Patient ID request field Q, 3, 1, 1 D
Accession request field Q, 3, 1, 2 D
Request Information Status Code Q, 13, 1, 1 D

117
Field Descriptions
This section provides detailed information for each field listed in the previous section,
and is a complement to the information in Section 8.2.
Interpreting the ASTM position
This section is intended to give background information to help understand the
Field Description Section.
14.6.13.2.1.1.Understanding Field Delimiter Counter
This position refers to the second term in the ASTM position description in the
table above. For instance, in (H, 5, 1, 1), the field position would be “5”.
The position of a field in the record is determined the following way. Position
1 is the start of the line. Then, each subsequent position will be introduced by
a “|”. For instance, the first thirteen positions would be placed the following
way:
1| 2 |3 |4|5 |6 |7 |8 | 9 | 10 | 11 |12 | 13
In the following example, field “H” is at position 1, field “\^&” is at position 2,
field “Becton Dickinson” is at position 5, field “V1.0” is at position 13, field
“20151120171114” is at position 14.
H|\^&| | |Becton Dickinson| | | | | | | |V1.0 |20151120171114
This field position refers to the second term in the ASTM position description
in the table above. For instance, in (H, 5, 1, 1), the field position would be “5”.
14.6.13.2.1.2.Understanding Component Delimiter Counter
This component position refers to the fourth term in the ASTM position
description in the table above. For instance, in (R, 14, 1, 5), the component
position would be “5”.
Field Position (separated by “|”):
1| 2 |3 |4|5 |6 |7 |8 | 9 | 10 | 11 |12 | 13 | 14 | 15^^^|
Component Position (separated by “^”):
| 1^2^3^4^5|
In the following example, “62-A4-A-BOT-10” is at field position 14,
component position #5.
R|1|^^ÂND|INST_NEGATIVE|||||P|||20140823132809||BDMAX_AND^^^1^
62-A4-A-BOT-10^^^SA|^FALSE
Header Fields
See also Section 8.2.
Delimiter Fields (H, 2, 1, 1) – These single characters can be used to process
the remainder of the message. These characters denote the field, repeat,
component and escape delimiters as described in the ASTM E_1394
specification. These fields are defaulted to “|”, “\”, “^”, and “&” respectively, as
shown in shaded grey below.
118
Sender Name (H, 5, 1, 1) – Messages coming from a BD instrument have the

BD identifier in this field as shown in shaded grey below.
Version Number (H, 13, 1, 1) – This version number represents the version of
the LIS interface used for communications. For the BD MAX instrument, the
version number will begin with Vs1.00, as shown in shaded grey below.
constructing this message, formatted as described in the ASTM E_1394
specification in section 6.6.2 (YYYYMMDDHHMMSS), as shown in shaded
grey below.
Patient Fields
See also Section 8.2.2.
Patient ID (P, 4, 1, 1) – Identifier that uniquely identifies a patient. This field
can be up to 20 characters long. This field is optional.
P|1| |PatId123
Order Fields
Accession Number (O, 3, 1, 1) – The unique alphanumeric string that identifies
a specimen. This field can be up to 20 characters long. This is a required field
for a result upload to the LIS.
O|1|23878||^^^BDMAX_AND||||||||||BD MAX MRSA
Test ID (O, 5, 1, 4) – The unique string that identifies the BD instrument type
and test type. In the case of the BD MAX instrument, this will always be
BDMAX_AND.
Test/Assay Name (O, 16,1,1) – The name of the assay or test to be run. This
field is ignored empty on upload and mandatory on download. Limit of 40
characters.
Result Fields
Once a result has been successfully sent to the LIS in the unsolicited mode of
operation, it will not be resent to the LIS. If the BD MAX is configured for
Solicited mode operation, any time the result is requested by the LIS, it will be
sent to the LIS if it is within the specified date/time range of the request.
119
Result ID Code (R, 3, 1, 4) – This is a BD defined code that indicates the type
of information being exchanged in the result record. The BD MAX transmits a
“AND” (Amplification and Detection) as the Result ID Code.
R|1|^^ÂND|INST_NEGATIVE|||||P|||20140823132809||BDMAX_AND^^^1^6
Test Status (R, 4, 1, 1) – The status value for a particular test. This field is filled
for all test results. For the BD MAX instrument tests, the status code is one of
the pre-defined values. The possible values are:
x INST_POSITIVE
x INST_NEGATIVE
x CONFIRMED_POSITIVE
R|1|^^ÂND|INST_POSITIVE|||||P|||20111105075215||BDMAX_AND^^^1^98
2-B12-B-TOP-12^^^SA|^CONFIRMED POSITIVE
User Result Identifier (R, 4, 1, 2) – A user defined result string. This field is
optional.
Preliminary/Final Status (R, 9, 1, 1) – This field contains a “P” to indicate the
results should be considered Preliminary Results for the INST_POSITIVE and
INST_NEGATIVE test results.
Start Date/Time (R, 12, 1, 1) – This is the date and time that the test was first
started or entered into an instrument. This field is formatted as described in the
ASTM E_1394 specification in section 6.6.2 (YYYYMMDDHHMMSS format).
Instrument Type (R, 14, 1, 1) – This field indicates which BD instrument

produced the result. This field contains the value, “BDMAX_AND”.
Machine Instrument Number (R, 14, 1, 4) – This is the user number assigned
to the instrument that ran the test. This value can be between 1 and 99.
Location Information (R, 14, 1, 5) – – This value indicates the position inside
of the instrument where the test was performed.
120
Test Name (analyte) (R, 14, 1, 8) – This is the Assay name from the BD MAX
instrument that ran the test. The maximum length of the test name is 40
characters. It should be noted that for multi-analyte assays such as Staph SR,
the assay name is replaced by the analyte name. A table of LIS codes is below.
For UDP, analytes are based on the Results Logic settings.
Confirmed Positive (R, 15, 1, 2) – This is the user set indication that the
positive test has been “confirmed” as a positive.
R|1|^^ÂND|INST_POSITIVE|||||P|||20111105075215||BDMAX_AND^^^1^982
-B12-B-TOP-12^^^BD MAX MRSA IUOv3|^CONFIRMED POSITIVE
NOTE : When the “confirmed positives“ setting is not enabled, strings for
inst_negative and ins_positive will always include a FALSE in this field.
(“FALSE” meaning “not confirmed by the user”)
14.6.13.2.5.1.Summary of the Syntax (Result Fields)
General syntax Example with BD MAX™ StaphSR
H|\^&|||Becton H|\^&|||Becton Dickinson||||||||V1.0|20140823151055

Dickinson||||||||V1.0|Date-Time
P|1||Patient- ID P|1||12345678
O|1|Accession-Number||^^^TestID O|1|AB99990008||^^^BDMAX_AND
*TestID will always be “BDMAX_AND”
R|1|^^^ResultIDCode Example 1:
|TestStatus|||||Preliminary/Final|||Date
- R|1|^^ÂND|INST_NEGATIVE|||||P|||201408231328
Time||InstrumentType^^^N°instrume 09||BDMAX_AND^^^1^62-A4-A-BOT-
nt^Position of Sample^^^Test 10^^^SA|^FALSE
Results|^ConfirmationTRUE/FALSE
Example 2:
R|2|^^ÂND|INST_NEGATIVE|||||P|||201408231328
09||BDMAX_AND^^^1^62-A4-A-BOT-
10^^^MRSA|^FALSE
*ResultIDCode will always be “AND”
*InstrumentType will always be “BDMAX_AND”
* When the “confirmed positives“ setting is not

enabled, strings for inst_negative and ins_positive
will always include a FALSE after the test results.
L|1|N L|1|N
121
Request Fields
The ASTM 1394 protocol defines this as a Request Information Record

message. A download Request record is also known as a “Query”. A request
will typically be originating from the LIS System. The only type of download
“Query” request that the BD MAX instrument accepts is a request for test
results. A Terminator record with a termination code of “F”(processed) or
“Q”(error) is used to signal the last packet of a query response. If a query
request was invalid, the instrument interface responds with only the Terminator
record with a termination code of “Q”. If the instrument interface cannot locate
any specimens in the active or history databases that meet the query criteria, it
responds with only the Terminator record with a termination code of “F”.
specimen(s) to access. For instance, if the LIS requests information about “All
Confirmed Positive Results from November 5th, 2011 00:00:00 to November 6th,
2011 22:30:00”, this would result in the following query (detailed information
about each field can be found below):
Q|1|ALLÂLL||^CONFIRMED_POSITIVE||20111105000000|20111106223000
|||||P
The following tables define the ASTM 1394 Request record fields that can be
transmitted from the LIS in a Download message and are accepted and acted
upon by the BD MAX. The Starting Date/Time to Ending Date/Time range is
important for this query because all tests within the Starting Date/Time to
Ending Date/Time will be sent to the LIS when requested, whether or not they
have been previously sent.
Patient ID Request Field (Q, 3, 1, 1) – The only accepted value in this field is
ALL.
|||||P
Accession Request Field (Q, 3, 1, 2) – The only accepted value in this field is
ALL.
|||||P
Test Status (Q, 5, 1, 2) The BD MAX instrument accepts queries for vials with
a status as follows:
INST_POSITIVE = POSITIVE
INST_NEGATIVE = NEGATIVE
CONFIRMED_POSITIVE = CONFIRMED POSITIVES
ALL = POSTIVE & NEGATIVE & CONFIRMED POSITIVES
00|||||P
122
Starting Date\Time (Q, 7, 1, 1) – Requested starting time for query - the

beginning of the Date/Time range for which data should be collected. If it is
null, the BD MAX will use today’s date minus 30 days. NOTE: The time that is
used for any starting date/time is 12:00:00 a.m.
|||||P
End Date\Time (Q, 8, 1, 1) – Requested ending time for the query - the ending
of the Date/Time range for which data should be collected. It must be greater
than the Starting Date/Time or the query will be rejected. If it is null, the
BD MAX will use the current date time. NOTE: The time that is used for any
ending date/time is 12:00:00 a.m.
|||||P
Request Information Status Code (Q, 13, 1, 1) – The following codes are the
only codes that will be used in the BD MAX:
A – abort/cancel last request.
P – preliminary results.
|||||P
Details for Bi-directional connection (worklist upload to BD MAX)
The following information can be downloaded to the BD MAX from LIS and will be
imported to the worklist:
Test/assay name (O, 16, 1, 1) (can only be downloaded)

Accession number (O, 3, 1, 1)

Test ID (O, 5, 1, 4) (constant, stay the same regardless of the test/assay name or patient
info)

Once the worklist imported, the user will need to scan/enter the accession number to
highlight the right tube. The SBT barcode can then be assigned to the sample.
123
LIS Codes for Current BD MAX Assays

The table below outlines the strings that will be sent to the LIS in the Test/assay name field in the result
fields of an LIS message. LIS Code is the value that will appear in the Test Name field.
NOTE: Assays LIS Order Code Remap Feature is also available. Refer to BD MAX User’s Manual
(8089571/8089571) for additional details.
Assay Name (kit box Test names (ADF names) LIS Targets Common organism name
name) *Names in italic refer to ADF (Analyte
name in previous 3-snap in name)
configuration
BD MAX™ Cdiff BD MAX Cdiff CDIFF Clostridium difficile
BD MAX Cdiff 56
BD MAX™ Enteric BD MAX Ent Bac Shig Shigella species
Bacterial Panel BD MAX ENT BAC 52 STX Shiga toxin (E coli O157 + others)
Campy Campylobacter
Salm Salmonella species
BD MAX™ Extended BD MAX EX ENT BAC 26 Shig Shigella species
Enteric Bacterial STX Shiga toxin (E coli O157 + others)
Panel Campy Campylobacter
Salm Salmonella species
*The 4 first targets Plesiomonas shigelloides
are detected by the Vibrio (V.vulnificus, V.parahaemolyticus,
BD MAX™ Enteric Vibrio V.cholerae)
Bacterial Panel Plesio Enterotoxigenic E.coli
Master Mix, used in ETEC Yersinia enterocolitica
conjunction with the Yersi
BD MAX™ Extended
Enteric Bacterial
Panel.
BD MAX™ Enteric BD MAX Ent Parasite Glamb Giardia lamblia
Parasite Panel BD MAX ENT PARA 53 Ehist Cryptosporidium (C.hominis and
Crypto C.parvum)
Entamoeba histolytica
BD MAX™ GBS BD MAX GBS GBS Group B Strep
BD MAX GBS 61
BD MAX™ GC rt BD MAX GC rt PCR GC N. gonorrhoeae
PCR BD MAX GC rt PCR 60
BD MAX™ CT GC BD MAX CT GC CT C.trachomatis
BD MAX CT GC 59 GC N. gonorrhoeae
BD MAX™ CT GC BD MAX CT GC TV CT C.trachomatis
TV BD MAX CT GC TV 58 GC N. gonorrhoeae
TV Trichomonas vaginalis
BD MAX™ MRSA BD MAX MRSA MRSA MRSA
BD MAX™ MRSA BD MAX MRSA XT MRSA MRSA
XT BD MAX MRSA XT 54
BD MAX™ StaphSR BD MAX StaphSR SA S. aureus (MSSA, sensitive Staph)
BD MAX StaphSR 55 MRSA MRSA
BD MAX™ Vaginal BD MAX Vaginal 46 BV Bacterial vaginosis markers
Panel Cgroup Candida spp.
Ckru Candida glabrata
Cgla Candida krusei
TV Trichomonas vaginalis
BD MAX™ CRE BD MAX CRE RUO KPC Carbapenem-resistant Enterobacteriaceae
RUO OXA-48
NDM
124
14.6.14.Guidelines for setting up a connection

Tools and Information required
When setting up a new LIS connection, the customer must provide the list of assays and
UDP (User Defined Protocols) that will have to be connected to the LIS.
A computer will be required during installation.
Required Cables and Adapters
Cables and, in some cases, adapters will be required for installation. Required cables and
adapters may change depending on the LIS system used by the customer. These cables
and adapters must be provided by the customer (there is no part number for these).
COM-Port to Network (RJ45) Adapter
The LIS provider and/or local IT determines the settings.
COM-Port
If a COM port (DB9) is not available on the computer connecting to the
BD MAX, a COM port adapter will need to be installed.
Null-Modem Cable
For all direct connections with a COM-Port, a Null Modem Cable must be used.
Setting the connection to LIS
a) Physically connect the LIS cabling system.
b) Set the LIS configuration according to the LIS provider parameters and customer
options.
c) Provide an example of the string for each assay that will be uploaded/downloaded to
and from the LIS to the LIS vendor.
d) Test the connection for upload and download.
125

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LIS Vendor Interface Document

BECTON, DICKINSON AND COMPANY

(B) 3/00 All New fields added to EpiCenter interface to support

(C) 3/01 All Added BD Phoenix 100 section. Updated list of

(E) 10/01 All Formatting changes

(F) 3/02 All Various updates throughout the document to cleanup

(G) 12/03 All Updates for EpiCenter Version 4 Features

(H) 12/03 18,31,63,65-76 Updates for Phoenix Version 4

(K) 03/14/05 All Various updates throughout the document to cleanup

(M) 9/11/2008 83-98 Added section 14.4 describing BACTEC FX

(Q)(17) 10/24/2013 69-75 Added additional information for Viper LT

18 10/2016 Preface; sections Added information for BD Phoenix M50

19 04/2017 Section 14.6 Added information for BD MAX

8.2. Field Descriptions ....................................................................................................................... 23

Order Fields ..................................................................................................................................................... 70

14.6.3. Unresolved (UNR)/Indeterminate (IND)/Incomplete (INC) Results Handling ................................. 108

4.1. Physical Cable Interface

4.2. Communication Protocols

4.3. System Configurations

4.4. EpiCenter- LIS Communication

5.1. Uploaded Test Results

5.2. Uploaded Isolate Results

The relationships and hierarchy of the finalization scheme in the BD EpiCenter is

5.3. Unsolicited Downloads

5.4. File Import

5.6. Error Reporting

6.1. Physical Protocols

on download message sizes. The BD EpiCenter expects to be able to handle

EpiCenter Default Value Corresponding BDModem/Emulate 9000 Value

Sequence Number to R, 3, 1, 5 Sequence Number to R, 3, 1, 4

Media Type to R, 14, 1, 2 Media Type to R, 3, 1, 5

Instrument Type to R, 14, 1, 1 Instrument Type to R, 14, 1, 5

Instrument Location to R, 14, 1, 5 Instrument Location to R, 14, 1, 1

Request Test Status Code to Q, 5, 1, 2 Request Test Status Code to Q, 5, 1, 4

Request Instrument Number Q, 5, 1, 4 Request Instrument Number to Q, 5, 1, 2

Comment Text C, 4, 1, 1 Comment Text C, 3, 1, 1

Test Status LIS Codes

6.2. Logical Protocols

7.1. Port parameters

Data Bits – acceptable values range from 5 to 8.

7.2. Auto-Populating Lists

7.3. Logical Protocol Parameters

7.4. ASTM Field Mapping

7.5. User Defined Fields

8.1. Field List

Header Record Field Name ASTM Pos. Direction

Patient Record Field Name ASTM Pos. Direction

Patient Record Field Name ASTM Pos. Direction

Order Record Field Name ASTM Pos. Direction

Result Record Field Name ASTM Pos. Direction

Result Record Field Name ASTM Pos. Direction

Comment Record Field Name ASTM Pos. Direction

Request Record Field Name ASTM Pos. Direction

Request Starting Patient Id Q, 3, 1, 1 D

Terminator Record Field Name ASTM Pos. Direction

8.2. Field Descriptions

H|\^&| | |Becton Dickinson| | | | | | | |V1.00|19981019184200

8.2.2. Patient Fields

P|1| |PatId123| |Doe^John^R^Jr.^Dr.| |19651029|M| |2 Main