Interface Protocols Specification For GEMweb Plus 2.1 in 2021

[Year]
Interface Protocols
Specification
For GEMweb Plus 2.1
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summary of the contents of the document. Type the abstract of the document
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Sam Cowan
Instrumentation Labs
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1 Document Summary _______________________________________________________________ 15
2 External Connectivity Module ________________________________________________________ 15
2.1 Background ___________________________________________________________________ 15
2.2 Interaction with Other Systems ___________________________________________________ 17
2.2.1 Creating a Session __________________________________________________________ 17
2.2.2 Sending Messages __________________________________________________________ 17
2.2.3 Receiving Messages _________________________________________________________ 18
2.2.4 Session Management ________________________________________________________ 19
2.2.5 External Interaction _________________________________________________________ 19
2.3 Protocols _____________________________________________________________________ 20
2.3.1 High Level Protocols _________________________________________________________ 20
2.3.1.1 LIS2-A (ASTM-1394) _____________________________________________________ 20
2.3.1.2 NCCLS POCT1-A _________________________________________________________ 21
2.3.1.3 HL7 other than NCCLS POCT1-A ____________________________________________ 22
2.3.2 Low Level Protocols _________________________________________________________ 22
2.3.2.1 NCCLS LIS1-A (formerly ASTM E1381-02) _____________________________________ 23
2.3.3 Physical Transfer Layer ______________________________________________________ 23
2.3.3.1 RS-232 ________________________________________________________________ 24
2.3.3.2 TCP/IP ________________________________________________________________ 24
3 Physical Layer _____________________________________________________________________ 24
3.1 TCP/IP sockets _________________________________________________________________ 24
3.1.1 HIS/LIS/CIS as Server ________________________________________________________ 24
3.1.1.1 Description ____________________________________________________________ 24
3.1.1.2 Configuration __________________________________________________________ 25
3.1.2 HIS/LIS/CIS as Client _________________________________________________________ 25
3.1.2.1 Description ____________________________________________________________ 25
3.1.2.2 Configuration __________________________________________________________ 25
3.2 RS-232 _______________________________________________________________________ 25
3.2.1 Overview _________________________________________________________________ 25
3.2.2 Configurable settings ________________________________________________________ 26
3.2.3 Interface connections _______________________________________________________ 26
4 Low Level Protocol (Data Link Layer) ___________________________________________________ 27
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4.1 Background ___________________________________________________________________ 27
4.2 NCCLS LIS1-A (formerly ASTM E1381) Data Link Layer __________________________________ 27
4.2.1 Overview _________________________________________________________________ 27
4.2.1.1 Establishment Phase (Link Connection) ______________________________________ 27
4.2.1.1.1 Operation __________________________________________________________ 27
4.2.1.2 Transfer Phase _________________________________________________________ 28
4.2.1.2.1 Frames ____________________________________________________________ 28
4.2.1.2.2 Frame number ______________________________________________________ 29
4.2.1.2.3 Checksum __________________________________________________________ 29
4.2.1.2.4 Acknowledgements __________________________________________________ 30
4.2.1.2.5 Receiver Interrupts __________________________________________________ 30
4.2.1.3 Termination Phase (link release) ___________________________________________ 31
4.2.1.4 Error Recovery _________________________________________________________ 31
4.2.1.4.1 Defective frames ____________________________________________________ 31
4.2.1.4.2 Timeouts __________________________________________________________ 31
4.2.1.5 Valid Characters in the Text part ___________________________________________ 32
4.2.1.6 Checking channel status __________________________________________________ 32
4.2.1.7 Connection Test ________________________________________________________ 32
4.3 HL7 HYBRID LOWER LAYER PROTOCOL______________________________________________ 33
4.3.1 Overview _________________________________________________________________ 33
4.3.2 Frame definition____________________________________________________________ 33
4.3.3 Communication flow ________________________________________________________ 34
4.3.3.1 Communication parameters _______________________________________________ 34
4.3.3.2 G4K/GWP acting as the sender _____________________________________________ 34
4.3.3.3 G4K/GWP acting as the receiver ____________________________________________ 34
4.3.3.4 Connection Test ________________________________________________________ 35
5 High Level Protocol ________________________________________________________________ 35
5.1 Overview _____________________________________________________________________ 35
5.2 NCCLS LIS2-A (formerly ASTM E1394-97) ____________________________________________ 35
5.2.1 Background and Terminology _________________________________________________ 35
5.2.2 Message Structure and contents _______________________________________________ 37
5.2.2.1 Records _______________________________________________________________ 37
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5.2.2.2 Fields _________________________________________________________________ 38
5.2.2.3 Hierarchy ______________________________________________________________ 39
5.2.2.4 Character Codes ________________________________________________________ 39
5.2.2.5 Delimiters _____________________________________________________________ 40
5.2.3 Message Transmission Control ________________________________________________ 42
5.2.3.1 Storage _______________________________________________________________ 42
5.2.3.2 Error Recovery _________________________________________________________ 43
5.3 ORI (HL7 v2.4) _________________________________________________________________ 43
5.3.1 Background and conventions__________________________________________________ 43
5.3.2 Message Structure and contents _______________________________________________ 44
5.3.2.1 Segments______________________________________________________________ 45
5.3.2.2 Fields _________________________________________________________________ 46
5.3.2.3 Character Codes ________________________________________________________ 47
5.3.2.4 Delimiters _____________________________________________________________ 48
5.3.2.6 Message Processing Rules ________________________________________________ 50
5.3.3 Message Transmission Control ________________________________________________ 50
5.3.3.1 Initiation ______________________________________________________________ 51
5.3.3.2 Response ______________________________________________________________ 51
5.3.3.3 Error Recovery _________________________________________________________ 51
5.3.3.3.1 Resend timeout _____________________________________________________ 51
5.3.3.3.2 Non-expected message received ________________________________________ 52
6 ORI Messages (HL7 v4.2) ____________________________________________________________ 52
6.1 Overview _____________________________________________________________________ 52
6.2 Upload Patient Sample Results to HIS/LIS/CIS ________________________________________ 52
6.2.1 Message 1: ORU^R32 (uploading) ______________________________________________ 53
6.2.1.1 Message Header Segment - MSH ___________________________________________ 55
6.2.1.2 Patient Identification Segment - PID_________________________________________ 57
6.2.1.3 Common Order Segment - ORC ____________________________________________ 59
6.2.1.4 Observation Request Segment - OBR ________________________________________ 60
6.2.1.5 Notes and Comment Segment (related to message) - NTE (MSG) __________________ 62
6.2.1.6 Observation Result Segment - OBX__________________________________________ 63
6.2.1.6.1 Special fields sent in the OBX segment . __________________________________ 66
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6.2.1.7 Notes and Comment Segment (related to Observation) - NTE (OBX) _______________ 71
6.2.2 Message 2: ACK (downloading) ________________________________________________ 73
6.2.2.2 General Acknowledgement Segment - MSA ___________________________________ 75
6.2.3 Message 3/3E: ACK^R33 (downloading) _________________________________________ 75
6.2.4 Message 4/4E: ACK (uploading) ________________________________________________ 77
6.2.5 Transmission examples ______________________________________________________ 79
6.2.5.1 Successful upload _______________________________________________________ 79
6.2.5.2 HILS/LIS rejects GEM 4000 message _________________________________________ 80
6.2.5.3 HIS/LIS/CIS fails to process transmission _____________________________________ 81
6.3 Upload Calibration Results to HIS/LIS/CIS____________________________________________ 82
6.3.1 Message 1: OUL^R21 (uploading) ______________________________________________ 82
6.3.1.2 Specimen and Container Detail Segment - SAC ________________________________ 85
6.3.1.3 Observation Request Segment - OBR ________________________________________ 86
6.3.1.4 Observation Result Segment - OBX__________________________________________ 89
6.3.2 Message 2: ACK (downloading) ________________________________________________ 91
6.3.3 Transmission examples ______________________________________________________ 91
6.3.3.1 B calibration ___________________________________________________________ 91
6.3.3.2 Full Calibration _________________________________________________________ 92
6.3.3.3 C Calibration ___________________________________________________________ 96
6.3.3.4 D Calibration ___________________________________________________________ 97
6.4 Upload iQM-CVP Results to HIS/LIS/CIS _____________________________________________ 99
6.4.1 When CVP Results are Transmitted _____________________________________________ 99
6.4.2 CVP Sample Results Message Flow _____________________________________________ 99
6.4.3 Message 1: OUL^R21 (uploading) ______________________________________________ 99
6.4.3.1 Message Header Segment - MSH __________________________________________ 100
6.4.3.2 Specimen and Container Detail Segment - SAC _______________________________ 101
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6.4.3.3 Substance Identifier Segment - SID_________________________________________ 101
6.4.3.4 Notes and Comment Segment - NTE _______________________________________ 102
6.4.3.5 Observation Request Segment - OBR _______________________________________ 103
6.4.3.6 Observation Result Segment - OBX_________________________________________ 106
6.4.3.7 Notes and Comment Segment (related to Observation) - NTE (OBX) ______________ 109
6.4.4 Message 2: ACK (downloading) _______________________________________________ 109
6.4.5 Transmission examples _____________________________________________________ 109
6.5 Upload iQM CAR Reports to HIS/LIS/CIS ____________________________________________ 110
6.5.1 When Corrective Action Report (CAR) Data Are Transmitted ________________________ 110
6.5.2 CAR Message Flow _________________________________________________________ 110
6.5.3 Message 1: LSUÛ12 (uploading) _____________________________________________ 110
6.5.3.2 Equipment Instance Identifier - EQU _______________________________________ 113
6.6 Upload iQM Delta Chart Data to HIS/LIS/CIS ________________________________________ 115
6.6.1 When iQM Delta Chart Data Are Transmitted ____________________________________ 115
6.6.2 Delta Chart Data Message Flow _______________________________________________ 115
6.6.3.3 Equipment Log/Service Segment - EQP _____________________________________ 116
6.6.5 Delta Chart Transmission examples ____________________________________________ 116
6.7 Upload RiliBAEK Chart to HIS/LIS/CIS ______________________________________________ 117
6.7.1 When RiliBAEK Chart Are Transmitted__________________________________________ 117
6.7.2 RiliBAEK Chart Message Flow_________________________________________________ 117
6.7.3.3 Equipment Log/Service Segment - EQP _____________________________________ 118
6.8 Upload RiliBAEK Report to HIS/LIS/CIS _____________________________________________ 120
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6.8.1 When RiliBAEK Report Data Are Transmitted ____________________________________ 120
6.8.2 RiliBAEK Report Message Flow _______________________________________________ 121
6.8.3.3 Equipment Log/Service Segment - EQP (RiliBAEK Report) _______________________ 124
6.9 Fetch Demographics from HIS/LIS/CIS (query by Patient ID) ____________________________ 125
6.9.1 Message 1: QRYÂ19 (uploading) _____________________________________________ 125
6.9.1.2 Query Definition Segment - QRD __________________________________________ 128
6.9.1.3 Query Filter Segment - QRF ______________________________________________ 128
6.9.2 Message 2: ADRÂ19 (downloading) ___________________________________________ 129
6.9.2.2 General Acknowledgement Segment - MSA __________________________________ 132
6.9.2.3 Query Definition Segment - QRD __________________________________________ 133
6.9.2.4 Query Filter Segment - QRF ______________________________________________ 133
6.9.2.5 Patient Identification Segment - PID________________________________________ 135
6.9.2.6 Patient Visit Segment - PV1 ______________________________________________ 137
6.9.3.1 Patient exists by Patient ID _______________________________________________ 137
6.9.3.2 Patient does not exists by Patient ID _______________________________________ 137
6.9.3.3 Patient exists by Sample Number __________________________________________ 138
6.9.3.4 Patient does not exist by Sample Number ___________________________________ 138
6.10 Download test orders from HIS/LIS/CIS ___________________________________________ 138
6.10.1 Message 1: OMLÔ21 (Downloading) _________________________________________ 138
6.10.1.1 Message Header Segment - MSH _________________________________________ 140
6.10.1.2 Patient Identification Segment - PID_______________________________________ 141
6.10.1.3 Patient Visit Segment - PV1 _____________________________________________ 143
6.10.1.4 Common Order Segment - ORC __________________________________________ 144
6.10.1.5 Observation Request Segment - OBR ______________________________________ 145
6.10.1.6 Specimen and Container Detail Segment - SAC ______________________________ 148
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6.10.2 Message 2: ACK (uploading) ________________________________________________ 148
6.10.3 Transmission examples ____________________________________________________ 148
6.11 Cancel Previous test order from HIS/LIS/CIS _______________________________________ 149
6.11.1 Message 1: OMLÔ21 (Downloading) _________________________________________ 149
6.11.2 Message 2: ACK (Uploading) ________________________________________________ 150
6.11.3 Message 3/3E: ACK (Uploading) _____________________________________________ 150
6.11.3.2 General Acknowledgement Segment - MSA_________________________________ 152
6.11.4 Message 4/4E: ACK (Downloading) ___________________________________________ 152
6.12 Connection Test _____________________________________________________________ 152
6.12.1 Message 1: TEST (uploading) ________________________________________________ 152
6.12.2 Message 2: ACK (downloading) ______________________________________________ 154
6.12.2.2 General Acknowledgement Segment - MSA_________________________________ 156
7 LIS2-A Messages (GEM 4000 Native Mode)_____________________________________________ 156
7.1 Overview ____________________________________________________________________ 156
7.2 Upload Patient Sample Results to HIS/LIS/CIS _______________________________________ 157
7.2.1 Uploading message ________________________________________________________ 157
7.2.1.1 Message Header Record (H) ______________________________________________ 158
7.2.1.2 Patient Information Record (P) ____________________________________________ 159
7.2.1.3 Comment Record associated to a Patient Information Record (C)_________________ 159
7.2.1.4 Test Order Record (O) ___________________________________________________ 161
7.2.1.5 Comment Record associated to a Test Order Record (C) ________________________ 162
7.2.1.6 Result Record (R)_______________________________________________________ 166
7.2.1.7 Comment associated to a RSR ____________________________________________ 169
7.2.1.8 Message Terminator Record (L) ___________________________________________ 169
7.2.2 Expected responses ________________________________________________________ 169
7.3 Upload Calibration Results to HIS/LIS/CIS___________________________________________ 170
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7.3.1.4 Result Record (R)_______________________________________________________ 172
7.4 Upload iQM-CVP Results to HIS/LIS/CIS ____________________________________________ 178
7.4.1.4 Comment Record associated to a Test Order Record (C) ________________________ 180
7.4.1.5 Result Record (R)_______________________________________________________ 181
7.4.1.6 Comment associated to a Result Record ____________________________________ 183
7.5 Upload iQM-CAR Reports to HIS/LIS/CIS ___________________________________________ 184
7.5.1.2 Manufacturer Record (M) ________________________________________________ 186
7.5.1.3 Comment Record (C) ____________________________________________________ 186
7.6 Upload iQM-Delta Charts to HIS/LIS/CIS ____________________________________________ 187
7.6.1.3 XXX Comment Record (C) ________________________________________________ 189
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7.7 Upload RiliBAEK Chart to HIS/LIS/CIS ______________________________________________ 190
7.7.1.3 XXX Comment Record (C) ________________________________________________ 191
7.8 Upload RiliBAEK Report to HIS/LIS/CIS _____________________________________________ 191
7.8.1.3 Comment Record (C) ____________________________________________________ 193
7.9 Fetch Demographics from HIS/LIS/CIS _____________________________________________ 194
7.9.1.2 Request Information Record (Q) ___________________________________________ 196
7.9.1.2.1 Query based on Patient ID ____________________________________________ 196
7.9.1.2.2 Query based on Account Number or Order Number _______________________ 196
7.9.1.2.3 Query based on Sample Number _______________________________________ 197
7.9.1.2.4 Query based on a custom defined field __________________________________ 197
7.9.2.1 Patient exists __________________________________________________________ 197
7.9.2.1.1 Message Header Record (H) __________________________________________ 198
7.9.2.1.2 Query Information Record (Q) _________________________________________ 198
7.9.2.1.3 Patient Information Record (P) ________________________________________ 201
7.9.2.1.4 Message Terminator Record (L) ________________________________________ 201
7.9.2.2 Patient does not exist ___________________________________________________ 201
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7.9.2.2.2 Request Information Record (Q) _______________________________________ 202
7.9.3.1 Patient exists by Patient ID _______________________________________________ 204
7.9.3.2 Patient does not exist by Patient ID ________________________________________ 205
7.9.3.3 Patient exists by Sample Number __________________________________________ 205
7.9.3.4 Patient does not exist by Sample Number ___________________________________ 206
8 LIS2-A Messages (GEM 3000 Mode) __________________________________________________ 206
8.1 Overview ____________________________________________________________________ 206
8.2.1.4 Comment Record (CMR) associated with Test Order Record (TOR)________________ 209
8.2.1.5 Result Record (R)_______________________________________________________ 210
8.3.1.4 Result Record (R)_______________________________________________________ 214
8.4 Upload iQM-CVP Results to HIS/LIS/CIS ____________________________________________ 218
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8.4.1.4 CMR associated to TOR __________________________________________________ 220
8.4.1.5 Result Record (R)_______________________________________________________ 221
8.5 Upload iQM-CAR Reports to HIS/LIS/CIS ___________________________________________ 223
8.5.1.3 Comment Record (C) ____________________________________________________ 225
8.6 Upload iQM-Delta Charts to HIS/LIS/CIS ____________________________________________ 226
8.6.1 Upload iQM-Delta Charts to HIS/LIS/CIS ________________________________________ 226
8.6.1.3 Comment Record (C) ____________________________________________________ 226
8.7 Fetch Demographics from HIS/LIS/CIS _____________________________________________ 228
8.7.1 Fetch Demographics from HIS/LIS/CIS __________________________________________ 228
8.7.1.2 Request Information Record (Q) ___________________________________________ 229
8.7.2.1 Patient exists __________________________________________________________ 230
8.7.2.1.2 Patient Information Record (P) ________________________________________ 231
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8.7.2.2.2 Request Information Record (Q) _______________________________________ 232
8.7.3.1 Patient exists __________________________________________________________ 232
9 Synthesis Mode __________________________________________________________________ 233
9.1 General considerations _________________________________________________________ 233
10 Appendix A. Tables_______________________________________________________________ 233
10.1 Analyte names ______________________________________________________________ 233
10.2 Analytes / Instrument origin matrix.______________________________________________ 235
10.3 Patient sample types__________________________________________________________ 238
10.4 Containers __________________________________________________________________ 238
10.5 Age Units ___________________________________________________________________ 239
10.6 Sample Panels _______________________________________________________________ 239
10.7 CVP Panels__________________________________________________________________ 239
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1 Document Summary
This document describes how data is transferred between a GEM 4000 system and external systems,
like a DMS, HIS, LIS or other analyzers. The GEM 4000 system refers to either a GEM Premier 4000
analyzer or a GEMwebPlus server.
The data transfer protocol specified in this document is implemented according to ASTM (American
Society for Testing and Materials) E1394-91 and E1381-91 high and low level clinical data transfer
protocols. The documentation for ASTM E1394-91 and E1381-91 should also serve as reference
material.
2 External Connectivity Module

2.1 Background
The external connectivity of the instrument will be handled by the External Communication Module
(ECM). The ECM is intended to provide communications with HIS/LIS/CIS systems, external instruments,
as well as bedside monitoring stations.
ECM intends to provide a common front-end between the DM and other foreign systems translating
from/to different communication protocols. It means that the ECM is able to manage connections for a
wide range of IL and non IL devices like:
GEM 3000, GEM Premier, Synthesis. IL682, GEM PCL, and GEM OPL
Competitor BG instruments (Radiometer, Bayer, NOVA, etc.).
HIS/LIS/CIS systems.
Other medical devices (glucometers, cardiac markers, POCT coagulation devices, bed-side patient
monitors, etc.)
Protocols to be translated are CIC, HL7 or ASTM. New protocols will be added with minimum
development efforts.
The ECM will emulate other instruments.
When communication is desired among devices from different vendors, the communication functions
are broken down into a hierarchical set of layers (the Protocol Stack). Each layer performs a related
subset of the functions required to communicate with another system. It relies on the next lower layer
to perform more primitive functions and to conceal the details of those functions. It provides services to
the next higher layer. The layers are defined in such a manner so that changes in one layer do not
require changes in the other layers. By partitioning the communication functions into layers, the
problem at hand is much more manageable.
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Internally, the ECM is a set of interchangeable modules that allow the construction of multiple protocol
stacks. The more relevant are shown in the following table:
ECM Module Description Protocols
High Level Messaging This library uses a module called Message Transla- ASTM-1394
tor, which contains a “dictionary” that translates POCT1-A
between different protocols.
Low Level Messaging ASTM-1381
Data Transmission Physical layer RS-232
IrDA
Sockets
File/FTP
HTTP
The ECM software will provide the ability to:
Operate as a service to the GEM4000 DM component.
Create a communication session to an external device or an HIS/LIS/CIS system.
Specify the parameters to establish a session based on HLP, LLP, transport protocol, and possibly
communication mode.
Send and/or receive data from an active session.
Allow more than one active session.
Assign a priority level to a message.
Query any active session for status, pending messages, configuration, etc.
Operate in active (master) or passive (slave) mode where applicable by the requirements of the
protocol, or the operating (compatibility) mode.
Define a software framework that would allow development of future HLP, LLP, transport
modules.
Perform parameter name translations.
Perform unit conversions
The purpose of this section is enumerate the requirements of the ECM (i.e. the present and future
capabilities of the module)., not the actual requirements. The actual requirements are described in this
document commencing at chapter 4 and in the rest of the SFS documents.
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2.2 Interaction with Other Systems
2.2.1 Creating a Session
The ECM will operate as a service to the DM component of the GEM4000.
The client would request an ECM session, specifying the session requirements (LLP, HLP, transport,
emulation mode).
If applicable, the client will subscribe to receive any pertinent events for that session.
The ECM client can only interact with the external device using the ECM session.
The ECM client will specify a transmission queue size (default is 1000). When the queue is full, the
ECM will reject the addition of new items to the queue.
The ECM will allow the client to enable tracing within any module for debugging purposes.
The ECM client will specify a Session ID. This ID will be used for future references to this session.
2.2.2 Sending Messages

The ECM is allowed to send messages only through an active ECM session.
When sending a message, DM will specify to the ECM the following information:
The message to send, in the GEM Common Language.
Priority:
An outgoing message will have an associated queue priority. Message priorities are
numbered from 0 (lowest) to 255 (highest).
All outgoing messages without a specified priority will be assigned the same (default)
priority (128).
Maximum number of retries. Default is infinite (note: this is needed for the patient verification,
where only 1 retry can be done.
Answer is expected.
Yes: The ECM shall wait for the answer without sending any other message.
No: The ECM shall not wait for the answer, sending other message.
A message ID. This ID will be used for future references to this message (the client can cancel a
pending message using the message ID, answers are referenced to this ID).
Outgoing messages will be sent in FIFO mode according to the assigned priority.
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To send a message, the ECM will perform the following operations:
Transform the parameter names, units, samples types, etc. to the recipient convention.
Initiate the sending process. This includes:
Apply names changes and unit conversions from G4K default to the recipient convention.
Do all the needed “handshaking” operations with the recipient.
If the message is delivered, ECM is notified and the message is removed from the transmission queue.
If the message cannot be delivered, it can be due to different reasons:
Temporary condition like the recipient is physically unreachable or busy. Those conditions are
temporary, so the message is resent. DM is not notified.
Permanent condition, i.e. the recipient cannot process the message because there is an error or
does not recognize it. The message is removed from the transmission queue and the DM is notified.
The outcome of a message can be:
Message delivered. The message has been delivered to the recipient. The ECM will notify DM:
Message ID.
Timestamp.
Delivery status. The recipient acknowledges the message reception with a code
Message undeliverable. The message cannot reach the recipient because of a permanent
condition:
Message ID.
Timestamp.
Reason. Why the recipient cannot receive the message.
Messages may be encrypted in two ways:
Physical Layer accepts encryption (sockets, HTTPS).
As a translation module if transport does not support encryption.
2.2.3 Receiving Messages

The client can subscribe to receive incoming messages once an ECM session is established.
The reception process is as follows:
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Receive and -if applicable- acknowledge the reception of the message. From now on, the sender
has transferred the ownership of the message to the G4K.
Apply names changes and unit conversions from G4K default to the recipient convention.
Save the message in a permanent storage.
Send the message to the DM.
When the DM acknowledges the reception of the message, delete from the permanent storage.
Note: This is very important, because when an instrument sends a message to a DMS, and the DMS
acknowledges the reception of the message, the instrument is no longer responsible for that message,
being able to delete it.
2.2.4 Session Management

It is the responsibility of the session to:
Initiate the session, with the appropriate handshaking.
If applicable, send keep alive messages.
If communication cannot be established, retry as many times as needed
The DM can manage the active sessions using the following commands:
Close session
Get status. At any time the client (DM) will be able to request to the ECM the status of all the
active sessions. This state has the following information:
Session status.
Pending messages.
HLP Status. Each HLP has a defined status.
LLP Status. Each LLP has a defined status.
Physical Layer Status. Each Physical Layer has a defined status.
Delete outgoing messages.
Get session properties (configuration parameters).
2.2.5 External Interaction

The ECM will connect to external devices using the transport protocol specifications provided by the
client.
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External communications are handled by the transport protocol only.
External data could be processed by one of the lower ECM modules (Transport, LLP) without reaching
the ECM client.
2.3 Protocols
2.3.1 High Level Protocols
Using a high level protocol shall be mandatory.
The ECM shall provide support for the following protocols:
LIS2-A (based on ASTM-1394)
NCCLS POCT1-A (originated by CIC):
DML (Device Massaging Layer). Phase 2, will be used to interface to 3rd party DML-
compliant analyzers
ORI (Observation Reporting Interface), which is based on HL7 v2.4. Used to interface ECM
to HIS/LIS/CIS.
These protocols are explained in the following sections.
2.3.1.1 LIS2-A (ASTM-1394)

Although ASTM-1394 is an unambiguous standard, many vendors have different interpretations. The
ECM will provide support for different interpretations. The ECM shall provide the capability to configure:
Termination Code :
Use Termination Codes (ASTM Standard). Default.
Do not use Termination Codes.
The ECM will be able to provide support for different modes:
Native mode (GEM 4000).
GEM 3000 mode.
Other ASTM/HL7 based protocols - phase 2
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2.3.1.2 NCCLS POCT1-A
NCCLS - POCT1-A Point of Care Connectivity - Approved Standard is the reference document derived
from CIC document. The Connectivity Industry Consortium (http://www.poccic.org) developed the
point-of-care connectivity specifications:
“The vision of the CIC is to expeditiously develop, pilot, and transfer the foundation for a set of
seamless 'plug and play' POC communication standards ensuring fulfillment of the critical user
requirements of bi-directionality, device connection commonality, commercial software interoperability,
security, and QC / regulatory compliance.”
The CIC defines three actors in the POCT systems:
Device (Devices, Docking Stations).
Observation Reviewer (POC Data Managers, Access Points, Concentrators).
Observation Recipient (LIS, CDR, ADT and HIS).
And two interfaces:
Device interface: Communication between devices and the observation reviewer. The CIC protocol
stack defines two layers, the Device Messaging Layer (DML) specification, which sits on top of the
Device and Access Point (DAP) interface specification, as shown in the figure below. The role of
those layers is detailed below:
DAP: This standard specifies the lower-layer communication protocols and physical
interfaces for POC Devices and Access Points. It specifies the use of a single transport
protocol running over either of two physical layers: IrDA-Infrared, and cable-connected.
DML: This standard specifies the messaging protocol, that is, the message structures and
flows.
The DML is a High Level Protocol (HLP). It means that it has to run on top of a robust and reliable
lower-level transport (Low Level Protocol or LLP).
Robust: Messages are communicated with perfect integrity, i.e. the message contents will
not be mangled or disrupted in transit. This capability is often provided using checksums,
parity bits, retry schemes, etc.
Reliable: The protocol guarantees that the sender will be informed if a message cannot be
delivered to the recipient.
The DAP is one of those protocols. Since the HLP and the LLP are completely decoupled, the DML
can be used only on top of the DAP but also on top of any other robust and reliable LLP (TCP/IP,
IEEE 802.11a/b, HTTP, HTTPS, Bluetooth…).
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Observation Reporting (EDI) Interface: Communication between the observation reviewer and
the observation recipient. It is an HL7 v2.4 Messaging Implementation Guide.
This is shown in the following figure:
As set out above, and GEM 4000 will completely integrate the data management. The analyzers and the
server (that can be one of the analyzers or a computer) are a unique system. So the role of GEM4000
must be of Observation Reviewer, having the capability to be connected to:
Other CIC devices (Device Interface). Phase 2.
Observation Recipients (EDI Interface). Phase 1.
ID : INT_PROT-147
2.3.1.3 HL7 other than NCCLS POCT1-A

The ECM shall be able at a future release provide support for HL7 transactions not part of POCT1-A
(order reception, ADT…).
2.3.2 Low Level Protocols

Using a low level protocol is optional.
The ECM will fully support the use of the ASTM-1381 protocol as it is defined in the protocol
specifications.
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The ECM design shall not exclude the ability of supporting other Low Level Protocols.
2.3.2.1 NCCLS LIS1-A (formerly ASTM E1381-02)

This will be configurable:
Contention Management: When the two systems simultaneously transmit <ENQ> the data link is
in contention. In the Observation Reporting Interface (G4K, which acts as an observation reviewer,
connected to an observation recipient), the G4K has priority. In the Device Interface (a device
connected to the G4K, which acts as an observation reviewer), the device has priority.
Those options are possible:
Priority On Contention=True.
Priority On Contention=False.
Record length: From 240 to 64,000 (boundaries included). Default is 240 (old ASTM default).
Frame split: The standard specifies that messages longer than 240 characters be split in frames
(ASTM E 1381-95 §6.3.1.2). Nevertheless, some vendors cut the messages at the end of the ASTM-
1394 records. Those options are possible
Split frames always at 240 characters (ASTM Standard). This is the default.
Split frames at 240 characters or at the end of a record.
Frame termination: The standard specifies that an intermediate frame terminates with the
character <ETB> and an end frame terminates with the character <ETX> (ASTM E 1381-95 §6.3.1.2).
Nevertheless, some vendors terminate intermediate frames that are the end of a record with the
<ETX> character. Those options are possible
Use always <ETB> in intermediate frames (ASTM Standard). This is the default.
Use <ETX> termination in intermediate frames that are the end of a record.
Timeouts: Protocol specifies timeouts in the state diagram, but should be configurable.
Retries: Should be configurable.
2.3.3 Physical Transfer Layer

Using a Physical Transfer Layer is mandatory.
The ECM will provide support for:
RS-232.
TCP/IP.
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The ECM design shall not exclude the ability of supporting other Physical Transfer Layers.
2.3.3.1 RS-232
The ECM can be configured for serial data transmission with the following parameters:
Port.
Baud Rate.
2.3.3.2 TCP/IP
The ECM will support the use of TCP/IP sockets. It will be configurable:
Mode: ECM will be able to operate in either Server or Client mode. Those options are possible:
Mode=Server
Mode=Client (default).
Port Number.
Server IP Address (only in client mode)
Connection Timeout.
Retry Delay.
Retry limit.
3 Physical Layer
3.1 TCP/IP sockets

The GEM 4000 will have multiple modes of operation and will be configurable for each of the following
modes:
TCP/IP (HIS/LIS/CIS as Client).
TCP/IP (GEM 4000 as Client).
3.1.1 HIS/LIS/CIS as Server
3.1.1.1 Description
The GEM 4000 shall be considered the client and the remote system shall be the server (master).
The remote system opens a port and listens for a connection request. The GEM 4000 requests for
connection.
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Once the request has been accepted, the GEM 4000 shall be able to transmit and receive according to
the rules specified by the Low Level Protocol.
If connection is lost (remote system closes the server socket or an error occurs), GEM4000 will request a
new connection every one minute.
3.1.1.2 Configuration
The following parameters shall be configurable
Port Number: The port used to establish the connection. Allowed values are from 1024 to 65,535,
boundaries inclusive. Defaults are 1183 and 1184 (see Volume 4b)
Server Address: A valid Address (IP or host name). Default is null.
The following parameters shall not be configurable but accessible to technical people in case of
communication problems:
Connection Timeout. Timeout set when trying to establish a connection. Allowed values are from
1 to No timeout. Default is 5s
3.1.2 HIS/LIS/CIS as Client
3.1.2.1 Description
The GEM 4000 shall be considered the server (master) and the remote system shall be the client (slave).
The GEM 4000 opens a port and listens for a connection request.
Once the request has been accepted, the GEM 4000 shall be able to transmit and receive according to
the rules specified by the Low Level Protocol.
If connection is lost (remote system closes connection or an error occurs), GEM4000 will wait for
another connection.
Note: This is the mode used when GEM 4000 connects to IMPACT.
3.1.2.2 Configuration
The following parameters shall be configurable
Port Number: The port used to establish the connection. Allowed values are from 1024 to 65,535
boundaries inclusive. Defaults are 1183 and 1184 (see Volume 4b).
3.2 RS-232
3.2.1 Overview
This section describes those issues related to mechanical and electrical connection between the GEM
4000 and external devices like an HIS/LIS/CIS or an external instrument. The topology is point-to-point, a
direct connection between both devices.
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The SW shall use a word length (Data Bits) of 8 bits
The rest of settings are configurable as it is described in the next section
3.2.2 Configurable settings

The SW shall allow the configuration of the following settings.
Port. The SW shall display the ports available in the back panel of the instrument, labeled the
same way as on the analyzer’.
Baud Rate.
3.2.3 Interface connections

The serial ports of the instrument are a PC-standard DB-9 (EIA/TIA 574) male connector (also known as
RS-232 connectors).
The following are the PIN connections for a standard PC serial communications interface. Note that
these ports are wired as DTE (Data Terminal Equipment).
TABLE 1: PIN CONNECTIONS FOR A STANDARD PC SERIAL COMMUNICATIONS INTERFACE

Used by
Mnemon EIA/TIA Signal DB-9 DB-25
CCITT V.24 Description the
ic Name direction Pin Pin
Instrument
TD BA 103 Out 3 2 Transmitted Data Yes
RD BB 104 In 2 3 Received Data Yes
RTS CA/CJ 105/133 Out 7 4 Request To Send Yes
CTS CB 106 In 8 5 Clear To Send Yes
DSR CC 107 In 6 6 Data Ready Set Yes
SG AB 102 - 5 7 Signal Ground Yes
DCD CF 109 In 1 8 Carrier Detect No
DTR CD 108/1, /2 Out 4 20 Data Terminal Yes

Ready
RI CE 125 In 9 22 Ring Indicator No
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4 Low Level Protocol (Data Link Layer)
4.1 Background
The data link layer has procedures for link connection and release, delimiting and synchronism,
sequential control, error detection and error recovery. The application messages passed from the upper
layer are framed and then transmitted. The frames received are packaged and then passed to the upper
layer. A primary function of this layer is to prevent loss of data between devices.
The Data Link Layer protocol supported by the GEM 4000 is the ASTM E1381 (refer to [1.a] Data Link
Layer, section 6).
Please, note that ASTM E1381 Low Level Protocol is only supported with LIS2-A High level protocol
and that HL7 Hybrid Low Level Protocol is only supported with HL7 High level protocol in the GEM
4000. See Section §6.1 for GEM 4000 High Level Protocol / Low Level Protocol / transport layer
compatibility matrix.
4.2 NCCLS LIS1-A (formerly ASTM E1381) Data Link Layer

4.2.1 Overview
This standard uses a character-oriented protocol to send messages between directly connected systems.
The coding is the ANSI X3.4-1986 and some restrictions are placed on the characters that can appear in
the message content.
The data link mode of operation is a one-way transfer of information with alternate supervision.
Information flows in one direction at a time. Replies occur after information is sent, never at the same
time. It is a simple stop-and-wait protocol. The sender and receiver use timeouts to detect the loss of
coordination between them and provide a method for recovery the communication.
The two systems operate actively to transfer information. The remainder of the time the data link is in a
Neutral State. There are three phases involved in the transmission of message frames:
 Establishment Phase (or Link Connection). Determines the direction of information flow and
prepares the receiver to accept information.
 Transfer Phase in which the sender transmits messages to the receiver using frames.
 Termination Phase in which the link is released and the sender notifies the receiver that all
messages are sent.
4.2.1.1 Establishment Phase (Link Connection)
4.2.1.1.1 Operation
The establishment phase determines the direction of the information flow and prepares the receiver to
accept the information.
The system with information available, the sender, initiates the establishment phase to notify the
receiver that information is available.
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A system that does not have information to send monitors the data link to detect the Establishment
Phase. It acts as a receiver, waiting for the other system.
The sequence is as follows:
1.- The sender determines that the data line is in a Neutral State.
2.- The sender sends the <ENQ> transmission control character to the receiver. Sender will ignore
all responses other than <ACK>, <NAK> or <ENQ>.
3a.- If the receiver is prepared to receive data, it responds with the <ACK> character to the sender.
The link connection is established, entering the Transfer Phase.
3b.- If the receiver is not ready to receive data it responds with the <NAK> character. Upon receiving
a <NAK>, the sender shall wait at least 10 seconds before transmitting another <ENQ> transmission
control character.
4.2.1.1.1.1 Contention
When the two systems simultaneously transmit <ENQ> the data link is in contention.
In the Observation Reporting Interface (G4K, which acts as an observation reviewer, connected to an
observation recipient), the G4K has priority.
In the Device Interface (a device connected to the G4K, which acts as an observation reviewer), the
device has priority.
So, when an <ENQ> is received in response to an <ENQ>, the situation is solved as follows:
The system with priority waits at least 1 second before sending another <ENQ>.
The system without priority must stop trying to transmit and prepare to receive. When the next
<ENQ> is received it replies with an <ACK> or <NAK> depending on its readiness to receive.
4.2.1.2 Transfer Phase

During the Transfer Phase, the sender shall transmit messages to the receiver until all messages are
sent.
4.2.1.2.1 Frames
Messages are sent in frames, each frame contains a maximum of N+7 bytes (N message text plus 7
control characters). N is a configurable number which ranges from 240 to 64,000 (see volume 4a).
Messages longer than N bytes are divided between two or more frames.
Multiple messages are never merged in a single frame. Every message must begin in a new frame.
A frame is one of two types: the Intermediate Frame (IF) and the End Frame (EF). Their only difference
relies on one transmission control character, but they are semantically different (see below for details)
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 Intermediate frame <STX> FN Text <ETB> C1 C2 <CR> <LF>
 End frame <STX> FN Text <ETX> C1 C2 <CR> <LF>
The last frame of a message always is an End Frame. All previous frames are sent as Intermediate
Frames.
A message containing 240 characters or less is sent in a single End Frame.
Longer messages are sent in intermediate frames with the last part of the message sent in an end frame.
A brief description for every part of a frame is given in the table below:
Frame Part Frame Part Description

<STX> Start of Text transmission control character
FN Frame Number (single digit comprised in the range 0-7) – See details in
section Frame Number
Text Data content of Message
<ETB> End of Transmission Block transmission control character
<ETX> End of Text transmission control character
C1 Most significant character of checksum (belonging to {0-9, A-F}) –
See details in section Checksum
C2 Least significant character of checksum (belonging to {0-9, A-F}) –

See details in section Checksum
<CR> Carriage Return ASCII character
<LF> Line Feed ASCII character
4.2.1.2.2 Frame number

The frame number (FN) permits the receiver to distinguish between new and retransmitted frames.
The frame number begins at 1 with the first frame of the Transfer phase (see below). The frame number
is incremented by one for every new frame transmitted. After 7, the frame number rolls over to 0, and
continues in this fashion.
4.2.1.2.3 Checksum
The checksum permits the receiver to detect a defective frame. The checksum is encoded as two
characters.
The checksum is computed by adding the binary values of the characters, and keeping the least
significant eight bits of the result. It is an addition module 256.
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The checksum is initialized to zero with the <STX> character. The checksum computation uses the FN, all
characters belonging to Text and <ETB> or <ETX>. The computation for the checksum does not include
<STX>, the checksum characters, or the trailing <CR> and <LF>.
The checksum is an integer of eight bits, and can be considered as two groups of four bits. Both groups
of four bits are converted to the ASCII characters of the hexadecimal representation, and transmitted as
the message checksum.
Example: A checksum of 89 can be represented as 01011011 in binary or 5B in hexadecimal. The

checksum is transmitted as the ASCII character 5 followed by the ASCII character B.
4.2.1.2.4 Acknowledgements
After a frame is sent, the sender stops transmitting until a reply is received (stop-and-wait protocol). The
receiver can reply to each frame in three ways:
A reply of <ACK> means the last frame was successfully received and the receiver is ready to
receive the next one. The sender must send a new frame or terminate.
A reply of <NAK> signifies the last frame was not successfully received and the receiver is prepared
to receive the frame again.
A reply of <EOT> means the last frame was successfully received, but the receiver requests the
sender to stop transmitting.
This reply must be transmitted within the timeout period specified in the timeouts section
4.2.1.2.5 Receiver Interrupts

During the transfer phase, if the receiver responds to a frame with an <EOT> in place of the usual <ACK>,
the sender must interpret this reply as a receiver interrupt request. The <EOT> is a positive
acknowledgement of the end frame, signifies the receiver is prepared to receive next frame and is a
request to the sender to stop transmitting.
If the sender chooses to ignore the <EOT>, the receiver must re-request the interrupt for the request to
remain valid.
If the sender chooses to honor the <EOT>, it must first enter the termination phase to return the data
link to the neutral state. The original sender must not enter the establishment phase for at least 15
seconds or until the receiver has sent a message and returned the data link to the neutral state.
G4K usage: G4K shall ignore the interrupt request. G4K ignores the <EOT> until the message
transmission is completed. If G4K receives and <EOT> as an answer to the last frame, it waits 15 seconds
until it goes to the establishment phase.
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4.2.1.3 Termination Phase (link release)
The Termination Phase returns the data link to the neutral state. The sender initiates the Termination
Phase by transmitting the <EOT> character and then regards the line to be in the Neutral State. After
receiving the <EOT> the receiver also regards the line to be in the neutral state.
4.2.1.4 Error Recovery
4.2.1.4.1 Defective frames

A receiver checks every frame to guarantee it is valid. A reply of <NAK> is transmitted for invalid frames.
Upon receiving the <NAK>, the sender retransmits the last frame with the same frame number.
A frame should be rejected because take place some of the following situations:
Any character errors are detected (parity errors, framing error…).
The frame checksum does not match the checksum computed on the received frame.
The frame number is not the same as the last accepted frame or one number higher (modulo 8).
There are invalid characters in the message body. See section 5.2.1.5 or invalid characters
Any characters occurring before <STX> or <EOT>, or after the end of the block characters (<ETB> or
<ETX>), are ignored by the receiver when checking for frame validity.
Every time the sender tries to transmit a particular frame, and receives a <NAK> or any other character
different from <ACK> or <EOT> (a <NAK> condition), a retransmission counter for the given frame is
increased. If this counter shows a single frame was sent and not accepted six times, the sender must
abort this message by proceeding to the termination phase.
4.2.1.4.2 Timeouts
The sender and the receiver use timers to detect loss of coordination between them:
During the establishment phase, the sender sets a timer when transmitting the <ENQ>. A timeout
occurs if a reply of an <ACK>, <NAK> or <ENQ> is not received within 15 seconds. After a timeout,
the sender enters the termination phase.
During the establishment phase, if the system without priority detects contention, it sets a timer.
If the subsequent <ENQ> is not received within 20 seconds, it will regard the line to be in the neutral
state.
During the transfer phase, the sender sets a timer when transmitting the last character of a frame.
If the reply is not received within 15 seconds, a timeout occurs. After a timeout, the sender aborts
the message transfer by proceeding to the termination phase.
During the transfer phase, the receiver sets a timer when first entering the transfer phase or when
replying to a frame. If a frame or an <EOT> is not received within 30 seconds, a timeout occurs. After
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a timeout, the receiver discards the last incomplete message and regards the line to be in the
neutral state.
A receiver must reply to a frame within 15 seconds or the sender will timeout.
4.2.1.5 Valid Characters in the Text part

The data link protocol is designed for sending character based message text. There are restrictions on
which characters may appear in the message text. These restrictions make it simpler to recognize
frames, replies and avoid interfering with software controls for devices
The restricted characters are: <SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>,
<ETB>, <LF>, <DC1>, <DC2>, <DC3> and <DC4>.
4.2.1.6 Checking channel status

To test the connection, the GEM 4000 transmits the ASCII <ENQ> transmission control character,
decimal value 5. If the receiving system responds within fifteen seconds with one of the following:
The ASCII <ACK> transmission control character, decimal value 6,
The ASCII <NAK> transmission control character, decimal value 21, or
<ENQ>.
The GEM 4000 enters the Termination phase and the result of the connection test is success. If the GEM
4000 does not receive one of the above responses within 15 seconds, the GEM 4000 enters the
Termination phase and the result of the connection test is failure. See Volume 4a for a description of
when connection test is performed.
4.2.1.7 Connection Test

GEM 4000 implements a Connection Test mechanism by making use of the LIS1-A Protocol. All
connections configured to use this protocol as Low Level Protocol in the GEM 4000 will be able to test if
there is connectivity with the HIS/LIS system by following the message flow described in Figure 1.
CONNECTION TEST TO HIS/LIS/CIS.
GEM 4000 HIS/LIS
<ENQ>
<ACK>
<EOT>
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4.3 HL7 HYBRID LOWER LAYER PROTOCOL
4.3.1 Overview
This Lower Level Protocol is intended for those environments where communications primarily occur
over LANs. These environment usually have much lower bit error rate and flow control is already
available from the network. Therefore, this protocol avoids implementing controls that are already
provided by the network.
The mode of operation is a one-way transfer of information, from the sender to the receiver. The
receiver shall reply once all the information block has been received or an error was identified.
4.3.2 Frame definition

Frame or Blocks in HL7 Hybrid Low Level Protocol can be of type data or NAK. All frames will have the
same structure regardless the kind of message they are:
<SB>tvv<CR>ddddccccxxx<EB><CR>
Frames consist of the following fields:
<SB> : Start frame ASCII character (1 byte). <VT> ASCII character code is used.
t : Frame type (1 byte). It will be ‘D’ for data frames and ‘N’ for NAK frames.
vv : Protocol id (2 bytes). HL7 version being used by the G4K/GWP. For instance “24” as for HL7
2.4.
<CR> : Carriage return ASCII character (1 byte).
dddd : Data (variable number of bytes). In a data type frame this will be the content of the frame.
Note that G4K/GWP does not support <CR> stuffing in data frames.
In NAK type frames it will contain a 1-byte reason code as follows:
 ‘C’: character count wrong in previous data block received.
 ‘X’: checksum wrong in previous data block received.
 ‘B’: data too long for input buffer in previous block received.
 ‘G’: Error not covered elsewhere.
ccccc: Frame size (5 bytes). Character count of all characters so far in the data block up to and
including the last data character.
xxx: Checksum (3 bytes). Exclusive-OR checksum of all characters in the block up to and including
the last data character. The checksum is expressed as a decimal number in three ASCII digits.
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<EB>: End block character (1 byte). <FS> ASCII character code is used.
<CR>: Carriage return (1 byte).
4.3.3 Communication flow

The communication flow with this protocol is very simple. In the usual way, the initiating system sends
an initiate message to the receiver and the responding system sends back a response message.
4.3.3.1 Communication parameters

See the list below for the communication parameters assumed in G4K/GWP:
Receive message timeout: 10 seconds. It is the amount of time G4K/GWP will wait for a reply after
sending a message.
Number of retries to resend a message: 5 times. It is the number of times G4K/GWP will resend a
message due to either a receive timeout or any error in the received message.
4.3.3.2 G4K/GWP acting as the sender

These are the steps the G4K/GWP will perform (send a message and receive a response) when behaving
as message sender:
Build frame with message contents.
Send the data frame that contains the message.
Receive the response from the responding system.
If a complete frame is not received before the receive timeout the original frame will be
resent.
Ignore all incoming characters until a Start Frame is received. Any time another Start
Frame is received before the end of the frame, all previous characters will be ignored.
Receive characters until <EB><CR> is recognized. This is the end of the block.
If a frame is received with an error in the frame structure or control data (checksum, etc),
resend the original frame.
If the frame is acceptable and is a NAK the original frame will be resent.
If the frame is acceptable and is a data frame, the data will be processed.
4.3.3.3 G4K/GWP acting as the receiver

These are the steps the G4K/GWP will perform when acting as a responding system (receive a messange
and send back response):
Receive the frame that contains the initial message.
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Ignore all incoming characters until the Start Frame character is received. Any time
another Start Frame character is received before the end of a block, ignore all previous
characters. Receive characters until <EB><CR> is recognized. This is the end of the Frame.
If an incorrect frame is received, build a NAK frame message with appropriate rejection
reason and send it back to the sender.
If the received frame message is correct, continue with next step.
Process message
Create response to the received message. Response frame is created.
Send response back to sender.
4.3.3.4 Connection Test

There is no good way to test if a connection is established by using this Low Level Protocol. As a result,
HL7 connection test is implementing by using the High Level Protocol. Please, see section 7.11 for
details.
5 High Level Protocol
5.1 Overview
The high-level protocols supported on the GEM 4000 are ORI (HL7 v2.4) and LIS2-A
The GEM 4000 shall allow the following combinations:
TABLE 1: ALLOWED COMBINATIONS OF HLP, LLP AND PL

High Level Protocol Low Level Protocol Physical Layer
ORI (HL7 v2.4) HL7 Minimal (default) TCP/IP sockets
HL7 Hybrid TCP/IP sockets
LIS2-A None TCP/IP sockets
LIS1-A TCP/IP sockets
RS-232
5.2 NCCLS LIS2-A (formerly ASTM E1394-97)

5.2.1 Background and Terminology
This protocol specifies the communication between clinical instruments and computers.
GEM 4000 uses the protocol to interchange information with non-G4K instruments and with the
HIS/LIS/CIS:
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The Observation Reporting Interface (ORI), covers the communication between the GEM 4000
system and the HIS/LIS/CIS. In the ORI, the GEM 4000 plays the role of Clinical Instrument and the
HIS/LIS/CIS plays the role of Computer System.
The Device Interface (DI), covers the communication between the non-G4K devices and the GEM
4000 system. In the DI, the non-G4K devices play the role of Clinical Instrument and the GEM 4000
plays the role of Computer System.
Data transmitted from a computer system to a clinical instrument is called download.
Data transmitted from a clinical instrument to a computer system is called upload.
The role of clinical instruments and computer systems
When describing the syntax of the protocol, the following conventions shall be used:
Convention Meaning
X 1 Element X is required and can only appear once
{X} 1…* Element X is required and can appear more than once
[X] 0,1 Element X is not required and can only appear once
[{X}]={[X]} 0…* Element X is not required and can appear more than once
+ And
| Or
Each record is described by means of a table, with the following columns:
Field, Field Name and Description. ASTM definitions for the field.
Comp.: If the field has only one component, is empty. If the field has only one repeat, it indicates
the component (1, 2, 3…). If it has more than one repeat, indicates repeat and component (1.1, 1.2,
1.3, 2.1, 2.2…).
Max. Len.: A dash indicates that length is implicit in the field or has no maximum.
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Req.:
R: Required.
O: Optional.
U: Unused.
Values Formats and Comments:
Quoted text shall appear exactly like this.
Elements in italics refer to the GEM 4000 database fields.
TABLE 1: ORI. LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR ASSOCIATED TO A TOR
Field Field Name Description [INFO] Comp Max Len Req Values, formats and comments
1 Record Type ID Identifies the record 1 R "C"
2 Sequence Number Defines the I’th occurrence of the associated record 1 R "1"
3 Comment Source Comment Origination Point 1 R "I" (clinical instrument system)
4 Comment Text Comment codes and text 1 1 R Exception Code.
2 128 R Exception Description.
5 Comment Type Comment type qualifier 1 R "I" (instrument flags(s) comment)
5.2.2 Message Structure and contents

This standard specifies the conventions for structuring the content of the messages exchanged and for
representing the data elements contained within those structures.
The standard specifies a message system in which messages are composed by a hierarchy of records
that are defined using a positional convention. Each record describes one aspect of the complete
message and can be of various types. Records are composed by an aggregate of fields, also defined
using a positional convention.
5.2.2.1 Records
Table below details the records used by the GEM 4000.
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RECORD FIELDS USED BY GEM 4000
Record First Character
Message Header Record H
Patient Identifying Record P
Test Order Record O
Result Record R
Comment Record C
Request Information Record Q
Manufacturer Information Record M

Scientific Record (not used by GEM 4000) S
The standard does not impose a maximum record length. Ingoing and outgoing messages can be of any
size.
5.2.2.2 Fields
A field can be seen as a specific attribute of a record, which may contain aggregates of data elements
further refining the basic attribute. There are two kinds of aggregates within a message, the repeat field
and the component field:
Repeat field: a single data element that expresses a duplication of the field definition. Each
element of a repeat field is to be treated as heaving equal priority to associated repeat fields
Component field: single data element or data elements that express a finer aggregate or extension
of data elements, which precede it.
Example: A patient’s name is recorded as last name, first name, and middle initial, each of which is
separated by a component delimiter.
The standard does not impose a maximum field length, and assumes that all fields are variables in
length. The GEM 4000 implementation restricts the maximum field length to a concrete value
depending on the field, but never uses more characters than required by the given field value (according
to the standard)
Maximum field lengths are specified in the different modes supported by the GEM 4000.
If the length of a received field is greater of the specified by the mode, the field shall be truncated (ex: if
“Urruticoechea-Jiménez” is received as a last name in the GEM 3000 mode -which is 16 characters
maximum- shall be truncated to “Urruticoechea-Ji”).
Same consideration shall apply when sending fields.
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5.2.2.3 Hierarchy
Message records are logically structured by levels:
Records at level 0 contain information about the sender identification (Message Header Record)
and the completion of the message (Message Terminator Record).
Records at level 1 contain information about patients (Patient Information Record), queries
(Request Information Record) or scientific records (Scientific Information Record). Scientific Records
are not used by GEM 4000.
Records at level 2 contain information about test order requests and specimens (Test Order
Record). An order record may never appear without a preceding patient record.
Records at level 3 contain information about test results (Result Record). A test result record may
never appear without a preceding order record.
Comments (Comment Record) and manufacturer records (Manufacture Information Record) may
be inserted at any level in the hierarchy. These records relate to the immediately preceding it.
A sequence of records at one level is terminated by the appearance of a record type of same or higher
level.
5.2.2.4 Character Codes

All data shall be represented as 8-bit, single-byte, coded graphic character values as defined in ISO 8859-
1:1987.
The allowed and disallowed characters are as follows:
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Code Status Comments
0-6 Disallowed NUL (Null char.)
SOH (Start of Header)
STX (Start of Text)
ETX (End of Text)
EOT (End of Transmission)
ENQ (Enquiry)
ACK (Acknowledgment)
7 Allowed BEL (Bell)
8 Disallowed BS (Backspace)
9 Allowed HT (Horizontal Tab)
10 Disallowed LF (Line Feed)
11-13 Allowed VT (Vertical Tab)
FF (Form Feed)
CR (Carriage Return)
14-31 Disallowed SO (Shift Out)
SI (Shift In)
DLE (Data Link Escape)
DC1 (XON) (Device Control 1)
DC2 (Device Control 2)
DC3 (XOFF) (Device Control 3)
NAK (Negative Acknowledgement)
SYN (Synchronous Idle)
ETB (End of Trans. Block)
CAN (Cancel)
EM (End of Medium)
SUB (Substitute)
ESC (Escape)
FS (File Separator)
GS (Group Separator)
RS (Request to Send)(Record Separator)
US (Unit Separator)
32-126 Allowed Space
! " # $ % & ' ( ) * + , - . /
0 1 2 3 4 5 6 7 8 9
: ; < = > ? @
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
[ \ ] ^ _ `
a b c d e f g h i j k l m n o p q r s t u v w x y z
{ | } ~
127 Disallowed DEL (Delete)
128-254 Allowed Undefined by the standard. See description below
255 Disallowed
The 8-bit values, within the range from 0 to 127 of ISO 8859-1:1987 correspond to the ASCII standard
character set.
Values between 128 and 254 are undefined by standard. The standard states: “it is responsibility of the
instrument vendor and computer system to understand the representation of any extended or alternate
character set being used”.
GEM 4000 shall use the ISO-8859-1 (Latin-1) extended character set.
If a disallowed character is received in a field, the G4K shall process the field, ignoring the disallowed
character (ex: “S<BEL>mith” shall be processed as “Smith”).
5.2.2.5 Delimiters
Delimiters are used to establish separate sections within a message. There are five different delimiters.
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Record delimiter: It signals the end of any of the defined record types. It is fixed to carriage return
character Latin-1 (13) (ASCII 13).
Field delimiter: It is used to separate adjacent fields. It is configurable, and is specified in the
message header record. It shall be a single character excluding Latin-1 (13) (ASCII 13).
Repeat delimiter: Used to separate variable number of descriptors for fields containing parts of
equal members of the same set. It is configurable, and is specified in the message header record. It
shall be a single character, excluding Latin-1 (13) (ASCII 13) and the value used by the field delimiter.
Component delimiter: It is used to separate data elements of fields of a hierarchical or qualifier

nature. It is configurable, and is specified in the message header record. It shall be a single
character, excluding Latin-1 (13) (ASCII 13), the value used by the field delimiter and the value used
by the repeat delimiter.
Escape delimiter: Used within text fields to signify special case operations. It is configurable, and is
specified in the message header record. It has a complex structure, but mainly use a single
character. The chosen character shall be different from Latin-1 (13) (ASCII 13) and the field, repeat,
and component delimiter values.
Alphanumeric characters should not be used as delimiters, according to the standard. GEM 4000 shall
allow the use of the following characters as delimiters. (Boundary values are also included)
Any value from ASCII (33) to ASCII (47)
The default delimiters shall be the following set (these values depend on the mode, see the different
modes description below in this document):
Record delimiter - carriage return (represented as “<CR>”) (Latin 1 / ASCII 13)
Field delimiter - vertical bar (“|”) (Latin 1 / ASCII 124)
Repeat delimiter - at (“@”) (Latin 1 / ASCII 64)
Component delimiter - caret (“^”) (Latin 1 / ASCII 94)
Escape delimiter - backslash (“\”) (Latin 1 / ASCII 92)
The escape delimiter may be used to signal certain special characteristics of portions of a text field (for
example, imbedded delimiters, line feed, carriage return, etc). An escape sequence shall consist of the
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escape delimiter character followed by a single escape code ID (listed below), followed by zero or more
data characters followed by another (closing) occurrence of the escape delimiter character.
No escape sequence shall contain a nested escape sequence.
The following predefined escape sequences shall be used by the GEM 4000 (assuming “\” as the escape
delimiter, replace by the appropriate escape delimiter when different):
\F\ Imbedded field delimiter character
\S\ Imbedded component field delimiter character
\R\ Imbedded repeat field delimiter character
\E\ Imbedded escape delimiter character
The following predefined escape sequences shall be ignored by the GEM 4000.
\H\ Start highlighting text (ignored by GEM 4000).
\N\ Normal text (end highlighting) (ignored by GEM 4000).
Fields shall be identified by their position, obtained by counting field delimiters from the front of the
record. This position-sensitive identification procedure requires that when the contents of the field are
null, its corresponding field delimiter shall be included in the record to ensure that the i’th field can be
found by counting (i-1) delimiters. Delimiters shall not be included for trailing null fields.
5.2.3 Message Transmission Control
5.2.3.1 Storage
In order to ensure proper error logging and error recovery, the next rule is followed according to the
standard.
Since data content is structured in hierarchical fashion, any decreasing change in the hierarchical level
shall trigger storage of all data transmitted prior to said level change, and not previously saved.
An example of the prior rule application is the following.
Record # Record Type Level (level variation)

Storage action
1 Message Header L0 (0)
2 Patient1 L1 (+1)
3 Order1 L2 (+1)
4 Result1 L3 (+1)
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5 Order2 L2 (-1) {Save 1 - 4}
6 Order3 L2 (0)
7 Patient2 L1 (-1) {Save 5 - 6}
8 Order1 L2 (+1)
9 Comment1 L3 (+1)
10 Result1 L3 (0)
11 Comment1 L4 (+1)
12 Result2 L3 (-1) {Save 7 - 11}
13 Order2 L2 (-1) {Save 12}
14 Patient3 L1 (-1) {Save 13}
15 Order1 L2 (+1)
16 Result1 L3 (+1)
17 Message Terminator L0 (-3) {Save 14 - 16}
Note: Record # 17 is assumed as saved by virtue of the record type function

If a transmission failure occurs, the protocol requires that transmission starts only at the last record not
presumed saved as outlined the previous section (Storage). GEM 4000 shall transmit the complete
message.
5.3 ORI (HL7 v2.4)

5.3.1 Background and conventions
This section defines the HL7 implementation used by the GEM 4000. This specification handles the
communication of test result and ordering information between the GEM 4000 and the HIS/LIS/CIS.
This implementation is compliant with version 2.4 of the Health Level Seven (HL7) Standard.
The reporting of patient sample results to the HIS/LIS/CIS is compliant with the POCT1-A Standard (as
well as with HL7 v2.4):
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Point-Of-Care Connectivity; Approved Standard. NCCLS Document POCT1.A (ISBN 1-56238-450-3)
Appendix C: Observation Reporting Interface.
According to the POCT1-A Standard, the interface described in this chapter is the Observation Reporting
Interface, where the GEM 4000 system plays the role of Observation Reviewer and the HIS/LIS/CIS plays
the role of Observation Recipient.
Data transmitted from the HIS/LIS/CIS to GEM 4000 is called download.
Data transmitted from the GEM 4000 to HIS/LIS/CIS is called upload.
The POCT1-A Observation Reporting Interface
When describing the syntax of the protocol, the following conventions shall be used:
Convention Meaning
X 1 Element X is required and can only appear once
{X} 1…* Element X is required and can appear more than once
[X] 0,1 Element X is not required and can only appear once
[{X}]={[X]} 0…* Element X is not required and can appear more than once
+ And
| Or
5.3.2 Message Structure and contents

This section defines the components of messages and provides the methodology for defining abstract
messages that are used in later sections. A message is the atomic unit of data transferred between
systems. It is comprised of a group of segments in a defined sequence. Each message has a message
type that defines its purpose. For example the ADT Message type is used to transmit portions of a
patient’s Patient Administration (ADT) data from one system to another. A three-character code
contained within each message identifies its type. Messages used by the GEM 4000 are listed below
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HL7 MESSAGES USED BY THE GEM 40000
Message Description
ACK General acknowledgement Message
ORU Observation Result Unsolicited Message
OUL Unsolicited Laboratory Observation Message
The real-world event that initiates an exchange of messages is called a trigger event. These events (a
three letter code) represent values such as “A patient is admitted” or “An order event occurred”. There
is a one-to-many relationship between message types and trigger event codes. The same trigger event
code may not be associated with more than one message type; however a message type may be
associated with more than one trigger event. Triggers used by the GEM 4000 are listed below
HL7 TRIGGERS USED BY THE GEM 4000

Trigger Description Initiated by
ORU^R31 New Observation. Search for an Order
G4K
ORU^R32 Preordered Observation G4K
ACK^R33 Acknowledgement of ORU^R30/31/32, HIS/LIS/CIS
OUL^R21 Update calibrations, QCs and CVP

G4K
5.3.2.1 Segments
A segment is a logical grouping of data fields. Segments of a message may be required or optional.
They may occur only once in a message or they may be allowed to repeat. Each segment is given a
name. For example, the ADT message may contain the following segments: Message Header (MSH),
Event Type (EVN), Patient ID (PID), and Patient Visit (PV1).
Each segment is identified by a unique three-character code known as the Segment ID. Segments used
by the GEM 4000 are listed below
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HL7 SEGMENTS USED BY THE GEM 4000
Segment Description
MSA Message Acknowledgment Segment
MSH Message Header Segment
NTE Notes and Comments Segment
OBR Observation Request Segment
OBX Observation Segment
ORC Common Order Segment

PID Patient identification Segment
SAC Specimen and Container Detail Segment
5.3.2.2 Fields
Definition: A field is a string of characters.
HL7 does not care how systems actually store data within an application. When fields are transmitted,
they are sent as character strings. Except where noted, HL7 data fields may take on the null value.
Sending the null value, which is transmitted as two double quote marks (“”), is different from omitting
an optional data field. The difference appears when the contents of a message will be used to update a
record in a database rather than create a new one. If no value is sent, (i.e., it is omitted) the old value
should remain unchanged. If the null value is sent, the old value should be changed to null.
The various sections in §7 contain segment attribute tables. These tables list and describe the data
fields in the segment and characteristics of their usage. In defining a segment, the following
information is specified about each field:
Field, Field Name and Description. HL7 definitions for the field.
Comp.: If the field has only one component, is empty. If the field has only one repeat, it indicates
the component (1, 2, 3…). If it has more than one repeat, indicates repeat and component (1.1, 1.2,
1.3, 2.1, 2.2…).
Max. Len.: A dash indicates that length is implicit in the field or has no maximum.
Req.:
R: Required.
RE: Required may be empty.
O: Optional.
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X: Unused.
Values Formats and Comments:
Quoted text shall appear exactly like this.
Elements in italics refer to the GEM 4000 database fields.
5.3.2.3 Character Codes

All data shall be represented as 8-bit, single-byte, coded graphic character values as defined in ISO 8859-
1:1987.
The allowed and disallowed characters are as follows:
Code Status Comments

0-31 Disallowed NUL (Null char.)
SOH (Start of Header)
STX (Start of Text)
ETX (End of Text)
EOT (End of Transmission)
ENQ (Enquiry)
ACK (Acknowledgment)
BEL (Bell)
BS (Backspace)
HT (Horizontal Tab)
LF (Line Feed)
VT (Vertical Tab)
FF (Form Feed)
CR (Carriage Return)
SO (Shift Out)
SI (Shift In)
DLE (Data Link Escape)
DC1 (XON) (Device Control 1)
DC3 (XOFF) (Device Control 3)
NAK (Negative Acknowledgement)
SYN (Synchronous Idle)
ETB (End of Trans. Block)
CAN (Cancel)
EM (End of Medium)
SUB (Substitute)
ESC (Escape)
FS (File Separator)
GS (Group Separator)
RS (Request to Send)(Record Separator)
US (Unit Separator)
32-126 Allowed Space

! " # $ % & ' ( ) * + , - . /
0 1 2 3 4 5 6 7 8 9
: ; < = > ? @
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
[ \ ] ^ _ `
a b c d e f g h i j k l m n o p q r s t u v w x y z
{ | } ~
127 Disallowed DEL (Delete)
128-254 Allowed ISO-8859-1 (Latin-1) extended character set.
255 Disallowed
GEM 4000 shall use the ISO-8859-1 (Latin-1) extended character set.
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If a disallowed character is received in a field, the G4K shall process the field, ignoring the disallowed
character (ex: “S<BEL>mith” shall be processed as “Smith”).
The following predefined escape sequences shall be used by the GEM 4000 (being “\”the escape
delimiter):
\F\ Imbedded field delimiter character
\S\ Imbedded component field delimiter character
\R\ Imbedded repeat field delimiter character
\T\ Imbedded subcomponent delimiter character
\E\ Imbedded escape delimiter character
The following predefined escape sequences shall be ignored by the GEM 4000.
\H\ Start highlighting text (ignored by GEM 4000).
\N\ Normal text (end highlighting) (ignored by GEM 4000).
5.3.2.4 Delimiters
In constructing a message, certain special characters are used. They are the segment terminator, the
field separator, the component separator, subcomponent separator, repetition separator, and escape
character.
The segment terminator is always a carriage return (in ASCII, a hex 0D). The other delimiters are defined
in the MSH segment, with the field delimiter in the 4th character position, and the other delimiters
occurring as in the field called Encoding Characters, which is the first field after the segment ID. The
delimiter values used in the MSH segment are the delimiter values used throughout the entire message.
GEM 4000 shall always use the suggested values by HL7, found below
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HL7 SEPARATORS
Delimiter Suggested Value Usage
Segment Terminator <cr> (0x0D) Terminates a segment record.

Field Separator Separates two adjacent data fields within a segment. It also separates the segment ID from
|
the first data field in each segment.
Component Separator ^ Separates adjacent components of data fields where allowed.
Subcomponent Separator Separates adjacent subcomponents of data fields where allowed. If there are no
&
subcomponents, this character may be omitted.
Repetition Separator ~ Separates multiple occurrences of a field where allowed.
Escape Character Escape character for use with any field represented by an ST, TX or FT data type, or for use
with the data (fourth) component of the ED data type. If no escape characters are used in a
\
message, this character may be omitted. However, it must be present if subcomponents are
used in the message.
5.3.2.5 Message Construction Rules
Step 1: Construct the segments in the order defined for the message. Each message is constructed as
follows:
The first three characters are the segment ID code.
Each data field in sequence is inserted in the segment in the following manner:
A field separator is placed in the segment.
If the value is not present, no further characters are required.
If the value is present, but null, the characters "" (two consecutive double quotation marks) are
placed in the field.
Otherwise, place the characters of the value in the segment. As many characters can be
included as the maximum defined for the data field. It is not necessary, and is undesirable, to
pad fields to fixed lengths. Padding to fixed lengths is permitted.
If the field definition calls for a field to be broken into components, the following rules are used:
If more than one component is included they are separated by the component separator.
Components that are present but null are represented by the characters "".
Components that are not present are treated by including no characters in the component.
Components that are not present at the end of a field need not be represented by
component separators. For example, the two data fields are equivalent:
|ABC^DEF^^| and |ABC^DEF|.
If the component definition calls for a component to be broken into subcomponents, the
following rules are used:
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If more than one subcomponent is included they are separated by the subcomponent
separator.
Subcomponents that are present but null are represented by the characters "".
Subcomponents that are not present are treated by including no characters in the
subcomponent.
Subcomponents that are not present at the end of a component need not be represented by
subcomponent separators. For example, the two data components are equivalent:
^XXX&YYY&&^ and ^XXX&YYY^.
If the field definition permits repetition of a field, the repetition separator is used only if more
than one occurrence is transmitted. In such a case, the repetition separator is placed between
occurrences. If three occurrences are transmitted, two repetition separators are used.)
In the example below, two occurrences of telephone number are being sent:
|234-7120~599-1288B1234|
Repeat Step 1b while there are any fields present to be sent. If all the data fields remaining in the
segment definition are not present there is no requirement to include any more delimiters.
End each segment with an ASCII carriage return character.
Step 2: Repeat Step 1 until all segments have been generated.
5.3.2.6 Message Processing Rules

The following rules apply to receiving HL7 messages and converting their contents to data values:
Ignore segments, fields, components, subcomponents, and extra repetitions of a field that are present
but were not expected.
Treat segments that were expected but are not present as consisting entirely of fields that are not
present.
Treat fields and components that are expected but were not included in a segment as not present.
5.3.3 Message Transmission Control

Because the protocol describes an exchange of messages, it is described in terms of two entities, the
initiating and responding systems. The GEM 4000 can play both roles.
Each is both a sender and receiver of messages. The initiating system sends first and then receives,
while the responding system receives and then sends.
The HL7 protocols prescribes two kinds of acknowledge, original and enhanced. The GEM 4000 shall
support the original as well as the enhanced acknowledgement mode.
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In overview this exchange proceeds as described in the following sections.
5.3.3.1 Initiation
The initiating application creates a message with data values according to the rules described in §6.3.2.
The Message Header Segment (MSH) contain several fields that control the later message flow
MSH-10 contains a unique identifier for the message. Acknowledgements shall refer to this ID.
 MSH-15 is set to AL, meaning that the message requires an accept acknowledgement
MSH-16, depending on the nature of the message, can be set to
AL: The message requires an application acknowledgement
NE: The message does not require an application acknowledgement.
5.3.3.2 Response
The responding system returns a general acknowledgment message (ACK) with:
A commit accept (CA) in MSA-1-acknowledgment code if the message can be accepted for processing.
A commit reject (CR) in MSA-1-acknowledgment code if the one of the values of MSH-9-message type,
MSH-12-version ID or MSH-11-processing ID is not acceptable to the receiving application.
A commit error (CE) in MSA-1-acknowledgment code if the message cannot be accepted for any other
reason (e.g., sequence number error or a required field is not present).
The ACK message contain a NE in fields MSH-5 and MSH-6.
If the message header segment indicates that the initiating system also requires an application
acknowledgment, this will be returned as the initial message of a later exchange.
For this message, the receiving system acts as the initiator. Since the message it sends is application-
specific, the layouts of these application-level response messages are defined in the relevant
application-specific chapter. If needed, this application acknowledgment message can itself require (in
MSH-15-accept acknowledgment type) an accept acknowledgment message (MSA). MSH-16-application
acknowledgment type, however, is always null, since the protocol does not allow the application
acknowledgment message to have an application acknowledgment.
At this point, the application acknowledgment portion of this message exchange is considered complete.
5.3.3.3.1 Resend timeout

When GEM 4000 acting as the initiator, if the accept acknowledgement is not received in 60 seconds,
the GEM 4000 shall resend the message until the acknowledgement is received or the transmission
queue is cleared.
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5.3.3.3.2 Non-expected message received
If the message does not required accept acknowledge, the SW shall take no action
If the message requires accept acknowledge, the SW shall reply with a message having the structure
defined below
ORI.HL7. UPLOAD ACK OF A NON EXPECTED MESSAGE

Message Comments
MSH See Table 10

MSA See Table 11
ORI. HL7. UPLOAD ACK OF A NON-EXPECTED MESSAGE. MSA

Field Field Name Description [INFO] Comp Len Req Values, formats and comments
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “CR”
2 Message Control ID From MSH-10 of the non expecte message 20 R 0 – 4294967295
3 Text Message Note (2) 80 O “Non Expected Message”
4 Expected Sequence Number 15 X
5 Delayed Acknowledgement Type 1 X
6 Error Condition Coded Error 100 O Null
6 ORI Messages (HL7 v4.2)
6.1 Overview
The HL7 v2.4 protocol details stated in §6.3 shall apply.
6.2 Upload Patient Sample Results to HIS/LIS/CIS

This specification is compliant with HL7 v2.4 and NCCLS POCT1-A
Point-of-care workflow for measurement and ordering is quite complex, dynamic, and flexible. However,
most scenarios may be reduced to three use cases:
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A test is performed without an order and the Observation Recipient should place an order.
A test is performed which may or may not have an order previously placed.
A test is performed that was previously ordered.
These three use cases all rely on the ORU message to communicate the appropriate mix of result and
order information. Currently, the ORU message has no trigger event appropriate for the common POC
Use Cases. Four new trigger events are required to distinguish between the ORU messages that support
these three use cases. The HL7 organization has issued an Authoritative Use Statement permitting the
use of the new triggers: R30, R31 and R32, in advance of being balloted by HL7 for a future version of
the standard.
The GEM 4000 shall use only use cases 2 and 3 (Use case 1, order generation, is planned for phase 2
development):
Use case #2. Search for an Order:
Use case #3. Preordered Observation:
The message flow of both use case is described below
The following sections describe these triggers and their use in more detail.
Upload Patient Sample Results to HIS/LIS/CIS.
6.2.1 Message 1: ORU^R32 (uploading)

This message shall be an uploading message.
Shall have the structure defined in the following table.
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ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. PREVIOUSLY ORDERED. MESSAGE 1
Message Comments
MSH See §7.2.1.1: Message Header Segment – MSH.

PID See §7.2.1.2: Patient Identification Segment – PID.
ORC See §7.2.1.3: Common Order Segment – ORC.
OBR See §7.2.1.4: Observation Request Segment – OBR.
[NTE] See §7.2.1.5: Notes and Comment Segment (related to message) – NTE (MSG).
{
OBX See §7.2.1.6: Observation Result Segment – OBX.
[NTE] See §7.2.1.7: Notes and Comment Segment (related to Observation) – NTE (OBX).
}
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6.2.1.1 Message Header Segment - MSH
ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. MSH
1 Field Separator 1 R “|”
2 Encoding Characters 4 R “^~\&”
3 Sending Application Identifies the application (company, pg 273 of 1 180 RE “IL”

the specs, application and version)
2 "GEM Premier 4000"
3 "1.0" (Data Format version)
4 Sending Facility 1 180 RE Area Name
2 Analyzer Name
3 Analyzer Model
4 Analyzer Serial Number
5 Analyzer Cartridge Serial Number
6 Analyzer SW Version Number
5 Receiving Application 180 RE Null
6 Receiving Facility 180 RE Null
7 Date/Time Of Message Date time the message was generated 26 R YYYYMMDDHHMMSS

(HL7/ASTM format).
8 Security 40 X
9 Message Type ORU^R30, ORU^R31, ORU^R32, 7 R ORU^R32/ORU^R31: See note below

ACK^R33.
10 Message Control ID Unique identifier for the message (32 bits PK). 20 R 0 - 4294967295
11 Processing ID “T/D/P”: Training/Debug/Production 3 R “P”
12 Version ID 8 R "2.4"
13 Sequence Number 15 X
14 Continuation Pointer 180 X
15 Accept Acknowledgement Type All source messages should specify “AL” 2 R “AL”
16 Application Acknowledgement Type All ORU messages will specify “AL” 2 R “AL”
17 Country Code Not used by GEM 4000 2 RE Null
Page 55 of 239
Notes:
MSH-4: Items that appear in MSH-4 shall refer to those of the analyzer that ran the sample at analysis
date time (i.e, cartridge serial number at that time, not current inserted cartridge).
MSH-9: Possible values shall be:
ORU^R32: indicates that this is a ORU^R32 trigger (“preordered observation”), the use case #3 in
the POCT1-A standard.
ORU^R31: indicates that this is a ORU^R31 trigger (“search for an order”), the use case #2 in the
POCT1-A standard.
Comments (informative only):
MSH-15 is set to “AL” (always), so the message requires acknowledge at accept level (which is
message 2).
MSH-16 is set to “AL” (always), so the message requires acknowledge at application level (which is
message 4).
Page 56 of 239
6.2.1.2 Patient Identification Segment - PID
Page 57 of 239
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. PID
1 Set ID - Patient ID Optional. Set ID 4 O “1”

Sequence Number.
2 Patient ID 20 X
3 Patient Identifier List Use Case #1, #2 G4K shall always consider this fields as 24 O Patient ID
Patient ID required. optional.
4 Alternate Patient ID – PID 20 X
5 Patient Name Extension to the standard 1 24 O Patient Last Name
2 24 O Patient First Name
3 1 O Patient Middle Initial
6 Mother’s Maiden Name 48 X
7 Date/Time of Birth Extension to the standard 26 O Patient Birth Date

(YYYYMMDDHHMMSS)
8 Administrative Sex Extension to the standard 1 O “M”/”F”/”U”/””
9 Patient Alias 48 X
10 Race 1 X
11 Patient Address 106 X
12 Country Code Empty for USA. 4 RE Null
13 Phone Number – Home 40 X
14 Phone Number – Business 40 X
15 Primary Language 60 X
16 Marital Status 1 X
17 Religion 3 X
18 Patient Account Number Account number, if available. 24 O Patient account number.
19 SSN Number – Patient 16 X
20 Driver's License Number - Patient 25 X
21 Mother's Identifier 250 X
22 Ethnic Group 250 X
23 Birth Place 250 X
24 Multiple Birth Indicator 1 X
25 Birth Order 2 X
26 Citizenship 250 X
27 Veterans Military Status 250 X

Page 58 of 239
PID-2 and PID-4 are deprecated fields.
PID-5, PIC-7 and PID-8 are HL7 valid extensions to the POCT1-A standard.
6.2.1.3 Common Order Segment - ORC

TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. ORC
1 Order Control Use Case #1, #2: “NW.” Use Case #3:“RE.” 2 R “RE”: Preordered Observation
“NW”: Search for an order

2 Placer Order Number. Use Case #3 Only: Order Number 24 X/R Null: Search for an Order
Order Number: Preordered observation.
3 Filler Order Number External identifier for these results in the 24 O Sample Number
Observation Reviewer.
4 Placer Group Number 22 X
5 Order Status 2 X
6 Response Flag 1 X
7 Quantity/Timing 200 X
8 Parent 200 X
9 Date/Time of Transaction 26 X
10 Entered By 120 X
11 Verified By 120 X
12 Ordering Provider 120 X
13 Enterer's Location 80 X
14 Call Back Phone Number 40 X
15 Order Effective Date/Time 26 X
16 Order Control Code Reason 200 X
17 Entering Organization 60 X
18 Entering Device 60 X
Page 59 of 239
6.2.1.4 Observation Request Segment - OBR
Page 60 of 239
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBR
1 Set ID – OBR Optional. Set ID 4 R 1

Sequence Number
2 Placer Order Number See ORC-2 75 X
3 Filler Order Number See ORC-3 75 X
4 Universal Service ID 1 250 R Sample panel. LOINC Number.
See Table 157.

2 R Sample panel. Component/Analyte.
See Table 157.

5 Priority 2 X
6 Requested Date/Time 26 X
7 Observation Date/Time 26 X
8 Observation End Date/Time 26 X
9 Collection Volume 1 20 X
10 Collector Identifier 60 X
11 Specimen Action Code “O” (Specimen obtained by service other than 1 R “O”
Lab)
12 Danger Code 60 X
13 Relevant Clinical Info. 300 X
14 Specimen Received Date/Time 26 X
15 Specimen Source. e.g., The specimen source name 1 300 R Patient Sample types are described in Table
BLDA^^^LLFA^^^P (Patient test from 154.
arterial blood taken from left lower
forearm). Optional in the spec Free text additives to the specimen such as 2 X
Heparin, EDTA, or Oxlate, when applicable.
Free text component describing the method of 3 R Sample size and container. See below.
collection
Body site from which the specimen was 4 X
obtained.
Site modifier. For example, the site could be 5 X
antecubital fossa, and the site modifier “right.”
Indicates whether the specimen is frozen as part 6 X
of the collection method. If the component is
blank, the specimen is assumed to be at room
temperature.
Sample Role. 7 R “P”
16 Ordering Provider e.g., Only clinician ID transmitted 24 64 O Ordering Clinician ID

Smith^John^J^Dr
17 Order Callback Phone Number 40 X
18 Placer Field 1 60 X
Page 61 of 239
OBR-15.3: This component shall contain
Sample size: (“M” for Micro Sample, "T" for 100 uL, “N” for Normal Size).
A dash (“-”).
Container used.
Examples:
“M-SY”: Sample Type: Defined in OBR-15-1. Size: Micro. Container: Syringe.
“N-CP”: Sample Type: Defined in OBR-15-1. Size: Normal. Container: Capillary.
6.2.1.5 Notes and Comment Segment (related to message) - NTE (MSG)

ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. NTE (MSG)
1 Set ID – NTE 4 R As only one NTE record is sent in HL7, it will

have always value “1”
2 Source of Comment 8 X
3 Comment 64k RE See below.
Page 62 of 239
6.2.1.6 Observation Result Segment - OBX
Page 63 of 239
ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBX
1 Set ID Optional. Provided by some Devices. 10 R Sequence number 1,2, 3…
2 Value Type All POCT1 values are “ST” (string). 2 R “ST”
3 Observation Identifier 1 590 X
2 X
3 X
4 R Parameter Name See description below
5 X
6 X
4 Observation Sub-ID 20 O Used to differentiate different records with

same Observation Identifier. It will usually
be a sequence.
5 Observation Value E.g., “150,” “<50,” “HI,” “LO” 65536 RE Parameter Value. See description below
6 Units “mg/dL” or similar 60 RE Parameter Units. See description below
7 References Range 70^mg/dl-105^mg/dl 60 O See note below.
8 Abnormal Flags. 40 RE See note below.
9 Probability 5 X
10 Nature of Abnormal Test 2 X
11 Result Status 1 R "F" (valid result) or "X" (result has an

error)
12 Date Last Observed Normal Values 26 X
13 User Defined Access Checks 20 X
14 Date/Time of the Observation Format is CCYYMMDDHHMMSS 26 O Date and time the instrument completed
the test.
15 Producer's ID 60 X
16 Responsible Observer POC User Operator who performed the analysis 1 80 O Operator Run ID (only the first result)
IDôptional Last^First name
2 O Operator Run Last Name (only the first
result) (note: for future use)
3 O Operator Run First Name (only the first

4 O Operator Run Middle Initial (only the first

17 Observation Method 60 O Null
18 Equipment Instance Identifier IEEE 22 O Serial number of the instrument that

EUI-64 format. Page
performed the64
testof
or239
the calculation.
A Result record shall be transmitted for a parameter if the parameter is part of the test panel selected
for the sample. If the parameter is not part of the test panel that was selected for the sample, no Result
record will be transmitted for that parameter.
Results shall always be sent using the format defined in Volume 3.
Decimal separator shall be always the default (1234.56).
Note that the standard does not specify that Result records be transmitted in a particular order.
OBX-3: Field OBX-3.4 contains one of the parameter names, in the G4K column
OBX-6: Parameter units (OBX-6) shall be sent in the display units configured in the system. Available
units are described in Volume 3.
OBX-7: The reference range values (OBX-7) shall be encoded using the following scheme:
If both lower (lo) and upper (hi) limit are known:
lo_value^lo_units-hi_value^hi_units (e.g., 70^mg/dl-105^mg/dl)
If only the lower limit is known:
>lo_value^lo_units (e.g., >70^mg/dl)
If only the upper limit is known:
<hi_value^hi_units (e.g., <105^mg/dl)
(note: POCT1-A specs specify a length of 10, which is not enough even for the examples).
OBX-8: Possible values are:
Null: Reference ranges are unknown or result has an error.
"LL", Below lower critical ranges.
"L": Below low reference ranges.
"N": Inside reference ranges.
"H": Above high reference ranges.
"HH": Above upper critical ranges.
Exceptions are handled according to the table below
Page 65 of 239
ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1.
OBX. EXCEPTION HANDLING
Field contents
Exception
OBX-5 OBX-7, OBX-8 OBX-11 NTE-3
None Actual Value Yes, when available “F” No NTE segement
C Null No “X” “CÎncalculable”
> High reportable range No “X” “>Ôutside Reportable Range”
< Low reportable range No “X” “<Ôutside Reportable Range”
I Actual Value Yes, when available “X” “IÎnterference Detected”
T Actual Value Yes, when available “X” “T^Micro Clot Detected”
M Actual Value Yes, when available “X” “M^Temporary Sensor Error”
S Actual Value Yes, when available “X” “S^SHb Interference Detected”
R Actual Value Yes, when available “X” “R^Corrected for SHb”
B Actual Value Yes, when available “X” “B^High Turbidity Detected”
LA Actual Value Yes, when available “X” “LA^Fetal Corrected/<1 Month”
LB Actual Value Yes, when available “X” “LB^ Fetal Corrected/1-2 Month”
LC Actual Value Yes, when available “X” “LC^Fetal Corrected/<2 Month”
A Actual Value Yes, when available “X” “AÂbsorbance Error”
H Actual Value Yes, when available “X” “H^High MetHb Warning”
W Actual Value Yes, when available “X” “W^SHb and High MetHb Warning”
X Actual Value Yes, when available “X” “XÛnknown Exception”
L Actual Value Yes, when available “X” “LÂbove Linearity Range”
AB Actual Value Yes, when available “X” “AB^Result Abnormal”
Note1: Error X is reserved for external instruments.
Note2: Errors LA and LB are kept for backward compatibility.
6.2.1.6.1 Special fields sent in the OBX segment .

Sample related information different than Sample results shall be sent on the OBX segment only if
configured on the ECM HL7 connection setup.
The OBX segment shall be used to send other Sample related information, different that Sample results,
that needs to be processed by the LIS vendor drivers. These new records shall be appended at the end
of the regular Observation results. As a result of that, all the Sample related information specified below
shall have the following fields values in common:
OBX-1: They shall continue the incremental sequential value defined by the regular OBX data.
OBX-2: They shall have the same value as in the regular OBX information. This is a fixed value of
‘ST’.
OBX-11: They shall have a fixed value of ‘F’. Therefore all Sample related field values shall be
considered valid results.
The concrete Sample related fields sent in the OBX segment shall be:
Draw Date. If there is not Draw Date information, no Draw Date record shall be sent:
Page 66 of 239
Component Length Required OBX Record Position Contents Description
Drawn Date 10 R OBX-3 1 “Drawn Date”
tag
Drawn Date 14 R OBX-5 1 Drawn Date in YYYYMMDD format.
Draw Time. If there is not Draw Time information, no Draw Time record shall be sent:

Drawn time 10 R OBX-3 1 “Drawn Time”
tag
Drawn time 14 R OBX-5 1 Drawn Time in HHMM format.
Patient Age. If there is not Patient Age information, no Patient Age record shall be sent:

Patient age 11 R OBX-3 1 “Patient Age”
tag
Patient age 3 R OBX-5 1 Patient Age
Units 2 R OBX-6 1 Units. Units for age are described
in §A.5
User-defined patient and sample demographics fields. Format is described as follows:

Field name 24 R OBX-3 1 Field Name. Thename assigned
in configuration (ex, if user
creates a “Número de SS”,
the entered text shall be sent in
the Field Name field).
Field value 24 R OBX-5 1 Field value
Units 12 O OBX-6 1 Units.
Operator comments to the sample. Note that there can be more than one comment per sample,
and so, more than one result or OBX records with the following format. Sub-code field (OBX-4)
shall be used to differentiate different Comment records. If there are no comments related to the
Sample being sent, no Comment records shall be sent:
Page 67 of 239
Comment 7 R OBX-3 1 “COMMENT”
tag
Comment 20 R OBX-4 1 Sequence number to identify the For first Comment record it
sequence comment position in the comment list will have value 1, for second
scope. It will start from value 1. comment record it will have
value 2, and so on.
Comment 255 O OBX-5 1 Comment text
text
Datetime 14 R OBX-14 1 Date Time the comment was
performed, in
YYYYMMDDHHMMSS format.
Operador id 24 O OBX-16 (1) 1 Operator ID.
Operador 24 O OBX-16 (2) 1 Operator Last Name (note: for future
lastname use)
Operator 24 O OBX-16 (3) 1 Operator First Name (note: for future
firstname use)
Operator 1 O OBX-16 (4) 1 Operator Middle Initial (note: for
Middle future use)
initial
Indicates which fields have been edited after the sample has been accepted. To avoid having a
compound result field (OBX-5) value, every Edit operation shall be sent by means of three OBX
records. The first record shall contain the G4K edited field name along with additional information
like operator and units. The second record shall contain the old value the edited field contained. The
third record will contain the new value. All three fields shall have the same Sub-code (OBX-4) as this
is used to differentiate different Edit operations. Note that there may be more than one Edit
operation and, as a result, the three result record group defined below may be sent more than
once. Sub-code field (OBX-4) shall be used to differentiate different Edit operations. If there is not
any Edit operation related to the Sample being sent, no Edit records shall be sent. Format of the
three records involved on an Edit operation description is as follows:
Page 68 of 239
Edit tag 4 R OBX-3 1 "EDIT.FIELD"
Edit 20 1 Sequence number related to this Edit

R OBX-4
sequence operation. It will start from value 1.
Field/Param 24 1 Field Name or Parameter Name. Example:

eter R OBX-5
Patient Lastname
Units 12 O OBX-6 1 Units
Datetime 14 R OBX-14 1 Date time the edit was performed, in

YYYYMMDDHHMMSS format.
Operador id 24 O OBX-16 (1) 1 Operator ID.
Operator 24 O OBX-16 (2) 1 Operator Last Name (note: for future

lastname use)
Operator 24 O OBX-16 (3) 1 Operator First Name (note: for future

firstname use)
Operator 1 O OBX-16 (4) 1 Operator Middle Initial (note: for

Middle future use)
initial

Edit tag 8 R OBX-3 1 "EDIT.OLD"

R OBX-4
Old value 24 O OBX-5 1 Edited field old value Example:

Lopez

Edit tag 8 R OBX-3 1 “EDIT.NEW”

R OBX-4
New value 24 O OBX-5 1 Edited field new value Example:

Smith
Operator’s notification of the sample results to a clinician. This information is split into different
patient result records as the result part of the observation result record does not accept a
compound value. Therefore, the following records shall be sent. Whenever there is Notification Info,
all the following records shall be sent consecutively and with this order. Otherwise, no notification
records shall be sent:
Page 69 of 239
1 11 R OBX-3 1 “NOTIFY.TIME”
2 4 1 Time the sample was notified, in Example:
R OBX-5
HHMM format. 1052

1 9 R OBX-3 1 “NOTIFY.OP”
2 24 O OBX-5 1 Notified By ID Example:
JLopez

1 10 R OBX-3 1 “NOTIFY.PHY”
2 24 O OBX-5 1 Notified To ID Example:
Smith

1 13 R OBX-3 1 “NOTIFY.VERIFY”
2 1 R OBX-5 1 Read Back and Verified (Y or N)

1 11 R OBX-3 1 “NOTIFY.NOTE”
2 255 O OBX-5 1 Note Text Example:
Check blood temperature
Field names for non-user defined fields shall always be sent in English.
For user defined fields the user entered name shall be sent (ex, if user enters “Número de SS” for Pat.2,
the entered text shall be sent in the Field Name field).
Please, note that the defined length, requirement and value constraints defined in the tables listed
above do not contradict the general OBX segment requirements defined in Table 18. This is to keep
consistency with HL7 protocol and POCT1-A standard.
This specific OBX records will not have NTE related records.
Page 70 of 239
6.2.1.7 Notes and Comment Segment (related to Observation) - NTE (OBX)
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. NTE (MSG)

3 Comment 64k RE See Table 1.See Below.
Additionally to the result exceptions, the Notes and Comment Segment related to the Observation
Result record (OBX) shall be used to send special type of information as, for instance, Sample related
comments, etc. This is only true if HL7 connection is configured to send this information in this segment.
In that case, these special NTE information records shall be sent only as part of the NTE segment related
to the first OBX record.
The comment record shall be used to send several pieces of information, separated by the comma
character:
Draw Time:
Component Length Required Contents

1 5 R “FIELD”
2 10 R “Drawn Time”
3 14 R Drawn Time in HHMM format.
Example: “FIELD,Drawn Time,1015”
User-defined patient and sample demographics fields. Format is described is as follows:

1 5 R “FIELD”
2 24 R name assigned in configuration (ex, if user creates a “Número de
Field Name. The
SS”, the entered text shall be sent in the Field Name field).
3 24 R Field value
4 12 O Units.
Example: “FIELD,Social Security Number,12345”
Field Name is the name assigned in configuration (ex, if user creates a “Número de SS”, the
entered text shall be sent in the Field Name field).
Page 71 of 239
Operator comments to the sample. Format is as follows:

1 7 R “COMMENT”
2 14 R Date Time the comment was performed, in YYYYMMDDHHMMSS format.
3 24 O Operator ID.
4 255 O Comment Text
Example: “COMMENT,20053112173456,ggalilei,Eppur si muove”
Indicate which fields have been edited after the sample has been accepted. Format is as follows:

1 4 R "EDIT"
2 24 R Field Name or Parameter Name.
3 24 O Old Value
4 24 O New Value
5 12 O Units
6 14 R Date time the edit was performed, in YYYYMMDDHHMMSS format.
7 24 O Operator ID.
Example: “EDIT,Temperature,37.2,38.2,ºC^20053112173456,lordkelvin”
Operator’s notification of the sample results to a clinician.

1 6 R “NOTIFY”
2 4 R Time the sample was notified, in HHMM format.
3 24 O Notified By ID
4 24 O Notified To ID
5 1 R Read Back and Verified (Y or N)
6 255 O Note Text
Example: “NOTIFY,1052,jlopez,smith,N,check blood pressure”
Fields without value shall
Page 72 of 239
6.2.2 Message 2: ACK (downloading)
This message shall be a downloading message.
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 2

Message Comments
MSH See §7.2.2.1: Message Header Segment – MSH

MSA See §7.2.2.2: General Acknowledgement Segment – MSA
Page 73 of 239
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 2. MSH
3 Sending Application Identifies the application (company, pg 273 of 180 RE Ignored by the GEM 4000
4 Sending Facility 180 RE Ignored by the GEM 4000
5 Receiving Application 180 RE Ignored by the GEM 4000
6 Receiving Facility 180 RE Ignored by the GEM 4000

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R “ACK”
11 Processing ID “T/D/P”: Training/Debug/Production 3 R “P”. Ignored by the GEM 4000
12 Version ID 8 R “2.4”. Ignored by the GEM 4000
15 Accept Acknowledgement Type All source messages should specify “AL” 2 R “NE”
16 Application Acknowledgement Type All ORU messages will specify “AL” 2 R “NE”
17 Country Code Not used by GEM 4000 2 RE Ignored by the GEM 4000
Page 74 of 239
6.2.2.2 General Acknowledgement Segment - MSA
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 2. MSA
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “CA” / “CE” / “CR”
2 Message Control ID From MSH-10 of associated message 20 R 0 – 4294967295
3 Text Message 80 O Text description.

Empty if “CA”
6 Error Condition Coded Error 100 O Coded Error
Notes:
MSA-1: Possible values are:
 “CA”: Message accepted.
 “CE”: Error (message not accepted).
 “CR”: Rejection (message not accepted).
Upon reception of the message, the GEM 4000 shall remove the record from the transmission queue
If the message has not been accepted, the SW the event shall be traced indicating the contents of MSA-
3 and MSA-6.
6.2.3 Message 3/3E: ACK^R33 (downloading)

Once the HIS/LIS/CIS has processed the message, it returns the result of the processing using this
message.

Message Comments

Page 75 of 239

(HL7/ASTM format).
8 Security 40 X
9 Message Type ORU^R30, ORU^R31, ORU^R32, 7 R “ACK^R33”

ACK^R33.
15 Accept Acknowledgement Type All source messages should specify “AL” 2 R “AL” (always)
16 Application Acknowledgement Type All ORU messages will specify “AL” 2 R “NE” (never)
Page 76 of 239
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “AA” / “AE” / “AR”
3 Text Message Note (2) 80 O Text description
Notes:
MSA-1: Possible values are:
 “AA”: Message accepted.
 “AE”: Error (message not accepted).
 “AR”: Rejection (message not accepted).
If the message has not been accepted, the SW event shall be traced indicating the contents of MSA-3
and MSA-6.
Note (Informative only): This message will be used in the future to receive “returned orders”.
6.2.4 Message 4/4E: ACK (uploading)


Message Comments

Page 77 of 239

"1.0" (Data Format version)
2 Analyzer Name
3 Analyzer Model
5 Cartridge Serial Number

(HL7/ASTM format).
8 Security 40 X
9 Message Type ORU^R30, ORU^R31, ORU^R32, 7 R “ACK”

ACK^R33.
Page 78 of 239
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “CA”
3 Text Message Note (2) 80 O Null
6.2.5 Transmission examples
6.2.5.1 Successful upload

Message 1 (GEM4000):
MSH|^~\&|IL^GEM Premier 4000^1.0|ICU^G4K^GEM Premier 4000^123^334Â.1.0.0.0.10.0.1.b4|||

20040316152054||ORU^R32|124|P|2.4|||AL|AL<CR>
PID|1||1234567890||BLAKE^LINDSEY||19221123000000|U<CR>
ORC|RE|99999<CR>
OBR|1|||24338-6^GAS PANEL|||||||O||||BLDA^^N-VC^^^^P|Freeman^Dyson^J<CR>
OBX|1|ST|^^^pH ||7.22||||||F|||20040316151015||5555||123|20040316152054<CR>
OBX|2|ST|^^^pCO2||62|mmHg|19^mmHg-67^mmHg|N|||F<CR>
OBX|3|ST|^^^pO2||81|mmHg|>43^mmHg|L|||F<CR>
OBX|4|ST|^^^Na+||131.1|mmol/L|||||F<CR>
OBX|5|ST|^^^K+||5.14|mmol/L|<6.2^mmol/L|H|||F<CR>
OBX|6|ST|^^^Ca++||5.00|mmol/L|||||X<CR>
NTE|1||>Ôutside Reportable Range<CR>
OBX|7|ST|^^^Hct||65|%|||||F<CR>
OBX|8|ST|^^^Ca++(7.4)||1.14|mmol/L|||||F<CR>
Page 79 of 239
OBX|9|ST|^^^HCO3std||25.3|mmol/L|||||F<CR>
OBX|10|ST|^^^TCO2||27.2|mmol/L|||||F<CR>
OBX|11|ST|^^^FIO2||100|%|||||F<CR>
Message 2 (HIS/LIS/CIS):
MSH|^~\&|||||20040316152056||ACK|12478|||||NE|NE<CR>
MSA|CA|124<CR>
MSH|^~\&|||||20040316152056||ACK^R33|12480|||||AL|NE<CR>
MSA|AA|124<CR>
MSH|^~\&|||||20040316152056||ACK|128|||||NE|NE<CR>
MSA|CA|12480<CR>
6.2.5.2 HILS/LIS rejects GEM 4000 message


20040316152054||ORU^R32|124|P|2.4|||AL|AL<CR>
ORC|RE|99999<CR>
OBR|1|||24338-6^GAS PANEL|||||||O||||BLDA^^N-VC^^^^P|Freeman^Dyson^J<CR>
OBX|1|ST|^^^pH||7.22||||||F|||20040316151015||5555||123|20040316152054<CR>
NTE|1||>^ Outside Reportable Range <CR>
Page 80 of 239
OBX|7|ST|^^^Hct||65|%|||||F<CR>
OBX|11|ST|^^^FIO2||100|%|||||F<CR>
MSH|^~\&|||||20040316152056||ACK|12478|||||NE|NE<CR>
MSA|CA|124<CR>
MSH|^~\&|||||20040316152056||ACK^R33|12480|||||AL|NE<CR>
MSA|AR|124|LIS not ready|||9812<CR>
MSH|^~\&|||||20040316152056||ACK|128|||||NE|NE<CR>
MSA|CA|12480<CR>
6.2.5.3 HIS/LIS/CIS fails to process transmission


20040316152054||ORU^R32|124|P|2.4|||AL|AL<CR>
ORC|RE|99999<CR>
OBR|1|||24338-6^GAS PANEL||||||O||||A^^N-VC^^^^P|Freeman^Dyson^J<CR>
OBX|1|ST|^^^pH||7.22||||||F|||20040316151015||5555||123|20040316152054<CR>
Page 81 of 239
NTE|1||>^ Outside Reportable Range <CR>
OBX|7|ST|^^^Hct||65|%|||||F<CR>
OBX|11|ST|^^^FIO2||100|%|||||F<CR>
MSH|^~\&|||||20040316152056||ACK|12478|||||NE|NE<CR>
MSA|CE|124|TCP Com Error, Invalid HL7 Message|||3214<CR>
6.3 Upload Calibration Results to HIS/LIS/CIS

The message flow is described below
Upload Calibration Results to HIS/LIS/CIS.
6.3.1 Message 1: OUL^R21 (uploading)

TABLE 1: ORI. HL7. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. MESSAGE 1

Message Comments

SAC See §7.3.1.2: Specimen and Container Detail Segment – SAC.
OBR See §7.3.1.3: Observation Request Segment – OBR.
{OBX} See §7.3.1.4: Observation Result Segment – OBX
Note (informative only): This spec follows HL7 v2.4, section 13.5, about QC usage.
Page 82 of 239
Use the 7th component of OBR-15-specimen source or SAC-6 -specimen source to indicate that
this is a control specimen. Use SAC-3-container identifier for the identification of a control
specimen container. The SID segment appended to this SAC segment specifies the manufacturer,
lot identifiers, etc. for the control specimen.
The identification of the instrument performing the QC measurement, should be transferred with
the OBX-18-equipment instance identifier), the measurement data/time with the OBX-19
date/time of the analysis.
MSH|^~\&|INSTPROG|AUTINST|LASPROG|LASSYS|19980630080040|SECURITY
|OUL^R21|MSG00001|P|2.4|<cr>
SAC|||Q092321^LAS|||SER^^^^^^Q |19980620080037|R^PROCESS COMPLETED<cr>
SID|01230^Na|ABCDE-01234567890||04^RD<cr>
ORC|RE|5212498721A|||||^^^^^R<CR>
OBR|1|5212498721A||2951-2^SODIUM^LN|||199807240826||||||||SER^^^^^^Q<CR>
OBX|1|NM|2951-2^SODIUM^LN||24.3|ug/g||N<CR>
Page 83 of 239
TABLE 1: ORI. HL7 . UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. MESSAGE 1. MSH

2 Analyzer Name
3 Analyzer Model

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R OUL^R21
16 Application Acknowledgement Type 2 R “NE”
MSH-4: Items that appear in MSH-4 shall refer to those of the analyzer that ran the sample at analysis
date time (i.e, cartridge serial number at that time, not current inserted cartridge).
Page 84 of 239
message 2).
MSH-16 is set to “NE” (never), so the message does not require acknowledge at application level.
6.3.1.2 Specimen and Container Detail Segment - SAC

TABLE 1: ORI. HL7 . UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. MESSAGE 1. SAC
1 External Accession Identifier 80 X
2 Accession Identifier 80 X
3 Container Identifier 80 X
4 Primary (parent) Container Identifier 80 X
5 Equipment Container Identifier 80 X
6 Specimen Source. e.g., The specimen source name 1 300 X

BLDA^^^LLFA^^^P (Patient test from
arterial blood taken from left lower Free text additives to the specimen such as 2 X
forearm). Optional in the spec Heparin, EDTA, or Oxlate, when applicable.
Free text component describing the method of 3 X
collection
obtained.
temperature.
Sample Role. 7 R “C”
Page 85 of 239
Page 86 of 239
TABLE 1: ORI. HL7. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBR

Sequence Number
4 Universal Service ID 1 250 X
2 X
3 X
4 R Calibration Type. See Table 86.
5 X
6 X
5 Priority 2 X
9 Collection Volume 20 X
11 Specimen Action Code 1 X
12 Danger Code 60 X
15 Specimen Source. The specimen source name 1 300 X
Free text additives to the specimen such as 2 X

collection
obtained.
temperature.
Sample Role. 7 R “C”
Page 87 of 239
Page 88 of 239
Page 89 of 239
TABLE 1: ORI. HL7. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBX
3 Observation Identifier e.g., 1 590 X

^^ÂaDpO2,T&E - a mnemonic
identifying the parameter along with a 2 X
subcomponent specifying the type of
observation, in this case [E]stimated).
3 X
4 R One of the calibration records. See below.
5 X
6 X
4 Observation Sub-ID 20 X
5 Observation Value 65536 RE Calibration result. Null if incalculable
6 Units “mg/dL” or similar 60 RE Calibration Units. See below.
7 References Range 70^mg/dl-105^mg/dl 10 X
8 Abnormal Flags. 40 X
9 Probability 5 X
11 Result Status 1 R "F" (valid result) or
"X" (calibration failure)

the calibration
16 Responsible Observer POC User 80 X

17 Observation Method 60 X

EUI-64 format. performed the calibration.
Only needed in the first result.
19 Date/Time of Analysis The timestamp when the Device performed the 26 O Date and time the instrument completed
test. Format is CCYYMMDDHHMMSS the calibration.
Page 90 of 239
A Result record shall be transmitted if the record is reported for a calibration. Otherwise, no record shall
be transmitted for that parameter
Parameter units shall be sent in the default units. Default units are described in Volume 3.
The available calibration records are described in Table 88 and Table.

This section is identical to §7.2.2
6.3.3.1 B calibration
MSH|^~\&|IL^GEM Premier 4000^1.0|ICU^G4K^GEM Premier 4000^123^334Â.1.0.0.0.10.0.1.B4|||

20040416152054||OUL^R21|1245|P|2.4|||AL|NE<CR>
SAC||||||^^^^^^C<CR>
OBR|1|||^^^BCal|||||||||||^^^^^^C<CR>
OBX|1|ST|^^^pHDriftB||0.00||||||F|||20040316151015||||123|20040416152054<CR>
OBX|2|ST|^^^pCO2DriftB||0|mmHg|||||F<CR>
OBX|3|ST|^^^pO2DriftB||0|mmHg|||||F<CR>
OBX|4|ST|^^^Na+DriftB||0.0|mmol/L|||||F<CR>
OBX|5|ST|^^^K+DriftB||0.0|mmol/L|||||F<CR>
OBX|6|ST|^^^Cl-DriftB||0.0|mmol/L|||||F<CR>
OBX|7|ST|^^^HCO3-DriftB||0.0|mmol/L|||||F<CR> For future use!
OBX|8|ST|^^^Ca++DriftB||0.25|mmol/L|||||X<CR>
OBX|9|ST|^^^HctDriftB||0|%|||||F<CR>
OBX|10|ST|^^^GluDriftB||0.0|mg/dL|||||F<CR>
Page 91 of 239
OBX|11|ST|^^^LacDriftB||0.0|mmol/L|||||F<CR>
OBX|12|ST|^^^BUNDriftB||0.0|mg/dL|||||F<CR> For future use!
OBX|13|ST|^^^CreatDriftB||0.0|mg/dL|||||F<CR> For future use!
OBX|14|ST|^^^tHbDriftB||0.0|g/dL|||||F<CR>
OBX|15|ST|^^^pHMeasuredB||7.41||||||F<CR>
OBX|16|ST|^^^pCO2MeasuredB||35|mmHg|||||F<CR>
OBX|17|ST|^^^pO2MeasuredB||199|mmHg|||||F<CR>
OBX|18|ST|^^^Na+MeasuredB||136.0|mmol/L|||||F<CR>
OBX|19|ST|^^^K+MeasuredB||6.00|mmol/L|||||F<CR>
OBX|20|ST|^^^Cl-MeasuredB||12.00|mmol/L|||||F<CR>
OBX|21|ST|^^^HCO3-MeasuredB||1.00|mmol/L|||||F<CR> For future use!
OBX|22|ST|^^^Ca++MeasuredB||2.07|mmol/L|||||F<CR>
OBX|23|ST|^^^HctMeasuredB||11|%|||||F<CR>
OBX|24|ST|^^^GluMeasuredB||66.00|mg/dL|||||F<CR>
OBX|25|ST|^^^LacMeasuredB||78.00|mmol/L|||||F<CR>
OBX|26|ST|^^^BUNMeasuredB||58.00|mg/dL|||||F<CR> For future use!
OBX|27|ST|^^^CreatMeasuredB||83.00|mg/dL|||||F<CR> For future use!
OBX|28|ST|^^^tHbMeasuredB||18|g/dL|||||F<CR>
MSH|^~\&|||||20040316152056||ACK|478|||||NE|NE<CR>
MSA|CA|1245<CR>
6.3.3.2 Full Calibration


20040416152054||OUL^R21|45|P|2.4|||AL|NE<CR>
SAC||||||^^^^^^C<CR>
Page 92 of 239
OBR|1|||^^^FullCal|||||||||||^^^^^^C<CR>
OBX|1|ST|^^^pHSlope||62|mV/dec|||||F|||20040316151015||||123|20040416152054<CR>
OBX|2|ST|^^^pCO2Slope||54|mV/dec|||||F<CR>
OBX|3|ST|^^^pO2Slope||8|pA/mmHg|||||F<CR>
OBX|4|ST|^^^Na+Slope||64|mV/dec|||||F<CR>
OBX|5|ST|^^^K+Slope||58|mV/dec|||||F<CR>
OBX|6|ST|^^^Cl-Slope||27|mV/dec|||||F<CR>
OBX|7|ST|^^^HCO3-Slope||32|mV/dec|||||F<CR> For future use!
OBX|8|ST|^^^Ca++Slope||24|mV/dec|||||F<CR>
OBX|9|ST|^^^HctSlope||38|mV/mho|||||F<CR>
OBX|10|ST|^^^GluSlope||15|pA/mg/dL|||||F<CR>
OBX|11|ST|^^^LacSlope||27|pA/mg/dL|||||F<CR>
OBX|12|ST|^^^BUNSlope||32|mV/dec|||||F<CR> For future use!
OBX|13|ST|^^^CreatSlope||50|pA/mg/dL|||||F<CR> For future use!
OBX|14|ST|^^^tHbSlope||3| |||||F<CR>
OBX|15|ST|^^^BUNSlope2||42||||||F<CR> For future use!
OBX|16|ST|^^^CreatSlope2||71|pA/mg/dL|||||F<CR> For future use!
OBX|17|ST|^^^pHDriftA||0.01||||||F<CR>
OBX|18|ST|^^^pCO2DriftA||0|mmHg|||||F<CR>
OBX|19|ST|^^^pO2DriftA||0|mmHg|||||F<CR>
OBX|20|ST|^^^Na+DriftA||0.01|mmol/L|||||F<CR>
OBX|21|ST|^^^K+DriftA||-0.01|mmol/L|||||F<CR>
OBX|22|ST|^^^Cl-DriftA||0.0|mmol/L|||||F<CR>
OBX|23|ST|^^^HCO3-DriftA||0.0|mmol/L|||||F<CR> For future use!
OBX|24|ST|^^^Ca++DriftA||0.25|mmol/L|||||F<CR>
Page 93 of 239
OBX|25|ST|^^^HctDriftA||0|%|||||F<CR>
OBX|26|ST|^^^GluDriftA||0.0|mg/dL|||||F<CR>
OBX|27|ST|^^^LacDriftA||0.0|mmol/L|||||F<CR>
OBX|28|ST|^^^BUNDriftA||0.0|mg/dL|||||F<CR> For future use!
OBX|29|ST|^^^CreatDriftA||0.0|mg/dL|||||F<CR> For future use!
OBX|30|ST|^^^tHbDriftA||0.0|g/dL|||||F<CR>
OBX|31|ST|^^Ô2HbDriftA||0.0|%|||||F<CR>
OBX|32|ST|^^^COHbDriftA||0.0|%|||||F<CR>
OBX|33|ST|^^^MetHbDriftA||0.0|%|||||F<CR>
OBX|34|ST|^^^HHbDriftA||0.0|%|||||F<CR>
OBX|35|ST|^^^tBiliDriftA||0.0|mg/dL|||||F<CR>
OBX|36|ST|^^^pHMeasuredA||6.93||||||F<CR>
OBX|37|ST|^^^pCO2MeasuredA||63|mmHg|||||F<CR>
OBX|38|ST|^^^pO2MeasuredA||0|mmHg|||||F<CR>
OBX|39|ST|^^^Na+MeasuredA||154.0|mmol/L|||||F<CR>
OBX|40|ST|^^^K+MeasuredA||1.89|mmol/L|||||F<CR>
OBX|41|ST|^^^Cl-MeasuredA||12.00|mmol/L|||||F<CR>
OBX|42|ST|^^^HCO3-MeasuredA||1.00|mmol/L|||||F<CR> For future use!
OBX|43|ST|^^^Ca++MeasuredA||0.19|mmol/L|||||F<CR>
OBX|44|ST|^^^HctMeasuredA||11|%|||||F<CR>
OBX|45|ST|^^^GluMeasuredA||
OBX|46|ST|^^^LacMeasuredA||78.00|mmol/L|||||F<CR>
OBX|47|ST|^^^BUNMeasuredA||58.00|mg/dL|||||F<CR> For future use!
OBX|48|ST|^^^CreatMeasuredA||83.00|mg/dL|||||F<CR> For future use!
OBX|49|ST|^^^tHbMeasuredA||18|g/dL|||||F<CR>
Page 94 of 239
OBX|50|ST|^^Ô2HbMeasuredA||0.1|%|||||F<CR>
OBX|51|ST|^^^COHbMeasuredA||3|%|||||F<CR>
OBX|52|ST|^^^MetHbMeasuredA||0.6|%|||||F<CR>
OBX|53|ST|^^^HHbMeasuredA||7|%|||||F<CR>
OBX|54|ST|^^^tBiliMeasuredA||3.5|mg/dL|||||F<CR>
OBX|55|ST|^^^pHDriftD||0.0||||||F<CR>
OBX|56|ST|^^^pCO2DriftD||0.0|mmol/L|||||F<CR>
OBX|57|ST|^^^pO2DriftD||0.0|mmol/L|||||F<CR>
OBX|58|ST|^^^Na+DriftD||0.0|mmol/L|||||F<CR>
OBX|59|ST|^^^K+DriftD||0.0|mmol/L|||||F<CR>
OBX|60|ST|^^^Cl-DriftD||0.0|mmol/L|||||F<CR>
OBX|61|ST|^^^HCO3-DriftD||0.0|mmol/L|||||F<CR> For future use!
OBX|62|ST|^^^Ca++DriftD||0.00|mmol/L|||||F<CR>
OBX|63|ST|^^^GluDriftD||0.0|mg/dL|||||F<CR>
OBX|64|ST|^^^LacDriftD||0.0|mmol/L|||||F<CR>
OBX|65|ST|^^^BUNDriftD||0.0|mg/dL|||||F<CR> For future use!
OBX|66|ST|^^^CreatDriftD||0.0|mg/dL|||||F<CR> For future use!
OBX|67|ST|^^^tHbDriftD||0.0|g/dL|||||F<CR>
OBX|68|ST|^^Ô2HbDriftD||0.0|%|||||F<CR>
OBX|69|ST|^^^COHbDriftD||0.0|%|||||F<CR>
OBX|70|ST|^^^MetHbDriftD||0.0|%|||||F<CR>
OBX|71|ST|^^^HHbDriftD||0.0|%|||||F<CR>
OBX|72|ST|^^^tBiliDriftD||0.0|mg/dL|||||F<CR>
OBX|73|ST|^^^pHMeasuredD||6.93||||||F<CR>
OBX|74|ST|^^^pCO2MeasuredD||63|mmHg|||||F<CR>
Page 95 of 239
OBX|75|ST|^^^pO2MeasuredD||0|mmHg|||||F<CR>
OBX|76|ST|^^^Na+MeasuredD||136.0|mmol/L|||||F<CR>
OBX|77|ST|^^^K+MeasuredD||6.00|mmol/L|||||F<CR>
OBX|78|ST|^^^Cl-MeasuredD||12.00|mmol/L|||||F<CR>
OBX|79|ST|^^^HCO3-MeasuredD||1.00|mmol/L|||||F<CR> For future use!
OBX|80|ST|^^^Ca++MeasuredD||2.07|mmol/L|||||F<CR>
OBX|81|ST|^^^GluMeasuredD||66.00|mg/dL|||||F<CR>
OBX|82|ST|^^^LacMeasuredD||78.00|mmol/L|||||F<CR>
OBX|83|ST|^^^BUNMeasuredD||58.00|mg/dL|||||F<CR> For future use!
OBX|84|ST|^^^CreatMeasuredD||83.00|mg/dL|||||F<CR> For future use!
OBX|85|ST|^^^tHbMeasuredD||18|g/dL|||||F<CR>
OBX|86|ST|^^Ô2HbMeasuredD||0.1|%|||||F<CR>
OBX|87|ST|^^^COHbMeasuredD||3|%|||||F<CR>
OBX|88|ST|^^^MetHbMeasuredD||0.6|%|||||F<CR>
OBX|89|ST|^^^HHbMeasuredD||7|%|||||F<CR>
OBX|90|ST|^^^tBiliMeasuredD||3.5|mg/dL|||||F<CR>
MSH|^~\&|||||20040316152056||ACK|2478|||||NE|NE<CR>
MSA|CA|45<CR>
6.3.3.3 C Calibration

20040416152054||OUL^R21|124|P|2.4|||AL|NE<CR>
SAC||||||^^^^^^C<CR>
OBR|1|||^^^CCal|||||||||||^^^^^^C<CR>
OBX|1|ST|^^^pHSlopeC||0.0|mV/dec|||||F|||20040316151015||||123|20040416152054<CR>
Page 96 of 239
OBX|2|ST|^^^pCO2SlopeC||0|mV/dec|||||F<CR>
OBX|3|ST|^^^pHDriftC||0.0||||||F<CR>
OBX|4|ST|^^^pCO2DriftC||0|mmHg|||||F<CR>
OBX|5|ST|^^^pO2DriftC||0|mmHg|||||F<CR>
OBX|6|ST|^^^K+DriftC|||mmol/L|||||X<CR>
OBX|7|ST|^^^BUNDriftC|||mg/dL|||||X<CR> For future use!
OBX|8|ST|^^^pHMeasuredC||7.41||||||F<CR>
OBX|9|ST|^^^pCO2MeasuredC||35|mmHg|||||F<CR>
OBX|10|ST|^^^pO2MeasuredC||199|mmHg|||||F<CR>
OBX|11|ST|^^^K+MeasuredC||6.00|mmol/L|||||F<CR>
OBX|12|ST|^^^BUNMeasuredC|||mg/dL|||||F<CR> For future use!
MSH|^~\&|||||20040316152056||ACK|12478|||||NE|NE<CR>
MSA|CA|124<CR>
6.3.3.4 D Calibration

20040416152054||OUL^R21|24|P|2.4|||AL|NE<CR>
SAC||||||^^^^^^C<CR>
OBR|1|||^^^DCal|||||||||||^^^^^^C<CR>
OBX|1|ST|^^^pHDriftD||0.0||||||F<CR>
OBX|2|ST|^^^pCO2DriftD||0.0|mmol/L|||||F<CR>
OBX|3|ST|^^^pO2DriftD||0.0|mmol/L|||||F<CR>
ID : INT_PROT-1057
OBX|4|ST|^^^Na+DriftD||0.0|mmol/L|||||F<CR>
OBX|5|ST|^^^K+DriftD||0.0|mmol/L|||||F<CR>
Page 97 of 239
OBX|6|ST|^^^Cl-DriftD||0.0|mmol/L|||||F<CR>
OBX|7|ST|^^^HCO3-DriftD||0.0|mmol/L|||||F<CR> For future use!
OBX|8|ST|^^^Ca++DriftD||0.00|mmol/L|||||F<CR>
OBX|9|ST|^^^GluDriftD||0.0|mg/dL|||||F<CR>
OBX|10|ST|^^^LacDriftD||0.0|mmol/L|||||F<CR>
OBX|11|ST|^^^BUNDriftD||0.0|mg/dL|||||F<CR> For future use!
OBX|12|ST|^^^CreatDriftD||0.0|mg/dL|||||F<CR> For future use!
OBX|13|ST|^^^tHbDriftD||0.0|g/dL|||||F<CR>
OBX|14|ST|^^Ô2HbDriftD||0.0|%|||||F<CR>
OBX|15|ST|^^^COHbDriftD||0.0|%|||||F<CR>
OBX|16|ST|^^^MetHbDriftD||0.0|%|||||F<CR>
OBX|17|ST|^^^HHbDriftD||0.0|%|||||F<CR>
OBX|18|ST|^^^tBiliDriftD||0.0|mg/dL|||||F<CR>
OBX|19|ST|^^^pHMeasuredD||6.93||||||F<CR>
OBX|20|ST|^^^pCO2MeasuredD||63|mmHg|||||F<CR>
OBX|21|ST|^^^pO2MeasuredD||0|mmHg|||||F<CR>
OBX|22|ST|^^^Na+MeasuredD||136.0|mmol/L|||||F<CR>
OBX|23|ST|^^^K+MeasuredD||6.00|mmol/L|||||F<CR>
OBX|24|ST|^^^Cl-MeasuredD||12.00|mmol/L|||||F<CR>
OBX|25|ST|^^^HCO3-MeasuredD||1.00|mmol/L|||||F<CR> For future use!
OBX|26|ST|^^^Ca++MeasuredD||2.07|mmol/L|||||F<CR>
OBX|27|ST|^^^GluMeasuredD||66.00|mg/dL|||||F<CR>
OBX|28|ST|^^^LacMeasuredD||78.00|mmol/L|||||F<CR>
OBX|29|ST|^^^BUNMeasuredD||58.00|mg/dL|||||F<CR> For future use!
OBX|30|ST|^^^CreatMeasuredD||83.00|mg/dL|||||F<CR> For future use!
Page 98 of 239
OBX|31|ST|^^^tHbMeasuredD||18|g/dL|||||F<CR>
OBX|32|ST|^^Ô2HbMeasuredD||0.1|%|||||F<CR>
OBX|33|ST|^^^COHbMeasuredD||3|%|||||F<CR>
OBX|34|ST|^^^MetHbMeasuredD||0.6|%|||||F<CR>
OBX|35|ST|^^^HHbMeasuredD||7|%|||||F<CR>
OBX|36|ST|^^^tBiliMeasuredD||3.5|mg/dL|||||F<CR>
MSH|^~\&|||||20040316152056||ACK|247|||||NE|NE<CR>
MSA|CA|24<CR>
6.4 Upload iQM-CVP Results to HIS/LIS/CIS

6.4.1 When CVP Results are Transmitted
CVP sample results are transmitted to the interface whenever a CVP sample is run and accepted by the
operator. For the sample to be transmitted, one of the analyzer’s interface ports must be configured for
sending of the iQM data. The receiving computer generates the iQM CVP Monthly Report from the
individual CVP results received during that month. The format of that report is given in software
specification volume 4a (Data Management).
6.4.2 CVP Sample Results Message Flow

The message flow is described in the following figure.
Upload CVP Results to HIS/LIS/CIS.
6.4.3 Message 1: OUL^R21 (uploading)

Page 99 of 239
TABLE 1: ORI. HL7. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1
Message Comments

SAC See §7.4.3.2: Specimen and Container Detail Segment – SAC
SID See §7.4.3.3: Substance Identifier Segment – SID
[NTE] See §7.4.3.4: Notes and Comment Segment – NTE
OBR See §7.4.3.5: Observation Request Segment – OBR
{
OBX See §7.4.3.6: Observation Result Segment – OBX
[NTE] See §7.4.3.7: Notes and Comment Segment (related to Observation) – NTE (OBX)
}
Note (informative only): This spec follows HL7 v2.4, section 13.5, about QC usage.
Use the 7th component of OBR-15-specimen source or SAC-6 -specimen source to indicate that
this is a control specimen. Use SAC-3-container identifier for the identification of a control
specimen container. The SID segment appended to this SAC segment specifies the manufacturer,
lot identifiers, etc. for the control specimen.
The identification of the instrument performing the QC measurement, should be transferred with
the OBX-18-equipment instance identifier), the measurement data/time with the OBX-19
date/time of the analysis.
MSH|^~\&|INSTPROG|AUTINST|LASPROG|LASSYS|19980630080040|SECURITY
|OUL^R21|MSG00001|P|2.4|<cr>
SAC|||Q092321^LAS|||SER^^^^^^Q |19980620080037|R^PROCESS COMPLETED<cr>
SID|01230^Na|ABCDE-01234567890||04^RD<cr>
ORC|RE|5212498721A|||||^^^^^R<CR>
OBR|1|5212498721A||2951-2^SODIUM^LN|||199807240826||||||||SER^^^^^^Q<CR>
OBX|1|NM|2951-2^SODIUM^LN||24.3|ug/g||N<CR>

This section is identical to §7.3.1.1 (Upload Calibrations, ORI HL7).
Page 100 of 239

TABLE 1: ORI. HL7 . UPLOAD CVP RESULTS TO HIS/LIS/CIS. MESSAGE 1. SAC
1 External Accession Identifier 80 X
6 Specimen Source. e.g., The specimen source name 1 300 X

BLDA^^^LLFA^^^P (Patient test from
arterial blood taken from left lower Free text additives to the specimen such as 2 X
forearm). Optional in the spec Heparin, EDTA, or Oxlate, when applicable.
collection
obtained.
temperature.
Sample Role. 7 R “Q”
6.4.3.3 Substance Identifier Segment - SID

TABLE 1: ORI. HL7. UPLOAD CVP RESULTS TO HIS/LIS/CIS. MESSAGE 1. SID
1 Application / Method Identifier 1 250 X
2 X
3 X
4 R “CVP ” +CVP Lot Level (ex “CVP 1”)
5 R CVP Lot Description
2 Substance Lot Number 20 R CVP Lot Number
3 Substance Container Identifier X
4 Substance Manufacturer Identifier 250 R “IL”
Page 101 of 239

6.4.3.4 Notes and Comment Segment - NTE
TABLE 1: ORI. HL7. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. NTE (MSG)

3 Comment 64k RE See below.
The comment record shall be used to send several comments, separated by the repeat character:
Format for each comment is as follows:

1 7 R “COMMENT”
2 14 R Date Time the comment was performed, in YYYYMMDDHHMMSS format.
3 24 R Operator Id
4 24 O Operator Last Name (note: for future use)
5 24 O Operator Firs Name (note: for future use)
6 1 O Operator Middle Initial (note: for future use)
7 255 R Comment Text
Example: “COMMENT^20053112173456^ggalilei^^^Êppur si muove”
Page 102 of 239

Page 103 of 239

TABLE 1: ORI. HL7. UPLOAD CVP RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBR

Sequence Number
4 Universal Service ID 1 250 R CVP panel.
2 R CVP panel. Component/Analyte.
3 X
4 X
5 X
6 X
5 Priority 2 X
9 Collection Volume 20 X
11 Specimen Action Code 1 X
12 Danger Code 60 X

collection
obtained.
temperature.
Sample Role. 7 R “Q”
18 Placer Field 1 60 X Page 104 of 239

Page 105 of 239
Page 106 of 239

TABLE 1: ORI. HL7. UPLOAD CVP RESULTS TO HIS/LIS/CIS. MESSAGE 1. OBX
3 Observation Identifier e.g., 1 590 X

^^ÂaDpO2,T&E - a mnemonic
identifying the parameter along with a 2 X
subcomponent specifying the type of
observation, in this case [E]stimated).
3 X
4 R One of the CVP parameter names. See

below
5 X
6 X
4 Observation Sub-ID 20 X
5 Observation Value 65536 CE CVP result.
6 Units “mg/dL” or similar 60 CE CVP Units. See description below
7 References Range 70^mg/dl-105^mg/dl R lo_value^lo_units-hi_value^hi_units. See

below
8 Abnormal Flags. 40 X
9 Probability 5 X
"X" (error)
the CVP
16 Responsible Observer POC User 80 X

17 Observation Method 60 X

EUI-64 format. performed the CVP.
19 Date/Time of Analysis The timestamp when the Device performed the 26 O Date and time the instrument completed
test. Format is CCYYMMDDHHMMSS the CVP.
Page 107 of 239

A Result record shall be transmitted if the record is reported for a CVP. Otherwise, no record shall be
transmitted for that parameter
Parameter units shall be sent in the display units.
OBX-3: Field OBX-3.4 contains one of the parameter names listed in Table 153, in the G4K column.
OBX-6: Parameter units (OBX-6) shall be sent in the display units configured in the system. Available
units are described in Volume 2a.
OBX-7: The reference range values (OBX-7) shall be encoded using the following scheme:
lo_value^lo_units-hi_value^hi_units (e.g., 70^mg/dl-105^mg/dl)
Units shall be the display units.
Exceptions are handled according to the following table:
TABLE 1: ORI. HL7. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1.

OBX. EXCEPTION HANDLING
Field contents
Exception
OBX-5 OBX-11 NTE-3
None Actual Value “F” No NTE segment
Q Null “X” “QîQM Error”
C Null “X” “CÎncalculable”
F Actual Value “X” “FÔutside of CVP Range”
> High Reportable Range “X” “>Ôutside Reportable Range”
< Low Reportable Range “X” “<Ôutside Reportable Range”
Page 108 of 239

6.4.3.7 Notes and Comment Segment (related to Observation) - NTE (OBX)
TABLE 1: ORI. HL7. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 1. NTE (MSG)

3 Comment 64k RE See Table 1.


MSH|^~\&|IL^GEM Premier 4000^1.0|ICU^G4K^GEM Premier 4000^123^334^

A.1.0.0.0.10.0.1.B4|||20040416152054||OUL^R21|1247|P|2.4|||AL|NE<CR>
SAC||||||^^^^^^Q<CR>
SID|^^^CVP 1^GEM CVP 1|811||IL<CR>
OBR|1||||5^CVP PANEL||||||||||^^^^^^Q<CR>
OBX|1|ST|^^^pH||7.12||7.11-7.17||||F|||20040316151015||||123|20040416152054<CR>
OBX|2|ST|^^^pCO2||80|mmHg|71^mmHg-85^mmHg||||F<CR>
OBX|3|ST|^^^pO2|||mmHg|||||X<CR>
NTE|1||QîQM Error<CR>
OBX|4|ST|^^^Na+||131|mmol/L|123^mmol/L-131^mmol/L||||F<CR>
OBX|5|ST|^^^K+||3.6|mmol/L|3.4^mmol/L-3.8^mmol/L||||F<CR>
OBX|6|ST|^^^Cl-||108|mmol/L|105^mmol/L-113^mmol/L||||F<CR>
OBX|7|ST|^^^HCO3-||22|mmol/L|20^mmol/L-26^mmol/L||||F<CR> For future use!
OBX|8|ST|^^^Ca++||1.58|mmol/L|1.52^mmol/L-1.66^mmol/L||||F<CR>
OBX|9|ST|^^^Glu||322|mg/dL|312^mg/dL-380^mg/dL||||F<CR>
OBX|10|ST|^^^Lac||7.0|mmol/L|6.5^mmol/L-8.3^mmol/L||||F<CR>
Page 109 of 239

OBX|11|ST|^^^BUN||11.0|mg/dL|10.6^mg/dL-13.16^mg/dL||||F<CR> For future use!
OBX|12|ST|^^^Creat||1.0|mg/dL|0^mg/dL-100^mg/dL||||F<CR> For future use!
OBX|13|ST|^^^tHb||17.0|g/dL|16.7^g/dL-18.5^g/dL||||F<CR>
OBX|14|ST|^^Ô2Hb||87.0|%|85.6^%-88.4^%||||F<CR>
OBX|15|ST|^^^COHb||3.0|%|2.5^%-4.5^%||||F<CR>
OBX|16|ST|^^^MetHb||3.7|%|3.0^%-5.0^%||||F<CR>
OBX|17|ST|^^^HHb||5.0|%|4.8^%-6.8^%||||F<CR>
OBX|18|ST|^^^tBili||19.5|mg/dL|14.4^mg/dL-21.6^mg/dL||||F<CR>
MSH|^~\&|||||20040316152056||ACK|4718|||||NE|NE<CR>
MSA|CA|1247<CR>
6.5 Upload iQM CAR Reports to HIS/LIS/CIS

6.5.1 When Corrective Action Report (CAR) Data Are Transmitted
The CAR data are transmitted to the interface once a day at the time configured for the C calibration to
run. For the CAR to be transmitted, one of the analyzer’s interface ports must be configured for sending
of the iQM data. Each daily transmission of the CAR information contains all the current month-to-date
CAR events.
The same CAR data can be transmitted on demand by selecting “Transmit iQM Data” on the
Management screen.
The receiving computer generates the iQM CAR Monthly Report from the transmitted CAR information.
The format of that report is specified in software specification volume 4a (Data Management).
6.5.2 CAR Message Flow

The message flow is described in the following figure
Upload CAR to HIS/LIS/CIS.
6.5.3 Message 1: LSUÛ12 (uploading)

Page 110 of 239

TABLE 1: ORI. HL7. UPLOAD IQM CAR TO HIS/LIS/CIS. MESSAGE 1
Message Comments
MSH See §7.5.3.1 Message Header Segment - MSH

EQU See §7.5.3.2: Equipment Instance Identifier – EQU
{ EQP } See §7.5.3.3: Equipment Log/Service Segment – EQP
Page 111 of 239

TABLE 1: ORI. HL7 . UPLOAD CAR TO HIS/LIS/CIS. MESSAGE 1. MSH

2 Analyzer Name
3 Analyzer Model
5 Cartridge Serial Number of last installed

cartridge in report time window or the
cartridge directly linked to the last corrective
action in the report time window.

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R LSUÛ12
18 Character set ID 180 X
19 Principal language of message Language 250 R nn, , being the ISO 639.2 language code for
which the iQM report is transmitted.
“en” English
“fr” French
Page 112 of 239
message 2).
MSH-16 is set to “NE” (never), so the message does not require acknowledge at application level.
6.5.3.2 Equipment Instance Identifier - EQU

TABLE 1: ORI. HL7. UPLOAD CAR OR DELTA CHART TO HIS/LIS/CIS. MESSAGE 1. EQU
1 Equipment Instance 1 22 R Analyzer Serial Number
Identifier 2 R
“IL”
3 X
4 R “L” (local namespace)
2 Event Date/Time 26 R YYYYMM, year and month of the CAR or delta

chart
3 Equipment State 250 X
4 Local/Remote Control State 250 X
5 Alert Level 250 X
6.5.3.3 Equipment Log/Service Segment - EQP
Each event of the Corrective Action Report shall be reported in an EQP record.
Page 113 of 239

TABLE 1: ORI. HL7. UPLOAD CAR TO HIS/LIS/CIS. MESSAGE 1. EQP
1 Event type 250 R “LOG”
2 File Name X
3 Start Date/Time 14 R YYYYMMDDHHMMSS
date time of the event

4 End Date/Time X
5 Transaction Data 1 64k R “iQM-MCA”
2 R Cartridge Lot Number
3 R Detected Event Description (in the language

of the analyzer)
4 R Corrective Action Description (in the

language of the analyzer)
5 R Corrective Action Result (in the language of

the analyzer)


MSH|^~\&|IL^GEM Premier 4000^1.0|ICU^G4K^GEM Premier 4000^123^^

A.1.0.0.0.10.0.1.B4|||20040416152054||LSUÛ12|91245|P|2.4|||AL|NE<CR>
EQU|123ÎL^^L|200404<CR>
EQP|LOG||20040406130746||iQM-MCA^213966^Persistent pH Sensor Error^Sensor Output

Adjusted^pH Disabled<CR>
EQP|LOG||20040406230504||iQM-MCA^213966Înterference Detected After Sample# 38. Operator

John Smith^ Operator Notified. Sensor Output Adjusted.^Cleared<CR>
MSH|^~\&|||||20040316152056||ACK|4798|||||NE|NE<CR>
MSA|CA|91245<CR>
Page 114 of 239

6.6 Upload iQM Delta Chart Data to HIS/LIS/CIS
6.6.1 When iQM Delta Chart Data Are Transmitted
The iQM delta chart data are transmitted to the interface once a day at the time configured for the C
calibration to run. For the delta chart data to be transmitted one of the analyzer’s interface ports must
be configured for sending of the iQM data. Each daily transmission of the delta chart data contains all
the current month daily data through the previous day, for all the relevant analyte/process control
solution combinations. If the transmission is occurring on the first day of the month, it will contain all
the previous month daily data.
The same delta chart data can be transmitted on demand by selecting “Transmit iQM Data” on the
Management screen.
The receiving computer generates the iQM Monthly Delta Chart Report from the transmitted
information. The format of that report is specified in software specification volume 4a (Data
Management).
6.6.2 Delta Chart Data Message Flow

Upload DC to HIS/LIS/CIS.

TABLE 1: ORI. HL7. UPLOAD IQM DELTA CHART DATA TO HIS/LIS/CIS. MESSAGE 1
Message Comments

Page 115 of 239

This section is identical to §7.5.3.1 (Upload CAR, ORI HL7), except that the field MSH-19 (language code)
will be empty.

This section is identical to §7.5.3.2 (Upload iQM-CAR, ORI HL7).

This segment shall contain the contents of a delta chart file. There will be a segment for each delta chart
sent (i.e. each parameter/process control combination),
TABLE 1: ORI. HL7. UPLOAD IQM DELTA CHART DATA TO HIS/LIS/CIS. MESSAGE 1. EQP
3 File Name X
3 Start Date/Time 14 R YYYYMM
Year and month of the chart

4 End Date/Time X
5 Transaction Data 1 64k R “iQM-MDC”
2 R Parameter Name
3 R PC Solution “A|B|C|D”
4.1-4.48 R Each subcomponent of the field contains one

of the lines described in The
iQM delta
chart files contents are given in
the following table.
Table 49.

6.6.5 Delta Chart Transmission examples

MSH|^~\&|IL^GEM Premier 4000^1.0|ICU^G4K^GEM Premier 4000^123^^

A.1.0.0.0.10.0.1.B4|||20040416152054||LSUÛ12|81245|P|2.4|||AL|NE<CR>
EQU|123ÎL^^L|200401<CR>
EQP|LOG||200401||iQM-MDC^Hct^B^Header:&Device,An11,99936&Month,Jan,2004&Cartridge
insertion days,05, 22&Cartridge lot,213266,213167&Target
Page 116 of 239

value,11,12&Parameter,Hct,%&Material,B&Mean,0&Low,-2.0&High, 2.0&Precision,1&y-
Interval,0.5&Min,-1.5&Max,1.5&x-Interval,1,31&Data:&01/01/2004,66,0.0,1.8,0.6,
61.3&01/02/2004,70,-1.2,0.9,-0.2,33.3&01/03/2004,62,-0.1,1.1,0.9,21.7&01/04/2004,70,-0.6,1.2,
0.1,11.4<CR>
EQP|LOG||200401||iQM-MDC^HctÂ^Header:&Device,An11,99936&Month,Jan,2004&Cartridge
insertion days,05, 22&Cartridge lot,213266,213167&Target
value,11,12&Parameter,Hct,%&Material,A&Mean,0&Low,-2.0&High, 2.0&Precision,1&y-
Interval,0.5&Min,-1.5&Max,1.5&x-Interval,1,31&Data:&01/01/2004,66,0.0,1.8,0.6,
61.3&01/02/2004,70,-1.2,0.9,-0.2,33.3&01/03/2004,62,-0.1,1.1,0.9,21.7&01/04/2004,70,-0.6,1.2,
0.1,11.4<CR>
MSH|^~\&|||||20040316152056||ACK|4788|||||NE|NE<CR>
MSA|CA|81245<CR>
6.7 Upload RiliBAEK Chart to HIS/LIS/CIS

6.7.1 When RiliBAEK Chart Are Transmitted
The RiliBAEK Chart is transmitted to the interface at the time after the reports data are generated. For
the RiliBAEK chart to be transmitted one of the analyzer’s interface ports must be configured for sending
of the RiliBAEK chart. Each transmission of the RiliBAEK chart shall contain all the current data being
populated for all the relevant analyte/process control solution combinations.
The RiliBAEK chart can be transmitted on demand by selecting “Transmit RiliBAEK Reports” on the
Management screen.
The receiving computer generates the monthly RiliBAEK Report from the transmitted information.
6.7.2 RiliBAEK Chart Message Flow

Upload RiliBAEK Chart to HIS/LIS/CIS.
Page 117 of 239

TABLE 50: ORI. HL7. UPLOAD RILIBAEK CHART DATA TO HIS/LIS/CIS. MESSAGE 1
Message Comments


This section is identical to §6.5.3.1 (Upload CAR, ORI HL7), except that the field MSH-19 (language code)
will be empty.

This section is identical to §6.5.3.2 (Upload iQM-CAR, ORI HL7).

This segment shall contain the contents of a RiliBAEK Chart file. There will be a segment for each
RiliBAEK Chart sent (i.e. each parameter/process control combination),
Page 118 of 239

TABLE 51: ORI. HL7. UPLOAD RILIBAEK CHART T DATA TO HIS/LIS/CIS. MESSAGE 1. EQP
2 File Name X
3 Start Date/Time 14 R YYYYMM
Year and month of the chart

4 End Date/Time X
5 Transaction Data 1 64k R “RiliBAEK”
2 R Parameter Name
3 R PC Solution “A|B|C|D”
4.1-4.15 R Each subcomponent of the field contains one

of the lines described in The
RiliBAEK
chart files contents are given in
the following table.
Table: INT_PROT-1994
Page 119 of 239

Contents of a Rilibaek data File:
Line Contents Description [INFO] Example
1 Header: Marks the start of the header section
of the file.
2 Device, name, SSSSS Defines the analyzer name. SSSSS is
the serial number.
3 Month, mmm, yyyy Defines the month of the data Month, Jul, 2002
4 Cartridge,SN,LotNumber Defines the Cartridge Serial Number Cartridge, 23,1080
5 Target value, nnn Defines the target value of the Target value, 144
analyte for the inserted cartridges
6 Parameter, pppp, uuuuuu Defines the analyte being charted Parameter, Na+, mmol/L
and display units
7 Material, X Defines the PC solution, where X is Material, B
A, B, C or D.
8 RiliBAEK Low, nnnn Defines the y-axisRiliBAEK lower RiliBAEK Low, -3.00
range value
9 RiliBAEK High, nnnn Defines the y-axis Rilibaek upper RiliBAEK High, 3.00
range value
10 iQM Low, nnnn Defines the iQM low limit iQM Low, -3.00
11 iQM High, mmm Defines the iQM high limit iQM High, 3.00
12 Mean Square Root Defines the value of mean squre root Mean Square Root, 2.0
13 Data: Defines the start of the data section
14 Data Point Number, Date, Defines the first set of data points to 1, 20020711152242, 1.70
Calibration Value plot, in the selected units
15-45 Define the remaining set of daily
points to plot for the month (note: the
plot may begin/end at any day of the
month, and some days may contain
blank data)

6.8 Upload RiliBAEK Report to HIS/LIS/CIS

6.8.1 When RiliBAEK Report Data Are Transmitted
The RiliBAEK Report data are transmitted to the interface when the data are collected. For the RiliBAEK
Report to be transmitted, one of the analyzer’s interface ports must be configured for sending of the
RiliBAEK Reports data. The data shall only contain the set in the current event.
The RiliBAEK Report data can be transmitted on demand by selecting “Transmit RiliBAEKReports” on the
Management screen.
The receiving computer generates the RiliBAEK Report Monthly Report from the transmitted RiliBAEK
Report information. The format of that report is specified in software specification volume 4a (Data
Management).
Page 120 of 239

6.8.2 RiliBAEK Report Message Flow
Upload RiliBAEK Report to HIS/LIS/CIS.

TABLE 1: ORI. HL7. UPLOAD RILIBAEK REPORT TO HIS/LIS/CIS. MESSAGE 1

Message Comments
MSH See §6.8.3.1 Message Header Segment - MSH

Page 121 of 239

Page 122 of 239

TABLE 1: ORI. HL7 . UPLOAD RILIBAEK REPORT TO HIS/LIS/CIS. MESSAGE 1. MSH

2 Analyzer Name
3 Analyzer Model
5 Cartridge Serial Number of last installed

action in the report time window.

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R LSUÛ12
18 Character set ID 180 X
19 Principal language of message Language 250 R nn, , being the ISO 639.2 language code for
which the iQM report is transmitted.
“en” English
Page 123 of 239
“fr” French
message 2).
MSH-16 is set to “NE” (never), so the message does not require acknowledge at application level.

TABLE 1: ORI. HL7. UPLOAD RILIBAEK REPORT TO HIS/LIS/CIS. MESSAGE 1. EQU
1 Equipment Instance 1 22 R Analyzer Serial Number
Identifier 2 R
“IL”
3 X
4 R “L” (local namespace)
2 Event Date/Time 26 R YYYYMM, year and month of the report
3 Equipment State 250 X
4 Local/Remote Control State 250 X
5 Alert Level 250 X
6.8.3.3 Equipment Log/Service Segment - EQP (RiliBAEK Report)

This segment shall contain the contents of a RiliBAEK Report file. There will be a segment for each
RiliBAEK Report sent.
Page 124 of 239

TABLE 1: ORI. HL7. UPLOAD RILIBAEK REPORT TO HIS/LIS/CIS. MESSAGE 1. EQP
2 File Name X
3 Start Date/Time 14 R YYYYMMDDHHMMSS
date time of the event

4 End Date/Time X
5 Transaction Data 1 64k R “RILIBAEK-MCA”
2 R Cartridge SN

of the analyzer)

6.9 Fetch Demographics from HIS/LIS/CIS (query by Patient ID)

This trigger event is served by QRY (a query from another system) and ADR (a response from an Patient
Administration system.) [HL7 v2.4 §3.3.19]
Fetch Demographics from HIS/LIS/CIS.
6.9.1 Message 1: QRYÂ19 (uploading)

Page 125 of 239

TABLE 13: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS. MESSAGE 1
Message Comments

QRD See §7.8.1.2: Query Definition Segment – QRD
[QRF] See §7.7.1.3: Query Filter Segment - QRD
Page 126 of 239

TABLE 14: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS . MESSAGE 1. MSH

2 RE Analyzer Name
3 RE Analyzer Model
4 RE Analyzer Serial Number
5 O Cartridge Serial Number
6 RE Analyzer SW Version Number

(HL7/ASTM format).
8 Security 40 X
9 Message Type ORU^R30, ORU^R31, ORU^R32, 7 R QRYÂ19

ACK^R33.
15 Accept Acknowledgement Type All source messages should specify “AL” 2 X
16 Application Acknowledgement Type All ORU messages will specify “AL” 2 X
Page 127 of 239

6.9.1.2 Query Definition Segment - QRD
TABLE 15: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS. MESSAGE 1. QRD
1 Query Date/Time Contains the date the query was generated by 26 R YYYYMMDDHHMMSS
the application program.
2 Query Format Code D/R/T 1 R “R”- Response is in record-oriented format
3 Query Priority Contains the time frame in which the response 1 R “I”- Immediate
is expected
4 Query ID Contains a unique identifier for the query. 10 R 0 - 4294967295 (32 bits UID)
Assigned by the querying application.
Returned intact by the responding application
5 Deferred Response Type 1 X
6 Deferred Response Date/Time 26 X
7 Quantity Limited Request Contains the maximum length of the response 10 R “1^RD” (one record)
that can be accepted by the requesting system.
Valid responses are numerical values (in the
first component) given in the units specified in
the second component
8 Who Subject Filter Identifies the subject, or who the inquiry is 24 R Patient ID
about.
9 What Subject Filter Describes the kind of information that is 250 R “DEM”
required to satisfy the request. Valid values
define the type of transaction inquiry and may
be extended locally during implementation.
10 What Department Data Code This field should not have been a required field. 250 R Not Used.
However, for backwards compatibility it
remains a required field. There are some queries
in the standard that have not required this field.
11 What Data Code Value Qual. 20 X
12 Query Results Level 1 X
6.9.1.3 Query Filter Segment - QRF

Please, note that the QRF Segment is only sent when the demographics query criteria is different than
by Patient ID.
Page 128 of 239

TABLE 16: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS . MESSAGE 1. QRF
1 Where Subject Filter Identifies the department, system, or 20 R “GEM4000”

subsystem to which the query pertains.
.
2 When Data Start Date/Time 26 X
3 When Data End Date/Time 26 X
4 What User Qualifier 60 X
5 Other Subject Filter Contains a filter defined locally for use between 60 R Possible values are:
two systems. It uses codes that have specific
meaning only to the applications involved.  “ACCOUNT_NUMBER”. Used when
the query demographics is
done by the Account Number
field.
 “ORDER_NUMBER”. Used when
done by the Order Number
field.
 “SAMPLE_NUMBER”. Used when
done by the Sample Number
field.
 “CUSTOM^<fieldname>”. Used
when the query demographics
is done by a custom defined
field. <fieldname> is the
name of the custom defined
field.
6 Which Date/time Qualifier 12 X
7 Which Date/Tiime Status Qualifier 12 X
8 Date/Time Selection Qualifier 12 X
9 When Quantity/Timing Qualifier 60 X
10 Search Confidence Threshold 10 X
6.9.2 Message 2: ADRÂ19 (downloading)

If patient is found, shall have the structure defined in the following table.
Page 129 of 239

TABLE 17: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 2. PATIENT FOUND
Message Comments
MSH
MSA Message contains an application acknowledge “AA”
QRD Copy of the query sent in the uploading message
[QRF] Copy of the query filter sent in the uploading message
PID Record containing the requested patient demographics
PV1 Dummy record, needed to HL7 compliant
If patient is not found, shall have the structure defined in the following table.
TABLE 1: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. MESSAGE 2. PATIENT NOT FOUND
Message Comments
MSH
MSA Message contains an application error “AE”
Page 130 of 239

TABLE 18: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 2. MSH

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R “ADRÂ19”
15 Accept Acknowledgement Type All source messages should specify “AL” 2 X
16 Application Acknowledgement Type All ORU messages will specify “AL” 2 X
Page 131 of 239

TABLE 19: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 2. MSA. PATIENT FOUND
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “AA”
3 Text Message 80 O Empty
6 Error Condition Coded Error 100 O Empty
TABLE 60: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 2. MSA. PATIENT NOT FOUND
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “AE”
3 Text Message 80 O Any text, ignored by the GEM 4000
6 Error Condition Coded Error 100 O Any text, ignored by the GEM 4000
Page 132 of 239

6.9.2.3 Query Definition Segment - QRD
TABLE 61: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 2. QRD
1 Query Date/Time Contains the date the query was generated by 26 R YYYYMMDDHHMMSS
the application program.
2 Query Format Code D/R/T 1 R “R”- Response is in record-oriented format
3 Query Priority Contains the time frame in which the response 1 R “I”- Immediate
is expected
4 Query ID Contains a unique identifier for the query. 10 R 0 - 4294967295 (32 bits UID)
Assigned by the querying application.
Returned intact by the responding application
5 Deferred Response Type 1 X
6 Deferred Response Date/Time 26 X
7 Quantity Limited Request Contains the maximum length of the response 10 R “1^RD” (one record)
that can be accepted by the requesting system.
Valid responses are numerical values (in the
first component) given in the units specified in
the second component
8 Who Subject Filter Identifies the subject, or who the inquiry is 24 R Patient ID
about. Must match the ID sent on the query
request
9 What Subject Filter Describes the kind of information that is 250 R “DEM”
required to satisfy the request. Valid values
define the type of transaction inquiry and may
be extended locally during implementation.
10 What Department Data Code This field should not have been a required field. 250 R Not Used
However, for backwards compatibility it
remains a required field. There are some queries
in the standard that have not required this field.
11 What Data Code Value Qual. 20 X
12 Query Results Level 1 X
6.9.2.4 Query Filter Segment - QRF

Please, note that the QRF Segment is only sent when the demographics query criteria is different than
by Patient ID.
Page 133 of 239

TABLE 62: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS . MESSAGE 1. QRF
1 Where Subject Filter Identifies the department, system, or 20 R “GEM4000”

subsystem to which the query pertains.
.
2 When Data Start Date/Time 26 X
3 When Data End Date/Time 26 X
4 What User Qualifier 60 X
5 Other Subject Filter Contains a filter defined locally for use between 60 R Possible values are:
two systems. It uses codes that have specific
meaning only to the applications involved.  “ACCOUNT_NUMBER”. Used when
done by the Account Number
field.
 “ORDER_NUMBER”. Used when
done by the Order Number
field.
 “SAMPLE_NUMBER”. Used when
done by the Sample Number
field.
 “CUSTOM^<fieldname>”. Used
when the query demographics
is done by a custom defined
field. <fieldname> is the
name of the custom defined
field.
6 Which Date/time Qualifier 12 X
7 Which Date/Tiime Status Qualifier 12 X
8 Date/Time Selection Qualifier 12 X
9 When Quantity/Timing Qualifier 60 X
10 Search Confidence Threshold 10 X
Page 134 of 239

Page 135 of 239

TABLE 13: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 1. PID

Sequence Number.
2 Patient ID 20 X
3 Patient Identifier List Use Case #1, #2 24 R Patient ID

Patient ID required.
5 Patient Name Extension to the standard 1 24 O Patient Last Name
7 Date/Time of Birth Extension to the standard 14 O Patient Birth Date

(YYYYMMDDHHMMSS)
8 Administrative Sex Extension to the standard 1 RE “M”/”F”/”U” or Null
10 Race 1 X
17 Religion 3 X
18 Patient Account Number Account number, if available. 24 O Null
25 Birth Order 2 X

Page 136 of 239
6.9.2.6 Patient Visit Segment - PV1
TABLE 14: ORI. HL7. QUERY PATIENT DEMOGRAPHICS TO HIS/LIS/CIS (QUERY BY PATIENT ID). MESSAGE 1. PID
2 Patient Class This field is used by systems to categorize 1 R “U” - Unknown

patients by site. It does not have a consistent
industry-wide definition. It is subject to
site-specific variations. It is required
6.9.3.1 Patient exists by Patient ID


A.1.0.0.0.10.0.1.B4|||20040416152054||QRYÂ19|31245|P|2.4 <CR>
QRD|20040416152054|R|I|6123|||1^RD|PatID9|DEM<CR>
MSH|^~\&|||||20040316152056||ADRÂ19|4788|P|2.4<CR>
MSA|AA|4788<CR>
PV1|1|U<CR>
6.9.3.2 Patient does not exists by Patient ID


A.1.0.0.0.10.0.1.B4|||20040416152054||QRYÂ19|31245|P|2.4 <CR>
MSH|^~\&|||||20040316152056||ACK|4788|||||NE|NE<CR>
MSA|AE|4788<CR>
Page 137 of 239

6.9.3.3 Patient exists by Sample Number

A.1.0.0.0.10.0.1.B4|||20040416152054||QRYÂ19|31245|P|2.4 <CR>
QRD|20040416152054|R|I|6123|||1^RD|SAMNUM9|DEM<CR>
QRF|GEM4000||||SAMPLE_NUMBER<CR>
MSH|^~\&|||||20040316152056||ADRÂ19|4788|P|2.4<CR>
MSA|AA|4788<CR>
PV1|1|U<CR>
6.9.3.4 Patient does not exist by Sample Number


A.1.0.0.0.10.0.1.B4|||20040416152054||QRYÂ19|31245|P|2.4 <CR>
QRD|20040416152054|R|I|6123|||1^RD|SAMNUM9|DEM<CR>
MSH|^~\&|||||20040316152056||ACK|4788|||||NE|NE<CR>
MSA|AE|4788<CR>
6.10 Download test orders from HIS/LIS/CIS

Download Test Orders from HIS/LIS/CIS.
6.10.1 Message 1: OMLÔ21 (Downloading)

This message shall be a downloading message. The message shall have the structure defined in the
following table.
Page 138 of 239

TABLE 15: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1
Message Comments

PID See $7.9.1.2: Patient Identification Segment – PID
{
PV1 See 7.9.1.3: Patient Visit Segment – PV1
ORC See § 7.9.1.4: Common Order Segment - ORC
OBR See §7.9.1.5: Observation Request Segment – OBR
SAC See $Error! Reference source not found.: Error! Reference source not found.
}
Page 139 of 239

TABLE 16: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. MSH

(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R “OMLÔ21”
10 Message Control ID Unique identifier for the message 20 R Any 20 characters string
16 Application Acknowledgement Type All cancel order messages will specify “AL” 2 R “NE”/“AL”
Page 140 of 239

Page 141 of 239

TABLE 17: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. PID

Sequence Number.
2 Patient ID 20 X
3 Patient Identifier List 24 R Patient ID
5 Patient Name 1 24 O Patient Last Name
7 Date/Time of Birth 14 O Patient Birth Date

(YYYYMMDDHHMMSS)
8 Administrative Sex 1 R “M”/”F”/”U”
10 Race 1 X
17 Religion 3 X
18 Patient Account Number 24 O Account Number
25 Birth Order 2 X
Page 142 of 239

6.10.1.3 Patient Visit Segment - PV1
TABLE 18: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. PV1
2 Patient Class This field is used by systems to categorize 1 R “U” - Unknown

patients by site. It does not have a consistent
industry-wide definition. It is subject to
site-specific variations. It is required
3 Assigned Patient Location This field contains the patient’s initial assigned 2 24 O Area
location or the location to which the patient is
being moved.
6 O Room Number
Page 143 of 239

6.10.1.4 Common Order Segment - ORC
TABLE 19: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. ORC
1 Order Control 2 R “NW”: New Order
“CA”: Cancel Order

2 Placer Order Number. Order Number 24 R Order Number: Preordered observation.
3 Filler Order Number External identifier for these results in the 24 O Sample Number
Observation Reviewer.
4 Placer Group Number 22 X
5 Order Status 2 X
6 Response Flag 1 X
7 Quantity/Timing 200 X
8 Parent 200 X
9 Date/Time of Transaction 26 X
10 Entered By 120 X
11 Verified By 120 X
13 Enterer's Location 80 X
14 Call Back Phone Number 40 X
15 Order Effective Date/Time 14 O Fill By Date Time in YYYYMMDDHHMM
16 Order Control Code Reason 200 X
17 Entering Organization 60 X
18 Entering Device 60 X
Page 144 of 239

Page 145 of 239

TABLE 70: ORI. HL7. DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. OBR

Sequence Number
2 Placer Order Number See ORC-2 24 R Order Number: Preordered observation.
3 Filler Order Number See ORC-3 24 O Sample Number
4 Universal Service ID 200 O See note below.
5 Priority 2 X
9 Collection Volume Extension to the standard. A null value is 1 20 X

assumed as a normal sample.
2 X
10 Collector Identifier 60 O Sample Container. See Table 155.
11 Specimen Action Code “O” (Specimen obtained by service other than 1 R “O”
Lab)
12 Danger Code 60 X
15 Specimen Source. e.g., The specimen source name 1 300 R Patient Sample types are described in Table
BLDA^^^LLFA^^^P (Patient test from 154.
arterial blood taken from left lower
forearm). Optional in the spec Free text additives to the specimen such as 2 X
Free text component describing the method of 3 R “N” (Normal size)
collection “M” (Micro Sample)
“T” (tBili/COOX)
obtained.
temperature.
Sample Role. 7 R “P”
16 Ordering Provider e.g., 1 64 O Ordering Clinician ID

Smith^John^J^Dr
Page 146 of 239

OBR-4: This field is used to specify which results are requested by the HIS/LIS/CIS. The field shall contain
the analytes to report separated by the repeat delimiter (~):
Analytes shall be any of the measured analytes, as described in §A1, case insensitive.
If null or empty, the G4K shall report all the analytes.
If some analytes are unknown, the G4K shall ignore the unknown ones and report the known ones.
The GEM 4000 shall always report the derived analytes that can be calculated from the requested
ones.
The GEM 4000 shall always report the entered and O2 and Vent Settings.
OBR-15.3 takes precedence over OBR-9 in case of discrepancies.
Examples:
Null or “”: Report all analytes.
ph~pco2~Plutonium~BUN: Measured pH. PCO2 and BUN shall be reported as well as PCO2(TC) and
any other derived analyte deducible from those.
Page 147 of 239

TABLE 71: ORI. HL7 . DOWNLOAD TEST ORDERS FROM HIS/LIS/CIS. MESSAGE 1. SAC
1 External Accession Identifier 24 O Sample Id.

collection
obtained.
temperature.
Sample Role. 7 X
6.10.2 Message 2: ACK (uploading)

This section shall be identical to §7.2.4.

Message1 (HIS/LIS/CIS):
MSH|^~\&|||||20040607152056||OMLÔ21|124978|||||AL|NE<CR>
ORC|NW|99999|123<CR>
OBR|1|99999|123|||||150^ml||O||||BLDA^^N^^^^P|Freeman^Dyson^J<CR>
SAC|10<CR>
Message2 (GEM4000):
MSH|^~\&|||||20040607152058||ACK|1268|||||NE|NE<CR>
MSA|CA|124978<CR>
Page 148 of 239

Message1 (HIS/LIS/CIS):
MSH|^~\&|||||20040607152056||OMLÔ21|1249|||||AL|NE<CR>
ORC|NW|99999|123<CR>
OBR|1|99999|123|na+~K+~Ca++~Glu~Lac||||||O||||BLDA^^N^^^^P|Freeman^Dyson^J<CR>
SAC|10<CR>
Message2 (GEM4000):
MSH|^~\&|||||20040607152058||ACK|1270|||||NE|NE<CR>
MSA|CA|1249<CR>
6.11 Cancel Previous test order from HIS/LIS/CIS

The function of this message is to allow the HIS/LIS/CIS to cancel a previous test order. The message
flow is described below
Cancel a Test Order from HIS/LIS/CIS
GEM 4000 HIS/LIS
1:OMLÔ21
2:ACK(MSA, CA/CE if error)
If error, end of exchange, else GEM4000

processes the message
Success processing the cancel request
3:ORLÔ22(MSA: AA, comment if any)
4:ACK(MSA; CA/CE if error)
Error processing the cancel request
3E:ORLÔ22(MSA: AE, comment if any)
4E:ACK(MSA; CA/CE if error)
6.11.1 Message 1: OMLÔ21 (Downloading)

This message is the same as the one described in section 7.9.1.
Page 149 of 239

6.11.2 Message 2: ACK (Uploading)
6.11.3 Message 3/3E: ACK (Uploading)

This message shall be an uploading message and shall have the structure defined in the following table.
TABLE 12: ORI. HL7. CANCEL PREVIOUS TEST ORDER FROM HIS/LIS/CIS. MESSAGE 3/3E.
Message Comments
Page 150 of 239

TABLE 13: ORI. HL7. CANCEL PREVIOUS TEST ORDER FROM HIS/LIS/CIS. MESSAGE 3/3E. MSH

"1.0" (Data Format version)
2 Analyzer Name
3 Analyzer Model

(HL7/ASTM format).
8 Security 40 X
9 Message Type ORLÔ22 7 R “ORLÔ22”
16 Application Acknowledgement Type All ORL messages will specify “NE” 2 R “NE”
Page 151 of 239

TABLE 14: ORI. HL7. CANCEL PREVIOUS TEST ORDER FROM HIS/LIS/CIS. MESSAGE 3/3E. MSA
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R “AA” / “AE” / “AR”. Currently only “AA” is
used.
3 Text Message Note (2) 80 O Null
6.11.4 Message 4/4E: ACK (Downloading)

6.12 Connection Test

CONNECTION TEST TO HIS/LIS/CIS.
GEM 4000 HIS/LIS
1:TEST
2:ACK (MSA:’CR’, error if any)
6.12.1 Message 1: TEST (uploading)

Shall have the structure
TABLE 15: ORI. HL7. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. PREVIOUSLY ORDERED. MESSAGE 1
Message Comments
MSH See §7.11.1.1: Message Header Segment – MSH.
Page 152 of 239

TABLE 16: ORI. HL7. CONNECTION TEST. MESSAGE 1. MSH

4 Sending Facility 180 RE Null

(HL7/ASTM format).
8 Security 40 X
9 Message Type TEST 7 R TEST: See note below
Notes:
MSH-9: Possible values shall be:
TEST: This is not a standard HL7 message type. This should generate an ACK response with an
unsupported event trigger error message from the HIS/LIS system, which is sufficient to state the
connection with the HIS/LIS system is established.
Page 153 of 239

message 2).
MSH-16 is set to “NE” (always), so the message does not require acknowledge at application level.

TABLE 17: ORI. HL7. CONNECTION TEST. MESSAGE 2

Message Comments

Page 154 of 239


(HL7/ASTM format).
8 Security 40 X
9 Message Type 7 R “ACK”
Page 155 of 239

TABLE 19: ORI. HL7. CONNECTION TEST. MESSAGE 2. MSA
1 Acknowledgement Code “CA,” “CE,” ”CR,” ”AA,” ”AE,” ”AR” 2 R Any code sent by LIS system is accepted.
3 Text Message 80 O Text description.

Empty if “CA”
7 LIS2-A Messages (GEM 4000 Native Mode)
7.1 Overview
The LIS-2A mode uses the NCCLS LIS2-A protocol. Considerations stated in §6.2 shall apply.
Comments shall be used for many purposes. Table summarizes the usage of comments.
TABLE 80: LIS-2A NATIVE MODE. USAGE OF COMMENTS

Purpose of the Description
comment
Sending analyte error Source “I” (clinical instrument)
information, as a Text Instrument Error Code + “^”+ Error Text
comment to a result Type “I” (Instrument flag(s) comments)
record. Example C|1|I|T^Microclot Detected|I
Sending Demographic Source “P” (practice)
fields, as a comment to a Text “FIELD” + “^”+ Field Name + “^”+ Field Value + “^”+ Field Units
Patient Information Type “G” (generic/free text comment)
Record or a Test Order Example C|1|P|FIELD^SSNumber^12-34-567|G
Record
Sending Operator Source “P” (practice)
Comments, as a Text “COMMENT” + “^”+ Comment Text + “^”+ Date Time+ “^”+ OperatorId
comment to a Test Type “G” (generic/free text comment)
Order Record Example C|1|P|COMMENT^Hello World^20031222131512^pdirac|G
Indicating that sample Source “P” (practice)
has been edited: Text “EDIT” + “^”+ Field Name + “^”+Old Value + “^”+New Value+ “^”+Units+
Which field, old and “^”Date Time+ “^”+ Operator Id
new value, who did it Type “G” (generic/free text comment)
and when C|1|P|EDIT^Temp^37.4^38.2^ºC^20041231185555^pdirac|G
Example
Indicating that the Source “P” (practice)
sample has been notified Text “NOTIFY” + “^”+ Time Value + “^”+Notified by Id Value+ “^”+ Notified to Id Value+ “^”+ Read Back and Verified
to a clinician. Value + “^”+Note Text Value
Type “G” (generic/free text comment)
Example C|1|P| NOTIFY ^ 11000^ John^Helen^Yes^ No results outside range|G
Page 156 of 239

Fields without value shall not be sent.

This conversation is initiated by the G4K and allows the G4K to send the results of one sample for an
individual patient to the HIS/LIS/CIS.
7.2.1 Uploading message

The uploading message shall have the structure defined in the following table.
TABLE 81: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
H 1 Master Header Record
P 1 Patient Information Record
[{C}] 0 or more Comments associated to the patient
{O} 1 Test Order Record. In Phase 2: 1 or 2 Test Order Records (2 only when
AV-Pair)
[{C}] 0 or more Comments associated to the order
{R} 1 or more results
[C] 0 or 1 Comments associated to the result
L 1 Message Termination Record
Page 157 of 239

7.2.1.1 Message Header Record (H)
TABLE 12: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MHR
1 Record Type ID Identifies the record 1 R "H"
2 Delimiter Definition Define the delimiters to be used throughout the

subsequent records of the message 4 R "|@^\"
5 Sender Name or ID Defines the manufacturer/instrument specific to this 1 8 R "GEM Premier 4000"
line. May use the repeat or component delimiter to
reflect software revisions or firmware revisions, 2 - R "1.0" (Data Format version)
multiple instruments available on this line, etc.
3 10 R Area Name
4 10 R Analyzer Name
5 16 R Analyzer Model
6 10 R Analyzer Serial Number
7 24 R Cartridge Serial Number
8 20 R Analyzer SW Version Number
12 Processing ID Indicates how this message is to be processed 1 R "P" (Production)
13 Version No. Version level of the specification. 6 R "LIS2-A"
14 Date and Time of Message The date and time that the message was generated. 14 R ASTM date format
Items that appear in field 5 (sender name or ID) shall refer to those of the analyzer that ran the sample
at analysis date time (i.e, cartridge serial number at that time, not current inserted cartridge).
Page 158 of 239

7.2.1.2 Patient Information Record (P)
TABLE 13: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. PIR
1 Record Type ID Identifies the record 1 R "P"
2 Sequence Number Defines the i’th occurrence of the associated record 1 R "1"
3 Practice Assigned PatientID Patient ID used by the analzyer. In case that Patient
ID is not required, this is the only way that the Host
can refer to this sample. 36 O Patient PK
4 Laboratory Assigned Patient "True" patient ID

ID 24 O Patient ID
5 Patient ID No. 3 Alternate patient identifier. U O Patient Account Number
6 Patient Name The patient’s name 1 24 O Patient Last Name
8 Birthdate
8 O Patient DOB in ASTM format
9 Patient Genger 1 O Patient Gender ("M", "F", "U" or “”)
15 Special Field 1 U
26 Location Room/Bed of patient U
7.2.1.3 Comment Record associated to a Patient Information Record (C)

The comment records shall be used for
Sending the following fields (Table 75):
Patient Demographics User defined fields. The user shall be able to define additional
patient demographic fields (see Volume 4b). Defined fields shall be sent.
Patient Age.
The Units component shall only be used in conjunction with the Patient Age field. Units for age are
described in §A.5.
Page 159 of 239

TABLE 14: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR ASSOCIATED TO A PIR
2 Sequence Number Defines the i’th occurrence of the associated record - R [1,+inf[
3 Comment Source Comment Origination Point 1 R "P" (practice)
4 Comment Text Comment codes and text 1 5 R "FIELD" (Comment type is field)
2 24 R Field Name
3 24 R Value
4 12 O Units
5 Comment Type Comment type qualifier 1 R "G" (generic/free text comment)
Page 160 of 239

7.2.1.4 Test Order Record (O)
TABLE 15: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
1 Record Type ID Identifies the record as TOR 1 R "O"
2 Sequence Number Defines the i’th occurrence of the associated record 1 R “1”. In Phase 2: A-V Pair. Arterial: "1".
Venous: "2". Non A-V Pairs: "1"
3 Specimen ID A unique id. for the specimen assigned by the HOST 24 O Order Number
4 Instrument Specimen ID A unique ID for the specimen assigned by G4K 24 O Sample Number
7 Requested/Ordered Date Date and time the order was received or recorded Ordered Date Time (phase 2)
and Time U
8 Specimen Collection Date Date and time the specimen was collected or 1 8 O Drawn Date in ASTM format
and Time obtained
2 6 O Drawn Time in ASTM format
15 Date/Time Specimen Date and time the specimen was approved/saved

Received U
16 Specimen Descriptor Sample type 5 R Sample Type, Size and Container. See below
17 Ordering Physician Name of the ordering physician 1 24 64 O Ordering Clinician ID
23 Date/Time Results Reported Date and time of the results 14 R Sent Date Time in ASTM format
or Last Modified
26 Report Type 1 R "F" (Final results) / "C" (correction of

previously transmitted)
28 Location U
Field 16 shall contain:
Patient Sample type and size. Possible values are listed in Section 10.3 (INT_PROT-1900)
A dash (“-”).
Container used to collect the sample. Possible values are listed in Section 10.4 (INT_PROT-1906)
Examples:
“A-SY”: Sample Type: Arterial. Size: Normal. Container: Syringe.
“CM-VC”: Sample Type: Capillary. Size: Micro. Container: Vacutainer.
“AT-SY”: Sample Type: Arterial. Size: 100 uL. Container: Syringe.
Page 161 of 239

7.2.1.5 Comment Record associated to a Test Order Record (C)
The comment records shall be used for three purposes:
Sending those sample demographics fields that are not sent in the TOR. Those are the user-defined
fields. Format is described in Table 77. Field Name is the name assigned in configuration.
Sending Operator comments to the sample. Format is described in Table 78.
Indicating which patient demographics and sample demographics fields have been edited after the
sample has been accepted. Format is described in Table 79.
Sending the notification of the sample. Format is described in Table 80.
TABLE 16: LIS2-A. NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CMR ASSOCIATED TO A TOR. DEMOGRAPHIC FIELDS
4 Comment Text Comment codes and text 1 5 R "FIELD" (Comment type is field)
2 24 R Field Name
3 24 R Value
4 12 O Units
Page 162 of 239

TABLE 17: LIS2-A. NATIVE MODE. UPLOAD PATIENT OR CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CMR ASSOCIATED TO A TOR. OPERATOR COMMENTS
2 Sequence Number Defines the i’th occurrence of the associated record 1 R [1,42]
3 Comment Source Comment Origination Point 1 R “P” (practice)
4 Comment Text Comment codes and text 1 7 R "COMMENT" (Comment type is comment)
2 255 R Comment Text
3 14 R Date time in ASTM format
4 24 O Operator ID
6 24 O Operator First Name (note: for future use)
Page 163 of 239

TABLE 18: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CMR ASSOCIATED TO A TOR. EDITED FIELDS
4 Comment Text Comment codes and text 1 4 R "EDIT" (Comment type is field)
2 24 R Field Name or Analyte Name
3 24 O Old Value
4 24 O New Value
5 12 O Units
6 14 R Date time in ASTM format
7 24 O Operator ID
9 24 O Operator First Name (note: for future use)
Page 164 of 239

TABLE 19 : LIS2-A. NATIVE MODE. UPLOAD PATIENT OR CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CMR ASSOCIATED TO A TOR. NOTIFY INFORMATION
2 Sequence Number Defines the i’th occurrence of the associated record 1 R [1,42]
3 Comment Source Comment Origination Point 1 R “P” (practice)
4 Comment Text Comment codes and text 1 6 R "NOTIFY" (Comment type is notify)
2 4 R Time the sample was notified HHMM
3 24 O Notified By Id
4 24 O Notified To Id
5 3 R Read Back and Verified (“Yes“, “No”)
6 255 O Note Text
Page 165 of 239

7.2.1.6 Result Record (R)
Page 166 of 239

TABLE 90: LIS2-A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
1 Record Type ID Identifies the record 1 R "R"
2 Sequence Number Defines the i’th occurrence of the associated record R [1,+inf[
3 Universal Test ID Universal Test ID Part 1 1 U
Universal Test ID Part 2 2 U
Universal Test ID Part 4 4 16 R Parameter Name See description below
Part 5 (allowed by ASTM) U
4 Data or Measurement Value Observed, calculated or implied result value 10 R Parameter Value. See description below
5 Units Abbreviation of units for numerical results 16 R Parameter Units. See description below
6 Reference Ranges When available reports the reference ranges O RefLow + " to " + RefHigh
-If both ranges defined: “2.34 to 3.15”.
-If only Min range defined: “2.34 to”.
-If only Max range defined: “to 3.15”.
-If no ranges defined: “” (null).
7 Result Abnormal Flags 2 O "LL", "L", "N", "H", "HH"
8 Nature of Abnormality Normal testing performed by Age, Sex, Race or 2 O "N" (Generic ranges) or "AS" (based on age
Testing Generic and sex)
9 Result Status 1 R "F" (valid result) or "X" (result has an error)
11 Identifies the instrument operator and the verifier for 1.1 24 O Operator Run ID (only the first result)
the test
1.2 24 O Operator Run Last Name (only the first result)
(note: for future use)
1.3 24 O Operator Run First Name (only the first result)

1.4 1 O Operator Run Middle Initial (only the first

2.1 24 O Operator Accept ID (only the first result)

2.2 24 O Operator Accept Last Name (only the first

2.3 24 O Operator Accept First Name (only the first

2.4 1 O Operator Accept Middle Initial (only the first

Page 167 of 239
Field RSR.3.4 contains one of the parameter names listed in Table 153, in the G4K column
Parameter units shall be sent in the display units configured in the system. Available units are described
in Volume 3.
Exceptions are handled according Table:
TABLE 91: LIS2-A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. EXCEPTION HANDLING
Contents of the ASTM field
Exception
R.4 R.6, R.7, R.8 R.9 C.4
None Actual Value Yes, when available “F” No comment record
C Null No “X” “CÎncalculable”
> High reportable range No “X” “>Ôutside Reportable Range”
< Low reportable range No “X” “<Ôutside Reportable Range”
I Actual Value Yes, when available “X” “IÎnterference Detected”
T Actual Value Yes, when available “X” “T^Micro Clot Detected”
M Actual Value Yes, when available “X” “M^Temporary Sensor Error”
S Actual Value Yes, when available “X” “S^SHb Interference Detected”
R Actual Value Yes, when available “X” “R^Corrected for SHb”
LA Actual Value Yes, when available “X” “LA^Fetal Corrected/<1 Month”
LB Actual Value Yes, when available “X” “LB^Fetal Corrected/1-2 Month”
LC Actual Value Yes, when available “X” “LC^Fetal Corrected/<2 Month”
B Actual Value Yes, when available “X” “B^High Turbidity Detected”
A Actual Value Yes, when available “X” “AÂbsorbance Error”
H Actual Value Yes, when available “X” “H^High MetHb Warning”
W Actual Value Yes, when available “X” “W^SHb and High MetHb Warning”
X Actual Value Yes, when available “X” “XÛnknown Exception”
L Actual Value Yes, when available “X” “LÂbove Linearity Range”
AB Actual Value Yes, when available “X” “AB^Result Abnormal”
Note1: Errors LA and LB are kept for backward compatibility.
Page 168 of 239

7.2.1.7 Comment associated to a RSR
TABLE 12: LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR ASSOCIATED TO A TOR
4 Comment Text Comment codes and text 1 2 R Exception Code. See below
2 128 R Exception Description. See below
This record is used to report an exception. Table describes the contents of field 4 in the event of an
analyte exception.
7.2.1.8 Message Terminator Record (L)

TABLE 13: ORI. LIS-2A NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MTR
1 Record Type ID Identifies the record 1 R "L"
Provides explanation of end of session 1 R "N" (Normal Termination)

3 Termination code
7.2.2 Expected responses

None
Page 169 of 239

EXAMPLE: NATIVE MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
Level Records
0 H|@^\|||^1.0ÎCU^G4K^GEM Premier 4000^123^334Â.1.0.0.0|||||CERNER||P|LIS2-A|20030922142358<CR>
1 P|1||1234567890|LBLAKE01|BLAKE^LINDSEY|19221123|U<CR>
2 C|1|P|FIELD^Billing Number^235634|G<CR>
2 O|1|99999|123||||||||||||A-VC<CR>
3 C|1|P|FIELD^Priority^High|G<CR>
3 C|2|P|COMMENT^What a wonderful day^20030922141516^fdyson|G<CR>
3 R|1|^^^pH|7.22|||||F||123456789||20030922142357<CR>
3 R|2|^^^pCO2|62|mmHg||||F<CR>
3 R|3|^^^pO2| 81|mmHg||||F<CR>
3 R|4|^^^Na+|131.1|mmol/L||||F<CR>
3 R|5|^^^K+|5.14|mmol/L||||F<CR>
3 R|6|^^^Ca++|5.00|mmol/L||||X<CR>
4 C|1|I|>Ôutside Reportable Range|I<CR>
3 R|7|^^^Hct|65|%||>||||F<CR>
3 R|8|^^^Ca++(7.4)|1.14|mmol/L||||F<CR>
3 R|9|^^^HCO3std|25.3|mmol/L||||F<CR>
3 R|10|^^^TCO2|27.2|mmol/L||||F<CR>
3 R|11|^^^FIO2|100|%||||F<CR>
0 L|1|N<CR>

This conversation is initiated by the G4K and allows the G4K to send the results of one calibration to the
HIS/LIS/CIS.

TABLE 14: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
O 1 Test Order Records

This section is identical to §8.2.1.1 (Upload Patient Sample, ORI LIS-2A Native Mode).
Page 170 of 239

TABLE 15: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. PIR

TABLE 16: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
16 Specimen Descriptor Sample type 7 R Calibration type. See Table 86.
Test Order field 16 contains one of the following character strings to indicate the calibration type:
TABLE 17: CALIBRATION TYPES

Character String Description
CCal C Calibration
BCal B Calibration
DCal D Calibration
FullCal Full Calibration
Note: 2Ptcal shall be needed when interfacing GEM 3000
Page 171 of 239

TABLE 18: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
Field Field Name Description Comp Max Len Req Values, formats and comments
2 Sequence Number Defines the i’th occurrence of the associated record R [1, Infinity]
Universal Test ID Part 4 4 16 R One of the calibration records See below
Part 5 (allowed by ASTM) 5 U
4 Data or Measurement Value Observed, calculated or implied result value 10 O Calibration result. Null if incalculable
7 Result Abnormal Flags U
"X" (calibration failure)
13 Date Time Test Completed Date and time the instrument completed the test 14 O ASTM date time (only the first result)
14 Instrument Identification Identifies the instrument that performed this U Identification of the instrument if different
measurement than GEM 4000- Phase 2
be transmitted for that parameter
The available calibration records are described in Table 88 and Table.
Page 172 of 239

TABLE 19: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CALIBRATION RECORDS (TABLE 1 / 2)
Analyte Slope DriftA MeasuredA DriftB MeasuredB DriftC
pHSlope pHDriftA pHMeasuredA pHDriftB pHMeasuredB pHDriftC

pH
pCO2 pCO2Slope pCO2DriftA pCO2MeasuredA pCO2DriftB pCO2MeasuredB pCO2DriftC
pO2 pO2Slope pO2DriftA pO2MeasuredA pO2DriftB pO2MeasuredB pO2DriftC
Na+ Na+Slope Na+DriftA Na+MeasuredA Na+DriftB Na+MeasuredB
K+ K+Slope K+DriftA K+MeasuredA K+DriftB K+MeasuredB K+DriftC
Cl- Cl-Slope Cl-DriftA Cl-MeasuredA Cl-DriftB Cl-MeasuredB
HCO3-Slope HCO3-DriftA HCO3-MeasuredA HCO3-DriftB HCO3-MeasuredB

HCO3-
(*) (*) (*) (*) (*)
Ca++ Ca++Slope Ca++DriftA Ca++MeasuredA Ca++DriftB Ca++MeasuredB
Hct HctSlope HctDriftA HctMeasuredA HctDriftB HctMeasuredB
Glu GluSlope GluDriftA GluMeasuredA GluDriftB GluMeasuredB
Lac LacSlope LacDriftA LacMeasuredA LacDriftB LacMeasuredB
BUNSlope BUNDriftA BUNMeasuredA BUNDriftB BUNMeasuredB BUNDriftC

BUN
(*) (*) (*) (*) (*) (*)
CreatSlope CreatDriftA CreatMeasuredA CreatDriftB CreatMeasuredB

Creat (*) (*) (*) (*) (*)
tHb tHbSlope tHbDriftA tHbMeasuredA tHbDriftB tHbMeasuredB
O2Hb O2HbDriftA O2HbMeasuredA
COHb COHbDriftA COHbMeasuredA
MetHb MetHbDriftA MetHbMeasuredA
HHb HHbDriftA HHbMeasuredA
tBili tBiliDriftA tBiliMeasuredA
Page 173 of 239

TABLE 100: LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
CALIBRATION RECORDS (TABLE 2 / 2)
Analyte MeasuredC SlopeC DriftD MeasuredD Slope2
pHMeasuredC pHSlopeC pHDriftD pHMeasuredD

pH
pCO2 pCO2MeasuredC pCO2SlopeC pCO2DriftD pCO2MeasuredD
pO2 pO2MeasuredC pO2DriftD pO2MeasuredD
Na+ Na+DriftD Na+MeasuredD
K+ K+MeasuredC K+DriftD K+MeasuredD
Cl- Cl-DriftD Cl-MeasuredD
HCO3-DriftD HCO3-MeasuredD
HCO3-
(*) (*)
Ca++ Ca++DriftD Ca++MeasuredD
Hct
Glu GluDriftD GluMeasuredD
LacDriftD LacMeasuredD
Lac
BUNMeasuredC BUNDriftD BUNMeasuredD BUNSlope2

BUN
(*) (*) (*) (*)
CreatDriftD CreatMeasuredD CreatSlope2

Creat
(*) (*) (*)
tHb tHbDriftD tHbMeasuredD
O2Hb O2HbDriftD O2HbMeasuredD
COHb COHbDriftD COHbMeasuredD
MetHb MetHbDriftD MetHbMeasuredD
HHbDriftD HHbMeasuredD
HHb
tBiliDriftD tBiliMeasuredD
tBili
(*): For future use!


None
Page 174 of 239

EXAMPLE: B CALIBRATION LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
0 H|@^\|||^1.0ÎCU^G4K^GEM Premier 4000^123^334Â.1.0.0|||||CERNER||P|LIS2-A|20050922142358<CR>
1 P|1<CR>
2 O|1||||||||||||||BCal<CR>
3 R|1|^^^pHDriftB|0.00|||||||||20050922142350<CR>
3 R|2|^^^pCO2DriftB|0|mmHg||||F<CR>
3 R|3|^^^pO2DriftB|0|mmHg||||F<CR>
3 R|4|^^^Na+DriftB|0.0|mmol/L||||F<CR>
3 R|5|^^^K+DriftB|0.00|mmol/L||||F<CR>
3 R|6|^^^Cl-DriftB|0.00|mmol/L||||F<CR>
3 R|7|^^^HCO3-DriftB|0.00|mmol/L||||F<CR> For future use!
3 R|8|^^^Ca++DriftB|0.25|mmol/L||||X<CR>
3 R|9|^^^HctDriftB|0|%||||F<CR>
3 R|10|^^^GluDriftB|0.0|mg/dL||||F<CR>
3 R|11|^^^LacDriftB|0.0|mmol/L||||F<CR>
3 R|12|^^^BUNDriftB|0.0|mg/dL||||F<CR> For future use!
3 R|13|^^^CreatDriftB|0.0|mg/dL||||F<CR> For future use!
3 R|14|^^^tHbDriftB|0.0|g/dL||||F<CR>
3 R|15|^^^pHMeasuredB|7.41||||F<CR>
3 R|16|^^^pCO2MeasuredB|35|mmHg||||F<CR>
3 R|17|^^^pO2MeasuredB|199|mmHg||||F<CR>
3 R|18|^^^Na+MeasuredB|136.0|mmol/L||||F<CR>
3 R|19|^^^K+MeasuredB|6.00|mmol/L||||F<CR>
3 R|20|^^^Cl-MeasuredB|5.00|mmol/L||||F<CR>
3 R|21|^^^HCO3-MeasuredB|12.00|mmol/L||||F<CR> For future use!
3 R|22|^^^Ca++MeasuredB|2.07|mmol/L||||F<CR>
3 R|23|^^^HctMeasuredB|11|%||||F<CR>
3 R|24|^^^GluMeasuredB|35.00|mg/dL||||F<CR>
3 R|25|^^^LacMeasuredB|16.00|mmol/L||||F<CR>
3 R|26|^^^BUNMeasuredB|2.00|mg/dL||||F<CR> For future use!
3 R|27|^^^CreatMeasuredB|25.00|mg/dL||||F<CR> For future use!
3 R|28|^^^tHbMeasuredB|0.00|g/dL||||F<CR>
0 L|1|N<CR>
Page 175 of 239

EXAMPLE: FULL CALIBRATION LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Leve Records
l
1 P|1<CR>
2 O|1||||||||||||||FullCal<CR>
3 R|1|^^^pHSlope|62|mV/dec||||||||19980825133636<CR>
3 R|2|^^^pCO2Slope|54|mV/dec||||F<CR>
3 R|3|^^^pO2Slope|8|pA/mmHg||||F<CR>
3 R|4|^^^Na+Slope|64|mV/dec||||F<CR>
3 R|5|^^^K+Slope|58|mV/dec||||F<CR>
3 R|6|^^^Cl-Slope|51|mV/dec||||F<CR>
3 R|7|^^^HCO3-Slope|57|mV/dec||||F<CR> For future use!
3 R|8|^^^Ca++Slope|24|mV/dec||||F<CR>
3 R|9|^^^HctSlope|38|mV/mho||||F<CR>
3 R|10|^^^GluSlope|58|pA/mg/dL||||F<CR>
3 R|11|^^^LacSlope|12|pA/mg/dL||||F<CR>
3 R|12|^^^BUNSlope|27|mV/dec||||F<CR> For future use!
3 R|13|^^^CreatSlope|50|pA/mg/dL||||F<CR> For future use!
3 R|14|^^^tHbSlope|3|||||F<CR>
3 R|15|^^^BUNSlope2|42|||||F<CR> For future use!
3 R|16|^^^CreatSlope2|71|pA/mg/dL||||F<CR> For future use!
3 R|17|^^^pHDriftA|0.01|||||F<CR><CR>
3 R|18|^^^pCO2DriftA|0|mmHg||||F<CR>
3 R|19|^^^pO2DriftA|0|mmHg||||F<CR>
3 R|20|^^^Na+DriftA|0.01|mmol/L||||F<CR>
3 R|21|^^^K+DriftA|-0.01|mmol/L||||F<CR>
3 R|22|^^^Cl-DriftA|0.0|mmol/L||||F<CR>
3 R|23|^^^HCO3-DriftA|0.0|mmol/L||||F<CR> For future use!
3 R|24|^^^Ca++DriftA|0.25|||F|mmol/L||||F<CR>
3 R|25|^^^HctDriftA|0|||F|%||||F<CR>
3 R|26|^^^GluDriftA|0.0|||F|mg/dL||||F<CR>
3 R|27|^^^LacDriftA|0.0|||F|mmol/L||||F<CR>
3 R|28|^^^BUNDriftA|0.0|||F|mg/dL||||F<CR> For future use!
3 R|29|^^^CreatDriftA|0.0|||F|mg/dL||||F<CR> For future use!
3 R|30|^^^tHbDriftA|0.0|||F|g/dL||||F<CR>
3 R|31|^^Ô2HbDriftA|0.0|||F|%||||F<CR>
3 R|32|^^^COHbDriftA|0.0|||F|%||||F<CR>
3 R|33|^^^MetHbDriftA|0.0|||F|%||||F<CR>
3 R|34|^^^HHbDriftA|0.0|||F|%||||F<CR>
3 R|35|^^^tBiliDriftA|0.0|||F|mg/dL||||F<CR>
3 R|36|^^^pHMeasuredA|6.93|||||F<CR>
3 R|37|^^^pCO2MeasuredA|63|mmHg||||F<CR>
3 R|38|^^^pO2MeasuredA|0|mmHg||||F<CR>
3 R|39|^^^Na+MeasuredA|154.0|mmol/L||||F<CR>
3 R|40|^^^K+MeasuredA|1.89|mmol/L||||F<CR>
3 R|41|^^^Cl-MeasuredA|12.00|mmol/L||||F<CR>
3 R|42|^^^HCO3-MeasuredA|1.00|mmol/L||||F<CR> For future use!
3 R|43|^^^Ca++MeasuredA|0.19|mmol/L||||F<CR>
3 R|44|^^^HctMeasuredA|11|%||||F<CR>
3 R|45|^^^GluMeasuredA|66.00|mg/dL||||F<CR>
3 R|46|^^^LacMeasuredA|78.00|mmol/L||||F<CR>
3 R|47|^^^BUNMeasuredA|58.00|mg/dL||||F<CR> For future use!
3 R|48|^^^CreatMeasuredA|83.00|mg/dL||||F<CR> For future use!
3 R|49|^^^tHbMeasuredA|18|g/dL||||F<CR>
3 R|50|^^Ô2HbMeasuredA|0.1|%||||F<CR>
3 R|51|^^^COHbMeasuredA|3|%||||F<CR>
3 R|52|^^^MetHbMeasuredA|0.6|%||||F<CR>
3 R|53|^^^HHbMeasuredA|7|%||||F<CR>
3 R|54|^^^tBiliMeasuredA|3.5|mg/dL||||F<CR>
3 R|55|^^^pHDriftD||0.0||||||F<CR>
3 R|56|^^^pCO2DriftD||0.0|mmol/L|||||F<CR>
3 R|57|^^^pO2DriftD||0.0|mmol/L|||||F<CR>
3 R|58|^^^Na+DriftD||0.0|mmol/L|||||F<CR>
3 R|59|^^^K+DriftD|0.00|mmol/L||||F<CR>
3 R|60|^^^Cl-DriftD||0.0|mmol/L|||||F<CR>
3 R|61|^^^HCO3-DriftD||0.0|mmol/L|||||F<CR> For future use!
3 R|62|^^^Ca++DriftD|0.00|mmol/L||||F<CR>
Page 176 of 239

EXAMPLE: C CALIBRATION LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||||||||||||||CCal<CR>
3 R|1|^^^pHSlopeC|0.0|mV/dec||||||||20050922142350<CR>
3 R|2|^^^pCO2SlopeC|0.0|mV/dec||||||||F<CR>
3 R|3|^^^pHDriftC|0.00|||||||||F<CR>
3 R|4|^^^pCO2DriftC|0|mmHg||||F<CR>
3 R|5|^^^pO2DriftC|0|mmHg||||F<CR>
3 R|6|^^^K+DriftC|0.00|mmol/L||||F<CR>
3 R|7|^^^BUNDriftC|0.0|mg/dL||||F<CR> For future use!
3 R|8|^^^pHMeasuredC|7.41||||F<CR>
3 R|9|^^^pCO2MeasuredC|35|mmHg||||F<CR>
3 R|10|^^^pO2MeasuredC|199|mmHg||||F<CR>
3 R|11|^^^K+MeasuredC|6.00|mmol/L||||F<CR>
3 R|12|^^^BUNMeasuredC|2.00|mg/dL||||F<CR> For future use!
0 L|1|N<CR>
EXAMPLE: D CALIBRATION LIS-2A NATIVE MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||||||||||||||DCal<CR>
3 R|1|^^^pHDriftD|0.00|||||||||20050922142350<CR>
3 R|2|^^^pCO2DriftD|0|mmHg||||F<CR>
3 R|3|^^^pO2DriftD|0|mmHg||||F<CR>
3 R|4|^^^Na+DriftD|0.0|mmol/L||||F<CR>
3 R|5|^^^K+DriftD|0.00|mmol/L||||F<CR>
3 R|6|^^^Cl-DriftD|0.00|mmol/L||||F<CR>
3 R|7|^^^HCO3-DriftD|0.00|mmol/L||||F<CR> For future use!
3 R|8|^^^Ca++DriftD|0.25|mmol/L||||X<CR>
3 R|9|^^^GluDriftD|0.0|mg/dL||||F<CR>
3 R|10|^^^LacDriftD|0.0|mmol/L||||F<CR>
3 R|11|^^^BUNDriftD|0.0|mg/dL||||F<CR> For future use!
3 R|12|^^^CreatDriftD|0.0|mg/dL||||F<CR> For future use!
3 R|13|^^^tHbDriftD|0.0|g/dL||||F<CR>
3 R|14|^^Ô2HbDriftD|0.0|%||||F<CR>
3 R|15|^^^COHbDriftD|0.0|%||||F<CR>
3 R|16|^^^MetHbDriftD|0.0|%||||F<CR>
3 R|17|^^^HHbDriftD|0.0|%||||F<CR>
3 R|18|^^^tBiliDriftD|0.0|mg/dL||||F<CR>
3 R|19|^^^pHMeasuredD|7.41||||F<CR>
3 R|20|^^^pCO2MeasuredD|35|mmHg||||F<CR>
3 R|21|^^^pO2MeasuredD|199|mmHg||||F<CR>
3 R|22|^^^Na+MeasuredD|136.0|mmol/L||||F<CR>
3 R|23|^^^K+MeasuredD|6.00|mmol/L||||F<CR>
3 R|24|^^^Cl-MeasuredD|5.00|mmol/L||||F<CR>
3 R|25|^^^HCO3-MeasuredD|12.00|mmol/L||||F<CR> For future use!
3 R|26|^^^Ca++MeasuredD|2.07|mmol/L||||F<CR>
3 R|27|^^^GluMeasuredD|35.00|mg/dL||||F<CR>
3 R|28|^^^LacMeasuredD|16.00|mmol/L||||F<CR>
3 R|29|^^^BUNMeasuredD|2.00|mg/dL||||F<CR> For future use!
3 R|30|^^^CreatMeasuredD|25.00|mg/dL||||F<CR> For future use!
3 R|31|^^^tHbMeasuredD|0.00|g/dL||||F<CR>
3 R|32|^^Ô2HbMeasuredD|0.00|%||||F<CR>
3 R|33|^^^COHbMeasuredD|0.00|%||||F<CR>
3 R|34|^^^MetHbMeasuredD|0.00|%||||F<CR>
3 R|35|^^^HHbMeasuredD|0.00|%||||F<CR>
3 R|36|^^^tBiliMeasuredD|3.5|mg/dL||||F<CR>
0 L|1|N<CR>
Page 177 of 239

This conversation is initiated by the G4K and allows the G4K to send the results of one CVP sample to
the HIS/LIS/CIS. See 7.4.1 for “When CVP Results are Transmitted”.

TABLE 101: LIS-2A NATIVE MODE. UPLOAD CVP RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
[C] 0 or 1 Comment Record associated to the result


This section is identical to §8.3.1.2 (Upload Calibration Results, ORI LIS-2A Native Mode).
Page 178 of 239

TABLE 12: LIS-2A NATIVE MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
3 Specimen ID A unique id. for the specimen assigned by the HOST U
7 Requested/Ordered Date Date and time the order was received or recorded U
and Time
8 Specimen Collection Date Date and time the specimen was collected or U
and Time obtained
15 Date/Time Specimen Date and time the specimen was approved/saved U

Received
16 Specimen Descriptor Sample type 1 3 R "CVP"
2 10 R CVP Lot Number
3 20 R CVP Lot Description
4 2 R CVP Level
17 Ordering Physician Name of the ordering physician 1 U
23 Date/Time Results Reported Date and time of the results 14 R Sent Date Time in ASTM format
or Last Modified
26 Report Type 1 R "F" (Final results) / "C" (correction of

previously transmitted)
28 Location U
For CVP samples, Test Order field 16 contains three components to describe the CVP sample completely.
The first component is a character string “CVP” to identify sample as CVP sample.
The second component is a character string containing the CVP lot number, a maximum of ten
characters
The third component is a character string containing the CVP lot description, a maximum of 20
characters.
The fourth component is the CVP lot level (the first digit of the lot number).
Page 179 of 239

7.4.1.4 Comment Record associated to a Test Order Record (C)
The comment records shall be used to send Operator comments to the sample. Format is described in
Table 1.
Page 180 of 239

Page 181 of 239

TABLE 13: LIS2-A NATIVE MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
Universal Test ID Part 4 4 16 R Parameter Name See description below
Part 5 (allowed by ASTM) U
6 Reference Ranges When available reports the reference ranges R RefLow + " to " + RefHigh
7 Result Abnormal Flags U
8 Nature of Abnormality Normal testing performed by Age, Sex, Race or U

Testing Generic
9 Result Status 1 R "F" (valid result) or "X" (result has an error)
11 Identifies the instrument operator and the verifier for 1.1 24 O Operator Run ID (only the first result)
the test
1.2 24 O Operator Run Last Name (only the first result)
1.3 24 O Operator Run First Name (only the first result)

1.4 1 O Operator Run Middle Initial (only the first

2.1 24 O Operator Accept ID (only the first result)

2.2 24 O Operator Accept Last Name (only the first

2.3 24 O Operator Accept First Name (only the first

2.4 1 O Operator Accept Middle Initial (only the first

13 Date Time Test Completed Date and time the instrument completed the test 14 O Run Date Time (only the first result)
14 Instrument Identification Identifies the instrument that performed this 10 O Analyzer Serial Number (only first result and
measurement when different than G4K) (phase 2)
Page 182 of 239

A Result record shall be transmitted for a parameter if the parameter is part of the CVP sample. If the
parameter is not part of the CVP sample, no Result record will be transmitted for that parameter.
Field RSR.3.4 contains one of the parameter names listed in Table 153, in the G4K column.
in Volume 3.
Exceptions are handled according Table 91:
TABLE 14: LIS2-A NATIVE MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. EXCEPTION HANDLING
Contents of the ASTM field
Exception
R.4 R.9 C.4
None Actual Value “F” No comment record
Q Null “X” “QîQM Error”
C Null “X” “CÎncalculable”
F Actual Value “X” “FÔutside of CVP Range”
> High Reportable Range “X” “>Ôutside Reportable Range”
< Low Reportable Range “X” “<Ôutside Reportable Range”
7.4.1.6 Comment associated to a Result Record

TABLE 15: LIS-2A NATIVE MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR ASSOCIATED TO A TOR
4 Comment Text Comment codes and text 1 1 R Exception Code. See above.
2 128 R Exception Description. See above.
This record is used to report an exception. Table 1 describes the contents of field 4 in the event of a
parameter exception.
Page 183 of 239


None

EXAMPLE: CVP RESULT LIS-2A NATIVE MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||23||||||||||||P^1802^GEM CVP 1^1|||||||20050922142350|||F<CR>
3 R|1|^^^pH|7.12||7.11 to 7.17|||F||123456789||20050922142350<CR>
3 R|2|^^^pCO2|80|mmHg|71 to 85|||F<CR>
3 R|3|^^^pO2||mmHg||||X<CR>
4 C|1|I|QîQM Error|I<CR>
3 R|4|^^^Na+|131|mmol/L|123 to 131|||F<CR>
3 R|5|^^^K+|3.1|mmol/L|2.4 to 3.4|||F<CR>
3 R|6|^^^Cl-|108|mmol/L|105 to 113|||F<CR>
3 R|7|^^^HCO3-|22|mmol/L|20 to 26|||F<CR> For future use!
3 R|8|^^^Ca++|1.58|mmol/L|1.52 to 1.66|||F<CR>
3 R|9|^^^Glu|322|mg/dL|312 to 380|||F<CR>
3 R|10|^^^Lac|7.0|mmol/L|6.5 to 8.3|||F<CR>
3 R|11|^^^BUN|11.0|mg/dL|10.6 to 13.16|||F<CR> For future use!
3 R|12|^^^Creat|1.0|mg/dL|0 to 100|||F<CR> For future use!
3 R|13|^^^tHb|17.0|g/dL|16.7 to 18.5|||F<CR>
3 R|14|^^Ô2Hb|87.0|%|85.6 to 88.4|||F<CR>
3 R|15|^^^COHb|3.0|%|2.5 to 4.5|||F<CR>
3 R|16|^^^MetHb|3.7|%|3.0 to 5.0|||F<CR>
3 R|17|^^^HHb|5.0|%|4.8 to 6.8|||F<CR>
3 R|18|^^^tBili|19.5|mg/dL|14.4 to 21.6|||F<CR>
0 L|1|N<CR>
7.5 Upload iQM-CAR Reports to HIS/LIS/CIS

This conversation is initiated by the G4K and allows the G4K to send the results of a monthly Corrective
Action Report to the HIS/LIS/CIS. See 7.5.1 for when CAR data are transmitted.

TABLE 16: LIS-2A NATIVE MODE. UPLOAD CAR RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
M 1 Manufacturer Record
{C} 1 or more Comments containing iQM data
Page 184 of 239

TABLE 17: LIS-2A NATIVE MODE. UPLOAD IQM-CAR RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MHR

3 10 R Area Name
Cartridge Serial Number of last installed

7 24 O action in the report time window.
Page 185 of 239

7.5.1.2 Manufacturer Record (M)
TABLE 18: LIS-2A NATIVE MODE. UPLOAD IQM-CAR TO HIS/LIS/CIS. UPLOADING MESSAGE. MANUFACTURER RECORD
1 Record Type ID Identifies the record as Manufacturer Record 1 R "M"
2 Sequence Number Defines the i’th occurrence of the associated 1 R "1"
Record
3 iQM Report Type iQM report type/descriptor. Valid values for this 7 R "iQM-MCA"
component are “iQM-MDC”, or “iQM-MCA” for iQM
Monthly Delta Chart or iQM Monthly Corrective
Action.
4 iQM Report Date The first component is a 4 digit string for the year of 1 4 R 4 digit string for the year of iQM report
iQM report, and the second component is a 2 digit
string (01 thru 12) for the month of iQM report. 2 2 R 2 digit string (01 thru 12) for the month of
iQM report
5 Sensor Name and PC Language 2 R nn, , being the ISO 639.2 language code for
Solution/Language which the iQM report is transmitted.
“en” English
“fr” French
“de” German
“it” Italy
“es” Spanish
“sv” Swedish
The iQM CAR report shall be transmitted in the language configured in the server.
7.5.1.3 Comment Record (C)

For each event present in the Corrective action report there shall be a comment record.
Page 186 of 239

TABLE 19: LIS-2A NATIVE MODE. IQM-CAR RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMENT RECORD
4 Comment Text Comment codes and text 1 14 R YYYYMMDDHHMMSS of the event

of the analyzer)
4 R Corrective Action Description (in the

language of the analyzer)
5 R Corrective Action Result (in the language of

the analyzer)


None

EXAMPLE: LIS-2A NATIVE MODE. UPLOAD IQM-CAR TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 M|1|iQM-MCA|2004^04|en<CR>
2 C|1|I|213966^Persistent pH Sensor Error^Sensor Output Adjusted^pH Disabled|G<CR>
2 C|2|I|213966Înterference Detected After Sample# 38. Operator John SmithÔperator Notified.
Sensor Output Adjusted^Cleared|G<CR>
0 L|1|N<CR>
7.6 Upload iQM-Delta Charts to HIS/LIS/CIS

This conversation is initiated by the G4K and allows the G4K to send the monthly delta charts to the
HIS/LIS/CIS. See 7.6.1 for when the iQM delta chart data are transmitted.

Page 187 of 239

TABLE 110: LIS-2A NATIVE MODE. UPLOAD IQM DELTA CHARTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4

This section is identical to 8.5.1.1(Upload IQM-CAR, LIS-2A Native Mode).

TABLE 111: LIS-2A NATIVE MODE. UPLOAD IQM DELTA CHARTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MANUFACTURER RECORD
1 Record Type ID Identifies the record as TOR 1 R "M"
record
3 iQM Report Type iQM report type/descriptor. Valid values for this 7 R "iQM-MDC"
component are “iQM-MDC”, or “iQM-MCA” for iQM
Delta charts or iQM Corrective Action.
4 iQM Report Date The first component is a 4 digit string for the year of 1 4 R 4 digit string for the year of iQM report
iQM report, and the second component is a 2 digit
string (01 thru 12) for the month of iQM report. 2 2 R 2 digit string (01 thru 12) for the month of
iQM report
5 Sensor Name and PC Only used in Delta Charts 1 16 R Parameter Name

Solution
2 1 R PC Solution "A/B/C/D"
Page 188 of 239

7.6.1.3 XXX Comment Record (C)
TABLE 12: LIS-2A NATIVE MODE. UPLOAD IQM DELTA CHARTS TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMENT RECORD
4 Comment Text Comment codes and text 1 1 R Each record contains one of the lines
delta chart files
described in The iQM
contents are given in the
following table.
Table 1.


None

EXAMPLE: LIS-2A NATIVE MODE. UPLOAD A DELTA CHART TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 M|1|iQM-MDC|2004^04|Hct^B<CR>
2 C|1|I|Header:|G<CR>
2 C|2|I|Device,ANL1,99936|G<CR>
2 C|3|I|Month,Jan,2004|G<CR>
2 C|4|I|Cartridge insertion days, 05, 22|G<CR>
2 C|5|I|Cartridge lot, 213266, 213167|G<CR>
2 C|6|I|Target value,11,12|G<CR>
2 C|7|I|Parameter,Hct,%|G<CR>
2 C|8|I|Material,B|G<CR>
2 C|9|I|Mean,0|G<CR>
2 C|10|I|Low,-2.0|G<CR>
2 C|11|I|High,2.0|G<CR>
2 C|12|I|Precision,1|G<CR>
2 C|13|I|y-Interval,0.5|G<CR>
2 C|14|I|Min,-1.5|G<CR>
2 C|15|I|Max,1.5|G<CR>
2 C|16|I|x-Interval, 1, 31|G<CR>
2 C|17|I|Data:|G<CR>
2 C|18|I|01/01/2004, 66, 0.0, 1.8, 0.6, 61.3, 0.1|G<CR>
2 C|19|I|01/02/2004, 70, -1.2, 0.9, -0.2, 33.3, 0.3|G<CR>
2 C|20|I|01/03/2004, 62, -0.1, 1.1, 0.9, 21.7, 0.4|G<CR>
2 C|21|I|01/04/2004, 70, -0.6, 1.2, 0.1, 11.4, 0.1|G<CR>
0 L|1|N<CR>
Page 189 of 239

7.7 Upload RiliBAEK Chart to HIS/LIS/CIS
This conversation is initiated by the G4K and allows the G4K to send the RiliBAEK Chart to the
HIS/LIS/CIS. See 6.7.1 for when the RiliBAEK data are transmitted.

TABLE113: LIS-2A NATIVE MODE. UPLOAD RILIBAEK CHART TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
{C} 1 or more Comments containing RiliBAEK Chart

This section is identical to 7.5.1.1(Upload IQM-CAR, LIS-2A Native Mode).

TABLE 114: LIS-2A NATIVE MODE. UPLOAD RILIBAEK CHART TO HIS/LIS/CIS. UPLOADING MESSAGE. MANUFACTURER RECORD
1 Record Type ID Identifies the record as TOR 1 R "M"
record
3 RiliBAEK Report Type RiliBAEK report type/descriptor. Valid value for this 7 R "RILIBAEK-CHART"
component is “RILIBAEK”
4 RiliBAEK Report Date The first component is a 4 digit string for the year of 1 4 R 4 digit string for the year of RiliBAEK report
RiliBAEK Chart report, and the second component is
a 2 digit string (01 thru 12) for the month of 2 2 R 2 digit string (01 thru 12) for the month of
RiliBAEK Chart report.
RiliBAEK report
5 Sensor Name and PC Only used in RiliBAEK Chart 1 16 R Parameter Name

Solution
2 1 R PC Solution "A/B/C/D"
Page 190 of 239

7.7.1.3 XXX Comment Record (C)
TABLE 15: LIS-2A NATIVE MODE. UPLOAD RILIBAEK CHART TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMENT RECORD
described in The RiliBAEK chart
files
contents are given in the
following table.
Table : INT_PROT-1994


None
7.8 Upload RiliBAEK Report to HIS/LIS/CIS

This conversation is initiated by the G4K and allows the G4K to send the results of RiliBAEK Report to the
HIS/LIS/CIS. See 6.8.1 for when RiliBAEK Report data is transmitted.

TABLE 16: LIS-2A NATIVE MODE. UPLOAD RILIBAEK REPORT RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
{C} 1 or more Comments containing RiliBAEK report data
Page 191 of 239

TABLE 17: LIS-2A NATIVE MODE. UPLOAD RILIBAEK REPORT RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MHR

3 10 R Area Name
Cartridge Serial Number of last installed

7 24 O action in the report time window.
Page 192 of 239

TABLE 18: LIS-2A NATIVE MODE. UPLOAD RILIABEK REPORT TO HIS/LIS/CIS. UPLOADING MESSAGE. MANUFACTURER RECORD
1 Record Type ID Identifies the record as Manufacturer Record 1 R "M"
Record
3 RiliBAEK Report Type RiliBAEK report type/descriptor. Valid values for this 7 R "RILIABEK-MCA"
component are “RILIBAEK-CHART”, or “RILIBAEK-
MCA”.
4 RILIBAEK Report Date The first component is a 4 digit string for the year of 1 4 R 4 digit string for the year of iQM report
RiliBAEK report, and the second component is a 2
digit string (01 thru 12) for the month of RiliBAEK 2 2 R 2 digit string (01 thru 12) for the month of
report.
RiliBAEK report
5 Sensor Name and PC Language 2 R nn, , being the ISO 639.2 language code for
Solution/Language which the iQM report is transmitted.
“en” English
“fr” French
“de” German
“it” Italy
“es” Spanish
“sv” Swedish
The RiliBAEK report shall be transmitted in the language configured in the server.

For each event present in the RiliBAEK report there shall be a comment record.
Page 193 of 239

TABLE 19: LIS-2A NATIVE MODE. RILIBAEK REPORT RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMENT RECORD
4 Comment Text Comment codes and text 1 14 R YYYYMMDDHHMMSS of the event
2 R Cartridge SN

of the analyzer)


None

EXAMPLE: LIS-2A NATIVE MODE. UPLOAD RILIBAEK TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 M|1|RILIBAEK-MCA|2004^04|en<CR>
2 C|1|I|213966^Process control result outside RiliBAEK range for analyte PH in PC Solution B.<CR>
0 L|1|N<CR>
7.9 Fetch Demographics from HIS/LIS/CIS

Page 194 of 239

TABLE 16: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
Q 1 Query Information Record

TABLE 17: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE. MHR

3 10 R Area Name
7 24 O Cartridge Serial Number
Page 195 of 239

7.9.1.2 Request Information Record (Q)
7.9.1.2.1 Query based on Patient ID

TABLE 18: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE. Q
1 Record Type ID Identifies the record as RIR 1 R "Q"
2 Sequence Number Defines the i’th occurrence of the associated record

type 1 R "1"
3 Starting Range ID Number Computer System Patient ID No 1 24 R Patient ID
2 3 R
“PID”
13 Request Info Status Codes 1 R "D" - Requesting demographics only
7.9.1.2.2 Query based on Account Number or Order Number


type 1 R "1"
3 Starting Range ID Number Computer System Patient ID No 1 X
2 X
3 24 R Account Number or Order Number

value
Possible values are:
4 10 R  “ACCTNUM”. Account number.
 “ORDERNUM”. Order number.
Page 196 of 239

7.9.1.2.3 Query based on Sample Number

type 1 R "1"
2 24 R
Sample Number
3 X
4 10 R
“SPECIMENID”
7.9.1.2.4 Query based on a custom defined field


type 1 R "1"
2 X
3 24 R
Field value
4 10 R
“CUSTOM”
5 24 R
Custom field name

7.9.2.1 Patient exists

The downloading message shall have the structure defined in the following table.
Page 197 of 239

TABLE 122: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
[Q] 1 Query Information Record
7.9.2.1.1 Message Header Record (H)

TABLE 123: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE. M

7.9.2.1.2 Query Information Record (Q)
7.9.2.1.2.1 Query by Patient ID

No Query Information Record shall be sent when que patient demographics request was done by
Patient ID (see section 8.7.1.2.1).
Page 198 of 239

7.9.2.1.2.2 Query based on Account Number or Order Number

type 1 R "1"
2 X

value
13 Request Info Status Codes 1 R "F" – Final Results
7.9.2.1.2.3 Query based on Sample Number


type 1 R "1"
2 24 R
Sample Number
3 X
4 10 R
“SPECIMENID”
Page 199 of 239

7.9.2.1.2.4 Query based on a custom defined field

type 1 R "1"
2 X
3 24 R
Field value
4 10 R
“CUSTOM”
5 24 R
Custom field name
Page 200 of 239

7.9.2.1.3 Patient Information Record (P)
TABLE 17: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNOADING MESSAGE. P
can refer to this sample. U

ID 24 R Patient ID
5 Patient ID No. 3 U
6 Patient Name The patient’s name
1 24 O Patient Last Name
8 Birthdate
9 Patient Genger Patient Gender ("M", "F", "U" or

1 RE Null)
7.9.2.1.4 Message Terminator Record (L)

TABLE 18: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE. L
Provides explanation of end of session 1 R "F" (Last request for information processed)
3 Termination code
7.9.2.2 Patient does not exist

Page 201 of 239

TABLE 19: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4

This section is identical to §8.8.2.1.1.
7.9.2.2.2 Request Information Record (Q)
7.9.2.2.2.1 Query based on Patient ID

TABLE 130: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE. Q

type 1 R "1"
3 Starting Range ID Number Computer System Patient ID No 24 O Patient ID
13 Request Info Status Codes "X" - Results can not be done, request
1 R cancelled
Page 202 of 239

7.9.2.2.2.2 Query based on Account Number or Order Number

type 1 R "1"
2 X

value
1 R cancelled
7.9.2.2.2.3 Query based on Sample Number


type 1 R "1"
2 24 R
Sample Number
3 X
4 10 R
“SPECIMENID”
1 R cancelled
Page 203 of 239

7.9.2.2.2.4 Query based on a custom defined field

type 1 R "1"
2 X
3 24 R
Field value
4 10 R
“CUSTOM”
5 24 R
Custom field name
1 R cancelled

TABLE 134: LIS-2A NATIVE MODE . QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE. L
3 Termination code Provides explanation of end of session 1 R "I" - No information available from last
query
"Q" - Error in last request for information
7.9.3.1 Patient exists by Patient ID

EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE.
Level Records
1 Q|1|PatID9^PID||||||||||D<CR>
0 L|1|N<CR>
Page 204 of 239

EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE.
Level Records
0 H|@^\||||||||||P|LIS2-A|20050922142458<CR>
1 P|1||PatID9||Smith^John^M|20010829|M<CR>
0 L|1|F<CR>
7.9.3.2 Patient does not exist by Patient ID

EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). UPLOADING MESSAGE.
Level Records
1 Q|1|PatID99^PID||||||||||D<CR>
0 L|1|N<CR>
EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY PATIENT ID). DOWNLOADING MESSAGE.
Level Records
0 H|@^\||||||||||P|LIS2-A|20050922142458<CR>
1 Q|1|PatID99||||||||||X<CR>
0 L|1|I<CR>
7.9.3.3 Patient exists by Sample Number

EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY SAMPLE NUMBER). UPLOADING MESSAGE.
Level Records
1 Q|1|^SampleNum19^^SPECIMENID||||||||||D<CR>
0 L|1|N<CR>
EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY SAMPLE NUMBER). DOWNLOADING MESSAGE.
Level Records
0 H|@^\||||||||||P|LIS2-A|20050922142458<CR>
1 Q|1|^SampleNum19^^SPECIMENID||||||||||F<CR>
0 L|1|F<CR>
Page 205 of 239

7.9.3.4 Patient does not exist by Sample Number
EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY SAMPLE NUMBER). UPLOADING MESSAGE.
Level Records
1 Q|1|^SampleNum19^^SPECIMENID||||||||||D<CR>
0 L|1|N<CR>
EXAMPLE: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS (QUERY BY SAMPLE NUMBER). DOWNLOADING MESSAGE.
Level Records
0 H|@^\||||||||||P|LIS2-A|20050922142458<CR>
1 Q|1|^SampleNum19^^SPECIMENID||||||||||X<CR>
0 L|1|I<CR>
8 LIS2-A Messages (GEM 3000 Mode)
8.1 Overview
The ORI-GEM 3000 mode uses the NCCLS LIS2-A protocol. See §6.2. The message formats corresponds
to the format used on the GEM 3000 analyzer.

This conversation is initiated by the G4K and allows the G4K to send the results of one sample for an
individual patient to the HIS/LIS/CIS.

TABLE 15: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
{O} 1 Test Order Record.
Page 206 of 239

TABLE 16: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MHR

subsequent records of the message 4 R "|\^&"
5 Sender Name or ID Defines the manufacturer/instrument specific to this 1 16 R Analyzer Model

reflect software revisions or firmware revisions, 2 20 R Analyzer SW Version Number
4 16 O Analyzer Name
5 9 R Cartridge Serial Number
6 3 R "3.0" (Data Format version)
10 Receiver ID Text value includes name or other ID of the receiver.

Used to verify that the transmission is indeed for the
receiver U
12 Processing ID Indicates how this message is to be processed U
13 Version No. Version level of the specification. U
Items that appear in field 5 (sender name or ID) shall refer to those of the analyzer that ran the sample.
Page 207 of 239

TABLE 17: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. PIR
3 Practice Assigned PatientID 36 O Patient PK

ID 24 O Patient ID
5 Patient ID No. 3 Social Security Account No. U
8 Birthdate
9 Patient Sex 1 O "M", "F", "U", or “”
15 Special Field 1 Used by IMPACT to receive the patient Billing

Number U
16 Special Field 2 Used By Impact to receive the Medical Number U
Page 208 of 239

TABLE 18: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
1 Record Type ID Identifies the record as TOR 1 R

2 Sequence Number Defines the i’th occurrence of the associated record 1 R “1”
3 Specimen ID A unique id. for the specimen assigned by the HOST 24 O Order Number
7 Requested/Ordered Date Date and time the order was received or recorded
and Time U
8 Specimen Collection Date Date and time the specimen was collected or 14 O Drawn Date Time in ASTM format
and Time obtained
15 Date/Time Specimen Date and time the specimen was approved/saved by
Received IMPACT U
16 Specimen Descriptor Sample type 5 R Sample Type
2 U
3 U
4 U
23 Date/Time Results Reported Date and time of the results
or Last Modified U
26 Report Type
U
28 Location Area Drawn U
Patient Sample types are described in Section 10.3 (INT_PROT-1900)
8.2.1.4 Comment Record (CMR) associated with Test Order Record (TOR)
TABLE 19: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR UNDER TOR

2 Sequence Number Defines the i’th occurrence of the associated record - R [1,Infinity]
3 Comment Source Comment Origination Point 1 R "I" (clinical instrument)
1 255 R Comment text
2 U
4 Comment Text Comment codes and text 3 U
5 Comment Type Comment type qualifier R "G" (generic/free text comment)
Page 209 of 239

TABLE 140: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
1 Record Type ID Identifies the record 1 R

"R"
Universal Test ID Part 4 4 16 R Parameter Name
6 Reference Ranges When available reports the reference ranges 10 O Ranges. See description below
7 Result Abnormal Flags 2 O Error or abnormal flag. See description

below
8 Nature of Abnormality Normal testing performed by Age and Sex U

Testing
9 Result Status U
11 Operator Identification Identifies the instrument operator and the verifier for 24 O Operator ID (only the first result)
the test
measurement than GEM 4000 (phase 2)
Field RSR.3.4 contains one of the parameter names listed in Table 153.
Page 210 of 239

in Volume 3.
Table 127 defines the contents of fields RSR.4, RSR.6 and RSR.7.
The format of field RSR.6 (Reference Ranges) shall be the two ranges separated by a blank:
If both ranges defined: “2.34 3.15”.
If only Min range defined: “2.34 ”.
If only Max range defined: “ 3.15”.
If no ranges are defined: “” (null).
Note that the GEM 3000 mode shall not allow flag results for patient results with an exception.
TABLE 141: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR FIELDS 4, 6 AND 7.
Exception on Analyte Contents of the ASTM field
RSR.4 RSR.7 RSR.6
None Actual value Null Null
C (Incalculable) Null C Null
> (Outside Reportable Range) Reportable Range – High > Null
< (Outside Reportable Range) Reportable Range – Low < Null
I (Interference Detected) Actual value I Null
T (Micro Clot Detected) Actual value T Null
M (Temporary Sensor Error) Actual value M Null
S (SHb Interference Detected) Actual value S Null
R (Corrected for SHb) Actual value R Null
B (High Turbidity Detected) Actual value B Null
LA(Fetal Corrected/<1 Month) Actual value LA Null
LB (Fetal Corrected/1-2 Month) Actual value LB Null
LC (Fetal Corrected/<2 Month) Actual value LC Null
A(Absorbance Error) Actual value A Null
H (High MetHb Warning) Actual value H Null
W (SHb and High MetHb Warning) Actual value W Null
X (Unknown Exception) Actual value or blank X Null
P (Outside Critical Limits) Actual value P Critical Ranges “Low High”
N (Outside Reference Range) Actual value N Reference Ranges “Low High”
L (Above Linearity Range) Actual value L Null
AB (Result Abnormal) Actual value AB Reference Ranges “Low High”
Note: Errors LA and LB are kept for backward compatibility.
Page 211 of 239

TABLE 142: LIS2-A GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MTR

3 Termination code Provides explanation of end of session U

None

EXAMPLE: GEM 3000 MODE. UPLOAD PATIENT SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
GEM 4000 uploads a sample to HIS/LIS/CIS
Leve Records
l
0 H|\^&|||GEM Premier 4000^V1.0r2^7040^999^123456^3.00|||||||||20030922142358<CR>
1 P|1||1234567812345678||^BLAKE^LINDSEY<CR>
2 O|1|99999|123||||||||||||A<CR>
3 R|1|^^^pH|7.22|||||||123456789||20030922142357<CR>
3 R|2|^^^pCO2|62|mmHg<CR>
3 R|3|^^^pO2| 81|mmHg<CR>
3 R|4|^^^Na+|131.1|mmol/L<CR>
3 R|5|^^^K+|5.14|mmol/L<CR>
3 R|6|^^^Ca++|1.14|mmol/L<CR>
3 R|7|^^^Hct|65|%||><CR>
3 R|8|^^^Ca++(7.4)|1.14|mmol/L<CR>
3 R|9|^^^HCO3std|25.3|mmol/L<CR>
3 R|10|^^^TCO2|27.2|mmol/L<CR>
3 R|11|^^^BEecf||||C<CR>
3 R|12|^^^BE(B)||||C<CR>
3 R|13|^^^SO2c||||C<CR>
3 R|14|^^^%FiO2|100|%<CR>
0 L|1<CR>

This conversation is initiated by the G4K and allows the G4K to send the results of one calibration to the
HIS/LIS/CIS.

Page 212 of 239

TABLE 143: GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4

This section is identical to §9.2.1.1 (Upload Patient Sample, ORI GEM 3000 Mode).

This section is identical to §8.3.1.2 (Upload Calibration Sample, ORI Native Mode).

TABLE 144: LIS2-A GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
16 Specimen Descriptor Sample type 7 R Calibration type. See Table 131.
Test Order field 16 contains one of the following character strings to indicate the calibration type:
TABLE 15: CALIBRATION TYPES

Character String Description
LOCal C Calibration
1PtCal B Calibration
DCal D Calibration
FullCal Full Calibration
Note: 2Ptcal shall be needed when interfacing GEM 3000
Note: LOCal and 1PtCal names retained for backwards compatibility.
Page 213 of 239

TABLE 16: LIS2-A GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
Universal Test ID Part 4 4 16 R One of the calibration records See below
4 Data or Measurement Value Observed, calculated or implied result value 10 O Calibration result. Null if incalculable
7 Result Abnormal Flags 1 O "F" if calibration failure. Null otherwise
9 Result Status U
measurement than GEM 4000. Phase 2
be transmitted for that parameter.
Notice that if the parameter is unitless (ex: pH), the field shall be empty.
Notice, that the only difference with the Native Mode is the usage of fields 7 and 9. The native mode
uses field 9 to indicate a failure (following the standard), while the GEM 3000 uses incorrectly the field
7.
Notice that the only differences with the records in the native mode are the ones described in Table
153. See Table 1 for available records.
Page 214 of 239


None

EXAMPLE. B CALIBRATION. CA++ HAS A DRIFT ERROR.
GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||||||||||||||1PtCal<CR>
3 R|1|^^^pHDriftB|0.00|||||||||20050922142350<CR>
3 R|2|^^^pCO2DriftB|0|mmHg<CR>
3 R|3|^^^pO2DriftB|0|mmHg<CR>
3 R|4|^^^Na+DriftB|0.0|mmol/L<CR>
3 R|5|^^^K+DriftB|0.00|mmol/L<CR>
3 R|6|^^^Cl-DriftB|0.00|mmol/L<CR>
3 R|7|^^^HCO3-DriftB|0.00|mmol/L<CR> For future use!
3 R|8|^^^Ca++DriftB|0.25|mmol/L||F<CR>
3 R|9|^^^HctDriftB|0|%<CR>
3 R|10|^^^GluDriftB|0.00|mg/dL<CR>
3 R|11|^^^LacDriftB|0.00|mmol/L<CR>
3 R|12|^^^BUNDriftB|0.00|mg/dL<CR> For future use!
3 R|13|^^^CreatDriftB|0.00|mg/dL<CR> For future use!
3 R|14|^^^THbDriftB|0.00|g/dL<CR>
3 R|15|^^^pHMeasuredB|7.41<CR>
3 R|16|^^^pCO2MeasuredB|35|mmHg<CR>
3 R|17|^^^pO2MeasuredB|199|mmHg<CR>
3 R|18|^^^Na+MeasuredB|136.0|mmol/L<CR>
3 R|19|^^^K+MeasuredB|6.00|mmol/L<CR>
3 R|20|^^^Cl-MeasuredB|8.00|mmol/L<CR>
3 R|21|^^^HCO3-MeasuredB|6.00|mmol/L<CR> For future use!
3 R|22|^^^Ca++MeasuredB|2.07|mmol/L<CR>
3 R|23|^^^HctMeasuredB|11|%<CR>
3 R|24|^^^GluMeasuredB|35.00|mg/dL<CR>
3 R|25|^^^LacMeasuredB|16.00|mmol/L<CR>
3 R|26|^^^BUNMeasuredB|2.00|mg/dL<CR> For future use!
3 R|27|^^^CreatMeasuredB|25.00|mg/dL<CR> For future use!
3 R|28|^^^THbMeasuredB|0.00|g/dL<CR>
0 L|1<CR>
Page 215 of 239

EXAMPLE. FULL CALIBRATION. CA++ HAS A DRIFTA ERROR.
GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Leve Records
l
1 P|1<CR>
2 O|1||||||||||||||FullCal<CR>
3 R|1|^^^pHSlope|62|mV/dec||||||||19980825133636<CR>
3 R|2|^^^pCO2Slope|54|mV/dec<CR>
3 R|3|^^^pO2Slope|8||pA/mmHg <CR>
3 R|4|^^^Na+Slope|64|mV/dec<CR>
3 R|5|^^^K+Slope|58|mV/dec<CR>
3 R|6|^^^Cl-Slope|51|mV/dec<CR>
3 R|7|^^^HCO3-Slope|57|mV/dec<CR> For future use!
3 R|8|^^^Ca++Slope|24|mV/dec<CR>
3 R|9|^^^HctSlope|38|mV/mho<CR>
3 R|10|^^^GluSlope|58|pA/mg/dL<CR>
3 R|11|^^^LacSlope|12|pA/mg/dL<CR>
3 R|12|^^^BUNSlope|51|mV/dec<CR> For future use!
3 R|13|^^^CreatSlope|50|pA/mg/dL<CR> For future use!
3 R|14|^^^THbSlope|3<CR>
3 R|15|^^^BUNSlope2|42<CR> For future use!
3 R|16|^^^CreatSlope2|50|pA/mg/dL<CR> For future use!
3 R|17|^^^pHDriftA|0.01<CR>
3 R|18|^^^pCO2DriftA|0|mmHg<CR>
3 R|19|^^^pO2DriftA|0|mmHg<CR>
3 R|20|^^^Na+DriftA|0.01|mmol/L<CR>
3 R|21|^^^K+DriftA|-0.01|mmol/L<CR>
3 R|22|^^^Cl-DriftA|0.0|mmol/L<CR>
3 R|23|^^^HCO3-DriftA|0.0|mmol/L<CR> For future use!
3 R|24|^^^Ca++DriftA|0.25|mmol/L<CR>
3 R|25|^^^HctDriftA|0|%<CR>
3 R|26|^^^GluDriftA|0.0|mg/dL<CR>
3 R|27|^^^LacDriftA|0.0|mmol/L<CR>
3 R|28|^^^BUNDriftA|0.0|mg/dL<CR> For future use!
3 R|29|^^^CreatDriftA|0.0|mg/dL<CR> For future use!
3 R|30|^^^THbDriftA|0.0|g/dL<CR>
3 R|31|^^Ô2HbDriftA|0.0|%<CR>
3 R|32|^^^COHbDriftA|0.0|%<CR>
3 R|33|^^^MetHbDriftA|0.0|%<CR>
3 R|34|^^^HHbDriftA|0.0|%<CR>
3 R|35|^^^tBiliDriftA|0.0|mg/dL<CR>
3 R|36|^^^pHMeasuredA|6.93<CR>
3 R|37|^^^pCO2MeasuredA|63|mmHg<CR>
3 R|38|^^^pO2MeasuredA|0|mmHg<CR>
3 R|39|^^^Na+MeasuredA|154.0|mmol/L<CR>
3 R|40|^^^K+MeasuredA|1.89|mmol/L<CR>
3 R|41|^^^Cl-MeasuredA|12.00|mmol/L<CR>
3 R|42|^^^HCO3-MeasuredA|1.00|mmol/L<CR> For future use!
3 R|43|^^^Ca++MeasuredA|0.19|mmol/L<CR>
3 R|44|^^^HctMeasuredA|11|%<CR>
3 R|45|^^^GluMeasuredA|66.00|mg/dL<CR>
3 R|46|^^^LacMeasuredA|78.00|mmol/L<CR>
3 R|47|^^^BUNMeasuredA|58.00|mg/dL<CR> For future use!
3 R|48|^^^CreatMeasuredA|83.00|mg/dL<CR> For future use!
3 R|49|^^^THbMeasuredA|18|g/dL<CR>
3 R|50|^^Ô2HbMeasuredA|0.1|%<CR>
3 R|51|^^^COHbMeasuredA|3|%<CR>
3 R|52|^^^MetHbMeasuredA|0.6|%<CR>
3 R|53|^^^HHbMeasuredA|7|%<CR>
3 R|54|^^^tBiliMeasuredA|3.5|mg/dL<CR>
3 R|55|^^^pHDriftD|0.01<CR>
3 R|56|^^^pCO2DriftD|0|mmHg<CR>
3 R|57|^^^pO2DriftD|0|mmHg<CR>
3 R|58|^^^Na+DriftD|0.01|mmol/L<CR>
3 R|59|^^^K+DriftD|0.00|mmol/L<CR>
3 R|60|^^^Cl-DriftD|0.0|mmol/L<CR>
3 R|61|^^^HCO3-DriftD|0.0|mmol/L<CR> For future use!
3 R|62|^^^Ca++DriftD|0.00|mmol/L<CR>
Page 216 of 239

EXAMPLE. C CALIBRATION. GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||||||||||||||LOCal<CR>
3 R|1|^^^pHSlopeC|0.0|mV/dec||||||||20050922142350<CR>
3 R|2|^^^pCO2SlopeC|0.0|mV/dec||||||||20050922142350<CR>
3 R|3|^^^pHDriftC|0.00|||||||||<CR>
3 R|4|^^^pCO2DriftC|0|mmHg<CR>
3 R|5|^^^pO2DriftC|0|mmHg<CR>
3 R|6|^^^K+DriftC|0.00|mmol/L<CR>
3 R|7|^^^BUNDriftC|0.00|mg/dL<CR> For future use!
3 R|8|^^^pHMeasuredC|7.41<CR>
3 R|9|^^^pCO2MeasuredC|35|mmHg<CR>
3 R|10|^^^pO2MeasuredC|199|mmHg<CR>
3 R|11|^^^K+MeasuredC|6.00|mmol/L<CR>
3 R|12|^^^BUNMeasuredC|2.00|mg/dL<CR> For future use!
0 L|1<CR>
EXAMPLE. D CALIBRATION. GEM 3000 MODE. UPLOAD CALIBRATION RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 P|1<CR>
2 O|1||||||||||||||DCal<CR>
3 R|1|^^^pHDriftD|0.00|||||||||20050922142350<CR>
3 R|2|^^^pCO2DriftD|0|mmHg<CR>
3 R|3|^^^pO2DriftD|0|mmHg<CR>
3 R|4|^^^Na+DriftD|0.0|mmol/L<CR>
3 R|5|^^^K+DriftD|0.00|mmol/L<CR>
3 R|6|^^^Cl-DriftD|0.00|mmol/L<CR>
3 R|7|^^^HCO3-DriftD|0.00|mmol/L<CR> For future use!
3 R|8|^^^Ca++DriftD|0.25|mmol/L||F<CR>
3 R|10|^^^GluDriftD|0.00|mg/dL<CR>
3 R|11|^^^LacDriftD|0.00|mmol/L<CR>
3 R|12|^^^BUNDriftD|0.00|mg/dL<CR> For future use!
3 R|13|^^^CreatDriftD|0.00|mg/dL<CR> For future use!
3 R|14|^^^THbDriftD|0.00|g/dL<CR>
3 R|15|^^Ô2HbDriftD|0.0|%<CR>
3 R|16|^^^COHbDriftD|0.0|%<CR>
3 R|17|^^^MetHbDriftD|0.0|%<CR>
3 R|18|^^^HHbDriftD|0.0|%<CR>
3 R|19|^^^tBiliDriftD|0.0|mg/dL<CR>
3 R|20|^^^pHMeasuredD|7.41<CR>
3 R|21|^^^pCO2MeasuredD|35|mmHg<CR>
3 R|22|^^^pO2MeasuredD|199|mmHg<CR>
3 R|23|^^^Na+MeasuredD|136.0|mmol/L<CR>
3 R|24|^^^K+MeasuredD|6.00|mmol/L<CR>
3 R|25|^^^Cl-MeasuredD|8.00|mmol/L<CR>
3 R|26|^^^HCO3-MeasuredD|6.00|mmol/L<CR> For future use!
3 R|27|^^^Ca++MeasuredD|2.07|mmol/L<CR>
3 R|28|^^^GluMeasuredD|35.00|mg/dL<CR>
3 R|29|^^^LacMeasuredD|16.00|mmol/L<CR>
3 R|30|^^^BUNMeasuredD|2.00|mg/dL<CR> For future use!
3 R|31|^^^CreatMeasuredD|25.00|mg/dL<CR> For future use!
3 R|32|^^^THbMeasuredD|0.00|g/dL<CR>
3 R|33|^^Ô2HbMeasuredD|0.1|%<CR>
3 R|34|^^^COHbMeasuredD|3|%<CR>
3 R|35|^^^MetHbMeasuredD|0.6|%<CR>
3 R|36|^^^HHbMeasuredD|7|%<CR>
3 R|37|^^^tBiliMeasuredD|3.5|mg/dL<CR>
0 L|1<CR>
Page 217 of 239

This conversation is initiated by the G4K and allows the G4K to send the results of a CVP Sample Result
to the HIS/LIS/CIS. See 7.4.1 for “When CVP Results are Transmitted”.

TABLE 17: GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
O 1 Test Order Record
[C] 0 or 1 comment associated to the order

This section is identical to §9.2.1.1 (Upload Patient Sample, GEM 3000 Mode).

This section is identical to §8.3.1.2 (Upload Calibration Sample, Native Mode).
Page 218 of 239

TABLE 18: LIS2-A GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. TOR
1 Record Type ID Identifies the record as TOR 1 R

3 Specimen ID A unique id. for the specimen assigned by the HOST U

7 Requested/Ordered Date Date and time the order was received or recorded
and Time U
8 Specimen Collection Date Date and time the specimen was collected or
and Time obtained U
15 Date/Time Specimen Date and time the specimen was approved/saved by
Received IMPACT U
16 Specimen Descriptor Sample type 1 3 R "P"
2 10 R CVP Lot Number
3 20 R CVP Lot Description
4
U
2 U
3 U
4 U
23 Date/Time Results Reported Date and time of the results
or Last Modified U
26 Report Type
U
28 Location Area Drawn U
For CVP samples, Test Order field 16 contains three components to describe the CVP sample completely.
The first component is the character “P” to identify sample as CVP sample.
The second component is a character string containing the CVP lot number, a maximum of ten
characters
The third component is a character string containing the CVP lot description, a maximum of 20
characters.
NOTE that the CVP lot level (the first digit of the lot number) is not included in the report
Page 219 of 239

8.4.1.4 CMR associated to TOR
TABLE 19 : LIS2-A GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. CMR UNDER TOR

2 Sequence Number Defines the i’th occurrence of the associated record - R [1,Infinity]
3 Comment Source Comment Origination Point 1 R "I" (clinical instrument)
1 255 R Comment text (see description below)
2 U
4 Comment Text Comment codes and text 3 U
The comment text shall contain the date and time of the comment, the Operator ID of the person that
did the comment and the comment text itself, separated by blanks: “YYYYMMDD OperatorID
Comment”
Page 220 of 239

TABLE 150: LIS2-A GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR
1 Record Type ID Identifies the record 1 R

"R"
Universal Test ID Part 4 4 16 R Parameter Name
4 Data or Measurement Value Observed, calculated or implied result value 10 R

Parameter Value. See description below
6 Reference Ranges When available reports the reference ranges R Critical Ranges “Low High”
7 Result Abnormal Flags O See table below
8 Nature of Abnormality Normal testing performed by Age and Sex U

Testing
9 Result Status U
11 Operator Identification Identifies the instrument operator and the verifier for 24 O Operator ID (only the first result)
the test
measurement than GEM 4000 (phase 2)
Field RSR.3.4 contains one of the parameter names listed in Table 153.
in Volume 2.
Page 221 of 239

Table 137 defines the contents of fields RSR.4 and RSR.7.
The format of field RSR.6 (Reference Ranges) shall be the two ranges separated by a blank (ex: “2.34
3.15”).
TABLE 151: LIS2-A GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. RSR FIELDS
4 AND 7.
Exception on Analyte Contents of the ASTM field
RSR.4 RSR.7
None Actual value Null
Q (iQM Error) Null Q
C (Incalculable) Null C
F (Outside of CVP Range) Actual value F
> (Outside of Reportable Range) High Reportable Range >
< (Outside of Reportable Range) Low Reportable Range <


None

EXAMPLE: GEM 3000 MODE. UPLOAD CVP SAMPLE RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
GEM 4000 uploads a CVP sample result to the HIS/LIS/CIS
Leve Records
l
1 P|1<CR>
2 O|1||23||||||||||||P^1802^GEM CVP 1<CR>
3 R|1|^^^pH|7.12||7.11 7.17|||||123456789||20030922142357<CR>
3 R|2|^^^pCO2|80|mmHg|71 85<CR>
3 R|3|^^^pO2||mmHg||Q<CR>
3 R|4|^^^Na+|131|mmol/L|123 131<CR>
3 R|5|^^^K+|3.1|mmol/L|2.4 3.4<CR>
3 R|6|^^^Cl-|108|mmol/L|105 113<CR>
3 R|7|^^^HCO3-|22|mmol/L|20 26<CR> For future use!
3 R|8|^^^Ca++|1.58|mmol/L|1.52 1.66<CR>
3 R|9|^^^Glu|322|mg/dL|312 380<CR>
3 R|10|^^^Lac|7.0|mmol/L|6.5 8.3<CR>
3 R|11|^^^BUN|11.0|mg/dL|10.6 13.16<CR> For future use!
3 R|12|^^^Creat|1.0|mg/dL|0 100<CR> For future use!
3 R|13|^^^THb|17.0|g/dL|16.7 18.5<CR>
3 R|14|^^Ô2Hb|87.0|%|16.7 18.5<CR>
3 R|15|^^^COHb|3.0|%|2.5 4.5<CR>
3 R|16|^^^MetHb|3.7|%|3.0 5.0<CR>
3 R|17|^^^HHb|5.0|%|4.8 6.8<CR>
3 R|18|^^^tBili|19.5|mg/dL|14.4 21.6<CR>
0 L|1<CR>
Page 222 of 239

8.5 Upload iQM-CAR Reports to HIS/LIS/CIS
This conversation is initiated by the G4K and allows the G4K to send the results of one CAR to the
HIS/LIS/CIS. See 7.5.1 for when CAR data are transmitted.

TABLE 152: LIS-2A GEM 3000 MODE. UPLOAD IQM-CAR RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
Page 223 of 239

TABLE 153: LIS2-A GEM 3000 MODE. UPLOAD IQM-CAR RESULTS RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. MHR


5 Cartridge Serial Numbe. Cartridge Serial

Number of last installed cartridge in report
time window or the cartridge directly linked
to the last corrective action in the report time
9 O window.

receiver U
Items that appear in field 5 (sender name or ID) shall refer to those of the analyzer that ran the sample.

This section is identical to §0 (Upload iQM-CAR Reports, LIS2-A Native Mode).
Page 224 of 239

TABLE 154: LIS-2A GEM 3000 MODE. IQM-CAR RESULTS TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMNET RECORD
4 Comment Text Comment codes and text 128 R Each of the lines of the CAR in HTML
format ready to be read by a browser,
according to the format shown in the
following table
TABLE 15: FORMAT OF THE HTLM CAR REPORT

Line Contents Example
1 <html> <head> <html> <head> </head> <body> 
2 HTTP Tag containing the character set. <meta HTTP-EQUIV="content-type" CONTENT="text/html; charset=eucjis">
3 </head> <body> </head> <body> 
Then, for each event (I=0…N-1, the total number of events), 4 lines with the following format
4I+4 [TS] Cartridge Lot No.: 01/05/2002 01:00:03 Cartridge Lot No.: 213966 
[CartLotNum] 
4I+5 [Detected failure description] Interference Detected After Sample# 38. Operator John
Smith 
4I+6 [Corrective Action Description] Operator Notified. Sensor Output Adjusted. 
4I+7 [Corrective Action Report] <pre> Cleared <pre> </pre>
</pre>
Finally, the last line shall contain

4N+3 </body> </html>| </body> </html>
The character set is the character set (http://www.iana.org/assignments/character-sets) needed for the
language.
Line 2 can be omitted when sending the report in Western European languages.

This section is identical to §9.2.1.6 (Upload Patient Sample, LIS2-A GEM 3000 Mode).
Page 225 of 239

None

EXAMPLE: CVP RESULT LIS-2A GEM 3000 MODE. UPLOAD CORRECTIVE ACTION REPORTS TO HIS/LIS/CIS. UPLOADING MESSAGE.
Level Records
1 M|1|iQM-MCA|2004^04|en<CR>
2 C|1|I|<html> <head>|G<CR>
2 C|2|I|</head> <body> |G<CR>
2 C|3|I|01/05/2002 01:00:03 Cartridge Lot No.: 213966 |G<CR>
2 C|4|I|Persistent pH Sensor Error|G<CR>
2 C|5|I|Sensor Output Adjusted |G<CR>
2 C|6|I|pH Disabled|G<CR>
2 C|7|I|</body> </html>|G<CR>
0 L|1<CR>
8.6 Upload iQM-Delta Charts to HIS/LIS/CIS

8.6.1 Upload iQM-Delta Charts to HIS/LIS/CIS
The uploading message shall have the structure defined in the following table. See 7.6.1 for when the
iQM delta chart data are transmitted.
TABLE 16: LIS-2A GEM 3000 MODE. UPLOAD DELTA CHART DATA TO HIS/LIS/CIS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4

This section is identical to §9.5.1.1 (Upload IQM-CAR, LIS2-A GEM 3000 Mode).

This section is identical to §8.6.1.2 (Upload iQM Delta Chart Data, LIS2-A Native Mode).
Page 226 of 239

TABLE 17: LIS-2A GEM 3000 MODE. UPLOAD IQM DELTA CHARTS TO HIS/LIS/CIS. UPLOADING MESSAGE. COMMENT RECORD
described in Table 145.
TABLE 17: CONTENTS OF A DELTA CHART FILE

Line Contents Description Example
1 Header: Marks the start of the header

section of the file.
2 Device, analyzer model, Defines the analyzer model, the Device, GEM Premier 4000, 123456789,
SSSSS, name serial number and the analyzer G4K
name.
3 Month, mmm, yyyy Defines the month of the data Month, Jul, 2002
4 Cartridge insertion days, Defines the dates during the month Cartridge insertion days, 2, 23
aa, bb… when cartridges were inserted
5 Cartridge lot, aaaaaa, Defines the lot numbers of the Cartridge lot, 359870, 359871
bbbbbb, …. inserted cartridges
6 Parameter, pppp, uuuuuu Defines the analyte being charted Parameter, Na+, mmol/L
and selected units
7 Nominal target value, nnn Defines the nominal target value of Nominal target value, 144
the analyte
8 Material, X Defines the PC solution, where X is Material, B

A, B, C or D.
9 Mean, 0 Defines the y-axis center value,

always zero.
10 Low, nnnn Defines the y-axis lower range value Low, -3.00
11 High, nnnn Defines the y-axis upper range value High, 3.00
12 Precision, x Defines the resolution (number of Precision, 2

decimal points) of the y-axis values
13 Interval, m, nn Defines the x-axis daily range values Interval, 1, 31

for the charted month
14 Data: Defines the start of the data section
15 Date, no. of data points, Defines the first set of daily points to 07/01/2002, 5, 0.00, 1.00, 0.60, 3.00
min, max, mean, sum plot, in the selected units
16-45 Define the remaining set of daily

points to plot for the month (note: Page 227 of 239
This section is identical to §9.2.1.6 (Upload Patient Sample, LIS2-A GEM 3000 Mode).

None
8.7 Fetch Demographics from HIS/LIS/CIS

8.7.1 Fetch Demographics from HIS/LIS/CIS
TABLE 161: LIS-2A NATIVE MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE

ASTM Level Comments
0 1 2 3 4
Page 228 of 239

TABLE 162: LIS2-A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE. MHR


5 9 O Cartridge Serial Number

receiver U
8.7.1.2 Request Information Record (Q)

TABLE 163: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE. Q

type 1 R "1"

Page 229 of 239


TABLE 164: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4

TABLE 165: LIS-2A G3K MODE. QUERY DEMOGRAPHICS. DOWNLOADING MESSAGE. M

Page 230 of 239

8.7.2.1.2 Patient Information Record (P)
TABLE 166: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. DOWNOADING MESSAGE. P
can refer to this sample. U

ID 24 O Patient ID
5 Patient ID No. 3 U
8 Birthdate
9 Patient Gender Patient Gender ("M", "F", "U" or

1 RE Null)


TABLE 17: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE
ASTM Level Comments
0 1 2 3 4
Page 231 of 239

This section is identical to §9.8.2.1.1.
8.7.2.2.2 Request Information Record (Q)

TABLE 18: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. DOWNLOADING MESSAGE. Q

type 1 R "1"
1 R cancelled


EXAMPLE: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE.
Level Records
1 Q|1|PatID9||||||||||D<CR>
0 L|1<CR>
EXAMPLE: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. DOWNLOADING MESSAGE.

Level Records
0 H|\^&||||||||||||20030922142358<CR>
0 L|1<CR>

EXAMPLE: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. UPLOADING MESSAGE.
Level Records
1 Q|1|PatID99||||||||||D<CR>
0 L|1<CR>
Page 232 of 239

EXAMPLE: LIS-2A GEM 3000 MODE. QUERY DEMOGRAPHICS. DOWNLOADING MESSAGE.
Level Records
0 H|\^&||||||||||||20030922142358<CR>
1 Q|1|PatID99||||||||||X<CR>
0 L|1<CR>
9 Synthesis Mode
9.1 General considerations

To be filled

To be filled

To be filled
10 Appendix A. Tables
10.1 Analyte names

The following table contains the conversion table between the GEM 4000 notation and the several
modes for the factory default ones.
User defined analytes shall be always sent with the name defined in configuration in all the modes.
Page 233 of 239

TABLE 1: FACTORY DEFAULT ANALYTE NAMES
G3K (bolded if different External Analyzers

G4K fromG4K) Code Name Synthesis (Phase 2)
(1)
pH pH
pCO2 pCO2
pO2 pO2
Na+ Na+
K+ K+
Cl- Cl- (N)
HCO3- HCO3-
Ca++ Ca++
Hct Hct
Glu Glu
Lac Lac
BUN BUN (N)
Urea Urea (N)
Creat Creat (N)
tHb THb
O2Hb O2Hb
COHb COHb
MetHb MetHb
HHb HHb
sO2 SO2
tBili tBili
pH(T) pH(T)
pCO2(T) pCO2(T)
pO2(T) pO2(T)
TCO2 TCO2
BEecf BEecf
tHb(c) THbc
BE(B) BE(B)
Ca++(7.4) Ca++(7.4)
AG AG (N)
Osm Osm (N)
BUN/Creat BUN/Creat (N)
Urea/Creat Urea/Creat (N)
P/F Ratio P/F Ratio (N)
pAO2 pAO2
CaO2 CaO2
CvO2 CvO2
p50 P50
O2cap O2cap
sO2(c) SO2c
HCO3-(c) HCO3-(c)
HCO3-std HCO3std
A-aDO2 A-aDO2
paO2/pAO2 paO2/pAO2 Page 234 of 239
RI RI
CcO2 CcO2
a-vDO2 a-vDO2
(1): pH analyte might be reported as cH when pH units configured as nEq/L or nmol/L.
Note: Items marked with (N) are not present in the GEM 3000 analyzer. G4K shall send those analytes in
G3K mode.
Note: Items that do not have G3K entry will only be sent from GWP, that only supports G4K style names.
10.2 Analytes / Instrument origin matrix.

Interfaces connected to the GWP might receive not only analytes that are specific to the G4K, but also
analytes that are specific to other external devices connected to the GWP such as GEM 3000, GEM PCL
or other type of instruments. The following table defines the possible sources for each specific analyte.
This table will make it easier for LIS managers to define only the analyte mapping that applies for their
specific setup.
Page 235 of 239

Instrument of origin
Analyte
GEM 4000 GEM 3000 / GEM 3500 Triage Meter
pH √ √
pCO2 √ √
pO2 √ √
Na+ √ √
K+ √ √
Cl- √
HCO3- √
Ca++ √ √
Hct √ √
Glu √ √
Lac √ √
BUN √
Urea √
Creat √
tHb √ √
O2Hb √ √
COHb √ √
MetHb √ √
HHb √ √
sO2 √ √
tBili √
pH(T) √ √
pCO2(T) √ √
pO2(T) √ √
TCO2 √ √
BEecf √ √
tHb(c) √ √
BE(B) √ √
Ca++(7.4) √ √
AG √
Osm √
BUN/Creat √
Urea/Creat √
P/F Ratio √ √ (G3500 only)
pAO2 √ √
CaO2 √ √
O2ct √ √
CvO2 √ √
p50 √ √
O2cap √ √
sO2(c) √ √
HCO3-(c) √ √
HCO3-std √ √
A-aDO2 √ √
paO2/pAO2 √ √
RI √ √
CcO2 √ √
a-vDO2 √ √
Qsp/Qt(est) √ √
Qsp/Qt √ √
Hct(c) √
Temp √ √
BP √ √
O2 √ √
FIO2 √ √ Page 236 of 239
Mech VT √
Spont VT √
Set Minute Vol √
Total Minute Vol √
Instrument of origin
Analyte
GEM 4000 GEM 3000 / GEM 3500 Triage Meter
PEEP √ √
CPAP √ √
BIPAP(I) √ √
BIPAP(E) √ √
PS √
PC √
Pulse Ox √
Flow √
Amplitude √
Delta P √
High PEEP √
Low PEEP √
IPAP √
EPAP √
ASV √
PAV √
Nitric Oxide √
Mode #1 √
Mode #2 √
Mode √
VT √
APTT-P √
PT-P √
PT INR √
ACT √
ACT-LR √
CKMB √
MYO √
TNI √
BNP √
AMP √
mAMP √
BAR √
BZO √
COC √
OPI √
PCP √
THC √
TCA √
APAP √
STR √
DDIM √
MMP9 √
S100 √
MPO √
ACS √
MTD √
NGAL √
CYSC √
Page 237 of 239

10.3 Patient sample types
TABLE 1: PATIENT SAMPLE TYPES
Sample Type G4K (*) G3K HL7 ICC (Phase 2) Synthesis
(Phase 2)
Arterial A A BLDA 4 4
Venous V V BLDV 6 6
Capillary C C BLDC 5 5
Mixed Venous M M BLMV M -
Other O O BLDO 9 9
Arterial - Micro sample AM A BLDA 4 4
Venous – Micro sample VM V BLDV 6 6
Capillary – Micro sample CM C BLDC 5 5
Mixed Venous – Micro sample MM M BLMV M -
Other - Micro sample OM O BLDO 9 9
Arterial – 100 uL sample AT A BLDA 4 4
Venous – 100uL sample VT V BLDV 6 6
Capillary – 100uL sample CT C BLDC 5 5
Mixed Venous – 100uL sample MT M BLMV M -
Other – 100uL sample OT O BLDO 9 9
*: This field shall contain also container information. See section below
Notes on POCT1-A:
 “Other” is not defined in HL7, so a new code (BLDO) has been created
Sample size is reported in fields OBR-9 and OBR-15.3.
Note: the following sample type shall be required in phase 2
Gas G G 7 7
10.4 Containers
Available containers are depicted in the table below:
TABLE 1: CONTAINERS
SY Syringe
CP Capillary
VC Vacutainer
AP Ampoule
U Unknown
Container information is sent to the LIS in two situations:
In HL7 mode, in field OBR-15.3, as a qualifier to the sample size (“M”, "T" or “N”). See §7.2.1.4
Example:
Page 238 of 239

 “M-SY”: Sample Type: Defined in OBR-15. Size: Micro. Container: Syringe.
 “N-CP”: Sample Type: Defined in OBR-15. Size: Normal. Container: Capillary.
 “T-SY”: Sample Type: Defined in OBR-15. Size: 100uL. Container: Syringe.
In the G4K mode, as a qualifier to the sample type. See §8.2.1.4. Example:
 “A-SY”: Sample Type: Arterial. Size: Normal. Container: Syringe.
 “CM-VC”: Sample Type: Capillary. Size: Micro. Container: Vacutainer.
 “AT-SY”: Sample Type: Arterial. Size: 100 uL. Container: Syringe.
10.5 Age Units

The units for age shall use the HL7 convention, described in Table 156.
TABLE 1: UNITS FOR AGE

HL7 Name Description
D Days
MO Months
YR Years
The SW shall choose the appropriate units (i.e 3 days instead of 0.082 years) according to the rules
specified in Volume 1a (Sec 4.10.1), so the transmitted units will match the units displayed in the UI.
10.6 Sample Panels

The sample panels use the LOINC codes described in Table 157.
TABLE 1: LOINC CODES

LOINC # Component/Analyte Description
24343-6 GAS & CO PANEL Blood gas and COOX sample.
24338-6 GAS PANEL Blood gas only sample.
24343-6 GAS & CO PANEL COOX only sample.
Null Cardiac Marker Sample Sample from a Cardiac Marker.
10.7 CVP Panels

The CVP panels codes are described in Table 158.
TABLE 1: CVP CODES

CODE # Component/Analyte Description
5 CVP PANEL CVP sample.
Page 239 of 239

Interface Protocols Specification For GEMweb Plus 2.1 in 2021

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Interface Protocols Specification For GEMweb Plus 2.1 in 2021

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2 External Connectivity Module

Competitor BG instruments (Radiometer, Bayer, NOVA, etc.).

The ECM will emulate other instruments.

ECM Module Description Protocols

The ECM software will provide the ability to:

Operate as a service to the GEM4000 DM component.

Create a communication session to an external device or an HIS/LIS/CIS system.

Send and/or receive data from an active session.

Allow more than one active session.

Assign a priority level to a message.

Perform parameter name translations.

Perform unit conversions

2.2.2 Sending Messages

The message to send, in the GEM Common Language.

Initiate the sending process. This includes:

Do all the needed “handshaking” operations with the recipient.

If the message cannot be delivered, it can be due to different reasons:

The outcome of a message can be:

Reason. Why the recipient cannot receive the message.

Messages may be encrypted in two ways:

Physical Layer accepts encryption (sockets, HTTPS).

As a translation module if transport does not support encryption.

2.2.3 Receiving Messages

The reception process is as follows:

Save the message in a permanent storage.

Send the message to the DM.

2.2.4 Session Management

Initiate the session, with the appropriate handshaking.

If applicable, send keep alive messages.

If communication cannot be established, retry as many times as needed

HLP Status. Each HLP has a defined status.

LLP Status. Each LLP has a defined status.

Physical Layer Status. Each Physical Layer has a defined status.

Delete outgoing messages.

Get session properties (configuration parameters).

2.2.5 External Interaction

The ECM shall provide support for the following protocols:

LIS2-A (based on ASTM-1394)

NCCLS POCT1-A (originated by CIC):

These protocols are explained in the following sections.

2.3.1.1 LIS2-A (ASTM-1394)

Use Termination Codes (ASTM Standard). Default.

Do not use Termination Codes.

The ECM will be able to provide support for different modes:

Native mode (GEM 4000).

GEM 3000 mode.

Other ASTM/HL7 based protocols - phase 2

The CIC defines three actors in the POCT systems:

Device (Devices, Docking Stations).

Observation Reviewer (POC Data Managers, Access Points, Concentrators).

Observation Recipient (LIS, CDR, ADT and HIS).

And two interfaces:

This is shown in the following figure:

Other CIC devices (Device Interface). Phase 2.

Observation Recipients (EDI Interface). Phase 1.

2.3.1.3 HL7 other than NCCLS POCT1-A

2.3.2 Low Level Protocols

2.3.2.1 NCCLS LIS1-A (formerly ASTM E1381-02)

Those options are possible:

Split frames at 240 characters or at the end of a record.

Retries: Should be configurable.

2.3.3 Physical Transfer Layer