SW Prime Analyzer

POCT1 Protocol

Authors:

Name Position Signature Date

Khanh Nguyen Software Engineer

Approvals:

Name Position Signature Date

Dharmin Patel Software Quality Assurance

Tom Peterson Program Manager

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Revision Control History:

Date Rev. No. Revised by Revisions (add, change, delete)

04/29/2013 0.0 Khanh Nguyen Initial document for review.
05/16/2013 1.0 Khanh Nguyen Updated after formal review
11/18/2013 2.0 Khanh Nguyen Updated before 1st release
02/13/2014 2.1 Khanh Nguyen If a result could not be produced because there
were, transmit an empty string for value and “ERR”
for interpretation_cd
04/15/2014 2.2 Khanh Nguyen Transmit QC corrective action
05/12/2014 2.3 Khanh Nguyen Transmit species for veterinary samples
05/16/2014 2.4 Khanh Nguyen Remove project name
9/18/2014 2.5 Khanh Nguyen Add transmission of a proficiency sample
9/25/2014 3.0 Khanh Nguyen Modified after further review
4/30/2015 3.1 Khanh Nguyen Transmit sample error for patient results
9/29/2015 4.0 Khanh Nguyen Add new modes of therapy.
Add transmission will be in UTF-8 format
Add documentation for “PT.patient_id”
10/06/2015 4.1 Khanh Nguyen Add Specimen object.
Change vent setting “MMC” to “MMV”
11/05/2015 4.2 Khanh Nguyen Add sample type Tube, Capillary, Serum, Dialysis
Fluid, CSF, and Urine.
06/19/2016 5.0 Khanh Nguyen Add transmission of Analyzer States and Cartridges
Status.
07/20/2016 5.1 Khanh Nguyen Add transmission of Patient Query
07/26/2016 5.2 Khanh Nguyen Add documentation for “PT.pat_id”

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 Contents

1 Introduction ........................................................................................................................................... 5
1.1 Scope ............................................................................................................................................. 5
2 Definitions............................................................................................................................................. 5
3 References ............................................................................................................................................. 5
4 Message encoding format ..................................................................................................................... 5
5 Continuous mode .................................................................................................................................. 5
6 Transmission of Analyzer State ............................................................................................................ 6
7 Transmission of Cartridges’ Status ....................................................................................................... 6
8 Topic ..................................................................................................................................................... 6
8.1 Analyzer State Topic..................................................................................................................... 6
8.1.1 Analyzer State Message ........................................................................................................ 7
8.2 Cartridge Status Topic .................................................................................................................. 8
8.2.1 Cartridge Status Message ...................................................................................................... 8
8.2.2 End of Topic Message......................................................................................................... 10
8.2.3 Examples ............................................................................................................................. 10
9 Patient Query ...................................................................................................................................... 11
10 Facility and Location Validation..................................................................................................... 14
11 Basic Profile .................................................................................................................................... 15
12 Time and Time Zone ....................................................................................................................... 15
13 Application Timeout ....................................................................................................................... 16
14 Header Object ................................................................................................................................. 16
15 Hello message ................................................................................................................................. 16
16 Device Status message .................................................................................................................... 17
17 Observations Message..................................................................................................................... 17
17.1 Patient Observation Message ...................................................................................................... 17
17.1.1 Service Object ..................................................................................................................... 17
17.1.2 Patient Object ...................................................................................................................... 18
17.1.3 Observation Object ............................................................................................................. 19
17.1.4 Operator Object ................................................................................................................... 20
17.1.5 Order Object........................................................................................................................ 20
17.1.6 Specimen object .................................................................................................................. 20
17.1.7 Sample Comment ................................................................................................................ 20
17.1.8 Species ................................................................................................................................ 21
17.1.9 Tray’s Cup Position ............................................................................................................ 21
17.1.10 Sample Error ................................................................................................................... 21
17.2 Non Patient Observation Message - QC sample ......................................................................... 22
17.2.1 Service Object ..................................................................................................................... 22
17.2.2 Control Object ..................................................................................................................... 22
17.2.3 Observation Object ............................................................................................................. 22
17.2.4 Operator Object ................................................................................................................... 23
17.2.5 Corrective Action Comments.............................................................................................. 23
17.2.6 Tray’s Cup Position ............................................................................................................ 24
17.3 Non Patient Observation Message - Proficiency sample ............................................................ 24
17.3.1 Service Object ..................................................................................................................... 24
17.3.2 Control Object ..................................................................................................................... 24
17.3.3 Observation Object ............................................................................................................. 25
17.3.4 Operator Object ................................................................................................................... 25

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 17.3.5 Comment ............................................................................................................................. 25
17.3.6 Tray’s Cup Position ............................................................................................................ 26
18 Result identifiers for measured results ............................................................................................ 26
19 Result identifiers for calculated results ........................................................................................... 27
20 Result identifiers for entered results ............................................................................................... 28
21 Appendix ......................................................................................................................................... 29
21.1 Location List Topic from NovaNet ............................................................................................. 29

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1 Introduction
This document defines the POCT1 protocol as implemented between the Prime Analyzer and a
Laboratory Information System computer. The POCT1 protocol is used to transmit the patient results,
quality control results, proficiency results, analyzer states, and cartridges status from the Prime Analyzer
to a Laboratory Information System computer.

1.1 Scope
 The Prime Analyzer POCT1 interface adheres to the Device Messaging Layer specification of the
POCT1 Specification.
 The “POCT1” Specification refers to the entire set of technical proposals and specifications: the
Observation Reporting Interface specification, the Device and Access Point specification, and the
Device Messaging Layer specification (the Prime Analyzer uses this specification). For simplicity,
this document will use the term “POCT1” Specification instead of the “Device Messaging Layer”
specification.
 This document defines how the Prime Analyzer complies with the protocol and specifies where the
Analyzer diverges from the protocol. This document does not cover the Device Messaging Layer
specification. Interested readers can refer to the Device Messaging Layer Specification, version
POCT1-A2, from the Clinical and Laboratory Standards Institute.

2 Definitions
Term Definitions
Conversation A bounded communication session between the analyzer and an
external system.
GMT Greenwich Mean Time
LIS Laboratory Information System
NovaNet Nova Biomedical Data Management System
QC Quality Control
Topic This is a POCT1 term which refers to a bounded series of
messages that is used to transfer a complete set of data. For
example, an Observations Topic is composed of a series of
messages. Each message contains one or more results.

3 References
The following references have been considered in preparing this document:
Document Revision Date
POCT1-A2 : Point-of-Care Connectivity ; Approved Standard- Vol. 26 No. 28 July 2006
Second Edition

4 Message encoding format

 The exchanged messages between the Analyzer and the LIS shall be encoded in the UTF-8 format

5 Continuous mode
 The analyzer will support Continuous mode.

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 The analyzer will indicate that it supports Continuous mode by transmitting the following field in the
Hello message:
<DSC.directives_supported_cd V="START_CONTINUOUS"/>
 The analyzer will enter Continuous Mode if it indicates that it supports Continuous Mode in the Hello
message and it receives a Basic Directive message “DTV.R01” with the command
“DTV.command_cd V=”START_CONTINUOUS”.
 In Continuous mode, the analyzer will:
o Transmit new patient, QC, and proficiency samples to LIS.
o Transmit analyzer state to LIS.
o Transmit status of cartridges to LIS.
o Transmit Patient Query to LIS

6 Transmission of Analyzer State

 The analyzer will send its state (Ready, No Ready, etc.) to LIS in Continuous mode.
 The analyzer will send its state when its state has changed.
 The analyzer state will be sent in a Custom Topic.
 The analyzer will indicate that it supports this custom topic by transmitting the following field in the
Hello message:
<DSC.topics_supported_cd V="NOVA.ANALYZER_STATE"/>

7 Transmission of Cartridges’ Status

 The analyzer will send the status of its cartridges to LIS in Continuous mode.
 The cartridges’ status will be sent to LIS when:
o The data of any cartridge has changed or,
o When a new cartridge is installed.
 The cartridges’ status will be sent in a Custom Topic.
 The analyzer will indicate that it supports this custom topic by transmitting the following field in the
Hello message:
<DSC.topics_supported_cd V="NOVA.CARTRIDGE_STATUS"/>

8 Topic
 The Analyzer shall transmit patient results, QC results and proficiency results in the Observations
topic.
 The Analyzer shall support the following custom topics:
o Analyzer State Topic: This custom topic is used to send the state of the analyzer to LIS.
o Cartridge Status Topic: This custom topic is used to send the status of all cartridges to LIS.

8.1 Analyzer State Topic

 The custom Analyzer State topic is used to send the analyzer state to LIS.
 The topic is illustrated in the following figure:

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 (Analyzer) (LIS)

1: Analyzer State Message

2: Acknowledgement

3: End Of Topic

Figure 1- Analyzer State Topic

8.1.1 Analyzer State Message

 The type of this message is NOVA.ANALYZER.STATE
 The following figure is an example of the Analyzer State message:

<NOVA.ANALYZER_STATE>
<HDR>
<HDR.control_id V="1004"/>
<HDR.version_id V="POCT1"/>
<HDR.creation_dttm V="2016-03-18T14:13:50+00:00"/>
</HDR>
<ANALYZER_STATE>
<state V="R"/>
</ANALYZER_STATE>
</NOVA.ANALYZER_STATE>

This message contains an ANALYZER_STATE element, which contains the state of the analyzer.

8.1.1.1 ANALYZER_STATE Element

The following table describes the fields of the ANALYZER_STATE element:

Field Description
state A code that indicates the current state of the analyzer. See Table 2 – Analyzer State
Code Values for valid codes.
Table 1- Analyzer State Object

Code Meaning
I Initialize. The analyzer is performing power up mechanical initialization.
W Warm Up. The analyzer is completing warm up after mechanical initialization.
E Error. The analyzer has encountered a severe error.
B Busy. The analyzer is in the process of running a sequence or maintenance activity.
R Ready. The analyzer is ready to run a sequence.
S Standby. The analyzer is in a sleep mode where it runs just the idle trickle sequences
to keep the fluid flow path lubricated.
SV Service mode. The analyzer is in service mode.
NR Not Ready. The analyzer is initialized however cannot run a sample since it either
requires a consumable or all tests are not calibrated or locked.
Table 2 – Analyzer State Code Values

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8.1.1.2 End of Topic Message
The field “EOT.topic_cd” will contain the topic code “NOVA.ANALYZER_STATE”.

8.2 Cartridge Status Topic

 The custom Cartridge Status topic is used to send the status of all cartridges on the analyzer to LIS
when the status/data of any cartridge has changed.
 The topic is illustrated in the following figure:
(Analyzer) (LIS)

1: Cartridge Status Message

2: Acknowledgement

3: End Of Topic

8.2.1 Cartridge Status Message

 The type of this message is NOVA.ANALYZER.STATE
 The following figure is an example of the Cartridge Status message:

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 <NOVA.CARTRIDGE_STATUS>

<HDR>
<HDR.control_id V="1006"/>
<HDR.version_id V="POCT1"/>
<HDR.creation_dttm V="2016-03-22T08:26:25+00:00"/>
</HDR>

<CARTRIDGE_STATUS>
<name V="Sensor"/>
<status V="CARTRIDGE_PRESENT"/>
<lot_number V="16311254"/>
<lot_expiration_date V="2017-06-30"/>
<uselife_expiration_date V="2016-03-23"/>
<remaining_samples V="172"/>
<uselife_remaining V="78"/>
</CARTRIDGE_STATUS>

<CARTRIDGE_STATUS>
<name V="Calibrator"/>
<status V="CARTRIDGE_PRESENT"/>
<lot_number V="14303881"/>
<lot_expiration_date V="2016-07-02"/>
<uselife_expiration_date V="2016-04-26"/>
<remaining_samples V="140"/>
<uselife_remaining V="100"/>
</CARTRIDGE_STATUS>

<CARTRIDGE_STATUS>
<name V="Auto QC"/>
<status V="CARTRIDGE_PRESENT"/>
<lot_number V="14309784"/>
<lot_expiration_date V="2018-07-12"/>
<uselife_expiration_date V="2016-04-16"/>
<remaining_samples V="252"/>
<uselife_remaining V="78"/>
</CARTRIDGE_STATUS>
</NOVA.CARTRIDGE_STATUS>

 One “CARTRIDGE_STATUS” element will be transmitted for each cartridge.

 The fields of the “CARTRIDGE_STATUS” element are described in the following table:

Field Description
name The name of the cartridge:
“Sensor” for the sensor cartridge.
“Calibrator” for the calibrator cartridge.
“Auto QC” for the QC cartridge.
status The status of the cartridge.
“CARTRIDGE_NOT_PRESENT” cartridge is removed.
“CARTRIDGE_PRESENT” cartridge is in analyzer.
“CARTRIDGE_EXPIRED” cartridge has expired.
“CARTRIDGE_UNKNOWN” invalid cartridge.
“CARTRIDGE_INVALID” invalid cartridge.
lot_number Lot number of cartridge.
lot_expiration_date Lot expiration date in POCT Date format
uselife_expiration_date Use Life expiration date in POCT Date format

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 remaining_samples The number of remaining samples.
uselife_remaining The percentage of remaining use life.

The following fields are transmitted one time with the CARTRIDGE_STATUS element when a new
cartridge is installed:

Field Description
replaced_dttm The date time of the installation
operator_id If an operator was logged in at the time the cartridge was installed, this field
will contain the operator identifier.

8.2.2 End of Topic Message

The field “EOT.topic_cd” will contain the topic code “NOVA.CARTRIDGE_STATUS”.

8.2.3 Examples
Following is an example of the CARTRIDGE_STATUS element of a sensor cartridge that has been
removed:
<CARTRIDGE_STATUS>
<name V="Sensor"/>
<status V="CARTRIDGE_NOT_PRESENT"/>
<lot_number V=""/>
<lot_expiration_date V=""/>
<uselife_expiration_date V=""/>
<remaining_samples V=""/>
<uselife_remaining V=""/>
</CARTRIDGE_STATUS>

Following is an example of the CARTRIDGE_STATUS element of a sensor cartridge that has been
expired:
<CARTRIDGE_STATUS>
<name V="Sensor" />
<status V="CARTRIDGE_EXPIRED" />
<lot_number V="16311254" />
<lot_expiration_date V="2017-06-30" />
<uselife_expiration_date V="2016-03-23" />
<remaining_samples V="0" />
<uselife_remaining V="0" />
</CARTRIDGE_STATUS>

Following is an example of the CARTRIDGE_STATUS element of a sensor cartridge that is not expired:

<CARTRIDGE_STATUS>
<name V="Sensor"/>
<status V="CARTRIDGE_PRESENT"/>
<lot_number V="16311254"/>
<lot_expiration_date V="2017-06-30"/>
<uselife_expiration_date V="2016-03-23"/>
<remaining_samples V="172"/>
<uselife_remaining V="78"/>
</CARTRIDGE_STATUS>

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9 Patient Query
 A Patient Query is sent as a custom Directive Message from the Analyzer to the LIS.
 The message will contain the patient identifier and the identifier type (MRN, or Patient ID, or
Account Number).
 If the patient is found, the LIS will reply with a positive Acknowledgement message ACK.R01 with
the Patient Demographics information included in the Acknowledgement message. The Patient
Demographics will be included in child element “PT” of the field “ACK.note_txt”.
 The Patient Demographics information will include:
o First Name
o Last Name
o Middle Initial if available.
o Gender.
o Date of Birth
 If the patient is not found, the LIS will reply with a negative Acknowledgement message ACK.R01.
 The Analyzer will transmit the following field in the Hello message to indicate that it supports Patient
Query:
<DSC.directives_supported_cd V="PATIENT_QUERY"/>

 The Analyzer will only transmit the Patient Query directive message in Continuous mode.

 The following figure illustrates the format of the Patient Query directive message:

<DTV.NOVA_REQ.R02>

<HDR>
<HDR.control_id V="1008"/>
<HDR.version_id V="POCT1"/>
<HDR.creation_dttm V="2016-06-24T16:33:59-04:00"/>
</HDR>

<DTV>
<DTV.command_cd V="PATIENT_QUERY"/>
</DTV>

<PARAM>
<PARAM.serial_id V="0-4-163-133-184-177"/>
<PARAM.query_type V="PATIENT"/>
<PARAM.query_id V="223344">MRN</PARAM.query_id>
</PARAM>

</DTV.NOVA_REQ.R02>

 The Message Type is “<DTV.NOVA_REQ.R02>”

 The field DTV.command_cd will contain the command code “PATIENT_QUERY”.

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 The following table describes the field of the PARAM element:
Field Description
PARAM.serial_id The serial number of the analyzer
PARAM.query_type The query type. It is “PATIENT” for patient query.
PARAM.query_id The value of this field contains the patient identifier.
The text node of this field contains the identifier type:
MRN: for MRN number
PATID: for Patient ID
ACCT: for Account Number
PARAM.ignore_location This is an optional field. It can be used to specify whether the Patient
Query will perform the patient search in the facility and location to
which the analyzer is assigned to or will perform the patient search in
ALL facilities and locations.

The default is to perform the patient search in the facility and location to
which the analyzer is assigned to. An absence of this field will assume
the default behavior.

Following are the valid values for this field:

“T” – Perform the patient search in ALL facilities and locations.
“F” – Perform the patient search in the facility and location to which the
analyzer is assigned to.

 The following figure illustrates the format of the positive Acknowledgement message “ACK.R01”
that contains the Patient Demographics data.

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 <ACK.R01>
<HDR>
<HDR.control_id V="4007"/>
<HDR.version_id V="POCT1"/>
<HDR.creation_dttm V="2016-06-24T16:35:01-04:00"/>
</HDR>

<ACK>
<ACK.type_cd V="AA"/>
<ACK.ack_control_id V="1008"/>

<ACK.note_txt V="PATIENT_QUERY">

<PT>
<PT.patient_id V="223344">223344^PATID222^ACC222</PT.patient_id>
<PT.name V="Bobby Phillis">
<FAM V="Phillis"/>
<GIV V="Bobby"/>
</PT.name>
<PT.birth_date V="1970-01-25"/>
<PT.gender_cd V="M"/>
</PT>

</ACK.note_txt>
</ACK>
</ACK.R01>

 The field “ACK.type_cd” will have the value “AA” for Positive Acknowledgement.
 The field “ACK.note_txt” will have the value “PATIENT_QUERY”. This field will contain the child
element “PT” which contains the Patient Demographics data.

 The field PT.patient_id will:

o Contain the patient identifier in its value.
o In the text node, contain the MRN, Patient ID, Account Number separated by the caret
character ^ and in the specified order.
 The field PT.name contains the name of the patient. The value of the “V” attribute will contain the
name of the patient as it is displayed at the LIS.
o The FAM element contains the Last Name.
o The GIV element contains the First Name.
o The MID element contains the Middle Initial if available.
 The field PT.birth_date contains the date of birth in the POCT date format.
 The field PT.gender_cd contains the patient’s gender. Valid values are:

Code Description
F Female
M Male
O Other
U Unknown

 The following figure illustrates the format of the Negative Acknowledgement Message “ACK.R01”
sent to the analyzer when the patient is not found at the LIS.

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 <ACK.R01>
<HDR>
<HDR.control_id V="1513" />
<HDR.version_id V="POCT1" />
<HDR.creation_dttm V="2013-12-19T16:45:21.00-05:00" />
</HDR>

<ACK>
<ACK.type_cd V="AE" />
<ACK.ack_control_id V="4014" />
<ACK.note_txt V="PATIENT_QUERY" />
</ACK>
</ACK.R01>

 The field “ACK.type_cd” will have the value “AE” for Negative Acknowledgement.
 The field “ACK.note_txt” will have the value “PATIENT_QUERY”.

10 Facility and Location Validation

 The analyzer must be assigned a Facility and Location before it can send a Patient Query message
to the LIS.
 From the User Interface of the analyzer, user can enter the name of the Facility and Location.
 After the Facility and Location are entered, the analyzer starts a new conversation to the LIS to
verify if the entered Facility and Location are valid.
 In this conversation:
o The analyzer will transmit the name of the facility and the name of the location in the
field DEV.device_id of the Hello message.

<DEV.device_id>facility^location</DEV.device_id>

o The analyzer will transmit zero new results in the field DST.new_observations_qty of
the Device Status message.

<DST.new_observations_qty V="0" />

 If the LIS detects that either the facility or the location is invalid, the LIS can send a Location List
Topic (see Location List Topic in Appendix) to the analyzer to indicate to the analyzer that its
facility and location are invalid. The location list sent to the analyzer can contain one fictitious
facility and a list of fictitious units in the facility since this is just a way for the LIS to indicate
that the facility and location are invalid. After the End of Topic message “EOT.R01” is sent for
the Location List topic, the LIS will send the message “END.R01” to terminate the conversation.
 If the LIS detects that the facility and location are valid, it LIS will send a message to tell the
analyzer to go into Continuous mode.
 The following figure illustrates the conversation that validates the facility and location:

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 (Analyzer) (LIS)

<DEV.device_id>facility^location</DEV.device_id>
1: Hello Message

2: Acknowledgement

<DST.new_observations_qty V="0" />

3: Device Status Message

4: Acknowledgement

LIS detects invalid Facility & Location

5: Location List message

6: Acknowledgement

7: End of Topic message

8: Terminate

9: Acknowledgement

..… Or …..
Valid Facility & Location

5: Start Continuous

6: Acknowledgement

11 Basic Profile
 When a patient sample or a non-patient sample is available, the analyzer shall connect to the LIS, use
the Basic profile to transmit the sample to the LIS and then the conversation is terminated.
 If the analyzer receives a negative acknowledgement in reply to either the Hello message or the
Device Status message the analyzer shall wait for a Terminate message from the LIS. If the analyzer
does not receive a terminate message within the application timeout period the analyzer shall send a
terminate message to the LIS to end the conversation.

12 Time and Time Zone

 The Analyzer does not keep track of its time zone.
 All date times shall be reported as local time with zero hours offset and zero minutes offset from
GMT.
 The following XML fragment illustrates how the analyzer will communicate that an observation was
made on November 1, 2000 at 5:09:10 PM
<SVC.observation_dttm V="2000-11-01T17:09:10+00:00"/>

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13 Application Timeout
 An application timeout occurs when the LIS does not send an expected response within a
predetermined period. The Analyzer reports this interval in the “DCP.application_timeout” field of
the Hello message.
 When an application timeout occurs, the Analyzer shall send a Terminate message to terminate the
Conversation.

14 Header Object
 Object Type : HDR
 Each message will contain a Header object.
 The Analyzer will support the following fields in the Header object
Field Description
HDR.control_id Message control id.
HDR.version_id “POCT1” to specify that this message adhere to the POCT1
standard.
HDR.creation_dttm The sender’s time when the message was sent.

15 Hello message
 Message Type : HEL.R01
 The Analyzer shall support the following fields in the Hello message :

Field Description
Header fields See Header object

DEV.device_id An empty string will be sent for this field if the analyzer is not
assigned to a facility and location.
If the analyzer is assigned a facility and location, the facility
and location will be transmitted in the text node of this field,
in the following format:

<DEV.device_id>facility^location</DEV.device_id>
The facility and location are separated by the caret character.

DEV.vendor_id The vendor identifier. “NOVABIO” will be sent for this field.
DEV.model_id The model identifier. This will be one of the following
identifiers:
“E” for Basic Electrolyte
“ELI” for Electrolyte Li
“FE” for Full Electrolyte
“BG” Blood Gas Only
“BGE” Blood Gas Electrolyte
“BGEM” Blood Gas Electrolyte Metabolyte
“FULL” Full Analyzer
“VETE” Vet Electrolyte
“VETB” Vet Blood Gas Electrolyte Metabolyte

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Field Description

If the analyzer has a tray assembly, the string

“_WITH_TRAY” will be appended to the end of the model
identifier. For example: “E_WITH_TRAY”.
DEV.serial_id The serial number of the analyzer.
DEV. manufacturer_name “Nova Biomedical” will be sent for this field
DEV.sw_version The system’s software version of the analyzer.
DEV.device_name The Analyzer Identifier.

DCP.application_timeout Application timeout in seconds

DSC.connection_profile_cd Always “SA”

DSC.directives_supported_cd “START_CONTINUOUS”: if analyzer supports continuous
mode
“PATIENT_QUERY”: if analyzer supports Patient Query
DSC.topics_supported_cd “NOVA.ANALYZER_STATE”: if analyzer supports
transmission of analyzer state to LIS.
“NOVA.CARTRIDGE_STATUS”: if analyzer supports
transmission of cartridges status to LIS.

16 Device Status message

 Message Type : DST.R01
 The Analyzer shall support the following fields in the Device Status message :
Field Description
Header fields See Header fields
DST.status_dttm Current date and time.
DST. new_observations_qty The number of samples the analyzer is reporting.
DST.condition_cd Always “R” for ready.

17 Observations Message
 The analyzer shall transmit patient results in Patient Observation Message (OBS.R01).
 The analyzer shall transmit QC results and Proficiency results in Non-Patient Observation Message
(OBS.R02)

17.1 Patient Observation Message

 Message Type: OBS.R01
 Each Patient Observation Message shall contain patient results for one patient sample.

17.1.1 Service Object

 Object Type: SVC
 Each Service object will contain information and results for one patient sample.
 The Service object shall support the following fields:
Field Description
SVC.role_cd “OBS” for patient results

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Field Description
SVC.observation_dttm The analyzed on date time of the sample.

17.1.2 Patient Object

 Object Type: PT
 The Patient object shall support the following fields:
Field Description
PT.patient_id The text node of this field shall be a formatted string that contains MRN,
Patient ID, and Account Number. Following is the format of this string:
mrn^patid^acct

where:
mrn: MRN number if one was entered for the sample.
patd: patient ID if one was entered for the sample.
Acct: account number if one was entered for the sample.

Prime’s patient sample does not have a patient identifier. But since the value
of “PT.patient_id” is required, Prime will set the value of “PT.patient_id” as
the first available component from the text node of “PT.patient_id”.

Examples for “PT.patient_id”:

<PT.patient_id V="">^^</PT.patient_id>
<PT.patient_id V="MRN10">MRN10^^</PT.patient_id>
<PT.patient_id V="PATID20">^PATID20^</PT.patient_id>
<PT.patient_id V="ACCT30">^^ACCT30</PT.patient_id>

<PT.patient_id V="MRN10">MRN10^PATID20^ACCT30</PT.patient_id>
<PT.patient_id V="MRN10">MRN10^PATID20^</PT.patient_id>
<PT.patient_id V="PATID20">^PATID20^ACCT30</PT.patient_id>
<PT.patient_id V="MRN10">MRN10^^ACCT30</PT.patient_id>
PT.name The name of the patient.
The format is: “Last,First,Middle”

Also, the child element “FAM” will contain the last name, the child element
“GIV” will contain the first name, and the child element “MID” will contain
the middle name

Example:
<PT.name V="Smith,John,Edward">
<FAM V="Smith"/>
<GIV V="John"/>
<MID V=”Edward” />
</PT.name>
PT.birth_date The patient’s date of birth, if available.
PT.gender_cd The patient’s gender, if available.
F: Female
M: Male
U: Unknown

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17.1.3 Observation Object
 Object Type: OBS
 Each Observation object contains one patient result.
 The Observation object shall support the following fields:
Field Description
OBS.observation_id The unique identifier for the result.
 Refer to section 15 “Result identifiers for measured results”
 Refer to section 16 “Result identifiers for calculated results”
 Refer to section 17 “Result identifiers for entered results”
OBS.value The observation result.
 If the observation result is below the low operational limit,
this field shall contain the low operation limit value and
“interpretation_cd” field shall be set to “<”
 If the observation result is above the high operational limit,
this field shall contain the high operation limit value and the
“interpretation_cd” field shall be set to “>”
 If an observation result is not reported because the test
parameter is not calibrated, this field shall contain an empty
string and the “interpretation_cd” shall be set to “UC”
 If an observation result is not reported because the test
parameter is QC locked, this field shall contain an empty
string and the “interpretation_cd” shall be set to “QC”.
 If an observation result is not reported because there were
errors, this field shall contain an empty string and the
“interpretation_cd” shall be set to “ERR”.
OBS.method_cd “M” for measured result.
“C” for calculated result
“I” for entered result
OBS. interpretation_cd This field shall contain the abnormal flags
“L” : result is below low normal
“H” : result is above high normal
“LL” : result is below low critical limit
“HH” : result is above high critical limit
“<” : result is below low operational limit
“>” : result is above high operational limit
“null” : No range was defined or there was no range check.
“UC”: result is not reported because the test parameter is not
calibrated.
“QC”: result is not reported because the test parameter is QC
locked.
“ERR”: result is not reported because there were errors.

This field shall not be transmitted if the result does not have
any abnormal flags.
OBS. normal_lo-hi_limit The normal range limits if available and if the test parameter is
calibrated. If the test parameter is not calibrated, this field is
not transmitted.
OBS. critical_lo-hi_limit The critical range limits if available and if the test parameter is
calibrated. If the test parameter is not calibrated, this field is

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Field Description
not transmitted.

17.1.4 Operator Object

 Object Type: OPR
 One Operator object will be transmitted if an operator was identified with the sample analysis.
 The Operator Object shall support the following fields.
Field Description
OPR.operator_id The operator identifier

17.1.5 Order Object

 Object Type: ORD
 An Order object will be transmitted if the sample analysis is associated with an accession number
 The Order object shall support the following fields:
Field Description
ORD.order_id Accession number

17.1.6 Specimen object

 Object Type: SPC
 The Specimen object shall support the following fields
Field Description
SPC.specimen_dttm The date and time the sample was drawn if available.
SPC.type_cd The sample type.
"BLDA" : Arterial
"BLDV" : Venous
"BLMV" : Mixed Venous
“BLDC” : Capillary
“TUB” : Tube
“UR” : Urine
“CSF” : Cerebral spinal fluid
“SERUM” : Serum
“DIAF” : Dialysis fluid
"ORH" : Other

17.1.7 Sample Comment

There are 2 sample comment types:
 Comment
 Additional comment

All sample comments shall be transmitted in a “NTE” element and as a child element of the Service
object “SVC”

17.1.7.1 Comment
Following is the format of the NTE element that is used to communicate a Comment.

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<NTE>
<NTE.text V=”comment text”>TY=C</NTE.text >
</NTE>

where:
The “V” attribute shall contain the comment text.
“TY=C”: to specify the type is a sample comment.

17.1.7.2 Additional Comment

Following is the format of the NTE element that is used to communicate an Additional Comment

<NTE>
<NTE.text V=”comment text”>TY= C_ADDITIONAL </NTE.text >
</NTE>

where:
The “V” attribute shall contain the comment text.
“TY=C_ADDITIONAL”: to specify the type is an additional comment.

17.1.8 Species
Following is the format of the NTE element that is used to communicate the species for a veterinary
sample.

<NTE>
<NTE.text V=”chihuahua puppies”>TY= SPECIES </NTE.text >
</NTE>

where:
The “V” attribute shall contain the species.
“TY=SPECIES”: to specify the type is species for a veterinary sample.

17.1.9 Tray’s Cup Position

Following is the format of the NTE element that is used to communicate the tray’s cup position of the
sample.

<NTE>
<NTE.text V=”1”>TY=TRAY_CUP_POSITION </NTE.text >
</NTE>

where:
The “V” attribute shall contain the cup position. The position shall be 1 through 10.
“TY=TRAY_CUP_POSITION”: to specify the type is tray’s cup position.

17.1.10 Sample Error

Each sample error shall be transmitted with a NTE element. Following is the format of the NTE element
that is used to communicate a sample error.

<NTE>

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 <NTE.text V=”error text”>TY=ERROR</NTE.text >
</NTE>

where:
The “V” attribute shall contain the error text (Example: Sample Position Not Confirmed).
“TY=ERROR”: to specify the type is a sample error.

17.2 Non Patient Observation Message - QC sample

 Message Type: OBS.R02
 Each Non Patient Observation Message shall contain results for one QC sample

17.2.1 Service Object

 Object Type: SVC
 Each Service object shall contain information and results for one QC sample
 The Service object shall support the following fields.
Field Description
SVC.role_cd “LQC” for QC results
SVC.observation_dttm The completion date and time of the analysis.

17.2.2 Control Object

 Object Type: CTC
 The Control object shall contain identification information for the QC analysis.
 The Control object shall support the following fields:
Field Description
CTC.name Format is:

For QC Lot
QC, Lot xxx Level yy zz
where:
xx is lot number
yy is the QC level
zz is “Internal” or “External”
CTC.lot_number The QC lot number
CTC.expiration_date The year, month, day when the QC lot will expire
CTC.level_cd The QC level

17.2.3 Observation Object

 Object Type: OBS
 Each Observation object contains one QC result
 The Observation object will support the following fields for QC results:
Field Description
OBS.observation_id The unique identifier of the result.
 Refer to section 15 “Result identifiers for measured results”
OBS.value The observation result.
 If the observation result is below the low operational limit,
this field shall contain the low operation limit value and
“interpretation_cd” field shall be set to “<”

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Field Description
 If the observation result is above the high operational limit,
this field shall contain the high operation limit value and the
“interpretation_cd” field shall be set to “>”
OBS.method_cd “M” for measured result.
OBS. interpretation_cd This field shall contain the abnormal flags
“L” : result is below low normal
“H” : result is above high normal
“<” : result is below low operational limit
“>” : result is above high operational limit
“null” : No range was defined or there was no range check.
“UC”: result is not reported because the test parameter is not
calibrated.
“QC”: result is not reported because the test parameter is QC
locked.

This field shall not be transmitted if the result is not associated

with any of the above abnormal flags
OBS. normal_lo-hi_limit The normal range limits if available.

17.2.4 Operator Object

 Object Type: OPR
 An Operator object will be transmitted if an operator was identified with the sample analysis.
 The Operator Object will support the following fields.
Field Description
OPR.operator_id The operator identifier

17.2.5 Corrective Action Comments

 Each QC sample may have one corrective action comment.
 Each QC sample may have one additional corrective action comment.
 Corrective action comment and additional corrective action comment shall be transmitted in a “NTE”
element and as a child element of the Service object “SVC”.

17.2.5.1 Corrective action comment

Following is the format of the NTE element that is used to communicate a corrective action comment.

<NTE>
<NTE.text V=”comment text”>TY=CA</NTE.text >
</NTE>

where:
The “V” attribute shall contain the corrective action text
“TY=CA”: to specify the type is a corrective action

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17.2.5.2 Additional corrective action comment
Following is the format of the NTE element that is used to communicate an additional corrective action
comment

<NTE>
<NTE.text V=”comment text”>TY= CA_ADDITIONAL </NTE.text >
</NTE>

where:
The “V” attribute shall contain the additional corrective action comment.
“TY=CA_ADDITIONAL”: to specify the type is an additional corrective action

17.2.6 Tray’s Cup Position

Following is the format of the NTE element that is used to communicate the tray’s cup position of the
sample.

<NTE>
<NTE.text V=”1”>TY=TRAY_CUP_POSITION </NTE.text >
</NTE>

where:
The “V” attribute shall contain the cup position. The position shall be 1 through 10.
“TY=TRAY_CUP_POSITION”: to specify the type is tray’s cup position.

17.3 Non Patient Observation Message - Proficiency sample

 Message Type: OBS.R02

17.3.1 Service Object

 Object Type: SVC
 The Service object shall support the following fields.
Field Description
SVC.role_cd “PRF” for proficiency results
SVC.observation_dttm The completion date and time of the analysis.

17.3.2 Control Object

 Object Type: CTC
 The Control object shall contain identification information for the proficiency analysis.
 The Control object shall support the following fields:
Field Description
CTC.name Format is:
Proficiency, Lot xxx
where:
xx is lot number
CTC.lot_number The QC lot number
CTC.expiration_date The year, month, day when the lot will expire
CTC.level_cd The proficiency level. If there is no proficiency level, this field

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Field Description
will not be transmitted.

17.3.3 Observation Object

 Object Type: OBS
 The Observation object will support the following fields:
Field Description
OBS.observation_id The unique identifier of the result.
 Refer to section 15 “Result identifiers for measured results”
OBS.value The observation result.
 If the observation result is below the low operational limit,
this field shall contain the low operation limit value and
“interpretation_cd” field shall be set to “<”
 If the observation result is above the high operational limit,
this field shall contain the high operation limit value and the
“interpretation_cd” field shall be set to “>”
 If a result could not be produced, the field shall contain an
empty string.
OBS.method_cd “M” for measured result.
OBS. interpretation_cd This field shall contain the following abnormal flags if a result
could not be produced:
“<” : result is below low operational limit
“>” : result is above high operational limit
“UC”: result is not reported because the test parameter is not
calibrated.
“QC”: result is not reported because the test parameter is QC
locked.
“ERR”: result could not be produced because there were errors

This field shall not be transmitted if the result is not associated

with any of the above abnormal flags

17.3.4 Operator Object

 Object Type: OPR
 An Operator object will be transmitted if an operator was identified with the sample analysis.
 The Operator Object will support the following fields:
Field Description
OPR.operator_id The operator identifier

17.3.5 Comment
 If a comment was entered for the Proficiency analysis, the comment shall be transmitted in a NTE
element. This NTE element shall be a child element of the “SVC” element.
 Following is the format of the NTE element:
<NTE>
<NTE.text V="comment text">TY=C</NTE.text >
</NTE>

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where:
“comment text”: the comment text string.
“TY=C”: to specify the type is a sample comment.

17.3.6 Tray’s Cup Position

Following is the format of the NTE element that is used to communicate the tray’s cup position of the
sample.

<NTE>
<NTE.text V=”1”>TY=TRAY_CUP_POSITION </NTE.text >
</NTE>

where:
The “V” attribute shall contain the cup position. The cup position shall be 1 through 10.
“TY=TRAY_CUP_POSITION”: to specify the type is tray’s cup position.

18 Result identifiers for measured results

The following table lists the result identifiers for measured results. These identifiers are used in the
“observation_id” field of an OBS element for patient and QC results.

Identifier Description
Cl- Chloride Concentration
K Potassium Concentration
Na Sodium Concentration
pH pH Concentration
H H Concentration. Alternate name for pH
pCO2 PCO2 Concentration
pO2 PO2 Concentration
Ca++ Ionized Calcium Concentration
Mg++ Ionized Magnesium Concentration
Glu Glucose Concentration
Lac Lactate Concentration
Li Lithium Concentration
Hct Hematocrit Concentration

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19 Result identifiers for calculated results
The following table lists the result identifiers for calculated results. These identifiers are used in the
“observation_id” field of an OBS element for calculated results of a patient sample analysis.

Identifier Description
pH(TC) pH Concentration Corrected to Patient Temperature
H(TC) H Concentration Corrected to Patient Temperature
pCO2(TC) PCO2 Concentration Corrected to Patient Temperature
pO2(TC) PO2 Concentration Corrected to Patient Temperature
HCO3- Bicarbonate Ion Concentration
TCO2 Total CO2
BEecf Base Excess, Extra-Cellular Fluid
BEb Base Excess, Blood
SBC Standard Bicarbonate
O2Ct Oxygen Content
O2CAP Oxygen Capacity
A Alveolar Air PO2
a/A a/A, Alveolar Ratio
RI Respiratory Index
P50 PO2 @ 50% SO2
PO2/FIO2 PO2/FIO2 Ratio
SO2% SO2 Percent
Hb Hemoglobin
Gap Anion Gap, calculated without K+
nCa Normalized Calcium
nMg Normalized Magnesium
nCa/nMg nCa/nMg, Normalized Calcium, Normalized Magnesium
Ratio
AaDO2 Alveolar Arterial Oxygen Gradient

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20 Result identifiers for entered results
The following table lists the result identifiers for results that are entered in the information fields of a
patient sample analysis. These identifiers are used in the “observation_id” field of an OBS element for
patient results.

Parameter Name Description

FIO2 Percent Fraction Inspired Oxygen
TemP Patient Temperature
THb Total Hemoglobin
ventilator_rate Ventilator Rate
tidal_volume Tidal volume
peep_cpap Peep Cpap
mode_of_therapy Mode of Therapy.
“CMV”, “ACV”, “SMV”, “PEEP”, “CPAP”,
“PSV”, “PCV”, “HFOV”, “BiPAP”
oxygen_rate Oxygen Rate
respiratory_rate Respiratory Rate
pressure_support Pressure Support
vent_setting Vent setting.
"AC_CMV", "SIMV_PS", "SIMV", "CPAP_PS",
"CPAP", "BIPAP", "PC", "MMV",
"PRESS_CYCLE", "PRESS_CONTROL", "HF",
"JET", "MAND_MINUTE"
MMV MMV
frequency Frequency
PAP PAP
MML MML
itime ITime
amplitude Amplitude
EPAP EPAP
IPAP IPAP
IP IP
Allen's Test Allen’s test.
“PASS”, “FAIL”,
pulse_oximeter Pulse Oximeter
oxygen_delivery_mode Oxygen delivery mode.
"ROOM_AIR", "NASAL_CANNULA",
"NRB_MASK", "PRB_MASK", "VENTI_MASK",
"TRACH_COLLAR", "SIMPLE_MASK",
"T_PIECE", "AEROSOL_MASK", "HOOD",
"BVM", "TENT", "BLOW_BY", "OXYMIZER",
"ISOLET", "VENTILATOR"

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 puncture_site Puncture Sites
"Unspecified"
"Radial"
"Femoral"
"Scalp"
"Bracial"
"Arterial Catheter"
"Cord"
arterial_puncture_site Arterial Puncture Sites
"Unspecified"
"Radial Left"
"Bracial Left"
"Femoral Left"
"Heel Left"
"Popiletial Left"
"A Line"
"Radial Right"
"Bracial Right"
"Femoral Right"
"Heel Right"
"Popiletial Right"
other_puncture_site Other Puncture Sites
"Unspecified"
"Scalp"
"Central Venous Line"
"Umbilical Cord"
"Umbilical Arterial"
"Arterial Catheter"

21 Appendix
21.1 Location List Topic from NovaNet
 The Location List Topic is a custom topic implemented by NovaNet.
 The Location List Topic is used by NovaNet to transmit a list of Facilities and Locations to the
analyzer.
 The message type of the Location List Message is: NOVA.LOC
 The Topic code of the Location List Topic is: NOVA.LOC
 The following figure illustrates the message flow of the Location List Topic.

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 (Analyzer) (LIS)

1: Location List Message

2: Acknowledgement

Repeat until nothing left to send

4: End Of Topic

The following figure illustrates the format of a Location List message:

<NOVA.LOC>
<HDR>
<HDR.control_id V="4009"/>
<HDR.version_id V="POCT1"/>
<HDR.creation_dttm V="2016-06-27T13:27:49-04:00"/>
</HDR>

<!-- One LOC element -->

<LOC>
<LOC.facility V="Mass General Hosp">
<unit V="Pulmonary" DF="F"/>
<unit V="Pediatrics" DF="F"/>
<unit V="Adult Medicine" DF="F"/>
<unit V="Urology" DF="F"/>
</LOC.facility>
</LOC>

</NOVA.LOC>

 The Location List Topic contains one or more messages.

 Each message contains one LOC element.
 Each LOC element contains one Facility and units within the facility.
 Each LOC element contains one LOC.facility element. The value of this element contains the
name of the Facility.
 The LOC element has one or more unit elements.
 Each unit element represents one department in the facility . The value of the unit element
contains the name of the department.

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