SW Project FirepHOx

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

Tim Kelleher Lead Software Engineer

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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

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 Contents

1 Introduction ........................................................................................................................................... 4
1.1 Scope ............................................................................................................................................. 4
2 Definitions............................................................................................................................................. 4
3 References ............................................................................................................................................. 4
4 Message encoding format ..................................................................................................................... 4
5 Topic ..................................................................................................................................................... 4
6 Directive Messages ............................................................................................................................... 5
7 Continuous mode .................................................................................................................................. 5
8 Basic Profile .......................................................................................................................................... 5
9 Time and Time Zone ............................................................................................................................. 5
10 Application Timeout ......................................................................................................................... 5
11 Header Object ................................................................................................................................... 5
12 Hello message ................................................................................................................................... 6
13 Device Status message ...................................................................................................................... 6
14 Observations Message....................................................................................................................... 6
14.1 Patient Observation Message ........................................................................................................ 7
14.1.1 Service Object ....................................................................................................................... 7
14.1.2 Patient Object ........................................................................................................................ 7
14.1.3 Observation Object ............................................................................................................... 7
14.1.4 Operator Object ..................................................................................................................... 8
14.1.5 Order Object.......................................................................................................................... 9
14.1.6 Sample Comment .................................................................................................................. 9
14.2 Non Patient Observation Message - QC sample ........................................................................... 9
14.2.1 Service Object ....................................................................................................................... 9
14.2.2 Control Object ..................................................................................................................... 10
14.2.3 Observation Object ............................................................................................................. 10
14.2.4 Operator Object ................................................................................................................... 11
15 Result identifiers for measured results ............................................................................................ 11
16 Result identifiers for calculated results ........................................................................................... 12
17 Result identifiers for entered results ............................................................................................... 13

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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 and
quality control results 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 FirepHOx 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
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 ASCII format.

5 Topic
 The Analyzer shall support Observations Topic.
 The Analyzer shall not support other topics.

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6 Directive Messages
The Analyzer shall not support directive messages (standard or custom)

7 Continuous mode
The Analyzer shall not support Continuous mode.

8 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.
 When the Observations topic is complete (End of Topic message is sent by the analyzer) the analyzer
shall wait for the Terminate message from the LIS to end the conversation. If the analyzer does not
receive a Terminate message within the application timeout period, the analyzer shall send a
Terminate message to end the conversation.

9 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"/>

10 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.
 The Analyzer shall timeout after 60 seconds.
 When an application timeout occurs, the Analyzer shall send a Terminate message to terminate the
Conversation.

11 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.

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12 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
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

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 if available. Currently the
Prime analyzer does not have a serial number.
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 Id.

DCP.application_timeout Application timeout in seconds

13 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.

14 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)

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

14.1.1 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
SVC.observation_dttm The analyzed on date time of the sample.

14.1.2 Patient Object

 Object Type: PT
 The Patient object shall support the following fields:
Field Description
PT.patient_id The patient identifier
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

14.1.3 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”
for the identifiers for measured results.
 Refer to section 16 “Result identifiers for calculated results”
for the identifiers for calculated results.
 Refer to section 17 “Result identifiers for entered results” for

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Field Description
the 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”.
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.

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
not transmitted.

14.1.4 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

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14.1.5 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

14.1.6 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”

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

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

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

14.1.6.2 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:
“comment text”: the comment text string.
“TY=C_ADDITIONAL”: to specify the type is an additional comment.

14.2 Non Patient Observation Message - QC sample

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

14.2.1 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.

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Field Description
SVC.role_cd “LQC” for QC results
SVC.observation_dttm The completion date and time of the analysis.

14.2.2 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”

For Proficiency Lot

Proficiency, Lot xxx
where:
xx is lot number
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

14.2.3 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”for the 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 “>”
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.

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Field Description
“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.

14.2.4 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

15 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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16 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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17 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”
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", "MMC",
"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"

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