Prime - ASTM Interface-LIS2 - Protocol - V3 - 0

SW Project FirepHOx
(Nova STP PRIME)

LIS2 Protocol
(Formerly ASTM-E1394)
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)

02/13/2013 0.0 Khanh Nguyen Initial document for review.
05/16/2013 1.0 Khanh Nguyen Updated after review.
07/22/2013 2.0 Khanh Nguyen Added “Prime” for Platform Identifier.
Used shorter name for Model Identifier
11/18/2013 3.0 Khanh Nguyen Updated before 1st release
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Contents
1 Scope and Introduction ......................................................................................................................... 4

2 LIS2 Protocol ........................................................................................................................................ 4
2.1 Header Record .............................................................................................................................. 5
2.2 Patient Information Record ........................................................................................................... 6
2.2.1 Patient Information Record For Patient Samples .................................................................. 6
2.2.2 Patient Information Record for QC Samples ........................................................................ 8
2.2.3 Patient Information Record Proficiency Samples ................................................................. 9
2.3 Test Order Record ....................................................................................................................... 10
2.3.1 Test Order Record for Patient Samples............................................................................... 10
2.3.2 Test Order Record for QC Samples .................................................................................... 11
2.3.3 Test Order Record For Procifiency Samples ...................................................................... 12
2.4 Result Record .............................................................................................................................. 13
2.5 Comment Record ........................................................................................................................ 14
2.6 Message Terminator Record ....................................................................................................... 15
2.7 Parameter names for measured test results ................................................................................. 16
2.8 Parameter names for calculated results ....................................................................................... 17
2.9 Parameter names for entered results ........................................................................................... 18
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1 Scope and Introduction
This document defines the LIS2 protocol (formerly ASTM E1394) as implemented between the
FirepHOx Analyzer and a Laboratory System Information computer.
In 2001, the ASTM Committee decided to transfer responsibility for ASTM standards to the NCCLS
(Clinical And Laboratory Standards Institute). Following this transfer, the ASTM E1394 standard
(Specification for Transferring Information between Clinical Laboratory Instruments and Information
Systems) was re-designated as NCCLS standard LIS2.
The FirepHOx Analyzer LIS2 interface adheres to the LIS2-A2 standard. This document defines how the
FirepHOx Analyzer complies with the protocol and specifies where the Analyzer diverges from the
protocol.
2 LIS2 Protocol
• The LIS2 protocol is used to transmit the Patient and Quality Control results (internal and
external) from the FirepHOx Analyzer to a Laboratory System Information computer.
• The tables that follow describe the data records that are sent by the Analyzer. The column
"FIELD NAME" lists the field name that appears in the LIS2 specification.
• Each data record ends with a carriage return.
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2.1 Header Record
FIELD NAME IMPLEMENTATION
Record Type ID Single character: "H"
Delimiter Definition Standard delimiters: |\^&
Message Control ID Not Used
Access Password Not used
Sender Name or ID Format is : NOVA^aaa^bbb^ccc^ddd
where:
“aaa” : Platform Identifier. This will always be “Prime”
“bbb” : Software Version.
“ccc” : Analyzer Identifier.
“ddd” : Model Identifier. This will be one of the following
identifiers:
E: Basic Electrolyte
ELI: Electrolyte Li
FE: 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 “TRAY” shall be

appended to the end of the model identifier. For example:
“FE_TRAY”.
Sender Street Address Not used
Reserved Field Not used
Sender Telephone Number Not used
Characteristics of Sender Not used
Receiver ID Not used
Comment or Special Not used
Instruction
Processing ID Not used
Version Number Version of the LIS2 specification.
This field will be "LIS2-A2"
Date and Time of Message Date and time at which message was transmitted.
Format is “YYYYMMDDHHMMSS”
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2.2 Patient Information Record
2.2.1 Patient Information Record For Patient Samples
Record Type Single character: "P"
Sequence Number Single character: "1". (This will always be "1" because there
will be only one patient record per message.)
Practice Assigned Patient ID MRN number if available.
Format is an alphanumeric string.
Laboratory Assigned Patient Patient ID if available.
ID Format is an alphanumeric string.
Patient ID No. 3 Patient Account # if available.
Patient Name Patient Name. Field format is “Last^First^Middle”
Mother's Maiden Name Not used
Birthdate Date of Birth.
Format is “YYYYMMDD”.
Patient Sex Patient Gender. Format is
F – Female
M – Male
U- Unknown
Patient Race-Ethnic Origin Not used
Patient Address Not used
Patient Telephone Number Not used
Attending Physician ID Not used
Special Field 1 Not used
Patient Height Not used
Patient Weight Not used
Patient's Known or Suspected Not used
Diagnosis
Patient Active Medications Not used
Patient's Diet Not used
Practice Field No. 1 Not used
Admission and Discharge Not used
Dates
Admission Status Not used
Location Not used
Nature of Alternative Not used
Diagnostic Code and
Classifiers
Alternative Diagnostic Code Not used
and Classification
Patient Religion Not used
Marital Status Not used.
Isolation Status Not used
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Language Not used
Hospital Service Not used
Hospital Institution Not used
Dosage Category Not used
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2.2.2 Patient Information Record for QC Samples
Practice Assigned Patient ID Not used
Laboratory Assigned Patient QC Lot Number.
Patient ID No. 3 Not used
Patient Name Not used
Birth date Lot Expiration Date.
Format is “YYYYMMDD”.
Patient Sex Not used
Special Field 1 Not used.
Diagnosis
Dates
Location Not used
Diagnostic Code and
Classifiers
and Classification
Language Not used
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2.2.3 Patient Information Record Proficiency Samples
Practice Assigned Patient ID Not used
Laboratory Assigned Patient Sample Identifier.
Patient ID No. 3 Not used
Patient Name Not used
Birth date Not used
Patient Sex Not used
Special Field 1 Not used.
Diagnosis
Dates
Location Not used
Diagnostic Code and
Classifiers
and Classification
Language Not used
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2.3 Test Order Record
2.3.1 Test Order Record for Patient Samples
Record Type ID Single character: "O"
will be only one Order record per message.)
Specimen ID Accession Number if available.
Instrument Specimen ID Not used
Universal Test ID Not used
Priority Not used
Requested/Ordered Date and Not used
Time
Specimen Collection Date Date Time Sample Drawn.
and Time Field format is “YYYYMMDDHHMMSS”
Collection End Time Not used
Collection Volume Not used
Collector ID Not used
Action Code Not used
Danger Code Not used
Relevant Clinical Information Not used
Date/Time Specimen Not used
Received
Specimen Descriptor Sample Type. This field shall contain the following sample
type strings
Arterial, Venous,
Mixed Venous, Cord
Ordering Physician Not used
Physician's Telephone Not used
Number
User Field No. 1 Not used
Laboratory Field No. 1 Not used
Day/Time Results Reported Not used
or Last Modified
Instrument Charge to Not used
Computer System
Instrument Section ID Not used
Report Types 'F' - final results
Location or Ward of Not used
Specimen Collection
Nosocomial Infection Flag Not used
Specimen Service Not used
Specimen Institution Not used
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2.3.2 Test Order Record for QC Samples
Specimen ID Format is
QCnn Level nn xx
where:
nn is the QC level
xx is “Internal” or “External”
Priority Not used
Time
Specimen Collection Date Not used
and Time
Received
Specimen Descriptor “Control”
Number
or Last Modified
Computer System
Specimen Collection
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2.3.3 Test Order Record For Procifiency Samples
Specimen ID Format is
QCn Level n Proficiency
where n is the Proficiency level
Priority Not used
Time
Specimen Collection Date Not used
and Time
Received
Specimen Descriptor “Proficiency”
Number
or Last Modified
Computer System
Specimen Collection
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2.4 Result Record
Record Type Single character: "R"
Sequence Number Counts the parameters sent for this order; '1' for the first
parameter, '2' for the second, etc.
Universal Test ID Format is
^^^parameter^type
where:
parameter: parameter name of the result.
See section 2.7 for the parameter names of
measured test results.
See section 2.8 for parameter names of calculated
test results.
See section for parameter names of entered test
results.
type: result type.
“M” for measured results.
“C” for calculated results.
“E” for entered results.
Example: : “^^^Glu^M”, “^^^SBC^C”, “^^^FIO2^E”
Data or Measurement The test result as an ASCII string.
Value
If the field “Result Abnormal Flags” is either “UC”, “QC”,
this field will contain an empty string.
If the field “Result Abnormal Flags” is either “>”, or “<”

because the measured result is outside of the technical range
this field will contain the technical upper/lower limit. For
example if the result is “Glu” and the Result Abnormal Flags
is “>” this field may contain the value “600” (for 600 mg/dL)
Units Units of measure
Reference Ranges Reference Ranges. The reference range format is an
alphanumeric string “xx.xx to xx.xx”. Will be blank if there
are no ranges assigned.
Example: “3.5 to 4.5”
Result Abnormal Flags HH - Above High Panic value
H - Above High Reference value
L - Below Low Reference value
LL - Below Low Panic value
> - Above the range of the analyzer
< - Below the range of the analyzer
UC – the test result is not reported because the test parameter
is not calibrated.
QC – the test result is not reported because the test parameter
is QC locked.
Nature of Abnormality Not used
Testing
Result Status 'F' - final results.
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Date of Change of Not used
Instrument Normative
Values or Units
Operator Identification Operator Identifier.
Date/Time Test Started Not used
Date/Time Test Completed Date and time at which the analysis completed. Field format is
“YYYYMMDDHHMMSS”.
Instrument Identification Analyzer Identifier
2.5 Comment Record
Comment record is used to send a sample comment or a sample additional comment. For these 2
comment types, the comment records are sent immediately after the Order record.

Record Type Single character: "C"
Sequence Number Counts the comments sent for this order; '1' for the first
comment, '2' for the second, etc.
Comment Source Single character: "I" for clinical instrument system
Comment Text A comment type label followed by descriptive text.
“comment_type: comment text”
where:
“comment_type”: is either
“sample_comment”, or
“sample_additional_comment”
“comment text”: descriptive text of the comment
Comment Type Single character: "G" for generic/free result comment
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2.6 Message Terminator Record
LIS2 REF LIS2 NAME IMPLEMENTATION
13.1.1 Record Type Single character: "L"
13.1.2 Sequence Number For this record type this is always "1".
13.1.3 Termination Code One of the following:
N - normal termination
T - sender aborted
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2.7 Parameter names for measured test results
The following table lists the parameter names for all measured test results.
Table 2.6.1 - Parameter names for measured test results

Parameter Name 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
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2.8 Parameter names for calculated results
The following table lists the parameter names for all calculated results.
Table 2.7.1 - Parameter names for calculated results

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
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2.9 Parameter names for entered results
The following table lists the parameter names for all entered results.
Table 2.8.1 - Parameter names for entered results

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.
“P” for Pass
“F” for Fail
“N” for Not Done
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"
MAP MAP
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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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Prime - ASTM Interface-LIS2 - Protocol - V3 - 0

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SW Project FirepHOx

(Nova STP PRIME)

Name Position Signature Date

Khanh Nguyen Software Engineer

Name Position Signature Date

Dharmin Patel Software Quality Assurance

Tom Peterson Program Manager

Tim Kelleher Lead Software Engineer

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

1 Scope and Introduction ......................................................................................................................... 4

If the analyzer has a tray assembly, the string “TRAY” shall be

If the field “Result Abnormal Flags” is either “>”, or “<”

2.5 Comment Record

FIELD NAME IMPLEMENTATION

Table 2.6.1 - Parameter names for measured test results

Table 2.7.1 - Parameter names for calculated results

Table 2.8.1 - Parameter names for entered results

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