Host Interface Manuel IT1k

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cobas IT 1000 application Interface Description R Revision 10 – July 2012 1 Host Interface Description cobas IT 1000 Application Revision 10 for cobas IT 1000 Version 2.00.01

Transcript of Host Interface Manuel IT1k

Page 1: Host Interface Manuel IT1k

cobas IT 1000 application Interface Description R

Revision 10 – July 2012 1

Host Interface Description cobas IT 1000 Application

Revision 10 for cobas IT 1000 Version 2.00.01

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Table of Contents 1. Overview & Scope ................................................................................................. 5 2. HL7 TCP/IP Low Level Interface ........................................................................ 5 3. ASTM TCP/IP Interface ....................................................................................... 5 4. HL7 Message Acknowledgment ........................................................................ 6 4.1 Acknowledgment Sending ......................................................................................................... 6 4.1.1 Example Message .............................................................................................................................................................. 6 4.2 MSH Segment ................................................................................................................................. 6 4.3 MSA Segment ................................................................................................................................. 7 4.4 Acknowledgment Reception ..................................................................................................... 7 4.5 Segments Used ............................................................................................................................... 7 4.5.1 Example Message .............................................................................................................................................................. 7 4.6 MSH Segment ................................................................................................................................. 8 4.7 MSA Segment ................................................................................................................................. 8 5. HL7 Patient Result Interface (Variant A) ......................................................... 9 5.1 Segments Used ............................................................................................................................... 9 5.1.1 Example Messages ............................................................................................................................................................ 9 5.2 MSH Segment ............................................................................................................................... 11 5.3 PID Segment .................................................................................................................................. 11 5.4 PV1 Segment ................................................................................................................................. 11 5.5 ORC Segment ................................................................................................................................ 12 5.6 OBR Segment ................................................................................................................................ 12 5.7 OBX Segment ................................................................................................................................ 12 5.7.1 Abnormal Flags ................................................................................................................................................................. 13 5.7.2 Upload Codes .................................................................................................................................................................... 13 6. HL7 Patient Result Interface (Variant B) ....................................................... 14 6.1 Segments Used ............................................................................................................................. 14 6.1.1 Example Messages .......................................................................................................................................................... 14 6.1 MSH Segment ............................................................................................................................... 15 6.2 PID Segment .................................................................................................................................. 16 6.3 NTE Segment ................................................................................................................................. 16 6.4 PV1 Segment ................................................................................................................................. 16 6.5 ORC Segment ................................................................................................................................ 16 6.6 OBR Segment ................................................................................................................................ 17 6.7 NTE Segment ................................................................................................................................. 17 6.8 OBX Segment ................................................................................................................................ 17 6.8.1 Observation Identifiers ................................................................................................................................................... 17 6.8.2 Abnormal Flags ................................................................................................................................................................. 18 6.9 NTE Segment ................................................................................................................................. 18 7. HL7 ADT Interface .............................................................................................. 19 7.1 Supported ADT Events ............................................................................................................... 20 7.1.1 Basic Events Supported by cobas IT 1000 .............................................................................................................. 21 7.2 Segments Used ............................................................................................................................. 22 7.2.1 Example Message ............................................................................................................................................................ 22 7.3 MSH Segment ............................................................................................................................... 22 7.4 EVN Segment ................................................................................................................................ 22 7.5 PID Segment .................................................................................................................................. 23 7.6 PV1 Segment ................................................................................................................................. 23

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7.7 MRG Segment ............................................................................................................................... 23 8. ASTM Patient Results Interface (Variant A) ................................................. 24 8.1 Records Used ................................................................................................................................ 24 8.1.1 Example Messages .......................................................................................................................................................... 24 8.2 Header Record .............................................................................................................................. 26 8.3 Patient Information Record ...................................................................................................... 27 8.4 Patient Information Comment ................................................................................................. 27 8.5 Test Order Record ....................................................................................................................... 27 8.6 Test Order Comment .................................................................................................................. 27 8.7 Result Record ................................................................................................................................ 28 8.7.1 Abnormal Flags ................................................................................................................................................................. 28 8.7.2 Universal Test IDs ............................................................................................................................................................. 28 8.8 Test Order Comment .................................................................................................................. 29 8.9 Message Terminator Record ................................................................................................... 29 9. ASTM Patient Results Interface (Variant B) ................................................. 30 9.1 Records Used ................................................................................................................................ 30 9.1.1 Example Messages .......................................................................................................................................................... 30 9.2 Header Record .............................................................................................................................. 34 9.3 Patient Information Record ...................................................................................................... 34 9.4 Result Record ................................................................................................................................ 35 9.4.1 Abnormal Flags ................................................................................................................................................................. 35 9.4.2 Upload Codes .................................................................................................................................................................... 36 9.5 Test Order Record ....................................................................................................................... 36 9.6 Message Terminator Record ................................................................................................... 36 10. HL7 QC Result Interface (Variant A) .............................................................. 37 10.1 Segments Used ............................................................................................................................. 37 10.1.1 Example Message ............................................................................................................................................................ 37 10.2 MSH Segment ............................................................................................................................... 38 10.3 ORC Segment ................................................................................................................................ 38 10.4 OBR Segment ................................................................................................................................ 38 10.5 OBX Segment ................................................................................................................................ 39 10.5.1 Abnormal Flags ................................................................................................................................................................. 39 10.5.2 Upload Codes .................................................................................................................................................................... 40 11. HL7 QC Result Interface (Variant B) .............................................................. 41 11.1 Segments Used ............................................................................................................................. 41 11.1.1 Example Message ............................................................................................................................................................ 41 11.2 MSH Segment ............................................................................................................................... 41 11.3 ORC Segment ................................................................................................................................ 42 11.4 OBR Segment ................................................................................................................................ 42 11.5 OBX Segment ................................................................................................................................ 42 11.6 NTE Segment ................................................................................................................................. 43 11.6.1 Abnormal Flags ................................................................................................................................................................. 43 11.6.2 Observation Identifiers ................................................................................................................................................... 43 12. ASTM QC Results Interface (Variant A) ........................................................ 44 12.1 Records Used ................................................................................................................................ 44 12.1.1 Example Message ............................................................................................................................................................ 44 12.2 Header Record .............................................................................................................................. 44 12.3 Patient Information Record ...................................................................................................... 44 12.4 Test Order Record ....................................................................................................................... 45 12.5 Result Record ................................................................................................................................ 45 12.5.1 Abnormal Flags ................................................................................................................................................................. 46 12.5.2 Universal Test IDs ............................................................................................................................................................. 46

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12.6 Comment Record ......................................................................................................................... 46 12.7 Message Terminator Record ................................................................................................... 46 13. ASTM QC Results Interface (Variant B)......................................................... 47 13.1 Records Used ................................................................................................................................ 47 13.1.1 Example Message ............................................................................................................................................................ 47 13.2 Header Record .............................................................................................................................. 47 13.3 Patient Information Record ...................................................................................................... 48 13.4 Test Order Record ....................................................................................................................... 48 13.5 Result Record ................................................................................................................................ 48 13.5.1 Abnormal Flags ................................................................................................................................................................. 49 13.5.2 Upload Codes .................................................................................................................................................................... 49 13.6 Message Terminator Record ................................................................................................... 49 14. Limitations ............................................................................................................ 50 15. Revisions ............................................................................................................... 51 15.1 Revision 6 ........................................................................................................................................ 51 15.2 Revision 7 ........................................................................................................................................ 51 15.3 Revision 8 ........................................................................................................................................ 51 15.4 Revision 9 ........................................................................................................................................ 52 15.5 Revision 10 ..................................................................................................................................... 52

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1. Overview & Scope This document describes the host interface for the cobas IT 1000 application. The messages described are to be considered an outline, as the default configuration and mapping may be adapted to a specific installation to consider a specific protocol implementation used by customer systems.

Note: The host interface does not support secure data transmission. When using host communication, it has to be ensured by the infrastructure of the customer that data in transport is protected appropriately. It is the customer's responsibility that access to the network is restricted only to authorized entities and/or the communication protocol is secured. This can be achieved by using application level tunnelling protocols like TLS or other means of network encryption.

2. HL7 TCP/IP Low Level Interface The host (HIS and/or LIS) and cobas IT 1000 application computers will communicate using two TCP/IP sockets. For ADT Messages, the cobas IT 1000 application will open a listening port (server mode) to which the external host computer will connect to (client mode). The Results Message socket is opened in the Connect (Client) mode. The host computer must have the results socket opened in the Listen (Server) mode. If the cobas IT 1000 application server cannot connect, it will try to reopen the socket periodically.

The packet of information is formatted as follows:

VT {HL7 Message} FS CR

Where:

VT ASCII character 0x0B

{HL7 Message} The actual HL7 message with ending CR

FS ASCII character 0x1C

CR Carriage Return, ASCII character 0x0D

There is no checksum or other method to determine the packet integrity other than the one provided by the TCP/IP layer.

3. ASTM TCP/IP Interface The host (LIS) and cobas IT 1000 application computers will communicate using one TCP/IP socket. Typically the Results Message socket is opened in the Connect (Client) mode. The host computer then must have the results socket opened in the Listen (Server) mode. If the cobas IT 1000 application server cannot connect, it will try to reopen the socket periodically.

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4. HL7 Message Acknowledgment This message is sent to the transmitting computer from the receiving computer upon receipt of a message. The receiving computer can accept or reject the message.

4.1 Acknowledgment Sending The cobas IT 1000 application at this stage sends a positive acknowledgment message for every received message received. Nevertheless, the acceptance of the message by cobas IT 1000 does not declare that the message can be processed.

4.1.1 Example Message MSH|^~\&|SCC|SCC|HIS|cobasIT1000|20090904155450||ACK|0909042FC511D9889|P|2.3 MSA|AA|1003|Message Ok

4.2 MSH Segment MSH|^~\&|SCC|SCC|HIS|cobasIT1000|20090904155450||ACK|0909042FC511D9889|P|2.3 Parameter Segment Value CommentLine ID 0 MSH Static ValueField Separator 1 ^~\& Static ValueSending Application 2 SCC Static ValueSending Facility 3 SCC Static ValueReceiving Application 4 HIS Static ValueReceiving Facility 5 cobasIT1000 Static ValueDate / Time of Message 6 20090904155450 YYYYMMDDHHMM Security 7 Static ValueMessage Type 8 ACK Static ValueMessage control ID 9 0909042FC511D9889Processing ID 10 P Static ValueHL7 Version ID 11 2.3 Static Value

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4.3 MSA Segment MSA|AA|1003|Message Ok Parameter Segment Value CommentLine ID 0 MSA Static Value

Acknowledgment Code 1 AA Static Value, currently only AA (Application Accept) supported

Message Control ID 2 1003 ID of acknowledged message Text Message 3 Message Ok Static Value

4.4 Acknowledgment Reception The respective MSH segments (Accept Acknowledge and Application Acknowledge) of a result message sent from the cobas IT 1000 application to the host indicate what type of acknowledgment is required from the application receiving results. In the default configuration the cobas IT 1000 application does not expect an accept acknowledgment (Accept Acknowledge = NE) but requires an acknowledgment after successful processing of the message by the receiving application (Application Acknowledge = SU). Only finally accepted messages (Acknowledgement Code = AA and Delayed Acknowledgment Type = F or empty) are regarded as accepted. The cobas IT 1000 application is resending a result message unless it is finally accepted.

4.5 Segments Used Value Description MSH Message Header MSA Message Acknowledgment

4.5.1 Example Message MSH|^~\&||LISPower||cobasIT1000|20090904155450||ACK|0909042FC511D9889|P|2.3 MSA|AA|1003|Message Ok||F|

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4.6 MSH Segment

MSH|^~\&|SCC|SCC|HIS|cobasIT1000|20090904155450||ACK|0909042FC511D9889|P|2.3 Parameter Segment Value CommentLine ID 0 MSHField Separator 1 ^~\&Sending Application 2 Sending Facility 3 LIS PowerReceiving Application 4 Receiving Facility 5 cobasIT1000Date / Time of Message 6 20090904155450 YYYYMMDDHHMM Security 7 Message Type 8 ACKMessage control ID 9 0909042FC511D9889Processing ID 10 PHL7 Version ID 11 2.3

4.7 MSA Segment MSA|AA|1003|Message Ok||F| Parameter Segment Value CommentLine ID 0 MSA Static Value

Acknowledgment Code 1 AA

AA=Application (acknowledgment) AcceptAE=Application (acknowledgment) Error AR=Application (acknowledgment) Reject CA=Accept acknowledgment: Commit Accept CE=Accept acknowledgment: Commit Error CR=Accept acknowledgment: Commit Reject

Message Control ID 2 1003 ID of acknowledged message Text Message 3 Message Ok

Delayed Acknowledgement Type 5 F

D=Message received, stored for later processing F=Acknowledgement after processing <empty>=Processing not deferred

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5. HL7 Patient Result Interface (Variant A) When all test results of a sample have been accepted, the Host Connectivity Agent (HCA) will generate an HL7 message and transmit the message to the Host system. Result messages transmitted include patient results, patient demographics and comments.

The cobas IT 1000 application works exclusively with unsolicited result sending.

5.1 Segments Used Value Description MSH Message Header PID Patient Identification PV1 Patient Visit ORC Common Order OBR Observation Request OBX Results Segment

5.1.1 Example Messages

5.1.1.1 Example of a result with one test parameter per sample MSH|^~\&|cobasIT1000||LIS||20120524105447||ORU^R01|12052430F65C2662|P|2.3|||NE|SU PID|1||PT0010||BUDD^AURELIO^||19241024|M|||||||||| PV1|1||D01|||||||||||||||| ORC|NW|^HIS|||CM||||20111011163032 OBR||^HIS||||||||||||||||||||20111011162931|||F OBX|1|ST|PATID|1|PT0010||||||F OBX|2|ST|VISIT|1|||||||F OBX|3|ST|LASTNAME|1|BUDD||||||F OBX|4|ST|FIRSTNAME|1|AURELIO||||||F OBX|5|ST|SEX|1|M||||||F OBX|6|ST|DATEOFBIRTH|1|19241024||||||F OBX|7|ST|ANALYZERNAME|1|ACI II UU11000310||||||F OBX|8|ST|ANALYZEDATETIME|1|20111011162931||||||F OBX|9|ST|OPID|1|OP0110||||||F OBX|10|ST|Glu2|1|> 600|mg/dL|-||||F|||20111011162931 OBX|11|ST|1|1|Alarm flag received from instrument||||||F OBX|12|ST|2|1|Operator not certified for this instrument type||||||F

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5.1.1.2 Example of a result with several test parameter per sample MSH|^~\&|cobasIT1000||LIS||20120524104935||ORU^R01|1205241E4D9AB2881|P|2.3|||NE|SU PID|1||PT0009||OROURKE^HANNELORE^||19861213|F|||||||||| PV1|1||D01|||||||||||||||| ORC|NW|^HIS|||CM||||20111107151721 OBR||^HIS||||||||||||||||||||20111107151500|||F OBX|1|ST|PATID|1|PT0009||||||F OBX|2|ST|VISIT|1|||||||F OBX|3|ST|LASTNAME|1|OROURKE||||||F OBX|4|ST|FIRSTNAME|1|HANNELORE||||||F OBX|5|ST|SEX|1|F||||||F OBX|6|ST|DATEOFBIRTH|1|19861213||||||F OBX|7|ST|ANALYZERNAME|1|Urisys 1100 425||||||F OBX|8|ST|ANALYZEDATETIME|1|20111107151500||||||F OBX|9|ST|OPID|1|||||||F OBX|10|ST|Glu (UA)|1|50|MG/DL|-||||F|||20111107151500 OBX|11|ST|1|1|Alarm flag received from instrument||||||F OBX|12|ST|2|1|Test material LOT not valid||||||F OBX|13|ST|3|1|Patient result above instrument normal range||||||F OBX|14|ST|pH (UA)|1|7.0||-||||F|||20111107151500 OBX|15|ST|1|1|Test material LOT not valid||||||F OBX|16|ST|Ket|1|neg|MG/DL|-||||F|||20111107151500 OBX|17|ST|1|1|Test material LOT not valid||||||F OBX|18|ST|Leu|1|25|LEU/UL|-||||F|||20111107151500 OBX|19|ST|1|1|Alarm flag received from instrument||||||F OBX|20|ST|2|1|Test material LOT not valid||||||F OBX|21|ST|3|1|Patient result above instrument normal range||||||F OBX|22|ST|Nit|1|pos||-||||F|||20111107151500 OBX|23|ST|1|1|Alarm flag received from instrument||||||F OBX|24|ST|2|1|Test material LOT not valid||||||F OBX|25|ST|3|1|Patient result above instrument normal range||||||F OBX|26|ST|Pro|1|neg|MG/DL|-||||F|||20111107151500 OBX|27|ST|1|1|Test material LOT not valid||||||F OBX|28|ST|Ery|1|50|ERY/UL|-||||F|||20111107151500 OBX|29|ST|1|1|Alarm flag received from instrument||||||F OBX|30|ST|2|1|Test material LOT not valid||||||F OBX|31|ST|3|1|Patient result above instrument normal range||||||F

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5.2 MSH Segment MSH|^~\&|cobasIT1000||LIS||20120524104935||ORU^R01|1205241E4D9AB2881|P|2.3|||NE|SU Parameter Segment Value CommentLine ID 0 MSH Static ValueField Separator 1 ^~\& Static ValueSending Application 2 cobasIT1000 Static ValueReceiving Application 4 LIS Static ValueDate / Time of Message 6 20120524104935 YYYYMMDDHHMMSS Message Type 8 ORU^R01 Static ValueMessage control ID 9 1205241E4D9AB2881Processing ID: 10 P Static ValueHL7 Version ID 11 2.3 Static ValueAccept Acknowledge 14 NE Static ValueApplication Acknowledge 15 SU Static Value

5.3 PID Segment PID|1||PT0009||OROURKE^HANNELORE^||19861213|F||||||||||

Parameter Segment Value Comment Line ID 0 PID Static ValueSet ID - Patient ID 1 1 Static ValuePatient ID (Internal ID) 3 PT0009 PA_ID1 (Primary Patient ID) Alternate Patient ID 4 PA_ID2Patient's Name 5 OROURKE^HANNELORE^ Last Name^First Name^Middle NameDate of Birth 7 19861213 YYYYMMDDPatient Gender 8 FEthnic Origin 10

5.4 PV1 Segment PV1|1||D01|||||||||||||||| Parameter Segment Value CommentLine ID 0 PV1 Static ValueSet Id - PV1 1 1 Static ValueAssigned Patient Location 3 D01Visit Number 19

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5.5 ORC Segment ORC|NW|^HIS|||CM||||20111107151721 Parameter Segment Value CommentLine ID 0 ORC Static ValueOrder Control 1 NW Static Value (NW = New Order)Placer Order Number 2 ^HIS Static ValueOrder Status 5 CM Static Value (CM = Custom Made)Date/Time of Transaction 9 20111107151721 YYYYMMDDHHMMSS

5.6 OBR Segment OBR||^HIS||||||||||||||||||||20111107151500|||F Parameter Segment Value CommentLine ID 0 OBR Static Value Placer Order Number 2 ^HIS Static Value Results Reported 22 20111107151500 Result Status 25 F Static Value

5.7 OBX Segment OBX|1|ST|PATID|1|PT0009||||||F OBX|2|ST|VISIT|1|||||||F OBX|3|ST|LASTNAME|1|OROURKE||||||F OBX|4|ST|FIRSTNAME|1|HANNELORE||||||F OBX|5|ST|SEX|1|F||||||F OBX|6|ST|DATEOFBIRTH|1|19861213||||||F OBX|7|ST|ANALYZERNAME|1|Urisys 1100 425||||||F OBX|8|ST|ANALYZEDATETIME|1|20111107151500||||||F OBX|9|ST|OPID|1|||||||F OBX|10|ST|Glu (UA)|1|50|MG/DL|-||||F|||20111107151500 OBX|11|ST|1|1|Alarm flag received from instrument||||||F OBX|12|ST|2|1|Test material LOT not valid||||||F OBX|13|ST|3|1|Patient result above instrument normal range||||||F Parameter Segment Value CommentLine ID 0 OBX Static ValueCounter 1 10Value Type 2 ST Static ValueObservation Identifier 3 Glu (UA) TestsObservation Sub-Id 4 1Observation Results 5 50Units 6 MG/DLReference Range 7 - From - ToAbnormal Flags 8 Observ. Result Status 11 F Static ValueDate/Time of Observation 14 20111107151500

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5.7.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

5.7.2 Upload Codes

In addition to the Test Abbreviations used in the cobas IT 1000 application for uploading results, the following upload codes are used to upload data within the framework of OBX segments.

PATID Primary patient IDVISIT Visit ID LASTNAME Patient last nameFIRSTNAME Patient first nameSEX Patient sex DATEOFBIRTH Patient date of birthANALYZERNAME Name attributed to the instrumentANALYZEDATETIME Date and Time the measurement was doneOPID ID of the operator performing the test

COMMENTn Sample or test related comment(n is replaced by a counter starting with 1)

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6. HL7 Patient Result Interface (Variant B) When all test results of a sample have been accepted, the Host Connectivity Agent (HCA) will generate an HL7 message and transmit the message to the Host system. The cobas IT 1000 application works exclusively with unsolicited result sending.

For version 2.00.01 and higher, it is possible to send alarms as result comments to the host(s) in the message NTE segment (please refer to section 6.9 NTE Segment for more details).

6.1 Segments Used Value Description MSH Message Header PID Patient Identification NTE Notes and Comments PV1 Patient Visit ORC Common Order OBR Observation Request OBX Results Segment

6.1.1 Example Messages

6.1.1.1 Example of a result with one test parameter per sample MSH|^~\&|cobas IT 1000|LAB|LAB||20120626184649||ORU^R01|120626399C5967368|P|2.3|||NE|SU PID|1||B00704||DOE^JOHN^||20011031|M|||||||||| PV1|1||ER1|||||||||||||||| NTE|1||Patient recently admitted and about to change HIS Location ORC|NW||626000002||CM||^^^^^R||20120626184137|||||||||UU11041986 OBR|1|||GLUCOSE|||20120626184318||||A|||20120626184318||||||||20120626184358|||F||^^^^R|||||ROCHE NTE|1||No samples involved OBX|1|ST|Glu2||450|mg/dL|-||||F|||20120626184318||ROCHE NTE|1|O|Operator testing outside assigned unit(s) NTE|2|O|Operator not certified for this instrument type NTE|3|O|No QC done in defined interval NTE|4|O|No reference range defined

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6.1.1.2 Example of a result with several test parameter per sample MSH|^~\&|cobas IT 1000|LAB|LAB||20120626174559||ORU^R01|12062636214912435|P|2.3|||NE|SU PID|1||B00704||DOE^JOHN^||20011031|M|||||||||| PV1|1||ER1|||||||||||||||| NTE|1||Patient recently admitted and about to change HIS Location ORC|NW||622000008||CM||^^^^^R||20120622110025|||||||||INSKT01 OBR|1|||BG/ISE/MSS/COOX|||20120607092001||||A|||20120607092001|BLD|||||||20120626174556|||F||^^^^R|||||ROCHE NTE|1||Test comment OBX|1|ST|Hct(c)VB||45.2|nmol/L|-||||F|||20120607092001||ROCHE NTE|1|P|Test comment - results NTE|2|O|Result unit not defined for this test NTE|3|O|Operator not certified for this instrument type NTE|4|O|No reference range defined OBX|2|ST|tHb VB||6.8|g/dL|-||||F|||20120607092001||ROCHE NTE|1|O|Operator not certified for this instrument type NTE|2|O|No QC done since routine started. NTE|3|O|No reference range defined OBX|3|ST|PCO2 VB||7|kPa|-||||F|||20120607092001||ROCHE NTE|1|O|Result unit not defined for this test NTE|2|O|Operator not certified for this instrument type NTE|3|O|No QC done since routine started. NTE|4|O|No reference range defined OBX|4|ST|pH VB||7.321||-||||F|||20120607092001||ROCHE NTE|1|O|Patient result below instrument normal range NTE|2|O|Alarm flag received from instrument NTE|3|O|Operator not certified for this instrument type NTE|4|O|No QC done since routine started. NTE|5|O|No reference range defined OBX|5|ST|Phys. VB||-||-||||F|||20120607092001||ROCHE NTE|1|O|Operator not certified for this instrument type NTE|2|O|No reference range defined

6.1 MSH Segment MSH|^~\&|cobas IT 1000|LAB|LAB||20120626184649||ORU^R01|120626399C5967368|P|2.3|||NE|SU Parameter Segment Value CommentLine ID 0 MSH Static ValueField Separator 1 ^~\& Static ValueSending Application 2 cobas IT 1000 Static ValueSending Facility 3 LAB Static ValueReceiving Application 4 LAB Static ValueDate/Time of Message 6 20120626184649 YYYYMMDDHHMM Message Type 8 ORU^R01Message Control ID 9 120626399C5967368 Static ValueProcessing ID 10 P Static ValueVersion ID 11 2.3 Static Value Accept Acknowledge 14 NE Static ValueApplication Acknowledge 15 SU Static Value

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6.2 PID Segment PID|1||B00704||DOE^JOHN^||20011031|M|||||||||| Parameter Segment Value CommentLine ID 0 PID Static ValueSet ID 1 1 Static ValuePatient ID (Internal ID) 3 B00704 Primary Patient ID, PA_ID1 Alternate Patient ID 4 PA_ID2Patient's Name 5 DOE^JOHN^ Last Name^First Name^Middle NameDate of Birth 7 20011031 YYYYMMDDSex 8 MRace 10 Religion 17 Patient Account Number 18

6.3 NTE Segment NTE|1||Patient recently admitted and about to change HIS Location Parameter Segment Value CommentLine ID 0 NTESet ID - NTE 1 1 Counter

Comment 3 Patient recently admitted and about to change HIS Location

Comment on Patient

6.4 PV1 Segment PV1|1||ER1|||||||||||||||| Parameter Segment Value CommentLine ID 0 PV1 Static ValueSet Id - PV1 1 1 Static ValueAssigned Patient Location 3 ER1Visit Number 19

6.5 ORC Segment ORC|NW||626000002||CM||^^^^^R||20120626184137|||||||||UU11041986 Parameter Segment Value CommentLine ID 0 ORC Static ValueOrder Control 1 NW Static Value, NW = New Order Filler Order Number 3 626000002Order Status 5 CM Static Value, CM = Order completedQuantity/Timing 7 ^^^^^R Static Value, R = Routine Date/Time of Transaction 9 20120626184137 YYYYMMDDHHMMSS Entering Device 18 UU11041986 Instrument Serial Number

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6.6 OBR Segment OBR|1|||GLUCOSE|||20120626184318||||A|||20120626184318||||||||20120626184358|||F||^^^^R|||||ROCHE Parameter Segment Value CommentLine ID 0 OBR Static ValueSet ID - Observation Request

1 1 Static Value

Universal Service ID 4 GLUCOSE Test Type

Observation Date/Time 7 20120626184318 Results Reported Date/Time YYYYMMDDHHMMSS

Specimen Action Code 11 ASpecimen Rcv'd. Date/Time

14 20120626184318 Results Reported Date/Time YYYYMMDDHHMMSS

Specimen Source 15 Results Rpt./Status Change

22 20120626184358 Validation Date/Time YYYYMMDDHHMMSS

Result Status 25 F Static Value, F = Final Quantity/Timing 27 ^^^^R Static Value, R = Routine Principal Result Interpreter

32 ROCHE Validating User ID

6.7 NTE Segment NTE|1||No samples involved Parameter Segment Value CommentLine ID 0 NTESet ID - NTE 1 1 CounterComment 3 No samples involved Comment on Order

6.8 OBX Segment OBX|1|ST|Glu2||450|mg/dL|-||||F|||20120626184318||ROCHE Parameter Segment Value CommentLine ID 0 OBX Static ValueSet ID - OBX 1 1 CounterValue Type 2 ST Static Value, ST = String Observation Identifier 3 Glu Test Abbreviation Observation Results 5 450Units 6 mg/dLReference Range 7 - Min. Range - Max. Range Abnormal Flags 8 Observ. Result Status 11 F Static ValueDate/Time of Observation 14 20120626184318 Result Date/Time, YYYYMMDDHHMMSSResponsible Observer 16 ROCHE Performing Operator ID

6.8.1 Observation Identifiers

The Test Abbreviations used in the cobas IT 1000 application are used for uploading results.

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6.8.2 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

6.9 NTE Segment For versions below 2.00.01, the NTE segment will have the following format:

NTE|1||Example Parameter Segment Value CommentLine ID 0 NTESet ID - NTE 1 1 CounterComment 3 Example Comment on Result For version 2.00.01 and above, the NTE segment will have the following format if the user has enabled the feature that allows sending result alarms as comments.

NTE|1|O|Operator not certified for this instrument type NTE|1|P|Example Parameter Segment Value CommentLine ID 0 NTESet ID - NTE 1 1 Counter

NTE source 2 O or P

O for Other System (cobas IT 1000 alarm) comment Or P for Orderer/Placer (user) comment

Comment 3 Operator not certified for this instrument type Example

Comment on Result or Result alarm text

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7. HL7 ADT Interface The ADT (Admit, Transfer, Discharge) Interface is responsible for updating the patients in the cobas IT 1000 application. Patients discharged from the system are deleted if there is no result data. The interface follows the HL7 2.3 specification and can receive all the ADT message types defined. This section describes the message types that are processed, all other types are ignored. Additional fields not described in the ADT messages are ignored and will not cause a problem if sent to the cobas IT 1000 application. In the default configuration concurrent visits/account numbers are not supported. Alternate configurations enabling the support of concurrent visits/accounts or alternate leading IDs may influence the types of supported ADT events.

Patient information maintained in the cobas IT 1000 application are maintained and updated in relation to the selected primary patient identifier. To ensure correct behaviour, this primary patient identifier needs to be chosen with respect to the institutions' information infrastructure and prior to making changes to it, their effect on connected systems alike the cobas IT 1000 application needs to be taken into consideration. Patient information provided by the cobas IT 1000 application to other systems (e.g. connected instruments or result receiving host systems) as well as patient information based functionality (e.g. range checking) use the information available at the time of sending/processing. Later updates to this patient information as such do not trigger the alteration of information already provided or the reprocessing of result information. The ADT messages are processed in alphabetical order. For instance, if the following files exist in the folder from where the ADT files are read, A03.hl7 A010.hl7 QMG.hl7 A0100.hl7 A0109.hl7 A01000.hl7 A011.hl7 the files will be processed in the following order: 1. A010.hl7 2. A0100.hl7 3. A01000.hl7 4. A0109.hl7 5. A011.hl7 6. A03.hl7 7. QMG.hl7

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7.1 Supported ADT Events Event Description Function in cobas IT 1000 A01 Admit / visit notification ADD A02 Transfer a patient MODA03 Discharge/end visit DELA04 Register a patient ADDA05 Pre-admit a patient ADDA06 Change an outpatient to an inpatient MODA07 Change an inpatient to an outpatient MODA08 Update patient information MODA09 Patient departing - tracking MODA10 Patient arriving - tracking MODA11 Cancel admit/visit notification DELA12 Cancel transfer MODA13 Cancel discharge/end visit ADD A14 Pending admit PADDA15 Pending transfer PMOD A16 Pending discharge PDELA17 Swap patients MODA18 Merge patient information MERGEA19 Patient query DISA20 Bed status update DISA21 Patient goes on a “leave of absence" MODA22 Patient returns from a “leave of absence" MODA23 Delete a patient record DISA24 Link patient information DISA25 Cancel pending discharge CDELA26 Cancel pending transfer CMODA27 Cancel pending admit CADD A28 Add person information ADDA29 Delete person information DELA30 Merge person information DISA31 Update person information DISA32 Cancel patient arriving - tracking MODA33 Cancel patient departing - tracking MODA34 Merge patient information - patient ID only MERGEA35 Merge patient information - account number only MODA36 Merge patient information - patient ID and account number MERGEA37 Unlink patient information DISA38 Cancel pre-admit DELA39 Merge person - external ID DISA40 Merge patient - internal ID MERGEA41 Merge account - patient account number MOD A42 Merge visit - visit number MODA43 Move patient information - internal ID DISA44 Move account information - patient account number MODA45 Move visit information - visit number MODA46 Change external ID DISA47 Change internal ID MERGE

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A48 Change alternate patient ID MODA49 Change patient account number MODA50 Change visit number MODA51 Change alternate visit ID MOD

7.1.1 Basic Events Supported by cobas IT 1000 Function in cobas IT 1000 DescriptionADD Admit DEL Discharge DIS Ignore eventMOD Modify patient informationMERGE Merge patient informationPADD Pending admitPMOD Pending modificationPDEL Pending dischargeCADD Cancel pending admitCMOD Cancel pending modificationCDEL Cancel pending discharge

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7.2 Segments Used Value Description MSH Message Header EVN Event Type PID Patient Identification PV1 Patient Visit MRG Merge Patient Information

7.2.1 Example Message MSH|^~\&||LISPower||cobas|200821318856||ADT^A01|5004|P|2.5|||NE|NE|AU|ASCII EVN|A01||20081231083000 PID|1||5004^^^100^A||MEYER^PAUL||19940520|F||4|^^^^3121||||1201||||||||1100|||||||||AAA PV1|1||ICU15||||||||||||||||534536| MRG|||||6004

7.3 MSH Segment MSH|^~\&||LISPower||cobas|200821318856||ADT^A01|5004|P|2.5|||NE|NE|AU|ASCII Parameter Segment^Component Value CommentSending Application 2 Internally converted to 'HIS' Sending Facility 3 LISPower Internally converted to '1' Receiving Application 4 Internally converted to '1' Receiving Facility 5 cobas Internally converted to '1' Message Type 8^0 ADTADT Event 8^1 A01Message Control ID 9 5004

7.4 EVN Segment EVN|A01||20081231083000 Parameter Segment Value Comment

Planned Event 3 20081231083000 Date/Time of Event, YYYYMMDDHHMMSS

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7.5 PID Segment

! Do not use special characters in the patient IDAny non-printing or special characters in patient IDs, such as spaces or accent marks, will cause serious problem in cobas IT 1000 and in instruments and communications. Only the following characters are allowed in the patient ID: 0-9 A-Z, a-z,_,-

PID|1||5004^^^100^A||MEYER^PAUL||19940520|F||4|^^^^3121||||1201||||||||1100|||||||||AAA Parameter Segment Value CommentPatient ID (Internal ID) 3 5004 Primary Patient ID, PA_ID1

Patient ID (Internal ID) 3 5004 Patient ID used on Accu-Check Inform and Accu-Check Inform II Instruments

Patient ID (Internal ID) 3 5004 Patient Source (used for Patient Merge, survives merge)Patient ID (Internal ID) 3 5004 Planned Event IDAlternate Patient ID 4 PA_ID2Patient's Last Name 5^0 MEYERPatient's First Name 5^1 PAULPatient's Middle Name 5^2 Date of Birth 7 19940520 YYYYMMDDSex 8 F Ethnic Origin 10 4 Religion 17

7.6 PV1 Segment PV1|1||ICU15||||||||||||||||534536| Parameter Segment Value CommentAssigned Patient Location

3 ICU15

Attending Doctor 7 Visit Number 19 534536

7.7 MRG Segment MRG|||||6004 Parameter Segment Value CommentPrior Patient ID 5 6004 Merged Patent ID, will disappear from the system

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8. ASTM Patient Results Interface (Variant A) When all test results of a sample have been accepted, the Host Connectivity Agent (HCA) will generate an ASTM message and transmit the message to the Host system. The cobas IT 1000 application exclusively works with unsolicited result sending.

8.1 Records Used Value Description H Header P Patient Information O Test order R Result C Comment L Message Terminator

8.1.1 Example Messages

8.1.1.1 Example of a result with one test parameter per sample H|\^&|09090721CD2CB6810||Accu-Chek Inform Ser.# :UJ48033647||||||Meas|P|2.2|20090907115043 P|1|C22620313|133628||POST^BILLY^||19421115|F|||||||||||||||||CV07| C|1|I|Example Comment|G O|1|1206000112|MEASUREMENT||||||||||||Blood C|1|I|Example Comment|G R|1|^^^Glu|8.2|mmol/l| to|||F||50946||20071206113134 C|1|I|Example Comment|G L|1|N

8.1.1.2 Example of a result with several test parameter per sample H|\^&|0909073583C377374||Roche OMNI S Ser.# :6767||||||Meas|P|2.2|20090907173514 P|1|LACB14592917|14464||POST^BILLY^||19320628|M|||||||||||||||||08||| C|1|I|Critical condition|G O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Baro|768.4|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^AG|12|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^ALLEN|Acceptable|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BB|49.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BE|3.7|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BE(act)|2.9|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BEecf|4.6|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BO2|12.2|| to|||F||ROCHE||20090903221922

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O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^BUN|7.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Ca++|.94|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^cH+|47.1|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^cH+t|47.1|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^cHCO3-|30.5|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^cHCO3st|27.1|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Cl-|101.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^COHb|2.3|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^ctCO2B|66|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^ctCO2P|72.5|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^ctO2|4.8|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^FO2Hb|.4|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Hct|30.3|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Hct(c)|26.7|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^HHb|58.6|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^niCa|.91|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^K+|3.05|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Lac|1.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^MCHC|29.4|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^MetHb|.7|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Na+|140.7|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^O2Hb|38.4|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Osm|278|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^P/FIndex|113.8|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^P50|26.9|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^PCO2|8|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^PCO2t|8|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^pH|7.327|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^pHst|7.455|| to|||F||ROCHE||20090903221922

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O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^pHt|7.327|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^PO2|3.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^PO2t|3.2|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^SO2|39.6|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^SO2(c)|37.3|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^R|.84|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Temp|37|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^tHb|8.9|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Blood R|1|^^^Urea|2.6|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^FIO2|.21|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^Glu (BG)|4.9|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^a/f|>1year|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^tHB(e)|15|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^TimeDraw|0|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^DateChan|20070417|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^HbFactor|3|| to|||F||ROCHE||20090903221922 O|1|903000001|MEASUREMENT||||||||||||Not Available R|1|^^^TimeChan|222226|| to|||F||ROCHE||20090903221922 L|1|N

8.2 Header Record H|\^&|09090721CD2CB6810||Accu-Chek Inform Ser.# :UJ48033647||||||Meas|P|2.2|20090907115043 Parameter Segment Value Comment Record type 0 H Static Value Field Separator 1 \^& Static Value Message Control ID (unique) 2 09090721CD2CB6810

Sender Name 4 Accu-Chek Inform Ser.# :UJ48033647 [Instrument Type][Ser.# :][Instrument Serial Number]

Comment or special instruction 10 Meas Static Value

Processing ID 11 P Static Value, P = Production

Version number 12 2.2 Static Value Date and Time of Message 13 20090907115043 YYYYMMDDHHMMSS

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8.3 Patient Information Record P|1|C22620313|133628||POST^BILLY^||19421115|M|||||||||||||||||CV07|||| Parameter Segment^Component Value CommentRecord type 0 P Static ValueSequence number 1 1 Static ValuePractice assigned Patient ID 2 C22620313 Practice assigned patient ID (PA_ID2)Laboratory assigned Patient ID 3 133628 Laboratory assigned ID (PA_ID1) Patient ID No.3 4 PA_ID3Patient Last Name 5^0 POSTPatient First Name 5^1 BILLYPatient Middle Name 5^2Birthdate 7 19421115 YYYYMMDD Patient sex 8 MEthnic Origin 9Attending Physicisan ID 13Admission Status 24Location 25 CV07Patient Religion 28

8.4 Patient Information Comment C|1|I|Example Comment|G Parameter Segment Value CommentRecord type 0 C Static ValueSequence number 1 1 CounterComment Source 2 I Static Value, I = Clinical Instrument SystemComment Text 3 Example Comment Comment Type 4 G Static Value, G = Generic / Free text

8.5 Test Order Record O|1|1206000112|MEASUREMENT||||||||||||Blood Parameter Segment Value CommentRecord Type ID 0 O Static ValueSequence Number 1 1 Static ValueSpecimen ID 2 1206000112 Generated by the cobas IT 1000 application Instrument Specimen ID 3 MEASUREMENTSpecimen Descriptor 15 Blood

8.6 Test Order Comment C|1|I|Example Comment|G Parameter Segment Value CommentRecord type 0 C Static ValueSequence number 1 1 CounterComment Source 2 I Static Value, I = Clinical Instrument SystemComment Text 3 Example Comment Comment Type 4 G Static Value, G = Generic / Free text

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8.7 Result Record R|1|^^^Glu|8.2|mmol/l| to|||F||50946||20071206113134 Parameter Segment^Component Value Comment Record type 0 R Static Value Sequence Number 1 1 Counter Universal Test ID 2^3 ^^^GluData or Measurement Value 3 8.2Units 4 mmol/l

Reference Ranges 5 to [Min. Range][ to ][Max. Range]

Result abnormal Flag 6Result Status 8 F Static Value, F = FinalOperator identification 10 50946Date/time test completed 12 20071206113134 YYYYMMDDHHMMSS

8.7.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

8.7.2 Universal Test IDs

The Test Abbreviations used in the cobas IT 1000 application are used for uploading results.

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8.8 Test Order Comment C|1|I|Example Comment|G Parameter Segment Value CommentRecord Type 0 C Static ValueSequence Number 1 1 CounterComment Source 2 I Static Value, I = Clinical Instrument SystemComment Text 3 Example Comment Comment Type 4 G Static Value, G = Generic / Free text

8.9 Message Terminator Record L|1|N Parameter Segment Value CommentRecord type 0 L Static ValueSequence Number 1 1 Static ValueTermination Code 2 N Static Value, N = Normal termination

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9. ASTM Patient Results Interface (Variant B) When all test results of a sample have been accepted, the Host Connectivity Agent (HCA) will generate an ASTM message and transmit the message to the Host system. Results transmitted are patient results and demographics.

9.1 Records Used Value Description H Header P Patient Information O Test order R Result L Message Terminator

9.1.1 Example Messages

9.1.1.1 Example of a result with one test parameter per sample H|\^&||DataCare^1^1|||||HOST||P|1|20081020170734 P|1|||5004|MEYER^PAUL^||19940101|M|||||||||||||||||CV05||| R|0|^^^MEDREC|5004|||N||F||ROCHE|20081020154755|20081020154755|123 R|1|^^^PATID||||N||F||ROCHE|20081020154755|20081020154755|123 R|2|^^^VISIT||||N||F||ROCHE|20081020154755|20081020154755|123 R|3|^^^LASTNAME|MEYER|||N||F||ROCHE|20081020154755|20081020154755|123 R|4|^^^FIRSTNAME|PAUL|||N||F||ROCHE|20081020154755|20081020154755|123 R|5|^^^DOB|19940101|||N||F||ROCHE|20081020154755|20081020154755|123 R|6|^^^SEX|M|||N||F||ROCHE|20081020154755|20081020154755|123 R|7|^^^ANALYZERNAME|123|||N||F||ROCHE|20081020154755|20081020154755|123 R|8|^^^OPID|ROCHE|||N||F||ROCHE|20081020154755|20081020154755|123 R|9|^^^ANALYZEDATETIME|20081020154755|||N||F||ROCHE|20081020154755|20081020154755|123 R|10|^^^ORDERNUM|1020000001|||N||F||ROCHE|20081020154755|20081020154755|123 R|11|^^^TESTCODE|GLUCOSE|||N||F||ROCHE|20081020154755|20081020154755|123 O|1|1020000001||1020000001|^^^GLUCOSE|20081020154755|20081020154755||||||||Blood R|1|^^^Glu|150|mg/dL|-|||F||ROCHE|20081020154755|20081020154755|123 L|1|N

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9.1.1.2 Example of a result with several test parameter per sample H|\^&||DataCare^1^1|||||HOST||P|1|20090907173749 P|1|||14464|MEYER^PAUL^||19320628|M|||||||||||||||||08||| R|0|^^^MEDREC|14464|||N||F||ROCHE|20090903221922|20090903221922|6767 R|1|^^^PATID|LACB14592917|||N||F||ROCHE|20090903221922|20090903221922|6767 R|2|^^^VISIT||||N||F||ROCHE|20090903221922|20090903221922|6767 R|3|^^^LASTNAME|MEYER|||N||F||ROCHE|20090903221922|20090903221922|6767 R|4|^^^FIRSTNAME|PAUL|||N||F||ROCHE|20090903221922|20090903221922|6767 R|5|^^^DOB|19320628|||N||F||ROCHE|20090903221922|20090903221922|6767 R|6|^^^SEX|M|||N||F||ROCHE|20090903221922|20090903221922|6767 R|7|^^^ANALYZERNAME|cobas b 221|||N||F||ROCHE|20090903221922|20090903221922|6767 R|8|^^^OPID|ROCHE|||N||F||ROCHE|20090903221922|20090903221922|6767 R|9|^^^ANALYZEDATETIME|20090903221922|||N||F||ROCHE|20090903221922|20090903221922|6767 R|10|^^^ORDERNUM|903000001|||N||F||ROCHE|20090903221922|20090903221922|6767 R|11|^^^TESTCODE|BG/ISE/MSS/COOX|||N||F||ROCHE|20090903221922|20090903221922|6767 R|12|^^^COMMENT1|Critical condition|||N||F||||| O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BE(act)|2.9|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^AG|12|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^ALLEN|Acceptable||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Baro|768.4|mmHg|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BB|49.2|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BE|3.7|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BEecf|4.6|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BO2|12.2|vol%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^BUN|7.2|mg/dL|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Ca++|.94|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^cH+|47.1|nmol/L|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^cH+t|47.1|nmol/L|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^cHCO3-|30.5|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767

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O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^cHCO3st|27.1|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Cl-|101.2|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^COHb|2.3|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^ctCO2B|66|vol%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^ctCO2P|72.5|vol%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^ctO2|4.8|vol%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^FO2Hb|.4|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Hct|30.3|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Hct(c)|26.7|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^HHb|58.6|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^niCa|.91|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^K+|3.05|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Lac|1.2|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^MCHC|29.4|g/dL|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^MetHb|.7|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Na+|140.7|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^O2Hb|38.4|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Osm|278|mOsm/kg|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^P/FIndex|113.8|mmHg|-|||F||ROCHE|20090903221922|20090903221922|6767

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O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^P50|26.9|mmHg|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^PCO2|8|kPa|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^PCO2t|8|kPa|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^pH|7.327||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^pHst|7.455||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^pHt|7.327||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^PO2|3.2|kPa|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^PO2t|3.2|kPa|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^SO2|39.6|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^SO2(c)|37.3|%|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^R|.84||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Temp|37|C|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^tHb|8.9|g/dL|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Blood R|1|^^^Urea|2.6|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^FIO2|.21||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^Glu (BG)|4.9|mmol/l|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^a/f|>1year||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^tHB(e)|15|g/dL|-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^TimeDraw|0||-|||F||ROCHE|20090903221922|20090903221922|6767

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O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^DateChan|20070417||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^HbFactor|3||-|||F||ROCHE|20090903221922|20090903221922|6767 O|1|903000001||903000001|^^^BG/ISE/MSS/COOX|20090903221922|20090903221922||||||||Not Available R|1|^^^TimeChan|222226||-|||F||ROCHE|20090903221922|20090903221922|6767 L|1|N

9.2 Header Record H|\^&||DataCare^1^1|||||HOST||P|1|20081020170734 Parameter Segment Value CommentRecord type 0 H Static ValueField Separator 1 \^& Static ValueAccess Password 3 DataCare^1^1 Static ValueCharacteristics of sender 8 HOST Static ValueComment or special instruction 10 P Static ValueProcessing ID 11 1 Static ValueDate and time of message 12 20081020170734 YYYYMMDDHHMMSS

9.3 Patient Information Record P|1|||5004|MEYER^PAUL^||19940101|M|||||||||||||||||CV05||| Parameter Segment Value CommentRecord type 0 P Static ValueSequence number 1 1 Static ValueLaboratory assigned Patient ID 3 Patient Visit Number Patient ID No.3 4 5004 Laboratory assigned ID (PA_ID1)Patient Last Name 5^0 MEYERPatient First Name 5^1 PAULPatient Middle Name 5^2 Birthdate 7 19940101 YYYYMMDD Patient sex 8 MEthnic Origin 9 Attending Physicisan ID 13 Admission Status 24 Location 25 CV05Patient Religion 28

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9.4 Result Record R|1|^^^Glu|150|mg/dL|-|||F||ROCHE|20081020154755|20081020154755|123 Parameter Segment^Component Value Comment Record type 0 R Static Value Sequence Number 1 1 Counter Universal Test ID 2^3 ^^^GluData or Measurement Value 3 150Units 4 mg/dlReference Ranges 5 - [Min. Range][ - ][Max. Range]Result abnormal Flag 6Result Status 8 F Static Value, F = FinalOperator identification 10 ROCHEDate/time test completed 11 20081020154755 YYYYMMDDHHMMSSDate/time test completed 12 20081020154755 YYYYMMDDHHMMSSInstrument Serial Number 13 123

9.4.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

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9.4.2 Upload Codes

In addition to the Test Abbreviations used in the cobas IT 1000 application for uploading results, the following upload codes are used to upload data within the framework of result records.

MEDREC Primary patient IDPATID Secondary patient IDVISIT Visit ID LASTNAME Patient last nameFIRSTNAME Patient first nameSEX Patient sex DOB Name attributed to the instrumentANALYZERNAME Name attributed to the instrumentANALYZEDATETIME Name attributed to the instrument

OPID ID of the operator performing the test

ORDERNUM Specimen ID (generated by the cobas IT 1000 application)

TESTCODE Test panel (alias to the instrument type)

COMMENTn Sample or test related comment (n is replaced by a counter starting with 1)

9.5 Test Order Record O|1|1206000100||1206000100|^^^GLUCOSE|20071206112014|20071206112014||||||||Blood Parameter Segment Value CommentRecord Type ID 0 O Static ValueSequence Number 1 1 Static Value

Specimen ID 2 1206000100 Sample ID (generated by the cobas IT 1000 application

Universal Test ID 4 1206000100 Sample ID (generated by the cobas IT 1000 application (same as Segment 2)

Priority 5 ^^^GLUCOSE Instrument Type Requested/Ordered Date and Time 6 20071206112014 Date/Time test completed Specimen Collection Date and Time 7 20071206112014 Date/Time test completed Specimen Descriptor 15 Blood Specimen Name

9.6 Message Terminator Record L|1|N Parameter Segment Value CommentRecord type 0 L Static ValueSequence Number 1 1 Static ValueTermination Code 2 N Static Value, N = Normal termination

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10. HL7 QC Result Interface (Variant A) When a QC result has been accepted, the Host Connectivity Agent (HCA) will generate an HL7 message and transmit the message to the Host system. QC Results transmitted include result values and comments.

10.1 Segments Used Value Description MSH Message Header ORC Common Order OBR Observation Request OBX Results Segment

10.1.1 Example Message MSH|^~\&|cobasIT1000||LIS||20090907124844||ORU^R01|QC090907251F10F9459|Q|2.3 ORC|RE|^HIS|||CM||||||1234 OBR|1|^HIS|||||||VL|||||20081120095406|GLU-QC|||||20081120095406||20081120095406|||F||1234||||||1234|1234|1234 OBX|1|ST|LOTCONTROLNAME|1|GLU-QC||||||F OBX|2|ST|ANALYZERNAME|1|AC Inform UJ50021373||||||F OBX|3|ST|ANALYZERSERIAL|1|UJ50021373||||||F OBX|4|ST|LOTNUMBER|1|02710||||||F OBX|5|ST|LOTEXPIRATIONDATE|1|20101010||||||F OBX|6|ST|LOTNUMBER2|1|450707||||||F OBX|7|ST|LOTCONTROLNAME2|1|GLU-T||||||F OBX|8|ST|LOTEXPIRATIONDATE2|1|20101010||||||F OBX|9|ST|QCLEVEL|1|1||||||F OBX|10|ST|ANALYZEDATETIME|1|20081120095406||||||F OBX|11|ST|OPID|1|1234||||||F OBX|12|ST|Glu|1|133||113-153||||F|||20081120095406

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10.2 MSH Segment MSH|^~\&|cobasIT1000||LIS||20090907124844||ORU^R01|QC090907251F10F9459|Q|2.3

Parameter Segment Value CommentLine ID 0 MSH Static Value Field Separator 1 ^~\& Static Value Sending Application 2 cobasIT1000 Static Value Receiving Application 4 LIS Static Value Date / Time of Message 6 20090907124844 YYYYMMDDHHMM Message Type 8 ORU^R01 Static Value Message control ID 9 QC090907251F10F9459Processing ID 10 Q Static Value HL7 Version ID 11 2.3 Static Value

10.3 ORC Segment ORC|RE|^HIS|||CM||||||1234

Parameter Segment ^Component Value Comment Line ID 0 ORC Static ValueOrder Control 1 RE Static ValuePlacer Order Number 2^1 ^HIS Static ValueOrder Status 5 CM Static ValueVerified By 11 1234 Operator ID

10.4 OBR Segment OBR|1|^HIS|||||||VL|||||20081120095406|GLU-QC|||||20081120095406||20081120095406|||F||1234||||||1234|1234|1234

Parameter Segment ^Component Value Comment Line ID 0 OBR Static Value Sequence Number 1 1 Static Value Placer Order Number 2^1 ^HIS Static Value Collection Volume 9 VL Static Value Date/Time Control Completed 14 20081120095406 YYYYMMDDHHMMSSControl Material Name 15 GLU-QC Date/Time Control Completed 20 20081120095406 YYYYMMDDHHMMSSDate/Time Control Completed 22 20081120095406 YYYYMMDDHHMMSSResult Status 25 F Static Value, F = FinalOperator Identification 27 1234 Operator ID Operator Identification 33 1234 Operator ID Operator Identification 34 1234 Operator ID

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10.5 OBX Segment OBX|12|ST|Glu|1|133||113-153||||F|||20081120095406

Parameter Segment ^Component Value Comment Line ID 0 OBX Static ValueSequence Number 1 1 Static Value Field Type 2 ST Static ValueItem Code (Upload code) 3 Glu Observation SubID 4 1 Static Value Results for the Item 5 133 Units 6 QC Range 7 113-153 Abnormal Flags 8 Result Status 11 F Static Value, F = FinalResult Date/Time 14 20081120095406 YYYYMMDDHHMMSS

10.5.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

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10.5.2 Upload Codes

In addition to the Test Abbreviations used in the cobas IT 1000 application for uploading results, the following upload codes are used to upload data within the framework of OBX segments.

LOTCONTROLNAME Name of control materialANALYZERNAME Name of analyzerANALYZERSERIAL Serial number of analyzerLOTNUMBER Lot number of control materialLOTEXPIRATIONDATE Expiration date of control material lotLOTNUMBER2 Lot number of test materialLOTCONTROLNAME2 Name of test materialLOTEXPIRATIONDATE2 Expiration date of test material lotQCLEVEL QC level ANALYZEDATETIME Date and Time the measurement was doneOPID ID of the operator performing the test COMMENTn Comment

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11. HL7 QC Result Interface (Variant B) When a control result has been accepted, the Host Connectivity Agent (HCA) will generate an HL7 message and transmit the message to the Host system. The cobas IT 1000 application works exclusively with unsolicited result sending.

11.1 Segments Used Value Description MSH Message Header ORC Common Order OBR Observation Request OBX Results Segment NTE Notes and Comments

11.1.1 Example Message MSH|^~\&|cobas IT 1000|LAB|LAB||20090907125405||ORU^R01|QC090907256D83F9081|Q|2.3 ORC|NW||||CM||^^^^^R|||||||||||UJ50021373 OBR|1|||QC|||20081120112237||||A|||20081120112237|GLU-QC^02710^20101010^1^GLU-T^450707^20101010||||||||||F||^^^^R||||| OBX|1|ST|Glu||133||113-153||||F|||20081120112237||1234 NTE|1||Example

11.2 MSH Segment MSH|^~\&|cobas IT 1000|LAB|LAB||20090907125405||ORU^R01|QC090907256D83F9081|Q|2.3

Parameter Segment Value CommentLine ID 0 MSH Static Value Field Separator 1 ^~\& Static Value Sending Application 2 cobas IT 1000 Static Value Sending Facility 3 LAB Static Value Receiving Application 4 LAB Static Value Date / Time of Message 6 20090907125405 YYYYMMDDHHMM Message Type 8 ORU^R01 Static Value Message control ID 9 QC090907256D83F9081Processing ID 10 Q Static Value HL7 Version ID 11 2.3 Static Value

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11.3 ORC Segment ORC|NW||||CM||^^^^^R|||||||||||UJ50021373

Parameter Segment ^Component Value Comment Line ID 0 ORC Static ValueOrder Control 1 NW Static ValueOrder Status 5 CM Static ValuePriority (Routine) 7 ^^^^^R Static ValueDate/Time of receiving result from instrument 9 Instrument Serial Number 18 UJ50021373

11.4 OBR Segment OBR|1|||QC|||20081120112237||||A|||20081120112237|GLU-QC^02710^20101010^1^GLU-T^450707^20101010||||||||||F||^^^^R|||||

Parameter Segment ^Component Value Comment Line ID 0 OBR Static Value Sequence Number 1 1 Static ValueUniversal Service ID 4 QC Static Value Date/Time Control Completed 7 20081120112237 YYYYMMDDHHMMSSSpecimen Action Code 11 A Static Value Date/Time Control Completed 14 20081120112237 YYYYMMDDHHMMSSControl Material Name 15 GLU-QC Control Material Lot Number 15^1 02710 Control Material Lot Expiration Date 15^2 20101010 YYYYMMDD QC Level 15^3 1 Test Material Name 15^4 GLU-T Test Material Lot Number 15^5 450707 Test Material Lot Expiration Date 15^6 20101010 YYYYMMDDResult Status 25 F Static Value, F = Final Priority (Routine) 27^4 R Static Value

11.5 OBX Segment OBX|1|ST|Glu||133||113-153||||F|||20081120112237||1234

Parameter Segment ^Component Value Comment Line ID 0 OBX Static Value Sequence Number 1 1 Static Value Field Type 2 ST Static Value Item Code (Upload code) 3 Glu Test Abbreviation Results for the Item 5 133 QC Range 7 113-153 Abnormal Flags 8 Result Status 11 F Static Value, F = Final Result Date/Time 14 20081120112237 YYYYMMDDHHMMSSOperator ID 16 1234

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11.6 NTE Segment NTE|1||Example Parameter Segment Value Comment Line ID 0 NTE Static ValueSet ID - NTE 1 1 Counter Comment 3 Example Comment on Result

11.6.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

11.6.2 Observation Identifiers

The Test Abbreviations used in the cobas IT 1000 application are used for uploading results.

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12. ASTM QC Results Interface (Variant A) When all test results of a sample have been accepted, the Host Connectivity Agent (HCA) will generate an ASTM message and transmit the message to the Host system. The cobas IT 1000 application works exclusively with unsolicited result sending.

12.1 Records Used Value Description H Header P Patient Information O Test order R Result C Comment L Message Terminator

12.1.1 Example Message H|\^&|09090725E7A499375||Accu-Chek InformSer.# :UJ32008458||||||QC|Q|2.2|20090907130226 P|1 O|1||QC^20580^20101010^450707^20101010||||||||||||GLU-QC^1^GLU-T R|1|^^^Glu|133||113-153|||F||111||20081031103714 C|1|I|Example|G L|1|N

12.2 Header Record H|\^&|09090725E7A499375||Accu-Chek InformSer.# :UJ32008458||||||QC|Q|2.2|20090907130226 Parameter Segment Value Comment Record type 0 H Static Value Field Separator 1 \^& Static Value Message Control ID (unique) 2 09090725E7A499375

Sender Name 4 Accu-Chek InformSer.# :UJ32008458

[Instrument Type][Ser.# :][Instrument Serial Number]

Comment or special instruction 10 QC Static Value Processing ID 11 Q Static Value, P = ProductionVersion number 12 2.2 Static Value Date and Time of Message 13 20090907130226 YYYYMMDDHHMMSS

12.3 Patient Information Record P|1 Parameter Segment Value Comment Record type 0 P Static Value Sequence number (always 1) 1 1 Static Value

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12.4 Test Order Record O|1||QC^20580^20101010^450707^20101010||||||||||||GLU-QC^1^GLU-T Parameter Segment^Component Value Comment Record type 0 O Static Value Sequence number (always 1) 1 1 Static Value Instrument specimen ID 3^0 QC Static Value Control Material Lot Number 3^1 20580 Control Material Lot Expiration Date

3^2 20101010

Test Material Lot Number 3^3 Test Material Lot Expiration Date

3^4 20101010

Control Material Name 15 GLU-QC QC Level 15^1 1 Test Material Name 15^2 GLU-T

12.5 Result Record R|1|^^^Glu|133||113-153|||F||111||20081031103714 Parameter Segment^Component Value Comment Record type 0 R Static Value Sequence Number 1 1 Counter Universal Test ID 2^3 Glu Data or Measurement Value 3 133

Reference Ranges 5 113-153 [Min. Range][-][Max. Range]

Result abnormal Flag 6 Result Status 8 F Static Value, F = FinalOperator identification 10 111 Date/time test completed 12 20081031103714 YYYYMMDDHHMMSS

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12.5.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

12.5.2 Universal Test IDs

The Test Abbreviations used in the cobas IT 1000 application are used for uploading results.

12.6 Comment Record C|1|I|Example|G Parameter Segment^Component Value Comment Record type 0 C Static Value Sequence Number 1 1 Counter Comment Source 2 I Static Value Comment 3 Example Comment type 4 G Static Value

12.7 Message Terminator Record L|1|N Parameter Segment Value Comment Record type 0 L Static Value Sequence Number 1 1 Static Value

Termination Code 2 N Static Value, N = Normal termination

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13. ASTM QC Results Interface (Variant B) When a control result has been accepted, the Host Connectivity Agent (HCA) will generate an ASTM message and transmit the message to the Host system.

13.1 Records Used Value Description H Header P Patient Information O Test order R Result L Message Terminator

13.1.1 Example Message H|\^&||DataCare^1^1|||||HOST||Q|1|20081120131921 P|1 O|1|||||20081120131735|20081120131735||||||||GLU-QC^1^02710^^GLU-T^1^450707 R|1|^^^LOTCONTROLNAME|GLU-QC|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|2|^^^LOTNUMBER|02710|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|3|^^^LOTEXPIRATIONDATE|20101010|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|4|^^^LOTNUMBER2|450707|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|5|^^^LOTCONTROLNAME2|GLU-T|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|6|^^^LOTEXPIRATIONDATE2|20101010|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|7|^^^QCLEVEL|1|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|8|^^^ANALYZERNAME|AC Inform UJ50021373|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|9|^^^OPID|1234|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|10|^^^ANALYZEDATETIME|20081120131735|||N||F||1234|20081120131735|20081120131735|UJ50021373 R|11|^^^Glu|133||113-153|||F||1234|20081120131735|20081120131735|UJ50021373 L|1|N

13.2 Header Record H|\^&||DataCare^1^1|||||HOST||Q|1|20081120131921 Parameter Segment Value Comment Record type 0 H Static Value Field Separator 1 \^& Static Value Access Password 3 DataCare^1^1 Static Value Characteristics of sender 8 HOST Static Value Comment or special instruction 10 Q Static Value Processing ID 11 1 Static Value Date and time of message 12 20081120131921 YYYYMMDDHHMMSS

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13.3 Patient Information Record P|1 Parameter Segment Value Comment Record type 0 P Static Value Sequence number (always 1) 1 1 Static Value

13.4 Test Order Record O|1|||||20081120131735|20081120131735||||||||GLU-QC^1^02710^^GLU-T^1^450707 Parameter Segment^Component Value Comment Record type 0 O Static Value Sequence number (always 1) 1 1 Static Value Date/Time test completed 6 20081120131735 YYYYMMDDHHMMSSDate/Time test completed 7 20081120131735 YYYYMMDDHHMMSSControl Material Name 15^0 GLU-QC QC Level 15^1 1 Control Material Lot Number 15^2 02710 Test Material Name 15^4 GLU-T QC Level 15^5 1 Test Material Lot Number 15^6 450707

13.5 Result Record R|11|^^^Glu|133||113-153|||F||1234|20081120131735|20081120131735|UJ50021373 Parameter Segment^Component Value Comment Record type 0 R Static Value Sequence Number 1 11 Counter Universal Test ID 2^3 Glu Data or Measurement Value 3 133

Reference Ranges 5 113-153 [Min. Range][-][Max. Range]

Result abnormal Flag 6 Result Status 8 F Static Value, F = FinalOperator identification 10 111 Date/time test completed 11 20081031103714 YYYYMMDDHHMMSSDate/time test completed 12 20081031103714 YYYYMMDDHHMMSSInstrument serial number 13 UJ50021373

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13.5.1 Abnormal Flags

Value Description

Blank Normal Range

< Result below Instrument displayable range

> Result above Instrument displayable range

A Out of Normal Range

B Better

D Significant change down

H Result above Instrument normal range

HH Result above Instrument critical range

L Result below Instrument normal range

LL Result below Instrument critical range

N Normal Range

S Susceptible

U Significant change up

W Worse

13.5.2 Upload Codes

In addition to the Test Abbreviations used in the cobas IT 1000 application for uploading results, the following upload codes are used to upload data within the framework of result records.

LOTCONTROLNAME Name of control materialLOTNUMBER Lot number of control materialLOTEXPIRATIONDATE Expiration date of control material lotLOTNUMBER2 Lot number of test materialLOTCONTROLNAME2 Name of test materialLOTEXPIRATIONDATE2 Expiration date of test material lotQCLEVEL QC level ANALYZERNAME Name of analyzerOPID Id of the operator performing the testANALYZEDATETIME Date and Time the measurement was doneCommentn Comment

13.6 Message Terminator Record L|1|N Parameter Segment Value CommentRecord type 0 L Static ValueSequence Number 1 1 Static ValueTermination Code 2 N Static Value, N = Normal termination

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14. Limitations • In the current version the cobas IT 1000 application does not support a concept of

concurrent visits where a patient is identified for testing by a permanent ID (not a visit ID).

• HL7 result interfaces work only in asynchronous mode.

• Acknowledgment sending: The cobas IT 1000 application acknowledges every received message positively, also when the message cannot be processed.

• Acknowledgment reception: The cobas IT 1000 application does not parse the ERR segment, hence information sent there will not be available to the user.

• When a message cannot be processed on a parsing level, no acknowledgment message is sent to the host. In case of a synchronous workflow this will result in a stop of ADT message reception as the host will always resend the same message.

• The ASTM protocol does not support Thai characters in combination with checksums

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15. Revisions

15.1 Revision 6 Revision No. Release Date Affected Chapters Valid with SW Version6 September 2009 4, 4.1, 4.2, 5.1, 5.2, 6.1, 6.2, 8.1, 8.2, 10.1, 10.2, 11.1,

11.2, 12.1, 12.2 1.11

Chapter Modification / Addition4.1, 4.2, 5.1, 5.2, 6.1, 6.2, 8.1, 8.2, 10.1, 10.2, 11.1, 11.2, 12.1, 12.2

Format of Message Identifier changed

4 Handling of acknowledgement messages by cobas IT 1000 corrected Information about expected message processing speed added

4.2 Segment numbers corrected5.2 Segment numbers corrected11.2 Missing field Sending Facility added14 Chapter Limitations added5.1, 6.1, 8.1, 9.1 Example messages of a result with several test parameters per sample added

15.2 Revision 7 Revision No. Release Date Affected Chapters Valid with SW Version7 November 2009 4.4 1.12 Chapter Modification / Addition4.4 Acknowledgment processing updated

15.3 Revision 8 Revision No. Release Date Affected Chapters Valid with SW Version8 March 2010 4.4 1.13 Chapter Modification / Addition11.1, 11.5, 11.6 Corrected order of OBX and NTE segments in message

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15.4 Revision 9 Revision No. Release Date Affected Chapters Valid with SW Version9 September 2011 4.1, 4.4 2.00.00 Chapter Modification / AdditionGeneral Alignment of product name, headline formatting1 Addition of information that host connectivity security relies on environment security4.1 Removed statement about acknowledgment performance issue 4.4 Removed statement about version 1.12

15.5 Revision 10 Revision No. Release Date Affected Chapters Valid with SW Version10 July 2012 1, 2, 3,4 5, 6, 6.3, 6.7, 6.9 2.00.01 Chapter Modification / AdditionOverview & scope Corrected typo HL7 TCP/IP Low Level Interface

Minor text correction

ASTM TCP/IP Interface Corrected typo HL7 Message Acknowledgment

Minor text correction

HL7 Patient Result Interface (Variant A)

Minor text change

HL7 Patient Result Interface (Variant B)

Added information on the new requirement for version 2.00.01 to send alarms as result comments

Example of a result with alarms set as result comments

Added example of the message format which derives from the new requirements for version 2.00.01 to send alarms as result comments

NTE Segment Reworked with information on the NTE segment derived from the new requirement for version 2.00.01 to send alarms as result comments

HL7 ADT interface Fix for ICATT CITP00034941