The document discusses the host interface for the cobas 4800 system, including communication layers, scenarios, protocols (ASTM and HL7), and record definitions.
The document discusses the communication layers and scenarios like full run inquiry, full order response, test result export, and work order inquiry. It describes scenarios like inquiry, response, and result export.
The document discusses using ASTM and HL7 protocols for communication between the cobas 4800 system and the LIS. It provides details on the record mappings for inquiries, responses and results for both protocols.
cobas 4800 system
Host Interface Manual
Software Version 1.02 r DRAFT
March 2010 Roche Diagnostics
Host Interface manual Page i cobas 4800 system Host interface Manual DRAFT Table of Contents General 1 .................................................................................... 1 Target audience .................................................................................... 1 References .................................................................................... 1 Document Revision History .................................................................................... 2 Contacts, Trademarks .................................................................................... 3 Glossary Overview 4 .................................................................................... 4 Communication Overview .................................................................................... 5 Communication layers Workflow 6 .................................................................................... 6 Communication Scenarios .................................................................................... 6 Work Order Inquiry .................................................................................... 8 Result export Message types 8 .................................................................................... 8 General Information .................................................................................... 8 Full Run Inquiry .................................................................................... 8 Full Order Response .................................................................................... 10 Test Result Export .................................................................................... 13 FLAGS Test Result Export workflow 16 March 2010 Roche Diagnostics Page ii Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol 17 .................................................................................... 19 COBAS 4800 ASTM Record Definitions .................................................................................... 20 Inquiry records Mappings (ASTM) .................................................................................... 20 H Segment .................................................................................... 21 P Segment .................................................................................... 21 Q Segment .................................................................................... 21 L Segment .................................................................................... 22 Inquiry Response Mapping .................................................................................... 22 H Segment .................................................................................... 23 P Segment .................................................................................... 23 O Segment .................................................................................... 24 L Segment .................................................................................... 25 Inquiry/response examples .................................................................................... 26 Results Mapping (ASTM) .................................................................................... 26 H Segment .................................................................................... 27 P Segment .................................................................................... 27 O Segment .................................................................................... 28 R Segment .................................................................................... 28 L Segment .................................................................................... 29 Results Example ASTM HL7 Protocol 31 .................................................................................... 32 COBAS 4800 HL7 Record Definitions .................................................................................... 33 Inquiry Records mapping (HL7) .................................................................................... 33 Inquiry Mapping .................................................................................... 35 Inquiry Response Mapping .................................................................................... 37 Results Mapping (HL7) .................................................................................... 40 Result Example HL7 March 2010 Roche Diagnostics Host Interface manual Page iii cobas 4800 system Host interface Manual DRAFT Communication setup 42 .................................................................................... 42 Network connection .................................................................................... 42 Instrument Setup Simulator 43 .................................................................................... 43 Installing simulators .................................................................................... 43 HL7 Simulator .................................................................................... 46 Setting up the simulator connection .................................................................................... 49 Connection test .................................................................................... 50 Sending an order to the system .................................................................................... 54 Receiving results from the system. .................................................................................... 57 ASTM Simulator Troubleshooting / logfiles 58 Known restrictions 58 Roche Diagnostics March 2010 Page 1 Host Interface manual Host interface Manual cobas 4800 system DRAFT General General 1
Target audience The intended audience for this manual is Host Interface programmers and the Roche Field engineers supporting the system. References [1] HL 7 Documentation Version 2.4, Health Level Seven, Ann Arbor MI, USA, www.HL7.org [2] ASTM Documentation 1394 LIS2 Note: Although ASTM and HL7 are the base of the data exchange, the result transmission is not a strict ASTM or HL7 format. The system presents CT/NG or HPV as global blocks of results and transmits them as such.
See the Result topics for the respective ASTM and HL7 formats for details. Document Revision History Document Version Revision Date 1.0 January 2009 1.02 Manual rev 02 March 2010 Copyright 2009, 2010, Roche Diagnostics Ltd. All rights reserved. Rev 02: Corrected some errors and omissions. Clarified the target audience of manual and simulators. Added definition Client / server. Added complete results fields tables Added examples multiple flags Added information regarding media types Added information regarding order handling (Tubes without orders) at various places. Timeout for order response from LIS increased to 180 seconds. This manual applies to Software Version 1.02 Information in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics GmbH. Every effort has been made to ensure that all the information contained in this manual is correct at the time of publishing. However, Roche Diagnostics Ltd. reserves the right to make any changes necessary without notice as part of ongoing product development. Document references These are internal Roche references DVS Number: 05702950001 Material Number: 10330010 Roche Diagnostics March 2010 Page 2 Host Interface manual cobas 4800 system Host interface Manual DRAFT General Contacts, Trademarks Contact Addresses Manufacturer Roche Diagnostics Ltd. Forrenstrasse CH-6343 Rotkreuz Switzerland Distribution Roche Diagnostics GmbH Sandhofer Strae 116 D-68305 Mannheim Germany Distribution in the US Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250 USA Questions or comments regarding the contents of this manual can be directed to the address below or to your Roche representative. Roche Diagnostics Ltd. Global Service Support Forrenstrasse 6343 Rotkreuz, Switzerland email: [email protected] Trademarks cobas is a trademark of Roche. Other brands or product names are trademarks of their respective holders. Roche Diagnostics March 2010 Page 3 Host Interface manual Host interface Manual cobas 4800 system DRAFT General Glossary MTS Medium Throughput System This name is sometimes used inside the protocol. Where the Acronym MTS is used, it means the cobas 4800 system.. A&D Amplification and detection. The system will only perform Amplification and detection on already prepared MWP, using the z 480 instrument. The A&D runs are not supported by the LIS workflow. AnD Same meaning as A&D - Often used inside records as the "&" character would be interpreted as separator and therefore cannot be used. Full run Samples will be prepared into a MWP by the cobas x 480, then the plate will be transferred manually to the cobas z 480 for the A&D run. GUID Stands for Global Unique Identifier. A unique identifier created by the system. It is a 128 bits number written in a pattern of hexadecimal numbers similar to : 3F2504E0-4F89-11D3-9A0C-0305E82C3301 It is used to identify a unique run in the transmission records. MWP Microwell plates. Transformer A software module that conforms XML communication files to the communication server. cobas x 480 instrument The cobas x 480 prepares the samples. The cobas x 480 is loaded with samples, consumables and reagents. After sample preparation, the multiwell plate with the PCR-ready samples is unloaded, sealed, and transferred to the cobas z 480 for amplification and detection. cobas z 480 analyzer The cobas z 480 utilizes fluorescence to detect nucleic acids amplified by using realtime PCR methodology. the loading and unloading of the multiwell plate is done manually. Roche Diagnostics March 2010 Page 4 Host Interface manual cobas 4800 system Host interface Manual DRAFT General Overview 2 The structure of the document is as follow The topic General describes general functions of the subsystem or the unit having influence on the implementation. This chapter contains no specifications but provides background information and context information for the specifications stated in the next chapter. The goal is to increase the legibility of the document. Topic HL7 contains all the specifications for the HL7 protocol. Topic ASTM contains all the specifications for the ASTM protocol. Communication Overview The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol. The connection is TPC/IP over ethernet. The RS-232 connection is not supported by the system. The cobas 4800 system offers two transmission protocols: -ASTM -HL 7 The communication is realized by xml files which are exchanged and evaluated between cobas 4800 sw <-> Transformer and Transformer <-> cobas 5000 IT Communications Server. Client /Server structure The communication is always established by the cobas 4800 control unit; the cobas 4800 system is always the TCP/IP client and the LIS is always the TCP/IP server. Roche Diagnostics March 2010 Page 5 Host Interface manual Host interface Manual cobas 4800 system DRAFT Overview Communication layers As all the communication is based on network connections, this manual addresses mostly the upper layer (application) related topics. This layer corresponds to the upper layer in the well known OSI model: Roche Diagnostics March 2010 Page 6 Host Interface manual cobas 4800 system Host interface Manual DRAFT Overview Workflow 3 Communication Scenarios The following table shows the communication scenarios existing for the cobas 4800. Table 1 Communications Scenarios Name Description Input Output Work Order Inquiry Full The cobas 4800 ask the LIS to get order details for one or more Samples Run Type, Test Type, Sample Ids For each sample: Sub Test Type, Media Type Work Order Inquiry A&D Only This mode is not supported by the LIS workflow Run Type, Test Type, Id of the MWP For each sample: Sub Test Type, Media Type, MWP Position Test Result Upload The cobas 4800 System sends the test result of a Run to the LIS Run Id, Run Type, Test Type Sub Test Type, Media Type, Test Result, Flags, Sample Id, Test Time Stamp, Order Time Stamp, Accepted Flag - Once the LIS has been enable by Roche support, the LIS must always respond to order requests. There is no possibility to work with "results sending only" and manually ordering. If the LIS cannot respond to order requests, the system cannot run tests unless the LIS is disabled again to work completely offline. Work Order Inquiry Figure 1 Work Order Inquiry The Work Order Inquiry Scenario is described In Figure 1. If a cobas 4800 user starts a run to test samples it loads the samples or the MWP plate. After the plate loading, the cobas 4800 system starts the above inquiry sequence to the LIS server. Roche Diagnostics March 2010 Page 7 Host Interface manual Host interface Manual cobas 4800 system DRAFT Workflow Missing orders: When sample numbers are received that do not have a corresponding test request in the Host system, the whole sample record must be skipped. No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure. See in Each protocol for details. When order numbers are skipped, the mismatch will be signaled on the screen as shown below (1): (Mismatch occurred between loaded and expected samples Please press "Unload Sample" ) The sample positions are indicated in (2) Possible correcting actions : 1. Unload the sample rack(s), remove the indicated sample tubes (2), reload the sample rack. or 2. Unload the sample rack, add orders to the indicated samples into the LIS system, reload the sample rack(s) Work order inquiry timeout: The timeout after a work order inquiry from the instrument is currently set at 180 seconds and cannot be changed. The complete work order list has to be completely transmitted within these 180 seconds, otherwise a timeout message will result. Roche Diagnostics March 2010 Page 8 Host Interface manual cobas 4800 system Host interface Manual DRAFT Workflow Result export The results can be manually exported to the LIS using the selected protocol (ASTM or HL7). The LIS has to be enabled to be able to export the results. If the system works in offline mode and tests are ordered manually , results cannot be exported via LIS. The total transmission time should not exceed 120 seconds otherwise the last results may not be transmitted. Message types 4 General Information The Full run, the A&D Only run and the result export have different data to transfer. The following tables show the detail of this data. Full Run Inquiry Table 2 Full Run Inquiry cobas 4800 Query Example HL7-Mapping ASTM-Mapping Run Type Full QPD-3-2 Q-5-6 Test Type CT/NG QPD-3-1 Q-5-4 Software MTS MSH-3 H-5-3 Version 0.9.1.0843 MSH-4 H-5-4 Sample Ids (1-94) 100101001 QPD-4 Q-3 Full Order Response Table 3 Full Order Response cobas 4800 Query Example HL7-Mapping ASTM-Mapping Run Type Full OBR-4-3 O-5-6 Test Type CT/NG OBR-4-1 O-5-4 Software LIS MSH-3-1 H-5-3 Version 6.3 MSH-4-1 H-5-4 Sample Id 0010212 OBR-3-1 O-3-1 SubTestType NG OBR-4-2 O-5-5 Media Type UT OBR-15 O-16
Roche Diagnostics March 2010 Page 9 Host Interface manual Host interface Manual cobas 4800 system DRAFT Message types
Table 4 Possible values SubTestType (order response) Type Possible values for subtype field (order response) CT/NG CT/NG CT NG HPV HPV High Risk Panel + Genotyping HPV High Risk Panel Table 5 * Possible values media Type Test subtype Possible value field Media Type Media names CT/NG CT UT UUT = UniTrans = Urine UniTrans NG CT/NG HPV HPV High Risk Panel PC SP = PreserveCyt = SurePath original tube is not validated on cobas 4800 PC and SP are used, whether the samples are in original containers or in secondary tube round base 13mL HPV16 HPV18 Roche Diagnostics March 2010 Page 10 Host Interface manual cobas 4800 system Host interface Manual DRAFT Message types Test Result Export Table 6 Test Result Export Test Result Export Example HL7 Mapping ASTM Mapping Start Time 2008-10-14T13:49:39 OBR-7 R-12 End Time 2008-10-14T13:50:45 OBR-8 R-13 Test Type CT/NG OBR-4 R-3 Run Type Full OBR-4 O-4 Run Id 83b6f32c-d31b-49a8-8239-13be65486ea3 MSH-10 O-4;H-5-1 User Id Laboperator OBX-16 R-11 Software MTS MSH-3 H-5-3 Version 0.9.3.0847 MSH-4 H-5-4 Created Admin ORC-10 O-17 Creation Date 2008-06-11T15:56:58 ORC-7-4 O-8 Plate Id (A&D Only) AD000012 OBX-3;OBR-3 O-3;H-5 For each Sample Test Result Examples: Invalid ; CT POS, NG POS ; See Test results combination tables for all possibilities. OBX-5-1 R-4-1 Flag Pattern M1,M3 OBX-5-2 R-4-2 Sub Test Type CT OBR-4 R-3 Sample Id 100101001 OBX-3;OBR-3 O-3;H-5 Media Type UUT OBR-15 O-16 Order Date 2008-10-14T13:50:38 OBR-27 O-15 Accepted Flag False OBX-11 O-26 MWP Position A5 OBX-3;OBR-3 O-3;H-5 Test result Possible values (Samples) invalid positive (POS) negative (NEG)
Test result Possible values (Controls) invalid Valid 11 Roche Diagnostics March 2010 Page 11 Host Interface manual Host interface Manual cobas 4800 system DRAFT Message types Test results combination tables : Table 7 cobas 4800 CT/NG Test Result Report and Interpretation CT POS, NG POS CT Positive, NG Positive. Specimen is positive for the presence of both CT and NG DNA. CT NEG, NG NEG CT Negative*, NG Negative*. Neither CT nor NG DNA, if present, could be detected. CT POS, NG NEG CT Positive, NG Negative*. Specimen is positive for the presence of CT DNA. NG DNA, if present, could not be detected. CT POS, NG Invalid CT Positive, NG Invalid. Specimen is positive for the presence of CT DNA. NG result is Invalid. Original specimen should be re-tested to obtain valid NG result. CT NEG, NG POS CT Negative*, NG Positive. CT DNA, if present, could not be detected. Specimen is positive for the presence of NG DNA. CT Invalid, NG Positive. CT Invalid, NG POS CT result is Invalid. Original specimen should be re-tested to obtain valid CT result. Specimen is positive for the presence of NG DNA. CT Invalid, NG NEG CT Invalid, NG Negative*. CT result is Invalid. Original specimen should be re-tested to obtain valid CT results. NG DNA, if present, could not be detected. CT NEG, NG Invalid CT Negative*, NG Invalid. CT DNA, if present, could not be detected. NG result is Invalid. Original specimen should be re-tested to obtain valid NG result. Invalid CT Invalid, NG Invalid. Both CT and NG results are Invalid. Original specimen should be re-tested to obtain valid CT and NG results. Failed No Result for Specimen Consult the cobas 4800 system Operators Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid CT and NG results. Roche Diagnostics March 2010 Page 12 Host Interface manual cobas 4800 system Host interface Manual DRAFT Message types Table 8 cobas 4800 HPV Test Result Report and Interpretation SubTest HPV High Risk Panel: HR HPV POS High Risk HPV Positive Specimen is positive for the DNA of any one of, or combination of, the following high risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HR HPV NEG High Risk HPV Negative* HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Invalid High Risk HPV Invalid Results are invalid. Original specimen should be re-tested to obtain valid result. Failed No Result for Specimen Consult the cobas 4800 system Operators Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid result. SubTest HPV High Risk Panel Plus Genotyping: Other HR HPV POS, HPV16 POS, HPV18 POS Other High Risk HPV Positive, HPV16 Positive, HPV18 Positive. Specimen is positive for HPV types 16 and 18 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. Other HR HPV POS, HPV16 POS, HPV18 NEG Other High Risk HPV Positive, HPV16 Positive, HPV18 Negative*. Specimen is positive for HPV type 16 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 18 DNA was undetectable or below the pre-set threshold. Other HR HPV POS, HPV16 NEG, HPV18 POS Other High Risk HPV Positive, HPV16 Negative*, HPV18 Positive. Specimen is positive for HPV type 18 DNA and the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 16 DNA was undetectable or below the pre-set threshold. Other HR HPV POS, HPV16 NEG, HPV18 NEG Other High Risk HPV Positive, HPV16 Negative*, HPV18 Negative*. Specimen is positive for the DNA of any one of, or combination of, the following high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. HPV types 16 and 18 DNA were undetectable or below the pre- set threshold. Other HR HPV NEG, HPV16 POS, HPV18 POS Other High Risk HPV Negative*, HPV16 Positive, HPV18 Positive. HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Specimen is positive for HPV types 16 and 18 DNA. Other HR HPV NEG, HPV16 NEG, HPV18 POS Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Positive. HPV types 16, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Specimen is positive for HPV type 18 DNA. Other HR HPV NEG, HPV16 POS, HPV18 NEG Other High Risk HPV Negative*, HPV16 Positive, HPV18 Negative*. HPV types 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Specimen is positive for HPV type 16 DNA. Other HR HPV NEG, HPV16 NEG, HPV18 NEG Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Negative*. HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA were undetectable or below the pre-set threshold. Invalid Invalid. The results are Invalid. Original specimen should be re-tested to obtain valid results. Failed No Result for Specimen Consult the cobas 4800 system Operators Manual for instructions to review run flags and recommended actions. Original specimen should be re-tested to obtain valid results. Roche Diagnostics March 2010 Page 13 Host Interface manual Host interface Manual cobas 4800 system DRAFT Message types FLAGS Result Interpretation Table 9 Flag Code Source Severity Description R1 RI Error General exception raised. R2 RI Error The Well Result List is null or empty. R3 RI Error The Well Result Node is invalid. R4 RI Error The Result Interpretation Parameters Node is null. R5 RI Error The Result Interpretation Parameters Node is invalid. R6 RI Error Input Xml Nodes mapping failed. R7 RI Error The Result Interpretation provides 4-dyes result interpretation. R8 RI Error The test ingredients have not been specified. R9 RI Error The test should have at least one target and at least one internal control. R10 RI Error The probes have not been specified. R11 RI Error The Well Result Node attributes are invalid. R12 RI Error The Algorithm Results Node is incomplete. R13 RI Error The Qualitative Interpretation Tables Node is invalid. R14 RI Error The Result Table Node is invalid. R15 RI Error The SubTest type or the ResultTable is invalid. R16 RI Error The Intermediate-Result Interpretation failed. R17 RI Error The Well-Result Interpretation failed. R18 RI Error The Multi-Well Result Interpretation failed. R19 RI Error The Ct ranges for the intermediate interpretation are invalid. R20 RI Warning The positive external control is invalid. R21 RI Warning The negative external control is invalid. Multiple or other reason Table 10 Flag Code Source
Severity Description M1 SW Error Software error. Additional information can be found in messages and the trace log files. M2 Other Error Aborted by the user M5 SW Warning PCR run only with a user defined sample preparation M6 SW Warning The connection to the instrument was temporarily lost Note: One Result can have several flags. Roche Diagnostics March 2010 Page 14 Host Interface manual cobas 4800 system Host interface Manual DRAFT Message types Calculation Table 11 Flag Code Source
Severity Description C1 CP Error General exception raised. C2 CP Error The RawData node is null. C3 CP Error The CalculationParameters node is null. C4 CP Error The RawData node is invalid. C5 CP Error The CalculationParameters node is invalid. C6 CP Error Input XmlNodes mapping failed. C7 CP Error The HpvCtng-CalculationPackage provides 4-dyes result interpretation. C8 CP Error The test ingredients have not been specified. C9 CP Error The test should have at least one target and at least one internal control. C10 CP Error The probes have not been specified. C11 CP Error The computation algorithm has not been specified. C12 CP Error The specified algorithm is not supported by this calculation package. C13 CP Error The specified algorithm version is not supported by this calculation package. C14 CP Error The calculation parameters for the numeric algorithm are incomplete. C15 CP Error The fluorescence measurements data is incomplete. C101 XT Error The CrossTalk compensation has failed. C102 XT Error The CrossTalkMatrix is null. C103 XT Error The Background vector is null. C104 XT Error CrossTalk Matrix has invalid entries. C105 XT Error The length of the background vector is not equal with CrossTalkMatrix filter combinations count. C106 XT Error Matrix coefficients calculation has failed. C107 XT Error Matrix inversion has failed. C108 XT Error Resolution matrix size and channel count do not match. C121 XT Error The RawData node is null. C122 XT Error The CalculationParameters node is null. C123 XT Error The RawData node is invalid. C124 XT Error The CalculationParameters node is invalid. C125 XT Error General exception raised. C221 KA2 Error The RawData node is null. C222 KA2 Error The AlgorithmParameters node is null. C223 KA2 Error The RawData node is invalid. Roche Diagnostics March 2010 Page 15 Host Interface manual Host interface Manual cobas 4800 system DRAFT Message types C224 KA2 Error The AlgorithmParameters node is invalid. C225 KA/KA2 Error General exception raised. C301 ELCA Warning CurvatureFailure C302 ELCA Error InterceptOutOfRange C303 ELCA Error SlopeOutOfRange C304 ELCA Warning CurveFitFailure C305 ELCA Warning AFIMinFailure C306 ELCA Error DataRangeFailure C307 ELCA Info InsufficientCurvature C308 ELCA Info DeclineCorrected C309 ELCA Error CTOutOfRange C321 ELCA Error The RawData node is null. C322 ELCA Error The CalculationParameters node is null. A&D errors Table 12 Flag Code Source
Severity Description Z1 AnDI Error Hardware or software error from the instrument. The run was aborted. SPI errors Table 13 Flag Code Source
Severity Description X1 SPI Error Hardware or software error from the instrument. The run was aborted. X2 SPI Info Barcode was entered manually. X3 SPI Error Clot detected for a sample. This sample will have an invalid result. X4 SPI Error Not enough liquid while processing a sample. This sample will have an invalid result. X5 SPI Error Reagent onboard time exceeded when the user tried to start the sample preparation process. The run was aborted. X6 SPI Error Working Master Mix with extract timed out after sample preparation has finished. The run was aborted. X7 SPI Error Error during processing of external control. Run results will be invalid. X8 SPI Error Hardware or software error from the instrument. Processing of the sample was aborted. Roche Diagnostics March 2010 Page 16 Host Interface manual cobas 4800 system Host interface Manual DRAFT Message types Test Result Export workflow 5 Figure 2 Test Result Export After a test run the results are shown to the user and become available to be exported. Figure 2 shows this scenario. Roche Diagnostics March 2010 Page 17 Host Interface manual Host interface Manual cobas 4800 system DRAFT Test Result Export workflow ASTM Protocol 6 The cobas 4800 ASTM protocol also implements the ASTM E1381-91 Low Level Protocol, although this is not the focus of this manual. No changes can be made at this level and because the system is implemented over a network communication, it just acts as an intermediate level inside the application layer, transmitting the data to the upper ASTM layer. The short description of the ASTM lower layer is here for information. Message example with intermediate frame: c4800 00:08:17,763 [ENQ] HOST 00:08:17,763 [ACK] c4800 00:08:17,883 [STX]1H|\^&|||MTS^c9507f52-37bc-43d4-bba6-360fb 74bd898^OrderFileValidator^1.0.0.0918^1394.LIS2 |||||LIS|TSREQ^REAL|P|1|20091001085217|[CR][ETX ]80[CR][LF] HOST 00:08:17,883 [ACK] c4800 00:08:17,983 [STX]2P|1|[CR][ETX]BB[CR][LF] HOST 00:08:17,983 [ACK] c4800 00:08:18,103 [STX]3Q|1|^RDR0003406\RDR0003408\RDR0003407\RDR 0003405\RDR0003404\RDR0003403\RDR0003424\RDR000 3423\RDR0003422\RDR0003421\RDR0003420\RDR000341 9\RDR0003418\RDR0003417\RDR0003416\RDR0003415\R DR0003414\RDR0003413\RDR0003412\RDR0003411\RDR0 003410\RDR0[ETB]5D[CR][LF] HOST 00:08:18,113 [ACK] c4800 00:08:18,203 [STX]4003409\RDR0000829\RDR0003494||^^^CT/NG^^F ull|[CR][ETX]FB[CR][LF] HOST 00:08:18,203 [ACK] c4800 00:08:18,314 [STX]5L|1|[CR][ETX]BA[CR][LF] HOST 00:08:18,314 [ACK] c4800 00:08:18,414 [EOT]
Frame Configurations For Middle Frame <STX> FN text <ETB> C1 C2 <CR><LF> For Last Frame <STX> FN text <ETX> C1 C2 <CR><LF> C1C2 represent the checksum characters. Control character (characters enclosed in < > <ENQ> is control character (HEX 05) <STX> is control character (HEX 02) <ETB> is control character (HEX 17) <CR> is control character (HEX 0D) <LF> is control character (HEX 0A) <ETX> is control character (HEX 03) <ACK> is control character (HEX 06) Roche Diagnostics March 2010 Page 18 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol Maximum Length of the Frame For one frame, maximum of 240 characters for text, 7 characters for frame control characters (not included in the 240). Messages equal to or less than 240 characters are transmitted as one final frame. Messages greater than 240 characters are split into frames that have character lengths that fall within the 240-character limit. The only or final remaining frame becomes the last frame and is indicated by <ETX>. All others are intermediate (middle) frames and are indicated by <ETB>. Results timeout: Timeout for messages sent by the cobas 4800 system: From the ENQ, the transmission including multiple frames should not exceed 120 seconds. Intermediate frames sent past this time will not be sent, the system will close the transmission with an EOT, Roche Diagnostics March 2010 Page 19 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol COBAS 4800 ASTM Record Definitions Message Structure The Message structures are defined in the syntax also used in [2 ] Work order inquiry H Record MESSAGE HEADER SEGMENT P Record Patient Record (empty, needed by protocol) Q Record Query information L Record ASTM message closing record Work order response H Record MESSAGE HEADER SEGMENT P Record Patient Record (empty, needed by protocol) O Record Order information : : Following O records until end of message L Record ASTM message closing record Test result export H Record MESSAGE HEADER SEGMENT P Record Patient Record (empty, needed by protocol) O Record Order information R Record Result information O Record Order information R Record Result information : : Following O / R records until end of message L Record ASTM message closing record 1 Roche Diagnostics March 2010 Page 20 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol cobas 4800 Field mappings The tables in topic Inquiry records Mappings (ASTM) are showing the mappings between the cobas 4800 xml file and the xml file which the host interface needs to work with. Inquiry records Mappings (ASTM) H Segment Table 14 ASTM Inquiry Message Header Segment Name and Number Type Comment Values Required H-1 String The character H identifies the record as a message header record H Yes H-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order |^ \ & Yes H-5-1 String Name of the application which sent this message MTS Yes H-5-2 GUID GUID representing the unique identifier of this message given from MTS by its xml-filename 128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFF- FFFF-FFFF- FFFFFFFFFFFF Yes H-5-3 String The name or shortcut of the user which create the message Any string Yes H-5-4 String The version of the sending software 0.9.4.0847 Yes H-5-5 Number Protocol version used as a version check to make sure that this message is interpreted correctly 1394.LIS2 Yes H-10 String Name of the application which has to receive this message LIS Yes H-11-1 String Message type used to delegate the tasks to the analyzer TSREQ (e.g TSREQ^REAL) Yes H-11-2 String Event trigger used to delegate the tasks to the analyzer REAL (e.g TSREQ^REAL) Yes H-12 String Processing mode (processing priority) P = Production P Yes H-13 Number Version number currently a constant number set to 1 1 Yes H-14 DateTime DateTime of the message put by the creating system on creation of this message YYYYMMDDhhmm ss e.g. 20081122121212 Yes 20 Roche Diagnostics March 2010 Page 21 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol P Segment The MTS software doesnt have any patient informations but the ASTM protocol does need a P record. Table 15 ASTM Inquiry Patient Information Segment Name and Number Type Comment Values Required P-1 String The character P identifies the record as a patient record P Yes P-2 Number For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined 1 Yes Q Segment Table 16 ASTM Inquiry Request Information Segment Name and Number Type Comment Values Required Q-1 String This field is coded as Q. Q Yes Q-2 Number For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined 1 Yes Q-3-2 String List of specimens separated by \ or The Plate Id for AnD Only runs (AnD workflow not supported) 020404~789043 2~098398 or AD0000034 Yes Q-5-4 String Test type. Example CT/NG or HPV ^^^CT/NG ^^Full Yes Q-5-6 Run type - Can only be Full (Not supported SpiOnly, AnDiOnly) ^^^CT/NG^^ Full Yes L Segment ASTM Inquiry L Segment (Message Terminator) Segment Name and Number Type Comment Values Required L-1 String This field is coded as L. L Yes L-2 int The Terminator field 1 Yes Roche Diagnostics March 2010 Page 22 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol Inquiry Response Mapping H Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment. Table 17 ASTM Response Message Header Segment Name and Number Type Comment Values Required H-1 String The character H identifies the record as a message header record H Yes H-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order |^ \ & Yes H-5-1 String Name of the application which sent this message LIS Yes H-5-2 GUID GUID representing the unique identifier of this message given from MTS by its xml-filename 128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF- FFFF-FFFF-FFFF- FFFFFFFFFFFF Yes H-5-3 String The name or shortcut of the user which create the message Any string Yes H-5-4 String The version of the sending software 6.2 Yes H-5-5 Number Protocol version used as a version check to make sure that this message is interpreted correctly 1394.LIS2 Yes H-10 String Name of the application which has to receive this message MTS Yes H-11-1 String Message type used to delegate the tasks to the analyzer TSREQ (e.g TSREQ^REAL) Yes H-11-2 String Event trigger used to delegate the tasks to the analyzer REAL (e.g TSREQ^REAL) Yes H-12 String Processing mode (processing priority) P = Production P Yes H-13 Number Version number currently a constant number set to 1 1 Yes H-14 DateTime DateTime of the message put by the creating system on creation of this message YYYYMMDDhhmmss e.g. 20081122121212 Yes Roche Diagnostics March 2010 Page 23 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol P Segment
The cobas 4800 software does not have any patient information but the ASTM protocol does need a P record. Table 18 ASTM Response Patient Information Segment Name and Number Type Comment Values Required P-1 String The character P identifies the record as a patient record P Yes P-2 Number For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined 1 Yes O Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment. The test order segment is holding all information related to a sample. Note: Missing orders. For samples that do not have a corresponding test request in the Host system, the whole O segment record must be skipped. Table 19 ASTM Response Test Order Segment Name and Number Type Comment Values Required O-1 String The character assigned to the order record shall be O O Yes O-2 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes O-3-1 String Unique identifier of the sample usually a barcode assigned to the sample (Specimen ID) 0001301^AD0000013^A6 Yes O-3-2 String Plate ID only for "AnD Only" runs (see Note 1) 0001301^AD0000013^A6 NO O-3-3 String MWP Position only for "AnD Only" runs 0001301^AD0000013^A6 NO O-5-4 String Identifies the testtype of the sample Known values are: - CT/NG - HPV ^^^CT/NG^NG^Full Yes O-5-5 String Identifies the sub test type of a sample. Can be different for each sample but must be a sub type of the TestType. Values, see Table ^^^CT/NG^NG^Full YES O-5-6 String Identifies the runtype of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only. See Note 1 ^^^CT/NG^NG^Full Yes O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSS e.g. 20081203143400 Yes (Note see restriction ) O-16 String Media Type. Allowed values, see Table String ex: UT Yes O-17 String Contents the user who has created the order admin Yes Note 1: A&D mode not supported by LIMS workflow 9 58 9 Roche Diagnostics March 2010 Page 24 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol L Segment ASTM response L Segment (Message Terminator) Segment Name and Number Type Comment Values Required L-1 String This field is coded as L. L Yes L-2 int The Terminator field 1 Yes Roche Diagnostics March 2010 Page 25 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol Inquiry/response examples outgoing - ASTM: H|\^&|||MTS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394. LIS2|||||LIS|TSREQ^REAL|P|1|20090403081313| P|1| Q|1|^15200049\15200059\15200043\15200073\15200013\15200071\15200041 \15200011\15200069\15200039\15200009\15200067\15200037\15200007\15200065 \15200035\15200005\15200093\15200063\15200033\15200003\15200091\15200061 \15200031\15200027||^^^CT/NG^^Full| L|1| incoming - ASTM: H|\^&|||LIS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394. LIS2|||||MTS|TSREQ^REAL|P|1|20090403083315| P|1 O|1|15200049^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|2|15200059^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|3|15200043^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|4|15200073^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|6|15200071^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|7|15200041^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|8|15200011^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|9|15200069^^||^^^CT/NG^CT^Full|||20090403083315||||||||UT|none O|10|15200039^^||^^^CT/NG^NG^Full|||20090403083315||||||||UT|none O|11|15200009^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UT|none O|12|15200067^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UUT|none O|13|15200037^^||^^^CT/NG^NG^Full|||20090403083315||||||||UUT|none O|14|15200007^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|15|15200065^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|none O|16|15200035^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|17|15200005^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|18|15200093^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|19|15200063^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|20|15200033^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|21|15200003^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|22|15200091^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|23|15200061^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|24|15200031^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none O|94|15200027^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|none L|1 Note: When sample numbers are received that do not have a corresponding test request in the Host system, the whole sample record must be skipped. No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure. Example: If the sample numbers 15200065 and 15200027 do not have a test for cobas 4800, the lines marked in bold in the ASTM response from the Host would not exist. Roche Diagnostics March 2010 Page 26 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol Results Mapping (ASTM) H Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment. Table 20 ASTM Response Message Header Segment Name and Number Type Comment Values Required H-1 String The character H identifies the record as a message header record H Yes H-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order |^ \ & Yes H-5-1 String Name of the application which sent this message LIS Yes H-5-2 GUID GUID representing the unique identifier of this message given from MTS by its xml-filename 128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF- FFFF-FFFF-FFFF- FFFFFFFFFFFF Yes H-5-3 String The name or shortcut of the user which create the message Any string Yes H-5-4 String The version of the sending software 6.2 Yes H-5-5 Number Protocol version used as a version check to make sure that this message is interpreted correctly 1394.LIS2 Yes H-10 String Name of the application which has to receive this message MTS Yes H-11-1 String Message type used to delegate the tasks to the analyzer TSREQ (e.g TSREQ^REAL) Yes H-11-2 String Event trigger used to delegate the tasks to the analyzer REAL (e.g TSREQ^REAL) Yes H-12 String Processing mode (processing priority) P = Production Yes H-13 Number Version number currently a constant number set to 1 1 Yes H-14 DateTime DateTime of the message put by the creating system on creation of this message YYYYMMDDhhmmss e.g. 20081122121212 Yes Roche Diagnostics March 2010 Page 27 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol P Segment
The cobas 4800 software does not have any patient information but the ASTM protocol does need a P record. Table 21 ASTM Response Patient Information Segment Name and Number Type Comment Values Required P-1 String The character P identifies the record as a patient record P Yes P-2 Number For the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined 1 Yes O Segment This table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment. The test order segment is holding all information related to a sample. Table 22 ASTM Test Order Segment Name and Number Type Comment Values Required O-1 String The character assigned to the order record shall be O O Yes O-2 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes O-3-1 String Unique identifier of the sample usually a barcode assigned to the sample (Specimen ID) 0001301^AD0000013^A6 Yes O-3-2 String Plate ID only for AnD Only runs 0001301^AD0000013^A6 NO O-3-3 String MWP Position only for AnD Only runs 0001301^AD0000013^A6 NO O-4 String Run type of the test Full or AnD Only Yes O-5-4 String Identifies the testtype of the sample allowed values are: - CTNG - HPV ^^^CT/NG^NG^Full Yes O-5-5 String Identifies the sub test type of a sample. Can be diffrent for each sampl but must be a sub type of the TestType. See Table ^^^CT/NG^NG^Full YES O-5-6 String Identifies the runtype of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only ^^^CT/NG^NG^Full Yes O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSS e.g. 20081203143400 Yes O-16 String Media Type Allowed values see Table String ex: UT Yes O-17 String Contents the user who has created the order admin Yes O-26 String Type of Results: F=Final Results; P=preliminary results depends of the result export flag ccepted. F Means result was accepted P Means result was not accepted (yet) F or P Yes 9 9 Roche Diagnostics March 2010 Page 28 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol . R Segment Note: The system presents CT/NG or HPV as global blocks of results and transmits them as such. The Host system may have to further parse the result block if a further separation of individual subcomponents is required . See the tables for details and possible combinations inside result blocks. Table 23 ASTM Result Record Segment Name and Number Type Comment Values Require d R-1 String The record type ID is coded as R. R Yes R-2 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes R-3-4 String Identifies the testtype of the sample Known values are: - CT/NG - HPV ^^^CT/NG^NG^Full Yes R-3-5 String Identifies the sub test type of a sample. Can be diffrent for each sampl but must be a sub type of the TestType Ex: CT see table ^^^CT/NG^NG^Full YES R-3-6 String Identifies the runtype of the sample Allowed values are: - Full = Full run of all system components - AnDiOnly = AmpDetect only ^^^CT/NG^NG^Full Yes R-4-1 String Application package defined test result e.g. Positive, see table . Positive^M1\M2 Yes R-4-2 String Flags for the test result See example Positive^M1\M2 Yes R-4-3 String CT-Values of the controls CT_DYE1^NaN^ CT_DYE5^NaN^ CT_DYE3^NaN^ CT_DYE0^NaN NO R-11 String User who has run the test laboperator Yes R-12 DateTime Time when the test was started on the instrument YYYYMMDDHHMMS S e.g. 20081203143400 Yes R-13 DateTime Time when the test was finished on the instrument YYYYMMDDHHMMS S e.g. 20081203143400 Yes L Segment Segment Name and Number Type Comment Values Required L-1 String This field is coded as L. L Yes L-2 int The Terminator field 1 Yes 11 9 10 30 Roche Diagnostics March 2010 Page 29 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol Results Example ASTM (Simulator log) outgoing - ASTM:
c4800 00:11:52,652 [ENQ] HOST 00:11:52,652 [ACK] c4800 00:11:52,762 [STX]1H|\^&|||MTS^e5052475-cdb3-4c13-97d4-2bb43 467e75f^^1.0.0.0918^1394.LIS2|||||LIS|TSREQ^REA L|P|1|20091001085550|[CR][ETX]FA[CR][LF] HOST 00:11:52,782 [ACK] c4800 00:11:52,872 [STX]2P|1|[CR][ETX]BB[CR][LF] HOST 00:11:52,872 [ACK] c4800 00:11:52,982 [STX]3O|1|0NCL010145A03DC^AD6002095^B1||CT/NG^F ull|||20090825020548|||||||20090825143017|NegCt rl||||||||||F|[CR][ETX]B0[CR][LF] HOST 00:11:52,992 [ACK] c4800 00:11:53,092 [STX]4R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\NaN\ CT_DYE5\34.949874877929688\CT_DYE1\NaN|||||||La bmanager|20090825140628|20090825170656|[CR][ETX ]7F[CR][LF] HOST 00:11:53,102 [ACK] c4800 00:11:53,203 [STX]5O|2|1C1M014196A012R^AD6002095^A1||CT/NG^F ull|||20090825020548|||||||20090825143017|PosCt rl||||||||||F|[CR][ETX]B4[CR][LF] HOST 00:11:53,213 [ACK] c4800 00:11:53,313 [STX]6R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\36.5 50521850585938\CT_DYE5\35.303115844726562\CT_DY E1\35.388565063476562|||||||Labmanager|20090825 140628|20090825170656|[CR][ETX]B4[CR][LF] HOST 00:11:53,323 [ACK] c4800 00:11:53,423 [STX]7O|3|RDR0003428^AD6002095^H1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]98[CR][LF] HOST 00:11:53,433 [ACK] c4800 00:11:53,533 [STX]0R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGPOS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B4[CR][LF] HOST 00:11:53,543 [ACK] c4800 00:11:53,643 [STX]1O|4|RDR0003430^AD6002095^G1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8B[CR][LF] HOST 00:11:53,653 [ACK] c4800 00:11:53,753 [STX]2R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGPOS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B6[CR][LF] HOST 00:11:53,753 [ACK] c4800 00:11:53,854 [STX]3O|5|RDR0003432^AD6002095^F1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8F[CR][LF] HOST 00:11:53,864 [ACK] c4800 00:11:53,964 [STX]4R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGPOS^| ||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C0[CR][LF] HOST 00:11:53,974 [ACK] c4800 00:11:54,074 [STX]5O|6|RDR0003433^AD6002095^E1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF] HOST 00:11:54,084 [ACK] c4800 00:11:54,184 [STX]6R|1|^^^CT/NG^CT/NG^Full|CTPOS,NGNEG^| Roche Diagnostics March 2010 Page 30 Host Interface manual cobas 4800 system Host interface Manual DRAFT ASTM Protocol ||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C2[CR][LF] HOST 00:11:54,194 [ACK] c4800 00:11:54,294 [STX]7O|7|RDR0003435^AD6002095^C1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]95[CR][LF] HOST 00:11:54,304 [ACK] c4800 00:11:54,404 [STX]0R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGNEG^ X2|||||||Labmanager|20090825140628|200908251706 56|[CR][ETX]4E[CR][LF] HOST 00:11:54,414 [ACK] c4800 00:11:54,515 [STX]1O|8|RDR0003436^AD6002095^D1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF] HOST 00:11:54,525 [ACK] c4800 00:11:54,625 [STX]2R|1|^^^CT/NG^CT/NG^Full|CTNEG,NGNEG^ |||||||Labmanager|20090825140628|20090825170656 |[CR][ETX]C6[CR][LF] HOST 00:11:54,635 [ACK] c4800 00:11:54,725 [STX]3L|1|[CR][ETX]B8[CR][LF] HOST 00:11:54,735 [ACK] c4800 00:11:54,835 [EOT] Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings. example |CTPOS,NGNEG^| should look in reality: |CT POS, NG NEG^| The character used in the transmission is a regular space (Hex 20). Example multiple flags (R segment only, simulator log) outgoing - ASTM: c4800 06:53:16,137 [STX]6R|1|^^^HPV^HPVHighRiskPanel+Genotypi ng^Full|Failed^X3\X4\X1|||||||GT|20091211133042 |20091211153236|[CR][ETX]69[CR][LF] Roche Diagnostics March 2010 Page 31 Host Interface manual Host interface Manual cobas 4800 system DRAFT ASTM Protocol HL7 Protocol 7 Minimal Layer Protocol The data framing uses the MLLP, Minimal Lower Layer Protocol defined in the HL7 standard. HL7 messages are embedded in block delimited by special (non printable) characters. <start_block>data<end_block><CR> The values of the special characters are <VT> for the start block and <FS> for the end block. See table below. <start_block> Start Block character (1 byte) ASCII <VT> Data (variable number of bytes) The HL7 data is comprised of any displayable ASCII characters and the carriage return character, <CR>. <end_block> End Block character (1 byte) ASCII <FS>. . <CR> Carriage Return (1 byte) Char (ASCII) Dcimal Octal Hex Name VT 011 013 0B Vertical Tab FS 028 034 1C File Separator CR 013 015 0D Carriage Return Graphical representation of data framing: <VT> HL7 data <FS><CR> Roche Diagnostics March 2010 Page 32 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol COBAS 4800 HL7 Record Definitions The tables in the topic Inquiry Records mapping (HL7) show the mappings between the cobas 4800 xml file and the HL7 segment / records file which the host interface needs to work with. Message Structure The Message structures are defined in the syntax also used in [1] Work order inquiry MSH MESSAGE HEADER SEGMENT QPD QUERY PARAMETER DEFINITION RCP RESPONSE CONTROL PARAMETER SEGMENT Work order response MSH MESSAGE HEADER SEGMENT { ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR { OBR OBSERVATION REQUEST SEGMENT } } Test result export MSH MESSAGE HEADER SEGMENT { ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR + OBX { OBR OBSERVATION REQUEST SEGMENT OBX OBSERVATION/RESULT SEGMENT } } 33 1 Roche Diagnostics March 2010 Page 33 Host Interface manual Host interface Manual cobas 4800 system DRAFT HL7 Protocol Inquiry Records mapping (HL7) Inquiry Mapping MSH Segment (Message Header) Table 24 HL7 Inquiry Message Header Segment Name and Number Type Comment Values Required MSH-1 String Field delimiter | Yes MSH-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order ^ ~ \ & Yes MSH-3 String Name of the application which sent this message MTS Yes MSH-4 String The version of the sending software e.g. 1.3.5 Yes MSH-5 String Name of the application which has to receive this message LIS Yes MSH-7 DateTime DateTime of the message YYYYMMDDhh mmss e.g. 20081122121212 Yes MSH-9-1 String Message type code see HL7 Doc.: [1] Table 0076 - Message type QBP (QBP^Q11) Yes MSH-9-2 String Trigger event code see HL 7 Doc.: [1] Table 0003 - Event type Q21 (QBP^Q11) Yes MSH-10 GUID Message Id Generated by the Transformer Software 128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFF- FFFF-FFFF- FFFFFFFFFFFF Yes MSH-11 String Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID P = Production Yes MSH-12 Number HL7 Version ID used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 Version ID 2.4 Yes MSH-17 String Country ISO code used for currency-, datetime- and other specifications. [1] Table 0399 Country code [A-Z]{3} e.g. CHE = Switzerland, USA = United States Yes MSH-18 String Character char set used for the whole message - see HL7 Doc.: [1] Table 0211 Alternate character sets The COBAS 4800 project has decided to use the not documented character set UTF-8 UTF-8 Yes Roche Diagnostics March 2010 Page 34 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol QPD - Query Parameter Definition Table 25 HL7 Inquiry Query Parameter Definition Segment Name and Number Type Comment Values Required QPD-1 String This field contains the name of the query FullRunQuery or AnDOnlyQuery YES QPD-3 String Test Specification contains the Test Type and the Run Type (only "Full" supported) CT/NG^FULL YES QPD-4 String All Samples or the Plate ID of the MWP Plate AD0000012 or 0001~0002~000 3~0004 YES RCP - Response Control Parameter Segment Table 9 HL7 Inquiry Response Control Parameter Segment Segment Name and Number Type Comment Values Required RCP-1 String Query priority For cobas 4800 always I=Immediate I YES RCP-3 String Response modality For cobas 4800 always R=Real Time R YES Roche Diagnostics March 2010 Page 35 Host Interface manual Host interface Manual cobas 4800 system DRAFT HL7 Protocol Inquiry Response Mapping MSH Segment (Message Header) Table 26 HL7 Response Message Header Segment Name and Number Type Comment Values Required MSH-1 String Field delimiter | Yes MSH-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order ^ ~ \ & Yes MSH-3-1 String Name of the application which sent this message LIS Yes MSH-4-1 String The version of the sending software 6.2 Yes MSH-5-1 String Name of the application which has to receive this message MTS Yes MSH-7 DateTime DateTime of the message YYYYMMDDhhm mss e.g. 20081122121212 Yes MSH-9-1 String Message type code see HL7 Doc.: [1] Table 0076 - Message type OML (OML^O21) Yes MSH-9-2 String Trigger event code see HL 7 Doc.: [1] Table 0003 - Event type O21 (OML^O21) Yes MSH-10 GUID Message Id Generated by the Transformer Software 128-Bit-Integer Min. Value = 0 Max. Value = FFFFFFFF-FFFF- FFFF-FFFF- FFFFFFFFFFFF Yes MSH-11 String Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID P = Production Yes MSH-12 Number Version ID used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 Version ID 2.4 Yes MSH-17 String Country ISO code used for currency-, datetime- and other specifications. The value is mapped from the current thread of the Transformer application [1] Table 0399 Country code [A-Z]{3} e.g. CHE = Switzerland, USA = United States Yes MSH-18 String Character char set used for the whole message - see HL7 Doc.: [1] Table 0211 Alternate character sets The cobas 4800 project has decided to use the not documented character set UTF-8 UTF-8 Yes Roche Diagnostics March 2010 Page 36 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol ORC Segment (Common Order) Table 11 HL7 Response Common Order Segment Name and Number Type Comment Values Required ORC-1 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes ORC-7-4 DateTime This field contains the creation time of the order out of the cobas 4800 order file 20081202154500 YES ORC-10 String This field contains the identity of the user who actually created the order out of the cobas 4800 order file. e.g ADMIN YES OBR Segment (Observation Request) This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message version 2.4 observation request segment. The observation request segment is holding all information related to a sample. Table 12 HL7 Response Observation Request Segment Name Type Comment Values Require d OBR-1 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes OBR-3-1 String Unique identifier of the sample usually a barcode assigned to the sample 0001301 ^AD0000013^A6 YES OBR-3-2 String Plate ID only for A&D Only runs. See Note 1 0001301^AD0000013 ^A6 NO OBR-3-3 String MWP Position only for A&D Only runs 0001301^AD0000013^ A6 NO OBR-4-1 String Identifies the testtype of the sample Known values are: CTNG - HPV CT/NG^NG^Full Yes OBR-4-2 String The sub test type of a sample. Values, see Table CT/NG^NG^Full YES OBR-4-3 String Identifies the runtype of the sample Allowed values are: See Note 1 - Full = Full run of all system components - SpiOnly = Sample Extraction only - AnDiOnly = AmpDetect only CT/NG^NG^Full Yes OBR-15 String Media Type Allowed values : see Table String ex: UT Yes OBR-27 XML DateTime Xml DateTime of the message put by the creating system on creation of this message YYYYMMDDhhmmss e.g. 20081122121212 Yes Note 1 : Only "Full" is supported by the HIF workflow. Note 2 : Missing orders For samples that do not have a corresponding test request in the Host system, the whole ORC + OBR segment records pair must be skipped. 9 9 Roche Diagnostics March 2010 Page 37 Host Interface manual Host interface Manual cobas 4800 system DRAFT HL7 Protocol Results Mapping (HL7) MSH Segment (Message Header) Table 13 HL7 Result Message Header Segment Name and Number Type Comment Values Requir ed MSH-1 String Field delimiter | Yes MSH-2 String Component, Repetition, Escape and Subcomponent delimiter exactly in this order ^ ~ \ & Yes MSH-3-1 String Name of the application which sent this message MTS Yes MSH-4-1 String The version of the sending software 0.9.4.847 Yes MSH-5-1 String Name of the application which has to receive this message LIS Yes MSH-7 DateTime DateTime of the message YYYYMMDDhh mmss e.g. 20081122121212 Yes MSH-9-1 String Message type code see HL7 Doc.: [1] Table 0076 - Message type ORU (ORU^O21) Yes MSH-9-2 String Trigger event code see HL 7 Doc.: [1] Table 0003 - Event type O21 (ORU^O21) Yes MSH-10 GUID Message Id Generated by the Transformer Software TBD Yes MSH-11 String Processing mode (processing priority) see HL7 Doc.: [1] Table 0103 - Processing ID P = Production Yes MSH-12 Number Version ID used as a version check to make sure that this message is interpreted correctly see HL7 Doc.: [1] Table 0104 Version ID 2.4 Yes MSH-17 String Country ISO code used for currency-, datetime- and other specifications. [1] Table 0399 Country code [A-Z]{3} e.g. CHE = Switzerland, USA = United States Yes MSH-18 String Character char set used for the whole message - see HL7 Doc.: [1] Table 0211 Alternate character sets The cobas 4800 project has decided to use the not documented character set UTF-8 UTF-8 Yes ORC Segment (Common Order) Table 14 HL7 Result Common Order Segment Name and Number Type Comment Values Requir ed ORC-1 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes ORC-7-4 DateTime This field contains the creation time of the order out of the cobas 4800 order file 20081202154500 YES ORC-10 String This field contains the identity of the user who actually created the order out of the cobas 4800 order file. e.g ADMIN YES Roche Diagnostics March 2010 Page 38 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol OBR - Segment (Observation Request) This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message observation request segment. The observation request segment is holding all information related to a sample. Table 15 HL7 Result Observation Request Segment Name and Number Type Comment Values Require d OBR-1 Number Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes OBR-3-1 String Unique identifier of the sample usually a barcode assigned to the sample 0001301^AD000001 3^A6 YES OBR-3-2 String Plate ID only for AnD Only runs 0001301^AD000001 3^A6 NO OBR-3-3 String MWP Position only for AnD Only runs 0001301^AD000001 3^A6 NO OBR-4-1 String Identifies the testtype of the sample Known values are: CT/NG - HPV CT/NG^NG^FULL YES OBR-4-2 String The sub test type of a sample See possible value table : CT/NG^NG^FULL YES OBR-4-3 String The run type of the test CT/NG^NG^FULL YES OBR-7 DateTime Time the test was started on the instrument YYYYMMDDhhmms s e.g. 20081122121212 YES OBR-8 DateTime Time the test was finished on the instrument YYYYMMDDhhmms s e.g. 20081122121212 YES OBR-15 String Allowed values are: See table UUT YES OBR-27 DateTime Time when the order was created YYYYMMDDhhmms s e.g. 20081122121212 YES 9 9 Roche Diagnostics March 2010 Page 39 Host Interface manual Host interface Manual cobas 4800 system DRAFT HL7 Protocol OBX - Segment (Observation / Result Segment) Note: The system presents CT/NG or HPV as global blocks of results and transmits them as such. The Host system may have to further parse the result block if a further separation of individual subcomponents is required . See the tables for details and possible combinations inside result blocks. Table 16 HL7 Result Observation / Result Segment Segment Name and Number Type Comment Values Require d OBX-1 String Set ID for each order which is transmitted a own number is set starting from 1 to n Continuous ID starting by 1 1, 2, n Yes OBX-2 String This field contains the format of the observation value in OBX For the cobas 4800 the format is ST = String Data ST YES OBX-3-1 String Unique identifier of the sample usually a barcode assigned to the sample 0001301^AD000001 3^A6 YES OBX-3-2 String Plate ID only for AnD Only runs 0001301^AD000001 3^A6 NO OBX-3-3 String MWP Position only for AnD Only runs 0001301^AD000001 3^A6 NO OBX-5-1 String Application package defined test result e.g. Postive, Failed, See table Positive^M1~M2 YES OBX-5-2 String Flags for the test result Positive^M1~M2 YES OBX-5-3 String CT-Values of the controls CT_DYE1^NaN^ CT_DYE5^NaN^ CT_DYE3^NaN^ CT_DYE0^NaN NO OBX-11 String Accepted Flag possible values are: Final results = F or Final results = P it depends on the accepted flags from the cobas 4800 result export file F Means result was accepted P Means result was not accepted (yet) F or P YES OBX-16 String User of the instrument who run the test laboperator YES 11 10 Roche Diagnostics March 2010 Page 40 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol Result Example HL7 HL7 Result Export (Simulator log) c4800 10:14:27,257 [VT] c4800 10:14:27,257 MSH|^~\&|MTS|1.0.0.0918|LIS||20090918101319||OR U^O21|9a7b5dab-8049-4ba8-83b7-6e8aefcbbed1|P|2. 5.1|||||CHE|UTF-8|[CR] c4800 10:14:27,257 ORC|1||||||^^^20090826114803||||[CR] c4800 10:14:27,257 OBR|1||0NCL010145A037Y^AD6002084^B1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||NegCtrl ||||||||||||20090826114803|[CR] c4800 10:14:27,257 OBX|1|ST|0NCL010145A037Y^AD6002084^B1||Valid^^C T_DYE3~NaN~CT_DYE5~NaN~CT_DYE1~NaN~CT_DYE0~NaN| |||||P|||||Labmanager|[CR] c4800 10:14:27,273 ORC|2||||||^^^20090826114803||||[CR] c4800 10:14:27,273 OBR|2||R0000814^AD6002084^G1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,273 OBX|2|ST|R0000814^AD6002084^G1||OtherHRHPVNE G,HPV16POS,HPV18NEG^||||||P|||||Labmanager| [CR] c4800 10:14:27,288 ORC|3||||||^^^20090826114803||||[CR] c4800 10:14:27,288 OBR|3||R0000815^AD6002084^F1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,288 OBX|3|ST|R0000815^AD6002084^F1||OtherHRHPVNE G,HPV16NEG,HPV18POS^||||||P|||||Labmanager| [CR] c4800 10:14:27,288 ORC|4||||||^^^20090826114803||||[CR] c4800 10:14:27,304 OBR|4||R0000816^AD6002084^D1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,304 OBX|4|ST|R0000816^AD6002084^D1||OtherHRHPVPO S,HPV16NEG,HPV18NEG^||||||P|||||Labmanager| [CR] c4800 10:14:27,304 ORC|5||||||^^^20090826114803||||[CR] c4800 10:14:27,304 OBR|5||R0000817^AD6002084^E1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,320 OBX|5|ST|R0000817^AD6002084^E1||OtherHRHPVPO S,HPV16POS,HPV18NEG^||||||P|||||Labmanager| [CR] c4800 10:14:27,320 ORC|6||||||^^^20090826114803||||[CR] c4800 10:14:27,320 OBR|6||R0000819^AD6002084^C1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,335 OBX|6|ST|R0000819^AD6002084^C1||OtherHRHPVPO S,HPV16POS,HPV18POS^||||||P|||||Labmanager| [CR] c4800 10:14:27,335 ORC|7||||||^^^20090826114803||||[CR] c4800 10:14:27,335 OBR|7||R0000818^AD6002084^H1|HPV^HPVHighRisk Panel+Genotyping^Full|||20090826120921|200908 Roche Diagnostics March 2010 Page 41 Host Interface manual Host interface Manual cobas 4800 system DRAFT HL7 Protocol 26154328|||||||PC||||||||||||20090826114803|[CR ] c4800 10:14:27,335 OBX|7|ST|R0000818^AD6002084^H1||OtherHRHPVIn valid,HPV16Invalid,HPV18POS^||||||P|||||Lab manager|[CR] c4800 10:14:27,351 ORC|8||||||^^^20090826114803||||[CR] c4800 10:14:27,351 OBR|8||2H1M015776A02IG^AD6002084^A1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||PosCtrl ||||||||||||20090826114803|[CR] c4800 10:14:27,351 OBX|8|ST|2H1M015776A02IG^AD6002084^A1||Valid^^C T_DYE3~37.381362915039062~CT_DYE5~35.7265472412 10938~CT_DYE1~36.203384399414062~CT_DYE0~35.940 170288085938|||||| Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings. example OtherHRHPVPOS should look in reality: Other HR HPV POS The character used in the transmission is a regular space (Hex 20). Example multiple flags (OBX segment only, simulator log) outgoing - HL7: c4800 08:05:32,833 OBX|79|ST|A2482185^AD6201793^D3||Failed^X3~X4~X1|| ||||F|||||GT|[CR] Roche Diagnostics March 2010 Page 42 Host Interface manual cobas 4800 system Host interface Manual DRAFT HL7 Protocol Communication setup 8 Network connection The physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol. The network address of the instrument is normally determined by the installation of a cobas IT firewall. To change the network address, you must log into the operating system as local Administrator. Please ask the Roche service representative. Instrument Setup By default the HIF modules are not installed, for the instrument setup, please refer to the Network Configuration Guide cobas 4800 system. This installation has to be performed by qualified Roche service personnel. Once the software for host interface has been installed, some parameters can be changed to match the requirements of the LIS system. The default protocol after installation is HL7. To change to ASTM, or back to HL7, change the target IP (LIS system) or the port, see the the Network Configuration Guide cobas 4800 system. Roche Diagnostics March 2010 Page 43 Host Interface manual Host interface Manual cobas 4800 system DRAFT Communication setup Simulator 9 Installing simulators Roche has developed specific host simulators to make simple testing of the ASTM or HL7 protocol, for the cobas 4800 Instrument. This software can be installed on Windows computers and are intended to be used only by Roche trained personnel. When used as an instrument simulator, the goal is to provide only a quick test tool for testing the transmission formats. Please keep in mind that the simulator does not react like a real instruments in all situations. The simulator is intended to be used for several Roche instruments, periodically new ones will be added. From version 2.0 on, all the host interface tools come together in a common installation package. They will be installed by default under Host Interface tools. Requirements The Roche ASTM/HL7 simulators can be installed on Windows XP computers. The user needs administrator rights to be able to install the host tools package properly. After the basic installation of the "Host tools" package, some patches may be required depending on the simulator you intend to use. Please ask the Roche service representative for further information. Software requirement: Windows XP professional SP2, with current patches. Access to network settings Recommended hardware: Any computer able to run Windows XP professional. Network card HL7 Simulator Roche has developed a specific host simulator to make simple testing of the HL7 protocol, for the cobas 4800 Instrument. To start the simulator, simply select from the stat menu as shown. Roche Diagnostics March 2010 Page 44 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator You must accept the disclaimer to be able to start the program. Roche Diagnostics March 2010 Page 45 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator Roche Diagnostics March 2010 Page 46 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Setting up the simulator connection Some parameters must be setup before the cobas 4800 system is able to communicate with the simulator. The simulator must be set up as a server. That is, it will listen on a defined port. Port 5555 is often used as a default. The server IP address is the address of the network card and cannot be changed for a server. It comes from the network settings of the computer hosting the simulator. This is the same as the LIS address that must be set on the cobas 4800 when installing or setting up the Host. See Instrument setup 42 Roche Diagnostics March 2010 Page 47 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator Select the Instrument "cobas 4800" from the drop down list and "Host" as shown. This has the effect of enabling the correct responses from the simulator to the selected type of instrument. Note: The simulator can also simulate a cobas 4800 system, but this mode goes beyond the scope of this manual Roche Diagnostics March 2010 Page 48 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Once parameters are setup correctly the simulator will start listening on the defined port. Once every minute, the cobas 4800 communication server will attempt a connection on the defined IP address and port. If the simulator is reached, the connection indicator will turn from yellow to green as shown. Additionally, the IP address of the connected system will appear in the lower part of the blue box (Remote). At this point the simulator can be used and will display the HL7 records received and sent. Roche Diagnostics March 2010 Page 49 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator Connection test When the simulator is connected, the connection test gives a possibility to check the responsiveness of the client. In some circumstances, the simulator may erroneously indicate an active connection. This can be the case if there are elements in the network that where temporarily disconnected. If the LIS seems unresponsive although the connection is displayed as active, make the connection check. In case of test failure, close the simulator and restart it. If the connection is not re-established within two minutes, shutdown the cobas 4800 system and restart it. Roche Diagnostics March 2010 Page 50 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Sending an order to the system Actually, you cannot "send" an order, as the instrument is always master. The simulator is able to reply to an order request. For this it must have certain information in its database. You can edit this database manually to prepare a correct answer to instrument queries. Simulator Database: The simulator has a small database where basic records can be stored. The simulator will use its database records to respond to the instrument requests. If the instrument sends a request related to a certain Sample ID, the simulator will search its database for a matching record. If one is found, the simulator will attempt to generate an order upload, using the information stored in the simulator database record. To open the database on the simulator: Then in the DB, select the table as shown. Roche Diagnostics March 2010 Page 51 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator You can generate new records, either blank ones: Or duplicate existing ones and editing them: Roche Diagnostics March 2010 Page 52 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Editing the duplicate record: Roche Diagnostics March 2010 Page 53 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator There are further fields on the right that can be edited: (Use lower slide bar to view them). Note: Be aware that the simulator does not perform any check on the type of data. Verify with the protocol definitions that you enter valid data. For example, if you type a number where another type is required, an error will probably be generated at the instrument level and the order rejected. (see also restrictions ) 58 Roche Diagnostics March 2010 Page 54 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Receiving results from the system. Once the LIS systems have been installed by a Roche engineer, the system must be configured to work with LIS: To configure cobas 4800 software for LIS communication, the user must first open cobas 4800 software and log in with username FSE. Only a user with administrator rights to the application can switch the LIS on. Go to 1)utilities tab, select 2) configuration tab, select 3) System Settings and 4) enable the checkbox LIS present. Exit cobas 4800 software. TO be able to transmit results, once the LIS has been activated, it is necessary to log in as 1. Open the cobas 4800 Software 2. Login with user name FSE Go to 1) result tab, select 2) performed run, select 3) sample, click 4) Export All results present in the page will be transmitted, even if only one is selected. Roche Diagnostics March 2010 Page 55 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator Results received by the simulator will be stored in the database as shown below. Roche Diagnostics March 2010 Page 56 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Roche Diagnostics March 2010 Page 57 Host Interface manual Host interface Manual cobas 4800 system DRAFT Simulator ASTM Simulator Roche has developed a specific host simulator to make simple testing of the ASTM protocol, for the cobas 4800 Instrument. This software can be used on Windows XP computers and can be delivered upon request. Contact your Roche Diagnostics representative. The simulator is intended to be used for several Roche instruments, periodically new ones will be added. Requirements The Roche ASTM simulator can be installed on Windows XP computers and is part of the complete host tools package. refer to the previous topic HL7 simulator, the ASTM simulator works in a very similar way and shares the loacl simulator database with the HL7 simulator. The user needs administrator rights to be able to install the host tools package properly. Software requirement: Windows XP professional SP2, with current patches. Access to network settings Recommended hardware: Any computer able to run Windows XP professional. Network card Setting up and operating the ASTM simulator To setup and operate the ASTM simulator as a host, read the HL7 simulator sections . The ASTM simulator operates in a very similar way and shares the simulator datatabase for cobas 4800. 43 Roche Diagnostics March 2010 Page 58 Host Interface manual cobas 4800 system Host interface Manual DRAFT Simulator Troubleshooting / logfiles 10 Troubleshoting: Most errors in the incoming communications i.e. a missing parameter in a filed, will result in a timeout message on the instrument. Errors generated by the conversion from incoming HTML or ASTM are not passed to the application, the Transformer program will only pass XML files if the parsing or the different fields succeeds. If any error occur it will just stop parsing the information and do nothing, therefore if the application is awaiting an answer, it will just timeout. To find the source of the problem, see the logfiles section. If the cobas 4800 system has an active connection to the host system but fails to request order information after loading sample racks, one possible cause is the "operator" is not logged into the operating system of the cobas 4800 control unit. If an administrator is logged into the windows operating system, the LIS service will connect to the ASTM or HL7 server but the system will not be able to communicate. Corrective action: log off the administrator user in Windows, the system will automatically re-log as "operator" Logfiles: In the directory c:\data\log, the trafic for the selected protocol is logged: Hl7_trace.log for the Hl7 data exchange. astm_trace.log for the astm data exchange. The transformation activity of the transformer program .xml <=> active protocol is logged in the file cserver.log cserver logfiles are collections of incremental files like cserver.log.1, cserver.log.2 ....... As soon as the cserver.log reaches a size of 1025 kB, a number is appended to the extension and a new cserver.log is created. In the directory C:programm files\Roche diagnosticsAG\cobas_4800_v1.0.0.0918\bin\log\ the file MTS-Transformer-session-trace-file.log contains the parsing activity for the active protocol. To find the captured errors, open the file with the windows notepad program and make a search fro "ERROR". You may find some limited indications about protocol errors. (e.g an incorrect type or missing mandatory parameter). Known restrictions 11 Workflow: Only the Full run is supported by LIS. The "A&D" and "Sample extraction only" modes are not supported by the LIS system. The timeout after an order request from the instrument is currently set at 30 seconds and cannot be changed. Because of this relatively short time out, it is recommended to use only direct network connections between the LIS and the cobas 4800 system. Avoid any bottlenecks, i.e. converters to RS232 serial line. Order processing on the LIS should be optimized to avois a timeout when loading the maximum samples. Troubleshooting errors: In case of protocol errors (i.e. the LIS sending an incorrect data type or unexpected values), the instrument will report LIS system does not answer (timeout) in most cases. This can be misleading, however some information might be available in the logfiles. See Troubleshooting ASTM: 58 Roche Diagnostics March 2010 Page 59 Host Interface manual Host interface Manual cobas 4800 system DRAFT Known restrictions O segment in order response: Field O-8 if left blank will not create a failure, although this is documented as required field. HL7: No Known problem Keywords index - A - A&D 3, 8, 13 A&D Only 6 active connection 49 AnD 3 ASCII 31 ASTM simulator 57 - C - Calculation 13 checksum 17 Client /Server structure 4 cobas x 480 3 cobas z 480 3 Control character 17 - D - data framing 31 - E - empty orders 6 error 13, 50 errors 58 - F - FLAGS 13 Frame final frame 17 intermediate frame 17 Length of the Frame 17 Middle Frame 17 Full 6 Full run 3, 8 - G - GUID 3, 20, 22, 26, 33, 35 - H - host simulator 43 - I - inquiry timeout 6 installation Manual 42 - L - layer 5 Logfiles 58 - M - Media Type 8 Message Terminator 24 Micro Well Plate 3 Minimal Layer Minimal Layer Protocol 31 Missing orders 6, 23, 35 MLLP 31 MTS 3 MWP 3 MWP plate 6 - N - Network Configuration Guide 42 - O - order request 50 OSI model 5 - P - patient information 23, 27 physical connection 4 - R - requirement 43 Requirements 43 reserveCyt 8 Results timeout 17 run 8 Run Type 6, 8 - S - server 6, 46 server IP address 46 simulator 43, 57 Database 50 Simulator database 50 Simulator Database 50 special characters FS 31 VT 31 SPI 13 SubTestType 8 SurePath 8 - T - TCP/IP client 4 TCP/IP server 4 Test Type 6, 8 timeout 6, 58 Timeout (Results) 17 Transformer 4 transmit results 54 - U - UniTrans 8 Urine UniTrans 8 - W - Warning 13 Work Order 6 Work order inquiry timeout 6 Workflow 58 Personal notes: Roche Diagnostics Ltd. 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