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Roche Diagnostics GmbH ®

Elecsys Analyzer Host Interface Manual

®

Elecsys Analyzer Host Interface Manual ID No. 1804022-001

V 4.2 –Version 01/05

Document: RDElec4.2 Final.doc

®

Elecsys Host Interface Manual

V 4.2 –Version 01/05

Elecsys® Host Interface Manual

WARRANTY Roche Diagnostics makes no warranties for the RD Host Interface and Elecsys Analyzer Host Interface Manual beyond those set forth in the operations manual for the Elecsys Analyzer. Roche Diagnostics disclaims all other warranties, express or implied, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. In no event shall Roche Diagnostics be liable for the incidental or consequential damages arising from the use of the interface.

TRADEMARKS AND COPYRIGHTS Elecsys is a trademark of a member of the Roche group. Copies of Documents E1381 – 91 and E1394 – 91 have been reproduced with permission, from the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 194282959, U.S.A

VERSIONS Version

Date

Software

1.0

June 96

released

1.4

May 97

not released

2.0 3.0

Aug. 97 Mar. 98

released not released

4.0

August 00

4.01 4.02 4.2

Nov. 00 Dez. 00 Jan. 05

Modifications corrections by RD as regard contents; re-format update to version 1.4x (mainly chapter 4) – protocol changes Elecsys 2010 – add events/traces from implem. Refer. – add Elecsys 1010 How to ...(chapter 2) review to version 2.x (mainly chapter 4) update to version 2.x (chapter 4.3.6, 4.3.7) – protocol changes Elecsys 2010 – add LSM – Assay Reference Table 5.1 – Auto Dilution Reference Table 5.2 update to version 4.0, changes in CI, add new features of Elecsys 1010 (batch, query mode and MSRs) inclusion of minor corrections Page 157, leding zeros New Alarms in Chapter 5.3 for E2010

© 2000, Roche Diagnostics GmbH. All rights reserved. Lab Diagnostics Global System Support Sandhofer Straße 116 D-68305 Mannheim, Germany No part of the contents of this book may be reproduced or transmitted in any form or by any means without the written permission of Roche Diagnostics GmbH.

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Table of Contents 1

INTRODUCTION ........................................................................................................... 1-9 1.1 How to read this Manual................................................................................................................ 1-9 1.1.1 Intended Audience.................................................................................................................................................. 1-9 1.1.2 Documentation Conventions.............................................................................................................................1-10 1.1.3 Further Help .............................................................................................................................................................1-10

2

1.2

Short Description of Elecsys 2010 .............................................................................................1-11

1.3

Short Description of Elecsys 1010 .............................................................................................1-12

1.4

Features of the Elecsys Host Interface...................................................................................... 1-13

HOW TO ... ...................................................................................................................2-15 2.1 ... use the Interface for Elecsys 2010.........................................................................................2-15 2.1.1 ... connect the Interface for Elecsys 2010.....................................................................................................2-15 2.1.2 ... set up the Interface for Elecsys 2010 ........................................................................................................2-15 2.1.3 ... operate the Interface of Elecsys 2010.......................................................................................................2-18 2.2 ... use the Interface for Elecsys 1010.........................................................................................2-20 2.2.1 ... connect the Interface for Elecsys 1010.....................................................................................................2-20 2.2.2 ... set up the Interface for Elecsys 1010 ........................................................................................................2-20 2.2.3 ... operate the Interface of Elecsys 1010.......................................................................................................2-26 2.3

3

... do Troubleshooting and Maintenance ..................................................................................2-27

THEORY OF OPERATION ..........................................................................................3-29 3.1

Overview of the Interface.............................................................................................................3-29

3.2 Description of Transmission Protocol.......................................................................................3-29 3.2.1 Basics..........................................................................................................................................................................3-29 3.2.1.1 OSI model.............................................................................................................................................................3-29 3.2.1.2 ASTM......................................................................................................................................................................3-31 3.2.1.3 Description of Terms Specific to ASTM...................................................................................................3-33 3.2.2 Application Layer ...................................................................................................................................................3-34 3.2.2.1 Types of Events ..................................................................................................................................................3-34 3.2.2.2 Event Related Data Processing ...................................................................................................................3-38 3.2.2.3 Message Priorities ............................................................................................................................................3-39 3.2.2.4 Events.....................................................................................................................................................................3-39 3.2.2.5 Error Detection and Recovery......................................................................................................................3-41 3.2.3 Presentation Layer.................................................................................................................................................3-45 3.2.3.1 Message Structure: Records ........................................................................................................................3-45 3.2.3.2 Message Structure: Fields.............................................................................................................................3-51 3.2.3.3 Common Field Types: ......................................................................................................................................3-54 3.2.4 Data Link Layer.......................................................................................................................................................3-55 3.2.4.1 General Description .........................................................................................................................................3-55 3.2.4.2 Establishment Phase (Link Connection)..................................................................................................3-56 3.2.4.3 Transfer Phase....................................................................................................................................................3-61 3.2.4.4 Termination Phase (Link Release) .............................................................................................................3-64 3.2.4.5 Frame Format......................................................................................................................................................3-64 3.2.5 Physical Layer..........................................................................................................................................................3-66 3.3 Example ...........................................................................................................................................3-66 3.3.1 Test Selection for New Sample ID ..................................................................................................................3-66 3.3.2 Upload Results after Tests are Performed...................................................................................................3-67

4

ENGINEERING REFERENCE ......................................................................................4-69

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4.1 Physical Layer................................................................................................................................ 4-69 4.1.1 Cabling ....................................................................................................................................................................... 4-69 4.1.2 Interface Specifications....................................................................................................................................... 4-71 4.1.3 Critical Timings ....................................................................................................................................................... 4-72 4.2 Data Link Layer.............................................................................................................................. 4-73 4.2.1 State Diagram ......................................................................................................................................................... 4-73 4.2.2 Control Codes.......................................................................................................................................................... 4-74 4.2.3 Critical Timings ....................................................................................................................................................... 4-74 4.2.4 Message Frame / Checksum Calculation.................................................................................................... 4-75 4.2.5 ASCII Table............................................................................................................................................................... 4-77 4.3 Presentation Layer........................................................................................................................ 4-78 4.3.1 Allowed and Disallowed Characters.............................................................................................................. 4-78 4.3.2 Delimiters .................................................................................................................................................................. 4-78 4.3.3 Common Field Types............................................................................................................................................ 4-78 4.3.4 Table of Record Levels ........................................................................................................................................ 4-80 4.3.5 Structure of Messages ........................................................................................................................................ 4-81 4.3.6 ASTM 1394 Standard Records ......................................................................................................................... 4-83 4.3.6.1 Message Header Record (Level 0) (H Record).................................................................................. 4-84 4.3.6.2 Message Terminator Record (Level 0) (L Record)........................................................................... 4-86 4.3.6.3 Patient Information Record (Level 1) (P Record).............................................................................. 4-88 4.3.6.4 Test Order Record (Level 2) (O Record)............................................................................................... 4-90 4.3.6.5 Result Record (Level 3) (R Record)........................................................................................................ 4-98 4.3.6.6 Comment Record (Level 0...3) (C Record) .........................................................................................4-101 4.3.6.7 Request Information Record (Level 1) (Q Record).........................................................................4-102 4.3.7 RD Specific Records and their IDs ...............................................................................................................4-105 4.3.7.1 Action Confirmation Record (Level 1) .................................................................................................4-105 4.3.7.2 Action Request Record (Level 1)...........................................................................................................4-106 4.3.7.3 Calibrator Parameters Record (Level 2)..............................................................................................4-107 4.3.7.4 Calibration Result Record (Level 2)......................................................................................................4-108 4.3.7.5 Diluent Parameters Record (Level 2)...................................................................................................4-110 4.3.7.6 Instrument Configuration Record (Level 1) .....................................................................................4-111 4.3.7.7 Instrument Status Record (Level 1)......................................................................................................4-114 4.3.7.8 Log File Record (Level 1) ..........................................................................................................................4-117 4.3.7.9 Processing Message Record (Level 1)...............................................................................................4-118 4.3.7.10 Control Parameters Record (Level 2) ............................................................................................4-119 4.3.7.11 Result Context Record (Level 1) .......................................................................................................4-120 4.3.7.12 Raw Result Record (Level 4) ..............................................................................................................4-121 4.3.7.13 Service Data Record (Level 1) ...........................................................................................................4-122 4.3.7.14 Sample Status Record (Level 1)........................................................................................................4-124 4.3.7.15 Test Application Record (Level 1) ....................................................................................................4-126 4.3.7.16 Test Conditions Record (Level 1) .....................................................................................................4-127 4.3.7.17 Substance Data Record (Level 1).....................................................................................................4-128 4.3.8 Error States and Error Recovery ....................................................................................................................4-131 4.4 Application Layer ........................................................................................................................ 4-133 4.4.1 Message Priorities...............................................................................................................................................4-133 4.4.2 Types of Messages..............................................................................................................................................4-133 4.4.2.1 Test Order Message ......................................................................................................................................4-133 4.4.2.2 Result Message ...............................................................................................................................................4-135 4.4.2.3 Substance Data Message ...........................................................................................................................4-137 4.4.2.4 Calibrator Parameters Message ...............................................................................................................4-141 4.4.2.5 Control Parameters Message ....................................................................................................................4-142 4.4.2.6 Calibration Data Message...........................................................................................................................4-143 4.4.2.7 Instrument Status Message........................................................................................................................4-144 4.4.2.8 Log File Message............................................................................................................................................4-145 4.4.2.9 Test Conditions Message ............................................................................................................................4-146 4.4.2.10 Test Application Message......................................................................................................................4-147 4.4.2.11 Instrument Configuration Message....................................................................................................4-148

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4.4.2.12 Service Data Message ............................................................................................................................ 4-149 4.4.2.13 Processing Message................................................................................................................................ 4-149 4.4.2.14 Action Request / Action Confirmation Message ......................................................................... 4-150 4.4.3 Trigger events (Overview) ............................................................................................................................... 4-151 4.5 Test Selection via Specific Test Number ................................................................................4-154 4.5.1 Get Test Numbers from Test Condition Message:................................................................................ 4-154

5

TABLES...................................................................................................................... 5-155 5.1

Assay Reference Table Version 1.48.......................................................................................5-155

5.2 Auto Dilution Reference Table..................................................................................................5-159 5.2.1 General Specification: ....................................................................................................................................... 5-159 5.2.2 Detailed Specification ....................................................................................................................................... 5-159

6

5.3

Alarm Flags Elecsys 2010 ..........................................................................................................5-160

5.4

Alarm Flags Elecsys 1010 ..........................................................................................................5-162

EXAMPLES ............................................................................................................... 6-165 6.1 Trace Examples Standard Records ..........................................................................................6-165 6.1.1 Trace: Test Selection Disk Version .............................................................................................................. 6-165 6.1.2 Trace: Test Selection Rack Version (1st sample without bar-code) .............................................. 6-166 6.1.3 Trace: Test Selection Batch Mode (Elecsys 1010)................................................................................. 6-169 6.1.4 Trace: Test Selection Batch Mode (Elecsys 2010)................................................................................. 6-169 6.1.5 Trace: Result Message...................................................................................................................................... 6-170 6.2 Trace Examples Standard Records ..........................................................................................6-173 6.2.1 Trace: Batch Result Upload from Result Screen.................................................................................... 6-173 6.2.2 Trace: Host Cancels Test Selections (Example for Contention) ...................................................... 6-175 6.2.3 Trace: Sample Scan............................................................................................................................................ 6-176 6.3 Trace Examples Manufacturer Specific Records..................................................................6-181 6.3.1 Trace: Reagent Scan.......................................................................................................................................... 6-181 6.3.2 Trace: Substance Data Message.................................................................................................................. 6-186 6.3.3 Trace: Calibrator Parameters Message...................................................................................................... 6-191 6.3.4 Trace: Control Parameters Message........................................................................................................... 6-192 6.3.5 Trace: Calibration Data Message................................................................................................................. 6-193 6.3.6 Trace: Instrument Status Message .............................................................................................................. 6-193 6.3.7 Trace: Test Conditions Message................................................................................................................... 6-194 6.3.8 Trace: Test Application Message ................................................................................................................. 6-195 6.3.9 Trace: Instrument Configuration Message............................................................................................... 6-196 6.3.10 Trace: Service Data Message ........................................................................................................................ 6-197 6.3.11 Trace: Processing Message............................................................................................................................ 6-199

7

ASTM DESIGNATION: E 1381 - 91...................................................................... 7-201 7.1

Scope .............................................................................................................................................7-202

7.2

Referenced Documents..............................................................................................................7-203

7.3

Terminology ..................................................................................................................................7-203

7.4

Significance and Use ..................................................................................................................7-204

7.5 Physical Layer ..............................................................................................................................7-204 7.5.1 Overview Physical Layer................................................................................................................................... 7-204 7.5.2 Electrical Characteristics.................................................................................................................................. 7-205 7.5.3 Mechanical Characteristics ............................................................................................................................ 7-206 7.6 Data Link Layer ............................................................................................................................7-208 7.6.1 Overview Data Link Layer ............................................................................................................................... 7-208 V 4.2 –Version 01/05

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Establishment Phase (Link Connection) ....................................................................................................7-208 Transfer Phase ......................................................................................................................................................7-209 Termination Phase (Link Release)................................................................................................................7-211 Error Recovery.......................................................................................................................................................7-212 Restricted Message Characters.....................................................................................................................7-213 Appendix 1: STATE DIAGRAM.................................................................................................. 7-214

7.8 Appendix 2: Seven-Bit ASCII Code Charts ............................................................................ 7-215 7.8.1 Appendix 2.1: Decimal Character Code .....................................................................................................7-215 7.8.2 Appendix 2.2: Hexadecimal Character Code............................................................................................7-216

8

ASTM DESIGNATION: E 1394 - 91.......................................................................8-217 8.1

Scope............................................................................................................................................. 8-217

8.2

Referenced Documents ............................................................................................................. 8-218

8.3 Terminology ................................................................................................................................. 8-218 8.3.1 Description of Terms Specific to this Standard:......................................................................................8-218 8.4 Significance and Use ................................................................................................................. 8-219 8.4.1 General Information:...........................................................................................................................................8-219 8.5 Information Requirements in Clinical Testing ...................................................................... 8-221 8.5.1 General Approach ...............................................................................................................................................8-221 8.5.2 Logical Structure of the Message Level Protocol ..................................................................................8-223 8.6 Message Content - General Considerations......................................................................... 8-225 8.6.1 Character Codes ..................................................................................................................................................8-225 8.6.2 Maximum Field Lengths ...................................................................................................................................8-226 8.6.3 Maximum Record Length.................................................................................................................................8-226 8.6.4 Delimiters ................................................................................................................................................................8-226 8.6.5 Data Record Usage Overview.........................................................................................................................8-229 8.6.6 Common Field Types..........................................................................................................................................8-230 8.6.7 Examples of Basic Record Types...................................................................................................................8-232 8.7

Message Header Record........................................................................................................... 8-237

8.8

Patient Information Record....................................................................................................... 8-239

8.9 Test Order Record....................................................................................................................... 8-244 8.9.1 Multiple Orders.....................................................................................................................................................8-244 8.9.2 General Applications..........................................................................................................................................8-245 8.10

Result Record .............................................................................................................................. 8-251

8.11

Comment Record ........................................................................................................................ 8-254

8.12

Request Information Record..................................................................................................... 8-255

8.13

Message Terminator Record .................................................................................................... 8-258

8.14

Scientific Record......................................................................................................................... 8-259

8.15

Manufacturer Information Record .......................................................................................... 8-261

8.16 APPENDIX - Non mandatory Information .............................................................................. 8-262 8.16.1 X1. Comparison of Specifications E1238 and E1394.............................................................................8-262

9

HOST INTERFACE SIMULATOR FOR THE ASTM PROTOCOL.........................9-263 9.1

Purpose of the ASTM Interface Test Tool .............................................................................. 9-263

9.2

Main Screen of the Test Tool.................................................................................................... 9-264

9.3

Main Menu System .................................................................................................................... 9-265

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Multifunctional text editor .........................................................................................................9-267

9.5 Technical Details .........................................................................................................................9-268 9.5.1 Record editor rules............................................................................................................................................. 9-268 9.5.2 TCP/IP Communication .................................................................................................................................... 9-269 9.6 Data Flow of ASTM Test program ............................................................................................9-270 9.6.1 ELECSYS 2010...................................................................................................................................................... 9-270 9.6.2 ELECSYS 1010...................................................................................................................................................... 9-273 9.6.3 STA, STA-C, STA-R............................................................................................................................................. 9-275 9.6.4 Cardiac Reader .................................................................................................................................................... 9-276 9.6.5 Modular................................................................................................................................................................... 9-278 9.6.6 VS II........................................................................................................................................................................... 9-279 9.6.7 LSM .......................................................................................................................................................................... 9-280 9.6.8 PSM .......................................................................................................................................................................... 9-281 9.6.9 Amplilink................................................................................................................................................................. 9-282 9.7

10

Software Updates of the ASTM Host Interface Test Tool ...................................................9-283

INDEXES .............................................................................................................. 10-291

10.1

Tables.......................................................................................................................................... 10-291

10.2

Figures ........................................................................................................................................ 10-293

10.3

Record Names........................................................................................................................... 10-294

11

GLOSSARY...............................................................................................................11-1

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Introduction

Introduction This section contains • how to read this manual • short description of Elecsys 2010 and Elecsys 1010 • features of the host interface

1.1

How to read this Manual

1.1.1 Intended Audience This manual is intended to meet the needs of the following groups of readers: • Operators of the Elecsys Analyzers or the Laboratory Systems Manager (not available in US) • Maintenance and service personnel • Software Engineers developing host interfaces for laboratory management software Only part of the information in this manual is needed in common by all groups mentioned above. Major parts of the manual are specific to each of these groups. To facilitate information retrieval the structure and outline of this manual takes account of these specific demands: • Section 1 "Introduction" contains general information about the Elecsys analyzer and its host interface helpful to all groups of readers. • Section 2 "How to" meets the needs of operators as well as maintenance and service personnel. This section contains detailed instructions for procedures and methods. • Section 3 "Theory of operation" provides information to software engineers who intend to develop interface software on host computers. This section contains a detailed introduction to the basic operation of the host interface (for example transmission protocol). • Section 4 "Engineering Reference" is a reference based on the basic information of section 3. Whereas section 3 is a systematic introduction and is to be continuously read like a tutorial, this section provides reference oriented access to information. The software engineer familiar with section 3 will most likely refer to this section. • Section 5 "Tables" is reference oriented. It contains additional information to all sections. • Section 6 "Examples" contains traces recorded with a simulator and/or host test tools.

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1.1.2 Documentation Conventions This manual uses the following special typefaces: Typeface

Meaning

Special font

This font is used for system and screen output, such as prompt signs and screen messages.

Italic and special font

This font is used for user input, such as commands, options to commands and arguments.

Table 1-1: Special Typefaces

1.1.3 Further Help In case of questions or difficulty please contact your local Roche Diagnostics Service Department. Field Sales Representatives (FSRs) may contact the central Service Management of Roche Diagnostics GmbH (Germany): Roche Diagnostics GmbH Lab Diagnostics Global System Support Sandhofer Straße 116 D-68305 Mannheim Germany

Tel:

+49 621 / 759-4204

Fax:

+49 621 / 759-4394

E-Mail: [email protected] [email protected] [email protected]

US Roche Response Center Customer Technical Support: Tel:

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Introduction

Short Description of Elecsys 2010 Elecsys 2010 is a fully automatic analyzing system with direct, random access for the determination of immunological tests using an electrochemiluminescent (ECL) process. The analyzer can measure serum and plasma samples. The results are output in a quantitative form. The handling of Elecsys 2010 is very easy; manual error sources have been reduced to a minimum. By using ready-to-use reagents and calibrators, the preparation of these materials is no longer required. RD ready-to-use controls are also available dependent on the test. The closed reagent containers (reagent packs) are kept at a constant temperature of 20 °C in the reagent disk, thus ensuring long stability. Because the reagents and calibrators are registered using bar-codes, manual registration is also no longer necessary. By using bar-coded sample containers, the time for measurement preparation is reduced enormously. Top Cover (right)

Top Cover (left)

Incubator User Interface

System Reagents Circuit breaker

Reagent Disk Interface Connector

Distilled Water Bar Code Reader Tips Sample Disk

Cups

Liquid Waste

Floppy Disk Drive & Solid Waste

Operation Switch Figure 1-1: Elecsys 2010 Disk Version

Elecsys 2010 is especially suited for use in medium to large size laboratories. By means of the Laboratory-System-Manager (LSM) designed by Roche Diagnostics, several Elecsys 2010 analyzers can be centrally controlled (not available in US). The analyzer can also be connected to an existing laboratory EDP (Host).

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Figure 1-2: Elecsys 2010 Rack Version

1.3

Short Description of Elecsys 1010 The Elecsys 1010 is a fully automatic analyzer system for determination of immunological tests using an electrochemiluminescent (ECL) process. All components and reagents for the laboratory routine are integrated in or on the analyzer. Incubator

Sipper arm

S/R Probe

Measuring Cell

S/R Arm

ProCell & CleanCell

Liquid Waste Container

Distilled water container

S/R Disk

Control unit Printer

Figure 1-3: Elecsys 1010

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Operation of the analyzer is easy and intuitive. The reagents are stable and can generally be directly loaded on to the analyzer system. The consistent use of bar-coded reagents greatly reduces the need for time consuming manual inputs when performing the daily routine. Additional automation can be achieved by connecting a laboratory EDP system. Serum and plasma samples in primary tubes or secondary cups on tubes can be used. Bar-coded sample tubes are recognized. There are also two STAT positions available for STAT samples. Results are produced either qualitative or quantitative depending on the test. The typical test throughput is 50 results per hour.

1.4

Features of the Elecsys Host Interface • Bi-directional data transfer according to ASTM specifications: The host interface adds the ability of bi-directional data transfer to Elecsys analyzers via a RS232C asynchronous serial interface. The interface protocol relies on ASTM standard specifications 1381-91 (low level protocol) and 1394-91 (high level protocol; reference see page 3-32). • Test selection query mode (auto request): When samples are scanned (registered), the analyzer requests test orders from the host as soon as a sample bar-code is scanned. The host answers directly to the inquiry with appropriate test selections (Elecsys 1010 and Elecsys 2010). • Test selection batch mode: The host can download new or additional test orders to the instrument at any time before samples are scanned (registered). Also it is possible to cancel whole samples by the host (Elecsys 1010 and Elecsys 2010). • Automatic result upload: If set up the analyzer sends test results as soon as all measured data are available for one sample. • Specific result upload: If set up the operator decides whether undocumented results should be sent to the host (single or all). • Communicate additional manufacturer specific information: Beneath the above mentioned standard information (test orders and test results) the host interface updates regularly manufacturer specific information like alarms or instrument status. It communicates additionally inventory data, quality control and calibration data. Combined with the Laboratory Systems Manager (not available in US) you can take full control of those available data in a comfortable way. Since there is no need for interpretation the host ignores this data according to the ASTM specifications.

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How to ...

How to ... This section contains • how to set up the interface • how to operate the interface • how to do troubleshooting and maintenance

2.1

... use the Interface for Elecsys 2010

2.1.1 ... connect the Interface for Elecsys 2010 To connect the Elecsys 2010 analyzer to a laboratory EDP system (host) use a serial connection cable and the bi-directional interface connection on the left side of the instrument. The cable is described in section 4.1.1. Caution: Switch off the instrument before connecting the cable.

2.1.2 ... set up the Interface for Elecsys 2010 After switching on the instrument with the circuit breaker (right back side) it is also necessary to switch on the communication. Synchronize the parameters of the instrument interface with the host before turning on communication. The adjustments stay active when the instrument is powered off at the operation switch.

Buttons relevant for communication setup

Figure 2-1: UTIL Screen

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The DOCUMENTATION SETUP screen offers the operator options for managing results: Print and/or Upload to the Host. This setup influences what should be performed when the DOC key or the “document all” button is touched or when automatic documentation is performed. To set up automatic upload of test results to the host computer • touch the UTIL screen button • touch the DOCUMENTATION SETUP screen • touch the "Print/Upload" or "Upload" button. • touch the "Automatic ON" to receive requests as soon as they are available or the "Automatic OFF" button to manually send results.

Figure 2-2: DOCUMENTATION SETUP screen

To enter or change the setup parameters • touch the UTIL screen button • touch the INTERFACE SETUP screen button • touch the "Communication Off" button if communication is on. • touch the buttons for setting the correct values (color must be cyan) Baud Rate

2400, 4800, 9600, 19200

Data Bits

7,8

Stop Bits

1,2

Parity

none, odd, even and

Sync

on, off

• touch the "Communication On" button to reinitialize communication.

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Figure 2-3: INTERFACE SETUP screen

Note:

Only the buttons that are actually colored cyan (light blue) are active, i.e. can be selected.

Figure 2-4: Screen "Communication Confirmation"

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2.1.3 ... operate the Interface of Elecsys 2010 The need for operator interaction during up- and downloads depends on the mode in which the interface is running. In general all pending information, mostly manufacturer specific information will be sent when the communication is switched on. While the host can download test selections any time as batch or as response to an inquiry, the handling of results depends on the DOCUMENTATION SETUP setting. Both communication partners can send whenever they have data to send. In case that both want to transfer simultaneously the instrument has higher priority so the host must wait until the instrument is ready. The DOCUMENTATION SETUP screen influences what should be performed when the DOC key or the [“document all”] button is touched or when automatic documentation is performed. • Document Options Upload or Print/Upload and Automatic ON: When selected all results will automatically be transmitted by the analyzer in the order of sampling. When the bar code of a sample is scanned the sample will be assigned a sequence and position number (which is carrier number and position in the carrier) automatically. The analyzer requests test orders for each sample from the host using the sample bar code for bar-coded samples or the rack identification and position number for non bar-coded samples for identification. It is necessary to perform the sample programming at the host prior to that procedure. • Document Options Upload or Print/Upload and Automatic OFF: In this mode the operator must decide if the samples should be printed and/or sent to the host automatically or by manual initialization (setup see Figure 2-2). When this option is set to "AUTOMATIC Off" the transfer of results to the host can be triggered manually by using the DOC key or the "Document All“ button in the folder "Results“ (see Figure 2-5). Then there is an additional choice if the results already documented ("DOC"), or the results not yet documented ("Non Doc") or if all results ("All’) will be printed and/or uploaded at once. Pressing the DOC key initializes upload of the actual displayed sample. • Transfer of data due to manual events: If the host initializes the sending of Manufacturer Specific Records events like Reagent Scan, Bar Code Card Scan, Sample Scan or Start will trigger information exchange initiated by the analyzer (substance data, inventory) (see chapter 4.3.7.6). • Transfer of data due to automatic events: If the host initializes the sending of Manufacturer Specific Records events like alarm messages, consumption of inventory, changing instrument configuration or status, as well as calibrations create automatic information flow to the host. This information can be ignored by the host.

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Figure 2-5: Manual trigger to upload results

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How to ...

... use the Interface for Elecsys 1010

2.2.1 ... connect the Interface for Elecsys 1010 To connect the Elecsys 1010 analyzer to a laboratory EDP system (host) use a serial connection cable and the bi-directional interface connection on the left side of the instrument. The cable is described in section 4.1.1. Caution: Switch off the instrument before connecting the cable.

2.2.2 ... set up the Interface for Elecsys 1010 After switching on the instrument it is also necessary to switch on the communication. Synchronize the parameters of the instrument interface with the host before switching on communication. To set up communication parameters use the UTILITIES menu

Interface Setup

Utilities

Figure 2-6: UTILITIES Screen

• Press the UTILITIES key to open the UTILITIES main menu.

The arrow keys can be used to navigate between the input fields.

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Figure 2-7: INTERFACE Setup Screen

• Press the soft key to open the INTERFACE SETUP screen. Use the arrow keys to navigate between the fields. • Select the field HOST PROTOCOL. Press ENTER to open the pop-up window with selectable options. Use the arrow keys to select the appropriate host protocol. Press the ENTER key when complete. Refer to Fig. 2-8.

Figure 2-8: Select Host Protocol

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OFF:

A host is not connected.

HOST:

A host is connected.

LSM:

A host with a Laboratory Systems Manager is connected (not available in the US).

INTERNAL:

Not a customer option. Only for service personnel.

• HOST QUERY: Indicates whether host query mode is on or off. This field is only active if a setting other than OFF is selected for HOST PROTOCOL. The default setting is ON. If the setting is OFF, the host works in batch mode. • Input Instrument Network name: Displays the name of the analyzer as used in a network. The default setting is ELECSYS 1010. This name can be changed. • Select SERIAL INTERFACE HOST and touch the buttons for setting the correct values Baud Rate

1200, 2400, 4800, 9600, 19200

Data Bits

7,8

Stop Bits

1,2

Parity

none, odd, even

COMMENT: The Elecsys 1010 works without handshake. BAUD RATE: Displays the used communication speed in bits per second.

When ENTER is pressed, a pop-up window opens where a communication speed can be selected. DATA BITS: Displays the number of bits per data word that is used for communication.

When ENTER is pressed, a pop-up window opens where the number of data bits can be selected.

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STOP BITS: Displays the number of stop bits per data word that is used for communication.

When ENTER is pressed, a pop-up window opens where the number of stop bits can be selected. PARITY: Displays the parity recognition used for communication.

When ENTER is pressed, a pop-up window opens where the parity can be selected. SENDING ADDITIONAL DATA: Displays the following additional manufacturer specific records: RR: Raw Result RC: Result Context PM: Processing Message

Select YES or NO using the horizontal soft key at the bottom right of the screen. SUBSTANCE DATA TIMEOUT: Specifies the timeout for a manufacturer-specific record. This record contains general substance information (reagents, diluents, pretreatments, system reagents, calibrators, instrument calibrators, control, waste).

A number between 0 and 9 can be entered. The default setting is 0. The LSM may download substance data for a reagent pack after an upload for that pack without query from the instrument. No diluent parameter record is added for V 4.2 –Version 01/05

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diluent packs. After the upload after the run preparation scan the instrument should not use reagent pack inventory for inventory check or run calculation until a configurable time-out has run down. The respective action should be delayed. The time-out should be different from the time-out for order queries. The instrument should accept a reagent pack data download in every instrument state and use the information for all further actions. If the instrument receives such a download after the time-out has run down, a warning should be generated and added to the message history. HOST QUERY TIMEOUT: Specifies the timeout for the host query mode.

A number between 0 and 99 can be entered. The default setting is 99.

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SAMPLE BAR CODES: This area is used to specify the types of sample bar codes most frequently used on the analyzer. This reduces the read time significantly. DELETE LEADING ZEROS: Displays whether the sample bar code is processed with (YES) or without (NO) a fixed cut leading zero. AUTOMATIC POSITIONING: This mode is used when working with non-bar-coded samples and the host download is without a position number. Select YES or NO using the horizontal soft key at the bottom right of the screen. OPTIMIZED BATCH SEQUENCING: Selects the sequence change for complementary tests. Select YES or NO using the horizontal soft key at the bottom right of the screen.

Figure 2-9: Instrument Setup Screen

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DOCUMENTATION OPTION: Displays the Documentation Options which defines the behavior of result print out and/or upload to the Host.

AUTOMATIC, RESULT ORDER: Results are uploaded automatically in the order in which the results of individual test were measured. AUTOMATIC, SAMPLE ORDER: Results are uploaded automatically when all tests for a sample have been measured. MANUAL When this option is selected, the UPLOAD RESULT key displayed in the TEST REPORT screen. This option allows individual results to be sent to the host. OFF Results are not uploaded. Note:

Results must be either printed out, stored on a floppy disk or sent to the laboratory EDP (host). If one of these functions has been performed, the result is said to be documented and the position number is released for further use.

2.2.3 ... operate the Interface of Elecsys 1010 The Elecsys 1010 interface works in batch mode or in query mode. The need for operator interaction during uploads and downloads depends on the mode in which the interface is running. In general all pending information will be send when the communication is switched on. While the host can download test selections any time as batch or as response to an inquiry, the handling of results depends on the Documentation Options setting. Both communication partners can send whenever they have data to send. In case that both want to transfer simultaneously the instrument has higher priority so the host must wait until the instrument is ready.

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... do Troubleshooting and Maintenance The Elecsys User Interface software does not provide any means to troubleshoot the communication line. There are sophisticated error treatments inherent to the interface protocol. The host system must be able to trace and interpret error related protocol information and may react by outputting adequate screen messages. Following two hints may help you in case of • no communication at all: Check the cabling and the interface setup. • problems with the protocol: A simulator program is available as a software tool for analyzing communication problems as well as for development of host drivers. It can simulate either communication partner (host or analyzer) and writes communication traces to files to be analyzed off-line in a very convenient way supported by extensive help files. If you require this program, please contact your local Roche representative.

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Theory of Operation

Theory of Operation This section contains • an overview of the Interface • a description of Transmission Protocol • an example

3.1

Overview of the Interface As described in section 1.3 the host interface enables the Elecsys analyzer to exchange test results, test requests and all related data with a laboratory host computer system. Physically, the analyzer and host are connected by an RS 232 interface. Logically they use a standard protocol called ASTM (with proprietary extensions). ASTM is an implementation of the OSI model, which tries to classify the diversity of functions needed for such a message exchange using hierarchical layers. Once you are familiar with the OSI model you will easily understand the ASTM protocol layers. Whereas OSI defines seven layers, ASTM summarizes these layers into just four. In the next section after a short introduction to the OSI model and ASTM we will describe every layer of the ASTM protocol in detail.

3.2

Description of Transmission Protocol

3.2.1 Basics

3.2.1.1 OSI model The Elecsys Host Interface Protocol is consistent with the OSI (Open System Integration) model of the ISO (Organization for International Standards). The OSI model describes a system-independent method of transferring messages. Sending and receiving of messages is broken down into functions which are hierarchically classified into seven layers. Each layer restricts communication to the next higher and the next lower layer. It makes its communication services available only to the next higher layer. The layers do not interpret the messages. They just add transportation services like cutting the message in portions, putting envelopes around, calculating checksums, watching for a transmission receipt or converting bits and bytes into electrical current. Although the message has to travel through the different layers to be sent or received, transportation is virtually horizontal. This means a layer communicates with its partner layer on the other end of the communication link at equal hierarchical position without knowing about the functions of the lower layers (they are fully transparent to the higher layers). So protocols are defined between equal layers. Interchange of information between the next higher and the next lower layer is system specific and need not be known to the communication partner. This classification of

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communication functions is a highly efficient method to break down complex communication tasks into small portions that are easy to handle and interchangeable.

Figure 3-1: The OSI model explained by example

For you as a software engineer it is important to know, that you can program a low level layer (e.g. the Data Link Layer) without having to know about the protocol. You need not know what kind of messages the doctor and the laboratory are exchanging or what the phone numbers of the lab are. All you need to know is the protocol for the Data Link Layer and the interface structure to the neighboring layers. In our example you have to know that you will get messages from the Network Layer. The task is to break them down into words. You then have to program a packing algorithm meeting the protocol definitions of your layer. That means putting the words in frames with "$$$" around the words. Then you must add a trailing checksum calculated according to the protocol definitions. The ready to send frames must be transferred to the Physical Layer with a request to send these frames. Please note that this example does not reflect the processes of the Elecsys host interface. It shows a strongly simplified communication process to clarify classification of the diverse communication functions into layers. OSI implementations can

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summarize communication functions into less than seven layers like the ASTM protocol does with its four layers.

3.2.1.2 ASTM The ASTM protocol uses four hierarchical layers for processing communication data: • Application layers virtually exchange messages (e.g. test results) • Presentation layers virtually exchange records. One message consists of multiple records. • Data link layers virtually exchange frames. One record consists of one or more frames. • Physical layers physically exchange 8 bit ASCI codes through standard serial interfaces. One frame consists of max. 240 record letters (bytes) and 7 bytes of delimiter and checksum data.

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Frame

Send/Receive

Record

Record

Build Message Record Message

Communication Data Analyze Message

Record

Record

Figure 3-2: Correlation between Message
 Record
 Frame

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Figure 3-3: Layers of the ASTM-Protocol

The ASTM protocol definition is divided into a low level and a high level protocol. The ASTM low level protocol defines the data communication method by frames and is described in sections 3.2.4 and 3.2.5. The ASTM high level protocol defines the message structure, message resending process, record structure and types of records and their use. It is described in sections 3.2.2 and 3.2.3. Details of the ASTM protocol can be found in the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A

• ASTM E1381-94 Low Level Protocol: Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems. • ASTM E1394-91 High Level Protocol: Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems.

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3.2.1.3 Description of Terms Specific to ASTM To clarify some terms this chapter defines some specific wording according to the ASTM specifications (see also Glossary). • message - a textual body of information. Example: The test results of all orders for a group of patients and the related data. • battery - a group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name. • test - a determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute. Example: Determination of TSH in serum. • record - an aggregate of fields describing one aspect of the complete message. Example: The Patient Information Record in a "Measured Data Message" contains information related to the patient whose test results are reported. • field - one specific attribute of a record which may contain aggregates of data elements further referring the basic attribute. Example: The Patient Name Field in the Patient Information Record. • repeat field - a single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields. Example: The Test ID Field of an Order Record may contain the IDs of more than one test. The IDs of the multiple tests are all listed in the Test ID Field separated by the Repeat Delimiter. • component field - a single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields. • upload - data transmitted from a clinical instrument to a computer system. Example: When the analyzer has finished all tests for a certain sample it downloads the results to the host. • download - data transmitted from a computer system to a clinical instrument. Example: The host orders the tests for a group of patients by uploading a test order message to the instrument.

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3.2.2 Application Layer At the Application Layer the Instrument (i.e. the analyzer) and the Host (i.e. LIS / HIS) exchange messages. The high level ASTM protocol defines the structure of these messages but cannot define the trigger events for messages or the reactions to messages. Such specifications are part of the individual implementation of the ASTM protocol, typically they depend on features of the Instrument (and Host). As you will see in section 3.2.2.1 messages are constructed by combining predefined records. The predefined set of records covers the typical messages to be exchanged between Instrument and Host. By use of manufacturer defined records this set can be extended to the needs of special features of the Instrument. More detailed information on the manufacturer specific records is beyond the scope of this section, however will be found in the section Engineering Reference. In the next sections the messages, trigger events, reactions and error handling are discussed.

3.2.2.1 Types of Events Most analyzers operate in a sample oriented manner, which means essential data transmission can be done by ordering tests and sending results. For further types of messages which do not need any intervention by the operator or host please refer to the section Engineering Reference. The standard messages can be divided into 6 types of events: • Inquiry to Host Example: The Instrument has scanned the sample bar-codes and needs the worklist (list of tests) to be performed with these samples (test selection). It informs the Host of this need by use of an request information message to the Host.

Message Header

Request Information

Message Terminator

H Q L

Figure 3-4: Inquiry to Host

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• Response from Host Example: The Host receives the inquiry for test selections. It reacts by sending the data using a test order message from Host.

H P

Message Header

Patient Information

O

Test Order

L

Message Terminator

Figure 3-5: Response from Host

• Inquiry to Instrument Example: The Host needs the results of a specific sample. It informs the Instrument of this need by use of a request information message to Instrument. Comment: Usually with the option "Automatic Upload On" all results for a sample will be sent to the Host as soon as ready. So there is no need to ask for results at the Elecsys 2010.

H Q L

Message Header

Request Information

Message Terminator

Figure 3-6: Inquiry to Instrument

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• Response from Instrument Example: The Instrument receives the inquiry for test results. It reacts by sending the data using a result message from Host.

Message Header

H P

Patient Information

O

Test Order

R

Result

Message Terminator

L

Figure 3-7: Response from Instrument

• Unrequested Upload to Host Example 1 "Query Mode" ("Automatic Upload On"): The Instrument sends all test results directly after completion of all tests for a sample without prior reception of an inquiry from the Host. Example 2 "Batch Mode" ("Auto. Upload Off" and "Auto. Printout Off"): The operator initializes manually to send all test results without prior reception of an inquiry from the Host.

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H

Message Header

P

Patient Information

O

Test Order

R

Result

L

Message Terminator

Figure 3-8: Automatic Upload to Host

• Unrequested Download from Host Example: The Host operator has completed the selection of tests for a set of samples. The Host sends this test selection data by a test order message without prior reception of an inquiry from the Instrument.

H P

Message Header

Patient Information

O

Test Order

L

Message Terminator

Figure 3-9: Batch Download from Host

The first four types of messages occur in a synchronous exchange of messages alternatively requesting and responding (e.g. triggered by a sample bar-code scan or all test for a sample are performed). This procedure is called "Query Mode" or "Auto Request Mode" (Documentation Setup is Automatic Upload ON).

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The last two types of messages occur in an asynchronous transfer of messages. An operator triggers the transmission of an up- or download message and the receiver of the message has to be prepared to interpret, store and react to this message. This procedure is used in "Batch Mode" (Documentation Setup is Automatic Upload OFF and Automatic Printout OFF). Beneath the above mentioned standard messages a couple of manufacturer information is sent automatically from the Elecsys instrument. This extensive information will provide a very comfortable information handling and interchange together with the Laboratory Systems Manager (LSM). Standard Hosts should ignore all manufacturer data like it is defined in the ASTM specification. Most Manufacturer Messages are typically asynchronous messages (one way information), like the Alarm Messages from the Instrument. Others, like the above mentioned Test Selection or Test Result Messages, can be exchanged in the synchronous as well as asynchronous way (answer & response).

3.2.2.2 Event Related Data Processing Instrument requests a message from the Host (instrument is sending): • After the request the instrument waits for the response from the Host for a certain time. • When the certain time has passed and another message has to be sent the instrument starts sending the new message to the Host. • When the instrument fails in sending a request to the Host the instrument stops resending the request. Instrument responds to requests from Host (instrument is sending). • After having received the request the instrument responds to this request at first priority. • When the instrument fails to send the response it stops resending the response. Instrument provides the Host with information (instrument is sending) • When the transfer of an upload message fails the instrument re-sends the upload message. • Resending the upload message is allowed twice. When the resending of the message fails twice the sending of this upload message is stopped. Host requests information from the instrument (instrument is receiving): • After having received a request from the Host the instrument responds to this request at first priority. • When the instrument fails to send the response message it tries again. • When resending the response fails twice, the response to this request is stopped. • When the Host requests canceling the inquiry, the response to this inquiry is also stopped. V 4.2 –Version 01/05

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Instrument requests from the Host • After having received the response from the Host the instrument updates the data base (DB) based on this response. (The update of the DB based on the response depends on the instrument status. When the DB is not updated the instrument reports this status to the Host as an alarm message.) Host provides the instrument with information • After having received the download from the Host the instrument updates the data base (DB) based on this download. (The update of the DB based on the download depends on the instrument status. When the DB is not updated the instrument reports this status to the Host as an alarm message.)

3.2.2.3 Message Priorities As message transmission is triggered by external events, it is possible, that more than one message is waiting to be sent by the instrument. Therefore priority levels are defined for each class of message (see Table 3-1).

Priority

Sending Order

Types of messages

High

1

Response (re-send)

Low

2

Response

3

Report the received message situation (re-send)

4

Report the received message situation

5

Inquiry (re-send)

6

Inquiry

7

Upload (re-send)

8

Upload

Table 3-1: Message Priorities

3.2.2.4 Events Table 3-2 to Table 3-7 summarize the messages used by the Elecsys analyzer with their events. The column "Records" shows the record types mentioned earlier which are used to construct the message. Records are discussed in detail in section 3.2.3.1. Please note that ASTM standard specifications primarily define the exchange of messages between analyzer and host for ordering tests, receiving results and managing patient related data. For system related, manufacturer dependent data as it is exchanged between the instrument and the LSM (Laboratory Systems Manager, not available in US), the ASTM standard specifies a "Manufacturer Information Record".

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This definition guarantees the exchange of "Manufacturer Specific Records" (MSR) by still using a standardized message exchange. As manufacturer defined messages contain highly specific information and can be subject to modifications by Roche Diagnostics without notification they are not listed in the following tables but for completeness in chapter 4.3

Messages

Records

Trigger Events

Inquiry of test selection information

Q

sample disk scanning

Messages

Records

Reception by Instrument

Test selection information

P, O

after inquiry

Table 3-2: Request from instrument to Host

Table 3-3: Response from Host to instrument

When executing the sample disk scanning, the instrument sends a request message for the test selection information to the Host after each sample bar-code scanned. The data is only requested for normal samples and control samples of which test selection information has not yet been registered.

Messages

Records

Reception by Instrument

Inquiry of test selection information

Q

any time

Inquiry of measured data

Q

any time

Table 3-4: Request from Host to instrument

Messages

Records

Trigger Events

Test selection information

P, O

Inquiry from Host

Measured data

P, O, R, C

Inquiry from Host

Table 3-5: Response from instrument to Host

The transmission of upload messages is asynchronous, i.e. it is not requested by an inquiry of the Host but triggered by events: • Measured data: ⇒ When all the measured result data of a normal or control sample are performed the instrument uploads the data under the condition that "Upload Options: Automatic ON" is requested on the DOCUMENTATION SETUP screen. This is configurable on Elecsys 1010 and the data can be sent automatically, in result order, or sample order. ⇒ When pressing the "Print All" button key on the Results screen on Elecsys 2010, the instrument uploads the measured data under the condition that "Upload

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Options" and "Print Options" are set to "Automatic OFF" on the DOCUMENTATION SETUP screen. ⇒ After turning on the power switch, the instrument is in the stand-by status. The instrument uploads all the remaining measured data which have not been uploaded before.

Messages

Records

Trigger Events

Measured data

P, O, R, C,

Completion of Tests, pressing "Print All"-button, power on

Table 3-6: Upload from instrument to Host

Messages

Records

Reception by Instrument

Test selection information

P, O

any time

Request cancel

Q

any time

Table 3-7: Download from Host to instrument

Please note that on Elecsys 2010 according to the ASTM specifications only one request record may be outstanding at a time, the receiver of a request record must terminate the request, when finished, via the message terminator record, or the sender must cancel the request before sending a second logical request. Therefore the "Request Information Record" (Q) can be used by the Host for canceling requests previously transmitted to the instrument. This is done by leaving fields 3 to 12 empty, field 1 is "Q", 2 is "1" and 13 is "A" (see 4.3.6.7). Canceling / deleting of samples in the data base will be done with the "Test Order record" (O) where the Action Code is "C".

3.2.2.5 Error Detection and Recovery Communication errors are detected at all different layers. The layers try to correct these errors at their level. If an error cannot be corrected by the error recovery procedures of a specific layer, it reports that error to the next higher layer. At last the Application Layer has to try a correction of the detected error condition or has to generate an alarm. In general there are six types of errors as following (see also description of errors in the specific sections of the related layer): • Send error: When the sending of a message fails at the Data Link Layer because of time outs or exceeded retransmission counts this error type is detected. Recovery: Resending of the message. • Receive error: When the receiving of a message fails at the Data Link Layer because of time outs or at the Presentation Layer because of detection of invalid Records this error type V 4.2 –Version 01/05

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is detected. Recovery: Sending of the appropriate termination code for "receiving message failed" in the Termination Record of the receipt message (see Table 3-8). • Improper message error: When the Presentation Layer receives an invalid message this error type is detected. A message is invalid because of wrong structure (see 3.2.3.1 Message Structure: Records) or record data not based on the rules (see 3.2.3.2 Message Structure: Fields). Recovery: Sending of the appropriate termination code for "receiving message failed" in the Termination Record of the receipt message (see Table 3-8). • Message acceptance error: As mentioned earlier response and download messages normally result in an update of the instrument's data base. There are certain conditions of the instrument, when an update of the data base is not possible. Such an impossibility of updating the data base results in a "Message acceptance error". Recovery: Sending of the appropriate termination code for "refusing received message" in the Termination Record of the receipt message (see Table 3-8). • Hardware error: When the Physical Layer reports a communication error this error type is detected. Recovery: After re-initialization of the communication circuit and a delay of 40 seconds sending messages are re-sent to the Host. • Application error: When the Data Link Layer detects an unrecoverable error this error type is picked up. Recovery: After re-initialization of the communication circuit and a delay of 40 seconds those messages are re-sent to the Host. The result status after the reception of a message from the Host is reported to the Host by the response message (in case of a received inquiry) or (in case of a received response or download) a Receipt Message containing only the framing "H" and "L" (Header and Termination) records (see 3.2.3.1). In both cases the reception status is reported by using the Termination Code Field in the Termination record ("L"). When receiving "response" and "download" messages normally, the instrument does not report the message receiving situation to the Host.

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Attribute of message

Theory of Operation

Message receiving situation normal

Inquiry abnormal

There is a response data.

F

There is no response data.

I

Not all data in records are in accordance to the rules. (Improper message error)

Q

Receive error Hardware error Application error

E

normal

Response & Download

Invalid attribution

*

abnormal

abnormal

Termination code

no message All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*)

E

The last record is not the Termination record.

R

Improper message error Receive error Hardware error Application error (*)

E

The instrument reflects the valid record data on the data base. Table 3-8: Termination Codes to different Error States

The occurrence of communication errors which cannot be corrected (e.g. by retransmission) results in an alarm condition of the Instrument. All layers report error states to the Application Layer. There they are reported to the operator. Communication errors detected by the Host are also reported to the Instrument’s Application Layer by the Termination Code in the Message Termination Record which is terminating every message. Table 3-9 summarizes the possible Alarms.

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Alarm Name

Contents

Cause of Alarm

Source Layer

Communication re-sending occurred

When sending a message, re-sending of the message occurred

Re-sending a message succeeded

Application

Communication re-sending failed

Re-sending a message failed

Re-sending a message failed

Application

Communication message acceptance error

Impossible to update the data base using the message.

Picked up the message acceptance error.

Application, Message Acceptance error

Communication message format illegal error

• There was a valid record, but no Termination Record. • There was no valid record. • The first record was not a header record. • There was an undefined record. • There was a record that was not in accordance to the rules.

• The last record was not the Termination record • Picked up the improper message errors.

Presentation, Improper Message Error

Communication application error

Application error happened.

Picked up the application error.

Data Link, Application Error

Communication sending error

Re-sending a message failed at the low level

Picked up sending error

Data Link, Send Error

Communication sending error

Time out happened at the lower level

Picked up sending error

Data Link, Send Error

Communication receiving error

Time out happened at the lower level

Picked up receiving error

Data Link, Receive Error

Communication device error

Hardware error happened.

Picked up the hardware error.

Physical, Hardware Error

Communication sending message aborted

Sending a message has been aborted

Received the Termination code = R

Any, from Host (Presentation)

Communication receiving message aborted

Receiving a message has been aborted

Received the Termination code = T

Any, from Host (Presentation)

Table 3-9: List of Alarm Conditions

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3.2.3 Presentation Layer

3.2.3.1 Message Structure: Records The typical message contains a set of information. E.g. the response message to a test result inquiry contains four levels (0-3) of information: • Data relating to the patients who’s test results are transmitted. • Data relating to the orders (test batteries) the test results belong to. • Data relating to the test results of each test battery for every patient. • Comment data with information belonging to each result. As you can see, there is a hierarchical structure in this set of information. Multiple comments can belong to one test result. Multiple test results can belong to one order (requested test profile). Multiple orders can belong to one patient. Multiple patients can belong to one message transmitted. Instead of repeating the patient data and order data for each test result, the order and patient data can be used like headlines in a hierarchical outline like the one of this document. This reduces transmission of redundant data and reflects the typical relational database model used for storing the message information. Note:

Elecsys 2010 only uses one patient per message and only one order per message can be made (with multiple test selections via repeat fields).

ASTM defines messages to consist of a hierarchy of records of various types (see Figure 3-10). Records at level zero contain information pertaining to the sender identification and completion of transmission. They can be seen as a kind of framing information relating to the message. Records at level one of the hierarchy contain information about individual patients. Records at level two contain information about test order requests and specimens. Records at level three contain information about test results. Comment records may be inserted at any level in the hierarchy. A comment record always relates to the immediately preceding patient, order, result, scientific or manufacturer information record. Therefore, if a comment record were to follow a patient record (level one), then that comment record would be treated as a level two record. A comment record may not follow the message terminator record. Manufacturer information records may be inserted at any level in the hierarchy (with the exception of level 0). This record type always relates to the immediately preceding patient, order result, scientific or comment record. Therefore, if a manufacturer information record were to follow a patient record (level one), then the record would be treated as a level two record. This record may not follow the message terminator record.

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Additional record types are the request-information record and the terminator record. The request-information record provides for the request of demographics or test results to or from the clinical instrument for specified patients, specimens, tests, dates, and so on. The message terminator record must be the very last record of the message.

(Level 0) (Level 1) (Level 1) (Level 2) (Level 2) (Level 3) (Level 3) (Level 3) (Level 4) (Level 4) (Level 4) (Level 4) (Level 4) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 4) (Level 1) (Level 1) (Level 1) (Level 1) (Level 0)

HEADER MANUFACTURER INFORMATION 1 PATIENT 1 (general information about patient) | COMMENT 1 Record (relates to previous patient PATIENT 1) | ORDER 1 (information about the first battery requested) | | COMMENT 1 Record (relates to previous order ORDER 1 ) | | RESULT 1 (information about the first result of battery 1) | | RESULT 2 (information about the second result of battery 1) | | | COMMENT 1 Record (Relates to RESULT 2) | | | COMMENT 2 Record (Relates to RESULT 2) | | |
| | |
| | |
| | RESULT n (information about the last result of battery 1) | ORDER 2 (information about battery 2) | | RESULT 1 (information about the first result of battery 2) | | RESULT 2 (information about the second result of battery 2) | |
| |
| |
| | RESULT n (information about the last result of battery 2) | ORDER n (information about the last battery for the first patient) | | RESULT 1 (first result of the last order) | |
| |
| |
| | RESULT n (information about the last result of battery n) | | | COMMENT 1 Record (Relates to RESULT n) PATIENT 2 (all of the structure repeats)

PATIENT n MESSAGE TERMINATOR Figure 3-10: Hierarchical Structure of Messages

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ASTM defines a given set of record types (see Table 3-10). One type (manufacturer information, identifier "M") can be used for manufacturer specific extension of this set (see Table 3-11). Most of the record types are related to each other in a definite hierarchy. At level zero is the message header and message terminator. At level one is the patient record, the request-information record and the scientific record. At level two is the test order record. At level three is the result record. The comment records do not have an assigned level. Level

Record Name

Identifier

0

Message Header Record

H

1

Patient Information Record

P

2

Test Order Record

O

3

Result Record

R

0..3

Comment Record

C

0..3

Manufacturer Information Record

M

0

Message Terminator Record

L

1

Request Information Record

Q

1

Scientific Record (This record is not used by the Roche Diagnostics implementation)

S

Table 3-10: Standard Record Types and Levels

The Roche Diagnostics specific records (MSR) follow the levels described below.

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Level

Record Name

Identifier

1

MSR - Action Confirmation (This record is not used by the

M-AC

Roche Diagnostics implementation) 1

MSR - Action Request

M-AR

(This record is not used by the Roche Diagnostics implementation) 1

1

MSR - Calibration Result

M-CR

(This record is not used by the Roche Diagnostics implementation) MSR - Calibration Order (Elecsys 1010 only) (This record is M-CO not used by the Roche Diagnostics implementation)

1

MSR - Calibrator Parameters

M-CP

1

MSR - Calibration Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)

M-CS

2

MSR - Control Parameters

M-QP

1

MSR - Control Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)

M-QS

2 1 1 1 1

MSR - Diluent Parameters MSR - Instrument Configuration MSR - Instrument Status MSR - Log File MSR - Processing Message

M-DP M-IC M-IS M-LF M-PM

1

MSR - Change Communication Protocol (Elecsys 1010 only) M-PX (This record is not used by the Roche Diagnostics implementation)

4 4 1

MSR - Raw Result MSR - Result Context MSR - Sample Status

M-RR M-RC M-SS

(This record is not used by the Roche Diagnostics implementation) 1 1 1 1

MSR - Service Data MSR - Substance Data MSR - Test Application MSR - Test Conditions

M-SD M-XT M-TA M-TC

Table 3-11: Manufacturer Defined Records and Levels

• Message Header Record (H) - This record contains information about the sender and the receiver, that is, it identifies the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters. • Patient Information Record (P) -This record type contains information about an individual patient. • Test Order Record (O) - When sent from the computer system to the instrument, this record represents a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it provides information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries). • Result Record (R) - Each result record contains the results of a single analytic determination.

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• Comment Record (C) - Comment records can apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure. • Request Information Record (Q) - This record is used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results (only on Elecsys 2010) for an individual test, multiple tests, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc. • Scientific Record (S) - This record is used to exchange results between clinical sites for the purposes of proficiency testing or method development (not used by the Roche Diagnostics implementation). • Manufacturer Information Record (M) - This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer. • The manufacturer specific records defined by Roche Diagnostics are classified by a sub record ID (see Table 3-11). They were introduced for the communication with the Laboratory Systems Manager. A standard host usually will ignore those messages. A sequence of patient records, order records, or result records at one level is terminated by the appearance of a record type of the same or higher level. Thus, a sequence of results for one battery of tests is terminated by the next test order, patient, manufacturer information, request information, or message terminator record. An order record may never appear without a preceding patient record and a result record may never appear without a preceding order record. When an order is transmitted, it must be preceded by a patient record. All orders that follow apply to the patient in the preceding patient record. When a result is transmitted, it must be preceded by an order record and a patient record to maintain the prescribed hierarchy. In order to determine buffering requirements, both transmitter and receiver must use common rules for storing transmitted data in order to ensure proper error logging and error recovery procedures. Since data content is structured in a hierarchical fashion, any decremental change in the hierarchical level will trigger storage of all data transmitted prior to said level change. This rule may be considered as the minimal implementation. In the following example (Table 3-13), permanent storage of data, by the receiver, should occur at points: E, G, L, M, N, Q. Q is assumed as saved by virtue of the record type function.

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Line #

Record Type

(Level) Increment

A

Header

(Level 0)+0

B

Patient 1

C

(Level 1)+1 Order 1

D

(Level 2)+1 Result 1

E

(Level 3)+1

Order 2

F

(Level 2)-1

Order 3

G

(Level 1)-1 Order 1 Comment 1

(Level 3)+1

J

Result 1

(Level 3)+0

K

Comment Result 2

M

Order 2

N

Patient 3

O

Order 1

P Q

{Save E-F}

(Level 2)+1

I

L

{Save A-D}

(Level 2)+0

Patient 2

H

Action

(Level 4)+1 (Level 3)-1

{Save G-K}

(Level 2)-1

{Save L}

(Level 1)-1

{Save M}

(Level 2)+1 Result 1

Message Terminator

(Level 3)+1 (Level 0)-3

{Save N-P}

Table 3-12: Information Storage Requirements, Transmission Example

Line Failure Occurs At:

Requires Retransmission Of:

A

A

B

A, B

C

A, B, C

D

A, B, C, D

E

A, B, C, D, E

F

A, B, E, F

G

A, B, E, F

H

A, G, H

I

A, G, H, I

J

A, G, H, I, J

K

A, G, H, I, J, K

L

A, G, H, I, J, K, L

M

A, G, H, L, M

N

A, G, M

O

A, N, O

P

A, N, O, P

Q

A, N, O, P, Q

Table 3-13: Error Recovery at Presentation Layer

Transmission line failure, determined at the transmission protocol level, requires a mechanism for restarting the incomplete message. If a transmission failure occurs, transmission shall restart at the last logical record not presumed saved as outlined. In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point must be repeated prior to transmitting the record where

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line failure originally occurred. Using the transmission example as given, the following record recovery examples would be valid. 3.2.3.2 Message Structure: Fields The smallest element of information in any record is the field, containing a single item of information, such as a date, a patient name, or a numeric test result. In the upper layers, ASTM does not define a limit for the length of a message, record or field, so the length of a message is flexible. There are special delimiter characters to indicate the end of record fields (see Table 3-14). ASTM defines specific sets of fields for each record type (see section 4.3.7). All data are represented as eight bit values, within the range (0-255), where 0-127 are defined by the ASCII standard (ANSI X3.4-1986) and values 128-255 are undefined by this standard. Values 0-31 are disallowed with the exception of 7, 9, 11, 12, and 13, where 13 is reserved as a record terminator. Values 32-126 and 128-254 are allowed. Values 127 and 255 are also disallowed. It is the responsibility of the instrument vendor and computer system vendor to understand the representation of any extended or alternate character set being used. As an example, the numeric value 13.5 would be sent as four byte value characters 13.5 or ASCII(49), ASCII(51), ASCII(47), ASCII(53). Allowed Characters:

7, 9, 11, 12, 13, 32-126. 128-254

Disallowed Characters:

0-6, 8, 10, 14-31, 127, 255

Within text data fields, only the ASCII characters 32-126 and the undefined characters 128-254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. Delimiter characters are defined for each message in the header record. The sender is responsible for screening all text data fields to ensure that the text does not contain those delimiters. Alphanumeric characters should not be used as delimiters because they are likely to appear within field content. Moreover, some alphabetic characters have special uses as follows:

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H, P, O, R, C, Q, E, L, M

record type IDs

.

decimal point (period)

,

comma

S, P, R, C

priority codes

L, H, , N, U, D, B, W

result codes

C, P, F, X, I, O

result status

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The following delimiters are used as standard in the ASTM specifications:

Delimiter

Character

Char.

ASCII decimal

ASCII hex.

Record delimiter

= carriage return

13

0Dh

Field delimiter

= vertical bar

|

124

7Ch

Repeat delimiter

= backslash

\

92

5Ch

Component delimiter

= caret

^

94

5Eh

Escape delimiter

= ampersand

&

37

26h

Table 3-14: Delimiter Characters as used in ASTM Specifications

• Record Delimiter - Carriage return (ASCII 13) is the delimiter for the end of any of the defined record types. • Field Delimiter - A single allowable character excluding ASCII 13 (carriage return), separates adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record. • Repeat Delimiter - A single allowable character excluding ASCII 13 and the value for the field delimiter. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set. • Component Delimiter - A single allowable character excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters. • Escape Delimiter - A single allowable character excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. Use of Escape Delimiter - The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences are pre-defined.

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&H&

start highlighting text

&N&

normal text (end highlighting)

&F&

imbedded field delimiter character

&S&

imbedded component field delimiter character

&R&

imbedded repeat field delimiter character

&E&

imbedded escape delimiter character

&Xhhhh&

hexadecimal data Any number of hexadecimal digits (0-9, A-F) may follow (that is, &XA& could equal line feed).

&Zcccc&

Local (manufacturer defined) escape sequence Any number of legal characters may follow.

Fields are identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to ensure that the i'th field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters. Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified. A system may transmit a null value for a field because (1) it does not know the value, (2) it knows the value is irrelevant to the receiving system, or (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's date of birth, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s date of birth when the date of birth was actually unknown, the receiving system should replace its existing value for a field with a null value. A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.

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3.2.3.3 Common Field Types: • Universal Test ID - This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record, there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered. • Universal Test ID (Part 1) - This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time. • Universal Test ID Name (Part 2) - This would be the test or battery name associated with the universal test ID code described in 5.1. • Universal Test ID Type (Part 3) - In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields. • Manufacturer’s or Local Code (Part 4) - This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as - Dilution^Diluent^Description. • Dates and Times - In all cases, dates are recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they are represented as HHMMSS, and are linked to dates as specified by ANSI X3.43. Date and time together are specified as up to a fourteen-character string: YYYYMMDDHHMMSS. • Time Zone - The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender. • Telephone Numbers - Phone numbers are recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc. • Multiple Phone Numbers - When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number.

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• Fixed Measurements and Units - When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955. • Addresses - An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country need only be transmitted when it cannot be assumed from the context. The components of this field are position dependent. • Provider and User IDs - Physician's and other health staff codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name are (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. When necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters. • Record Sequence Number - This is a required field used in record types that may occur multiple times within a single message. The number used defines the i'th occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records).

3.2.4 Data Link Layer 3.2.4.1 General Description As described earlier the Data Link Layer has to perform the following services: • Link and release of connection: Establishes which system sends and which systems receives information.

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• Cut messages in smaller frames of text, delimit frames: Provides for recognition of frames • Synchronize transfer of frames and sequential control: Maintains the sequential order of information across the connection. • Error detection: Senses transmission and format errors. • Error recovery: Attempts to recover from detected errors by re-transmitting defective frames or returning the link to a neutral state from otherwise unrecoverable errors. The ASTM low level protocol is a simplex stop and wait protocol. E.g. information always flows in one direction at a time. Replies occur after information is sent, never at the same time. In contradiction to other communication protocols there is no master slave relation. Both instrument as well as host may initialize the communication. To establish which system sends and which system receives information and to assure the actions of sender and receiver are well coordinated, there are three distinct phases in transferring information: • Establishment Phase (Link Connection) • Transfer Phase • Termination Phase (Link Release)

Establishment Phase

Sender

ENQ

Termination Phase

Transfer Phase

intermediate frame

end frame

EOT

Receiver ACK

ACK

ACK

Figure 3-11: Three Phases at Data Link Layer

3.2.4.2 Establishment Phase (Link Connection) At the Data Link Layer both communication partners can be in one of the three following states: • Idle: Waiting to become a receiver • Sender: Initiates establishment phase, sends record information in frames and ends with termination phase

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• Receiver: Receives frames and sends acknowledgment codes. At the same time only one device can be sender and only one device can be receiver. Both devices can be in idle state at the same time. If the Presentation Layer asks the Data Link Layer to transfer a record, the device must change from idle state to sender state. To ensure that only a single device tries to become sender at one time and the communication partner is listening (i.e. in receiver state) the device intending to become sender has to initiate the Establishment Phase. Therefore it sends the ASCII code 5 [ENQ] and waits for the partner to send code 6 [ACK] to signal that it changed from Idle to receiver state. The reception of [ACK] completes the Establishment Phase and starts the Transfer Phase. In idle state any other character received than [ENQ] will be ignored. Receiving an [ENQ] should be answered with [ACK] and sets the receiver into receiver state. This would be the regular procedure for the Establishment Phase. In case of error there are three more ways the receiver can respond to an [ENQ]: • The receiver sends any character than [ACK]. Typically this would be an ASCII code 21 (15hex) [NAK] when the receiver is busy. The sender waits an amount of time (e.g. Elecsys waits 10 seconds) and then tries establishment with another [ENQ]. This cycle is repeated until a [ACK], [NAK], or any other character is received.

Establishment Phase

retry

retry 10 sec

ENQ

Sender

1 sec

ENQ

ENQ

Transfer Phase

abort 15 sec

EOT

ENQ

Receiver xxx

ENQ

ACK

Figure 3-12: Response is any character

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• The receiver sends an [ENQ]. In ASTM terms this situation is called "Contention" as both devices try to become senders. The instrument system has by definition the higher priority to transmit information when contention occurs. Therefore the host system has to stop sending [ENQ] but has to answer with [ACK] or [NAK] when it detects contention. On the other hand the Elecsys waits at least 1 second and then returns another [ENQ]. This cycle is repeated until a [ACK], [NAK], or any other character is received.

Establishment Phase

retry 10 sec

ENQ

Sender

retry 1 sec

ENQ

ENQ

Transfer Phase

abort 15 sec

EOT

ENQ

Receiver xxx

ENQ

ACK

Figure 3-13: Contention: Response is any [ENQ]

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• The receiver does not respond. The receiver waits 15 seconds, initiates the Termination Phase by sending an [EOT] (ASCII code 4), and displays an error message.

Establishment Phase

retry

retry 10 sec

ENQ

Sender

1 sec

ENQ

Transfer Phase

abort 15 sec

ENQ

EOT

ENQ

Receiver xxx

ACK

ENQ

Figure 3-14: Time out: No response

• The receiver sends an [ACK]. The sender changes to Transfer Phase and initiates the record transfer. Alternatively, if the Elecsys is in Test Mode, it initiates the Termination Phase by sending an [EOT] (ASCII code 4).

Establishment Phase

retry 10 sec

ENQ

Sender

retry 1 sec

ENQ

ENQ

Transfer Phase

abort 15 sec

EOT

ENQ

Receiver xxx

ENQ

ACK

Figure 3-15: Establishment Phase confirmed, continue with Transfer Phase

Figure 3-16 shows the four possible responses to an [ENQ] in a flowchart presentation. Entry point "A" is triggered by the Presentation Layer when requesting

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transmission service from the Data Link Layer. Point "B" is the entry point for retrials in case of errors. Point "C" marks the transition to the Transfer Phase of this layer (Figure 3-17).

A Message to be sent

B Send [ENQ]

Start Timer

Read RS232

No

Yes Message received ?

Yes

No

No

Yes [ACK] ?

[ENQ] ?

Time out (15 s) ? Yes

Device = Analyzer

Yes

No Wait 20 sec

Error: 'No answer from host'

No

Wait 1 sec

Error: Contention on Line

Error: 'Answer different from [ACK]'

No Error: Go on with Transfer Phase

Send [EOT]

B

B

B

C

Figure 3-16: Establishment Phase, Flowchart

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3.2.4.3 Transfer Phase The Presentation Layer builds and interprets records containing the information of the messages. These records are exchanged with the Data Link Layer, which is expected to transmit them during the Transfer Phase. As the records may have an extensive byte length, one task of the Data Link Layer is to cut records into portions not longer than 240 bytes. These portions are packed in frames. Another seven bytes of delimiters, checksum and identifiers are added as frame overhead to the frame message. Thus the frame length may vary between 8 and 247 bytes. There are two types of frames: intermediate frames and end frames. Messages (i.e. records) longer than 240 bytes are cut into one or more portions of 240 byte put into an intermediate frame. The remaining bytes for the last frame are put into the end frame. For example there are two intermediate frames and one end frame for records with a length from 481 up to 720 bytes. Records with a maximum length of 240 bytes result in only one end frame. Two different Records are never put together in a single frame! After each frame sent, the sender stops transmission until a reply is received or a timeout occurs. Normally the receiver sends an [ACK] or [EOT] receipt to signal that the last frame was received successfully and that it is prepared to receive the next frame. [EOT] has the meaning of [ACK] but additionally requests the Sender to stop transmission as soon as possible (Receiver Interrupt). ASTM specifications allow the sender to treat a receiver interrupt like a normal [ACK], i.e. it is able to implement a special receiver interrupt routine. The receiver sends a [NAK] response to signal that the last frame was not successfully received and that it is prepared for a retransmission of the last frame. So there are 3 ways a host can respond to frame transmission of the analyzer: • The host sends an [ACK] or [EOT]. The Elecsys sends the next record. Since the Elecsys has more data to transfer it continues to transmit records (starting with Establishment Phase). • The Host sends any other character but [ACK] or [EOT] (e.g. [NAK]). The Elecsys repeats the transmission of the record. This cycle is repeated until a "Number of On Error Retries" of six is reached. At this point the Elecsys initiates the Termination Phase by sending an [EOT] and displays an error message. • The Host does not respond. The Elecsys waits 15 seconds, initiates the Termination Phase by sending an [EOT] and displays an error message. These are the reactions to different host responses to a frame transmission of the Elecsys. When the Elecsys is in Receiver State and waits to receive a frame from the host, there are three possible scenarios: • The host sends frame characters. If a complete frame is received it is checked for the right frame number and a

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correct checksum. Valid frames are answered with an [ACK] by the Elecsys. Invalid frames result in a [NAK] response and rejection of the invalid frame. • The host does not complete sending a frame. When neither Reception of a frame is completed nor an [EOT] is received 30s after Elecsys responded with the last [ACK] or [NAK], a time-out occurs. Elecsys discards the last incomplete message, changes to Idle State and regards the line to be in the neutral state. • The host sends an [EOT]. This resets the Elecsys to Idle State. Only completely received frames are regarded to be valid. Figure 3-17: Transfer Phase, Flowchart shows the three possible responses to a frame transmission. Entry point "C" is triggered by successful completion of the Establishment Phase. It is also reentry point for subsequent successful frame transmissions. Point "D" is the entry point for retrials in case of answers different from [ACK]. Point "E" marks the transition to the Termination Phase of this Layer (Figure 3-18).

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C Reset Retry Counter

D Send Frame

Start Timer

Read RS232

Message received ?

Yes

No

No

No

Yes [ACK] or [EOT] ?

Time out (15 sec) ? Yes

Send next record

Retry no. +1

No Retry Counter > x ? (X=1 to 9) Yes

Error: 'No answer from host'

Error: 'Answer different from [ACK]'

E

E

No

D

Last record ?

C

Yes

E

Figure 3-17: Transfer Phase, Flowchart

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3.2.4.4 Termination Phase (Link Release) The Termination Phase is the transition of both communication partners to idle state. It can only be initiated by the sender by simply sending an [EOT] code. There is no response of the receiver to that message. Whenever a receiver detects an [EOT] it has to change to idle state, regarding the line to be in the neutral state.

E Send EOT

A Figure 3-18: Termination Phase, Flowchart

3.2.4.5 Frame Format As mentioned earlier there are two kinds of frames: • The intermediate frame [STX]

FN

Text first char. ...... Text last char.

ETB

CH

CL

[CR]

[LF]

ETX

CH

CL

[CR]

[LF]

• The end frame [STX]

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[STX]

is the ASCII code 2, indicating the beginning of a frame transmission.

FN

is a one digit Frame Number (1,2,3,4,5,6,7 or 0). Frames are cyclically numbered to enable the receiver to check for valid frame sequences. The first frame of a message gets number 1, the eighth frame gets number 0, the ninth gets number 1 again and so on.

[ETB]

is the ASCII code 23 (17hex), indicating the end of the text block of an intermediate frame.

[ETX]

is the ASCII code 3, indicating the end of the text block of an end frame.

CH, CL

represent the high nibble (= most significant 4 bit) and the low nibble (=least significant 4 bit) of the 8 bit checksum, respectively. CH and CL are represented as two digits of hex numbers. The checksum is the modulo 8 of the sum of ASCII values of the frame characters starting with and including "FN" and completing with [ETX] respectively [ETB] (Example see Table 4-7).

Text

is the data content of a frame (max. 240 characters). Records are sub divided into intermediate frames with 240 characters maximum indicated by [ETB]. The only or last remaining frame will be indicated by [ETX]. Different records must be sent in different frames! Allowed characters are listed in Table 3-15 and Table 3-16.

Allowed Characters:

7, 9, 11, 12, 13, 32-126, 128-254

Disallowed Characters:

0-6, 8, 10, 14-31, 127, 255

Table 3-15: Allowed and disallowed ASCII codes

The Presentation Layer uses some characters as special delimiter codes. These characters may not be used as normal message text:

Delimiter

Character

Char.

ASCII decimal

ASCII hex.

Record delimiter

= carriage return

13

0Dh

Field delimiter

= vertical bar

|

124

7Ch

Repeat delimiter

= backslash

\

92

5Ch

Component delimiter

= caret

^

94

5Eh

Escape delimiter

= ampersand

&

37

26h

Table 3-16: Delimiter Characters

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3.2.5 Physical Layer Physical connection between the Elecsys analyzer and a host computer system is established by means of standard serial interfaces and a RS232C cable with three cores. For the cable (scheme see 4.1.1) and connectors a special 0-modem type with 9 pin female sub-D connector on host side and 9 pin male sub-D connector on Elecsys side is used. Synchronization (not used in US= is achieved by passive software handshaking (XON/XOFF) but can be switched off completely during the interface setup of the Elecsys analyzer. The Elecsys itself never will send Xon/Xoff. If you switch off synchronization at the Physical Layer, the next higher synchronization will be a software synchronization by frame packages performed by the Data Link Layer. As the maximum length of a frame is 247 bytes, the host interface will then have to buffer or process at least 247 bytes in real time. Baud rate (2400 to 19200), data bits (7 or 8), stop bits (1 or 2) and parity (none, odd, even) are also adjustable during the interface setup of the Elecsys analyzer.

3.3

Example

3.3.1 Test Selection for New Sample ID Communication is switched on. Start Run is requested. After the scanner recognized the sample bar code the analyzer requests the lists of tests to be performed with this sample. The host responds by sending the test selection data. This procedure repeats for each sample in the sample disk:

Instrument requests test selections for sample 000004: Message Header

Requ. Info.: ID# 000004

Message Terminator

H ELEC HOST ELEC HOST

[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]

ELEC

HOST

[STX]2Q|1|^000004^278^0^19^^SAMPLE^NORMAL||ALL| |||||||O[CR] [ETX]38[CR][LF] [ACK]

ELEC HOST ELEC

[STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]

Q

L

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Host responds with test selections for, sample 000004 10=TSH, 20=T4, 30=FT4:

H

P

O

L

Message Header

HOST ELEC HOST ELEC

[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK]

HOST ELEC

[STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]

HOST ELEC

[STX]3O|1|000004|278^0^19|^^^10^0\^^^20^0|R|||||| N||||||||||||||O[CR][ETX]58[CR][LF] [ACK]

HOST ELEC HOST

[STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]

Patient Info. ID# 000004

Test Order: TSH, T4

Message Terminator

3.3.2 Upload Results after Tests are Performed Communication is switched on. Upload option is "Automatic ON". After the tests of a sample are being performed the instrument sends the results to the host. This procedure repeats for each sample in the sample disk: Message Header

Patient Info. ID# 000004

Test Order: ID# 000004

H ELEC HOST ELEC HOST

[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]

ELEC HOST

[STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]

ELEC

[STX]3O|1|000004|278^0^19^^SAMPLE^NORMAL|ALL| R|19960614142107|||||X||||||||||||||0[CR][ETX]25[CR] [LF] [ACK]

P

O

HOST Result TSH: 2.01 µIU/ml

R ELEC HOST

Result T4: 320.0 nmol/l

R ELEC HOST

Comment: out of range

[STX]5R|2|^^^20^0|320.0|nmol/l|58.80^151.0|L||F||| 19970425120351|19970425122213|[CR][ETX]EC[CR][LF] [ACK]

C ELEC

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[STX]6C|1|I|49^Above normal(expected)range|I [CR][ETX]58[CR][LF]

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Result HBSAG: negative

HOST

[ACK]

ELEC

[STX]7R|1|^^^400^|-1^0.453|COI|^|||F||| 19970618105515|19970618111337|[CR][ETX]0A[CR][LF] [ACK] [STX]0L|1[CR][ETX]39[CR][LF] [ACK] [EOT]

R

HOST ELEC HOST ELEC

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4

Engineering Reference

Engineering Reference This section contains • Physical layer • Data link Layer • Presentation layer • Trace Examples

4.1

Physical Layer

4.1.1 Cabling There are two different versions of connection plugs for Elecsys instruments. The older instruments have a female socket so cable type b) is needed. The newer instruments have a male socket so cable type a) must be used.

a) Plug to Elecsys

Plug to Host

b)

Plug to Host

Plug to Elecsys

Figure 4-1: Data Cable Wiring Diagram (----- for optional bridges)

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Figure 4-1 illustrates the wiring of the 3 core data cable used to connect the Elecsys analyzer to a DTE - host (e.g. PC) with 9 pin or 25 pin D-sub-connector. Connect the cable to the 9-pin socket at the left hand side of the analyzer. Do not connect pin 1 on both sides of the cable shield. Note: on host side do not use pins 4-6, 7-8 (US only). Caution: Switch off the instrument at the circuit breaker on the right side of the analyzer before connecting the cable. Host Connector

Printer

User Interface

Figure 4-2: Elecsys 2010 connectors (left case side)

Printer

Host Connector

Figure 4-3: Elecsys 1010 connectors (left case side)

Pin No. Signal 1 GND

Explanation Analyzer frame

Direction (only DTE) use for shield

3

Txd

Transmit Data

out

2

Rxd

Receive Data

in

5

SG

Signal Ground

-

Table 4-1: Pin-Out Descriptions

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Table 4-1 gives the pin-out descriptions of the used pins. None of the handshake lines is used. They remain unconnected. The Elecsys analyzer does not need bridges between handshake pins. Since most host systems need bridges, you should use them equally on both sides so that there is no danger of mixing up the two connectors. There is no hardware handshake. Therefore you must shorten pins 8 (CTS) to 7 (RTS) and 4 (DTR) to 6 (DSR) at least for the host connector. If your host interface supports only 25-pin connectors, you will probably have to shorten pins 4 (RTS) to 5 (CTS) and 6 (DSR) to 20 (DTR). The interfaces of the Elecsys analyzers are defined as Data Terminal Equipment (DTE). As the interfaces of most computer systems (e.g. PCs) are defined as DTEs too, both sides will send data on pin 3 (Txd) and receive data on pin 2 (Rxd) (This is only for 9 pin connectors. The sub-D 25 connector has Rxd on pin 3 and Txd on pin 2). To avoid this you will have to cross over lines 2 and 3 as is usually done with 0-modem cables. If your computer system is defined as a Data Communication Equipment (DCE) or you use modems to connect your Elecsys analyzer to a host system, you must not cross over lines 2 and 3. DCEs send data on pin 2 and receive data on line 3 (with sub-D 25 connectors vice versa!). Pin 1 of the Elecsys connector is used as a shielded connection. It is grounded to the analyzer's frame. To avoid ground loops do not connect line 1 on both sides to pin 1 of the connectors. Pin 1 should be left open on one side of the cable. At the other side the cable shield should be connected.

4.1.2 Interface Specifications The data transmission specifications are given below. Item

Specification

Remarks

Interface

RS232C Asynchronous Serial Interface

Max. cable length 15m

Handshaking*

Software, can be switched off

XON/XOFF

Communication Method

Half duplex

Data bits

7 or 8

Stop bits

1 or 2

Parity bit

None, even, odd

Transmission speed

1200, 2400,4800,9600,19200

BPS

Maximum data block size

247 bytes

max. frame size

Character Code

ASCII, shift JIS

Table 4-2: Transmission Specification

(*Not used in US)

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4.1.3 Critical Timings Phase

State

Timer Starts

Timer Stops

Time-out

Reaction

Transmission of [ENQ]

Reply of [ACK],[NAK],[ENQ]

15 s

Sender enters Termination Phase

Contention (Host Timer)

[ENQ] from Analyzer

20 s

Host enters Idle + retransmits [ENQ]

Contention (Analyzer Timer)

After Time-out

1s

Analyzer retransmits [ENQ]

Receiver

after sending of last [ACK]

complete reception of valid frame or [EOT]

30 s

Receiver enters Idle State

Sender

after transmission of last character of frame

any reply of Receiver

15 s

Sender enters Termination Phase

Establishme Sender nt

Transfer

Table 4-3: Critical timings: Summary of Time-outs

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Engineering Reference

Data Link Layer

4.2.1 State Diagram

Figure 4-4: Sender / Receiver State Diagram (according to ASTM E1381-91)

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4.2.2 Control Codes Code

Description

Mnemonic

0A hex

Line Feed

[LF]

0D hex

Carriage Return

[CR]

02 hex

Start of Text

[STX]

03 hex

End of Text

[ETX]

04 hex

End of Transmission

[EOT]

05 hex

Inquiry

[ENQ]

06 hex

Acknowledge

[ACK]

15 hex

Not Acknowledged

[NAK]

17 hex

End of Transmission Block

[ETB]

Table 4-4: Control Codes

Allowed Characters:

7, 9, 11, 12, 13, 32-126, 128-254

Disallowed Characters:

0-6, 8, 10, 14-31, 127, 255

Table 4-5: Allowed and disallowed ASCII codes

4.2.3 Critical Timings Phase

State

Timer Starts

Timer Stops

Time-out

Reaction

Transmission of [ENQ]

Reply of [ACK],[NAK],[ENQ]

15 s

Sender enters Termination Phase

Contention (Host Timer)

[ENQ] from Analyzer

20 s

Host enters Idle + retransmits [ENQ]

Contention (Analyzer Timer)

After Time-out

1s

Analyzer retransmits [ENQ]

Receiver

after sending of last [ACK]

complete reception of valid frame or [EOT]

30 s

Receiver enters Idle State

Sender

after transmission of last character of frame

any reply of Receiver

15 s

Sender enters Termination Phase

Establishme Sender nt

Transfer

Table 4-6: Summary of Time-outs

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4.2.4 Message Frame / Checksum Calculation The intermediate frame [STX]

FN

Text first char. ...... Text last char.

ETB

CH

CL

[CR]

[LF]

Text first char. ...... Text last char.

ETX

CH

CL

[CR]

[LF]

The end frame [STX]

FN

[STX]

is the ASCII code 2, indicating the beginning of a frame transmission.

FN

is the frame number modulo 8. Frames of a single Transmission Phase are consecutively numbered beginning with 1. So FN runs from 1 to 7, continues with 0, 1 and so on. Use ASCII codes for the digits "0" to "7" (4855)!

Text

is the data content of a frame (max. 240 characters). Records are sub divided into intermediate frames with 240 characters maximum indicated by [ETB]. The only or last remaining frame will be indicated by [ETX]. Different records must be sent in different frames! Allowed characters are listed in Table 4-5.

[ETB]

is the ASCII code 23 (17hex), indicating the end of the text block of an intermediate frame.

[ETX]

is the ASCII code 3, indicating the end of the text block of an end frame.

CH, CL

represent the high nibble (= most significant 4 bit) and the low nibble (=least significant 4 bit) of the 8 bit checksum, respectively. CH and CL are represented as two digits of hex numbers. The checksum is the modulo 8 of the sum of ASCII values of the frame characters starting with and including "FN" and completing with [ETX] respectively [ETB] (Example see Table 4-7).

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Symbol

Character

Value (decimal)

Sum

Value (hex)

Sum

[STX]

[STX]

002

0

02h

00h

FN

‘1’

049

49

31h

31h

Text

[ETX]

‘T’

+084

133

+54h

85h

‘e’

+101

234

+65h

EAh

‘s’

+115

349

+73h

15Dh

‘t’

+116

465

+74h

1D1h

[ETX]

+003

468

+03h

468

= 468

MOD 256 212

1D4h = 1D4h

Mod 100h = 212

= D4h

CH

‘D’

068

44h

CL

‘4’

052

34h

[CR]

[CR]

013

0Dh

[LF]

[LF]

010

0Ah

Table 4-7: Calculation of Checksum

Checksum is sum of transmitted character codes including from FN to [ETX] or [ETB] modulo 100 hex. It is an 8 bit value expressed and transmitted as a two digit hex number, most significant digit first.

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4.2.5 ASCII Table

Char Hex

Dec

NUL 00

Char

Char

Char

Char

Char

Hex Dec

Hex Dec

Hex Dec

Hex Dec

Hex Dec

Hex Dec

Hex Dec

DLE 10

1

11

2

12

3

13

04

14

5

15

ENQ 05

06

16

7

17

8

18

9

19

10

1A

BEL

20

1C

13

1D

14

1E

15

1F

33

28

25

29

36

34

37

35

2B

28

2C

29

2D

30

2E

38

36

39

37

31

2F

51

43

40

38

41

39

42

3A

52

44

53

45

54

46

55

47

45

3D

56

48

46

3E

57

49

58

4A

47

3F

68

54

69

55

60

4C

61

4D

62

4E

63

4F

62

83

63

70

56

71

57

72

58

73

59

74

5A

84

64

85

65

86

66

87

67

77

5D

88

68

78

5E

89

69

90

6A

79

5F

100

74

101

75

92

6C

93

6D

94

6E

102

76

103

77

104

78

105

79

106

7A

95

6F

118

w 119

x 120

y 121

z 122

{ 107

7B

108

7C

109

7D

110

7E

111

7F

123

|

m

124

}

n

_

117

v

l

^

116

u

k 6B

115

t

j

91

114

s

i

]

O

73

h

\

N

99

113

r

g

[

M

72

f

Z

5C

98

112

q

e

Y

76

71

d

X

5B

97

c

W

75

70

b

V

L

?

82

p 96

a

U

K 4B

61

T

J

59

81

S

I

>

/

53

H

=

.

67

60

R

G


?

064 065 066 067 068 069 070 071 072 073 074 075 076 077 078 079

@ A B C D E F G H I J K L M N O

080 081 082 083 084 085 086 087 088 089 090 091 092 093 094 095

P Q R S T U V W X Y Z [ \ ] ^ _

096 097 098 099 100 101 102 103 104 105 106 107 108 109 110 111

` a b c d e f g h i j k l m n o

112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127

p q r s t u v w x y z { | } ~ DEL

Table 7-2: Decimal Character Code

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7.8.2 Appendix 2.2: Hexadecimal Character Code

hex

CHR ASCII Character

Hexadecimal Character Code 00 01 02 03 04 05 06 07 08 09 0A 0B 0C 0D 0E 0F

NUL SOH STX ETX EOT ENQ ACK BEL BS HT LF VT FF CR SO SI

10 11 12 13 14 15 16 17 18 19 1A 1B 1C 1D 1E 1F

DLE DC1 DC2 DC3 DC4 NAK SYN ETB CAN EM SUB ESC FS GS RS US

20 21 22 23 24 25 26 27 28 29 2A 2B 2C 2D 2E 2F

SP ! " # $ % & ' ( ) * + , . /

30 31 32 33 34 35 36 37 38 39 3A 3B 3C 3D 3E 3F

0 1 2 3 4 5 6 7 8 9 : ; < = > ?

40 41 42 43 44 45 46 47 48 49 4A 4B 4C 4D 4E 4F

@ A B C D E F G H I J K L M N O

50 51 52 53 54 55 56 57 58 59 5A 5B 5C 5D 5E 5F

P Q R S T U V W X Y Z [ \ ] ^ _

60 61 62 63 64 65 66 67 68 69 6A 6B 6C 6D 6E 6F

` a b c d e f g h i j k l m n o

70 71 72 73 74 75 76 77 78 79 7A 7B 7C 7D 7E 7F

p q r s t u v w x y z { | } ~ DEL

Table 7-3: Hexadecimal Character Code

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ASTM Designation: E 1394 - 91

ASTM Designation: E 1394 - 91

Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems Reprinted, with permission, from the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A This standard is issued under the fixed designation E1394; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

8.1

Scope • This standard covers the two-way digital transmission of remote requests and results between clinical instruments and computer systems. It is intended to document the common conventions required for the interchange of clinical results and patient data between clinical instruments and computer systems. This standard specifies the message content for transferring information between a clinical instrument and a computer system. It enables any two such systems to establish a logical link for communicating text to send result, request, or demographic information in a standard and interpretable form. This standard does not necessarily apply to general analytical instruments in an industrial analytical nor research and development setting. • This standard specification is intended to apply to the structure of messages exchanged between clinical instruments and computer systems by means of defined communications protocols. Low-level communications protocols and data transfer requirements are beyond the scope of this standard. A separate specification is available from ASTM detailing a standard for low-level data transfer communications. • This standard specifies the conventions for structuring the content of the message and for representing the data elements contained within those structures. It is applicable to all text oriented clinical instrumentation. It has been specifically created to provide common conventions for interfacing computers and instruments in a clinical setting. It would also be applicable to interfacing instruments in clinical practice settings, such as physicians' offices, clinics, and satellite laboratories.

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ASTM Designation: E 1394 - 91

Referenced Documents ASTM Standards: E1238 Specification for Transferring Clinical Laboratory Data Messages Between Independent Computer Systems (1) E1239 Guide for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Automated Patient Care Information Systems (2) ANSI Standards:(2) X3.30 ANSI Information System Codes X3.40 ANSI Information System Codes X3.43 ANSI Information Systems Codes X3.50 ANSI Information Systems Codes ISO Standards:(3) ISO 5218 Information Interchange-Representation of Human Sexes ISO/lEC JTC1 ISO 2955-93 Information Processing-Representation of SI and Other Units in Systems with Limited Character Sets.

(1) Annual Book of ASTM Standards, Vol 14.01. (2) Available from American National Standards Institute, 1430 Broadway, New York, NY 10018. (3) Available from International Standards Organization, 1 Rue de Varembe. Case Postale 56, Crt 1221, Geneva 20 Switzerland.

8.3

Terminology

8.3.1 Description of Terms Specific to this Standard: message A textual body of information. battery A group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name.

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test A determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute. record An aggregate of fields describing one aspect of the complete message. field One specific attribute of a record which may contain aggregates of data elements further referring the basic attribute. repeat field A single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields. component field A single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields. upload Data transmitted from a clinical instrument to a computer system. download Data transmitted from a computer system to a clinical instrument.

8.4

Significance and Use

8.4.1 General Information: • This specification provides for two-way transmission allowing for data-flow in either direction. It provides for sending demographic and test information to or from clinical instruments. This specification has sufficient flexibility to permit the addition of fields to existing record types or the creation of new record types to accommodate new test and reporting methodologies. • This specification is related to Specification E1238. Both standards use positional convention to define the structure of messages that exchange information about

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clinical test requests and results. The set of conventions specifies a hierarchical set of records in which the records higher in the hierarchy contain information that is common to all records lower in the hierarchy and thus avoids redundancy in linking data together. The positional convention is simple and direct to implement, requiring only a sequence of strings each having variable length delimited fields which are positionally specified. • Specification E1238, in its entirety, is not appropriate for use as a clinical instrument to computer system interface. The conventions of Specification E1238 regarding record types and the organization of data elements within the records have been adhered to as closely as possible to ensure that common data elements defined there and used within instruments are specified as closely as possible. This facilitates the use of this specification consistent with Specification E1238 in a number of settings. There are three compelling reasons for developing a separate standard which deviates from Specification E1238. • The scope of Specification E1238 is specifically targeted to accommodate information transfer between two independent computer systems requiring shared patient demographic and test result data. Specification E1238 contains extensive requirements and limitations, much of which may be of little, if any, use by clinical instrument systems. Further, clinical instruments have test and instrument specific requirements outside the scope of Specification E1238 and, as such, are not available within the existing Specification E1238. • The structure of Specification E1238 provides great flexibility in the ordering and reporting of test results and patient demographics. While this is appropriate for use by advanced computer systems of equivalent rank, Specification E1238 clearly falls beyond the technical limitations of many clinical laboratory instruments. This specification attempts to identify, and simplify, all complex data structures and interface procedures and, where practical, restricts multiple procedural options to single procedures appropriate for the clinical instrument setting. Further, this specification has attempted to assign a master/slave hierarchy where conflicts may occur, assigning appropriate responsibility for data processing or reporting operations to the party (clinical instrument or computer system) better able to process a particular task. For example, in all cases involving the ordering or reporting of tests, the instrument manufacturer is solely responsible for assigning the test and result ID numbers (see 8.6.6). These reductions in flexibility directly result in increased structure and clarity, which is deemed more appropriate for ensuring successful interface implementation within the clinical instrument setting. • Specification E1238 was developed independent of data protocol and transfer considerations. Specification E1238 uses maximum field and record lengths. Combined with its record level checksum and error recovery facilities, Specification E1238 may be implemented without a data protocol layer. By contrast, this message-content specification has been developed in cooperative effort with a correlative ASTM low-level data transfer and protocol specification. V 4.2 –Version 01/05

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While each specification (message-content and low-level protocol) is designed to be independently implemented and maintained, the message-content specification presumes that a protocol layer exists that will handle record blocking/deblocking, error detection and recovery, and other associated data transport tasks. As such, all protocol level operations and limitations existing in Specification E1238 are not applicable, and therefore not included in this document.

8.5

Information Requirements in Clinical Testing

8.5.1 General Approach • Messages may contain one or more requests/results for one or more patients. Tests may be requested as groups of many individual tests. These groups are referred to as batteries. Examples of batteries are tests produced on a multichannel analyzer, such as a CHEM12, physiological groupings of tests (such as liver function tests) and Minimum Inhibitory Concentration tests (MICs) in microbiology testing. The fact that a series of tests is contained in a battery does not imply that they are all performed on the same analytic instrument. • Messages consist of a hierarchy of records of various types. Records at level zero contain information pertaining to the sender identification and completion of transmission. Records at level one of the hierarchy contain information about individual patients. Records at level two contain information about test order requests and specimens. Records at level three contain information about test results. • Comment records may be inserted at any level in the hierarchy. A comment record always relates to the immediately preceding patient, order, result, scientific or manufacturer information record. Therefore, if a comment record were to follow a patient record (level one), then that comment record would be treated as a level two record. A comment record may not follow the message terminator record. • Manufacturer information records may be inserted at any level in the hierarchy. This record type always relates to the immediately preceding patient, order result, scientific or comment record. Therefore, if a manufacturer information record were to follow a patient record (level one), then the record would be treated as a level two record. This record may not follow the message terminator record. • Additional record types are the request-information record and the terminator record. The request-information record provides for the request of demographics or test results to or from the clinical instrument for specified patients, specimens, tests, and dates, and the like. The message terminator record must be the very last record of the message. • The smallest element of information in any record is the field, containing a single item of information, such as a date, a patient name, or a numeric test result.

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• The test order record contains information about ordering a single test, test battery, or a series of tests or batteries, as discussed in 8.6.5 and 8.9. • Most of the record types are related to each other in a definite hierarchy. At level zero is the message header and message terminator. At level one is the patient record, the request-information record and the scientific record. At level two is the test order record. At level three is the result record. The comment and manufacturer information records do not have an assigned level. • A sequence of patient records, order records, or result records at one level is terminated by the appearance of a record type of the same or higher level. Thus, a sequence of results for one battery of tests is terminated by the next test order, patient, manufacturer information, request information, or message terminator record. • An order record may never appear without a preceding patient record and a result record may never appear without a preceding order record. • When an order is transmitted, it must be preceded by a patient record. All orders that follow apply to the patient in the preceding patient record. When a result is transmitted, it must be preceded by an order record and a patient record to maintain the prescribed hierarchy. • Each instrument manufacturer adhering to this standard may decide which fields are applicable for their particular application with the exception of those fields necessary to identify the record type or parse individual fields. Thus the need to send the hierarchy of records need not generate large messages.

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8.5.2 Logical Structure of the Message Level Protocol

Table 8-1: Logical Structure of a Message

• Logical Information Storage Requirements - In order to determine buffering requirements, both transmitter and receiver must use common rules for storing transmitted data in order to ensure proper error logging and error recovery procedures (see paragraph below). Since data content is structured in a hierarchical fashion, any decremental change in the hierarchical level shall trigger storage of all data transmitted prior to said level change. This rule may be considered as the minimal implementation. Data may be saved at more frequent intervals at the receiver's option. See Table 8-2.

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Table 8-2: Logical Information Storage Requirements

• Logical Transmission Error Recovery Requirements - Transmission line failure, determined at the transmission protocol level, requires a mechanism for restarting the incomplete message. If a transmission failure occurs, transmission shall restart at the last logical record not presumed saved as outlined in the upper paragraph. Procedures for determining time before retransmission or maximum number of retransmissions are not within the scope of this document. In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point must be repeated prior to transmitting the record where line failure originally occurred. Using the transmission example as given in the upper paragraph, the following record recovery examples would be valid.

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8.6

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Line Failure Occurs At:

Requires Retransmission Of:

A

A

B

A, B

C

A, B, C

D

A, B, C, D

E

A, B, C, D, E

F

A, B, E, F

G

A, B, E, F

H

A, G, H

I

A, G, H, I

J

A, G, H, I, J

K

A, G, H, I, J, K

L

A, G, H, I, J, K, L

M

A, G, H, L, M

N

A, G, M

O

A, N, O

P

A, N, O, P

Q

A, N, O, P, Q

Message Content - General Considerations

8.6.1 Character Codes • All data shall be represented as eight bit values, within the range (0-255), where 0-127 are defined by the ASCII standard (ANSl X3.4-1986) and values 128-255 are undefined by this standard. Values 0-31 are disallowed with the exception of 7, 9, 11, 12, and 13, where 13 is reserved as a record terminator. Values 32-126 and 128-254 are allowed. Values 127 and 255 are, also, not allowed. It is the responsibility of the instrument vendor and computer system vendor to understand the representation of any extended or alternate character set being used. As an example, the numeric value 13.5 would be sent as four byte value characters 13.5 or ASCII(49), ASCII(51), ASCII(47), ASCII(53). Allowed Characters:

7, 9, 11, 12, 13, 32-126. 128-254

Disallowed Characters:0-6, 8, 10, 14-31, 127, 255 • Within text data fields, only the ASCII characters 32-126 and the undefined characters 128-254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. The sender is responsible for screening all text data fields to ensure that the text does not contain those delimiters. Unless otherwise stated, contents of data fields shall be case sensitive.

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8.6.2 Maximum Field Lengths This specification assumes that all fields are variable in length. No storage is allocated (except for the delimiter) for a null field. When, for example, ten characters of data are entered within a field, only ten characters will be used. This specification does not define a maximum length for any field or record and relies upon the receiver's buffering capabilities, and the logical layer's transport facilities, to parse information into workable lengths for transmission and processing purposes. It is the responsibility of the instrument vendor and computer system vendor to agree on any arbitrary field or record truncation that may need to be imposed. It is recommended that the instrument vendor provide documentation disclosing any field or record limits that will be mandated by the clinical instrument.

8.6.3 Maximum Record Length None imposed.

8.6.4 Delimiters • Alphanumeric characters should not be used as delimiters because they are likely to appear within field content. Moreover, some alphabetic characters have special uses as follows:

H, P, O, R, C, Q, E, L, M

record type IDs

.

decimal point (period)

,

comma

S, P, R, C

priority codes

L, H, , N, U, D, B, W

result codes

C, P, F, X, I, O

result status

For the purpose of providing examples, the following delimiters are used in this specification: Record Delimiter carriage return () Carriage return (ASCII 13) shall be the delimiter for the end of any of the defined record types. Field Delimiter Default: vertical bar (|) A single allowable character as defined in 8.6.1 excluding ASCII 13 (carriage return), shall separate adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record.

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Repeat Delimiter Default: backslash (\) A single allowable character as defined in 8.6.1 excluding ASCII 13 and the value for the field delimiter defined in 8.6.4. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set. Component Delimiter Default: caret (^) A single allowable character as defined in 8.6.1 excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters. Escape Delimiter Default: ampersand (&) A single allowable character, as defined in 8.6.1 excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. • Use of Escape Delimiter The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences pre-defined.

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start highlighting text

&N&

normal text (end highlighting)

&F&

imbedded field delimiter character

&S&

imbedded component field delimiter character

&R&

imbedded repeat field delimiter character

&E&

imbedded escape delimiter character

&Xhhhh&

hexadecimal data

&Zcccc&

Local (manufacturer defined) escape sequence

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Any number of hexadecimal digits (0-9, A-F) may follow (that is, &XA& could equal line feed).

Note 2

Any number of legal characters may follow.

Specification of Delimiters The actual delimiters to be employed in a given transmission shall be specified in the header message. It is the responsibility of the sender to avoid the inclusion of any delimiter characters within the field contents. The receiving computer will determine what characters to use by reading the specifications of the header it receives. See 8.6.4 for examples of delimiters used for this document. Delimiters for Null Values Fields shall be identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to ensure that the i'th field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters. Fields of No Concern to the Receiving System Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified. Fields with Null Values • A system may transmit a null value for a field because (1) it does not know the value, (2) it knows the value is irrelevant to the receiving system, or (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's birthdate, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. • Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s birthdate when the birthdate was actually unknown, the receiving system should replace its existing value for a field with a null value. • A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.

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8.6.5 Data Record Usage Overview Data shall be exchanged in records of different types. Each record is introduced by a field (number one) identifying the record type, and terminated by a carriage return. The following record types are defined. Note 3

The record type ID field shall be case insensitive.

Message Header Record (H) This record shall contain information about the sender and the receiver, that is, it shall identify the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters. see also structure of Message Header Record (8.7) Patient Identifying Record (P) This record type contains information about an individual patient. see also structure of Patient Information Record (8.8) Test Order Record (O) When sent from the computer system to the instrument, this record shall represent a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it shall provide information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries). see also structure of Test Order Record (8.9) Result Record (R) Each result record shall contain the results of a single analytic determination. see also structure of Result Record (8.10) Comment Record (C) Comment records shall apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure. see also structure of Comment Record (8.11) Request Information Record (Q) This record shall be used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results for an individual test,

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multiple test, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc. see also structure of Request Information Record (8.12) Scientific Record (S) This record shall be used to exchange results between clinical sites for the purposes of proficiency testing or method development. see also structure of Scientific Record (8.14) Manufacturer Information Record (M) This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer. see also structure of Manufacturer Information Record (8.15)

8.6.6 Common Field Types Universal Test ID This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record (8.10), there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered. • Universal Test ID (Part 1) This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time. This field may alternatively contain multiple codes separated by repeat delimiters, or the field may contain the text ALL, which signifies a request for all results on all tests or batteries for the patients/specimens/tests defined in 0 and within the dates described in 8.12. • Universal Test ID Name (Part 2) This would be the test or battery name associated with the universal test ID code described in Universal Test ID (Part 1) (see above).

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• Universal Test ID Type (Part 3) In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields. • Manufacturer’s or Local Code (Part 4) This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as - Dilution^Diluent^Description. Dates and Times In all cases, dates shall be recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they shall be represented as HHMMSS, shall be linked to dates as specified by ANSI X3.43. Date and time together shall be specified as up to a fourteencharacter string: YYYYMMDDHHMMSS. • Time Zone The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender. Telephone Numbers Phone numbers shall be recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc. • Multiple Phone Numbers When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number. Fixed Measurements and Units When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955.

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Addresses An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country needs only to be transmitted when it cannot be assumed from the context. The components of this field are position dependent. Provider and User IDs Physician's and other care givers' codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name shall be (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. If necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters. Record Sequence Number This is a required field used in record types that may occur multiple times within a th

single message. The number used defines the i occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records). E.g. for the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined.

8.6.7 Examples of Basic Record Types The following examples are given for a set of transmitted results for a given patient. These will show how the employment of the conventions defined lead to a valid message. In these examples the first two fields of each line (record) of the message body contain the record type and the integer record sequence number (excepting the header record). Carriage return is indicated by (CR). To simplify the example, all the V 4.2 –Version 01/05

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components of each record have not been included. Ellipses (...) are used to indicate fields that are left out and comments are enclosed in square brackets. Record hierarchical levels are shown by indentation. Note 4

You may wish to study the record definitions outlined in Section 7 before reviewing the samples shown in Figs. 3, 4, 5, 6, and 7. Trailing fields, unused, may or may not have field delimiters transmitted. Both cases should be handled by the receiving parser.

Minimal Implementation (No Patient ID or Specimen ID) Figure 3: H|\^& P|1 O|1|||^^^A1 R|1||0.356 P|2| O|1|||^^^A2 R|1||1.672 . . P|96 O|1|||^^^H12 R|1||0.402 L|1

Note 1

This sample is not recommended for implementation.

Note 2

Direction: instrument to computer system.

No Patient ID; Specimen ID and Multiple Results Shown Figure 4: H|\^& P|1 O|1|927529||^^^A1\^^^A2 R|1|^^^A1|0.295||||||||19890327132247 R|2|^^^A2|0.312||||||||19890327132248 P|2| O|1|927533||^^^A3\^^^A4 R|1|^^^A3|1.121||||||||19890327132422 R|2|^^^A4|1.097||||||||19890317132422 L|1

Request from Analyzer for Test Selections Figure 5a: on Specimens 032989325 - 032989327 H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 Q|1|^032989325|^032989327|ALL||||||||O

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Response from Computer System from Previous Request Figure 5b: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2734|123|306-87-4587|BLAKE^LINDSEY^ANN^MISS O|1|032989325||^^^BUN|R O|2|032989325||^^^ISE|R O|3|032989325||^^^HDL\^^^GLU|R P|2|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER\^^^GLU|S P|3|1583|250|151-37-6926|SIMPSON^ALBERT^MR O|1|032989327||^^^CHEM12\^^^LIVER|R L|1|F

Results from Given Ordered Test Selections Shown in Various Formats Figure 5c: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2734|123|306-87-4587|BLAKE^LINDSEY^ANN^MISS C|1|L|Notify IDC if tests positive|G O|1|032989325||^^^BUN|R R|1|^^^BUN|8.71 C|1|I|TGP^Test Growth Positive|P C|2|I|colony count >10,000|P O|2|032989325||^^^ISE|R R|1|^^^ISE^NA|139\mEq/L R|2|^^^ISE^K|4.2\mEq/L R|3|^^^ISE^CL|111\mEq/L O|3|032989325||^^^HDL|R R|1|^^^HDL|70.29 O|4|032989325||^^^GLU|R R|1|^^^GLU|92.98 C|1|I|Reading is Suspect|I P|2|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER|S R|1|^^^LIVER^AST|29 R|2|^^^LIVER^ALT|50 R|3|^^^LIVER^TBILI|7.9 R|4|^^^LIVER^GGT|29 O|2|032989326||^^^GLU|S R|1|^^^GLU|91.5 P|3|1583|250|151-37-6926|SIMPSON^ALBERT^MR O|1|032989327||^^^LIVER|R R|1|^^^AST|28 (Test ID field Implicitly Relates to LIVER order) R|2|^^^ALT|49 R|3|^^^TBILI|7.3 R|4|^^^GGT|27

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O|2|032989327||^^^CHEM12|R R|1|^^^CHEM12^ALB-G|28 (Test ID field Explicitly Relates to CHEM12 order) R|2|^^^CHEM12^BUN|49 R|3|^^^CHEM12^CA|7.3 R|4|^^^CHEM12^CHOL|27 R|5|^^^CHEM12^CREAT|4.2 R|6|^^^CHEM12^PHOS|12 R|7|^^^CHEM12^GLUHK|9.7 R|8|^^^CHEM12^NA|138.7 R|9|^^^CHEM12^K|111.3 R|10|^^^CHEM12^CL|6.7 R|11|^^^CHEM12^UA|7.3 R|12|^^^CHEM12^TP|9.2 L|1

Request from Computer System to Instrument for Previously Run Results Figure 5d: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 Q|1|^032989326|ALL||||||||O L|1

Reply to Result Request Figure 5e: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER|S R|1|^^^AST|29 R|2|^^^ALT|50 R|3|^^^TBILI|7.9 R|4|^^^GGT|29 O|2|032989326||^^^GLU|S R|1|^^^GLU|91.5 L|1

Microbiology Order and Result Download of Demographics and Order Figure 6a: H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500 P|1||52483291||Smith|John|Samuels|19699401|M|W|4526 C Street^Fresno^CA^ 92304||(402)7823424x242|542^Dr.Brown|||72^in.|175^lb.||Penicilin|||| 19890428|IP|Ward1||C|M|WSP||ER|PC^Prompt Care O|1|5762^01||^^^BC^BloodCulture^POSCOMBO|R|198905011530| 198905020700||| 456^Farnsworth|W|||198905021130|BL^Blood| 123^Dr.Wirth|||||||Instrument#1||ER|N R|1|^^^Org#|51^Strep Species||||N

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ASTM Designation: E 1394 - 91

R|2|^^^Bio|BH+^Beta Hemolytic|||N L|1

Microbiology Order and Result Upload of Finalized Results Figure 6b: H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500 P|1||52483291 O|1|5762^01||^^^BC^^|||||||||||BL||||||||||F R|1|^^^ORG#|103^Group D Entero R|2|^^^AM^MIC|>16 R|3|^^^AM^INTERP1|++ R|4|^^^AM^DOSAGE1|PO 250-500 mg Q6h R|5|^^^AM^DOSAGE1^COSTCODE|$25 R|6|^^^AM^INTERP2|+++ R|7|^^^AM^DOSAGE2|IV 1.0-2.0 gm Q4h R|2|^^^P^MIC| 28 KB) with several text parts is displayed with the Editor option, the Search option automatically loads the next text part when the search text is not found.

NEW

An additional option box on the Delimiter Selection screen makes it possible to select between using the locally defined delimiters or the received delimiters. If the second option is selected the received delimiters in the header record from the other side overwrite then locally defined delimiters.

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Host Interface Simulator for the ASTM Protocol

Version 1.04 BUG

On the ‘Options > RS232 Parameters’ screen the handshake options Xon/Xoff and RTS/CTS were exchanged.

BUG

If a TA frame with empty application data was received the program was terminated with an error message.

BUG

If a large file with additional scroll bar was displayed in the record editor and a default host or instrument message was selected, the scroll bar did not disappear.

NEW

There are menu options for opening help files that contain the ASTM Specifications 1394 and 1381 in the Help menu.

NEW

There are different device names (host and instrument) stored for each supported instrument.

Version 1.05 BUG

Elimination of trailing delimiters and blanks.

Version 1.06 BUG

If a result message with multiple result records was received by the Host simulator, only the last result was stored in the database.

NEW

On the ‘Mode of Operation’ screen an 18-character operator name can be entered which appears in the head lines of the trace and record files.

NEW

The records of the trace file of the CAEV evaluation system can also be extracted with the trace extract function.

Version 1.07 NEW

If an update of the test program (newer version) is started after installation the ASTM.INI is deleted and newly created with default values.

Version 1.08 BUG

The delimiter definition within the Header record was misinterpreted in the parser window.

NEW

The two ASTM Specification help files have been updated.

NEW

The actually selected instrument is displayed in the title bar of the Host- / Instrument Messages Windows within the record editor.

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Version 1.09 BUG

If STA was selected as instrument, TS default profile was deactivated and there is no worklist for a specific request, the host simulator sent a Header and a Termination Record to the instrument.

BUG

The option not to save the Manufacturer Records in the trace file did not work well. Now all messages that contain a Manufacturer Record as second (!) record after the Header record are not stored in the trace file.

BUG

The TS Request/TS Info handling after Contention was improved.

BUG

The size of the Action Code field in the Test Selection and Test Results tables had to be enlarged to avoid error messages when receiving records with more than 1 character information in this field.

Version 1.10 BUG

If the Editor screen was left via the Close menu option of the Control box, the software crashed.

BUG

A software send buffer allows to create and send a record file (ELECSYS 2010 in INST mode) with multiple requests completely, even if the host interrupts by answering test selections. The max. number of records for the send buffer is limited to 200. If the record file contains more records a corresponding error message is displayed and the last incomplete message in the record file is removed.

NEW

For ELECSYS 2010 the non-barcode mode is supported. Test selections can be requested by barcode or by sequence No. The test selection table has additional fields for sequence, carrier and position No.

NEW

On the Error simulation screen there is an additional option of sending a record without the record delimiter (carriage return before ETX). In the receiving routine the existence of this record delimiter is checked.

NEW

On the ‘Operation Mode’ screen the colors for host and instrument trace messages can be selected.

NEW

Different instrument icons on the main screen.

NEW

There is an additional ‘System Info’ window available on the Info screen.

Version 1.11 NEW

The Elecsys 1010 is implemented. It can be selected on the ‘Operation Mode’ screen. There is a separate database and parser info file.

NEW

If Elecsys 2010 or 1010 is selected, there is an additional menu option in the Help menu of the Trace/Record editor. This menu option ‘ELECSYS Test List’ displays all test codes and names of the Elecsys systems.

NEW

Wherever the BM test No. appears in a field of a record, the test name is displayed in the parser information window behind the code in brackets.

NEW

As additional indication the text color within the trace/record editor changes to blue as soon as a text change takes place. When the text is stored it appears again in black.

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Version 1.2 BUG

In the German version, the Parity options ‘Gerade’ and ‘Ungerade’ have been exchanged.

BUG

The software crashed, if in Host mode DB Access was disabled and requests have been received.

NEW

The instrument icons are integrated in the software. They are no longer included as ICO files.

NEW

The sequence No. is echoed within the test selection message from host to the ELECSYS.

NEW

A new menu option in the ‘Trace’ menu allows to enter a comment line which is inserted into the trace file. This option is also available by clicking the right mouse button on the trace window.

NEW

The actual trace file size is displayed below the trace file name.

Version 1.3 NEW

Not only the sequence No. is echoed within the test selection message from host to the ELECSYS but all components of the instrument specimen ID.

NEW

There are new columns for the Container Type info in the Request, Test Selection and Result database tables for ELECSYS 2010 and 1010. The database files are not compatible with the previous version !!!

Version 1.4 NEW

On the ‘Mode of Operation’ screen there are separate option controls for echoing Sequence No., Carrier No., Position No., Carrier Type, Container Type of the Request Record Q within the Order Record O of the test selection message from Host to analyzer.

Version 1.5 NEW

A different send buffer structure allows to send multiple request (as instrument simulator) where, with the appropriate timing setting, the host may answer each single request. The number of messages to send is displayed above the trace window. The new main menu item ‘Clear Send Buffer’ allows to delete all messages to send and thus abort a running transmission.

NEW

A comment above the trace window indicates an active error simulation.

NEW

On the DB form there is a main menu item ‘Create Report’ displayed, if the results table is displayed. If exactly one sample in the results table is selected, a report with all results of that sample in generated and stored to the text file ‘REPORT.TXT’.

NEW

When installing the software version 1.5, the database files are normally not updated. However, since the version 1.4 the structure of the Elecsys databases has changed. If an old database structure is detected when starting the 1.5 for the first time, the database files for Elecsys are deleted and the operator is asked to install the software again. Then a default database with the new structure is installed.

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Version 1.6 BUG

In Elecsys 2010-Host mode, you may select on the ‘Operation Mode’ screen which data item shall be echoed within the order record of the test selection message (Seq. No., Carrier No., ...). This setting is now also used if the default profile is sent or if the empty test selection (‘Z’ as Report Type) is sent to the Elecsys 2010.

BUG

If the above mentioned empty test selection was sent, there were two field delimiters instead of one between Test ID and Priority (fields 5 and 6 of the Order Record).

BUG

In Elecsys 2010-Host mode, the tool displayed an error message as soon as it received a Request Record with empty ID field.

Version 1.7 BUG

There were invalid time values within the Communication Trace when the tool was activated over midnight.

Version 2.0 BUG

When the tool worked as Elecsys 2010 Host, a field delimiter was missing within the ‘empty’ test selection message. This message is sent if no TS is found in the database and Default Profile is disabled.

BUG

The Parser Information files for the Elecsys 2010 is adapted to Host Manual version 3.x.

NEW

The LSM was added as additional instrument on the ‘Operating Mode’ screen. There is a separate database, message and parser file for the LSM included.

NEW

On the main screen there is a list where the last x messages are entered as ‘realtime monitor’. The max. number of messages to store is set by default to 20 and may be modified within the ASTM.INI file with any text editor. (see section ‘Not in GUI’).

Version 3.0 - Eval 2 BUG

When working as host the simulator sent two L records within the test selection message as answer to a realtime request.

BUG

The trace time is now identical with the system time.

BUG

The cancel request message (Status A) really cancels a previous TS request (=> the TS message is not sent).

NEW

The Modular was added as new instrument.

NEW

The tool was developed with VB 5.0 and therefore needs a 32-bit operating system like Windows 95 or Windows NT.

NEW

TCP/IP was implemented as an alternative to the RS232 interface.

Version 3.0 - Eval 3 - 28th of October 1998 BUG

When receiving a TS request from Modular with leading spaces, the Host test tool did not find the corresponding TS in the database.

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Version 3.0 - Eval 4 - 11th of November 1998 BUG

All BM Test Number fields in all tables of database E20_DATA.MDB (Elecsys 2010) have been enlarged to 4 characters.

BUG

Simulator as Modular Host appends all component delimiters in the third field of the order record.

BUG

Simulator as Modular Host echoes seq, ID, type, rack, pos, specID in the default test selection according to the echo setting on the Mode of Operation screen.

NEW

It is possible to start more than one instance of the program.

NEW

The main screen of the program may be minimized.

Version 3.0 - Eval 5 - 17th of November 1998 BUG

The Operation Mode screen is displayed again.

Version 3.0 - Eval 6 - 28th of November 1998 BUG

When sending TS request as Modular the P record was missing.

BUG

When sending TS request as Modular the ID field is enlarged to 13 characters by leading spaces.

BUG

When sending results as Modular the ID field is enlarged to 13 characters by leading spaces, the operator ID and comment fields are filled with spaces.

Version 3.0 - Eval 7 – 10th of December 1998 NEW

For serial communication COM ports 1 to 10 may be selected (if available via interface board and Windows configuration).

NEW

The selection of the type of handshake was removed from the Interface Setting screen. No handshake is taken as default.

NEW

The TCP/IP functionality was improved.

NEW

If the Modular TS request contains a ************* as ID because of unreadability of the barcode, the TestSelection database is searched for matching rack and position number.

NEW

If the Modular TS request has an empty ID field the TestSelection database is searched for matching sequence number.

NEW

If the result message from the Modular contains Absorbance data, they are written to the database. !!!! Structure of MOD_DATA.MDB was changed !!!!

NEW

When sending Modular results out of the database, there is a question if absorbance data shall be sent, if available in the database table.

Version 3.0 - Eval 8 – December 1998 BUG

The simulator as LSM host stores all results of a multi-order result message.

NEW

The delay between records, delay between messages and reaction to request time may be entered in milliseconds.

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Version 3.12 – March 1999 NEW

When working as Modular host it is possible to activate and define rules for a reflex testing.

NEW

The ‚Trace File / Extract Records‘ function also extract records from Modular communication trace files.

Version 3.2 – March 1999 NEW

Length of port numbers on the TCP/IP setting screen was increased from 4 to 5 digits.

NEW

Address on the About window was changed.

Version 3.3 – March 1999 BUG

Complete software crashed if record editor was opened, then default profile was selected in the Messages menu and the cursor was placed into the Order record.

BUG

Within the record editor the key combination Crtl+V inserted the clipboard text two times.

NEW

Cardiac Reader as instrument option implemented.

NEW

Parser Info has been changed within xxx_CONF.MDB databases. Databases incompatible with former version !!! Full Installation necessary !!!

Version 3.4 – April 1999 NEW

The parser function now allows option lists for single components within a field. Therefore parser info has been changed within xxx_CONF.MDB databases Databases incompatible with former version !!! Full Installation necessary !!!

NEW

The complete test list is displayed for Elecsys 1010,2010 and Modular with menu option ?/Test List within the Record Editor. The test list is displayed sorted by code as well as by test name.

NEW

During installation of the tool, sub-directories for each supported instrument are created and example traces and record files are copied into those sub-directories.

NEW

The line wrap feature within the record editor window was disabled so that each complete record is displayed in one line.

Version 3.5 – April 1999 BUG

After sending two messages out of the database table the main menu options remained disabled.

BUG

Within the parser info window also 2-digit test numbers are provided with the corresponding test name out of the test list.

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Version 3.6 – May 1999 NEW

Received Cardiac Reader messages are stored in the database. Requests are answered.

Version 3.7 – July 1999 NEW

The Aliquoter VS II is supported.

NEW

When opening the file dialogue for display or delete record (*.DAT) or trace (*.TRC) files a preview of the selected file is displayed in a text window beside the file list control.

Version 3.8 – September 1999 BUG

The software does not hang up anymore if a message only consists of [NUL] characters.

NEW

The PSM is supported.

NEW

The Roche ASTM Standard as Instrument was removed.

NEW

Manufacturer records for Elecsys 1010 are implemented.

NEW

Frames around the device icons and the date/time on the main screen.

NEW

Each database got an additional field ‚Received‘ in the 1. Position of each table where the date and time (format: YYYYMMDDHHMMSS) of reception is entered.

NEW

The configuration data tables moved from the xxx_CONF.MDB to the xxx_DATA.MDB database files. The xxx_CONF.MDB files are no longer needed.

NEW

The database tables may be sorted by clicking on the header of the corresponding column.

NEW

When sending results from the database screen, there are options for sending absorbance data or not, sending sample per message or multiple samples per message and sending only the selected entries or all table entries with the same sample ID.

NEW

On the ‚Mode of Operation‘ screen the function ‚Realtime Result Generator‘ may be activated if the tool works as instrument. For each received test selection the tool generates a result message and sends it after a specified time.

NEW

The Amplilink is supported.

Databases incompatible with former version !!! Full Installation necessary !!!

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Indexes

Indexes

10.1 Tables TABLE 1-1: SPECIAL TYPEFACES...........................................................................................................................................................1-10 TABLE 3-1: MESSAGE PRIORITIES.........................................................................................................................................................3-39 TABLE 3-2: REQUEST FROM INSTRUMENT TO HOST ..........................................................................................................................3-40 TABLE 3-3: RESPONSE FROM HOST TO INSTRUMENT .......................................................................................................................3-40 TABLE 3-4: REQUEST FROM HOST TO INSTRUMENT ..........................................................................................................................3-40 TABLE 3-5: RESPONSE FROM INSTRUMENT TO HOST .......................................................................................................................3-40 TABLE 3-6: UPLOAD FROM INSTRUMENT TO HOST ...........................................................................................................................3-41 TABLE 3-7: DOWNLOAD FROM HOST TO INSTRUMENT ....................................................................................................................3-41 TABLE 3-8: TERMINATION CODES TO DIFFERENT ERROR STATES...................................................................................................3-43 TABLE 3-9: LIST OF ALARM CONDITIONS ...........................................................................................................................................3-44 TABLE 3-10: STANDARD RECORD TYPES AND LEVELS ....................................................................................................................3-47 TABLE 3-11: MANUFACTURER DEFINED RECORDS AND LEVELS ...................................................................................................3-48 TABLE 3-12: INFORMATION STORAGE REQUIREMENTS, TRANSMISSION EXAMPLE ....................................................................3-50 TABLE 3-13: ERROR RECOVERY AT PRESENTATION LAYER .............................................................................................................3-50 TABLE 3-14: DELIMITER CHARACTERS AS USED IN ASTM SPECIFICATIONS ...............................................................................3-52 TABLE 3-15: ALLOWED AND DISALLOWED ASCII CODES ...............................................................................................................3-65 TABLE 3-16: DELIMITER CHARACTERS ................................................................................................................................................3-65 TABLE 4-1: PIN-OUT DESCRIPTIONS ...................................................................................................................................................4-70 TABLE 4-2: TRANSMISSION SPECIFICATION........................................................................................................................................4-71 TABLE 4-3: CRITICAL TIMINGS: SUMMARY OF TIME-OUTS .............................................................................................................4-72 TABLE 4-4: CONTROL CODES ...............................................................................................................................................................4-74 TABLE 4-5: ALLOWED AND DISALLOWED ASCII CODES .................................................................................................................4-74 TABLE 4-6: SUMMARY OF TIME-OUTS ................................................................................................................................................4-74 TABLE 4-7: CALCULATION OF CHECKSUM .........................................................................................................................................4-76 TABLE 4-8: ASCII CODES .....................................................................................................................................................................4-77 TABLE 4-9: ALLOWED AND DISALLOWED ASCII CODES .................................................................................................................4-78 TABLE 4-10: DELIMITER CHARACTERS ................................................................................................................................................4-78 TABLE 4-11: COMMON FIELD TYPES...................................................................................................................................................4-79 TABLE 4-12: DATA TYPE DEFINITION ..................................................................................................................................................4-79 TABLE 4-13: STANDARD RECORD TYPES AND LEVELS ....................................................................................................................4-80 TABLE 4-14: MANUFACTURER DEFINED RECORDS AND LEVELS ...................................................................................................4-80 TABLE 4-15: MESSAGE HEADER RECORD ..........................................................................................................................................4-84 TABLE 4-16: FIELD OPTIONS FOR MESSAGE HEADER RECORD ......................................................................................................4-85 TABLE 4-17: PROCEDURE FOR ASSIGNMENT OF SENDER ID AND RECEIVER ID..........................................................................4-85 TABLE 4-18: MESSAGE TERMINATOR RECORD .................................................................................................................................4-86 TABLE 4-19: FIELD OPTIONS FOR MESSAGE TERMINATOR RECORD .............................................................................................4-86 TABLE 4-20: TERMINATION CODES TO DIFFERENT ERROR STATES ................................................................................................4-87 TABLE 4-21: PATIENT INFORMATION RECORD ..................................................................................................................................4-89 TABLE 4-22: TEST ORDER RECORD .....................................................................................................................................................4-92 TABLE 4-23: AUTO DILUTION FACTOR IS SET CORRESPONDING TO THIS TABLE ..........................................................................4-93 TABLE 4-24: PRIORITY FOR SAMPLE REGISTRATION ELECSYS 2010 ..............................................................................................4-93 TABLE 4-25: SAMPLE REGISTRATION AND UPDATE ELECSYS 2010 ...............................................................................................4-94 TABLE 4-26: FIELD OPTIONS FOR TEST REPORT TYPE ......................................................................................................................4-94 TABLE 4-27: RESULT RECORD ..............................................................................................................................................................4-99 TABLE 4-28: REFERENCE RANGES .......................................................................................................................................................4-99 TABLE 4-29: RESULT ABNORMAL FLAGS ............................................................................................................................................4-99 TABLE 4-30: RESULT STATUS ............................................................................................................................................................ 4-100 TABLE 4-31: COMMENT RECORD ..................................................................................................................................................... 4-101 TABLE 4-32: REQUEST INFORMATION RECORD .............................................................................................................................. 4-103 TABLE 4-33: FIELD OPTIONS FOR REQUEST INFORMATION RECORD.......................................................................................... 4-103 TABLE 4-34: SAMPLE/RESULT HANDLING - BEHAVIOR ............................................................................................................... 4-104 TABLE 4-35: ACTION CONFIRMATION RECORD.............................................................................................................................. 4-105 TABLE 4-36: ACTION REQUEST RECORD ......................................................................................................................................... 4-106 TABLE 4-37: CALIBRATOR PARAMETERS RECORD ......................................................................................................................... 4-107 V 4.2 –Version 01/05

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TABLE 4-38: CALIBRATION RESULT RECORD ..................................................................................................................................4-109 TABLE 4-39: CALIBRATION RESULT CHARACTERISTICS .................................................................................................................4-110 TABLE 4-40: CALIBRATION ORDER RECORD ....................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-41: CALIBRATION SCHEME RECORD ..................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-42: DILUENT PARAMETERS RECORD.................................................................................................................................4-110 TABLE 4-43: INSTRUMENT CONFIGURATION RECORD ...................................................................................................................4-113 TABLE 4-44: INSTRUMENT STATUS RECORD ...................................................................................................................................4-114 TABLE 4-45: INSTRUMENT STATUS FLAGS .......................................................................................................................................4-115 TABLE 4-46: ALARM LEVEL OF PROCESSING ...................................................................................................................................4-115 TABLE 4-47: LOG FILE RECORD .........................................................................................................................................................4-117 TABLE 4-48: PROCESSING MESSAGE RECORD ................................................................................................................................4-118 TABLE 4-49: ALARM LEVEL ................................................................................................................................................................4-118 TABLE 4-50: CHANGE COMMUNICATION PROTOCOL RECORD .....................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-51: CONTROL PARAMETERS RECORD ...............................................................................................................................4-119 TABLE 4-52: CONTROL SCHEME RECORD.........................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-53: RESULT CONTEXT RECORD ..........................................................................................................................................4-120 TABLE 4-54: RAW RESULT RECORD ..................................................................................................................................................4-121 TABLE 4-55: SERVICE DATA RECORD ...............................................................................................................................................4-123 TABLE 4-56: SAMPLE STATUS RECORD ............................................................................................................................................4-124 TABLE 4-57: SAMPLE STATUS ............................................................................................................................................................4-125 TABLE 4-58: TEST APPLICATION RECORD ........................................................................................................................................4-126 TABLE 4-59: TEST CONDITIONS RECORD .........................................................................................................................................4-127 TABLE 4-60: SUBSTANCE DATA RECORD.........................................................................................................................................4-130 TABLE 4-61: INFORMATION STORAGE REQUIREMENTS, TRANSMISSION EXAMPLE..................................................................4-131 TABLE 4-62: ERROR RECOVERY REQUIREMENTS, TRANSMISSION EXAMPLE ............................................................................4-132 TABLE 4-63: MESSAGE PRIORITIES ....................................................................................................................................................4-133 TABLE 4-64: TERMINATION CODES TO DIFFERENT ERROR STATES ..............................................................................................4-152 TABLE 4-65: ABILITY TO RENEW DATA BASE ..................................................................................................................................4-153 TABLE 4-66: LIST OF ALARM CONDITIONS ......................................................................................................................................4-153 TABLE 4-67: CROSS REFERENCE LIST TEST CODE AND TEST NUMBER .........................................................................................4-154 TABLE 5-1: ASSAY REFERENCE TABLE ..............................................................................................................................................5-158 TABLE 5-2: AUTO DILUTION RATIO REFERENCE TABLE .................................................................................................................5-159 TABLE 5-3: LIST OF ALARM FLAGS FOR ELECSYS 2010 ................................................................................................................5-161 TABLE 7-1: CONNECTOR CONTACT ASSIGNMENTS ......................................................................................................................7-206 TABLE 7-2: DECIMAL CHARACTER CODE .........................................................................................................................................7-215 TABLE 7-3: HEXADECIMAL CHARACTER CODE ...............................................................................................................................7-216 TABLE 8-1: LOGICAL STRUCTURE OF A MESSAGE ..........................................................................................................................8-223 TABLE 8-2: LOGICAL INFORMATION STORAGE REQUIREMENTS ...................................................................................................8-224 TABLE 8-3: REQUIREMENT COMPARISON BETWEEN SPECIFICATIONS E1238 AND E1394 ....................................................8-262 TABLE 9-1: DATA FLOW OPTIONS FOR THE ELECSYS 2010 ANALYZER; INSTRUMENT MODE.............................................9-271 TABLE 9-2: DATA FLOW OPTIONS FOR THE ELECSYS 2010 ANALYZER; HOST MODE ..........................................................9-272 TABLE 9-3: DATA FLOW OPTIONS FOR THE ELECSYS 1010 ANALYZER; INSTRUMENT MODE.............................................9-273 TABLE 9-4: DATA FLOW OPTIONS FOR THE ELECSYS 1010 ANALYZER; HOST MODE ..........................................................9-274 TABLE 9-5: DATA FLOW OPTIONS FOR THE STA ANALYZER; INSTRUMENT MODE ..................................................................9-275 TABLE 9-6: DATA FLOW OPTIONS FOR THE STA ANALYZER; HOST MODE ................................................................................9-275 TABLE 9-7: DATA FLOW OPTIONS FOR THE CARDIAC READER; INSTRUMENT MODE ...............................................................9-276 TABLE 9-8: DATA FLOW OPTIONS FOR THE CARDIAC READER; HOST MODE ............................................................................9-277 TABLE 9-9: DATA FLOW OPTIONS FOR THE MODULAR ANALYZER; INSTRUMENT MODE ........................................................9-278 TABLE 9-10: DATA FLOW OPTIONS FOR THE MODULAR ANALYZER; HOST MODE...................................................................9-278 TABLE 9-11: DATA FLOW OPTIONS FOR THE ALIQUOTER VS II; INSTRUMENT MODE ..............................................................9-279 TABLE 9-12: DATA FLOW OPTIONS FOR THE ALIQUOTER VS II; HOST MODE ...........................................................................9-279 TABLE 9-13: DATA FLOW OPTIONS FOR THE LSM; INSTRUMENT MODE ...................................................................................9-280 TABLE 9-14: DATA FLOW OPTIONS FOR THE LSM; HOST MODE ................................................................................................9-280 TABLE 9-15: DATA FLOW OPTIONS FOR THE PSM; INSTRUMENT MODE ...................................................................................9-281 TABLE 9-16: DATA FLOW OPTIONS FOR THE PSM; HOST MODE ................................................................................................9-281 TABLE 9-17: DATA FLOW OPTIONS FOR THE AMPLILINK; INSTRUMENT MODE .........................................................................9-282 TABLE 9-18: DATA FLOW OPTIONS FOR THE AMPLILINK; HOST MODE ......................................................................................9-282

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10.2 Figures FIGURE 1-1: ELECSYS 2010 DISK VERSION .......................................................................................................................................1-11 FIGURE 1-2: ELECSYS 2010 RACK VERSION ......................................................................................................................................1-12 FIGURE 1-3: ELECSYS 1010...................................................................................................................................................................1-12 FIGURE 2-1: UTIL SCREEN ....................................................................................................................................................................2-15 FIGURE 2-2: DOCUMENTATION SETUP SCREEN .......................................................................................................................2-16 FIGURE 2-3: INTERFACE SETUP SCREEN .......................................................................................................................................2-17 FIGURE 2-4: SCREEN "COMMUNICATION CONFIRMATION" ............................................................................................................2-17 FIGURE 2-5: MANUAL TRIGGER TO UPLOAD RESULTS ......................................................................................................................2-19 FIGURE 2-6: UTILITIES SCREEN ..........................................................................................................................................................2-20 FIGURE 2-7: INTERFACE SETUP SCREEN .........................................................................................................................................2-21 FIGURE 2-8: SELECT HOST PROTOCOL ................................................................................................................................................2-21 FIGURE 2-9: INSTRUMENT SETUP SCREEN ..........................................................................................................................................2-25 FIGURE 3-1: THE OSI MODEL EXPLAINED BY EXAMPLE ...................................................................................................................3-30 FIGURE 3-2: CORRELATION BETWEEN MESSAGE  RECORD  FRAME............................................................................3-31 FIGURE 3-3: LAYERS OF THE ASTM-PROTOCOL ...............................................................................................................................3-32 FIGURE 3-4: INQUIRY TO HOST .............................................................................................................................................................3-34 FIGURE 3-5: RESPONSE FROM HOST....................................................................................................................................................3-35 FIGURE 3-6: INQUIRY TO INSTRUMENT ................................................................................................................................................3-35 FIGURE 3-7: RESPONSE FROM INSTRUMENT ......................................................................................................................................3-36 FIGURE 3-8: AUTOMATIC UPLOAD TO HOST ......................................................................................................................................3-37 FIGURE 3-9: BATCH DOWNLOAD FROM HOST ...................................................................................................................................3-37 FIGURE 3-10: HIERARCHICAL STRUCTURE OF MESSAGES ...............................................................................................................3-46 FIGURE 3-11: THREE PHASES AT DATA LINK LAYER ........................................................................................................................3-56 FIGURE 3-12: RESPONSE IS ANY CHARACTER ....................................................................................................................................3-57 FIGURE 3-13: CONTENTION: RESPONSE IS ANY [ENQ]...................................................................................................................3-58 FIGURE 3-14: TIME OUT: NO RESPONSE .............................................................................................................................................3-59 FIGURE 3-15: ESTABLISHMENT PHASE CONFIRMED, CONTINUE WITH TRANSFER PHASE ..........................................................3-59 FIGURE 3-16: ESTABLISHMENT PHASE, FLOWCHART .......................................................................................................................3-60 FIGURE 3-17: TRANSFER PHASE, FLOWCHART ..................................................................................................................................3-63 FIGURE 3-18: TERMINATION PHASE, FLOWCHART ............................................................................................................................3-64 FIGURE 4-1: DATA CABLE WIRING DIAGRAM (----- FOR OPTIONAL BRIDGES) ..........................................................................4-69 FIGURE 4-2: ELECSYS 2010 CONNECTORS (LEFT CASE SIDE) .........................................................................................................4-70 FIGURE 4-3: ELECSYS 1010 CONNECTORS (LEFT CASE SIDE) .........................................................................................................4-70 FIGURE 4-4: SENDER / RECEIVER STATE DIAGRAM (ACCORDING TO ASTM E1381-91) ........................................................4-73 FIGURE 4-5: STRUCTURE OF MESSAGES .............................................................................................................................................4-82 FIGURE 7-1: CONNECTOR STRATEGY FOR INSTRUMENT COMPUTER CONNECTION - CABLE MOUNTED ............................ 7-207 FIGURE 7-2: CONNECTOR STRATEGY FOR INSTRUMENT COMPUTER CONNECTIONS - CHASSIS MOUNTED ...................... 7-207 FIGURE 7-3: STATE DIAGRAM ............................................................................................................................................................ 7-214 FIGURE 9-1: MAIN SCREEN OF THE TEST TOOL .............................................................................................................................. 9-264 FIGURE 9-2: MULTIFUNCTIONAL TEXT EDITOR ................................................................................................................................ 9-267

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10.3 Record Names For field definitions see pages printed in bold.

A ACTION CONFIRMATION ....................................................................................................................................................3-46, 4-79, 4-104 ACTION REQUEST ...............................................................................................................................................................3-46, 4-79, 4-105

AUTO DILUTION FACTOR ...................................................................................................................................................................... 4-92

C C................................................................................................................................................................... SEE COMMENT SEE COMMENT

CALIBRATION ORDER ....................................................................................................................................................3-46, 4-79, 4-110 CALIBRATION RESULT ......................................................................................................................................... 3-46, 4-79, 4-107, 4-108 CALIBRATION SCHEME ................................................................................................................................. 3-46, 4-79, 4-111, 4-112 CALIBRATOR PARAMETERS ................................................................................................................................................3-46, 4-79, 4-106 CHANGE COMMUNICATION PROTOCOL .................................................................................................................. 3-46, 4-79, 4-121 COMMENT .................................................................................................................................................................................... 4-78, 4-100 COMMENT ................................................................................................................................................................................................... 3-45 COMMENT .................................................................................................................................................................................................... 3-47 CONTROL PARAMETERS .....................................................................................................................................................3-46, 4-79, 4-122 CONTROL SCHEME ...................................................................................................................................................... 3-46, 4-79, 4-123

D DILUENT PARAMETERS.......................................................................................................................................................3-46, 4-79, 4-112

H H ...................................................................................................................................... SEE MESSAGE HEADER SEE MESSAGE HEADER

I INSTRUMENT CONFIGURATION ............................................................................................................................ 3-46, 4-79, 4-113, 4-115 INSTRUMENT STATUS .........................................................................................................................................................3-46, 4-79, 4-116

L L ..................................................................................................................... SEE MESSAGE TERMINATOR SEE MESSAGE TERMINATOR LOG FILE ............................................................................................................................................................................3-46, 4-79, 4-119

M M ......................................................................................................................................................... SEE MANUFACTURER INFORMATION M-AC............................................................................................................ SEE ACTION CONFIRMATION SEE ACTION CONFIRMATION MANUFACTURER INFORMATION.................................................................................................................................................................... 4-78 MANUFACTURER INFORMATION ......................................................................................................................................................... 3-37, 3-45 M-AR................................................................................................................................... SEE ACTION REQUEST SEE ACTION REQUEST

M-CO ................................................................................................................... SEE CALIBRATION ORDER SEE CALIBRATION ORDER M-CP ................................................................................................ SEE CALIBRATOR PARAMETERS SEE CALIBRATOR PARAMETERS M-CR .................................................................................................................... SEE CALIBRATION RESULT SEE CALIBRATION RESULT M-CS ................................................................................................................................................................. SEE CALIBRATION SCHEME M-DP ................................................................................................................ SEE DILUENT PARAMETERS SEE DILUENT PARAMETERS MESSAGE HEADER .............................................................................................................................................................................4-78, 4-83 MESSAGE HEADER ....................................................................................................................................................................................... 3-45 MESSAGE HEADER ........................................................................................................................................................................................ 3-46 MESSAGE TERMINATOR ................................................................................................................................................................... 4-78, 4-85 MESSAGE TERMINATOR ............................................................................................................................................................................... 3-45 M-IC .......................................................................................SEE INSTRUMENT CONFIGURATION SEE INSTRUMENT CONFIGURATION M-IS........................................................................................................................ SEE INSTRUMENT STATUS SEE INSTRUMENT STATUS M-LF...................................................................................................................................................................SEE LOG FILE SEE LOG FILE M-PM............................................................................................................ SEE PROCESSING MESSAGE SEE PROCESSING MESSAGE M-PX ......... SEE CONTROL SCHEME SEE CHANGE COMMUNICATION PROTOCOL SEE CHANGE COMMUNICATION PROTOCOL V 4.2 –Version 01/05

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M-QP .............................................................................................................SEE CONTROL PARAMETERS SEE CONTROL PARAMETERS

M-QS ........................................................................................................................................................................SEE CONTROL SCHEME M-RC ...................................................................................................................................SEE RESULT CONTEXT SEE RESULT CONTEXT M-RR ........................................................................................................ SEE SUBSTANCE DATA SEE RAW RESULT SEE RAW RESULT M-SD ............................................................................................................................................. SEE SERVICE DATA SEE SERVICE DATA M-SS....................................................................................................................................... SEE SAMPLE STATUS SEE SAMPLE STATUS M-TA ............................................................................................................................... SEE TEST APPLICATION SEE TEST APPLICATION M-TC...................................................................................... SEE TEST CONDITIONS SEE TEST CONDITIONS SEE TEST CONDITIONS M-XT .......................................................................................................................................................................... SEE SUBSTANCE DATA

O O ............................................................................................................................................................ SEE TEST ORDER SEE TEST ORDER

P P ....................................................................................................................... SEE PATIENT INFORMATION SEE PATIENT INFORMATION PATIENT INFORMATION ........................................................................................................................................3-46, 4-78, 4-87, 4-88 PATIENT INFORMATION ......................................................................................................................................................................3-31, 3-45 PATIENT INFORMATION ................................................................................................................................................................................. 3-31 PROCESSING MESSAGE ..................................................................................................................................................... 3-46, 4-79, 4-120

Q Q ................................................................................................................... SEE REQUEST INFORMATION SEE REQUEST INFORMATION

R R ...............................................................................................................................................................................SEE RESULT SEE RESULT RAW RESULT ..................................................................................................................................................................... 3-46, 4-79, 4-125 REQUEST INFORMATION .................................................................................................................................................. 4-78, 4-101, 4-102 REQUEST INFORMATION .....................................................................................................................................................................3-39, 3-45 REQUEST INFORMATION ................................................................................................................................................................................ 3-47 RESULT ................................................................................................................................................................................ 4-78, 4-97, 4-98 RESULT ......................................................................................................................................................................................................... 3-45 RESULT CONTEXT .............................................................................................................................................................. 3-46, 4-79, 4-124 RESULT ......................................................................................................................................................................................................... 3-47

S S ................................................................................................................................................................................................ SEE SCIENTIFIC SAMPLE STATUS................................................................................................................................................................ 3-46, 4-79, 4-128

SCIENTIFIC .................................................................................................................................................................................................4-78 SCIENTIFIC .................................................................................................................................................................................................... 3-45 SCIENTIFIC ..................................................................................................................................................................................................... 3-47 SERVICE DATA................................................................................................................................................... 3-46, 4-79, 4-126, 4-127 SUBSTANCE DATA ............................................................................................................................................... 3-46, 4-79, 4-132, 4-134

T TEST APPLICATION ............................................................................................................................................................ 3-46, 4-79, 4-130 TEST CONDITIONS ............................................................................................................................................................. 3-46, 4-79, 4-131 TEST ORDER ............................................................................................................................................................ 4-78, 4-89, 4-92, 4-93 TEST ORDER ................................................................................................................................................................................................. 3-45 TEST ORDER .................................................................................................................................................................................................. 3-46

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Glossary

Glossary

Definition

ASTMReference

Description

addresses

6.6.05

An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country needs only to be transmitted when it cannot be assumed from the context. The components of this field are position dependent.

battery

3.1.02

A group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name.

component field

3.1.07

A single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields.

data record usage overview

6.5

Data is exchanged in records of different types. Each record is introduced by field (number one) identifying the record type, and terminated by a carriage return. The following record types are defined. Note: The record type ID field shall be case insensitive.

dates and times

6.6.02

In all cases, dates are recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they are represented as HHMMSS, and are linked to dates as specified by ANSI X3.43. Date and time together shall be specified as up to a fourteen-character string: YYYYMMDDHHMMSS.

delimiter, component delimiter

6.4.05

A single allowable character as defined in 6.1.1 excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters.

delimiter, escape delimiter

6.4.06

A single allowable character, as defined in 6.1.1, excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. - Use of Escape Delimiter: The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences are pre-defined.

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Definition

ASTMReference

Description

delimiter, field delimiter

6.4.03

A single allowable character as defined in 6.1.1 excluding ASCII 13 (carriage return), shall separate adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record.

delimiter, record delimiter

6.4.02

Carriage return (ASCII 13) is the delimiter for the end of any of the defined record types.

delimiter, repeat delimiter

6.4.04

A single allowable character as defined in 6.1.1 excluding ASCII 13 and the value for the field delimiter defined in 6.4.3. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set.

delimiter, specification of delimiters

6.4.07

The actual delimiters to be employed in a given transmission are specified in the header message. It is the responsibility of the sender to avoid the inclusion of any delimiter characters within the field contents. The receiving computer will determine what characters to use by reading the specifications of the header it receives. See 6.4.1 for examples of delimiters used for this document.

delimiters for null values

6.4.08

Fields are identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to th ensure that the i field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters.

download

3.1.09

Data transmitted from a computer system to a clinical instrument.

field

3.1.05

One specific attribute of a record which may contain aggregates of data elements further referring the basic attribute.

fields of no concern to the receiving system

6.4.09

Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified.

fields with null values

6.4.10

A system may transmit a null value for a field because - (1) it does not know the value, - (2) it knows the value is irrelevant to the receiving system, or - (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's date of birth, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. - Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s date of birth when the date of birth was actually unknown, the receiving system should replace its existing value for a field with a null value. - A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.

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Definition

ASTMReference

Description

fixed measurements and units

6.6.04

When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955.

manufacturer's or local code (part 4)

6.6.01.4

This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as

message

3.1.01

A textual body of information.

multiple phone numbers

6.6.03.1

When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number.

provider and user IDs

6.6.06

Physician's and other health staff codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name shall be (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. When necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters.

record

3.1.04

An aggregate of fields describing one aspect of the complete message.

record sequence number

6.6.07

This is a required field used in record types that may occur multiple th times within a single message. The number used defines the i occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records).

record, comment (C)

6.5.05

Comment records can apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure.

record, manufacturer information (M)

6.5.08

This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer.

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Definition

ASTMReference

Description

record, message header (H)

6.5.01

This record contains information about the sender and the receiver, that is, it identifies the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters.

record, patient identifying (P)

6.5.02

This record type contains information about an individual patient.

record, request information (Q)

6.5.06

This record is used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results for an individual test, multiple test, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc.

record, result

6.5.04

Each result contains the results of a single analytic determination.

record, scientific (S)

6.5.07

This record is used to exchange results between clinical sites for the purposes of proficiency testing or method development.

record, test order (O)

6.5.03

When sent from the computer system to the instrument, this record represents a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it provides information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries).

repeat field

3.1.06

A single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields.

telephone numbers

6.6.03

Phone numbers are recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc.

test

3.1.03

A determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute.

time zone

6.6.02.1

The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender.

universal test ID

6.6.01

This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record, there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered.

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Definition

ASTMReference

Description

universal test ID (part 1)

6.6.01.1

This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time.

universal test ID name (part 2)

6.6.01.2

This would be the test or battery name associated with the universal test ID code described in 6.6.1.1.

universal test ID type (part 3)

6.6.01.3

In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields.

Upload

3.1.08

Data transmitted from a clinical instrument to a computer system.

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