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    KONELAB

    LIMS AND LASINTERFACES

    Code: 895304-4301

    Manual version: H

    Date: 1.10.2003

    The CE mark attached on Konelab indicates the conformity with

    the EMC (electromagnetic compatibility) directive 89/336/EC.

    Thermo Electron Oy, Clinical DiagnosticsClinical Chemistry & Automation SystemsRatastie 2, P.O. Box 100FIN-01621 VANTAA, FinlandTel.: +358 9 329 100Fax: +358 9 3291 0300

    www.thermo.com/konelab

    Information in this manual is subject to change withoutprior notice.

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    Konelab

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    I LIMS INTERFACE

    1. HARDWARE INTERFACE .......................................................................................................... 1

    1.1 HOW TO INSTALL AND CONFIGURE THE ASTM SOFTWARE ..............................................2

    1.1.1 INSTALLATION..........................................................................................................................2

    1.1.2 CONFIGURATION.....................................................................................................................3

    2. Konelab ONLINE (=KONE ONLINE) PROTOCOL................................................................... 4

    2.1 BI-DIRECTIONAL MODE ...............................................................................................................42.1.1 COMMUNICATION RECORDS ................................................................................................5

    2.1.1.1 INITIALISATION RECORDS..............................................................................................................52.1.1.2 PATIENT INFORMATION RECORD ...................... ....................... ...................... ....................... .......6

    2.1.1.3 SAMPLE INFORMATION RECORD ..................................................................................................72.1.1.4 TEST ANALYSIS RECORD ................................................................................................................7

    2.1.1.5 RESULT RECORD................................................................................................................................82.1.1.6 FINISHING RECORD...........................................................................................................................8

    2.1.2 BI-DIRECTIONAL PROTOCOLS ..............................................................................................9

    2.1.3 DATA VALIDITY CHECK........................................................................................................142.1.3.1 CHECK SUM ......................................................................................................................................14

    2.1.4 TIMING REQUIREMENTS......................................................................................................142.2 EXAMPLES OF COMMUNICATION ...........................................................................................15

    2.2.1 SAMPLE AND TEST DATA ENTRY.........................................................................................15

    2.2.2 RECEIVING NEW READY RESULTS......................................................................................16

    2.2.3 RECEIVING ALL READY RESULTS .......................................................................................17

    2.2.4 RECEIVING RESULTS FOR A SPECIFIC SAMPLE ..............................................................17

    2.2.5 SENDING TEST DATA FOR OLD SAMPLES.........................................................................182.2.6 ENQUIRING TESTS IN USE IN THE ANALYSER ..................................................................19

    2.3 ERROR HANDLING.......................................................................................................................20

    2.3.1 ERROR RECORD.....................................................................................................................20

    2.3.2 RESULT ERROR CODES.........................................................................................................21

    2.3.3 COMMUNICATION ERROR CODES......................................................................................21

    2.3.4 ON LINE ERROR CODES........................................................................................................222.3.5 EXAMPLES OF ERROR HANDLING......................................................................................24

    2.4 REQUESTING A CALCULATED TEST .......................................................................................25

    3. ASTM PROTOCOL................................................................................................................... 27

    3.1 FEATURES......................................................................................................................................27

    3.2 ASTM IN KONELAB ..........................................................................................................................28

    3.2.1 ASTM 1394 91 STRUCTURE OF MESSAGES .....................................................................283.2.1.1 Header record (level 0).................. .................... ..................... .................... ....................... ................... 283.2.1.2 Message terminator record (level 0)..... ..................... .................... ..................... ...................... ............29

    3.2.1.3 Patient information record (level 1) ................... .................... .................... ..................... ..................... 29

    3.2.1.4 Test order record (level 2) ....................................................................................................................313.2.1.5 Result record (level 3) ..........................................................................................................................333.2.1.6 Comment record (level 4) used with the Result Record.......... ..................... ..................... ................... 353.2.1.7 Comment record (level 3) used with transmission related error conditions .................. ................... ....36

    3.2.1.8 Request information record (level 1)............. .................... .................... .................... ...................... .....37

    3.2.2 FIELD LENGTHS USED BY Konelab .....................................................................................38

    3.2.3 EXAMPLES OF COMMUNICATION BETWEEN Konelab AND THE HOST

    COMPUTER.............................................................................................................................................39

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    II LAS INTERFACE

    4. KONELAB / LAS INTERFACE .................................................................................................. 44

    4.1 HARDWARE INTERFACE ............................................................................................................44

    4.2 GENERAL DESCRIPTION.............................................................................................................44

    4.2.1 MESSAGE RECORD FORMAT ...............................................................................................444.2.2 CALCULATION OF CHECKSUM...........................................................................................45

    4.2.3 SEQUENCE FOR INITIALISING THE COMMUNICATION INTERFACE............................46

    4.2.4 ANALYSER BOOT SEQUENCE...............................................................................................46

    4.2.5 KUSTI STATES AND ERROR RECOVERY .............................................................................47

    4.3. COMMUNICATION RECORDS....................................................... .............................................494.3.1 INITIALISATION RECORD.....................................................................................................49

    4.3.2 ILLEGAL COMMAND RECORD.............................................................................................49

    4.3.3 ANALYSER STATUS QUERY RECORD..................................................................................49

    4.3.4 ANALYSER STATUS RECORD................................................................................................50

    4.3.5 ASPIRATE SAMPLE RECORD................................................................................................50

    4.3.6 SAMPLE DISPENSING COMPLETE RECORD......................................................................514.3.7 REINITIALISE COMMUNICATION RECORD .......................................................................51

    4.4 COMMUNICATION EXAMPLES .................................................................................................52

    4.4.1 INITIALISATION SEQUENCE.................................................................................................52

    4.4.2 SAMPLE ASPIRATION SEQUENCE FOR TWO SAMPLES...................................................52

    4.4.3 SAMPLE ASPIRATION FAILS, RECOVERY SUCCESSFUL 1...............................................53

    4.4.4 SAMPLE ASPIRATION FAILS, RECOVERY SUCCESSFUL 2...............................................544.4.5 SAMPLE ASPIRATION FAILS, RECOVERY UNSUCCESSFUL ............................................55

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    Konelab

    LIMS and LAS Interfaces

    29.09.03

    895304-4301 1

    1. HARDWARE INTERFACE

    The Konelab LIMS hardware interface works through serial communication channel.

    Figure 1: The connectors for serial communication channels are at the back of the

    Konelab workstation.The connectors are 9-pin male D-connectors.

    The channel (COM1,COM2) as well as the LIMS protocol (Konelab Online or

    ASTM) and communication parameters (baud rate, number of bits in character,

    number of start and stop bits and the use of parity) to be used can be configured in

    the Konelab LIMS Configuration window.

    LIMS Configuration

    Main window

    F8/F1

    Configuration

    Configuration

    F7

    LIMSConfiguration

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    The signals needed at the Konelab end of cable

    Pin 2 Receive Data

    Pin 3 Transmit Data

    Pin 5 Ground

    An example of the cabling between Konelab and LIMS

    Konelab and a PC (RS-232)

    Konelab PC

    Pin 2 RxD--------------------------- TxD

    Pin 3 TxD----------------------------- RxD

    Pin 5 Gnd ----------------------------- Gnd

    1.1 HOW TO INSTALL AND

    CONFIGURE THE ASTM SOFTWARE

    1.1.1 INSTALLATION

    The ASTM software can be taken into use after the Konelab V3.0 software isinstalled. If Konelab application is running, close the application by selecting

    Management and Exit. Select Start->Programs->Konelab Lims Selection and select

    ASTM from there. Now the LIMS interface will use ASTM software instead of

    Konelab Online software. The ASTM configurations should be checked after

    starting the Konelab application again, because the configuration file is updated in

    start of the application.

    The cable should be

    made according to the

    documentation of LIMS

    system in use.

    This example describes

    the minimum cable

    connections needed.

    Some computer systems

    may require some

    additional signals

    connected locally within

    connector. Please refer

    to your LIMS

    documentation for

    further information.

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    1.1.2 CONFIGURATION

    ASTM software has additional configurations as compared to Konelab Online

    software. The configuration file is Konelab.ini and it is in folder C:\Konelab\Config.

    The changes to the configuration are:

    LimsProtocol = ASTM

    - This is a new choice for protocol.

    LimsAutomaticResultSending = YES

    - When YES the new results are automatically send to Laboratory computer.

    LimsThreadPriority = LOW

    - This enables the Lims thread to use lower priority and give other software

    processes more time.

    LimsInterruptible = NO

    - When YES the ASTM protocol allows the receiver to ask for interruption of

    sending information.

    LimsHostQuery =YES

    - When YES the Konelab software will automatically send a query for sample

    information and requests when new sample is introduced into Konelab.

    SentryWaitsLimsRequests = YES

    - When YES the sample entry function waits for the response to a query when new

    sample is introduced.

    ASTMControlResultSending = NO

    - When YES the new control sample analysis results are automatically send to

    Laboratory computer.

    ASTMStandardResultSending = NO

    - When YES the new calibrator sample analysis results are automatically send to

    Laboratory computer.

    SampleIdSendingDelay = 0

    - If value is not 0, Konelab will use this delay between successive sending of new

    sample Id's. This can be used to ease the burden on Laboratory computer when

    e.g. a full segment with 14 samples is introduced. The value is expressed in

    milliseconds.

    ResultSendingDelay = 0

    - If value is not 0, Konelab will use this delay between successive sending of newsample results. This can be used to ease the burden on Laboratory computer. The

    value is expressed in milliseconds.

    In order to take ASTM protocol in use the configuration file should be edited

    manually. Close the Konelab application by selecting MANAGEMENT and EXIT

    from there. Wait for the Konelab application to shut down. Start Windows NT

    Explorer by selecting Start-> Programs->Windows NT Explorer. Select the folder

    C:\Konelab\Config and on the right side of Explorer display should be seen files

    Konelab and UserText. Double click with mouse on Konelab file. Now the Notepad

    program should open with the Konelab.ini file. Change the configuration manually

    and after that save the modified file selecting File->Save. Now the Konelab software

    can be started again with ASTM configurations.

    The ASTM software

    supports sending results

    on ready sample or on

    ready request basis. The

    sending of results on

    ready request basis will

    load the interface heavily

    and it is recommended

    that sending results by

    ready sample should be

    used. This selection can

    be done through the

    Konelab Configuration

    function.

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    2. Konelab ONLINE (=KONE

    ONLINE) PROTOCOL

    2.1 BI-DIRECTIONAL MODE

    Konelab uses bi-directional data communication between the analyser and the

    external computer i.e. both an external computer and the analyser can communicate

    with each other. For example, the external computer can send test requests to

    Konelab and the analyser can send completed results to the computer.

    Bi-directional mode consists of seven different functions:

    Function 1 is used when Patient data, Sample data and Test data is sent tothe analyser.

    Function 2 is used to send Sample and Test data only to the analyser.Control and Calibrator sample data can also be sent to the analyser using this

    function.

    Function 3 is used when a laboratory computer wishes to receive all newlycompleted results which have not already been sent.

    Function 4 is used when a laboratory computer wishes to receive allresults completed that day.

    Function 5 is used when a laboratory computer wishes to receive allresults for a particular sample. Complete and incomplete tests are sent by the

    analyser.

    Function 6 is used for request inquiry i.e. a laboratory computer wishes to

    know which patient samples exist in the database of the analyser. The laboratory

    computer can then send new requests.

    Function 7 is used when a laboratory computer wishes to know which testsexist in the database of the analyser.

    These functions are activated using the initialisation records. Refer to section 2.1.1.1.

    The analyser is always

    acting as co-operator

    and the computer is the

    host.

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    2.1.1 COMMUNICATION RECORDS

    The following records are used when the analyser and the host computer

    communicates with each other.

    2.1.1.1 INITIALISATION RECORDS

    Initialisation records are activating commands which the host computer sends to the

    analyser when the communication begins.

    INITIALISATION RECORD 1

    This record is used when Patient data, Sample data and Test data is sent to the

    analyser.

    :I:PR1/C/

    C = check sum, refer to section 2.1.3.1.

    INITIALISATION RECORD 2

    This record is used to send Sample and Test data only to the analyser. Control and

    Calibrator sample data can also be sent to the analyser using this initialisation record.

    :I:PR2/C/

    INITIALISATION RECORD 3

    This record is used when a laboratory computer wishes to receive all newly

    completed results which have not already been sent.

    :I:PR3/C/

    INITIALISATION RECORD 4

    This record is used when a laboratory computer wishes to receive all results

    completed that day.

    :I:PR4/C/

    INITIALISATION RECORD 5

    This record is used when a laboratory computer wishes to receive all results for a

    particular sample. Complete and incomplete tests are sent by the analyser.

    :I:PR5/C/

    INITIALISATION RECORD 6

    This record is used when a laboratory computer wishes to know which patient

    samples exist on the database of the analyser. The laboratory computer can then send

    new requests.

    :I:PR6/C/

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    INITIALISATION RECORD 7

    This record is used when a laboratory computer wishes to know which tests exist on

    the database of the analyser.

    :I:PR7/C/

    2.1.1.2 PATIENT INFORMATION RECORD

    :P:nn..n/ii..i/M or F/A or C/b..b/ss..s/n or o/C/

    P - identifies the record to be a

    Patient Information Record

    nn..n - Patient Name (up to 24 characters)

    ii..i - Patient Identification (up to 16 characters)

    M - Male (M) or Female (F) Konelab ignores this; reference

    class is always 0

    A - Adult (A) or Child (C) Konelab ignores this; reference

    class is always 0

    bb..b - Age or Date of Birth (up to 8 characters)

    ss..s - Sender name (up to 24 characters)

    n or o - New (n) or Old (o) (1 character)

    C - check sum, refer to section2.1.3.1.

    The slash (/) must be entered into the string, since it is the field delimiter. This

    means that the number of slashes in a record is always constant. Note that the slash is

    a forbidden character inside a field.

    For example, if no sender information and no age information is sent, the Data String

    looks like:

    :P:nn..n/ii..i/M/A///n or o/C/

    New or Old: If the

    switch is N or n - the

    analyser expects the

    patient to be new. If

    already present, an error

    message is sent to the

    computer. If the switch is

    O or o and the patient

    does not exist in the

    analyser, again an error

    message is sent. If the

    switch is omitted thepatient is accepted in

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    2.1.1.3 SAMPLE INFORMATION RECORD

    :S:ii..i/pn/pp/st/nn/dd..d/tt..t/rrr/n or o/C/

    S - identifies the record to be a sample

    information record

    ii..i - sample identification (up to 16 characters)

    pn - sample segment number (up to 2 characters)

    pp - sample segment position (up to 3 characters)

    st - sample type (up to 2 characters)

    nn - sample note data e.g. icteric (ic),

    haemolysed (HE), a user defined character

    code, handled only as an information string

    (up to 2 characters)

    dd..d - collection date, a user defined character

    code, handled only as an information string

    (up to 8 characters)

    tt..t - collection time, a user defined character

    code, handled only as an information string

    (up to 5 characters)

    rrr - dilution ratio (format is 1 + rrr) (up to 3 characters)

    n or o - new/old (1 character)

    C - check sum, refer to section 2.1.3.1.

    2.1.1.4 TEST ANALYSIS RECORD

    :A:xx..x/!/yy..y/..../C/

    A - identifies the record to be the test analysis

    record

    ! - STAT identifier for following request (1 character)

    xx..x

    yy..y,etc

    - test identification (up to 8 characters)

    C - Check sum, refer to section 2.1.3.1.

    The STAT identifier indicates that the following request must be performed urgently.

    This is valid only for one request following the STAT identifier. If there is a STAT

    profile to be sent, each test identification must have its separate STAT identifier. If

    the'!'is omitted then the request is performed routinely,

    i.e. :A:xx..x/yy..y/.../C/

    Sample Type:

    If the type is @S, acalibrator name (i.e.

    S0...S19) is expected as the

    id. If the identification is not

    a calibrator name, an error

    message will be sent.

    If the type is @C, a control

    name (i.e. C1...C19) is

    expected as the id. If the

    identification is not a

    control name, an error

    message will be sent.

    New or Old:

    If the switch is N or n - the

    analyser expects the sample

    to be new. If already

    present, an error message is

    sent to the computer.

    If the switch is O or o and

    the sample does not exist in

    the analyser, again an error

    message is sent. If the switch

    is omitted, the sample is

    accepted in either case.

    Use the same test

    identification as in test'sparameters.

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    2.1.1.5 RESULT RECORD

    :R:ii..i/aa..a/rr..r/ddd/ee..e/aa..a/rr..r///.../C/

    R - identifies the record to be a result type record

    ii..i - sample identification, a shorter identification is

    filled with blanks by the analyser

    (16 characters)

    aa..a - analysis identification, a shorter identification

    is filled with blanks by the analyser

    (8 characters)

    rr..r - result, right justified, field is filled with blanks

    by the analyser. A possible minus sign is leading

    the most significant character. The 6 characters

    might include a decimal point which position is

    defined by the parameter 'Number of decimals'

    in the TEST DEFINITION window.

    (6 characters)

    ddd - dilution ratio (format is 1+ddd), total dilution

    including both manual and automatic dilution

    (up to 3

    characters)

    ee..e - result error codes, refer to section 2.3.2. (up to 10

    characters)

    If the result was obtained without a dilution, the dilution field is skipped (/ remains).

    If the result has no error, the error field is skipped, (/ remains).

    2.1.1.6 FINISHING RECORD

    Finishing record is used in data sending as the last record to indicate to receiver that

    communication is over. The receiver must always acknowledge finishing record by

    .

    Finishing record has always the same format:

    :F:PR/C/

    where C is the check sum. Refer to section 2.1.3.1 for the calculation of the check

    sum.

    SPECIAL NOTE:

    The most significant

    digit is lost if the

    result includes more

    than 6 characters.

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    2.1.2 BI-DIRECTIONAL PROTOCOLS

    PROTOCOL FOR SENDING PATIENT, SAMPLE AND TEST DATA

    TO THE ANALYSER

    *A number of Test Analysis records may follow, which must be acknowledged by

    (ACK)

    LABORATORY COMPUTER ANALYSER

    (Initialization record 1)(CR)(LF)

    (ACK)

    (Patient info record)(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Patient info record)(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

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    PROTOCOL FOR SENDING SAMPLE AND TEST DATA TO THE

    ANALYSER

    * A number of Test Analysis records may follow, which must be acknowledged by(ACK).

    PROTOCOL FOR RECEIVING NEWLY COMPLETED RESULTS

    FROM THE ANALYSER

    * A number of Result Records may follow, which must be acknowledged by

    (ACK).

    LABORATORY COMPUTER ANALYSER

    (Initialization record 3)(CR)(LF)

    (ACK)

    (Result record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

    LABORATORY COMPUTER ANALYSER

    (Initialization record 2)(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

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    PROTOCOL FOR RECEIVING ALL COMPLETED RESULTS FROM

    THE ANALYSER, I.E. RECOVERY WHEN THE ANALYSER OR

    COMPUTER GOES DOWN

    * A number of Result Records may follow, which must be acknowledged by (ACK).

    LABORATORY COMPUTER ANALYSER

    (Initialization record 4)(CR)(LF)

    (ACK)

    (Result record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

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    PROTOCOL FOR RECEIVING RESULTS ON A SPECIFIC SAMPLE,

    I.E. STAT SAMPLE

    * A number of Result Records may follow, which must be acknowledged by

    (ACK).

    ** A short delay (10 ms) must exist in these phases.

    LABORATORY COMPUTER ANALYSER

    (Initialization record 5)(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Result record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

    ***

    (Sample info record)(CR)(LF)

    (ACK)

    (Result record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

    ***(Finishing record)(CR)(LF)

    (ACK)

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    PROTOCOL FOR SENDING REQUESTS FOR OLD SAMPLES

    * A number of Test Analysis Records may follow, which must be acknowledged by

    (ACK).

    ** A short delay must exist in these phases.

    PROTOCOL FOR ENQUIRING TESTS IN USE IN THE ANALYSER

    * A number of Test Analysis Records may follow, which must be acknowledged by

    (ACK).

    LABORATORY COMPUTER ANALYSER

    (Initialization record 6)(CR)(LF)

    (ACK)

    = = 1 = =

    (Sample info record)*(CR)(LF)

    (ACK)

    **(Test analysis record)(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

    = = 2 = =

    (Finishing record)(CR)(LF)

    (ACK)

    Sample info record is

    identical to the record

    used by the laboratory

    computer to send sample

    info.The part between '== 1

    ==' and '== 2 ==' is

    repeated until all the

    samples in the analyser's

    database have been

    processed, excluding

    calibrators and controls.

    LABORATORY COMPUTER ANALYSER

    (Initialization record 7)(CR)(LF)

    (ACK)

    (Test analysis record)*(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

    Test analysis record is

    identical to the record

    used by the host to send

    requests, except it never

    contains the STAT

    identifier ('!').

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    2.1.3 DATA VALIDITY CHECK

    The communication is full duplex and ASCII characters are used, but the user can

    select the number of data bits, stop bits, parity and speed in the Configuration

    window.

    Each record begins with a colon ':'and ends with a check character 'C'followed by aslash '/', carriage return and line feed.

    Maximum record length is 132, including check sum.

    2.1.3.1 CHECK SUM

    The check sum is calculated from the colon to the last slash before the check sum

    character.

    The check sum is defined by the following formula (decimal system):

    C = i(Ci- 32) mod64

    + 32

    where Ci= each character

    EXAMPLE OF CALCULATING A CHECK SUM

    String without check sum

    : I : P R 2 /

    ASCII VALUE 58 73 58 80 82 50 47

    SUBTRACT 32 26 41 26 48 50 18 15

    TOTAL 26 67 93 141 191 209 224

    MODULUS 64 26 3 29 13 63 17 32

    ADD 32 64

    CHARACTER @

    String with check sum and delimiter

    : I : P R 2 / @ /

    2.1.4 TIMING REQUIREMENTS

    The host computer has max. 60 seconds time for answering by (ACK) or (NAK).

    Otherwise the protocol has to be restarted.

    The time the analyser needs for validation of a record depends on the situation and in

    the worst case it may take few minutes. Recommended time out value is at least 3

    minutes when waiting the response from the analyser.

    When the host computer asks results from the analyser with certain intervals, the

    recommended minimum time between consecutive asking is at least 5 minutes.

    The string begins with

    the : character and

    includes all charactersup to, and including,

    the / character before

    the check sum

    character.

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    2.2 EXAMPLES OF COMMUNICATION

    This section gives brief examples of the protocol as it would be used in practice.

    The examples are only intended to give an indication of the stages involved in each

    operation, the data transmitted is arbitrary.

    The direction in which the message is going.

    means from the computer to the analyser

    means from the analyser to the computer

    2.2.1 SAMPLE AND TEST DATA ENTRY

    WITH PATIENT DATA

    LABORATORY COMPUTER ANALYSER

    :I:PR1/?/

    ACK

    :P:SMITH JOHN/4///30/2/N/8/

    ACK

    :S:6///PL/HA/97-12-18/12:13/0/N/7/

    ACK

    :A:ISE/ALB/ALK.PH/ALT/DBIL/GGT/PROT/T/

    ACK

    :P:JONES SUSAN/23423///97-12-08/3/O/_/

    ACK

    :S:12/2/1/SE//97-12-07/09:45/0/O/)/

    ACK

    :A:!/ALB/!/ALK.PH/!/ALT/!/DBIL/!/GGT/@/

    ACK

    :F:PR/+/

    ACK

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    WITHOUT PATIENT DATA

    2.2.2 RECEIVING NEW READY RESULTS

    LABORATORY COMPUTER ANALYSER

    :I:PR2/@/

    ACK

    :S:6///PL/HA/97-12-18/12:13/0/N/7/

    ACK

    :A:ISE/ALB/ALK.PH/ALT/DBIL/GGT/PROT/T/

    ACK

    :S:12/2/1/SE//97-12-07/09:45/0/O/)/

    ACK

    :A:!/ALB/!/ALK.PH/!/ALT/!/DBIL/!/GGT/@/

    ACK

    :F:PR/+/

    ACK

    Sample number 12 has

    been allocated to position

    1 on segment 2, but sample

    number 6 will be allocatedto a position when the

    sample is entered to the

    analyser. Also, the tests for

    sample number 12 are to

    be performed as STAT

    tests.

    LABORATORY COMPUTER ANALYSER

    :I:PR3/A/

    ACK

    :R:2/ K / 4.7///NA /136//102; 137/CL///002;/-/

    ACK

    :R:2 /ALB / 43.3///PROT / 48.4//102; 60/^/

    ACK

    :F:PR/+/

    ACK

    Results which had

    been transmitted

    previously will not be

    sent again.

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    2.2.3 RECEIVING ALL READY RESULTS

    2.2.4 RECEIVING RESULTS FOR A SPECIFIC

    SAMPLE

    LABORATORY COMPUTER ANALYSER

    :I:PR4/B/

    ACK

    :R:1/ LDH / 600/5.0//CREA /67///G/

    ACK

    :R:2 /K / 4.7///NA / 136//102; 137/CL ///002;/-/

    ACK

    :R3 /ALB / 43.3///PROT / 48.4//102; 60/^/

    ACK

    :F:PR/+/

    ACK

    The results for

    sample 1 had been

    transmitted

    previously but were

    sent again along

    with new results for

    samples 2 and 3.

    LABORATORY COMPUTER ANALYSER

    :I:PR5/C/

    ACK

    :S:6/// PL/HA/97-12-18/12:13/0/N/7/

    ACK

    :R:6 /ALB ///001;/PROT / 48.4//102; 60.0/C/

    ACK

    :F:PR/+/ACK

    :F:PR/+/

    ACK

    The error message

    against the ALB

    test indicates that

    the result is not

    ready.

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    2.2.5 SENDING TEST DATA FOR OLD

    SAMPLES

    LABORATORY COMPUTER ANALYSER

    :I:PR6/D/

    ACK

    :S:6 / 1/ 19/PL/HA/97-12-19/14:55/ 0//D/

    ACK

    :A:GLUC/CREA/CA/ALB/CHOL/_/

    ACK

    :F:PR/+/

    ACK

    :S:12 / 1/20/SE/CO/97-12-13/11:35/ 0//N/ACK

    :A:CA/ALB/CHOL/;/

    ACK

    :F:PR/+/

    ACK

    :F:PR/+/

    ACK

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    2.2.6 ENQUIRING TESTS IN USE IN THE

    ANALYSER

    LABORATORY COMPUTER ANALYSER

    :I:PR7/E/

    ACK

    :A:ALT /ALB / ALP /AMYL / AST/CA /CHOL /CL /CPK /CREA/CRP / FE / GGT /F/

    ACK

    :A:GLUC /K /LDH /LI / MG /NA /P/PH / TBIL/ TPROT / TRIGLY /UR

    AC /J/

    ACK

    :F:PR/+/

    ACK

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    2.3 ERROR HANDLING

    In the event of an error in the data transmission, the analyser returns an error record

    instead of ACK. This situation could arise for instance when the laboratory

    computer sends a test analysis record for a test which does not exist in the analyser.

    For example:

    When the laboratory computer receives an error record, the analyser expects a

    finishing record to be sent back to acknowledge the error situation. The analyser

    acknowledges this by sending back an ACK. After this, the protocol begins again

    with the laboratory computer starting the bidding with the initialisation record. All

    data up to the ACK sent by the analyser prior to the error is saved in the analyser,

    including also the requests at the beginning of an analysis record up to the wrong test

    identification.

    2.3.1 ERROR RECORD

    :E:xx..x/C/

    E - identifies the record to be an error record

    xx..x - communication error code, refer to section 2.3.3 (up to 30 characters)

    LABORATORY COMPUTER ANALYSER

    (Initialization record 1)(CR)(LF)

    (ACK)

    (Patient info record)(CR)(LF)

    (ACK)

    (Sample info record)(CR)(LF)

    (ACK)

    (Test analysis record)(CR)(LF)- error in this record

    (Error record)(CR)(LF)

    (ACK)

    (Finishing record)(CR)(LF)

    (ACK)

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    2.3.2 RESULT ERROR CODES

    ERROR CODE EXPLANATION

    001; result not ready, in this case result is skipped in result record

    002; result rejected, result will never come, e.g. one ISE electrodewas disabled

    003; screening test not measurable, condition due to screening test

    rejection

    101;xx..x result over reference, xx..x is the limit

    102;xx..x result under reference, xx..x is the limit

    2.3.3 COMMUNICATION ERROR CODESERROR CODES EXPLANATION

    001; format error, this error occurs when the laboratory computer

    has three times sent a record which either has wrong check

    sum or is too long (> 132 characters)

    003; invalid initialisation record

    004; invalid record identification

    005; protocol error

    101;x..xx invalid sender identification, x..xx means the invalid sender id

    103;x..xx invalid sample identification, x..xx means the invalid sample

    id

    104;x..xx invalid sample plate position, x..xx means the invalid position

    105;x..xx invalid analysis identification, x..xx means the invalid id

    106;x..xx calibrator or control name does not exist, x..xx is the name

    107;x..xx invalid sample type, x..xx is the type

    - this error occurs when @C or @S is the sample type when

    initialisation record 1 is used

    108; number of samples / patient exceeded, max nbr is 10

    201;x..xx sample segment position is reserved, x..xx is the sample

    segment position

    210;x..xx patient already exists, x..xx is the patient name

    211;x..xx patient does not exist, x..xx is the patient name

    220;x..xx sample already exists, x..xx is the sample id

    221;x..xx sample does not exist, x..xx is the sample id

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    2.3.4 ON LINE ERROR CODES

    The message 'Online' is given on the Main window during data transmission. If there

    are errors on the transmission, error messages are given via the analyser.

    32 WRONG DATA FROM AN OTHER PROCESS (LIMS)

    Internal software problem in the database. Restart the workstation.

    401 SERIAL LINE PARAMETER ERROR (LIMS)

    Check the serial interface parameters in the Configuration window.

    402 WRONG SERIAL PORT (LIMS)

    Check the serial interface parameters in the Configuration window.

    403 WRITE ERROR (LIMS)

    407 TRANSMISSION ERROR (LIMS)

    409 MESSAGE BUFFER ERROR (LIMS)

    External computer has received the data but transmission has been detected to be

    incorrect.

    Possible causes E.g. electronic malfunction, software error,initialisation error or power failure.Check the cable and cable connection. If the problem

    persists, print the reports and call service.

    404 READ ERROR (LIMS)

    The analyser has received the data but transmission has been recognised to be

    incorrect.

    Possible causesE.g. electronic malfunction, software error,

    initialisation error or power failure.

    Check the cable and cable connection. If the problempersists, print the reports and call service.

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    405 SYNCRONIZATION ERROR (LIMS)

    The analyser received a data record1while it was expecting an ACK character or it

    received ACK/NAK while expecting a data record.

    Possible causesE.g. faulty cable, electronic malfunction, software

    error.Check the cable and cable connection. If the problem

    persists, print the reports and call service.

    1)A data record is a string of any characters beginning with ':' and ending with

    (0D hex) or a string of any characters whose length exceeds the size of input buffer

    (currently 132).

    406 COMMUNICATION TIMEOUT (LIMS)

    External computer did not answer in the allowed time.

    Possible causesE.g. faulty cable, electronic malfunction or wrong

    initialisation data.

    Check the cable and cable connection. If the problem

    persists, print the reports and call service.

    408 ERROR WHEN DOING DATABASE OPERATION

    (LIMS)

    Warning about internal software problem in the database. Analysiscontinues. If the problem persists restart the workstation.

    410 LIMS TYPE MISMATCH BETWEEN LIMS PROCESS

    AND KONELAB.INI

    To continue using the Konelab program, first exit from it by selectingF8/F3 in the Management window. Then select the correct LIMS process from

    Start: Programs: lims selection. Finally, start the Konelab program again by

    clicking the konelab icon.

    999 LIMS ERROR MESSAGE (%u)

    - %u MEANS THE ERROR NUMBER

    - Software problem. Analysis continues.

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    2.3.5 EXAMPLES OF ERROR HANDLING

    INVALID CHECK SUM

    ERROR IN DATA TRANSMITTED

    LABORATORY COMPUTER ANALYSER

    :I:PR2/?/

    NAK

    :I:PR2/@/

    ACK

    The check sum in thefirst message was

    incorrect, so the

    analyser requested the

    message to be sent

    again.

    LABORATORY COMPUTER ANALYSER

    :I:PR2/@/

    ACK

    :S:126///SE//97-12-18/12:13/0/N/O/

    ACK

    :A:XXX/PROT/@/

    :E:105;XXX /A/

    ACK

    :F:PR/+/

    ACK

    The analyser does not

    recognise XXX as a valid

    test id and so it sends

    error message 105 which

    the computer

    acknowledges. The

    computer would

    probably now try to send

    the other tests for

    samples and inform theuser of the problem.

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    2.4

    REQUESTING A CALCULATED

    TEST

    Calculated tests can be requested online. All needed test requests belonging to the

    calculated test are generated automatically. The analyser is trying to use the latestintroduced samples. If it doesn't success in that it uses the older ones.

    The following requirements for requesting calculated tests

    online must be fulfilled:

    1) Tests

    All tests including into the calculated test and the calculated test itself

    must be defined in use.

    All tests including into the calculated test and the calculated test itselfmust have the online name.

    This concerns also external tests belonging to the calculated test.

    To define a calculated test refer toKonelab Reference manual, chapter 4.1.4.

    2) Samples

    First introduce samples with the right sample types, after that give the test request for

    the calculated test.

    The right sample type here means the sample type belonging to the calculated test

    request.

    A

    B

    A

    B

    If requirements are

    not fulfilled the error

    message '105:

    Analysing error'is

    appearing.

    http://reference.pdf/http://reference.pdf/
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    An example of requesting a calculated (patient) test (=CC)

    and

    a calculated (sample) test (=LDL) via LIMS:

    :I:PR1/?/

    :P:Patient1///////3/

    :S:Sample1///S//////4/

    :S:Sample2///U//////7/

    :A:CC/J/

    :F:PR/+/

    :I:PR2/@/

    :S:Sample3///S//////6/

    :A:LDL/@/

    :F:PR/+/

    Reporting

    Reporting gives result of calculated (patient) test according to a patient. In addition

    the external test is reported according to a patient. Results of tests including into the

    calculated test are reported separately according to samples.

    When a calculated

    (patient) test has been

    requested there must

    be a PR1-record or thepatient must have been

    introduced in the

    Patient entry window

    in the user interface.

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    3. ASTM PROTOCOL

    The ASTM Laboratory Information Management System interface is based on the

    following ASTM standards: ASTM 1394-91 "Standard Specification for

    Transferring Information Between Clinical Instruments and Computer Systems" and

    ASTM 1381-95 "Standard Specification for Low-Level Protocol to Transfer

    Messages Between Clinical Laboratory Instruments and Computer Systems.

    3.1 FEATURES

    The physical transmission layer is implemented according to ASTM 1381. The cable

    connector is a 9-pin male connector instead of the standard 25-pin male connector.

    The logical layer contains selected portions of ASTM 1394. The detailed record

    structure is described in section 3.2.1 ASTM in Konelab: ASTM 1394-91 Structure

    of messages.

    The main features are:

    - automatic request for sample information when new sample is introduced to the

    instrument (configurable ON/OFF)

    - automatic sending of results either on ready sample or ready request basis

    (configurable reporting basis and ON/OFF)

    - automatic sending of control sample results (configurable ON/OFF)

    - automatic sending of calibrator sample results (configurable ON/OFF)

    - response to sample information requests from Laboratory computer

    - response to control sample information requests from Laboratory computer

    - response to sample information received from Laboratory computer

    - cancelling of requests through ASTM by Laboratory computer

    - error situation management

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    3.2 ASTM in Konelab

    3.2.1 ASTM 1394 91 STRUCTURE OF

    MESSAGES

    Following sections show the ASTM records used by Konelab. The tables in sections

    include field name and number, next two fields has the information about the fields

    usage by the host or the instrument, and a comment on use of the field. If the field is

    optional the mark at usage information is between brackets. Host can send all fields,

    but only the ones with mark are processed.

    3.2.1.1 Header record (level 0)

    Field Name No Host Instr. Comment

    Record type

    ID

    1 X X Always H. Starts every message. Note: no

    delimiter between the first and the second

    field

    Delimiter

    definition

    2 X X Field, repeat, component and escape

    delimiters

    Message

    control ID

    3 - -

    Access

    password

    4 - -

    Sender name

    or ID

    5 -

    -

    -

    X

    X

    X

    Instrument type 60/30/20

    ^instrument ID InstrumentData.iId

    ^software version Get_version ?

    Sender streetaddress

    6 - -

    Reserved

    field

    7 - -

    Sender

    telephone

    number

    8 - -

    Characteristic

    s of sender

    9 - -

    Receiver ID 10 - -

    Comment or

    special

    instructions

    11 - -

    Processing

    ID

    12 X

    X

    X

    X

    X

    X

    X

    X

    P production

    T training

    D debugging

    Q QC

    Version No. 13 - -

    Date and time

    of message

    14 - (X) Form YYYYMMDDHHMMSS. Only in

    debug mode

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    3.2.1.2 Message terminator record (level 0)

    Field Name No Host Instr. Comment

    Record type ID 1 X X Always L. Ends every message.

    Sequence

    number

    2 X X Always 1. One terminator per message.

    Termination

    code

    3 (X)

    X

    X

    X

    -

    -

    -

    (X)

    X

    X

    X

    X

    X

    X

    N or missing normal termination

    T sender aborted

    R receiver requested abort

    E unknown error

    Q error in last request for information

    I no information available from last

    query

    F last request for information processed

    3.2.1.3 Patient information record (level 1)

    Field Name No Host Instr. Comment

    Record type ID 1 X X Always P.

    Sequence

    number

    2 X X Running number within Message. Starts

    with 1.

    Practice

    assigned patient

    ID

    3 (X) (X) If no code is given, this gets the value of

    Patient name.

    PatientData.sCode

    Laboratory

    assigned patient

    ID

    4 - -

    Patient ID No.

    3

    5 - -

    Patient name 6 (X)

    -

    -

    -

    -

    (X)

    -

    -

    -

    -

    Last name

    ^First name

    ^middle name or initial

    ^suffix

    ^title

    Only one text field. The whole name

    should be given there. Optional if no

    patient relates to sample.

    PatientData.sName

    Mothers

    maiden name

    7 - -

    Date of birth 8 (X) (X) Form YYYYMMDD.

    PatientData.acBirthDate

    Patient sex 9 (X) - RefClassData.sName

    Patient race-

    ethnic origin

    10 - -

    Patient address 11 - -

    Reserved field 12 - -

    Patient

    telephone

    number

    13 - -

    Attending

    physician ID

    14 - -

    Special field 1 15 - -

    Special field 2 16 - -

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    Patient height 17 - -

    Patient weight 18 - -

    Patients known

    or suspected

    diagnosis

    19 - -

    Patient activemedications

    20 - -

    Patients diet 21 - -

    Practice field 1 22 - -

    Practice field 2 23 - -

    Admission or

    discharge dates

    24 - -

    Admission

    status

    25 - -

    Location 26 (X) (X) SenderData.sID

    Native ofalternative

    diagnostic code

    and classifiers

    27 - -

    Alternative

    diagnostic code

    and

    classification

    28 - -

    Patient religion 29 - -

    Marital status 30 - -

    Isolation status 31 - -

    Language 32 - -

    Hospital

    service

    33 - -

    Hospital

    institution

    34 - -

    Dosage

    category

    35 - -

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    3.2.1.4 Test order record (level 2)

    Field Name No Host Instr. Comment

    Record type ID 1 X X Always O.

    Sequence

    number

    2 X X Running number within Patient

    information. Starts with 1.

    Specimen ID 3 (X) (X) SpecimenID^ManualDilution^Segment^P

    osition

    Optional if no sample in order.

    Mapping to Konelab internal presentation:

    SpecimenID

    PatientSampleData.sID

    ManualDilution

    PatientSampleData.fManualDilRatio

    Segment

    StorageCollectionData.iId

    Position

    StorageItemData.ucPositionIf ManualDilution, Segment and Position

    information is omitted, the value of 0 will

    be used for each. Segment value 0 with

    position value 0 refer to a virtual

    collection and can be used safely, when no

    actual position is known.

    Instrument

    specimen ID

    4 - -

    Universal test

    ID

    5 -

    -

    -

    X

    -

    -

    -

    -

    X

    X

    Universal test ID

    ^universal test name

    ^universal test ID type

    ^manufacturer defined test code

    TestData.sOnlineName^auto-dilution factor

    Multiple tests can be ordered separated by

    repeat delimiter.

    Priority 6 (X)

    (X)

    (X)

    -

    -

    (X)

    (X)

    (X)

    -

    -

    S stat REQ_PRIOR_STAT

    A asap REQ_PRIOR_ASAP

    R routine REQ_PRIOR_NORMAL

    C callback

    P preoperative

    *.ucPriority

    Optional if no sample or sample is

    calibrator or control.

    Requested/ordered date and

    time

    7 - -

    Specimen

    collection date

    and time

    8 (X) (X) Form YYYYMMDDHHMMSS

    PatientSampleData.sCollectionInfo

    Collection end

    time

    9 - -

    Collection

    volume

    10 - -

    Collector ID 11 - -

    If even one test is

    requested as stat the

    priority of test order

    record is set to stat (S)

    when results are

    reported by samples.

    When results are

    reported by requests

    the right test priority isalways seen.

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    Action code 12 X

    X

    X

    -

    -

    -

    X

    X

    -

    -

    X

    -

    X

    X

    C cancel

    A add test requests to existing specimen

    N new test requests + new specimen

    P pending specimen

    L reserved

    X specimen or test in process

    Q QC specimenMultiple action codes can be given

    separated by repeat delimiter. For example

    X\Q.

    Danger code 13 - -

    Relevant

    clinical

    information

    14 (X) (X) PatientSampleData.osComment

    Date/time

    specimen

    received

    15 - -

    Specimen

    descriptor (typeand source)

    16 X

    -

    X

    -

    Type

    ^SourceType is coded as: 1 Serum, 2 Plasma, 3

    Urine, 4 CSF, 5 Other

    PatientSampleData.ucSampleType

    Ordering

    physician

    17 - -

    Physicians

    telephone

    number

    18 - -

    User field No.1 19 - -

    User field No.2 20 - -

    Laboratory fieldNo.1

    21 - -

    Laboratory field

    No.2

    22 - -

    Date/time

    results reported

    or last modified

    23 - -

    Instrument

    charge to

    computer

    system

    24 - -

    Instrument

    section ID

    25 (X) (X) Optional if no sample. InstrumentData.iId

    Report types 26 X

    -

    -

    X

    X

    -

    -

    -

    X

    -

    -

    X

    X

    X

    X

    X

    X

    X

    O order

    C correction to previously transmitted

    results

    P preliminary results

    F final results

    X requests cancelled

    I in instrument pending

    Y no order for test (response to query)

    Z no record of this patient (response to

    query)

    Q response to query (info)

    Multiple report types can be given

    separated by repeat delimiter. For exampleY\Z.

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    Reserved field 27 - -

    Location or

    ward of

    specimen

    collection

    28 - -

    Nosocomialinfection flag 29 - -

    Specimen

    service

    30 - -

    Specimen

    institution

    31 - -

    3.2.1.5 Result record (level 3)

    Field Name No Host Instr. Comment

    Record type ID 1 X X Always R.

    Sequencenumber 2 X X Running number within Test order.Starts with 1.

    Universal test

    ID

    3 -

    -

    -

    X

    (X)

    -

    -

    -

    X

    X

    Universal test ID

    ^universal test name

    ^universal test ID type

    ^manufacturer defined test code

    TestData.sOnlineName

    ^dilution factor used in calculation

    Data or

    measurement

    value

    4 X (X) If result status is X (cancelled) or result

    is UNSTABLE, no result is given.

    *.fResult

    The range of result will be [99999.9

    0.00000] and [-0.00000 -99999.9]. If

    actual result exceeds these values, thenearest value will be shown.

    Units 5 X X TestData.sResultUnit

    Reference

    ranges

    6

    -

    -

    -

    X

    X

    -

    Components:

    Low

    TRCLimitsData.fLowerlimit

    ^High

    TRCLimitsData.fUpperlimit

    ^Description

    Result

    abnormal flags

    7 -

    -

    -

    -

    -

    -

    X

    X

    X

    X/-

    -

    -

    L/H below/above normal

    LL/HH below/above panic normal

    -below/above absolute low/high (off

    the scale of instrument)N/A normal/abnormal

    U/D significant change up/down (delta)

    B/W better/worse (used when direction

    is not relevant)

    *.ulErrorFlags

    Nature of

    abnormality

    testing

    8 - -

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    Result status 9 -

    -

    X

    -

    -

    -

    --

    -

    -

    -

    -

    X

    X

    X

    X

    -

    -X

    -

    X

    -

    C correction

    P preliminary

    F final

    X cancelled,

    I pending

    S partial

    M MIC levelR reported

    N contains necessary information to run a

    new order

    Q response to query

    V verified

    Multiple status flags can be given separated

    by repeat delimiter. For example F\Q.

    REQ_ASKED ~ I, REQ_FIXABLE ~ I

    REQ_FIXED ~ I , REQ_CALCULATED

    ~ P, REQ_MEASURED ~ P,

    REQ_XXX_ACC ~ F, REQ_XXX_REJ ~X

    Date of change

    in instrument

    normative

    values or units

    10 - -

    Operator

    identification

    11 - (X) User login name if User levels have been

    set on

    Date/time test

    started

    12 - -

    Date/time test

    completed

    13 (X) (X) Form YYYYMMDDHHMMSS. No value

    if test is not completed. *.iResultDateTime

    Instrument

    identification

    14 - X InstrumentData.iId

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    3.2.1.6 Comment record (level 4) used with the Result Record

    Field Name No Host Instr. Comment

    Record type ID 1 - X Always C. Used to transfer instrument

    flags after Result record.

    SequenceNumber

    2 - X Always 1, because of the use.

    Comment

    source

    3 -

    -

    -

    -

    -

    X

    P practice

    L computer system

    I clinical instrument system

    Comment text 4 - X Error condition identified with a number

    and a text in English

    1 Init abs.

    2 Bichr. net abs.

    3 Linearity

    4 Unstable

    5 Instr, error

    6 Addl. meas. error

    7 Sample blank error

    8 Dil. limit low

    9 Dil. limit high

    10 Test limit low

    11 Test limit high

    12 Antigen limit high

    13 Out of limit

    14 QC

    15 Calc. error

    16 Outlier

    17 Cut curve

    18 Bias corr. limit

    19 Antigen limit low20 AE meas error

    21 Blank resp. low

    22 Blank resp. high

    23 Blank init abs. low

    24 Blank init abs. High

    25 Critical limit low

    26 Critical limit high

    27 Instrument abs. Limit

    28 Not measurable

    Multiple flags can be given separated

    with repeat delimiter.

    *.ulErrorFlags

    Comment type 5 --

    -

    -

    -

    --

    -

    -

    X

    G generic/free text documentT test name comment

    P positive test comment

    N negative test comment

    I instrument flag(s) comment

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    3.2.1.7

    Comment record (level 3) used with transmission

    related error conditions

    Field Name No Host Instr. Comment

    Record type ID 1 - X Always C. Used to transfer instrument

    flags after Result record.Sequence

    Number

    2 - X Always 1, because of the use.

    Comment

    source

    3 -

    -

    -

    -

    -

    X

    P practice

    L computer system

    I clinical instrument system

    Comment text 4 - X Error condition identified by 'E' followed

    by a number

    E3 - wrong initialising character in

    record

    E4 - wrong termination code or

    request code in record

    E5 - records found in wrong orderE104 - invalid sample plate position

    sample position already

    reserved in analyzer by another

    sample or calibrator or control.

    The new sample was wrongly

    positioned by LIS. Use position

    0^0 for any sample when the

    position is defined at a later

    moment with sample insertion

    into the Konelab.

    E105 - problems with analysis request,

    request could not be created

    E108 - maximum number of samples/patient exceeded

    E201 - sample segment position is

    reserved

    E210 - problems with updating patient

    information

    E211 - patient information could not be

    found

    E220 - sample already exists

    E221 - problems with sample

    information

    Comment type 5 -

    -

    -

    -

    -

    X

    -

    -

    -

    -

    G generic/free text document

    T test name comment

    P positive test comment

    N negative test comment

    I instrument flag(s) comment

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    3.2.1.8 Request information record (level 1)

    Field Name No Host Instr. Comment

    Record type ID 1 X X Always Q. Used by Instrument to ask

    external test results or orders to new

    samples, and by host for requestingresults and orders that are in

    instruments database.

    Sequence

    number

    2 X X Always 1. Only one request may be

    outstanding at a time.

    Starting range

    ID number

    3 (X)

    (X)

    (X)

    (X)

    (X)

    (X)

    (X)

    (X)

    patient ID or ALL

    ^ sample ID or ALL

    ^segment

    ^position

    Patient ID and sample ID are text fields,

    so field is not used as range. Multiple

    patients or samples can be requested

    separated by repeat delimiter.

    Ending range

    ID number

    4 - -

    Universal test

    ID

    5 -

    -

    -

    (X)

    -

    -

    -

    -

    (X)

    -

    Universal test ID

    ^universal test name

    ^universal test ID type

    ^manufacturer defined test code

    TestData.sOnlineName

    ^auto-dilution factor

    Multiple tests can be requested separated

    by repeat delimiter.

    Nature of

    request time

    limits

    6 -

    (X)

    -

    (X)

    S specimen collect date

    R result test date

    According to standard R is taken asdefault, so it is optional.

    Beginning

    request results

    date and time

    7 (X) (X) Form YYYYMMDDHHMMSS

    Ending request

    results date and

    time

    8 (X) (X) Form YYYYMMDDHHMMSS

    Requesting

    physician name

    9 - -

    Requesting

    physician

    telephone

    number

    10 - -

    User field No.1 11 - -

    User field No.2 12 - -

    Request

    information

    status codes

    13 -

    X

    X

    X

    X

    -

    -

    X

    -

    -

    X

    X

    X

    X

    -

    -

    X

    -

    C correction

    P preliminary

    F final

    X cancelled

    I pending

    S unfinalized results

    M MIC level,

    R previously transmitted

    A cancel last request criteria

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    X

    X

    -

    X

    X

    -

    N requesting new or edited results only,

    O requesting test orders only (no

    results)

    D requesting demographics only

    Note: not repeated.

    3.2.2 FIELD LENGTHS USED BY Konelab

    Field Length in charactersInstrument type 3

    instrument ID 2

    software version 16

    Date and time of message 14

    Laboratory assigned patient ID 16

    Patient name 24

    Date of birth 8

    Patient sex 10Hospital institution 24

    Specimen ID 16

    Instrument specimen ID Segment , Position integers max 6

    characters

    Universal test ID 30

    Specimen collection date and time 14

    Relevant clinical information 30

    Instrument section ID 2

    Data or measurement value 8

    Units 10

    Reference ranges Low 6, High 6

    Date/time test completed 14Beginning request results date and

    time

    14

    Ending request results date and time 14

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    3) Konelab has analysed the sample and sends the results to

    host computer.

    Konelab:

    Host:

    Konelab::1H|\ &|||60^1^5.0|||||||P||200105021056269C

    Host: Konelab::2P|1|112233-

    4455|||TestPatient|||Adult|||||||||||||||||||||||||59

    Host:

    Konelab::3O|1|TestSample^0.0^1^1||^^^ALL^|R||||||X||||1|||||||||1|F8E

    Host:

    Konelab::4R|1| ^^Ca^0.0|2.3|mmol/l|2.2^2.7^Adult|L||F||||20010502105628|102

    Host:

    Konelab::5L|1|N08

    Host:

    Konelab:

    4) New sample is introduced to Konelab. Konelab send

    request for information of the sample:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||200105021246469F

    Host:

    Konelab:2Q|1| S1234^^||^^^ALL^||||||||O6B

    Host:

    Konelab:3L|1|N06

    Host: Konelab:

    5) The host computer responds:

    Host:

    Konelab:

    Host: 1H|\^&|||60^Host^5.0|||||||P||2001050212470212

    Konelab:

    Host: 2P|1|123456-789A|||LastName

    FirstName|||Adult|||||||||||||||||||||||||C2

    Konelab:

    Host: 3O|1|S1234^3.0||^^^Ca^0.0|R||||||X||||1|||||||||1|Q\O9DKonelab:

    Host: 4L|1|FFF

    Konelab:

    Host:

    Note the reference

    class limit and name

    presentation in R-

    record

    (Min^Max^Name)

    and the 'L'-flag forvalue 2.3 in range

    from 2.2 to 2.7.

    Note that the sample

    has been manually

    diluted with dilution

    1 + 3.0!

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    6) Analysing the sample is completed. Konelab sends the

    results:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||200105021248339D

    Host: Konelab:2P|1|123456-789A|||LastName

    FirstName|||Adult|||||||||||||||||||||||||C2

    Host:

    Konelab:3O|1|S1234^3.0^1^2||^^^ALL^|R||||||X||||1|||||||||1|FAD

    Host:

    Konelab:4R|1| ^^Ca^3.0|9.2|mmol/l|2.2^2.7^Adult|HH||F||||20010502124835|1

    50

    Host:

    Konelab:5L|1|N08

    Host:

    Konelab:

    7) New sample is introduced to Konelab. Communication

    sequence:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||200105021255269D

    Host:

    Konelab:2Q|1| ICU Sample^^|| ^^ALL^||||||||OB1

    Host:

    Konelab:3L|1|N06

    Host: Konelab:

    8) The host computer responds. Communication sequence:

    Host:

    Konelab:

    Host: 1H|\^&|||60^Host^5.0|||||||P||2001050212555115

    Konelab:

    Host: 2P|1|223311-9876|||ICU Patient||||||||||||||||||||||||||||CC

    Konelab:

    Host: 3O|1|ICU

    Sample||^^^ISE.Na^0.0|R||||||X||||1|||||||||1|Q\O0EKonelab:

    Host: 4L|1|FFF

    Konelab:

    Host:

    Note the reference

    class 'HH'-flag in R-

    record.

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    9) Konelab has analysed the sample and sends the results to

    host computer.

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||2001050212561097

    Host: Konelab:2P|1|223311-9876||ICU Patient||||||||||||||||||||||||||||50

    Host:

    Konelab:3O|1|ICU

    Sample^0.0^1^4||^^^ALL^|R||||||X||||1|||||||||1|FF2

    Host:

    Konelab:4R|1| ^^ISE.Na^0.0|9999999.9|mmol/l|^^|>||F||||20010502125556|150

    Host:

    Konelab:5C|1|I|11 Test limit high\15 Calc. error|I29

    Host:

    Konelab:6L|1|N09

    Host:

    Konelab:

    10) New sample is introduced to Konelab. Communication

    sequence:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||200105021252389D

    Host:

    Konelab:2Q|1| SomeSample^ ||^^^ALL^||||||||O44

    Host:

    Konelab:3L|1|N06Host:

    Konelab:

    11) The host computer responds. Communication sequence:

    Host:

    Konelab:

    Host: 1H|\^&|||60^Host^5.0|||||||P||200105021252390B

    Konelab:

    Host: 2P|1|221121-6655|||SomePatient||||||||||||||||||||||||||||54

    Konelab:

    Host:3O|1|SomeSample||^^^TestTest^0.0|R||||||X||||1|||||||||1|Q\O23

    Konelab:

    Host: 4L|1|FFF

    Konelab:

    Host:

    Note the result value of

    9999999.9, which

    represents the maximum

    value for result. This isdue to calculation error

    causing the value to

    reach the maximum

    internal presentation.

    Please check always the

    existence of C-record

    after a R-record for

    error conditions. Note

    also the '>'-flag in R-

    record. This is due to the

    result exceeding the test

    maximum limit.

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    12) The request 'TestTest' is invalid, because Konelab's test

    repertoire does not contain any test with OnlineName

    'TestTest'. Error condition sequence:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||P||2001050212524096Host:

    Konelab:2P|1|221121-6655|||SomePatient||||||||||||||||||||||||||||54

    Host:

    Konelab:3O|1|SomeSample||^^^TestTest^0.0|R||||||C||||1|||||||||1|X6A

    Host:

    Konelab:4C|1|I|E105|G13

    Host:

    Konelab:5L|1|Q0B

    Host:

    Konelab:

    13) Sending of control sample analysis results is enabled and

    Konelab performs Ca analysis on control sample Nortrol.

    Communication sequence:

    Konelab:

    Host:

    Konelab:1H|\ &|||60^1^5.0|||||||Q||2001050213002594

    Host:

    Konelab:2P|1||||||||||||||||||||||||||||||||BF

    Host:

    Konelab:3O|1|Nortrol||^^^Ca^0.0|R||||||Q||||1|||||||||1|C4

    Host: Konelab:4R|1| ^^Ca^0.0|2.3|mmol/l|^^|N||F||||20010502130024|0D4

    Host:

    Konelab:5L|1|N08

    Host:

    Konelab:

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    4. KONELAB / LAS INTERFACE

    The communication interface between Konelab analyser and a Laboratory

    Automation System (LAS) is described in the following sections.

    4.1 HARDWARE INTERFACE

    Communication between the analyser and LAS is performed using standard three-

    wire RS 232- interface. Maximum cable length is 15 meters and the cable should be

    shielded. The pins used in 9-pin male D-connector on analyser side are:

    Signal Pin

    RxD (received data) 2

    TxD (transmitted data) 3

    GND (ground) 5

    Communication parameters are 9600 baud, 8 bit, 1 start bit, 1 stop bit, no parity. No

    hardware or software flow control is used.

    4.2 GENERAL DESCRIPTION

    When debug log is on, all messages between analyser and LAS are recorded to the

    log file C:\Konelab\tmp\ksdebug.txt.

    4.2.1 MESSAGE RECORD FORMAT

    The following abbreviations are used in this document for some special

    communication characters.

    STX 0x02

    ETX 0x03

    ACK 0x06

    NACK 0x15

    Start of transmission (STX) character is used at the beginning of communication

    record and End of transmission (ETX) character is used at the end of communication

    record.

    Each communication record contains checksum. After communication record has

    been received, an acknowledgement is always sent by the analyser or LAS. The

    analyser or LAS sends positive acknowledgement character (ACK), if the checksum

    in message is correct and negative acknowledgement character (NACK), if the

    checksum in message is incorrect. Analyser waits for ACK or NACK up to 1 second.

    If the analyser receives NACK, it tries to re-send the record max two times.

    You can set debug on

    by F8/F1 function in

    the Konelab

    programs

    Management

    window. With the

    same button it is also

    set off.

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    Each communication record contains also field for message length. Message length

    doesnt include STX and ETX characters.

    The general format of a message record is:

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id

    4 - n Message data Optional

    n+1 Checksum

    n+2 ETX

    4.2.2 CALCULATION OF CHECKSUMThe calculation of checksum does not include the STX-character, the checksum itself

    or the ETX-character. The calculation starts with zeroing the checksum. Every

    character of the message is added to the checksum (modulo 256) excluding the above

    mentioned characters and the result is an 8-bit checksum. For example the characters

    in normalAnalyser Status record are 0x02 0x04 0x04 0x00 0x08 0x03, where 0x02

    is the STX-character, 0x04 is the length of message, 0x04 is message id, 0x00 is the

    status, 0x08 is the checksum and 0x03 is the ETX-character.

    The example for calculation of the checksum in C language:

    unsigned char CalculateChecksum( unsigned char * pString, int iNumOfChars )

    {unsigned charucChecksum;

    unsigned charucTemp;

    int iIndex;

    ucChecksum = 0;

    for (iIndex = 0; iIndex < iNumOfChars; iIndex++)

    {

    ucTemp = pString[iIndex];

    ucChecksum = ucChecksum + ucTemp;

    }

    return ucChecksum;

    }

    When calling CalculateChecksum function, pointer pString should point to the

    Message length - field and iNumOfChars variable should contain value Message

    length - 1.

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    4.2.3 SEQUENCE FOR INITIALISING THE

    COMMUNICATION INTERFACE

    When the communication between analyser and LAS is restarted, the initialisation

    sequence described in this chapter has to be performed. Communication is restarted

    every time, when LAS has sentReinitialise communication recordor a fatalcommunication error occurs.

    Analyser starts the initialisation sequence by sendingInitialisation record. Analyser

    sendsInitialisation recordevery 5 seconds as long as LAS responses by sending

    ACK.

    After that LAS sendsAnalyser status query recordto the analyser. Analyser waits

    for this record up to 10 seconds. If the record is received in time, analyser responses

    with ACK and sendsAnalyser status recordto LAS. LAS sends ACK to the analyser

    to finish the initialisation sequence.

    4.2.4 ANALYSER BOOT SEQUENCE

    When analyser has been booted and it is ready to aspirate a sample, it starts listening

    the communication line. LAS can check the connection by sending a status query or

    it can directly start a sample aspiration sequence. If the analyser is down or booting,

    it will not acknowledge the message and LAS can then start the initialisation

    sequence.

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    4.2.5 KUSTI STATES AND ERROR RECOVERY

    Dispensing

    complete status

    Status record status LAS status

    0 ok 0 ok

    1 no freesample

    position

    2 duplicate

    sample id

    3 timeout

    5 short sample

    Free to move tubes and retry aspirate

    sample.

    4 fatal error Not allowed to move sample tubes.

    Re-check status with status query.

    2 out of

    order

    Not allowed to move sample tubes.

    Konelab requires operator actions

    before it will retry aspirate sample.

    6 not in use 3 not in use Allowed to move sample tubes.Konelab requires operator actions

    before it will retry aspirate sample.

    7 busy 1 busy Not allowed to move sample tubes.

    Wait for a couple of seconds and check

    status again.

    When busy response is received from Konelab either as response to status query or

    to aspirate sample command, Konelab is either initializing or recovering from an

    error situation. This is a temporary state and LAS should start polling with status

    query (or aspirate sample command) until status value other than busy is received.

    Typically this will take 10-20 seconds and shouldnt take more than a minute. Until

    then sample tubes must not be moved as KUSTI dispenser may be extended at the

    LAS position. If status value ready is received, the recovery was successful and

    another aspirate sample command may be sent. If the recovery was unsuccessful,

    status out of order or not in use is returned.

    Konelab does not automatically try to recover from states out of order or not in

    use.

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    The diagram below explains the possible states and transitions of the Konelab LAS

    interface and when LAS is allowed to move sample tubes.

    State Status response Aspirate response

    1 0 (ready) starts dispensing

    2 1 (busy) protocol error

    3 1 (busy) 7 (busy)

    4 2 (out of order) 4 (fatal error)

    5 3 (not in use) 6 ( not in use)

    1. Analyser is ready for sample aspiration

    LAS status : moving allowed

    analyzer status: ok

    2. Analyser is busy

    LAS status : moving not allowed

    analyzer status: ok

    4. Analyser has fatal error situationLAS status : moving not allowed

    analyzer status: not ok

    5. Analyser not inuseLAS status : moving allowed

    analyzer status: not ok

    ASPIRATE

    SAMPLE

    RECORD

    sended

    SAMPLE DISPENSING

    COMPLETE

    RECORD,

    status=0,1,2,3 or 5

    received

    SAMPLE DISPENSING

    COMPLETE

    RECORD,

    status=4 or 7

    received

    3. Fatal error when aspiration

    LAS status : moving not allowed

    analyzer status: unknown

    ANALYSER STATUS

    RECORD,

    status=3 (not in use)

    received

    ANALYSER STATUS

    RECORD,

    status=2 (fatal error)

    received

    ANALYSER STATUS

    RECORD,

    status=0 (ok)

    received

    ANALYSER STATUS

    RECORD,

    status=0 (ok)

    received

    ANALYSER STATUS

    RECORD,

    status=0 (ok)

    received

    SAMPLE DISPENSING

    COMPLETE

    RECORD,

    status=6 (not in use)

    received

    ANALYSER STATUS

    RECORD,

    status=1(busy)

    received

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    4.3 COMMUNICATION RECORDS

    4.3.1 INITIALISATION RECORD

    This record in sent by analyser to inform LAS, that analyser is ready to start thecommunication.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x01)

    4 Checksum

    5 ETX

    4.3.2 ILLEGAL COMMAND RECORD

    This record in sent by analyser or LAS to inform that data of the received message

    has not been valid.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x02)

    4 Error type 0x00 = message id not valid0x01 = unexpected record

    0x02 = invalid message data

    5 Error info1 Message id in received

    message

    6 Error info2 0x00 = no additional

    information

    0x01 = invalid sample id

    7 Checksum

    8 ETX

    4.3.3 ANALYSER STATUS QUERY RECORD

    This record in sent by LAS to ask the status of the analyser. LAS can send this record

    at any time after the initialisation sequence has been successfully performed.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x03)

    4 Checksum

    5 ETX

    Note! All the fields

    in the records, that

    are not used, should

    be set to 0x00.

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    4.3.4 ANALYSER STATUS RECORD

    This record in sent by the analyser as a response toAnalyser status query record.

    Byte Field Comment

    1 STX2 Message length

    3 Message id (0x04)

    4 Status 0x00 = analyser is ready for

    sample aspiration

    0x01 = analyser is busy (i.e.

    initialising or dispensing

    sample). Sample tubes may not

    be moved.

    0x02 = analyser has fatal error

    situation and sample aspiration

    cant be performed. Sample

    tubes may not be moved.

    0x03 = analyser is not in use and

    sample aspiration cant be

    performed. Sample tubes may be

    moved.

    5 Checksum

    6 ETX

    4.3.5 ASPIRATE SAMPLE RECORDThis record in sent by LAS to inform that theres a sample to be aspirated.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x05)

    4 Sample tube type 0x00 (Not used at the moment)

    5 Sample ID length

    6 n Sample ID Maximum length of sample ID is16 characters

    n+1 Checksum

    n+2 ETX

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    4.3.6 SAMPLE DISPENSING COMPLETE

    RECORD

    This record in sent by the analyser to inform the LAS, that sample dispensing is

    completed. If Status- field in the message is not 0, the sample dispensing hasnt been

    performed successfully.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x06)

    4 Status 0x00 = OK

    0x01 = No empty sample

    positions in the sample disk for

    sample dispensing

    0x02 = Duplicate sample id

    0x03 = Timeout in sample

    dispensing

    0x04 = Analyser couldnt

    perform operation due to a fatal

    error situation. Sample tubes

    may not be moved.

    0x05 = Not enough sample

    found in sample tube

    0x06 = Analyser not in use and

    sample aspiration cant be

    performed. Sample tubes may be

    moved.0x07 = Analyser is busy and

    sample aspiration cant be

    performed. Sample tubes may

    not be moved.

    5 Sample ID length

    6 n Sample ID Maximum length of sample ID is

    16 characters

    n+1 Checksum

    n+2 ETX

    4.3.7 REINITIALISE COMMUNICATION

    RECORD

    This record in sent by the LAS to reinitialise the communication.

    Byte Field Comment

    1 STX

    2 Message length

    3 Message id (0x07)

    4 Checksum

    5 ETX

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    4.4 COMMUNICATION EXAMPLES

    4.4.1 INITIALISATION SEQUENCE

    LAS ANALYSER

    Initialisation record

    5 s timeout

    Initialisation record

    ACK

    Max 10 s

    Status query recordACK

    Status Record

    ACK

    4.4.2 SAMPLE ASPIRATION SEQUENCE FOR

    TWO SAMPLES

    LAS ANALYSER

    Aspirate sample record

    ACK

    Sample dispensing complete record

    ACK

    Aspirate sample record

    ACK

    Sample dispensing complete record

    ACK

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    4.4.3 SAMPLE ASPIRATION FAILS, RECOVERY

    SUCCESSFUL 1

    LAS ANALYSER

    Aspirate sample recordACK

    sample dispensing complete

    record

    status = FATAL ERROR

    ACK

    wait 10 s

    Status query record

    ACK

    status recordstatus = BUSY

    ACK

    wait 10 s

    Status query record

    ACK

    status record

    status = BUSY

    ACK

    wait 10 s

    Status query record

    ACK

    status record

    status = READY

    ACK

    Aspirate sample record ACK

    sample dispensing complete

    record

    status = OK

    ACK

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    4.4.4 SAMPLE ASPIRATION FAILS, RECOVERY

    SUCCESSFUL 2

    LAS ANALYSER

    Aspirate sample recordACK

    sample dispensing complete

    record

    status = FATAL ERROR

    ACK

    wait 10 s

    Aspirate sample record

    ACK

    sample dispensing completerecord

    status = BUSY

    ACK

    wait 10 s

    Aspirate sample record

    ACK

    sample dispensing complete

    record

    status = BUSY

    ACK

    wait 10 s

    Aspirate sample record

    ACK

    sample dispensing complete

    record

    status = OK

    ACK

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    4.4.5 SAMPLE ASPIRATION FAILS, RECOVERY

    UNSUCCESSFUL

    LAS ANALYSER

    Aspirate sample recordACK

    Sample dispensing complete

    record

    Status = FATAL ERROR

    ACK

    wait 10 s

    Status query record

    ACK

    Status recordStatus = BUSY

    ACK

    wait 10 s

    Status query record

    ACK

    Status record

    Status = BUSY

    ACK

    wait 10 s

    Status query record

    ACK

    Status record

    Status = NOT IN USE or

    Status = OUT OF ORDER

    ACK

    Error message to operator,

    cannot recover automatically