Miura - Host Interface Manual [PDF]

Zitiervorschau

I.S.E. – Sistemi Intelligenti Elettronici

Miura

Instrumentation Series

Random Access Autoanalyzers

L.I.S. Connection – Technical Manual

I.S.E. S.r.l. – Italy Rome

MNT-10910-01-B Rev.A ENG

MIURA Instrumentation Series L.I.S. Connection – Technical Manual

i.1

Identification Data

This document applies to the MIURA Series instrument family, Random Access direct reading automated laboratory analyzers for Clinical Chemistry. Refer to the proper instrument User Manual for the detailed operation and handling.

i.1.1 • • •

i.1.2 • • •

i.1.3 •

i.2

Document Codice del documento: Revisione del documento: Data di revisione:

MNT-10910-01-B B 23 Aprile 2008

Instrument MIURA: MIURA 200: MIURA 100:

p/n 10001-xx-A (xx=version) p/n 10674-xx-A (xx=version) p/n 10750-xx-A (xx=version)

Producer I.S.E. S.r.l. Via delle Driadi, 45 00133 Roma – Italy Phone: +39 06 20610289 Fax: +39 06 2018131 E-mail: [email protected] WEB: www.logotech-ise.com

Copyright

The content of this document, the pictures, the tables and the graphics included, is intellectual property of I.S.E. S.r.l. Unauthorized copies, total or partial, could cause legal actions in order to preserve owner’s interests.

i.3

Purpose of This Document

This document defines and states the communication protocol used for the instrument connection to the Laboratory Information System (L.I.S.). It is addressed to technical personnel expert at Laboratory Information Systems setting up and programming.

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i.4 AD FW HW L.I.S. SW TBD TBC TBV

Definitions, Acronyms ed Abbreviations Applicable Document Firmware Hardware Laboratory Information System Software To Be Defined To Be Confirmed To Be Verified

i.5

Documentation

i.5.1

Applicable Documents

The proper MIURA Instrument User Manual.

i.5.2

Reference Documents

NCCLS, code LIS02-A2, Vol.24 Nr.33 “Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition”. ASTM, code E1381-02 “Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems”. IEEE, 802.3 “Carrier sense multiple access with collision detection (CSMA/CD) access method and physical layer specifications”. ANSI, X3.15-1976 “Bit sequencing of the code for information interchange in serial by bit data transmission (with ANSI X3.15-1976)” ANSI, X3.16-1976 “Character structure & character parity sense for serial by bit data communication in the code for information interchange (with ANSI X3.16-1976/R1983)”.

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i.6

List of Contents

i.1 Identification Data .....................................................................................................2 i.1.1 Document ................................................................................................................2 i.1.2 Instrument.................................................................................................................2 i.1.3 Producer...................................................................................................................2 i.2 Copyright .....................................................................................................................2 i.3 Purpose of This Document.........................................................................................2 i.4 Definitions, Acronyms ed Abbreviations .................................................................3 i.5 Documentation ..........................................................................................................3 i.5.1 Applicable Documents..........................................................................................3 i.5.2 Reference Documents...........................................................................................3 i.6 List of Contents............................................................................................................4 1. General ........................................................................................................................5 2. System Configuration.................................................................................................5 3. Structure of This Document .......................................................................................6 3.1. Communication Physical Layer............................................................................6 3.2. Communication Level 1 ........................................................................................7 3.2.1. Connection Establishing Phase .....................................................................7 3.2.2. Conflict Resolution Phase...............................................................................7 3.2.3. Data Transfer Phase ........................................................................................7 3.3. Application Level....................................................................................................9 3.3.1. Header Message .......................................................................................... 10 3.3.2. PatientInformation Message ...................................................................... 11 TestOrder Message....................................................................................... 13 3.3.3. 3.3.4. Result Message ............................................................................................. 16 3.3.5. Terminator Message..................................................................................... 18 3.3.6. RequestInformation Message..................................................................... 19 3.4. Communication Scenarios................................................................................. 20 3.4.1. Analysis Request – Communication Sequence....................................... 21 3.4.2. Analysis Results Request – Communication Sequence.......................... 22

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1.

General

This document describes the electronic transmission of digital data information between a laboratory instrument and an information computer system. In particular, in the following of this document the data exchange protocol has been exposed and the connection schematic between the MIURA instrument (in the following called Autoanalyzer) and the Host Computer (part of the Laboratory Information System - in the following called Host) has been shown. This kind of connection allows the “Autoanalyzer to/from Host” bi-directional communication to improve automation in data request transmission (i.e.: work-lists and patient data) and in patient final results data response. This document finally defines the digital message structure allowing the data transfer between Autoanalyzer and Host.

2.

System Configuration

The communication between the Miura System and the external Host is compliant to the IEEE 802.3 standard, that regulates the most common local area network (LAN) technology based on Ethernet standard. The Miura System Personal Computer is then provided with an internal network interface (Ethernet interface); it is linked to the laboratory information local area network through a Hub or through a Switch Hub the connects several other stations for communication purposes. The Host Computer is obviously part of the same network and it is connected in the same manner. The following picture shows the functional diagram of connection.

MIURA FAMILY INSTRUMENT

RS-232C

MIURA PC

HUB

HOST PC

MIURA SYSTEM AUTOANALYZER

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3.

Structure of This Document

This document describes the electronic transmission of digital data. It includes four main parts: 1. Communication Physical Layer 2. Communication Level 1 3. Application Level 4. Communication Scenarios.

3.1.

Communication Physical Layer

The electrical connection for TCP/IP data transmission between the instrument and the L.I.S. Host Computer has been described in the following. The type of connection is not one-to-one (i.e.: Autoanalyzer-to-Host direct connection), but a network central hub can be used. Electrical voltage levels are compliant to the IEEE 802.3 standard. The transmission exchange method is TCP/IP. The bit sequence, the transmitted character structure and the parity check are compliant to the ANSI X3.15-1976 and X3.16-1976 standards. The transmission speed (in accordance with IEEE 802.3) is at least 10MB/sec. The TCP/IP computer port used for the connection is 4000. The Host Computer: • must get in connection, • must run a “connect TCP/IP”, to the IP address assigned from the network administrator to the MIURA System, directly on the 4000 port, • on that port the MIURA Software is listening and ready to communicate.

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3.2.

Communication Level 1

This level must guarantee the connection procedure carrying out, the outflow, the sequence control, the error detection and recovering. This communication level makes use of a protocol based on ASCII character coding. The information, in a defined moment, transfers in one direction only (one communication element becomes “sender” the other one “receiver”) with the message confirmation by the side of the receiver. During the information transfer can be identified three different phases: 1. Connection establishing phase; 2. Conflict resolution phase; 3. Data transfer phase. Those phases have been exposed in the following paragraphs.

3.2.1.

Connection Establishing Phase

The “sender” notifies the “receiver” the need to transmit data by sending a to the receiver. The receiver answers with in order to confirm the availability to receive data . In that case the Data transfer phase can start. On the other hand, in the event that the receiver answers , the sender must wait at least 10 seconds prior to try again to connect. NOTE: during this phase the receiver can only receive , e . Other messages are ignored.

3.2.2.

Conflict Resolution Phase

If the receiver gets as the answer to its previous request, the autoanalyzer (the instrument) has the priority to transmit data informations. The Host Computer (L.I.S.) cannot send other messages and must wait for the next coming from the autoanalyzer. In this case it must answer and must become receiver. The instrument must wait a minimum time of 1 second prior to transmit the second .

3.2.3.

Data Transfer Phase

Messages are transmitted in “blocks”. Each block can contain 64,000 character at most (including: header, crc, …). The block structure has been described in the following table:

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Chracters

FN text

C1 C2

Description Start of text Block number Message content End of text Checksum Most Significant character Checksum Last Significant character Carriage return Line Feed

Value 12H ‘0’-‘7’ 13H ‘0’-‘9’ o ‘A’-‘F’ ‘0’-‘9’ o ‘A’-‘F’ 0DH 0AH

The block number hallows the receiver to recognize the block that have been retransmitted. This number is sent as an ASCII character and it is increased for each message (the number “7” is followed by the number “0”). The checksum allows the receiver to recognize a message that has not been correctly received. The checksum can be calculated as the arithmetic sum of all received bytes without carry-over (the calculation doesn’t take into consideration: , the checksum characters and the final and ). The data transfer phase is terminated with the message (End of Text) whose value is: 04 hexadecimal (HEX).

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3.3.

Application Level

The list of message that can be sent has been shown in the following table: Message Description Code Header Defins fields delimiter ’H’ PatientInformation Information about the patient ‘P’ TestOrder Request of analysis ‘O’ Result Results ‘R’ Terminator End of data transmission ‘L’ RequestInformation Request of results ‘Q’ All fields related to the messages described in the following of this document must always be present in order to allow the correct interpretation of the messages themselves. The fields the actually have no meaning for the MIURA System can be “nul value”, that means: no character is send in between the headers. Note – In the following Message Description Tables, the column MS (Miura Sensitive) can get the following values: • “N” - needed field - the field itself must have a value different from nul • “O” - option field – the field itself can have any value (as well as nul) because it is not used. Note: In the following Message Description Tables, the column “L” defines the message length for the fixed length fields. No value is inserted for the fields that have no fixed length.

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3.3.1.

Header Message Field

RecordTypeID DelimiterDefinition

MessageControlID AccessPassword SenderID SenderStreetAddress ReservedField SenderTelephoneNumber CharacteristicsOfSender ReceiverID Comment ProcessingID

Description Message Identifier Delimiter definitions

L

Values

1 ‘H’ 4 Field delimiter

VersionNumber DateAndTimeOfMessage

I

Repet delimiter

\

Component delimiter

^

Escape delimiter

&

“Miura”

Message interpretation mode (P-production)

MS

1 ‘P’

7 “LIS2-A2” 14 Format: YYYYMMDDHHMMSS

N N

O O O O O O O O O N

N N

Where: Field delimiter = vertical bar (|) Latin-1(124) Repeat delimiter = backslash (\) Latin-1(96) Component delimiter = caret (^) Latin-1(94) Escape delimiter = ampersand (&) Latin-1(38).

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3.3.2.

PatientInformation Message Field

RecordTypeID SequenceNumber

Description Message Identifier Message sequence number

PracticeAssignedPatientID LaboratoryAssignedPatientI Patient Barcode D PatientIDNumber3 PatientName Patient Name MotherMaidenName Birthdate PatientSex PatientRaceOrEthnicOrigin

PatientAddress ReservedField PatientTelephoneNumber AttendingPhysicianID SpecialField1 SpecialField2 PatientHeight PatientWeight PatientKnownOrSuspected Diagnosis PatientActiveMedications PatientDiet PracticeFieldNumber1 PracticeFieldNumber2 AdmissionAndDischargeD ates AdmissionStatus

Location NatureOfAlternativeDiagn osticCodeAndClassifiers AlternativeDiagnosticCod eAndClassification PatientReligion

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L

Values

1 ‘P’

MS N N O N

Surname ^ Name 8 Fomat: YYYYMMDD 1 M, F, or U W - white B - black O - Asian/Pacific Islander NA - Native American/Alaskan Native H - Hispanic

O N N N O

O O O O O O O O O O O O O O OP - outpatient PA - preadmit IP - inpatient ER - emergency room

O

O O O P - Protestant

O

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Field

MaritalStatus

IsolationStatus

Language HospitalService HospitalInstitution DosageCategory

Location

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Description

L

Values C - Catholic M - Church of the Latter Day Saints (Mormon) J - Jewish L - Lutheran H - Hindu M - married S - single D - divorced W - widowed A - separated ARP - antibiotic resistance precautions BP - blood and needle precautions ENP - enteric precautions NP - precautions for neutropenic patient PWP - precautions for pregnant women RI - respiratory isolation SE - secretion/excretion precautions SI - strict isolation WSP - wound and skin precautions

A - ADULT, P1 - PEDIATRIC (one to six months), P2 - PEDIATRIC (six months to three years)

MS

O

O

O O O N

O

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3.3.3.

TestOrder Message

In this message the field UniversalTestID contains the necessary information to identify the test to be run. It is composed by four elements delimited by the character “^” (component delimiter). The first and the third elements are actually not used. The second element (barcode_test) is the barcode associated to the method to be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by the Miura system). See Note below to identify the value to assign to that field. The last element (dil) symbolizes the code for the sample dilution ratio to be used during the test execution. Note: The Miura system generates automatically a file listing all of the methods stored, any time that the operator saves or deletes a method. This file over-writes the previous older one. This files is exported into a special folder for user handling; it can be copied on a media or accessed by the Host computer when the MIURA managing PC has been connected into a LAN. In case that the MIURA PC has been included into a LAN, the “MethodList” folder must be “shared” in network in order to allow an host computer to download and treat the file itself. The exported file is named method.csv (with delimiter “;”). IT IS VERY IMPORTANT TO ACCES THIS FILE ANY TIME A NEW METHOD IS ADDED IN ORDER TO UPDATE THE METHOD LIST. This file gives the association between methods and their Id Code. This file is created every time a method is saved and over-writes the last one. Location: %ProgramRoot% \ MethodList File name: methods.csv File Structure Format: Record delimiter character: ascii code 10 (Line Feed) Record Field delimiter: ascii code 59 (‘;’) Record fields: Method Name Method Method Method Acronym Barcode Internal Index Fields meaning: • Method Name: • Method Acronym: • Method Barcode: •

Method Internal Index:

name given to the analysis method acronym given to the analysis method. identification barcode of the analysis method (placed on the reagent bottle). Associate this value to the second element of UniversalTestID. identification code of the analysis method.

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Field RecordTypeID SequenceNumber SpecimenID InstrumentSpecimenID UniversalTestID Priority

Description Message Identifier Message sequence number Patient Barcode Identification if the test method to be run Request priority

RequestedDateAndTime SpecimenCollectionDateA ndTime CollectionEndTime CollectionVolume CollectorID ActionCode

L

Values

MS

1 ‘O’

N N O N N

^barcode_test^^dil

N

1 S stat A as soon as possible R routine C callback P preoperative Format: YYYYMMDDHHMMSS

N O O O O N

1 C cancel request for the battery or tests named A add the requested tests or batteries to the existing specimen with the patient and specimen N new requests accompanying a new specimen P pending specimen X specimen or test already in process Q treat specimen as a Q/C test specimen

DangerCode RelevantClinicalInformation DateTimeSpecimenReceiv ed SpecimenDescriptor OrderingPhysician UserFieldNumber1 I.S.E. S.r.l. – Sistemi Intelligenti Elettronici MNT-10910-01-B Rev.B ENG

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Field UserFieldNumber2 LaboratoryFieldNumber1 LaboratoryFieldNumber2 DateTimeResultsReportedO rLastModified InstrumentChargeToInform ationSystem InstrumentSectionID ReportTypes ReservedField LocationOfSpecimenColle ction NosocomialInfectionFlag SpecimenService SpecimenInstitution

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Description

L

Values

MS O O O O O

1 O order record; user asking that analysis be performed

O N O O O O O

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3.3.4.

Result Message

In this message the field UniversalTestID contains the necessary information to identify the test and the patient whose result is transmitted. It is composed by four elements delimited by the character “^” (component delimiter). The first and the third elements are actually not used. The second element (barcode_test) is the barcode associated to the method to be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by the Miura system). The last element (barcode_paziente) symbolizes the code associated to the patient. Field RecordTypeID SequenceNumber

Description Message Identifier Message sequence number

UniversalTestID DataOrMeasurementValue Result value, in float format (i.e.: 23.354) Units Measurement Unit (text containing the used measurement unit) ReferenceRanges Reference values, in format: min-max (i.e.: 0.2-3.45) ResultAbnormalFlags

L

Values

1 ‘R’

MS N N

^barcode_test^^barcode_paz N iente N N

min-max

N

L below low normal

N

H above high normal LL below panic normal HH above panic high N normal A abnormal NatureOfAbnormalityTestin g

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O

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Field

Description

ResultStatus

L

Values

1 F final results

MS N

X order cannot be done I in instrument, results pending

DateOfChangeInInstrumen Standard, execution tNormativeValuesOrUnits date OperatorIdentification DateTimeTestStarted DateTimeTestCompleted InstrumentIdentification

“Miura”

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W Warning: Validity is questionable 14 Format: YYYYMMDDHHMMSS

14 Format: YYYYMMDDHHMMSS

O O O N N

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3.3.5.

Terminator Message Field

RecordTypeID SequenceNumber TerminationCode

Description Message Identifier

L

Values

1 ‘L’ 1 N normal termination

MS N N N

T sender aborted R receiver requested abort E unknown system error Q error in last request for information I no information available from last query F last request for information processed

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3.3.6.

RequestInformation Message

In this message the field UniversalTestID contains the necessary information to identify the test whose result has been requested. It is composed by four elements delimited by the character “^” (component delimiter). The first, the third and the fourth elements are actually not used. The second element (barcode_test) is the barcode associated to the method to be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by the Miura system). If this field is empty, it means that all results obtained for the patient identified by the barcode paziente have been requested. If the patient barcode field is empty, it means that all results obtained for the method identified by the field UniversalTestID have been requested. Field

Description

RecordTypeID Message Identifier SequenceNumber StartingRangeIDNumber Patient Identifier EndingRangeIDNumber UniversalTestID NatureOfRequestTimeLimits BeginningRequestResultsDa teAndTime EndingRequestResultsDate AndTime RequestingPhysicianName RequestingPhysicianTeleph oneNumber UserFieldNumber1 UserFieldNumber2 RequestInformationStatusC odes

L

Values

1 ‘Q’ Barcode paziente ^barcode_test ^^

MS N N N O N O O O O O

P preliminary results

O O N

F final results X results cannot be done, request cancelled

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3.4.

Communication Scenarios

In the following sub-paragraphs the communication scenarios under functional block form have been shown in sequence.

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3.4.1.

Analysis Request – Communication Sequence

L.I.S.

MIURA

MIURA L.I.S. Server

Communication request with positive feedback

PatientInfo Patient Info

TestOrder Add analysis

Terminator End of transaction



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3.4.2.

Analysis Results Request – Communication Sequence

L.I.S.

MIURA

MIURA L.I.S. Server

Communication request with positive feedback

RequestInfo

Result

Query over results

Data formatting

Terminator



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