UTF-8'en'QL ASTM Protocol

ASTM communication protocol QUANTA Link™

ASTM communication protocol

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Index

1. INTRODUCTION ..................................................................................................................... 3

2. REFERENCES .......................................................................................................................... 3

3. LOW LEVEL PROTOCOL .......................................................................................................... 3

4. PHYSICAL LAYER ................................................................................................................... 3

4.1. DATA LINK LAYER......................................................................................................................... 3 4.1.1. Establishment Phase ......................................................................................................... 4 4.1.2. Transfer Phase ................................................................................................................. 5 4.1.3. Termination Phase ............................................................................................................ 5 4.1.4. Error Recovery .................................................................................................................. 5 4.1.5. Restrictions ...................................................................................................................... 6

5. HIGH LEVEL PROTOCOL ........................................................................................................ 6

5.1. MESSAGE SPECIAL CHARACTERS ........................................................................................................ 7 5.2. DATA RECORD USAGE ..................................................................................................................... 7

5.2.1. Message Header Record .................................................................................................... 7 5.2.2. Patient Identifying Record.................................................................................................. 8 5.2.3. Test Order Record ........................................................................................................... 10 5.2.4. Result Record ................................................................................................................. 11 5.2.5. Comment Record ............................................................................................................ 12 5.2.6. Scientific Record ............................................................................................................. 13 5.2.7. Manufacturer Information Record ..................................................................................... 13 5.2.8. Message Terminator Record ............................................................................................. 13

ANEX I. MESSAGES EXAMPLES .............................................................................................. 14


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1. Introduction

This document describes the standard Instrument Interface for Quanta Link. The interface is based in ASTM standards E 1381 91 and E 1394 91. Covers low level protocol (physical and data link layer) and high level protocol.

The following lines are all the available messages between Quanta Link and the instrument:

New Requests from HOST to Quanta Link. (T requests) Results from Quanta Link to HOST.

2. References

Low level Protocol: As specified in ASTM standard E 1381 91 High level Protocol: As specified in ASTM standard E 1394 91

3. Low level protocol

This section provides information on the low-level implementation of the ASTM low-level protocol in Quanta Link communication.

4. Physical Layer

Quanta Link allows asynchronous Network connections via TCP/IP Sockets, acting as a server. The communication is permanent and not only established when there are messages to send.

Quanta Link will be listening in a specific IP address and Port. The IP address and Port will be defined during the phase of implantation of the system in the specific customer. It is possible to test the system via Internet.

4.1. Data Link Layer

The data link layer uses a character-oriented protocol to send message between directly connected systems. The data link mode of operation is one-way transfer of information with alternate supervision. Information flows in one direction at a time. It is a simplex stop-and-wait protocol.

It specifies procedures for link connection and release (establish which system sends and which receives), delimiting and synchronism (framing of data and recognition of frames), sequence control (sequential order of information across the connection), error detection and error recovery (by retransmitting defective frames or returning the link to a neutral state).

There are three phases to assure the actions of sender and receiver are coordinated. The three phases are establishment, transfer and termination.


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4.1.1. Establishment Phase

After the sender determines the data link is in neutral state, it transmits the <ENQ> transmission control character to the intended receiver.

Upon receiving the <ENQ>, the receiver prepares to receive information. All other characters are ignored. It replies with the <ACK> transmission control character signifying it is ready. At this point the establishment phase ends and the transfer phase begins.

A receiver that cannot immediately receive information replies with the <NAK> transmission control character.

Upon receiving <NAK>, the sender must wait at least 10 seconds before transmitting another <ENQ>.

In case of contention (both systems simultaneously transmit an <ENQ>) Quanta Link has priority to transmit information.


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4.1.2. Transfer Phase

During the transfer phase, the sender transmits messages to the receiver. Messages are sent in frames that contain a maximum of 247 characters (7 for control and 240 for the message itself). Messages longer than 240 characters are divided between two or more frame. So there are two type of frames, Intermediate and End.

Each frame starts with the <STX> character and a frame number that is a digit ranging from 0 to

7. The frame number begins with 1 with the first frame and it is incremented by one for every new frame, rolling over to 0 after 7. This number permits the receiver to distinguish between new and

retransmitted frames.

The checksum permits the receiver to detect a defective frame, and is encoded as two characters

that are sent after the <ETB> or <ETX>. The computation for the checksum does not include <STX>, the checksum characters, or the trailing <CR> and <LF>. Each other characters are

added to the checksum modulo 256. The checksum is an integer represented by eight bits that can

be considered as two groups of four bits. Each group is converted to the ASCII character of the hexadecimal representation. The two characters are transmitted as the checksum.

After a frame is sent, the sender stops the transmission until a reply is received. The receiver can reply with:

<ACK> that signifies that the last frame was received successfully

<NAK> that signifies that the last frame was not successfully

<EOT> that signifies that the last frame was received successfully but the receiver is requesting to stop the transmitting. Its not mandatory to stop the transmission, but if the sender chooses to honor the receiver interrupt request, it must first enter the termination phase to return the data link to the neutral state, giving the receiver an opportunity to enter the establishment phase and become a sender. The original sender must not enter the establishment phase for at least 15 seconds or until the receiver has sent a message and returned the data link to the neutral state.

4.1.3. Termination Phase

The termination phase returns the data link to the neutral state. The sender notifies the receiver that all messages have been sent.

The sender transmits the <EOT> control character and then regards the data link to be in a neutral state. Upon receiving <EOT>, the receiver also regards the data link to be in neutral state.

4.1.4. Error Recovery

4.1.4.1. Defective Frames

The receiver reply <NAK> for invalid frames. Upon receiving a <NAK> the sender increments a retransmission counter and retransmits the last frame with the same frame number. If this counter shows a single frame was sent and not accepted six times, the sender must abort the message by proceeding to the termination phase.

4.1.4.2. Timeouts

Timers provide a method for recovery if the communication line or other device fails to respond.

Timeouts during the establishment phase:


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The sender sets a timer when transmitting the <ENQ>. If a reply of <ACK>, <NAK>, or <ENQ> is not received within 15 seconds, a timeout occurs. After a timeout, the sender enters the termination phase.

In case of contention (both systems simultaneously transmit an <ENQ>), if the computer (as receiver) sets a timer. If an <ENQ> is not received within 20 seconds, a timeout occurs. After a timeout, the receiver regards the line to be in neutral state.

Timeouts during the transfer phase:

The sender sets a timer when transmitting the last character of a frame. If a reply is not received within 15 seconds a timeout occurs. After a timeout, the sender enters the termination phase.

The receiver sets a timer when first entering the transfer phase or when replying to a frame. If a frame or <EOT> is not received within 30 seconds, a timeout occurs. After a timeout, the receiver regards the line to be in neutral state.

4.1.5. Restrictions

The data link protocol is designed for sending character based message text. Restrictions are placed on which characters may appear in the message text. The restrictions make it simpler for senders and receivers to recognize replies and frame delimiters. Additional characters are restricted to avoid interfering with software controls for devices such as multiplexes.

A <LF> character is not permitted to appear in the message text; it can appear only as the last character of a frame.

None of the ten transmission control characters, the <LF> format effect or control character, or four device control characters may appear in message text. The restricted characters are: <SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>, <DC2>, <DC3>, and <DC4>.

5. HIGH LEVEL PROTOCOL

This standard covers the two-way digital transmission of remote requests and results between Quanta Link and another system. This standard specifies the conventions for structuring the content of the message and for representing the data elements within those structures.

Message may contain one or more request/results for one or more patient. Tests may be requested as groups of many individual tests. These groups are referred to as batteries

Messages consist of a hierarchy of records of various types. Records at level zero contain information pertaining to the sender identification and completion of transmission. Records at level one of the hierarchy contain information about individual patients. Records at level two contain information about test order requests and specimens. Records at level three contain information about test results.

The smallest element of information in any record is the field.


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5.1. Message special characters

All data shall be represented as eight bit values, within the range (0-255). Within text data fields, only the ASCII characters 32-126 and the undefined characters 128-254 are permitted. Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. For our purpose, the following delimiters will be always used:

Delimiter Character

Record delimiter Carriage return (ASCII 13)

Field delimiter Vertical bar (|)

Repeat delimiter Backslash (\)

Component delimiter Caret (^)

Escape delimiter Ampersand (&)

A null value for a field does not overwrite existing data in the receiving system. A field containing only a pair of double quotes (ASCII 32) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.

5.2. Data record usage

Data shall be exchanged in records of different types. The Following is a list of records when transmitting:

from HOST to Quanta Link: 1. Header Record (H) 2. Patient Information Record (P) 3. Test Order Record (O) 4. Terminator Record (L)

from Quanta Link to HOST: 1. Header Record (H) 2. Patient Information Record (P) 3. Test Order Record (O) 4. Result Record (R) 5. Results Comment Record (C) 6. Terminator Record (L)

Each record is introduced by field identifying the record type, and terminated by carriage return.

5.2.1. Message Header Record

Is a level 0 record and must always be the first record in the transmission. It contains identifier of both the sender and the receiver.

ASTM Field

ASTM Field Name Received from Host

Transmitted to Host

Description

1 Record Type * * H

2 Delimiters Definition * * Always the standard "|\^&"

3 Message Control ID Ignored

4 Access Password Ignored

5 Sender Name or ID Ignored when received.

Quanta Link always sends


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ASTM Field


Transmitted to Host

Description

"Quanta Link"

6 Sender Street Address Ignored

7 Reserved Field Ignored

8 Sender Phone Number Ignored

9 Characteristics of Sender Ignored

10 Receiver ID Ignored when received.

Quanta Link always sends the text "DMS"

11 Comment or Special Ins Ignored

12 Processing ID * * Always assumed "P" when

received. Quanta Link always sends "P"

13 Version Number * * Ignored when received. Quanta Link always sends the

text "1.0"

14 Message Date and Time * * In standard format YYYYMMDDHHMMSS

Example:

H|\^&|||Quanta Link|||||DMS||P|1.0|19990213134530<CR>

5.2.2. Patient Identifying Record

Is a level 1 record and each line of the patient record shall begin with a record type and end with carriage return.

ASTM Field


Transmitted to Host

Description

1 Record Type * * P

2 Sequence Number * * Sequence number of the patient transmitted.

3 Practice Assigned Patient ID * * Request Label

4 Laboratory Assigned Patient ID * External ID

5 Patient ID No. 3 * NTS^SSNÎDENTITYCARD

6 Patient Name * * Surname^Name

7 Mother’s Maiden Name Ignored

8 Birthdate * Birthdate (YYYYMMDDhhmmss)

9 Patient Sex * M for male, F for female or U for unknown

10 Patient Race Ignored

11 Patient Address * Adress^City^State



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ASTM Field


Transmitted to Host

Description

13 Patient Telephone * Telephone

14 Attending Physician ID * Doctor

15 Special Field 1 * Admitted o Cited o Urgent

16 Special Field 2 * Status Patient

17 Patient Height Ignored

18 Patient Weight Ignored

19 Patient Diagnosis * Diagnosis

20 Patient Medications Ignored

21 Patient Diet Ignored

22 Practice Field No. 1 Ignored

23 Practice Field No. 2 * Comments

24 Admission and Discharge Dates

Ignored

25 Admission Status Ignored

26 Location * Location

27 Nature of Alt.Diag.Code & Class

Ignored

28 Alternative Diagnostic Code

and Classification

Ignored

29 Patient Religion Ignored

30 Marital Status Ignored

31 Isolation Status Ignored

32 Language Ignored

33 Hospital Service * ServiceID

34 Hospital Institution * DestinationCode

35 Dosage Category Ignored

Example:

P|1|00095020|28269|123456^1234567^12345678|SURNAME^NAME||19701010120000|M||ADRESS^CITY^STATE||6297471 71|Doctor 1|ICU||||d1||||comments|||Location|||||||Service 1||<CR>


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5.2.3. Test Order Record

Is a level 2 record and defines the attributes of a particular request for a clinical instrument's services and contains all specimen information

ASTM Field


Transmitted to Host

Description

1 Record Type * * O

2 Sequence Number * * Sequence number of the test order transmitted.

3 Specimen ID * * Request Label

4 Instrument Specimen ID Ignored

5 Universal Test ID * * ^^^TestCode for ELISA tests

^^^TestCode^Dillution for IFA tests

6 Priority * * R / S (Routine / Stat)

7 Requested Date and Time * * Request Date (YYYYMMDDhhmmss)

8 Collection Date and Time Ignored

9 Collection End Time Ignored

10 Collection Volume Ignored

11 Collector ID Ignored

12 Action Code * * Action: C for Cancel Test/Request, or A for Add Test

For Cancel Request: not send field 5 and not send record R.

13 Danger Code Ignored

14 Relevant Clinical Info Ignored

15 Date/Time Specimen Received Ignored

16 Specimen Descriptor Ignored

17 Ordering Physician * Doctor

18 Physician’s Phone Number Ignored

19 User field Number1 * Collector Center

20 User field Number2 Ignored

21 Laboratory field No 1 Ignored

22 Laboratory field No 2 Ignored

23 Date/Time Ignored

24 Instrument Charge to Computer Ignored

25 Instrument Section ID Ignored

26 Report Types * F for Final Result (Facultative Validation or Test Sent status)

X for Cancel if Action Code = C.

(F for Transmission to Quanta Link; X sent from Quanta Link to instrument)


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ASTM Field


Transmitted to Host

Description


28 Location or ward of speciment Ignored

29 Nosocomial infection flag Ignored

30 Specimen Service * Service

31 Specimen Institution Ignored

Examples:

O|1|90015041||^^ÂFOL|R|20071127111010|20071127120000||||A|||||Doctor1||Collection center|||||||F||||Service1|<CR>

O|2|90015041||^^^C1^1:20|R|20071127111010|20071127120000||||A|||||Doctor1||Collection center 2|||||||F||||Service1|<CR>

5.2.4. Result Record

Is a level 3 record sent by Quanta Link to notify results to the host. For both ELISA and IFA tests, the test result (and interpretation) shall be informed. In IFA tests, additional result records can be sent to notify the result and patterns found for each of the dillutions performed to the sample.

ASTM Field

ASTM Field Name Transmitted to Host

Description

1 Record Type * R

2 Sequence Number * Sequence number of the result record transmitted.

3 Universal Test ID * For ELISA and IFA global results:

^^^TESTCODE

For dilutions results:

^^^DILLUTION^^^DILLUTION_INDEX

For dilutions patterns:

^^^PATTERN CODE^PATTERN DESCRIPTION^^^

4 Data Measurement * For ELISA and IFA global results:

Result

For Dilutions:

RESULTCODE^RESULTDESC

(Ignored for Dilution patterns)

5 Units * For ELISA and IFA global results:

Interpretation

(Ignored for Dilution patterns)

6 Reference Ranges Ignored

7 Result Abnormal Flags * Defines the pathology status of the result (used for

ELISA and IFA global results). Values shall be:

L for below low normal.

H for above high normal.


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ASTM Field

ASTM Field Name Transmitted to Host

Description

LL for below panic normal

HH for above panic normal.

8 Nature of Abnormality testing

Ignored

9 Result Status * F for FINAL RESULTS

10 Date of Change * GETTIMESTAMP (YYYYMMDDhhmmss)

11 Operator Identification

Ignored

12 Date/Time Test

Started

Ignored

13 Date/Time Test

Completed

Ignored

14 Instrument Identification

Ignored

Examples:

Sending an ELISA result:

R|1|^^ÊLISA|result 2|Interpretation||||F|20091126155243|admin|

Sending an IFA result with dilutions. Note the Order Test record to identify dilution results belonging to the same test:

R|1|^^^HEP2|result 2|Interpretation||||F|20091126155243|admin|

O|2|12345677^1^||^^^HEP2|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^^Dillution^^^1:80|2^dilution_res 2|||||F|20091126155243|admin|||

R|2|^^^HOM^Homogeneous^^^||||||F|20091126155243|admin|||

R|3|^^^SPE^Speckled^^^||||||F|20091126155243|admin|||

O|3|12345677^2^||^^^HEP2|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^^Dillution^^^1:160|4^dilution_res 4|||||F|20091126155243|admin|||


5.2.5. Comment Record

Comment record of test result.

ASTM Field


Transmitted to Host

Description

1 Record Type * C

2 Sequence Number * Sequence number of the request

information record transmitted.

3 Comment Source Ignored

4 Comment text * Comment


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ASTM Field


Transmitted to Host

Description

5 Comment type Ignored

Example:

C|1||Comments||<CR>

5.2.6. Scientific Record

The Scientific Record is ignored when received by the Quanta Link and is not created or sent. Record type ID S.

5.2.7. Manufacturer Information Record

The Manufacturer Information Record is ignored when received by the Quanta Link and is not created or sent. Record type ID M.

5.2.8. Message Terminator Record

This is the last record in the message. A header record may be transmitted after this record signifying the start of a second message.

ASTM Field


Transmitted to Host

Description

1 Record Type * * L

2 Sequence Number * * Sequence number of the message terminator record transmitted.

3 Terminator Code * Ignored

Example:

L|1|N<CR>


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ANEX I. Messages examples

New Test Requesting Example (from HOST to Quanta Link)

H|\^&|||HOST|||||HOST||P|1.0|20071127120338<CR>

P|1|90015042|1002|NTS1002^SSN1002ÎDCARD1002|SMITH^JOHN||19701010120000|F||1002 STREET^TOWN^REGION ||931234567|Doctor 1|ICU||||d1||||COMMENTS|||REQUEST LOCATION|||||||Service 1||<CR>

O|1|90015042||^^ÂFOL|R|20071127120000|20071127120000||||A|||||Doctor 1|||||||||F||||Service 1|<CR>

O|2|90015042||^^^HEP2^1:80|R|20071127120000|20071127120000||||A|||||Doctor 1|||||||||F||||Service 1|<CR>

O|3|90015042||^^^ HEP2^1:320|R|20071127120000|20071127120000||||A|||||Doctor 1|||||||||F||||Service 1|<CR>

L|1|N<CR>

Result Record Example (from Quanta Link to HOST)

H|\^&|||Quanta Link|||||DMS||P|1.0|20091126165508

P|1|12345677|10007|10007^10007^10007|10007 SMITH^JOHN||19610716120000|M||10007^City10007^CHICAGO||10007|||AE|||0||||1212

O|1|12345677||^^^HEP2|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^^HEP2|dilution_result2|Interpretation||||F|20091126155243|admin|

O|2|12345677^1^||^^^HEP2|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^^Dillution^^^1:80|2^dilution_result2|||||F|20091126155243|admin|||

R|2|^^^HOM^Homogeneous^^^||||||F|20091126155243|admin|||


O|3|12345677^2^||^^^HEP2|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^^Dillution^^^1:160|4^dilution_result4|||||F|20091126155243|admin|||

R|2|^^^FSPE^Fine Speckled^^^||||||F|20091126155243|admin|||

O|4|12345677||^^ÛR|R|20091125120000|||||A|||||||99|||||||F|||||

R|1|^^ÛR|123|mg/dL|10.0 - 50.0|HH||F|20091126155154|admin|||

L|1|N


Inova Diagnostics, Inc. is a company of the Werfen Group QUANTA Link™ is property of Inova Diagnostics, Inc.

All brands named in this document belong to their respective owners

QUANTA Link™ – ASTM communication protocol Version 1.0 © Inova Diagnostics, Inc. 2011 – All rights reserved

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