ASTM communication protocol QUANTA Link™ ASTM communication protocol 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. 4.1.2. 4.1.3. 4.1.4. 4.1.5. 5. Establishment Phase .........................................................................................................4 Transfer Phase .................................................................................................................5 Termination Phase ............................................................................................................5 Error Recovery ..................................................................................................................5 Restrictions ......................................................................................................................6 HIGH LEVEL PROTOCOL........................................................................................................ 6 5.1. 5.2. MESSAGE SPECIAL CHARACTERS ........................................................................................................7 DATA RECORD USAGE .....................................................................................................................7 ANEX I. MESSAGES EXAMPLES .............................................................................................. 14 5.2.1. 5.2.2. 5.2.3. 5.2.4. 5.2.5. 5.2.6. 5.2.7. 5.2.8. Message Header Record ....................................................................................................7 Patient Identifying Record..................................................................................................8 Test Order Record........................................................................................................... 10 Result Record ................................................................................................................. 11 Comment Record ............................................................................................................ 12 Scientific Record ............................................................................................................. 13 Manufacturer Information Record ..................................................................................... 13 Message Terminator Record ............................................................................................. 13 Page 2 of 15 ASTM communication protocol 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: 2. References 3. New Requests from HOST to Quanta Link. (T requests) Results from Quanta Link to HOST. Low level Protocol: As specified in ASTM standard E 1381 91 High level Protocol: As specified in ASTM standard E 1394 91 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. Page 3 of 15 ASTM communication protocol 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. Page 4 of 15 ASTM communication protocol 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. 4.1.4.1. Error Recovery 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: Page 5 of 15 ASTM communication protocol 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. Page 6 of 15 ASTM communication protocol 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 Page 7 of 15 ASTM communication protocol ASTM Field ASTM Field Name Received from Host 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 ASTM Field Name Received from Host 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^SSN^IDENTITYCARD 6 Patient Name * 7 Mother’s Maiden Name 8 Birthdate * Birthdate (YYYYMMDDhhmmss) 9 Patient Sex * M for male, F for female or U for unknown 10 Patient Race 11 Patient Address 12 Reserved Field * Surname^Name Ignored Ignored * Adress^City^State Ignored Page 8 of 15 ASTM communication protocol ASTM Field ASTM Field Name Received from Host 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 20 Patient Medications Ignored 21 Patient Diet Ignored 22 Practice Field No. 1 Ignored 23 Practice Field No. 2 24 Admission and Discharge Dates Ignored 25 Admission Status Ignored 26 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 34 Hospital Institution 35 Dosage Category * Diagnosis * Comments * Location * ServiceID * DestinationCode 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> Page 9 of 15 ASTM communication protocol 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 ASTM Field Name Received from Host 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 5 Universal Test ID Ignored * * ^^^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 18 Physician’s Phone Number 19 User field Number1 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 * Doctor Ignored * * Collector Center 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) Page 10 of 15 ASTM communication protocol ASTM Field ASTM Field Name Received from Host Transmitted to Host Description 27 Reserved Field Ignored 28 Location or ward of speciment Ignored 29 Nosocomial infection flag Ignored 30 Specimen Service 31 Specimen Institution * Service Ignored Examples: O|1|90015041||^^^AFOL|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 7 Result Abnormal Flags Ignored * 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. Page 11 of 15 ASTM communication protocol 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|^^^ELISA|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||| R|2|^^^SPE^Speckled^^^||||||F|20091126155243|admin||| 5.2.5. Comment Record Comment record of test result. ASTM Field ASTM Field Name Received from Host Transmitted to Host Description 1 Record Type * C 2 Sequence Number * Sequence number of the request information record transmitted. 3 Comment Source 4 Comment text Ignored * Comment Page 12 of 15 ASTM communication protocol ASTM Field ASTM Field Name 5 Received from Host Transmitted to Host Comment type Description 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 ASTM Field Name Received from Host 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> Page 13 of 15 ASTM communication protocol 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^SSN1002^IDCARD1002|SMITH^JOHN||19701010120000|F||1002 STREET^TOWN^REGION ||931234567|Doctor 1|ICU||||d1||||COMMENTS|||REQUEST LOCATION|||||||Service 1||<CR> O|1|90015042||^^^AFOL|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||| R|3|^^^SPE^Speckled^^^||||||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||^^^UR|R|20091125120000|||||A|||||||99|||||||F||||| R|1|^^^UR|123|mg/dL|10.0 - 50.0|HH||F|20091126155154|admin||| L|1|N Page 14 of 15 ASTM communication protocol 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 Page 15 of 15