PATHFAST

Host Interface Specifications

(Based on ASTM Specifications)

Final Version (Rev1.0)

05/December/2005
1. Index

1. Index 2
2. Revision History 3
3. Introduction 4
3.1 Purpose 4
4. General Description 6
4.1 Product Perspective 6
5. Specific Requirements 7
5.1 Protocol Specification 7
5.2 Low Level Interface 7
5.3 Data Link and Logical Layer 7
5.4 Sessions 7
5.4.1 Common: Message Header and Message Terminator Records 8
5.4.1.1 Message Header Record ("H" Record) 8
5.4.1.2. Message Terminator Record ("L" Record) 9
5.5 Test Order Downloading 10
5.5.1 Receive Session from DMS 10
5.5.2 Host Query 10
5.5.3 Test Request Message (from PATHFAST to Host) 10
5.5.3.1 Request Information Record ("Q" Record) 12
5.5.4 Test Order Message (from Host to PATHFAST) 12
5.5.4.1 Patient Information Record ("P" Record) 12
5.5.4.2 Test Order Record ("O" Record) 14
5.6 Rejected Test Order Message Uploading 16
5.6.1 Rejected Test Order Message 16
5.6.1.1 Comment Record (“C” Record) 16
5.7 Test Results Uploading 18
5.7.1 Test Result Message (from PATHFAST to Host) 18
5.7.1.1 Patient Information Record (“P” Record) 18
5.7.1.2 Test Order Record (“O” Record) 20
5.7.1.3 Result Record (“R” Record) 22
5.7.1.4 Comment Record (“C” Record) 24
5.7.1.5 Error Messages 25
6. Not Supported Record 27
7. Transmission Abort and Errors 27
7.1 Error Conditions and Actions 27
7.2 List of Communication Errors 28
8. Appendix- PATHFAST Test Codes 29
9. Appendix –Supported Characters by PATHFAST 29
9.1 Supported Characters for Sample ID 29
9.2 Supported Characters for Patient name 29
9.3 Supported Characters for Delimiters 29
9.4 Connecting with Host Computer 29
9.4.1 Using D-Sub Type Connector with 25 Pins 30
9.4.2 Using D-Sub Type Connector with 9 Pins 30
10. Limitations 30

2
2. Revision History

Revision History

Revision Date Modifications Revised By

0.0 3/3/2005 Newly Created T. Inoue
0.1 3/10/2005 -. Changed expression of Japanese words. T. Inoue
-. Added some description
0.2 3/14/2005 -. Index was translated into Japanese and words in T. Inoue
the body were changed accordingly
-. Added explanation and appendices
-. Made modifications of expression
0.3 4/27/2005 -. Added supported fields of birth date and sex of T. Inoue
patient
1.0 7/31/2005 -. Added limitations T. Inoue
-. Other addition and revision
12/5/2005 -. The content of the Remarks is updated. K.Kashiyama

3
3. Introduction

3.1 Purpose
This document is a guide to integrate a Laboratory Information Management system with
PATHFAST instrument using the ASTM (American Society for Testing and Materials)
specification to transfer information between clinical instruments and computer systems.

Communication between PATHFAST and Host computer consists of receiving test request from
Host computer and sending test results to Host computer. Communication is performed
through RS232C based on ASTM1394 (High Level) and ASTM1381 (Low Level) standards.
ASTM1381 (Low Level) communication protocol is used for transferring or receiving messages
in Host Interface of PATHFAST instrument.

ASTM1394-91 standard defines how to treat the transferred data as messages. The message
consists of several records as described in the following. These messages are translated into
one or more frames. Frames are transmitted based on ASTM1381 standard.

About frame configuration

Frame used by PATHFAST is based on the contents defined in ASTM1381-91.
[Frame Configuration (from ASTM 1381-91)]

<STX>[frame #][Text] <ETB> [Check Sum: upper byte][Check Sum: lower byte]<CR><LF>
<ETX>

[Text] consists of [Record] and <CR>=0x0d(hex).

When a [Text] exceeds 240 bytes, the rest is set in the next frame by setting control code of
<ETB> =0x17(hex) for the first frame, called [Intermediate Frame]. When a [Text] is less than
or equal to 240 bytes, control code of <ETX> =0x03 is set. Do not set <ETB> for a [Text] not
more than 240 bytes.
Check sum is indispensable and can not be omitted.

The [Text] in a frame above consists of one single record of followings and <CR>=0x0d(hex) at
the end.
Records are: Header (H), Terminator (L), Patient (P), Test Order (O), Test Result (R),and
Comment (C)

PATHFAST does not support frames with more than one [Record] set inside.
Set only one [Text] in a single frame though the text length is less than or equal to 240 bytes.
When a [Text] exceeds 240 bytes, it is divided into more than two frames by setting <ETB> at
the end of the divided frame.

4
Examples:
<STX>[frame #][H Record]<CR><ETX><C1><C2><CR><LF>
<STX>[frame #][P Record]<CR><ETX><C1><C2><CR><LF>
<STX>[frame #][O Record]<CR><ETX><C1><C2> <CR><LF>
<STX>[frame #][R Record]<CR><ETX><C1><C2><CR><LF>
<STX>[frame #][C Record]<CR><ETX><C1><C2><CR><LF>
<STX>[frame #][L Record]<CR><ETX><C1><C2><CR><LF>
Here: <C1> means upper byte of checksum and <C2> means lower byte of checksum.

Example for the [Text] exceeded 240 bytes (R Record exceeded 239 bytes)
[Intermediate Frame]
<STX>[frame #][R Record]<CR><ETB><C1><C2><CR><LF>
=>R Record contains first 239 bytes.
For last frame: R Record contains less than or equal to 239 bytes of data
<STX>[frame #][R Record]<CR><ETX><C1><C2><CR><LF>

About Check Sum

Check sum consists of two characters and set after <ETB> or <ETX>. Check sum is calculated
by adding characters in binary code and then the least significant byte of the result is used as
Check sum. Characters used for this calculation are frame number next to <STX> through
<ETB> or <ETX>. <STX>, Check sum, <CR> and <LF> are not used for this calculation.
Check sum is an eight bit integer consisting of two nibbles. These nibbles are expressed in
hexadecimal form ASCII characters. These two ASCII characters are set as check sum
characters, in the order of upper and lower.
For example, if the Check sum is 122 in decimal, it is expressed 01111010 in binary and 7A in
hexadecimal form.

5
4. General Description

4.1 Product Perspective

Communication sessions with host computer can be started by the operator request or the
completion of the assay on PATHFAST instrument automatically.
The operator can request to start download session, and the host computer shall transmit test
orders to PATHFAST instrument.

If the operator requires an upload session, PATHFAST instrument will transmit a subset of
sample results (identified by the user) stored in the instrument patient database or QC database.

If the instrument is properly configured, automatic downloading or uploading sessions can be

started by PATHFAST instrument.
Automatic downloading will occur at session start if host query is configured. In this condition
PATHFAST instrument will request test orders for specific sample IDs recognized by using
handheld barcode reader.

The second condition will occur, if automatic uploading has been requested, at session
completion.

In case the communication session is not generated from PATHFAST instrument, any host
computer message is ignored.

All information received by the host computer must be associated with a Sample ID which is the
primary key of the database. In addition to programmed tests a certain amount of information
can be associated with a Sample ID (patient data) and PATHFAST stores only information that
PATHFAST uses.

The sample ID is the primary key to access information in the database.

If the checks fail, PATHFAST sends order reject information to the host computer.
The test orders that PATHFAST can receive are only those of samples PATHFAST queried by
Sample IDs within the period of time (60 seconds) designated in low level standard. When
timeout occurred or if PATHFAST received orders for different Sample ID, PATHFAST transmits
reject information or error status in low level reported. Host computer shall not send such
erroneous data.

PATHFAST can receive six (6) test orders for one batch assay at maximum. For example, when
eight (8) test orders, PATHFAST sends reject information for those tests which could not be
received. For those test, you need to start again with querying the host computer to get test
orders. The host computer needs to send residual test orders and those retesting is needed.
The ordered tests are set for lanes in the order of received test order records (“O” record).

The host computer must refer to the PATHFAST specific computer codes of the tests so that
PATHFAST identifies tests ordered. Refer to “Appendix – PATHFAST Test Codes” of this
document.

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5. Specific Requirements

5.1 Protocol Specification

5.2 Low Level Interface

Low level interface conforms to ASTM specification E-1381-91. The following characteristics are
supported and are configurable through Operator Interface in PATHFAST:

Baud Rate 2400, 4800, 9600

Stop Bit 1 or 2 bit

Character Length 7 or 8 bits

Parity Odd, Even or None

Flow Control None

5.3 Data Link and Logical Layer

For the Data Link and Logical Layer the ASTM specification E-1381-91 has been maintained as
a reference. Protocol limits and constraints are those declared by the standard.
To mention some of them, the data part of the frames exchanged between the PATHFAST
instrument and the host computer cannot exceed 240 bytes. As a consequence during
transmission sessions specific routines provide the ability to divide large records into multiple
frames and during a reception session they re-build partial frames in a single record. The
application level has no evidence of this mechanism.

According to ASTM standard the following characters cannot be part of data records:
<SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>,
<DC1>, <DC2>, <DC3>, <DC4>.

Timeout and retry logic are those specified by ASTM standard; the Low Level Clinical Message
State Diagram representing the automatic operation executed had been referenced.
In interrupt request status PATHFAST instrument accepts EOT from host computer. And
message transmission is aborted. Refer to “Transmission Abort and Error Messages” for details.
PATHFAST sends [NAK] up to 6 times which request the host computer to retry transmission,
when received message is invalid frame. When the repetition exceeds 6 or in case of error
needed to be aborted, PATHFAST sends [EOT] of abort request to the host computer and wait
for [EOT] to be sent.

5.4 Sessions
There are two types of sessions that PATHFAST instrument handles with the ASTM interface:
the test orders download and the test results upload. These sessions can be initiated by the
operator or automatically activated by the instrument.

When the user requests a download operation, PATHFAST instrument will send a request to
the host computer for test orders requested for specific sample using Sample ID as a key, and
the host will transmit test orders for that specific sample.

PATHFAST does not accept test orders initiated by the host computer.

Test results upload is initiated by the user or automatically by PATHFAST instrument.

At the end of a record, <CR> (0DH) is always added to show the end of record.

7
The maximum length of a record is defined as 1000 for PATHFAST instrument.
Delimiters used in a record are described in field description of Header Message Record
section.
In general, delimiters for repetition and components can be omitted if they are not used but the
delimiter which defines field component is not allowed to omit in any cases.

5.4.1 Common: Message Header and Message Terminator Records

According to ASTM specification, each type of transaction between the instrument (DTE) and
the host computer (DCE) shall have two common records, the Message Header record and the
Message Terminator record. These records are used to open or close data transmission
between PATHFAST instruments and the host computer.

Refer to the following table for record configuration.

5.4.1.1 Message Header Record (“H” Record)

Refer to the following table for “H” Record configuration.
This record is not allowed to omit.

Message Header Record (“H” Record)

No. Field Name Description

1 Record Type ID Always set ‘H’. Identify message as header
2 Delimiter Definition The 5 ASCII characters composing this field
define the type of delimiters that will be used in
the following records.
PATHFAST supports only those defined in the
following.
| : Field
delimiter between fields
@ : Repetition
delimiter for repetitious component in a field
^ : Component
Delimiter for elements in a field
\ : Escape
delimiter for special character used

ex)
|@^\| (Not allowed to omit)
3 Message Control ID Not Supported
4 Access Password Not Supported
5 Sender Name or ID Consists of three components.
When sending to host computer from
PATHFAST, the following three components are
set as instrument information.
Component 1: instrument name PATHFAST01
Component 2: serial number (9 bytes)
Component 3: software version (11 bytes)
Ex)
PATHFAST01^0502A0123^01.00.00.00
6 Sender Street Address Not Supported
7 Reserved Fields Not Supported
8 Sender Telephone Number Not Supported
9 Characteristics of Sender Not Supported

8
 10 Receiver ID Set instrument name PATHFAST01 as Receiver
ID when sending from host to PATHFAST (Not
allowed to omit).
Instrument serial number is not supported.
11 Comment or special Instructions Not Supported
12 Processing ID Always set to ‘P’ meaning Production
13 Version No. Set to the current ASTM standard version = ‘1’
14 Date and Time of Message Format is YYYYMMDDHHMMSS
System date of the data transmission.

Sample Record

From PATHFAST to the host computer

H|@^\|||PATHFAST01^1000000001^01-00-00-00|||||||P|1|20050228105347<CR>

From the host computer to PATHFAST

H|@^\|||||||| PATHFAST01||P|1|20050228105347<CR>

5.4.1.2 Message Terminator Record (“L” Record)

Refer to the following table for “L” Record configuration.

This record is not allowed to omit.

Message Terminator Record (“L” Record)

No. Field Name Description

1 Record Type ID Always set ‘L’. Identify message as terminator
(Not allowed to omit)
2 Sequence Number Always set ‘1’ (Not allowed to omit)
3 Termination Code Set ‘N’ for normal termination and ‘E’ for
abnormal termination while transmitting to host;
not considered for received data

Sample Record
L|1|N<CR>

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5.5 Test Order Downloading
Test order downloading is used to request test orders available on the host computer and to
have them on PATHFAST instrument.

When starting download session, the host computer shall be ready and it shall send the test
orders stored for the specific sample designated by PATHFAST using Sample ID.
If PATHFAST is configured to communicate with the host computer, PATHFAST sends a query
message created by reading Sample ID with handheld barcode reader to the host computer.
And the host computer shall transmit test order information to PATHFAST within the designated
time (60 seconds).

5.5.1 Receive Session from DMS

Host driven transmission of test orders are not supported.

5.5.2 Host Query

The host query is manually activated by PATHFAST instrument when the operator makes read
of the Sample ID barcode. PATHFAST creates and sends Test Request Message for the
specific Sample ID to host computer. The host computer shall create and send Test Order
Message for that sample to PATHFAST.

The host computer sends all the requested tests need to be assayed by PATHFAST. The host
computer shall send the test orders in separate messages, which means one Test Order
Message shall contain null or only one test item. So there exist messages corresponding to the
number of test items ordered by host computer. These Test Order Messages for one Sample ID
shall be sent in one downloading session.

PATHFAST receives Test Order Messages and recognizes each needed field to store the data.
The rest of the data which are not needed for PATHFAST shall be ignored.

Because PATHFAST is asking for information regarding a specific Sample ID, it will reject any
type of information associated with different Sample IDs.

If the test order is not recognized as one of those supported by PATHFAST, it will be rejected.
PATHFAST will inform the host computer by creating and sending Reject Message to the host
computer
The details will be given in section 5.6.

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5.5.3 Test Request Message (from PATHFAST to Host)
The Test Request Message is used by PATHFAST to request information for each specific
sample that PATHFAST read its Sample ID barcode. It is composed from a Message Header
Record, a Request Information Record and a Message Terminator Record.
The Request Information record requests information for one specific Sample ID at a time. (The
ASTM protocol limits the number of Request Information records to one). As a consequence
PATHFAST will wait for the host answer before sending a second Request Information record
for a second sample.

5.5.3.1 Request Information Record (“Q” Record)

Based on the ASTM specification the fields composing the Request Information are described
in the following.

This record is not allowed to omit.

Request Information Record:

No. Field Type Description
1 Record Type ID Always set to ‘Q’, Identify record type as
request.
2 Sequence Number As defined by the standard set to ‘1’ when
query is sent
3 Starting Range ID Number This field consists of two components.
Component 1: Not used.
Component 2: Sample ID to request
sample information, 20 bytes at maximum.
Ex.) ^12345678901234567890
4 Ending Range ID Number Not Supported
5 Universal Test ID Not Supported
6 Nature of Request Time Limit Not Supported
7 Beginning request Results Not Supported
Date and Time
8 Ending request Results Date Not Supported
and Time
9 Requesting Physician Name Not Supported
10 Requesting Physician Phone # Not Supported
11 User Field #1 Not Supported
12 User Field #2 Not Supported
13 Request Information Status Always set to ‘O’ (requesting test orders
Code and patient information)

An example for the complete message (composed by header message record, request
information record and message terminator record) is given by:

H|@^\|||PATHFAST01^1000000001^01.00.00.00|||||||P|1|20050228105347<CR>
Q|1|^00228411303||||||||||O<CR>
L|1|N<CR>

11
5.5.4 Test Order Message (from Host to PATHFAST)
As an answer to the PATHFAST Test Request Message, the host computer sends the Test
Order Message. It contains the records specifying which tests are being requested for the
queried Sample ID.
The host computer shall send this message within the designated time (60 seconds).

The message consists of Header Record, Patient Record, Order Record and Terminator
Record.
If no requested assay found in the database, the host computer shall send only Header Record
and Terminator Record.

PATHFAST process assays according to the information received from the host computer.
The maximum number of assays that PATHFAST can receive is 6.
The host computer shall not send assay item information which had been completed.

5.5.4.1 Patient Information Record (“P” Record)

Refer to the following table for record configuration.

This record is not allowed to omit, excepting no order exists.

Patient Information Record

No Field Description
1 Record Type ID Always set “P”, Identify record type as
patient information. (Can not be omitted)
2 Sequence Number As defined by the standard set to ‘1’
when query is sent. (Can not be omitted)
3 Practice Assigned Patient ID Not Supported
4 Laboratory Assigned Patient Patient ID, 20 bytes at maximum.
ID
5 Patient ID #3 Not Supported
6 Patient Name This field consists of three components.
Set patient name of the Patient Name.
Component 1: Family Name
Component 2: First Name
Component 3: Middle Name or Initial
20 bytes maximum for these three
components in total.
Ex.)
Smith^John^M
Note: PATHFAST will show the name
putting the three components together.
If you need space in between, set
spaces before after each component.
7 Mother’s maiden Name Not Supported
8 Birth date Patient birth date is set in the format of
YYYYMMDD
9 Patient Sex Patient sex is expressed with following letters
M or m for male, F or f for female, U or u for
unknown sex. Any other letter shall be
recognized as unknown.
10 Patient Race-Ethnic Origin Not Supported
11 Patient Address Not Supported

12
 12 Reserved Field Not Supported
13 Patient Telephone Number Not Supported
14 Attending Physician ID Not Supported
15 Special Field #1 Not Supported
16 Special Field #2 Not Supported
17 Patient Height Not Supported
18 Patient Weight Not Supported
19 Patient’s Known or Not Supported
Suspected Diagnosis
20 Patient Active Medications Not Supported
21 Patient’s Diet Not Supported
22 Practice Field #1 Not Supported
23 Practice Field #2 Not Supported
24 Admission and Discharged Not Supported
Dates
25 Admission Status Not Supported
26 Location Not Supported
27 Nature of Alternative Not Supported
Diagnostic Code and
Classifiers
28 Alternative Diagnostic Code Not Supported
and Classifiers
29 Patient Religion Not Supported
30 Marital Status Not Supported
31 Isolation Status Not Supported
32 Language Not Supported
33 Hospital Service Not Supported
34 Hospital Institution Not Supported
35 Dosage Category Not Supported

Sample record:
P|1||99999991||Smith^John^M||19980305|M||||||||||||||||||||||||||<CR>

13
5.5.4.2 Test Order Record (“O” Record)

Refer to the following table for “O” Record configuration.

This record is not allowed to omit, excepting no order exists.

Test Order Record

No Field Description
1 Record Type ID Always set “O”. Identify record type as
test order. (Not allowed to omit.)
2 Sequence Number 1 through n. Sequential number starting
from 1. (Not allowed to omit)
3 Specimen ID Sample ID(received from PATHFAST)
20 bytes maximum. (Not allowed to
omit)
4 Instrument Specimen ID Not Supported
5 Universal Test ID This field consists of four components,
but first three components are not
used. Only manufacturer’s test codes
are supported.
Component 4: Manufacturer’s test code
Only one test code shall be set,
repetition is not allowed.
Ex.)
^^ Manufacturer’s test code
When one sample has more than one
test, individual Test Order Record shall
be created for each test. (Not allowed to
omit)
6 Priority Not Supported
7 Requested/Ordered Date Not Supported
and Time
8 Specimen Collection Date Not Supported
and Time
9 Collection End Time Not Supported
10 Collection Volume Not Supported
11 Collector ID Not Supported
12 Action Code Not Supported
13 Danger Code Not Supported
14 Relevant Clinical Not Supported
Information
15 Date and Time Specimen Not Supported
Received
16 Specimen Descriptor Not Supported
17 Ordering Physician Not Supported
18 Physician’s Telephone Not Supported
Number
19 User Field #1 Not Supported
20 User Field #2 Not Supported
21 Laboratory Field #1 Not Supported
22 Laboratory Field #2 Not Supported

14
 23 Date/time Results Reported Not Supported
or Last Modified
24 Instrument Charge to Not Supported
Computer System
25 Instrument Section Not Supported
26 Report Type Always set “O” which means test order.
(Not allowed to omit)
27 Reserved Field Not Supported
28 Location of Ward of Not Supported
specimen Collection
29 Hospital Information Flag Not Supported
30 Specimen Service Not Supported
31 Specimen Institution Not Supported

Sample Record:
O|1|00228411303||^^^11|||||||||||||||||||||O|||||<CR>

The Test Order Message consists of Header Record, Patient Information Record, Test
Order Record and Terminator Record.
Sample message is shown below.

H|@^\||||||||PATHFAST01||P|1|20050228105347<CR>
P|1||99999991||Smith^John^M|||||||||||||||||||||||||||||<CR>
O|1|00228411303||^^^1|||||||||||||||||||||O|||||<CR>
O|2|00228411303||^^^2|||||||||||||||||||||O|||||<CR>
O|3|00228411303||^^^3|||||||||||||||||||||O|||||<CR>
O|4|00228411303||^^^4|||||||||||||||||||||O|||||<CR>
L|1|N<CR>

When the sample has no item to order, Test Order Message becomes as follows.

H|@^\||||||||PATHFAST01||P|1|20050228105347<CR>
L|1|N<CR>

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5.6 Rejected Test Order Message Uploading
At completion of download operations, PATHFAST will transmit a message to inform the host
computer about rejected test orders and samples.

5.6.1 Rejected Test Order Message

The Rejected Test Order Message consists of a Message Header record, one or more
Comment records and the Message Terminator Record. A comment record will be transmitted
for each rejected information.

When PATHFAST received illegal information from the host, it informs the host of the reason of
rejection by using the above message.
If the download process has been completed normally, no Rejected Test Order Message shall
be sent.

5.6.1.1 Comment Record (“C” Record)

Refer to the following table for “C” Record configuration.

Record Type ID Always set ‘C’. Identify record type as comment record.
Sequence Number 1 through n. Sequential number starting from 1. “1” is
for the first comment record in a packet. “n” is for the
last comment record before Terminator Record.
Comment Source Always set to ‘I’
Comment Text This field indicates the reason of the test order rejection. It
consists of three components.
Component 1: Reason of Rejection.
BAD_TEST: Invalid test code.
QC_MA_ID: The ID is already used in QC database
BAD_S_ID: Invalid Sample ID.
WRONG_ID: SID sent by the host is already used
PDB_FULL: Patient data base is full
M_TEST_E: Too many tests received than supported
UKNOWN_T: Unknown test requested
NO_TESTS: No test ordered for patient record
NO_PATIE: No patient information record received
BAD_RECO: Incorrect record format

Component 2: Sample ID
Sample ID corresponding with the rejected test. Nothing is
set depending on reason of rejection.

Component 3: Assay Item Number

Assay item number which is rejected. Nothing is set
depending on reason of rejection.

Ex.) when item number of 0001 is invalid,

BAD_TEST^0305990001^0001
Comment Type Always set to ‘I’

16
The possible reasons for the rejection are summarized in the following table.

Component 1: Component 2: Component 3:

Rejection Reason Sample ID Assay Item Number
QC_MA_ID sample ID (causing the problem) UNKNOWN
BAD_S_ID sample ID (causing the problem) UNKNOWN
PDB_FULL sample ID (causing the problem) Test ID
NO_TESTS UNKNOWN UNKNOWN
NO_PATIE sample ID (causing the problem) Test ID
INSTR_ID UNKNOWN UNKNOWN
M_TEST_E sample ID test ID (causing the problem)
UNKWOWN_T sample ID test ID (causing the problem)
BAD_TEST sample ID test ID (causing the problem)
BAD_RECO Record No. (debug purpose) Field No. (debug purpose)

Sample Record
C|1|I|BAT_TEST^00228310234^0011|I<CR>

Reject Message consists of Header Record, Comment Record and Terminator Record.
Following is an example.
H|@^\|||PATHFAST01^1000000001^01.00.00.00|||||||P|1|20050228105347<CR>
C|1|I|BAT_TEST^00228310234^0011|I<CR>
C|2|I|BAT_SID^00228310234^|I<CR>
L|1|N<CR>

Note that all sample information is deleted because of the reject message. The valid test order
for the sample is stored in PATHFAST, though some order for the sample is rejected.

17
5.7 Test Results Uploading
Test Result Uploading allows transmission of results of the tests performed on PATHFAST to
the host computer. Results, related to patient, QC samples are transmitted on explicit user
request or automatically at assay completion.
Beside the above, the operator can choose samples of which result data shall be transmitted to
the host and manually start the uploading session.
The type of data to be transferred during an automatic upload session depends upon the
instrument set-up (the automatic data transmission can be set to ON or OFF).

PATHFAST does not accept inquiries for test results.

5.7.1 Test Result Message (from PATHFAST to Host)

The Test Result Message is used by PATHFAST to transmit any available test results for a
sample. The test results are automatically sent by item upon one assay batch has been
completed or by the operator indication.

The message consists of a Message Header record, a Patient Information record, one or more
pair Test Order records followed by one or more Results records (depending upon the number
of available test results and the number of results for each specific test).

In the message, unit combined with the specific assay item is also sent to the host.
The Message Terminator record completes the transmission of data.
The Patient Information Record is set for each Test order record.

5.7.1.1 Patient Information Record (“P” Record)

This information is transmitted to the host only if available on the instrument.

This record is not allowed to omit.

Refer to the following table for “P” Record configuration.

Patient Information Record:

No Field Patient Sample QC Sample
1 Record Type ID Always set “P”. Identify this record as Patient
Information Record.
2 Sequence Number 1 through n. Sequential number starting from 1. “1”
is for the first patient record in a packet. “n” is for
the last patient record before Terminator Record.
3 Practice Assigned Not Supported
Patient ID
4 Laboratory Assigned Character string of up to 20 Not Supported
Patient ID bytes.
5 Patient ID #3 Not Supported
6 Patient Name Single character string of Not Supported
up to 20 bytes. Component
1 through 3 of Patient name
received from the host are
combined in a single
character string.
7 Mother’s maiden Name Not Supported
8 Birth date Patient birth date is set in Not Supported
the format of YYYYMMDD

18
 9 Patient Sex Patient sex is expressed Not Supported
with following letters.
M or m for male, F or f for
female, U or u for unknown
sex. Any other letter shall
be recognized as unknown.
10 Patient Race-Ethnic Not Supported
Origin
11 Patient Address Not Supported
12 Reserved Field Not Supported
13 Patient Telephone Not Supported
Number
14 Attending Physician ID Not Supported
15 Special Field #1 Not Supported
16 Special Field #2 Not Supported
17 Patient Height Not Supported
18 Patient Weight Not Supported
19 Patient’s Known or Not Supported
Suspected Diagnosis
20 Patient Active Not Supported
Medications
21 Patient’s Diet Not Supported
22 Practice Field #1 Not Supported
23 Practice Field #2 Not Supported
24 Admission and Not Supported
Discharged Dates
25 Admission Status Not Supported
26 Location Not Supported
27 Nature of Alternative Not Supported
Diagnostic Code and
Classifiers
28 Alternative Diagnostic Not Supported
Code and Classifiers
29 Patient Religion Not Supported
30 Marital Status Not Supported
31 Isolation Status Not Supported
32 Language Not Supported
33 Hospital Service Not Supported
34 Hospital Institution Not Supported
35 Dosage Category Not Supported

Sample record:
P|1||99999991||SmithJohnM|||||||||||||||||||||||||||||<CR>

19
5.7.1.2 Test Order Record (“O” Record)
This record is not allowed to omit.

Refer to the following table for “O” Record configuration.

Test Order Record:

No Field Patient Sample QC Sample
1 Record Type ID Always set “O”. Identify this record as Test Order record.
2 Sequence Number 1 through n. Sequential number starting from 1. “1” is
for the first order record in a packet. “n” is for the last
order record before Terminator Record.
3 Sample ID This field consists of three This field consists of three
components. components.
Component 1: Sample ID Component 1: QC ID
which equals Component 2: Lane Number
to barcode ID Component 3: QC Level
of the sample One of the followings
or QC QC1
sample ID. QC2
Component 2: Lane QC3
Number
Component 3: not used Ex.)
QC ID^Lane Number^QC
Ex.) Level
Sample ID^Lane Number^
4 Instrument Specimen ID Not Supported
5 Universal Test ID This field consists of six components.
The first three components are not supported.

Component 4: Test Item Number

Component 5: Test Name
Component 6: Reagent Lot Number
Ex.)
^^^01^cTnI^011010612
When one sample has plural tests, “O” Record is created for
each test item.
6 Priority Not Supported
7 Requested/Ordered Not Supported
Date and Time
8 Specimen Collection Not Supported
Date and Time
9 Collection End Time Not Supported
10 Collection Volume Not Supported
11 Collector ID Not Supported
12 Action Code Not Supported Always set “Q”.
13 Danger Code Not Supported
14 Relevant Clinical Not Supported
Information
15 Date and Time Not Supported
Specimen Received
16 Specimen Descriptor Sample Type is set: “1” for Not Supported
whole blood and “2” for
serum/plasma/urine
17 Ordering Physician Not Supported
18 Physician’s Telephone Not Supported
Number

20
 19 User Field #1 Not Supported
20 User Field #2 Not Supported
21 Laboratory Field #1 Not Supported
22 Laboratory Field #2 Not Supported
23 Date/time Results Not Supported
Reported or Last
Modified
24 Instrument Charge to Not Supported
Computer System
25 Instrument Section Not Supported
26 Report Type Always set “F”
27 Reserved Field Not Supported
28 Location of Ward of Not Supported
specimen Collection
29 Hospital Information Not Supported
Flag
30 Specimen Service Not Supported
31 Specimen Institution Not Supported

Sample Record:
O|1|00228411303^1^QC1||^^^2^Myo^00000000001|||||||||||1||||||||||F|||||<CR>

21
5.7.1.3 Result Record (“R” Record)

A result record is sent to the host computer for each available test result. For double tests all
available single values will be transmitted to the host computer (no mean values). Each result
record will contain only one of available test results.

For quantitative assay, the test result is the quantitative value. So only one result record is
created and sent to the host computer.
For qualitative assay, the test results are quantitative value and the judgment. So two result
records are created and sent to the host computer.

This record is not allowed to omit.

Refer to the following table for “R” Record configuration.

Result Record:
No Field Patient Sample QC Sample
1 Record Type ID Always set “R”. Identify this record as Result.
2 Sequence Number 1 through n. Sequential number starting from 1.
“1” is for the first result record in a packet. “n” is
for the last result record before Terminator
Record.
3 Universal Test ID This field consists of six components.
The first three components are not supported.
Component 4: Test Item Number
Component 5: Test Name
Component 6: Reagent Lot Number
Ex.)
^^^12^Myo^1234567890
4 Data or Measurement This field consists of two components.
Value Component 1: test result (one of the
quantitative value or judgment)
Component 2: “F” for quantitative result or “I” for
qualitative result
“I” is on of the followings
“-“, “+-“, “+”, “2+”, “3+”, “4+”, “5+”
Ex.)
123.4^F
5 Units Unit is set in this field when the previous field
(field #4 above) is filled with quantitative value.
None is set for qualitative result.
6 Reference range Not Supported

22
 7 Result Abnormal Flag This field contains one or combination of the
following result abnormal flags.
N: Normal
A: Abnormal (Detailed remarks are set in
comment record)
>: Exceeded measurable upper limit
<: Exceeded measurable lower limit
L: Lower than normal range(Detailed remarks
are set in comment record)
H: Higher than normal range(Detailed remarks
are set in comment record)
Result abnormal flags are set at maximum of
three of the above.
@ is used as Repetition Delimiter.
“L” or “H” is not added for qualitative assay
result.
Ex.)
Ａ＠＞＠Ｈ
8 Nature of Abnormality Flag Not Supported
9 Result Status Always set “F”
10 Data of Change in Not Supported
Instrument Normative
Values or Units
11 Operator Identification Operator ID is set, 20 bytes maximum.
12 Date/Time Test Started Not Supported
13 Date/Time Test Assay date and time is set in the format of
Completed YYYYMMDDHHMMSS
14 Instrument Identification Not Supported

Sample Record:
R|1|^^^2^Myo^00000000001|14.70^F|ng/dl||>@A||F||OperaterID||20050228105910|<CR>

5.7.1.4 Comment Record (“C” Record)

23
The Comment record allows integration of the transmitted test results with possible error
messages.
One comment record always follows the result records.

This record is not allowed to omit.

Refer to the following table for “C” Record configuration.

Comment Record:
No Field Description
1 Record Type ID Always set “C”. Identify this field as Comment
Record.
2 Sequence Number 1 through n. Sequential number starting from 1. “1”
is for the first comment record in a packet. “n” is
for the last comment record before Terminator
Record.
3 Comment Source Always set “I”.
4 Comment Text This field consists of five components.
Component 1: Remark
When “A” is set in “Abnormal Result Flag” field,
remarks are set here. Five remarks can be set
at maximum. @ is used as repetition delimiter.
Component 2: Judge against reference range.
When “L” is set in “Abnormal Result Flag” field,
one of the following remarks is set here.
“L”, “2L”, “3L”, “4L”, “5L”
When “H” is set in “Abnormal Result Flag” field,
one of the following remarks is set here.
“H”, “2H”, “3H”, “4H”, “5H”
Component 3: Information of mechanical error
When mechanical error has been detected,
errors are set here up to five at maximum. @ is
used as repetition delimiter.
Component 4: Hematocrit Value (%)
When whole blood sample is assayed, HCT% is
set here. None is set for samples other than
whole blood.
Component 5: Calibration date and time
Date and time when calibration assay was
performed for the test item corresponding to the
assay result is set here. The format is
YYYYMMDDHHMMSS

Ex.) For remarks of “Ab”, “Cd” and “2H” and

mechanical error of “ME_ERR_01”
Ab@Cd^2H^48.5^ME_ERR_01^20050423104535
Refer to error codes for details.
5 Comment Type Always set “I”.

Sample Record:
C|1|I|Ab@Cd^^ME_ERR_01^48.5^20050423104535|I<CR>

Test Result Message containing Header Record, Patient Information Record, Result Record,
Comment Record and Terminator Record is shown below as an example.

24
H|@^\|||PATHFAST01^000000001^01.00.00.00|||||||P|1|20050228105347<CR>
P|1||99999991||SmithJohnM ||19980305|F||||||||||||||||||||||||||<CR>
O|1|00228411303^1^||^^^2^Myo^0000000001|||||||||||1||||||||||F|||||<CR>

R|1|^^^2^Myo^0000000001|44.70^F|ng/dl||>@A||F||Administrator||20050228105910|

<CR>

R|2|^^^2^Myo^0000000001|+^I|||>@A||F||Administrator||20050228105910|<CR>
C|1|I|Ab@Cd^^ME_ERR_01^56.3^20050228080000|I<CR>
P|2||99999991||SmithJohnM ||19980305|F||||||||||||||||||||||||||<CR>
O|1|00228411303^1^||^^^1^cTn I^0000000002|||||||||||1||||||||||F|||||<CR>
R|1|^^^1^cTn I^0000000002|128.5^F|ng/dl||H@A||F|| Administrator
||20050228121532|<CR>
C|1|I|SS@SA^3H^ME_ERR_01^64.1^20050228081512|I<CR>
L|1|N<CR>

5.7.1.5 Error Messages

Errors reported by PATHFAST are categorized in two types, Remark and Error Codes.
Remarks are mostly assay related errors accompanied with assay results. Error Codes are
mostly related to hardware and system malfunctions.

Remarks
Remarks are sent to the host computer in “C” record after the assay run completed.
They show the reason of the blank data in result data field and they also indicate that the
numeric result data sent shall be suspected as erroneous data.
In the table below, remarks are listed with their meanings, how the data is treated in
PATHFAST.

Remark
Code Description Data Handling User Action
The Remark Code is added to the
S No Sample found result. Asterisks are printed Re assay
instead of data.
The Remark Code is added to the
NT No Tip found result. Asterisks are printed Re assay
instead of data.
The Remark Code is added to the
No valid calibration available on
NC result. Asterisks are printed Re calibration
assay completion.
instead of data.
The Remark Code is added to the
Contact your
Secondary count is lower than
ED result. Asterisks are printedPATHFAST
predefined value.
instead of data. representative
Contact your
Temperature of Heat Block L is The Remark Code is added to the
H1 PATHFAST
too high. result.
representative
Contact your
Temperature of Heat Block S is The Remark Code is added to the
H2 PATHFAST
too high. result.
representative
Contact your
Temperature of Heat Block T is The Remark Code is added to the
H3 PATHFAST
too high. result.
representative

25
 Contact your
Temperature of Heat Block L is The Remark Code is added to the
L1 PATHFAST
too low. result.
representative
Contact your
Temperature of Heat Block S is The Remark Code is added to the
L2 PATHFAST
too low. result.
representative
Contact your
Temperature of Heat Block T is The Remark Code is added to the
L3 PATHFAST
too low. result.
representative
The Remark Code is added to the Contact your
Error reported by sample
UK result. Asterisks are printed PATHFAST
recognition sensor
instead of data. representative
Contact your
LED light signal of sample
ER Assay run will be aborted. PATHFAST
recognition sensor too low.
representative
Assay result was calculated
DF Data will print with remark added. None
with default Hct%.
Measured QC is out of control
OR Data will print with remark added. Re assay
range.
Remark added for recalculated
data using new Hct% value
RS None None
when transmitted to the host
computer.
The Remark Code is added to the
AE Abnormal luminescent count result. Asterisks are printed Re assay
instead of data
The Remark Code is added to the Contact your
HC Hct% calculation error result. Asterisks are printed PATHFAST
instead of data representative
The Remark Code is added to the Contact your
Calculation error other than HC
CI result. Asterisks are printed PATHFAST
above
instead of data representative
The Remark Code is added to the Contact your
BE PMT position error result. Asterisks are printed PATHFAST
instead of data representative

Error Codes
Error Codes are also sent to the host computer in “C” record after the assay run
completed.

26
 Only Error Codes reported during assay run are sent to host computer when the assay
run completed and the results are reported. If the assay run is aborted by the operator or
PATHFAST, no Error Codes are sent to host computer.

Kind Message Message Note

Code
Related with F0050 %s file can not be opened
File Handling F0051 %s file can not be read
F0052 %s file can not be written into
F0053 %s file does not exist
Related with P0200 Failed to open PMT Shutter
PMT P0201 Failed to close PMT Shutter
P0202 No PMT count data
P0203 Detected PMT error
Related with T0250 Error detected during setting temperature for Communication
Temperatur Temperature Controller error
e Controller T0251 Error detected during getting temperature from Communication
Temperature Controller error

27
6. Not Supported Records
The Scientific record and the Manufacturer Information record are not supported by PATHFAST
protocol.

As a consequence the instrument ignores any type of information they contain.

7. Transmission Abort and Errors

The cases of transmission abort are described below.
The sender must initiate [EOT] to end the communication session.

-. Host computer is not responding

-. Host computer sent EOT
-. PATHFAST ’s operator requested to stop communication
-. Number of retry in low level communication exceeded the designated number
-. Other:Invalid codes were received during waiting for ENQ or EOT

7. 1 Error Conditions and Actions

Each error condition is described in the following with actions that PATHFAST makes:

Condition Action

Host computer is not If PATHFAST is the sender, it initiates [EOT] to end the session and if it
responding is the receiver, it initiates [EOT] to request for abortion to the host and
wait for [EOT] from the host.
No further messages are sent to the host.
PATHFAST informs the operator by showing corresponding message.
Host computer sent EOT If PATHFAST is the sender, it initiates [EOT] to end the session and if it
is the receiver, it does nothing.
No further messages are sent to the host.
PATHFAST informs the operator by showing corresponding message.
PATHFAST ’s operator If PATHFAST is the sender, it initiates [EOT] to end the session and if it
requested to stop is the receiver, it initiates [EOT] to request for abortion to the host and
communication waits for [EOT] from the host.
No further messages are sent to the host.
PATHFAST informs the operator by showing corresponding message.
Number of retry in low level If PATHFAST is the sender, it initiates [EOT] to end the session and if it
communication exceeded is the receiver, it initiates [EOT] to request for abortion to the host and
the designated number wait for [EOT] from the host.
No further messages are sent to the host.
PATHFAST informs the operator by showing corresponding message.
Checks which need to be retried when failed:
-. Check for starting [STX]
-. Check for modular 8
-. Check for checksum
-. Check for limited characters
-. Check for text length
-. Check for record sequence
-. Check for number of fields
-. Check for each field (specific for each field)
-. Others
Frame error found in low PATHFAST initiates [EOT] to request communication abort to the host
level communication to and wait for [EOT] from the host.
abort No further messages are sent to the host.
PATHFAST informs the operator by showing corresponding message

28
 Checks which need abortion when failed:
-. The number of frames in a message received exceeded 100.
-. More than one record was found in a text
-. Frame numbers inconsistent
-. Other unexpected errors
-. Total record length received exceeded 1000
-. Others
Other: PATHFAST sends nothing when it is waiting for [ENQ] from the host.
Invalid codes were PATHFAST informs the operator by showing corresponding message
received during waiting for When it is waiting for [EOT], it initiates [EOT] to request for abortion to
ENQ or EOT the host and waits for [EOT] from the host.

7. 2 List of Communication Errors

Errors occurred in low level are listed in the following table.

Errors Description Level/Action

None Normal None
STimeOut Sender timeout (15 Seconds) FATAL(Abort communication)
RTimeOut Receiver timeout (30 Seconds) FATAL(Abort communication)
OWTimeOut Timeout for waiting order (60 seconds) FATAL(Abort communication)
UsrCan Canceled by User FATAL(Abort communication)
SCntOver Exceeded retry counts for sender (5 times) FATAL(Abort communication)
RCntOver Exceeded retry counts fro receiver (6 times) FATAL(Abort communication)
HostCan Requested by the host (Received [EOT]) FATAL(Abort communication)
FrmCntErr Received frames exceeded 100 FATAL(Abort communication)
RecCntErr More than two records found in a text FATAL(Abort communication)
FrmPlgErr Frame numbers inconsistent FATAL(Abort communication)
FrmOtherErr Other unexpected error FATAL(Abort communication)
NotEnqErr Received other than [ENQ] when waiting for
FATAL(Abort communication)
[ENQ]
NotEotErr Received other than [EOT] when waiting for
FATAL(Abort communication)
[EOT]
PtherFatalErr Other fatal error FATAL(Abort communication)
RecLenErr Combined record length exceeded 1000 FATAL(Abort communication)

NotStxErr Error in first [STX] check Warning(Retry)

Mod8Err Error in Modular 8 check Warning(Retry)
ChkSumErr Checksum error Warning(Retry)
DefCharErr Error in limited character check Warning(Retry)
TxtLenErr Error in text length check Warning(Retry)
RecSeqErr Error in record sequence check Warning(Retry)
FildCntErr Error in number of fields check Warning(Retry)
FildChkErr Error in each field check (specific for each field) Warning(Retry)
RealOtherErr Other errors Warning(Retry)
OtherWarningErr Other warnings Warning(Retry)
SContErr Contention Error of the sender Warning
SBusyRcvErr Sender busy error Warning

29
8. Appendix- PATHFAST Test Codes

PATHFAST Test codes are listed in the following table.

Test Code Number Test Name

1 cTn I
2 Myo
3 CK-MB
5 D-Dimer

9. Appendix –Supported Characters by PATHFAST

9.1 Supported Characters for Sample ID

The ASCII set of characters considered is in the decimal range 32 to 126, because a Sample ID
can be accepted only if it contains at least one character different from a space.

9.2 Supported Characters for Patient name

The ASCII set of characters considered is in the decimal range 32 to 255.

9.3 Supported Characters for Delimiters

Delimiters used in PATHFAST ASTM messages are defined in section 5.4.1. No other
characters are supported.

9.4 Connecting with Host Computer

To connect PATHFAST with the host computer, use RS232cC cross cable. The
connector of PATHFAST is located on the back (refer to Operators Manual for details.)
The connector prepared on PATHFAST is D-Sub type female connector with 25 pins.

In the drawings on the next page, “1:SLD” means shield line and it shall be connected
on PATHFAST side, but it shall not be connected on PC side.

30
9.4.1 Using D-Sub Type Connector with 25 Pins
When you want to use D-sub type connector with 25 pins to hookup with the host computer,
refer to the following drawing for cable wiring. Numeric value in front of each signal name is pin
number of the connector.

Pins
Pins, Pins,
Male Female

9.4.2 Using D-Sub Type Connector with 9 Pins

When you want to use D-sub type connector with 9 pins to hookup with the host computer, refer
to the following drawing for cable wiring. Numeric value in front of each signal name is pin
number of the connector.

Pins
Pins, Pins,
Male Female

10. Limitations

PATHFAST communicates with host computer under the specifications based on

ASTM specifications and its own limits (refer to the sentences with underlines in this
document). Read this document and ASTM specifications get familiar with them before
making interface program for PATHFAST instrument.

31