Automated Clinical Analyzer

CM200 / CM250

Bi-directional Communication
Specifications

Software v4.4.0.12

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1. INTRODUCTION

This document describes the Bi-directional communication between CM200/CM250 and the host computer
based on the ASTM E1381-95 and E1394-97 standards. It describes the protocol and the format of the
records returned from the Autoanalyzer software. It also gives examples and highlights issues to be
especially addressed; all needed by the programmer that shall interface to this protocol on the LIMS side.

The specifications may change without notice.

1.1 Revisions of this Document

Current
Revision Date Author Comments
Software
0 03/01/2014 AW 4.4.0.10 First version of the document
1 09/04/2014 AW 4.4.0.10 Specimen Descriptor functionality added
1.1 10/04/2014 AW 4.4.0.10 Minor format corrections to 8.1.9 and 9.4.16
1.2 20/08/2014 AW 4.4.0.10 Changes in software v3 added to this document
1.3 15/05/2015 AW 4.4.0.11 Corrections to Header record
1.4 07/10/2015 AW 4.4.0.12 Changes to Header record
1.5 08/03/2016 AW 4.4.0.12 Undocumented STAT handling using BCR

1.2 Autoanalyzer Software Changes Related with LIS

Software Software Correction /

Change Description
v4 v3 Improvement
4.4.0.12 No Improvement 7.1.5 Sender Name includes instrument serial number.
4.4.0.11 No Correction 7.1.7 Reserved Field is added. Additional Field Separator is
removed from Header Record.
4.4.0.10 N/A Improvement 9.4.16 Specimen Type (‘0’ for Serum, ‘1’ for Urine, ‘2’ for CSF and
‘3’ for other) is recognized and applied to sample type.
4.4.0.10 No Correction Header Record is completed with Sender Name, Version level “E
1394-97” and Date and Time of Message.
4.4.0.10 N/A Correction Error is corrected when accepting new tests.
4.4.0.9 N/A Improvement 10.1.7 Result Abnormal Flags (N–normal , A–abnormal) and
10.1.9 Result Status (F–final results, X–order cannot be done)
are used for observed results.
4.4.0.8 No Correction STATs are considered when loading or verifying BCR labels.
4.4.0.4 3.11.0.36 Correction Date and time is set for ISE results.
4.3.0.17 No Improvement The last MB of communication is logged into LIS.log file (trace).
4.3.0.7 3.11.0.61 Correction Sample is set as STAT when receiving 9.4.6 Priority 'S' or 'A'.
4.3.0.7 3.11.0.59 Correction 8.1.9 Patient Sex uses 'F' instead of 'N' for female.
4.3.0.1 N/A Improvement A new communication component (Delphi code) is implemented.
4.0.0.27 3.11.0.49 Improvement Whole day is considered when 12.1.7 Beginning Request Results
Date and Time and 12.1.8 Ending Request Results Date and Time
are identical and time is ‘000000’

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1.3 Glossary

Term Meaning
Software Software managing Autoanalyzer instrument CM200/CM250

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2. GENERAL DESCRIPTION

The following information may be useful to implement an effective communication:

Our actual implementation only sends results when the host asks for them using the request information
record (Item 12, ASTM E1394 standard).
The instrument has no 'online' connection, results are not sent to the host computer without a request. This
logic has proven to be effective in other LIS systems.

You can ask for only one test id at a time or ALL.

From ALL patients and samples, or a specific patient id and sample id.
For the later, Patient id is optional and Sample id is mandatory.
If the sample was defined having a Patient id, this must be used together with the Sample id.
You can also filter records between two dates.

The results are taken ONLY from the historic data file.

Please also check these general items:

External LIS operates based on two standards:

1) ASTM E1381 for low-level protocol to transfer messages and,
2) ASTM E1394 for transferring information.

The scope of these standards is wide enough to cover the requirements of our system. However, the actual
implementation works as a listener only attending requests from the host, both receiving new samples and
tests, and requesting results.

Results are taken only from Historic Data File (user approved), in response to a query from the host.

Autoanalyzer software doesn't manage with patients directly: information about the patient is included as
sample detail.

Additionally, Data/Check LIMS menu command is intended only to manually append information on
sample's table from input buffer (tests request). It is used exceptionally since this operation is automatically
offered to the user when needed.

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3. TRANSMISSION OF MESSAGES
CM200/CM250 uses the cross cable of RS-232C for connection to Host.
Assignment of pins

3.1 Low-Level Protocol

Low-Level Protocol follows ASTM E1381-95 standard.

3.2 Physical Layer

RS232
Connector Contact Assignments
Contact No. Description Direction
Instrument Computer
1 Shield ... No Connection
2 Transmitted Data Output Input
3 Received Data Input Output
7 Signal Ground ... ...

3.3 Software Communications Setting

Comport: COM1, COM2 (default), COM3, COM4.

Transmission speed: 2400, 4800, 9600, 19200, 38400 bps (default).
[2] Parity: None (default), Odd, Even, Mark, Space.
[?] Data bits: 7, 8 (default).
[1] Stop bit: 1 (default), 1.5, 2.

A software option can be used to split a message at record level for better readability and troubleshooting
purposes.

If one message is longer than 240 characters, it will be broken into multiple messages using <ETB>.

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4. High-Level Protocol and Message Structures

Req.:
F ... mandatory fixed value
C ... calculated values (e.g. date/time, sequences)
R ... required
O ... optional
- ... Not used

4.1 HEADER RECORD (level 0)

ASTM Field Field name Implementation Req.
7.1.1 Record Type ID Single character: “H” F
7.1.2 Delimiter Definition Standard delimiters: |\^& F
7.1.3 Message Control ID Not Used -
7.1.4 Access Password Not used -
7.1.5 Sender Name or ID “Autoanalyzer^4.4.0.12^15102899”. F
Part 1 is a simple description of instrument (sender) name.
Part 2 is the current version of software.
Part 3 is the serial number of the instrument.
7.1.6 Sender Street Address Not used -
7.1.7 Reserved Field Not used -
7.1.8 Sender Telephone Number Not used -
7.1.9 Characteristics of Sender Not used -
7.1.10 Receiver ID Not used -
7.1.11 Comment or Special Not used -
Instruction
7.1.12 Processing ID Not used -
7.1.13 Version No. Version of ASTM Spec.: “E 1394-97” F
7.1.14 Date and Time of Message Date and time at which message was transmitted. C
Format is “YYYYMMDDHHMMSS”.
(This is not the time of the analysis or calibration)

4.2 PATIENT INFORMATION RECORD (level 1)

ASTM Field Field name Implementation Req.
8.1.1 Record Type Single character: “P” F
8.1.2 Sequence Number Starting by “1” increases by 1 for each patient transmitted. C
A message may have more than one patient record.
NOTE: This is NOT the Frame Number (FN).
8.1.3 Practice Assigned Patient Patient ID is optional. Format is an alphanumeric string up to 12 chars. O
ID
8.1.4 Laboratory Assigned Not used -
Patient ID
8.1.5 Patient ID No. 3 Not used
8.1.6 Patient Name Patient Name. Format is an alphanumeric string up to 30 chars. O
8.1.7 Mother’ s Maiden Name Not used
8.1.8 Birthdate Date of Birth. Format is “YYYYMMDD” O
8.1.9 Patient Sex Patient Sex. O
Receiving: Format is “M” for Male, otherwise Female.
Sending: Format is “M” for Male, “F” for Female or undefined.
Note that the field value will set limit reference values for each sample type.
8.1.10 Patient Race-Ethnic Origin Not used -
8.1.11 Patient Address Not used -
8.1.12 Reserved Field Not used -
8.1.13 Patient Telephone Number Not used -
8.1.14 Attending Physician ID Physician Name. Format is an alphanumeric string up to 30 chars. O

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ASTM Field Field name Implementation Req.
8.1.15 Special Field 1 Not used -
8.1.16 Special Field 2 Not used -
8.1.17 Patient Height Not used -
8.1.18 Patient Weight Not used -
8.1.19 Patient’s Known or Diagnosis. Format is an alphanumeric string up to 10 chars. O
Suspected Diagnosis
8.1.20 Patient Active Medications Not used -
8.1.21 Patient’s Diet Not used -
8.1.22 Practice Field No. 1 Not used -
8.1.23 Practice Field No. 2 Not used -
8.1.24 Admission and Discharge Not used -
Dates
8.1.25 Admission Status Not used -
8.1.26 Location Patient Location. Format is “section^bed” and is an alphanumeric string up O
to 20+“^”+10 chars both optional.
8.1.27 Nature of Alternative Not used -
Diagnostic Code and
Classifiers
8.1.28 Alternative Diagnostic Not used -
Code and Classification
8.1.29 Patient Religion Not used -
8.1.30 Marital Status Not used -
8.1.31 Isolation Status Not used -
8.1.32 Language Not used -
8.1.33 Hospital Service Not used -
8.1.34 Hospital Institution Not used -
8.1.35 Dosage Category Not used -

4.3 TEST ORDER RECORD (level 2)

ASTM Field Field name Implementation Req.
9.4.1 Record Type ID Single character: “O” F
9.4.2 Sequence Number Starting by “1” increases by 1 for each Order of the same patient. C
A patient may have more than one Test Order record.
NOTE: This is NOT the Frame Number (FN).
9.4.3 Specimen ID Sample ID. Format is an alphanumeric string up to 10/16 chars (soft v3/v4). O
9.4.4 Instrument Specimen ID Correlative internal number. C
9.4.5 Universal Test ID The first three components are not used (see sections 6.6.1.1-6.6.1.3 of O
ASTM E1394-91).
The fourth is a parameter name assigned by the instrument software.
Format is “^^^TestID” and accepts multiple TestID’s.
9.4.6 Priority Used to set routine or STAT (urgency) condition on sample. O
Format is “A” or “S” for STAT, “R” or any other char for Routine. The default
is Routine.
9.4.7 Requested/Ordered Date Not used -
and Time
9.4.8 Specimen Collection Date Time Sample Drawn Optional Field. Format is “YYYYMMDDHHMMSS” O
and Time
9.4.9 Collection End Time Not used -
9.4.10 Collection Volume Not used -
9.4.11 Collector ID Not used -
9.4.12 Action Code Not used -
9.4.13 Danger Code Not used -
9.4.14 Relevant Clinical Not used -
Information
9.4.15 Date/Time Specimen Not used -
Received
9.4.16 Specimen Descriptor Part 1: Specimen Type (Only the first character is used). O
Format for patient samples is:
“0” for Serum,
“1” for Urine,

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ASTM Field Field name Implementation Req.
“2” for CSF,
“3” for other.
Default is Serum.
Part 2: Specimen Source not supported.
Software v3 ignores this field.
9.4.17 Ordering Physician Not used -
9.4.18 Physician’ s Telephone Not used -
Number
9.4.19 User Field No. 1 Not used -
9.4.20 User Field No. 2 Not used -
9.4.21 Laboratory Filed No. 1 Not used -
9.4.22 Laboratory Filed No. 2 Not used -
9.4.23 Day/Time Results Not used -
Reported or Last Modified
9.4.24 Instrument Charge to Not used -
Computer System
9.4.25 Instrument Section ID Not used -
9.4.26 Report Types Single character: “Q” F
9.4.27 Reserved Field Not used -
9.4.28 Location or Ward of Not used -
Specimen Collection
9.4.29 Nosocomial Infection Flag Not used -
9.4.30 Specimen Service Not used -
9.4.31 Specimen Institution Not used -

4.4 RESULT RECORD (level 3)

ASTM Field Field name Implementation Req.
10.1.1 Record Type Single character: “R” F
10.1.2 Sequence Number Starting by “1” increases by 1 for each result of the same order. C
A Test Order may have more than one Result record.
NOTE: This is NOT the Frame Number (FN).
10.1.3 Universal Test ID The first three components are not used (see sections 6.6.1.1-6.6.1.3 of R
ASTM E1394-91).
The fourth is a parameter name assigned by the instrument software.
Format is “^^^TestID”.
10.1.4 Data or Measurement Numerical test result. R
Value
10.1.5 Units Format is an alphanumeric string up to 8 chars. R
10.1.6 Reference Ranges Reference Ranges. Format is “Low^High” with Low and High being numbers. O
10.1.7 Result Abnormal Flags Format is: “N” for Normal, “A” for Abnormal. R
Software v3 ignores this field.
10.1.8 Nature of Abnormality Not used -
Testing
10.1.9 Result Status Format is: “I” for Pending, “F” for Normal/Final result, “X” for Abnormal/Not R
done, “P” for Preliminary.
Software v3 ignores this field.
10.1.10 Date of Change of Not used -
Instrument Normative
Values or Units
10.1.11 Operator Identification Not used -
10.1.12 Date/Time Test Started Not used -
10.1.13 Date/Time Test Completed Date and time at which the analysis was measured. Format is R
“YYYYMMDDHHMMSS”.
10.1.14 Instrument Identification Analyzer name as translated in the software. Format is an alphanumeric O
string.

4.5 COMMENT RECORD is not used.

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4.6 QUERY RECORD (level 1) from Host to Autoanalyzer
ASTM Field Field name Implementation Req.
12.1.1 Record Type Single character: “Q” F
12.1.2 Sequence Number Single character: “1”. Only one query per message is supported. F
NOTE: This is NOT the Frame Number (FN).
12.1.3 Starting Range ID Number Format 1 is “Patient ID^Specimen ID”. R
Format 2 is “^Specimen ID” can be used only if Patient ID is not defined.
Format 3 is “ALL” to query over all specimen results.
12.1.4 Ending Range ID Number Not used -
12.1.5 Universal Test ID The first three components are not used (see sections 6.6.1.1-6.6.1.3 of R
ASTM E1394-91).
The fourth is a parameter name assigned by the instrument software.
Format 1 is “^^^TestID”. Not multiple test request is allowed.
Format 2 is “ALL” to query over all tests.
12.1.6 Nature of Request Time This field is Ignored. The soft always uses the result test date option “R”. -
Limits
12.1.7 Beginning Request Results This field specifies a beginning (oldest) date and time for which results are R
Date&Time being requested.
Format is “YYYYMMDDHHMMSS”.
12.1.8 Ending Request Results This field specifies the ending or latest (or most recent) date and time for R
Date&Time which results are being requested.
Format is “YYYYMMDDHHMMSS”.
12.1.9 Requesting Physician Not used -
Name
12.1.10 Requesting Physician Not used -
Telephone Number
12.1.11 User Field No. 1 Not used -
12.1.12 User Field No. 2 Not used -
12.1.13 Request Information Not used -
Status Codes

4.7 MESSAGE TERMINATOR RECORD (level 0)

ASTM Field Field name Implementation Req.
13.1.1 Record Type Single character: “L” F
13.1.2 Sequence Number Single character: “1”. F
NOTE: This is NOT the Frame Number (FN).
13.1.3 Termination Code Format is: R
“N” for normal termination,
“I” for no information available from last query.

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