Microdom - Mitis 2 – SFD – Format ASTM v.

2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 1/11

Mitis2
ASTM format
Detailed functional specification
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 2/11

Summary

SUMMARY 2

OVERVIEW 3

DESCRIPTION OF THE COMMUNICATION PROTOCOL 3

COMMUNICATION MODES 3
COM COMMUNICATION MODE 3
COM link parameters 3
Transmission errors 4
FILE COMMUNICATION MODE 4
NUMBER OF RECORDS 4

ASTM FRAME FORMAT WITH MITIS2 5

OVERVIEW 5
FORMAT DESCRIPTION 5
Header Record 6
Patient record 7
Comment record after a patient record 8
Test Order record 9
Results record 10
Comment record after a Result record 10
Message Terminator Record 11
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 3/11

Overview
Mitis2 software can be connected to a LIS (Laboratory Information System) to
download routine data to Mitis2 system and upload data from Mitis2 system.

The purpose of the bi-directional link of Mitis2 is to:

• download from the LIS patient data (demographics) and test orders for the routine
samples,
• upload analysis results and additional traceability data on the reaction (reagent
ID, operator data) from Mitis2 database to the LIS.

The communication protocol is based on a standard ASTM protocol (American

Society of Testing and Materials) as defined in the specification documents E 1381-
95 and E 1394-95.

Description of the communication protocol

Communication modes
Two communication modes can be activated:
• A mode based on a serial link with communication error management that
conforms with the ASTM standard.
• A mode that involves exchange files and operates via an Ethernet-type network.
In this mode, Mitis2 takes in charge files that have been copied onto its hard drive
and generates the upload files that are required by the LIS.

In both cases, it is important to check that all the uploaded data is integrated at LIS
level before sending a new test order to Mitis2: a repeat test order for data already
available in Mitis2 database would be ignored.

COM communication mode

The serial link is conforming with the RS232C standard. The simplex-type mode is
used, i.e. a single frame is sent on the line at a given point in time. The low level
protocol management conforms strictly with ASTM specification E 1381-95.

COM link parameters

The default frame format is:
9600 baud, 8 bit, no parity, 1 stop bit.

Frame parameters can be configured as follows:

• Speed: 300/1200/2400/4800/9600/19200/38400.
• Parity: Without/Even/Odd.
• Stop bits: 1 or 2.
• The number of data bits is set to 8.
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 4/11

Transmission errors
If the receiving system detects a transmission error (missing frame / communication
error) it returns a NACK to inform the originator of the frame. After six attempts the
emitting system aborts the session and returns to a neutral state.

During the upload process, the communication module of Mitis2 software identifies
the record that could not be transferred successfully. This record will be transferred
during the next transfer process.

Record sequencing errors (e.g. a missing Test Order Record, "O") are responsible for
the cancellation of the data analysis process until the record analysis automate
recovers a stable state. This type of error is saved in a "log" file that makes it possible
to trace the absence of records in the database.

The same process applies to application errors (incorrect data format) that are saved
in another "log" file. This makes it possible to differentiate frame format errors and
application errors.

File communication mode

In this mode, the directory into which the communication files are located is defined.
The current Mitis2 directory is the default directory.
In this mode 2 files exist :
• One file with the data downloaded by the LIS.
• One file with the results generated by Mitis2 software and the data to upload to
the LIS.

These files are handled in "Append" mode, i.e. new data is added at the end of the
file.

These files are archived after they have been processed either by the LIS or Mitis2
software. In order to avoid errors, these files can only be opened by a single software
at a given point in time. If for example, the LIS is reading data from a file, Mitis2
software cannot add new frames into it. It has to wait until the file is closed again.

In this mode, there is no communication error management. However, the decoding

and application error "log" files still exist.

Number of records
The number of records is limited by the capacity of the sample database of Mitis2
software:
• 10.000 samples
• 10.000 patients.
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 5/11

ASTM frame format with Mitis2

Overview
This section describes the format of the ASTM records for Mitis2. It includes the
format for the following record types:

Header Record H System data, date and time

Patient Record P Sample data, demographics
Test Order record O Tests requests linked to specimen ID's
Results record R Result data linked to specimen ID's
Comment record C Miscellaneous information
Message Terminator Record L Indicates the end of the transfer session

All other record types are ignored.

Format description
The tables hereafter define the specifics of Mitis2 software both during upload (U
column) and download (D column) operations:

R Required A Always
Download O Optional Upload S Optional
I Ignored N Never

Each field may specify a maximum length for the transferred data; if so, this length is
taken into account for uploading only (emission), not downloading (reception).
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
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Header Record
Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record type ID R A 1 H
2 Delimiter definition R A 4 Following the order of emission:
| field delimiter
\ repeat delimiter
^ component delimiter
& escape delimiter
3 Message control ID I N
4 Access Password I N
5 Sender (name or ID) R N 7 Download: laboratory PC name
6 Sender address I A Upload: "Mitis2-VX.XX" (software version)
7 Reserved field I N
8 Sender telephone I N
9 Sender characteristics I N
10 Receiver ID I N
11 Comments / Special I N
12 Session ID I N
13 Current ASTM version I N
14 Current date and time R A 14 Format CCYYMMDDHHNNSS

Actions when receiving:

• Session opening.
• Saving the first 4 received characters : field and repeat delimiter, component
delimiter.
• Saving the beginning of the session.
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 7/11

Patient record
Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record type ID R A 1 P
2 Sequence number R A 1 (in the list of P)
3 Practice Assign Patient ID R A 20 Code number associated to the specimen.
If ID and name exist in the database, new data
overwrites existing data (transmitted fields only) ;
otherwise any subsequent O record is ignored.
4 Laboratory Assign Patient ID O S 10 Patient file number
5 Patient ID No. 3 O S 20 Social Security ID for France
6 Patient name O S 40 Name[ 20], ^, first name[ 20],
7 Maiden name O S 20 Maiden name
8 Birth date O S 8 Format CCYYMMDD
9 Patient sex O S 1 M / F/U(unknown)
10 Patient Race/Ethnic Origin I N
11 Patient Address O S 60 Part 1[30] ^ part 2[30]
12 Reserved field I N
13 Patient Tel. Number I N
14 Attending Physician ID O S 40 Collector ID[20]^ Collector function[20]
15 Special Field 1 I N
16 Special Field 2 I N
17 Patient height I N
18 Patient weight I N
19 Patient Illness I N
20 Patient active medication I N
21 Patient Diet I N
22 Practice field No. 1 I N
23 Practice field No. 2 I N
24 Admission and Discharge Date O S 14 Collection date/time – CCYYMMDD000000
25 Admission status I N
26 Location I N
27 Nature of Alternative Diag. Code I N
28 Alternative Diagnostic Code I N
29 Patient Religion I N
30 Marital Status I N
31 Isolation Status I N
32 Language I N
33 Hospital Service O S 40 Collection requested by[20]^ Ward or service
name[20]
34 Hospital Institution I N
35 Dosage Category I N

Actions when receiving:

1. Opening of a new patient field.
2. Integration of patient data.

Comment:
"Birth Place" and comments are not accessible via the patient fields.

Please note:
In reception, all fields except the "Practice Assign Patient ID" are optional. If no other
field is available a sample record with no counterpart in the patient database is
created in the sample database. (please refer to the database definition of Mitis2).
If additional patient data is available, patient first name and name are required in
order to create the record in the patient database. If the patient record already exists,
Patient ID, first name and name must be identical in order to overwrite existing data
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 8/11

with the value of the new fields. The request on the sample (patient data and test
requests) would otherwise be ignored.

Comment record after a patient record

The format hereunder is only valid for a "Comment record" that follows a "Patient
record".

Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record Type ID R A 1 C
2 Sequence Number R A 1 (in the list of C)
4 Comment Text O S 70 Birth Place[30]^comment on the patient[40]

Actions when receiving:

This field is used to transfer additional data on the patient. If several "Comment
records" are associated to a patient, only the last one is saved.
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 9/11

Test Order record

Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record Type ID R A 1 O
2 Sequence Number R A 3 (in the list of O)
3 Specimen ID N I
4 Instrument Specimen ID R A 40 Code of the specimen/recipient sample ^ Code of
*
the donor sample
5 Universal Test ID R A 20+3 ^^^Name of the Test Order as defined in Mitis2
†
software
‡
6 Priority O N S(tat) or R(outine) Default : R
7 Request Ordered Date/Time I N
8 Specimen Collect Date/Time I N
9 Collection End Time I N
10 Collection Volume/Units I N
11 Collector ID I N
12 Action Code O N 1 C(anceled) or N(ew). Default : N
13 Danger Code I N
14 Relevant Clinical Info. I N
15 Date/Time Specimen Received I N
16 Specimen Type/Source I N
17 Ordering Physician I N
18 Physician Tel. Number I N
19 User Field No. 1 I N
20 User Field No. 2 I N
21 Lab. Field No. 1 I N
22 Lab. Field No. 2 I N
23 Date/Time Results Reported Last I A 14 Date of last modification of sample results
or Modified CCYYMMDDHHNNSS
24 Instrument Charge I N
25 Instrument Section ID I N
26 Record Types I N
27 Reserved I N
28 Location or Ward of Specimen I N
Collection
29 Nosocomial Infection Flag I N
30 Specimen Service I N
31 Specimen Institution I N

*
Sample code number management :
• in the case of a simple test the code is that of the sample,
• in the case of a X-match, the codes are those of the recipient followed by that of the donor.
†
A "test request" stands for a group of protocols and the associated results to be transmitted (ABO,
ABScreen, Rh/Phenotype, Kell, Dat). The name and content of the test requests must be defined in
Mitis2 software. If the test request name cannot be identified it is ignored.
‡
priority: a sample may be marked as "stat", which means that it will appear in a stat list in the Mitis2;
this is only an indication for the operator, and has nothing to do with the notion of stat samples in
Mitis2 sample management (those samples are to be run in a normal way, it'up to the operator to run
them before or not).
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 10/11

Results record
Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record Type ID R A 1 R
2 Sequence Number R A 1
3 Universal Test ID I A 20+3 ^^^type^num^type of reagent^Test Order name as
defined in Mitis2 software^determination level of
the Test Order
type = W for unit results (well or column)
type = Gn for interpreted group of reactions
num = well or column number following the
protocol order if type = W
num = 99 for interpreted group of reactions
4 Data or Measurement Data I A 7*11 Result code (configurable)*
W : result for a well or column
Gn : interpretation when possible
5 Units of Measure I A 1 Type of reaction support
C : BioVue cassette
M : microplate
6 Reference Ranges I N

7 Result Abnormal Flags I N

8 Nature of Abnormality I N
9 Result Status I S 1 R : automated reading result
M : operator modified result
10 Date of Change in Instrument I N
Normative Values or Units
11 Operator ID I A 20 Name of the operator who has last edited the
sample results
12 Date/Time Test Started I A 14 Date/Time of last modification
CCYYMMDDHHMMSS
13 Date/Time Test Completed I N
14 Instrument ID I N

Comment record after a Result record

*
List of interpretations:
• G1 : Group interpretation 1 determination level
st

• G2 : empty
• G3 : IAT+ENZ interpretation
• G4 : Rh/Pheno interpretation 1 determination level
st

• G5 : Unused
• G6 : IAT interpretation
• G7 : Unused
• G8 : Group interpretation 2 determination level
nd

• G9 : Rh/Pheno interpretation 2 determination level

nd

• G10 : Unused
• G11 : Group interpretation 1 + 2 determination level
st nd

• G12 : Rh/Pheno interpretation 1 + 2 determination level

st nd

• G13 : Unused
• G14 : Enzyme test interpretation
• G15 : Rhesus D 1 determination level
st

• G16 : Rhesus D 2 determination level

nd

• G17 : Rhesus D 1 + 2 determination level

st nd
 Microdom - Mitis 2 – SFD – Format ASTM v. 2
Document reference Revision Edition date Author Page
M2SFDFormatASTM 003 18/03/02 DM/PF 11/11

The format hereunder is only valid for a "Comment record" that follows a "Results
record".

Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record Type ID R A 1 C
2 Sequence number R A 1
4 Comment text I A 64k additional data

Actions when receiving:

The "comment record" makes it possible to string additional data to a "results" record.
If several "comment records" are linked to a "result record" the last one only is saved.
The format of the additional data is edited with the formatting software included in
Mitis2 package. This additional data can be divided into two groups :
• W for well or column information,
• G for global information.

The content of the "Comment record" makes it possible to transfer to the distant
system information such as the reaction support number or information about the
reagent used for the reaction.

Message Terminator Record

Direction
# Field title M2 Max. Description and Valid Values
D U
1 Record Type ID R A 1 L
2 Sequence Number R A 1 1
3 Termination Code R A 1 N,T,R,E,Q,I,F