LIS Interface

Document code: INS700.LIS

Revision: 7.0A, October 2018
Copyright © 2018 Thermo Fisher Scientific Inc. and its subsidiaries. All rights reserved.
In the European Union Optilite® is a registered trademark of The Binding Site Group Ltd, Birmingham, UK.
This document is provided to customers with an analyzer purchase to use in the analyzer operation. This document is copyright
protected and any reproduction of the whole or any part of this document is strictly prohibited, except with the written
authorization of Thermo Fisher Scientific.
The contents of this document are subject to change without notice. No representations are made that this document is complete,
accurate or error free. All technical information in this document is for reference purposes only. System configurations and
specifications in this document supersede all previous information received by the purchaser.
Use of this analyzer in a manner not specified by the manufacturer could impair any protection provided by the analyzer. No
responsibility and no liability is assumed for any errors, omissions, damage or loss that might arise out of the use or inability to use
this analyzer.
This document is not part of any sales contract. This document shall in no way govern or modify any Terms and Conditions of
Sale, which Terms and Conditions of Sale shall govern all conflicting information between the two documents.

MANUFACTURER
Thermo Fisher Scientific Oy
Ratastie 2, FI-01620 Vantaa, FINLAND
Tel. +358 10 329 200
www.thermofisher.com

Commercial vendor
The Binding Site Group Limited
8 Calthorpe Road
Edgbaston
Birmingham
B15 1QT
England
Tel: +44 (0) 121 456 9500
Fax: +44 (0) 121 456 9749
E-mail: info@bindingsite.co.uk
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Notices
When the system is delivered to you, it meets the pertinent electromagnetic compatibility (EMC)
and safety standards as described below.

Standards
Table 1. Conformity with the following international standards and regulations

Standard Title

• EN ISO 13485 Medical devices - Quality management systems - Requirements

for regulatory purposes.

• EN ISO 14971 Medical devices - Application of risk management to medical

devices.

• EN 61010-1 Safety requirements for electrical equipment for measurement,

• IEC 61010-1 control, and laboratory use - Part 1: General requirements.
• UL 61010-1
• CAN/CSA-C22.2 No.
61010-1

• EN 61010-2-010 Safety requirements for electrical equipment for measurement,

• IEC 61010-2-010 control, and laboratory use - Part 2-010: Particular
requirements for laboratory equipment for the heating of
• CAN/CSA-C22.2 No.
material.
61010-2-010

• EN 61010-2-081+A1 Safety requirements for electrical equipment for measurement,

• IEC 61010-2-081+A1 control, and laboratory use - Part 2-081: Particular
requirements for automatic and semi-automatic laboratory
• CAN/CSA-C22.2 No.
equipment for analysis and other purposes.
61010.2.081

• EN 61010-2-101 Safety requirements for electrical equipment for measurement,

• IEC 61010-2-101 control, and laboratory use - Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment.
• CAN/CSA-C22.2 No.
61010.2.101

• EN 61326-1 Electrical equipment for measurement, control and laboratory

use – EMC requirements – Part 1: General requirements.

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 Standard Title

• EN 61326-2-6 Electrical equipment for measurement, control and laboratory

use – EMC requirements – Part 2-6: Particular requirements -
In vitro diagnostic (IVD) medical equipment.

• FCC CFR 47 Part 15 Subpart B, Class B. EMC Requirements for US.

• EN 62304 Medical device software - Software life-cycle processes.

• IEC 62304

• EN 50581 Technical documentation for the assessment of electrical and

electronic products with respect to the restriction of hazardous
substances.

• CLSI LIS01-A2 (2nd Specification for Low-Level Protocol to Transfer Messages

edition) Between Clinical Laboratory Instruments and Computer
Systems; Approved Standard.

• CLSI LIS02-A2 (2nd Specification for Transferring Information Between Clinical

edition) Laboratory Instruments and Information Systems; Approved
Standard.

CE
The CE mark attached on Optilite® (clinical chemistry analyzer, type 864)
indicates the conformity with the IVD (in vitro diagnostic medical devices)
directive 98/79/EC and RoHS directive (Restriction of the use of certain
hazardous substances in electrical and electronic equipment) 2011/65/EU.

Changes that you make to your system may void compliance with one
or more of these EMC and safety standards. Changes to your system
include replacing a part or adding components, options, or peripherals not
specifically authorized and qualified by Thermo Fisher Scientific. To ensure
continued compliance with EMC and safety standards, replacement parts
and additional components, options, and peripherals must be ordered from
Thermo Fisher Scientific or one of its authorized representatives.

FCC Notice
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with

iv
 the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for help.

WEEE Compliance
This product is required to comply with the European Union’s Waste Electrical & Electronic
Equipment (WEEE) Directive 2012/19/EU. It is marked with the following symbol:

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Contents

Preface Preface.......................................................................................................................ix
Intended use.................................................................................................. ix
Intended audience..........................................................................................ix
Product documentation................................................................................. ix
Document revision history......................................................................... x
Document symbols and conventions.............................................................. x
Symbols in manual.....................................................................................x
Document conventions.............................................................................. x
Chapter 1 Hardware interface.................................................................................................. 1
Chapter 2 Configuring ASTM software................................................................................... 3
Configuring serial connection.........................................................................5
Configuring TCP/IP connection.................................................................... 6
Socket Communication..............................................................................6
Communication protocol........................................................................... 6
Configuration.............................................................................................6
Connection management........................................................................... 7
Configuring test online names....................................................................... 8
Chapter 3 ASTM protocol...........................................................................................................9
Features.......................................................................................................... 9
CLSI LIS2-A message structure....................................................................10
Header record (level 0)............................................................................ 10
Message terminator record (level 0)......................................................... 11
Patient information record (level 1)......................................................... 12
Test order record (level 2)....................................................................... 13
Result record (level 3).............................................................................. 17
Comment record (level 4) used with result record....................................18
Comment record (level 3) used with transmission error conditions........ 20
Request information record (level 1)........................................................21
Chapter 4 Field lengths.............................................................................................................23
Chapter 5 Examples: communication between analyzer and host computer................ 25
Chapter 6 Windows 7 firewall activation and rule configuration................................... 31
Enabling Windows 7 firewall....................................................................... 31
Configuring Network Profiles.................................................................. 31
Remove all rules.......................................................................................32
Creating a Rule........................................................................................ 33

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Contents

Example Rule: Allow ASTM connection to use TCP/IP.......................... 34

Required firewall rules..................................................................................37

Glossary.....................................................................................................................39

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 P

Preface

LIS Interface contains instructions on how to integrate the analyzer into the laboratory
information system (LIS). This manual describes the communication between the analyzer and
the host.

Intended use
The Optilite® Clinical Chemistry Analyzer is a fully automated random access analyzer used to
measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

Intended audience
This manual is addressed to the personnel responsible for integrating the analyzer into the
laboratory information system (LIS). The personnel must be trained in and should have a
knowledge of handling the analyzer.

Note It is recommended to follow good laboratory practices (GLP).

Product documentation
The product documentation consists of the following manuals:
• Operation Manual contains instructions on how to operate the analyzer during normal
operation once it has been installed. The manual can be used to find out what needs to
be done before running analyses and how to run analyses. The manual also contains daily
maintenance task descriptions and a troubleshooting guide.
• Reference Manual contains operational and analysis principle descriptions and lists test
parameters per test.
• Installation Manual contains instructions on how to install the analyzer. The manual
describes procedures for mechanical and electrical installation. The chapters are organized in
the chronological order in which the analyzer should be installed.
• Service Manual contains instructions on how to service and maintain the analyzer. The
manual also describes procedures for adjusting the analyzer and information about the
analyzer parts. The manual also lists spare parts and accessories. Service Manual is provided
only to the trained service engineers.

ix
Preface

• The LIS Interface manual contains instructions on how to integrate the analyzer into the
Laboratory Information System (LIS). The manual describes the communication between the
analyzer and the host, using the RS-232 or TCP/IP interface.

Document revision history

Document version and Document Software History
date code version

A/October 2013 INS700.LIS 5.1 Document created.

A/July 2014 INS700.LIS 5.2 Intermediate result sending added. Additional information added about
CLSI LIS2-A message structure.

A/June 2015 INS700.LIS 5.3 Updated CLSI LIS2-A message structure and contact information. Updated
contact information.

A/October 2016 INS700.LIS 6.0 Updated CLSI LIS2-A message structure.

B/March 2018 INS700.LIS 6.0 Added instructions to enable Windows firewall.

A/October 2018 INS700.LIS 7.0 Updated CLSI LIS2-A message structure. Added firewall configuration
instructions.

The original language of these instructions is English.

Document symbols and conventions

Symbols in manual
This manual uses notes that point out important information related to the correct and safe
operation of the analyzer. Therefore, comply fully with all notices.

Note The note icon informs the operator of relevant facts and conditions.

CAUTION The caution icon indicates important information or warnings related to the
concept discussed in the text. It might indicate the presence of a hazard which could result in
the corruption of software or damage to equipment or property.

Document conventions
• Important abbreviations and terms in this manual are spelled out in Glossary.
• The last command of the user interface menu path is presented in bold, for example: Select
F2 > Samples > New.

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 Preface

• Menu names in the user interface are shown in bold, for example: Select the correct test from
the Test name drop-down menu in the Results view.
• Parameter names are shown in italics, for example: The test can be taken into or out of use
with the In use parameter.
• Parameter values are indicated with quotation marks, for example: The values of the In use
parameter are “Yes” and “No”.
• The statuses and messages are shown in Courier font, for example No valid
calibration.

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 1

Hardware interface
The analyzer LIS hardware interface works through a serial communication channel or an
ethernet interface. The ethernet connector and the connector for serial communication are at
the back of the analyzer workstation. An ethernet cable is used for the TCP/IP connection. The
connector for the serial communication channel is a 9-pin male D-connector.

Note Do not use network cable connection for the internet or other LAN connections.

Figure 1. Connections

1 - Serial connection
2 - Ethernet connection

Table 2. The signals needed at the analyzer end of cable

Pin Description

Pin 2 Receive Data

Pin 3 Transmit Data

Pin 5 Ground

Note Configure the cable according to the documentation of LIS system in use.

Table 3. Example of cabling between analyzer and LIS

Analyzer PC (RS-232)

Pin 2 RxD Pin 3 TxD

Pin 3 TxD Pin 2 RxD

Pin 5 Gnd Pin 5 Gnd

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1 Hardware interface
Hardware interface

Note This example describes the minimum cable connections needed. Some computer
systems may require some additional signals connected locally within connector. For more
information about requirements, refer to the LIS documentation (Standards CLSI LIS01-A2
and CLSI LIS2-A 2).

2
 2

Configuring ASTM software

To configure ASTM software:
1. Before configuration, take LIS into use.
a) Select F5 > Configuration > Analyzer.
b) Select Yes from the LIS connection in use drop-down menu.
Figure 2. Selecting LIS connection in use

2. Select F5 > Configuration > LIS to configure parameters shown in Configuration

modifications on page 3. The ASTM software has additional configurations comparing
to the analyzer online software. The configuration file is saved into the database.

Note The ASTM software supports sending results on ready sample or ready request
basis. The sending of results on ready request basis loads the interface heavily. It is
recommended to send results by ready sample. The selection can be done through the
analyzer configuration function.

Table 4. Configuring parameters

Parameter Value to be used Description

Type of communication TCP/IP, Serial Select a connection type

Result sending criteria Request, Sample Define whether the sample results are sent according to the
request or sample.

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2 Configuring ASTM software
Configuring ASTM software

Parameter Value to be used Description

Automatic result sending Yes If the value is set to "Yes", new sample results and QC results
(if defined) are automatically sent to the laboratory computer.

Host query in use Yes If the value is set to "Yes", the analyzer software sends a query
for sample information and requests when a sample is added
into the analyzer and barcode is read.

Multiple host query Yes/No If the value is set to "Yes", the analyzer sends the host query
every time the barcode of the sample is read. If the value is
set to "No", the analyzer sends the host query only for new
samples.

Sample ID sending delay (ms) 0 If the value is not set to "0", the analyzer uses the delay between
successive sending of new sample IDs. The sending delay
can be used to ease the burden on laboratory computer, for
example, when a full rack is introduced. The value is expressed
in milliseconds.

Result sending delay (ms) 0 If the value is not set to "0", the analyzer uses the delay between
successive sending of new sample results. The sending delay can
be used to ease the burden on laboratory computer. The value
is expressed in milliseconds.

QC result sending in use Yes If the value is set to "Yes", QC results are sent to the laboratory
computer. The program also supports requests for archived QC
results.

Send intermediate results No If the value is set to

• Yes - intermediate results are sent from all requests to
the laboratory computer when the related final result is
accepted. Intermediate results are flagged as such in result
status field of the result record.
• Partial - intermediate results are only sent to tests which
contains prozone check, antigen excess or sample addition
antigen excess
• No - No intermediate results are sent, only the final results
are sent to the laboratory computer.

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 2 Configuring ASTM software
Configuring serial connection

Figure 3. LIS Configuration

• Configuring serial connection

• Configuring TCP/IP connection
• Configuring test online names

Configuring serial connection

If the Type of communication is set to Serial, configure parameters for serial interface.

Table 5. Serial interface parameters

Parameter Values Description

Serial port COM1, COM3, COM4, Select the serial port.

COM5, COM6

Baud rate 2400, 4800, 9600, 19200 Select the baud rate between 2400 and 19200.

Data bits 8 The number of data bits is set to 8.

Stop bits 1, 2 The number of stop bits can be set to 1 or 2.

Parity Even, Odd, No, Space, mark Select the type of parity checking. If the value is set to "No",
the parity checking is not performed.

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2 Configuring ASTM software
Configuring TCP/IP connection

Configuring TCP/IP connection

For safe network connection, activate the firewall as insturucted in Enabling Windows 7 firewall
on page 31.

Socket Communication
Analyzer’s socket communication is based on Windows Sockets which uses TCP/IP connection
oriented sockets. A connection is needed between two parts, which are able to communicate,
before information transmission can occur. After the communication, the connection can be
terminated. The connection remains open until the session is closed, a request to clear the daily
files is initiated or an error is occurred.
Analyzer can act as a client or a server in a socket communication. If the analyzer is run as a client,
the analyzer tries to establish a connection to a given port at the given IP address. If the analyzer
is run as a server, the analyzer creates a listening socket for a given port at given IP address and
accepts client connection requests.
Communication requires a server at one end and a client at another end. Furthermore, the
analyzer server mode can serve only one connection at a time and any attempt to create
more connections may lead to malfunction. When the Windows firewall is in use, allow the
ArcASTM.exe process to pass the firewall. It is allowed to disable the firewall only for testing
purposes.

Communication protocol
Analyzer uses the ASTM protocol in socket communication. The serial channel is replaced with
the socket communication. All interactions and message structures are similar when using a serial
channel.

Configuration
Configure a new network card to use the specific TCP/IP address that is reserved for the
communication. Configure the new card using Network Connections in Windows Control
Panel.

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 2 Configuring ASTM software
Connection management

Figure 4. LIS configuration

Furthermore, define the connection parameters for socket communication. Select TCP/IP from
the Type of communication drop-down menu and configure parameters shown in TCP/P
connection parameters on page 7. For successful communication, both ends must use same
port number and matching IP addresses.
Table 6. TCP/IP connection parameters

Parameter Values Description

Socket communication type Server, Client Analyzer software can be socket server or socket client

Analyzer address IP address configured to a new network card

LIS address IP address for LIS system

LIS port 10100 A communication port which is opened to ASTM

communication

Connection management
Analyzer tries to connect when possible. In client mode, the analyzer tries to create a connection
once in every 20 milliseconds. In server mode, the analyzer waits for a connection. After the
connection has been established, the analyzer does not disconnect until the application is closed,
a request to clear the daily files is initiated or an unrecoverable error condition is occurred in
communication.
Furthermore, clearing daily files and changing the LIS connection communication parameters
disconnects the analyzer, but the connection is restored after the operation has been performed.
The analyzer waits for a few seconds before accepting any new data through the LIS connection.
This ensures that the analyzer is internally stable before starting a new session. Error messages
are not shown when the connection is terminated due to the clearing of daily files. If a

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2 Configuring ASTM software
Configuring test online names

communication error occurs, analyzer disconnects and one of the following error messages is
shown:
4403 Write error (LIMS)
4404 Read error (LIMS)
4406 Communication time-out (LIMS)
4407 Transmit error (LIMS)

Error messages indicate the problems in communication. Analyzer tries to restore the connection
immediately after it is disconnected. A flashing yellow signal on workstation screen indicates a
communication trial is going on, but it does not indicate a successful communication.

Configuring test online names

Each test must have a test online name defined, if results or requests need to be transferred into
the LIS system through the ASTM protocol. The test online name must match with the LIS test
name, otherwise an error message is shown. The test online name must be unique for each test. If
the online name is invalid, a comment message is sent to the LIS server.
Figure 5. Configuring test online names

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ASTM protocol
The ASTM laboratory information management system interface is based on the following
standards:
• CLSI LIS1-A: Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems
• CLSI LIS2-A: Standard Specification for Transferring Information Between Clinical
Instruments and Computer Systems

• Features
• CLSI LIS2-A message structure

Features
The physical transmission layer is implemented according to CLSI LIS1-A. The connection can
be established through the serial communication channel or the ethernet interface. The logical
layer contains selected portions of CLSI LIS2-A. The detailed record structure is described in
CLSI LIS2-A message structure on page 10.
Main features:
• automatic request for sample information when new sample is introduced to the analyzer
(configurable ON/OFF)
• automatic sending of results either on ready sample or ready request basis (configurable
reporting basis and ON/OFF)
• automatic sending of quality control results (configurable ON/OFF)
• response to sample information requests from the laboratory computer
• response to sample information received from the laboratory computer
• response to quality control information requested from the laboratory computer
• error situation management

Signal Pin

RxD (received data) 2

TxD (transmitted data) 3

GND (ground) 5

Default communication parameters:

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3 ASTM protocol
CLSI LIS2-A message structure

• 9600 baud
• 8 bit
• 1 start bit
• 1 stop bit
• no parity
No hardware or software flow control is used.

CLSI LIS2-A message structure

Following sections describe the ASTM records used by the analyzer.
The tables include:
• field name
• field number
• information about the field usage by the host
• information about the field usage by the analyzer
• description about the field usage
Optional fields have the usage information in brackets (X). The host can send data filled in all
the fields, but only the marked fields are processed. The maximum length of the record is 247
characters without control characters and checksum. The ASTM software uses windows 1252
character encoding that supports characters 128-255 in ASCII table.

Header record (level 0)

The checksum is initialized to zero with the <STX> character. The first character used in
computing the checksum is the frame number. Each character in the message text is added to
the checksum (modulo 256). The computation for the checksum does not include <STX>, the
checksum characters, or the trailing <CR> and <LF>.

Field name No. Host Analyzer Description

Record type ID 1 X X Always H. Starts every message. Do not use

delimiter between the first and the second field

Delimiter definition 2 X X Field, repeat, component and escape delimiters

Message control ID 3 -

Access password 4 -

Sender name or ID 5 - X Analyzer type [1]

- X Analyzer ID

- X Database version

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 3 ASTM protocol
Message terminator record (level 0)

Field name No. Host Analyzer Description

Sender street address 6 - -

Reserved field 7 - -

Sender telephone number 8 - -

Characteristics of sender 9 - -

Receiver ID 10 - -

Comment or special instructions 11 - -

Processing ID 12 X X P (production)

X X T (training)

X X D (debugging)

X X Q (QC)

Version No. Date and time of 13 - -

message

Date and time of message 14 - (X) Form YYYYMMDDHHMMSS. Only in debug

mode.

Message terminator record (level 0)

Field name No. Host Analyzer Description

Record type ID 1 X X Always L. Ends every message.

Sequence number 2 X X Always 1. One terminator per message.

Termination code 3 (X) (X) N or missing (normal termination)

X X T (sender aborted)

X X R (receiver requested abort)

X X E (unknown error)

- X Q (error in last request for information)

- X I (no information available from last query)

- X F (last request for information processed)

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3 ASTM protocol
Patient information record (level 1)

Patient information record (level 1)

If patient information is used, the patient ID field is required.

Field name No. Host Analyzer Description

Record type ID 1 X X Always P.

Sequence number 2 X X Running number within Message. Starts with 1.

Practice assigned patient ID 3 (X) (X) If no code is given, this gets the value of Patient
name.

Note This is mandatory information, if

patient information is transferred to the
analyzer.

Laboratory assigned patient ID 4 - -

Patient ID No. 3 5 - -

Patient name 6 (X) (X) Last name. Only one text field. Type the whole
name. Optional if no patient relates to sample.

- - First name

- - Middle name or initials

Mothers maiden name 7 - -

Date of birth 8 (X) (X) Form YYYYMMDD.

Patient sex 9 (X) (X) Used as a reference range name. The field is case-
sensitive.

Patient race-ethnic origin 10 - -

Patient address 11 - -

Reserved field 12 - -

Patient telephone number 13 - -

Attending physician ID 14 - -

Special field 1 15 - -

Special field 2 16 - -

Patient height 17 - -

Patient weight 18 - -

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 3 ASTM protocol
Test order record (level 2)

Field name No. Host Analyzer Description

Patient’s known or suspected 19 - -

diagnosis

Patient active medications 20 - -

Patient’s diet 21 - -

Practice field 1 22 - -

Practice field 2 23 - -

Admission or discharge dates 24 - -

Admission status 25 - -

Sender 26 (X) (X) Ordering doctor

Native of alternative diagnostic code 27 - -

and classifiers

Alternative diagnostic code and 28 - -

classification

Patient religion 29 - -

Marital status 30 - -

Isolation status 31 - -

Language 32 - -

Hospital service 33 - -

Hospital institution 34 - -

Dosage category 35 - -

Test order record (level 2)

Field name No. Host Analyzer Description

Record type ID 1 X X Always O.

Sequence number 2 X X Running number within Patient information.

Starts with 1.

Sample ID 3 X X Sample ID or Control ID^Manual dilution

Note: Manual dilution is not recommended.

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3 ASTM protocol
ASTM protocol

Field name No. Host Analyzer Description

Manual dilution is optional. If manual dilution information is not used, the

value is set "0".

Analyzer Sample ID 4 - -

Universal test ID 5 - - Universal test ID

- - Universal test name

- - Universal test ID type

X X Manufacturer defined test code

(X) X Auto-dilution factor

When auto-dilution is used, it overrides sample
type dilution defined in the user interface.

Multiple tests can be ordered separated by repeat delimiter

Priority 6 (X) (X) S (stat)

(X) (X) A (asap)

(X) (X) R (routine)

- - C (callback)

- - P (preoperative)

Optional, if there is no sample or sample is calibrator or control.

Requested/ordered date and time 7 - -

Sample collection date and time 8 (X) (X) Form YYYYMMDDHHMMSS

Collection end time 9 - -

Collection volume 10 - -

Collector ID 11 - -

Action code 12 X - A (add test requests to existing sample)

X - N (new test requests + new sample)

- X P (pending sample)

- - L (reserved)

- X X (sample or test in process)

- X Q (QC sample)

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 3 ASTM protocol
ASTM protocol

Field name No. Host Analyzer Description

- X C (comment)

Multiple action codes can be typed separated by repeat delimiter. For

example X\Q.

Danger code 13 - -

Relevant clinical information 14 (X) (X) Sample information field

Date/time sample received 15 - -

Sample descriptor (type and source) 16 X X Type

- - Source

Type coding: 1 - serum 2- Plasma 3- Urine, 4 - CSF, 5 - Oral fluid, 6 -

Whole blood, 7 - Hemol. Blood, 8 - Other
Note: Control results do not contain sample type information.

Ordering physician 17 - -

Physicians telephone number 18 - -

User field No.1 19 - -

User field No.2 20 - -

Laboratory field No.1 21 - (X) Control lot ID

- (X) Concentration

- (X) Control lot standard deviation

Laboratory field No.2 22 - X Calculated concentration of the lowest calibrator

or the average of the calculated concentrations
of the lowest calibrator in case of duplicate or
triplicate points

- X Calculated concentration of the highest calibrator

or the average of the calculated concentrations
of the highest calibrator in case of duplicate or
triplicate points

- X Reagent ID1

- X Lot

- X Vial ID1

- X Reagent ID2

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3 ASTM protocol
ASTM protocol

Field name No. Host Analyzer Description

- X Lot

- X Vial ID2

Date/time results reported or last 23 - -

modified

Instrument charge to computer 24 - -

system

Instrument section ID 25 (X) (X) Optional if no sample, Optilite always 1

Report types 26 X - O (order)

- - P (preliminary results)

- - C (correction to previously transmitted results)

- X F (final results)

X X X (requests cancelled)

X X I (in analyzer pending)

- X Y (no order for test (response to query))

- X Z (no record of this patient (response to query))

X X Q (response to query (info))

Multiple report types can be typed separated by repeat delimiter. For

example Y\Z.

Reserved field 27 - -

Location or ward of sample 28 - -

collection

Nosocomial infection flag 29 - -

Sample service 30 - -

Sample institution 31 - -

Note If even one test is requested as STAT, the priority of test order record is set to stat (S)
when results are reported by samples. When results are reported by requests, the right test
priority is always seen.

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 3 ASTM protocol
Result record (level 3)

Result record (level 3)

Field name No. Host Analyzer Description

Record type ID 1 - X Always R.

Sequence number 2 - X Running number within Test order. Starts with 1.

Universal test ID 3 - - Universal test ID

- - universal test name

- - universal test ID type

- X manufacturer defined test code

- X dilution factor used in calculation

Data or measurement value 4 - (X) If the result status is X (cancelled) or result is

UNSTABLE, no result is given. The range
of result will be [99999.9 … 0.00000] and
[-0.00000 … -99999.9]. If the actual result
exceeds the values, the nearest value is shown.
If the result has Outside calibration error, the
result is displayed as "> [calibration limit]" or "<
[calibration limit]" instead of a numeric value.

Units 5 - (X) Text field. All special characters (e.g. µ) are not
supported. Unsupported characters are replaced
with "?" character.

Reference ranges 6 Components:

- X Low limit

- X High limit

- - Description

Result abnormal flags 7 - X L/N/H (below lower limit/normal/above higher

limit)

Nature of abnormality testing 8 - -

Result status 9 - - C (correction)

- X P (preliminary)

- X F (final)

- X X (cancelled)

- X I (pending/intermediate)

17
3 ASTM protocol
Comment record (level 4) used with result record

Field name No. Host Analyzer Description

- - S (partial)

- - M (MIC level)

- X R (reported)

- - N (contains necessary information to run a new

order)

- X Q (response to query)

- - V (verified)

- - S (result from pretreated sample)

Multiple status flags can be given separated by repeat delimiter. For example
F\Q.

Date of change in analyzer normative 10 - -

values or units

Operator identification 11 - X User login name if User levels have been set on.
When a result is manually accepted, current user's
login name is sent with the result. If the result is
automatically accepted the text is "Automatic".
Intermediate results are always automatically
accepted and the the operator identification text is
"Automatic".

Date/time test started 12 - -

Date/time test completed 13 - (X) Form YYYYMMDDHHMMSS. No value if test

is not completed.

Analyzer identification 14 - X Analyzer ID is defined in the configuration

parameter AnalyzerName.

Comment record (level 4) used with result record

Field name No. Host Analyzer Description

Record type ID 1 - X Always C. Used to transfer analyzer flags after

Result record.

Sequence Number 2 - X Always 1, because of the use.

Comment source 3 - - P (practice)

- - L (computer system)

18
 3 ASTM protocol
ASTM protocol

Field name No. Host Analyzer Description

- X I (clinical analyzer system)

Comment text 4 - X Error condition identified with a number and

a text in English. When the text in a comment
record differs from the text in the Measurement
Errors chapter in Operation Manual, the
Operation Manual text is shown in parentheses.
2 - Addl. meas. error
3 - Instrument abs. limit (Abs. high)
4 - Init abs. low
5 - Init abs. high
6 - Bichr. net abs.
7 - Linearity
8 - Point(s) out of curve
9 - Reaction direction
10 - Blank init abs. low
11 - Blank init abs. high
12 - Blank resp. low
13 - Blank resp. high
14 - Unstable
15 - Unstable cal.
16 - Liquid movement
18 - Dil. limit low
19 - Dil. limit high
20 - Test limit low
21 - Test limit high
22 - Crit. limit low
23 - Crit. limit high
24 - Antigen limit low
25 - Antigen limit high
27 - QC (Batch incomplite)
28 - Calc. error
30 - Outside of cal.
31 - Square limit low (Coeff. of det. limit)
32 - Factor limit low (Slope limit min)
33 - Factor limit high (Slope limit max)
34 - Bias limit low
35 - Bias limit high
37 - Activity check
38 - Reference range low
39 - Reference range high

Multiple flags can be given separated with repeat delimiter.

Comment type 5 - (X) G (result approval comment)

- - T (test name comment)

- - P (positive test comment)

- - N (negative test comment)

19
3 ASTM protocol
Comment record (level 3) used with transmission error conditions

Field name No. Host Analyzer Description

- X I (analyzer flag(s) comment)

Comment record (level 3) used with transmission error conditions

Field name No. Host Analyzer Description

Record type ID 1 - X Always C. Used to transfer analyzer flags after

Result record.

Sequence Number 2 - X Always 1, because of the use.

Comment source 3 - - P (practice)

- - L (computer system)

- X I (clinical analyzer system)

Comment text 4 - X Error condition identified by 'E' followed by a

number
E3 - wrong initializing character in record
E4 - wrong termination code or request code in
record
E5 - records found in wrong order
E104 - invalid sample plate position, sample
position already reserved in analyzer by another
sample or calibrator or control. The new sample
was wrongly positioned by LIS. Use position 0^0
for any sample when the position is defined at
a later moment with sample insertion into the
analyzer.
E105 - problems with analysis request, request
could not be created
E201 sample rack position is reserved
E210 - problems with updating patient
information
E211 - patient information could not be found
E220 - sample already exists
E221 - problems with sample information
E222 - Invalid test online name

Comment type 5 - X G (generic/free text document)

20
 3 ASTM protocol
Request information record (level 1)

Field name No. Host Analyzer Description

- - T (test name comment)

- - P (positive test comment)

- - N (negative test comment)

- - I (analyzer flag(s) comment)

Request information record (level 1)

Field name No. Host Analyzer Description

Record type ID 1 X X Always Q. Analyzer requests external test results

or orders new samples. Host requests sample and/
or control results and monitors that results are in
analyzer’s database.

Sequence number 2 X X Always 1. Only one request can be outstanding at

a time.

Starting range 3 - - Patient ID or ALL

ID number (X) (X) Sample ID or ALL

(X) (X) Rack

(X) (X) Position

Patient ID and sample ID are text fields, so field is not used as range.
Multiple patients or samples can be requested separated by repeat delimiter.

Ending range 4 - -

ID number

Universal test ID 5 - - Universal test ID

- - Universal test name

- - Universal test ID type

(X) (X) Manufacturer defined test code or ALL

- - Auto-dilution factor

Multiple tests can be requested separated by repeat delimiter.

Nature of request time limits 6 - - S (sample collect date)

21
3 ASTM protocol
ASTM protocol

Field name No. Host Analyzer Description

(X) (X) R (result test date)

According to standard R is taken as default, so it is optional.

Beginning request results date and 7 (X) (X) Form YYYYMMDDHHMMSS

time

Ending request results date and time 8 (X) (X) Form YYYYMMDDHHMMSS

Requesting physician name 9 - -

Requesting physician telephone 10 - -

number

User field No.1 11 - -

User field No.2 12 - -

Request information status codes 13 - - C (correction)

(X) (X) P (preliminary)

(X) (X) F (final)

(X) (X) X (cancelled)

(X) (X) I (pending)

- - S (unfinalized results)

- - M (MIC level)

(X) (X) R (previously transmitted)

- - A (cancel last request criteria)

(X) (X) N (requesting new or edited results only)

(X) (X) O (requesting test orders only (no results)

- - D (requesting demographics only)

Note: not repeated.

22
 4

Field lengths

Field Length in characters

Analyzer type 1

Analyzer ID 20

Date and time of message 14

Practice assigned test ID 20

Patient name 24

Sample ID / Control ID 20

Manufacturer defined test code 30

Sample collection date and time 20

Relevant clinical information 80

Data or measurement value 9

Units 10

Date/time test completed 14

Beginning request results date and time 14

Ending request results date and time 14

23
(this page was intentionally left blank)
 5

Examples: communication between analyzer and

host computer
Examples show transmissions between the analyzer and the host computer, when the analyzer
is configured to use automatic sample ID Sending and automatic result Sending. The control
characters are presented between '<>'. For example <enq> means an ASCII character ENQ which
hexadecimal value is 05. Examples give only an overview, the actual communication may vary.
Before starting the communication, it is possible to turn on the debugging of communication
by selecting F5 > Actions. Click Change debug status and select the debug level. The file
lsdebug.txt in the folder c:\ARC\tmp includes the LIS communication messages sent
between the analyzer and LIS.

25
5 Examples: communication between analyzer and host computer
Examples: communication between analyzer and host computer

New sample introduced to the analyzer

Send: <ENQ>
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118101825<CR><ETX>A1
Read: <ACK>
Send: <STX>2Q|1|^SampleID_03^^||^^^ALL^||||||||O<CR><ETX>FF
Read: <ACK>
Send: <STX>3L|1|N<CR><ETX>06
Read: <ACK>
Send: <EOT>

Read: <ENQ>
Send: <ACK>
Read: <STX>1H|\^&|||1^LIS host^1.0|||||||P<CR><ETX>0D
Send: <ACK>
Read: <STX>2P|1|PatientID_03|||Patient Name_3|||U|||||||||||||||||Doctor Name|<CR><ETX>60
Send: <ACK>
Read: <STX>3O|1|SampleID_03||^^^Test_1|S||20101102100000||||||Test information field||3||||||||||O<CR><ETX>2E
Send: <ACK>
Read: <STX>4L|1|F<CR><ETX>FF
Send: <ACK>
Read: <EOT>

Send: <ENQ>
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118104132<CR><ETX>9B
Read: <ACK>
Send: <STX>2P|1|PatientID_03|||Patient Name_3||||||||||||||||||||Doctor Name||||||||<CR><ETX>F5
Read: <ACK>
Send: <STX>3O|1|SampleID_03^0.0^3^1||^^^Test_1^0|R||20101102100000||||X||Test information field||3|||||||||1|F<CR><ETX>21
Read: <ACK>
Send: <STX>4R|1|^^^Test_1^5|0.00830|µmol/l||||||||20101118104459|Analyzer_1<CR><ETX>D6
Read: <ACK>
Send: <STX>5L|1|N<CR><ETX>08
Read: <ACK>
Send: <EOT>

26
 5 Examples: communication between analyzer and host computer
Examples: communication between analyzer and host computer

Query and several tests to single sample

Send: <ENQ>
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118143543<CR><ETX>A4
Read: <ACK>
Send: <STX>2Q|1|^SampleID_07^^||^^^ALL^||||||||O<CR><ETX>03
Read: <ACK>
Send: <STX>3L|1|N<CR><ETX>06
Read: <ACK>
Send: EOT

Read: <ENQ>
Send: <ACK>
Read: <STX>1H|\^&||||||||||P<CR><ETX>0D
Send: <ACK>
Read: <STX>2P|1|PatientID_07|||Patient Name_7|||U|||||||||||||||||<CR><ETX>68
Send: <ACK>
Read: <STX>3O|1|SampleID_07^0.0^0^0||^^^Test_1\^^^Photo_reflex_test\^^^Photometric_test|R||||||||||3||||||||||O<CR><ETX>31
Send: <ACK>
Read: <STX>4L|1|F<CR><ETX>FF
Send: <ACK>
Read: <EOT>

Send: ENQ
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118143705<CR><ETX>A4
Read: <ACK>
Send: <STX>2P|1|PatientID_07|||Patient Name_7||||||||||||||||||||||||||||<CR><ETX>F3
Read: <ACK>
Send: <STX>3O|1|SampleID_07^0.0^5^1||^^^Test_1^0|R||||||X||||3|||||||||1|F<CR><ETX>9E
Read: <ACK>
Send: <STX>4R|1|^^^Test_1^5|0.00675|µmol/l||||||||20101118143620|Analyzer_1<CR><ETX>D6
Read: <ACK>
Send: <STX>5O|2|SampleID_07^0.0^5^1||^^^Photo_reflex_test^5|R||||||X||||3|||||||||1|F<CR><ETX>B4
Read: <ACK>
Send: <STX>6R|1|^^^Photo_reflex_test^0|0.74143|mmol/l||||||||20101118143621|Analyzer_1<CR><ETX>9C
Read: <ACK>
Send: <STX>7O|3|SampleID_07^0.0^5^1||^^^Photometric_test^5|R||||||X||||3|||||||||1|F<CR><ETX>56
Read: <ACK>
Send: <STX>0R|1|^^^Photometric_test^0|0.80626|nmol/l||||||||20101118143620|Analyzer_1<CR><ETX>39
Read: <ACK>
Send: <STX>1O|4|SampleID_07^0.0^5^1||^^^Reflex_test_done^5|S||||||X||||3|||||||||1|F<CR><ETX>2F
Read: <ACK>
Send: <STX>2R|1|^^^Reflex_test_done^5|0.18109|g/l||||||||20101118143705|Analyzer_1<CR><ETX>D0
Read: <ACK>
Send: <STX>3L|1|N<CR><ETX>06
Read: <ACK>
Send: EOT

27
5 Examples: communication between analyzer and host computer
Examples: communication between analyzer and host computer

Invalid test request

Read: <ENQ>
Send: <ACK>
Read: <STX>1H|\^&|||60^ASTM_Tester^5.0|||||||P||<CR><ETX>C5
Send: <ACK>
Read: <STX>2P|1|PatientID_06|||Patient Name_6||||||||||||||||||||Doctor Name||||||||<CR><ETX>D7
Send: <ACK>
Read: <STX>3O|1|SampleID_06||^^^Invalid_test|S||20101102100000||||A||Test information field||1|||||||||1|Q\O<CR><ETX>78
Send: <ACK>
Read: <STX>4L|1|F<CR><ETX>FF
Send: <ACK>
Read: <EOT>

Send: <ENQ>
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118141519<CR><ETX>A5
Read: <ACK>
Send: <STX>2P|1|PatientID_06|||Patient Name_6||||||||||||||||||||Doctor Name||||||||<CR><ETX><CR><ETX>F1
Read: <ACK>
Send: <STX>3O|1|SampleID_06||^^^^0|S||||||C||Test information field||3|||||||||1|X<CR><ETX>8D
Read: <ACK>
Send: <STX>4C|1|I|E105|G<CR><ETX>21
Read: <ACK>
Send: <STX>5L|1|Q<CR><ETX>0B
Read: <ACK>
Send: <EOT>

28
 5 Examples: communication between analyzer and host computer
Examples: communication between analyzer and host computer

Measurement error in result

Send: ENQ
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118151136<CR><ETX>A1
Read: <ACK>
Send: <STX>2Q|1|^SampleID_20^^||^^^ALL^||||||||O<CR><ETX>FE
Read: <ACK>
Send: <STX>3L|1|N<CR><ETX>06
Read: <ACK>
Send: EOT

Read: <ENQ>
Send: ACK
read: <STX>1H|\^&||||||||||P<CR><ETX>0D
Send: ACK
read: <STX>2P|1|PatientID_20|||Patient Name_20||20010101|M|||||||||||||||||<CR><ETX>0B
Send: ACK
read: <STX>3O|1|SampleID_20^0.0^0^0||^^^Photometric_test|R||||||||||2||||||||||O<CR><ETX>31
Send: ACK
read: <STX>4L|1|F<CR><ETX>FF
Send: ACK
Read: <EOT>

Send: ENQ
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20101118151301<CR><ETX>9B
Read: <ACK>
Send: <STX>2P|1|PatientID_20|||Patient Name_20||||||||||||||||||||||||||||<CR><ETX>19
Read: <ACK>
Send: <STX>3O|1|SampleID_20^0.0^4^1||^^^Photometric_test^0|R||||||X||||2|||||||||1|F<CR><ETX>44
Read: <ACK>
Send: <STX>4R|1|^^^Photometric_test^0|0.92129|nmol/l||||||||20101118151221|Analyzer_1<CR><ETX>38
Read: <ACK>
Send: <STX>5C|1|I|20 AE meas error|I<CR><ETX>55
Read: <ACK>
Send: <STX>6L|1|N<CR><ETX>09
Read: <ACK>
Send: EOT

29
5 Examples: communication between analyzer and host computer
Examples: communication between analyzer and host computer

Result with user comment

Send: ENQ
Read: <ACK>
Send: <STX>1H|\^&|||1^Analyzer_1^|||||||P||20110706101620<CR><ETX>9E
Read: <ACK>
Send: <STX>2P|1|PatientID_001|||Patient Name_1||||||||||||||||||||||||||||<CR><ETX>17
Read: <ACK>
Send: <STX>3O|1|SampleID_001^0.0^3^1||^^^Photometric_test^0.0|R||||||X||||3|||||||||1|F<CR><ETX>D4
Read: <ACK>
Send: <STX>4R|1|^^^Photometric_test^0.0|0.80496|nmol/l||||||||20110706101439|Analyzer_1<CR><ETX>A6
Read: <ACK>
Send: <STX>5C|1|I|21 Test limit high|I<CR><ETX>5F
Read: <ACK>
Send: <STX>6C|2|I|The result is commented|G<CR><ETX>FA
Read: <ACK>
Send: <STX>7L|1|N<CR><ETX>04
Read: <ACK>
Send: EOT

Sending control results

Send: ENQ
Read: <ACK>
Send: <STX>1H|\^&|||60^1^5.0|||||||Q||20010502130025<CR><ETX>94
Read: <ACK>
Send: <STX>2P|1||||||||||||||||||||||||||||||||<CR><ETX>BF
Read: <ACK>
Send: <STX>3O|1|Control_1||^^^Ca^0.0|R||||||Q||||1|||||||||1|<CR><ETX>C4
Read: <ACK>
Send: <STX>4R|1|^^^Ca^0.0|2.3|mmol/l|^^|N||F||||20010502130024|0<CR><ETX>D4
Read: <ACK>
Send: <STX>5L|1|N<CR><ETX>08
Read: <ACK>
Send: EOT

30
 6

Windows 7 firewall activation and rule

configuration
Introduction
A firewall is a software or hardware that checks information coming from the Internet or a
network, and then either blocks it or allows it to pass through to your computer, depending on
your firewall settings. A firewall can help prevent hackers or malicious software from gaining
access to your computer through a network or the Internet. A firewall can also help stop your
computer from sending malicious software to other computers.

Note Installing any third party antivirus software to the workstation PC is not allowed

Referencies
https://support.microsoft.com/en-us/help/4028544/windows-turn-windows-firewall-on-or-
off
https://technet.microsoft.com/en-us/library/cc753558(v=ws.11).aspx

• Enabling Windows 7 firewall

Enabling Windows 7 firewall

1. Click Start and in the Search for Programs and Files text box, type firewall.
2. In the search results, click Windows Firewall.
3. If the Windows Firewall is disabled, the Windows Firewall state will be off. If it is off, click
Change settings or Turn Windows Firewall on or off in the left column.
4. In the Firewall Settings window, select On and click OK.

Configuring Network Profiles

The Windows firewall uses three different profiles:
• Domain Profile: Used when your computer is connected to a domain.
• Private: Used when connected to a private network, such as a work or home network.
• Public: Used when connected to a public network, such as a public Wi-Fi access point or a
direct connection to the Internet.
Windows asks whether a network is public or private when you first connect to it.

31
6 Windows 7 firewall activation and rule configuration
Remove all rules

Remove all rules

The system has predefined inbound rules by default. You must delete these rules before you can
create new ones.
1. In the Windows Firewall with Advanced Security window, select Inbound rules.

2. Select all rules.

3. Click Delete.

32
 6 Windows 7 firewall activation and rule configuration
Creating a Rule

Creating a Rule
To create a rule, select the Inbound Rules or Outbound Rules category at the left side of the
window and click the New rule link at the right side.

Note The rules described will only allow the network connection to be used for
communication with the LIS.

The Windows firewall offers four types of rules:

• Program – Block or allow a program.
• Port – Block or allow a port, port range, or protocol.
• Predefined – Use a predefined firewall rule included with Windows.
• Custom – Specify a combination of program, port, and IP address to block or allow.

33
6 Windows 7 firewall activation and rule configuration
Example Rule: Allow ASTM connection to use TCP/IP

Example Rule: Allow ASTM connection to use TCP/IP

34
6 Windows 7 firewall activation and rule configuration
Windows 7 firewall activation and rule configuration

35
6 Windows 7 firewall activation and rule configuration
Windows 7 firewall activation and rule configuration

36
Required firewall rules
Following inbound firewall rules are needed for safe network connection. All other programs and protocols should be disabled.

Local Remote Local Remote Allowed Allowed

Name Group Profile Enabled Action Override Program Protocol
Address Address Port Port Users Computers
allow ping All Yes Allow No Any Any Any ICMPv4 Any Any Any Any
Private,
ASTM Yes Allow No C:\arc\bin\arcastm.exe Any Any TCP Any Any Any Any
Public
Private,
ASTM Yes Allow No C:\arc\bin\arcastm.exe Any Any UDP Any Any Any Any
Public
Core Networking -
Destination Unreachable Core
All Yes Allow No System Any Any ICMPv4 Any Any Any Any
Fragmentation Needed Networking
(ICMPv4-In)

Core Networking - Dynamic

Core %SystemRoot%\system32\s
Host Configuration Protocol All Yes Allow No Any Any UDP 68 67 Any Any
Networking vchost.exe
(DHCP-In)
 G

Glossary

A T
ASTM American Society for Testing and Materials TxD Transmitted Data

C
CLSI Clinical and Laboratory Standards Institute

G
GLP Good Laboratory Practices

GND Ground

I
ID Identification

L
LAN Local Area Network

LIS Laboratory Information System

Q
QC Quality Control

R
RxD Received Data

S
STAT Statim; immediately

39