LB000867revA D-100 LIS Technical Bulletin

D-100™ LB000867revA
Hemoglobin Testing System
LIS Requirements
For Use With Catalog No. 290-1000

D-100™ Hemoglobin Testing System
ii LIS Requirements LB000867revA

Table of Contents
1 Introduction..................................................................................................................................... 3
1.1 Purpose...............................................................................................................................................3
1.2 Scope..................................................................................................................................................3
1.3 References and Related Documents..................................................................................................3
1.4 Definitions and Abbreviations..............................................................................................................3
2 LIS Functions.................................................................................................................................. 4
2.1 Settings/LIS Screen.............................................................................................................................4
2.1.1 LIS Options............................................................................................................................4
2.1.2 LIS Settings Tab.....................................................................................................................4
2.1.3 Test LIS Tab............................................................................................................................5
2.1.4 Order Rejection Tab...............................................................................................................6
2.2 Receiving Orders.................................................................................................................................7
2.2.1 Broadcast Download..............................................................................................................7
2.2.2 Merging Orders and Updating Demographics.......................................................................7
2.2.3 Rejected Orders.....................................................................................................................7
3 Physical Layer................................................................................................................................. 8
3.1 Mechanical Interface...........................................................................................................................8
4 LIS1-A Layer.................................................................................................................................... 8
4.1 Configuration Settings.........................................................................................................................8
4.2 Control Characters..............................................................................................................................9
4.3 Communications Protocol Summary...................................................................................................9
4.3.1 Establishment Phase.............................................................................................................9
4.3.2 Transfer Phase.....................................................................................................................10
5 LIS2-A Layer.................................................................................................................................. 10
5.1 Record Types.....................................................................................................................................11
6 D-100 to LIS Transmissions......................................................................................................... 12

6.1 Header Record (H)............................................................................................................................12
6.2 Patient Record (P).............................................................................................................................13
6.3 Test Order Record (O).......................................................................................................................14
6.4 Comment Record (C)........................................................................................................................17
6.5 Result Record (R)..............................................................................................................................18
6.6 Terminator Record (L).......................................................................................................................20
7 LIS to D-100 Transmissions......................................................................................................... 21

7.1 Patient Demographics.......................................................................................................................21
7.2 Loading Orders and Demographics..................................................................................................22
7.3 Active Sample Time Interval..............................................................................................................22
LB000867revA LIS Requirements 1

8 Printing to a Network Folder....................................................................................................... 23

8.1 Configure the D-100 to Print Results in PDF Format........................................................................23
9 Troubleshooting............................................................................................................................ 24
9.1 Port Verification.................................................................................................................................24
9.2 Sending a Test Message...................................................................................................................26
10 LIS Transmission Examples........................................................................................................ 27

10.1 Order With Demographics Transmission From LIS to D-100 ...........................................................27
10.2 Result Transmission From D-100 to LIS............................................................................................27
10.2.1 Default Option (D-100) - Released With Comment “D-100 Format”
Manually Added During Result Review...............................................................................28
10.2.2 CDM 3.X Option...................................................................................................................29
10.2.3 CDM 4.0X Option.................................................................................................................30
10.2.4 CDM 4.1 Option...................................................................................................................31
10.2.5 CDM 5.X Option...................................................................................................................32
10.2.6 D-10 Option..........................................................................................................................33
10.2.7 Default (D-100) Option - Additional Example Released With Comment
From Onboard Advisor........................................................................................................34
2 LIS Requirements LB000867revA

1 Introduction
1.1 Purpose
This document defines the requirements for the communications interface between the Bio-Rad
D-100 instrument and all Laboratory Information Systems (LIS).
1.2 Scope
This document is provided to the LIS vendor to aid in the design, maintenance and troubleshooting
of a compatible interface between the Computer System and the Instrument. It is intended that all
application-specific requirements of the interface be covered by this document. Selected generic
requirements, that may be found within the LIS1-A and LIS2-A documents, are also covered.
The implementation follows LIS1-A and LIS2-A specifications.
1.3 References and Related Documents

• LIS1-A (formerly ASTM E1381-02) Standard Specification for Low Level Protocol to Transfer
Messages Between Clinical Laboratory Instruments and Computer Systems. Maintained by
CLSI (Clinical and Laboratory Standards Institute).
• LIS2-A2 (formerly ASTM E1394-97) Standard Specification for Transferring Information Between
Clinical Instruments and Computer Systems. Maintained by CLSI.
• D-100 Operation Manual
1.4 Definitions and Abbreviations

• Bidirectional interface: Either the Instrument or the Laboratory Information System may
be the Sender or Receiver. The Sender initiates a message sequence that causes message
transmissions to be sent to the Receiver.
• LIS: Laboratory Information System.
• Instrument: The D-100.
• Host Computer System: The LIS.
• 1..n: One to many.
• A1c: Hemoglobin A1c.

2 LIS Functions
2.1 Settings/LIS Screen
2.1.1 LIS Options
• LIS Connection –
Can be turned ON or OFF.
• Release Settings – Activates
Manual or Automatic release for
Patient or Control sample results.
If the Automatic Release to LIS
box is not checked, the operator
must manually export results.
• Result Types – Allows the
operator to enable the type
of result data included in the
transmission.
• Advanced Settings – Clicking
Edit will open the LIS Advanced
Settings tabs. The Advanced
Settings are listed in this section
and are changed by selecting the
Edit button. See sections 2.1.2,
2.1.3, and 2.1.4.
2.1.2 LIS Settings Tab
• Accept Demographics in
Orders – Must be selected to
accept Patient Demographics
with Orders.
• Record Framing – Select single
record per frame or multiple
records per frame. Frame size
is selectable: 240 or 63993
characters.
• Port Settings – Standard
RS‑232 communication port
settings. Bio-Rad supports the
9600 Baud Rate.
• Result Record Format
Options – Transmission will
be formatted to conform to the
selected Bio-Rad software.
• LIS Identifier – The default setting is 4 for the HbA1c assay. The setting can be changed
to match the customers LIS system.

2.1.3 Test LIS Tab

Allows the operator to log low level bidirectional transmission between the instrument and
the LIS.
• Communications Logging – Enables or Disables logging. Logging should be disabled
as a default setting for normal operation.
• Test LIS Button – When the Test LIS button is selected, a query is sent to request all
pending orders for a dummy accession number. Results of the query will be displayed in
the Communications Log.
• When monitoring messages in the Communications Log with the LIS set to transmit
multiple records/frame, the log displays complete messages in real time. Closing, then
reopening the log will truncate the message.

Complete Transmission in Real Time:
Transmission After Closing Then Reopening the Log:
2.1.4 Order Rejection Tab

All rejected test orders and fields are listed in the Order Rejection Log.

2.2 Receiving Orders

2.2.1 Broadcast Download
If the “LIS Connection” is activated in the Settings/LIS screen, the D-100 will accept orders
whenever they are transmitted by the LIS. It enters these orders in an internal Pending
Orders list unless they are rejected for the reasons in 2.2.3. The Pending Orders list can not
be viewed with the Application Software.
2.2.2 Merging Orders and Updating Demographics
If the accession number already exists in the pending orders list, it will be overwritten with
the new order. If a field in the existing order contains data but the corresponding field in the
new order does not, the instrument will retain the existing order’s field data.
2.2.3 Rejected Orders
Orders can be rejected by the D-100 for the following reasons:
• Missing Accession Number (Specimen Number) or Assay Code (LIS Test ID)
• Invalid Accession Number:
Greater than 22 characters
Includes forbidden characters (|\&^)
• Invalid Assay Code:
Greater than 25 Characters
Includes forbidden characters (|\&^)
• Invalid Format (H, O, P, or L records are missing)
Order Accepted But Assay Code Field Rejected
• If the Order includes a valid Assay Code, but it does not match the LIS Test ID assigned
to HbA1c in the LIS Settings Tab, the order will be accepted but the Assay Code Field
(Universal Test ID field 5 in the Order Record) will be rejected. The sample will be run.
The result will include the order demographics with the Test ID assigned to the HbA1c
assay, not the rejected Test ID.
• Section 2.1.4 includes an example of the rejection log if the Test ID in the order is ^^^3,
but the Test ID assigned to the HbA1c assay is ^^^4. The transmitted result will include
^^^4 in the Test ID Field.

3 Physical Layer
This lowest communications layer defines the physical means by which the Instrument is connected with
the Computer System.
3.1 Mechanical Interface

The Instrument provides a standard DB9 male connector mounted on the back panel. The
Instrument RS‑232 interface is configured as a DTE (Data Terminal Equipment, e.g., a terminal or
PC). A DTE normally connects to a DCE (Data Communications Equipment, e.g., a modem). In this
case, the Computer System is also configured as a DTE, thus a null modem cable or connector is
required to hook up to the Computer System. The cable or connector may convert the 9-pin output
to 25-pin male or female, as required, at the Computer System.
Pins on the DB9 Connector:
Pin
Name Description
Number
1 DCD Data Carrier Detect. Not used.
2 RD Receive Data. An input.
3 TD Transmit Data. An output.
4 DTR Data Terminal Ready.
5 SGND Ground
6 DSR Data Set Ready. An input. Not used.
7 RTS Request to Send.
8 CTS Clear to Send.
9 RI Ring Indicator. An input. Not used.
4 LIS1-A Layer
This data communications layer fits just above the Physical Layer and defines the format and content of
the message packets sent between the Computer System and Instrument.
4.1 Configuration Settings

The following user configuration parameters control the speed and method of data transfer. The
default settings are provided.
Port COM1
Baud Rate 9600
Data Bits 8
Stop Bits 1
Parity None

4.2 Control Characters

LIS1-A senders and receivers communicate via seven bit ASCII codes. None of the ten control
characters, the <LF> format effector control character, or four device control characters may appear
in the message text. The restricted characters are: <SOH>, <STX>, <ETX>, <EOT>, <ENQ>,
<ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>, <DC2>, <DC3>, <DC4>.
4.3 Communications Protocol Summary

The following is a summary of the LIS1-A communication low level protocol standard. Refer to
the LIS1-A (formerly ASTM E1381-02) Standard Specification for Low Level Protocol to Transfer
Messages Between Clinical Laboratory Instruments and Computer Systems for details. Maintained
by CLSI.
STX First character of any message frame.

Character immediately after the message text of a message frame. Signifies the last
ETX
message frame of a group.
Character immediately after the message text of a message frame. Signifies that at
ETB
least one more frame of a group is to be transmitted.
CR Next to last character of any message frame.
LF Last character of any message frame.
Receiver replies with ACK when it has successfully (no checksum error) received a
ACK
message frame.
Receiver replies with NAK when it has unsuccessfully (checksum error or timeout)
NAK
received a message frame.
ENQ Sender sends to receiver to indicate ready to send message frame(s).
Sent by receiver to indicate that the last frame sent to receiver was received
EOT
successfully, but also is a request to the sender to temporarily stop sending.
4.3.1 Establishment Phase

• The Sender notifies the receiver that a message is available: The sender sends
an <ENQ> to signal that it has a message to send; it waits 15 seconds for a response
before retrying.
• The Receiver notifies the sender it is ready for a message: The Receiver responds
with an <ACK> signaling that it is ready to receive a message. If the receiver is not ready
to receive the message, it responds with a <NAK>. Upon receiving the <NAK>, the
Sender will wait 10 seconds before sending another <ENQ>.
• Contention: If both Sender and Receiver send messages at the same time (both send
an <ENQ> at the same time), the line is in contention. The instrument system has priority
to transmit information when this occurs. The instrument waits 1 second before sending
<ENQ> again. The LIS should wait 20 seconds. If it does not receive an <ENQ> from
the instrument in that time, it assumes the line is in a neutral state and can retry sending
another <ENQ> to the instrument.

4.3.2 Transfer Phase

• Frames – Messages are sent in frames. Multiple messages can not be combined into a
single frame. Every message must begin in a new frame. As per LIS1-A protocol, each
frame can contain a maximum of 64,000 characters. The D-100 can be set to limit the
number of characters to 240, or to allow the maximum number of 64,000 characters per
frame (Section 2.1.2). Messages longer than the maximum number of characters set,
240 or 64,000, are divided into two or more frames.
A frame is one of two types, Intermediate or End Frame. If the message is less than
the maximum characters set per frame, the transmission is sent in a single End Frame
terminated by the <ETX> End of Text control character. If the message is larger than the
maximum characters set per frame, it is sent in one or more Intermediate frames (each
intermediate frame contains the maximum characters set per frame) terminated with the
<ETB> End of Block control character. The Intermediate Frame is followed by an End
Frame containing the remainder of the message.
• Intermediate Frames – Terminate with <ETB> End of Block control Character,
Checksum, <CR>, <LF>.
• End Frames – Terminate with <ETX> End of Text control Character, Checksum,
<CR>, <LF>.
Frame Structure:
<STX> Frame # Message Text <ETB> Checksum <CR> <LF> Intermediate Frame
<STX> Frame # Message Text <ETX> Checksum <CR> <LF> End Frame
• Acknowledgments – After a frame is sent, the Sender stops transmitting until the
receiver replies. When it is ready to receive the next frame, the Receiver sends one of
three replies to acknowledge the last frame:
<ACK> The last frame was received, prepared to receive the next frame.
<NAK> The last frame was not successfully received, prepared to receive the frame
again.
<EOT> The last frame was received successfully.
5 LIS2-A Layer
This data communications layer fits just above the LIS1-A Layer. The LIS2-A layer defines the format and
content of the messages that may be sent back and forth from the Instrument and the LIS.
This layer operates as a bidirectional interface, meaning that either the Instrument or the Computer
System may initiate the sequence of messages which load demographics or transmit test results to be
sent from the Instrument to the Computer System or vise versa. The system that initiates a message
sequence is known as the Sender, the other system the Receiver. There is no hardware configuration
required to designate a Sender or Receiver.

5.1 Record Types

Each LIS2-A message is composed of a group of Record types. Each record type contains one or
more fields. Fields are separated by the (|) delimiter.
Various fields contain more than 1 component. In this case, the ^ component delimiter is used
to define the component within the field. Unused components within a field may be skipped by
inserting the Component Delimiter Character (^).
The following record types are shown in the order that they are transmitted.
Record
Record Type Description
ID
Message Header H Includes delimiter identifiers of both the sender and receiver.
Contains the record type and sequence number fields as well
Patient Records P
as optional patient demographic information.
Includes the Accession number for the patient sample as well
Test Order O
as the specific test to be run.
Comment C Optional; follows Test Order.
Result R Results of a single test
Manufacturer Information M Not used
Scientific S Not used
Terminator L Last record of a message
The characters in the table below should not be used in field data as they are reserved delimiter
characters used by the LIS2-A protocol.
D-100 Acceptable Delimiters
Delimiter Type Delimiter Description

Field | Separates fields within a record (not supported on D-100)
Repeat \ Separates multiple sets of the same information within a field
Component ^ Divides one field into several subfields
Escape & Used to embed a special character in the data

6 D-100 to LIS Transmissions

Test Results are transmitted to the Host Computer System automatically after each injection, or manually
when the operator releases the sample after review. When sending results to the LIS after each injection,
the instrument exports all results even if a result does not have a matching test order. This includes
results for controls as well as non-barcoded sample vials.
The following sections define the D-100 Record Types and the supported fields contained within them.
6.1 Header Record (H)

All ASTM fields are shown; only the bold underlined fields are supported by the D-100:
Record Type ID (H) | Delimiter Definition (| \ ^ &) | Message Control ID | Access Password |
Sender Name or ID | Sender Street Address | Reserved Field | Sender Telephone Number |
Characteristics of Sender | Receiver ID | Comment or Special Instructions | Processing ID |
Version No. | Date and Time of Message <CR>
Header Record
ASTM LIS Fields Field Contents
#1 Record Type H - Header
Defines delimiters sent to or received from the LIS, used to parse the
#2 Included Delimiters message. Fields are separated by the | delimiter.
The D-100 uses delimiters |\^&
D-100, CDM 4.0X, System Name
CDM 4.1, CDM 5.X “Instrument 1^”
D-10 System NameÎnstrument
#5 Sender Name or ID
Number^Software Version
“Instrument1^01^1.00”
CDM 3.X Not Used
D-100 transmits this as option P (Production) – Active message to be
completed according to standard processing.
#12 Processing ID
Inserted in field for all formats except D-10.
Not used in D-10 Format.
#14 Date and Time of Format: YYYYMMDDhhmmss
message Inserted in field for all formats.
Example of Header string included in result transmission to the LIS:

H|\^&|||Instrument 1^|||||||P||20140829094158

6.2 Patient Record (P)

Record Type (P) | Sequence Number (1,2,3,…) | Practice Assigned Patient ID | Laboratory
Assigned Patient ID | Patient ID No. 3 | Patient Name | Mother’s Maiden Name | Birth Date |
Patient Sex | Patient Race-Ethnic Origin | Patient Address | Reserved Field | Patient Telephone
Number | Attending Physician ID | Special Field 1 | Special Field 2 | Patient Height | Patient
Weight | Patient’s Known or Suspected Diagnosis | Patient Active Medications | Patient’s Diet |
Practice Field No. 1 | Practice Field No. 2 | Admission and Discharge Dates | Admission Status |
Location | Nature of Alternative Diagnostic Code and Classifiers| Alternative Diagnostic Code and
Classification | Patient Religion | Marital Status | Isolation Status | Language | Hospital Service |
Hospital Institution | Dosage Category <CR>
Patient Record
#1 Record Type P - Patient
1 for first sample transmitted,
#2 Sequence Number
2 for second sample transmitted, etc.
Returned by the instrument only if received from the LIS with Patient
#3 Practice Assigned Demographics.
Patient ID Field is blank for Control Results and D-10 Format.
Maximum number of characters accepted by the D-100 is 32.
Demographics.
Field is blank for Control Results and D-10 Format.
#6 Patient Name Format: Last Name^First name^Middle^Suffix^Title
Maximum number of characters accepted by the D-100:
• Last Name – 25
• First Name – 15
Demographics.
#8 Birth Date
All Formats: YYYYMMDD
Demographics.
M - male
#9 Sex
F - female
U (or blank) - unknown
#14 Attending
Demographics.
Physician ID

Example of Patient Record with Demographics:

P|1|PATIENT4000|||JOHN^SMITH^^^||20140101|M|||||DR504
If the user disables “Accept Demographics in Orders” option in the LIS Settings tab, then all
demographics fields in the P record will be blank:
P|1
6.3 Test Order Record (O)

Orders are received only for patient samples, not controls.
Record Type (O) | Sequence Number | Specimen ID | Instrument Specimen ID | Universal Test
ID | Priority | Requested/Ordered Date and Time | Specimen Collection Date and Time | Collection
End Time | Collection Volume | Collector ID | Action Code | Danger Code | Relevant Clinical
Information | Date/Time Specimen Received | Specimen Descriptor (Specimen Type ^ Specimen
Source) | Ordering Physician | Physician’s Telephone Number | User Field No. 1 | User Field No. 2 |
Laboratory Field No. 1 | Laboratory Field No. 2 | Date/Time Results Reported or Last Modified |
Instrument Charge to Computer System | Instrument Section ID | Report Types | Reserved
Field | Location or Ward of Specimen Collection | Nosocomial Infection Flag | Specimen Service |
Specimen Institution <CR>
Order Record
#1 Order O - Order
#2 Sequence Number 1 for first Order requested, 2 for second, etc.

Order Record
Accession Number (Sample ID) is included on the sample barcode label.
Orders sent from LIS:
Accession Number is sent to the D-100 in Field #3.
O|1|BR2229||^^^4|R||||||||||||||||||||O
Maximum number of characters accepted by the D-100 is 22.
Order Record transmitted with results from the D-100:
Rack ID component is blank for samples run in the STAT area.
D-100 Accession Number^Rack ID^Tube Position
CDM 4.1, 5.X Accession Number^Tube Position^Replicate
Number^Rack ID (Replicate Number is always 01)
CDM 4.0, 3.X Accession Number^Tube Position^Replicate Number
(Replicate Number is always 01)
#3 Specimen ID D-10 Accession Number
Control (QC) Output as Accession Number in Field Component 1:

O|1|QC1-1-201408aÛ10^1|A1CQC1|^^^4||||||
|Q|||||||||||||1
D-100, All QCz-x-yyyy
CDM Versions z = Control Level
x = Instrument Number
y = Lot Number
D-10 Barcoded Label (A1CQC1)
Tubes with no barcode or unread barcodes:

For all formats, Sample ID is automatically generated and labeled as
unknown (UNK).
“UNK”-Rack ID-Sample Position-Injection Number
O|1|UNK-U01-02-161Û01^2||^^^4|R|||||||||||||||||||1
D-100 Blank for all Samples except Controls.
If sample is a Control, the field includes the sample
tube barcode (e.g., A1CQC1).
#4 Instrument CDM All Not Used
Specimen ID D-10 Specimen ID-Tube Position-Injection Number-Analysis
Date-Instrument Number^
O|1|BR2229|BR2229-1-127-20140829-
01|^^^4|||||||||||||||||||||F

Order Record
LIS Test Identifier. Received with Order from LIS for A1c test and
transmitted with results from the instrument.
Defined in 4th component within the field.
For D-100 the test ID is defined in the LIS Advanced Settings screen,
#5 Universal Test ID
section 2.1.2 (Default is |^^^4|)
For all formats except D-100 the HbA1c assay is universally defined as
4.
Example: |^^^4|
Supported with D-100 format only.
Received with Order from LIS and transmitted with results from the
instrument.
#6 Priority
S = Stat
R = Routine
Blank for controls
Not supported in order from LIS.
D-100 Format Only result transmission to LIS:
#12 Action Code Patients = Blank
Controls = Q
O|1|QC1-1-201408aÛ10^1|A1CQC1|^^^4||||||
|Q|||||||||||||1
Included in the result transmission to LIS.
#25 Instrument Instrument ID of the instrument which performed the test.
Section ID D-10 Format, Field is blank
All other formats ID=1
Received in order from LIS:
O = Order record; user asking that analysis be performed.
Can also be blank
#26 Report Type Result transmission to LIS:
D-10 Format = F (Final Results)
All other formats field is blank.
Example of order received from the LIS:

O|1|BR2229||^^^4|R||||||||||||||||||||O
Example of Order transmitted from the D-100:
O|1|BR2229Û01^1||^^^4|R|||||||||||||||||||1

6.4 Comment Record (C)

All ASTM fields in the following table are supported by the D-100:
Record Type ID (C) | Sequence Number | Comment Source | Comment Text | Comment Type
Comment Record
#1 Comment C - Comment
1 for first comment record for this order, 2 for second record, etc.
#2 Sequence Number
There is normally only one comment record per order.
#3 Comment Source I = Clinical instrument system
#4 Comment Text Comment text (specimen comment, not the Note to user)
#5 Comment Type I = Instrument flag(s)
Example:
C|1|I|D-100 Format|I
If enabled, Comment records immediately follow the Order record for the specimen. Comments
are entered in the D-100 application Results screen and are included in the transmission from the
D-100 to the LIS only.

6.5 Result Record (R)

An R record is transmitted for each result message.
Record Type ID (R) | Sequence Number | Universal Test ID | Data or Measurement Value |
Units | Reference Ranges | Result Abnormal Flags | Nature of Abnormality Testing | Result
Status | Date of Change in Instrument Normative Values or Units| Operator Identification | Date/
Time Test Started | Date/Time Test Completed | Instrument Identification <CR>
Result Record
#1 Result R - Result
#2 Sequence Number 1 for first result record for this order, 2 for second record, etc.
Bio-Rad uses component 4 and 5 of the Universal Test ID field.
|^^^Peak Name^Data Type|
D-100 Format
Component 4 is used in three different ways:
^^Â1a, A1b, A1c,
Name of Identified Peak
etc^
For Calculated Peaks (HbA1c), the User IFCC = ^^Â1cIFCC^
Selected reporting unit. NGSP = ^^Â1c^
In the last message Total Area is reported.
^^^Total^
The text “Total” is used in this message only.
Component 5 Data Type:

#3 Universal Test ID Identifies the Measurement Value which follows in Field 4
“AREA” is transmitted if the
measurement value in Field 4
is an NGSP area percent or ^^^Component 4ÂREA|
IFCC value of the item defined in
Component 4.
“TIME” is transmitted if the
measurement in Field 4 is the
^^^ Component 4^TIME|
Retention Time of the item defined
in Component 4.
“VALUE” is transmitted if a
calibrated peak is not found. This ^^^ Component 4^VALUE
is followed by a zero in Field 5.

Result Record
The value in field 4 is the numeric result in user selected units with
appropriate decimal precision.
If a calibrated peak is not found, R records for TIME and AREA are sent
with a measurement Value of “0.0”. The Universal Test ID component 5
is “VALUE” rather than “AREA”.
#4 Data or Measurement
Value R|3|^^Â1c^VALUE|0.0||||||||||1
R|4|^^Â1c^TIME|0.0||||||||||1
If a peak was found, but no result was reported, the data measurement
value for the TIME message will be the retention time of the peak. The
AREA message will be zero.
D-100 format only:
Used only for calibrated peaks. This field is blank for non-calibrated
peaks.
Field includes the instrument reporting units set in the Applications
#5 Units
Software.
Reporting Unit Field Text

IFCC mmol/mol IFCC
NGSP % NGSP
Used with D-100 format only:
#9 Result Status
“F” = Final Result
Used with D-100 format only:
A two component field. D-100 uses only Component 2.
Release Method Component 2
#11 Operator Instrument inserts the Logged in
Identification Result released manually User Name
|Âdmin|
Instrument inserts “AUTO”
Result released automatically
|ÂUTO|
#12 Date/Time Test Used in CDM 5.X
Started Date/Time format: YYYYMMDDhhmmss
#13 Date/Time Test Used in D-100 and D-10 formats
Completed Date/Time format: YYYYMMDDhhmmss
#14 Instrument Instrument ID of the instrument which performed the test.
Identification In D-100 only a 1 is used.

6.6 Terminator Record (L)

The following fields are used by D-100: Record Type ID (L) | Sequence Number (1) |
Termination Code
Terminator Record
#1 Terminator L - Terminator
#2 Sequence Number Always 1.
#3 Termination Code N for normal termination.
Example:
L|1|N

7 LIS to D-100 Transmissions

7.1 Patient Demographics
Patient Demographics sent with an Order from the LIS to the D-100 are loaded into the Pending
Orders list if the instrument is configured to accept them (2.1.2). These demographic fields are
included in the Patient record. The Patient record fields associated with demographics are as
follows. Refer to Patient Record Section 6.2 for a complete field listing and details pertaining to
each field.
Patient Record
#3 Patient ID Practice Assigned Patient ID
#6 Patient Name Last Name^First Name^Middle^Suffix^Title
#8 Birth Date Date of birth Format: YYYYMMDD
M = male
#9 Sex F = female
U = unknown
#14 Attending
Physician ID
Physician ID
The Patient record is followed by the test order. Only field #3, Specimen ID, in the record is
mandatory. All other fields can be blank. The fields associated with the Test Order are as follows.
Refer to Test Order Record Section 6.3 for a complete field listing and details pertaining to each
field.
Order Record
#3 Specimen ID Accession Number
#5 Universal Test ID Test Assay Requested
#6 Priority S = Stat
#26 Report Type O = Order record

7.2 Loading Orders and Demographics

The D-100 will accept Broadcast Downloaded orders whenever they are transmitted by the LIS.
Rejected orders are listed in the rejection log (2.1.4).
A current Order in the Pending Orders List can be overwritten by a new order with an identical
Sample ID number if it is received before the sample is run.
• Previously loaded demographic fields in the current order will be overwritten by the new.
• If the previously loaded order includes data in a field and the same field in the new order is
blank, the original data is retained in the field.
The following Rules must be followed for the instrument to add an Order with Demographics to the
Pending Orders List:
• Files must not include more than 1500 orders in a single transmission. Bio‑Rad suggests limiting
the number of orders to 1000.
• Demographics must be transmitted (loaded into the pending orders list) before the sample is run.
• If reusing accession numbers, new orders must not be sent within the Active time window
(Section 7.3).
• The order must not be rejected for any of the reasons listed in section 2.2.3.
7.3 Active Sample Time Interval

The active sample time interval can be
set via the “Label as repeat if run within
this interval” setting in the Settings/
Instrument screen. During this time
interval, samples with repeated Sample
ID’s are labeled Repeat and are
associated with the Demographics of the
initial order.
If the lab reuses accession numbers, this
time period must be set appropriately to
prevent new samples from being labeled
Repeat and associated with incorrect
demographics.
The time interval begins when the initial sample is run. The time interval is reset (time = 0) each
time a repeated Sample ID is run within the time window. A new order for the repeated Sample ID
sent within the time window is ignored.

8 Printing to a Network Folder

The D-100 can be configured to direct the Result Chromatogram as a pdf file to a network folder. This
makes it possible for the customer to capture both the LIS transmission and the chromatogram onto their
network.
8.1 Configure the D-100 to Print Results in PDF Format

1. In the Settings screen select the
Reports tab.
2. Select “Print to PDF” option in the
Printers list.
3. Touch the Browse button to direct the
result to a mapped Network folder.
4. Select the “Print sample reports
automatically” box to enable automatic
printing to the selected Network folder.
5. Result reports, including the
Chromatogram, will be automatically
sent to the selected folder as a pdf file
with the following naming convention,
which includes the date and time the
sample was run:
Sample ID-YYYY-MM-DD_HH-MM-SS.PDF
Example File:
BR2229-2014-08-29_08-24-20.pdf

9 Troubleshooting
9.1 Port Verification
1. To test the communication port, the Transmit and Receive lines must be connected together.
Create a loopback connector per the following diagram. This is simply a test connector
which shorts pins 2 and 3 (receive and transmit) together. This allows the port to essentially
communicate with itself.
2. Plug the loopback connector into one of the two communication ports on the rear of the D-100.
Looking at the rear of the instrument COM 1 is on the right; COM 2 is on the left.
3. In the Settings/LIS screen, select “LIS Connection” On. Touch the Edit button to open the LIS
Advanced Settings screen.

4. The selected COM port must be the port that has the loopback connector installed.
5. To change the port:
a. Return to the Settings/LIS screen and select
“LIS Connection” Off.
b. Return to the LIS Advanced Settings screen
and change the Port selection.
c. Return to the Settings/LIS screen and select
“LIS connection” On.
6. Select the Test LIS tab. With “Communications Logging” On, touch the Test LIS button. The
instrument will send the <ENQ> command to signal the LIS that it has a message to send.
Since the transmit line is directly connected to the receive line, the <ENQ> is echoed back. This
verifies that the port is operational.
7. If the port is not operational or the Transmit and Receive lines are not connected, the command
is not echoed back. The instrument sends the <ENQ> and gets no response; after a time‑out
period, it sends the <EOT> command and the cycle repeats.

9.2 Sending a Test Message

Touching the Test LIS button with an LIS system connected allows the operator to send a message
from the D-100 to the LIS and record the low level communications between the two systems.
The following example shows the message sent in both the Single record/frame and the Multiple
records/frame transmission options. In both cases, the D-100 sends the <ENQ> command
signaling the LIS that it has a message to send. The LIS answers with the <ACK> command
acknowledging that it can receive the message. The message is sent to the LIS. When the last
message is sent, the D-100 responds with the <EOT> end of transmission command.

10 LIS Transmission Examples

10.1 Order With Demographics Transmission From LIS to D-100
Example:
H|\^&
P|1|PATIENT4000|||JOHN^SMITH||20140101|M|||||DR504
O|1|BR2229||^^^4|R||||||||||||||||||||O
L|1|N
Format:
P|1|Patient4000|||LastName^First^Middle^Suffix^Title||20140101|M|||||
DR504
Field 3 – Patient ID
Field 6 – Patient Name
Field 8 – Date of Birth
Field 9 – Sex
Field 14 – Physician
O|1|BR2229||^^^4|R||||||||||||||||||||O
Field 3 – Specimen ID
Field 5 – Universal Test ID
Field 6 – Priority (R = Routine)
Field 26 – Report Type (O = Order record)
10.2 Result Transmission From D-100 to LIS

The examples in this section show the same sample transmitted in each of the 6 format options.
The Order With Demographics example in section 10.1 was sent to the D-100 before the sample
was run.

10.2.1 Default Option (D-100) - Released With Comment “D-100 Format” Manually Added
During Result Review
H|\^&|||Instrument 1^|||||||P||20140829094158
O|1|BR2229Û01^1||^^^4|R|||||||||||||||||||1
C|1|I|D-100 Format|I
R|1|^^Â1aÂREA|0.99|||||F||Âdmin||20140829082420|1
R|2|^^Â1a^TIME|5.60|||||F||Âdmin||20140829082420|1
R|3|^^Â1bÂREA|1.07|||||F||Âdmin||20140829082420|1
R|4|^^Â1b^TIME|6.98|||||F||Âdmin||20140829082420|1
R|5|^^^FÂREA|1.39|||||F||Âdmin||20140829082420|1
R|6|^^^F^TIME|8.26|||||F||Âdmin||20140829082420|1
R|7|^^^LA1cÂREA|1.37|||||F||Âdmin||20140829082420|1
R|8|^^^LA1c^TIME|11.55|||||F||Âdmin||20140829082420|1
R|9|^^Â1cÂREA|5.3|% NGSP||||F||Âdmin||20140829082420|1
R|10|^^Â1cIFCCÂREA|35|mmol/mol IFCC||||F||Âdmin||20140829082420|1
R|11|^^Â1c^TIME|13.83|||||F||Âdmin||20140829082420|1
R|12|^^^P3ÂREA|4.50|||||F||Âdmin||20140829082420|1
R|13|^^^P3^TIME|18.95|||||F||Âdmin||20140829082420|1
R|14|^^ÛnknownÂREA|1.34|||||F||Âdmin||20140829082420|1
R|15|^^Ûnknown^TIME|20.26|||||F||Âdmin||20140829082420|1
R|16|^^Â0ÂREA|84.97|||||F||Âdmin||20140829082420|1
R|17|^^Â0^TIME|24.31|||||F||Âdmin||20140829082420|1
R|18|^^^TOTALÂREA|70375|||||F||Âdmin||20140829082420|1
L|1|N

10.2.2 CDM 3.X Option

H|\^&||||||||||P||20140829094514
O|1|BR2229^1^01||^^^4||||||||||||||||||||1
R|1|^^Â1aÂREA|0.99||||||||||1
R|2|^^Â1a^TIME|5.60||||||||||1
R|3|^^Â1bÂREA|1.07||||||||||1
R|4|^^Â1b^TIME|6.98||||||||||1
R|5|^^^FÂREA|1.39||||||||||1
R|6|^^^F^TIME|8.26||||||||||1
R|7|^^^LA1cÂREA|1.37||||||||||1
R|8|^^^LA1c^TIME|11.55||||||||||1
R|9|^^Â1cÂREA|5.3||||||||||1
R|10|^^Â1c^TIME|13.83||||||||||1
R|11|^^^P3ÂREA|4.50||||||||||1
R|12|^^^P3^TIME|18.95||||||||||1
R|13|^^ÛnknownÂREA|1.34||||||||||1
R|14|^^Ûnknown^TIME|20.26||||||||||1
R|15|^^Â0ÂREA|84.97||||||||||1
R|16|^^Â0^TIME|24.31||||||||||1
R|17|^^^TOTALÂREA|70375||||||||||1
L|1|N

10.2.3 CDM 4.0X Option

H|\^&|||Instrument 1^|||||||P||20140829094541
O|1|BR2229^1^01||^^^4||||||||||||||||||||1
R|1|^^Â1aÂREA|0.99||||||||||1
R|2|^^Â1a^TIME|5.60||||||||||1
R|3|^^Â1bÂREA|1.07||||||||||1
R|4|^^Â1b^TIME|6.98||||||||||1
R|5|^^^FÂREA|1.39||||||||||1
R|6|^^^F^TIME|8.26||||||||||1
R|7|^^^LA1cÂREA|1.37||||||||||1
R|8|^^^LA1c^TIME|11.55||||||||||1
R|9|^^Â1cÂREA|5.3||||||||||1
R|10|^^Â1c^TIME|13.83||||||||||1
R|11|^^^P3ÂREA|4.50||||||||||1
R|12|^^^P3^TIME|18.95||||||||||1
R|13|^^ÛnknownÂREA|1.34||||||||||1
R|14|^^Ûnknown^TIME|20.26||||||||||1
R|15|^^Â0ÂREA|84.97||||||||||1
R|16|^^Â0^TIME|24.31||||||||||1
R|17|^^^TOTALÂREA|70375||||||||||1
L|1|N

10.2.4 CDM 4.1 Option

H|\^&|||Instrument 1^|||||||P||20140829094609
O|1|BR2229^1^01Û01||^^^4||||||||||||||||||||1
R|1|^^Â1aÂREA|0.99||||||||||1
R|2|^^Â1a^TIME|5.60||||||||||1
R|3|^^Â1bÂREA|1.07||||||||||1
R|4|^^Â1b^TIME|6.98||||||||||1
R|5|^^^FÂREA|1.39||||||||||1
R|6|^^^F^TIME|8.26||||||||||1
R|7|^^^LA1cÂREA|1.37||||||||||1
R|8|^^^LA1c^TIME|11.55||||||||||1
R|9|^^Â1cÂREA|5.3||||||||||1
R|10|^^Â1c^TIME|13.83||||||||||1
R|11|^^^P3ÂREA|4.50||||||||||1
R|12|^^^P3^TIME|18.95||||||||||1
R|13|^^ÛnknownÂREA|1.34||||||||||1
R|14|^^Ûnknown^TIME|20.26||||||||||1
R|15|^^Â0ÂREA|84.97||||||||||1
R|16|^^Â0^TIME|24.31||||||||||1
R|17|^^^TOTALÂREA|70375||||||||||1
L|1|N

10.2.5 CDM 5.X Option

H|\^&|||Instrument 1^|||||||P||20140829094632
O|1|BR2229^1^01Û01||^^^4||||||||||||||||||||1
R|1|^^Â1aÂREA|0.99||||||||20140829082416||1
R|2|^^Â1a^TIME|5.60||||||||20140829082416||1
R|3|^^Â1bÂREA|1.07||||||||20140829082416||1
R|4|^^Â1b^TIME|6.98||||||||20140829082416||1
R|5|^^^FÂREA|1.39||||||||20140829082416||1
R|6|^^^F^TIME|8.26||||||||20140829082416||1
R|7|^^^LA1cÂREA|1.37||||||||20140829082416||1
R|8|^^^LA1c^TIME|11.55||||||||20140829082416||1
R|9|^^Â1cÂREA|5.3|% NGSP|||||||20140829082416||1
R|10|^^Â1cIFCCÂREA|35|mmol/mol IFCC|||||||20140829082416||1
R|11|^^Â1c^TIME|13.83||||||||20140829082416||1
R|12|^^^P3ÂREA|4.50||||||||20140829082416||1
R|13|^^^P3^TIME|18.95||||||||20140829082416||1
R|14|^^ÛnknownÂREA|1.34||||||||20140829082416||1
R|15|^^Ûnknown^TIME|20.26||||||||20140829082416||1
R|16|^^Â0ÂREA|84.97||||||||20140829082416||1
R|17|^^Â0^TIME|24.31||||||||20140829082416||1
R|18|^^^TOTALÂREA|70375||||||||20140829082416||1
L|1|N

10.2.6 D-10 Option

H|\^&|||Instrument 1^01^1.00|||||||||20140829094653
P|1
O|1|BR2229|BR2229-1-127-20140829-01|^^^4|||||||||||||||||||||F
R|1|^^Â1aÂREA|0.99|||||||||20140829082420
R|2|^^Â1a^TIME|5.60|||||||||20140829082420
R|3|^^Â1bÂREA|1.07|||||||||20140829082420
R|4|^^Â1b^TIME|6.98|||||||||20140829082420
R|5|^^^FÂREA|1.39|||||||||20140829082420
R|6|^^^F^TIME|8.26|||||||||20140829082420
R|7|^^^LA1cÂREA|1.37|||||||||20140829082420
R|8|^^^LA1c^TIME|11.55|||||||||20140829082420
R|9|^^Â1cÂREA|5.3|||||||||20140829082420
R|10|^^Â1c^TIME|13.83|||||||||20140829082420
R|11|^^^P3ÂREA|4.50|||||||||20140829082420
R|12|^^^P3^TIME|18.95|||||||||20140829082420
R|13|^^ÛnknownÂREA|1.34|||||||||20140829082420
R|14|^^Ûnknown^TIME|20.26|||||||||20140829082420
R|15|^^Â0ÂREA|84.97|||||||||20140829082420
R|16|^^Â0^TIME|24.31|||||||||20140829082420
R|17|^^^TOTALÂREA|70375|||||||||20140829082420
L|1|N

10.2.7 Default (D-100) Option - Additional Example Released With Comment From Onboard
Advisor
H|\^&|||Instrument 1^|||||||P||20140829054823
O|1|BR4000Û02^1||^^^4|R|||||||||||||||||||1
C|1|I|Possible sample degradation or variant. Possible variant
interference|I
R|1|^^Â1aÂREA|3.83|||||F||^BRRND||20140829053745|1
R|2|^^Â1a^TIME|5.54|||||F||^BRRND||20140829053745|1
R|3|^^Â1bÂREA|12.43|||||F||^BRRND||20140829053745|1
R|4|^^Â1b^TIME|6.95|||||F||^BRRND||20140829053745|1
R|5|^^ÛnknownÂREA|0.86|||||F||^BRRND||20140829053745|1
R|6|^^Ûnknown^TIME|10.22|||||F||^BRRND||20140829053745|1
R|7|^^^LA1cÂREA|2.45|||||F||^BRRND||20140829053745|1
R|8|^^^LA1c^TIME|11.96|||||F||^BRRND||20140829053745|1
R|9|^^Â1cÂREA|4.0|% NGSP||||F||^BRRND||20140829053745|1
R|10|^^Â1cIFCCÂREA|21|mmol/mol IFCC||||F||^BRRND||20140829053745|1
R|11|^^Â1c^TIME|14.02|||||F||^BRRND||20140829053745|1
R|12|^^^P3ÂREA|10.37|||||F||^BRRND||20140829053745|1
R|13|^^^P3^TIME|18.67|||||F||^BRRND||20140829053745|1
R|14|^^Â0ÂREA|66.81|||||F||^BRRND||20140829053745|1
R|15|^^Â0^TIME|24.19|||||F||^BRRND||20140829053745|1
R|16|^^^TOTALÂREA|53990|||||F||^BRRND||20140829053745|1
L|1|N


Effective Date: November 2014

LB000867revA D-100 LIS Technical Bulletin

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LB000867revA D-100 LIS Technical Bulletin

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D-100™ LB000867revA

Hemoglobin Testing System

For Use With Catalog No. 290-1000

ii LIS Requirements LB000867revA

6 D-100 to LIS Transmissions......................................................................................................... 12

7 LIS to D-100 Transmissions......................................................................................................... 21

LB000867revA LIS Requirements 1

8 Printing to a Network Folder....................................................................................................... 23

10 LIS Transmission Examples........................................................................................................ 27

2 LIS Requirements LB000867revA

1.3 References and Related Documents

1.4 Definitions and Abbreviations

LB000867revA LIS Requirements 3

4 LIS Requirements LB000867revA

2.1.3 Test LIS Tab

LB000867revA LIS Requirements 5

Complete Transmission in Real Time:

Transmission After Closing Then Reopening the Log:

2.1.4 Order Rejection Tab

6 LIS Requirements LB000867revA

2.2 Receiving Orders

LB000867revA LIS Requirements 7

3.1 Mechanical Interface

4.1 Configuration Settings

8 LIS Requirements LB000867revA

4.2 Control Characters

4.3 Communications Protocol Summary

STX First character of any message frame.

4.3.1 Establishment Phase

LB000867revA LIS Requirements 9

4.3.2 Transfer Phase

10 LIS Requirements LB000867revA

5.1 Record Types

Delimiter Type Delimiter Description

LB000867revA LIS Requirements 11

6 D-100 to LIS Transmissions

6.1 Header Record (H)

Example of Header string included in result transmission to the LIS:

12 LIS Requirements LB000867revA

6.2 Patient Record (P)

LB000867revA LIS Requirements 13

Example of Patient Record with Demographics:

6.3 Test Order Record (O)

14 LIS Requirements LB000867revA

Control (QC) Output as Accession Number in Field Component 1:

Tubes with no barcode or unread barcodes:

LB000867revA LIS Requirements 15

Example of order received from the LIS:

16 LIS Requirements LB000867revA

6.4 Comment Record (C)

LB000867revA LIS Requirements 17

6.5 Result Record (R)

Component 5 Data Type:

18 LIS Requirements LB000867revA

Reporting Unit Field Text

LB000867revA LIS Requirements 19

6.6 Terminator Record (L)

20 LIS Requirements LB000867revA

7 LIS to D-100 Transmissions

LB000867revA LIS Requirements 21

7.2 Loading Orders and Demographics

7.3 Active Sample Time Interval

22 LIS Requirements LB000867revA

8 Printing to a Network Folder