Cell-Dyn 4000 SYSTEM Laboratory Information System Interface Specification

CELL-DYN® 4000 SYSTEM
LABORATORY INFORMATION SYSTEM

INTERFACE SPECIFICATION
LIST NO. 01H27-01

REVISION G
ABBOTT DIAGNOSTICS DIVISION

Abbott Laboratories
Abbott Park, IL 60064
CELL-DYN  4000 SYSTEM
LABORATORY INFORMATION SYSTEM
INTERFACE SPECIFICATION
1997, 1999, 2001 ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories

01H27-01G – July 2001 Abbott Park, IL 60064
NOTES
1997, 1999, 2001 ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories

01H27-01G – July 2001 Abbott Park, IL 60064
TABLE OF CONTENTS
1.0 INTRODUCTION............................................................................................................ 1
1.1 Purpose
1.2 Scope
1.3 Definitions, Synonyms, and Abbreviations
1.4 References
1.5 Overview
2.0 STANDARDS AND GENERAL CONFORMANCE........................................................ 2

2.1 Applicable Standards
2.2 E1381 Conformance
2.4 Independence of Instrument Message Transactions
3.0 SUPPORTED TRANSACTIONS ................................................................................... 4

3.1 Overview
3.2 Serial Communications Test (Link Test)
3.3 Submit Worklist Entries
3.4 Transfer of Test Results
4.0 ERROR HANDLING .................................................................................................... 32
A-0 APPENDIX A — EXAMPLES ...................................................................................... 33

A-1 Worklist Entry Request to the CLIMS
A-2 Worklist Entry Submission Messages
A-3 Worklist Entry Rejection message
A-4 Test Result Transfer Message
CELL-DYN® 4000 LIS Interface Specification i

01H27-01G – July 2001
NOTES
ii CELL-DYN® 4000 LIS Interface Specification

01H27-01G – July 2001
1.0 Introduction
1.1 Purpose
The purpose of this document is to allow Clinical Laboratory Information System vendors to
develop hardware and software that will connect to a CELL-DYN 4000 instrument and
successfully exchange messages with a CELL-DYN 4000 instrument.
1.2 Scope
This document applies to the CELL-DYN 4000 instrument (CELL-DYN 4000 SL model). It
specifies the messages and behaviors of the initial version of the CELL-DYN 4000 LIS
Interface (see section 3.3.2.1.3; LISVID).
NOTE: The parameters: WVF, PCT, and PDW are provided for laboratory use only and
are not reportable in the U.S.A.
1.3 Definitions, Synonyms, and Abbreviations

Instrument - a CELL-DYN 4000 instrument
LIS - Laboratory Information System
CLIMS - Clinical Laboratory Information Management System
E1394 - ASTM Standard E 1394-91
E1381 - ASTM Standard E 1381-91
1.4 References
1.4.1 ASTM Standards
E 1381-91, Specification for Low-Level Protocol to Transfer Messages Between Clinical
Laboratory Instruments and Computer Systems, 1991 Annual Book of ASTM
Standards, Section 14, Volume 14.01
E 1394-91, Standard Specification for Transferring Information Between Clinical
Instruments and Computer Systems, 1991 Annual Book of ASTM Standards, Section
14, Volume 14.01
1.5 Overview
The remainder of this document is divided into the following sections:
Section 2
indicates the standards to which the interface will conform, and specifies general
implementation-dependent behavior. Implementation-dependent behavior that is context-
specific (i.e., within a particular message) shall be specified in the next section under the
appropriate context (i.e., message, field, etc.).
Section 3
specifies all of the transactions supported by instruments, all messages that make up the
transactions and their ordering, and the format of the messages. Implementation-dependent
behavior is specified in the appropriate context (i.e., if the contents of a field in message 1 are
different from the contents of the same field in message 2, the description of the field in
message 1 contains only those contents allowable within the context of message 1).
Section 4
the handling of semantic errors, and logical transmission errors.
CELL-DYN® 4000 LIS Interface Specification Page 1 of 38

01H27-01G – July 2001
Appendix A
contains one or more examples of each transaction message for reference purposes.
2.0 Standards and General Conformance
2.1 Applicable Standards

The instrument LIS interface conforms to E1381 and E1394. General implementation-
dependent behavior (behavior not dependent on context) is described in the following
subsections.

The interface shall conform to E1381 with the following exceptions and specifications for
implementation-dependent behavior:
2.2.1 Character Structure (E1381 paragraph 5.2.2.5) - The CELL-DYN 4000 LIS interface
can be configured (in the CELL-DYN 4000 application) to support the following
character structure options:
Options Character Structure Elements Default
CELL-DYN 4000 Settings
seven, eight Number of Bits per Character eight
one, two Number of Stop Bits one
even, odd, none Parity none
Eight-bit characters shall be interpreted according to the iso8559 encoding scheme
(which uses ASCII encoding for characters in the range 0-127)
2.2.2 Speed (E1381 paragraph 5.2.3.1; 5.2.3.2) - The CELL-DYN 4000 LIS interface can be
configured in the CELL-DYN 4000 application to support data transmission rates of
1200, 2400, 4800, or 9600 baud. The default setting is 9600 baud.
2.2.3 Interface Connections (E1381 paragraph 5.2.4) - The CELL-DYN 4000 Data Station
serial card used for the LIS connection has an external connector different from that
described in E1381. The LIS interface connector is a DB9, male, with the following
contact assignments:
(DB9) Contact Number Description Direction (from Data Station)
2 RxD Input
3 TxD Output
5 Gnd ...
(Connector contacts not listed are unused)
2.2.4 Timeout periods (E1381 paragraphs 6.5.2.1, 6.5.2.3, 6.5.2.4, 6.5.25) – The
CELL-DYN 4000 defaults for these timeouts are per E1381. The values can be
changed outside the CELL-DYN 4000 application by editing the CELL-DYN 4000 LIS
configuration file.
2.2.5 Wait periods (E1381 paragraph 6.2.7.1 and 6.2.6) - The CELL-DYN 4000 defaults for
these wait periods are per E1381. The values are viewable outside the
CELL-DYN 4000 application via the CELL-DYN 4000 LIS Configuration file; the default
values should never be altered.
Page 2 of 38 CELL-DYN® 4000 LIS Interface Specification

01H27-01G – July 2001
2.3.1 2The interface shall conform to E1394 with the following specifications for general
implementation-dependent behavior:
2.3.1.1 Use of Escape Delimiter (E1394 paragraph 6.4.6.1) - Instruments shall
support escape sequences.
2.3.1.2 Fields with Null Values (E1394 paragraph 6.4.10.1-3) - The
CELL-DYN 4000 shall interpret a null field value to mean that the contents of
that field are unknown or irrelevant. Only unsupported or optional fields may
take on null values. If the CELL-DYN 4000 must have a value for the
information assigned to an optional field in order to process the specimen,
receipt of a null value shall cause the CELL-DYN 4000 to use its default
setting for that information. The CELL-DYN 4000 does not support CLIMS
directed deletion of any information that it has received.
2.3.1.3 Comment Records (E1394 section 11.0) - Comment records must not be sent
to the CELL-DYN 4000. However, comment records are generated by the
CELL-DYN 4000 as part of the transfer of test results from the
CELL-DYN 4000 to the CLIMS and as part of the Worklist Entry Rejection
message from the CELL-DYN 4000 to the CLIMS.
2.3.1.4 Request Information Records (E1394 section 12.0) - Request information
records must not be sent to the CELL-DYN 4000. The CELL-DYN 4000 shall
generate a single form of request information record in order to elicit Worklist
Entries from the CLIMS.
2.3.1.5 Scientific Records (E1394 section 14.0) - Scientific Records must not be sent
to the instrument and are never generated by the instrument.
2.3.1.6 Manufacturer Information Records (E1394 Section 15.0) Manufacturer
Information Records must not be sent to the instrument and are never
generated by the instrument.
2.4 Independence of Instrument Message Transactions

2.4.1 Message transactions initiated by the instrument, such as a Worklist Entry Request by
Specimen ID, or a Test Results message, are initiated from independent processes in
the instrument. This may result in a scenario where the instrument sends Test Results
messages right after it has sent a Worklist Entry Request message. The instrument
does not wait for the response to the Worklist Entry Request before sending Test
Results messages.

01H27-01G – July 2001
3.0 Supported Transactions
3.1 Overview
There are three conversations that can be held between the CLIMS and the CELL-DYN 4000
Instrument. The CELL-DYN 4000 Instrument maintains coordination between separate send
and receive threads; however all conversations are funneled through one serial port driver.
The conversations are:
• Serial Communications Link Test
• Submission of Worklist Entries
• Transfer of Test Results
3.1.1 Serial Communications Link Test
3.1.1.1 The Serial Communications Link Test is used to determine if the connection
between the CELL-DYN 4000 instrument and the CLIMS is operational. It
can also be held between the CELL-DYN 4000 instrument and Serial
Loopback Device in order to check that the CELL-DYN 4000 Data Station
hardware supporting the LIS link is functional. If this complete conversation
takes place, the “Host Up” status is shown on the CELL-DYN 4000 Data
Station screen; otherwise the Link status is shown as “Host Down” and the
CELL-DYN 4000 and CLIMS will be unable to converse with each other.
3.1.2 Submission of Worklist Entries
3.1.2.1 The Submit Worklist Entries request shall be initiated by the CELL-DYN 4000
instrument at a programmable interval (default value = every 60 seconds)
whenever the CELL-DYN 4000 instrument’s “Autodownload” Feature is
enabled. The CLIMS may send one or many Worklist Entries while the
Autodownload Feature is enabled. The CELL-DYN 4000 checks through each
entry and sends a rejection message for each entry that is not accepted. If
the CELL-DYN 4000 rejects a Worklist Entry, the CLIMS will have to re-submit
the entry. No acknowledgment is sent for Worklist Entries that are accepted.
3.1.2.2 The CELL-DYN 4000 does not allow the CLIMS to update or delete a Worklist
Entry after it has been submitted to the CELL-DYN 4000. However, the
CELL-DYN 4000 instrument will accept multiple independent Worklist Entries
pertaining to the same specimen identifier. Therefore, if the first Worklist
Entry received for Patient A (with Specimen ID = M34566) was semantically
and syntactically correct, but not what the doctor ordered, the CLIMS may
send a second Worklist Entry for Patient A (Specimen ID = M34566). Both
Worklist Entries will co-exist in the CELL-DYN 4000 instrument’s Worklist.
Worklist Entries are deleted from the CELL-DYN 4000 instrument by the
CELL-DYN 4000 operator or by execution (aspiration) of the test specified in
the Worklist Entry. The CLIMS cannot instruct the CELL-DYN 4000
instrument to delete a Worklist Entry.

01H27-01G – July 2001
3.1.3 Conversation for the Transfer of Test Results
3.1.3.1 The Transfer of Test Results conversation shall be initiated by the
CELL-DYN 4000 instrument. If the CELL-DYN 4000 instrument is set to “auto-
transmit,” the transfer is initiated as the test results become available and
qualify for transmission. The transfer of test results is also initiated by the
CELL-DYN 4000 if the CELL-DYN 4000 operator highlights a result in the
Datalog and selects “Transmit.” Each conversation of this type contains
information about a single aspiration on the CELL-DYN 4000. The CLIMS
must acknowledge that it has received the information via 1381 level frame
ACKs. Once acknowledged, the CELL-DYN 4000 marks the Sample Record
as having been transmitted and removes it from the “to be transmitted” group
which is maintained on the CELL-DYN 4000 instrument. If the CLIMS NAKs
the message, the CELL-DYN 4000 issues a message to the CELL-DYN 4000
operator, and leaves the Sample Record in the “to be transmitted” group.
3.1.3.2 The CELL-DYN 4000 produces all Test Results in USA units of measure. If it
is desirable to convert the results into international units, this must be done by
the CLIMS. Conversion is typically a shift by one or more powers of 10,
however hemoglobin (HGB), mean corpuscular hemoglobin (MCH), and
mean corpuscular hemoglobin concentration (MCHC) must be converted
using a numerical multiplier (0.6206) because of the change from grams to
millimoles.
3.1.4 The CELL-DYN 4000 identifies itself and the Specimen ID in each conversation (except
the serial link test) in order to help the CLIMS track multiple instances of the
conversations, or conversations with multiple CELL-DYN 4000 instruments. Similarly,
the CLIMS must provide the Specimen ID in any 1394 level message that it sends to
the CELL-DYN 4000 instrument. The CLIMS does not have to identify itself, because
the CELL-DYN 4000 can only communicate to one CLIMS at a time.
3.1.5 The CELL-DYN 4000 instrument communicates using text strings for the message
content. The character set range is from 32-127 for 7 bit characters (ASCII encoding),
and from 32-255 for 8 bit characters (ASCII/iso8559 encoding) regardless of the
National Language support installed or active on the CELL-DYN 4000 instrument.
3.2 Serial Communications Test (Link Test)

3.2.1 The Serial Communications Test is transacted at the low level interface level (E1381)
and consists of the CELL-DYN 4000 issuing an <ENQ> and then waiting for a
response.
3.2.2 The CLIMS response should be either <ACK>, <NAK>, or <ENQ>.
3.2.3 The Serial Loopback Device response should be <ENQ>.
3.2.4 If the CELL-DYN 4000 receives a response of <ACK>, <NAK>, or <ENQ> within 15
seconds from its transmission of the initiating <ENQ>, the link status is reported as “up.”
Any other response, or a timeout (15 seconds expire without response) will result in the
CELL-DYN 4000 reporting that the link status is “down.”
3.2.5 The Serial Communications Test will be initiated by the CELL-DYN 4000 at Application
startup.
3.2.6 The Serial Communications Test will also be initiated by the CELL-DYN 4000 at the
CELL-DYN 4000 operator’s request.

01H27-01G – July 2001
3.2.7 The Serial Communications Test may be conducted with the CLIMS connected to the
CELL-DYN 4000 Data Station or with the Serial Loopback Device connected to the
CELL-DYN 4000 Data Station.
3.3 Submit Worklist Entries

3.3.1 The Submit Worklist Entry mode
3.3.1.1 Transactions when in Submit Worklist Entry mode occur via high level
(E1394) messages.
3.3.1.2 The CELL-DYN 4000 shall initiate Submit Worklist Entry mode with a Worklist
Entry Request message consisting of one (1) Header Record, followed by one
(1) Request Information Record, followed by one (1) Message Terminator
Record. The CELL-DYN 4000’s ability to send this message is determined
by the instrument’s “autodownload” feature. If the feature is disabled, the
CELL-DYN 4000 instrument shall not request Worklist Entries from the
CLIMS and shall refuse to accept Worklist Entries sent by CLIMS.
3.3.1.3 The time interval at which the CELL-DYN 4000 sends Worklist Entry request
messages is configurable in the CELL-DYN 4000 LIS Configuration file; the
default value is every 60 seconds. The CELL-DYN 4000 LIS Setup must be
configured to enable “autodownload” and the link status must be “up” for the
CELL-DYN 4000 to send the messages.
3.3.1.4 If the CLIMS has no test orders pending to be sent to the CELL-DYN 4000
instrument which issued the request for information, the CLIMS should not
respond to the inquiry (except as to acknowledge the request as required by
1381 level protocol).
3.3.1.5 If the CLIMS had one or more test orders pending to be sent to the
CELL-DYN 4000 instrument which issued the request, then the CLIMS should
respond with a Worklist Entry Submission message consisting of
one (1) Header Record, followed by one or more (1, n) Patient-Order Record
Combinations, followed by one (1) Message Terminator Record. A Patient-
Order Record Combination shall consist of one (1) Patient Information
Record, followed by one (1) Test Order Record. There must be one (1) and
may be up to 3000 Patient-Order Record Combinations in a single Worklist
Entry Submission message. [Note: Due to the CELL-DYN 4000’s multi-
tasking capability which allows it to process Worklist Entries out of the
Worklist even as additional entries are being submitted, 3000 is not an
implementation limit. However, it is the current capacity of the
CELL-DYN 4000 Worklist, and thus a practical limitation.]
3.3.1.6 The CELL-DYN 4000 shall parse the Worklist Entry Submission and respond
with a Worklist Entry Rejection message for each Patient-Order Record
Combination in the Worklist Entry Submission that was not accepted. A
Worklist Entry Rejection message shall consist of one (1) Header Record,
followed by one (1) Patient Identification Record, followed by one (1) Test
Order Record, followed by one (1) Comment Record, followed by one (1)
Message Terminator Record. The Test Order Record’s Specimen ID field
(E1394, 9.4.3) and Report Type field (E1394, 9.4.26) will be used to encode
the CELL-DYN 4000’s rejection of the Worklist Entry for the Patient-Order
Record combination parsed.

01H27-01G – July 2001
3.3.1.7 When a given Patient-Order combination is not accepted, the CLIMS will be
responsible for maintaining the test order in its list of pending orders and
downloading it to the CELL-DYN 4000 later on.
3.3.1.8 No acknowledgment is sent for Worklist entries that are accepted.
3.3.2 Worklist Entry Request (issued by CELL-DYN 4000, received by CLIMS)
3.3.2.1 Header Record
The Header Record shall conform to E1394 section 7.0, with the fields used
and mapped as shown in Table 1. Required fields shall be provided with non-
null. Fields not listed in the table are nulled or not produced by the
CELL-DYN 4000 as per E1394, sections 6.4.8 and 6.4.9.
Table 1 — Submit Worklist Entry Header Record Field Usage
1394 ref Item Required Optional If used, maps to
CELL-DYN 4000
7.1.1 Record ID x
7.1.2 Delimiters x
7.1.5 Sender ID x Analyzer Serial Number,
CELL-DYN 4000 Family
Member,
CELL-DYN 4000 Model,
CELL-DYN 4000 Software
Version ID
CELL-DYN 4000 LIS
Interface Revision ID
7.1.12 Processing ID x
7.1.13 ASTM Version No. x
3.3.2.1.1 Record ID
The Record ID must be the single letter H in either upper or lower
case.
3.3.2.1.2 Delimiter Definition
The Delimiter Definition field contents must conform to E1394
with no additional restrictions. The CELL-DYN 4000 shall use
delimiters of |\^& in any record which it sends to the CLIMS.
3.3.2.1.3 Sender ID
The Sender ID field shall be composed of five component fields
as described in Table 2; the field order shall be
ASN^FM^M^SVID^LISVID. The first three components
collectively describe the CELL-DYN 4000’s concept of Analyzer
ID.
Table 2 — Sender ID components
Mnemonic Definition
ASN Analyzer Serial Number
FM CELL-DYN 4000 Family Member
M CELL-DYN 4000 Model
SVID CELL-DYN 4000 Software Version ID
LISVID CELL-DYN 4000 LIS Revision ID

01H27-01G – July 2001
3.3.2.1.3.1 Analyzer Serial Number
The Analyzer Serial Number shall be an ASCII character
string of at least one and at most 16 characters. Mixed
case, punctuation, alpha, and numeric characters are
allowed. All characters must be in the ASCII range 32-
255, inclusive. This string is used to uniquely identify the
CELL-DYN 4000(Analyzer) Instrument to its
manufacturer.
3.3.2.1.3.2 CELL-DYN 4000 Family Member
The CELL-DYN 4000 Family Member shall be the seven-
character upper case ASCII character string,
“CELL-DYN 4000R.”
3.3.2.1.3.3 CELL-DYN 4000 Model
The CELL-DYN 4000 Model shall be the two-character
upper case ASCII character string, “SL.”
3.3.2.1.3.4 CELL-DYN 4000 Software Version ID
The CELL-DYN 4000 Software Version ID shall be an
ASCII character string of at least one and at most five
characters. Mixed case, punctuation, alpha, and numeric
characters are allowed. All characters must be in the
ASCII range 32-255, inclusive. The string is used to
uniquely identify the version of the CELL-DYN 4000
application software resident on the CELL-DYN 4000
Instrument.
3.3.2.1.3.5 CELL-DYN 4000 LIS Revision ID
The CELL-DYN 4000 LIS Revision ID shall be the three-
character ASCII character string “1.0.” It uniquely
identifies the version of CELL-DYN 4000 LIS interface
supported in this communication.
3.3.2.1.4 Processing ID
The Processing ID field must be the single letter P in either upper
case or lower case.
3.3.2.1.5 ASTM Version No.
The ASTM Version No. field must be the single digit 1.
3.3.2.1.6 Example
An example of a conforming header record is:
H|\^&|||400096030101^CELL-DYN 4000R^SL^R5-
4H^1.0|||||||P|1<CR>

01H27-01G – July 2001
3.3.2.2 Request Information Record (RIR)
The Request Information Record shall conform to E1394 section 12.0, with
the fields used and mapped as shown in Table 3. Required fields shall be
provided with non-null values. Fields not listed in the table are nulled or not
produced by the CELL-DYN 4000 as per E1394 sections 6.4.8 and 6.4.9.
Table 3 — Request Information Record Fields
1394 ref Item Required
12.1.1 Record ID x
12.1.2 RIR Sequence Number x
12.1.3 Starting Range ID Number x
3.3.2.2.1 Record ID
The Record ID must be the single letter Q in either upper or lower
case.
3.3.2.2.2 Request Information Record (RIR) Sequence Number
The RIR Sequence Number shall be the single digit 1.
3.3.2.2.3 Starting Range ID Number
The Starting Range ID Number shall be a two component field.
The first component shall be null. The second component shall
be the uppercase 3 character ASCII string, “ALL” to request all
Test Orders and shall be a Specimen ID as described in Section
3.3.3.3.3 to request all Test Orders for that Specimen ID. When
requesting Test Orders for a particular Specimen ID, the
CELL-DYN 4000 waits for the Host Query Timeout period
(default = 5.5 seconds, LIS response time + 1 second) before
using the CELL-DYN 4000 Work List defaults to process the
sample. The LIS must respond within 4.5 seconds. That part of
the Host Query Timeout period within which the LIS must
respond begins when the CELL-DYN 4000 transmits the E1381
end of transmission (EOT) character at the end of the Worklist
Entry Request Message and ends when the CELL-DYN 4000
receives the E1381 EOT character at the end of the Worklist
Entry Submission message.
3.3.2.2.4 Examples
Examples of CD4000 Request Information Records are:
Q|1|ÂLL<CR> to request all Test Orders
Q|1|^M34566<CR> to request all Test Orders
for M34566

01H27-01G – July 2001
3.3.2.3 Message Terminator Record (MTR)
The Message Terminator Record shall conform to E1394 section 13.0, with
the fields used and mapped as shown in Table 4. Required fields shall be
provided with non-null values; optional fields may have null or non-null values.
Fields not listed in the table are nulled or not produced by the
CELL-DYN 4000 as per E1394 sections 6.4.8 and 6.4.9.
Table 4 — Message Terminator Record Fields
1394 ref Item Required Optional
13.1.1 Record ID x
13.1.2 MTR Seq Number x
13.1.3 Termination Code x
3.3.2.3.1 Record ID
The Record ID must be the single letter L in either upper or lower
case.
3.3.2.3.2 Sequence Number
The Sequence Number shall be the single digit 1.
3.3.2.3.3 Termination Code
The Termination Code must be either N, T, or E. If the
Termination Code is N, the message shall be processed
normally. If the Termination Code is T or E, the entire message
should/shall be discarded.
3.3.2.3.4 Example
A valid example of a Message Terminator Record is:
L|1|N<CR>
3.3.3 Worklist Entry Submission (issued by CLIMS, received by CELL-DYN 4000)
The Header Record issued by the CLIMS as part of its Worklist Entry
Submission must conform to section 7.0 of the E1394. Table 5, below,
indicates which fields are of interest to the CELL-DYN 4000. Required fields
must contain non-null entries; optional fields may contain null or non-null
values. Optional fields need not be included in the record unless needed for
field count (see E1394, section 6.4.8 and 6.4.9). Any additional fields
produced by the CLIMS as part of the Header Record shall be ignored by the
CELL-DYN 4000. Extra fields, if properly delimited, shall not invalidate the
record.

01H27-01G – July 2001
Table 5 — Header Record Field Map for Worklist Entry Submission Message
7.1.1 Record ID x
7.1.2 Delimiters x
7.1.12 Processing ID x
7.1.13 ASTM Version ID x
All Header Record field definitions are identical to the definitions provided in
Section 3.3.2.1 (Worklist Entry Request - Header Record).
3.3.3.2 Patient Identification Record (PIR)
The Patient Information Record shall conform to E1394 section 8.0, with the
fields used as shown in Table 6.
Table 6 — Submit Worklist Entry Patient Information Record Field Usage
CELL-DYN 4000
8.1.1 Record ID x
8.1.2 PIR Seq Number x
8.1.6 Patient Name x last name
first name
8.1.8 Birthdate x date of birth
8.1.9 Patient Sex x sex
8.1.14 Attending x doctor’s name
Physician
8.1.15 Special Field 1 x age
unit
8.1.16 Special Field 2 x User Defined A
User Defined B
User Defined C
User Defined D
3.3.3.2.1 Record ID
The Record ID must be the single letter P in upper or lower case.
3.3.3.2.2 PIR Sequence Number
The Sequence Number for the first Patient Identification Record
in the Worklist Entry Submission message must be the single
digit 1; each successive Patient Identification Record contained
in the same Worklist Entry Submission message shall increment
the Sequence Number by one (1).

01H27-01G – July 2001
3.3.3.2.3 Patient Name
If present, the Patient Name field shall consist of two
components ordered as LASTNAME^FIRSTNAME; that is, the
surname of the patient followed by the given name. The surname
must be 16 characters or less in length; the given name must be
12 characters or less in length. The characters must be in the
ASCII range from 32-255, inclusive. The contents of the Patient
Name field shall be mapped into the last and first name fields of
the Specimen Name of the Sample Descriptor on the
CELL-DYN 4000. Either component of the Patient Name may be
null.
3.3.3.2.4 Birthdate
If present, the Birthdate field shall consist of a date string
(YYYYMMDD) as per Section 6.6.2 of E1394. This field shall be
mapped to the birthdate field of the Demographics of the Sample
Descriptor on the CELL-DYN 4000.
3.3.3.2.5 Patient Sex
If present, the Patient Sex must be one character in length. The
valid character choices for the representation of Patient Sex are
“M” for male, “F” for female, “U” for unknown; either upper or
lower case is acceptable. The contents of the Patient Sex field
are mapped to the patient sex field of the Demographics of the
Sample Descriptor on the CELL-DYN 4000.
3.3.3.2.6 Attending Physician
If present, the Attending Physician field shall consist of a 16-
character or less string. The characters must be in the ASCII
range from 32-255, inclusive. The contents of this field are
mapped to the Doctor’s Name field of the Demographics in the
Sample Descriptor of the CELL-DYN 4000.
3.3.3.2.7 Special Field 1 - age
If present, Special Field 1 shall consist of two components
ordered as AGEÛNIT where AGE is a 1-3 characters string of
decimal digits representing the patients age, and UNIT is a single
character indicating the unit of measure to be used to interpret
the digits. Zero is a valid numerical age. The characters used to
represent the age unit of measure shall be “d” for days; “m” for
months; and “y” for years; either upper or lower case is
acceptable. The Special Field 1 field contents are stored in the
age field of the Demographics of the Sample Descriptor on the
CELL-DYN 4000.

01H27-01G – July 2001
3.3.3.2.8 Special Field 2 - User Defined Demographics
If present, Special Field 2 shall consist of four components,
ordered as UDAÛDBÛDCÛDD. Each component shall be 16
characters or less in length. Any component may be null, as per
the ASTM standard. All characters must be in the ASCII range
32-255, inclusive. The components shall be mapped to the User
Defined Demographic fields of the Sample Descriptor of the
CELL-DYN 4000 as shown in Table 7. Use of and interpretation
of these fields should be defined by conventions established
between the laboratory staff and CLIMS system. The
CELL-DYN 4000 instrument does not interpret these fields.
Table 7 — Special Field 2 Component Mapping
Mnemonic CELL-DYN 4000 Definition in
Demographics
UDA User Defined A
UDB User Defined B
UDC User Defined C
UDD User Defined D
3.3.3.2.9 Example
An example of a conforming Patient Information Record is:
P|1||||Jones^David||19640315|M|||||Roberts|32^y
|Phillips^sickle crisisÎCU^327-56-9567<CR>
3.3.3.3 Test Order Record (TOR)
The Test Order Record shall conform to E1394 section 9.0, with the fields
used as shown in Table 8. Multiple test orders within a single Test Order
Record are not supported; however, replicate analysis of the same specimen
under the same test conditions is supported within a single Test Order
Record.

01H27-01G – July 2001
Table 8 — Worklist Entry Submission’s Test Order Record Field Usage
CELL-DYN 4000
9.4.1 Record ID x
9.4.2 TOR Seq Number x
9.4.3 Specimen ID x Specimen ID
9.4.5 Universal Test ID x Test Selection,
Parameter Set
Selection,
Limit Set Selection,
Replicate Count,
Numerical Result Label
9.4.8 Spec. Collection Date x draw date
& Time draw time
9.4.16 Specimen Descriptor x Specimen Type
Specimen Subtype
9.4.26 Report Types x
3.3.3.3.1 Record ID
The Record ID must be the single letter O in either upper or lower
case.
3.3.3.3.2 Sequence Number
The Sequence Number for the Test Order Record in the Worklist
Entry Submission message shall be the single digit 1 as there
shall be one and only one Test Order Record per Patient
Identification Record. There can be only one test selected per
Test Order Record (see section 3.3.3.3.4 Universal Test ID).
3.3.3.3.3 Specimen ID
The Specimen ID must be at least one (1) and not more than
twelve (12) characters in length. The Specimen ID may not be
blank; it may not have embedded blanks. The Specimen ID
should match the bar code label on the sample tube that contains
the blood sample from the Patient identified in the associated
Patient Identification Record. Use of a check digit on the bar
code or as part of the Specimen ID should be coordinated
against the CELL-DYN 4000’s Analyzer Bar Code Reader Check
Digit Setup selections. The bar-coded sample tube has its bar
code read by the CELL-DYN 4000 Analyzer, transferred to the
CELL-DYN 4000 Data Station, and matched against the
Specimen ID field of the Worklist Entries to identify which test is
to be run on the specimen which is being aspirated. The content
of this field is critical to proper identification, analysis, and
reporting of patient results.
NOTE: A specimen ID that matches an identification string
reserved for Abbott use (such as “CD61” used on a CD61
Reagent Tube, or “CD34” or “CD38” used on CD3/4/8 Reagent
Tubes) will be accepted by the CELL-DYN 4000, but will never
be matched to and run from the work list.

01H27-01G – July 2001
3.3.3.3.4 Universal Test ID
If present, the Universal Test ID is composed of eight
components as described in Table 9, which follows; the field
order shall be ^^^TS^PSS^LSS^RC^NRL. The first three
components of the Universal Test ID are reserved by E1394 and
thus are presented as null components in the Universal Test ID.
Null values in any of the components 4 through 7 will cause the
CELL-DYN 4000 instrument to supply the appropriate value from
the Worklist Standard Processing Setup current at time that the
CELL-DYN 4000 begins to parse the Worklist Entry Submission
Message.
Table 9 — Worklist Entry Submission – Universal Test ID
Component Field Definition
Component Universal Test ID Definition
Field Mnemonic
(positional)
1 Universal Test ID Reserved by E1394 std
Name
Type
4 TS CELL-DYN 4000 Test Selection
5 PSS CELL-DYN 4000 Parameter Set
Selection
6 LSS CELL-DYN 4000 Patient Limit
Set Selection
7 RC CELL-DYN 4000 Replicate Count
8 NRL CELL-DYN 4000 Numerical
Result Label
3.3.3.3.4.1 Universal Test ID - reserved, E1394

3.3.3.3.4.2 Universal Test ID Name - reserved, E1394
3.3.3.3.4.3 Universal Test ID Type - reserved, E1394
3.3.3.3.4.4 CELL-DYN 4000Test Selection
If present, the Test Selection component must be one of
the LIS Interface Strings shown in the left column of Table
10. The Test Selection does control which test is run,
analyzed, and reported by the CELL-DYN 4000
Instrument.
Table 10 — CELL-DYN 4000 Test Selection Representations
CLIMS Interface String Corresponding CELL-DYN 4000 OI
menu
CBC CBC
CBCEC CBC, WBC Extended Count
CBCEL CBC, Resistant RBC
CBC+RETC CBC+RETC
CBCEL+RETC CBC+RETC, Resistant RBC
CBCEC+CD61 CBC+CD61, WBC Extended Count
CBCEC+CD3/4/8 CBC+CD3/4/8, WBC Extended Count

01H27-01G – July 2001
3.3.3.3.4.5 CELL-DYN 4000 Parameter Set Selection
If present, the Parameter Set Selection component must
be a number between 1 and 16 (no leading zeroes on
single digit values). The Parameter Set Selection is used
by the CELL-DYN 4000 to control local presentation of
the CELL-DYN 4000’s test results; it does not affect the
information reported to the CLIMS.
3.3.3.3.4.6 CELL-DYN 4000 Patient Limit Set Selection
If present, the Limit Set Selection component must be a
single digit in the range 1 to 8. The Limit Set Selection is
used by the CELL-DYN 4000 to control local presentation
of the CELL-DYN 4000’s test results; it does not affect the
information reported to the CLIMS, although it may affect
the delivery of that report.
3.3.3.3.4.7 CELL-DYN 4000 Replicate Count
If present, the Replicate Count shall be a single digit
number between 1 and 5. The Replicate Count shall be
used by the CELL-DYN 4000 to control the number of
aspirations (and replicates of a given test) that are run on
a single sample tube of patient blood. The replicates are
immediate, and each will generate its own test results to
be reported independently to the CLIMS. The
CELL-DYN 4000 does not average or identify replicate
results in its interface to the CLIMS (see section 3.4.2 for
further details of the CELL-DYN 4000 reporting
mechanisms.)
Note: The CELL-DYN 4000 will set the Replicate Count to
1 if the Test Selection is CBCEC+CD61 or
CBCEC+CD3/4/8.
3.3.3.3.4.8 CELL-DYN 4000 Numerical Result Label
The Numerical Result Label component in the Universal
Test ID of a Test Order Record of a Worklist Entry
Submission must be null.
3.3.3.3.5 Specimen Collection Date and Time
If present, the Specimen Collection Date and Time field must
conform to the E1394 specification, section 6.6.2, i.e.,
YYYYMMDDHHMMSS. It shall be stored by the
CELL-DYN 4000 in the Draw Date and Draw Time fields of the
Sample Descriptor.

01H27-01G – July 2001
3.3.3.3.6 Specimen Descriptor
If present, the Specimen Descriptor shall be composed of two
component fields as described in Table 11; the field order shall be
ST^SST.
Table 11 — Specimen Descriptor Component Definitions
Mnemonic Definition
ST Specimen Type
SST Specimen Subtype
3.3.3.3.6.1 Specimen Type

If present, the Specimen Type shall be one of the
following case-sensitive ASCII character strings:
“Patient,” “QC,” or “Background.” The choice of Specimen
Type should reflect the nature of the specimen whose
Worklist Entry is being defined.
3.3.3.3.6.2 Specimen Subtype
If the Specimen Type is Patient, then the Specimen
Subtype is the case-sensitive ASCII string “Human.” If the
Specimen Type is QC, then the Specimen Subtype is a
one- or two-character string representing the
CELL-DYN 4000 QC file number whose current definition
of Test Selection, Parameter Set Selection, Limit Set
Selection, and Replicate Count shall be used for any
corresponding Universal Test ID component field found to
be null in this Test Order Record.
If the Specimen Type is Background, then the Specimen
Subtype is the case sensitive ASCII string “Normal.”
If the Specimen Type is null, then the Specimen Subtype
must be null.
3.3.3.3.7 Report Types
If present, the Report Type of the Test Order record of a Worklist
Entry Submission message shall be either the single character O
or the single character Q.
3.3.3.3.8 Example
An example of a conforming Test Order Record is (using the
delimiters specified in the Header Record example):
O|1|19345||^^^CBCEL+RETC^9^5^2|||19960810153028
||||||||Patient^Human<CR>
The Message Terminator Record for a Worklist Entry Submission message
shall be as described in section 3.3.2.3 of this document.

01H27-01G – July 2001
3.3.4 Worklist Entry Rejection (issued by CELL-DYN 4000, received by CLIMS)
The Header Record for a Worklist Entry Rejection message shall be as
described in section 3.3.2.1 of this document.
The contents of the Patient Information Record shall be an exact copy of the
Patient Information Record of the Patient-Order Combination of the Worklist
Entry Submission message that is being rejected with the exception of the
Patient Identification Record Sequence Number shall be the single digit 1.
(See section 3.3.3.2 of this document.)
The contents of the Test Order Record shall be an exact copy of the Test
Order Record of the Submit Worklist Entry message that is being rejected,
with the exception that there shall be a non-null entry in the Report Types field
(E1394, section 9.4.26). Note that the non-blank, non-null Specimen ID field
is available to ensure correct association of the particular Worklist Entry
Rejection with the CLIMS Patient-Order being rejected. (See section 3.3.3.3.
of this document.)
The Report Type field value shall be “X” to indicate that no Worklist Entry has
been made in the CELL-DYN 4000 Worklist for the associated Patient-Test
Order. This is essentially a high level (E1394) NAK. The reason for the
CELL-DYN 4000’s rejection of the Patient-Order combination shall be
provided in a Comment Record that shall immediately follow the Test Order
Record.
The CLIMS should resend the rejected Patient-Order combinations in a new
message at a later date.
3.3.4.4 Comment Record (CR)
The Comment Record shall conform to E1394 section 11.0, making use of the
fields listed in Table 12. The Comment Record shall specify the reason the
Patient-Order combination of the Worklist Entry message was rejected. The
rejection may occur for two reasons:
a. Worklist Full - The instrument has a fixed size for the worklist. If all
worklist entries are used, the instrument cannot add another entry.
b. Parsing error - Some part of the message did not conform to this
specification in either syntax or semantic content.
Table 12 — Worklist Entry Rejection Comment Record Field Usage
11.1.1 Record ID x
11.1.2 CR Sequence Number x
11.1.3 Comment Source x
11.1.4 Comment Text x
11.1.5 Comment Type x

01H27-01G – July 2001
3.3.4.4.1 Record ID
The Record ID shall be the single character C in either upper or
lower case.
3.3.4.4.2 CR Sequence Number
The Comment Record Sequence Number shall be the single digit 1.
3.3.4.4.3 Comment Source
The Comment Source shall be the single character I in either
upper or lower case.
3.3.4.4.4 Comment Text
The Comment Text shall be one of the strings shown in the
leftmost column of Table 13. The choice of Comment Text shall
reflect the reason for rejecting the Patient-Test Order
combination.
Table 13 — Worklist Entry Rejection Indications
CLIMS Interface String Associated Rejection Criterion
Worklist Full The CELL-DYN 4000 instrument worklist is
full; a Worklist Entry for this Patient-Order
combination could not be made at this time.
Parsing Error A parsing error occurred or the value
associated with one or more of the fields was
incorrect in content.
3.3.4.4.5 Comment Type

The Comment Type shall be the single character G in either
upper or lower case.
3.3.4.4.6 Example
The following is an example of a Worklist Entry Rejection
Comment Record detailing the rejection reason as being due to a
worklist full condition.
C|1|I|Worklist Full|G<CR>
The Message Terminator Record for a Worklist Entry Rejection message shall
be as described in section 3.3.2.3 of this document.

01H27-01G – July 2001
3.4 Transfer of Test Results
3.4.1 Transfer Test Results Conversation
3.4.1.1 The Transfer Test Results conversation is transacted in high-level (E1394)
messages. The conversation results in the transfer of the set of Test Results
for one (1) aspiration on the CELL-DYN 4000 Instrument (i.e., one Sample
Record).
3.4.1.2 The CELL-DYN 4000 must begin the conversation with a Test Result Transfer
message consisting of one (1) Header Record, followed by one (1) Patient
Information Record, followed by one (1) Test Order Record, followed by
twelve (12) Comment Records, followed by either twenty eight (28) or thirty-
five (35) Result Records, followed by one (1) Message Terminator Record.
3.4.1.3 The twelve Comment Records will always be sent and will be in fixed order.
The first Comment Record indicates the outcome of the CELL-DYN 4000
resident Delta Check program at the time of transmission of the associated
specimen. The second Comment Record describes any data-invalidating
sample processing conditions experienced on the CELL-DYN 4000
instrument during aspiration and fluidic processing of the associated
specimen. The next ten (10) Comment Records each detail the existence or
non-existence of a given suspect data population, which the CELL-DYN 4000
is capable of detecting.
3.4.1.4 The twenty-eight (28) or thirty-five (35) Result Records (depending on a
setting in the CELL-DYN 4000 LIS Configuration file) will always be sent and
will be in fixed order. Each record itemizes a single quantitative result
produced by the CELL-DYN 4000 instrument. The status of each ‘numerical
result’ as determined by the CELL-DYN 4000 instrument is also reported in
the pertinent Result Record.
3.4.1.5 The CELL-DYN 4000-CLIMS link must be “up” for the CELL-DYN 4000 to
begin a Transfer Test Results conversation. The CELL-DYN 4000 shall
begin a Transfer Test Results conversation when directed to do so by the
CELL-DYN 4000 operator. In addition, if auto-transmit is enabled on the
CELL-DYN 4000 Instrument, the CELL-DYN 4000 shall begin the Transfer
Test Results conversation whenever a Sample Record that qualifies for
auto-transmission becomes available at the conclusion of sample
processing of the associated aspiration. The ability to auto-transmit and the
qualification criteria for auto-transmission of a Sample Record are configured
by the CELL-DYN 4000 operator in the LIS/Auto-Transmit Setup. Note that
the above behavior does imply that the CELL-DYN 4000 may transmit Test
Results to the CLIMS, which are associated with specimens other than the
ones submitted to the CELL-DYN 4000 by the CLIMS.
3.4.1.6 The CLIMS must parse the Test Results Transfer message and issue a 1381
level ACK or NAK of the Test Results Transfer message. If the Test Results
Transfer message for a given Sample Record is ACK’ed, the CELL-DYN 4000
removes that Sample Record from its “to be transmitted” queue and marks the
Sample Record as “transmitted.” No further attempts to transmit this Sample
Record will be made unless the CELL-DYN 4000 Instrument is explicitly
directed to do so by the CELL-DYN 4000 operator. If the Test Results Transfer
message is NAK’ed, the CELL-DYN 4000 retains the associated Sample
Record in its “to be transmitted” queue and resends the message later.

01H27-01G – July 2001
3.4.1.7 The CELL-DYN 4000 Instrument’s “to be transmitted” queue is automatically
purged of all pending Sample Records when the CELL-DYN 4000-CLIMS link
goes down. Additionally, it may be purged of all pending Sample Records by
direct instruction from the CELL-DYN 4000 operator to the
CELL-DYN 4000 Instrument. Restoration of the link does not cause the
CELL-DYN 4000 to reconstruct the “to be transmitted” queue; however new
Sample Records may be added by the auto-transmit facility or by the
CELL-DYN 4000 operator.
3.4.2 Test Results Message (issued by CELL-DYN 4000, received by CLIMS)
The Header Record for a Test Results Transfer message shall be as
described in Section 3.3.2.1 of this document.
The Patient Identification Record of a Test Results Transfer message shall
conform to section 8.0 of E1394. The usage and definition of the record fields
shall be as described in section 3.3.3.2 of this document, with the exception
that the Patient Identification Record Sequence Number shall be the single
digit 1. There will be one and only one Patient Identification Record per Test
Results Transfer message.
The Test Order Record of a Test Results Transfer message shall conform to
section 9.0 of E1394 with the field usage and mapping shown in Table 14.
Table 14 — Field use in Test Order Record of Test Results Transfer Message
CELL-DYN 4000
9.4.1 Record ID x
9.4.2 TOR Seq Number x
9.4.3 Specimen ID x Specimen ID
9.4.4 Instrument x DSOS Seq. Number
Specimen ID
Parameter Set
Selection,
Replicate Count,
Numerical Result Label
9.4.8 Spec. Collection x Draw date
Date & Time Draw time
9.4.16 Specimen x Specimen Type
Descriptor Specimen Subtype
9.4.26 Report Types x

01H27-01G – July 2001
3.4.2.3.1 Record ID
The Record ID shall be the single character O, in either upper or
lower case.
3.4.2.3.2 TOR Sequence Number
The Sequence Number shall be the single digit 1.
3.4.2.3.3 Specimen ID
The Specimen ID shall be an ASCII string of one to 12 characters
in length. It shall be the actual Specimen ID value recorded on
the CELL-DYN 4000 instrument. As such, it may or may not
have been received from the CLIMS in a previous Worklist Entry
Submission (as per section 3.4.1.5 of this document).
3.4.2.3.4 Instrument Specimen ID
The Instrument Specimen ID shall be a four-character ASCII
string of digits in the range 0000 to 9999, inclusive. The
Instrument Specimen ID represents the CELL-DYN 4000
Instrument’s Datalog sequence number that is used, along with
the date and time of the test, to uniquely identify a given
aspiration on the CELL-DYN 4000 instrument. As the Datalog
sequence number does roll over at 9999, it does not represent
truly unique identifier in and of itself.
The Universal Test ID field of the Test Order record of a Test
Transfer Message shall be as defined in section 3.3.3.3.4 of this
document with the exception that component fields 4, 5, and 6
shall always be non-null and component field 7 shall always be
null.
3.4.2.3.6 Specimen Collection Date & Time
The Specimen Collection Date and Time shall be as described in
section 3.3.3.3.5 of this document.
3.4.2.3.7 Specimen Descriptor
The Specimen Descriptor shall be as described in section
3.3.3.3.6 of this document.
3.4.2.3.8 Report Types
The Report Type of the Test Order record of a Test Results
Transfer message shall be the single character F.
3.4.2.4 Comment Record(s)
Test Result Comment Records shall be as described in section 3.3.4.4 of this
document with the exception of the Comment Text field definition and
Comment Type. There are three types of comment records issued as part of
the Test Results Transfer message. The types differ in the component syntax
and interpretation of the Comment Text field. The Comment Type field for all
Test Result Comment Records shall be I.

01H27-01G – July 2001
3.4.2.4.1 Comment Record Type 1 (CR #1)
The Type 1 Comment Record is a Delta Check Comment. The
comment text field shall contain the CELL-DYN 4000 Instrument-
resident Delta Check outcome, current at time of transmission to
the CLIMS. No reference is provided as to which other
CELL-DYN 4000 Sample Record participated in the Delta Check;
nor are the specifics of the Delta Check configuration or data
discrepancies given.
3.4.2.4.1.1 CR Sequence Number
The Comment Record Sequence Number shall be the
single digit 1.
3.4.2.4.1.2 Comment Text
The Comment Text field of the type 1 Comment Record
shall be a two-component field, whose components are
ordered as DC^DCO. The component definitions are as
shown in Table 15.
Table 15 — Delta Check Comment Record Text
Component Descriptions
Mnemonic Definition Possible Values
DC Comment The two-character ASCII string
Identifier “DC”
DCO Delta Check One of the following four-
Outcome character ASCII strings
NONE
NOMA
FAIL
PASS
The Delta Check Outcome of “NONE” indicates that a
CELL-DYN 4000 resident Delta Check was not
attempted.
The Delta Check Outcome of “NOMA” indicates that a
CELL-DYN 4000 resident Delta Check was attempted,
but an earlier record matching the selection criteria was
not found.
The Delta Check Outcome of “FAIL” indicates that a
CELL-DYN 4000 resident Delta Check was performed
and that the associated Test Results failed the then-
current Delta Check Criteria on the CELL-DYN 4000.
The Delta Check Outcome of “PASS” indicates that a
CELL-DYN 4000 resident Delta Check was performed
and that the associated Test Results passed the then-
current Delta Check Criteria on the CELL-DYN 4000.

01H27-01G – July 2001
3.4.2.4.1.3 Example of Type 1 Comment Record:
C|1|I|DC^PASS|I<CR>
3.4.2.4.2 Comment Record Type 2 (CR #2)
The Type 2 Comment Record is a Data Invalidation Comment.
The comment text field shall contain an encoded description of
sample processing conditions in effect on the CELL-DYN 4000
Instrument as the associated specimen was processed. The
encoding encrypts sample processing error conditions; thus, if
decoded to a zero value the indication is that this aspiration was
processed without error. The CLIMS should interpret this
comment record, at least to the point of establishing the
existence or non-existence of a sample processing error to be
associated with these Test Results.
The Sequence Number for the Type 2 Comment Record
of a Test Results Transfer message shall be the single
digit 2.
The Comment Text of the Type 2 Comment Record shall
be a three-component field ordered as DI^MSP^LSP.
The component field definitions are as shown in Table 16.
Table 16 — Definitions of Data Invalidation Comment Text
Components.
Mnemonic Definition
DI Comment Identifier
MSP Most Significant Part of the encoded data
invalidation flag
LSP Least Significant Part of the encoded data
invalidation flag
3.4.2.4.2.2.1 Data Invalidation Comment Identifier

The Comment Identifier shall be the two-
character ASCII string of “DI”.
3.4.2.4.2.2.2 Encoded Data Invalidation Flag
The MSP and LSP components of the
Comment Text for a Type 2 Comment Record
shall each be a five-character ASCII string of
digits in the range 00000 to 65535, inclusive.
The pattern that results from concatenation of
the binary numerical equivalents of these two
strings indicates which sample processing
errors occurred during this aspiration.

01H27-01G – July 2001
Example 1. No Sample Processing Errors:
C|2|I|DI^00000^00000|I<CR>
Example 2. Sample Processing Errors:
C|2|I|DI^00648^00002|I<CR>
Interpretation of MSP and LSP, “00648”
“00002,” yields the decimal numbers 648 and 2,
which result in a bit pattern of
0000 0010 1000 1000 0000 0000 0000 0010
The bit pattern can be used in a binary test for
data invalidation or interpreted against Table 17
to indicate the following sample processing
invalidations:
Bit 1 = Impedance Aperture Clog
Bit 19 = Insufficient Reticulocyte Reagent
Bit 23 = Retic Count Rate error
Bit 25 = RBCi Count Rate error
Table 17 — DIF/DIA Interpretation
Bit # If Bit # .... is set, the following sample
processing invalidation was detected.
0 Aspiration Clot
1 Impedance Aperture Clog
2 Residual Fluid Detected in WBC Dilution Cup
3 Laser Current too high
4 Hot Pot Temperature Error
5 Hot Pot Speed Error
6 Autoloader Failure
7 HGB Dilution Syringe failed to home
8 Missing Reagent Tube
9 Incorrect Reagent Tube
10 RBC Reagent Syringe failed to home
11 RETC Reagent Syringe failed to home
12 WBC Reagent Syringe failed to home
13 Pneumatics Failure in high pressure range
14 Pneumatics Failure in medium pressure range
15 Pneumatics Failure in low pressure range
16 Pneumatics Failure in vacuum range
17 Aspiration Deposition Pump failed to home
18 Aspiration Probe not up
19 Insufficient Reticulocyte Reagent
20 VPM Communications failure
21 Insufficient Diluent/Sheath Reagent to Complete Multi-tube Assay
22 Short Sample
23 RETC Count Rate error
24 WBC Count Rate error
25 RBCi Count Rate error
26 PLTi Count Rate error
27 PLTo Count Rate error
28 CD61 Optical Platelet Stream Mismatch
29 CD3/4/8 Count Rate/Mismatch
30 Reserved for future use
31 Reserved for future use

01H27-01G – July 2001
3.4.2.4.3 Comment Record Type 3 (CR #3-12)
Comment Records of Type 3 are Suspect Population Comments
and are used to report the existence or non-existence of suspect
population flags associated with these Test Results.
The Comment Record Sequence Number for Type 3
Comment Records shall be in the range 3 to 12, inclusive.
The Comment Records shall appear in numerical order in
the Test Results Transfer Message. The Sequence
Number is tied directly to the Suspect Population Flag
Name as shown in Table 18 in section 3.4.2.4.3.2 of this
document.
The Comment Text for Type 3 Comment Records shall be
a four-component field ordered as
SP^NAME^VALUE^CONF. The component descriptions
are as shown in Table 18.
Table 18 — Suspect Population Flag Components (*For
laboratory use only)
Mnemonic Description
SP Comment Identifier
NAME Suspect Population Flag Name
VALUE Suspect Population Flag Value
CONF* Suspect Population Flag Confidence Level
3.4.2.4.3.2.1 Comment Identifier

The Comment Identifier for a Suspect
Population Flag Comment Record shall be the
two-character ASCII string “SP.”
3.4.2.4.3.2.2 Suspect Population Flag Name
The Suspect Population Flags and their
associated Comment Record ID are as
described in Table 19. Table 19 shows the
exact case-sensitive string as it will appear in
the Comment Record.

01H27-01G – July 2001
Table 19 — Suspect Population Flag Names
Comment Record ID Suspect Population Flag Name
3 Nonviable WBCs
4 Bands
5 Blasts
6 Variant Lymphoids
7 Immature Granulocytes
8 Unidentified Fluorescent Cells
9 Resistant RBCs
10 Asymmetric RBC
11 High Number Immature Reticulocytes
12 Platelet Clumps
3.4.2.4.3.2.3 Suspect Population Flag Value

The Suspect Population Flag Value shall be the
three-character ASCII string “YES”, if and only if
the associated flag (as named) is present.
The Suspect Population Flag Value shall be the
two-character ASCII string “NO”, if and only if
the associated flag (as named) is not present.
3.4.2.4.3.2.4 Suspect Population Flag Confidence Level
The Suspect Population Flag Confidence Level
(for laboratory use only) shall be a four-
character ASCII string representing the decimal
values between 0.00 and 1.00, inclusive.
Although all Type 3 Comment Record Text
fields have confidence level component strings,
not all Suspect Population Flags have
meaningful confidence level values. Refer to
the CELL-DYN 4000 Operator’s Manual for
guidelines of interpretation of confidence levels.
3.4.2.4.3.3 Example
An example of a Type 3 Comment record is:
C|9|I|SP^Resistant RBCs^YES^1.00|I<CR>

01H27-01G – July 2001
3.4.2.5 Results Record(s)
The Result Records shall conform to section 10.0 of E1394, with field usage
as shown in Table 20. There are either 28 or 35 quantitative (numerical) test
results reported in each Test Result Transfer Message, depending on a
setting in the CELL-DYN 4000 LIS Configuration file. Each numerical result is
reported in USA units of measure. Each test result is reported in a separate
Results Record, distinguished by the Numerical Result Label component of
the Universal Test ID field. Although the LIS interface provides the Test
Results in fixed order, the Results Record Sequence Number is not a
guaranteed mapping; thus the CLIMS should map numerical quantities based
on the Numerical Result Label.
Table 20 — Results Record Field Usage
CELL-DYN 4000
10.1.1 Record Type x
10.1.2 RR Seq Num x
Parameter Set
Selection,
Replicate Count,
Numerical Result
Label
10.1.4 Data Meas. Value x Numerical Result
Value
10.1.9 Result Status x Numerical Result
Status
10.1.11 Operator ID x Operator ID
10.1.12 Date/Time Test x Aspiration Date & Time
Started
3.4.2.5.1 Record Type

The Record Type of a Results Record of a Test Results Transfer
message shall be the single character R in either upper or lower
case.
3.4.2.5.2 RR Sequence Number
The Result Record Sequence Number shall be in the range 1 to
28 or 1 to 35, inclusive, depending on a setting in the
CELL-DYN 4000 LIS Configuration file. The Result Records shall
appear in numerical order in the Test Results Transfer Message.
The Sequence Number is tied directly to the Numerical Result
Label as shown in Table 21 in section 3.4.2.5.3.8.

01H27-01G – July 2001
The Universal Test ID shall conform to the component definitions
shown in Table 9 of section 3.3.3.3.4 of this document. The
Universal Test ID shall be present in a Results Record.
3.4.2.5.3.1 Universal Test ID - reserved; null
3.4.2.5.3.2 Universal Test ID Name - reserved; null
3.4.2.5.3.3 Universal Test ID Type - reserved; null
3.4.2.5.3.4 CELL-DYN 4000 Test Selection
The Test Selection shall be present in a Results Record
and shall be an exact copy of the Test Selection in the
associated Test Order Record.
3.4.2.5.3.5 CELL-DYN 4000 Parameter Set Selection
The Parameter Set Selection of a Results Record shall be
null.
3.4.2.5.3.6 CELL-DYN 4000 Patient Limit Set Selection
The Limit Set Selection of a Results Record shall be null.
3.4.2.5.3.7 CELL-DYN 4000 Replicate Count
The Replicate Count of a Results Record shall be null.
3.4.2.5.3.8 CELL-DYN 4000 Numerical Result Label
The Numerical Result Label component of the Universal
Test ID shall be one of the 2 - 4 character case-sensitive
ASCII strings shown below. The Record ID and the
Numerical Result Label of a given Result Record shall be
as shown in Table 21.

01H27-01G – July 2001
Table 21 — Record ID and Numerical Results Mapping
for Result Records of a Test Results Transfer Message
(* = For laboratory use only. Not reportable in the US.
**Included only if enabled in CELL-DYN 4000 LIS
Configuration file.)
Record ID Numerical Result Labels
1 WBC
2* WVF
3 NEU
4 LYM
5 MONO
6 EOS
7 BASO
8 %N
9 %L
10 %M
11 %E
12 %B
13 NRBC
14 NR/W
15 RBC
16 HGB
17 MCV
18 MCH
19 MCHC
20 HCT
21 RDW
22 PLT
23 MPV
24* PDW
25* PCT
26 RETC
27 %R
28 IRF
29** CD3T
30** CD4T
31** CD8T
32** %CD3
33** %CD4
34** %CD8
35** 4/8

01H27-01G – July 2001
3.4.2.5.4 Data or Measurement Value
The Data Value field shall be one of the four-character ASCII
strings shown in Table 22. The actual string shall depend upon
the actual quantitative Numerical Result determined by the
CELL-DYN 4000 instrument.
Table 22 — Data/Measurement Value Representations
Tie Data Value Description Interpretation
String
1 ---- four dashes no data recorded from which to
derive this result
2 >>>> four right result is higher than
chevrons instrument’s reportable range
3 <<<< four left chevrons result is lower than
instrument’s reportable range
4 four blanks data was recorded, but result
(ASCII 32); was not calculated
5 0.00 string of four actual numerical/ quantitative
999. decimal digits result; always four characters,
with floating but decimal point floats with
decimal point magnitude
3.4.2.5.5 Result Status

The Result Status shall be a single character as indicated in
Table 23. Note that these codes make use of a proposed
extension to E1394. The result status is tied to Data
Measurement Value Representations as indicated in Tables 22
and 23. The number shown in the “Tied to” column of Table 23
are the numbers indicated in the “Tie” column of Table 22.
Table 23 — Result Status
Result Interpretation Tied to
Status
F Final; quantitative result is reportable although it 5
may be associated with a suspect population flag
W Warning; quantitative result is suspect or out of 2,3,5
range; should be reviewed as per lab protocol
before being reported
X Unavailable; no data was recorded or the 1,4
quantitative result was not computed
3.4.2.5.6 Operator ID
If present, the Operator ID shall be a four-character ASCII string
(32-255, inclusive). It is mapped from the Operator ID field of the
CELL-DYN 4000. This field may be null.

01H27-01G – July 2001
3.4.2.5.7 Date/Time Test Started
The Date/Time Test Started shall be a 14-character date/time
string, YYYYMMDDHHMMSS, as per E1394 section 6.6.2. The
value shall be the date and time of aspiration on the
CELL-DYN 4000 instrument of the specimen which produced
these results.
3.4.2.5.8 Example of a Results Record:
R|19|^^^CBC^^^^MCHC|33.2|||||F|||19960810082234<CR>
The Message Terminator Record of a Test Results Transfer message shall be
as described in section 3.3.2.3 of this document.
3.4.3 Test Results Acknowledgment Message (issued by CLIMS, received by
CELL-DYN 4000)
The CLIMS must issue 1381-level ACKs for each frame of the Test Results Transfer
Message that it properly receives and parses. If each and every frame is ACKed, the
CELL-DYN 4000 shall interpret the outcome as a successful transfer of the Test Results
Message to the CLIMS and clear the associated Sample Record from the
CELL-DYN 4000 “to be transmitted” queue.
4.0 Error Handling

4.1 If the header of a Worklist Entry Submission received by the CELL-DYN 4000
instrument is garbled so that it does not parse, the CELL-DYN 4000 shall issue an error
message to the CLIMS which will consist of a single header and single terminator
record. The form of this error message header shall be as described in 3.3.2.1 of this
document. The terminator record shall be as described in section 3.3.2.3, with the
exception that the Termination Code shall be the single character E.
4.2 If the CELL-DYN 4000 Instrument cannot parse a Worklist Entry Submission message,
it shall respond with a Worklist Entry Rejection message indicating a Parsing Error as
described in section 3.3.4 of this document. The following conditions shall be
considered parsing errors:
• records within a message being sent out of the prescribed hierarchical order
• field length violations for required fields; in particular invalid specimen ID lengths
4.3 The CELL-DYN 4000 Instrument shall truncate optional fields which exceed the
specified field lengths (e.g., physician names longer than 16 characters) and shall
ignore the content of fields not specified in this document.
4.4 The CELL-DYN 4000 Instrument uses default values for Worklist entry data items
associated with optional fields in an accepted Worklist Entry Submission message
when such fields are not interpretable.

01H27-01G – July 2001
Appendix A — Examples
A-1 Example of the CELL-DYN 4000 sending Worklist Entry Request to the CLIMS (Request Record):
The following message, issued by the CELL-DYN 4000, would request that the CLIMS send all pending Worklist Entries for the CELL-DYN 4000
System identified as having Analyzer Serial Number 400096030101.
H|\^&|||400096030101^CD4000R^SL^R5-4F^1.0|||||||P|1<CR>
Q|1|ÂLL<CR>
L|1|N<CR>
A-2 Examples of Worklist Entry Submission Messages (sent by CLIMS to CELL-DYN 4000 in response to query)
Ex A-2.1 — The minimum Worklist Entry Submission Message (one (1) Worklist Entry, required elements only)
H|\^&<CR>
P|1<CR>
O|1|18465<CR>
L|1|N<CR>
This message will cause the CELL-DYN 4000 to put one (1) Worklist Entry in the Worklist for a human patient identified by Specimen ID = 18465.
The test, parameter set, limit set, and number of replicates to run will be whatever the CELL-DYN 4000 has in its Worklist Setup at the time that this
message is received from the CLIMS. The Worklist Entry will be activated (selected and run) when a sample tube labelled with bar code = 18465 is
presented to the aspiration probe by the Autoloader.
Ex A-2.2 — A Worklist Entry Submission using all required and optional elements of significance to the CELL-DYN 4000 (records terminated after
last used field)
H|\^&||||||||||P|1<CR>
P|1||||Jones^David||19640315|M|||||Roberts|32^y|Phillips^sickle crisisÎCU^327-56-9567<CR>
O|1|19345||^^^CBCEL+RETC^9^5^2|||19960810153028||||||||Patient^Human||||||||||Q<CR>
L|1|N<CR>
This message will cause the CELL-DYN 4000 to put one Worklist Entry in the Worklist for a human patient identified by Specimen ID = 19345. The
test to be run against this specimen will be an Extended Lyse CBC and RETC test. The chartable report will use Parameter Set #9, and the results
will have been evaluated against Limit Set #5. Two replicate aspirations will be conducted using the same test selection and reporting schemes. The
demographic information recorded on the CELL-DYN 4000 about this specimen includes the patient name (David Jones), birthdate (Mar 15, 1964),
sex (Male), and age (32 years old). The attending physician is Dr. Roberts.
Assuming the Laboratory and CLIMS have agreed upon definitions of the “user defined demographic fields” of the CELL-DYN 4000 to be: A = 2nd
physician, B = presenting symptoms, C = current patient location, and D = patient social security number; the additional information recorded in the
CELL-DYN 4000 demographics area will be: 2nd physician = Dr. Phillips; symptoms = sickle cell crisis; patient location = ICU; patient social security
# = 327-56-9567. The Worklist Entry will be activated (selected and run) when a sample tube labeled with bar code = 19345 is presented to the
aspiration probe by the Autoloader.

01H27-01G – July 2001
Ex A-2.3 Worklist Entry Submission using multiple Worklist Entries, packaged together in response to the CELL-DYN 4000’s query
H|\^&<CR>
P|1<CR>
O|1|00000|||||||||||||QC^02<CR>
O|1|19345||^^^CBCEL+RETC^9^5^2|||19960810153028||||||||Patient^Human<CR>
P|3<CR>
O|1|18465<CR>
L|1|N<CR>
This message will cause three Worklist Entries to be put in the Worklist.
The first entry is for a QC Control specimen as defined in QC File #2 on the CELL-DYN 4000. The QC File Setup for QC File #2 recorded on the
CELL-DYN 4000 at the time that this message is received controls what test selection, parameter set, limit set and replicate runs are to be used.
The Worklist entry will be activated (selected and run) when a sample tube with bar code = 00000 is presented to the aspiration probe by the Auto-
loader.
The second entry is for the human patient, David Jones, who is identified by Specimen ID = 19345. See Example A-2.2. The Worklist entry will be
activated (selected and run) when a sample tube with bar code = 19345 is presented to the aspiration probe by the Autoloader.
The third entry is for the human patient identified by Specimen ID = 18465. See Example A-2.1. The Worklist Entry will be activated (selected and
run) when a sample tube labeled with bar code = 18465 is presented to the aspiration probe by the Autoloader.
A-3 Examples of a Worklist Entry Rejection message sent by the CELL-DYN 4000 to the CLIMS
This example consists of the single Worklist Entry Rejection message sent in response to the Patient Order combinations of Example A-2.3. In this
example, the first Patient-Order combination has been accepted, the second Patient-Order combination is rejected due to a Worklist Full condition;
the third is accepted.
NOTE: The multitasking nature of the CELL-DYN 4000 Instrument software permits this type of behavior.
<no message in response to first(correctly received)Patient-Order combination>
H|\^&|||400096030101^CD4000R^SL^R5-4F^1.0|||||||P|1<CR>
O|1|19345||^^^CBCEL+RETC^9^5^2|||19960810153028||||||||Patient^Human||||||||||X<CR>
C|1|I|Worklist Full|G<CR>
L|1|N<CR>
<no message in response to third (correctly received) Patient-Order combination>

01H27-01G – July 2001
A-4 Example of Test Result Transfer Message (sent by CELL-DYN 4000, to the CLIMS)
NOTE: The parameters: WVF, PCT, and PDW are provided for laboratory use only and are not reportable in the U.S.A.
A-4.1. The minimum message, with the CELL-DYN 4000 LIS Configuration file set to disable transmission of CD3/4/8 results records (assumes
anything that can be blank or null on the CELL-DYN 4000 is nulled in this transmission)
H|\^&|||400096030101^CD4000R^SL^R5-4F^1.0|||||||P|1<CR>
P|1||||||||||||||<CR>
O|1|18465|0098|^^^CBC^2^1|||||||||||Patient^Human||||||||||F<CR>
C|1||DC^NONE|I<CR>
C|2|I|DI^00000^00000|I<CR>
C|3|I|SP^Nonviable WBCs^NO^0.00|I<CR>
C|4|I|SP^Bands^YES^0.95|I<CR>
C|5|I|SP^Blasts^NO^0.00|I<CR>
C|6|I|SP^Variant Lymphoids^NO^0.00|I<CR>
C|7|I|SPÎmmature Granulocytes^YES^0.62|I<CR>
C|8|I|SPÛnidentified Fluorescent Cells^NO^0.00|I<CR>
C|10|I|SPÂsymmetric RBC^NO^0.00^|I<CR>
C|11|I|SP^High Number Immature Reticulocytes^NO^0.00|I<CR>
C|12|I|SP^Platelet Clumps^NO^0.00|I<CR>
R|1|^^^CBC^^^^WBC|72.5|||||F|||19960810082334<CR>
R|2|^^^CBC^^^^WVF|.002|||||F|||19960810082234<CR>
R|3|^^^CBC^^^^NEU|48.9|||||F|||19960810082234<CR>
R|4|^^^CBC^^^^LYM|14.7|||||F|||19960810082234<CR>
R|5|^^^CBC^^^^MONO|8.92|||||F|||19960810082234<CR>
R|6|^^^CBC^^^ÊOS|0.00|||||F|||19960810082234<CR>
R|7|^^^CBC^^^^BASO|0.00|||||F|||19960810082234<CR>
R|8|^^^CBC^^^^%N|67.4|||||F|||19960810082234<CR>
R|9|^^^CBC^^^^%L|20.3|||||F|||19960810082234<CR>
R|10|^^^CBC^^^^%M|12.3|||||F|||19960810082234<CR>
R|11|^^^CBC^^^^%E|0.01|||||F|||19960810082234<CR>
R|12|^^^CBC^^^^%B|0.00|||||F|||19960810082234<CR>
R|13|^^^CBC^^^^NRBC|0.00|||||F|||19960810082234<CR>
R|14|^^^CBC^^^^NR/W|0.00|||||F|||19960810082234<CR>

01H27-01G – July 2001
R|15|^^^CBC^^^^RBC|5.83|||||F|||19960810082234<CR>
R|16|^^^CBC^^^^HGB|16.1|||||F|||19960810082234<CR>
R|17|^^^CBC^^^^MCV|83.4|||||F|||19960810082234<CR>
R|18|^^^CBC^^^^MCH|27.7|||||F|||19960810082234<CR>
R|19|^^^CBC^^^^MCHC|33.2|||||F|||19960810082234<CR>
R|20|^^^CBC^^^^HCT|48.6|||||F|||19960810082234<CR>
R|21|^^^CBC^^^^RDW|11.6|||||F|||19960810082234<CR>
R|22|^^^CBC^^^^PLT|>>>>|||||W|||19960810082234<CR>
R|23|^^^CBC^^^^MPV|<<<<|||||W|||19960810082234<CR>
R|24|^^^CBC^^^^PDW| |||||X|||19960810082234<CR>
R|25|^^^CBC^^^^PCT| ||||X|||19960810082234<CR>
R|26|^^^CBC^^^^RETC|----|||||X|||19960810082234<CR>
R|27|^^^CBC^^^^%R|----|||||X|||19960810082234<CR>
R|28|^^^CBC^^^ÎRF|----|||||X|||19960810082234<CR>
L|1|N<CR>

01H27-01G – July 2001
A-4.2. Maximum message, with the CELL-DYN 4000 LIS Configuration file set to enable transmission of CD3/4/8 results records . every field pro-
duced by the CELL-DYN 4000 has non-null, maximal (actual) length
H|\^&|||400096030101^CD4000R^SL^R5-4F^1.0|||||||P|1<CR>
P|1||||Southerland-Roth^Christophere||19960229|U|||||Schwartzenberger|5^m|0123456789ABCDEF^345-765-459-
2318^McDonnell Elaine^725 S. Robert #2<CR>
O|1|18465|0098|^^^CBC^2^1|||19960801073254||||||||Patient^Human||||||||||F<CR>
C|1|I|DC^NONE|I<CR>
C|2|I|DI^00000^00000|I<CR>
C|3|I|SP^Nonviable WBCs^NO^0.00|I<CR>
C|4|I|SP^Bands^YES^0.95|I<CR>
C|5|I|SP^Blasts^NO^0.00|I<CR>
C|6|I|SP^Variant Lymphoids^NO^0.00|I<CR>
C|7|I|SPÎmmature Granulocytes^YES^0.62|I<CR>
C|8|I|SPÛnidentified Fluorescent Cells^NO^0.00|I<CR>
C|10|I|SPÂsymmetric RBC^NO^0.00^|I<CR>
C|11|I|SP^High Number Immature Reticulocytes^NO^0.00|I<CR>
C|12|I|SP^Platelet Clumps^NO^0.00|I<CR>
R|1|^^^CBC^^^^WBC|72.5|||||F||jbws|19960810082334<CR>
R|2|^^^CBC^^^^WVF|.002|||||F||jbws|19960810082234<CR>
R|3|^^^CBC^^^^NEU|48.9|||||F||jbws|19960810082234<CR>
R|4|^^^CBC^^^^LYM|14.7|||||F||jbws|19960810082234<CR>
R|5|^^^CBC^^^^MONO|8.92|||||F||jbws|19960810082234<CR>
R|6|^^^CBC^^^ÊOS|0.00|||||F||jbws|19960810082234<CR>
R|7|^^^CBC^^^^BASO|0.00|||||F||jbws|19960810082234<CR>
R|8|^^^CBC^^^^%N|67.4|||||F||jbws|19960810082234<CR>
R|9|^^^CBC^^^^%L|20.3|||||F||jbws|19960810082234<CR>
R|10|^^^CBC^^^^%M|12.3|||||F||jbws|19960810082234<CR>
R|11|^^^CBC^^^^%E|0.01|||||F||jbws|19960810082234<CR>
R|12|^^^CBC^^^^%B|0.00|||||F||jbws|19960810082234<CR>
R|13|^^^CBC^^^^NRBC|0.00|||||F||jbws|19960810082234<CR>
R|14|^^^CBC^^^^NR/W|0.00|||||F||jbws|19960810082234<CR>
R|15|^^^CBC^^^^RBC|5.83|||||F||jbws|19960810082234<CR>

01H27-01G – July 2001
R|16|^^^CBC^^^^HGB|16.1|||||F||jbws|19960810082234<CR>
R|17|^^^CBC^^^^MCV|83.4|||||F||jbws|19960810082234<CR>
R|18|^^^CBC^^^^MCH|27.7|||||F||jbws|19960810082234<CR>
R|19|^^^CBC^^^^MCHC|33.2|||||F||jbws|19960810082234<CR>
R|20|^^^CBC^^^^HCT|48.6|||||F||jbws|19960810082234<CR>
R|21|^^^CBC^^^^RDW|11.6|||||F||jbws|19960810082234<CR>
R|22|^^^CBC^^^^PLT|>>>>|||||W||jbws|19960810082234<CR>
R|23|^^^CBC^^^^MPV|<<<<|||||W||jbws|19960810082234<CR>
R|24|^^^CBC^^^^PDW| |||||X||jbws|19960810082234<CR>
R|25|^^^CBC^^^^PCT| ||||X||jbws|19960810082234<CR>
R|26|^^^CBC^^^^RETC|----|||||X||jbws|19960810082234<CR>
R|27|^^^CBC^^^^%R|----|||||X||jbws|19960810082234<CR>
R|28|^^^CBC^^^ÎRF|----|||||X||jbws|19960810082234<CR>
R|29|^^^CBC^^^^CD3T|----|||||X||jbws|19960810082234<CR>
R|30|^^^CBC^^^^CD4T|----|||||X||jbws|19960810082234<CR>
R|31|^^^CBC^^^^CD8T|----|||||X||jbws|19960810082234<CR>
R|32|^^^CBC^^^^%CD3|----|||||X||jbws|19960810082234<CR>
R|33|^^^CBC^^^^%CD4|----|||||X||jbws|19960810082234<CR>
R|34|^^^CBC^^^^%CD8|----|||||X||jbws|19960810082234<CR>
R|35|^^^CBC^^^^4/8|----|||||X||jbws|19960810082234<CR>
L|1|N<CR>

01H27-01G – July 2001

Cell-Dyn 4000 SYSTEM Laboratory Information System Interface Specification

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CELL-DYN® 4000 SYSTEM

LABORATORY INFORMATION SYSTEM

LIST NO. 01H27-01

ABBOTT DIAGNOSTICS DIVISION

1997, 1999, 2001 ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories

1997, 1999, 2001 ABBOTT DIAGNOSTICS DIVISION Abbott Laboratories

2.0 STANDARDS AND GENERAL CONFORMANCE........................................................ 2

3.0 SUPPORTED TRANSACTIONS ................................................................................... 4

4.0 ERROR HANDLING .................................................................................................... 32

A-0 APPENDIX A — EXAMPLES ...................................................................................... 33

CELL-DYN® 4000 LIS Interface Specification i

ii CELL-DYN® 4000 LIS Interface Specification

1.3 Definitions, Synonyms, and Abbreviations

CELL-DYN® 4000 LIS Interface Specification Page 1 of 38

2.0 Standards and General Conformance

2.1 Applicable Standards

2.2 E1381 Conformance

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2.4 Independence of Instrument Message Transactions

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3.2 Serial Communications Test (Link Test)

CELL-DYN® 4000 LIS Interface Specification Page 5 of 38

3.3 Submit Worklist Entries

Page 6 of 38 CELL-DYN® 4000 LIS Interface Specification

7.1.13 ASTM Version No. x

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3.3.3.3.4.1 Universal Test ID - reserved, E1394

CELL-DYN® 4000 LIS Interface Specification Page 15 of 38

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3.3.3.3.6.1 Specimen Type

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3.3.4.4.5 Comment Type

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3.4.2.4.2.2.1 Data Invalidation Comment Identifier

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CELL-DYN® 4000 LIS Interface Specification Page 25 of 38

3.4.2.4.3.2.1 Comment Identifier

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3.4.2.4.3.2.3 Suspect Population Flag Value

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3.4.2.5.1 Record Type

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3.4.2.5.5 Result Status

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4.0 Error Handling

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