Immunoassay System

LIS Vendor Information

Revision 101968X
Revised Aug 2005
Printed in U.S.A.
2005 Beckman Coulter, Inc.
BECKMAN COULTER, INC. FULLERTON, CA 92835

Publication Notes
Each page of this manual is identified with its revision and release date. For pages other than
the title page, revision information is located at the bottom of the page.
This manual includes pages from three revision releases.
The pages listed below are issued as revision 101968X, release date 8/05.
Title page and Publication Notes
Pages 21 through 24
The pages listed below were issued as revision 101968T, release date 1/02:
Pages 12 and 14
All other pages in this manual are issued as revision 101968P, release date 3/00.
This manual is intended for use with the Access Immunoassay System analyzer.
Ostase is trademark of Hybritech Incorporated, a subsidiary of Beckman Coulter, Inc.
Access, AccuTnI, Hybritech, and the BECKMAN COULTER logo are trademarks of
Beckman Coulter, Inc.
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Table of Contents
Table of Contents
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Frame Layer Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Physical Layer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Message Layer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Record Field Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Test Codes Used by the Access System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Sample Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Limits and Performance Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Table of Contents
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LIS Vendor Information
LIS Vendor Information
This document is intended as a guide to LIS vendors developing interfaces
that communicate with the Access Immunoassay System. Provide this
information to your LIS vendor prior to interfacing the Access System and
the LIS.
This document is based on the following ASTM standard protocols:
ASTM E1394-91
ASTM E1381-95
Refer to Appendix A, LIS Interface, of the Access Reference Manual for
information on configuration and use of the Access System LIS interface.
Definitions
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Definitions The following is a list of terms used in this document and a definition of each
term as it is used by Beckman Coulter, Inc.
Term Definition
<ACK> Acknowledgment (ASCII Decimal 6).
[C1] The most significant character of Checksum.
[C2] The least significant character of Checksum.
[DATA] The data contents of the record.
<ENQ> Inquire (ASCII Decimal 5).
<ETB> End of Transmission Block (ASCII Decimal 23). For use
only when a single record is too large to fit into one frame.
<ETX> End of Text (ASCII Decimal 3). Required at the end of
each record.
[frame number] Single digit frame number 0 to 7. Starts with 1.
<LF> Line Feed (ASCII Decimal 10).
<NAK> Negative Acknowledgment (ASCII Decimal 21).
<STX> Start of Frame (ASCII Decimal 2).
Communications
packet
All framing required for transmission of data. This
framing includes: <STX>[frame number][DATA] [<ETB>
or <ETX>][C1][C2] <LF>.
Component Field One of several related pieces of information within a field.
Download The transmission of data from the LIS to the Access
System.
Field A specific location within a record for a piece of
information, indicated by a field delimiter and position.
Frame A complete communications packet.
LIS Laboratory Information System.
Message A collection of related information; a group of records
that begins with a Header record and ends with a
Terminator record. A single record could theoretically
constitute a message, but within this context, a message
always contains multiple records. Refer to the Message
Layer section and the descriptions of each type of record
included later in this document.
Receiver The device that responds to the sender. The receiver in
this document is either the Access System or the LIS.
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Definitions
<EOT> End of Transmission (ASCII decimal 4).
<CR> Carriage Return (ASCII decimal 13).
Record In reference to the low level protocol, a record is the
message data (shown as [DATA]) as described within the
communications packet. If the data is longer than 240
characters, then it must be split into two parts and sent in
two communications packets. The intermediate packet
uses the <ETB> character, and the ending packet uses the
<ETX> character. No single communications packet
contains more than one record.
In reference to the message layer, a record can be one of
the following codes: H (header), P (patient), O (order),
R (result), L (terminator), C (comment). Refer to the
Message Layer section later in this document.
Repeat Field An additional field of the preceding type when indicated
by a repeat delimiter. The Access System parses and may
produce repeat fields in the Universal Test ID field of a
Test Order Record, but ignores other occurrences of repeat
fields.
Sender The device that has a message to send and initiates the
transmission process, in this case between the LIS and the
Access System. The sender in this document is either the
Access System or the LIS.
Session A total unit of communication activity used in this
standard to indicate the events starting with the
Establishment phase and ending with the Termination
phase. Refer to Frame Layer Protocol later in this
document.
Test A determination of a single analyte or a combination of
values from other determinations or observations from
which a variable or gradable result is derived.
Upload The transmission of data from the Access System to the
LIS.
Term Definition (continued)
Frame Layer Protocol
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Frame Layer
Protocol
The recommended Low Level Protocol to use for transferring messages is based
on an ACK/WAIT protocol. The low level protocol transfers messages as
specified by the ASTM E1381-95 standard.
Establishment Phase
During the establishment protocol phase, the communication link between the
Access System and the LIS is set up.
After an <ENQ> is sent, the state of the sender must then change to allow data to
be received.
If both the Access System and the LIS send an <ENQ> simultaneously, the Access
System has priority.
Transfer Phase
During the transfer protocol phase, data is sent back and forth between the Access
System and the LIS. The Access System uses data transfer conventions outlined in
the ASTM E1381-95 standard for the data layer protocol. Any conventions that are
not supported are noted and addressed. Refer to the Message Layer section later
in this document.
Termination Phase
During the termination protocol phase, a sequence of characters or conditions
causes communication between the Access System and the LIS to cease, either
normally or abnormally.
Transport Layer Sequence
The following tables illustrate a transport layer sequence:
Receiver State Sender Receiver
Receiver Ready <ENQ> -->
<-- <ACK>
Receiver Not Ready <ENQ> -->
<-- <NAK>
Session Description Sender Receiver
Normal Session: <ENQ> ->
<-
<STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
<EOT> ->
<ACK>
<ACK>
No Response
Expected
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Frame Layer Protocol
Session Description Sender Receiver
Failure Session (NAK): <ENQ> ->
<-
(Delay 10 seconds)
(Repeat up to 6 times) <ENQ> ->
<-
(Before 6 <NAK>s) <STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
<EOT> ->
<NAK>
<ACK>
<ACK>
No Response
Expected
Session Description Sender Receiver
Failure Session (Max <NAK>s): <ENQ> ->
<-
(Delay 10 seconds) <ENQ> ->
(Repeat up to 6 times) <-
<EOT> ->
(After 6 <NAK>s)
<NAK>
<NAK>
No Response
Expected
Session Description Sender Receiver
Failure Session (No Response): <ENQ> ->
(Time-out after 15 seconds) <EOT> ->
No Response
No Response
Expected
Session Description Sender Receiver
Failure Session (Max <NAK>s): <ENQ> ->
<- <ACK>
<STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
(Delay 10 seconds)
(Repeat up to 6 times) <STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
(Before 6 <NAK>s) <STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
<EOT> ->
<NAK>
<NAK>
<ACK>
No Response
Expected
Physical Layer
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Physical Layer All communications are expected to use the RS232 communication protocol,
based upon the Electronics Industries Association (EIA) standard RS232-C.
As part of the conformance to this standard, the Access System is configured as
Data Terminal Equipment (DTE).
The Access System is cabled to the LIS via the DB-9-M or DB-9-F connector on the
Access System (labeled LIS; located near the printer and terminal ports).
The DB-9 Connector provides RXD at pin 2, TXD at pin 3, and signal ground at
pin 5. No other connections are used for the ASTM E1381-95 protocol. The
following table shows the pin assignments for both the Access System and the
LIS.
The operator defines the baud rate, choosing either 1200 or 2400 baud. The
number of data bits per character, parity bit, and number of stop bits are as
defined in ASTM standard E1381-95.
Message
Layer
This document references the ASTM standard E1394-91, and the recommended
support of the ASTM protocol. The intent of this section is to develop a complete
understanding of the particular records and fields as supported by the Access
System.
Session Description Sender Receiver
Failure Session (Max <NAK>s): <ENQ> ->
<- <ACK>
<STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
(Delay 10 seconds)
(Repeat up to 6 times) <STX> [F1] [DATA] <ETX> [C1] [C2] <CR> <LF> ->
<-
<NAK>
<NAK>
(After 6 <NAK>s) <EOT> ->
No Response
Expected
Pin
Access LIS Port
Configuration
LIS Cable Must Provide
2
RXD TXD
3
TXD RXD
5
Ground Ground
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Message Layer
The low level protocol communications are separate from the message level. It is
recommended that the ACK/WAIT protocol specified in the Frame Layer
Protocol section be used with this ASTM standard.
Message Content
The following is a list of the limitations and general considerations regarding
message content.
Allowed
Characters
Allowed are ASCII 7 (BEL), 9 (HT), 11 (VT), 12 (FF),
13 (CR), 32-126, 128-254. However, the message data
(shown as [DATA]) sent to the Access System must be
restricted to ASCII 32-126 for proper operation of the
Access System Software. Specific fields may further
restrict allowed characters.
Maximum Field
Length
No maximum field length is imposed within the
message-receiving mechanism. However, the message
parsing performed by the Access System/LIS Interface
Software enforces certain restrictions. Refer to the record
tables later in this document for specific field
restrictions.
Maximum Record
Length
No maximum record length is imposed within the
message-receiving mechanism. However, the message
parsing performed by the Access System Software
restricts records to 1024 characters in length.
Delimiters Any of the allowable characters, as specified in ASTM
E1394-91, may be used as delimiters. Unless otherwise
documented, the following characters should be used:
Field delimiter = vertical bar (|)
Repeat delimiter = backslash (\)
Component delimiter = caret (^)
Escape delimiter = ampersand (&)
Record Codes The following codes are required in relation to the
ASTM standard:
Header Record H
Patient Record P
Test Order Record O
Result Record R
Comment Record C
Scientific Record S
Manufacturer Record M
Request Information Record Q
Final Record L
Fields with Null
Values
Nulls are sent when data need not be updated. A null
value does not conflict with existing data in most cases.
Erroneous data is the responsibility of the sender.
Record Field Contents
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Record Field
Contents
This section lists the following records and the fields they contain:
Message Header Record
Patient Information Record
Test Order Record
Result Record
Comment Record
Request Information Record
Message Terminator Record
Following each record is a list of the requirements and general considerations
regarding the contents of one or more fields of the record.
Manufacturer
Information
Record
The Manufacturer Information Record is ignored when
received by the Access System and not created or sent
by the Access System.
Scientific Record The Scientific Record is ignored when received by the
Access System and not created or sent by the Access
System.
Message Header Record
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
Record Identifier H 1 * *
Delimiters:
Field | 1 * *
Repeat \ 1 * *
Component ^ 1 * *
Escape & 1 * *
Message Control ID | Ignored No
Access Password | Ignored No
Sender Name or ID | LIS 40 Ignored Yes
System ID ^ 40 Ignored Yes
* Required
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Record Field Contents
Sender Street Address | Ignored No
Reserved Field | Ignored No
Sender Telephone Number | Ignored No
Characteristics of Sender | Ignored No
Receiver ID | Access 40 Yes Yes
System ID ^ System1 40 Yes Yes
Comment or Special
Instructions
| Ignored No
Processing ID | P 1 Yes Yes
Version Number | 1 12 Yes Yes
Date and Time of Message | 19971119161505 14 Yes Yes
End of Record <CR> 1 * *
Message Header Record (continued)
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
* Required
Processing ID Indicates how this message is to be processed. The
following code is used:
P Production: Treat message as an active
message to be completed according to
standard processing.
Sender Name
or ID
The Access System sends the word Access followed by a
System ID in a component field (for example, Access
System1). The System ID is entered in system
configuration in the Laboratory Information screen.
Receiver ID Indicates the intended message receiver. If the Access
System will be the receiver, the word Access is used,
followed by an optional System ID. The System ID
should be designated only when there are multiple
Access Systems using the LIS, and the message is
intended only for the named Access System. The
message is rejected when Access is the Receiver ID and
the System ID component field does not match the
System ID entered and stored in the laboratory
information of system configuration.
Record Field Contents
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Patient Information Record
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
Record Identifier P 1 * *
Sequence Number | 1 5 * *
Practice Assigned Patient
ID
| Smith, John 15 * When
available*
Laboratory Assigned
Patient ID
| Ignored No
Patient ID #3 | Ignored No
Patient Name: 30 Yes No
Last Name | LASTNAME
First Name ^ FIRSTNAME
Middle Name ^
Suffix ^ JR
Title ^ DR
Mothers Maiden Name | Ignored No
Birthdate | 19631124 8 Yes No
Patient Sex | F 1 Yes No
Patient Race | Ignored No
Patient Address | Ignored No
Reserved Field | Ignored No
Patient Telephone | Ignored No
Attending Physician ID | Ignored No
Special Field 1 | Ignored No
Special Field 2 | Ignored No
Patient Height | Ignored No
Patient Weight | Ignored No
Patient Diagnosis | Ignored No
Patient Medications | Ignored No
Patient Diet | Ignored No
* Required
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Record Field Contents
Practice Field #1 | Ignored No
Practice Field #2 | Ignored No
Admission and
Discharge Dates
| Ignored No
Admission Status | Ignored No
Location | Ignored No
Nature of Alt. Diag.
Code & Class.
| Ignored No
Alt. Diag. Code & Class. | Ignored No
Patient Religion | Ignored No
Marital Status | Ignored No
Isolation Status | Ignored No
Hospital Service | Ignored No
Hospital Institution | Ignored No
Dosage Category | Ignored No
End of Record <CR> 1 * *
Patient Information Record (continued)
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
* Required
Practice Assigned
Patient ID
When this field is downloaded, it appears on the Test
Request screen in the Patient ID column. It is also sent
on uploads, if available. If the test order is entered at the
Access System and the operator does not enter a Patient
ID, this field is blank on uploads.
Record Field Contents
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Test Order Record
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
Record Identifier O 1 * *
Sequence Number | 1 5 * *
Specimen ID | SPEC1234 15 * *
Instrument Specimen ID:
Sample Tag | Ignored No
Tray Number ^ 1 4 Ignored Yes
Sample Position ^ 10 2 Ignored Yes
Universal Test ID:
Identifier | Ignored No
Name ^ Ignored No
Type ^ Ignored No
Local Code: Test ^ Ferritin 8 * Yes
Local Code: Replicate ^ 2 2 Ignored Yes
Priority | R 9 Yes No
Requested Date and Time | Ignored No
Collection Date and Time | Ignored No
Collection End Time | Ignored No
Collection Volume | Ignored No
Collector ID | Ignored No
Action Code | A 1 Yes No
Danger Code | Ignored No
Relevant Clinical Info. | Ignored No
Date/Time Specimen Rcvd | Ignored No
Specimen Descriptor:
Specimen Type | Serum 8 Yes Yes
Specimen Source ^ Ignored No
* Required
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Record Field Contents
Ordering Physician | Ignored No
Physicians Phone Number | Ignored No
User Field #1 | Ignored No
User Field #2 | Ignored No
Laboratory Field #1 | Ignored No
Laboratory Field #2 | Ignored No
Date/Time Results
Reported/Mod.
| Ignored No
Inst. Charge to Computer
System
| Ignored No
Inst. Section ID | Ignored No
Report Types | F 1 Ignored Yes
Reserved Field | Ignored No
Loc. Specimen Collection | Ignored No
Noscomial Infection Flag | Ignored No
Specimen Service | Ignored No
Specimen Institution | Ignored No
End of Record <CR> 1 * *
Test Order Record (continued)
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
* Required
Specimen ID Alphanumeric characters are accepted (0-9, A-Z both
upper and lower case, /, +, and -). Spaces and
punctuation are not allowed.
Instrument
Specimen ID
The three components are: Sample Tag, Tray Number,
and Sample Position. Tray Number and Sample Position
are uploaded to the LIS but are ignored on downloads.
The Tray Number is 1-9999, and the Sample Position is
the position within the sample tray (1-10). Sample Tag is
unused.
Record Field Contents
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Universal Test ID The first three components of this field are not used by
the Access System, and should be left blank by the LIS
as they are ignored. The fourth component is required,
representing the test code, and should be the last
component specified. Refer to the Test Codes Used by
the Access Systemsection later in this document.
On uploads, the Access Systemincludes a fifth
component field indicating the test replicate number.
If one replicate of a test is ordered, the replicate number
is 1. If two replicates of a test are ordered, the test
appears in the test order record twice, with replicate
numbers of 1 and 2. Replicate numbers are ignored on
test order downloads.
The Access Systemparses repeat delimiters in this field
for received Test Order Records. The Access Systemmay
also produce repeat delimiters in this field when
sending Test Order Records, to list each test code for
each Result Record to follow for a specific sample
position.
Repeat delimiters are not parsed or produced for this
field in the Result Record.
Priority Test priority codes are as follows:
S Stat
A As Soon as Possible
R Routine
C Callback
P Preoperative
Although the systemaccepts up to nine characters, the
priority code is the first character in the field.
Code S (Stat) is treated as a Stat patient sample by the
Access System. Any other priority code, including no
priority code, is treated as a routine patient sample by
the Access System.
Action Code This field indicates what will be done with the
specimens accompanying or preceding this test order
request received by the Access System. The following
codes are used:
C Cancel request for the test. The test is removed
fromany test request and fromthe LIS pool.
A Add the requested test to the existing
specimen with the patient and specimen
identifiers given in this record. If the specimen
does not exist, create it.
N Newrequests accompanying a newspecimen.
If the specimen already exists, the request is
considered invalid and is rejected.
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Record Field Contents
Specimen
Descriptor
Only the Specimen Type portion of the Specimen
Descriptor is used. The following types are supported
by the Access System: Serum, CSF, Urine, Blood,
Plasma, Other.
Report Types The following codes are used by the Access System
when uploading only:
F Final results.
X Results cannot be done, request canceled.
Result Record
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
Record Identifier R 1 No *
Sequence Number | 1 5 No *
Universal Test ID: No
Identifier | No
Name ^ No
Type ^ No
Local Code ^ Ferritin 8 *
Data Measurement/ Value:
Value | 105.6 9 No Yes
Interpretation ^ 10 No Yes
Units | ng/mL 8 No Yes
Reference Ranges | 23.9 to 336.2 21 No Yes
Reference Type ^ Normal 6 No Yes
Result Abnormal Flags | N 2 No Yes
Nature of Abnormality
Testing
| No No
Result Status | F 1 No Yes
Date of Change | No No
Operator Identification | No No
Date/Time Test Started | No No
* Required
Record Field Contents
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Date/Time Test
Completed
| 19971119165845 14 No Yes
Instrument
Identification
| No No
End of Record <CR> 1 No *
Result Record (continued)
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
* Required
Universal Test ID For considerations regarding this field, see the Test
Order Record descriptions in this document.
Result Abnormal
Flags
This field indicates the status of the result. The
following codes are used:
L Below normal ref. low limit. Indicates the
Access System ORL flag.
H Above normal ref. high limit. Indicates the
Access System ORH flag.
LL Below panic low. Indicates the Access System
CRL flag.
HH Above panic high. Indicates the Access
System CRH flag.
> Out of range high. Indicates the Access
System OVR flag.
N Normal result. Result not flagged ORH, ORL,
CRL, CRH, or OVR.
< Under for positive slope assays (or over for
negative slope assays) the threshold limit
defined in the assay protocol file. Indicates the
Access System UNR flag.
Result Status The following codes are used on result uploads:
F Final results.
X Results cannot be done, request is not
honored.
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Record Field Contents
Comment Record
Description Delimiter Example
Max.
Length
Access
Receive
Access
Send
Record Identifier C 1 No *
Sequence Number | 1 5 No *
Comment Source | I 1 No Yes
Comment Text | CEX; PEX 160 No Yes
Comment Type | I 1 No Yes
End of Record <CR> 1 No *
* Required
Comment Source Used to indicate source of comment. The comment
record is only sent immediately following a result
record when the result contains one or more flags.
The following code is used:
I Clinical Instrument System
Comment Text Used to indicate result record flags. Not all flags apply
to all results. Some flags are currently not used, but are
listed here for future reference. The following codes are
defined:
CEX Curve expired.
CRH Result higher than critical (panic) reference
range.
CRL Result lower than critical (panic) reference
range.
EDT Result edit (currently unused).
GRY Qualitative result in gray zone.
IND Result is indeterminant.
LEX Lot expired.
LOW Result lower than the minimum reportable
result.
NCR No curve.
NRV Insufficient reagent, reaction vessels, wash,
substrate, waste, or reaction vessel waste.
OLD Sample old.
ORH Result higher than normal reference range.
Record Field Contents
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ORL Result lower than normal reference range.
OVR Result out of range of curve.
PEX Pack expired.
QCF Control is outside QC limits.
QEX Control lot expired.
QNS Quantity not sufficient.
RLU Relative light unit (RLU) value is outside of
the acceptable luminometer measuring range.
SYS Instrument error.
TMP One or more of the following is outside the
temperature specification: Incubator, wash/
read carousel, substrate, reagent.
UNR The measured sample signal (RLU) is less than
an RLU threshold limit for the least
concentrated calibrator or calibration control
for a positive slope assay, or is greater than the
least concentrated calibrator for a negative
slope assay, as defined in the assay protocol
file.
WVL Quality control sample result was generated
using a different reagent vial lot number than
the vial lot number used to calibrate the assay.
Comment Type Used to indicate type of comment. The following codes
are used:
G Generic/Free Text Comment (for error
messages)
I Instrument Flag Comment (for test result
flags)
Request Information Record
Description Delimiter Example Max.
Length
Access
Receive
Access
Send
Record Identifier Q 1 No *
Sequence Number | 1 5 No *
Starting Range ID Number:
Patient ID Number | No No
Specimen ID Number ^ Samp45 15 No Yes
*Required
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Record Field Contents
NOTE
The Access System queries the LIS whenever a tray containing samples that have
no test requests is loaded. The following example displays how the Access
System queries the LIS for test information:
Tray 14 appears as follows at the time of the query:
Ending Range ID Number | No No
Universal Test ID | No No
Nature of Request Time
Limits
| No No
Beg. Request Results
Date/Time
| No No
Ending Request Results
Date/Time
| No No
Requesting Physician
Name
| No No
Requesting Physician
Telephone Number
| No No
User Field No. 1 | No No
User Field No. 2 | No No
Request Info. Status Codes | O 1 No Yes
End of Record <CR> 1 No *
Starting Range ID
Number
Used by the Access System to query the LIS. This field
contains a single specimen ID which corresponds to the
Access Systems 15-character sample ID. The specimen
ID follows the unused patient ID in a component field.
Ending Range ID
Number
This field is unused, since the Access System does not
query for a range of specimen ID numbers.
Request Information Record (continued)
Description Delimiter Example Max.
Length
Access
Receive
Access
Send
*Required
Position Sample ID Tests Requested
1 QN195823 Folate, Ferritin
2 KNH483736 TSH
Record Field Contents
3/00 2000 Copyright Beckman Coulter, Inc.
20 Rev 101968P Access LIS Vendor Information
When tray 14 is loaded, the Access System identifies Samp45, 456, and
34543 as samples that require tests. The Access System queries the LIS for the
test information for each sample, starting with Samp45. The following is an
example of a query for the test information for Samp45:
H|\^&|||Access|||||LIS||P|1|19970901085833
Q|1|^Samp45||ALL||||||||O
L|1|F
After sending this message, the Access System waits for a response. The Access
System interprets the next message it receives as the response to its query. If the
LIS does not have any tests pending for Samp45, it should reply in a form
similar to the following:
H|\^&|
L|1|F
The Access System waits one minute for a response to the query. If the LIS does
not respond with a message in this time, the Access System assumes that no tests
are pending for Samp45. It then sends the LIS a query for 456. If the LIS
responds to the first query, the Access System immediately sends the next
pending query.
The Access System continues this cycle until it has issued a query for all sample
IDs that require test requests. If the host LIS sends a test request for a sample for
which the Access System has already prepared (but not yet sent) a query, the
Access System still sends the query.
3 Samp45
4 F049498 TU
5 456
6 SS51269 TotT4
7 91292IGM TotT4, TU
8 34543
9 D2SE3 Folate
10 JA456789 TbhCG2
Position Sample ID Tests Requested
2005 Beckman Coulter, Inc. 8/05
Access LIS Vendor Information Rev 101968X 21
Test Codes Used by the Access System
Test Codes
Used by the
Access
System
The following list contains typical test codes used by the Access System. This list
is subject to change without notification. Tests listed may or may not be available
for use with commercial systems. Contact your Beckman Coulter representative
for more information on test availability.
NOTES
You can view the list of available test codes on the Access System by
displaying the Configure Tests screen. Operators should provide the
vendor with a list of the test codes to be set up in the LIS.
All test codes are case-sensitive and must be entered as displayed on the
Configure Tests screen.
Message Terminator Record
Description Delimiter Example Max.
Length
Access
Receive
Access
Send
Record Identifier L 1 * *
Sequence Number | 1 5 * *
Termination Code | F 1 Ignored Yes
End of Record <CR> 1 * *
* Required
Termination Code Provides explanation for end of session. The following
code is used:
F Last request for information processed.
Access Test Codes
Access
Code
DL2000
Code Assay Name
AbHBsII A01 Hepatitis B Surface Antibody II (Not available in
the US)
AFP A02 Alpha-Feto Protein (cancer and ONTD utility)
AgHBs A64 Hepatitis B Surface Antigen (Not available in the
US)
Test Codes Used by the Access System
8/05 2005 Beckman Coulter, Inc.
22 Rev 101968X Access LIS Vendor Information
AgHBsBlk A65 Hepatitis B Surface Antigen Blocking (Not
available in the US)
AgHBsCtl A66 Hepatitis B Surface Antigen Control (Not
available in the US)
BR15-3Ag A04 BR Monitor
CEA A06 Carcino-embryonic Antigen
Chl-Ag A07 Chlamydia Antigen
ChlBlock A08 Chlamydia Blocking
CK-MB A49 Creatine Kinase - MB
Cortisol A10 Cortisol
cTnI A67 AccuTnI

DHEA-S A73 Dehydroepiandrosterone Sulfate

Dig A11 Digoxin
Dil-hCG2 A18 Diluted Human Chorionic Gonadotropin
ESTRDL A14 Estradiol
FastTSH A78 Thyroid Stimulating Hormone, Fast (2nd Gen)
Ferritin A19 Ferritin
FOL2 A75 Folate (new formulation P/N A14208)
Folate A20 Folate (previous formulation P/N 33010)
freePSA A63 Free Prostate Specific Antigen
FreeT3 A21 Free Triiodothyronine (previous formulation
P/N 33850)
FT3 A80 Free Triiodothyronine (new formulation P/N A13422)
FT4 A61 Free Thyroxine
FTIndex A24 Free Thyroxine Index (Calculated using TotT4
and TU results; do not order this test)
GI19-9Ag A05 GI Monitor
HAVAb A26 Hepatitis A Virus Total Antibody (Not available
in the US)
HAV-IgM A25 Hepatitis A Virus Immunoglobulin M (Not
available in the US)
Access Test Codes (continued)
Access
Code
DL2000
Code Assay Name
2005 Beckman Coulter, Inc. 8/05
Access LIS Vendor Information Rev 101968X 23
Test Codes Used by the Access System
HAV-IgM A25 Hepatitis A Virus Immunoglobulin M (Not
available in the US)
HBc-Ab A27 Hepatitis B core Total Antibody (Not available in
the US)
HBc-IgM A28 Hepatitis B core Immunoglobulin M (Not
available in the US)
HBsAg A31 Hepatitis B Surface Antigen (previous
formulation)
HBsAgBlk A32 Hepatitis B Surface Antigen Blocking (previous
formulation)
HBsAgCtl A33 Hepatitis B Surface Antigen Control (previous
formulation)
HCVPLUS A34 Hepatitis C Virus Antibody Plus (Not available in
the US)
hFSH A36 Human Follicle Stimulating Hormone
hGH A22 Human Growth Hormone
HIVAbNew A37 HIV 1, 2 New (Not available in the US)
hLH A39 Human Luteinizing Hormone
IFAb A72 Intrinsic Factor Antibody
IgG-Toxo A53 Toxoplasmosis Immunoglobulin G
IgM-Toxo A13 Toxoplasmosis Immunoglobulin M
Insulin A40 Insulin
MYO A30 Myoglobin
Ostase A12 Ostase
OV125Ag A03 OV Monitor (CA 125 Antigen)
PRL A42 Prolactin
Prog A43 Progesterone
PSA-Hyb A62 Hybritech Prostate Specific Antigen
RBC2 A76 Red Blood Cell Folate (new formulation P/N A14208)
RBCFol A45 Red Blood Cell Folate (previous formulation P/N
33010)
Access Test Codes (continued)
Access
Code
DL2000
Code Assay Name
Test Codes Used by the Access System
8/05 2005 Beckman Coulter, Inc.
24 Rev 101968X Access LIS Vendor Information
Rub-IgG A46 Rubella Immunoglobulin G
Rub-IgM A47 Rubella Immunoglobulin M (Not available in the
US)
SpIgE A58 Specific Immunoglobulin E
TBhCG2 A17 Total Beta Human Chorionic Gonadotropin
Testo A16 Testosterone
Tg A23 Thyroglobulin
TgAb A68 Thyroglobulin Antibody
Theo A48 Theophylline
TotIgE A51 Total Immunoglobulin E
TotT3 A50 Total Triiodothyronine
TotT4 A52 Total Thyroxine
TSH A57 HYPERsensitive Thyroid Stimulating Hormone
(3rd generation)
TU A59 Thyroid Uptake
uE3 A15 Unconjugated Estriol
VitB12 A60 Vitamin B12
Access Test Codes (continued)
Access
Code
DL2000
Code Assay Name
2000 Copyright Beckman Coulter, Inc. 3/00
Access LIS Vendor Information Rev 101968P 25
Sample Messages
Upload Example 2
The Access System reports results for Sample ID 47G. One replicate of Folate,
Ferritin, VitB12, and Rub-IgG were requested. The test request was entered at the
keyboard, without a Patient ID. The Rub-IgG test did not obtain a printable result.
Upload Example 3
The Access System operator cancels the TSH and Theo tests for Sample ID W4,
Patient ID 346;SIS.
Upload Example 4
The Access System reports results for Sample ID 002. Two replicates of Chl-Ag
and two replicates of ChlBlock were requested.
H|\^&|||Access|||||LIS||P|1|19971006115158
P|1|
O|1|47G|^1^3|^^^Folate^1\^^^Ferritin^1\^^^VitB12^1\^^^Rub-IgG^1|||||||||||Serum||||||||||F
R|1|^^^Folate^1|0.09|ng/mL||N||F||||19971006115045
R|2|^^^Ferritin^1|0.0|ng/mL||N||F||||19971006114745
R|3|^^^VitB12^1|00|pg/mL||N||F||||19971006115121
R|4|^^^Rub-IgG^1|No Value|RLU||N||F||||19971006115156
C|1|I|RLU, PEX|I
L|1|F
H|\^&|||Access|||||LIS||P|1|19971006115837
P|1|346;SIS
O|1|W4|^0^0|^^^TSH^1\^^^Theo^1|||||||||||Serum||||||||||F
R|1|^^^TSH^1||||||X
R|2|^^^Theo^1||||||X
L|1|F
H|\^&|||Access|||||LIS||P|1|19971006114523
P|1|Adams, John
O|1|002|^1^2|^^^Chl-Ag^1\^^^Chl-Ag^2\^^^ChlBlock^1\^^^ChlBlock^2|||||||||||Serum||||||||||F
R|1|^^^Chl-Ag^1|0.52^Non-React.|S/CO||N||F||||19971006114445
C|1|I|CEX|I
R|2|^^^Chl-Ag^2|1.43^Reactive|S/CO||N||F||||19971006114521
C|1|I|CEX|I
R|3|^^^ChlBlock^1|40.23^Not Conf.|% Supp||N||F||||19971006114409
C|1|I|CEX|I
R|4|^^^ChlBlock^2|87.23^Confirmed|% Supp||N||F||||19971006114508
C|1|I|CEX|I
L|1|F
Sample Messages
3/00 2000 Copyright Beckman Coulter, Inc.
26 Rev 101968P Access LIS Vendor Information
Upload Example 5
The Access System reports results for Sample ID 661. Two replicates of TotT4 and
two replicates of TU were requested. The FTIndex test was not explicitly ordered,
but is generated automatically when valid TotT4 and TU results are obtained for a
sample, regardless of the setting of the FTI Ratio option in system configuration.
Upload Example 6
The Access System sends rejection notification messages for Sample IDs W3 and
W4. These Sample IDs already exist in the Access System LIS pool and therefore
cannot be accepted as new test orders (action code N in the test order download
record).
H|\^&|||Access|||||LIS||P|1|19971006114936
P|1|DOEjane
O|1|661|^1^1|^^^TotT4^1\^^^TotT4^2\^^^TU^1\^^^TU^2\^^^FTIndex^1||||||||||Serum||||||||||F
R|1|^^^TotT4^1|0.00|ug/dL||N||F||||19971006114333
R|2|^^^TotT4^2|0.00|ug/dL||N||F||||19971006114633
R|3|^^^TU^1|696.793|%||N||F||||19971006114221
R|4|^^^TU^2|767.243|%||N||F||||19971006114857
R|5|^^^FTIndex^1|0.01|ug/dL||N||F||||19971006114931
L|1|F
H|\^&|||Access|||||LIS||P|1|19971007085833
P|1|675DRC4
O|1|W3||^^^Theo|||||||||||Serum||||||||||X
C|1|I|New order invalid: specimen already exists.|G
P|2|675DRC4
O|1|W3||^^^TSH|||||||||||Serum||||||||||X
C|1|I|New order invalid: specimen already exists.|G
P|3|730IDG8
O|1|W4||^^^Theo|||||||||||Serum||||||||||X
C|1|I|New order invalid: specimen already exists.|G
P|4|730IDG8
O|1|W4||^^^TSH|||||||||||Serum||||||||||X
C|1|I|New order invalid: specimen already exists.|G
L|1|F
2000 Copyright Beckman Coulter, Inc. 3/00
Access LIS Vendor Information Rev 101968P 27
Sample Messages
Request Information (Query) Example
The Access System sends a query to the LIS for test information for sample ID
Samp45, after the tray containing this sample is loaded onto the analyzer.
Query Response Test Available
The LIS responds to a query for test information for sample Samp45 with a
message indicating the TSH test.
Query Response Test Unavailable
The LIS responds to a query for test information for sample Samp45 with a
message indicating the no tests are available for the sample.
H|\^&|||Access|||||LIS||P|1|19970901085833
Q|1|^Samp45||ALL||||||||O
L|1|F
H|\^&|||Host LIS|||||Access||P|1|19970815080000
P|1|Abel, Cindy
O|01|Samp45||^^^TSH|R||||||A||||Serum
L|1|F
H|\^&|
L|1|F
Limits and Performance Guidelines
3/00 2000 Copyright Beckman Coulter, Inc.
28 Rev 101968P Access LIS Vendor Information
Limits and
Performance
Guidelines
The following table lists the limits for messages downloaded from the LIS to the
Access System. To ensure good system performance, use the Good Performance
Limits or Optimal Performance Guidelines rather than the Absolute Limits.
The Absolute Limit column lists system maximums. Messages
exceeding any of these limits are not processed completely and/or
properly. DO NOT violate these limits.
The Good Performance Limit column lists limitations that result in good
system performance. These limits are generally easily met in clinical
environments.
The Optimal Performance Guidelines column lists limitations that
afford the Access System the best performance with the LIS.
A description of each of the specifications, and an example of an optimal
download message follow the table.
Specification Absolute Limit
Good Performance
Limit
Optimal Performance
Guidelines
Max. Tests per Sample 99 40 10
Max. Data Characters per
Frame
240 240 240
Max. Total Characters per
Frame
247 247 247
Max. Record Length 1024 characters 1024 characters 240 characters
Max. Message Size 102,400 characters 122 frames 5 frames
Max. Samples in Database 1000 N/A N/A
Max. Tests in Database 2200 N/A N/A
Max. Tests per
Sample
The maximum number of tests that can be ordered on a
particular sample is 99.
Max. Data
Characters per
Frame
The maximum number of characters that can be
contained in the [DATA] portion of the frame. This
number is determined by ASTM Standard E1381-95.
Records containing more than 240 characters must be
spread over multiple frames.
Max. Total
Characters per
Frame
The maximum total number of characters that can be
contained in a frame, as determined by ASTM Standard
E1381-95. This number includes the 240 data characters
plus the 7 characters associated with sending a frame
(i.e., <ETX>).
2000 Copyright Beckman Coulter, Inc. 3/00
Access LIS Vendor Information Rev 101968P 29
Limits and Performance Guidelines
Optimal Download Example
Max. Record
Length
The maximum number of data characters that can be
contained in one record. A 1024 character record
requires 5 frames: 4 of 240 characters each, and 1
containing 64 characters.
Max. Message
Size
The maximum sum total of all the data characters in a
message. Since frames vary in length, the exact number
of frames that the maximum number of characters
requires cannot be determined, but messages
approaching the maximum are highly discouraged.
Max. Samples in
Database
The Access System allows a maximum of 1000 sample
records in the sample database. A sample record is
created in the database for each Order record received.
Sample records are cycled through the database on a
first-in-first-out basis, with unloaded sample records
being removed before those that have not yet been
loaded.
Max. Tests in
Database
The Access System allows a maximum of 2200 test
records in the sample database. A test record is created
in the database for each test ordered on a sample.
Sample records are cycled through the database on a
first-in-first-out basis, with unloaded sample records
being removed before those that have not yet been
loaded.
H|\^&|||Host LIS|||||Access^System 2||P|1|19970815080000
P|1|32445|||Baker^Tom^M^S^Mr||19530101|M
O|01|123458||^^^TSH\^^^TSH|R||||||A||||Serum
O|02|123458||^^^Cortisol|R||||||A||||Serum
L|1|F
Limits and Performance Guidelines
Printed in U.S.A. 3/00 2000 Copyright Beckman Coulter, Inc.
30 Rev 101968P Access LIS Vendor Information