Bechman Access

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.

© 2000 Copyright Beckman Coulter, Inc. 3/00Access LIS Vendor Information Rev 101968P i

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

3/00 © 2000 Copyright Beckman Coulter, Inc.ii Rev 101968P Access LIS Vendor Information

© 2000 Copyright Beckman Coulter, Inc. 3/00Access LIS Vendor Information Rev 101968P 1



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

3/00 © 2000 Copyright Beckman Coulter, Inc.2 Rev 101968P Access LIS Vendor Information

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.


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



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 PhaseDuring 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 PhaseDuring 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 PhaseDuring 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 SequenceThe 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




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>



Failure Session (Max <NAK>s): <ENQ> -><-

(Delay 10 seconds) <ENQ> ->(Repeat up to 6 times) <-

<EOT> ->(After 6 <NAK>s)

<NAK>

<NAK>



Failure Session (No Response): <ENQ> ->

(Time-out after 15 seconds) <EOT> ->No Response



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>


Physical Layer


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.


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


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 ContentThe 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 HPatient Record PTest Order Record OResult Record RComment Record CScientific Record SManufacturer Record MRequest Information Record QFinal 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



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

AccessReceive

AccessSend

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



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)


AccessReceive

AccessSend

* 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.



Patient Information Record


AccessReceive

AccessSend

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

Mother’s Maiden Name | Ignored No

Birthdate | 19631124 8 Yes No

Patient Sex | F 1 Yes No

Patient Race | Ignored No

Patient Address | 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



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


Patient Information Record (continued)


AccessReceive

AccessSend

* 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.


1/02 © 2002 Beckman Coulter, Inc.12 Rev 101968T Access LIS Vendor Information

Test Order Record


AccessReceive

AccessSend

Record Identifier O 1 * *


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 Rcv’d | Ignored No

Specimen Descriptor:

Specimen Type | Serum 8 Yes Yes

Specimen Source ^ Ignored No

* Required



Ordering Physician | Ignored No

Physician’s 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


Loc. Specimen Collection | Ignored No

Noscomial Infection Flag | Ignored No

Specimen Service | Ignored No

Specimen Institution | Ignored No


Test Order Record (continued)


AccessReceive

AccessSend

* 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.


1/02 © 2002 Beckman Coulter, Inc.14 Rev 101968T Access LIS Vendor Information

Universal Test ID The first three components of this field are not used bythe Access System, and should be left blank by the LISas they are ignored. The fourth component is required,representing the test code, and should be the lastcomponent specified. Refer to the Test Codes Used bythe Access System section later in this document.

On uploads, the Access System includes a fifthcomponent field indicating the test replicate number.If one replicate of a test is ordered, the replicate numberis 1. If two replicates of a test are ordered, the testappears in the test order record twice, with replicatenumbers of 1 and 2. Replicate numbers are ignored ontest order downloads.

The Access System parses repeat delimiters in this fieldfor received Test Order Records. The Access System mayalso produce repeat delimiters in this field whensending Test Order Records, to list each test code foreach Result Record to follow for a specific sampleposition.

Repeat delimiters are not parsed or produced for thisfield in the Result Record.

Priority Test priority codes are as follows:

S StatA As Soon as PossibleR RoutineC CallbackP Preoperative

Although the system accepts up to nine characters, thepriority code is the first character in the field.

Code S (Stat) is treated as a Stat patient sample by theAccess System. Any other priority code, including nopriority code, is treated as a routine patient sample bythe Access System.

Action Code This field indicates what will be done with thespecimens accompanying or preceding this test orderrequest received by the Access System. The followingcodes are used:

C Cancel request for the test. The test is removedfrom any test request and from the LIS pool.

A Add the requested test to the existingspecimen with the patient and specimenidentifiers given in this record. If the specimendoes not exist, create it.

N New requests accompanying a new specimen.If the specimen already exists, the request isconsidered invalid and is rejected.



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


AccessReceive

AccessSend

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



Date/Time Test Completed

| 19971119165845 14 No Yes

Instrument Identification

| No No

End of Record <CR> 1 No *

Result Record (continued)


AccessReceive

AccessSend

* 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.



Comment Record


AccessReceive

AccessSend

Record Identifier C 1 No *


Comment Source | I 1 No Yes

Comment Text | CEX; PEX 160 No Yes

Comment Type | I 1 No Yes


* 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.



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


AccessReceive

AccessSend

Record Identifier Q 1 No *


Starting Range ID Number:

Patient ID Number | No No

Specimen ID Number ^ Samp45 15 No Yes

*Required



NOTEThe 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


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 System’s 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)


AccessReceive

AccessSend

*Required

Position Sample ID Tests Requested1 QN195823 Folate, Ferritin2 KNH483736 TSH



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|19970901085833Q|1|^Samp45||ALL||||||||OL|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 Samp454 F049498 TU5 4566 SS51269 TotT47 91292IGM TotT4, TU8 345439 D2SE3 Folate10 JA456789 T�hCG2

Position Sample ID Tests Requested

© 2005 Beckman Coulter, Inc. 8/05Access LIS Vendor Information Rev 101968X 21

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

AccessReceive

AccessSend

Record Identifier L 1 * *


Termination Code | F 1 Ignored Yes


* 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)


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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. 8/05Access LIS Vendor Information Rev 101968X 23


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

Code

DL2000

Code Assay Name


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

Code

DL2000

Code Assay Name


Sample Messages

Upload Example 2The 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 3The Access System operator cancels the TSH and Theo tests for Sample ID W4, Patient ID 346;SIS.

Upload Example 4The Access System reports results for Sample ID 002. Two replicates of Chl-Ag and two replicates of ChlBlock were requested.

�� #��"�8��!��0��*��0�&&��9��)� ��%'�:�58��&'(��0%��0��*��1��53(��4��0��#��"�%� ��0�&&��1��53(��4��0��#��"�"�%�!��9��)� ��-53(��4��0��#�� %�"��%'�:�58��4�9*�'��%2��4��0��#��#��%2��67��0

�� #��!��!"#;��<"��$��$/��&'(��0%��$��7%� ��$/��7��0

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Sample Messages


Upload Example 5The 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 6The 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).

�� #��"�!#��@�6A*��##��$��$"��$��$"� ��$2��$2� ��0$��B��&'(��0%��$��$"��1��'53��4��0��#��"!!!%� ��$��$"� ��1��'53��4��0��#��"#!!%�!��$2��#�#1��!�?��4��0��#��" �%�"��$2� ��#�1 "!�?��4��0��#��"��%��0$��B��1��'53��4��0��#��"�!��0

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Sample Messages

Request Information (Query) ExampleThe 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 AvailableThe LIS responds to a query for test information for sample Samp45 with a message indicating the TSH test.

Query Response – Test UnavailableThe LIS responds to a query for test information for sample Samp45 with a message indicating the no tests are available for the sample.

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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>).



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.

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Printed in U.S.A. 3/00 © 2000 Copyright Beckman Coulter, Inc.30 Rev 101968P Access LIS Vendor Information

Documents

Bechman Access