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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


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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 ofBeckman Coulter, Inc.


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© 2000 Copyright Beckman Coulter, Inc. 3/00

Access 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


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Table of Contents

3/00 © 2000 Copyright Beckman Coulter, Inc.

ii Rev 101968P Access LIS Vendor Information


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© 2000 Copyright Beckman Coulter, Inc. 3/00 Access 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.


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Definitions


2 Rev 101968P Access LIS Vendor Information

Definitions The following is a list of terms used in this document and a definition of eachterm as it is used by Beckman Coulter, Inc.

Term Definition

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.

Inquire (ASCII Decimal 5).

End of Transmission Block (ASCII Decimal 23). For useonly when a single record is too large to fit into one frame.

End of Text (ASCII Decimal 3). Required at the end ofeach record.

[frame number] Single digit frame number “0” to “7”. Starts with “1”.

Line Feed (ASCII Decimal 10).

Negative Acknowledgment (ASCII Decimal 21).

Start of Frame (ASCII Decimal 2).

Communicationspacket

All framing required for transmission of data. Thisframing includes: [frame number][DATA] [or ][C1][C2] .

Component Field One of several related pieces of information within a field.

Download The transmission of data from the LIS to the AccessSystem.

Field A specific location within a record for a piece ofinformation, 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 recordsthat begins with a “Header” record and ends with a

“Terminator” record. A single record could theoreticallyconstitute a message, but within this context, a messagealways contains multiple records. Refer to the MessageLayer section and the descriptions of each type of recordincluded later in this document.

Receiver The device that responds to the sender. The receiver inthis document is either the Access System or the LIS.


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Access LIS Vendor Information Rev 101968P 3

Definitions

End of Transmission (ASCII decimal 4).

Carriage Return (ASCII decimal 13).

Record In reference to the low level protocol, a record is themessage data (shown as [DATA]) as described within thecommunications packet. If the data is longer than 240characters, then it must be split into two parts and sent intwo communications packets. The intermediate packetuses the character, and the ending packet uses the character. No single communications packetcontains more than one record.

In reference to the message layer, a record can be one ofthe following codes: H (header), P (patient), O (order),R (result), L (terminator), C (comment). Refer to theMessage 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 mayproduce repeat fields in the Universal Test ID field of aTest Order Record, but ignores other occurrences of repeatfields.

Sender The device that has a message to send and initiates thetransmission process, in this case between the LIS and theAccess System. The sender in this document is either theAccess System or the LIS.

Session A total unit of communication activity used in this

standard to indicate the events starting with theEstablishment phase and ending with the Terminationphase. Refer to Frame Layer Protocol later in thisdocument.

Test A determination of a single analyte or a combination ofvalues from other determinations or observations fromwhich a variable or gradable result is derived.

Upload The transmission of data from the Access System to theLIS.

Term Definition (continued)


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Frame Layer Protocol



Frame LayerProtocol

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 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 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 -->

No ResponseExpected


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Frame Layer Protocol

Session Description Sender Receiver

Failure Session (NAK): ->

No ResponseExpected


Failure Session (Max s): ->

(Repeat up to 6 times)

(After 6 s)

No ResponseExpected


Failure Session (No Response): ->

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

No ResponseExpected


Failure Session (Max s): ->

No ResponseExpected


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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 asData 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.

MessageLayer

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 s): -> (Delay 10 seconds)(Repeat up to 6 times) [F1] [DATA] [C1] [C2] ->

No ResponseExpected

PinAccess 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 ContentThe following is a list of the limitations and general considerations regarding

message content.

AllowedCharacters

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 berestricted to ASCII 32-126 for proper operation of theAccess System Software. Specific fields may furtherrestrict allowed characters.

Maximum Field

Length

No maximum field length is imposed within the

message-receiving mechanism. However, the messageparsing performed by the Access System/LIS InterfaceSoftware enforces certain restrictions. Refer to the recordtables later in this document for specific fieldrestrictions.

Maximum RecordLength

No maximum record length is imposed within themessage-receiving mechanism. However, the messageparsing performed by the Access System Softwarerestricts records to 1024 characters in length.

Delimiters Any of the allowable characters, as specified in ASTME1394-91, 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 theASTM standard:

Header Record HPatient Record PTest Order Record OResult Record RComment Record C

Scientific Record SManufacturer Record MRequest Information Record QFinal Record L

Fields with NullValues

Nulls are sent when data need not be updated. A nullvalue does not conflict with existing data in most cases.Erroneous data is the responsibility of the sender.


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Record Field Contents



Record FieldContents

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.

ManufacturerInformation

Record

The Manufacturer Information Record is ignored whenreceived 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 AccessSystem.

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


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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 SpecialInstructions

| 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 1 * *

Message Header Record (continued)

Description Delimiter ExampleMax.

LengthAccessReceive

AccessSend

* Required

Processing ID Indicates how this message is to be processed. Thefollowing code is used:

P Production: Treat message as an activemessage to be completed according tostandard processing.

Sender Nameor ID

The Access System sends the word Access followed by aSystem ID in a component field (for example, AccessSystem1). The System ID is entered in systemconfiguration in the Laboratory Information screen.

Receiver ID Indicates the intended message receiver. If the AccessSystem will be the receiver, the word Access is used,followed by an optional System ID. The System IDshould be designated only when there are multipleAccess Systems using the LIS, and the message isintended only for the named Access System. Themessage is rejected when Access is the Receiver ID andthe System ID component field does not match theSystem ID entered and stored in the laboratoryinformation of system configuration.


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Practice Field #1 | Ignored No

Practice Field #2 | Ignored No

Admission andDischarge Dates

| Ignored No

Admission Status | Ignored No

Location | Ignored No

Nature of Alt. Diag.Code & Class.

| Ignored No

Alt. Diag. Code & Class. | Ignored NoPatient 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 1 * *

Patient Information Record (continued)


LengthAccessReceive

AccessSend

* Required

Practice AssignedPatient ID

When this field is downloaded, it appears on the TestRequest screen in the Patient ID column. It is also senton uploads, if available. If the test order is entered at theAccess System and the operator does not enter a PatientID, this field is blank on uploads.


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1/02 © 2002 Beckman Coulter, Inc.

12 Rev 101968T Access LIS Vendor Information

Test Order Record


LengthAccessReceive

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


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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 ResultsReported/Mod.

| Ignored No

Inst. Charge to ComputerSystem

| 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

End of Record 1 * *

Test Order Record (continued)


LengthAccessReceive

AccessSend

* Required

Specimen ID Alphanumeric characters are accepted (0-9, A-Z bothupper and lower case, /, +, and -). Spaces andpunctuation are not allowed.

InstrumentSpecimen ID

The three components are: Sample Tag, Tray Number,and Sample Position. Tray Number and Sample Positionare uploaded to the LIS but are ignored on downloads.The Tray Number is 1-9999, and the Sample Position isthe position within the sample tray (1-10). Sample Tag isunused.


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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 last

component 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 Callback

P 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.


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SpecimenDescriptor

Only the Specimen Type portion of the SpecimenDescriptor 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 Systemwhen uploading only:

F Final results.X Results cannot be done, request canceled.

Result Record


LengthAccessReceive

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 AbnormalityTesting

| No No

Result Status | F 1 No Yes

Date of Change | No No

Operator Identification | No No

Date/Time Test Started | No No

* Required


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Date/Time TestCompleted

| 19971119165845 14 No Yes

InstrumentIdentification

| No No

End of Record 1 No *

Result Record (continued)


LengthAccessReceive

AccessSend

* Required

Universal Test ID For considerations regarding this field, see the TestOrder Record descriptions in this document.

Result AbnormalFlags

This field indicates the status of the result. Thefollowing codes are used:

L Below normal ref. low limit. Indicates theAccess System ORL flag.

H Above normal ref. high limit. Indicates theAccess System ORH flag.

LL Below panic low. Indicates the Access SystemCRL flag.

HH Above panic high. Indicates the AccessSystem CRH flag.

> Out of range high. Indicates the AccessSystem OVR flag.

N Normal result. Result not flagged ORH, ORL,CRL, CRH, or OVR.

< Under for positive slope assays (or over fornegative slope assays) the threshold limitdefined in the assay protocol file. Indicates theAccess 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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Comment Record


LengthAccessReceive

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 commentrecord is only sent immediately following a resultrecord 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 applyto all results. Some flags are currently not used, but arelisted here for future reference. The following codes aredefined:

CEX Curve expired.

CRH Result higher than critical (panic) referencerange.

CRL Result lower than critical (panic) referencerange.

EDT Result edit (currently unused).

GRY Qualitative result in gray zone.

IND Result is indeterminant.

LEX Lot expired.

LOW Result lower than the minimum reportableresult.

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.


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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 ofthe acceptable luminometer measuring range.

SYS Instrument error.

TMP One or more of the following is outside thetemperature specification: Incubator, wash/read carousel, substrate, reagent.

UNR The measured sample signal (RLU) is less thanan RLU threshold limit for the leastconcentrated calibrator or calibration controlfor a positive slope assay, or is greater than theleast concentrated calibrator for a negativeslope assay, as defined in the assay protocolfile.

WVL Quality control sample result was generatedusing a different reagent vial lot number thanthe vial lot number used to calibrate the assay.

Comment Type Used to indicate type of comment. The following codesare used:

G Generic/Free Text Comment (for errormessages)

I Instrument Flag Comment (for test resultflags)

Request Information Record

Description Delimiter Example Max.

Length

Access

Receive

Access

Send

Record Identifier Q 1 No *


Starting Range ID Number:

Patient ID Number | No No

Specimen ID Number ^ Samp45 15 No Yes

*Required


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NOTE

The Access System queries the LIS whenever a tray containing samples that haveno 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 fieldcontains a single specimen ID which corresponds to theAccess System’s 15-character sample ID. The specimenID follows the unused patient ID in a component field.

Ending Range ID

Number

This field is unused, since the Access System does notquery 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


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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 doesnot 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 TotT47 91292IGM TotT4, TU

8 34543

9 D2SE3 Folate

10 JA456789 ThCG2

Position Sample ID Tests Requested


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© 2005 Beckman Coulter, Inc. 8/05

Access LIS Vendor Information Rev 101968X 21

Test Codes Used by the Access System

Test CodesUsed by theAccessSystem

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

End of Record 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 inthe US)

AFP A02 Alpha-Feto Protein (cancer and ONTD utility)

AgHBs A64 Hepatitis B Surface Antigen (Not available in theUS)


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22 Rev 101968X Access LIS Vendor Information

AgHBsBlk A65 Hepatitis B Surface Antigen Blocking (Notavailable in the US)

AgHBsCtl A66 Hepatitis B Surface Antigen Control (Notavailable 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 formulationP/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 availablein the US)

HAV-IgM A25 Hepatitis A Virus Immunoglobulin M (Notavailable in the US)

Access Test Codes (continued)

Access

Code

DL2000

Code Assay Name


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© 2005 Beckman Coulter, Inc. 8/05

Access LIS Vendor Information Rev 101968X 23


HAV-IgM A25 Hepatitis A Virus Immunoglobulin M (Notavailable in the US)

HBc-Ab A27 Hepatitis B core Total Antibody (Not available inthe US)

HBc-IgM A28 Hepatitis B core Immunoglobulin M (Notavailable in the US)

HBsAg A31 Hepatitis B Surface Antigen (previousformulation)

HBsAgBlk A32 Hepatitis B Surface Antigen Blocking (previousformulation)

HBsAgCtl A33 Hepatitis B Surface Antigen Control (previousformulation)

HCVPLUS A34 Hepatitis C Virus Antibody Plus (Not available inthe 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/N33010)


Access

Code

DL2000

Code Assay Name


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24 Rev 101968X Access LIS Vendor Information

Rub-IgG A46 Rubella Immunoglobulin G

Rub-IgM A47 Rubella Immunoglobulin M (Not available in theUS)

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


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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.


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Sample Messages



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).


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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.


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Limits and Performance Guidelines



Limits andPerformanceGuidelines

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 LimitGood Performance

LimitOptimal Performance

Guidelines

Max. Tests per Sample 99 40 10

Max. Data Characters perFrame

240 240 240

Max. Total Characters perFrame

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 perSample

The maximum number of tests that can be ordered on aparticular sample is 99.

Max. DataCharacters per

Frame

The maximum number of characters that can becontained in the [DATA] portion of the frame. Thisnumber is determined by ASTM Standard E1381-95.Records containing more than 240 characters must bespread over multiple frames.

Max. Total

Characters perFrame

The maximum total number of characters that can becontained in a frame, as determined by ASTM StandardE1381-95. This number includes the 240 data charactersplus the 7 characters associated with sending a frame(i.e., ).


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Optimal Download Example

Max. RecordLength

The maximum number of data characters that can becontained in one record. A 1024 character recordrequires 5 frames: 4 of 240 characters each, and 1containing 64 characters.

Max. MessageSize

The maximum sum total of all the data characters in amessage. Since frames vary in length, the exact numberof frames that the maximum number of charactersrequires cannot be determined, but messagesapproaching the maximum are highly discouraged.

Max. Samples in

Database

The Access System allows a maximum of 1000 samplerecords in the sample database. A sample record iscreated in the database for each Order record received.Sample records are cycled through the database on afirst-in-first-out basis, with unloaded sample records being removed before those that have not yet beenloaded.

Max. Tests in

Database

The Access System allows a maximum of 2200 testrecords in the sample database. A test record is createdin the database for each test ordered on a sample.Sample records are cycled through the database on afirst-in-first-out basis, with unloaded sample records being removed before those that have not yet beenloaded.


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