Instrument Manager™ Supplemental Specifications for ...

Part No. J32862

Instrument Manager™

Supplemental Specifications for

Laboratory Information System

Export authorized under general license GTDA (General Technical Data Available)

IMPORTANT

The information contained herein is based on the experience and knowledge relating to the subject matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.

No patent license is granted by the information.

Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to the information. The company shall not be liable for any loss or damage, including consequential or special damages resulting from the use of this information, even if loss or damage is caused by its negligence or other fault.

VITROS is a registered trademark of Ortho-Clinical Diagnostics, Inc.enGen is a registered trademark of Ortho-Clinical Diagnostics, Inc.

Ortho Clinical Diagnostics, 2008 - 2017. All rights reserved.

Revision History

Revision Date Section Description

2017-07-10 3.2.1 Added ALT2 and ALTV Test Codes.Added Chloride - "Urine" Fluid Code.Removed “2” from Homocysteine Test Name.Removed HCY LIS Test Code.

3.2.2 Added INS, C-pep, HIV c, NCHEK, TIMP2 and IGFBP Test Codes.

2013-01-10 1.2 Updated references to Data Innovations documents.

3.2.1 Updated Fluid Codes for:• %MB• CKMB• CKMBECI• DGXN• PCP

3.2.2 Updated Fluid Code for TVITD

Test Order Records - updated reference to Data Innovations interface specifications

3.9 Updated default connection names:• Added FS7• Removed Immuno-Assay System• Removed VITROS® 950 Chemistry System• Added 365, 366, 367, 465, 566 and 567

3.12.1 Updated the LIS message

3.14 Updated the Standard Test Codes for Sorting Table

Part No. J32862 Instrument Manager™ Supplemental Specifications for Laboratory Information System iii2017-07-10

2012-06-05 Updated the Title of the document.

Global reformatting of this document.

1.1 Added new Definitions Section

1.2 Updated Introduction Section

2.1 Changed name to Message Options and updated the table.

3.2.1 Updated Test Code Definitions for D%A1CI and DTIBC and added HCY2*.

3.2.2 Added FPSA, %FPSA, TPSA, TVITD, SYPH, and IPTH Test CodesRemoved “International” from the following Test Names:• Anti-HBe• Anti-HIV 1 + 2• CMV IgG• CMV IgM• Free B-hCG• HBeAg• Rubella IgM• Syphilis• Toxoplasma IgG• Toxoplasma IgM• Thyroid Stimulating Hormone 30

3.3 Changed Title of Section

3.13.1 Added fluid Type explanation for AT Test Codes

3.13.2 Added new section for AT Test Code transmission

3.14 Updated Standard Test Codes for Sorting Table

4 Removed the Prefixes and Test with Multiple Result Components(non-VITROS®) Sections. Added 2 different options for connection of Non-OCD Instruments.

Eliminated “Version”. The Revision Date is now the version of the document.

*Product in development. For all assays, availability is subject to regulatory requirements.

Revision Date Section Description

iv Instrument Manager™ Supplemental Specifications for Laboratory Information System Part No. J328622017-07-10

Revision Date Version Description

2011-07-22 2.1 Update to include integration of VITROS® 4600 Chemistry System.

2008-10-31 2.0 Update to include integration of VITROS® 3600 Immunodiagnostic System and VITROS® 5600 Integrated System.

2008-07-18 1.1 Update to Test Code Definitions.

2008-04-30 1.0 First release of document.

List of Revised Pages

Each page in your manual should be at the effective date listed below

Revision Date Page

2017-07-10 All

2013-01-10 All

2012-06-05 All

:

Revision Date Version Page

2011-07-22 2.1 1-1, 3-25

2008-10-31 2.0 All

2008-07-18 1.1 3-4

2008-04-30 1.0 All

Part No. J32862 Instrument Manager™ Supplemental Specifications for Laboratory Information System v2017-07-10

vi Instrument Manager™ Supplemental Specifications for Laboratory Information System Part No. J328622017-07-10

Table of Contents

CHAPTER 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11.1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11.2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11.3 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

CHAPTER 2 Instrument Manager™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12.1 Message Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12.2 Communication Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

CHAPTER 3 VITROS® Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13.1 Fluid Code Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13.2 VITROS® Test Code Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

3.2.1 VITROS® Chemistry Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23.2.2 VITROS® Immunoassay Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

3.3 VITROS® Result Code and Flag Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-133.4 VITROS® Result Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-193.5 VITROS® Result Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19

3.5.1 Result Transmission Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-203.5.2 Impact of Intermediate Result Handling Selection in Result Transmission . . . . . . .3-223.5.3 Impact of Result Prefix Selection in Result Transmission . . . . . . . . . . . . . . . . . . . .3-223.5.4 Impact of Comment Selection in Result Transmission. . . . . . . . . . . . . . . . . . . . . . .3-23

3.6 Result Instrument ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-243.7 Result Date/Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-243.8 Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-243.9 Instrument IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-253.10 Operator IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-263.11 Laboratory Status Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

3.11.1 Using ASTM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-263.11.2 Using HL7 2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-273.11.3 Using HL7 2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27

3.12 Laboratory Storage Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-283.12.1 Using ASTM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-283.12.2 Using HL7 2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-293.12.3 Using HL7 2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29

3.13 Aliquoting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-303.13.1 Aliquot Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-303.13.2 Example of Transmission using HL7 2.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

3.14 Standard Test Codes for Sorting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31

Part No. J32862 Instrument Manager™ Supplemental Specifications for Laboratory Information System vii2017-07-10

CHAPTER 4 Non-OCD Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14.2 Non-OCD Instrument Interface Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2.1 Option 1: Non-OCD Instrument is NOT interfaced to OCD-IM but directly to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2.2 Option 2: Non-OCD Instrument is interfaced to OCD-IM . . . . . . . . . . . . . . . . . . . 4-1

viii Instrument Manager™ Supplemental Specifications for Laboratory Information System Part No. J328622017-07-10

1 Introduction

1.1 DefinitionsLIS Laboratory Information System

OCD Ortho Clinical Diagnostics

DI Data Innovations

IM Data Innovations Instrument Manager™

OCD-IM Instrument Manager™ Subsystem combined with an OCD standardized configuration file

1.2 IntroductionThe OCD-IM Controller is the interface platform between the instruments and the LIS. It uses an OCD-owned standardized configuration file (test codes mapping, fluid codes mapping, error flags, etc.) as described in this document.

The OCD-IM Controller can be connected to:

• enGen™ Laboratory Automation System track system (used for pre-analytical and post-analytical sample and data management)

• VITROS® Instruments (On-Track and Off-Track)• Non-OCD Instruments (On-Track only, see Chapter 4)

The LIS will not communicate directly with the on-track or off-track VITROS® Systems, but rather communicate with IM software applications developed and owned by DI.

Data Innovations has ASTM and an HL7 protocol documents that describe the specific communication parameters for communicating between Instrument Manager™ and the customer Laboratory Information System (LIS):

• Data Innovations Software Requirements Specifications (SRS) for Host Driver Ortho Clinical Diagnostics ASTM LIS ocdastml SRS-0315

• Data Innovations Software Requirements Specifications (SRS) for Host Driver Ortho Clinical Diagnostics HL7 LIS ocdhl7ml SRS-0314

Part No. J32862 Instrument Manager™ Supplemental Specifications for Laboratory Information System 1–12017-07-10

1.3 ScopeThis document is a supplemental interface specification. It is intended to provide additional information and guidance to the customer and the customer LIS vendor during development of the communication interface to the Instrument Manager™ for Ortho Clinical Diagnostics, Inc. (OCD-IM). The Interface should be tested prior to routine use.

The use of any assay and fluid combination is subject to limitations and recommendations defined in OCD Instructions for Use documents for each assay.

WARNING: Specification processed represent the default and standard configuration for the OCD-IM. This specification is only applicable to the OCD-IM.

WARNING: The Instrument Manager™ Supplemental Specifications for Laboratory Information System (LIS) document will be voided if the user changes the default mapping as described and/or write rules that impact Instrument Manager™ communication with the LIS.

1–2 Instrument Manager™ Supplemental Specifications for Laboratory Information System Part No. J328622017-07-10

2 Instrument Manager™

2.1 Message OptionsThe configuration of an OCD-IM varies from site to site depending on the LIS capabilities and how results will be processed. The following options are used to augment the results uploaded to the LIS.

Feature Option DescriptionIntermediate Result Handling Send All All results will be sent to the LIS

Send Final Intermediate results will not be sent to the LISResult Prefix Insert < > prefixes VITROS® System results greater or less than the

Reportable Range of the Instrument will be sent to the LIS with the prefix < or > in .

No prefix VITROS® System results greater or less than the Reportable Range of the Analyzer will be sent with the Analyzer flags only. No result prefix will be sent.

Result CommentsDetermines what, if any, information is sent with results that have flags or codes.

Comments Comments will be sent to the LIS to describe result codes and flags, including qualitative and semi-qualitative assay flags.

No comments No comments on error codes shall be sent in the Comments field.

Qualitative Assay Comments

Comments will be sent to the LIS containing text for range units associated with Q, R, S, T, and U, flags associated with qualitative and semi- qualitative assays.

2.2 Communication PortsConnection assignment for the LIS should be selected from the following table utilizing the corresponding port number that meets the site’s current LIS configuration. Individual IP Addresses for the Instrument Manager™ computer will be provided during installation.

Example: The LIS that requires two separate communication lines to send requests and receive results will need to connect on Ports 10011 and 10013. Instrument Manager™ will be in server mode by default.

Connection Mode IP Address Port No.LIS - combined orders/results Server n/a 10010LIS - receiving orders Server n/a 10011LIS - receiving orders (2nd) Server n/a 10012LIS - sending results Server n/a 10013LIS - auto-logging Server n/a 10014

Note: Upon request, serial communication with the LIS can be established through the use of device servers. Contact Ortho Clinical Diagnostics for more information.

Note: Upon request, Instrument Manager can also operate as a client. In this case, the IP Address of the LIS server must be provided.


3 VITROS® Systems

3.1 Fluid Code DefinitionsThis section includes the definition of fluid code character strings required to order tests on Instruments through OCD-IM.

The following standard fluid codes are defined in Instrument Manager™:

These codes are mandatory and must be processed as per Data Innovations LIS interface specifications defined in Section 1.1

• ASTM: O (Test Order Record), field 16.1• HL7 V2.2 and V2.4: OBR (Observation Request Segment), field 15.1

Note:

• If the LIS is unable to differentiate between Serum and Plasma fluid types, Serum should be used.• If Serum fluid type is used to identify both Serum and Plasma and a test is required for Plasma only, the system

will assume the specimen fluid type is plasma and will return the result as Plasma.• If a sample includes a request for a Serum only and Plasma only test, the system will decline the entire test

request.

LIS Fluid Code

LIS Fluid Code Definition

Alternate LIS Fluid Code

(request message only)SER Serum 1PLAS Plasma 4CSF Cerebrospinal Fluid 3URI Urine 2BLD Whole Blood 5AMNIO Amniotic Fluid 6


3.2 VITROS® Test Code DefinitionsThis section includes the definition of test code character strings needed to order tests on VITROS® Instruments through Instrument Manager™ regardless of which VITROS® Instrument is used to perform the test.

The following standard test codes are defined in the OCD-IM.

3.2.1 VITROS® Chemistry Tests

Fluid Codes

Test NameLIS Test

Code Serum PlasmaAmniotic

Fluid CSF Urine Blood

%MB %MB SER

% Iron Saturation %SAT SER PLAS

Alpha-1-antitrypsin AAT SER

Acetaminophen ACET SER PLAS

Acid Phosphatase ACP SER PLAS

A/G Ratio AG SER PLAS

Anion Gap AGP SER PLAS

Anion Gap (K+) AGPK SER PLAS

Albumin ALBALB1ALB2ALB3

SER PLAS

Alcohol ALC SER PLAS

Alkaline Phosphatase ALKPALKP1ALKP2ALKP3

SER PLAS

Alanine Aminotransferase ALTALT1ALT2ALT3ALTV

SER PLAS

Ammonia AMON PLAS

Amphetamines AMPH URI

Amylase AMYL SER PLAS URI

Amylase AMYL1AMYL2AMYL3

SER PLAS

ApoA1 APOA1 SER PLAS

ApoB APOB SER PLAS

Anti-streptolysin O ASO SER PLAS


Aspartate Aminotransferase

ASTAST1AST2AST3

SER PLAS

Barbiturates BARB URI

Conjugated Bilirubin BCBC1BC2BC3

SER PLAS

Benzodiazepines BENZ URI

Unconjugated Bilirubin BUBU1BU2BU3

SER PLAS

C3 C3 SER PLAS

C4 C4 SER PLAS

Calcium CA SER PLAS URI

Calcium CA1CA2CA3

SER PLAS

Caffeine CAFFN SER PLAS

CHOL/dHDL CH SER PLAS

Cholinesterase CHE SER PLAS

Cholesterol CHOLCHOL1CHOL2CHOL3

SER PLAS

Creatinine Kinase CKCK1CK2CK3

SER PLAS

Creatinine Kinase MB (U/L)

CKMB SER

Chloride CLCL1CL2CL3

SER PLAS URI

Cocaine Metabolite COCM URI

Carbamazepine CRBM SER PLAS

Fluid Codes

Test NameLIS Test




Creatinine CREACREA1CREA2CREA3CREA4CREA5CREA6CREA7CREA8CREA9

CREA10CREA11CREA12CREA13CREA14CREA15

SER PLAS URI

C Reactive Protein CRPCRP1CRP2CRP3

SER PLAS

d%A1c D%A1C BLD

mmA1c (International) D%A1CI BLD

Direct Bilirubin DBILDBIL1DBIL2DBIL3

SER PLAS

Delta Bilirubin DELB SER PLAS

Digoxin DGXN SER

Direct Hemoglobin A1c** DHA1C BLD

Direct Hemoglobin** DHB BLD

Direct HDL (slide methodology)

DHDL SER PLAS

Direct LDL (MicroTip methodology)

DLDL SER PLAS

Direct TIBC DTIBC SER

Fluid Codes

Test NameLIS Test




Enzymatic CO2 ECO2ECO2-1ECO2-2ECO2-3

SER PLAS

Iron FEFE1FE2FE3

SER PLAS

Gentamicin GENTGENTPGENTTGENTR

SER PLAS

Gamma Glutamyltransferase

GGTGGT1GGT2GGT3

SER PLAS

Globulin GLOB SER PLAS

Glucose GLU SER PLAS CSF URI

Glucose GLU1GLU2GLU3GLU4GLU5GLU6GLU7GLU8GLU9

GLU10GLU11GLU12GLU13GLU14GLU15GLU16GLU17GLU18GLU19GLU20GLU21GLU22GLU23GLU24GLU25

SER PLAS

Homocysteine HCY2 SER PLAS

Hemolysis (MicroSensor) HEM SER PLAS CSF

Haptoglobin HPT SER PLAS

High sensitivity C Reactive Protein

HSCRP SER PLAS

Icterus (MicroSensor) ICT SER PLAS CSF

Immunoglobulin A IGA SER PLAS

Fluid Codes

Test NameLIS Test




Immunoglobulin G IGG SER PLAS

Immunoglobulin M IGM SER PLAS

Potassium K SER PLAS URI

Potassium K1K2K3

SER PLAS

Lactate LACLAC1LAC2LAC3

PLAS

Lactate Dehydrogenase LDHLDH1LDH2LDH3

SER PLAS

Low Density Lipoprotein LDL SER PLAS

Lithium LI SER PLAS

Lipase LIPALIPA1LIPA2LIPA3

SER PLAS

Microalbumin MALB URI

Methadone METD URI

Magnesium MG SER PLAS URI

Magnesium MG1MG2MG3

SER PLAS

Sodium NA SER PLAS URI

Sodium NA1NA2NA3

SER PLAS

Neonatal Bilirubin NBIL SER PLAS

Opiates-Low Cutoff OP-LO URI

Opiates-High Cutoff OP-HI URI

Osmolality OSMO SER PLAS

Prealbumin PALB SER PLAS

Phencyclidine PCP URI

Phenobarbital PHBR SER PLAS

Phosphorus PHOS SER PLAS URI

Phosphorus PHOS1PHOS2PHOS3

SER PLAS

Fluid Codes

Test NameLIS Test




Phenytoin PHYT SER PLAS

CSF Protein PROT CSF

Rheumatoid Factor RF SER PLAS

Salicylate SALI SER PLAS

Total Bilirubin TBILTBIL1TBIL2TBIL3

SER PLAS

Cannabinoids THC URI

Theophylline THEO SER PLAS

Total Iron Binding Capacity

TIBC SER

Tobramycin TOBRATOBRAPTOBRATTOBRAR

SER PLAS

Total Protein TPTP1TP2TP3

SER PLAS

Transferrin TRFRNTRFRN1TRFRN2TRFRN3

SER PLAS

Triglycerides TRIGTRIG1TRIG2TRIG3

SER PLAS

Turbidity (MicroSensor) TUR SER PLAS CSF

UR/Creatinine Ratio UCR SER PLAS

UDA01 UDA01 SER PLAS AMNIO CSF URI BLD











Fluid Codes

Test NameLIS Test




** See the Instructions for Use for each assay

For all assays, availability is subject to regulatory requirements.

3.2.2 VITROS® Immunoassay Tests










Urine Protein UPRO URI

Urea Nitrogen UREA SER PLAS URI

Urea Nitrogen UREA1UREA2UREA3

SER PLAS

Uric Acid URIC SER PLAS URI

Uric Acid URIC1URIC2URIC3

SER PLAS

Valproic Acid VALP SER PLAS

Vancomycin VANCVANCRVANCPVANCT

SER PLAS

Very Low Density Lipoprotein

VLDL SER PLAS

Fluid Codes

Test Name LIS Code Serum PlasmaAmniotic

Fluid Urine Blood

Alpha-fetoprotein AFPAFP1

SER PLAS AMNIO

Anti-HBc AHBC SER PLAS

Anti-HBe AHBE SER

Fluid Codes

Test NameLIS Test




Anti-HBs (U.S.) AHBSQ SER

Anti-HBs (International) AHBS SER PLAS

Anti-HCV AHCV SER PLAS

Anti-HIV 1+2 AHIV SER PLAS

Vitamin B12 B12 SER PLAS

Total B-hCG BHCGBHCG1BHCG2BHCG3BHCG4BHCG5BHCG6BHCG7

SER PLAS

CA 125 II CA125CA125-1

SER PLAS

CA 15-3 CA153CA153-1

SER PLAS

CA 19-9 CA199CA199-1

SER PLAS

Carcinoembryonic Antigen CEACEA1

SER PLAS

Creatinine Kinase MB(ng/mL (ug/L))

CKMBECI SER PLAS

CMV IgG CMVG SER PLAS

CMV IgM CMVM SER PLAS

Cortisol CORT SER PLAS URI

Cortisol CORT1CORT2CORT3CORT4CORT5CORT6CORT7CORT8CORT9

CORT10CORT11CORT12

SER PLAS

C-peptide* C-pep SER PLAS

Estradiol E2E2-1E2-2E2-3E2-4E2-5

SER PLAS

Free B-hCG FBHCG SER

Fluid Codes


Fluid Urine Blood


Ferritin FERRFERR1FERR2FERR3FERR4FERR5

SER PLAS

Folate FOLAT SER PLAS BLD

Free PSA FPSA SER PLAS

% free PSA %FPSA SER PLAS

Follicle Stimulating Hormone FSHFSH1FSH2FSH3FSH4FSH5FSH6FSH7FSH8FSH9

FSH10FSH11FSH12

SER PLAS

Free T3 FT3 SER PLAS

Free T3 Index FT31 SER PLAS

Free T3 II FT3II SER PLAS

Free T4 FT4 SER

Free T4 Index FT4I SER PLAS

Anti-HAV IgM HAVM SER PLAS

Anti-HAV Total HAVT SER PLAS

Anti-HBc IgM HBCM SER PLAS

HBsAg Confirmatory HBCON SER PLAS

HBeAg HBE SER

HBsAg HBSAG SER PLAS

HIV Combo HIV c SER PLAS

IGFBP-7 IGFBP SER PLAS

Insulin INS SER PLAS

Intact PTH IPTH SER PLAS

LH/FSH Ratio LF SER PLAS

Fluid Codes


Fluid Urine Blood


Luteinizing Hormone LHLH1LH2LH3LH4LH5LH6LH7LH8LH9

LH10LH11LH12

SER PLAS

Myoglobin MYOGMYOG1MYOG2MYOG3MYOG4MYOG5

SER PLAS

AKIRisk NCHEK SER PLAS

NT-proBNP NTPBNP SER PLAS

N-Telopeptide NTX URI

Progesterone PROGPROG1PROG2PROG3PROG4PROG5

SER PLAS

Prolactin PROLPROL1PROL2PROL3PROL4PROL5PROL6PROL7PROL8PROL9

PROL10PROL11PROL12

SER PLAS

Prostate Specific Antigen PSA SER PLAS

Rubella IgG RUBG SER PLAS

Rubella IgM RUBM SER PLAS

Syphilis SYPH SER PLAS

TT3/TT4 Ratio T3T4 SER PLAS

T3 Uptake T3U SER PLAS

Fluid Codes


Fluid Urine Blood


*Product in development.For all assays, availability is subject to regulatory requirements.

Testosterone TESTOTESTO1TESTO2TESTO3TESTO4TESTO5

SER PLAS

TIMP-2 TIMP2 SER PLAS

Toxoplasma IgG TOXG SER PLAS

Toxoplasma IgM TOXM SER PLAS

Total PSA II TPSA SER PLAS

Troponin I TROP

TROP1

SER PLAS

Thyroid Stimulating Hormone TSHTSH1TSH2TSH3TSH4TSH5TSH6TSH7TSH8TSH9TSH10TSH11TSH12

SER PLAS

Thyroid Stimulating Hormone 30 TSH30 SER PLAS

Total T3 TT3 SER PLAS

Total T4 TT4 SER PLAS

25-OH Vitamin D Total TVITD SER

Fluid Codes


Fluid Urine Blood


Multiple LIS Codes

The above tables define additional test names for an assay, for example: GLU, GLU1, GLU2. These tests may be used to order the same test using different test names, for example, multiple samples for glucose tolerance test, multiple samples for peak and trough specimens.

Test Order RecordsThese test codes are included in the test order record and are mandatory and must be processed as per Data Innovations ASTM and HL7 interface specifications to order tests.

For ASTM:• Field 0.12 (Test Order Record/Specimen Action Code) should contain “A”

For HL7 2.2 and 2.4:

• Field ORC.1 (Common Order Segment/Order Control) should contain “XE”• Field OBR.11 (Observation Request Segment/Specimen Action) should contain “A”

Note:Any other value processed in this field is not supported by the enGen™ Laboratory Automation System.

Important: If additional tests are requested for the same sample (add-on tests), only the additional tests should be sent in the message and the appropriate action code (append) must be provided by the LIS as per Data Innovations ASTM or HL7 interface specifications. Tests should not be resent as appended with a new order.

Example 1: ASTM Order Transmission

H|\^&||||||||||P|1|<cr>P|1|1234567890||123-45-6789|LAST^FIRST^M||19011215|F|||||789^DrLast^DrFirst^M|||||||||PF2||F|Fac^Ward^Room^Bed^NS1<cr>O|1|123123123||^^^GLU^\^^^UREA^|R||200612140804||||A||||SER|||||||||<cr>L|1|N<cr>

Example 2: HL7 Order Transmission

MSH|^~\&||||||||||||||<cr>

PID|1||||LAST^FIRST^M||19011215|F||||||||||998877<cr>

ORC|XE|123123123|||||||||1000<cr>

OBR|1|123123123||GLU|||20061114102100|20061114103100|||A||||SER||||^^^^^^P||<cr>

OBR|2|123123123||UREA|||20061114102100|20061114103100||A|||||SER||||^^^^^^P||<cr>

<fs>

Result Records

The same test codes are included in the result record and will also be processed as per Data Innovations ASTM or HL7 interface specifications with every result sent by any VITROS® System connected to Instrument Manager™.

• ASTM: R (Result Record), field 3.4• HL7 V2.2 and V2.4: OBX (Observation Request Segment), field 3

3.3 VITROS® Result Code and Flag DefinitionsThese result codes are included in the result record and will be processed as per Data Innovations ASTM or HL7 interface specifications with every result sent (if applicable) by any VITROS® System connected to Instrument Manager™.• ASTM: R (Result Record), field 7.1• HL7 V2.2: OBX (Observation Request Segment), field 7• HL7 V2.4: OBX (Observation Request Segment), field 8


The following result codes may be associated with a test result when the test results are sent to the LIS from Instrument Manager™.

Result Flags/Code Description

AF Air Filter

AR Adjusted Result

AT Additional Test Result

BP Blank Prediction

CB Cuvette Blank

CC Configuration Conflict

CE Calibration Expired

DD Drop Detector Disabled

DE Drop Error

DL Sample Diluted

DP Substrate Depleted

EA Expired Aliquot

EC Expired Calibrator

ED Edited Result

EM Expired Maintenance

EP Edited Patient Data

ER Math Error

FC Flagged Component

FR Flagged Replicate

HB High Blank

HC High Concentration

HN High Noise

IC Invalid Component

ID Invalid Dilution

II Insufficient Inventory

IR Invalid Reading/Result

IS Insufficient Sample

IT Incubator Temperature

KE Kinetic Error

LS Lot Switch

LT Luminometer Temperature

M1 Category 1 modified values

M2 Category 2 modified values


ME Mechanical Error

MN Mean

MW Multiple Windows

NC Not Calibrated

ND No Drop

NF No Fluid

NI No Inventory

NQ No Quality Control

NR No Result

NS No Slide

NT No Tip

NW No Well

OC Dilution (Operator request Concentration)

OD Operator Requested Dilution

OR Outside Reportable Range

OS Outside Spline

PD Pressure Disabled

PF Prediction Failure

PI Potential Interferent

RC Reference Consistency

RD Reflex Diluted

RE Reagent Expired

RP Reflex Processed

RR Recalculated Result

RS Reduced Standard Dilution

SC Spread Check (currently not sent)

SD Standard Dilution

SE Sample Exited/Expired

SP Multiple Spikes

SR Outside Supplementary Range

ST Slide Time Out

TD Test Deleted

TR Trim Error

UC User Calibration

UD Unconfigured Diluent

VS Viscous Sample



WD Wetness Disabled

WE Wash Error

WT Well Temperature

ZS Negative Derived Test Result

efd0 No Error

efd1 Above derived test hospital range

efd2 Below derived test hospital range

efd3 Edited derived test result

efd4 Bad derived test component

efd5 No derived test result

efd7 Outside derived test supplement range

efd8 Pre-treated Multiple Sample Derived Test (MSDT)

efdA Above 2 SD from mean

efdB Above 3 SD from mean

efdC Not supported in QC database

efdD Below QC range

efdE Above QC range

efm0 No Error

efm1 Above laboratory’s range

efm2 Below laboratory’s range

efm3 Outside dynamic range

efm4 Above analyzer’s range (the value reported is the maximum limit of the range)

efm5 Below analyzer’s range (the value reported is the minimum limit of the range)

efm6 Prediction failure (reported as No Result)

efm7 Outside Supplementary Range

efmA Control result is more than 2 SDI from baseline interval mean but no more than 3 SDI

efmB Result is more than 3 SDI from baseline interval mean

efmC No baseline interval mean and SDI; or assay is not supported in QC database

efmD Control result below QC range #

efmE Control result above QC range #

efmF Greater than Dynamic Range

efmG Less than Dynamic Range

efmH Greater than Supplementary Range

efmI Less than Supplementary Range

wf0 No warning

wf1 Analyzer-generated warning



*When one of these flags is associated with a result, a comment that contains the interpreted text may be sent to the LIS with that result, depending on the option selected.

wf2 Operator-induced warning

wf3 Both analyzer and operator warning

ef0 No Error

ef1 Above Reference Range

ef2 Below Reference Range

ef4 Above Reportable Range

ef5 Below dynamic range (the value reported is the minimum limit of the range)

ef6 Prediction failure (with value reported as NO RESULT)

ef7 Above Supplementary Range

ef8 Below Supplementary Range

efA The value of the QC Result is at least 2, but less than 3 Baseline Standard Deviations below the Base Mean(-2SD)

efB The value of the QC Result is at least 2, but less than 3 Baseline Standard Deviations above the Baseline Mean (+2SD)

efC The value of the QC Result is at least 3 Baseline Standard Deviations below the Baseline Mean (-3SD)

efD The value of the QC Result is at least 3 Baseline Standard Deviations above the Baseline Mean (+3SD)

efE The values of two consecutive QC Results are both greater than two Standard Deviations above or below the baseline mean (22s)

efF The values of two consecutive QC Results have a change of at least 4 Standard Deviations (R4s)

efG The values of four consecutive QC Results are all greater than one standard deviation above or below the Baseline Mean (41s)

efH The values of ten consecutive QC results are all above or all below the Baseline Mean (10x)

efJ The Result of this Sample Integrity Test exceeds the threshold for this assay

efQ Range limit 1*

efR Range limit 2*

efS Range limit 3*

efT Range limit 4*

efU Range limit 5*



The following hemolysis, icterus, and turbidity flags may be associated with the test results, and sent with the result to the LIS from Instrument Manager™.

Note: For all assays, availability is subject to regulatory requirements.

Result Flags DescriptionHecES Hemolysis - Examine sampleHecME Hemolysis - Mechanical ErrorHecNA Hemolysis - SI Globally not availableHecNR Hemolysis - Not RunHecpi Hemolysis - Potential InterferentHef4 Hemolysis - Above Reportable RangeHef5 Hemolysis - Below Reportable RangeHef6 Hemolysis - Prediction Failure (with value reported as NO RESULT)HefJ Hemolysis - The result of this Sample Integrity Test exceeds the threshold for this assayHefU Hemolysis - H-Index flag on initial undiluted sampleIecES Icterus - Examine sampleIecME Icterus - Mechanical ErrorIecNA Icterus - SI Globally not availableIecNR Icterus - Not RunIecpi Icterus - Potential InterferentIef4 Icterus - Above Reportable RangeIef5 Icterus - Below Reportable RangeIef6 Icterus - Prediction Failure (with value reported as NO RESULT)IefJ Icterus - The result of this Sample Integrity Test exceeds the threshold for this assayIefU Icterus - I-Index flag on initial undiluted sampleTecES Turbidity - Examine sampleTecME Turbidity - Mechanical ErrorTecNA Turbidity - SI Globally not availableTecNR Turbidity - Not RunTecpi Turbidity - Potential InterferentTef4 Turbidity - Above Reportable RangeTef5 Turbidity - Below Reportable RangeTef6 Turbidity - Prediction Failure (with value reported as NO RESULT)TefJ Turbidity - The result of this Sample Integrity Test exceeds the threshold for this assayTefU Turbidity - T-Index Flag on initial undiluted sample


3.4 VITROS® Result ValuesResult values will be processed in the result record as per Data Innovations ASTM or HL7 interface specifications:• ASTM: R (Result Record), field 4.1• HL7 V2.2: OBX (Observation Result Segment), field 4• HL7 V2.4: OBX (Observation Result Segment), field 5

Warnings

• When a numeric result is received form a VITROS® System and begins with a decimal point, the enGen™ Laboratory Automation System will add a leading zero, for example, when “.3” is received, the enGen™ Laboratory Automation System will display and send “0.3” to the LIS.

• When the result “No Result” is received from a VITROS® System, the enGen™ Laboratory Automation System will change the result to “NO RESULT”.

• Some values are not always numeric, e.g., “No Result”. The LIS should not perform calculations when a non-numeric result is reported.

• The user has the option in Instrument Manager™ to insert the “<“ and “>” symbols when results are out of range. Should this option be selected, the LIS must decode these symbols in order to properly interpret the results. The LIS should not perform calculations when the “<“ or “>” symbols reported with a result, or if a result is accompanied by an “ef4” or “ef5” flag.

3.5 VITROS® Result UnitsVITROS® Systems can express results in different reporting units. The possible units are defined in the publications referenced in Section 1.2.

These units will be processed as per Data Innovations HL7 interface specifications with every numeric result sent by any VITROS® System connected to Instrument Manager™.

• HL7 V2.2: OBX (Observation Result Segment), field 5• HL7 V2.4: OBX (Observation Result Segment), field 6Non-exhaustive list of units currently available on the system:

• %• %Uptake• g/dL• g/L• IU/L• IU/mL• IU/mL• kIU/L• kU/L• meq/L• meq/L• mg/dL• mg/dL(A)• mg/L• mIU/L• mmol/L• mosm/kg• ng/mL• nkat/L• nmol/L• U/L• ug/dL• ug/L• ug/mL• ukat/L• umol/L

Warning

It is critical that the units defined in the LIS match the ones selected by the customer in the VITROS® Systems.


3.5.1 Result Transmission Examples

Example 3: ASTM result transmission

H|\^&|||DI||||||v8.00.0004|P|1|20061128030116

P|1|1234567890||123-45-6789|LAST^FIRST^M||19011215|F|||||789^DrLast^DrFirst^M|||||||||PF2||F|Fac^Ward^Room^Bed^NS1

O|1|123123123||^^^GLU^1.0\^^^CA^1.0\^^^HEM^1.0\^^ÎCT^1.0\^^^TUR^1.0|R||||||A||||SER|||||||||FS1

R|1|^^^GLU|111|||ef1||V|||||FS1

R|2|^^^CA|10.0|||ef0||V|||||FS1

R|3|^^^HEM|<15|||ef5||V|||||FS1

R|4|^^ÎCT|<2|||ef5||V|||||FS1

R|5|^^^TUR|<20|||ef5||V|||||FS1

L|1|N

Example 4: HL7 result transmission

MSH|^~\&|IM||||20061213075844||ORU^R01|5043483|P|2.2|||AL|NE

PID|1||1234567890||LAST,FIRST||19431111|M|||^^^^^||||||||

ORC|RE|123123123|||||^^^^^R|||||

OBR|1|123123123|||R||20061213040000||^||||||SER^^^|||FS1|^^^^^^P|36^1^|||||||^^^^^R|||||||||||||||||

OBX|1|NM|GLU|86|mg/dL||ef0|||V|||20061213061258||||FS1|20061213061258

OBX|2|NM|CL|94|mmol/L||ef0|||V|||20061213060931||||FS1|20061213060931

OBX|3|NM|K|5.8|mmol/L||ef0|||V|||20061213060950||||FS1|20061213060950

OBX|4|NM|NA|141|mmol/L||ef0|||V|||20061213060941||||FS1|20061213060941

OBX|5|NM|ECO2|26|mmol/L||ef0|||V|||20061213061239||||FS1|20061213061239

OBX|6|NM|PHOS|9.4|mg/dL||ef0|||V|||20061213061308||||FS1|20061213061308

OBX|7|NM|CA|8.8|mg/dL||ef0|||V|||20061213061327||||FS1|20061213061327

OBX|8|NM|MG|2.6|mg/dL||ef0|||V|||20061213061336||||FS1|20061213061336

OBX|9|NM|AGP|21|mmol/L||ef0|||V|||20061213061239||||FS1|20061213061239

OBX|10|NM|HEM|15|||ef5|||V|||20061213060815||||FS1|20061213060815

OBX|11|NM|ICT|2|||ef5|||V|||20061213060815||||FS1|20061213060815

OBX|12|NM|TUR|20|||ef5|||V|||20061213060815||||FS1|20061213060815

Example 5: ASTM Result transmission with sample integrity flag (HefJ)

R|1|^^ÎBIL|0.9|||HefJ\ef0||V|||||FS1

Example 6: ASTM Result transmission with sample integrity flag (HefJ) and Flagged Component (FC)

R|1|^^^DBIL|0.8|||HefJ\FC\ef0||V|||||FS1


Example 7: ASTM Result transmission of a result record that contains a NO RESULT

R|1|^^^GLU|NO RESULT|||HecNR\IecNR\TecNR\ME\OD\ef6||V|||||FS2

Note:The LIS should not perform numeric calculations on results that are not numeric (e.g. NO RESULT)

Example 8: ASTM Result transmission for microsensor data only (VITROS® 5,1 FS Chemistry System)

H|\^&|||DI||||||v8.00.0004|P|1|20061128011507

P|1|1234567890|||LAST^FIRST|||U|||||||||||||||||

O|1|123123123|Â#^1|^^^HEM^1.0\^^ÎCT^1.0\^^^TUR^1.0|R||||||||||SER|||||||||FS2

R|1|^^^HEM|33|||ef0||V|||||FS2

R|2|^^ÎCT|<2|||ef5||V|||||FS2

R|3|^^^TUR|<20|||ef5||V|||||FS2

L|1|N

Note: If the VITROS® 5,1 FS Chemistry System has processed a sample multiple times, it is possible microsensor data may be sent multiple times.


3.5.2 Impact of Intermediate Result Handling Selection in Result Transmission

This section only displays ASTM examples, however the same principle will be applicable for HL7 transmission.

Example 9: When "Send All" option is selected

First GLU result, > 625 (neat)

R|1|^^^GLU|625|||HefJ\ef4||V|||||FS2

Note: The “HefJ” flag indicates a potential interference with the result because the sample is hemolized.

Second GLU result, > 1250 (1st dilution)

R|1|^^^GLU|1250|||HefU\ef4||V|||||FS2

Note: The “HefU” flag indicates a potential interference with the result because the sample was found hemolized when undiluted.

Third GLU result, 1500 (2nd dilution)

R|1|^^^GLU|1500|||HefU\ef0||V|||||FS2

Note: The ” HefU” flag indicates a potential interference with the result because the sample was found hemolized when undiluted.

Example 10: When "Send Final" option is selected

R|1|^^^GLU|1500|||HefU\ef0||V|||||FS2

Note:

• In this mode, only the final result is sent, the intermediate results are suppressed and not sent to the LIS.• The “HefU” flag indicates a potential interference with the result because the sample was found hemolized

when undiluted.• When intermediate results are suppressed, the “HefU” flag is the only way for the LIS to know that a potential

interference was detected when the sample was tested undiluted.

3.5.3 Impact of Result Prefix Selection in Result Transmission

This section only presents ASTM examples, however these examples are also applicable for HL7 transmission. This option relates to results that are either above or below the reportable range of the Instrument.

Example 11: When "Insert < > prefixes" is selected, result above reportable range

R|1|^^^CRP|>9.0|||OR\ef4||V|||||FS2

Example 12: When "Insert < > prefixes" is selected, result below reportable range

R|1|^^^LI|<0.2|||OR\ef5||V|||||FS2

Example 13: When "No prefix" is selected, result above reportable range

R|1|^^^CRP|9.0|||OR\ef4||V|||||FS2

Note: The LIS must take into account that the presence of ef4 that indicates the result is above the reportable range.


Example 14: When "No prefix" is selected, result below reportable range

R|1|^^^LI|0.2|||OR\ef5||V|||||FS2

Note: The LIS must take into account that the presence of ef5 that indicates the result is below the reportable range.

3.5.4 Impact of Comment Selection in Result Transmission

This section only displays ASTM examples, however these examples are also applicable for HL7 transmission.

Example 15: When “Interpret” is selected, ECi result

R|1|^^^AHCV|0.2|||efQ||V|||||EC1

C|1|Negative

Example 16: When "Interpret" is selected, DAT result

R|1|^^^BARB|2.2|||efR||V|||||FS2

C|1|Reactive

Example 17: When "Interpret" is selected, DAT result above reportable range

R|1|^^^BARB||||OR\efR||V|||||FS2

C|1|Reactive

Note: When a DAT test result is above or below the analyzer's reportable range, the code OR is sent, as well as the “efR” flag. In that case, the result field is empty.

Example 18: When "No Comment" is selected

R|1|^^^AHCV|0.2|||efQ||V|||||EC1

Note: The LIS must translate the “efQ” flag into the correct interpretation.

Example 19: When "No Comment" is selected, DAT result

R|1|^^^BARB|2.2|||efR||V|||||FS2

Note:The LIS must translate the “efR” flag into the correct interpretation.

Example 20: When "No Comment" is selected, DAT result above reportable range

R|1|^^^BARB||||OR\efR||V|||||FS2

Note:• The LIS must translate the “efR” flag into the correct interpretation.• When a DAT test result is above or below the analyzer's reportable range, the code OR is sent, as well as the

“efR” flag. In that case, the result field is empty


3.6 Result Instrument IDInstrument Manager™ returns to the LIS with every test result, an instrument identification associated with the test performed. This instrument identification follows each individual specific result in the same record.

Instrument Manager™ specifies that the “Test Instrument ID” field contains the specific instrument on which the test was performed. The record where the results are located depends on the LIS specific interface. For example, if the test was performed in the HL7 interface, the Instrument ID is located in the OBX record and if the test was performed in the ASTM interface the Instrument ID is located in the R record. Refer to Section 3.5.1 for further examples.

Note: The HL7 driver will also send the Instrument ID in the OBR segment. It is not recommended to collect the Instrument ID from that segment since a specimen might be associated with results obtained from different instruments. LIS should collect the Instrument ID from the OBX segment as indicated above.

3.7 Result Date/TimeResult date/time is provided as per Data Innovations HL7 interface specifications with every result sent by any VITROS® System connected to Instrument Manager™:

• ASTM: R (Result Record), field 13• HL7 V2.2: OBX (Observation Result Segment), field 13• HL7 V2.4: OBX (Observation Result Segment), field 14

3.8 CommentsComments attached to a test result will be processed per Data Innovations ASTM and HL7 specifications.

• ASTM: C (Comment Record), field 4• HL7 V2.2 and V2.4: NTE (Note and Comments Segment), field 3


3.9 Instrument IDsInstrument IDs are provided as per Data Innovations ASTM or HL7 interface specifications with every result sent by any VITROS® System connected to Instrument Manager™:

• ASTM: R (Result Record), field 14• HL7 V2.2: OBX (Observation Result Segment), field 17• HL7 V2.4: OBX (Observation Result Segment), field 18

The default connection names are as follows, the names can be changed upon customer request:

VITROS® 5,1 FS Chemistry Systemn (on-track and off-track)• FS1• FS2• FS3• FS4• FS5• FS6• FS7VITROS® ECi/ECiQ Immunodiagnostic System (off-track)• EC1• EC2• EC3• EC4VITROS® 250/350 Chemistry System (off-track)• 251• 252VITROS® 3600 Immunodiagnostic System (on-track and off-track)• 361• 362• 363• 364• 365• 366• 367VITROS® 4600 Chemistry System (on-track)• 461• 462• 463• 464• 465VITROS® 5600 Integrated System (on-track and off-track)• 561• 562• 563• 564• 565• 566• 567


3.10 Operator IDs

Operator IDs are provided as per Data Innovations HL7 interface specifications with every result sent by any VITROS® System connected to Instrument Manager™:

• ASTM: R (Result Record), field 11.4• HL7 V2.2: OBX (Observation Result Segment), field 15• HL7 V2.4: OBX (Observation Result Segment), field 16

3.11 Laboratory Status Message

This message is sent to the LIS when the sample is put in any entry module of the track. The format of the message will depend on the configuration of Instrument Manager™.

Note: This is only available with the enGen™ Laboratory Automation System.

3.11.1 Using ASTM

The enGen™ Laboratory Automation System will send 1 or 2 messages. If the ASTM Robotics driver is used, the following message is sent to the LIS:

<stx>1H|\^&|||||||||v8.00.0004|P|1|20080502102115<cr>P|1|||||||<cr>O|1|2011|||R|||||||||20080502102115|||||||||| TCA IN<cr>C|1|I| TCA IN|I<cr>L|1|N<cr><etx>BD<cr>

<lf>

In addition, the enGen™ Laboratory Automation System will send the following result message regardless of the ASTM driver used. It contains the test code “ARRIV” and the result “1”.

<stx>1H|\^&|||||||||v8.00.0004|P|1|20080502101451<cr>

P|1|||||||<cr>

O|1|2011|^^|^^^ARRIV|R|||||||||20080502101421|SER||||||||| TCA IN<cr>

R|1|^^^ARRIV|1|||||F||||| TCA IN<cr>

L|1|N<cr>

<etx>EF<cr>

<lf>

In these examples, “2011” is the ID of the sample processed on the track. “TCA IN” is the name of the connection used in Instrument Manager™ to connect the track.


3.11.2 Using HL7 2.2

By default the enGen™ Laboratory Automation System will send 2 messages. The first message is the actual laboratory status message, as defined in the HL7 2.2 specifications:

<vt>MSH|^~\&|IM||||20080501165832||ORM^O01|18|P|2.2|||AL|NE<cr>

ORC|RE|101|||||^^^^^|||||<cr>

<fs><cr>

The second message is a result message that contains the test code “ARRIV”and the result “1”.

<vt>MSH|^~\&|IM||||20080501165559||ORU^R01|10|P|2.2|||AL|NE<cr>

ORC|RE|101|||||^^^^^R|||||Last^First^M<cr>

OBR|1|101|||R||20071225141503||^||||||SER^^^|Last^First^M|| TCA IN|^^^^^^P|^^|||||||^^^^^R|||||||||||||||||<cr>

OBX|1|NM|ARRIV|1||||||||||||| TCA IN<cr>

<fs><cr>


Note: It is possible multiple messages are sent to the LIS.

3.11.3 Using HL7 2.4

By default the enGen™ Laboratory Automation System will send 2 messages. The first message is the actual laboratory status message, as defined in the HL7 2.4 specifications:

<vt>MSH|^~\&|IM||||20080501170306||SSU^U03|27|P|2.4|||AL|NE<cr>

EQU| TCA IN|20080501170306<cr>

SAC|||1051||||20080501170306|I<cr>

<fs><cr>

The second message is a result message that contains the test code “ARRIV” and the result “1”.


ORC|RE|1051|||||^^^^^R|||||ID^Last^First^<cr>

OBR|1|1051|||R||20080501173735||^|^^^^^^|||||SER^^^^^^P|ID^Last^First^|| TCA IN||^^|||||||^^^^^R|||||||||||||||||<cr>

OBX|1|NM|ARRIV||1||||||||||||| TCA IN<cr>

<fs><cr>


Note: It is possible multiple messages are sent to the LIS.


3.12 Laboratory Storage Message

This message is sent to the LIS when the sample is sent to an exit module on the track. The format of the message will depend on the configuration of Instrument Manager™.

Note: This is only available with the enGen™ Laboratory Automation System.

3.12.1 Using ASTM

The enGen™ Laboratory Automation System will send 1 or 2 messages. If the ASTM Robotics driver is used, the following message is sent to the LIS:

<stx>1H|\^&|||||||||v8.00.0004|P|1|20080502103519<cr>

M|1|EQU|^ TCA IN^RD|20080502|OP|L|N<cr>

M|2|SAC|||2011||||20080502103518|R|Carrier|12345|A^1<cr>

L|1|N<cr>

<etx>FE<cr><lf>

In addition, the enGen™ Laboratory Automation System will send the following result message regardless of the ASTM driver used. It contains 2 results:

• “SRACK” is the ID of the rack• “SPOS” is the position of the sample on the rack

<stx>2H|\^&|||||||||v8.00.0004|P|1|20080502103523<cr>

P|1|||||||<cr>

O|1|2011|^^|^^^SRACK\^^^SPOS|R|||||||||20080502101421|SER||||||||| TCA IN<cr>

R|1|^^^SRACK|12345|||||F||||| TCA IN<cr>

R|2|^^^SPOS|1|||||F||||| TCA IN<cr>

L|1|N<cr>

<etx>FF<cr><lf>

In these examples:

• “2011” is the ID of the sample routed to the exit module• “Carrier” is the type of exit rack used• “12345” is the ID of the rack• “1” is the position of the rack


3.12.2 Using HL7 2.2

By default, the enGen™ Laboratory Automation System will send 1 message:



OBR|1|1056|||R||20080501175709||^|^^^^^^|||||SER^^^|ID^Last^First^|| TCA IN|^^^^^^P|^^|||||||^^^^^R|||||||||||||||||<cr>

OBX|1|TX|SRACK|12345||||||||||||| TCA IN<cr>

OBX|2|NM|SPOS|5||||||||||||| TCA IN<cr>

<fs><cr>

In this example:


3.12.3 Using HL7 2.4

The first message is the actual laboratory storage message, as defined in the HL7 2.4 specifications:

<vt>MSH|^~\&|IM||||20080501174507||SSU^U03|79|P|2.4|||AL|NE<cr>

EQU| TCA IN|20080501174507<cr>

SAC|||1052||||20080501174507|R|Carrier|M70RCD1R1|1^A<cr>

<fs><cr>

The second message is a result message that contains 2 results:

• “SRACK” is the ID of the rack• “SPOS” is the position of the sample on the rack



OBR|1|1052|||R||20080501174309||^|^^^^^^|||||SER^^^^^^P|ID^Last^First^|| TCA IN||^^|||||||^^^^^R|||||||||||||||||<cr>

OBX|1|TX|SRACK||12345||||||||||||| TCA IN<cr>

OBX|2|NM|SPOS||1||||||||||||| TCA IN<cr>

<fs><cr>

In these examples:



3.13 Aliquoting

3.13.1 Aliquot Requests

Aliquots are created by the enGen™ Laboratory Automation System based on test requests sent by the LIS. The enGen™ Laboratory Automation System expects the LIS to send one or multiple test requests associated with the primary ID of the sample.

Supported test codes are “AT01” - “AT999”.

• Aliquot test codes from “AT01” to “AT949” are assigned to fluid codes SER and PLAS• Aliquot test codes from “AT950” to “AT999” are assigned to fluid codes URI

The enGen™ Laboratory Automation System will determine how many aliquots and their respective volumes based on a table setup in the enGen™ Laboratory Automation System software.

3.13.2 Example of Transmission using HL7 2.2

MSH|^~\&|Sending Application|Sending Facility|Receiving Application|Receiving Facility|20120206161717||ORM^001|358773|P|2.2<cr>

PID|7||12345678||TEST^^|||M<cr>

PV1|1<cr>

ORC|XE<cr>

OBR|1|1202060888||ALT|R||||||||||SER||||||||||XE<cr>

OBR|2|1202060888||AST|R||||||||||SER||||||||||XE<cr>

OBR|3|1202060888||ALKP|R||||||||||SER||||||||||XE<cr>

OBR|4|1202060888||GGT|R||||||||||SER||||||||||XE<cr>

OBR|5|1202060888||AT05|R||||||||||SER||||||||||XE<cr><fs>


3.14 Standard Test Codes for Sorting

The system will route the samples to the following destination based on the test code sent by the LIS.

Note: Applies to enGen™ Laboratory Automation System only.

LIS Code Centrifuge Decapper First Exit

XA1 No No <Dr01R1>

CXA1 Yes No <Dr01R1>

DXA1 No Yes <Dr01R1>

CDXA1 Yes Yes <Dr01R1>

XA2 No No <Dr01R2>




XA3 No No <Dr01R3>




XA4 No No <Dr01R4>




XB1 No No <Dr02R1>

CXB1 Yes No <Dr02R1>

DXB1 No Yes <Dr02R1>

CDXB1 Yes Yes <Dr02R1>

XB2 No No <Dr02R2>




XB3 No No <Dr02R3>




XB4 No No <Dr02R4>




XC1 No No <Dr03R1>

CXC1 Yes No <Dr03R1>

DXC1 No Yes <Dr03R1>

CDXC1 Yes Yes <Dr03R1>


XC2 No No <Dr03R2>




XC3 No No <Dr03R3>




XC4 No No <Dr03R4>




XD1 No No <Dr04R1>

CXD1 Yes No <Dr04R1>

DXD1 No Yes <Dr04R1>

CDXD1 Yes Yes <Dr04R1>

XD2 No No <Dr04R2>




XD3 No No <Dr04R3>




XD4 No No <Dr04R4>




XE1 No No <Dr05R1>

CXE1 Yes No <Dr05R1>

DXE1 No Yes <Dr05R1>

CDXE1 Yes Yes <Dr05R1>

XE2 No No <Dr05R2>




XE3 No No <Dr05R3>




XE4 No No <Dr05R4>






XF1 No No <Dr06R1>

CXF1 Yes No <Dr06R1>

DXF1 No Yes <Dr06R1>

CDXF1 Yes Yes <Dr06R1>

XF2 No No <Dr06R2>




XF3 No No <Dr06R3>




XF4 No No <Dr06R4>




XG1 No No <Dr07R1>

CXG1 Yes No <Dr07R1>

DXG1 No Yes <Dr07R1>

CDXG1 Yes Yes <Dr07R1>

XG2 No No <Dr07R2>




XG3 No No <Dr07R3>




XG4 No No <Dr07R4>




XH1 No No <Dr08R1>

CXH1 Yes No <Dr08R1>

DXH1 No Yes <Dr08R1>

CDXH1 Yes Yes <Dr08R1>

XH2 No No <Dr08R2>






XH3 No No <Dr08R3>




XH4 No No <Dr08R4>




XI1 No No <Dr09R1>

CXI1 Yes No <Dr09R1>

DXI1 No Yes <Dr09R1>

CDXI1 Yes Yes <Dr09R1>

XI2 No No <Dr09R2>




XI3 No No <Dr09R3>




XI4 No No <Dr09R4>




XJ1 No No <Dr10R1>

CXJ1 Yes No <Dr10R1>

DXJ1 No Yes <Dr10R1>

CDXJ1 Yes Yes <Dr10R1>

XJ2 No No <Dr10R2>




XJ3 No No <Dr10R3>




XJ4 No No <Dr10R4>






XK1 No No <Dr11R1>

CXK1 Yes No <Dr11R1>

DXK1 No Yes <Dr11R1>

CDXK1 Yes Yes <Dr11R1>

XK2 No No <Dr11R2>




XK3 No No <Dr11R3>




XK4 No No <Dr11R4>




XL1 No No <Dr12R1>

CXL1 Yes No <Dr12R1>

DXL1 No Yes <Dr12R1>

CDXL1 Yes Yes <Dr12R1>

XL2 No No <Dr12R2>




XL3 No No <Dr12R3>




XL4 No No <Dr12R4>




XM1 No No <Dr13R1>

CXM1 Yes No <Dr13R1>

DXM1 No Yes <Dr13R1>

CDXM1 Yes Yes <Dr13R1>

XM2 No No <Dr13R2>




XM3 No No <Dr13R3>






XM4 No No <Dr13R4>




XN1 No No <Dr14R1>

CXN1 Yes No <Dr14R1>

DXN1 No Yes <Dr14R1>

CDXN1 Yes Yes <Dr14R1>

XN2 No No <Dr14R2>




XN3 No No <Dr14R3>




XN4 No No <Dr14R4>




XO1 No No <Dr15R1>

CXO1 Yes No <Dr15R1>

DXO1 No Yes <Dr15R1>

CDXO1 Yes Yes <Dr15R1>

XO2 No No <Dr15R2>




XO3 No No <Dr15R3>




XO4 No No <Dr15R4>




XP1 No No <Dr16R1>

CXP1 Yes No <Dr16R1>



DXP1 No Yes <Dr16R1>

CDXP1 Yes Yes <Dr16R1>

XP2 No No <Dr16R2>




XP3 No No <Dr16R3>




XP4 No No <Dr16R4>




XQ1 No No <Dr17R1>

CXQ1 Yes No <Dr17R1>

DXQ1 No Yes <Dr17R1>

CDXQ1 Yes Yes <Dr17R1>

XQ2 No No <Dr17R2>




XQ3 No No <Dr17R3>




XQ4 No No <Dr17R4>




XR1 No No <Dr18R1>

CXR1 Yes No <Dr18R1>

DXR1 No Yes <Dr18R1>

CDXR1 Yes Yes <Dr18R1>

XR2 No No <Dr18R2>




XR3 No No <Dr18R3>






XR4 No No <Dr18R4>




XS1 No No <Dr19R1>

CXS1 Yes No <Dr19R1>

DXS1 No Yes <Dr19R1>

CDXS1 Yes Yes <Dr19R1>

XS2 No No <Dr19R2>




XS3 No No <Dr19R3>




XS4 No No <Dr19R4>




XT1 No No <Dr20R1>

CXT1 Yes No <Dr20R1>

DXT1 No Yes <Dr20R1>

CDXT1 Yes Yes <Dr20R1>

XT2 No No <Dr20R2>




XT3 No No <Dr20R3>




XT4 No No <Dr20R4>




XU1 No No <Dr21R1>

CXU1 Yes No <Dr21R1>

DXU1 No Yes <Dr21R1>

CDXU1 Yes Yes <Dr21R1>



XU2 No No <Dr21R2>




XU3 No No <Dr21R3>




XU4 No No <Dr21R4>




XV1 No No <Dr22R1>

CXV1 Yes No <Dr22R1>

DXV1 No Yes <Dr22R1>

CDXV1 Yes Yes <Dr22R1>

XV2 No No <Dr22R2>




XV3 No No <Dr22R3>




XV4 No No <Dr22R4>




XW1 No No <Dr23R1>

CXW1 Yes No <Dr23R1>

DXW1 No Yes <Dr23R1>

CDXW1 Yes Yes <Dr23R1>

XW2 No No <Dr23R2>




XW3 No No <Dr23R3>




XW4 No No <Dr23R4>






XX1 No No <Dr24R1>

CXX1 Yes No <Dr24R1>

DXX1 No Yes <Dr24R1>

CDXX1 Yes Yes <Dr24R1>

XX2 No No <Dr24R2>




XX3 No No <Dr24R3>




XX4 No No <Dr24R4>




X1 No No <SORT01>

CX1 Yes No <SORT01>

DX1 No Yes <SORT01>

CDX1 Yes Yes <SORT01>

X2 No No <SORT02>

CX2 Yes No <SORT02>

DX2 No Yes <SORT02>


X3 No No <SORT03>

CX3 Yes No <SORT03>

DX3 No Yes <SORT03>


X4 No No <SORT04>

CX4 Yes No <SORT04>

DX4 No Yes <SORT04>


X5 No No <SORT05>

CX5 Yes No <SORT05>

DX5 No Yes <SORT05>


X6 No No <SORT06>

CX6 Yes No <SORT06>



DX6 No Yes <SORT06>


X7 No No <SORT07>

CX7 Yes No <SORT07>

DX7 No Yes <SORT07>


X8 No No <SORT08>

CX8 Yes No <SORT08>

DX8 No Yes <SORT08>


X9 No No <SORT09>

CX9 Yes No <SORT09>

DX9 No Yes <SORT09>


X10 No No <SORT10>

CX10 Yes No <SORT10>

DX10 No Yes <SORT10>


X11 No No <SORT11>




X12 No No <SORT12>




X13 No No <SORT13>




X14 No No <SORT14>




X15 No No <SORT15>




X16 No No <SORT16>






X17 No No <SORT17>




X18 No No <SORT18>




X19 No No <SORT19>




X20 No No <SORT20>




X21 No No <SORT21>




X22 No No <SORT22>




X23 No No <SORT23>




X24 No No <SORT24>




X25 No No <SORT25>




X26 No No <SORT26>






X27 No No <SORT27>




X28 No No <SORT28>




X29 No No <SORT29>




X30 No No <SORT30>






4 Non-OCD Instrument

4.1 IntroductionThis section applies only when a non-OCD Instrument is connected to the enGen™ Laboratory Automation System.

NOTE: Ortho Clinical Diagnostics makes no claims regarding the ability to interface non-OCD analyzers nor to the performance of non-OCD analyzers that are interfaced to the enGen™ Laboratory Automation System.

4.2 Non-OCD Instrument Interface Options

4.2.1 Option 1: Non-OCD Instrument is NOT interfaced to OCD-IM but directly to the LIS

This is the preferred way of interfacing non-OCD instruments to the enGen™ Laboratory Automation System and implies that the non-OCD instrument is LAS interfaced to the enGen™ Laboratory Automation System (On-Track) but the instrument LIS interface is directly connected to the LIS. In this case, OCD will provide the supplementary document “LIS Instructions for non-OCD Instrument Routing connected to the enGen Track” which will be used as a reference for routing purposes. However, all test order and result messages must be handled between the LIS and the non-OCD Instrument according to the LIS specifications from the non-OCD Instrument vender.

4.2.2 Option 2: Non-OCD Instrument is interfaced to OCD-IM

In case a non-OCD instrument is connected to the enGen™ Laboratory Automation System and the instrument is LIS interfaced to the OCD-IM, the customer or the LIS vendor should contact OCD for additional instructions.


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Ortho-Clinical Diagnostics1500 Boulevard Sébastien BrantB.P. 3033567411 IllkirchCEDEX, France

Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, NY 14626USA

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