HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health.

HL7 Version 2.5.1 Implementation HL7 Version 2.5.1 Implementation Guide:Guide:

Electronic Laboratory Reporting to Public HealthElectronic Laboratory Reporting to Public Health

Austin KreislerAustin Kreisler

SAIC Technical FellowSAIC Technical FellowSAIC consultant - CDC/National Healthcare SAIC consultant - CDC/National Healthcare

Safety Network Safety Network HL7 Technical Steering Committee MemberHL7 Technical Steering Committee MemberCo-Chair, HL7 Domain Experts Steering Co-Chair, HL7 Domain Experts Steering

DivisionDivisionCo-chair, HL7 Orders and Observations Work Co-chair, HL7 Orders and Observations Work

GroupGroup

DisclaimerDisclaimer

The findings and conclusions in this presentation are those The findings and conclusions in this presentation are those of the author(s) and do not necessarily represent the views of the author(s) and do not necessarily represent the views of the Centers for Disease Control and Prevention/the of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease RegistryAgency for Toxic Substances and Disease Registry

AgendaAgenda

ELR History – Timeline of various ELR ELR History – Timeline of various ELR versionsversions

High points of the 2.5.1 ELR High points of the 2.5.1 ELR Implementation GuideImplementation Guide

Future of ELR Implementation GuideFuture of ELR Implementation Guide

How to get the ELR IGHow to get the ELR IG

Q&AQ&A

First There Was 2.3.Z ELRFirst There Was 2.3.Z ELR

There were a number of implementers There were a number of implementers who wanted to do ELRwho wanted to do ELR

There were lots of ways of doing ELRThere were lots of ways of doing ELR

Then there was 2.3.z ELRThen there was 2.3.z ELR

Which quickly turned into 2.3.1 ELRWhich quickly turned into 2.3.1 ELR

And then there were many versions of And then there were many versions of ELRELR

ELR History – Timeline Of ELR History – Timeline Of Various ELR VersionsVarious ELR Versions

2.3.z ELR - 19972.3.z ELR - 19972.3.1 ELR - 20032.3.1 ELR - 20032.3.1 ELR for Microbiology – 20032.3.1 ELR for Microbiology – 20032.4.z ELR for Bioterrorism - 20032.4.z ELR for Bioterrorism - 20032.3.1 ELR Update - 20052.3.1 ELR Update - 20052.5 ELR Draft - 2004/20062.5 ELR Draft - 2004/20062.5.1 ELR Draft – 20082.5.1 ELR Draft – 20082.5.1 ELR HL7 Balloting - 20092.5.1 ELR HL7 Balloting - 20092.5.1 ELR Published through HL7 – Feb 20102.5.1 ELR Published through HL7 – Feb 20102.5.1 ELR IG named in MU final rule – July 20102.5.1 ELR IG named in MU final rule – July 2010

The ELR 2.5.1 Project – Some The ELR 2.5.1 Project – Some BackgroundBackground

The document is drawn from the HL7/HITSP The document is drawn from the HL7/HITSP 2.5.1 Interoperable Lab Result to EHR 2.5.1 Interoperable Lab Result to EHR Implementation GuideImplementation Guide

Aligned with and extends the existing 2.3.1 ELR Aligned with and extends the existing 2.3.1 ELR Implementation GuidesImplementation Guides

Cross-fertilization with the PHLIP and LIMSi Cross-fertilization with the PHLIP and LIMSi projectsprojects

Developed in conjunction with the PHIN Developed in conjunction with the PHIN Communities of Practice and the CSTE National Communities of Practice and the CSTE National ELR GroupELR Group

2.5.1 ELR IG Content2.5.1 ELR IG ContentIntroductionIntroduction

Messaging InfrastructureMessaging Infrastructure

Message ProfileMessage Profile

MessagesMessages

Segment and Field DescriptionsSegment and Field Descriptions

Code Systems and Value SetsCode Systems and Value Sets

Example Laboratory Result MessagesExample Laboratory Result Messages

Appendix A. HL7 Reporting of Culture and SusceptibilitiesAppendix A. HL7 Reporting of Culture and Susceptibilities

Appendix B. Clinical Laboratory Improvements Amendment Appendix B. Clinical Laboratory Improvements Amendment Considerations US Realm OnlyConsiderations US Realm Only

Appendix C. Strategy For Harmonizing Multiple HL7 Appendix C. Strategy For Harmonizing Multiple HL7 Implementation GuidesImplementation Guides

Appendix D. Recommended Changes to ExistingAppendix D. Recommended Changes to Existing

Chapter: IntroductionChapter: Introduction

Specification for laboratory results Specification for laboratory results reporting to local, state, territorial and reporting to local, state, territorial and federal public health agenciesfederal public health agenciesAddresses messaging content and Addresses messaging content and dynamics related to the transmission of dynamics related to the transmission of Laboratory Reportable Result MessagesLaboratory Reportable Result MessagesEach state and territory has its own Each state and territory has its own requirements for laboratories to report requirements for laboratories to report certain findings to health officialscertain findings to health officials

Chapter: Introduction - PurposeChapter: Introduction - Purpose

Messages described in IG are not specific to any Messages described in IG are not specific to any reportable condition and is applicable for most biological reportable condition and is applicable for most biological and chemistry laboratory-reportable findingsand chemistry laboratory-reportable findings

Intended to meet the needs and requirements of Intended to meet the needs and requirements of implementation guidance in Public Health entities, implementation guidance in Public Health entities, replacing the previous documentation regarding replacing the previous documentation regarding Electronic Laboratory Reporting (ELR)Electronic Laboratory Reporting (ELR)

Does not replace the need for documentation of the Does not replace the need for documentation of the constraints for specific implementationsconstraints for specific implementations

Does not replace the need to access to the underlying Does not replace the need to access to the underlying HL7 2.x standardHL7 2.x standard

Chapter: Introduction - ScopeChapter: Introduction - ScopeIG covers the transmission of laboratory results to IG covers the transmission of laboratory results to appropriate local, state, territorial and federal public appropriate local, state, territorial and federal public health agencieshealth agencies

Focuses on key points of broad interoperabilityFocuses on key points of broad interoperability– Use of strong identifiers for key information objectsUse of strong identifiers for key information objects– Use of vocabulary standards Use of vocabulary standards

Does not cover environmental lab reporting or result Does not cover environmental lab reporting or result reporting to cancer registriesreporting to cancer registries

Does cover reporting of laboratory results for individual Does cover reporting of laboratory results for individual human and animal testing.human and animal testing.

Chapter: Messaging InfrastructureChapter: Messaging Infrastructure

Messaging FrameworkMessaging Framework– Includes message delimiters, null values, Includes message delimiters, null values,

lengths, and snapshot processinglengths, and snapshot processing

Use of Escape SequencesUse of Escape Sequences– Discusses the required use of escape Discusses the required use of escape

sequence processingsequence processing

Data TypesData Types– Provides a detailed description of the data Provides a detailed description of the data

types used in the specificationtypes used in the specification

Chapter: Message ProfileChapter: Message ProfileUse Case ModelUse Case Model– Describes the use case, actors, assumptions and business rules Describes the use case, actors, assumptions and business rules

associated with the use caseassociated with the use case

Dynamic Interaction ModelsDynamic Interaction Models– Documented using a UML activity diagramsDocumented using a UML activity diagrams

Dynamic DefinitionsDynamic Definitions– Documents details for three HL7 conformance profiles covered Documents details for three HL7 conformance profiles covered

by the IG.by the IG.– Including the profile id, HL7 version, acknowledgment details, type of Including the profile id, HL7 version, acknowledgment details, type of

profile, message types used, and allowed encodingsprofile, message types used, and allowed encodings

InteractionsInteractions– Fore each conformance profile documents the supported Fore each conformance profile documents the supported

interactions, including trigger events, message types, receiver interactions, including trigger events, message types, receiver actions, important data values, and usage requirementsactions, important data values, and usage requirements

Chapter: Message Profile - ActorsChapter: Message Profile - ActorsDocuments four actor based profiles:Documents four actor based profiles:

Lab Result Sender - The laboratory result sender actor is Lab Result Sender - The laboratory result sender actor is an application capable of transmitting the results of an application capable of transmitting the results of laboratory testing on specimens and is not necessarily a laboratory testing on specimens and is not necessarily a laboratory systemlaboratory system– The profile for this actor is constructed that the messages it The profile for this actor is constructed that the messages it

sends conform to all the following receiver profilessends conform to all the following receiver profiles

ELR Receiver - A Laboratory Result Receiver conforming ELR Receiver - A Laboratory Result Receiver conforming to the ELR receiver message profileto the ELR receiver message profileNHSN Receiver - A Laboratory Result Receiver NHSN Receiver - A Laboratory Result Receiver conforming to the NHSN receiver message profileconforming to the NHSN receiver message profileLab to EHR Sender - A Laboratory Result Receiver Lab to EHR Sender - A Laboratory Result Receiver conforming to the Lab to EHR receiver message profileconforming to the Lab to EHR receiver message profile

ELR IG Profiles and ELR IG Profiles and Meaningful UseMeaningful Use

The only profile relevant to meaningful use is the The only profile relevant to meaningful use is the ELR profileELR profile

A sender can meet meaningful use requirements A sender can meet meaningful use requirements by conforming to the ELR Receiver Profileby conforming to the ELR Receiver Profile

The advantage gained by following the Lab The advantage gained by following the Lab Result Sender Profile is that it conforms to Result Sender Profile is that it conforms to multiple profiles so the same message can be multiple profiles so the same message can be used for multiple purposes.used for multiple purposes.

Chapter: MessagesChapter: Messages

The Messages chapter defines the The Messages chapter defines the structure for the two messages detailed in structure for the two messages detailed in the specification:the specification:– ORU^R01^ORU_R01 (Unsolicited ORU^R01^ORU_R01 (Unsolicited

Observation Message)Observation Message)– ACK^R01^ACKACK^R01^ACK

The chapter describes the HL7 message The chapter describes the HL7 message structures of the two messages as well as structures of the two messages as well as the constraints applied to the message the constraints applied to the message structures.structures.

Chapter: MessagesChapter: MessagesTABLE 4‑1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAXTABLE 4‑1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX

Segment in Standard

Name Cardinality

Lab Result Sender Usage

ELR Receiver Usage

NHSN Receiver Usage

Lab to EHR Receiver Usage

Description

MSH Message Header

[1..1] R R R R The message header (MSH) segment contains information describing how to parse and process the message. This includes identification of message delimiters, sender, receiver, message type, timestamp, etc.

[{SFT}] Software Segment

[1..*] R R O O Each HL7 aware application that touches the message on the way to the destination application must add a SFT segment for its application. For instance, PHIN MS is not HL7 aware and would not be expected to add an SFT. On the other hand, an integration engine is HL7 aware and would be expected to add an SFT.The first repeat (i.e., the Laboratory Result Sender actor) is required. Any other application that transforms the message must add an SFT segment for that application. Other applications that route or act as a conduit may add an SFT but are not required to do so.

{ PATIENT_RESULT Begin

[1..*] R R R R The NHSN Receiver profile can receive only 1 Patient_Result group.

[ PATIENT Begin [1..1] R R R RE For public health reporting, the patient group is required.

PID Patient Identification

[1..1] R R R R The patient identification (PID) segment is used to provide basic demographics regarding the subject of the testing. The subject may be a person or animal.

Chapter: Segment and Field Chapter: Segment and Field DescriptionsDescriptions

The Segment and Field Descriptions chapter provides The Segment and Field Descriptions chapter provides segment attribute tables for all the segments supported segment attribute tables for all the segments supported in the documentin the document– MSH, SFT, MSA, ERR, PID, NK1, PV1, PV2, ORC, OBR, OBX, MSH, SFT, MSA, ERR, PID, NK1, PV1, PV2, ORC, OBR, OBX,

SPM, NTE, FHS, FTS, BHS and BTS segmentsSPM, NTE, FHS, FTS, BHS and BTS segments

The segment tables provide information about the The segment tables provide information about the constraints applied to the fields within the segmentsconstraints applied to the fields within the segments

Constraints include Constraints include – Usage (R, RE, O, C, CE or X)Usage (R, RE, O, C, CE or X)– Cardinality [0..n]Cardinality [0..n]– Value Sets Value Sets – Description/CommentsDescription/Comments

Segment Attribute TableSegment Attribute TableTABLE 5‑12. OBSERVATION/RESULT SEGMENT (OBX)TABLE 5‑12. OBSERVATION/RESULT SEGMENT (OBX)

Seq

Len

DT Cardinality

Lab Result Sender Usage

ELR Receiver Usage

NHSN Receiver Usage

Lab to EHR Receiver Usage

Value Set

HL7 Element Name

Description/Comments

1 1..4 SI [1..1] R R R R Set ID – OBX For the first repeat of the OBX segment, the sequence number shall be one (1), for the second repeat, the sequence number shall be two (2), etc.

2 2..3 ID [0..1] CE CE CE CE HL70125 Value Type This field identifies the data type used for OBX-5. Conditional statement: If OBX-5 is populated, OBX-2 is required. See Section 5.8.1, HL7 Table 0125 for the data types that will be supported for this field and OBX-5.

3 CWE

[1..1] R R R R Laboratory Observation Identifier Value Set

Observation Identifier

Unique identifier for the type of observation. This field provides a code for the type of observation. OBX-3 in conjunction with OBX-4 Observation Sub-ID should uniquely identify this OBX from all other OBXs associated with this OBR. LOINC is used as the coding system for this field except where the test being reported has no equivalent LOINC code. In this case, use of local codes is allowed. This should only occur for new tests that have yet been coded by LOINC. When populating this field with values, this guide does not give …

Observation Identifiers, Observation Observation Identifiers, Observation Values, Interpretations and CommentsValues, Interpretations and Comments

Provides guidance use of observation identifiers Provides guidance use of observation identifiers (OBX-3) in conjunction with observation value (OBX-3) in conjunction with observation value (OBX-5), interpretations (OBX-8) and comments (OBX-5), interpretations (OBX-8) and comments (NTE’s)(NTE’s)Links the LOINC ® scale property with the data Links the LOINC ® scale property with the data type to be used with OBX-5 valuetype to be used with OBX-5 valueIdentifies when units of measure requiredIdentifies when units of measure requiredIdentifies clearly when coded data vs. numeric Identifies clearly when coded data vs. numeric vs. text data is to be populated in OBX-5vs. text data is to be populated in OBX-5

Testing Testing situationsituation

DiscussionDiscussion

OBX.OBX.22

ObserObservation vation TypeType

OBX.3OBX.3Observation Observation Identifier: Identifier:

LOINC part LOINC part = scale= scale

OBX.5OBX.5Observation valueObservation value

OBX.6OBX.6UnitsUnits

OBX.8OBX.8Abnormal Abnormal

FlagsFlags

OBX.7OBX.7ReferenReferen

ce ce RangeRange NTE SegmentNTE Segment

Numeric result Numeric result along with along with interpretationinterpretation NMNM QNQN numbernumber

UCUM UCUM Units Units requiredrequired

May be May be populated populated with codes with codes from HL7 from HL7 table 0078table 0078

May be May be populatedpopulated

May be May be populated with populated with comments, not comments, not clinical findings.clinical findings.

Numerical Numerical intervals, ratios, intervals, ratios, inequalities inequalities SNSN QNQN structured numericstructured numeric

UCUM UCUM Units Units requiredrequired

May be May be populated populated with codes with codes from HL7 from HL7 table 0078table 0078

May be May be populatedpopulated

May be May be populated with populated with comments, not comments, not clinical findings.clinical findings.

Time like Time like quantitative quantitative result with result with interpretationinterpretation

TS, TS, TM, TM, DT,DT, QNQN

timestamp, time or timestamp, time or datedate [empty][empty]

May be May be populated populated with codes with codes from HL7 from HL7 table 0078table 0078

May be May be populatedpopulated

May be May be populated with populated with comments, not comments, not clinical findings.clinical findings.

Conveys Conveys ordinal value ordinal value and and interpretationinterpretation CWECWE ORDORD

Ordinal as a code. Ordinal as a code. SNOMED CT shall be SNOMED CT shall be used when code exists, used when code exists, otherwise it’s a local otherwise it’s a local code. Sending ordinals code. Sending ordinals as codes is the as codes is the preferred ELR preferred ELR approach.approach. [empty][empty]

May be May be populated populated with codes with codes from HL7 from HL7 table 0078table 0078

May be May be populatedpopulated

May be May be populated with populated with comments, not comments, not clinical findings.clinical findings.

Types of ObservationsTypes of Observations

Chapter: Code Systems and Value Chapter: Code Systems and Value SetsSets

Includes a brief discussion of code system Includes a brief discussion of code system vs. value setvs. value set

Describes vocabulary constraints applied Describes vocabulary constraints applied to a variety of coding systems, both HL7 to a variety of coding systems, both HL7 and externally definedand externally defined

Significant external coding systems used Significant external coding systems used include:include:– LOINC ®LOINC ®– SNOMED CT ®SNOMED CT ®– Unified Codes for Units of Measure (UCUM)Unified Codes for Units of Measure (UCUM)

Final ChaptersFinal Chapters

Example ELR Messages Example ELR Messages Appendix A - HL7 Reporting of Culture and Appendix A - HL7 Reporting of Culture and SusceptibilitiesSusceptibilitiesAppendix B - Clinical Laboratory Appendix B - Clinical Laboratory Improvements Amendment ConsiderationsImprovements Amendment ConsiderationsAppendix C. Strategy For Harmonizing Appendix C. Strategy For Harmonizing Multiple HL7 Implementation GuidesMultiple HL7 Implementation GuidesAppendix D. Recommended Changes to Appendix D. Recommended Changes to ExistingExisting

How To Use The ELR IGHow To Use The ELR IG

The ELR IG is an HL7 constrainable message The ELR IG is an HL7 constrainable message profileprofile

That means the ELR IG still has optional That means the ELR IG still has optional elementselements

States and other jurisdictions implementing States and other jurisdictions implementing based on this ELR IG are probably going to add based on this ELR IG are probably going to add additional constraintsadditional constraints

State laws and regulations vary and certainly State laws and regulations vary and certainly trump anything produced by HL7trump anything produced by HL7

The History Of ELR Teaches Us The History Of ELR Teaches Us That:That:

Revisions to the 2.5.1 IG are inevitableRevisions to the 2.5.1 IG are inevitable– Correct errors Correct errors – Accommodate new requirementsAccommodate new requirements

The HL7 Public Health and Emergency The HL7 Public Health and Emergency Response Work Group is currently accepting Response Work Group is currently accepting change requests regarding the ELR IGchange requests regarding the ELR IG

New ELR IGs will be required to address newer New ELR IGs will be required to address newer HL7 versions (Version 3, CDA, 2.7, 2.8 ???)HL7 versions (Version 3, CDA, 2.7, 2.8 ???)

How To Obtain A Copy Of The IGHow To Obtain A Copy Of The IG

The ELR IG is copyrighted by HL7The ELR IG is copyrighted by HL7Individual copies can be purchased from the Individual copies can be purchased from the HL7 Store at: HL7 Store at: http://www.hl7.org/http://www.hl7.org/HL7 Members can get free copies, along with HL7 Members can get free copies, along with copies of other HL7 Standardscopies of other HL7 StandardsHL7 Organization Members have additional HL7 Organization Members have additional rights for using and distributing the guide and all rights for using and distributing the guide and all HL7 standardsHL7 standards

Don’t email me asking me to give you a copy of Don’t email me asking me to give you a copy of the IG, I can’t supply it to you!the IG, I can’t supply it to you!

Questions & AnswersQuestions & Answers

Contact InformationContact InformationAustin Kreisler Austin Kreisler

duz1@cdc.govduz1@cdc.gov

austin.j.kreisler@saic.comaustin.j.kreisler@saic.com

Useful LinksUseful Links

HL7 - HL7 - http://www.hl7.org/http://www.hl7.org/

HL7 PHER WG Wiki site: HL7 PHER WG Wiki site: http://wiki.hl7.org/index.php?title=Public_Health_anhttp://wiki.hl7.org/index.php?title=Public_Health_and_Emergency_Response_work_group_%28PHERd_Emergency_Response_work_group_%28PHER%29%29

CSTE National ELR Group Information:CSTE National ELR Group Information:www.coast2coastinformatics.comwww.coast2coastinformatics.com