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

2. Austin Kreisler SAIC Technical Fellow SAIC consultant - CDC/National Healthcare Safety Network HL7 Technical Steering Committee Member Co-Chair, HL7 Domain Experts Steering Division Co-chair, HL7 Orders and Observations Work Group

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

4. Agenda ELR History – Timeline of various ELR versions High points of the 2.5.1 ELR Implementation Guide Future of ELR Implementation Guide How to get the ELR IG Q&A

5. First There Was 2.3.Z ELR There were a number of implementers who wanted to do ELR There were lots of ways of doing ELR Then there was 2.3.z ELR Which quickly turned into 2.3.1 ELR And then there were many versions of ELR

6. ELR History – Timeline Of Various ELR Versions 2.3.z ELR - 1997 2.3.1 ELR - 2003 2.3.1 ELR for Microbiology – 2003 2.4.z ELR for Bioterrorism - 2003 2.3.1 ELR Update - 2005 2.5 ELR Draft - 2004/2006 2.5.1 ELR Draft – 2008 2.5.1 ELR HL7 Balloting - 2009 2.5.1 ELR Published through HL7 – Feb 2010 2.5.1 ELR IG named in MU final rule – July 2010

7. The ELR 2.5.1 Project – Some Background The document is drawn from the HL7/HITSP 2.5.1 Interoperable Lab Result to EHR Implementation Guide Aligned with and extends the existing 2.3.1 ELR Implementation Guides Cross-fertilization with the PHLIP and LIMSi projects Developed in conjunction with the PHIN Communities of Practice and the CSTE National ELR Group

8. 2.5.1 ELR IG Content Introduction Messaging Infrastructure Message Profile Messages Segment and Field Descriptions Code Systems and Value Sets Example Laboratory Result Messages Appendix A. HL7 Reporting of Culture and Susceptibilities Appendix B. Clinical Laboratory Improvements Amendment Considerations US Realm Only Appendix C. Strategy For Harmonizing Multiple HL7 Implementation Guides Appendix D. Recommended Changes to Existing

9. Chapter: Introduction Specification for laboratory results reporting to local, state, territorial and federal public health agencies Addresses messaging content and dynamics related to the transmission of Laboratory Reportable Result Messages Each state and territory has its own requirements for laboratories to report certain findings to health officials

10. Chapter: Introduction - Purpose Messages described in IG are not specific to any reportable condition and is applicable for most biological and chemistry laboratory-reportable findings Intended to meet the needs and requirements of implementation guidance in Public Health entities, replacing the previous documentation regarding Electronic Laboratory Reporting (ELR) Does not replace the need for documentation of the constraints for specific implementations Does not replace the need to access to the underlying HL7 2.x standard

11. Chapter: Introduction - Scope IG covers the transmission of laboratory results to appropriate local, state, territorial and federal public health agencies Focuses on key points of broad interoperability –Use of strong identifiers for key information objects –Use of vocabulary standards Does not cover environmental lab reporting or result reporting to cancer registries Does cover reporting of laboratory results for individual human and animal testing.

12. Chapter: Messaging Infrastructure Messaging Framework –Includes message delimiters, null values, lengths, and snapshot processing Use of Escape Sequences –Discusses the required use of escape sequence processing Data Types –Provides a detailed description of the data types used in the specification

13. Chapter: Message Profile Use Case Model –Describes the use case, actors, assumptions and business rules associated with the use case Dynamic Interaction Models –Documented using a UML activity diagrams Dynamic Definitions –Documents details for three HL7 conformance profiles covered by the IG. –Including the profile id, HL7 version, acknowledgment details, type of profile, message types used, and allowed encodings Interactions –Fore each conformance profile documents the supported interactions, including trigger events, message types, receiver actions, important data values, and usage requirements

14. Chapter: Message Profile - Actors Documents four actor based profiles: Lab Result Sender - The laboratory result sender actor is an application capable of transmitting the results of laboratory testing on specimens and is not necessarily a laboratory system –The profile for this actor is constructed that the messages it sends conform to all the following receiver profiles ELR Receiver - A Laboratory Result Receiver conforming to the ELR receiver message profile NHSN Receiver - A Laboratory Result Receiver conforming to the NHSN receiver message profile Lab to EHR Sender - A Laboratory Result Receiver conforming to the Lab to EHR receiver message profile

15. ELR IG Profiles and Meaningful Use The only profile relevant to meaningful use is the ELR profile A sender can meet meaningful use requirements by conforming to the ELR Receiver Profile The advantage gained by following the Lab Result Sender Profile is that it conforms to multiple profiles so the same message can be used for multiple purposes.

16. Chapter: Messages The Messages chapter defines the structure for the two messages detailed in the specification: –ORU^R01^ORU_R01 (Unsolicited Observation Message) –ACK^R01^ACK The chapter describes the HL7 message structures of the two messages as well as the constraints applied to the message structures.

17. Chapter: Messages TABLE 4 ‑ 1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX Segme nt in Standa rd NameCardinalityLab Result Sender Usage ELR Receiv er Usage NHSN Receiv er Usage Lab to EHR Receiv er Usage Description MSHMessage Header [1..1]RRRRThe 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..*]RROOEach 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_RES ULT Begin [1..*]RRRRThe NHSN Receiver profile can receive only 1 Patient_Result group. [ PATIENT Begin [1..1]RRRREFor public health reporting, the patient group is required. PIDPatient Identification [1..1]RRRRThe patient identification (PID) segment is used to provide basic demographics regarding the subject of the testing. The subject may be a person or animal.

18. Chapter: Segment and Field Descriptions The Segment and Field Descriptions chapter provides segment attribute tables for all the segments supported in the document –MSH, SFT, MSA, ERR, PID, NK1, PV1, PV2, ORC, OBR, OBX, SPM, NTE, FHS, FTS, BHS and BTS segments The segment tables provide information about the constraints applied to the fields within the segments Constraints include –Usage (R, RE, O, C, CE or X) –Cardinality [0..n] –Value Sets –Description/Comments

19. Segment Attribute Table TABLE 5 ‑ 12. OBSERVATION/RESULT SEGMENT (OBX) Se q Le n DTCardinali ty Lab Result Sender Usage ELR Receive r Usage NHSN Receive r Usage Lab to EHR Receive r Usage Value Set HL7 Element Name Description/Comments 11..4SI[1..1]RRRRSet ID – OBXFor 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. 22..3ID[0..1]CE HL70125Value TypeThis 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. 3CW E [1..1]RRRRLaborator y Observati on 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 …

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

21. Testing situation Discussion OBX. 2 Obser vation Type OBX.3 Observation Identifier: LOINC part = scale OBX.5 Observation value OBX.6 Units OBX.8 Abnormal Flags OBX.7 Referen ce Range NTE Segment Numeric result along with interpretation NMQNnumber UCUM Units required May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. Numerical intervals, ratios, inequalities SNQN structured numeric UCUM Units required May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. Time like quantitative result with interpretation TS, TM, DT, QN timestamp, time or date [empty] May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. Conveys ordinal value and interpretation CWEORD Ordinal as a code. SNOMED CT shall be used when code exists, otherwise it’s a local code. Sending ordinals as codes is the preferred ELR approach. [empty] May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. Types of Observations

22. Chapter: Code Systems and Value Sets Includes a brief discussion of code system vs. value set Describes vocabulary constraints applied to a variety of coding systems, both HL7 and externally defined Significant external coding systems used include: –LOINC ® –SNOMED CT ® –Unified Codes for Units of Measure (UCUM)

23. Final Chapters Example ELR Messages Appendix A - HL7 Reporting of Culture and Susceptibilities Appendix B - Clinical Laboratory Improvements Amendment Considerations Appendix C. Strategy For Harmonizing Multiple HL7 Implementation Guides Appendix D. Recommended Changes to Existing

24. How To Use The ELR IG The ELR IG is an HL7 constrainable message profile That means the ELR IG still has optional elements States and other jurisdictions implementing based on this ELR IG are probably going to add additional constraints State laws and regulations vary and certainly trump anything produced by HL7

26. The History Of ELR Teaches Us That: Revisions to the 2.5.1 IG are inevitable Revisions to the 2.5.1 IG are inevitable –Correct errors –Accommodate new requirements The HL7 Public Health and Emergency Response Work Group is currently accepting change requests regarding the ELR IG New ELR IGs will be required to address newer HL7 versions (Version 3, CDA, 2.7, 2.8 ???)

27. How To Obtain A Copy Of The IG The ELR IG is copyrighted by HL7 Individual copies can be purchased from the HL7 Store at: http://www.hl7.org/ http://www.hl7.org/ HL7 Members can get free copies, along with copies of other HL7 Standards HL7 Organization Members have additional rights for using and distributing the guide and all HL7 standards Don’t email me asking me to give you a copy of the IG, I can’t supply it to you!

28. Questions & Answers

29. Contact Information Austin Kreisler duz1@cdc.gov austin.j.kreisler@saic.com Useful Links HL7 - http://www.hl7.org/ http://www.hl7.org/ HL7 PHER WG Wiki site: http://wiki.hl7.org/index.php?title=Public_Healt h_and_Emergency_Response_work_group_%2 8PHER%29 http://wiki.hl7.org/index.php?title=Public_Healt h_and_Emergency_Response_work_group_%2 8PHER%29 http://wiki.hl7.org/index.php?title=Public_Healt h_and_Emergency_Response_work_group_%2 8PHER%29 CSTE National ELR Group Information: www.coast2coastinformatics.com www.coast2coastinformatics.com