V251_IG_SIF_LABRESULTS_R1_N1_2011SEP HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, Release 1 HL7 Version 2.5.1: ORU^R01 Draft Standard for Trial Use WIP: 0.7 TBD 2011 Sponsored by: Orders and Observations in collaboration with the Health and Human Services Standards and Interoperability Framework Laboratory Result Interface Working Group LRI Work Group Co-chair: Hans Buitendijk Siemens Healthcare LRI Work Group Co-chair: Ken McCaslin Quest Diagnostics LRI Vocabulary Work Group Cochair: Cindy Johns LabCorp LRI Vocabulary Work Group Cochair: Riki Merrick iConnect Consulting Questions or comments regarding this document should be directed to the Orders and Observations Workgroup (ord@lists.hl7.org). HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page i September 2011 Reviewers Notes, Acknowledgements, Copyrights Reviewers Notes The review of this draft specification is encouraged to provide feedback that will ensure broad support and adoption, as well as further the goals of interoperability of information between exchange mechanisms for structured data (v2.x message, xml, etc.). This guide therefore directs the reviewer to several areas where the authors seek broader input from the community in addition to any other items noted about this guide. 1) Pre-adoption - This implementation guide is dependent on both existing V2.x versions, as well as a new version, V2.7.1, that is going through ballot at the same time. We encourage the balloter to review both this implementation guide and the V2.7.1 ballot to ensure your concerns are addressed in the related documents. 2) Component Length Conformance - The introduction of V2.7.1 Conformance Length (C.LEN) and position on truncation. 3) Minimalism – The content is intended to focus on that which represents unique constraints to the base standard(s). Acknowledgments The authors of this document wish to recognize the following participants who contributed their time and expertise to the development of this guide. Austin Kreisler SAIC Bill Ormerod Siemens Healthcare Bob Yencha Lantana Consulting Group Cindy Johns LabCorp David Burgess LabCorp Erik Pupo Deloitte Consulting Ernest Grove SHAPE HITECH, LLC Frieda Hall Quest Diagnostics Glen Moy California HealthCare Foundation Hans Buitendijk Siemens Healthcare Jingdong Li Lantana Consulting Group Jitin Asnaani Office of the National Coordinator John Mooney BioReference Laboratories, Inc Jonathan Tadese Deloitte Consulting Kate Hamilton Lantana Consulting Group Page ii September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Reviewers Notes, Acknowledgments, Copyrights Ken Gurlach CDC Ken McCaslin American Clinical Laboratory Association (ACLA) Ken Willett Ignis Systems Corp Krishna Murali Brahmandam Proheamon, Inc. Lester Keepper SHAPE HITECH, LLC Nagesh Bashyam Harris Neelima Chennamaraja Harris Riki Merrick iConnect Consulting Rob Hausam Hausam Consulting Robert Dieterle Cal eConnect Robert Lutolf Gensa Corporation Robert Snelick National Institute of Standards and Technology Tom Boal Lockheed Martin Virginia Sturmfels Quest Diagnostics Ballot #2 Production Change History Date Ver Comment Nov 21, 2011 0.7 Addressed items noted in spreadsheet: V251_IG_SIF_LABRESULTS_R1_N1_2011SEP_consolidated-22-Nov-2011.xls HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page iii September 2011 Reviewers Notes, Acknowledgements, Copyrights Copyrights This document is © 2011 Health Level Seven International, All rights reserved This material includes SNOMED Clinical Terms ® (SNOMED CT®) which is used by permission of the International Health Terminology Standards Development Organization (IHTSDO). All rights reserved. SNOMED CT was originally created by The College of American Pathologists. "SNOMED ®" and "SNOMED CT ®" are registered trademarks of the IHTSDO. This material contains content from LOINC® (http://loinc.org). The LOINC table, LOINC codes, and LOINC panels and forms file are copyright (c) 1995-2011, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and available at no cost under the license at http://loinc.org/termsof-use. Page iv September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE OF CONTENTS 1. INTRODUCTION .......................................................................................................................................................... 1 1.1 Purpose ............................................................................................................................................ 1 1.2 Audience .......................................................................................................................................... 1 1.2.1 1.3 Scope ............................................................................................................................................... 1 1.4 Use Case And Context Diagrams .................................................................................................... 2 1.4.1 User Story .................................................................................................................................. 3 1.4.2 Use Case Assumptions ............................................................................................................. 3 1.4.3 Pre-Conditions ........................................................................................................................... 4 1.4.4 Post Condition ........................................................................................................................... 5 1.4.5 Functional Requirements........................................................................................................... 5 1.4.6 Sequence Diagram .................................................................................................................... 6 1.5 Key Technical Decisions .................................................................................................................. 6 1.5.1 Use of ISO Object Identifier (OID) ............................................................................................. 6 1.5.2 Use of Vocabulary Standards ................................................................................................... 6 1.5.3 Field Length and Truncation ...................................................................................................... 6 1.5.4 Referenced Profiles ................................................................................................................... 7 1.5.5 Interfaces ................................................................................................................................... 7 1.5.6 Conformance to this Guide ........................................................................................................ 7 1.6 2. Requisite Knowledge ................................................................................................................. 1 Organization of this Guide................................................................................................................ 8 1.6.1 Conventions ............................................................................................................................... 8 1.6.2 Message Element Attributes ...................................................................................................... 9 1.6.3 Keywords ................................................................................................................................. 10 1.6.4 Usage Conformance Testing Recommendations .................................................................... 11 1.6.4.1 Usage................................................................................................................................ 11 1.6.4.1.1 Definition of Conditional Usage ....................................................................................... 11 1.6.4.1.2 Sending and Receiving Application Conformance Requirements................................... 12 DATA TYPES........................................................................................................................................................... 14 2.1 CE – Coded Element ..................................................................................................................... 14 2.2 CWE – Coded with Exceptions – All Fields Except OBX-5............................................................ 15 2.3 CWE – Coded with Exceptions – For OBX-5 Only ........................................................................ 17 2.4 CX – GU – Extended Composite ID with Check Digit (Globally Unique) ....................................... 20 2.5 CX – NG – Extended Composite ID with Check Digit (Non-Globally Unique) ............................... 21 2.6 DR – Date/Time Range .................................................................................................................. 22 2.7 DT – Date ....................................................................................................................................... 23 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page v September 2011 Table of Contents 2.8 DTM – Date/Time ........................................................................................................................... 23 2.9 ED – Encapsulated Data ................................................................................................................ 23 2.10 EI GU – Entity Identifier (Globally Unique) ................................................................................... 24 2.11 EI NG – Entity Identifier (Non-Globally Unique) ........................................................................... 25 2.12 EIP – GU – Entity Identifier Pair (Globally Unique) ...................................................................... 25 2.13 EIP – NG – Entity Identifier Pair (Non-Globally Unique) .............................................................. 26 2.14 ERL – Error Location .................................................................................................................... 26 2.15 FT – Formatted Text Data ............................................................................................................ 26 2.16 HD GU – Hierarchic Designator (Globally Unique) ...................................................................... 27 2.17 HD NG – Hierarchic Designator (Non-Globally Unique) .............................................................. 28 2.18 ID – Coded Value for HL7-Defined Tables ................................................................................... 28 2.19 IS – Coded Value for User-Defined Tables .................................................................................. 29 2.20 MSG – Message Type .................................................................................................................. 29 2.21 NM – Numeric .............................................................................................................................. 29 2.22 PRL – Parent Result Link ............................................................................................................. 30 2.23 PT – Processing Type .................................................................................................................. 30 2.24 RP – Reference Pointer ............................................................................................................... 31 2.25 SI – Sequence ID ......................................................................................................................... 32 2.26 SN – Structured Numeric ............................................................................................................. 32 2.27 ST – String Data ........................................................................................................................... 32 2.28 TM – Time .................................................................................................................................... 33 2.29 TS – Time Stamp .......................................................................................................................... 33 2.30 TX – Text Data.............................................................................................................................. 34 2.31 VID – Version Identifier ................................................................................................................ 34 2.32 XAD – Extended Address............................................................................................................. 34 2.33 XCN – GU – Extended Composite ID Number and Name for Persons (Globally Unique) .......... 36 2.34 XCN – NG – Extended Composite ID Number and Name for Persons (Non-Globally Unique) .. 38 2.35 XON GU – Extended Composite Name and Identification Number for Organizations Globally Unique) .................................................................................................................................................... 39 2.36 XON NG – Extended Composite Name and Identification Number for Organizations (NonGlobally Unique) ...................................................................................................................................... 40 2.37 3. XPN – Extended Person Name ................................................................................................... 41 MESSAGES ............................................................................................................................................................. 43 3.1 ORU^R01^ORU_R01 ..................................................................................................................... 43 3.2 ACK^R01^ACK .............................................................................................................................. 47 3.3 Segment and Field Descriptions .................................................................................................... 47 3.3.1 MSH – Message Header Segment ............................................................................................. 48 3.3.2 SFT – Software Segment –replace with reference to 2.5.1 ........................................................ 51 Page vi September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Table of Contents 3.3.3 MSA – Acknowledgement Segment ............................................................................................ 52 3.3.4 ERR – Error Segment ................................................................................................................. 52 3.3.5 PID – Patient Identification Segment .......................................................................................... 53 3.3.6 NK1 – Next of Kin Segment – make ref ...................................................................................... 57 3.3.7 PV1 – Patient Visit Information ................................................................................................... 57 3.3.8 PV2 – Patient Visit – Additional Information Segment insert ref to base .................................... 60 3.3.9 ORC – Common Order Segment ................................................................................................ 60 3.3.10 OBR – Observation Request Segment ..................................................................................... 63 3.3.11 TQ1 – Timing/Quantity Segment ............................................................................................... 70 3.3.12 OBX – Observation/Result Segment ........................................................................................ 72 3.3.12.1 4. 5. Observation Identifiers, Observation Values, Interpretations and Comments ....................... 76 3.3.13 SPM – Specimen Segment ....................................................................................................... 79 3.3.14 NTE – Notes and Comments Segment ..................................................................................... 82 CODE SYSTEMS AND VALUE SETS ............................................................................................................................ 83 4.1 Vocabulary Distribution .................................................................................................................. 83 4.2 HL7 TableS ..................................................................................................................................... 83 4.3 LOINC ............................................................................................................................................ 83 4.4 SNOMED CT .................................................................................................................................. 84 4.5 UCUM............................................................................................................................................. 84 4.6 Vocabulary Constraints .................................................................................................................. 85 4.7 HL7 Tables ..................................................................................................................................... 91 4.7.1 HL7 Table 0065 – Specimen Action Code from HL7 V2.7 Message - Constrained .................... 91 4.7.2 HL7 Table 0076 – Message Type 2.5.1 (constrained) ................................................................ 91 4.7.3 HL7 Table 0078 – Interpretation Codes from HL7 V2.7 Message .............................................. 91 4.7.4 HL7 Table 0125 – Value Type (Constrained from the Full HL7 Table) ........................................ 93 4.7.5 HL7 Table 0203 – Identifier Type from HL7 V2.7 ........................................................................ 95 4.7.6 HL7 Table 0291 – Subtype Of Referenced Data ....................................................................... 100 4.7.7 HL7 Table 0301 - Universal ID Type ......................................................................................... 100 4.7.8 HL7 Table 0354 – Message Structurefrom 2.5.1 (constrained) ................................................ 101 4.7.9 HL7 Table 0834 – MIME Type ................................................................................................... 101 4.7.10 HL7 Table new – ??? from 2.7.1 ............................................................................................. 102 MESSAGE PROFILES ............................................................................................................................................. 103 5.1 Profile GU – Global Unique Identifiers ......................................................................................... 103 5.2 Profile NG – Non-Globally Unique Identifiers............................................................................... 105 5.3 Profile RU – Unique Placer/Filler Order Number ......................................................................... 107 5.4 Profile RN – Non-Unique Order Numbers .................................................................................... 107 6. EXAMPLE LABORATORY RESULT MESSAGES ........................................................................................................... 109 7. ADDITIONAL IMPLEMENATION GUIDANCE ................................................................................................................. 110 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page vii September 2011 Table of Contents 7.1 HL7 Reporting of Culture and Susceptibilities ............................................................................. 110 7.1.1 Introduction ............................................................................................................................... 110 7.1.2 Template for Culture Results ..................................................................................................... 110 7.1.3 Examples of Culture Results ..................................................................................................... 111 7.1.4 Template for Culture and Susceptibility Results........................................................................ 114 7.2 Examples of Culture and Susceptibility Results ........................................................................... 116 7.3 Linking Parent and Child Results ................................................................................................. 121 7.4 Clinical Laboratory Improvements Amendment Considerations, US Realm Only ....................... 121 7.4.1 Mandatory Reporting Requirements ......................................................................................... 121 7.5 Regulatory Compliance ................................................................................................................ 123 7.6 Authorized Parties ........................................................................................................................ 123 Page viii September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. INDEX OF TABLES Table 1-1. Information Interchange Requirements ....................................................................................... 5 Table 1-2. System Requirements ................................................................................................................. 5 Table 1-3. Message Element Attributes ........................................................................................................ 9 Table 1-4. Sending Application Conformance ............................................................................................ 12 Table 1-5. Receiving Application Conformance .......................................................................................... 12 Table 2-1. Coded Element (CE) .................................................................................................................. 14 Table 2-2. Coded with Exceptions − All Fields Except OBX-5 (CWE)........................................................ 15 Table 2-3. Coded with Exceptions – For OBX-5 Only (CWE)..................................................................... 18 Table 2-4. Extended Composite ID with Check Digit (CX GU) ................................................................... 20 Table 2-5. Extended Composite ID with Check Digit (CX NG) ................................................................... 21 Table 2-6. Date/Time Range (DR) .............................................................................................................. 22 Table 2-7. Date (DT) ................................................................................................................................... 23 Table 2-8. Date/Time (DTM) ....................................................................................................................... 23 Table 2-9. Encapsulated Data (ED) ............................................................................................................ 23 Table 2-10. Entity Identifier (EI GU) ............................................................................................................ 24 Table 2-11. Entity Identifier (EI NG) ............................................................................................................ 25 Table 2-12. Entity Identifier Pair (EIP GU) .................................................................................................. 25 Table 2-13. Entity Identifier Pair (EIP NG) .................................................................................................. 26 Table 2-14. Error Location (ERL) ................................................................................................................ 26 Table 2-15. Formatted Text Data (FT) ........................................................................................................ 27 Table 2-16. Hierarchic Designator (HD GU) ............................................................................................... 27 Table 2-17. Hierarchic Designator (HD NG) ............................................................................................... 28 Table 2-18. Coded Value for HL7-Defined Tables (ID) ............................................................................... 29 Table 2-19. Coded Value for User-Defined Tables (IS) .............................................................................. 29 Table 2-20. Message Type (MSG) .............................................................................................................. 29 Table 2-21. Numeric (NM)........................................................................................................................... 29 Table 2-22. Parent Result LInk (PRL) ......................................................................................................... 30 Table 2-23. Processing Type (PT) .............................................................................................................. 30 Table 2-24. Reference Pointer (RP) ........................................................................................................... 31 Table 2-25.SEQuence ID (SI) ..................................................................................................................... 32 Table 2-26. Structured Numeric (SN) ......................................................................................................... 32 Table 2-27. String Data (ST) ....................................................................................................................... 33 Table 2-28. Time (TM) ................................................................................................................................ 33 Table 2-29. Time Stamp (TS)...................................................................................................................... 33 Table 2-30. Text Data (TX) ......................................................................................................................... 34 Table 2-31. Version Identifier (VID) ............................................................................................................ 34 Table 2-32. Extended Address (XAD) ......................................................................................................... 34 Table 2-33. Extended Composite ID Number and Name for Persons (XCN GU) ...................................... 36 Table 2-34. Extended Composite ID Number and Name for Persons (XCN NG) ...................................... 38 Table 2-35. Extended Composite Name and Identification Number for Organizations (XON GU) ............ 39 Table 2-36. Extended Composite Name and Identification Number for Organizations (XON NG) ............ 40 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page ix September 2011 Index of Tables Table 2-37. Extended Person Name (XPN) ................................................................................................ 41 Table 3-1. ORU^R01^ORU_R01 Abstract Message Syntax ...................................................................... 43 Table 3-2. ACK^R01^ACK Abstract Message Syntax ................................................................................ 47 Table 3-3. Message Header Segment (MSH) ............................................................................................. 48 Table 3-4. Acknowledgment Segment (MSA) ............................................................................................. 52 Table 3-5. Error Segment (ERR) ................................................................................................................ 52 Table 3-6. Patient Identification Segment (PID) ......................................................................................... 53 Table 3-7. Patient Visit Information (PV1) ................................................................................................... 57 Table 3-8. Common Order Segment (ORC) ............................................................................................... 60 Table 3-9. Observation Request Segment (OBR) ...................................................................................... 63 Table 3-10. TimING/QuaNTity Segment for Order Group .......................................................................... 70 Table 3-11. Observation Result Segment (OBX) ........................................................................................ 72 Table 3-12. Observation Identifiers ............................................................................................................. 77 Table 3-13. Specimen Segment (SPM) ...................................................................................................... 79 Table 3-14. Notes and Comments Segment (NTE) .................................................................................... 82 Table 4-1. Value Set/Code System Summary ............................................................................................ 85 Table 4-2. HL7 Table 0065 Specimen Action Code - constrained ............................................................. 91 Table 4-3. HL7 Table 0078 from 2.7 ........................................................................................................... 91 Table 4-4. HL7 Table 0125 – Value Type ................................................................................................... 93 Table 4-5. HL7 Table 0291 – Subtype Of Referenced Data ..................................................................... 100 Table 4-6. HL7 Table 0301 - Universal ID Type ....................................................................................... 100 Table 4-7. HL7 Table 0834 – MIME Type ................................................................................................. 101 Table 7-1. Mandatory Reporting Requirements ........................................................................................ 121 Page x September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. INDEX OF FIGURES Figure 1-1. Use Case Diagram ..................................................................................................................... 3 Figure 1-2. Context Diagram ......................................................................................................................... 3 Figure 1-3. Sequence Diagram ..................................................................................................................... 6 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page xi September 2011 1. INTRODUCTION The HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, Release 1 (US Realm) is the result of collaborative efforts between HL7 and the Health and Human Services Standards and Interoperability Framework Laboratory Results Interface Initiative. By consensus the HL7 V2.5.1 ORU^R01 Message was selected as the basis to define the profile constraints expressed in this guide to meet the requirements of the transmission of laboratory reports, initially focused on the Results for Ambulatory Providers Use Case. 1.1 PURPOSE The Laboratory Results Interface Initiative focuses on identifying the requirements, specifications and standards, and on providing the implementation guidance for electronic reporting of laboratory test results to ambulatory care providers in the US Realm. The scope of this Use Case includes requirements to enable the incorporation of clinical laboratory test results into an Electronic Health Record (EHR) as standardized structured data using the defined interorganizational laboratory transaction. The Use Case requirements are directed at laboratory test results reporting between a laboratory information system and an ambulatory EHR system in different organizational entities, e.g., different corporate structure, ownership or governance. Future versions of this Guide may harmonize with existing guides to extend interoperability of laboratory results across care settings, e.g., acute care and public health. 1.2 AUDIENCE This guide is designed for use by analysts and developers who require guidance on data elements and components of the HL7 Version 2.5.1 ORU Unsolicited Observation Message relative to the Lab Results Interface (LRI) initiative. Users of this guide must be familiar with the details of HL7 message construction and processing. This guide is not intended to be a tutorial on that subject. 1.2.1 Requisite Knowledge HL7 V2.5.1, V2.7, V2.7.1 Messaging (www.HL7.org) SNOMED (www. http://www.ihtsdo.org/snomed-ct) LOINC (http://loinc.org) UCUM (http://unitsofmeasure.org) OIDS (http://www.hl7.org/oid) 1.3 SCOPE The scope is the sending of lab results from a laboratory to an ambulatory provider. The implementation design is as a series of constraining profiles on a base specification, itself a constraint on the HL7 V2.5.1 Message standard, for future use case expansion. In Scope Defining the core data elements required for ambulatory care clinical laboratory test results. Reporting of clinical laboratory test results for ambulatory care in the US Realm. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 1 of 150 September 2011 Sending clinical laboratory test results as standardized structured data so they can be incorporated that way into an EHR. Supporting Stage 2 certification criteria and Meaningful Use (MU) requirements by developing requirements for an interface that enables the incorporation of clinical laboratory test results into EHRs when data is sent as standardized structured data Reporting test results for an order that was placed either manually or electronically. Some order specific data has been included to enable the receiving EHR to correlate the results back to the originating order. Covering all CLIA reporting requirements, including but not limited to: result report statuses: preliminary, final, appended, corrected and/or amended. Receiving of laboratory results as a non-order placer. Out of Scope Specifications and implementation guidance on laboratory ordering transactions. However, the establishment of requirements in the laboratory result message that will allow the matching of the reported result to an existing order initiated from the ordering clinician’s EHR is within the scope of this effort. Querying for laboratory results. Querying for historical laboratory results. Receiving historical laboratory results. Secondary use of laboratory data (i.e., public health or bio surveillance uses of the reported laboratory results). In hospital ordering and reporting of laboratory results. Advanced error messages related to application transport. Results not transmitted using a standardized structured format. 1.4 RESULTS FOR AMBULATORY CARE USE CASE AND CONTEXT DIAGRAMS Laboratory is any facility that provides results to a Provider in an ambulatory setting. The Laboratory provides results based on a request for laboratory services from an authorized Provider. In this example, it is assumed that the receiving system is an EHR that can receive lab results even if it is not aware of the request, as there is no assumption that the receiving EHR provided the request for lab services. It does assume that the EHR can receive lab results even if it is not aware of the request. Page 2 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Lab Results Interface Figure 1-1. Use Case Diagram Figure 1-2. Context Diagram 1.4.1 User Story A Provider (order placer) may enter a laboratory order into an ambulatory EHR. A laboratory requisition is generated (paper or electronic) and is communicated to the laboratory. The information in the laboratory requisition is entered manually or captured electronically into the Laboratory Information System (LIS). After the specimen(s) has been collected and, if necessary, shipped or delivered to the laboratory, the laboratory processes the specimen(s). The laboratory performs or attempts to perform the test(s). If testing is successful, results are obtained and entered/released in the laboratory information system. An authorized person at the laboratory reviews and approves the laboratory test results to be sent to the ordering provider. The laboratory's LIS (results sender) transmits the results to the provider’s EHR (results receiver). The EHR incorporates the results into the patient’s electronic record. The provider logs into his/her EHR and views the laboratory results in order to inform patient care decisions. 1.4.2 Use Case Assumptions Providers securely access clinical information through an EHR system. Appropriate security and transport protocols; patient identification methodology; requisition (order) identification methodology; consent; privacy and security procedures; HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 3-150 September 2011 coding, vocabulary and normalization standards have been agreed to by all relevant participants. This Use Case only addresses the exchange of laboratory results that are associated with the In Scope laboratory tests. All relevant parties have agreed on a structured laboratory test results message format. This Use Case covers all CLIA reporting requirements, including but not limited to: result reports statuses; preliminary, final, appended, corrected and/or amended. For the specimen collection process the data included in the dataset considerations table are assumed to be available and reported in the result. Legal and governance issues regarding data access authorizations, data ownership, and data use are in effect. Established network and policy infrastructure to enable consistent, appropriate, and accurate information exchange across provider systems, data repositories and locator services. This includes, but is not limited to: Methods to identify and authenticate users; Methods to identify and determine Providers of care; Methods to enforce data access authorization policies; Methods to ensure the veracity of data; Detailed audit trails are kept as necessary by all participating systems. Security and privacy policies, procedures and practices are commonly implemented to support acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and EHR certification criteria. A LIS will be the sender of laboratory test results while an EHR will be the receiver. The transport mechanism will provide guaranteed delivery and error handling This Use Case acknowledges the variations in requirements for reporting across local, state, tribal, and territorial boundaries as well as voluntary versus mandatory requirements. Laboratories meet accreditation criteria according to jurisdiction requirements or agency criteria. 1.4.3 Pre-Conditions An order has been generated by an Ordering Provider for one or more laboratory tests results to be produced. The Laboratory receives an order (electronic, paper, etc.) or the Laboratory receives a request to re-run (repeat) a test, or determines a need to re-run a test for possible correction, or determines that reflex testing (which is based on criteria set by the medical review board) is required or determines the need to amend a test result based on erroneous information. The Laboratory receives the appropriate clinical information to perform the ordered test. Page 4 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Laboratory has entered manually or through the interface pertinent (or corrected) data from an order into the Laboratory Information System. Laboratory has received and processed properly identified specimen(s) related to the ordered test(s). Laboratory entered or received from the ordering EHR environment, pertinent data from/about the specimen into the Laboratory Information System. Laboratory performed the ordered tests on received specimens and/or incorporated calculated and reference data to produce the results referenced. The laboratory result message contains both the appropriate patient information and the originating order information to associate the laboratory results to the correct patient and original order. Laboratory information system is capable of and ready to send laboratory results electronically and in standardized structured format. EHR system is in place and capable of receiving laboratory results electronically and in standardized structured format. The laboratory result is verified and ready for release. 1.4.4 Post Condition The result is available for patient care. 1.4.5 Functional Requirements TABLE 1-1. INFORMATION INTERCHANGE REQUIREMENTS Information Information Initiating Interchange Receiving System System Requirement Name Laboratory Information System Sends Laboratory Test Result Receives Electronic Health Record System System Laboratory Information System Electronic Health Record System 1 TABLE 1-2. SYSTEM REQUIREMENTS System Requirement Form a laboratory message with standardized structured data1 meeting CLIA and other federal and state regulatory requirements Incorporate test data from the laboratory message as standardized structured data. See the S&I LRI Use Case, Section 2.3 Structured Data Definition HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 5-150 September 2011 1.4.6 Sequence Diagram Figure 1-3. Sequence Diagram 1.5 KEY TECHNICAL DECISIONS One of the primary features of this implementation guide is its focus on key points of broad interoperability. The HL7 implementation guides in Section 1.5.4-Referenced Profiles informed the content of this specification as analysis indicated that none of the candidate guides could satisfy the use case requirements without some adjustment. This guide is the result of combining the best practices from the current body of work while making further adjustment to meet the needs of ambulatory reporting and preparing for increased consistency of lab result reporting across care settings. 1.5.1 Use of ISO Object Identifier (OID) This guide defines multiple profiles, one of which employs the use of an ISO Object Identifier (OID) for universally unique identifiers as defined in clause 28 of ISO/IEC 8824:1990(E). The ISO OID specification is the globally accepted technology for this purpose and is recommended as the means to satisfy the requirement for a universally unique identifier. HL7 has developed an implementation guide for the use of OIDs, “HL7 Implementation Guidance for Unique Object Identifiers (OIDs), Release 12”, which provides guidance on how organizations can use and manage OIDs. OIDs provide a strong identifier that uniquely identifies the object in question and is global in scope. Examples of information that OIDs can identify are items about patients, orders, providers and organizations. This means the identifier includes enough information to remain unique when taken out of the context within which the identifier was created. 1.5.2 Use of Vocabulary Standards This guide calls for specific vocabulary standards for the exchange of laboratory information. Standard vocabularies, particularly coded laboratory results, enable automated decision support for patient healthcare, as well as for public health surveillance of populations. 1.5.3 Field Length and Truncation This guide pre-adopts field length definition conventions and the stated lengths from HL7 Version 2.7.1, Chapter 2 Control; it also provides further constraints to support the use case and scope defined in this guide. 2 The current version of the HL7 Implementation Guidance for Unique Object Identifiers (OIDs), Release 1 can be found at: http://www.hl7.org/documentcenter/ballots/2009may/downloads/V3_OIDS_R1_I2_2009MAY.zip. Page 6 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. The Conformance Length parameter (Version 2.7.1, Chapter 2 Control, Section 2.5.5.3, Conformance Length) has also been adopted in this guide and is defined in this excerpt from the base standard: --------- start citation --------If populated, the conformance length column specifies the minimum length that applications must be able to store. Conformant applications SHALL not truncate a value that is shorter than the length specified. The conformance length is also the minimum value that maybe assigned to maximum length in an implementation profile. In addition, the conformance length may be followed by a “=” or a “#”. The “=” denotes the value may never be truncated, and the “#” denotes that the truncation behavior defined for the data type applies. --------- end citation --------Note that truncation is not allowed in this guide except for the FT primitive datatype, where the base standard defines truncation behavior. 1.5.4 Referenced Profiles This specification documents a message profile for Laboratory Reporting Results Interface (LRI) - Receiver profile based on the HL7 version 2.5.1 3. Other laboratory results profiles were referenced and used as source materials in the development of this guide, including: HL7 Ambulatory Care Laboratory Result Implementation Guide: EHR-Laboratory Interoperability And Connectivity Specification (ELINCS) - Release 1, July 1, 2008 HL7 Version 2.5.1 Implementation Guide: Orders And Observations; Interoperable Laboratory Result Reporting To EHR (US Realm), Release 1, November, 2007 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) This document should not be considered the source of truth for any statement or assertion in regards to the referenced profiles. They are provided here as antecedent documentation and are not required for successful implmentation of this Guide. 1.5.5 Interfaces Two interfaces are described in this document: 3 Lab Result Sender – A sender of laboratory result messages conforming to the profile will satisfy the requirements of this profile, and may meet the requirements of future profiles. Lab Result Receiver – A message profile for receivers of electronic laboratory result messages. The referenced documents are all available from HL7 (www.hl7.org) – Members may obtain a copy without charge in the Members-only area of the site, others may purchase a copy for a nominal fee via the HL7 Store. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 7-150 September 2011 1.5.6 Conformance to this Guide Conformance to this guide is through the use of a combination of OIDs in MSH-21 as noted below: Common Profile Component– ID: 2.16.840.1.113883.9.16 Indicates that the message adheres to the rules set out in this guide. When this profile is present in MSH.21, it shall be accompanied by one of Profile GU or Profile NG and one of Profile RU or Profile RN. Additionally, other profiles may be present that further constrain the message as agreed to by two or more exchange parties. However, those profiles are strictly voluntary and shall not conflict with any of the three profiles already listed, nor shall any additional profile be marked by any exchange party as minimally required to successfully send or receive Lab Results when Profile LRI is present in MSH.21. GU Profile Component – ID: 2.16.840.1.113883.9.12 Indicates Globally Unique Identifiers are supported via required use of an ISO OID as noted in this guide. NG Profile Component – ID: 2.16.840.1.113883.9.13 Indicates Non-Global Identifiers (Profile NG) were constructed using an alternate method for providing identifiers noted in this guide; these identifiers are not guaranteed to be globally unique. RU Profile Component – ID: 2.16.840.1.113883.9.14 Indicates that the test can be identified by only using either the placer order number, and/or filler order number. RN Profile Component – ID: 2.16.840.1.113883.9.15 Indicates that the test can be identified by using the universal service identifier and either the placer order number or the filler order number. The Profiles GU and NG are mutually exclusive, as are RU and RN; allowable combinations: Base + GU + RU Base + GU + RN Base + NG + RU Base + NG + RN 1.6 ORGANIZATION OF THIS GUIDE 1.6.1 Conventions This guide adheres to the following conventions: The guide is constructed assuming the implementer has access to the 2.5.1 version of the HL7 Standard. Although some information from the standard is included in this implementation guide, much information from the standard has not been repeated here. The rules outlined in HL7 2.7.1, Chapter 2B, Section 2B5, Conformance Using Message Profiles, were used to document the use case for, and constraints applied to, the messages described in this guide. Page 8 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Data types have been described separately from the fields that use the data types. No conformance information is provided for optional message elements. This includes length, usage, cardinality, value sets and descriptive information. Implementers who want to use optional message elements should refer to the HL7 Standard to determine how these optional message elements will be used. Any information provided in this guide for optional elements is to be considered suggested best practices; this is particularly true of vocabulary and value sets associated with optional components. This guide uses “X” as a conformance usage indicator very sparingly. Where the underlying standard indicates the segments/field/component is present for backwards compatibility (“B”) an “X” will be used. For all other fields/components “O” is used to enable trading partners to explore additional capabilities. Note that without a clearly agreed to complementary profile between trading partners, a Lab does not have to send any elements marked as an "O", nor does a receiver of a lab result have to process any elements marked as an "O". Neither trading partners can mandate the other to accept any such complementary profiles to enable basic laboratory results interfacing "out-of-the-box". 1.6.2 Message Element Attributes The following table describes the various attributes used by this guide to document data type attribute tables, message structure attribute tables and segment attribute tables. Not all attributes apply to all attribute tables. Attribute TABLE 1-3. MESSAGE ELEMENT ATTRIBUTES Definition Seq Sequence of the elements as numbered in the HL7 message element. TheSEQ attribute applies to the data type attribute table and the segment attribute table. Segment Three-character code for the segment and the abstract syntax (e.g., the square and curly braces). [ XXX ] Optional { XXX } Repeating XXX Required [{ XXX }] Optional and Repeating Note that for segment groups there is no segment code present, but the square and curly braces will still be present. The Segment attribute only applies to the Message attribute table. Length – (V2.7.1) For each component in the data type table and field in a segment there is a normative length column (LEN) and conformance length (C.LEN). This guide follows the length definitions and conventions from V2.7.1. LEN – If populated, defines the minimum and maximum length that must be supported. The minimum or the maximum may be blank, e.g., “..20” or “2..”. indicating there is no minimum or maximum. C.LEN – If populated, the conformance length column specifies the minimum length that applications must be able to store. Note the following behaviors for the C.LEN: = - Truncation is not permitted # - Truncation behavior defined for the data type applies DT Data type used by this profile for HL7 element. The data type attribute applies to data type attribute tables and segment attribute tables. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 9-150 September 2011 Attribute TABLE 1-3. MESSAGE ELEMENT ATTRIBUTES Definition Usage Usage of the message element for this profile. Indicates whether the message element (segment, segment group, field, component, or subcomponent) is required, optional, or conditional in the corresponding message element. Usage applies to the message attribute table, data type attribute table and the segment attribute table Cardinality Minimum and maximum number of times the element may appear. [0..0] Element never present. [0..1] Element may be omitted and can have, at most, one occurrence. [1..1] Element must have exactly one occurrence. [0..n] Element may be omitted or may repeat up to n times. [1..n] Element must appear at least once, and may repeat up to n times. [0..*]Element may be omitted or repeat an unlimited number of times. [1..*] Element must appear at least once, and may repeat unlimited number of times. [m..n] Element must appear at least m, and at most, n times. Cardinality applies only to message attribute tables and segment attribute tables. See section Error! Reference source not found. for additional information on how cardinality is handled in this guide. Value Set The set of coded values to be used with the field. The value set attribute applies only to the data type attribute tables and the segment attribute tables. The value set may equate with an entire code system part of a code system, or codes drawn from multiple code systems. Note: Where a table constraint is indicated, or where HL7 Version 2.7.1 standards are pre-adopted, the constrained or specified HL7 table is included below the data type table. Name HL7 descriptor of the message element. Name applies to the message attribute table, data type attribute table and the segment attribute table. Description/Comments Context and usage for the element. Description/Comments applies to the message attribute table, data type attribute table and the segment attribute table. Note: In the tables throughout this document, Yellow = This Interoperability Specification does not support the use of this item. This corresponds with the Usage code “X”. 1.6.3 Keywords The following keywords in this document are to be interpreted as follows: MUST or the terms "REQUIRED" or "SHALL", mean that the definition is an absolute requirement of the specification. MUST NOT or the phrase "SHALL NOT", mean that the definition is an absolute prohibition of the specification. SHOULD or the adjective "RECOMMENDED", mean that there may exist valid reasons in particular circumstances to ignore a particular item, but the full implications must be understood and carefully weighed before choosing a different course. SHOULD NOT or the phrase "NOT RECOMMENDED" mean that there may exist valid reasons in particular circumstances when the particular behavior is acceptable or even useful, but the full implications should be understood and the case carefully weighed before implementing any behavior described with this label. Page 10 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. MAY or the adjective "OPTIONAL", mean that an item is truly optional. One software supplier may choose to include the item to enable certain capabilities while another software supplier may omit the same item. In either case, the communication partner cannot be expected to either provide it (sender) or process it (receiver) without clear and voluntary agreement between the partners. An implementation which does not include a particular segment/field/component marked as optional MUST be prepared to interoperate with another implementation which does include the optional segment/field/component, though perhaps with reduced functionality. In the same vein an implementation which includes a particular segment/field/component marked as optional MUST be prepared to interoperate with another implementation which does not include the optional segment/field/component. 1.6.4 Usage Conformance Testing Recommendations The following text is pre-adopted from the HL7 V2.7.1 Conformance (Chapter 2B) Draft Version (Aug 31, 2011) as revised by the S&I Framework Lab Implementation Guide Recommendations (Sept 2, 2011). Please refer to the base standard documentation for a full explanation of conformance concepts. Usage is described here as it introduces the revised approach to conditional element handling; upon successful ballot and publication this material will be replaced with a reference to the normative documentation. ---------- start citation--------1.6.4.1 Usage Message content is governed by the cardinality specification associated (explicitly or implicitly) with each element of an HL7 message. Message content is governed by the cardinality specification associated (explicitly or implicitly) with each element of an HL7 message. Usage rules govern the expected behavior of the sending application and place limited restrictions on the receiving application with respect to the element. These usage codes expand/clarify the optionality codes defined in the HL7 standard. The usage codes expand/clarify the optionality codes defined in the HL7 standard. Usage codes are employed in a message profile to constrain the use of elements defined in the standard. The usage code definitions are given from a sender and receiver perspective and specify operational and implementation requirements. The standard allows broad flexibility for the message structures that HL7 applications must be able to receive without failing. But while the standard allows that messages may be missing data elements or may contain extra data elements, it should not be inferred from this requirement that such messages are conformant. In fact, the usage codes specified in a message profile place strict conformance requirements on the behavior of the application. 1.6.4.1.1 Definition of Conditional Usage The conditional usage is defined as follows: C(a/b) - “a” and “b” in the expression are placeholders for usage codes representing the true (“a”) predicate outcome and the false (“b”) predicate outcome of the condition. The condition is expressed by a conditional predicate associated with the element (“See section 2.B.7.9, Condition Predicate" in V2.7.1 Chapter 2B). “a” and “b” shall be one of HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 11-150 September 2011 “R”, “RE”, “O” and/or “X”. In order not to render the condition statement redundant, “a” and “b” shall be different. The example C(R/RE) is interpreted as follows. If the condition predicate associated with the element is true then the usage for the element is R-Required. If the condition predicate associated with the element is false then the usage for the element is RERequired but may be empty. 1.6.4.1.2 Sending and Receiving Application Conformance Requirements TABLE 1-4. SENDING APPLICATION CONFORMANCE Symbol Definition Implementation Operational Requirement Requirement R Required The application SHALL The application SHALL populate “R” elements with a implement “R” elements. non-empty value. RE Required, but may be empty The application SHALL implement “RE” elements. C(a/b) Conditional An element with a conditional usage code has an associated condition predicate (See section 2.B.7.9, Condition Predicate in V2.7.1 Chapter 2B") that determines the operational requirements (usage code) of the element. If the condition predicate associated with the element is true, follow the rules for a which shall be one of “R”, “RE”, “O” or X”: If the condition predicate associated with the element is false, follow the rules for b which shall be one of “R”, “RE”, “O” or X”. a and b SHALL be different and defined by the message profile. X Not supported in The application SHALL NOT this guide implement “X” elements. O Optional The application SHALL populate “RE” elements with a non-empty value if there is relevant data. The term “relevant” has a confounding interpretation in this definition4. The application SHALL NOT populate “X” elements. None. The usage indicator for Not Applicable. this element has not yet been defined. For an implementation profile all optional elements must be profiled to R, RE, C, CE, or X. TABLE 1-5. RECEIVING APPLICATION CONFORMANCE Symbol Definition Implementation Operational Requirement Requirement 4 There are multiple interpretations of “RE” when a value is known. One is “the capability must always be supported and a value is sent if known”, the other is “the capability must always be supported and a value may or may not be sent even when known based on a condition external to the profile specification. The condition may be noted in the profile but cannot be processed automatically”. This is what can be interpreted from the “relevant” part of the definition. Regardless of the interpretation the “RE” usage code, a set of test circumstances can be developed to sufficiently test the “RE” element. See the “Conformity Assessment of Conformance Constructs” section for more details. Page 12 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 1-5. RECEIVING APPLICATION CONFORMANCE Symbol Definition Implementation Operational Requirement Requirement R Required The application SHALL implement “R” elements. The receiving application SHALL process (save/print/archive/etc.) the information conveyed by a required element. A receiving application SHALL raise an exception due to the absence of a required element. A receiving application SHALL NOT raise an error due to the presence of a required element, RE Required, but may be empty The application SHALL implement “RE” elements. C(a/b) Conditional The usage code has an associated condition predicate true (See section 2.B.7.9, Condition Predicate in V2.7.1 Chapter 2B"). If the condition predicate associated with the element is true, follow the rules for a which may be one of “R”, “RE”, “O” or X”: If the condition predicate associated with the element is false, follow the rules for b which may be one of “R”, “RE”, “O” or X”. a and b SHALL be different and defined by the message profile. X Not supported in The application SHALL NOT this guide implement “X” elements. O Optional The receiving application SHALL process (save/print/archive/etc.) the information conveyed by a required but may be empty element. The receiving application SHALL process the message if the element is omitted (that is, an exception SHALL NOT be raised because the element is missing). None, if the element is not sent. If the element is sent the receiving application may process the message, SHALL ignore the element, and MAY raise an exception. The receiving application SHALL NOT process (save/print/archive/etc.) the information conveyed by a not-supported element. None. The usage indicator for None. this element has not yet been defined. For an implementation profile all optional elements must be profiled to R, RE, C(a/b) or X. --------- end citation --------- HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 13-150 September 2011 2. DATA TYPES 2.1 CE – CODED ELEMENT Table 2-1. Coded Element (CE) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Identifier ST RE 1..20 = 2 Text ST RE 1..199 = 3 Name of Coding System ID C(R/X) 1..12 = 4 Alternate Identifier ST RE 1..20 = The alternate identifier (from the alternate coding system) should be the closest match for the identifier found in component 1. 5 Alternate Text ST RE 1..199 = It is strongly recommended that alternate text be sent to accompany any alternate identifier. 6 Name of Alternate Coding System ID C(R/X) 1..12 = It is strongly recommended that text be sent to accompany any identifier. When a coded value is not known, text can still be sent, in which case no coding system should be identified. HL70396 HL70396 Usage Note Senders should always populate the first triplet before populating the second triplet; the receiver needs to examine both triplets to find relevant values. Conformance Statements: Base Profile LRI-CE-1: If data is available for only one Coded Element then the triplet of CE.1 (Identifier), CE.2 (Text), and CE.3 (Name of Coding System) shall be valued in accordance with the rules given for CE.1, CE.2, and CE.3. LRI-CE-2: If CE.1 (Identifier) is not valued, then CE.2 (Text) SHALL be valued. LRI-CE-3: If CE.1 (Identifier) is valued, then CE.3 (Name of Coding System) SHALL be valued. Page 14 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. LRI-CE-4: If CE.4 (Alternate Identifier) is valued, then CE.6 (Name of Alternate Coding System) SHALL be valued. Example Release Note: Examples will be provided for each datatype defined in this section that are conformant to the statements in the final version of this Release (R1). 2.2 CWE – CODED WITH EXCEPTIONS – ALL FIELDS EXCEPT OBX-5 NOTE: Pre-adoption from V2.7.1 of Components 10-22 TABLE 2-2. CODED WITH EXCEPTIONS − ALL FIELDS EXCEPT OBX-5 (CWE) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Identifier ST RE 1..20 = 2 Text ST RE 1..199 = 3 Name of Coding System ID C(R/X) 1..12 = 4 Alternate Identifier ST RE 1..20 = The alternate identifier (from the alternate coding system) should be the closest match for the identifier found in component 1. 5 Alternate Text ST RE 1..199 = It is strongly recommended that alternate text be sent to accompany any alternate identifier. 6 Name of Alternate Coding System ID C(R/X) 1..12 = 7 Coding System Version ID ST O 1..10 = 8 Alternate Coding System Version ID ST O 1..10 = HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. It is strongly recommended that text be sent to accompany any identifier. When a coded value is not known, the original text attribute is used to carry the text, not the text component. HL70396 HL70396 See section 4 for description of the use of coding systems in this implementation guide. See section 4 for description of the use of coding systems in this implementation guide. The format for the version ID is determined by the coding system being used. The length has been increased to handle longer versioning strings. Page 15 of 150 September 2011 TABLE 2-2. CODED WITH EXCEPTIONS − ALL FIELDS EXCEPT OBX-5 (CWE) SEQ Component Name DT Use LEN C.LEN Value Set Comments 9 Original Text ST RE 1..199 = Either original Text is used to convey the text that was the basis for coding, or when there is no code to be sent, only free text. If neither the first or second triplet has values, this contains the text of the field. 10 Second Alternate Identifier ST O 1..20 = Additional local code. 11 Second Alternate Text ST O 1..199 = Additional local text. 12 Second Name of Alternate Coding System ID O 1..12 = 13 Second Alternate Coding System Version ID ST O 1..10 = Version for the coding system identified in components 12. 14 Coding System OID ST O 1..199 = OID for the coding system named in CWE.3. 15 Value Set OID ST O 1..199 = 16 Value Set Version ID DTM O 1..8 = 17 Alternate Coding System OID ST O 1..199 = 18 Alternate Value Set OID O 1..199 = 19 Alternate Value Set Version ID DTM O 1..8 = 20 Second Alternate Coding System OID ST O 1..199 = 21 Second Alternate Value Set OID ST O 1..199 = 22 Second Alternate Value Set Version ID DTM O 1..8 = Page 16 of 150 September 2011 ST HL70396 Note-Coding system identifier for transmitter code instance. May be the value ‘Transmitter’ or may be a standard coding system identifier. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Usage Note The CWE data type is used where it is necessary to communicate a code, text, coding system and the version of coding system the code was drawn from. It also allows the communication of an alternate code drawn from another coding system. Many coded fields in this specification identify coding systems or value sets that must be used for the field. When populating the CWE data types with these values, this guide does not give preference to the triplet in which the standard code should appear. The receiver is expected to examine the coding system names in components 3 and 6 to determine if it recognizes the coding system. The CWE data type allows communication of an early form of what has come to be called "null flavors." HL7 2.5.1 refers to these as CWE Statuses, where the values are drawn from HL7 Table 0353. The CWE Statuses are not supported in this guide. Conformance Statements: Base Profile LRI-CWE.a-1: If data is available for only one Coded Element then the triplet of CWE.1 (Identifier), CWE.2 (Text), and CWE.3 (Name of Coding System) shall be valued in accordance with the rules given for CE.1, CE.2, and CE.3. LRI-CWE.a-2: If CWE.1 (Identifier) is empty then CWE.2 (Text) SHALL NOT be valued. LRI-CWE.a-3: If CWE.1 (Identifier) is populated then CWE.3 (Name of Coding System) SHALL be valued. LRI-CWE.a-4: If CWE.4 (Alternate Identifier) is populated then CWE.6 (Name of Alternate Coding System) SHALL be valued. LRI-CWE.a-5: If CWE.4 (Alternate Identifier) is empty then CWE.5 (Alternate Text) SHALL NOT be valued. LRI-CWE.a-6: If CWE.1 (Identifier) and CWE.4 (Alternate Identifier) are not populated, then CWE.9 (Original Text) SHALL be valued. LRI-CWE.a-7: If the triplets identified by elements CWE.1 (Identifier), CWE.2 (Text) and CWE.3 (Name of Coding System) and CWE.4 (Alternate Identifier), CWE.5 (Alternate Text), and CWE.6 (Name of Alternate Coding System) are not valued then CWE.9 (Original Text) shall be valued. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 17 of 150 September 2011 2.3 CWE – CODED WITH EXCEPTIONS – FOR OBX-5 ONLY NOTE: Pre-adoption from V2.7.1 of Components 10-22 SEQ TABLE 2-3. CODED WITH EXCEPTIONS – FOR OBX-5 ONLY (CWE) Component Name DT Use LEN C.LEN Value Set Comments 1 Identifier ST R 1..20 = Note: The identifier component is always required. 2 Text ST RE 1..199 = It is strongly recommended that text be sent to accompany any identifier. When a coded value is not known, the original text attribute is used to carry the text, not the text component. 3 Name of Coding System ID R 1..12 = 4 Alternate Identifier ST RE 1..20 = The alternate identifier (from the alternate coding system) should be the closest match for the identifier found in component 1. 5 Alternate Text ST RE 1..199 = It is strongly recommended that alternate text be sent to accompany any alternate identifier. 6 Name of Alternate Coding System ID C(R/X) 1..12 = 7 Coding System Version ID ST O 1..10 = The length has been increased to handle longer versioning strings. 8 Alternate Coding System Version ID ST O 1..10 = The length has been increased to handle longer versioning strings. 9 Original Text ST R 1..199 = Original Text is used to convey the text that was the basis for coding. 10 Second Alternate Identifier ST O 1..20 = Additional local code. 11 Second Alternate Text ST O 1..199 = Additional local text. 12 Second Name of Alternate Coding System ID O 1..12 = Page 18 of 150 September 2011 HL70396 HL70396 See Section 4 for description of the use of coding systems in this implementation guide. See section 4 for description of the use of coding systems in this implementation guide. HL70396 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. SEQ TABLE 2-3. CODED WITH EXCEPTIONS – FOR OBX-5 ONLY (CWE) Component Name DT Use LEN C.LEN Value Set Comments 13 Second Alternate Coding System Version ID ST O 1..10 = Version for the coding system identified in components 12. 14 Coding System OID ST O 1..199 = OID for the coding system named in CWE.3. 15 Value Set OID ST O 1..199 = Not supported. 16 Value Set Version ID DTM O 1..8 = Not supported. 17 Alternate Coding System OID ST O 1..199 = Not supported. 18 Alternate Value Set OID ST O 1..199 = Not supported. 19 Alternate Value Set Version ID DTM O 1..8 = Not supported. 20 Second Alternate Coding System OID ST O 1..199 = Not supported. 21 Second Alternate Value Set OID ST O 1..199 = Not supported. 22 Second Alternate Value Set Version ID O 1..8 = Not supported. DTM Usage Note This version of the CWE is used only with OBX-5. The CWE data type is used where it is necessary to communicate a code, text, coding system and the version of coding system the code was drawn from. It also allows the communication of an alternate code drawn from another coding system. Many coded fields in this specification identify coding systems or value sets that must be used for the field. When populating the CWE data types with these values, this guide does not give preference to the triplet in which the standard code should appear. The receiver is expected to examine the coding system names in components 3 and 6 to determine if it recognizes the coding system. CWE.9 is always expected to be sent in this CWE to comply with CLIA regulation of matching result statements between reports of record at both sender and receiver system. The CWE data type allows communication of "null flavors", referred to as CWE Status(es), where the values are drawn from HL7 Table 0353. The CWE Statuses are not supported in this guide. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 19 of 150 September 2011 Conformance Statements: Base Profile LRI-CWE.b-1: If CWE.4 (Alternate Identifier) is valued, then CWE.6 (Name of Alternate Coding System) SHALL be valued. 2.4 CX – GU – EXTENDED COMPOSITE ID WITH CHECK DIGIT (GLOBALLY UNIQUE) SEQ TABLE 2-4. EXTENDED COMPOSITE ID WITH CHECK DIGIT (CX GU) Component Name DT Use LEN C.LEN Value Set Comments 1 ID Number ST R 1..15 = 2 Check Digit ST O 1..4 = 3 Check Digit Scheme ID O 3..3 = 4 Assigning Authority HD R 5 Identifier Type Code ID R 6 Assigning Facility HD O # 7 Effective Date DT O = 8 Expiration Date DT O = 9 Assigning Jurisdiction CWE O # Local 10 Assigning Agency or Department CWE O # Local Page 20 of 150 September 2011 The ID Number component combined with the Assigning Authority component must uniquely identify the associated object, i.e., any object with which the field is associated. Note despite the component being named “ID Number” this component is an ST string data type, not numeric, so the component is not limited to just numbers. HL7 0061 # 2..5 = The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID Number in component 1. HL70203 The Assigning Facility identifies the place or location that the ID Number was assigned for use. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Usage Note The CX data type is used to carry identifiers. This guide requires that all identifiers be accompanied by assigning authorities, and that all identifiers carry an identifier type. This method allows the exchange of unique identifiers for the associated object across organizational and enterprise boundaries, enabling broad interoperability. Although the Identifier Type Code component is required, it is not a part of the actual identifier. Rather, it is metadata about the identifier. The ID Number and Assigning Authority component, together, constitute the actual identifier. The reason for this requirement is to promote forward compatibility with HL7 Version 3 identifiers, where there is no concept of identifier type codes. Conformance Statement: LRI-GU Profile LRI-CX.a-1: The CX.4 (Assigning Authority) SHALL use the HD-GU datatype definition. 2.5 CX – NG – EXTENDED COMPOSITE ID WITH CHECK DIGIT (NON-GLOBALLY UNIQUE) TABLE 2-5. EXTENDED COMPOSITE ID WITH CHECK DIGIT (CX NG) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 ID Number ST R 1..15 = 2 Check Digit ST O 1..4 = 3 Check Digit Scheme ID O 3..3 = 4 Assigning Authority HD RE 5 Identifier Type Code ID R 6 Assigning Facility HD O The ID Number component combined with the Assigning Authority component must uniquely identify the associated object, i.e., any object with which the field is associated. Note - despite the component being named “ID Number” this component is an ST string data type, not numeric, so the component is not limited to just numbers. HL7 0061 # 2..5 = The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID Number in component 1. HL70203 # HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. The Assigning Facility identifies the place or location that the ID Number was assigned for use. Page 21 of 150 September 2011 TABLE 2-5. EXTENDED COMPOSITE ID WITH CHECK DIGIT (CX NG) SEQ Component Name DT Use LEN C.LEN Value Set Comments 7 Effective Date DT O = 8 Expiration Date DT O = 9 Assigning Jurisdiction CWE O # Local 10 Assigning Agency or Department CWE O # Local Usage Note The CX data type is used to carry identifiers. This guide requires that assigning authorities accompany all identifiers, and that all identifiers carry an identifier type. This method allows the exchange of unique identifiers for the associated object across organizational and enterprise boundaries, enabling broad interoperability. Although the Identifier Type Code component is required, it is not a part of the actual identifier. Rather, it is metadata about the identifier. The ID Number and Assigning Authority component, together, constitute the actual identifier. The reason for this requirement is to promote forward compatibility with HL7 Version 3 identifiers, where there is no concept of identifier type codes. Conformance Statement: LRI-NG Profile LRI-CX.b-1: The CX.4 (Assigning Authority) SHALL use the HD-NG datatype definition. 2.6 DR – DATE/TIME RANGE SEQ Component Name DT TABLE 2-6. DATE/TIME RANGE (DR) Use LEN C.LEN Value Set Comments 1 Range Start Date/Time TS RE # 2 Range End Date/Time TS RE # Page 22 of 150 September 2011 To be addressed per field (in SPM) HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.7 DT – DATE SEQ Component Name DT Use TABLE 2-7. DATE (DT) LEN C.LEN Value Set Comments 1 - R 4..8 Date = Format: YYYY[MM[DD]] 2.8 DTM – DATE/TIME TABLE 2-8. DATE/TIME (DTM) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 - R 4..24 = Format: YYYY[MM[DD[HH[MM[SS[.S[S[S[S]]]]]]]]][+/-ZZZZ] Date/Time Usage Note It is strongly recommended that the time zone offset always be included in the DTM particularly if the granularity includes hours, minutes, seconds, etc. Specific fields in this implementation guide may require Date/Time to a specific level of granularity, which may require the time zone offset. The granularity of the DTM as well as whether the time zone offset is required or recommended is set for each field separately in the comments section. 2.9 ED – ENCAPSULATED DATA SEQ Component Name DT TABLE 2-9. ENCAPSULATED DATA (ED) Use LEN C.LEN Value Set Comments 1 Source Application HD RE # 2 Type of Data ID R 4..11 = HL70834 (from HL7 2.7.1) Identifier of the type of data found in component 5. See section 0 for details of HL70834. 3 Data Subtype ID RE 1..32 = HL70291 (from HL7 2.7.1) Identifier of the subtype of data found in component 5. 4 Encoding ID R 1..6 = HL70299 Identifier of the type of encoding to be performed in the data component HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Identifier of the application that is the source of the encapsulated data. Page 23 of 150 September 2011 SEQ Component Name 5 Data DT TABLE 2-9. ENCAPSULATED DATA (ED) Use LEN C.LEN Value Set Comments TX R = The data in this component must be properly escaped after encoding. Receivers will need to un-escape the text prior to decoding. Usage Note Specific MIME type/MIME subtypes to be supported will be worked out for specific implementations. 2.10 EI GU – ENTITY IDENTIFIER (GLOBALLY UNIQUE) SEQ Component Name DT TABLE 2-10. ENTITY IDENTIFIER (EI GU) Use LEN C.LEN Value Set Comments 1 Entity Identifier ST R 1..199 = 2 Namespace ID IS RE 1..20 = 3 Universal ID ST R 1..199 = 4 Universal ID Type ID R 1..6 = Local See profile for stronger requirements. The coding system for this component is locally managed. HL70301 Constrained to the value "ISO" Usage Note The EI data type is used to carry identifiers. This guide requires that all entity identifiers be accompanied by assigning authorities. This allows the exchange of unique identifiers for the associated object across organizational and enterprise boundaries, enabling broad interoperability. In the EI data type, the Namespace ID, Universal ID and Universal ID type correspond to the HD data type identified elsewhere. These types, together, are commonly considered the assigning authority for the identifier. Conformance Statement: LRI-GU Profile LRI-EI.a-1: EI.4 (Universal ID Type) SHALL contain the value “ISO”. LRI-EI.a-2: EI.3 (Universal ID) SHALL be valued with an ISO-compliant OID. Page 24 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.11 EI NG – ENTITY IDENTIFIER (NON-GLOBALLY UNIQUE) SEQ Component Name DT TABLE 2-11. ENTITY IDENTIFIER (EI NG) Use LEN C.LEN Value Set Comments 1 Entity Identifier ST R 1..199 = 2 Namespace ID IS O 1..20 = 3 Universal ID ST C(R/RE) 1..199 = 4 Universal ID Type ID C(RE/O) 1..6 = Local The coding system for this component is locally managed. HL70301 Usage Note The EI data type is used to carry identifiers. This guide requires that all entity identifiers be accompanied by assigning authorities. This allows the exchange of unique identifiers for the associated object across organizational and enterprise boundaries, enabling broad interoperability. In the EI data type, the Namespace ID, Universal ID and Universal ID type correspond to the HD data type identified elsewhere. These types, together, are commonly considered the assigning authority for the identifier. 2.12 EIP – GU – ENTITY IDENTIFIER PAIR (GLOBALLY UNIQUE) SEQ Component Name TABLE 2-12. ENTITY IDENTIFIER PAIR (EIP GU) DT Use LEN C.LEN Value Set Comments 1 Placer Assigned Identifier EI * # * See specific usage in OBR-29 and SPM-2 2 Filler Assigned Identifier EI * # * See specific usage in OBR-29 and SPM-2 Conformance Statement: LRI-GU Profile LRI-EIP.a-1: The datatype EI-GU SHALL be used for EIP.1 (Placer Assigned Identifier) and EIP.2 (Filler Assigned Identifier). LRI-EIP.a-2: If EIP.2 (Filler Assigned Identifier) is not valued then EIP.1 (Placer Assigned Identifier) SHALL be valued. LRI-EIP.a-3: If EIP.1 (Placer Assigned Identifier) is valued then EIP.2 (Filler Assigned Identifier) MAY be valued. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 25 of 150 September 2011 2.13 EIP – NG – ENTITY IDENTIFIER PAIR (NON-GLOBALLY UNIQUE) SEQ Component Name TABLE 2-13. ENTITY IDENTIFIER PAIR (EIP NG) DT Use LEN C.LEN Value Set Comments 1 Placer Assigned Identifier EI * # * See specific usage in OBR-29 and SPM-2 2 Filler Assigned Identifier EI * # * See specific usage in OBR-29 and SPM-2 Conformance Statement: LRI-NG Profile LRI-EIP.b-1: The datatype EI-NG SHALL be used for EIP.1 (Placer Assigned Identifier) and EIP.2 (Filler Assigned Identifier). LRI-EIP.b-2: If EIP.2 (Filler Assigned Identifier) is not valued then EIP.1 (Placer Assigned Identifier) SHALL be valued. LRI-EIP.b-3: If EIP.2 (Filler Assigned Identifier) is valued then EIP.1 (Placer Assigned Identifier) MAY be valued. 2.14 ERL – ERROR LOCATION TABLE 2-14. ERROR LOCATION (ERL) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Segment ID ST R 3..3 = 2 Segment Sequence NM R 1..2 = 3 Field Position NM O 1..2 = The field number with the error. Should not be populated for errors involving the entire segment. 4 Field Repetition NM O 1..2 = The first field repetition is counted a 1. 5 Component Number NM O 1..2 = 6 Sub-component Number NM O 1..2 = The 3-character name for the segment (i.e., PID). 2.15 FN – NEW TABLE See datatypes spreadsheet Page 26 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.16 FT – FORMATTED TEXT DATA TABLE 2-15. FORMATTED TEXT DATA (FT) SEQ Component Name Formatted Text Data DT Use LEN C.LEN - R 1..65536 64,000 Value Set Comments Usage Note The FT data type allows use of the formatting escape sequences documented in HL7 Version 2.5.1, Chapter 2, Section 2.7.1 - Use of Escape Sequences in Text Fields. In this Profile, the only allowed escape sequences are those allowed in HL7 Version 2.5.1, Chapter 2, Section 2.7.4 - Special Characters. These are the escape sequences for the message delimiters (i.e., |^&~\). 2.17 HD GU – HIERARCHIC DESIGNATOR (GLOBALLY UNIQUE) TABLE 2-16. HIERARCHIC DESIGNATOR (HD GU) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Namespace ID IS RE 1..20 = Local The coding system for this component is locally managed. 2 Universal ID ST R 1..199 = 3 Universal ID Type ID R 1..6 = Must be an ISO-compliant OID HL70301 Constrained to the value ‘ISO’ except for Lab Result Receiver for MSH-4 where the value ‘CLIA’ is allowed. Usage Note The HD data type is used directly to identify objects such as applications or facilities. It is used also as a component of other data types, where it is typically an assigning authority for an identifier. Where this capability is used in this specification, the usage is described separately. Note that the HD datatype has been constrained to carry an OID identifying an application, a facility, or an assigning authority. The only exception to the use of OID’s for the HD is for the Lab Result Receiver profile for MHS-4 (Sending Facility) Conformance Statement: LRI-GU Profile LRI-HD.a-1: HD.2 (Universal ID) SHALL be valued with an ISO-compliant OID. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 27 of 150 September 2011 LRI-HD.a-2: HD.3 (Universal ID Type) SHALL contain the value “ISO”. 2.18 HD NG – HIERARCHIC DESIGNATOR (NON-GLOBALLY UNIQUE) TABLE 2-17. HIERARCHIC DESIGNATOR (HD NG) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Namespace ID IS O 1..20 = Local The coding system for this component is locally managed. 2 Universal ID ST C(R/RE) 1..199 = 3 Universal ID Type ID C(RE/O) 1..6 HL70301 Note: Conditions need to be negotiated by the trading partners = Usage Note The HD data type is used directly to identify objects such as applications or facilities. It is used also as a component of other data types, where it is typically an assigning authority for an identifier. Where this capability is used in this specification, the usage is described separately. Conformance Statement: LRI-NG Profile LRI-HD.b-1: If HD.1 (Namespace ID) is not valued then HD.2 (Universal ID) SHALL be valued. LRI-HD.b-1: If HD.2 (Universal ID) is valued then HD.3 (Universal ID Type) SHALL be valued. Page 28 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.19 ID – CODED VALUE FOR HL7-DEFINED TABLES TABLE 2-18. CODED VALUE FOR HL7-DEFINED TABLES (ID) SEQ Component Name DT Use LEN C.LEN 1 Coded Value for HL7-Defined Tables - R 1..15 = Value Set Comments 2.20 IS – CODED VALUE FOR USER-DEFINED TABLES SEQ Component Name 1 Coded Value for User-Defined Tables TABLE 2-19. CODED VALUE FOR USER-DEFINED TABLES (IS) DT Use LEN C.LEN Value Set Comments - R 1..20 = 2.21 MSG – MESSAGE TYPE SEQ Component Name DT TABLE 2-20. MESSAGE TYPE (MSG) Use LEN C.LEN Value Set Comments 1 Message Code ID R 3..3 = HL70076 2 Trigger Event ID R 3..3 = HL70003 3 Message Structure ID R 3..7 = HL70354 2.22 NM – NUMERIC TABLE 2-21. NUMERIC (NM) SEQ Component Name DT Use LEN C.LEN 1 Numeric - R 1..16 = HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Value Set Comments HL7 allows only ASCII numeric characters as well as an optional leading plus or minus sign and an option decimal point. Note that use of scientific notation for numbers is not supported by this data type. Page 29 of 150 September 2011 2.23 PRL – PARENT RESULT LINK TABLE 2-22. PARENT RESULT LINK (PRL) SEQ Component Name DT Use 1 Parent Observation Identifier CWE R 2 Parent Observation SubIdentifier ST RE 3 Parent Observation Value Descriptor TX O LEN 1..20 C.LEN Value Set Comments # Laboratory Identifier of the OBX-3 Observation ID of the parent Observation Value result. Typically, this is used in microbiology results Set where the sensitivities are linked to the specific culture OBX where the organism was identified. = Identifier of the OBX-4 Observation Sub-ID associated with the OBX-3 Observation ID of the parent result. Typically, this is used in microbiology results where the sensitivities are linked to the specific culture OBX where the organism was identified. The combination of OBX-3 and OBX-4 must be unique within a particular OBR. = Taken from the OBX-5 of the parent result. If OBX-5 contains coded data, this will be the value of the text component of the CE or CWE data type or the original text component of the CWE data type when there is no coded component. Usage Note See Section 7.1 of this document for details on how this data type and the EIP data type are used in parent/child result linking. Use of data type CWE for sequence 1 reflects a pre-adoption of HL7 Version 2.7.1 standards. 2.24 PT – PROCESSING TYPE TABLE 2-23. PROCESSING TYPE (PT) LEN C.LEN Value Set Comments SEQ Component Name DT Use 1 Processing ID ID R 1..1 = HL70103 2 Processing Mode ID O 1..1 = HL70207 Page 30 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.25 RP – REFERENCE POINTER SEQ Component Name DT TABLE 2-24. REFERENCE POINTER (RP) Use LEN C.LEN Value Set Comments 1 Pointer ST R 2 Application ID HD R 2.1 Namespace ID IS O 1..20 = 2.2 Universal ID ST R 1..199 = 2.3 Universal ID Type ID R 1..6 = HL70301 This component is constrained to support only universal Resource Identifier. Literal value: ‘URI’ 3 Type of Data ID RE 4..11 = HL70834 (2.7.1) Identifier of the type of data pointed to. For the URI example referenced above, this is '"application." 4 Subtype ID RE 1..32 = HL70291 (2.7.1) Identifier of the subtype of data pointed to. For the URI example above, this is "pdf," indicating portable document format. 1..999 = Pointer to the object. For URIs, it contains the path and query parts. Example: /phin/library/documents/pdf/DRAFT_PHIN_ORU_ELR _v2.5.1_20061221.pdf # Unique identifier of the application that holds the object being pointed to. For URIs, it contains the scheme and authority parts. Note that the HD data type used for this component is specialized for use in the RP data type, and is different than what is defined in section 2.18 (HD). Local This component is restricted to a universal resource identifier (URI). For URIs, contains the scheme and authority parts. Example: http://www.cdc.gov Usage Note The field uses the RP data type to allow communication of pointers to images, sound clips, XML documents, HTML markup, etc. The RP data type is used when the object being pointed to is too large to transmit directly. This specification defines the mechanism for exchanging pointers to objects, but does not address the details of applications actually accessing and retrieving the objects over a network. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 31 of 150 September 2011 This guide constrains this data type to support only Universal Resource Identifiers (URI). See http://ietf.org/rfc/rfc2396.txt for a detailed definition. The general format of a URI is in the form <scheme>://<authority><path>?<query>. The scheme and authority portions appear in the Application ID component, Universal ID subcomponent. The path and query portion of the URI appear in the Pointer component of the RP data type. 2.26 SAD – NEW TABLE SEE datatypes spreadsheet 2.27 SI – SEQUENCE ID TABLE 2-25.SEQUENCE ID (SI) SEQ Component Name DT Use LEN C.LEN 1 Sequence ID - R 1..4 = Value Set Comments Non-negative integer up to 9999. May be further constrained to limit the number of times a segment may repeat. 2.28 SN – STRUCTURED NUMERIC TABLE 2-26. STRUCTURED NUMERIC (SN) SEQ Component Name DT Use LEN C.LEN 1 Comparator ST RE 1..2 = 2 Num1 NM RE 3 Separator/Suffix ST RE 4 Num2 NM RE Value Set Comments Component that must be one of ">" or "<" or ">=" or "<=" or "=" or "<>". This component defaults to "=" if empty. = 1..1 = Component that must be one of "-" or "+" or "/" or "." or ":". = Usage Note The SN data type carries a structured numeric result value. Structured numeric values include intervals (^0^-^1), ratios (^1^/^2 or ^1^:^2), inequalities (<^10), or categorical results (2^+) Page 32 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 2.29 ST – STRING DATA TABLE 2-27. STRING DATA (ST) SEQ Component Name DT Use 1 - R String Data LEN C.LEN Value Set Comments Usage Note The ST data type is normally used for short text strings. No leading blanks (space characters) are permitted. Trailing blanks are permitted. In this Profile, the only allowed escape sequences are those allowed in HL7 Version 2.5.1, Chapter 2, Section 2.7.4 - Special Characters. These are the escape sequences for the message delimiters (i.e., |^&~\). 2.30 TM – TIME SEQ Component Name DT Use TABLE 2-28. TIME (TM) LEN C.LEN Value Set 1 - R 2..16 Time Comments Format: HH[MM[SS[.S[S[S[S]]]]]][+/-ZZZZ] Usage Note It is strongly recommended that the time zone offset always be included in the TM. Specific fields in this implementation guide may require time to a specific level of granularity, which may require the time zone offset. 2.31 TS – TIME STAMP SEQ Component Name DT Use 1 Time DTM R 2 Degree of Precision ID X TABLE 2-29. TIME STAMP (TS) LEN C.LEN Value Set HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comments Deprecated as of HL7 Version 2.3. See component 1 (DTM) for the current method of designating degree of precision. Page 33 of 150 September 2011 2.32 TX – TEXT DATA SEQ Component Name DT Use 1 - R Text Data TABLE 2-30. TEXT DATA (TX) LEN C.LEN Value Set Comments Usage Note The TX data type is used to carry string data intended for display purposes. It can contain leading blanks (space characters). In this Profile, the only allowed escape sequences are those allowed in HL7 Version 2.5.1, Chapter 2, Section 2.7.4 - Special Characters. These are the escape sequences for the message delimiters (i.e., |^&~\). 2.33 VID – VERSION IDENTIFIER TABLE 2-31. VERSION IDENTIFIER (VID) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 Version ID ID R 3..5 = HL70104 Restricted to 2.5.1 in this guide. Literal value: ‘2.5.1’ 2 Internationalization Code CWE O # Country Value Set 3 International Version ID CWE O # Local Conformance Statement: Base Profile LRI-VID-1: VID.1 (Version ID) SHALL be valued with the literal value: 2.5.1 2.34 XAD – EXTENDED ADDRESS TABLE 2-32. EXTENDED ADDRESS (XAD) SEQ Component Name DT Use 1 Street Address SAD RE 2 Other Designation ST RE 1..120 = 3 City ST RE 1..50 = Page 34 of 150 September 2011 LEN C.LEN Value Set Comments # Example: Suite 555 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 2-32. EXTENDED ADDRESS (XAD) SEQ Component Name DT Use LEN C.LEN Value Set Comments 4 State or Province ST RE 1..50 = State Value Set The 2 letter (alpha) codes should be used here. 5 Zip or Postal Code ST RE 1..12 = Postal Code Value In the US, the zip code takes the form 99999[-9999], Set while the Canadian postal code takes the form A9A9A9. 6 Country ID RE 3..3 = Country Value Set 7 Address Type ID RE 1..3 = HL70190 8 Other Geographic Designation ST O 1..50 = 9 County/Parish Code IS RE 1..20 = PHVS_County_FIP S_6-4 10 Census Tract IS O 1..20 = HL70288 11 Address Representation Code ID O 1..1 = HL70465 12 Address Validity Range DR X 13 Effective Date TS O 1..8 = 14 Expiration Date TS O 1..8 = Deprecated as of HL7 Version 2.5. See XAD-13 Effective Date and XAD-14 Expiration Date components. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 35 of 150 September 2011 2.35 XCN – GU – EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (GLOBALLY UNIQUE) TABLE 2-33. EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (XCN GU) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 ID Number ST RE 1..15 = The ID Number component combined with the Assigning Authority component (component 9) must uniquely identify the associated person. Note - despite the component being named “ID Number” this component is an ST string data type, not numeric, so the component is not limited to just numbers. 2 Family Name FN RE 3 Given Name ST RE 1..30 = 4 Second and Further Given Names or Initials Thereof ST RE 1..30 = 5 Suffix (e.g., JR or III) ST RE 1..20 = 6 Prefix (e.g., DR) ST RE 1..20 = 7 Degree (e.g., MD) IS X 1..20 = HL70360 8 Source Table IS O 1..20 = HL70297 9 Assigning Authority HD C(R/X) 10 Name Type Code ID RE 1..5 = 11 Identifier Check Digit ST O 1..4 = 12 Check Digit Scheme ID C(R/X) 3..3 = HL70061 13 Identifier Type Code ID C(R/X) 2..5 = HL70203 14 Assigning Facility HD O # Page 36 of 150 September 2011 # I.e., first name. # The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID Number in component 1. HL70200 Defaults to l (legal name) if empty. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 2-33. EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (XCN GU) SEQ Component Name DT Use LEN C.LEN Value Set 15 Name Representation Code ID O 1..1 = HL70465 16 Name Context CE O # H L70448 17 Name Validity Range DR X 18 Name Assembly Order ID O 1..1 = 19 Effective Date TS O 1..8 = 20 Expiration Date TS O 1..8 = 21 Professional Suffix ST O 1..199 = 22 Assigning Jurisdiction CWE O # 23 Assigning Agency or Department CWE O # Comments Deprecated as of HL7 Version 2.5. See XCN-19 Effective Date and XCN-20 Expiration Date components. HL70444 Suggest using values from HL7 table 360. Conformance Statement: LRI-GU LRI-XCN-1: If XCN.1 (ID Number) is valued, XCN.13 (Identifier Type Code) SHALL be valued. LRI-XCN-2: XCN.9 (Assigning Authority) SHALL use datatype HD-GU. LRI-XCN-3: If XCN.11 (Check Digit) is valued, then XCN.12 (Check Digit Scheme) SHALL be required. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 37 of 150 September 2011 2.36 XCN – NG – EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (NON-GLOBALLY UNIQUE) TABLE 2-34. EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (XCN NG) SEQ Component Name DT Use LEN C.LEN Value Set Comments 1 ID Number ST RE 1..15 = The ID Number component combined with the Assigning Authority component (component 9) must uniquely identify the associated person. Note - despite the component being named “ID Number” this component is an ST string data type, not numeric, so the component is not limited to just numbers. 2 Family Name FN RE 3 Given Name ST RE 1..30 = 4 Second and Further Given Names or Initials Thereof ST RE 1..30 = 5 Suffix (e.g., JR or III) ST RE 1..20 = 6 Prefix (e.g., DR) ST RE 1..20 = 7 Degree (e.g., MD) IS X 1..20 8 Source Table IS O 1..20 9 Assigning Authority HD NG C(RE/X) 10 Name Type Code ID RE 1..5 = 11 Identifier Check Digit ST O 1..4 = 12 Check Digit Scheme ID C(R/X) 3..3 = HL70061 13 Identifier Type Code ID RE 2..5 = HL70203 14 Assigning Facility HD NG O 15 Name Representation Code ID Page 38 of 150 September 2011 O # I.e., first name. HL70360 = HL70297 # The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID Number in component 1. HL70200 Defaults to l (legal name) if empty. # 1..1 = HL70465 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 2-34. EXTENDED COMPOSITE ID NUMBER AND NAME FOR PERSONS (XCN NG) SEQ Component Name DT Use LEN C.LEN Value Set 16 Name Context CE O 17 Name Validity Range DR X 18 Name Assembly Order ID O 1..1 = 19 Effective Date TS O 1..8 = 20 Expiration Date TS O 1..8 = 21 Professional Suffix ST O 1..199 = 22 Assigning Jurisdiction CWE O # 23 Assigning Agency or Department CWE O # # Comments H L70448 Deprecated as of HL7 Version 2.5. See XCN-19 Effective Date and XCN-20 Expiration Date components. HL70444 Suggest using values from HL7 table 360. Conformance Statement: LRI-NG Profile LRI-XCN-3: XCN.9 (Assigning Authority) SHALL use datatype HD-NG. LRI-XCN-5: If XCN.11 (Check Digit) is valued, then XCN.12 (Check Digit Scheme) SHALL be required. 2.37 XON GU – EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS GLOBALLY UNIQUE) TABLE 2-35. EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS (XON GU) SEQ Component Name DT Use LEN C.LEN Value Set 1 Organization Name ST RE 1..50 = 2 Organization Name Type Code IS O 1..20 = 3 ID Number NM X 4 Check Digit NM O Comments HL70204 (Deprecated as of HL7 Version 2.5.) Use XON-10 Organization Identifier. 1..4 = HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 39 of 150 September 2011 TABLE 2-35. EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS (XON GU) SEQ Component Name DT Use LEN C.LEN Value Set 5 Check Digit Scheme ID C(R/X) 3..3 = 6 Assigning Authority HD GU C(R/X) 7 Identifier Type Code ID 8 Assigning Facility HD GU O 9 Name Representation Code ID O 10 Organization Identifier ST C(R/RE) 1..20 C(R/X) Comments HL70061 # 2..5 = The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID in component 10. HL70203 # 1..1 = HL70465 = Conformance Statement: Base Profile LRI-XON.a-1: If XON.1 (Organization Name) is not valued then XON.10 (Organization Identifier) SHALL be valued. Note: both XON.1 and XON.10 may be populated, but at least one of them must be valued. Conformance Statement: LRI-GU Profile LRI-XON.a-3: XON.6 (Assigning Authority) SHALL use datatype HD-GU. 2.38 XON NG – EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS (NON-GLOBALLY UNIQUE) TABLE 2-36. EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS (XON NG) SEQ Component Name DT Use LEN C.LEN Value Set 1 Organization Name ST RE 1..50 = 2 Organization Name Type Code IS O 1..20 = 3 ID Number NM X 4 Check Digit NM O Page 40 of 150 September 2011 Comments HL70204 (Deprecated as of HL7 Version 2.5.) Use XON-10 Organization Identifier. 1..4 = HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 2-36. EXTENDED COMPOSITE NAME AND IDENTIFICATION NUMBER FOR ORGANIZATIONS (XON NG) SEQ Component Name DT Use LEN C.LEN Value Set 5 Check Digit Scheme ID C(R/X) 3..3 = 6 Assigning Authority HD 7 Identifier Type Code ID C(R/X) 8 Assigning Facility HD O 9 Name Representation Code ID O 1..1 = 10 Organization Identifier ST RE 1..20 = HL70061 # 2..5 = Comments The Assigning Authority component is used to identify the system, application, organization, etc. that assigned the ID in component 10. HL70203 # HL70465 Conformance Statement: Base Profile LRI-XON.b-1: XON.1 (Organization Name) or XON.10 (Organization Identifier) SHALL be valued. Note: both XON.1 and XON.10 may be populated, but at least one of them must be valued. 2.39 XPN – EXTENDED PERSON NAME TABLE 2-37. EXTENDED PERSON NAME (XPN) SEQ Component Name DT Use LEN C.LEN Value Set 1 Family Name FN RE 2 Given Name ST RE 1..30 = 3 Second and Further Given Names or Initials Thereof ST RE 1..30 = 4 Suffix (e.g., JR or III) ST RE 1..20 = 5 Prefix (e.g., DR) ST RE 1..20 = 6 Degree (e.g., MD) IS X 1..20 7 Name Type Code ID RE 1..5 Comments # I.e., first name. HL70360 = HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. HL70200 Defaults to l (legal name) if empty. Page 41 of 150 September 2011 TABLE 2-37. EXTENDED PERSON NAME (XPN) SEQ Component Name DT Use LEN C.LEN Value Set 8 Name Representation Code ID O 1..1 = HL70465 9 Name Context CWE O # HL70448 10 Name Validity Range DR X 11 Name Assembly Order ID O 12 Effective Date TS O = 13 Expiration Date TS O = 14 Professional Suffix ST RE Page 42 of 150 September 2011 Comments Deprecated as of HL7 Version 2.5. See XPN-12 Effective Date and XPN-13 Expiration Date components. 1..1 1..199 = = HL70444 Suggest using values from HL7 table 360. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 3. MESSAGES The following sections detail the structure of each message, including segment name, usage, cardinality and description. See Section 1.6.2 for a description of the columns in the Abstract Message Syntax Tables. 3.1 ORU^R01^ORU_R01 The ORU^R01 message is constrained for transmitting laboratory results from the testing source to the Receiver as defined in each Use Case. Segment in Name Standard MSH Message Header [{SFT}] { [ TABLE 3-1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX Use Cardinality Description R [1..1] 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. O [0..*] 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 R [1..1] PATIENT Begin R [1..1] Software Segment PID Patient Identification R [1..1] [PD1] Additional Demographics O [0..1] [{NTE}] Notes and Comments for PID O [0..1] HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 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. This notes and comments (NTE) segment should contain notes or comments pertaining to the patient identified in the PID segment. It should not contain order or result related comments. Page 43 of 150 September 2011 TABLE 3-1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX Segment in Name Use Cardinality Description Standard [{NK1}] Next of Kin/Associated Parties O [0..*] The next of kin (NK1) segment can be used to document the patient’s next of kin, employer, guardian, etc. Particular jurisdictions may require the NK1 segment to contain parent/guardian information when reporting lead testing results for children. When reporting results of animal testing (for example testing animals for rabies) the NK1 segment can be used to identify the owner of the animal. [ VISIT Begin O [0..1] PV1 Patient Visit R [1..1] [PV2] Patient Visit – Additional Information O [0..1] ] VISIT End ] PATIENT End { ORDER_OBSERVATION Begin HL7 requires that the patient visit (PV1) segment be present if the VISIT group is present. R [1..*] The order group is required and can repeat. This means that multiple ordered tests may be performed on a specimen. Snapshot processing of the result message involves processing as a snapshot all the repeats of the ORDER_OBSERVATION group together as a group. This is especially important when dealing with parent/child results (such as cultures and sensitivities) that will span multiple ORDER_OBSERVATION groups. All these must be processed from both a message sender and message receiver perspective as a single snapshot. [ORC] Order Common R [1..1] The common order (ORC) segment identifies basic information about the order for testing of the specimen. This segment includes identifiers of the order, who placed the order, when it was placed, what action to take regarding the order, etc. OBR Observations Request R [1..1] The observation request (OBR) segment is used to capture information about one test being performed on the specimen. Most importantly, the OBR identifies the type of testing to be performed on the specimen, and ties that information to the order for the testing. Notes and Comments for OBR RE [0..*] RE [0..1] [{NTE}] [{ TIMING_QTY Begin TQ1 Timing/Quantity R [1..1] [{TQ2}] Timing/Quantity Order Sequence O [0..1] }] Page 44 of 150 September 2011 Although Timing/Quantity may be necessary for orders, it’s not necessary for result reporting. TIMING_QTY End HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Segment in Name Standard [CTD] Contact Data [{ OBSERVATION Begin O [0..1] C(R/X) [0..*] Condition Predicate: If OBR.25 is A, C, F, P, or R Multiple Observation groups, each containing a single OBX and an optional repeating NTE, may be associated with a single order. Snapshot processing: Since the OBX segment in 2.5.1 does not contain a unique instance identifier; it is assumed that the repeating observation group will contain a complete set of observations (OBXs) associated with the OBR. Where a single OBX is being updated, all the OBXs related to the OBR must accompany the updated OBX, i.e., a full snapshot is sent. OBX Observation related to OBR R [1..1] The observation/result (OBX) segment contains information regarding a single observation (analyte) result. This includes identification of the specific type of observation, the result for the observation, when the observation was made, etc. For laboratory testing, the OBX is normally reporting the results of a test performed on a specimen, Because the ORU^R01^ORU_R01 message structure allows multiple specimens to be associated with a single OBR, there is no direct way to tell which specimen this OBX is associated with. There are other HL7 messages for laboratory results where this ambiguity does not exist, but were not chosen for this implementation guide. [{NTE}] Notes and Comments RE [0..*] The notes and comment (NTE) segment may carry comments related to the result being reported in the OBX segment. }] - TABLE 3-1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX Use Cardinality Description OBSERVATION End [{FTI}] Financial Transaction O [0..*] {[CTI]} Clinical Trial Identification O [0..*] RE [0..*] The specimen group is required if known in the ORU and is used to carry specimen information that is no longer contained in the OBR segment. It also provides a place for the specimen number. Each specimen group documents a single sample. R [1..1] The specimen information (SPM) segment describes the characteristics of a single sample. The SPM segment carries information regarding the type of specimen, where and how it was collected, who collected it, and some basic characteristics of the specimen. [{ SPM SPECIMEN Begin Specimen Information related to OBR HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 45 of 150 September 2011 TABLE 3-1. ORU^R01^ORU_R01 ABSTRACT MESSAGE SYNTAX Segment in Name Use Cardinality Description Standard [{OBX}] Observation related to Specimen RE [0..*] The Observation related to Specimen is generally used to report additional characteristics related to the specimen. It is not used to report the results of the requested testing identified in OBR-4 (Universal Service ID). The observations associated with the specimen are typically information that the ordering provider sends with the order. The laboratory forwards that information as part of the result message. One recommended value to report in the OBX related to Specimen is the age of patient at time of specimen collection. The appropriate LOINC code for this is 35659-2 (Age at specimen collection:TimeDif:Pt:^Patient:Qn). Other possible types of observations include: Was specimen sent out? Was it a specimen or isolate? Id of the specimen/isolate sent for testing Where was the specimen sent? Reason for send out? Implementers will need to provide a list of expected observations associated with specimen. }] } } [DSC] Page 46 of 150 September 2011 SPECIMEN End ORDER_ OBSERVATION End PATIENT_RESULT End Continuation Pointer X [0..0] Not supported. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 3.2 ACK^R01^ACK Segment Name in Standard MSH Message Header Use TABLE 3-2. ACK^R01^ACK ABSTRACT MESSAGE SYNTAX Cardinality C.LEN Description R [1..1] 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. 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 originator) 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. [{SFT}] Software Segment O [0..*] MSA Message Acknowledgment R [1..1] [{ ERR }] Error C(R/X) [0..*] Condition predicate: Required when MSA-1 is not "AA" or "CA." 3.3 SEGMENT AND FIELD DESCRIPTIONS This messaging guide provides notes for required (non-optional) fields. The following format is used in this document for listing and defining message segments and fields. First, the message segment use is defined and then a segment attribute table listing all fields defined in the segment is shown. See Section Error! Reference source not found. for a description of the columns in the Segment Attribute Tables. Note that any optional segments that are brought forward from the base will have to be used within the constraints set forth in this guide, e.g., constraint statements will be required to use the GU or NG profiles, or to use the correct CWE datatype. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 47 of 150 September 2011 3.3.1 MSH – MESSAGE HEADER SEGMENT TABLE 3-3. MESSAGE HEADER SEGMENT (MSH) Cardinality LEN C.LEN Value Set Description/Comments SEQ Element Name DT Use 1 Field Separator ST R [1..1] 1..1 Character to be used as the field separator for the rest of the message. Literal value: ‘|’ [ASCII (124)]. 2 Encoding Characters ST R [1..1] 4..5 Four characters, always appearing in the same order: |^~\&|. Literal value: ‘^~\&’. 3 Sending Application HD R [1..1] Field that may be used to identify the sending application uniquely for messaging purposes. For this field only, if all three components of the HD are valued, the first component defines a member in the set defined by the second and third components. 4 Sending Facility HD R [1..1] Field that uniquely identifies the facility associated with the application that plays the Laboratory Result Sender Actor (see section 3.1 Use Case Model) that sends the message. If acknowledgments are in use, this facility will receive any related acknowledgment message. 5 Receiving Application HD O [0..1] Field that may be used to identify the receiving application uniquely for messaging purposes. For this field only, if all three components of the HD are valued, the first component defines a member in the set defined by the second and third components. 6 Receiving Facility HD R [1..1] Field that uniquely identifies the facility for the application that plays the Laboratory Result Receiver Actor (see section 3.1 Use Case Model) and receives the message. If acknowledgments are in use, this facility originates any related acknowledgment message. 7 Date/Time Of Message TS R [1..1] Field containing the date/time the message was created by the sending system. Format: YYYYMMDDHHMMSS[.S[S[S[S]]]]+/-ZZZZ. Note that the time zone offset is required, and the minimum granularity is to the second, although more precise time stamps are allowed. Page 48 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-3. MESSAGE HEADER SEGMENT (MSH) Cardinality LEN C.LEN Value Set Description/Comments SEQ Element Name DT Use 8 Security ST O [0..1] 9 Message Type MSG R [1..1] 10 Message Control ID ST R [1..1] 11 Processing ID PT R [1..1] Field that may be used to indicate the intent for processing the message, such as "T" (training,) "D" (debug,) or "P" (production.) 12 Version ID VID R [1..1] HL7 version number used to interpret format and content of the message. For this message, the version ID will always be Literal Value: 2.5.1. Note that receivers must examine MHS-21 (Message Profile Identifier) to understand which message profile the message instance conforms with. 13 Sequence Number NM O [0..1] 14 Continuation Pointer ST O [0..1] 1..180= 15 Accept Acknowledgment Type ID R [1..1] 2..2 HL70155 16 Application Acknowledgment Type ID R [1..1] 2..2 HL70155 17 Country Code ID O [0..1] 3..3 Country Value Set 18 Character Set ID O [0..*] 5..15 HL70211 1..40= For the result message Literal Value: ‘ORU^R01^ORU_R01’. For the acknowledgement message Literal Value: ‘ACK^R01^ACK’. 1..199= HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 199= String that uniquely identifies the message instance from the sending application. Example formats for message control IDs include GUID, timestamp plus sequence number, OID plus sequence number or sequence number. The important point is that care must be taken to insure that the message control id is unique. The sending application (MSH-3) plus MSH-10 (message control id) needs to be globally unique. Lab Result Receiver - If empty the default is ’USA’ Page 49 of 150 September 2011 TABLE 3-3. MESSAGE HEADER SEGMENT (MSH) Cardinality LEN C.LEN Value Set Description/Comments SEQ Element Name DT Use 19 Principal Language Of Message CWE O [0..1] 20 Alternate Character Set Handling Scheme ID O [0..1] 21 Message Profile Identifier EI R [1..*] 3..13 HL70356 Field used to reference or assert adherence to a message profile. The sender asserts that the message conforms to all the profiles included. It must include one of the sender profiles defined in this implementation guide ("base profile"), while the combination of profiles cannot create conflicts, and the additional profiles must be properly constrained against the base profile. The indication whether to uniquely identify a result based on placer/filler order number + universal service identifier or just placer/filler order number is done through declaring a profile in this field. If Profile GU is declared to be in effect, all profiles shall use OIDs as defined by HD-GU, including the profiles not defined in this IG. If Profile NG, only the HL7 Profile identifier is required to be an OID (assigned and managed by HL7); all other local profiles can used locally agreed to identification. Usage Note The Message Header Segment (MSH) contains information describing how to parse and process the message. This includes identification of message delimiters, sender, receiver, message type, timestamp, etc. Note: When there is no performing lab is specified in the OBX, use the combination of MSH-3 and MSH-4 to define a local coding system. It is assumed that: Different applications within an organization with a single CLIA number may have different local coding systems (e.g., a clinical pathology application vs. an anatomic pathology application). Page 50 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. A single application within an organization with a single CLIA number has a single local coding system. That coding system may contain multiple value sets, for example, it may contain local value sets for observation identifier, observation value, interpretation code, race, ethnicity, reason for study, and others. Conformance Statement: Base Profile LRI-MHS-1: PID.17 (Principal Language Of Message) SHALL be valued using the CWE (Coded with Exceptions – All Fields Except OBX-5) datatype definition and constraints. Conformance Statement: LRI-GU Profile LRI-MSH-2: MSH.3 (Sending Application), MSH.4 (Sending Facility), MSH.5 (Receiving Application), MSH.6 (Receiving Facility) SHALL be valued using the HD-GU (Hierarchical Descriptor – Globally Unique) datatype constraints. LRI-MSH-3: MSH.21 (Message Profile Identifier) SHALL be valued with 2.16.840.1.113883.9.16 (Base LRI R1) and with 2.16.840.1.113883.9.12 (GU – Globally Unique) and SHALL also be valued with either the OID 2.16.840.1.113883.9.14 (RU) or 2.16.840.1.113883.9.15 (RN) but not both. Conformance Statement: LRI-NG Profile LRI-MSH-4: MSH.3 (Sending Application), MSH.4 (Sending Facility), MSH.5 (Receiving Application), MSH.6 (Receiving Facility) SHALL be valued using the HD-NG (Hierarchical Descriptor – Non-Globally Unique) datatype constraints. LRI-MSH-5: MSH.21 (Message Profile Identifier) SHALL be valued with 2.16.840.1.113883.9.16 (Base LRI R1) and with 2.16.840.1.113883.9.13 (NG – Non-Globally Unique) and SHALL also be valued with either the OID 2.16.840.1.113883.9.14 (RU) or 2.16.840.1.113883.9.15 (RN) but not both. 3.3.2 SFT – SOFTWARE SEGMENT The software segment provides information about the sending application or other applications that manipulate the message before the receiving application processes the message. This guide imposes no additional constraints on the base specification HL7 V2.5.1, Chapter 2. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 51 of 150 September 2011 3.3.3 MSA – ACKNOWLEDGEMENT SEGMENT The Message Response Segment (MSA) contains the information sent as acknowledgment to the order message received by a Laboratory Information System. SEQ Element Name TABLE 3-4. ACKNOWLEDGMENT SEGMENT (MSA) Value DT Use Cardinality LEN C.LEN Description/Comments Set 1 Acknowledgment ID Code R [1..1] 2..2 HL70008 Acknowledgment code indicating receipt of message. (Refer to HL7 Table 0008 Acknowledgment Code for valid values.) 2 Message Control ID ST R [1..1] 1..199 3 Text Message ST X [0..0] 4 NM Expected Sequence Number O [0..1] 5 ID Delayed Acknowledgment Type X [0..0] Deprecated as of HL7 Version 2.2 and the detail was withdrawn and removed from the standard as of HL7 Version 2.5. 6 Error Condition CWE X [0..0] Deprecated as of HL7 Version 2.4. See ERR segment. Identifier that enables the sending system to associate this response with the message for which it is intended. This value will be the MSH.10 message control ID from the message being acknowledged. Deprecated as of HL7 Version 2.4. See ERR segment. 3.3.4 ERR – ERROR SEGMENT The ERR segment is used to add error comments to acknowledgment messages. TABLE 3-5. ERROR SEGMENT (ERR) SEQ Element Name DT Use Cardinality LEN 1 Error Code and Location ELD X [0..0] 2 Error Location ERL O [0..1] 3 HL7 Error Code CWE R [1..1] Page 52 of 150 September 2011 C.LEN Value Set Description/Comments Deprecated as of HL7 Version 2.5. See ERR-2 Error Location and ERR-3 HL7 Error Code fields. HL70357 Identifies the HL7 (communications) error code. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-5. ERROR SEGMENT (ERR) SEQ Element Name DT Use Cardinality LEN 4 Severity ID R [1..*] 5 Application Error Code CWE O [0..1] 6 Application Error Parameter ST O [0..10] 1..80 7 Diagnostic Information TX RE [0..1] 1..2048 8 User Message TX O [0..1] 1..250 9 Inform Person Indicator IS O [0..*] 1..20 10 Override Type CWE O [0..0] 11 Override Reason Code CWE O [0..*] 12 Help Desk Contact Point XTN RE [0..*] C.LEN 1..1 Value Set Description/Comments HL70516 Identifies the severity of an application error. Knowing if something is Error, Warning, or Information is intrinsic to how an application handles the content. HL70533 Note that HL7 table 0533 has no suggested values. It is always a user defined table, and will generally contain locally defined codes. Information that may be used by help desk or other support personnel to diagnose a problem. Conformance Statement: Base Profile LRI-ERR-1: ERR.3 (HL7 Error Code), ERR.10 (Override Type), and ERR.11(Override Reason Code) SHALL be valued using the CWE - Coded with Exceptions (All Fields Except OBX-5) datatype definition and constraints. 3.3.5 PID – PATIENT IDENTIFICATION SEGMENT The Patient Identification Segment (PID) is used to provide basic demographics regarding the subject of the testing. The subject may be a person or animal. TABLE 3-6. PATIENT IDENTIFICATION SEGMENT (PID) SEQ Element Name DT Use Cardinality LEN 1 Set ID – PID SI R [1..1] 2 Patient ID CX X [0..0] 1..4 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. C.LEN Value Set Description/Comments Literal Value: ‘1’. Deprecated as of HL7 Version 2.3.1. See PID-3 Patient Identifier List. Page 53 of 150 September 2011 TABLE 3-6. PATIENT IDENTIFICATION SEGMENT (PID) SEQ Element Name DT Use Cardinality LEN 3 Patient Identifier List CX R [1..*] Field used to convey all types of patient/person identifiers. This includes social security numbers, driver’s license numbers, medical record numbers, etc. 4 Alternate Patient ID – PID CX X [0..0] Deprecated as of HL7 Version 2.3.1. See PID-3. 5 Patient Name XPN R [1..*] Patient name or aliases. When the name of the patient is not known, a value must still be placed in this field since the field is required. In that case, HL7 recommends the following: |~^^^^^^U|. The "U" for the name type code in the second name indicates that it is unspecified. Since there may be no name components populated, this means there is no legal name, nor is there an alias. This guide will interpret this sequence to mean there is no patient name. Stay with base V2.5.1 interpretation using ~ and U in component 7 of the second repeat when the name is unknown. 6 Mother’s Maiden Name XPN RE [0..1] May be included for identification purposes. Name type code is constrained to the value "M." 7 Date/Time of Birth TS RE [0..1] 4..24 8 Administrative Sex IS RE [0..1] 1..20 9 Patient Alias XPN X [0..0] Page 54 of 150 September 2011 C.LEN Value Set = Description/Comments Patient’s date of birth. The time zone component is optional. Note that the granularity of the birth date may be important. For a newborn, birth date may be known down to the minute, while for adults it may be known only to the date. Birth date may be used by the lab to calculate an age for the patient, which may affect what normal ranges apply to particular test results. Format: YYYY[MM[DD[HH[MM[SS[.S[S[S[S]]]]]]]]][+/-ZZZZ] Timezone offset is optional. Be as precise as appropriate and available. Particularly important for newborns. Precision at least YYYY Note: If a birth date is not provided in the PID, then the patient age at specimen collection must be reported as an observation associated with the specimen. HL70001 Patient’s gender. Deprecated as of HL7 Version 2.4. See PID-5 Patient Name. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-6. PATIENT IDENTIFICATION SEGMENT (PID) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set Description/Comments 10 Race CE RE [0..*] HL70005 One or more codes that broadly refer to the patient’s race(s). Note that state regulations may dictate other behaviors. 11 Patient Address XAD O [0..*] 12 County Code IS X [0..0] 13 Phone Number – Home XTN O [0..*] 14 Phone Number – Business XTN O [0..*] 15 Primary Language CWE O [0..*] PHVS_Language Need language for communication with the patient (i.e., phone, _ISO_639email, letter, etc.) 2_Alpha3 16 Marital Status CWE O [0..1] HL70002 17 Religion CWE O [0..1] HL70006 18 Patient Account Number CX O [0..1] 19 SSN Number – Patient ST X [0..0] Deprecated as of HL7 Version 2.3.1. See PID-3 Patient Identifier List. 20 Driver’s License Number – DLN Patient X [0..0] Deprecated as of HL7 Version 2.5. See PID-3 Patient Identifier List. 21 Mother’s Identifier CX O [0..*] 22 Ethnic Group CWE O [0..*] 23 Birth Place ST O [0..1] 1..250 24 Multiple Birth Indicator ID O [0..1] 1..1 25 Birth Order NM O [0..1] 1..2 26 Citizenship CWE O [0..*] HL70171 27 Veterans Military Status CWE O [0..1] HL70172 28 Nationality CWE X [0..0] 1..20 Deprecated as of HL7 Version 2.3. See PID-11 - Patient Address, component 9 County/Parish Code. HL70189 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. HL70136 Deprecated as of HL7 Version 2.4. See PID-10 Race, PID-22 Ethnic Group, and PID-26 Citizenship. Page 55 of 150 September 2011 TABLE 3-6. PATIENT IDENTIFICATION SEGMENT (PID) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set Description/Comments 29 Patient Death Date and Time TS O [0..1] 30 Patient Death Indicator ID O [0..1] 1..1 HL70136 31 Identity Unknown Indicator ID RE [0..1] 1..1 HL70136 32 Identity Reliability Code IS O [0..*] 1..20 HL70445 33 Last Update Date/Time TS O [0..1] Note: Used to indicate when demographics were last updated. Format: YYYY[MM[DD[HH[MM[SS[.S[S[S[S]]]]]]]]][+/-ZZZZ] 34 Last Update Facility HD O [0..1] This is the facility that originated the demographic update. : Condition predicate: If PID-33 is present this is required. 35 Species Code CWE X [0..1] PHVS_Animal_C DC 36 Breed Code CWE X [0..1] Local 37 Strain ST X [0..1] 38 Production Class Code CWE X [0..2] 39 Tribal Citizenship CWE X [0..*] Format: YYYY[MM[DD[HH[MM[SS[.S[S[S[S]]]]]]]]][+/-ZZZZ] If PID-29 is valued, then this field should be populated with “Y” since the patient is known to be dead. Not supported 1..80 HL70429 Conformance Statement: Base Profile LRI-PID-1: PID.7 (Date/Time of Birth) and PID.29 (Patient Death Date and Time) SHALL be valued with precision to the Year (YYYY) and SHOULD be precise to the hour. LRI-PID-2: PID.15 (Primary Language), PID.16 (Marital Status), PID.17 (Religion), PID.22 (Ethnic Group), PID.26 (Citizenship), and PID.27 (Veterans Military Status) SHALL be valued using the CWE – Coded with Exceptions – All Fields Except OBX-5 datatype definition and constraints. Conformance Statement: LRI-GU Profile LRI-PID-3: PID.3 (Patient Identifier List) SHALL be valued using the CX-GU (Extended Composite ID with Check Digit – Globally Unique) datatype constraints. Page 56 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. LRI-PID-4: If valued, PID.34 SHALL be valued per the HD – GU (Hierarchic Designator – Globally Unique) datatype definition and constraints. Conformance Statement: LRI-NG Profile LRI-PID-5: PID.3 (Patient Identifier List) SHALL be valued using the CX-NG (Extended Composite ID with Check Digit – NonGlobally Unique) datatype constraints. 3.3.6 NK1 – NEXT OF KIN SEGMENT – MAKE REF If the subject of the testing is something other than a person, the NK1 will document the person or organization responsible for or owning the subject. For patients who are persons, the NK1 documents the next of kin of the patient. This is particularly important for lead testing of minors, since the NK1 is used to document information about the parent or guardian. For animal patients, the NK1 documents the person or organization that owns or is responsible for the animal. This is where the employment information for the patient is documented. Refer to base standard 3.3.7 PV1 – PATIENT VISIT INFORMATION This segment contains basic inpatient or outpatient encounter information. SEQ Element Name DT Use TABLE 3-7. PATIENT VISIT INFORMATION (PV1) Cardinality LEN C.LEN Value Set Description/Comments 1 Set ID - PV1 SI R [1..1] 1..4 2 Patient Class IS R [1..1] 1..20 3 Assigned Patient Location PL O [0..1] 4 Admission Type IS O [0..1] 5 Preadmit Number CX O [0..1] 6 Prior Patient Location PL O [0..1] 7 Attending Doctor XCN O [0..*] 8 Referring Doctor XCN O [0..*] 9 Consulting Doctor XCN O [0..*] 10 Hospital Service IS O [0..1] 11 Temporary Location PL O [0..1] Literal Value: ‘1’. = HL70004 1..20 Admission Type Value Set 1..20 Local HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. A gross identification of the classification of patient’s visit Page 57 of 150 September 2011 SEQ Element Name DT Use TABLE 3-7. PATIENT VISIT INFORMATION (PV1) Cardinality LEN C.LEN Value Set Description/Comments 12 Preadmit Test Indicator IS O [0.1] 1..20 13 Re-admission Indicator IS O [0..0] 1..20 14 Admit Source IS O [0..1] 1..20 15 Ambulatory Status IS O [0..*] 1..20 16 VIP Indicator IS O [0..0] 1..20 17 Admitting Doctor XCN O [0..*] 18 Patient Type IS O [0..1] 19 Visit Number CX O [0..1] 20 Financial Class FC O [0..*] 21 Charge Price Indicator IS O [0..0] 1..20 22 Courtesy Code IS O [0..0] 1..20 23 Credit Rating IS O [0..0] 1..20 24 Contract Code IS O [0..*] 1..20 25 Contract Effective Date DT O [0..*] 26 Contract Amount NM O [0..*] 1..12 27 Contract Period NM O [0..*] 1..3 28 Interest Code IS O [0..0] 1..20 29 Transfer to Bad Debt Code IS O [0..0] 1..20 30 Transfer to Bad Debt Date DT O [0..1] 31 Bad Debt Agency Code O [0..1] 1..20 32 Bad Debt Transfer Amount NM O [0..1] 1..12 33 Bad Debt Recovery Amount NM O [0..1] 1..12 34 Delete Account Indicator IS O [0..1] 1..20 35 Delete Account Date DT O [0..1] Page 58 of 150 September 2011 IS 1..20 HL70087 HL70023 HL70018 HL70021 HL70111 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. SEQ Element Name DT Use TABLE 3-7. PATIENT VISIT INFORMATION (PV1) Cardinality LEN C.LEN Value Set Description/Comments 36 Discharge Disposition IS O [0..1] 37 Discharged to Location DLD O [0..1] 38 Diet Type CWE O [0..1] 39 Servicing Facility IS O [0..1] 1..20 40 Bed Status IS X [0..0] 1..20 41 Account Status IS O [0..1] 1..20 42 Pending Location PL O [0..1] 43 Prior Temporary Location PL O [0..1] 44 Admit Date/Time TS RE [0..1] Date and time patient arrived for services 45 Discharge Date/Time TS RE [0..*] Date and time patient services ended 46 Current Patient Balance NM O [0..1] 1..12 47 Total Charges NM O [0..1] 1..12 48 Total Adjustments NM O [0..1] 1..12 49 Total Payments NM O [0..1] 1..12 50 Alternate Visit ID CX O [0..1] 51 Visit Indicator IS O [0..1] 52 Other Healthcare Provider XCN O [0..*] 1..20 HL70112 Disposition of the patient at discharge or once the visit is completed, for example, "Discharged to Home/Self-Care", "Expired", "Left Against Medical Advice". Uses Uniform Billing codes. HL70114 1..20 HL70115 Not supported HL70117 HL70326 1 Conformance Statement: LRI-GU Profile LRI-PV1-1: PV1.38 (Diet Type) SHALL be valued using the CWE – Coded with Exceptions – All Fields Except OBX-5 datatype definition and constraints. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 59 of 150 September 2011 Conformance Statement: LRI-GU Profile LRI-PV1-2: PV1.5 (Preadmit Number), PV1. 19 (Visit Number), and PV1.50 (Alternate Visit ID) SHALL be valued using the CX – GU – Extended Composite ID with Check Digit datatype definition and constraints. Conformance Statement: LRI-NG Profile LRI-PV1-3: PV1.5 (Preadmit Number), PV1. 19 (Visit Number), and PV1.50 (Alternate Visit ID) SHALL be valued using the CX – NG – Extended Composite ID with Check Digit datatype definition and constraints. 3.3.8 PV2 – PATIENT VISIT – ADDITIONAL INFORMATION SEGMENT INSERT REF TO BASE The PV2 segment is an optional segment that is a continuation of information contained in the PV1 segment. 3.3.9 ORC – COMMON ORDER SEGMENT The Common Order Segment (ORC) identifies basic information about the order for testing of the specimen. This segment includes identifiers for the order, who placed the order, when it was placed, what action to take regarding the order, etc. SEQ Element Name DT Use TABLE 3-8. COMMON ORDER SEGMENT (ORC) Cardinality LEN C.LEN Value Set Description/Comments 1 Order Control ID R [1..1] 2 Placer Order Number EI RE [0..1] 3 Filler Order Number EI R [1..1] Note: In the circumstance where some of the lab results are generated by the lab, but others are performed by a reference lab, the sending lab can choose what filler order number to use. Regardless of what is used, the sending lab is expected to be able to trace all the observations in the lab result back to the appropriate source lab based on the filler order number provided in ORC-3. 4 Placer Group Number EI RE [0..1] The placer group number is used to identify a group of orders. In the laboratory setting this is commonly referred to as a "requisition number." 5 Order Status ID O [0..1] 2..2 HL70038 6 Response Flag ID O [0..1] 1..1 HL70121 Page 60 of 150 September 2011 2..2 HL70119 Determiner of the function of the order segment. In the ORU^R01 this should be the literal value: "RE." HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. SEQ Element Name DT Use TABLE 3-8. COMMON ORDER SEGMENT (ORC) Cardinality LEN C.LEN Value Set Description/Comments 7 Quantity/Timing TQ X [0..0] 8 Parent EIP O [0..1] 9 Date/Time of Transaction TS O [0..1] 10 Entered By XCN O [0..*] 11 Verified By XCN O [0..*] 12 Ordering Provider XCN R [1..1] 13 Enterer's Location PL O [0..1] 14 Call Back Phone Number XTN CE [0..*] 15 Order Effective Date/Time TS O [0..1] 16 Order Control Code Reason CWE O [0..1] Local 17 Entering Organization CWE O [0..1] Local 18 Entering Device CWE O [0..1] Local 19 Action By XCN O [0..*] 20 Advanced Beneficiary Notice CWE Code X [0..0] 21 Ordering Facility Name XON O [0..*] 22 Ordering Facility Address XAD O [0.*] 23 Ordering Facility Phone Number XTN O [0..*] 24 Ordering Provider Address XAD O [0..*] 25 Order Status Modifier CWE O [0..1] 26 Advanced Beneficiary Notice CWE Override Reason X [0..0] HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Deprecated as of HL7 Version 2.5. See TQ1 and TQ2 segments. Not supported. The address of the facility where the order was placed. The address of the ordering provider. Local Not supported. Page 61 of 150 September 2011 SEQ Element Name DT Use TABLE 3-8. COMMON ORDER SEGMENT (ORC) Cardinality LEN C.LEN Value Set Description/Comments 27 Filler's Expected Availability Date/Time TS O [0..1] 28 Confidentiality Code CWE O [0..1] HL70177 29 Order Type CWE O [0..1] HL70482 30 Enterer Authorization Mode CNE O [0..1] HL70483 31 Parent Universal Service Identifier CWE C(R/X) [0..1] Conformance Statement: Base Profile LRI-ORC-1: The value of ORC.2 (Placer Order Number) SHALL be identical to the value of OBR.2 (Placer Order Number). LRI-ORC-2: The value of ORC.3 (Filler Order Number) SHALL be identical to the value of OBR.3 (Filler Order Number). LRI-ORC-3: The value of ORC.12 (Ordering Provider) SHALL be identical to the value of OBR.3 (Ordering Provider). LRI-ORC-4: The value of ORC.14 (Call Back Phone Number) SHALL be identical to the value of OBR.17 (Order Callback Phone Number). LRI-ORC-5: ORC.16 (Order Control Code Reason), ORC.17 (Entering Organization), ORC.18 (Entering Device),ORC.25 (Order Status Modifier), ORC.28 (Confidentiality Code), ORC.29 (Order Type), ORC.31 (Parent Universal Service Identifier), SHALL be valued using the CWE – Coded with Exceptions – All Fields Except OBX-5 datatype definition and constraints. LRI-ORC-6: The value of ORC.31 (Parent Universal Service Identifier) SHALL be identical to the value of OBR.50 (Parent Universal Service Identifier). Conformance Statement: LRI-GU Profile LRI-ORC-11: ORC.2 (Placer Order Number), ORC.3 (Filler Order Number), and ORC.4 (Placer Group Number) SHALL be valued using the EI GU - Entity Identifier (Globally Unique) datatype definition and constraints. LRI-ORC-12: ORC.8 (Parent) SHALL be valued using the EIP – GU – Entity Identifier Pair (Globally Unique) datatype definition and constraints. LRI-ORC-13: ORC.10 (Entered By), ORC.11 (Verified By), ORC.12 (Ordering Provider), and ORC.19 (Action By) SHALL be valued using the XCN – GU – Extended Composite ID Number and Name for Persons (Globally Unique) datatype definition and constraints. Page 62 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Conformance Statement: LRI-NG Profile LRI-ORC-14: ORC.2 (Placer Order Number), ORC.3 (Filler Order Number), and ORC.4 (Placer Group Number) SHALL be valued using the SHALL be valued using the EI NG – Entity Identifier (Non-Globally Unique) datatype definition and constraints. LRI-ORC-15: ORC.8 (Parent) SHALL be valued using the EIP – NG – Entity Identifier Pair (Non-Globally Unique) datatype definition and constraints. 3.3.10 OBR – OBSERVATION REQUEST SEGMENT The Observation Request Segment (OBR) is used to capture information about one test being performed on the specimen. Most importantly, the OBR identifies the type of testing to be performed on the specimen and ties that information to the order for the testing. TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN 1 Set ID - OBR SI R [1..1] 2 Placer Order Number EI RE [0..1] 1..4 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. C.LEN Value Set Description/Comments For the first repeat of the OBR segment, the Sequence number shall be one (1), for the second repeat, the Sequence number shall be two (2), etc. This identifier is assigned by the placer of the order being fulfilled by this result message. This identifier distinguishes the placer’s order from all other orders created by the placer where an order is interpreted to be the testing identified in a single OBR segment. Normally, it is a type of system identifier assigned by the placer software application. The Placer Order Number and the Filler Order Number are essentially foreign keys exchanged between applications for uniquely identifying orders and the associated results across applications. Page 63 of 150 September 2011 TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN 3 Filler Order Number EI R [1..1] Order number associated with the Filling Application. This number is assigned to the test by the organization performing the test. This field should not contain the accession number or specimen identifier for a specimen unless these identifiers meet the criteria for a filler order number. The specimen or accession identifier should be placed in SPM-2. The Filler Order Number identifies this order as distinct from all other orders being processed by this filler where an order is interpreted to be the testing identified in a single OBR segment. Normally, this is a type of system identifier assigned by the filler software application. The Filler Order Number, along with the Placer Order Number, is essentially foreign keys exchanged between applications for uniquely identifying orders and the associated results across applications. In messages containing multiple OBRs, each OBR must be identified by a unique Filler Order Number. This is critical for making parent/child results relationships work properly. Microbiology cultures and sensitivities are linked in this fashion in this profile. See Appendix A, Section 7.2. Linking Parent and Child Results, of this document for more information on linking parent/child results. 4 Universal Service Identifier CE R [1..1] Identifier code for the requested observation/test/ battery. 5 Priority – OBR ID X [0..0] Deprecated as of HL7 Version 2.3. See TQ1-9 Priority Field. 6 Requested Date/Time TS X [0..0] Deprecated as of HL7 Version 2.3. See TQ1-8 Start Date/Time. Page 64 of 150 September 2011 C.LEN Value Set Description/Comments HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set Description/Comments 7 Observation Date/Time TS R [1..1] 8..24 = For specimen-based observations, the date/time the specimen was collected. Since a test may also involve drawing specimens at different times, e.g., tolerance tests, this date/time only covers the draw of the first specimen. All other specimen collection date/times, including the first one, are communicated in the SPM segment For unknown collection date/time use "0000". Format: YYYYMMDD[HH[MM[SS[.S[S[S[S]]]]]]]]+/-ZZZZ] except when reporting an unknown date of ‘0000” Timezone offset is optional, but encouraged. Be as precise as possible; particularly important for newborns. At least YYYYMMDD, and prefers HH and MM for newborns as well. 8 Observation End Date/Time TS RE [0..1] 8..24 = For specimen-based observations where the specimen was collected over a period of time, this represents the end point in time when the specimen was collected. Timezone offset is optional but encouraged. Be as precise as appropriate and available. Particularly important for newborns. At least YYYYMMDD, and prefers HH for newborns as welll. 9 Collection Volume CQ X [0..0] 10 Collector Identifier XCN O [0..*] 11 Specimen Action Code ID RE [0..1] 12 Danger Code CWE O [0..1] 13 Relevant Clinical Information ST RE [0..*] 14 Specimen Received Date/Time TS X [0..0] Deprecated as of HL7 Version 2.5. See SPM-12 Specimen Collection Amount. 1..1 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. HL70065 Local Deprecated as of HL7 Version 2.5. See SPM-18 Specimen Received Date/Time. Page 65 of 150 September 2011 TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN 15 Specimen Source SPS X [0..0] Deprecated as of HL7 Version 2.5. See SPM-4 Specimen Type. 16 Ordering Provider XCN R [1..1] Identifier of the provider who ordered the testing being performed. The National Provider Identifier (NPI) may be used as the identifier. Note that ORC.12 Ordering Provider is constrained to contain the same value as this field. 17 Order Call-back Phone Number XTN O [0..*] This is the number the laboratory can call with questions regarding the order. This should be a phone number associated with the original order placer. Note that ORC.17 Call-Back Phone Number is constrained to contain the same value as this field. 18 Placer Field 1 ST O [0..1] 1..199 19 Placer Field 2 ST O [0..1] 1..199 20 Filler Field 1 ST O [0..1] 1..199 21 Filler Field 2 ST O [0..1] 1..199 22 Results Rpt/Status Chng Date/Time TS R [1..1] 8..24 23 Charge to Practice MOC O [0..1] 24 Diagnostic Serv Sect ID ID O [0..1] 2..3 HL70074 25 Result Status ID R [1..1] 1..1 V2 Result Status Value Set Page 66 of 150 September 2011 C.LEN Value Set = Description/Comments Required field in this message. Applies to the entire report. Receipt of a subsequent message with the same Filler Number and a different status in this field implies that processing may need to occur at the receiving application level to update a previous report. Format: YYYYMMDDHHMMSS.SS[…]+/-ZZZZ Timezone offset is optional and encouraged. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN 26 Parent Result PRL C(R/RE) [0..1] Field that, together with OBR-29 Parent, allows this result to be linked to a specific OBX segment associated with another OBR segment. See Section 7.2. Linking Parent and Child Results, of this document for more information on linking parent/child results. 27 Quantity/Timing TQ X [0..0] Deprecated as of HL7 Version 2.5. See TQ1 and TQ2 segments. 28 Result Copies To XCN C(R/X) [0..*] Rational to use * instead of 5 is that the number of copies that is supported is most likely negotiated during the order transactions. Condition Predicate: If OBR.nnn is valued Conformance Statement: If OBR.nnn is "E" then OBR.28 must be valued with only one recipient's name. Conformance Statement: If OBR.nnn is "R" then OBR.28 must contain at least one recipient's name. 29 Parent EIP C(R/RE) [0..1f] Used to link this OBR with a parent OBR. Commonly used with microbiology messages to link a susceptibility result with the parent culture that identified the organism. For this linkage to work properly, the Placer Order Number and the Filler Order Number must uniquely identify the specific parent OBR. This means that the same Filler Number cannot be used to identify multiple OBRs. See Appendix A, Section 7.2. Linking Parent and Child Results, of this document for more information on linking parent/child results. 30 Transportation Mode ID X [0..0] 31 Reason for Study CWE O [0..*] 32 Principal Result Interpreter NDL O [0..1] 33 Assistant Result Interpreter NDL O [0..*] 34 Technician O [0..*] NDL 4..4 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. C.LEN Value Set Description/Comments Not supported. Reason For Study ICD9 is currently in use as of date of publication; intention is Value Set to support ICD10 when the US starts using it. Used for pathology results. Page 67 of 150 September 2011 TABLE 3-9. OBSERVATION REQUEST SEGMENT (OBR) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set 35 Transcriptionist NDL O [0..*] 36 Scheduled Date/Time TS O [0..1] 37 Number of Sample Containers NM X [0..0] 38 Transport Logistics of Collected Sample CWE X [0..0] 39 Collector's Comment CWE O [0..*] 40 Transport Arrangement Responsibility CWE X [0..0] 41 Transport Arranged ID X [0..0] 1..1 Not supported. 42 Escort Required ID X [0..0] 1..1 Not supported. 43 Planned Patient Transport Comment CWE X [0..0] 44 Procedure Code CWE O [0..1] HL70088 45 Procedure Code Modifier CWE O [0..*] HL70340 46 Placer Supplemental Service Information CWE O [0..*] HL70411 47 Filler Supplemental Service CWE Information O [0..*] HL70411 48 Medically Necessary Duplicate Procedure Reason CWE O [0..1] HL70476 49 Result Handling IS O [0..1] HL70507 50 Parent Universal Service Identifier CWE C(R/X) [0..1] 1..16 Description/Comments Not supported. See SPM-26 Not supported. Local Not supported. Not supported. OBR.50 contains the universal service identifier of the parent order. Usage Note Page 68 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. In the circumstance where some of the lab results are generated by the lab, but others are performed by a reference lab, the sending lab can choose what filler order number to use. Whichever filler order number is used, the sending lab is expected to be able to trace all the observations in the lab result back to the appropriate source lab based on the filler order number provided in OBR-3. Conformance Statement: Base Profile LRI-OBR-1: The value of OBR.2 (Placer Order Number) SHALL be identical to the value of OCR.2 (Placer Order Number). LRI-OBR-2: The value of OBR.3 (Filler Order Number) SHALL be identical to the value of OCR.3 (Filler Order Number). LRI-OBR-3: The value of OBR.7 (Observation Date/Time) and OBR.8 (Observation End Date/Time) SHALL be precise to the DAY (YYYYMMDD) and SHOULD be precise to the minute (YYMMDDHHMM) LRI-OBR-3: The value of OBR.22 (Results Rpt/Status Chng - Date/Time) SHALL be precise to the DAY (YYYYMMDD) and SHOULD be precise to the second (YYYYMMDDHHMMSS). LRI-OBR-4: If SPM segment is present, the value of OBR.7 (Observation Date/Time) SHALL be identical to SPM.17 (Specimen Collection Date/Time). LRI-OBX-5: If an OBX segment is related to this OBR, the value of OBX.14 (Date/Time of the Observation) SHALL be identical to OBR.7 (Observation Date/Time). LRI-OBR-6: OBR.11 (Specimen Action Code) SHALL be a value of A, G, L, or O or empty (blank). LRI-OBR-7: The value of OBR.12 (Ordering Provider) SHALL be identical to the value of OCR.3 (Ordering Provider). LRI-OBR-8: The value of OBR.17 (Call Back Phone Number) SHALL be identical to the value of OCR.14 (Order Callback Phone Number). LRI-OBR-9: OBR.12 (Danger Code), OBR.31 (Reason for Study), OBR.39 (Collector's Comment ) , OBR.44 (Procedure Code), OBR.45 (Procedure Code Modifier), OBR.46 (Placer Supplemental Service Information), OBR.47 (Filler Supplemental Service Information), OBR.48 (Medically Necessary Duplicate Procedure Reason), and OBR.50 (Parent Universal Service Identifier) SHALL be valued using the CWE – Coded with Exceptions – All Fields Except OBX-5 datatype definition and constraints. LRI-OBR-10: If OBR.29 (Parent) is valued, OBR.50 (Parent Universal Service Identifier) SHALL be valued and SHALL be identical to the value of ORC.31 (Parent Universal Service Identifier). LRI-OBR-11: If OBR.11 (Specimen Action Code) is valued “G”, then OBR.29 (Parent) and OBR. 26 (Parent Result) are Required/Mandatory and cannot be empty. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 69 of 150 September 2011 Conformance Statement: LRI-GU Profile LRI-OBR-12: OBR.2 (Placer Order Number) and OBR.3 (Filler Order Number) SHALL be valued using the EI GU - Entity Identifier (Globally Unique) datatype definition and constraints. LRI-OBR-13: OBR.29 (Parent) SHALL be valued using the EIP – GU – Entity Identifier Pair (Globally Unique) datatype definition and constraints. LRI-OBR-14: OBR.10 (Collector Identifier), OBR.16 (Ordering Provider), and OBR.28 (Result Copies To) SHALL be valued using the XCN – GU – Extended Composite ID Number and Name for Persons (Globally Unique) datatype definition and constraints. Conformance Statement: LRI-NG Profile LRI-OBR-15: OBR.2 (Placer Order Number) and OBR.3 (Filler Order Number) SHALL be valued using the SHALL be valued using the EI NG – Entity Identifier (Non-Globally Unique) datatype definition and constraints. LRI-OBR-16: OBR.29 (Parent) SHALL be valued using the EIP – NG – Entity Identifier Pair (Non-Globally Unique) datatype definition and constraints. LRI-OBR-17: OBR.10 (Collector Identifier), OBR.16 (Ordering Provider), and OBR.28 (Result Copies To) SHALL be valued using the XCN – NG – Extended Composite ID Number and Name for Persons (Non-Globally Unique) datatype definition and constraints. 3.3.11 TQ1 – TIMING/QUANTITY SEGMENT The TQ1 segment is used to specify the timing of events and actions such as those that occur in order management and scheduling systems. TABLE 3-10. TIMING/QUANTITY SEGMENT FOR ORDER GROUP SEQ Element Name DT Use Cardinality LEN 1 Set ID - TQ1 SI R [1..1] 2 Quantity CQ O [0..1] 3 Repeat Pattern RPT O [0..*] 4 Explicit Time TM O [0..*] Page 70 of 150 September 2011 C.LEN Value Set 1..4 Description/Comments Sequence number of the timing specification, the first of which shall be 1; the second of which shall be 2; and so on. Unified Code for Units of Measure (UCUM) HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-10. TIMING/QUANTITY SEGMENT FOR ORDER GROUP SEQ Element Name DT Use Cardinality LEN C.LEN Value Set 5 Relative Time and Units CQ O [0..*] Unified Code for Units of Measure (UCUM) 6 Service Duration CQ O [0..1] Unified Code for Units of Measure (UCUM) 7 Start date/time TS C(R/RE) [0..1] 4..24 = Conformance: Echo as received from the order. 8 End date/time TS C(R/RE) [0..1] 4..24 = Conformance: Echo as received from the order. 9 Priority CWE O [0..*] 10 Condition text TX O [0..1] 1..250 11 Text instruction TX O [0..1] 1..250 12 Conjunction ID O [0..1] 1..1 13 Occurrence duration CQ O [0..1] 14 Total occurrence's NM O [0..1] HL70485 Description/Comments Urgency of the request. If this field is blank, the default is R (routine). Multiple priorities may be assigned to one order. HL70472 Unified Code for Units of Measure (UCUM) 1..10 Usage Note In the circumstance where some of the lab results are generated by the lab, but others are performed by a reference lab, the sending lab can choose what filler order number to use., Which ever filler order number is used, the sending lab is expected to be able to trace all the observations in the lab result back to the appropriate source lab based on the filler order number provided in OBR-3. Conformance Statement: Base Profile LRI-TQ1-1: The value of TQ1.1 (Set ID – T Q1) SHALL be valued sequentially. LRI-TQ1-2: The value of TQ1.7 (Start Date/Time) and TQ1.8 (End Date/Time) SHALL be echoed from the order. LRI-TQ1-3: OBR.9 (Priority) SHALL be valued using the CWE – Coded with Exceptions – All Fields Except OBX-5 datatype definition and constraints. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 71 of 150 September 2011 3.3.12 OBX – OBSERVATION/RESULT SEGMENT The Observation/Result Segment (OBX) contains information regarding a single observation related to a single test (OBR) or specimen (SPM). This includes identification of the specific type of observation, the result for the observation, when the observation was made, etc. TABLE 3-11. OBSERVATION RESULT SEGMENT (OBX) SEQ Element Name DT Use Cardinality LEN 1 Set ID – OBX SI R [1..1] 1..4 2 Value Type ID C(R/X) [0..1] 2..3 3 Observation Identifier CWE R [1..1] 4 Observation Sub-ID ST C(R/RE) [0..1] 5 Observation Value Var RE [0..1] Field that documents each specific, allowed data type. For coded observation values, use Coded Laboratory Observation Value Set. 6 Units CWE C(R/RE) [0..1] Unified Code for UCUM® is an HL7-approved code system. Units of Measure For dimensionless units the UCUM representation would be (UCUM) {string}, e.g., for titer this would be {titer}. Page 72 of 150 September 2011 C.LEN Value Set Description/Comments 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. HL70125 This field identifies the data type used for OBX-5. Laboratory Observation Identifier Value Set 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. Local codes may also be used in conjunction with LOINC codes When populating this field with values, this guide does not give preference to the triplet in which the standard (LOINC) code should appear. 1..20 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-11. OBSERVATION RESULT SEGMENT (OBX) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set Description/Comments 7 References Range ST RE [0..1] 1..60 = Interpretation range that applies to the value reported in OBX5. It should provide enough information to understand the abnormal flags reported in OBX-8. Note-It is not appropriate to send the reference range for a result in an associated NTE segment. It would be appropriate to send information amplifying the reference range provided in this field in an NTE associated with this OBX. 8 Abnormal Flags CWE RE [0..*] 1..20 # HL70078 (2.7.1) Indicator of the normalcy of the result found in OBX-5. Cardinality indicates the possible need for multiple abnormal flags, as in the following example: Example: Hemoglobin has a normal range of 12-16 Initial result (reported in a separate ORU message based on testing an earlier specimen): HGB = 15.9 (results normal) Current result (in this OBX based on current specimen): HGB = 11.9 abnormality: (L) below low normal and a (D) significant change down (delta > 3). In this example, OBX-8 would be set to |L~D|. Microbiology example: Ceftazidime susceptibility (LOINC 133-9) value = |<=^1|, units = ug/ml, Abnormal flag = S Note that this IG is adopting HL70078 form 2.7.1. 9 Probability NM O [0..1] 1..5 10 Nature of Abnormal Test ID O [0..1] 1..2 HL70080 11 Observation Result Status ID R [1..1] 1..1 HL70085 12 Effective Date of Reference TS Range O [0..1] 13 User-Defined Access Checks ST O [0..1] Status of the observation result. 20 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 73 of 150 September 2011 TABLE 3-11. OBSERVATION RESULT SEGMENT (OBX) SEQ Element Name DT Use Cardinality LEN C.LEN 14 Date/Time of the Observation TS RE [0..1] = 15 Producer’s Reference CWE O [0..1] 16 Responsible Observer XCN RE [0..*] 17 Observation Method CWE RE [0..*] 18 Equipment Instance Identifier EI O [0..*] 19 Date/Time of the Analysis TS RE [0..1] Time at which the testing was performed. Timezone offset is required, format: YYYYMMDDHHMMSS.SS[…]+/-ZZZZ) Be as precise as appropriate and available. At least YYYYMMDDHH. 20 Reserved for harmonization (TBD) with Version 2.6. X [0..0] Not supported. 21 Reserved for harmonization (TBD) with Version 2.6. X [0..0] Not supported. Page 74 of 150 September 2011 8..24 Value Set Description/Comments Emphasize that it reflects the clinically relevant date/time, not when it is run on the machine or interpreted. For specimen based test, if it is valued it must be the same as SPM.17 If SPM.17 is present and relates to the same observation, then OBX.14 must be within the DR range. Timezone offset is optional, but strongly encourage, format: YYYYMMDDHHMMSS.SS[…]+/-ZZZZ) Be as precise as appropriate and available. Shall support at least YYYYMMDDHHMM. For newborn needs to be down to YYYYMMDDHH, possibly minutes, while other YYYYMMDD could be appropriate. Local If populated the field must identify the same performing organization as that identified in OBX-23 (Performing Organization Name). HL7 V3 Observation Method Method of testing by the laboratory. If the LOINC code in OBX3 is methodless, this field shall be populated. Sometimes the method may be extrapolated from the local test codes. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-11. OBSERVATION RESULT SEGMENT (OBX) SEQ Element Name DT 22 Reserved for harmonization (TBD) with Version 2.6. 23 Performing Organization Name XON 24 Performing Organization Address 25 Performing Organization Medical Director Use Cardinality LEN C.LEN Value Set Description/Comments [0..0] Not supported. R [1..1] The information for producer ID is recorded as an XON data type. For laboratories, this field specifies the laboratory that produced the test result described in this OBX segment. This information supports CLIA regulations in the US. For producing laboratories that are CLIA-certified, the CLIA identifier should be used for the organization identifier (component 10). XAD R [1..1] Address of the laboratory that actually performed the test when used as a reference laboratory. XCN RE [0..1] Name of the Medical Director of the reference laboratory. Required when OBX-24 indicates the performing lab is in a jurisdiction that requires this information. Conformance Statement: Base Profile LRI-OBX-1: The value of OBX.1 (Set ID – OBX) SHALL be valued sequentially. LRI-OBX-2: If there are multiple OBX segments with the same OBX-3 values under the same OBR, a combination of OBX-3 and OBX-4 SHALL create a unique identification under a single OBR. LRI-OBX-3: If OBX.5 (Observation Value) is valued, then OBX.2 (Value Type) SHALL support datatypes CE, DT, NM, SN, ST, TM, TS, TX, FT and CWE. LRI-OBX-4: If OBX.5 (Observation Value) is valued, then OBX.2 (Value Type) MAY support datatypes CX, EP, and RP. LRI-OBX-5: If OBX.5 (Observation Value) is valued, then OBX.2 (Value Type) SHALL NOT support remaining datatypes in Table HL70125. LRI-OBX-6: If OBX.5 (Observation Value) is CWE, then it SHALL be valued using the CWE – Coded with Exceptions – For OBX-5 Only datatype definition and constraints. LRI-OBX-7: If OBX.5 (Observation Value) is CE, then CE.1 (Identifier) and CE.3 (Name of Coding System) or CE. 4 (Alternate Identifier) and CE.6 (Name of Alternate Coding System) SHALL be valued. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 75 of 150 September 2011 LRI-OBX-8: If OBX.2 (Value Type) is valued as NM or SN and OBX.11 is not X, then OBX.6 (Units) SHALL be required/mandatory. LRI-OBX-9: If OBX.5 (Value Type) is not valued and OBX.11 is not X, then OBX.6 (Abnormal Flags) SHALL be required/mandatory. LRI-OBX-10: OBX.14 (Date/Time of the Observation ) SHALL be precise to the hour (YYYYMMDDHH) and MAY include the timezone offset. LRI-OBX-11: OBX19 (Date/Time of the Analysis) SHALL be precise to the hour (YYYYMMDDHH) and SHALL include the timezone offset. Conformance Statement: LRI-GU Profile LRI-OBX-12: The value of OBX.16 (Responsible Observer) and OBX.25 (Performing Organization Medical Director) SHALL be valued using the XCN – GU – Extended Composite ID Number and Name for Persons (Globally Unique) datatype definition and constraints. LRI-OBX-13: The value of OBX.23 (Performing Organization Name) SHALL be valued using the XON GU – Extended Composite Name and Identification Number for Organizations Globally Unique) datatype definition and constraints. Conformance Statement: LRI-GU Profile LRI-OBX-14: The value of OBX.16 (Responsible Observer) OBX.25 (Performing Organization Medical Director) SHALL be valued using the XCN – NG – Extended Composite ID Number and Name for Persons (Non-Globally Unique) datatype definition and constraints. LRI-OBX-15: The value of OBX.23 (Performing Organization Name) SHALL be valued using the XON NG – Extended Composite Name and Identification Number for Organizations (Non-Globally Unique) datatype definition and constraints. 3.3.12.1 OBSERVATION IDENTIFIERS, OBSERVATION VALUES, INTERPRETATIONS AND COMMENTS Laboratory results fall into several broad categories or types of results. The first type of result is a quantitative measure of some property of a specimen and is typically numerical in nature. Often these numeric results are also associated with some sort of interpretation, typically in terms of the normality or abnormality of the measured quantity in relationship to a reference range or normal range. Another type of result is a qualitative result related to the testing of a specimen. This is typically coded or textual in nature. Qualitative results may actually be interpretations of more detailed quantitative measurement. Finally, both quantitative and qualitative results may have comments associated with them. These comments may provide additional clarification, information regarding how the result was obtained, etc. How a particular result should be reported using the OBX segment above depends upon what is being used as an observation identifier for OBX-3. This guide assumes that LOINC is normally being used for the identification of observations. LOINC identifiers can easily be classified as quantitative or qualitative. The LOINC scale property QN (quantitative) indicates that the LOINC identifier is quantitative. All other LOINC identifiers can be treated as qualitative for the purpose of this discussion. Those OBX’s associated with quantitative LOINC identifiers should be using OBX-5 with either the NM (numeric), SN (structured numeric), TS (timestamp), DT (date) or TM (time) data Page 76 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. types. These quantitative results can be accompanied by an interpretation. Coded interpretations should be reported using OBX-8 (abnormal flags) when the values have been drawn from HL7 table 0078. When a coded interpretation is sent, or when a textual interpretation is sent, a second OBX using a non-quantitative LOINC identifier should be used. The above discussion has focused on actual clinical findings, whether they are quantitative or qualitative. Often, additional clarifying documentation is sent along with the clinical findings. These should be handled as comments, conveyed in an NTE segment(s) following the OBX in question. Comments typically fall into the following categories: Comments about how a clinical finding was reached Clarification regarding the meaning of a clinical finding Additional information not directly related to the clinical finding such as contact information for the lab, disclaimers, etc. Most canned, or boiler plate text associated with a result falls into the comment category The following table gives examples of how the different fields in the OBX segment interact to create the complete observation. Testing Situation Discussion Numeric result along with interpretation Numerical intervals, ratios, inequalities Time like quantitative result with interpretation TABLE 3-12. OBSERVATION IDENTIFIERS OBX.3 OBX.2 OBX.5 Observation OBX.6 OBX.8 Observation Observation Identifier: LOINC Units Abnormal Flags Type value part = scale May be populated May be populated with codes from HL7 NM QN number with UCUM Units table 0078 SN TS, TM, DT QN structured numeric QN timestamp, time or date HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. OBX.7 Reference Range NTE Segment May be populated May be populated with comments, not clinical findings. May be populated with UCUM Units May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. [empty] May be populated with codes from HL7 table 0078 May be populated May be populated with comments, not clinical findings. Page 77 of 150 September 2011 Testing Situation Discussion Conveys ordinal value and interpretation Conveys ordinal value and interpretation Conveys observation and interpretation Conveys observation and interpretation Conveys observation and interpretation TABLE 3-12. OBSERVATION IDENTIFIERS OBX.3 OBX.2 OBX.5 Observation OBX.6 OBX.8 Observation Observation Identifier: LOINC Units Abnormal Flags Type value part = scale Ordinal as a code. SNOMED CT shall be used when code exists; otherwise a local code. Sending ordinals as codes is May be populated the preferred ELR with codes from HL7 CWE ORD [empty] approach. table 0078 SN CWE FT, TX or ST FT, TX or ST Conveys imbedded object (ED) or pointer to object ED, RP (RP) Page 78 of 150 September 2011 OBX.7 Reference Range May be populated NTE Segment May be populated with comments, not clinical findings. ORD Ordinal as structured [empty] numeric May be populated with codes from HL7 Required table 0078 May be populated with comments, not clinical findings. NOM Coded observation. SNOMED CT shall be used when code exists; otherwise it’s [empty] a local code. May be populated with codes from HL7 May be populated table 0078 May be populated with comments, not clinical findings. text [empty] May be populated with codes from HL7 May be populated table 0078 May be populated with comments, not clinical findings. [empty] May be populated with codes from HL7 May be populated table 0078 May be populated with comments, not clinical findings. [empty] May be populated with comments, not clinical findings. NAR MULTI text Varies Object pointer or imbedded object [empty] [empty] HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 3.3.13 SPM – SPECIMEN SEGMENT The Specimen Information Segment (SPM) describes the characteristics of a single sample. The SPM segment carries information regarding the type of specimen, where and how it was collected, who collected it and some basic characteristics of the specimen. TABLE 3-13. SPECIMEN SEGMENT (SPM) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set 1 Set ID – SPM SI R [1..1] 2 Specimen ID EIP O [0..1] 3 Specimen Parent IDs EIP O [0..*] 4 Specimen Type CWE R [1..1] Specimen Type Description of the precise nature of the entity that is the source material for Value Set the observation. 5 Specimen Type Modifier CWE O [0..*] PHVS_Modifier Allows sending qualifiers for a SNOMED CT term from a single axis. Only OrQualifier_CD used if SPM-4 is a SNOMED code. C 6 Specimen Additives CWE O [0..*] HL70371 7 Specimen Collection Method CWE O [0..1] Specimen Collection Method Value Set 8 Specimen Source Site CWE O [0..1] Body Site Value Source from which the specimen was obtained. For environmental Set samples, this may describe the location of the source of the specimen. For biological samples, it may represent the anatomical site from which the specimen was collected. 1..4 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Description/Comments For the first repeat of the SPM segment, the sequence number shall be one (1), for the second repeat, the sequence number shall be two (2), etc. Unique identifier for the specimen as referenced by the Placer application, the Filler application, or both. Note that the specimen id is not the same thing as the placer/filler order number. Order numbers identify the specific test to be performed on a specimen. A particular specimen may be associated with multiple orders (and multiple placer/filler order numbers). The specimen id may be the same as an accession number, depending on how the particular lab assigns accession numbers. Method used to collect the specimen. Page 79 of 150 September 2011 TABLE 3-13. SPECIMEN SEGMENT (SPM) SEQ Element Name DT Use Cardinality LEN 9 Specimen Source Site Modifier CWE O [0..*] PHVS_Modifier Modifier or qualifier for the specimen source site (SPM-8). Allows sending OrQualifier_CD qualifiers for a SNOMED CT term from a single axis. Only used if SPM-8 is C a SNOMED code. This allows use of post-coordinated terminologies for specimen source. 10 Specimen Collection Site CWE O [0..1] HL70543 11 Specimen Role CWE O [0..*] HL70369 12 Specimen Collection Amount CQ O [0..1] Unified Code for Units of Measure (UCUM) 13 Grouped Specimen Count NM O [0..1] 14 Specimen Description ST O [0..1] 15 Specimen Handling Code CWE O [0..*] HL70376 16 Specimen Risk Code CWE O [0..*] HL70489 Page 80 of 150 September 2011 C.LEN Value Set Description/Comments Amount of sample collected. This can be reported as a volume or a weight/mass. 1..6 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 3-13. SPECIMEN SEGMENT (SPM) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set Description/Comments 17 Specimen Collection Date/Time DR R [1..1] = Time range over which the sample was collected, as opposed to the time the sample collection device was recovered. This value should be the same as OBR.7, unless a new specimen was drawn at the testing laboratory. The first component of the date range must match OBR-7 Observation Date/Time. The second component must match OBR-8 Observation End Date/Time. For OBXs reporting observations based on this specimen, OBX-14 should contain the same value as component 1 of this field. A minimum of year, month and day must be provided when the actual date/time is known. For unknown collection date/time use "0000". Format: |YYYYMMDD[HH[MM[SS[.S[S[S[S]]]]]]][+/ZZZZ]^YYYYMMDD[HH[MM[SS[.S[S[S[S]]]]]]][+/-ZZZZ]| Timezone offset is required. Be as precise as appropriate and available. At least YYYYMMDD. For newborn needs to be down to the hours, possibly minutes. 18 Specimen Received Date/Time TS O [0..1] 19 Specimen Expiration Date/Time TS O [0..1] 20 Specimen Availability ID O [0..1] 21 Specimen Reject Reason CWE O [0..*] HL70490 22 Specimen Quality CWE O [0..1] HL70491 23 Specimen Appropriateness CWE O [0..1] HL70492 24 Specimen Condition CWE O [0..*] HL70493 8..24 Time the specimen was received at the diagnostic service. The actual time that is recorded is based on how specimen receipt is managed, and may correspond to the time the sample is logged in. Format: YYYYMMDD[HH[MM[SS[.S[S[S[S]]]]]]][+/-ZZZZ] 1..1 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. HL70136 Page 81 of 150 September 2011 TABLE 3-13. SPECIMEN SEGMENT (SPM) SEQ Element Name DT Use Cardinality LEN C.LEN Value Set 25 Specimen Current Quantity CQ O [0..1] 26 Number of Specimen Containers NM O [0..1] 27 Container Type CWE O [0..1] Local 28 Container Condition CWE O [0..1] HL70544 29 Specimen Child Role CWE O [0..1] HL70494 Description/Comments Unified Code for Units of Measure (UCUM) 1..4 3.3.14 NTE – NOTES AND COMMENTS SEGMENT The Notes and Comments Segment (NTE) is used to convey additional comments regarding the associated segment. The NTE segment is not intended for automatic processing. The contents of the NTE segment are primarily intended for human use. Automated process should not be based upon the contents of NTE-3 (Comment); rather the content of that field should be displayed to humans. TABLE 3-14. NOTES AND COMMENTS SEGMENT (NTE) SEQ Element Name DT Use Cardinality LEN 1 Set ID – NTE SI R [1..1] 2 Source of Comment ID RE [0..1] 3 Comment FT R [1..*] 4 Comment Type CWE RE [0..1] Page 82 of 150 September 2011 C.LEN Value Set Description/Comments For the first repeat of the NTE segment, the sequence number shall be one (1), for the second repeat, the seqence number shall be two (2), etc. 1..1 HL70105 Comment contained in the segment. HL70364 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 4. CODE SYSTEMS AND VALUE SETS Successful message implementation requires that transmitted messages (message instances) contain valid values for coded fields. It is important to note that code sets are relatively dynamic and subject to change between publications of these implementation guides. Every code value passed in a message instance is drawn from a code system that either may have a globally unique identifier, such as an OID, an HL7 identifier (Table 0396), or a locally defined identifier. In general, the coded values allowed in a field (a) may be drawn from more than one code system, and (b) may be a subset of the codes from a given coding system. Combining (a) and (b) makes it possible for the allowed code value to be a combination of multiple subsets drawn from multiple coding systems. In most cases, only subsets of the codes defined in a code system are legal for use in a particular message. The subsets of the codes that are allowed for a particular field is identified by an HL7 construct known as a "value set." A value set is a collection of coded values drawn from code systems. Value sets serve to identify the specific set of coded values for the message from the universe of coded values across all coding systems. The segment tables in previous sections identify the value set or coding system used for each supported field containing a coded value. Some of these pre-coordinated value sets must be updated, or new ones created, as new needs are identified. Value sets are identified by a unique identifier but is not transmitted in the message. The identifier or code for the coding system from which the value is derived is sent in the message. However, the value set identifier is useful and important when vocabulary items are modified or replaced. 4.1 HL7 TABLES Tables in this guide are as specified in the HL7 Version 2.5.1 Standard, except as noted below. HL7 Table 0065-Specimen Action Code is pre-adopted from HL7 Version 2.7.1 HL7 Table 0078-Interpretation Codes is pre-adopted from HL7 Version 2.7.1 HL7 Table 0203-Identifier Type is pre-adopted from HL7 Version 2.7.1 HL7 Table 0291-Subtype of referenced data is pre-adopted from HL7 Version 2.7.1 HL7 Table 0301-Universal ID Type is pre-adopted from HL7 Version 2.7.1 HL7 Table 0834-MIME Types is pre-adopted from HL7 Version 2.7.1 4.2 LOINC The use of the Logical Observation Identifiers Names and Codes (LOINC) vocabulary is required. The LOINC terms transmitted by the sender in OBX.3 must be valid but it is not the intent of this guide to specify LOINC terms for a given test. Further information on LOINC and access to tools, please visit http://loinc.org/ HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 83 of 150 September 2011 4.3 SNOMED CT SNOMED CT is a required vocabulary for communicating coded results when reported as Coded With Exception (CWE) data types in OBX.5 for specific result categories as defined below. It is also recommended for specimen source terms in SPM.4. Further information on SNOMED can be found at the National Library of Medicine. 4.4 UCUM UCUM (Unified Code for Units of Measure) appears to be a viable option for reporting units of measure but must be pilot tested in order to understand the impact of key issues identified by various stakeholders. This guide does not preclude the use of UCUM coding where senders and receivers have localized this guide by mutual agreement. Further information on UCUM can be found at http://unitsofmeasure.org/ Page 84 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results © 2011 Health Level Seve 4.5 VOCABULARY CONSTRAINTS Table 4-1. Value Set/Code System Summary shows the various value sets/code systems used in this IG. It also provides information about the source of the vocabulary and an identifier for the vocabulary. The name found in the Value Set/Code System Name column corresponds with the value set identified in the Value Set column of the data type and segment attribute tables found above. Name TABLE 4-1. VALUE SET/CODE SYSTEM SUMMARY Source Unique Identifier Comments Country Value Set Source ID/ Reference HL70399 Administrative Sex HL70001 HL7 Version 2.5.1 2.16.840.1.113883.12.1 Marital Status HL70002 HL7 Version 2.5.1 2.16.840.1.113883.12.2 Event Type HL70003 HL7 Version 2.5.1 2.16.840.1.113883.12.3 Patient Class HL70004 HL7 Version 2.5.1 2.16.840.1.113883.12.4 Race Category HL70005 HL7 Version 2.5.1 2.16.840.1.113883.6.238 Acknowledgment Code HL70008 HL7 Version 2.5.1 2.16.840.1.113883.12.8 Check Digit Scheme HL70061 HL7 Version 2.5.1 2.16.840.1.113883.12.61 Specimen Action Code HL70065 HL7 Version 2.7.1 2.16.840.1.113883.12.65 Constrained to A, G, L, O Message Type HL70076 HL7 Version 2.5.1 2.16.840.1.113883.12.76 Constrained to ORU, ACK Observation Interpretation HL70078 HL7 Version 2.7.1 2.16.840.1.113883.12.78 Observation Result Status HL70085 HL7 Version 2.5.1 2.16.840.1.113883.12.85 Processing ID HL70103 HL7 Version 2.5.1 2.16.840.1.113883.12.103 Version ID HL70104 HL7 Version 2.5.1 2.16.840.1.113883.12.104 HL7 Version 2.5.1 Refer to HL7 V2.5.1 Message, Chapter 2, Section 2.15.9.1 This identifies the codes for the representation of names of countries, territories and areas of geographical interest. The complete set of 3166-1 codes. http://www.iso.org/iso/iso-3166-1_decoding_table HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Constrained to ‘R01’ Constrained to ‘v2.5.1’ Page 85 of 150 September 2011 Name Order Control Source ID/ Reference HL701119 Observation Result Status TABLE 4-1. VALUE SET/CODE SYSTEM SUMMARY Source Unique Identifier Comments HL7 Version 2.5.1 2.16.840.1.113883.12.119 HL70123 HL7 Version 2.5.1 2.16.840.1.113883.12.123 Value Type HL70125 HL7 Version 2.5.1 2.16.840.1.113883.12.125 Accept/Application Acknowledgment Condition HL70155 HL7 Version 2.5.1 2.16.840.1.113883.12.155 Ethnic Group HL70189 HL7 Version 2.5.1 2.16.840.1.113883.6.238 Address Type HL70190 HL7 Version 2.5.1 2.16.840.1.113883.12.190 Type of Referenced Data HL70191 HL7 Version 2.5.1 2.16.840.1.113883.12.191 Name type HL70200 HL7 Version 2.5.1 2.16.840.1.113883.12.200 Identifier type HL70203 HL7 Version 2.7.1 2.16.840.1.113883.12.203 Subtype of referenced data HL70291 HL7 Version 2.7.1 2.16.840.1.113883.12.291 Encoding HL70299 HL7 Version 2.5.1 2.16.840.1.113883.12.299 Universal ID type HL70301 HL7 Version 2.7.1 2.16.840.1.113883.12.301 Message structure HL70354 HL7 Version 2.5.1 2.16.840.1.113883.12.354 Message Error Condition Codes HL70357 HL7 Version 2.5.1 2.16.840.1.113883.12.357 Page 86 of 150 September 2011 Constrained as follows: R for CE, DT, NM, SN, ST, TM, TS, TX, FT, CWE RE for CX, ED, RP (requires agreement between trading partners) . Constrained to ORU_R01, ACK HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Name Coding Systems Source ID/ Reference HL70396 TABLE 4-1. VALUE SET/CODE SYSTEM SUMMARY Source Unique Identifier Comments HL7 2.16.840.1.113883.12.396 http://www.hl7.org/sp ecial/committees/voca b/table_0396/index.cf m Specimen Type HL70487 HL7 Version 2.5.1 2.16.840.1.113883.12.487 Sequence Condition Code HL70504 HL7 Version 2.5.1 2.16.840.1.113883.12.504 Cyclic Entry/Exit Indicator HL70505 HL7 Version 2.5.1 2.16.840.1.113883.12.505 Service Request Relationship HL70506 HL7 Version 2.5.1 2.16.840.1.113883.12.506 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. HL7 Table 0396 defines the standard coding systems recognized by HL7. The table defines a mechanism by which locally defined codes can be transmitted. Any code/coding system not defined in HL7 Table 0396 is considered a “local” coding system from the HL7 perspective. Coding systems that are identified in this implementation guide will be identified according to the recommended HL7 nomenclature from table 0396 as “99ELR-zzz” where “zzz” represents a string identifying the specific non-standard coding system. To maintain backwards compatibility with the 2.3.1 ELR implementation Guide, coding systems defined locally (i.e., not identified in this guide) and not defined in HL7 Table 0396 can continue to identify the coding system as “L”. It is strongly suggested that implementers instead adopt the use of “99zzz” approach to identifying local coding systems since HL7 has indicated that use of the “L” for local coding systems is retained only for backwards compatibility, and its use may be withdrawn in a subsequent 2.x version. Note that the local use of “99zzz” should not collide with any of the “locally” defined coding systems identified in this implementation guide. HL7 now maintains HL7 table 0396 “real time”. This means that values may be added to the table at any time so that implementers can have an up-to-date source of truth for the codes to be used to identify coding systems in any 2.x message. Users of this IG should acquire the latest version of HL7 table 0396. The latest version of HL7 table 0396 (independent of HL7 version) is available for download from HL7 at: http://www.hl7.org/special/committees/vocab/table_0396/index.cfm. Page 87 of 150 September 2011 Name Error severity Source ID/ Reference HL70516 MIME Types HL70834 TABLE 4-1. VALUE SET/CODE SYSTEM SUMMARY Source Unique Identifier Comments HL7 Version 2.5.1 2.16.840.1.113883.12.516 HL7 Version 2.7.1 2.16.840.1.113883.12.834 Imported Table 0834 Note that the HITSP Lab to EHR IG uses HL70191, which can be directly mapped to the 2.7.1 values imported from IANA. Laboratory Coded Observation Value Set TBD TBD Drawn from SNOMED CT. See Usage Notes. Laboratory Observation Identifier Value Set TBD TBD Unique identifiers for the type of observations. Values must be drawn from LOINC and is required for use with any test on the in-scope test list. LOINC LOINC 2.16.840.1.113883.6.1 (code system) Logical Observation Identifiers Names and Codes http://www.loinc.org New codesystem for new OBR Field TBD TBD Values are: R-Results Copy Requested E - Result Copy Enclosed per Order Provider's request 2.16.840.1.114222.4.11.829 Codes representing county of origin, address county, reporting county Also referred to as HL70289 2.16.840.1.114222.4.11.831 Primary spoken language Note that HITSP identifies a language value set as follows: “The value set is defined by Internet RFC 4646 (replacing RFC 3066). Please see ISO 639 language code set maintained by Library of Congress for enumeration of language codes and Frequently Asked Questions.” RFC4646 seems to point to ISO 639 as the source of the actual language codes, so this value set is consistent with the HITSP value set. County () FIPS 6-4 Language () ISO_6392_Alpha3 Page 88 of 150 September 2011 ISO HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Name Source ID/ Reference TABLE 4-1. VALUE SET/CODE SYSTEM SUMMARY Source Unique Identifier Comments Postal Code Value Set US Postal Service via 2.16.840.1.113883.3.88.12.80.2 This identifies the postal (ZIP) Code of an address in the United States HITSP C-80, 20090708 http://zip4.usps.com/zip4/welcome.jsp V1.1 SNOMED CT SNOMED CT 2.16.840.1.113883.6.96 SNOMED CT http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html Specimen Type Value Set TBD TBD Specimen Type Union of HL70487 and SNOMED CT Specimen hierarchy State Value Set FIPS 5-2 Unified Code for Units of Measure (UCUM) HITSP C-80,20090708 2.16.840.1.113883.3.88.12.80.1 Identifies addresses within the United States are recorded using the V1.1 FIPS 5-2 two-letter alphabetic codes for the State, District of Columbia, or an outlying area of the United States or associated area. http://www.itl.nist.gov/fipspubs/fip5-2.htm Regenstrief Institute, 2.16.840.1.113883.3.88.12.80.29 Units of measure concepts that includes atomic UCUM units as well as Inc. UCUM expression. Commonly used UCUM units of measure concepts http://www.regenstrief.o can be obtained from UCUM Web Site rg/medinformatics/ucu http://www.regenstrief.org/medinformatics/ucum m A tool for converting non-UCUM units of measure to the equivalent UCUM units is available at: http://www.regenstrief.org/medinformatics/ucum/unit-conversion-tool A pre-coordinated value set of common units is also available from PHIN VADS as: PHVS_UnitsOfMeasure_UCUM Usage Notes Laboratory Coded Observation Value Set For specific result categories: Organisms Identify using codes from the SNOMED CT “organism” hierarchy HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 89 of 150 September 2011 o This will normally exclude the use of codes from the “clinical finding” hierarchy representing the presence of a specific organism (e.g., "312210001^methicillin resistant staphylococcus aureus positive^SCT”, "431256002^culture positive for vancomycin resistant enterococcus^SCT”, "441070005^Human enterovirus present^SCT”). However, in some cases a specific absence finding may be appropriate (e.g., "404520004^no Chlamydia trachomatis found^SCT”). Organism-related substances (e.g. toxin, DNA, RNA, antigen, antibody, etc.) Identify using codes from the SNOMED CT “substance” hierarchy (e.g., "12671002^Clostridium difficile toxin^SCT”, "121181000^Chlamydia trachomatis DNA^SCT”, "121006005^influenza virus A antigen^SCT”) o This will normally exclude the use of codes from the “clinical finding” hierarchy representing the presence of a specific organism-related substance (e.g., "310541005^Clostridium difficile toxin A detected^SCT”). Currently (as of the January 2011 release) we are not aware of any SNOMED CT codes representing the absence of an organism-related substance. Presence and absence findings Identify using codes from the SNOMED CT “qualifier value" hierarchy (e.g., "52101004^present^SCT”, "10828004^positive^SCT”, "2667000^absent^SCT”, "260385009^negative^SCT”) Anatomic Pathology Use of SNOMED CT codes is recommended, but further evaluation is needed to determine which hierarchies are appropriate for use o The NAACCR examples list "abnormal morphology" codes Clinical genomics and additional clinical areas Consider whether other vocabularies in addition to, or in place of, SNOMED CT might apply Page 90 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 4.6 HL7 TABLES This section provides values for HL7 tables that have had constraints applied to them in this IG. 4.6.1 HL7 TABLE 0065 – SPECIMEN ACTION CODE FROM HL7 V2.7.1 MESSAGE - CONSTRAINED TABLE 4-2. HL7 TABLE 0065 SPECIMEN ACTION CODE - CONSTRAINED Value Description Comment A Add ordered tests to the existing specimen G Generated order; reflex order L Lab to obtain specimen from patient O Specimen obtained by service other than Lab 4.6.2 HL7 TABLE 0076 – MESSAGE TYPE 2.5.1 (CONSTRAINED) TABLE 4-3. HL7 TABLE 0076 FROM 2.5.1 - CONSTRAINED Comment Value Description ORU Unsolicited transmission of an observation message ACK General acknowledgment message 4.6.3 HL7 TABLE 0078 – INTERPRETATION CODES FROM HL7 V2.7.1 MESSAGE TABLE 4-3. HL7 TABLE 0078 FROM 2.7.1 Value Description L Below low normal H Above high normal LL Below lower panic limits HH Above upper panic limits HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comment Page 91 of 150 September 2011 TABLE 4-3. HL7 TABLE 0078 FROM 2.7.1 Value Description < Below absolute low-off instrument scale > Above absolute high-off instrument scale N Normal (applies to non-numeric results) A Abnormal (applies to non-numeric results) AA Very abnormal (applies to non-numeric units, analogous to panic limits for numeric units) null No range defined, or normal ranges don't apply U Significant change up D Significant change down B Better—use when direction not relevant W Worse—use when direction not relevant S Susceptible. Indicates for microbiology susceptibilities only. R Resistant. Indicates for microbiology susceptibilities only. I Intermediate. Indicates for microbiology susceptibilities only. MS Moderately susceptible. Indicates for microbiology susceptibilities only. VS Very susceptible. Indicates for microbiology susceptibilities only. POS Positive Added in HL7 Version 2.7.1 NEG Negative Added in HL7 Version 2.7.1 IND Indeterminate Added in HL7 Version 2.7.1 DET Detected Added in HL7 Version 2.7.1 Page 92 of 150 September 2011 Comment HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 4-3. HL7 TABLE 0078 FROM 2.7.1 Value Description Comment ND Not Detected Added in HL7 Version 2.7.1 AC Anti-complementary substances present Added in HL7 Version 2.7.1 TOX Cytotoxic substance present Added in HL7 Version 2.7.1 QCF Quality Control Failure Added in HL7 Version 2.7.1 RR Reactive Added in HL7 Version 2.7.1 WR Weakly reactive Added in HL7 Version 2.7.1 NR Non-reactive Added in HL7 Version 2.7.1 4.6.4 HL7 TABLE 0125 – VALUE TYPE (CONSTRAINED FROM THE FULL HL7 TABLE) TABLE 4-4. HL7 TABLE 0125 – VALUE TYPE Value Description Use CE Coded Entry R CWE Coded with Exceptions R CX Extended Composite ID With Check Digit O DT Date R HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. C.LEN Comment This Implementation Guide has a specially constrained version of the CWE data type in section 2.3 above which is used for OBX-5. The version of the CWE documented in section Error! Reference source not found. shall not be used for OBX-5. The version of the CWE constrained for use with OBX-5 requires sending coded data. If the lab is trying to send only string data, the ST, TX or FT data types should be used. Data type to be used where it is important to communicate the coding system and coding system version with the coded result being reported. Pre-adopted from Version 2.6. Page 93 of 150 September 2011 TABLE 4-4. HL7 TABLE 0125 – VALUE TYPE Value Description Use ED Encapsulated Data O Field using the ED data type to allow communication of images, sound clips, XML documents, html markup, etc. Requires agreement between trading partners FT Formatted Text (Display) R Field using the FT data type to carry a text result value. This is intended for display. The text may contain formatting escape sequences as described in the data types section. Numeric results and numeric results with units of measure should not be reported as text. These should be reported as NM or SN numeric results, with the units of measure in OBX-6. NM Numeric R Field using the NM data type to carry a numeric result value. The only nonnumeric characters allowed in this field are a leading plus (+) or minus (-) sign. The structured numeric (SN) data type should be used for conveying inequalities, ranges, ratios, etc. The units for the numeric value should be reported in OBX-6. RP Reference Pointer O Field using the RP data type to allow communication of pointers to images, sound clips, XML documents, html markup, etc. The RP data type is used when the object being pointed to is too large to transmit directly. This specification defines the mechanism for exchanging pointers to objects, but it does not address the details of applications actually accessing and retrieving the objects over a network. The most common scheme for passing a pointer is to use a Universal Resource Identifier (URI). See http://ietf.org/rfc/rfc2396.txt for detailed definition. The general format of a URI is in the form: <scheme>://<authority><path>?<query>. The scheme and authority portions appear in the Application ID component, Universal ID subcomponent. The path and query portion of the URI appear in the Pointer component of the RP data type. SN Structured Numeric R Field using the SN data type to carry a structured numeric result value. Structured numeric include intervals (^0^-^1), ratios (^1^/^2 or ^1^:^2), inequalities (<^10), or categorical results (2^+). The units for the structured numeric value should be reported in OBX-6. Page 94 of 150 September 2011 C.LEN Comment HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 4-4. HL7 TABLE 0125 – VALUE TYPE Value Description Use ST String Data R TM Time R TS Time Stamp (Date & Time) R TX Text Data (Display) R C.LEN Comment Field using the ST data type to carry a short text result value. Numeric results and numeric results with units of measure should not be reported as text. These shall be reported as NM or SN numeric results, with the units of measure in OBX-6. Field using the TX data type to carry a text result value this is intended for display. Numeric results and numeric results with units of measure should not be reported as text. These should be reported as NM or SN numeric results, with the units of measure in OBX-6. 4.6.5 HL7 TABLE 0203 – IDENTIFIER TYPE FROM HL7 V2.7.1 TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description AM American Express AN Account number ANC Account number Creditor AND Account number debitor ANON Anonymous identifier ANT Temporary Account Number APRN Advanced Practice Registered Nurse number BA Bank Account Number BC Bank Card Number HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comment Page 95 of 150 September 2011 TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description BR Birth registry number BRN Breed Registry Number CC Cost Center number CY County number DDS Dentist license number DEA Drug Enforcement Administration registration number DFN Drug Furnishing or prescriptive authority Number DI Diner_s Club card DL Driver_s license number DN Doctor number DO Osteopathic License number DPM Podiatrist license number DR Donor Registration Number DS Discover Card EI Employee number EN Employer number FI Facility ID GI Guarantor internal identifier GL General ledger number Page 96 of 150 September 2011 Comment HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description GN Guarantor external identifier HC Health Card Number IND Indigenous/Aboriginal JHN Jurisdictional health number (Canada) LI Labor and industries number LN License number LR Local Registry ID MA Patient Medicaid number MB Member Number MC Patient's Medicare number MCD Practitioner Medicaid number MCN Microchip Number MCR Practitioner Medicare number MD Medical License number MI Military ID number MR Medical record number MRT Temporary Medical Record Number MS MasterCard NE National employer identifier HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comment Page 97 of 150 September 2011 TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description NH National Health Plan Identifier NI National unique individual identifier NII National Insurance Organization Identifier NIIP National Insurance Payor Identifier (Payor) NNxxx National Person Identifier where the xxx is the ISO table 3166 3-character (alphabetic) country code NP Nurse practitioner number NPI National provider identifier OD Optometrist license number PA Physician Assistant number PCN Penitentiary/correctional institution Number PE Living Subject Enterprise Number PEN Pension Number PI Patient internal identifier PN Person number PNT Temporary Living Subject Number PPN Passport number PRC Permanent Resident Card Number PRN Provider number PT Patient external identifier Page 98 of 150 September 2011 Comment HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description QA QA number RI Resource identifier RN Registered Nurse Number RPH Pharmacist license number RR Railroad Retirement number RRI Regional registry ID SID Specimen identifier SL State license SN Subscriber Number SR State registry ID SS Social Security number TAX Tax ID number TN Treaty Number/ (Canada) U Unspecified identifier UPIN Medicare/CMS (formerly HCFA)_s Universal Physician Identification numbers VN Visit number VS VISA WC WIC identifier WCN Workers_ Comp Number HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comment Page 99 of 150 September 2011 TABLE 4-6. HL7 TABLE 0203 – FROM 2.7.1 Value Description XX Organization identifier Comment 4.6.6 HL7 TABLE 0291 – SUBTYPE OF REFERENCED DATA TABLE 4-5. HL7 TABLE 0291 – SUBTYPE OF REFERENCED DATA Description Comment Source RFC 2046 MIME media subtypes established in accordance with RFC 2046 (http://ietf.org/rfc/rfc2046.txt) and registered with the Internet Assigned Numbers Authority (http://www.iana.org/numbers.html). Note that the MIME media subtype values are case-insensitive, in accordance with RFC 2045. Value x-hl7-cda-level-one HL7 Clinical Document Architecture Level One document Not supported. 4.6.7 HL7 TABLE 0301 - UNIVERSAL ID TYPE TABLE 4-6. HL7 TABLE 0301 - UNIVERSAL ID TYPE Value Description Use Comments CLIA Clinical Laboratory Improvement Amendments. Allows for the ability to designate organization identifier as a "CLIA" assigned number (for labs) RE Use in MSH.4 allowed DNS An Internet dotted name. Either in ASCII or as integers ? ? GUID Same as UUID. ? ? CEN The CEN Healthcare Coding Scheme Designator. (Identifiers used in DICOM follow this assignment scheme.) ? ? HL7 Reserved for future HL7 registration schemes ? ? ISO An International Standards Organization Object Identifier R Used as the Universal ID Type in the CNN, EI and HD data types. Page 100 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. TABLE 4-6. HL7 TABLE 0301 - UNIVERSAL ID TYPE Value Description Use Comments L,M,N These are reserved for locally defined coding schemes. ? ? Random Usually a base64 encoded string of random bits. The uniqueness depends on the length of the bits. Mail systems often generate ASCII string _unique names," from a combination of random bits and system names. Obviously, such identifiers will not be constrained to the base64 character set. ? ? URI Uniform Resource Identifier R Used as the Universal ID Type in the RP data type UUID The DCE Universal Unique Identifier ? ? x400 An X.400 MHS format identifier ? ? x500 An X.500 directory name ? ? 4.6.8 HL7 TABLE 0354 – MESSAGE STRUCTUREFROM 2.5.1 (CONSTRAINED) Value ORU_R01 TABLE 4-8. HL7 TABLE 0354 – FROM 2.5.1 (CONSTRAINED) Description Use Comments Unsolicited transmission of an observation message R ACK_R01 General Acknowledgment Message for unsolicited transmission of an observation message R 4.6.9 HL7 TABLE 0834 – MIME TYPE TABLE 4-7. HL7 TABLE 0834 – MIME TYPE Use ? Value application Description Application data audio Audio data R image Image data R model Model data ? text Text data R HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 101 of 150 September 2011 Comments Value video Description Video data Use R multipart MIME multipart package ? Comments 4.6.10 HL7 TABLE NEW – ??? FROM 2.7.1 TABLE 4-10. HL7 TABLE 0??? – FROM 2.7.1 Usage Value Description E Result Copy Enclosed per Order Provider's request R R Results Copy Requested R Page 102 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Comments 5. MESSAGE PROFILES This implementation guide uses 5 profiles to enable communication of the conformance statements that are applicable to the message. The basic purpose of these profiles is defined in section 1.6 Conformance to this Guide {get hyperlink}. This chapter summarizes for four of those profiles the data types and segments which conformance statements change depending on the profile used. Note that the base profile is not summarized here is it indicates that all conformance statements in this implementation guide apply. 5.1 PROFILE GU – GLOBAL UNIQUE IDENTIFIERS This profile (2.16.840.1.113883.9.12) is used when all identifiers in the message use ISO OIDs to identify the respective objects. The following data types have specific conformance statement to conform to this profile: CX – Extended Composite ID with Check Digit Description: CX.4 - Assigning Authority is required o See section 1.14.5 CX – GU {get hyperlink} for the full data type definition o See section 1.14.17 HD - GU {get hyperlink} for the data type definition used in CX.4 -Assigning Authority. o All fields using these data types must use the data types per the definitions referenced above. That includes: PID.3 – Patient Identifier List PID.18 – Patient Account Number PID.21 – Mother’s Identifier NK1.12 - Next of Kin / Associated Parties Employee Number NK1.33 - Next of Kin/Associated Party’s Identifiers PV1.5 – Preadmit Number PV1.19 – Visit Number PV1.50 – Alternate Visit ID EI – Entity Identifier Description: EI.2 - NameSpace ID is required, but can be empty if not available, while EI.3 – Universal ID must be valued with OID and EI.4 – Universal ID Type must be valued to “ISO” o See section 1.14.11 EI – GU {get hyperlink} for the full data type definition o All fields using these data types must use the data types per the definitions referenced above. That includes: MSH.21 – Message Profile Identifier ORC.2 – Placer Order Number ORC.3 – Filler Order Number ORC.4 – Placer Group Number OBR.2 – Placer Order Number OBR.3 – Filler Order Number OBX.18 – Equipment Instance Identifier EIP – Entity Identifier Pair Description: The EI - GU datatype definition is used for both EIP.1 and EIP.2 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 103 of 150 September 2011 o See section 1.14.13 EIP – GU {get hyperlink} for the full data type definition o See section 1.14.11 EI – GU {get hyperlink} for the data type definition to be used for both EIP.1 and EIP.2 o All fields using these data types must use the data types per the definitions referenced above. That includes: ORC.8 – Parent OBR.29 – Parent SPM.2 – Specimen Identifier SPM.3 – Specimen Parent IDs HD – Hierarchy Identifier Description: HD.1 - NameSpace ID is required, but can be empty if not available, while HD.2 – Universal ID must be valued with OID and HD.3 – Universal ID Type must be valued to “ISO” o See section 1.14.17 HD – GU {get hyperlink} for the full data type definition o All fields using these data types must use the data types per the definitions referenced above. That includes: MSH.3 – Sending Application MSH.4 – Sending Facility MSH.5 – Receiving Application MSH.6 – Receiving Facility MSH.34 – Last Update Facility FSH.3 – File Sending Application FSH.4 – File Sending Facility FSH.5 – File Receiving Application FSH.6 – File Receiving Facility BHS.3 – Batch Sending Application BHS.4 – Batch Sending Facility BHS.5 – Batch Receiving Application BHS.6 – Batch Receiving Facility XCN – Extended Composite ID Number and Name for Persons Description: XCN.9 – Assigning Authority and XCN.14 – Assigning Facility use the HD – GU data type definition o See section 1.14.34 XCN – GU {get hyperlink} for the full data type definition o See section 1.14.17 HD – GU {get hyperlink} for the data type definition to be used o All fields using these data types must use the data types per the definitions referenced above. That includes: PV1.7 – Attending Doctor PV1.8 – Referring Doctor PV1.9 – Consulting Doctor PV1.17 – Admitting Doctor PV1.52 – Other Healthcare Provider PV2.13 – Referral Source Code ORC.10 – Entered By ORC.11 – Verified By ORC.12 – Ordering Provider Page 104 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. ORC.19 – Action By OBR.10 – Collector Identifier OBR.16 – Ordering Provider OBR.28 – Result Copies To OBX.16 – Responsible Observer OBX.25 – Performing Organization Medical Director XON – Extended Composite ID Number and Name for Organizations Description: XON.6 – Assigning Authority and XON.9 – Assigning Facility use the HD – GU data type definition o See section 1.14.?? XON – GU {get hyperlink} for the full data type definition o See section 1.14.17 HD – GU {get hyperlink} for the data type definition to be used o All fields using these data types must use the data types per the definitions referenced above. That includes: SFT.1 – Software Vendor Organization NK1.13 – Organization Name PV2.23 – Clinic Organization Name ORC.21 - Ordering Facility Name OBX.23 – Performing Organization Name 5.2 PROFILE NG – NON-GLOBALLY UNIQUE IDENTIFIERS This profile (2.16.840.1.113883.9.13) indicates that at least one of the identifiers used in this message is constructed using an alternate method to ISO OIDs for providing strong identification. As a result, identifiers are not guaranteed to be globally unique and require review between the trading partners to ensure appropriate identification can occur. The following data types have specific conformance statement to conform to this profile: CX – Extended Composite ID with Check Digit Description: CX.4 - Assigning Authority is required but can be empty o See section 1.14.6 CX – NG {get hyperlink} for the full data type definition o See section 1.14.18 HD - NG {get hyperlink} for the data type definition used in CX.4 -Assigning Authority. o All fields using these data types must use the data types per the definitions referenced above. That includes: PID.3 – Patient Identifier List PID.18 – Patient Account Number PID.21 – Mother’s Identifier NK1.12 - Next of Kin / Associated Parties Employee Number NK1.33 - Next of Kin/Associated Party’s Identifiers PV1.5 – Preadmit Number PV1.19 – Visit Number PV1.50 – Alternate Visit ID EI – Entity Identifier Description: EI.2 - NameSpace ID is optional o See section 1.14.12 EI – NG {get hyperlink} for the full data type definition o All fields using these data types must use the data types per the definitions referenced above. That includes: HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 105 of 150 September 2011 MSH.21 – Message Profile Identifier ORC.2 – Placer Order Number ORC.3 – Filler Order Number ORC.4 – Placer Group Number OBR.2 – Placer Order Number OBR.3 – Filler Order Number OBX.18 – Equipment Instance Identifier EIP – Entity Identifier Pair Description: The EI - NG datatype definition is used for both EIP.1 and EIP.2 o See section 1.14.12 EI – NG {get hyperlink} for the full data type definition to be used for both EIP.1 and EIP.2 o All fields using these data types must use the data types per the definitions referenced above. That includes: ORC.8 – Parent OBR.29 – Parent SPM.2 – Specimen Identifier SPM.3 – Specimen Parent IDs HD – Hierarchy Identifier Description: HD.1 – Namespace ID is optional, while HD.2 – Universal ID and HD.3 – Universal ID Type have conditions depending on HD.1 and HD.2 o See section 1.14.18 HD – NG {get hyperlink} for the full data type definition o All fields using these data types must use the data types per the definitions referenced above. That includes: MSH.3 – Sending Application MSH.4 – Sending Facility MSH.5 – Receiving Application MSH.6 – Receiving Facility MSH.34 – Last Update Facility FSH.3 – File Sending Application FSH.4 – File Sending Facility FSH.5 – File Receiving Application FSH.6 – File Receiving Facility BHS.3 – Batch Sending Application BHS.4 – Batch Sending Facility BHS.5 – Batch Receiving Application BHS.6 – Batch Receiving Facility XCN – Extended Composite ID Number and Name for Persons Description: XCN.9 – Assigning Authority and XCN.14 – Assigning Facility use the HD – NG data type definition o See section 1.14.35 XCN – NG {get hyperlink} for the full data type definition o See section 1.14.18 HD – NG {get hyperlink} for the data type definition to be used o All fields using these data types must use the data types per the definitions referenced above. That includes: PV1.7 – Attending Doctor PV1.8 – Referring Doctor Page 106 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. PV1.9 – Consulting Doctor PV1.17 – Admitting Doctor PV1.52 – Other Healthcare Provider PV2.13 – Referral Source Code ORC.10 – Entered By ORC.11 – Verified By ORC.12 – Ordering Provider ORC.19 – Action By OBR.10 – Collector Identifier OBR.16 – Ordering Provider OBR.28 – Result Copies To OBX.16 – Responsible Observer OBX.25 – Performing Organization Medical Director XON – Extended Composite ID Number and Name for Organizations Description: XON.6 – Assigning Authority and XON.9 – Assigning Facility use the HD – NG data type definition o See section 1.14.?? XON – NG {get hyperlink} for the full data type definition o See section 1.14.18 HD – NG {get hyperlink} for the data type definition to be used o All fields using these data types must use the data types per the definitions referenced above. That includes: SFT.1 – Software Vendor Organization NK1.13 – Organization Name PV2.23 – Clinic Organization Name ORC.21 - Ordering Facility Name OBX.23 – Performing Organization Name 5.3 PROFILE RU – UNIQUE PLACER/FILLER ORDER NUMBER This profile (2.16.840.1.113883.9.14) indicates that the test can be identified by only using either the placer order number, and/or filler order number. The following fields are subject to this profile: ORC.2 – Order Place Number ORC.3 – Filler Order Number ORC.8 – Parent OBR.2 – Placer Order Number OBR.3 – Filler Order Number OBR.29 – Parent When used, each of these fields must be able to uniquely identify the test being reported on within the ordering application without needing the universal service identifier. 5.4 PROFILE RN – NON-UNIQUE ORDER NUMBERS This profile (2.16.840.1.113883.9.15) indicates that the test can be identified by using the universal service identifier and either the placer order number or the filler order number as the placer or filler order number alone would not uniquely identify a test. To get to a unique order instance : HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 107 of 150 September 2011 ORC.2 – Placer Order Number + OBR.4 – Universal Service Identifier or: OBR.2 Placer Order Number + OBR.4 – Universal Service Identifier ORC.3 – Filler Order Number + OBR.4 – Universal Service Identifier or: OBR.3 – Filler Order Number + OBR.4 – Universal Service Identifier To get to a unique parent instance : ORC.8 – Parent + OBR.50 – Parent Universal Service Identifier or : OBR.29 – Parent + OBR.50 – Parent Universal Service Identifier Page 108 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 6. EXAMPLE LABORATORY RESULT MESSAGES Examples should not be used as the basis for implementing the messages in the implementation guide. Examples are handcrafted and as such are subject to human error. The information in this section is informative and not normative. Release Note: Examples will be provided for this section that are conformant to the statements in the final version of this Release (R1). HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 109 of 150 September 2011 7. ADDITIONAL IMPLEMENATION GUIDANCE 7.1 CULTURE AND SUSCEPTIBILITIES REPORTING 7.1.1 INTRODUCTION Parent-child relationships, such as culture and sensitivities, can be reported using the HL7 electronic messaging standard. However, this is an area where many vendors and large laboratories have augmented the standard to account for variations in the systems with which they work. This usually does not present a problem until these messages must be shared between systems (for instance, between laboratories and sub-contracted laboratories, or between laboratories and public health agencies). Parent-child information such as culture and susceptibilities (e.g., reporting of multi-resistant tuberculosis or drug-resistant gonococcus or pneumococcus) is a critical component of electronic, laboratory-based public health reporting. The approach described here is required for use in reporting microbiology results for this message profile. 7.1.2 TEMPLATE FOR CULTURE RESULTS A template report for the initial identification of three organisms from a single stool culture is presented below. For each field (i.e., the space between the pipes, "|"), a description of what should appear in that particular field is given, along with the segment-field number in parentheses (e.g., OBR-3) for some of the fields. Note that these examples use the ORU^R01 message type. Release Note: Revised examples will be provided for this section that are conformant to the statements in the final version of this Release (R1). The examples in the shaded below are all subject to change. MSH|… PID|… OBR|1| Placer number | Filler number | Identifier code for the requested test or panel of tests(OBR-4) |… OBX|1|CE| Specific organism identifier (OBX-3) | Sub-id for the first organism (OBX-4) | Description of organism (OBX-5) |… OBX|2|SN| Other identifier (OBX-3) | Sub-id for the first organism (OBX-4) | Observation on the organism (OBX-5) |… OBX|3|CE| Specific organism identifier (OBX-3) | Sub-id for the second organism (OBX-4) | Description of organism (OBX-5) |… OBX|4|SN| Other identifier (OBX-3) | Sub-id for the second organism (OBX-4) | Observation on the Organism (OBX-5) |… HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 110 of 150 September 2011 OBX|5|CE| Specific organism identifier (OBX-3) | Sub-id for the third organism (OBX-4) | Description of organism (OBX-5) |… OBX|6|SN| Other identifier (OBX-3) | Sub-id for the third organism (OBX-4) | Observation on the organism (OBX-5) |… SPM|1| Specimen identifier for the specimen being tested|_ This report has the MSH (Message Header), the PID (Patient Identification Segment), a single OBR (Observation Request Segment), and six OBX (Observation/Results) segments, and a single SPM (Specimen Segment). Note that the Set ID in the first field of each OBX isSEQuential, while the Sub-ID in the fourth field of each OBX is notSEQuential, but acts as a link for all of the OBX segments that are reporting information for a related observation. The Sub-ID field in the template above has the words "first," "second" and "third" in bold and highlighted in green. This is done to show that the identification of the first organism is the relating observation for the first two OBX segments (e.g., Set-ID numbers 1 and 2). The identification of the second organism is the relating observation for the second two segments (e.g., Set-ID numbers 3 and 4), and so on. An example using the template above is presented below. 7.1.3 EXAMPLES OF CULTURE RESULTS In this example, Reliable Labs, Inc. is sending preliminary results of a stool culture to state public health authorities. Three pathogens have been identified: Campylobacter jejuni, Salmonella and Shigella. This example shows the use of the Sub-ID in OBX-4 to connect related observations. The Sub-ID is shown in bolded letters and highlighted in green, as presented in the previous template. In this example, numbers are used for the Sub-ID. However, a text identifier such as "isolate1" could be used. The HL7 standard has defined the Sub-ID (e.g., OBX-4) as a "string" data type. Thus, it can be either a number or text. In this example, the information about colony counts in OBX segments with Set IDs 2, 4, and 6 is provided to show how the Sub-ID is used to relate the associated OBX segments to each other (e.g., 1 and 2, 3 and 4, 5 and 6). Some laboratories may not have this additional information and would therefore transmit only the identification of the organisms (e.g., OBX segments 1, 3 and 5). Identified organisms must be reported as coded data instead of text data. Coded data enables machine processing of results. String data can normally be interpreted only by humans. MSH|^~\&|Lab1^1234^CLIA|Reliable^1234^CLIA|ELR^2.16.840.1.113 883.19.3.2.3^ISO|SPH^2.16.840.1.113883.19.3.2^ISO|2007070 11325540400||ORU^R01^ORU_R01|20070701132554000008|P^T|2.5.1|||NE |NE|USA||||USELR1.0^^2.16.840.1.113883.19.9.7^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 111 of 150 September 2011 Lab System|56734||20080817 PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.1 6.840.1.113883.19.3.2.1&ISO~444333333^^^&2.16.840.1.11388 3.4.1^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^ ^^^M|19750602|M||2106-3^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^9 55^5551009|eng^English^ISO6392^^^^3/29/2007|M^Married^HL7 0002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||2008081510000700|Reliable^2.16.840.1.113883.19.3.1^ISO ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2 .16.840.1.113883.19.3.1.6^ISO|||||||||1234^Admit^Alan^A^I II^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1. 113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551005|||||| |Level Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2. 16.840.1.113883.19.3.1.6^ISO|625-4^Bacteria identified^LN^3456543^ CULTURE, STOOL^99USI^2.26|||2008081510300700||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^&2.16.840 .1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO ^^^^^^^^MD|^WPN^PH^^1^555^5551005|||||20080818300700|||P||||||787.91^DIARRHEA^I9CDX^^^^07/09/2008|1235&Sl ide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO OBX|1|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|1|6654300 0^Campylobacter jejuni^SCT^^^^January 2007||||||P|||200808151030-0700|||0086^Bacterial identification^OBSMETHOD^^^^501-20080815||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|2|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|1|^10000^^90000|1^^UCUM^^^^1.6|||||P|||2008081510300700|||||200808161030-0700||||Reliable Page 112 of 150 September 2011 Labs, HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|3|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|2|3026200 05^Salmonella group B phase 1 a-e^SCT^^^^January 2007||||||P|||200808151030-0700|||0086^Bacterial identification^OBSMETHOD^^^^501-20080815||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|4|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|2|>^100000|1^^UCUM^^^^1 .6|||||P|||200808151030-0700|||||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|5|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|3|7735200 2^Shigella^SCT^^^^January 2007||||||P|||2008081510300700|||0086^Bacterial identification^OBSMETHOD^^^^50120080815||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|6|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|3|<^1000|1^^UCUM^^^^1.6 |||||P|||200808151030-0700|||||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2. 16.840.1.113883.19.3.1.6&ISO||119339001^Stool specimen^SCT^^^^20080131|||||||P^Patient^HL60369^^^^2.5.1 |10^g&gram&UCUM&&&&1.6|||||2008081510300700|200808151100-0700 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 113 of 150 September 2011 7.1.4 TEMPLATE FOR CULTURE AND SUSCEPTIBILITY RESULTS The template and example in the Template for Culture Results section of this appendix describe a report for a culture. The following template shows how antimicrobial susceptibility results are reported for the culture described in that section. The connection of the culture to the susceptibilities is a "parent-child" relationship, where the culture is the parent result and the susceptibilities are the child results. This means that there can be many child results for a single parent result. In other words, there can be multiple OBR child segments for the single OBR parent segment presented in the Template for Culture Results section of this appendix. The template for the report containing the culture and susceptibilities appears below. The titles in Italics are given to highlight the individual parent and child segments and are not found in an actual HL7 message transmission. It is important to note that in each of the OBR child segments there is a pointer back to the parent result. This pointer is found in OBR-26 (Parent Result) and in OBR-29 (Parent Number). Message Header and Patient Identification Segment for the Parent-Child Message MSH|… PID|… Parent OBR Segment OBR|1| Placer number (OBR-2) | Filler order number (OBR-3) | Identifier code for the requested test or panel of tests (OBR-4) |… Parent OBX Segments for First Organism Identified OBX|1|CE| Specific organism identifier (OBX-3) | Sub-id for the first organism (OBX-4) | Description of organism (OBX-5) |… OBX|2|SN| Other identifier (OBX-3) | Sub-id for the first organism (OBX-4) | Observation on the organism (OBX-5) |… Parent OBX Segments for Second Organism Identified OBX|3|CE| Specific organism identifier (OBX-3) | Sub-id for the second organism (OBX-4) | Description of organism (OBX-5) |… OBX|4|SN| Other identifier (OBX-3) | Sub-id for the second organism (OBX-4) | Observation on the Organism (OBX-5) |… Parent OBX Segments for Third Organism Identified Page 114 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. OBX|5|CE| Specific organism identifier (OBX-3) | Sub-id for the third organism (OBX-4) | Description of organism (OBX-5) |… OBX|6|SN| Other identifier (OBX-3) | Sub-id for the third organism (OBX-4) | Observation on the organism (OBX-5) |… Child OBR for First Organism identified OBR|2| Placer number (OBR-2)| Filler order number (OBR-3) | Identifier code for the requested test or panel of tests (OBR-4) |||||||||||||||||||||| A pointer back to the parent OBX segment that contained the identification of the first organism, see below for description of "Pointers" (OBR-26) ||| Parent Filler order number (OBR-29) |... Child OBX Segments for Susceptibilities of First Organism Identified OBX|1|CE|Specific susceptibility identifier for first antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… OBX|2|CE|Specific susceptibility identifier for second antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… OBX|3|CE|Specific susceptibility identifier for third antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… Child OBR Segment for Susceptibilities of Second Organism Identified OBR|3| Placer number (OBR-2)| Filler order number (OBR-3) | Identifier code for the requested test or panel of tests (OBR-4) |||||||||||||||||||||| A pointer back to the parent OBX segment that contained the identification of the second organism, see below for description of "Pointers" (OBR-26) ||| Parent Filler order number (OBR-29) |... Child OBX Segments for Susceptibilities of Second Organism Identified OBX|1|CE|Specific susceptibility identifier for first antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 115 of 150 September 2011 OBX|2|CE|Specific susceptibility identifier for second antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… OBX|3|CE|Specific susceptibility identifier for third antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… Child OBR Segment Identified for Susceptibilities of Third Organism OBR|3| Placer number (OBR-2)| Filler order number (OBR-3) | Identifier code for the requested test or panel of tests (OBR-4) |||||||||||||||||||||| A pointer back to the parent OBX segment that contained the identification of the third organism, see below for description of "Pointers" (OBR-26) ||| Parent Filler order number (OBR-29) |... Child OBX Segments for Susceptibilities of Third Organism Identified OBX|1|CE|Specific susceptibility identifier for first antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… OBX|2|CE|Specific susceptibility identifier for second antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… OBX|3|CE|Specific susceptibility identifier for third antimicrobial (OBX-3) || Susceptibility finding (OBX-5) ||| Susceptibility interpretation (OBX-8) |… SPM Segment SPM|1| Specimen identifier for the specimen being tested|… 7.1.5 EXAMPLES OF CULTURE AND SUSCEPTIBILITY RESULTS Using the template above, this example shows a report of three pathogens identified from a stool specimen with their respective antimicrobial susceptibility tests. Page 116 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. MSH|^~\&| Lab1^1234^CLIA|Reliable^1234^CLIA|ELR^2.16.840.1.113883.1 9.3.2.3^ISO|SPH^2.16.840.1.113883.19.3.2^ISO|200707011325 540400||ORU^R01^ORU_R01|20070701132554000008|P^T|2.5.1|||NE |NE|USA||||USELR1.0^^2.16.840.1.113883.19.9.7^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817 PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.1 6.840.1.113883.19.3.2.1&ISO~444333333^^^&2.16.840.1.11388 3.4.1^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^ ^^^M|19750602|M||2106-3^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^9 55^5551009|eng^English^ISO6392^^^^3/29/2007|M^Married^HL7 0002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||2008081510000700|Reliable^2.16.840.1.113883.19.3.1^ISO ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2 .16.840.1.113883.19.3.1.6^ISO|||||||||1234^Admit^Alan^A^I II^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1. 113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551005|||||| |Level Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2. 16.840.1.113883.19.3.1.6^ISO|625-4^Bacteria identified^LN^3456543^ CULTURE, STOOL^99USI^2.26|||2008081510300700||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^&2.16.840 .1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO ^^^^^^^^MD|^WPN^PH^^1^555^5551005|||||20080818300700|||F||||||787.91^DIARRHEA^I9CDX^^^^07/09/2008|1235&Sl ide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO OBX|1|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|1|6654300 0^Campylobacter jejuni^SCT^^^^January 2007||||||F|||200808151030-0700|||0086^Bacterial identification^OBSMETHOD^^^^501-20080815||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 117 of 150 September 2011 Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|2|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|1|^10000^^90000|1^^UCUM^^^^1.6|||||F|||2008081510300700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|3|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|2|3026200 05^Salmonella group B phase 1 a-e^SCT^^^^January 2007||||||F|||200808151030-0700|||0086^Bacterial identification^OBSMETHOD^^^^501-20080815||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|4|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|2|>^100000|1^^UCUM^^^^1 .6|||||F|||200808151030-0700|||||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|5|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|3|7735200 2^Shigella^SCT^^^^January 2007||||||F|||2008081510300700|||0086^Bacterial identification^OBSMETHOD^^^^50120080815||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|6|SN|564-5^COLONY COUNT:NUM:PT:XXX:QN:VC^LN^^^^2.26|3|<^1000|1^^UCUM^^^^1.6 |||||F|||200808151030-0700|||||2008081610300700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. Page 118 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 840.1.113883.19.4.6&ISO^L^^^NPI SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2. 16.840.1.113883.19.3.1.6&ISO||119339001^Stool specimen^SCT^^^^20080131|||||||P^Patient^HL60369^^^^2.5.1 |10^g&gram&UCUM&&&&1.6|||||2008081510300700|200808151100-0700 OBR|2||9700124^Lab^2.16.840.1.113883.19.3.1.6^ISO|505453^Bacterial susceptibility panel::Pt:Isolate:OrdQn:MIC^LN^^^^2.26|||2008081510300700|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.11388 3.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^ MD|^WPN^PH^^1^555^5551005|||||2008081830-0700|||F|6254&Bacteria identified:Prid:Pt:Stool:Nom:Culture&LN^1^Campylobacter jejuni|||23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700123 &Lab&2.16.840.1.113883.19.3.1.6&ISO||787.91^DIARRHEA^I9CD X^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1. 113883.19.4.6&ISO OBX|1|SN|6979-9^AMPICILLIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|<^0.06|ug/mL^^UCUM^^^^1.6||S|||F|||200 808151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|2|SN|7016-9^GENTAMICIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|ug/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|3|SN|7002-9^CIPROFLOXACIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|ug/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBR|3||9700125^Lab^2.16.840.1.113883.19.3.1.6^ISO|505453^Bacterial susceptibility panel::Pt:Isolate:OrdQn:MIC^LN^^^^2.26|||2008081510300700|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.11388 3.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^ MD|^WPN^PH^^1^555^5551005|||||2008081830-0700|||F|625HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 119 of 150 September 2011 4&Bacteria identified:Prid:Pt:Stool:Nom:Culture&LN^2^Salmonella group B phase 1 ae|||23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700123&Lab& 2.16.840.1.113883.19.3.1.6&ISO||787.91^DIARRHEA^I9CDX^^^^ 07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.11388 3.19.4.6&ISO OBX|1|SN|6979-9^AMPICILLIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|<^0.06|ug/mL^^UCUM^^^^1.6||S|||F|||200 808151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|2|SN|7016-9^GENTAMICIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|ug/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|3|SN|7002-9^CIPROFLOXACIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|ug/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBR|4||9700126^Lab^2.16.840.1.113883.19.3.1.6^ISO|505453^Bacterial susceptibility panel::Pt:Isolate:OrdQn:MIC^LN^^^^2.26|||2008081510300700|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.11388 3.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^ MD|^WPN^PH^^1^555^5551005|||||2008081830-0700|||F|6254&Bacteria identified:Prid:Pt:Stool:Nom:Culture&LN^2^Shigella|||2345 6&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700123&Lab&2.16.840 .1.113883.19.3.1.6&ISO||787.91^DIARRHEA^I9CDX^^^^07/09/20 08|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6 &ISO OBX|1|SN|6979-9^AMPICILLIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|<^0.06|µg/mL^^UCUM^^^^1.6||S|||F|||200 808151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Page 120 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|2|SN|7016-9^GENTAMICIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|µg/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI OBX|3|SN|7002-9^CIPROFLOXACIN:SUSC:PT:ISLT:ORDQN:GRADIENT STRIP^LN^^^^2.26|1|^0.05|µg/mL^^UCUM^^^^1.6||S|||F|||2008 08151030-0700|||||200808161030-0700||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16. 840.1.113883.19.4.6&ISO^L^^^NPI 7.2 LINKING PARENT AND CHILD RESULTS The previous example uses the information in OBR-26 as a pointer to the parent OBX where the culture result is reported. OBR-26 has three components. The three components of OBR-26 are the OBX-3, OBX-4 and part of the OBX-5 from the parent OBX segment. The pointer to the parent (using PRL data type) requires only the first two components. 7.3 CLINICAL LABORATORY IMPROVEMENTS AMENDMENT CONSIDERATIONS In the United States, Clinical Laboratory testing of human specimens is regulated by the Clinical Laboratory Improvements Amendments of 1988 (CLIA). Several sections of the regulations implementing CLIA impact how electronic laboratory is formatted for the US Realm and these changes are outlined in this appendix. Impacted areas include mandatory reporting requirements, report retention and display, and those authorized to receive a report. Specifics on the CLIA Regulation are found at http://wwwn.cdc.gov/clia/regs/toc.aspx. 7.3.1 MANDATORY REPORTING REQUIREMENTS Section 493.1291 of the CLIA Regulations defines items that must appear on a clinical laboratory report in the US (http://wwwn.cdc.gov/clia/regs/subpart_k.aspx493.1291). Interpretative Guidelines on the elements required in a report may be found at http://www.cms.hhs.gov/CLIA/downloads/apcsubk2.pdf . Specific report fields impacted include the following: Segment PID-3 TABLE 7-1. MANDATORY REPORTING REQUIREMENTS Field CLIA Impact Patient Identifier List A unique patient identification number is required HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 121 of 150 September 2011 Segment 5 Field CLIA Impact PID-5 Patient Name Positive patient identification required. If the patient’s name is known, this must be that name. If it is not known, a unique patient identifier must be assigned. OBX-3 Observation Identifier5 Unique identification of the test performed is required. LOINC® is an HL7-approved code system and shall be used for the Observation Identifier as described in the appropriate HITSP Interoperability Specification. Use of LOINC codes for additional tests is strongly encouraged. See Section 6 for more details. Addition of a local laboratory code is allowed. For certain tests CLIA requires additional information: Laboratories using manufacturer's instruments, kits or test systems labeled for "investigational use only" or "research use only" must clearly state that the test results are not to be used for treatment or diagnostic purposes. If results of such tests are being reported without a disclaimer statement, or are being used by the provider for patient care, they are in the same category as in-house developed tests and the laboratory must establish performance specifications in accordance with §493.1253. The disclaimer for Analyte Specific Reagents (ASR) should state, "This test was developed and its performance characteristics determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration." The ASR disclaimer on the test report is required by the FDA under 21 CFR, Part 809.30, "Restrictions on the sale, distribution and use of analyte -specific reagents." OBX-5 Observation Value The laboratory result is required. No regulatory requirements are specified, outside of readability, regarding result appearance. OBX-6 Units Units, if required, or an interpretation must be given. For tests such as genetic screens the interpretation may actually be the test result. OBX-7 Reference Range Required. OBX-8 Abnormal flag. Use is not required, but a laboratory may use this field as part of its interpretation guidance. If reported, it should be displayed by an EHR. OBX-11 Observation Result Status Used to reflect CLIA required conditions such as specimen acceptability, result corrections, cancellations as well as report status (§493.1291 (c)(7) and (k)(1,2). See SPM-21 and -22 below. OBX-19 Date/Time of Analysis Use this field to meet the requirement for test report time. OBX-23, 24, 25 Laboratory Identification Fields The identification of the performing laboratory is required. Populating with the CLIA ID Number in OBX-23 meets the requirement if this receiving EHR has access to a look-up table that will convert the CLIA ID number to full demographics comprising OBX-23,Performing Organization Name; OBX-24, Performing While CLIA requires a laboratory to maintain positive identification of a specimen reporting, that information as part of the result is not required. Page 122 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Segment Field CLIA Impact Organization Address; and OBX-25, Performing Organization Medical Director. If the CLIA ID number is not used, all demographic fields (OBX-23, OBX-24 and OBX-25) must be populated with appropriate information. SPM-4 Specimen Type Reporting requirements call for the specimen source, which equates to the Specimen Type in the SPM segment. SPM-21 Specimen Reject Reason Use this field in connection with OBX-11 if a test is cancelled for specimen related reason. SPM-22 Specimen Quality Use this field to provide a coded version for Specimen Description. For Electronic Health Records, it is preferred that this field be used in place of, or in connection with, SPM-14. 7.4 REGULATORY COMPLIANCE There may be local, state or federal regulations where the electronic message from a performing laboratory is presumed to be the legal report of the tests performed. Hence, the receiver may be required to save the format or content of the message for the same time period as required for any other legal document. 7.5 AUTHORIZED PARTIES Local laws, generally at the State level, govern who is authorized to receive laboratory reports. CLIA restricts the availability of those authorized to receive laboratory reports to just those approved at the local level and sets no national standards. Testing laboratories may not report results to unauthorized parties under CLIA. Testing laboratories either have a trusted relationship with the ordering party or presume that the ordering party is authorized to receive results. However, testing laboratories need not have knowledge of the appropriateness of others requested to receive results, such as "Copy to" recipients. To maintain CLIA compliance, a US testing laboratory may choose to restrict its reports to only those recipients authorized and verified to receive them. Hence, a testing laboratory need not send copies of a result. Note that CLIA places no restrictions on the receiver of a laboratory report regarding its retransmission of the report to others. HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 123 of 150 September 2011 8. EXAMPLE UCUM CODES The following list of examples is presented by the kind permission of the National Library of Medicine. 1.7 PREFACE TO TABLE OF EXAMPLE UCUM CODES FOR ELECTRONIC MESSAGING Attached is a first draft of an enumeration of The Unified Code for Units of Measure (UCUM), designed to make it clear what the UCUM syntax would produce for specific unit patterns in electronic communication. This early version, composed in a relatively short time frame, is based on content provided by Intermountain Healthcare, from a National Library of Medicine/Regenstrief Institute project that is analyzing raw units from more than 23 laboratory sources and their translation to UCUM (http://unitsofmeasure.org/) and from the HL7 table of units. In this version we have not included all of the content from all of these sources. Specifically for this version, we excluded units for which we could not quickly find definitions or clear patterns of usage, units of measure that we believed would only be used in pharmacy dispensing, and units used for purely clinical reporting (e.g. cigarette pack-years). We have included most of the pure metric units that were in the source table whether they apply directly to the laboratory or not because they will be generally useful and because we could not always be sure what should be excluded. We have included a row number in the first column of the table. Please use this number when suggesting changes or identifying problems with a given term. This number has no significance beyond identifying a unique row in this table. In particular, it does not officially denote a UCUM code. The table is ordered alphabetically by the content of the column Description of the Unit. Some details of the UCUM syntax follow, but for a more complete explanation than this please refer to the full UCUM specification at http://unitsofmeasure.org/. The UCUM codes that you see in the table are mixed-case ASCII text. The standard metric units all have their usual mixed-case representation, so milligram per deciliter is portrayed in UCUM as mg/dL. US, British, and other special units are usually enclosed in square brackets, e.g. inches is [in_i] (inches international) — the “i” is needed because the British inch and the US inch were slightly different until about 1980 when all parties agreed the international inch. In UCUM a dot (.) means multiply, a number to the right of a string means a power, and the divisor sign (/) means divide. So m2 means meter squared. Strings that are often included in units of measure but are adornments for human reading and that are not formally units of measure are enclosed in curlicue brackets {}. For example, mg/mol{creat} means milligram per mole of creatinine. UCUM does not formally specify what to put inside of the curlicue brackets except to insist there be no spaces, because spaces will break the parser and the UCUM units converter. In principle, users could adjust the contents of any such curlicue brackets because they aren’t a formal part of UCUM. In this table, we encourage the use of the same string consistently within curlicue brackets, e.g. {creat} for creatinine and {Hb} for hemoglobin. However, this is not an absolute constraint of UCUM, and, when needed, users may adjust the content within the curlicue brackets. Page 124 of 150 September 2011 HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. 1.8 TABLE OF EXAMPLE UCUM CODES FOR ELECTRONIC MESSAGING As of March 24, 2016 (Table sorted by "Description of the Unit" column) Row # (not a code) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 UCUM_CODE 10.L/min 10.L/(min.m2) 10.uN.s/(cm5.m2) 10*4/uL 10*8 24.h {absorbance} {activity} [AU] {AHF’U} A A/m [arb'U] [arb'U]/mL {ARU} atm ag/{cell} bar Bq [beth’U] 10*9/L 10*9/uL 10*9/mL {binding_index} [bdsk'U] {CAG_repeats} cal {cells} {cells}/[HPF] {cells}/uL cg cL cm cm[Hg] cm[H2O] cm[H2O]/L/s cm[H2O]/s/m cP cSt {delta_OD} {clock_time} [CFU] [CFU]/L [CFU]/mL {CAE'U} {CH100'U} {copies} {copies}/ug {copies}/mL {count} {CPM} {CPM}/10*3{cell} [cin_i] m3/s Description of the Unit (using UCUM descriptions where they exist) 10 liter per minute 10 liter per minute per square meter 10 micronewton second per centimeter to the fifth power per square meter 10 thousand per microliter 100 million 24 hour absorbance activity allergy unit American Hospital Formulary unit ampere ampere per meter arbitrary unit arbitrary unit per milliliter aspirin response unit atmosphere attogram per cell bar Becquerel Bethesda unit billion per liter billion per microliter billion per milliliter binding index Bodansky unit CAG trinucleotide repeats calorie cells cells per high power field cells per microliter centigram centiliter centimeter centimeter of mercury centimeter of water centimeter of water per liter per second centimeter of water per second per meter centipoise centistoke change in (delta) optical density clock time e.g 12:30PM colony forming unit colony forming unit per liter colony forming unit per milliliter complement activity enzyme unit complement CH100 unit copies copies per microgram copies per milliliter count counts per minute counts per minute per thousand cells cubic inch (international) cubic meter per second HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 125 of 150 September 2011 Row # (not a code) 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 UCUM_CODE d dB dg dL dm deg Cel [degF] K K/W deg/s daL/min daL/min/m2 {dilution} [dr_av] [drp] dyn.s/cm dyn.s/(cm.m2) {Ehrlich’U} {Ehrlich’U}/100g {Ehrlich’U}/(2.h) {Ehrlich’U}/d {Ehrlich'U}/dL {EIA_index} {EIA_titer} {EIA'U} {EIA'U}/U {EV} eV {ELISA'U} U U/10 U/10*10 U/10*10{cells} U/(10.g){feces} U/(12.h) U/(2.h) U/(24.h) U/10*9 U/d U/dL U/g U/g{creat} U/g{Hb} U/g{protein} U/h U/kg{Hb} U/L U{25Cel}/L U{37Cel}/L U/mL U/mL{RBCs} U/mmol{creat} U/10*6 U/min U/s U/10*12 U/10*12{RBCs} eq eq/L Page 126 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) day decibel decigram deciliter decimeter degree (plane angle) degree Celsius degree Fahrenheit degree Kelvin degree Kelvin per Watt degree per second dekaliter per minute dekaliter per minute per square meter dilution dram (US and British) drop (1/12 milliliter) dyne second per centimeter dyne second per centimeter per square meter Ehrlich unit Ehrlich unit per 100 gram Ehrlich unit per 2 hour Ehrlich unit per day Ehrlich unit per deciliter EIA index EIA titer EIA unit EIA unit per enzyme unit EIA value electron Volt ELISA unit enzyme unit enzyme unit per 10 enzyme unit per 10 billion enzyme unit per 10 billion cells enzyme unit per 10 gram of feces enzyme unit per 12 hour enzyme unit per 2 hour enzyme unit per 24 hour enzyme unit per billion enzyme unit per day enzyme unit per deciliter enzyme unit per gram enzyme unit per gram of creatinine enzyme unit per gram of hemoglobin enzyme unit per gram of protein enzyme unit per hour enzyme unit per kilogram of hemoglobin enzyme unit per liter enzyme unit per liter at 25 deg Celsius enzyme unit per liter at 37 deg Celsius enzyme unit per milliliter enzyme unit per milliliter of red blood cells enzyme unit per millimole of creatinine enzyme unit per million enzyme unit per minute enzyme unit per second enzyme unit per trillion enzyme unit per trillion red blood cells equivalent equivalent per liter HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Row # (not a code) 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 UCUM_CODE eq/umol eq/mL eq/mmol erg F fg fL fm fmol fmol/g fmol/L fmol/mg fmol/mg{cytosol_protein} fmol/mg{protein} fmol/mL [foz_us] {FIU} [ft_i] {fraction} [Ch] {GAA_repeats} [gal_us] {genomes}/mL {Globules}/[HPF] g g.m g.m/{beat} g{creat} g{Hb} g{total_nit} g{total_prot} g{wet_tissue} g/kg/8.h g/100g g/(12.h) g/(24.h) g/(3.d) g/(4.h) g/(48.h) g/(5.h) g/(6.h) g/(72.h) g/(8.h){shift} g/cm3 g/d g/dL g/g g/g{creat} g/g{globulin} g/g{tissue} g/h g/h/m2 g/kg g/kg/(8.h){shift} g/kg/d g/kg/h g/kg/min g/L g/mg g/mL g/mmol Description of the Unit (using UCUM descriptions where they exist) equivalent per micromole equivalent per milliliter equivalent per millimole erg Farad femtogram femtoliter femtometer femtomole femtomole per gram femtomole per liter femtomole per milligram femtomole per milligram of cytosol protein femtomole per milligram of protein femtomole per milliliter fluid ounce (US) fluorescent intensity unit foot (international) fraction French (catheter gauge) GAA trinucleotide repeats gallon (US) genomes per milliliter globules (drops) per high power field gram gram meter gram meter per heart beat gram of creatinine gram of hemoglobin gram of total nitrogen gram of total protein gram of wet tissue gram per kilogram per 8 hour gram per 100 gram gram per 12 hour gram per 24 hour gram per 3 days gram per 4 hour gram per 48 hour gram per 5 hour gram per 6 hour gram per 72 hour gram per 8 hour shift gram per cubic centimeter gram per day gram per deciliter gram per gram gram per gram of creatinine gram per gram of globulin gram per gram of tissue gram per hour gram per hour per square meter gram per kilogram gram per kilogram per 8 hour shift gram per kilogram per day gram per kilogram per hour gram per kilogram per minute gram per liter gram per milligram gram per milliliter gram per millimole HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Page 127 of 150 September 2011 Row # (not a code) 176 177 178 179 180 181 182 183 184 185 186 187 188 189 UCUM_CODE g/min g/mol{creat} g/{specimen} g/m2 g/{total_output} g/{total_weight} Gy {beats}/min H Hz [HPF] h [APL'U]/mL [APL'U] 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 {APS'U} [GPL'U]/mL [GPL'U] {GPS'U} [MPL'U]/mL [MPL'U] {MPS'U} {MPS'U}/mL {ImmuneComplex’U} {ISR} {IFA_index} {IFA_titer} [in_i] [in_i'H2O] {index_val} {HA_titer} {INR} [IU] [IU]/(2.h) [IU]/(24.h) [IU]/10*9{RBCs} [IU]/d [IU]/dL [IU]/g [IU]/g{Hb} [IU]/h [IU]/kg [IU]/kg/d [IU]/L [IU]/L{37Cel} [IU]/mg{creat} [IU]/mL [IU]/min J J/L {JDF'U} {JDF'U}/L {KCT'U} kat kat/kg kat/L k[AU] k[AU]/L kU Page 128 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) gram per minute gram per mole of creatinine gram per specimen gram per square meter gram per total output gram per total weight Gray heart beats per minute Henry Hertz high power field hour IgA anticardiolipin unit per milliliter** IgA anticardiolipin unit** (**anticardiolipin can also be called "biologic activity of anticardiolipin" or "antiphospholipid") IgA antiphosphatidylserine unit IgG anticardiolipin unit per milliliter** IgG anticardiolipin unit** IgG antiphosphatidylserine unit IgM anticardiolipin unit per milliliter** IgM anticardiolipin unit** IgM antiphosphatidylserine unit IgM antiphosphatidylserine unit per milliliter immune complex unit immune status ratio immunofluorescence assay index Immunofluorescence assay titer inch (international) inch (international) of water index value influenza hemagglutination titer international normalized ratio international unit international unit per 2 hour international unit per 24 hour international unit per billion red blood cells international unit per day international unit per deciliter international unit per gram international unit per gram of hemoglobin international unit per hour international unit per kilogram international unit per kilogram per day international unit per liter international unit per liter at 37 degrees Celsius international unit per milligram of creatinine international unit per milliliter international unit per minute joule joule per liter Juvenile Diabetes Foundation unit Juvenile Diabetes Foundation unit per liter kaolin clotting time katal katal per kilogram katal per liter kilo allergy unit kilo allergy unit per liter kilo enzyme unit HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. All rights reserved. Row # (not a code) 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 UCUM_CODE kU/g kU/L kU/L{class} kU/mL k[IU]/L k[IU]/mL kcal kcal/d kcal/h kcal/kg/(24.h) kcal/[oz_av] kg kg.m/s kg/m3 kg/h kg/L kg/min kg/mol kg/s kg/(s.m2) kg/m2 kL km kPa ks [KA'U] {KRONU'U}/mL [KNK'U] L L/(24.h) L/(8.h) L/d L/h L/kg L/L L/min L/(min.m2) L/s L/s/s2 {Log_copies}/mL {Log_IU} {Log_IU}/mL {Log} [LPF] lm lm.m2 {Lyme_index_value} [MCLG'U] Ms m m/s m/s2 t uU/g uU/L uU/mL u[IU] u[IU]/mL ueq ueq/L ueq/mL Description of the Unit (using UCUM descriptions where they exist) kilo enzyme unit per gram kilo enzyme unit per liter kilo enzyme unit per liter class kilo enzyme unit per milliliter kilo international unit per liter kilo international unit per milliliter kilocalorie kilocalorie per day kilocalorie per hour kilocalorie per kilogram per 24 hour kilocalorie per ounce (US & British) kilogram kilogram meter per second kilogram per cubic meter kilogram per hour kilogram per liter kilogram per minute kilogram per mole kilogram per second kilogram per second per square meter kilogram per square meter kiloliter kilometer kilopascal kilosecond King Armstrong unit Kronus unit per milliliter Kunkel unit liter liter per 24 hour liter per 8 hour liter per day liter per hour liter per kilogram liter per liter liter per minute liter per minute per square meter liter per second liter per second per square second log (base 10) copies per milliliter log (base 10) international unit log (base 10) international unit per milliliter log base 10 low power field lumen lumen square meter Lyme index value Maclagan unit megasecond meter meter per second meter per square second metric ton micro enzyme unit per gram micro enzyme unit per liter micro enzyme unit per milliliter micro international unit micro international unit per milliliter microequivalent microequivalent per liter microequivalent per milliliter HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Page 129 of 150 September 2011 Row # (not a code) 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 UCUM_CODE ug ug/g{feces} ug{FEU}/mL ug/100g ug/(24.h) ug/(8.h) ug/m3 ug/d ug/dL ug/dL{RBCs} ug/g ug/g{creat} ug/g{dry_tissue} ug/g{dry_wt} ug/g{hair} ug/g{Hb} ug/g{tissue} ug/h ug/kg ug/kg/(8.h) ug/kg/d ug/kg/h ug/kg/min ug/L ug/L{RBCs} ug/L/(24.h) ug/mg ug/mg{creat} ug/mL ug/mL{class} ug/mL{eqv} ug/mmol ug/mmol{creat} ug/min ug/ng ug/{specimen} ug/[sft_i] ug/m2 u[IU]/L ukat uL uL/(2.h) uL/h um umol umol{BCE}/mol umol/(2.h) umol/(24.h) umol/(8.h) umol/d umol/dL umol/dL{GF} umol/g umol/g{creat} umol/g{Hb} umol/h umol/kg umol/kg{feces} umol/L umol/L{RBCs} Page 130 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) microgram microgram per gram of feces microgram fibrinogen equivalent unit per milliliter microgram per 100 gram microgram per 24 hour microgram per 8 hour microgram per cubic meter microgram per day microgram per deciliter microgram per deciliter of red blood cells microgram per gram microgram per gram of creatinine microgram per gram of dry tissue microgram per gram of dry weight microgram per gram of hair microgram per gram of hemoglobin microgram per gram of tissue microgram per hour microgram per kilogram microgram per kilogram per 8 hour microgram per kilogram per day microgram per kilogram per hour microgram per kilogram per minute microgram per liter microgram per liter of red blood cells microgram per liter per 24 hour microgram per milligram microgram per milligram of creatinine microgram per milliliter microgram per milliliter class microgram per milliliter equivalent microgram per millimole microgram per millimole of creatinine microgram per minute microgram per nanogram microgram per specimen microgram per square foot (international) microgram per square meter microinternational unit per liter microkatal microliter microliter per 2 hour microliter per hour micrometer micromole micromole bone collagen equivalent per mole micromole per 2 hour micromole per 24 hour micromole per 8 hour micromole per day micromole per deciliter micromole per deciliter of glomerular filtrate micromole per gram micromole per gram of creatinine micromole per gram of hemoglobin micromole per hour micromole per kilogram micromole per kilogram of feces micromole per liter micromole per liter of red blood cells HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Row # (not a code) 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 UCUM_CODE umol/L/h umol/umol umol/umol{creat} umol/mg umol/mg{creat} umol/mL umol/mL/min umol/mmol umol/mmol{creat} umol/min umol/min/g umol/min/g{mucosa} umol/min/g{protein} umol/min/L umol/mol umol/mol{creat} umol/mol{Hb} um/s uOhm us uV [mi_i] mU/g mU/mL mU/mL/min mU/mmol{creat} mU/mmol{RBCs} m[IU]/mL mU/g{Hb} mU/g{protein} mU/L mU/mg mU/mg{creat} m[IU]/L mA mbar mbar/L/s mbar.s/L meq meq/(2.h) meq/(24.h) meq/(8.h) meq/d meq/dL meq/g meq/g{creat} meq/h meq/kg meq/kg/h meq/L meq/mL meq/min meq/{specimen} meq/m2 meq/{total_volume} mg mg{FEU}/L mg/(10.h) mg/(12.h) mg/(2.h) mg/(24.h) Description of the Unit (using UCUM descriptions where they exist) micromole per liter per hour micromole per micromole micromole per micromole of creatinine micromole per milligram micromole per milligram of creatinine micromole per milliliter micromole per milliliter per minute micromole per millimole micromole per millimole of creatinine micromole per minute micromole per minute per gram micromole per minute per gram of mucosa micromole per minute per gram of protein micromole per minute per liter micromole per mole micromole per mole of creatinine micromole per mole of hemoglobin microns per second microOhm microsecond microvolt mile (international) milli enzyme unit per gram milli enzyme unit per milliliter milli enzyme unit per milliliter per minute milli enzyme unit per millimole of creatinine milli enzyme unit per millimole of red blood cells milli international unit per milliliter milli enzyme unit per gram of hemoglobin milli enzyme unit per gram of protein milli enzyme unit per liter milli enzyme unit per milligram milli enzyme unit per milligram of creatinine milli international unit per liter milliampere millibar millibar per liter per second millibar second per liter milliequivalent milliequivalent per 2 hour milliequivalent per 24 hour milliequivalent per 8 hour milliequivalent per day milliequivalent per deciliter milliequivalent per gram milliequivalent per gram of creatinine milliequivalent per hour milliequivalent per kilogram milliequivalent per kilogram per hour milliequivalent per liter milliequivalent per milliliter milliequivalent per minute milliequivalent per specimen milliequivalent per square meter milliequivalent per total volume milligram milligram fibrinogen equivalent unit per liter milligram per 10 hour milligram per 12 hour milligram per 2 hour milligram per 24 hour HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Page 131 of 150 September 2011 Row # (not a code) 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 UCUM_CODE mg/(6.h) mg/(72.h) mg/(8.h) mg/{collection} mg/m3 mg/d mg/d/(1.73_m2) mg/dL mg/dL{RBCs} mg/g mg/g{creat} mg/g{dry_tissue} mg/g{feces} mg/g{tissue} mg/g{wet_tissue} mg/h mg/kg mg/kg/(8.h) mg/kg/d mg/kg/h mg/kg/min mg/L mg/L{RBCs} mg/mg mg/mg{creat} mg/mL mg/mmol mg/mmol{creat} mg/min mg/{specimen} mg/m2 mg/{total_output} mg/{total_volume} mg/wk mL mL{fetal_RBCs} mL/(10.h) mL/(12.h) mL/(2.h) mL/(24.h) mL/(4.h) mL/(5.h) mL/(6.h) mL/(72.h) mL/(8.h) mL(8.h.kg) mL/cm[H2O] mL/d mL/dL mL/{beat} mL/{beat}/m2 mL/h mL/kg mL/kg/(8.h) mL/kg/d mL/kg/h mL/kg/min mL/mbar mL/mm mL/min Page 132 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) milligram per 6 hour milligram per 72 hour milligram per 8 hour milligram per collection milligram per cubic meter milligram per day milligram per day per 1.73 square meter milligram per deciliter milligram per deciliter of red blood cells milligram per gram milligram per gram of creatinine milligram per gram of dry tissue milligram per gram of feces milligram per gram of tissue milligram per gram of wet tissue milligram per hour milligram per kilogram milligram per kilogram per 8 hour milligram per kilogram per day milligram per kilogram per hour milligram per kilogram per minute milligram per liter milligram per liter of red blood cells milligram per milligram milligram per milligram of creatinine milligram per milliliter milligram per millimole milligram per millimole of creatinine milligram per minute milligram per specimen milligram per square meter milligram per total output milligram per total volume milligram per week milliliter milliliter of fetal red blood cells milliliter per 10 hour milliliter per 12 hour milliliter per 2 hour milliliter per 24 hour milliliter per 4 hour milliliter per 5 hour milliliter per 6 hour milliliter per 72 hour milliliter per 8 hour milliliter per 8 hour per kilogram milliliter per centimeter of water milliliter per day milliliter per deciliter milliliter per heart beat milliliter per heart beat per square meter milliliter per hour milliliter per kilogram milliliter per kilogram per 8 hour milliliter per kilogram per day milliliter per kilogram per hour milliliter per kilogram per minute milliliter per millibar milliliter per millimeter milliliter per minute HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Row # (not a code) 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 UCUM_CODE mL/min/{1.73_m2} mL/min/m2 mL/s mL/[sin_i] mL/m2 mm mm[Hg] mm[H2O] mm/h mm/min mmol mmol/(12.h) mmol/(2.h) mmol/(24.h) mmol/(5.h) mmol/(6.h) mmol/(8.h) mmol/d mmol/dL mmol/{ejaculate} mmol/g mmol/g{creat} mmol/h mmol/h/mg{Hb} mmol/h/mg{protein} mmol/kg mmol/kg/(8.h) mmol/kg/d mmol/kg/h mmol/kg/min mmol/L mmol/L{RBCs} mmol/mmol mmol/mmol{urea} mmol/mmol{creat} mmol/min mmol/mol mmol/mol{creat} mmol/s/L mmol/{specimen} mmol/m2 mmol/{total_vol} 10*6 10*6.[CFU]/L 10*6.[IU] 10*6/(24.h) 10*6/kg 10*6/L 10*6/uL 10*6/mL mosm mosm/kg mosm/L mPa mPa.s ms mV {minidrop}/min {minidrop}/s min mol Description of the Unit (using UCUM descriptions where they exist) milliliter per minute per 1.73 square meter milliliter per minute per square meter milliliter per second milliliter per square inch (international) milliliter per square meter millimeter millimeter of mercury millimeter of water millimeter per hour millimeter per minute millimole millimole per 12 hour millimole per 2 hour millimole per 24 hour millimole per 5 hour millimole per 6 hour millimole per 8 hour millimole per day millimole per deciliter millimole per ejaculate millimole per gram millimole per gram of creatinine millimole per hour millimole per hour per milligram of hemoglobin millimole per hour per milligram of protein millimole per kilogram millimole per kilogram per 8 hour millimole per kilogram per day millimole per kilogram per hour millimole per kilogram per minute millimole per liter millimole per liter of red blood cells millimole per millimole millimole per millimole of urea millimole per millmole of creatinine millimole per minute millimole per mole millimole per mole of creatinine millimole per second per liter millimole per specimen millimole per square meter millimole per total volume million million colony forming unit per liter million international unit million per 24 hour million per kilogram million per liter million per microliter million per milliliter milliosmole milliosmole per kilogram milliosmole per liter millipascal millipascal second millisecond millivolt minidrop per minute minidrop per second minute mole HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Page 133 of 150 September 2011 Row # (not a code) 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 UCUM_CODE mol/ mol/m3 mol/kg mol/kg/s mol/L mol/mL mol/mol mol/s {molecule}/{platelet} mo {mm/dd/yyyy} {M.o.M} {mutation} nU/mL nU/{RBC} ng ng{FEU}/mL ng/(24.h) ng/(8.h) ng/d ng/dL ng/U ng/g ng/g{creat} ng/h ng/kg ng/kg/(8.h) ng/kg/h ng/kg/min ng/L ng/mg ng/mg{creat} ng/mg{protein} ng/mg/h ng/mL{RBCs} ng/mL/h ng/10*6 ng/10*6{RBCs} ng/mL ng/min ng/s ng/m2 nkat nL nm nm/s/L nmol nmol{BCE} nmol{BCE}/L nmol{BCE}/mmol{creat} nmol{1/2cys}/mg{protein} nmol{ATP} nmol/(24.h) nmol/d nmol/dL nmol/dL{GF} nmol/g nmol/g{creat} nmol/g{dry_wt} nmol/h/L Page 134 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) mole per mole per cubic meter mole per kilogram mole per kilogram per second mole per liter mole per milliliter mole per mole mole per second molecule per platelet month month-day-year multiple of the median mutation nanoenzyme unit per milliliter nanoenzyme unit per red blood cell nanogram nanogram fibrinogen equivalent unit per milliliter nanogram per 24 hour nanogram per 8 hour nanogram per day nanogram per deciliter nanogram per enzyme unit nanogram per gram nanogram per gram of creatinine nanogram per hour nanogram per kilogram nanogram per kilogram per 8 hour nanogram per kilogram per hour nanogram per kilogram per minute nanogram per liter nanogram per milligram nanogram per milligram of creatinine nanogram per milligram of protein nanogram per milligram per hour nanogram per milliliter of red blood cells nanogram per milliliter per hour nanogram per million nanogram per million red blood cells nanogram per millliiter nanogram per minute nanogram per second nanogram per square meter nanokatal nanoliter nanometer nanometer per second per liter nanomole nanomole bone collagen equivalent nanomole bone collagen equivalent per liter nanomole bone collagen equivalent per millimole of creatinine nanomole of 1/2 cystine per milligram of protein nanomole of ATP nanomole per 24 hour nanomole per day nanomole per deciliter nanomole per deciliter of glomerular filtrate nanomole per gram nanomole per gram of creatinine nanomole per gram of dry weight nanomole per hour per liter HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Row # (not a code) 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 UCUM_CODE nmol/h/mg{protein} nmol/L nmol/L{RBCs} nmol/L/mmol{creat} nmol/m/mg{protein} nmol/umol{creat} nmol/mg nmol/mg{creat} nmol/mg{protein} nmol/mg{protein}/h nmol/mg/h nmol/mL nmol/mL/h nmol/mL/min nmol/mmol nmol/mmol{creat} nmol/min nmol/min/mg{Hb} nmol/min/mg{protein} nmol/min/mL nmol/min/10*6{cells} nmol/mol nmol/nmol nmol/s nmol/s/L ns N N.cm N.s {#} {#}/[HPF] {#}/L {#}/[LPF] {#}/uL {#}/mL {#}/min Ohm Ohm.m 10*5 {OD_unit} osm osm/kg osm/L [oz_av] {Pan_Bio'U} [ppb] [ppm] [ppm]{v/v} [ppth] [ppt] Pa /10*10 /10*4{RBCs} /100 /100{cells} /100{neutrophils} /100{spermatozoa} /100{WBCs} /[arb'U] /10*9 /cm[H2O] Description of the Unit (using UCUM descriptions where they exist) nanomole per hour per milligram of protein nanomole per liter nanomole per liter of red blood cells nanomole per liter per millimole of creatinine nanomole per meter per milligram of protein nanomole per micromole of creatinine nanomole per milligram nanomole per milligram of creatinine nanomole per milligram of protein nanomole per milligram of protein per hour nanomole per milligram per hour nanomole per milliliter nanomole per milliliter per hour nanomole per milliliter per minute nanomole per millimole nanomole per millimole of creatinine nanomole per minute nanomole per minute per milligram of hemoglobin nanomole per minute per milligram of protein nanomole per minute per milliliter nanomole per minute per million cells nanomole per mole nanomole per nanomole nanomole per second nanomole per second per liter nanosecond Newton Newton centimeter Newton second number number per high power field number per liter number per low power field number per microliter number per milliliter number per minute Ohm Ohm meter one hundred thousand optical density unit osmole osmole per kilogram osmole per liter ounce (US and British) panbio unit part per billion part per million part per million in volume per volume part per thousand part per trillion Pascal per 10 billion per 10 thousand red blood cells per 100 per 100 cells per 100 neutrophils per 100 spermatozoa per 100 white blood cells per arbitrary unit per billion per centimeter of water HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Page 135 of 150 September 2011 Row # (not a code) 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 UCUM_CODE /m3 /d /dL /{entity} /U /g /g{creat} /g{Hb} /g{tot_nit} /g{tot_prot} /g{wet_tis} /[HPF] /h /[IU] /kg /kg{body_wt} /L /[LPF] /uL /mg /mL /mm /mmol{creat} /10*6 /min /mo /{OIF} /s /m2 /10*3 /10*3.{RBCs} /10*12 /10*12{RBCs} /(12.h) /wk /a % %{loss_AChR} %{penetration} %{abnormal} %{activity} %{aggregation} %{at_60_min} %{basal_activity} %{binding} %{blockade} %{blocked} %{bound} %{breakdown} %{vol} %{deficient} %{dose} %{excretion} %{Hb} %{hemolysis} %{index} %{inhibition} %{loss} %{lysis} %{normal} Page 136 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) per cubic meter per day per deciliter per entity per enzyme unit per gram per gram of creatinine per gram of hemoglobin per gram of total nitrogen per gram of total protein per gram of wet tissue per high power field per hour per international unit per kilogram per kilogram of body weight per liter per low power field per microliter per milligram per milliliter per millimeter per millimole of creatinine per million per minute per month per oil immersion field per second per square meter per thousand per thousand red blood cells per trillion per trillion red blood cells per twelve hour per week per year percent percent loss of acetylcholine receptor percent penetration percent abnormal percent activity percent aggregation percent at 60 minute percent basal activity percent binding percent blockade percent blocked percent bound percent breakdown percent by volume percent deficient percent dose percent excretion percent hemoglobin percent hemolysis percent index percent inhibition percent loss percent lysis percent normal HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Row # (not a code) 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 UCUM_CODE %{normal_pooled_plasma} %{bacteria} %{baseline} %{cells} %{RBCs} %{WBCs} %{positive} %{reactive} %{recovery} %{reference} %{residual} %{saturation} %{total} %{uptake} %{viable} {percentile} [pH] {phenotype} pA pg pg/{cell} pg/dL pg/L pg/mg pg/mg{creat} pg/mL pg/mm pg/{RBC} pkat pL pm pmol pmol/(24.h) pmol/d pmol/dL pmol/g pmol/h/mg{protein} pmol/h/mL pmol/L pmol/umol pmol/umol{creat} pmol/mg{protein} pmol/mL pmol/mmol{creat} pmol/min pmol/min/mg{protein} pmol/{RBC} ps pT [pt_us] [lb_av] [psi] [qt_us] {ratio} {RBC}/uL %{relative} {relative_saturation} {Rubella_virus} {saturation} s s/{control} Description of the Unit (using UCUM descriptions where they exist) percent normal pooled plasma percent of bacteria percent of baseline percent of cells percent of red blood cells percent of white blood cells percent positive percent reactive percent recovery percent reference percent residual percent saturation percent total percent uptake percent viable percentile pH phenotype picoampere picogram picogram per cell picogram per deciliter picogram per liter picogram per milligram picogram per milligram of creatinine picogram per milliliter picogram per millimeter picogram per red blood cell picokatal picoliter picometer picomole picomole per 24 hour picomole per day picomole per deciliter picomole per gram picomole per hour per milligram of protein picomole per hour per milliliter picomole per liter picomole per micromole picomole per micromole of creatinine picomole per milligram of protein picomole per milliliter picomole per millimole of creatinine picomole per minute picomole per minute per milligram of protein picomole per red blood cell picosecond picotesla pint (US) pound (US and British) pound per square inch quart (US) ratio red blood cell per microliter relative percent relative saturation rubella virus saturation second second per control HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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Page 137 of 150 September 2011 Row # (not a code) 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 UCUM_CODE {shift} S Sv {s_co_ratio} {spermatozoa}/mL cm2 cm2/s dm2/s2 [sft_i] [sin_i] m2 m2/s mm2 [syd_i] {STDV} [tbs_us] [tsp_us] T 10*3 10*3{copies}/mL 10*3/L 10*3/uL 10*3/mL 10*3{RBCs} {TSI_index} {titer} [Todd’U] Torr 10*12/L [oz_tr] [tb'U] V Wb wk {WBCs} [yd_i] a Page 138 of 150 September 2011 Description of the Unit (using UCUM descriptions where they exist) shift Siemens Sievert signal to cutoff ratio spermatozoa per milliliter square centimeter square centimeter per second square decimeter per square second square foot (international) square inch (international) square meter square meter per second square millimeter square yard (international) standard deviation tablespoon (US) teaspoon (US) Tesla thousand thousand copies per milliliter thousand per liter thousand per microliter thousand per milliliter thousand red blood cells thyroid-stimulating immunoglobulin index titer Todd unit Torr trillion per liter Troy ounce tuberculin unit volt Weber week white blood cells yard (international) year HL7 Version 2.5.1 IG: Laboratory Results Interface for US Realm, Release 1 © 2011 Health Level Seven International. 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