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January 25, 2006 Oak Brook, Illinois

/ HL7. January 25, 2006 Oak Brook, Illinois. IHE Point-of-Care Devices:. ISO/IEEE 11073-60101 (draft) Observation Reporting Interface. Paul Schluter, GE Healthcare. / HL7. Overview: IEEE 1073 ORI. Goals of the ORI.

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January 25, 2006 Oak Brook, Illinois

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  1. /HL7 January 25, 2006 Oak Brook, Illinois IHE Point-of-Care Devices: ISO/IEEE 11073-60101 (draft)Observation Reporting Interface Paul Schluter, GE Healthcare

  2. /HL7 Overview: IEEE 1073 ORI Goals of the ORI The ISO/IEEE 11073-60101 Observation Reporting Interface further standardizes HL7 V2.6 messaging of vital signs data: • Standardize nomenclature • ISO/IEEE 11073-10101 Base Nomenclature • LOINC and UCUM terms may also be used • Standardize messaging conventions • Messages, triggers and segments • Leverages HL7 ‘triggers’ defined in CLSI/NCCLS POCT1-A • Added new HL7 V2.6 OBX field to support multiple measurement sites • Focus primarily on near real-time numeric parameter data. • Currently out of scope: • Waveforms, Alarms, Remote Command and Control This effort will facilitate integration of medical device data for existing acute care settings as well as facilitate growth in new areas such as home monitoring.

  3. /HL7 Overview: IEEE 1073 ORI Contributors Melvin Reynolds, AMS Consulting, editor John Firl, McKesson Home Health Care Bobby Barker, (previously with) Siemens Paul Schluter, GE Healthcare Jan Wittenber, Philips and leverages the work of the CLSI/NCCLS POCT1-A ‘ORI’ interface, Jeff Perry and Wayne Mullins, editors.

  4. /HL7 Device Interface Observation Reporting Interface Devices, Docking Stations Access Points LIS, CDR, other CIS POC Data Managers Network DML ORI DAP Test Results, QA/QC Information Test Results, Ordering Information Overview: IEEE 1073 ORI Extends POCT1 to ... CLSI/NCCLS POCT1-A defines three standard interfaces

  5. /HL7 1073 Device Monitor POCT Device legacy Device Access Point Overview: IEEE 1073 ORI ... support acute care Extend ORI to support standardized export of acute care data Real-time,mission-criticalnetwork IEEE 1073, POCT1 DML and legacy protocols Observation Reporting Interface HIS, CDR, other CIS EnterpriseGateway(s) ORI 1073 Device Ventilator IV Pump Vital signs data, Ordering Information POCT Device 1073 cable and IR legacy RS-232 RF-wireless

  6. /HL7 1073 Device Home PC POCT Device legacy Device Access Point Overview: IEEE 1073 ORI ... support home care ... and to support standardized export of chronic care data IEEE 1073, POCT1 DML, ORI and legacy protocols Observation Reporting Interface Internet HIS, CDR, other CIS DataManager ORI Telco ISP PatientApplication 1073 Device Dialysis NIBP Vital signs data, Ordering Information POCT Device 1073 cable and IR legacy RS-232 RF-wireless

  7. /HL7 IEEE/HL7 ‘ORI’ Observation Reporting Interface (ORI)

  8. /HL7 Overview: IEEE 1073 ORI HL7 Overview In HL7 Version 2.6, • Chapter 2 – Control • Chapter 3 – Patient Administration • Chapter 4 – Order Entry • Chapter 7 – Observation Reporting

  9. /HL7 Overview: IEEE 1073 ORI IEEE / HL7 ‘ORI’ Observation Reporting Interface (ORI) ORI handles bi-directional communication of result and order information Consists of: • HL7 v2.6 ‘Observation Reporting Interface’ (in ballot) • Triggers for conveying order context • New OBX field to support site location(s)

  10. /HL7 R R R Observation Observation Reviewer Recipient 3 ORI Use Cases • Unordered Observation, Recipient should place a new Order • New Observation, Recipient should search for existing Order • Pre-ordered Observation, with information about existing Order

  11. /HL7 Four Triggers • ORU^R30Unordered Observation - Place an Order • ORU^R31New Observation – Search for an Order • ORU^R32Preordered Observation • ACK^R33Acknowledgment, with Accession Number

  12. /HL7 ORI Observation Message ISO/IEEE ‘ORI’ OBSERVATION MESSAGE MSH Message Header PID Patient Identification ORC Common Order information OBR Observation Request [NTE] Notes or Comments for order/result, zero or one per message { OBX Observation Results, one per reported value [NTE] Notes or Comments for individual result, zero or one per reported value } HL7 Abstract Message Syntax Occurrence [] Zero or one {} One or more {[]} = [{}] Zero or more - no bracket or brace - One exactly

  13. /HL7 HL7 V2.6 OBX Observation • SEQ LEN DT OPT HL7 SEGMENT FIELD NAME NOTES ON ORI USE • 1 10 SI O Set ID Optional. Provided by some Devices. • 2 2 ID R Value Type All ORI values are “ST” (string). • 3 590 CE R Observation IdentifierMDC, LOINC, or other coding systems or local names • 4 20 ST X Observation Sub-IDUsage varies; can group devices hierarchically • 5 65536 * CE Observation Value E.g., “150,” “<50,” “HI,” “LO”. • 6 60 CE CE Units “mg/dL” or similar; MDC, UCUM, other. • 7 10 ST O References Range MDC, LOINC, or other coding systems or local names • 8 40 ID RE Abnormal Flags MDC, LOINC, or other coding systems or local names • 9 5 NM X Probability Not supported • 10 2 ID X Nature of Abnormal Test Not supported • 11 1 ID R Result Status Usually “F” (final result). • 12 26 TS X Date Last Observed Normal Values Not supported • 13 20 ST X User Defined Access Checks Not supported • 14 26 TS O Date/Time of the Observation Format is CCYYMMDDHHMMSS[+/-ZZZZ] • 15 60 CE X Producer's ID Not supported – information in OBR instead • 16 80 XCN O Responsible Observer May be left blank • 17 60 CE O Observation Method • 18 22 EI O Equipment Instance Identifier IEEE EUI-64 format. • 26 TS O Date/Time of Analysis The timestamp when the Device performed test. • 705 CWE C Observation Site IDMeasurement site(s), e.g. EEG lead site(s). • OBX21, OBX22, OBX23 Not supported.

  14. /HL7 OBX Examples - 1 Preordered test with single valued result ORU^R32 MSH|^~\&|Vendor_name|ORI|NUR||200312021203||ORU^R32|01234567890123456789|P|2.6||||AL||||||||||<cr> PID|||999999999 ||Smith^John^L |||||||||||||999999999 ||||||||||||<cr> PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr> OBR|||||||20031202120235|||||||||||||||||||||||||||||||||||||<cr> OBX||ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R|20031202120035|||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr> Simple device with subsystem containment disclosed MSH|^~\&|Vendor_name|ORI|NUR||200312021203||ORU^R32|01234567890123456789|P|2.6||||AL||||||||||<cr> PID|||999999999 ||Smith^John^L |||||||||||||999999999 ||||||||||||<cr> PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr> OBR|||||||20031202120235|||||||||||||||||||||||||||||||||||||<cr> OBX|1|ST|70673^MDC_DEV_PULS_MDS^MDC^^^||||||||R|||20031202120035|||||||||||||<cr> OBX|2|ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R|20031202120035|||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr> Note: multiple OBX and NTE segments are permitted for reporting multiple analytes.

  15. /HL7 OBX Examples - 2 Multiparameter device with full subsystem containment disclosed MSH|^~\&|Vendor_name|ORI|NUR|||200312021203||ORU^R31|01234567890123456789|P|2.6|||||NE||||||<cr> PID|||999999999 ||Smith^John^L |||||||||||||999999999 ||||||||||||<cr> PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr> OBR|||||||20031202120235|||||||||||||||||||||||||||||||||||||<cr> OBX|1|ST|69953^MDC_DEV_MON_PT_PHYSIO_MULTI_PARAM_MDS^MDC^^^||||||||R||20031202120035||||||||||||<cr> OBX|2|ST|69798^MDC_DEV_ECG_VMD^MDC^^^|2|||||||R|20031202120035||||||||||||<cr> OBX|3|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^|3|||||||R|20031202120035||||||||||||<cr> OBX|4|ST|147842^MDC_ECG_HEART_RATE^MDC^^^||=^83|264864 ^MDC_DIM_BEAT_PER_MIN^MDC^^^|||||R|20031202120035||||||||||||<cr> OBX|5|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^||||||||R|20031202120035|||||||||||||<cr> OBX|6|ST|134276^MDC_EVT_ECG_V_P_C^MDC^^^||=^0|264864^MDC_DIM_BEAT_PER_MIN^MDC^^^|||||R|20031202120035||||||||||||<cr> OBX|7|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^||||||||R|20031202120035||||||||||||<cr> OBX|8|ST|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R|20031202120035||||||||||||<cr> OBX|9|ST|131842^MDC_ECG_AMPL_ST_LEAD_II^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R|20031202120035||||||||||||<cr> OBX|10|ST|131901^MDC_ECG_AMPL_ST_LEAD_III^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R|20031202120035||||||||||||<cr> OBX|11|ST|69642^MDC_DEV_ANALY_SAT_O2_VMD^MDC^^^||||||||R|20031202120035||||||||||||<cr> OBX|12|ST|69643^MDC_DEV_ANALY_SAT_O2_CHAN^MDC^^^||||||||R|20031202120035||||||||||||<cr> OBX|13|ST|150324^MDC_SAT_O2_ART^MDC^^^||=^97|262688^MDC_DIM_PERCENT^MDC^^^|||||R|20031202120035|||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr> OBX|14|ST|70675^MDC_DEV_PULS_CHAN^MDC^^^||||||||R|20031202120035|||||||||||<cr> OBX|15|ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R|20031202120035|||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr> OBX|16|ST|69710^MDC_DEV_ANALY_PRESS_BLD_VMD^MDC^^^||||||||R|20031202120035|||||||||||<cr> OBX|17|ST|69711 ^MDC_DEV_ANALY_PRESS_BLD_CHAN^MDC^^^||||||||R|20031202120035||||||||||||<cr> OBX|18|ST|150302^MDC_PRESS_CUFF_DIA^MDC^^^||=^80|266016^MDC_DIM_MMHG^MDC^^^|||||R|20031202120030|||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr> OBX|19|ST|150303^MDC_PRESS_CUFF_MEAN^MDC^^^||=^93|266016^MDC_DIM_MMHG^MDC^^^|||||R|20031202120030|||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr> OBX|20|ST|150301^MDC_PRESS_CUFF_SYS^MDC^^^||=^120|266016^MDC_DIM_MMHG^MDC^^^|||||R|20031202120030|||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr> OBX|21|ST|70675 ^MDC_DEV_PULS_CHAN^MDC^^^||||||||R|20031202120035|||||||||||<cr> OBX|22|ST|149546^MDC_PULS_RATE_NON_INV^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^||||||R|20031202120030|||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr> Example from ISO/CD 11073-60101.0300, Section 17.3, example (h) – may be incorrect with regards to hierarchy identifiers.

  16. /HL7 OBX20 multiple sites Relative Power in EEG Alpha Band between |EEG| leads T3-C3 and T4-C4 Nasion FpZ Fp1 Fp2 OBX||SN|22996^MDC_EEG_PWR_SPEC_ALPHA_REL^MDC^^RelativeAlphaPower^local||=^97|262688^MDC_DIM_PERCENT^MDC^^%^local|||||R|||20031202120235||||||1249^MDC_HEAD_TEMPOR_L_3^^MDC^^T3^local~1137^MDC_HEAD_CENT_L_3^^MDC^^C3^local~1254^MDC_HEAD_TEMPOR_R_4^^MDC^^T4^local~1142^MDC_HEAD_CENT_R_4^^MDC^^C4^local<cr> F7 F3 Fz F4 F8 T3 C3 Cz C4 T4 P4 T6 T5 P3 Pz A1 A2 O2 O1 Oz Inion

  17. /HL7 Schedule Risks ISO/IEEE 11073-60101 is in the pre-ballot stage: • finish remaining editorial work • review and ballot by HL7 and IEEE Achieving interoperability at the HL7 EDI level: • Nomenclature options > 1 (MDC, LOINC, UCUM) • Workflow (define by IHE use cases) Also consider: • Flag ‘alert’ values using HL7 V2 OBX8 and related fields(suitable for record-keeping purposes and not real-time alarms if data is sent at one minute intervals)

  18. /HL7 Next Steps Next steps for ISO/IEEE 11073-60101 ‘ORI’: • Create exemplar mappings (start at IHE PCD meeting!) • Merge and edit remaining content • Review by additional HL7 experts and implementors • Include Cerner, McKesson and other CIS organizations • Review and ballot by HL7, possibly as a ‘guideline’? • Review and ballot by IEEE 1073 • Adoption and implementation of ISO/IEEE 11073-60101 ‘ORI’ will • facilitate enterprise integration of medical device data for existing acute care settings and • facilitate growth in new areas such as home monitoring by providing a uniform, straightforward and lower-cost way of connecting chronic-care monitoring systems to a hospital or other centralized facility.

  19. EXTRA SLIDES

  20. /HL7 Observation Reviewer Observation Recipient (POCT1DMS, OBSREV) (POCT1LIS, OBSRCPT) ORU^R30 1: ACK 2: (MSA: 'CA', error if any) If ‘CA’ commit-level error, end of exchange. Else, OBSRCPT processes message. If OBSRCPT Error processing ORU^R30... ACK^R33 3: (MSA: 'AE' or 'AR', and reason) ACK 4: (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R30)... ACK^R33 3: (MSA: 'AA', accession #) ACK 4: (MSA: 'CA' or 'CE/CR' error) Overview: IEEE 1073 ORI POCT1 Standards Example Message Flow: Use Case 1

  21. /HL7 Observation Reviewer Observation Recipient (POCT1DMS, OBSREV) (POCT1LIS, OBSRCPT) ORU^R31 1: ACK 2: (commit-level success or error) If ‘CA’ commit-level error, end of exchange. Else, OBSRCPT processes message. If OBSRCPT Error processing ORU^R31... ACK^R33 3: (MSA: 'AE' or 'AR', and reason) ACK 4: (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R31)... ACK^R33 3: (MSA: 'AA', accession #) ACK 4: (MSA: 'CA' or 'CE/CR' error) POCT1 Standards Example Message Flow: Use Case 2

  22. /HL7 Observation Reviewer Observation Recipient (POCT1DMS, OBSREV) (POCT1LIS, OBSRCPT) ORU^R32 1: ACK 2: (MSA: 'CA', error if any) If ‘CA’ commit-level error, end of exchange. Else, OBSRCPT processes message. If OBSRCPT Error processing ORU^R32... ACK^R33 3: (MSA: 'AE' or 'AR', and reason) ACK 4: (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R32)... ACK^R33 3: (MSA: 'AA', comment if any) ACK 4: (MSA: 'CA' or 'CE/CR' error) POCT1 Standards Example Message Flow: Use Case 3

  23. /HL7 Admit-Discharge (Create slides after –60101 draft is finalized)

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