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

/ 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.

Contributors / HL7 Melvin Reynolds, AMS Consulting, editor 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.

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

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

/ HL7 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 Home PC 1073 Device POCT Device legacy Device HIS, CDR, other CIS Data Manager ORI Telco ISP Patient Application 1073 Device Access Point Dialysis NIBP Vital signs data, Ordering Information POCT Device 1073 cable and IR legacy RS-232 RF-wireless

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

HL7 Overview / HL7 In HL7 Version 2.6, Chapter 2 – Control 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

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

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

Four Triggers / HL7 ORU^R30 Unordered Observation - Place an Order ORU^R31 New Observation – Search for an Order ORU^R32 Preordered Observation ACK^R33 Acknowledgment, with Accession Number

ORI Observation Message / 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

/ 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 Identifier MDC, LOINC, or other coding systems or local names 4 20 ST X Observation Sub-ID Usage 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 ID Measurement site(s), e.g. EEG lead site(s). OBX21, OBX22, OBX23 Not supported.

/ 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.

/ 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.

OBX20 multiple sites / HL7 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 A1 T5 P3 Pz P4 T6 A2 O1 O2 Oz Inion

Schedule Risks / HL7 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)

Next Steps / HL7 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.

EXTRA SLIDES

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

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

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

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