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

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

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

2 Goals of the ORI / HL7 Overview: IEEE 1073 ORI The ISO/IEEE Observation Reporting Interface further standardizes HL7 V2.6 messaging of vital signs data: Standardize nomenclature –ISO/IEEE 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 Contributors / HL7 Overview: IEEE 1073 ORI 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 Extends POCT1 to... / HL7 Overview: IEEE 1073 ORI CLSI/NCCLS POCT1-A defines three standard interfaces Device Interface Observation Reporting Interface DAP ORI Test Results, QA/QC Information Test Results, Ordering Information Devices, Docking Stations POC Data Managers LIS, CDR, other CIS Access Points Network DML

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

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

7 IEEE/HL7 ORI / HL7 Observation Reporting Interface (ORI)

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

9 IEEE / HL7 ORI / HL7 Overview: IEEE 1073 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 3 ORI Use Cases / HL7 1.Unordered Observation, Recipient should place a new Order 2.New Observation, Recipient should search for existing Order 3.Pre-ordered Observation, with information about existing Order

11 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

12 ORI Observation Message / HL7 ISO/IEEE ORI OBSERVATION MESSAGE MSHMessage Header PIDPatient Identification ORCCommon Order information OBRObservation Request [NTE]Notes or Comments for order/result, zero or one per message { OBXObservation Results, one per reported value [NTE] Notes or Comments for individual result, zero or one per reported value } HL7 Abstract Message SyntaxOccurrence []Zero or one {}One or more {[]} = [{}]Zero or more - no bracket or brace -One exactly

13 HL7 V2.6 OBX Observation / HL7 SEQLENDTOPTHL7 SEGMENT FIELD NAMENOTES ON ORI USE 110SIOSet ID Optional. Provided by some Devices. 22IDRValue Type All ORI values are ST (string). 3590CERObservation Identifier MDC, LOINC, or other coding systems or local names 420STXObservation Sub-ID Usage varies; can group devices hierarchically *CEObservation Value E.g., 150, <50, HI, LO. 660CECEUnits mg/dL or similar; MDC, UCUM, other. 710STOReferences Range MDC, LOINC, or other coding systems or local names 840IDREAbnormal Flags MDC, LOINC, or other coding systems or local names 95NMXProbability Not supported 102IDXNature of Abnormal Test Not supported 111IDRResult Status Usually F (final result). 1226TSXDate Last Observed Normal Values Not supported 1320STXUser Defined Access Checks Not supported 1426TSODate/Time of the Observation Format is CCYYMMDDHHMMSS[+/-ZZZZ] 1560CEXProducer's ID Not supported – information in OBR instead 1680XCNOResponsible Observer May be left blank 1760CEOObservation Method 1822EIOEquipment Instance Identifier IEEE EUI-64 format. 1926TSODate/Time of Analysis The timestamp when the Device performed test CWECObservation Site ID Measurement site(s), e.g. EEG lead site(s). 21 OBX21, OBX22, OBX23Not supported.

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

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

16 OBX20 multiple sites / HL7 OBX||SN|22996^MDC_EEG_PWR_SPEC_ALPHA_REL^ MDC^^RelativeAlphaPower^local||=^97| ^MDC_DIM_PERCENT^MDC^^%^local|||||R||| |||||| 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 Relative Power in EEG Alpha Band between |EEG| leads T3-C3 and T4-C4 FpZ Fp2Fp1 F7F3FzF4F8 T3C3CzC4T4 T5P3Pz P4T6 O1 Oz O2 Inion A1A2 Nasion

17 Schedule Risks / HL7 ISO/IEEE 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 Next Steps / HL7 Next steps for ISO/IEEE 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 ORI will (1)facilitate enterprise integration of medical device data for existing acute care settings and (2)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 POCT1 Standards / HL7 Overview: IEEE 1073 ORI 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^R : ACK (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R30)... 3: ACK^R33 (MSA: 'AA', accession #) 4: ACK (MSA: 'CA' or 'CE/CR' error)

21 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^R : ACK (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R31)... 3: ACK^R33 (MSA: 'AA', accession #) 4: ACK (MSA: 'CA' or 'CE/CR' error)

22 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^R : ACK (MSA: 'CA' or 'CE/CR' error) Else (success processing ORU^R32)... 3: ACK^R33 (MSA: 'AA', comment if any) 4: ACK (MSA: 'CA' or 'CE/CR' error)

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


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