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

2. / HL7
Overview: IEEE 1073 ORI
Goals of the 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 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.

4. 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

5. / 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

6. / 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

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

8. 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

9. 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)

10. / 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

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
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 Identifier MDC, LOINC, or other coding systems or local names
4 20 ST X Observation Sub-ID Usage varies; can group devices hierarchically
* 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.

14. / HL7
OBX Examples - 1
Preordered test with single valued result ORU^R32
MSH|^~\&|Vendor_name|ORI|NUR|| ||ORU^R32| |P|2.6||||AL||||||||||<cr>
PID||| ||Smith^John^L ||||||||||||| ||||||||||||<cr> PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr> OBR||||||| |||||||||||||||||||||||||||||||||||||<cr> OBX||ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R| |||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr>
Simple device with subsystem containment disclosed
MSH|^~\&|Vendor_name|ORI|NUR|| ||ORU^R32| |P|2.6||||AL||||||||||<cr>
PID||| ||Smith^John^L ||||||||||||| ||||||||||||<cr> PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr> OBR||||||| |||||||||||||||||||||||||||||||||||||<cr>
OBX|1|ST|70673^MDC_DEV_PULS_MDS^MDC^^^||||||||R||| |||||||||||||<cr>
OBX|2|ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R| |||||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||| ||ORU^R31| |P|2.6|||||NE||||||<cr>
PID|||  ||Smith^John^L |||||||||||||  ||||||||||||<cr>
PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||<cr>
OBR||||||| |||||||||||||||||||||||||||||||||||||<cr>
OBX|1|ST|69953^MDC_DEV_MON_PT_PHYSIO_MULTI_PARAM_MDS^MDC^^^||||||||R|| ||||||||||||<cr>
OBX|2|ST|69798^MDC_DEV_ECG_VMD^MDC^^^|2|||||||R| ||||||||||||<cr>
OBX|3|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^|3|||||||R| ||||||||||||<cr>
OBX|4|ST|147842^MDC_ECG_HEART_RATE^MDC^^^||=^83|264864 ^MDC_DIM_BEAT_PER_MIN^MDC^^^|||||R| ||||||||||||<cr>
OBX|5|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^||||||||R| |||||||||||||<cr>
OBX|6|ST|134276^MDC_EVT_ECG_V_P_C^MDC^^^||=^0|264864^MDC_DIM_BEAT_PER_MIN^MDC^^^|||||R| ||||||||||||<cr>
OBX|7|ST|69663^MDC_DEV_ANALY_ELEC_POTL_HEART_ACTIV_CHAN^MDC^^^||||||||R| ||||||||||||<cr>
OBX|8|ST|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R| ||||||||||||<cr>
OBX|9|ST|131842^MDC_ECG_AMPL_ST_LEAD_II^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R| ||||||||||||<cr>
OBX|10|ST|131901^MDC_ECG_AMPL_ST_LEAD_III^MDC^^^||=^1|266418 ^MDC_DIM_X_VOLT^MDC^^^|||||R| ||||||||||||<cr>
OBX|11|ST|69642^MDC_DEV_ANALY_SAT_O2_VMD^MDC^^^||||||||R| ||||||||||||<cr>
OBX|12|ST|69643^MDC_DEV_ANALY_SAT_O2_CHAN^MDC^^^||||||||R| ||||||||||||<cr>
OBX|13|ST|150324^MDC_SAT_O2_ART^MDC^^^||=^97|262688^MDC_DIM_PERCENT^MDC^^^|||||R| |||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr>
OBX|14|ST|70675^MDC_DEV_PULS_CHAN^MDC^^^||||||||R| |||||||||||<cr>
OBX|15|ST|149538^MDC_PLETH_PULS_RATE^MDC^^^||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^^|||||R| |||||460230^MDC_UPEXT_FINGER^MDC^^^|||||||<cr>
OBX|16|ST|69710^MDC_DEV_ANALY_PRESS_BLD_VMD^MDC^^^||||||||R| |||||||||||<cr>
OBX|17|ST|69711 ^MDC_DEV_ANALY_PRESS_BLD_CHAN^MDC^^^||||||||R| ||||||||||||<cr>
OBX|18|ST|150302^MDC_PRESS_CUFF_DIA^MDC^^^||=^80|266016^MDC_DIM_MMHG^MDC^^^|||||R| |||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr>
OBX|19|ST|150303^MDC_PRESS_CUFF_MEAN^MDC^^^||=^93|266016^MDC_DIM_MMHG^MDC^^^|||||R| |||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr>
OBX|20|ST|150301^MDC_PRESS_CUFF_SYS^MDC^^^||=^120|266016^MDC_DIM_MMHG^MDC^^^|||||R| |||||460532^MDC_UPEXT_ARM_UPPER^MDC^^^|||||||<cr>
OBX|21|ST|70675 ^MDC_DEV_PULS_CHAN^MDC^^^||||||||R| |||||||||||<cr>
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^^^|||||||<cr>
Example from ISO/CD , Section 17.3, example (h) – may be incorrect with regards to hierarchy identifiers.

16. 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||| |||||| 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

17. 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)

18. 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 ‘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. 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 #)

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

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

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