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

January 25, 2006 Oak Brook, Illinois

Paul Schluter, GE Healthcare

ISO/IEEE 11073-60101 (draft) Observation Reporting Interface

IHE Point-of-Care Devices:

/ HL7

Goals of the ORI/ HL7 Overview: IEEE 1073 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 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.

Extends POCT1 to .../ HL7 Overview: IEEE 1073 ORI

CLSI/NCCLS POCT1-A defines three standard interfaces

Device Interface

Observation Reporting Interface

DAPORI

Test Results,QA/QC Information

Test Results,Ordering Information

Devices, Docking Stations

POC DataManagers

LIS, CDR,other CIS

AccessPoints Network

DML

... 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


ORI

Vital signs data,Ordering Information

EnterpriseGateway(s)

HIS, CDR,other CIS

Access Point

1073 Device

Ventilator

IV Pump

POCT Device1073 cable and IR

legacy RS-232RF-wireless

Monitor 1073 Device

POCT Device

legacy Device

Real-time,mission-critical

network

... 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


ORI

Vital signs data,Ordering Information

DataManager

HIS, CDR,other CIS

Access Point

1073 Device

Dialysis

NIBP

POCT Device1073 cable and IR

legacy RS-232RF-wireless

Home PC 1073 Device

POCT Device

legacy Device

Internet

Telco

ISPPatient

Application

IEEE/HL7 ‘ORI’/ HL7

Observation Observation Reporting Reporting

Interface (ORI) Interface (ORI)

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

IEEE / HL7 ‘ORI’/ HL7 Overview: IEEE 1073 ORI

Observation Reporting Interface (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)

Observation Reviewer

Observation Recipient

RRR

Results, Order Information

Confirmations,Error Information

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

Observation Reviewer

Observation Recipient

RRR

Four Triggers/ HL7

• ORU^R30Unordered Observation - Place an Order

• ORU^R31New Observation – Search for an Order

• ORU^R32Preordered Observation

• ACK^R33Acknowledgment, with Accession Number

ORI Observation Message/ HL7

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 V2.6 OBX Observation/ HL7

SEQ LEN DT OPT HL7 SEGMENT FIELD NAME NOTES ON ORI USE1 10 SI O Set IDOptional. 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

names4 20 ST X Observation Sub-ID Usage varies; can group devices

hierarchically5 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

names8 40 ID RE Abnormal Flags MDC, LOINC, or other coding systems or local

names9 5 NM X Probability Not supported10 2 ID X Nature of Abnormal Test Not supported11 1 ID R Result Status Usually “F” (final result).12 26 TS X Date Last Observed Normal Values Not supported13 20 ST X User Defined Access Checks Not supported14 26 TS O Date/Time of the Observation Format is CCYYMMDDHHMMSS[+/-

ZZZZ]15 60 CE X Producer's ID Not supported – information in OBR

instead16 80 XCN O Responsible Observer May be left blank17 60 CE O Observation Method18 22 EI O Equipment Instance Identifier IEEE EUI-64 format.19 26 TS O Date/Time of Analysis The timestamp when the Device

performed test.20 705 CWE C Observation Site ID Measurement site(s), e.g. EEG lead

site(s).21 OBX21, OBX22, OBX23 Not supported.

OBX Examples - 1 / HL7

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>

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||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>

Simple device with subsystem containment disclosed

OBX Examples - 2 / HL7

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

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>

Relative Power in EEG Alpha Bandbetween |EEG| leads T3-C3 and T4-C4

FpZ

Fp2Fp1

F7 F3 Fz F4 F8

T3 C3 Cz C4 T4

T5 P3 Pz P4 T6

O1

Oz

O2

Inion

A1 A2

Nasion

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

(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.

EXTRA SLIDES

POCT1 Standards/ HL7 Overview: IEEE 1073 ORI

Example Message Flow: Use Case 1Example 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: ACK (MSA: 'CA' or 'CE/CR' error)

Else (success processing ORU^R30)...

3: ACK^R33 (MSA: 'AA', accession #)


POCT1 Standards/ HL7





1: ORU^R31

2: ACK (commit-level success or error)





3: ACK^R33 (MSA: 'AA', accession #)


POCT1 Standards/ HL7





1: ORU^R32

2: ACK (MSA: 'CA', error if any)





3: ACK^R33 (MSA: 'AA', comment if any)


Admit-Discharge/ HL7

(Create slides after –60101 draft is finalized)

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

Documents

ori interface

ieee hl7 ori hl7 overview

hl7 slide

hl7 overview hl7 overview

observation reporting

ori use cases hl7

ori clsinccls poct1

hl7 version