1. Integrating the Healthcare Enterprise- Patient Care Device Domain (IHE-PCD)

2. Agenda Evolution of the IHE PCD
Year 1 - Device Enterprise Communication Profile
Year 2 – Survey and Proposed Profile Development

3. Context and History R. Gilbert Jost, MD
Chairman, Mallinckrodt Institute of Radiology
Board of Directors, Radiological Society of North America

4. 1996
1997
1998
Andover Working Group
Medical HL7 Enterprise Communication Framework
Version 1.0

5. Discussion at 1996 RSNA annual meeting
1997
1998
Discussion at 1996 RSNA annual meeting
Kees Smedema – Philips
Bill Mortimore – Merge
Jack Harrington – Hewlett-Packard

6. 1996
1997
1998

7. 1998
1999
2000

8. Process
Problem Identification: Clinicians and IT experts identify common integration problems in access to information, clinical workflow, administration and underlying infrastructure.
Integration Profile Specification: Stakeholders select standards that address each identified integration need. The technical specifications for implementing these standards are documented in the IHE Technical Framework.
Implementation and Testing: Vendors implement these profiles and test their systems with software tools and at a face-to-face Connectathon, where they test interoperability with other vendors’ systems.
Integration Statements and RFPs: Vendors publish IHE Integration Statements to document the integration profiles supported by their products. Users can reference integration profiles in requests for proposals, simplifying the systems acquisition process.

9. Philips/AWG Contribution to IHE Process

10. Profiles Simplify Implementation
Single Standard – Constrain optionality, choose terminology, define dynamic interactions
HL7 Conformance
Multiple Standards – Coordinate workflow, define mappings between standards
HL7/DICOM – IHE Radiology
HL7/IEEE – Patient Care Devices

11. Static Message Profile

12. Profiles Simplify Implementation

14. Over 100 vendors involved world-wide, 5 Technical Frameworks
39 Integration Profiles, Testing at Connectathons
Demonstrations at major conferences world-wide
16 Active national chapters on 4 continents

15. IHE Patient Care Devices (PCD)
HIMSS Survey IHE pre-2005 Annual Conference results:
Survey of all IHE Users
Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

16. IHE 2005 Summer Survey Results
Highest priority devices for integration are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion Pumps
Highest priority departments are ICU, Emergency, OR/Anesthesia, and Lab (POC)
Highest technology priority is Enterprise Wide Sharing
Highest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support

17. IHE PCD Formed in September 2005
In September, 2005, the PCD gathered 60 vendors, purchasers, providers, and regulators in Washington D.C. for 2 days to explore the value propositions, explore the scope and mission of the domain, and begin the process of use case development.
IHE Charter - The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging.
Current membership is 100+ and growing.

18. IHE-PCD Domain Vision Statement
The IHE Patient Care Device Domain (IHE PCD) is the nexus for vendors and providers to jointly define and demonstrate unambiguous interoperability specifications, called profiles, which are based on industry standards, and which can be brought to market.

19. IHE-PCD Mission
The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to:
Deliver the technical framework for the IHE-PCD domain profiles;
Validate IHE-PCD profile implementations via Connectathons; and
Demonstrate marketable solutions at public trade shows.

20. Agenda Evolution of the IHE PCD
Year 1 - Device Enterprise Communication Profile
Year 2 – Survey and Proposed Profile Development

21. IHE Patient Care Devices (PCD)
One Patient – Many Devices

22. Product IHE Integration Statement
IHE Process
Product IHE Integration Statement
IHE Connect-a-thon Results
IHE Connect-a-thon
Product
With IHE
IHE Demonstration
Easy to
Integrate
Products
IHE Technical Framework
Standards
IHE Integration
Profiles B
Profile A
User Site
RFP

25. Device Enterprise Communication (DEC) Profile - Year 1

26. DEC Profile Mapping Model
ISO/IEEE Domain Information Model and Nomenclature mapped to HL7 Observation Report
ISO/IEEE Data Types mapped to HL7 Data Types
Mapping preserves measurement context for complex devices.

27. Measurement Context is Dynamic

28. IEEE 11073 Domain Information Model Defines Device Context

29. Mapping preserves measurement context

30. Example PCD-01 Message
MSH|^~\&|INFO_SRC_PHILIPS^ACDE ABCD^EUI-64|||| ||ORU^R01^ORU_R01|PMS |
P|2.5|||NE|AL||8859/1
PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L|| |M
PV1||I|UNIT_1^^Bed1
OBR|1|PMS ^INFO_SRC_PHILIPS^ACDE ABCD^EUI-64| PMS ^INFO_SRC_PHILIPS^ACDE ABCD^EUI-64| ^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC|||
OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC| |""||||||F
OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC| |Sinus Rhythm||||||F
OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC| |99|262688^MDC_DIM_PERCENT^MDC|||||F
OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC| |81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F
OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC| |126|266016^MDC_DIM_MMHG^MDC|||||F
OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC| |76|266016^MDC_DIM_MMHG^MDC|||||F
OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC| |92|266016^MDC_DIM_MMHG^MDC|||||F
OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC| |0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F
OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC| |26|266016^MDC_DIM_MMHG^MDC|||||F
OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC| |9|266016^MDC_DIM_MMHG^MDC|||||F
OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC| |14|266016^MDC_DIM_MMHG^MDC|||||F
OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC| |55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F
OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC| |4|266016^MDC_DIM_MMHG^MDC|||||F
OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC| |12|266016^MDC_DIM_MMHG^MDC|||||F

31. IHE PCD Connectathon Systems
ADT A04 Feed
CT (Time) Feed
MWB
LiveData OR Mgr
GE Centricity Periop CIS
Philips CareVue CIS
DOC
Validated Vitals export, Batch
Validated VS, Vent, Anesth & Med Export, max every 3 minutes
Unvalidated VS, Vent, Anesth. Data export every 1 minute
Unvalidated VS, Vent, Anesth. Data export every 1 minute
Validated VS, Vent, Anesth & Med Export, max every 5 minutes
Unvalidated Med (Infusion System) exported every 1 minute
Welch Allyn Connex
CIS
Draeger Innovian
CIS
GE Aware GW
Philips IIC GW
Philips CareVue
CIS
B. Braun DoseTrac GW
DOR
VS Mon
Pt Mon, Vent,
Anesthesia
Pt Mon, Vent,
Anesthesia
Pt Mon, Vent,
Anesthesia
Pt Mon, Vent,
Anesthesia
Infusion Devices

32. Connectathon 2007: 430 engineers, 80+ organizations, 160+ systems and applications

34. HIMSS Showcase Scenario
Emergency Care
Intensive Care
Perioperative Care
Philips
Intellivue Clinical
Information
Portfolio
LiveData
OR-DashBoard GE
Centricity®
Periop Anesthesia
Welch Allyn ConnexTM
Data
Management
System GE
Aware
Gateway
Philips
Intellivue
Information
Center
B. Braun DoseTracTM
Infusion
Management
Software
Draeger
Innovian®
Solution Suite
Vital Signs
Monitor
Patient Monitor,
Ventilator
Patient Monitor,
Ventilator
Infusion Devices
Patient Monitor,
Anesthesia Sys

35. Agenda Evolution of the IHE PCD
Year 1 - Device Enterprise Communication Profile
Year 2 – Survey and Proposed Profile Development

36. Device Enterprise Communication Profile – Year 2

37. Process for Year 2 2006 Survey Call for Short Proposals
“Vetting” by Planning and Technical Committees
Setting of Priorities

38. IHE-PCD Survey Summer-Fall 2006
Survey Managed by HIMSS Analytics
Open Solicitation to HIMSS, ACCE, AdvaMed, Anesthesia Patient Safety Foundation, ECRI
171 Responses, (103 Users, 68 Vendors)

39. Respondent Demographics 171 Individual Responses
= Hospital Based

40. Vendor Position on IHE and Interoperability 68 Vendor Responses (Checking all that apply)

41. Vendor Demographics: Vendor Products 68 Vendor Responses

42. Demographics: User Organization Types 77 Hospital Based Respondents*
*26 of the 103 Non-Vendor Respondents do not work in hospitals

43. Relationship of Clinical Engineering and IT at Respondents’ Hospitals 77 Hospital Based Respondents*
*26 of the 103 Non-Vendor Respondents do not work in hospitals

44. Importance of Interoperability to Hospital Based Respondents

45. Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE?
Percent of respondents that consider it important
= Vendors
= Users

46. Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE
Percent of respondents that consider it important
= Vendors
= Users

47. Survey Question: Which clinical applications should IHE target?
Percent of respondents that consider it important
= Vendors
= Users

48. Survey Question: Which technological areas are the most important for Patient Care Device integration?
= Vendors
= Users

49. IHE Profile Proposal (Short) Proposed Profile: Patient Identification
Proposal Editor: Ray Zambuto
Date: February 16, 2006
Version: 3
Domain: Patient Care Devices
The Problem
Manual entry of patient identification to Patient Care Devices is inefficient and subject to error. Patient Identification is perhaps the most essential component of any interoperability and communication process, particularly when PCD data is exported to the enterprise. It is the basis for communication and control of any medical device, data analysis, reporting and record keeping. Automation of the entry of patient identification to Patient Care Devices has the potential for reducing errors, and is an essential component of any effort to increase safety, device and drug effectiveness, and efficiency.
Key Use Case
1) Setup of PCD. The caregiver connects the patient to a Patient Care Device. The patient is physically identified by some institutionally unique means of identification such as a wrist band barcode, RFID or other means which may or may not be solely considered as authoritative. The caregiver uses the information from the physical patient identification to obtain an authoritative electronic identifier which is associated with all data communicated from the PCD. The interaction may involve direct entry of the data to the device based on the physical identifier, a dialog between a PCD Manager and an authoritative source, and the use of more than one identifier. The end result is that data communicated from the PCD or PCD Manager contains an authoritative institutionally unique identifier.
2) Disconnect PCD. The caregiver removes the PCD causing the data from that device to no longer be communicated to the enterprise.
Standards & Systems
This profile is intended for identification of patients by patient monitors, infusion pumps, ventilators, point of care glucometers etc..>
ISO/IEEE 11073, HL7, IHE-ITI Patient Administration, IHE-ITI PDQ
Discussion
Patient identification is a fundamental requirement for any electronic communication from or to a medical device. As such, the IHE with its broad scope, full range of stakeholders, and present or future involvement in the development of interoperability specifications for the vast number of types of medical devices and information technology is the ideal (and only) logical place for this universally needed specification.

50. Short Proposals Submitted for 2007
Profile Name
Patient ID
Cross-Enterprise Sharing of Patient Care Device Data Synchronous
Real-Time Clinical Data Management Storage and Retrieval
IHE-ECG-Workflow
Infusion Pump Integration to Medication Administration Process
PoC Real-Time PnP Device Integration
Small Data Element Exchange
HomeTelehealth
Alarm Interoperability
PCA Infusion Safety
PCD-02 Query

51. Short Proposals Vetting 2007 vs reconsideration in 2008
Profile Name
Patient ID
Cross-Enterprise Sharing of Patient Care Device Data-Synchronous
Real-Time Clinical Data Management Storage and Retrieval
IHE-ECG-Workflow
Infusion Pump Integration to Medication Administration Process
PoC Real-Time PnP Device Integration
Small Data Element Exchange
Home Telehealth
Alarm Interoperability
PCA Infusion Safety
PCD-02 Query

52. Short Proposals Setting Priorities Polling Results of Planning Committee Three Proposals for 2007*
Profile Name
Patient ID
PCD-02 Query
PoCRealTimePnPDeviceIntegration
HomeTelehealth
Small Data Element Exchange
PCA Infusion Safety 1 2 3
* Based on resource limitations. Additional work can be added if author/champion demonstrates sufficient additional resources

53. Summary
From its inception in September 2005 the IHE PCD has grown to 100+ members representing vendors, purchasers, providers, and regulatory agencies.
The Device Enterprise Communication (DEC) Framework for Trial Implementation published in August 2006.
6 Vendors and 8 systems/applications tested at Connectathon 2007
Process for developing Year 2 profiles is in progress.

54. To Learn More This Week – Visit the IHE PCD in the HIMSS Interoperability Showcase

55. Your Participation in IHE PCD is Encouraged
PCD CoChairs:
Todd Cooper
Jack Harrington -
Ray Zambuto
Other Contacts:
Manny Furst
Elliot Sloane