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Integrating the Healthcare EnterprisePatient Care Device Domain (IHE-PCD) Authors : Jack Harrington, Ray Zambuto, Todd Cooper September, 2005 What IHE Delivers Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development 1 IHE Patient Care Device (PCD) – A New Domain Electronic Health Record Radiology 16 Integration Profiles Cardiology 4 Integration Profiles Laboratory 5 Integration Profiles IHE IT Infrastructure 13 Integration Profiles Patient Care Coordination 1 Integration Profile Future Domains Pathology Eye Care Patient Care Device Oncology 2 IHE Patient Care Device (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 * 3 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 4 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 Device 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.2 5 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. 6 IHE-PCD Mission The IHE Patient Care Device 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. 7 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development 8 IHE Patient Care Devices (PCD) One Patient – Many Devices 9 IHE Process Product IHE Integration Statement IHE Connect-a-thon Results IHE Technical Framework Standards IHE IHE Integration Integration Profiles B Profile A Product With IHE Easy to Integrate Products IHE Connect-a-thon IHE Demonstration User Site RFP 10 IHE PCD Technical Framework Volume1 Integration Profiles 11 IHE PCD Technical Framework Volume 2 Transactions 12 Device Enterprise Communication (DEC) Profile - Year 1 Data O bse rvat io n C usto me r (DO C) EHR, CDR, CDSS… PC D-01: Co mmunicate viceData De De vice Obse rvat io n Re po rte r (DO R) Map Device Data to Consistent Syntax and Semantics De vice Mo nito r, Ventilato r, Infusio n Pump … 13 DEC Profile Mapping Model ISO/IEEE 11073 Domain Information Model and Nomenclature mapped to HL7 Observation Report ISO/IEEE 11073 Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices. 14 Measurement Context is Dynamic 15 IEEE 11073 Domain Information Model Defines Device Context 1 Medical Device System (MDS) 0..* 0 . . n 1 1 Virtual Medical Device (VMD) * 1 Channel (Chan) * 1 Metric * Numeric Enumeration 16 Mapping preserves measurement context Medical Device System (MDS) 0..* 1 1 Virtual Medical Device (VMD) * 1 Channel (Chan) * 1 Metric * Subject Numeric Containment Tree Hierarchical Level Medical: Enumeration OBX-4 Examples 1 2 3 Virtual (Medical) Ordinal Virtual (Medical) Ordinal Virtual (Medical) Ordinal 1 1 1 1 1 2 1 2 1 1 2
3 Recommend that Ordinal value is unique among entire set 17 Example PCD-01 Message MSH|^~\&|INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64||||20061215153500||ORU^R01^ORU_R01|PMS116621490051| P|2.5|||NE|AL||8859/1 PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L||19610101|M PV1||I|UNIT_1^^Bed1 OBR|1|PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| 69837^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC|||20061215153500 OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC|1.5130.1.184326|""||||||F OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC|1.5130.1.184327|Sinus Rhythm||||||F OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC|1.5238.1.150456|99|262688^MDC_DIM_PERCENT^MDC|||||F OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC|1.5130.1.147842|81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC|1.5190.1.150036|126|266016^MDC_DIM_MMHG^MDC|||||F OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC|1.5190.1.150036|76|266016^MDC_DIM_MMHG^MDC|||||F OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC|1.5190.1.150036|92|266016^MDC_DIM_MMHG^MDC|||||F OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.5130.1.148065|0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.5190.1.150044|26|266016^MDC_DIM_MMHG^MDC|||||F OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.5190.1.150044|9|266016^MDC_DIM_MMHG^MDC|||||F OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.5190.1.150044|14|266016^MDC_DIM_MMHG^MDC|||||F OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC|1.5238.1.149538|55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC|1.5190.1.150064|4|266016^MDC_DIM_MMHG^MDC|||||F OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC|1.5190.1.150084|12|266016^MDC_DIM_MMHG^MDC|||||F 18 IHE PCD Connectathon Systems ADT A04 Feed CT (Time) Feed MWB DOC LiveData OR Mgr GE Centricity Periop CIS Philips CareVue CIS 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 DOR Welch Allyn Connex CIS VS Mon Draeger Innovian CIS Pt Mon, Vent, Anesthesia GE Aware GW Pt Mon, Vent, Anesthesia Philips IIC GW Pt Mon, Vent, Anesthesia Philips CareVue CIS Pt Mon, Vent, Anesthesia B. Braun DoseTrac GW Infusion Devices 19 Connectathon 2007: 430 engineers, 80+ organizations, 160+ systems and applications 20 THE HI MS S / I H E IN TER OP ER A BI LI TY SHO WC AS E Proudl y pre se nts A H EARTFELT P ATIENT Starr ing: IBM, Mysis, Epic, Medinotes, GE, Acuo, McKesson, Alert, Siemens, Eclipsys, CPSI, Draeger, Philips, LiveData, Allscripts, eClinicalWorks, NextGen, Capmed, GHNIHE, Dy namic, Agfa, Kodak, Quovadx, Axolotl, Initiate Systems, Quadramed, HXTI, WebChart, NDMA , Welch Allyn, B. Braun … Cardiologist Office Primary Care Physician Office XDS, XDR Medical Summary And YOU XDS Medical Summary HIS SWF, XDS-I Radiology XDS EDR    EKG  Cardiology Home Ambulatory Care XDM, XPHR   XDS Medical Summary Acute DEC Care  ICU Act 3 Act 4   OR Act 1 Act 2 DEC 21 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 22 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development 23 Device Enterprise Communication Profile – Year 2 Data O bs ervation Cus tomer (DOC) PCD-0 2 : Su b scrib e PCD Da ta to P CD-01 : Co mm un icatDev iceDat a e Device Observation Filter (DOF) P CD-01 : Co mm un icatDev iceDat a e Device Obs ervation Reporter (DOR) Device 24 Process for Year 2 2006 Survey Call for Short Proposals “Vetting” by Planning and Technical Committees Setting of Priorities 25 IHE-PCD Survey Summer-Fall 2006 Survey Managed by HIMSS Analytics Open Solicitation to HIMAA, ACCE, AdvaMed, Anesthesiologist Patient Safety Foundation, ECRI 171 Responses, (103 Users, 68 Vendors) 26 Respondent Demographics 171 Individual Responses Purchaser / Materials Mgr. Regulator - Government or Other Hospital CIO Hospital Department Head User of Medical Devices / Caregiver Other Hospital Based I.T. Professional Other Hospital based Clinical Engineer Vendor 0 10 20 30 40 50 60 70 80 = Hospital Based 27 Vendor Position on IHE and Interoperability 68 Vendor Responses (Checking all that apply) We are designing IHE co mpliance into o ur pro ducts as they emerge We wo uld use IHE based so lutio ns if they were available We have pro prietary co nnectivity so lutio ns We do no t currently pro vide co nnectivity o ptio ns o utside o f o ur o wn pro ducts/systems 0 10 20 30 40 50 28 Vendor Demographics: Vendor Products 68 Vendor Responses Women's Health Pharmacy Bone Density Scanner Ultrasound Laboratory Dialysis Defibrillators Ventillators POC Lab Devices Infusion Devices Anesthesia Home Care Other Monitors - Vital Signs 0 5 10 Imaging - PACS ECG 0 1 2 3 4 5 6 15 20 25 30 29 Demographics: User Organization Types 77 Hospital Based Respondents* Ot her For P r of i t Chai n 100-299 B ed Non P r of i t M uni ci pal or St at e I nst i ut i on Smal l er Non P r of i t 300+B ed Non P r of i t Uni ver si t y / T er t i ar y Car e 0 5 10 15 20 25 30 35 40 *26 of the 103 Non-Vendor Respondents do not work in hospitals 30 Relationship of Clinical Engineering and IT at Respondents’ Hospitals 77 Hospital Based Respondents* CE i s Par t of IT CE and IT ar e separ ate - wor k cl osel y Do not cr oss paths CE i s Outsour ced Do not know 0 5 10 15 20 25 30 35 40 45 *26 of the 103 Non-Vendor Respondents do not work in hospitals 31 Importance of Interoperability to Hospital Based Respondents IHE compl i ance i s a r equi r ement f or pur chase i f i t i s avai l abl e Movi ng to compl i ance wi l l i ng to pay a pr emi um f or i nter oper abi l i ty Pr ef er i nter oper abl e devi ces but not r equi r ed Not a Pr i or i ty 0 5 10 15 20 25 30 35 40 32 Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE? Vital Signs Reporting Devices Physiological Waveform Monitors Ventilators Anesthesia Systems Infusion Pumps Intra-Aortic Balloon Pumps Dialysis (acute / chronic) 0 10 20 30 40 50 60 70 80 Percent of respondents that consider it important = Vendors = Users 33 Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE ICU Surgery ED Pharmacy Anesthesia General Med/Surg Infusion Therapy OB/GYN Oncology Home Health 0 20 40 60 80 100 Percent of respondents that consider it important = Vendors = Users 34 Survey Question: Which clinical applications should IHE target? Communicating physiologic measures to the EHR Real-time medical error detection / mitigation Medication Management Drug Administration Remote Viewing of patient information on PDA or Tablet devices Alarm Notification Management Clinical Decision Support Integration of live waveform information into Clinical Systems Remote viewing of waveforms Asset Utilization Management (Such as asset tracking, self-diagnosis / reporting systems) Image Guided Surgery Remote Consultation Home Health monitoring (Such as remote monitoring of key indicators, smart healthcare appliances, etc.) Wellness Monitoring (Such as non-clinical fitness activities) 0 = Vendors 10 20 30 40 50 60 70 80 Percent of respondents that consider it important = Users 35 Survey Question: Which technological areas are the most important for Patient Care Device integration? Common Terminology / Data Structures / Protocols Cross-enterprise information sharing Security RF Wireless Quality of Service Management 0 10 20 30 40 50 60 70 80 90 = Vendors = Users 36 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 enterpri se. 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 author itative. 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 specificati ons for the vast number of types of medical devices and information technology is the ideal (and only) logical place for this universally needed specification. 37 Short Proposals Submitted for 2007 Version Profile File Name Patient ID RealTimeClinicalDataManagementStorageAndRetrieval CrossEnterpriseSharingofPatientCareDeviceData-Synchronous IHE-ECG-Workflow InfusionPumpIntegrationToBPOC PoCRealTimePnPDeviceIntegration No. 4.11 1.0 1.0 1.0 1.0 1.0 Author/ Champion Name Ray Zambuto Jack Harrington Jack Harrington Jack Harrington Scott Zaffrin Todd Cooper SmallDataElementExchange HomeTelehealth AlarmInteroperability 1.1 1.1 1.0 Karen Witten, Beth Hurter Vern Williams, Jim McCain Elliot Sloane, Tobey Clark PCAInfusionSafety PCD-02Query 1.0 1.0 Julian M. Goldman, MD Paul Schluter 38 Short Proposals Vetting 2007 vs reconsideration in 2008 Version Profile File Name No. Author/ Champion Name Patient ID RealTimeClinicalDataManagementStorageAndRetrieval CrossEnterpriseSharingofPatientCareDeviceData-Synchronous IHE-ECG-Workflow InfusionPumpIntegrationToBPOC PoCRealTimePnPDeviceIntegration 4.11 1.0 1.0 1.0 1.0 1.0 Ray Zambuto Jack Harrington Jack Harrington Jack Harrington Scott Zaffrin Todd Cooper SmallDataElementExchange HomeTelehealth 1.1 1.1 Karen Witten, Beth Hurter Vern Williams, Jim McCain AlarmInteroperability PCAInfusionSafety PCD-02Query 1.0 1.0 1.0 Elliot Sloane, Tobey Clark Julian M. Goldman, MD Paul Schluter 39 Short Proposals Setting Priorities Polling Results of Planning Committee Three Proposals for 2007* Author/ Champion Profile File Name Name Ray Zambuto Paul Schluter Todd Cooper Vern Williams, Jim McCain 1 2 3 Patient ID PCD-02Query PoCRealTimePnPDeviceIntegration HomeTelehealth SmallDataElementExchange PCAInfusionSafety Karen Witten, Beth Hurter Julian M. Goldman, MD * Based on resource limitations. Additional work can be added if author/champion demonstrates sufficient additional resources 40 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. 41 Your Participation in IHE PCD is Encouraged http://www.ihe.net/Technical_Framework/index.cfm PCD CoChairs:  Todd Cooper - t.cooper@ieee.org  Jack Harrington - jack.harrington@philips.com  Ray Zambuto - rzambuto@techmed.com Other Contacts:  Manny Furst  Elliott Sloane - efurst@imp-tech.com - elliot.sloane@villanova.edu 42 September, 2005 What IHE Delivers
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