Patient Care Devices

IHE North America Webinar Series 2008IHE North America Webinar Series 2008

Todd CooperTodd Cooper Breakthrough Solutions Foundry, Inc.Breakthrough Solutions Foundry, Inc.

Ken FuchsKen FuchsDraeger Medical Systems, Inc.Draeger Medical Systems, Inc.

Agenda

PCD Domain Overview Published Profiles: DEC, PIB & SPD New Profiles: RTM, ACM, PIV Emerging Profiles: MEM, PNP, … Test Tooling Showcase Demonstrations ’08/’09 Schedule & Contacts Q & A

PCD Domain Overview

• Established in 2005 when the “charter” was awarded to the ACCE

• Jointly sponsored by ACCE and HIMSS as of July 1, 2006

• Technical Framework 2006-7 developed to communicate patient data (asynchronous)

• Successful demonstration at the 2007 & 2008 Connectathons and HIMSS Interoperability Showcases

PCD Domain Overview

IHE PCD CharterIHE PCD Charter

The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated regulated patient care devicepatient care device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and laboratory.

PCD Domain Overview

IHE PCD MissionIHE PCD Mission

The IHE Patient Care Devices Domain will apply the proven, Use Case drivenUse Case driven IHE processes to:

– DeliverDeliver the technical frameworktechnical framework for the IHE-PCD domain profiles;

– ValidateValidate IHE-PCD profile implementations via ConnectathonsConnectathons; and

– Demonstrate Demonstrate marketable solutions at public trade public trade showsshows.

PCD Domain Overview

• Heterogeneity – Coexistence in a multi-manufacturer / multi-modality world, leveraging shared infrastructure

• Semantic Interoperability – … from the sensor to the EHR

• Real-time Availability – Facilitating more timely clinical decisions

PCD Profile Value Objectives:PCD Profile Value Objectives:

Emerging IHE-PCD Workflows

Key Objectives 2007/2008Key Objectives 2007/2008• Enterprise sharing of Patient Care Data• Patient Identity Binding to Device Data• Subscribe to Patient Data

Key Objectives 2008/2009Key Objectives 2008/2009• Rosetta Stone Terminology Project• PCD Alarm Communication Management• Infusion Pump Integration - Drug Administration

Key Objectives 2009 and beyondKey Objectives 2009 and beyond• Point of Care Plug and Play (multiyear effort)• Real-time data archiving and communication• Medical Device Management• Mobile, enterprise-wide, reliable vital signs monitoring• … many more!

Initial device classes…vital sign monitors, bedside monitors, infusion pumps and ventilators

PCD - Published Profiles

DEC ProfileDEC Profile

Device to Enterprise CommunicationDevice to Enterprise Communication

Device Enterprise Communication (DEC) Profile - Year 1

DEC Profile Mapping Model

• ISO/IEEE 11073 Domain Information Model and Nomenclature mapped to HL7 (v2.5) Observation Report

• ISO/IEEE 11073 Data Types mapped to HL7 Data Types

• Mapping preserves measurement context for complex devices.

Measurement Context is Dynamic

IEEE 11073 Domain Information Model Defines Device Context

10..n

Medical Device System (MDS)

Virtual Medical Device (VMD)

Channel (Chan)

Numeric

Enumeration

1

*

1

*

1

*

1

0..*

Metric

Mapping preserves measurement context

Medical Device System (MDS)

Virtual Medical Device (VMD)

Channel (Chan)

Numeric

Enumeration

1

*

1

*

1

*

1

0..*

Metric

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

PCD - Published Profiles

PIB ProfilePIB Profile

Patient Identity BindingPatient Identity Binding

Patient ID Binding

Patient ID Binding

• Automates identity association / authentication process using standard ITI profiles.

• Option for the DEC Profile• Async identity access using ITI-21 Patient

Demographics Query (PDQ)• Sync identity acquisition using ITI-30 Patient

Admin Management / Patient Identity Feed (PAM)

DEC-PIB profile…DEC-PIB profile…

PCD - Published Profiles

SPD ProfileSPD Profile

Subscribe to Patient DataSubscribe to Patient Data

Note: SPD is a DEC Profile option.

DEC - Subscribe to Patient Data

DEC - Subscribe to Patient Data

PCD - New Profiles

RTM ProfileRTM Profile

Rosetta Terminology MappingRosetta Terminology Mapping

Rosetta for Semantic Interoperability

Rosetta for Semantic Interoperability

Migrating Toward True PCD Semantic Interoperability

Today HIMSS ’09!

ISO/IEEE 11073Semantic Standards

Vendor Semantics

IHE PCD TF Content

Vendor A

Vendor C

Vendor B

RosettaMappingTables(RTM)

11073PnP Comm

HL7 v3CDA/CCD

HL7 v2Messages

RTM Cardiovascular (multiple vendors)

Group REFERENCE_ID Vendor_Description

CODEVendor

A Vendor

BVendor

C

CVS_ECG_HR MDC_ECG_CARD_BEAT_RATE Heart Rate  (DBR 326) 16770 HR  HR  HR 

CVS_ECG_HR MDC_ECG_CARD_BEAT_RATE_BTB Beat-to-Beat Rate 16778 btbHR 

CVS_ECG_HR MDC_ECG_HEART_RATE Heart Rate  (DBR 2178) 16770 HR  HR  HR 

CVS_ECG_HR MDC_ECG_PACED_BEAT_RATE %PACED  16554 %PACED

CVS_ECG_HR MDC_ECG_TIME_PD_RR_GL R to R Interval  16168 rr_time  rr_time  rr_time 

CVS_ECG_QT MDC_ECG_TIME_PD_QT_GL QT interval  16160 QT 

CVS_ECG_QT MDC_ECG_TIME_PD_QTc QT interval (corrected) 16164 QTc 

CVS_ECG_RHY MDC_ECG_ARRHY Arrhythmia  4410 ARR 

CVS_ECG_RHY MDC_ECG_V_P_C_CNT PVC rate. 16993 PVC/min  PVC  PVC 

CVS_ECG_ST MDC_ECG_AMPL_ST ST generic label  768 ST  ST 

CVS_ECG_ST MDC_ECG_AMPL_ST_AVF ST lead aVF  832 STaVF  ST-AVF  ST-aVF 

CVS_ECG_ST MDC_ECG_AMPL_ST_AVL ST lead aVL  831 STaVL  ST-AVL  ST-aVL 

CVS_ECG_ST MDC_ECG_AMPL_ST_AVR ST lead aVR  830 STaVR ST-AVR ST-aVR

RTM Goals for 2008-2009

• ExpandExpand the number of numeric parameters supported by PCD-01 from 40 today to nearly 300, providing a more comprehensive set.

• HarmonizeHarmonize the use of existing nomenclature terms defined by ISO/IEEE 11073-10101.

• Specify the units-of-measureunits-of-measure and enumerated enumerated valuesvalues associated with each numeric parameter.

• Identify and add new nomenclature termsIdentify and add new nomenclature terms that are currently missing from ISO/IEEE 11073-10101.

RTM Technical Steps

1. Create the Rosetta Terminology Mapping Table• Current draft (1k) has over 930 rows submitted by six

vendors.

2. Identify implementation differences and resolve.• Resolve differences in interpretation.

• Pre- or post-coordinated measurement site location(s).

3. Identify missing terms and propose new terms to standards organizations.

• IHE PCD – need to add 40+ terms to ISO/IEEE 11073.

• Continua – need to add 100+ terms to ISO/IEEE 11073.

4. Generate final set of terms, units-of-measure and enumerations for testing.

• Working with NIST for HL7 test and validation tooling

Wiki: http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

PCD - New Profiles

ACM ProfileACM Profile

Alarm Communication ManagementAlarm Communication Management

ACM Statement

Alarm Communication Management enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration)

Alarm Communication Management enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration)

AlarmSource

AlarmAggregator

AlarmReceiver

AlarmCoordinator

AlarmDisseminator

AlarmCommunication

AlarmEndpoint

AlarmCommunication

(AC)

AlarmCommunication

(AC)

AlarmManagement

(AM)

AlarmManagement

(AM)

AlarmReporter

(AR)

AlarmReporter

(AR)

AlarmReporter

AlarmCache

Alarm

Query

(AQAQ)

Alarm

Query

(AQAQ)

Communication detailed in ACM profileCommunication detailed in ACM profile

Communication not detailed in ACM profileCommunication not detailed in ACM profile

.

.

.

.

.

.......

PCD Inputs(PM, NC, Resp,

Pump, etc.)

PCD Inputs(PM, NC, Resp,

Pump, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

Output Devices(Marquee Sign, Pager,

Wi-Fi Phone or Badge, etc.)

HIS, EMRHIS, EMROptionalOptional

ACM Actors

AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM

AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time

AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks

AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information

AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM

AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time

AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks

AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information

What Actor does What?

AlarmAlarmCommunicationCommunication

(AC)(AC)

AlarmAlarmCommunicationCommunication

(AC)(AC)

AlarmAlarmManagementManagement

(AM)(AM)

AlarmAlarmManagementManagement

(AM)(AM)

AlarmAlarmReporterReporter

(AR)(AR)

AlarmAlarmReporterReporter

(AR)(AR)

AlarmAlarmQueryQuery(AQ)(AQ)

AlarmAlarmQueryQuery(AQ)(AQ)

Alarm Status [ACM-02]*Alarm Status [ACM-02]*

Disseminate Alarm [ACM-03] Disseminate Alarm [ACM-03] Dissemination Status [ACM-04]Dissemination Status [ACM-04]

Subscribe to Alarm Cache [ACM-06]* Subscribe to Alarm Cache [ACM-06]*

Query for Alarm [ACM-07]* Query for Alarm [ACM-07]*

Subscribe to Alarm [ACM-05]*Subscribe to Alarm [ACM-05]*

Report Alarm [ACM-01]Report Alarm [ACM-01]

InputsInputs OutputsOutputs

Historical Captureand

Reporting

Historical Captureand

Reporting

OptionalOptional

Report Alarm [ACM-01] Report Alarm [ACM-01]

* Not planned for implementation in 2008/09

ACM Data Flows

PCD - New Profiles

PIV ProfilePIV Profile

Point-of-Care Infusion VerificationPoint-of-Care Infusion Verification

Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump.

Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump.

PIV Statement

PIV will reduce errorsreduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by onboard drug libraries. In addition to the reduction of medication administration errors, this integration may also increase caregiver productivityincrease caregiver productivity and provide more contextual information regarding infusion data.

PIV will reduce errorsreduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by onboard drug libraries. In addition to the reduction of medication administration errors, this integration may also increase caregiver productivityincrease caregiver productivity and provide more contextual information regarding infusion data.

PIV Benefits

PIV as part of overall workflow…

Nurse

Review

MAR Entry

Pharmacist reviews

order detail

(Pharmacy

System)

eMAR updated

Medication

DispensedNurse removes

Medication

from Dispensing

Unit or Med Room

Nurse Confirms 5

Rights:

Right Patient,

Medication,

Dose, Time, Route

AT THE BEDSIDE

Medication

Administered

Physician reviews

data and places

Orders

Nurse

Review

eMAR Entry

Pharmacist reviews

order detail

(Pharmacy

System)

eMAR updated

Medication

DispensedNurse removes

Medication

from Dispensing

Unit or Med Room

Nurse Confirms 5

Rights:

Right Patient,

Medication,

Dose, Time, Route

AT THE BEDSIDE

Medication

Administered

Physician reviews

data and places

Orders

PIV Actors

Infusion OrderFiller(IOF)

Device

PCD-03: Communicate Infusion Order

BPOC or BCMA

Infusion OrderPlacer (IOP)

PCD - Emerging Profiles

Volume 1Integration Profiles

(Use Cases)

Volume 3Content

Volume 2Transactions

SemanticInteroperability

TechnicalInteroperability

Real-WorldProblems

DECDEC-PIBDEC-SPD

ACM

MEM

PnP

DS-PUMP

DS-VENT

DS-PHYSIO

PCD Technical

Framework

PCD Profiles

RTM

Legend: ACM Alarm Comm. Management DDT Device Document Template DEC Device Enterprise Comm. DS- Device Specializations MEM Medical Equipment Mgmt. PIB Patient ID Binding PIV Point-of-Care Infusion

Verification PnP Plug-and-Play RTM Rosetta Term Mapping RM Remote Monitoring SPD Subscribe to Patient Data

PIV

RM

DDT

PCD - Testing

Test Tooling SupportTest Tooling Support

Test Tooling Support - NIST

• NIST Test Tools– ICSGeneratorICSGenerator

• Medical Device Profiles (specializations)• Implementation Conformance Statements

– ValidatePDUValidatePDU • X73 Application Layer Message Syntax and Semantic Validation

• NIST Medical Device Standards Work– ISO/IEEE 11073 Standard (X73): Medical Device Communication

• XML SchemaXML Schema: NIST P11073-10202 Domain Information Model

• Collaborations– Integrating Health Enterprise - Patient Care Devices (IHE-PCD)– IEEE 11073 Personal Health Devices (PHD) Working Group (WG)– ISO/IEEE 11073 WG

• On-going Work and Future Direction…– IHE-PCD profile and message generation and testing (includes enterprise – e.g.,

HL7 V2 & V3HL7 V2 & V3)– PHD X73 profile and message testing (ContinuaContinua)– X73 Java Class LibraryX73 Java Class Library

• NIST Team Members– John Garguilo (john.garguilo@nist.gov 301-975-5248), Sandra Martinez,

Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)

http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices

What is NIST doing? Test Tools!

Test Tools ICSGeneratorICSGenerator ValidatePDUValidatePDU

What is it? Implementation Conformance Statement Generator, Profile builder

X73 Message validation: profile and standard

Why? •Easy to use interface •Based on standard

Promote Interoperability

Who’s using it? Most major medial device manufacturers –IHE-PCD participants (pre-connectathon, connectathon, HIMSS)–PHD participants (smaller devices - Continua effort)

A few small manufactures have expressed interest

Countries participating: US, Europe, Japan, Korea, Canada

How is it being used?

•As a requirement to standard (ICSs)•Early stage interoperability•Help produce more accurate standards documentation

IHE-PCD profile validation

Message validation

Who are we working with?

•IHE-Patient Care Domain•IEEE 11073 Personal Health Device WG•IEEE 11073 WG

Test Tool Support – HL7 v2

Actor

Actor

2

Specification Tool (e.g. MWB)

IHE/PCD-01Validation

Criteria(XML)

HL7 Test

Messages

HL7 Test

Messages

MsgMappingProfile

TestReports

HL7 TestMessages

Message Generation(X73 + HL7 Partial Messages)

IHE-PCD MessageSpecifications

(IHE-PCD TF Vol 2)

HL7 V2 Profile(XML)

NIST Data Repository(HL7 Ref. DB,Table Values,

Sample Values,From Profiles,

Default Values,X73 Device Profiles)

(XML)

Device Table Values

[Rosetta Stone Terms]

(Manufacturer Specific)[e.g., B.Braun, Draeger, GE, Philips, Spacelabs,

Welch Allyn, etc.]

NIST HL7 V2.xTesting Tool

(Web Services)

Message Specification

Profiles

1

Device Content

HL7 Msgs

Msg Specifications

Arrow Key:

Test Tool Support – R-T PnP

PCD - Showcase

HIMSS ShowcaseHIMSS Showcase

Where we get to show off !!Where we get to show off !!

PCD @ HIMSS Showcase ‘08

HIMSS Showcase ’08 - Products

HIMSS Showcase ’08 – ER & OR

HIMSS Showcase ’08 – ICU

Why use IHE PCD profiles?

• Simplified standards-based integration of point-of-care device info & services

• Multi-vendor product integration testing @ Connectathons

• Visibility of products with care providers and peer technology organizations in Showcases

• Path to programs such as the U.S. National Health Information Network (NHIN)

PCD profiles will enable…PCD profiles will enable…

PCD 2008 Important Dates

• 2008.07.07 2008.07.07 Public Comment ClosesPublic Comment Closes

• 2008.07.08 PCD WebinarPCD Webinar @ 11:00 Central

• 2008.07.22 ITI Webinars <see schedule> • 2008.08.01 Trial Implementations Published • 2008.09.30 Connectathon Reg. Due • 2008.10.31 PCD Cycle 4 Proposals Due • 2009.02.23-27 2009 Connectathon (Chicago)• 2009.04.04-08 2009 HIMSS Showcase (Chicago)

www.IHE.net/pcdwww.IHE.net/pcd

PCD Contacts

PCD CoChairs:– Todd Cooper t.cooper@ieee.org – Ken Fuchs ken.fuchs@draeger.com – Ray Zambuto

ray.zambuto@techmed.lincfs.com

• PCD Technical Project Manager:– Manny Furst efurst@imp-tech.com

• IHE (International) Strategic Development Committee Co-Chair:– Elliot Sloane ebsloane@villanova.edu