IHE PCD Analysis Committee

MeetingOctober 26, 2009

The Integrated Clinical Environment

• Key abstract actors: – Network controller– ICE Supervisor

object ICE Top-Lev el Components

IceSuperv isor

responsibilitiesclinical workflowcontext-aware clinical decision supportphysiologic closed loop controlSafety interlockssmart integration of alarm conditions

IceNetworkController

responsibilities"Connectivity Awareness""Plug and Play"Common time basedata-patient identity bindinginterpretation of device model

IceDataLogger

notesLogging facili ty persisting significantevent data for forensic analysis.

ExternalInterface

notesInterface to system orsystems outside the scope of ICE, for the provision of data essential to ICE function, such as medication l ist.

MedicalDev ice

Patient

Operator

IceEquipmentInterface

Focus of ICE is single acute-care patient associated with multiple heterogeneous medical devices and equipment

ClinicalEnv ironmentCoordinator

responsibilitiesRemote control for one or more Integrated Clinical Environments

Dev iceModel

notesRepresentation of the accessible capabil ities of the equipment. Required to be exported through the ICD equipment interface to the ICE network controller for a "fully compliant" ICE system. Otherwise the device model may be obtainedby the ICE system by another means. Details of contents yet to be defined. Compare contents of IEEE 11073 Medical Data Information Base.

0..11..*

1

1..*

1..*

1

10..1

Protocol

• Set of clinical decision rules selected as applicable to a patient in a defined disease state

class PCA Protocol Objects

AuthorizedPCAProtocolSet

notesThe set of PCA protocols authorized in the institution or department. Since these change periodically, may affect many difference instances of the point of care, and include many elements other than ICE functions, they would logically be managedby a system at a more inclusive organizational level than single-bed ICE system..

AuthorizedPcaProtocol

notesTypical elements:-Specific intended use (patient categories, antecedent conditions)-Contraindications and cautions-Formulas-Dosage calculation method-Dosage schedule-Nursing worklist including assessment and recording requirements-Patient education requirements-Physiological requirements for continuation

Use: Typically wil l be accessed and applied by a combination of manual and automatic operations, only some of which are within ICE scope.

ProtocolContraindicationsAndCautions

- AnxiolyteUse- BenzodiazepineUse- SleepApneaPresent- MorbidObesityPresent

PcaPumpDosageSettings

- ContinuousConcentration- DemandDosage- LockoutTime- ClinicalBolusDose- ClinicalBolusFrequency- ClinicalBolusRepeatFrequency

Clinical Operations Context

• Required Clinical Observations• Required Vital Signs Set• Implies Required Device Set

class Point-of-CareClinicalObjects

MedicalDevice

PCAInfusionPump

- PcaDemandDosageSettings- ContinuousDosageSettings- BolusDosageSettings

+ PcaInactivate() : void+ PutSettings() : void

RequiredDev iceSet

- allDevicesAssociated: boolean- requiredDevices: MedicalDevice [0..*] (Set)

notesRequirements are actually for particular measurement functions (Virtual Medical Devices) rather than particular concrete devices; ICE system must support abstraction so that devices are freely substitutable so long as all elements of RequiredVitalSignSet are supported by theset (i.e. free-standing pulse oximeter or capnograph versus equivalent plug-in modules in a patient monitor).

RequiredVitalSignsSet

- RR- HR- NiBP- SpO2- etCO2

notesSet of vital signs required by ICEto execute algorithm. etCO2 measurement may be omitted for patient comfort; lack of etCO2 measurement may condition PCA assessment algorithms used.

MedicalDevice

Capnograph

notesData and control may be integral with patient monitor

MedicalDevice

PatientMonitor

notesMay be vital signs monitor giving episodic observationsat command or full continuous monitoring

MedicalDevice

PulseOximeter

notesData and control may be integral with patient monitor

«signal»

AllRequiredDev icesAssociatedSignal

notesSignal indicates all devices in RequiredDeviceSet have associated with the network controller.

ClinicalObserv ation

PainScore SedationScore

PatientIdentityBindingRule

+ isPatientIdentityVerified() : boolean

notesSite-specific procedure for reliable binding of patient identity to data sources. Ex. barcode-scan wristband, validate reasonableness of date-of-birth and gender data associated with the proposed patient id, and ask patient for name and date-of-birth if responsive and oriented, to validate that patient is correctly identified.

Startup

• Establish device connectivity• Establish network connectivity to external

systems

act Activ ityFlowOv erv iewPart1

ActivityInitial

WaitForDev iceConnectiv ity

StartController

AllRequiredDevicesAssociated

WaitForNetControllerConnectiv ity

NetControllerConnectivityOK

ClinicianVerifiesPatientIdentity

ReadyToMeasure

ActivityFinal

PatientIdentityBindingRule

+ isPatientIdentityVerified() : boolean

notesSite-specific procedure for reliable binding of patient identity to data sources. Ex. barcode-scan wristband, validate reasonableness of date-of-birth and gender data associated with the proposed patient id, and ask patient for name and date-of-birth if responsive and oriented, to validate that patient is correctly identified.

At startup, the system and attached devices carry out a number of concurrent activities preliminary to executing the operational part of the use case. These activities are common to many use cases. At the end of this period:

-the devices have established communications associations with the controller and reported their identity and self-test status.

-The network controller has verified its network connection with required external systems.

-The identity of the patient for the procedure has been verified using locally-defined procedure. This is obviously different in nature from the other preparation items but can be done concurrently with them, and it is just as much a precondition required before the operational part of the procedure is entered.

Connectivity for a device is deemed to include the device reporting its self-test and operational status to the controller, and its DeviceModel if it supports this capabil ity. See state machine.

Dev iceModel

notesRepresentation of the accessible capabil ities of the equipment. Required to be exported through the ICD equipment interface to the ICE network controller for a "fully compliant" ICE system. Otherwise the device model may be obtainedby the ICE system by another means. Details of contents yet to be defined. Compare contents of IEEE 11073 Medical Data Information Base.

Name:Package:Version:Author:

ActivityFlowOverviewPart1Domain Objects1.0usd04734

Safety Interlock

• A rule that constrains the operation of equipment based on the observable system state in order to prevent harm to the patient or another person. The system is defined to include all actors that may sense, communicate or indicate relevant observations or knowledge.

stm SafetyInterlock

VentilatorStateMachine

Vent state transitions depend on XRay state transitions exposureInitiated and exposureDone

Allow vent and patient to 'settle'

XRayStateMachine

XRayMachineWaiting

+ entry / Start settling delay timer

XRayMachineExposingXRayMachineIdle

VentilatorPaused

+ entry / start failsafe timer

VentilatorActiv e

Ventilator pauses when X-Ray exposure initiated

Ventilator restarts automatically when exposure done, or if failsafe timer times out

exposureDone

Settl ing time doneexposureInitiated

exposureDone,ReceivedFailsafeTimeout

exposureInitiated