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Introduction

Integrating the Healthcare Enterprise, IEEE 11073 and The National Institute of Standards and Technology Patient Care Devices Domain Test Effort September 2006. Introduction. NIST PCD Team John Garguilo ( john.garguilo@nist.gov , 301-975-5248)

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Introduction

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  1. Integrating the Healthcare Enterprise, IEEE 11073andThe National Institute of Standards and TechnologyPatient Care Devices DomainTest EffortSeptember 2006

  2. Introduction NIST PCD Team • John Garguilo (john.garguilo@nist.gov, 301-975-5248) • Sandra Martinez (sandra.martinez@nist.gov, 301-975-3579) Agenda • Meeting Goals • PCD background, IEEE 1073, IHE • Involvement in IHE PCD and IEEE 1073 • Year 1, Year 2+ • High Level Diagram • IHE PCD Test Cases • NIST Conformance Test Tools • HL7 Test Framework (including Message Maker) • Input POC (HL7) XML message profiles • Data source (physiologic) • Output: HL7 test messages • Test framework • ICSGenerator • Implementation Conformance Statements • Capabilities and Enhancements (since last WG meeting…) • ValidatePDU • PDU syntax • NIST 11073 XSchema • Issues and Open Discussion…

  3. Goals • Describe high-level test focus areas • Provide Tool Inventory/update: • Brief description/demonstration of development enhancements • Pointer/Links for more detail and contact information • NIST XSchema • Provide status update • Discuss/resolve outstanding issues • Call for vendor review/use of ICSGenerator • Discuss/Resolve any open issues…

  4. Integrating the Healthcare Enterprise IHE and NIST • IHE defines a Technical Framework for the implementation of established messaging standards to achieve specific clinical goals. • Volume I: Integration Profiles • Volume II: Transactions • NIST supports IHE fundamental objective: • To ensure that in the care of patients all required information for medical decisions is both correct and available to healthcare professionals. • NIST contributes to a rigorous testing process for the implementation of the Technical Framework. • Conformance claims by products must still be made in direct reference to specific standards. • Vendors implementing IHE integration capabilities shall use an IHE Integration Statement to describe the conformance of their product to the specifications in the IHE Technical Framework.

  5. IHE/PCD Year 1 Use Cases • The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. • Year One Profiles:- Profile 1: The Enterprise Communication of Patient Care Device Data Integration Profile Goal: Communicate PCD data to enterprise information systems. IHE PCD Profile Name: Device Enterprise Communication (DEC) IHE PCD Transactions: PCD-01: Communicate PCD Data PCD-02: Subscribe to PCD Data IHE PCD Actors: Device Observation Consumer, Filter, and ReporterIHE ITI Actor: Time Client - Profile 2:The Patient Identification Integration Profile Goal:Bind enterprise unique patient identification to the PCD Data which is communicated to the enterprise • PCD Test Cases

  6. IEEE 1073 System 11073 Device 11073 Device 11073 Device ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1](Application Gateway) 11073/HL7 Gateway 1073 Device 1073 Network HL7 Network HL7 System HL7 System 11073-based communications network where 11073 devices interact and an HL7-based communications network, where HL7-based systems interact. Problem: A communication gateway is needed between these two worlds! Solution: ISO/IEEE 11073-60101 HL7(V2.x) ORI [IEEE P1073.6.1.1]

  7. HL7 v2.x Standard IEEE 1073 Standard IHE-ITI Patient Administration -Attribute ID, Term codes, value ranges, qualifiers…-Object Containment Tree ICS-Generator ICS XML File P1073.6.1.1 ORI (Gateway) IHE/PCD Technical Framework (Vol. II) (Transactions) IHE Profile (Paper) HL7 MessageProfile Builder (e.g., MWB) *HL7 MessageProfilesXML How the NIST Test Framework/Message Maker and ICS-Generator could contribute to the IHE/PCD year one Initiative… 1073 Standard (DIM) n (Year 2+ ) NIST (XSLT) Testing Framework(Year 2+) *HL7 v2.x Message Profile: Captures and describes a set of HL7v2.x messages used to solve a Use Case.

  8. Conformance Test Tools • NIST HL7 Test Framework Message Maker • Message Maker dynamically constructs HL7 messages based on an HL7 message profile. • Data values for the primitive elements (i.e., Field, Component, and Subcomponent) defined in the profile are obtained from a number of data sources. • NIST developed database of HL7 primitive data items, HL7 tables, User tables, External tables, local tables, example values from the profiles and default values. • Test messages can be valid or invalid and contain variation from message to message. • Example of invalid message is a missing data item for a required field. • A number of test parameters control the variation in the construction of a message. • These may include segment and field cardinality, the usage of certain primitive fields, value sets, data content, and more. • Data content variation is achieved by randomly selecting items from the HL7 items database. • Framework to test HL7 implementations is under development • http://www.nist.gov/messagemaker • Robert Snelick (robert.snelick@nist.gov)

  9. Conformance Test Tools (continued)(based on 11073 DIM Schema) • ICSGenerator • Facilitates creation of vendor conformance statements. • Provides Medical device data such as parameters or attributes with value ranges and restrictions. [This data can be used as needed by Message Maker (in addition to testing options, data source(s) and HL2 V2.x profile file) to build the test messages.] • http://www.nist.gov/medicaldevices

  10. ICSGenerator Inputs/Outputs XSchemaFile IEEE 11073 Nomenclature ICSGenerator Valid XMLFile DIM XSLT ICS

  11. ICSGenerator Capabilities • Generates ICS’s as required in DIM document. • Ensures common format for ICS generation. • Generates an electronic (XML) version of device data model based strictly on the IEEE 11073 DIM. • Includes private or manufacturer-specific extensions. • Provides validation against DIM Schema. • A device data model generated using this tool can be validated against an updated version of the DIM XSchema. • Provides high level semantic interoperability • Ensuring correct containment relationship and terminology at the object class and related attribute, notification and behavior level. • Device ICS’s comparison capability aids in identifying potential interoperability issues.

  12. ICSGenerator Enhancements(since last WG meetings [San Antonio, May 06]) • Dynamic tree generation • Ability to generate UML diagrams • Device data model comparison reports. • Exported to HTML or PDF document format. • General and Service Support ICS captured in XML • Transport ICS for IRDA Cable Connected profile. • Ability to handle private or manufacturer-specific extensions. • DIM MOC, Attribute, Notification and Behavior ICS tables generated into HTML.

  13. ICSGenerator Enhancements(Continued…) • Ability to add an Application Guidance Statement for the MOC • CREATE/DELETE Service Support for MOC's • Ability to Add Attribute Access for an attribute. (e.g., GET, SET, SCAN...) • Enhanced ability to Add/Remove Attributes, Behaviors and Notifications.

  14. Conformance Test Tools (continued)(based on 11073 DIM Schema) • ValidatePDU • Provides a basic syntax and structure check for a set of captured messages. • Future Enhancements • Translating BER/MDER XML • Needed for 1073 syntax/structure/semantic testing • http://www.nist.gov/medicaldevices

  15. DIM XSchema • Checks common data types • Ensures DIM object definition (attributes, behaviors and notifications) • Ensures containment association • Represents attributes/notification/behavior inheritance • Ensures object cardinality • Ensures term codes (Managed Objects, attributes, behaviors and notifications) • Validates for proper XML structures • Checks syntax of XML instances • Allows for future extentions of the model

  16. Common data type <xsd:element name="InstNumber“ type=“instNumber”/> <xsd:simpleType name="instNumber"> <xsd:restriction base="iNT-U16"/> </xsd:simpleType>

  17. Containment/Object Definition <xsd:complexType name="Simple_MDS_Type"> <xsd:annotation> <xsd:documentation>This type defines the Simple_MDS object including its containment tree.</xsd:documentation> </xsd:annotation> <xsd:choice minOccurs="0" maxOccurs="unbounded"> <xsd:element name="OBJECT_NAME"> <xsd:complexType> <xsd:simpleContent> <xsd:extension base="Simple_MDS_Object_Name_Type"> <xsd:attribute name="Label" type="xsd:string"/> </xsd:extension> </xsd:simpleContent> </xsd:complexType> </xsd:element> <xsd:element name="OBJECT_ID" type="Simple_MDS_Object_Id_Type"/> <xsd:element name="TERM_CODE" type="Simple_MDS_Term_Code_Type"/> <xsd:element name="Reference" type="Simple_MDS_Reference_Type"/> <xsd:element ref="MOC_RESTRICTIONS"/> <xsd:element ref="MOC_APPLICATION_GUIDANCE"/> <xsd:element ref="MOC_SERVICES_SUPPORTED"/> <xsd:element ref="MOC_COMMENT"/> <xsd:element name="Attribute_Info" type="Simple_MDS_Attribute_InfoType" maxOccurs="unbounded"/> <xsd:element name="Behaviour_Info" type="Simple_MDS_Behaviour_InfoType" minOccurs="0" maxOccurs="unbounded"/> <xsd:element name="Notification_Info" type="Simple_MDS_Notification_InfoType" minOccurs="0" maxOccurs="unbounded"/> <xsd:element name="Alert" type="AlertType" minOccurs="0" maxOccurs="unbounded"/> <xsd:element name="Alert_Monitor" type="Alert_MonitorType" minOccurs="0"/> <xsd:element name="Alert_Scanner" type="Alert_ScannerType" minOccurs="0" maxOccurs="unbounded"/> <xsd:element name="Alert_Status" type="Alert_StatusType" minOccurs="0"/> <xsd:element name="Battery" type="BatteryType" minOccurs="0" maxOccurs="unbounded"/> <xsd:element name="Bedside_Communication_Controller" type="Bedside_Communication_ControllerType" minOccurs="0" …

  18. Attribute Definition <xsd:group name=“Simple_Mds_Attribute_InfoType"> <xsd:all> <xsd:element name="Mds-Status"> <xsd:complexType> <xsd:complexContent> <xsd:extension base="Mds_Mds-Status_Type"> <xsd:attributeGroup ref="System_Application_Attribute_Group"/> <xsd:attribute name="derivedFrom" type="xsd:string“ default="MDS"/> </xsd:extension> </xsd:complexContent> </xsd:complexType> </xsd:element> … </xsd:group>

  19. Attribute Definition (Cont.) <xsd:complexType name="Mds_Mds-Status_Type"> <xsd:sequence> <xsd:element name="ATTRIBUTE_NAME" type="xsd:string" fixed="Mds-Status"/> <xsd:element name="ATTRIBUTE_ID" type="xsd:string" fixed="MDC_ATTR_VMS_MDS_STAT"/> <xsd:element name="ATTRIBUTE_TYPE" type="xsd:string" fixed="MDSStatus"/> <xsd:element name="TERM_CODE" type="xsd:integer" fixed="2471"/> <xsd:element name="Reference" type="Mds_Attribute_Reference_Type"/> <xsd:element name="Qual" type="xsd:string" fixed="C"/> <xsd:group ref="Attribute_Information"/> </xsd:sequence> </xsd:complexType>

  20. Attribute Groups <xsd:attributeGroup name="System_Application_Attribute_Group"> <xsd:attribute name="attrGrpId" type="xsd:string" default="MDC_ATTR_GRP_SYS_APPL"/> <xsd:attribute name="attrGrpName" type="xsd:string" default="System Application Attribute Group"/> <xsd:attribute name="attrGrpTermCode" type="xsd:string" default="2058"/> </xsd:attributeGroup>

  21. Behavior Definition <xsd:complexType name="Simple_MDS_Behaviour_InfoType"> <xsd:sequence> <xsd:element name="Mds-Set_Status" type="Mds-Set-Status_Type"/> </xsd:sequence> </xsd:complexType> <xsd:complexType name="Mds-Set-Status_Type"> <xsd:sequence> <xsd:element name="METHOD_NAME" type="xsd:string" fixed="Mds-Set-Status"/> <xsd:element name="METHOD_ID" type="xsd:string" fixed="MDC_ACT_SET_MDS_STATE"/> <xsd:element name="BEHAVIOUR_ACTION_PARAMETER" type="xsd:string" fixed="MdsSetStateInvoke"/> <xsd:element name="BEHAVIOUR_ACTION_RESULT" type="xsd:string" fixed="MdsSetStateResult"/> <xsd:element name="TERM_CODE" type="xsd:integer" fixed="3087"/> <xsd:element name="Reference" type="xsd:string" fixed="clause 7.5.2.2"/> <xsd:element name="Qual" type="xsd:string" fixed="Confirmed"/> <xsd:element ref="BEHAVIOUR_RESTRICTIONS"/> <xsd:element ref="BEHAVIOUR_COMMENT"/> </xsd:sequence> </xsd:complexType>

  22. Notification Definition <xsd:complexType name="Simple_MDS_Notification_InfoType"> <xsd:sequence> <xsd:element name="System-Error" type="System-Error_Type"/> <xsd:element name="Mds-Create-Notification" type="Mds-Create- Notification_Type"/> <xsd:element name="Mds-Attribute-Update" type="Mds-Attribute- Update_Type"/> <xsd:group ref="Top_Notification_InfoType"/> </xsd:sequence> </xsd:complexType>

  23. Notification Definition (Cont.) <xsd:complexType name="System-Error_Type"> <xsd:sequence> <xsd:element name="NOTIFICATION_NAME" type="xsd:string" fixed="System-Error"/> <xsd:element name="NOTIFICATION_ID" type="xsd:string" fixed="MDC_NOTI_SYS_ERR"/> <xsd:element name="NOTIFICATION_EVENT_PARAMETER" type="xsd:string" fixed="MdsErrorInfo"/> <xsd:element name="TERM_CODE" type="xsd:integer" fixed="3349"/> <xsd:element name="Reference" type="xsd:string" fixed="clause 7.5.2.3"/> <xsd:element name="Qual" type="xsd:string" fixed="Unconfirmed"/> <xsd:element ref="NOTIFICATION_RESTRICTIONS"/> <xsd:element ref="NOTIFICATION_COMMENT"/> </xsd:sequence> </xsd:complexType>

  24. XML INSTANCE FILE <?xml version="1.0" encoding="utf-8"?> <DIM xmlns="http://www.nist.X73.gov"> <Simple_MDS> <OBJECT_NAME Label="">Simple_MDS</OBJECT_NAME> <OBJECT_ID>MDC_MOC_VMS_MDS_SIMP</OBJECT_ID> <TERM_CODE>37</TERM_CODE> <Reference>clause 7.5.3</Reference> <MOC_RESTRICTIONS/> <MOC_APPLICATION_GUIDANCE/> <MOC_COMMENT/> <Attribute_Info>

  25. XML Instance (cont.) <Mds-Status attrGrpId="MDC_ATTR_GRP_SYS_APPL" attrGrpName="System Application Attribute Group" attrGrpTermCode="2058" derivedFrom="MDS"> <ATTRIBUTE_NAME>Mds-Status</ATTRIBUTE_NAME> <ATTRIBUTE_ID>MDC_ATTR_VMS_MDS_STAT</ATTRIBUTE_ID> <ATTRIBUTE_TYPE>MDSStatus</ATTRIBUTE_TYPE> <TERM_CODE>2471</TERM_CODE> <Reference>clause 7.5.2.1</Reference> <Qual>C</Qual> <ATTRIBUTE_ACCESS/> <ATTRIBUTE_VALUE_RANGE/> <ATTRIBUTE_RESTRICTIONS/> <ATTRIBUTE_APPLICATION_GUIDANCE/> <ATTRIBUTE_COMMENT/> </Mds-Status> … </Attribute_Info>

  26. Infusion Pump Electronic profile Infusion pump

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