Notification Messaging to Support FDA

Drug Reaction Notification 2 October 2002 - Page: 1SAFER – HEALTHIER –

PEOPLE

CDC NEDSS

Notification Messaging to Notification Messaging to Support FDASupport FDA

Building an HL7 Version 3 Based Approach for Disease Notification & Applying it to Drug Reaction Reporting

Building an HL7 Version 3 Based Approach for Disease Notification & Applying it to Drug Reaction Reporting


PEOPLE

CDC NEDSS

A Basic Premise for the DiscussionA Basic Premise for the Discussion

There is a core concept that is something like “Notification”. That concept is sufficiently applicable to a wide range of public health activities, ranging from disease notification to drug reaction reporting, for the work done to support NEDSS to be relevant to FDA’s reporting needs.

There is a core concept that is something like “Notification”. That concept is sufficiently applicable to a wide range of public health activities, ranging from disease notification to drug reaction reporting, for the work done to support NEDSS to be relevant to FDA’s reporting needs.


PEOPLE

CDC NEDSS

Presentation ObjectivesPresentation Objectives

A little NEDSSCDC Messaging Development

Notification message contents as an example of the process

Using Notification Messaging to address FDA requirements Introduce the E2BM mappingReview mapping contents

HL7 standardization of Notification MessagingProposed next steps

A little NEDSSCDC Messaging Development

Notification message contents as an example of the process

Using Notification Messaging to address FDA requirements Introduce the E2BM mappingReview mapping contents

HL7 standardization of Notification MessagingProposed next steps


PEOPLE

CDC NEDSS

A Vision for National Electronic A Vision for National Electronic Disease Surveillance System Disease Surveillance System

(NEDSS)(NEDSS)

Gathers health data automatically from a variety of sources on a real-time basis

Monitors the health of communities Assists in ongoing analyses of trends and

detection of emerging public health problems

Provides information for setting public health policies

Is a system of interoperable systems like the Internet is a network of interoperable networks

Gathers health data automatically from a variety of sources on a real-time basis

Monitors the health of communities Assists in ongoing analyses of trends and

detection of emerging public health problems

Provides information for setting public health policies

Is a system of interoperable systems like the Internet is a network of interoperable networks


PEOPLE

CDC NEDSS

NEDSS & National StandardsNEDSS & National StandardsUsing

Use wherever possibleUse and publish “design specifications” in

order to do the workHave a very high bar to change vs. deriveBe prepared to follow the refinement of

standards Influencing

See that public health issues are represented in national standards

Document specification development activities

Use opportunities to promote the sometimes more difficult approach of using standards

UsingUse wherever possibleUse and publish “design specifications” in

order to do the workHave a very high bar to change vs. deriveBe prepared to follow the refinement of

standards Influencing

See that public health issues are represented in national standards

Document specification development activities

Use opportunities to promote the sometimes more difficult approach of using standards


PEOPLE

CDC NEDSS

Design Philosophy for CDC Design Philosophy for CDC Messaging ProjectsMessaging Projects

Develop HL7 Version 3 messages. Use the RIM and the Message Development

Framework. Use HL7 vocabulary domainsCreate a consistent set of work products across

the projects.Standardize by forwarding messages within

HL7 Influence HL7

Suggest RIM changes and vocabulary itemsPlan to submit message formats for

standardizationWork within the technical architecture

developed by NEDSS

Develop HL7 Version 3 messages. Use the RIM and the Message Development

Framework. Use HL7 vocabulary domainsCreate a consistent set of work products across

the projects.Standardize by forwarding messages within

HL7 Influence HL7

Suggest RIM changes and vocabulary itemsPlan to submit message formats for

standardizationWork within the technical architecture

developed by NEDSS


PEOPLE

CDC NEDSS

Using the MDF - CDC StyleUsing the MDF - CDC StyleDocument messaging requirementsMap relevant data to the RIM. Use data

mapping as a source for the R-MIM. (These two can be documented together with simple source data.)

HL7 tooling supports definition of HMDs, message types, and XML schemas.

Create mappings between message elements and source and target databases

Address vocabulary issues by looking at HL7 domains first, but not last.

Document messaging requirementsMap relevant data to the RIM. Use data

mapping as a source for the R-MIM. (These two can be documented together with simple source data.)

HL7 tooling supports definition of HMDs, message types, and XML schemas.

Create mappings between message elements and source and target databases

Address vocabulary issues by looking at HL7 domains first, but not last.


PEOPLE

CDC NEDSS

Current CDC ProjectsCurrent CDC ProjectsNotification Messaging

Communicate notifiable disease reports from states to CDC.

Core component of the NEDSS Base System.Vital Statistics

Provide a specification for Birth and Death information.

Also support “verification/certification”.Antimicrobial Use Reporting

Periodic (monthly) reporting of antibiotics use and organism susceptibility from providers to CDC.

Notification MessagingCommunicate notifiable disease reports from

states to CDC.Core component of the NEDSS Base System.

Vital StatisticsProvide a specification for Birth and Death

information.Also support “verification/certification”.

Antimicrobial Use ReportingPeriodic (monthly) reporting of antibiotics use

and organism susceptibility from providers to CDC.


PEOPLE

CDC NEDSS

The Elements of Messaging AnalysisThe Elements of Messaging Analysis

Use Case ModelStatement of Requirements

We did not do formal use case analysis. This would be important for a “new” area.

To a certain extent, documentation for the NEDSS Base System addresses this requirement.

Use Case ModelStatement of Requirements

We did not do formal use case analysis. This would be important for a “new” area.

To a certain extent, documentation for the NEDSS Base System addresses this requirement.


PEOPLE

CDC NEDSS

Messaging Analysis ContinuedMessaging Analysis Continued

Interaction Model Messaging Scenarios –

This documents needs for communication, as well as the discussion around those needs.

Interaction DiagramA record of the interactions to be supported

Interaction GridDocuments Trigger events, and message dependencies.

Interaction Model Messaging Scenarios –

This documents needs for communication, as well as the discussion around those needs.

Interaction DiagramA record of the interactions to be supported

Interaction GridDocuments Trigger events, and message dependencies.


PEOPLE

CDC NEDSS

Notification Messaging Notification Messaging ScenariosScenarios

I. Condition NotificationState or other reporting base system sends a notification to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

II. Change/Retraction of Prior NotificationState or other reporting base system sends a notification update/change/retraction. This message will always provide a reference to the earlier notification that is being updated, changed, or retracted. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

I. Condition NotificationState or other reporting base system sends a notification to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

II. Change/Retraction of Prior NotificationState or other reporting base system sends a notification update/change/retraction. This message will always provide a reference to the earlier notification that is being updated, changed, or retracted. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.


PEOPLE

CDC NEDSS

Notification Messaging Notification Messaging ScenariosScenarios

III. Summary NotificationState or other reporting base system provides total amounts for the reporting, during a specified time period, of a specific disease or condition to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

IV. Notification ResponseCDC will provide a response to the state or other reporting base system once the CDC base system has processed the message. This message will indicate that the message was successfully processed by the interface engine. The state or other reporting base system will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed

III. Summary NotificationState or other reporting base system provides total amounts for the reporting, during a specified time period, of a specific disease or condition to CDC. CDC will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed.

IV. Notification ResponseCDC will provide a response to the state or other reporting base system once the CDC base system has processed the message. This message will indicate that the message was successfully processed by the interface engine. The state or other reporting base system will acknowledge receipt. A negative acknowledgement will be sent if the message that has been received cannot be processed


PEOPLE

CDC NEDSS

Interaction SpecificationInteraction Specification

1: Condition Notification

Base System

CDC Base System

3: Summary Notification 4: Notification Response

2: Change/Retraction of Prior Notification


PEOPLE

CDC NEDSS

Diagram Based MappingDiagram Based MappingActmood: eventclass cd: notificaitontype cd: RCTTYPEtype cd: SYSVERcritical date time: YEAR,WEEKstatus code: REPSTATUS

Participationtype_cd: author

Roleclass cd:jurisdictiontype_cd reportingentity:

EntityClass cd: Placetype cd: netss stateplace name: STATE

EntityClass cd: living subjectentity id: SUBJECTIDbirth date: DOBsex cd: SEXrace cd: HISPANIC,ASIAN, BLACK, AMIND,NAHAQ, WHITE, ORACErace modf: : OTH_SPEC

Actmood:: eventClass cd: casetype cd: EVENTactivity id: REPORTIDcritidal date time:ONSETDATEclassification status cd:CASE STATUSdisease imported code:IMPORTED

Participationtype_cd: location

Roleclass cd:jurisdictiontype_cd reportingentity:

EntityClass cd: Placetype cd: netss siteentity id: SITE

Actmood:: eventclass cd: obsvobsv value: RCDCOUNT

Act_relationshiptype_cd: pertains

EntityClass cd: placetyppe cd: netss countyplace name: COUNTY

Participationtype_cd: subjecttarget

Roleclass cd:residence

Participationtype_cd: location

Roleclass cd:jurisdictiontype_cd :reporting entity

Actmood: eventclass cd: obsvtype cd: AGETYPEvalue: AGE

Actmood: eventclass cd: obsvtype cd: AGETYPEvalue: AGE CAT

Locatorclass cd: postal addresstype cd: NETSS zip codestreeet address: POSTCD

Actmood: eventclass cd: obsvtype cd:: netss educationvalue: EDUC

EntityClass cd: Entity Grouptype cd: adultgroup count: ADLTHOUSE

Roleclass cd:: grouptype cd:membership inhouushold

EntityClass cd: Entity Grouptype cd: adultgroup count: CHILDHOUS

Roleclass cd: grouptype cd:membership inhouushold

Actmood: eventclass cd: diagmpsistype cd::actv date time: DIAGDATE

Actmood: eventclass cd: HRAtype cd:: : specimen collectionactv date time: SPECDATE

Roleclass_cd :specimen

EntityClass cd: materialtype cd: SPECTYPE

Actmood: eventclass cd: notificaitontype cd: first report to publichealthactivity date time: PHDATE

Actmood: eventclass cd: notificaitontype cd: first report to CDCactivity date time:FSTMXDATE

Actmood: eventclass cd: obsvtype cd:: netss observationindiccatorvalue:: OUTBREAKIND

Actmood: eventclass cd: outbreakidentifier: OUTBREAKID

Actmood: eventclass cd: obsvtype cd:: LABTESTactivity date time: LABDATEvalue: LABRESULT

Actmood: eventclass cd: obsvtype cd:: netss outcomevalue: OUTCOME

Actmood: eventclass cd: obsvtype cd:: netsshospitilazation indicatorvalue: HOSPITAL














Participationtype_cd:specimen

Locator_relationshiptype_cd: case relevant

Used to discover detailed data requirements.

Can be constructed in a group session.

Becomes an education on the HL7 RIM.

Leads naturally into RMIM construction.

This is the stage we have reached with the FDA specifications.

Used to discover detailed data requirements.

Can be constructed in a group session.

Becomes an education on the HL7 RIM.

Leads naturally into RMIM construction.

This is the stage we have reached with the FDA specifications.


PEOPLE

CDC NEDSS

R-MIM for NotificationR-MIM for Notification Message header to carry transactional information Identification of the notification sender and receiver Case specific information Other notifications related to the case Patient encounters associated with the case Case participants including the patient or subject of

the case and locations associated with the case. Associations between participants in the case Case related specimens and specimen collection

procedures. Observation information, such as laboratory tests,

about participants or specimens related to the case.

Message header to carry transactional information Identification of the notification sender and receiver Case specific information Other notifications related to the case Patient encounters associated with the case Case participants including the patient or subject of

the case and locations associated with the case. Associations between participants in the case Case related specimens and specimen collection

procedures. Observation information, such as laboratory tests,

about participants or specimens related to the case.


PEOPLE

CDC NEDSS

R-MIM Part 1R-MIM Part 1 Diagram should contain the V3 Outer wrapper

and Controlled Act wrapper. Content determined by HL7 consistently for all

messages.

Diagram should contain the V3 Outer wrapper and Controlled Act wrapper.

Content determined by HL7 consistently for all messages.


PEOPLE

CDC NEDSS

A Few CommentsA Few Comments

This section of the message will change for consistency with new HL7 developments

HL7 will offer a single structure“Outer Wrapper”: Captures the message

header & message sender and receiver. This is basic transactional information.

“Message Control Act”: A single way to model data for the “trigger event”, the event that causes data to flow.

This section of the message will change for consistency with new HL7 developments

HL7 will offer a single structure“Outer Wrapper”: Captures the message

header & message sender and receiver. This is basic transactional information.

“Message Control Act”: A single way to model data for the “trigger event”, the event that causes data to flow.


PEOPLE

CDC NEDSS

Notification Payload V1Notification Payload V1AR_Observation_relationship

0..*

0..*

type_cd*: CS [1..1] <= PERT

A_Case_observation

class_cd* <= OBSmood_cd*: <= EVNcd: CV [1..1]effective_time: IVL<TS> [0..1]activity_time: IVL<TS> [0..1]value: ANY [1..1]interpretation_cd: CV [0..1]method_cd: CV [0..1]

0..*

AR_Case_observationtype_cd*: <= COMP

E_Case_related_place

class_cd* <= PLCdeterminer_cd* <= INSTANCEcd: CV [1..1]id: II [0..1]nm: EN [0..1]addr: AD [0..1]

E_Case_related_person

class_cd* <= PSNdeterminer_cd* <= INSTANCEadministrative_sex_cd: CV [0..1]birth_time: TS [0..1]deceased_ind: BL [0..1]deceased_time: TS [0..1]marital_status_cd: CV [0..1]education_level_cd: CV [0..1]race_cd: SET<CV> [0..*]ethnic_group_cd: SET<CV> [0..*]

1..1

0..1

R_Party_relationship

class_cd* <= ROL

0..*

0..*

1..1

0..1R_Case_related_party

class_cd* <= ROL

0..*

0..*

0..*P_Observation_participanttype_cd*: CS [1..1] <=PRF+PAT+LOC

1..*

P_Case_participanttype_cd*: <= PAT+LOC+PRF

E_Case_related_organization

class_cd* <= ENTdeterminer_cd* <= INSTANCEcd: CV [0..1]nm: EN [0..1]addr: AD [0..1]

E_Case_related_nonperson_living_subject

class_cd* <= NLIVdeterminer_cd* <= INSTANCEcd: CV [1..1]

E_Case_related_party

E_Specimen

class_cd* <= MATdeterminer_cd*: <= INSTANCEcd*: CV [1..1]

1..1

0..1

R_Specimen_responsibility

class_cd* <= ROL

0..*

0..*

1..1

0..1R_Specimen

class_cd* <= SPEC

0..*

0..*

A_Specimen_collection

class_cd* <= PROCmood_cd*: <= EVNactivity_time: IVL<TS> (0..1)

0..*

P_Specimen

0..*

type_cd*: <= SPC

0..*

P_Specimen_handling

0..*

type_cd*: <= PRF

0..*

AR_Specimen_collectiontype_cd*: <= PERT

A_Associated_notification

class_cd* <= ACTmood_cd*: <= EVNid: II [0..1]cd: CV [1..1]activity_time: IVL<TS> [0..1]

A_Patient_encounter

class_cd* <= ENCmood_cd*: <= EVNactivity_time: IVL<TS> [1..1]

0..*

AR_Associated_notificationtype_cd*: <= PERT

0..*

AR_Patient_encountertype_cd*: <= PERT

A_Public_health_case

class_cd* <= CASEmood_cd*: <= EVNid: II [1..1]cd: CV [1..1]status_cd: CS [0..1]effective_time: IVL<TS> [1..1]activity_time: IVL<TS> [1..1]detection_method_cd: CV [0..1]transmission_mode_cd: CV [0..1]disease_imported_cd: CV [0..1]


PEOPLE

CDC NEDSS

Comments on the “Payload”Comments on the “Payload”

The original design was based on the current NETSS system.

It only reluctantly added data concepts that were not supported there.

Glaring deficiencies are already clear.Insufficient data for personsOnly observations are linked to the caseDoes not address materials, e.g., vaccines.Insufficient information on specimens.

The original design was based on the current NETSS system.

It only reluctantly added data concepts that were not supported there.

Glaring deficiencies are already clear.Insufficient data for personsOnly observations are linked to the caseDoes not address materials, e.g., vaccines.Insufficient information on specimens.


PEOPLE

CDC NEDSS

Downstream ArtifactsDownstream Artifacts

Hierarchical Message DescriptionXML SchemasNotification Messaging

DocumentationImplementation Guides (Disease

Specific)Database/Message MappingMessaging Subsystem

Hierarchical Message DescriptionXML SchemasNotification Messaging

DocumentationImplementation Guides (Disease

Specific)Database/Message MappingMessaging Subsystem


PEOPLE

CDC NEDSS

Working on FDA MessagingWorking on FDA Messaging

Initial Premise – We can use the Notification Messages.Note, this will require enhancement to what is

there today.

First Step – Review the E2BM specifications, and recast in HL7 terms.This was done by mapping the data to the RIM.

Second Step – Determine additional requirements for the Notification Message specification. I have an initial cut at these.

Initial Premise – We can use the Notification Messages.Note, this will require enhancement to what is

there today.

First Step – Review the E2BM specifications, and recast in HL7 terms.This was done by mapping the data to the RIM.

Second Step – Determine additional requirements for the Notification Message specification. I have an initial cut at these.


PEOPLE

CDC NEDSS

Produced so FarProduced so Far

High level outline of the E2BM transaction.

Diagrammatic mapping of the specification.

Excel spreadsheet containing the mapping details.

List of proposed updates to the Notification R-MIM

High level outline of the E2BM transaction.

Diagrammatic mapping of the specification.

Excel spreadsheet containing the mapping details.

List of proposed updates to the Notification R-MIM


PEOPLE

CDC NEDSS

Drug Incident NotificationDrug Incident Notification

A_Event_report

class_cd* <= OBSmood_cd* <= EVENTLots of data

A_Reaction


A_Administration


1..*

type_cd* <= COMP

AR_Safety_report

1..*

1..*

type_cd* <= CAUS

AR_Associated*

1..1

R_Patient

class_cd* <= PAT

*

E_Patient

class_cd* <= PSNdeterminer_cd* <= INSTANCELots of data

1..1

P_Patient*type_cd* <= PAT

0..1

P_Parent_subj*type_cd* <= PAT

1..1R_Parent

class_cd* <= PAT

*

E_Parent

class_cd* <= PSNdeterminer_cd* <= INSTANCELots of data 1..1

R_Child

class_cd* <= CHILD

0..1

*

*

0..1

P_Subject*type_cd* <= PAT

1..*

type_cd* <= COMP

AR_Safety_report

1..1

P_Reporting*type_cd* <= PAT

1..1

R_Reporting_Party

class_cd* <= PAT

*

E_Reporting_Party

class_cd* <= PSNdeterminer_cd* <= INSTANCELots of data


PEOPLE

CDC NEDSS

E2BM MappingE2BM Mapping

A_Result_of_tests_procedures

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.2 RESULT OF TESTS0..1

type_cd* <= ?

AR_Test_result

1..1

type_cd* <= SPRT

AR_Addl_doc

A_Most_recent

class_cd* <= OBSmood_cd* <= EVENTactivity_time: A.1.7 DATE OF MOST RECENT RECEIPT1..1

type_cd* <= PREV

AR_Recent_report

1..1

type_cd* <= PERT

AR_Seriousness

0..* 0..*

type_cd* <= ?

AR_Indication

A_Reaction_or_event

class_cd* <= OBSmood_cd* <= EVENTcd: B.2.i.3 TERM HIGHLIGHTED BY REPORTERactivity_time: B.2.i.4 DATE OF START B.2.i.5 DATE OF END B.2.i.6 DURATION OF REACTIONtxt: B.2.i.0 REACTION AS REPORTED

1..1

type_cd* <= ?

AR_Lowest_level

1..1

type_cd* <= ?

AR_Preferred

0..1

type_cd* <= ?

AR_Initial_dose

0..1

type_cd* <= ?

AR_Last_dose

A_Lowest_level_term

class_cd* <= OBSmood_cd* <= EVENTcd: B.2.i.1 MEDRA LOWEST LEVEL

A_Preferred_term

class_cd* <= OBSmood_cd* <= EVENTcd: B.2.i2 MEDRA PREFERRED

A_First_dose_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.7.1 BEGINNING TIME INTERVAL

A_Last_dose_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.7.2 LAST DOSE TIME INTERVAL

1..1

type_cd* <= ?

AR_Outcome

A_Outcome

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.8 OUTCOME OF REACTION

A_Relevant_result

class_cd* <= OBSmood_cd* <= EVENTcd: B.3.1b TESTactivity_time: B.3.1a DATEvalue: B.3.1c RESULT B.3.1d UNIT OF MEASURE

1..*

type_cd* <= ?

AR_Normal_range*

A_Observation_normal_range

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.1e NORMAL LOW RANGE B.3.1f NORMAL HIGH RANGEinterpretation_cd

1..1

type_cd* <= ?

AR_Additional_result A_Additional_result

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.1g MORE INFORMATION Y/N

A_Direct_Administration

class_cd* <= SBADMmood_cd* <= EVENTactivity_time: B.4.k.3 NUMBER OF DOSAGES B.4.k.4 NUMBER OF UNITS IN INTERVAL B.4.k.5 DEFINITION OF INTERVAL UNIT B.4.k.12 DATE OF START OF DRUG B.4.k.14 DATE OF LAST ADMINISTRATION B.4.k.15 DURATION OF ADMINISTRATIONdose_qty: B.4.k.5.1 DOSE NUMBER B.4.k.5.2 DOSE UNITtxt: B.4.k.19 ADDITIONAL INFORMATION ON DRUG

0..* 0..*

type_cd* <= ?

AR_CharacterizationA_Drug_role

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.1 DRUG CHARACTERIZATION CODE

1..1

P_Administer_producttype_cd* <= CSM

1..1

0..1R_Content

class_cd* <= ROL

0..*

0..*

E_Therapeutic_product

class_cd* <= MMATdeterminer_cd* <= INSTANCEcd: B.4.k.2.1 MEDICINAL PRODUCT NAMElot_num: B.4.k.3 BATCH OR LOT NUMBERform:cd: B.4.k.7 PHARMACEUTICAL FORM

1..1

0..1R_Ingredient

class_cd* <= ROL

0..*

0..*

E_Therapeutic_product_ingredient

class_cd* <= MMATdeterminer_cd* <= INSTANCEcd: b.4.K.2.2 ACTIVE SUBSTANCE NAME

1..1

0..1 R_Sourced

class_cd* <= ROL

0..*

0..*

E_Country

class_cd* <= PLCdeterminer_cd* <= INSTANCEnm: B.4.k.2.3 ID OF COUNTRY

1..1

0..1

R_Authorization_holder

class_cd* <= ROL

0..*

0..*id: B.4.K.4.1 AUTHORIZATION NUMBER

E_Holder

class_cd* <= ORGdeterminer_cd* <= INSTANCEnm: B.4.k.4.3 NAME OF HOLDER

E_Country_of_authorization

class_cd* <= PLCdeterminer_cd* <= INSTANCEnm: B.4.k.4.2 COUNTRY OF AUTHORIZATION

1..1

P_Authorizationtype_cd* <= ?

0..* 0..*

type_cd* <= ?

AR_Cummulative

A_Cummulative_dose

class_cd* <= SBADMmood_cd* <= EVENTdose_qty: B.4.k.5.6 CUMM DOSE TO FIRST REACTION B.4.k.5.7 CUMM DOSE UNIT

A_Indication

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.11 INDICATION FOR USE

1..1

type_cd* <= ?

AR_Local_criteriaA_Local_seriousness_criteria

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.9 CASE FULLFILLS CRITERIA

1..1

type_cd* <= PERT

AR_Additional_case_idsA_Case_id

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.11 OTHER CASE ID

A_Report_nullification

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.13 REPORT NULLIFICATIONtxt: A.1.13.1 REASON FOR NULLIFICATION

A_Medical_Confirmation

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.14 CASE MEDICALLY CONFIRMED

1..1

type_cd* <= ?

AR_Nullification

1..1

type_cd* <= ?

AR_Confirmation

A_Linked_case

class_cd* <= OBSmood_cd* <= EVENTid: A.1.11.2 CASE ID

0..*

type_cd* <= ?

AR_Linked_case

1..*

P_Primary_sourcetype_cd* <= ?1..1

0..1R_Reporter

class_cd* <= ROL

0..*

0..*

cd: A.2.1.4 QUALIFICATION CODEaddr: A.1.2.1.2 REPORTER ADDRESS A.1.2.1.3 REPORTER COUNTRY

E_Reporter

class_cd* <= PSNdeterminer_cd* <= INSTANCEnm: A.2.1.1 REPORTER IDENTIFIER

0..*

type_cd* <= ?

AR_Reference A_Literature_reference

class_cd* <= OBSmood_cd* <= EVENTtxt: A.2.2 LITERATURE REFERENCE

0..1

type_cd* <= ?

AR_Study A_Study

class_cd* <= OBSmood_cd* <= EVENTid: A.2.3.2 SPONSOR STUDY NUMBERcd: A.2.3.3 STUDY TYPEtxt: A.2.3.1 STUDY NAME

0..*

P_Sender

0..*

type_cd* <= AUT

1..1

0..1 R_Report_Sender

class_cd* <= ROL

0..*

0..*

cd: A.3.1.1 TYPEaddr: A.3.1.4 ADDRESStelecom: A.3.1.4 ADDRESS

E_Report_sender

class_cd* <= ORGdeterminer_cd* <= INSTANCEnm: A.3.1.2 IDENTIFIER

E_Responsible_Person

class_cd* <= ENTdeterminer_cd* <= INSTANCEnm: A.3.1.3 PERSON RESPONSIBLE

0..*

P_Receiver

0..*

type_cd* <= ?1..1

0..1R_Report_Receiver

class_cd* <= ROL

0..*

0..*


E_Report_receiver


1..1

P_Patienttype_cd* <= ?

1..1

0..1

R_Patient

class_cd* <= ROL

0..*

0..*

id: B.1.1.1 MEDICAL RECORD NUM

E_Patient

class_cd* <= PSNdeterminer_cd* <= INSTANCE

0..*

P_Related_observation

0..*

type_cd* <= ?

A_Patient_characteristic

class_cd* <= OBSmood_cd* <= EVENTactivity_time: B .1.9.1 DATE OF DEATHvalue: B.1.2.1 DATE OF BIRTH B.1.2.2 AGE AT TIME OF ONSET B.1.2.2.1 GESTATION PERIOD OF FETUS B.1.2.3 AGE GROUP CODE B.1.3. WEIGHT B.1.4 HEIGHT B.1.5 SEX B.1.6 LAST MENSTRUAL PERIOD DATE B.1.9.2 REPORTED CAUSE OF DEATH B.1.9.3 PRESENCE OF AUTOPSY B.1.9.4 AUTOPSY DETERMINED CAUSE OF DEATH

A_Indication

class_cd* <= OBSmood_cd* <= ?value: B.1.8 INDICATION A_Reaction

class_cd* <= ACTmood_cd* <= ?value: B.1.8 REACTION

1..1

0..1

R_Child

class_cd* <= ROL

0..*

0..*

E_Parent

class_cd* <= PSNdeterminer_cd* <= INSTANCEnm: B.1.10.1 PARENT IDENTIFICATION

0..*

P_Parent_related_observation

0..*

type_cd* <= ?

A_Parent_characteristic

class_cd* <= OBSmood_cd* <= EVENTvalue: B.1.10.2.1 DATE OF BIRTH B.1.10.2.2 AGE AT TIME OF ONSET B.1.10.3 LAST MENSTRUAL PERIOD DATE B.1.10.4 WEIGHT B.1.10.5 HEIGHT B.1.10.6 SEX

0..*

type_cd* <= ?

AR_Indication

0..*

type_cd* <= ?

AR_Reaction

A_Direct_route

class_cd* <= SBADMmood_cd* <= EVENTroute_cd: B.4.k.8 ROUTE OF ADMINISTRATION

A_Proximate_route

class_cd* <= SBADMmood_cd* <= EVENTroute_cd: B.4.k.9 PARENT ROUTE OF ADMINISTRATION

0..*0..*

type_cd* <= ?

AR_Routing_Option

A_Proximate_administration

class_cd* <= SBADMmood_cd* <= EVENT

0..*0..*

type_cd* <= ?

AR_Routing_Option

A_Case_safety_report

class_cd* <= OBSmood_cd* <= EVENTcd: TYPE OF REPORTid: A.1.0.1 SAFETY REPORT ID A.1.10.1 REG AUTH CASE ID A..1.10.2 SENDER CASE ID A.1.11.1 CASE ID SOURCE A.1.11.2 CASE IDactivity_time: DATE OF TRANSMISSION

1..1

P_Report_sourcetype_cd* <= ?1..1

0..1R_Source_country

class_cd* <= ROL

0..*

0..*

cd:id: A.1.1 PRIMARY COUNTRY ID

1..1

P_Event_loctype_cd* <= ?1..1

0..1R_Event_country

class_cd* <= ROL

0..*

0..*

cd:id: A.1.2 COUNTRY OF EVENT ID

A_Serious_indication

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.5.1 SERIOUS

0..*

type_cd* <= EXPL

AR_Criteria

A_Criteria

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.5.2 SERIOUSNESS CRITERIA

1..1

type_cd* <= PERT

AR_Source_reportA_First_notification

class_cd* <= OBSmood_cd* <= EVENTactivity_time: A.1.6 DATE OF FIRST REPORT

A_Additional_document

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.8.1 ADDITIONAL DOC 0..*

type_cd* <= EXPL

AR_DocumentsA_Document_list

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.8.2 DOCUMENT HELD

0..*0..*

type_cd* <= ?

AR_Parental_Contact

A_Relevant_medical_history

class_cd* <= OBSmood_cd* <= EVENTcd: B.1.7.1 DISEASE/PROCEDURE/ETCactivity_time: B.1.7.1 START DATE, END DATE, CONTINUINGtxt: B.1.7.1 COMMENTvalue: B.1.7.2 TEXT FOR RELEVANT MEDICAL HISTORY

A_Relevant_drug_history

class_cd* <= OBSmood_cd* <= EVENTcd: = B.1.8 NAME OF DRUGactivity_time: B.1.7.1 START DATE, END DATE, CONTINUING B.1.8 START DATE, END DATE

A_Parent_reaction

class_cd* <= ACTmood_cd* <= ?value: B.1.10.8 REACTION A_Parent_indication

class_cd* <= OBSmood_cd* <= ?value: B.1.10.8 INDICATION

A_Parent_medical_history

class_cd* <= OBSmood_cd* <= EVENTcd: B.1.10.7.1 DISEASE/PROCEDURE/ETCactivity_time: B.1.10.7.1 START DATE, END DATE, CONTINUING txt: B.1.10.7.1 COMMENT value: B.1.10.7.2 TEXT FOR RELEVANT MEDICAL HISTORY

A_Parent_drug_history

class_cd* <= OBSmood_cd* <= EVENTcd: B.1.10.8 NAME OF DRUGactivity_time: B.1.10.8 START DATE, END DATE value:

0..*

type_cd* <= ?

AR_Reaction

0..*

type_cd* <= ?

AR_Indication

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

1..1

0..1

R_Parent_patient

class_cd* <= ROL

0..*

0..*

0..1

type_cd* <= ?

AR_Relevant_result

0..* 0..*

type_cd* <= ?

AR_Gestation

A_Gestation_period

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.10 GESTATION PERIOD AT TIME OF EXPOSURE

0..1

type_cd* <= ?

AR_Initial_dose

0..1

type_cd* <= ?

AR_Last_dose

A_Beginning_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.13.1 TIME INTERVAL BETWEEN BEGINNING OF DRUG ADMIN AND REACTION

A_Ending_interval

class_cd* <= OBSmood_cd* <= EVENTvalue:B.4.k.13.2 TIME INTERVAL BETWEEN END OF DRUG ADMIN AND REACTION

0..* 0..*

type_cd* <= ?

AR_Action_taken A_Action_taken

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.16 ACTION TAKEN WITH DRUG

1..1

type_cd* <= SPRT

AR_Rechallenge_reactionA_Rechallenge

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.17.1 REACTION Y/N

0..*

type_cd* <= EXPL

AR_Reaction

A_Rechallenge_reaction

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.17.2 REACTION OR EVENT

A_Reaction_Assessment

class_cd* <= OBSmood_cd* <= EVENTmethod_cd: B.4.k.18.3 METHOD OF ASSESSMENTvalue: B.4.K.18.4 RESULT 0..* 0..*

type_cd* <= ?sequence_nbr:

AR_Associated_reaction

0..*

0..*type_cd* <= ?

AR_Assoicated_administration

0..*

P_Assessor

0..*

type_cd* <= ?

1..1

0..1R_Assessor

class_cd* <= ROL

0..*

0..*

cd: B.4.k.18.2 SOURCE OF ASSESSMENT

A_Case_narrative

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.1 CASE NARRATIVE

1..1

type_cd* <= ?

AR_Associated_narrative

A_Reporter_comment

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.2 REPORTER’S COMMENTS

1..1

type_cd* <= ?

AR_Reporter_comment

A_Sender_comment

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.4 SENDER COMMENT

1..1

type_cd* <= ?

AR_Sender_comment

A_Sender_diagnosis

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.3 SENDER DIAGNOSIS

1..1

type_cd* <= ?

AR_Sender_diagnosis

1..*

type_cd* <= ?

AR_Case


PEOPLE

CDC NEDSS

Two Forms of MappingTwo Forms of Mapping

0..*

P_Sender

0..*

type_cd* <= AUT

1..1


class_cd* <= ROL

0..*

0..*


E_Report_sender




0..*

P_Receiver

0..*

type_cd* <= ?

1..1


class_cd* <= ROL

0..*

0..*


E_Report_receiver




0..*

P_Sender

0..*

type_cd* <= AUT

1..1


class_cd* <= ROL

0..*

0..*


E_Report_sender




0..*

P_Receiver

0..*

type_cd* <= ?

1..1


class_cd* <= ROL

0..*

0..*


E_Report_receiver





PEOPLE

CDC NEDSS

Report Patient & Other PartiesReport Patient & Other Parties

1..*

P_Primary_sourcetype_cd* <= ?1..1

0..1 R_Reporter

class_cd* <= ROL

0..*

0..*

cd: A.2.1.4 QUALIFICATION CODEaddr: A.1.2.1.2 REPORTER ADDRESS A.1.2.1.3 REPORTER COUNTRY

E_Reporter

class_cd* <= PSNdeterminer_cd* <= INSTANCEnm: A.2.1.1 REPORTER IDENTIFIER

0..*

P_Sender

0..*

type_cd* <= AUT

1..1

0..1

R_Report_Sender

class_cd* <= ROL

0..*

0..*


E_Sender_Organization




0..*

P_Receiver

0..*

type_cd* <= ?

1..1

0..1

R_Report_Receiver

class_cd* <= ROL

0..*

0..*


E_Report_receiver


1..1

P_Patienttype_cd* <= ?

1..1

0..1

R_Patient

class_cd* <= ROL

0..*

0..*

id: B.1.1.1 MEDICAL RECORD NUM

E_Patient

class_cd* <= PSNdeterminer_cd* <= INSTANCE

0..*


0..*

type_cd* <= ?

A_Patient_characteristic

class_cd* <= OBSmood_cd* <= EVENTactivity_time: B .1.9.1 DATE OF DEATHvalue: B.1.2.1 DATE OF BIRTH B.1.2.2 AGE AT TIME OF ONSET B.1.2.2.1 GESTATION PERIOD OF FETUS B.1.2.3 AGE GROUP CODE B.1.3. WEIGHT B.1.4 HEIGHT B.1.5 SEX B.1.6 LAST MENSTRUAL PERIOD DATE B.1.9.2 REPORTED CAUSE OF DEATH B.1.9.3 PRESENCE OF AUTOPSY B.1.9.4 AUTOPSY DETERMINED CAUSE OF DEATH

A_Indication

class_cd* <= OBSmood_cd* <= ?value: B.1.8 INDICATION

A_Reaction

class_cd* <= ACTmood_cd* <= ?value: B.1.8 REACTION

1..1

0..1

R_Child

class_cd* <= ROL

0..*

0..*

E_Parent

class_cd* <= PSNdeterminer_cd* <= INSTANCEnm: B.1.10.1 PARENT IDENTIFICATION

0..*


0..*

type_cd* <= ?

A_Parent_characteristic

class_cd* <= OBSmood_cd* <= EVENTvalue: B.1.10.2.1 DATE OF BIRTH B.1.10.2.2 AGE AT TIME OF ONSET B.1.10.3 LAST MENSTRUAL PERIOD DATE B.1.10.4 WEIGHT B.1.10.5 HEIGHT B.1.10.6 SEX

0..*

type_cd* <= ?

AR_Indication

0..*

type_cd* <= ?

AR_Reaction

1..1

P_Report_sourcetype_cd* <= ?1..1

0..1R_Source_country

class_cd* <= ROL

0..*

0..*

cd:id: A.1.1 PRIMARY COUNTRY ID

A_Relevant_medical_history

class_cd* <= OBSmood_cd* <= EVENTcd: B.1.7.1 DISEASE/PROCEDURE/ETCactivity_time: B.1.7.1 START DATE, END DATE, CONTINUINGtxt: B.1.7.1 COMMENTvalue: B.1.7.2 TEXT FOR RELEVANT MEDICAL HISTORY

A_Relevant_drug_history

class_cd* <= OBSmood_cd* <= EVENTcd: = FDA064 Relevant Drug Historyactivity_time: B.1.7.1 START DATE, END DATE, CONTINUING B.1.8 START DATE, END DATEtxt: B.1.8 NAME OF DRUG

A_Parent_reaction

class_cd* <= ACTmood_cd* <= ?value: B.1.10.8 REACTION

A_Parent_indication

class_cd* <= OBSmood_cd* <= ?value: B.1.10.8 INDICATION

A_Parent_medical_history

class_cd* <= OBSmood_cd* <= EVENTcd: B.1.10.7.1 DISEASE/PROCEDURE/ETCactivity_time: B.1.10.7.1 START DATE, END DATE, CONTINUING txt: B.1.10.7.1 COMMENT value: B.1.10.7.2 TEXT FOR RELEVANT MEDICAL HISTORY

A_Parent_drug_history

class_cd* <= OBSmood_cd* <= EVENTcd: FDA065 Parent Drug Historyactivity_time: B.1.10.8 START DATE, END DATEtxt: B.1.10.8 NAME OF DRUG

0..*

type_cd* <= ?

AR_Reaction

0..*

type_cd* <= ?

AR_Indication

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

0..*


0..*

type_cd* <= ?

1..1 0..1

R_Parent_patient

class_cd* <= ROL

0..*

0..*



E_Reporter_Department

class_cd* = ORGdeterminer_cd* <= INSTANCEnm: A.2.1.2 REPORTER ADDRESS

E_Reporter_Organization

class_cd* = ORGdeterminer_cd* <= INSTANCEnm: A.2.1.2 REPORTER ADDRESS

1..1

0..1

R_Reporter_Department

class_cd* <= ROL

0..*

0..*

E_Sender_Department

class_cd* = ORGdeterminer_cd* <= INSTANCEnm: A.3.1.3 PERSON RESPONSIBLE

1..1

0..1R_Sender_Department

class_cd* <= ROL

0..*

0..*

E_Receiver_Department

class_cd* = ORGdeterminer_cd* <= INSTANCEnm: A.3.2.2 IDENTIFIER

1..1

0..1 R_Receiver_Department

class_cd* <= ROL

0..*

0..*

E_Receiver_Organization

class_cd* = ORGdeterminer_cd* <= INSTANCEnm: A.3.2.2 IDENTIFIER

A_Continuing

class_cd* <= ACTmood_cd* <= ?value: B.1.7.1 CONTINUING

0..*

type_cd* <= ?

AR_CONTINUATION


PEOPLE

CDC NEDSS

Case Safety Report DetailsCase Safety Report Details

A_Result_of_tests_procedures

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.2 RESULT OF TESTS

0..1

type_cd* <= ?

AR_Test_result

1..1

type_cd* <= SPRT

AR_Addl_doc

A_Most_recent

class_cd* <= OBSmood_cd* <= EVENTactivity_time: A.1.7 DATE OF MOST RECENT RECEIPT1..1

type_cd* <= PREV

AR_Recent_report

1..1

type_cd* <= PERT

AR_Seriousness

A_Relevant_result

class_cd* <= OBSmood_cd* <= EVENTcd: B.3.1b TESTactivity_time: B.3.1a DATEvalue: B.3.1c RESULT B.3.1d UNIT OF MEASURE

1..*

type_cd* <= ?

AR_Normal_range*

A_Observation_normal_range

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.1e NORMAL LOW RANGE B.3.1f NORMAL HIGH RANGEinterpretation_cd

1..1

type_cd* <= ?

AR_Additional_result

A_Additional_result

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.1g MORE INFORMATION Y/N

1..1

type_cd* <= ?

AR_Local_criteriaA_Local_seriousness_criteria

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.9 CASE FULLFILLS CRITERIA

1..1

type_cd* <= PERT

AR_Additional_case_idsA_Case_id

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.11 OTHER CASE ID

A_Report_nullification

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.13 REPORT NULLIFICATIONtxt: A.1.13.1 REASON FOR NULLIFICATION

A_Medical_Confirmation

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.14 CASE MEDICALLY CONFIRMED

1..1

type_cd* <= ?

AR_Nullification

1..1

type_cd* <= ?

AR_Confirmation

A_Linked_case

class_cd* <= OBSmood_cd* <= EVENTid: A.1.11.2 CASE ID

0..*

type_cd* <= ?

AR_Linked_case

0..*

type_cd* <= ?

AR_Reference

A_Literature_reference

class_cd* <= OBSmood_cd* <= EVENTtxt: A.2.2 LITERATURE REFERENCE

0..1

type_cd* <= ?

AR_StudyA_Study

class_cd* <= OBSmood_cd* <= EVENTid: A.2.3.2 SPONSOR STUDY NUMBERcd: A.2.3.3 STUDY TYPEtxt: A.2.3.1 STUDY NAME



A_Serious_indication

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.5.1 SERIOUS 0..*

type_cd* <= EXPL

AR_Criteria

A_Criteria

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.5.2 SERIOUSNESS CRITERIA

1..1

type_cd* <= PERT

AR_Source_reportA_First_notification

class_cd* <= OBSmood_cd* <= EVENTactivity_time: A.1.6 DATE OF FIRST REPORT

A_Additional_document

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.8.1 ADDITIONAL DOC 0..*

type_cd* <= EXPL

AR_Documents

A_Document_list

class_cd* <= OBSmood_cd* <= EVENTvalue: A.1.8.2 DOCUMENT HELD

0..1

type_cd* <= ?

AR_Relevant_result

A_Case_narrative

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.1 CASE NARRATIVE 1..1

type_cd* <= ?

AR_Associated_narrative

A_Reporter_comment

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.2 REPORTER’S COMMENTS 1..1

type_cd* <= ?

AR_Reporter_comment

A_Sender_comment

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.4 SENDER COMMENT

1..1

type_cd* <= ?

AR_Sender_comment

A_Sender_diagnosis

class_cd* <= OBSmood_cd* <= EVENTvalue: B.5.3 SENDER DIAGNOSIS

1..1

type_cd* <= ?

AR_Sender_diagnosis

A_Test_Measurements

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.3.2 RESULT OF TESTS

1..1

type_cd* <= ?

AR_Measurements


PEOPLE

CDC NEDSS

Drug ReactionDrug Reaction

A_Reaction_or_event


1..1

type_cd* <= ?

AR_Lowest_level

1..1

type_cd* <= ?

AR_Preferred

0..1

type_cd* <= ?

AR_Initial_dose

0..1

type_cd* <= ?

AR_Last_dose

A_Lowest_level_term

class_cd* <= OBSmood_cd* <= EVENTcd: B.2.i.1 MEDRA LOWEST LEVEL

A_Preferred_term

class_cd* <= OBSmood_cd* <= EVENTcd: B.2.i2 MEDRA PREFERRED

A_First_dose_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.7.1 BEGINNING TIME INTERVAL

A_Last_dose_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.7.2 LAST DOSE TIME INTERVAL

1..1

type_cd* <= ?

AR_OutcomeA_Outcome

class_cd* <= OBSmood_cd* <= EVENTvalue: B.2.i.8 OUTCOME OF REACTION

1..1

P_Event_loctype_cd* <= ?

1..1

0..1R_Event_country

class_cd* <= ROL

0..*

0..*

cd:id: A.1.2 COUNTRY OF EVENT ID

1..*

type_cd* <= ?

AR_Case




PEOPLE

CDC NEDSS

Associated AdministrationAssociated Administration

0..* 0..*

type_cd* <= ?

AR_Indication

A_Direct_Administration

class_cd* <= SBADMmood_cd* <= EVENTactivity_time: B.4.k.3 NUMBER OF DOSAGES B.4.k.4 NUMBER OF UNITS IN INTERVAL B.4.k.5 DEFINITION OF INTERVAL UNIT B.4.k.12 DATE OF START OF DRUG B.4.k.14 DATE OF LAST ADMINISTRATION B.4.k.15 DURATION OF ADMINISTRATIONid: B.4.K.4.1 AUTHORIZATION NUMBERdose_qty: B.4.k.5.1 DOSE NUMBER B.4.k.5.2 DOSE UNITtxt: B.4.k.19 ADDITIONAL INFORMATION ON DRUG

0..* 0..*

type_cd* <= ?

AR_Characterization

A_Drug_role

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.1 DRUG CHARACTERIZATION CODE

1..1

P_Administer_producttype_cd* <= CSM

1..1

0..1R_Content

class_cd* <= ROL

0..*

0..*

E_Therapeutic_product

class_cd* <= MMATdeterminer_cd* <= INSTANCEcd: B.4.k.2.1 MEDICINAL PRODUCT NAMElot_num: B.4.k.3 BATCH OR LOT NUMBERform:cd: B.4.k.7 PHARMACEUTICAL FORM

1..1

0..1R_Ingredient

class_cd* <= ROL

0..*

0..*

E_Therapeutic_product_ingredient

class_cd* <= MMATdeterminer_cd* <= INSTANCEcd: b.4.K.2.2 ACTIVE SUBSTANCE NAME

1..1

0..1 R_Sourced

class_cd* <= ROL

0..*

0..*

E_Country

class_cd* <= PLCdeterminer_cd* <= INSTANCEnm: B.4.k.2.3 ID OF COUNTRY

1..1

0..1

R_Authorization_holder

class_cd* <= ROL

0..*

0..*

E_Holder

class_cd* <= ORGdeterminer_cd* <= INSTANCEnm: B.4.k.4.3 NAME OF HOLDER

E_Country_of_authorization

class_cd* <= PLCdeterminer_cd* <= INSTANCEnm: B.4.k.4.2 COUNTRY OF AUTHORIZATION

1..1

P_Authorizationtype_cd* <= ?

0..* 0..*

type_cd* <= ?

AR_Cummulative

A_Cummulative_dose

class_cd* <= SBADMmood_cd* <= EVENTdose_qty: B.4.k.5.6 CUMM DOSE TO FIRST REACTION B.4.k.5.7 CUMM DOSE UNIT

A_Indication

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.11 INDICATION FOR USE

A_Direct_route

class_cd* <= SBADMmood_cd* <= EVENTroute_cd: B.4.k.8 ROUTE OF ADMINISTRATION

A_Proximate_route

class_cd* <= SBADMmood_cd* <= EVENTroute_cd: B.4.k.9 PARENT ROUTE OF ADMINISTRATION

0..*0..*

type_cd* <= ?

AR_Routing_Option

A_Proximate_administration

class_cd* <= SBADMmood_cd* <= EVENT

0..*0..*

type_cd* <= ?

AR_Routing_Option0..*0..*

type_cd* <= ?

AR_Parental_Contact

0..* 0..*

type_cd* <= ?

AR_Gestation

A_Gestation_period

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.10 GESTATION PERIOD AT TIME OF EXPOSURE

0..1

type_cd* <= ?

AR_Initial_dose

0..1

type_cd* <= ?

AR_Last_dose

A_Beginning_interval

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.13.1 TIME INTERVAL BETWEEN BEGINNING OF DRUG ADMIN AND REACTION

A_Ending_interval

class_cd* <= OBSmood_cd* <= EVENTvalue:B.4.k.13.2 TIME INTERVAL BETWEEN END OF DRUG ADMIN AND REACTION

0..* 0..*

type_cd* <= ?

AR_Action_taken

A_Action_taken

class_cd* <= OBSmood_cd* <= EVENTcd:value: B.4.k.16 ACTION TAKEN WITH DRUG

1..1

type_cd* <= SPRT

AR_Rechallenge_reactionA_Rechallenge

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.17.1 REACTION Y/N

0..*

type_cd* <= EXPL

AR_Reaction

A_Rechallenge_reaction

class_cd* <= OBSmood_cd* <= EVENTvalue: B.4.k.17.2 REACTION OR EVENT

A_Reaction_Assessment

class_cd* <= OBSmood_cd* <= EVENTmethod_cd: B.4.k.18.3 METHOD OF ASSESSMENTvalue: B.4.K.18.4 RESULT

0..*

0..*

type_cd* <= ?sequence_nbr:

AR_Associated_reaction

0..*

0..*type_cd* <= ?

AR_Associated_administration

0..*

P_Assessor

0..*

type_cd* <= ?1..10..1

R_Assessor

class_cd* <= ROL

0..*

0..*

cd: B.4.k.18.2 SOURCE OF ASSESSMENT

A_Reaction_or_event


E_Assesor

class_cd* <= ORGdeterminer_cd* <= INSTANCEnm: B.4.k.18.2 SOURCE CODE


PEOPLE

CDC NEDSS

Proposed Notification Proposed Notification EnhancementsEnhancements Entity identification

Name and multiple identifiers for persons, organizations, and locations. Addresses and phone numbers also. [Supports: drug reaction responses, vaccinations. BT Response contacts.]

Material Information about products – materials – that are used in patient treatment, and in clinical trials. [Supports drug reporting, clinical trials.]

Entity associationRelevant time span associations between parties. [Supports BT Response contacts].

SpecimenSpecimen source, accession number, specimen details. [Supports BT Response and disease surveillance.]

Entity identificationName and multiple identifiers for persons, organizations, and locations. Addresses and phone numbers also. [Supports: drug reaction responses, vaccinations. BT Response contacts.]

Material Information about products – materials – that are used in patient treatment, and in clinical trials. [Supports drug reporting, clinical trials.]

Entity associationRelevant time span associations between parties. [Supports BT Response contacts].

SpecimenSpecimen source, accession number, specimen details. [Supports BT Response and disease surveillance.]


PEOPLE

CDC NEDSS

More Notification EnhancementsMore Notification Enhancements Location context for environmental specimens.

Detailed information describing the place where specimens were collected. Includes detailed location information, and managing the association between locations. [Supports BT Response investigations]

Observation informationDescriptive text related to an observation. [Supports Drug incident reporting]

Intervention informationInterventions, e.g., vaccinations, related to a case. [Supports BT Response, enhanced surveillance, drug incident reporting]

Materials informationAdd materials, in particular drugs and vaccines, to the list of entity types that can be related to a case, and to the acts associated with a case. [Supports vaccine preventable disease surveillance, drug reaction reporting.]

Location context for environmental specimens.Detailed information describing the place where specimens were collected. Includes detailed location information, and managing the association between locations. [Supports BT Response investigations]

Observation informationDescriptive text related to an observation. [Supports Drug incident reporting]

Intervention informationInterventions, e.g., vaccinations, related to a case. [Supports BT Response, enhanced surveillance, drug incident reporting]

Materials informationAdd materials, in particular drugs and vaccines, to the list of entity types that can be related to a case, and to the acts associated with a case. [Supports vaccine preventable disease surveillance, drug reaction reporting.]


PEOPLE

CDC NEDSS

Notification V2 - TodayNotification V2 - TodayPertinentInformationtype_cd*<= PERT0..*

subjectAct

0..* pertinentAct

sequence_nbr: INT [0..1]

0..* pertinentActEventPertinentInformationAtype_cd*<= PERT

0..* pertinentProcedureEvent

PertinentInformationBtype_cd*<= PERT

0..* pertinentEncounterEventPertinentInformationCtype_cd*<= PERT

0..* actComponenttype_cd*<= COMP

0..* act

0..* specimenSpecimentype_cd*<= SPC

0..* act

0..* participantPerformertype_cd*<= PRF

0..* participant

PerformerAtype_cd*<= PRF+PAT+LOCfunction_cd: CV [0..1]time: IVL<TS>

1..* participantPatienttype_cd*<= PAT+LOC+PRF

0..* srcActName

0..* participant

Participanttype_cd*<= ?

0..1player 0..1scoper

Roleclass_cd <= ROL

0..* scopedRole

0..* playedRolecd: CV [0..1]

0..1player

RoleAclass_cd <= ROL

0..* playedRoleB

0..1player

0..1scopingMaterial

RoleBclass_cd <= ROL

0..* scopedRole

0..* playedRoleA

0..1specimenMaterial

0..1source

SpecimenRoleclass_cd <= SPEC

0..* specimen

0..* specimenSource

0..1playingPlace

RoleCclass_cd <= ROL

0..* playedRoleid: II [0..1]cd: CV [1..1]

Place

class_cd* <= PLCdeterminer_cd* <= INSTANCEid: II [0..*]cd: CV [1..1]nm: EN [0..1]addr: AD [0..1]

Person

class_cd* <= PSNdeterminer_cd* <= INSTANCEid: II [0..*]nm: EN [0..1]birth_time: TS [0..1]deceased_ind: BL [0..1]deceased_time: TS [0..1]marital_status_cd: CV [0..1]education_level_cd: CV [0..1]race_cd: SET<CV> [0..*]ethnic_group_cd: SET<CV> [0..*]administrative_sex_cd: CV [0..1]

Material

class_cd* <= MATdeterminer_cd* <= INSTANCEid: II [0..1]cd*: CV [1..1]existence_time: IVL<TS> [0..1]form_cd: CV [0..1]lot_num: ST [0..1]expiration_time: TS [0..1]

Organization

class_cd* <= ORGdeterminer_cd* <= INSTANCEid: II [0..*]cd: CV [0..1]nm: EN [0..1]addr: AD [0..1]

NonPersonLivingSubject

class_cd* <= NLIVdeterminer_cd* <= INSTANCEid: II [0..*]cd: CV [1..1]

PlaceA

class_cd* <= PLCdeterminer_cd* <= INSTANCEcd: CV [0..1]nm: EN [0..1]

EntityChoice

ActChoiceObservationEventclass_cd* <= OBSmood_cd* <= EVNcd: CV [1..1]txt: ST [0..1]effective_time: IVL<TS> [0..1]activity_time: IVL<TS> [0..1]value: ANY [1..1]interpretation_cd: CV [0..1]method_cd: CV [0..1]

ActEventclass_cd* <= ACTmood_cd* <= EVNid: II [0..1]cd: CV [1..1]activity_time: IVL<TS> [0..1]

PublicHealthCaseEventclass_cd* <= CASEmood_cd* <= EVNid: II [1..*]cd: CV [1..1]txt: ST [0..1]status_cd: CS [0..1]effective_time: IVL<TS> [1..1]activity_time: IVL<TS> [1..1]detection_method_cd: CV [0..1]transmission_mode_cd: CV [0..1]disease_imported_cd: CV [0..1]

ProcedureEventclass_cd* <= PROCmood_cd* <= EVNactivity_time: IVL<TS> [0..1]

EncounterEventclass_cd* <= ENCmood_cd* <= EVNactivity_time: IVL<TS> [1..1]

ProcedureEventAclass_cd* <= PROCmood_cd* <= EVNcd: CV [1..1]activity_time: GTS [0..1]target_site_cd: CV [0..1]

SubstanceAdministrationEventclass_cd* <= SBADMmood_cd* <= EVNcd: CV [1..1]txt: ST [0..1]activity_time: GTS [0..1]route_cd: CV [0..1]dose_qty: PQ [0..1]

Case Report(UUDD_RMnnnnnn)

This message is used for thereporting of notifiable diseaseson the part of public health agenciesand BT response teams. It can alsobe used to support FDA drug incidentreporting (E2BM compliant)


PEOPLE

CDC NEDSS

Later: HL7 Specification ProcessLater: HL7 Specification Process

Start discussions in HL7.Pick the time to move forward with a

proposal.Work out whether a new message

format is needed – I think it will be.Address Committee Issues.Frame a concrete proposal.

Start discussions in HL7.Pick the time to move forward with a

proposal.Work out whether a new message

format is needed – I think it will be.Address Committee Issues.Frame a concrete proposal.


PEOPLE

CDC NEDSS

Next Steps for UsNext Steps for Us

Verify the detailed mappingThis has been done

Move forward with a standard messageCreate an enhanced Notification MessagePrepare a proposal for HL7 discussionCarry out education within HL7

Start process within FDA to lay out the steps leading towards message implementation.

Verify the detailed mappingThis has been done

Move forward with a standard messageCreate an enhanced Notification MessagePrepare a proposal for HL7 discussionCarry out education within HL7

Start process within FDA to lay out the steps leading towards message implementation.


PEOPLE

CDC NEDSS

Any More Questions?Any More Questions?

Mead Walkerhealthcare informatics

consultant

Voice: 610-518-6259Fax: 509-357-7983Email: [email protected]

Mead Walkerhealthcare informatics

consultant

Voice: 610-518-6259Fax: 509-357-7983Email: [email protected]