December 18, 2008

Version 1.0

HITSP Immunizations and Response Management Interoperability Specification

Submitted to:

Healthcare Information Technology Standards Panel

Submitted by:

Population Perspective Technical Committee
(Formerly Population Health Technical Committee)

Document Change History

Version Number	Description of Change	Name of Author	Date Published
	Template V2.4	Project Team	July 31, 2008
0.0.1	Review	Population Perspective Technical Committee	September 26, 2008
0.0.2	Review Copy	Population Perspective Technical Committee	December 10, 2008
1.0	Released for Implementation	Population Perspective Technical Committee	December 18, 2008

Table of Contents

1.0 Introduction. 6

1.1 Interoperability Specification Overview. 6

1.2 Interoperability Specification Document Map. 6

1.2.1 List of Constructs. 7

1.3 Copyright Permissions. 10

1.4 Reference Documents. 11

2.0 Requirements. 13

2.1 Use Case Synopsis. 13

2.2 Use Case Requirements. 13

2.2.1 Mapping of Use Case Actions to Information Exchange Requirements. 14

2.2.2 Data and Information Exchange Requirements. 14

2.2.3 Identification of Business Actors, Mapped to Requirements. 23

2.2.4 High-Level Diagrams. 28

3.0 Design. 30

3.1 Scope of Design. 30

3.1.1 Assumptions. 35

3.1.2 Constraints. 39

3.1.3 Pre-conditions. 40

3.1.4 Post-conditions. 41

3.1.5 Process Triggers. 41

3.2 Detailed Design. 42

3.2.1 Technical Actor Role Descriptions. 45

3.2.2 Construct Requirements. 45

3.2.3 Mapping of Business Actors to Technical Actors and Constructs with Optionality. 45

3.2.4 Construct Dependencies. 45

3.2.5 Additional Constraints on Required Constructs. 45

4.0 Standards Selection. 45

4.1 Standards. 45

4.1.1 Regulatory Guidance. 45

4.1.2 Selected Standards. 45

4.1.3 Informative Reference Standards. 45

4.2 Gaps Where There Are No Standards. 45

4.3 Standard Overlaps. 45

5.0 Conformance. 45

5.1 Conformance Criteria. 45

5.2 Conformance Scoping, Subsetting and Options. 45

5.3 Test Methods. 45

6.0 Appendix. 45

6.1 Description of Standards. 45

6.2 Vaccination and Patient Demographic Data Elements. 45

6.3 Use Case to Information Exchange and Data Requirements. 45

6.4 Use Case Sequence Diagrams. 45

6.5 Mapping of Constructs to Information Exchange and Data Requirements. 45

7.0 Document Updates. 45

7.1 December 10, 2008. 45

7.2 December 18, 2008. 45

Figures and Tables

Figure 1-1 Interoperability Specification Document Map. 7

Figure 2-1 Legend for Component Diagrams. 28

Figure 2-2 Immunizations and Response Management Component Data Flow Diagram.. 29

Figure 3-1 Communicate Vaccinations. 45

Figure 3-2 Immunization Query and Response. 45

Figure 3-3 Vaccine and Drug Inventory Reporting. 45

Figure 6-1 Immunizations and Response Management (IRM) Business Sequence Part 1 Clinician Perspective: Immunizations and Response Management Scenario 2: Vaccine and Drug Administration and Reporting 45

Figure 6-2 Immunizations and Response Management (IRM) Business Sequence Part 2 Registries Perspective: Immunizations and response management Scenario 2: Vaccine and Drug Administration and Reporting 45

Figure 6-3 Immunizations and Response Management (IRM) Business Sequence Part 3 Consumer Perspective: Immunizations and response management Scenario 2: Vaccine and Drug Administration and Reporting 45

Figure 6-4 Immunizations and Response Management (IRM) Business Sequence Part 4. 45

Table 1-1 List of Constructs. 8

Table 1-2 Reference Documents. 11

Table 2-1 Data Element and Information Requirements (DR) 15

Table 2-2 Information Exchange Requirements (IER) 22

Table 2-3 Business Actors. 24

Table 3-1 Scenario 1 Scope. 31

Table 3-2 Assumptions. 35

Table 3-3 Constraints. 39

Table 3-4 Pre-conditions. 40

Table 3-5 Post-conditions. 41

Table 3-6 Process Triggers. 41

Table 3-7 Technical Actor Role Descriptions. 45

Table 3-8 Business-Technical Actor Mapping to Transaction and/or Content 45

Table 3-9 Implementation Conditions/Constraints. 45

Table 3-10 Construct Dependencies. 45

Table 3-11 Additional Constraints on Required Constructs. 45

Table 4-1 Regulatory Guidance. 45

Table 4-2 Selected Standards Linked to HITSP Constructs. 45

Table 4-3 Informative Reference Standards. 45

Table 4-4 Use Case Requirements and Associated Standards Gaps. 45

Table 4-5 Use Case Requirements and Associated Standard Overlaps. 45

Table 6-1 Description of Standards. 45

Table 6-2 Data Elements Cross Reference. 45

Table 6-3 Patient Data Elements. 45

Table 6-4 Clinical Data Elements. 45

Table 6-5 Mapping of Use Case Actions to Information Exchange Requirements. 45

Table 6-6 Mapping of Requirements to HITSP Constructs. 45