August 27, 2008

Version 3.1

HITSP Electronic Health Records Laboratory Results Reporting Interoperability Specification

HITSP/IS01   Click here to download the PDF version of this document

Healthcare Information Technology Standards Panel (HITSP) logo

Submitted to:

Healthcare Information Technology Standards Panel

Submitted to:

Provider Perspective Technical Committee
(Formerly Care Delivery Technical Committee)

Document Change History

Version Number

Description of Change

Name of Author

Date Published

1.0

Final Draft

Electronic Health Record Technical Committee

August 18, 2006

1.1

Ready for Public Comment

Electronic Health Record Technical Committee

September 12, 2006

1.2

Ready for Implementation Testing

Electronic Health Record Technical Committee

October 20, 2006

1.3

Review Copy

Care Delivery Technical Committee

April 27, 2007

2.0

Released for Implementation

Care Delivery Technical Committee

May 11, 2007

2.0.1

Review Copy

Care Delivery Technical Committee

December 5, 2007

2.1

Released for Implementation

Care Delivery Technical Committee

December 13, 2007

2.1.1

Review Copy

Provider Perspective Technical Committee

May 8, 2008

3.0

Released for Implementation

Provider Perspective Technical Committee

May 16, 2008

3.0.1

Review Copy

Provider Perspective Technical Committee

August 20, 2008

3.1

Released for Implementation

Provider Perspective Technical Committee

August 27, 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. 8

1.4 Reference Documents. 9

2.0 Interoperability Requirements. 11

2.1 Use Case Synopsis. 11

2.2 Use Case Requirements. 11

2.2.1 Mapping of Use Case Requirements to Interoperability Requirements. 12

2.2.2 Data and Information Requirements Matrix. 20

2.2.3 Identification of Business Actors, and Scenarios. 20

2.2.4 High-Level UML Business Sequence Diagram.. 20

3.0 Design. 31

3.1 Scope of Design. 31

3.1.1 Assumptions. 32

3.1.2 Constraints. 32

3.1.3 Pre-conditions. 32

3.1.4 Post-conditions. 33

3.1.5 Process Triggers. 33

3.2 Detailed Design. 33

3.2.1 Technical Actor Role Descriptions. 33

3.2.2 Sequence Diagram for Process Flow. 35

3.2.3 Mapping of Business Actors to Technical Actors and Constructs with Optionality. 37

3.2.4 Construct Dependencies. 42

3.2.5 Additional Constraints on Required Constructs. 43

4.0 Standards Selection. 44

4.1 Standards. 45

4.1.1 Regulatory Guidance. 45

4.1.2 Selected Standards. 45

4.1.3 Informative Reference Standards. 47

4.2 Gaps Where There Are No Standards. 50

4.3 Standard Overlaps. 51

5.0 Technical Implementation. 53

5.1 Conformance. 53

5.1.1 Conformance Criteria. 53

5.1.2 Conformance Scoping, Subsetting and Options. 53

5.1.3 Test Methods. 53

6.0 Appendix. 54

6.1 Description of Standards. 54

7.0 Change History. 59

7.1 May 11, 2007. 59

7.2 December 5, 2007. 59

7.3 December 13, 2007. 59

7.4 May 8, 2008. 59

7.5 May 16, 2008. 60

7.6 August 20, 2008. 60

7.7 August 27, 2008. 60

Figures and Tables

Figure 1-1 Interoperability Specification Document Map. 7

Figure 2-1 Business Sequence Diagram Scenario 1: Ordering Clinicians Receive Results Integrated into the EHR Part 1. 21

Figure 2-2 Business Sequence Diagram Scenario 1: Ordering Clinicians Receive Results Integrated into the EHR Part 2. 22

Figure 2-3 Business Sequence Diagram Scenario 1: Ordering Clinicians Receive Results Integrated into the EHR Part 3. 23

Figure 2-4 Business Sequence Diagram Scenario 1: Ordering Clinicians Receive Results Integrated into the EHR Part 4. 24

Figure 2-5 Business Sequence Diagram Scenario 1: Ordering Clinicians Receive Results Integrated into the EHR Part 5. 25

Figure 2-6 Business Sequence Diagram Scenario 2: Clinician Queries for Historical Test Results Part 1. 26

Figure 2-7 Business Sequence Diagram Scenario 2: Clinician Queries for Historical Test Results Part 2. 27

Figure 2-8 Business Sequence Diagram Scenario 2: Clinician Queries for Historical Test Results Part 3. 28

Figure 2-9 Business Sequence Diagram Scenario 2: Clinician Queries for Historical Test Results Part 4. 29

Figure 2-10 Business Sequence Diagram Scenario 2: Clinician Queries for Historical Test Results Part 5 30

Figure 3-1 Detailed Sequence Diagram: Share and View Document Reports. 36

Figure 3-2 Detailed Sequence Diagram: Share Document Reports with Ordering Clinician and Other Providers of Care 36

Figure 3-3 Detailed Sequence Diagram: Send Result Message to Ordering Clinician. 37

Table 1-1 List of Constructs. 7

Table 1-2 Reference Documents. 9

Table 2-1 Mapping of Use Case Requirements to Interoperability Requirements. 13

Table 2-2 Data Element and Information Requirements. 20

Table 2-3 Business Actors. 20

Table 3-1 Assumptions. 32

Table 3-2 Constraints. 32

Table 3-3 Pre-conditions. 32

Table 3-4 Post-conditions. 33

Table 3-5 Process Triggers. 33

Table 3-6 Technical Actor Role Descriptions. 34

Table 3-7 Business-Technical Actor Mapping to Transaction and/or Content; Showing Optionality. 38

Table 3-8 Construct Dependencies. 43

Table 3-9 Additional Constraints on Required Constructs. 43

Table 4-1 Regulatory Guidance. 45

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

Table 4-3 Informative Reference Standards. 47

Table 4-4 Use Case Events and Associated Gaps. 51

Table 4-5 Resolution Plan. 51

Table 4-6 Standard Overlaps. 52

Table 6-1 Description of Standards. 54