Office of the National Coordinator for Health IT
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
U.S. Health and Human Services
Office of the National Coordinator for Health IT
S&I
Framework
Standards & Interoperability (S&I) Framework
Public Health Reporting Initiative
Public Health Reporting Specification – Clinical
Document Architecture (CDA)
Version for Public Comment
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Acknowledgements
Specific authors of this document who the initiative wishes to recognize as participants who contributed
their time and expertise to the development of this specification include:








Riki Merrick
Seth Foldy
Nikolay Lipskiy
Lise Stevens
Dina Dickerson
Wendy Blumenthal
Anna Orlova
Mike Coletta
Copyrights
This material includes SNOMED Clinical Terms ® (SNOMED CT®) which is used by permission of the
International Health Terminology Standards Development Organization (IHTSDO). All rights reserved.
SNOMED CT was originally created by The College of American Pathologists. "SNOMED ®" and "SNOMED
CT ®" are registered trademarks of the IHTSDO.
This material contains content from LOINC® (http://loinc.org). The LOINC table, LOINC codes, and LOINC
panels and forms file are copyright (c) 1995-2011, Regenstrief Institute, Inc. and the Logical Observation
Identifiers Names and Codes (LOINC) Committee and available at no cost under the license at
http://loinc.org/terms-of-use.
This material also includes or references content produced by:
 Health Level 7 (HL7): www.hl7.org
 Healthcare Information Technology Standards (HITSP): www.hitsp.org
 Integrating the Healthcare Enterprise (IHE): www.ihe.net
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Table of Contents
Table of Tables...................................................................................................................................... 10
Table of Figures .................................................................................................................................... 13
1.
Introduction ................................................................................................................................ 15
1.1.
Purpose and Approach........................................................................................................ 15
1.2.
Audience ............................................................................................................................. 16
1.2.1. Requisite Knowledge....................................................................................................... 16
1.3.
Scope ................................................................................................................................... 17
1.4.
Summary of Key Technical Decisions .................................................................................. 18
1.4.1. PHRI User Stories, Consolidated Use Case, Common Requirements and Standards ..... 18
1.4.2. Data Harmonization Profile - Core Common Requirements and Data Elements ........... 22
1.4.3. Existing Interoperability Standards and Addressing Standards Gaps ............................. 22
1.4.4. PHRI Interoperability Specification Organization ........................................................... 23
1.4.5. Use of Terms ................................................................................................................... 23
1.5.
HL7 CDA R2 Overview ......................................................................................................... 25
1.5.1. Use of Consolidated CDA ................................................................................................ 26
1.5.2. Conformance to this Specification .................................................................................. 27
1.5.3. Constraints in this Specification ...................................................................................... 29
1.5.4. Use of Value Sets in this Specification ............................................................................ 29
1.6.
Organization of the Specification for Developing New Interoperability Standards ........... 29
1.6.1. Conventions Used in this Specification ........................................................................... 29
2.
Public Health Reporting Specification – CDA Header ................................................................. 31
2.1.
Patient Information............................................................................................................. 32
2.1.1. Conformance of Patient Information.............................................................................. 33
2.1.2. Value Sets ........................................................................................................................ 34
2.1.3. Examples of Patient Information .................................................................................... 35
2.2.
Patient Contact Information ............................................................................................... 35
2.2.1. Conformance of Patient Contact Information ................................................................ 37
2.2.2. Value Sets ........................................................................................................................ 38
2.2.3. Examples of Patient Contact Information ....................................................................... 38
2.3.
Representing Report Data Elements ................................................................................... 39
2.3.1. Author within Public Health Report ................................................................................ 39
2.3.2. DataEnterer within Public Health Report ....................................................................... 40
2.3.3. LegalAuthenticator within Public Health Report ............................................................ 40
3.
Public Health Reporting Specification – CDA Document Level Templates ................................. 41
3.1.
Adverse Event Report ......................................................................................................... 42
3.1.1. High Level Conformance Requirements ......................................................................... 42
3.1.2. Template Structure for Adverse Event Report ............................................................... 43
3.2.
Communicable Disease Case Reporting (Public Health Case Report)................................. 44
3.2.1. High Level Conformance Requirements for Communicable Disease Case Reporting .... 45
3.2.2. Template Structure for Communicable Disease Case Reporting .................................... 45
3.2.3. Alignment of PHRI to PHCR 2009 .................................................................................... 46
3.2.4. Alignment of CDA to CSTE ............................................................................................... 47
4.
Public Health Reporting Specification – CDA Section Level Templates ...................................... 54
4.1.
Allergy/Adverse Event......................................................................................................... 54
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4.1.1. Conformance for Allergy/Adverse Event ........................................................................ 59
4.1.2. Value Sets ........................................................................................................................ 59
4.1.3. Examples of Allergy ......................................................................................................... 60
4.2.
Diagnosis (Health Problem) ................................................................................................ 61
4.2.1. Conformance to Diagnosis Section ................................................................................. 63
4.2.2. Value Sets ........................................................................................................................ 65
4.2.3. Example of Diagnosis ...................................................................................................... 65
4.3.
Employment Information.................................................................................................... 67
4.3.1. Conformance for Employment Information ................................................................... 68
4.3.2. Value Sets ........................................................................................................................ 69
4.3.3. Examples of Employment Information ........................................................................... 69
4.4.
Encounter ............................................................................................................................ 69
4.4.1. Conformance for Encounter ........................................................................................... 71
4.4.2. Value Sets ........................................................................................................................ 72
4.4.3. Examples of Encounters .................................................................................................. 73
4.5.
Exposure.............................................................................................................................. 77
4.5.1. Conformance for Exposure ............................................................................................. 78
4.5.2. Value Sets ........................................................................................................................ 78
4.5.3. Example of Exposure ....................................................................................................... 79
4.6.
Facility ................................................................................................................................. 79
4.6.1. Conformance of Facility .................................................................................................. 80
4.6.2. Value Sets ........................................................................................................................ 80
4.6.3. Examples of Facility ......................................................................................................... 80
4.7.
Family History ..................................................................................................................... 80
4.7.1. Conformance of Family History ...................................................................................... 83
4.7.2. Value Sets ........................................................................................................................ 83
4.7.3. Examples of Family History Section ................................................................................ 84
4.8.
Immunization ...................................................................................................................... 87
4.8.1. Conformance for Immunization ...................................................................................... 89
4.8.2. Value Sets ........................................................................................................................ 90
4.8.3. Example for Immunization .............................................................................................. 90
4.9.
Laboratory Report Item (IHE) .............................................................................................. 92
4.9.1. Conformance for Laboratory Report Item ...................................................................... 92
4.9.2. Example of Laboratory Report Item................................................................................ 93
4.10. Laboratory Specialty (IHE) ................................................................................................... 94
4.10.1.
Conformance for Laboratory Specialty ....................................................................... 94
4.10.2.
Example of Laboratory Specialty................................................................................. 95
4.11. Medical Equipment (Device) ............................................................................................... 96
4.11.1.
Conformance for Medical Equipment ......................................................................... 98
4.11.2.
Value Sets .................................................................................................................... 98
4.11.3.
Example for Medical Equipment ................................................................................. 98
4.12. Medication .......................................................................................................................... 98
4.12.1.
Conformance for Medication .................................................................................... 100
4.12.2.
Value Sets .................................................................................................................. 101
4.12.3.
Example of Medication ............................................................................................. 101
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4.13. Order/Diagnostic Test ....................................................................................................... 103
4.13.1.
Conformance for Order/Diagnostic Test................................................................... 104
4.13.2.
Value Sets .................................................................................................................. 105
4.13.3.
Examples of Order/Diagnostic Test........................................................................... 105
4.14. Payer Information ............................................................................................................. 105
4.14.1.
Conformance of Payer Information Section ............................................................. 105
4.14.2.
Value Sets .................................................................................................................. 106
4.14.3.
Examples of Payer Information ................................................................................. 106
4.15. PHCR Clinical Information ................................................................................................. 106
4.15.1.
Conformance of PHCR Clinical Information .............................................................. 107
4.15.2.
Value Sets .................................................................................................................. 107
4.15.3.
Examples of PHCR Clinical Information..................................................................... 108
4.16. PHCR Treatment Information ........................................................................................... 108
4.16.1.
Conformance of PHCR Treatment Information ........................................................ 109
4.16.2.
Value Sets .................................................................................................................. 109
4.16.3.
Examples of PHCR Treatment Information ............................................................... 110
4.17. Physical Exam .................................................................................................................... 111
4.17.1.
Conformance of Physical Exam Section .................................................................... 112
4.17.2.
Value Sets .................................................................................................................. 112
4.17.3.
Examples of Physical Exam........................................................................................ 112
4.18. Procedure .......................................................................................................................... 113
4.18.1.
Conformance of Procedure Section .......................................................................... 115
4.18.2.
Value Sets .................................................................................................................. 115
4.18.3.
Examples of Procedures ............................................................................................ 116
4.19. Provider Information......................................................................................................... 119
4.19.1.
Conformance of Provider Information...................................................................... 120
4.19.2.
Value Sets .................................................................................................................. 121
4.19.3.
Examples of Provider Information ............................................................................ 121
4.20. Result ................................................................................................................................ 122
4.20.1.
Conformance of Results Section ............................................................................... 124
4.20.2.
Value Sets .................................................................................................................. 125
4.20.3.
Examples of Result Section ....................................................................................... 125
4.21. Social History ..................................................................................................................... 131
4.21.1.
Conformance for Social History ................................................................................ 132
4.21.2.
Value Sets .................................................................................................................. 133
4.21.3.
Examples of Social History Section ........................................................................... 134
4.22. Specimen ........................................................................................................................... 135
4.22.1.
Conformance for Specimen ...................................................................................... 136
4.22.2.
Value Sets .................................................................................................................. 137
4.22.3.
Examples of Specimen .............................................................................................. 137
4.23. Vital Sign Indicators........................................................................................................... 137
4.23.1.
Conformance for Vital Signs ...................................................................................... 139
4.23.2.
Value Sets .................................................................................................................. 139
4.23.3.
Examples of Vital Signs.............................................................................................. 139
5.
Public Health Reporting Specification – CDA Entry Level Templates ....................................... 141
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5.1.
Age Observation................................................................................................................ 141
5.1.1. Conformance for Age Observation ............................................................................... 141
5.1.2. Value Sets ...................................................................................................................... 142
5.1.3. Example of Age Observation ......................................................................................... 142
5.2.
Allergy – Intolerance Observation .................................................................................... 142
5.2.1. Conformance for Allergy – Intolerance Observation .................................................... 142
5.2.2. Value Sets ...................................................................................................................... 144
5.2.3. Example of Allergy – Intolerance Observation ............................................................. 145
5.3.
Allergy Problem Act .......................................................................................................... 146
5.3.1. Conformance for Allergy Problem Act .......................................................................... 146
5.3.2. Value Sets ...................................................................................................................... 147
5.3.3. Example of Allergy Problem Act.................................................................................... 147
5.4.
Allergy Status Observation................................................................................................ 147
5.4.1. Conformance for Allergy Status Observation ............................................................... 147
5.4.2. Value Sets ...................................................................................................................... 148
5.4.3. Allergy Status Observation............................................................................................ 148
5.5.
Drug Vehicle ...................................................................................................................... 148
5.5.1. Conformance for Drug Vehicle...................................................................................... 148
5.5.2. Value Sets ...................................................................................................................... 149
5.5.3. Example of Drug Vehicle ............................................................................................... 149
5.6.
Encounter Activities .......................................................................................................... 149
5.6.1. Conformance for Encounter Activities .......................................................................... 150
5.6.2. Value Sets ...................................................................................................................... 151
5.6.3. Example of Encounter Activities ................................................................................... 151
5.7.
Encounter Diagnosis.......................................................................................................... 152
5.7.1. Conformance for Encounter Diagnosis ......................................................................... 152
5.7.2. Value Sets ...................................................................................................................... 152
5.7.3. Example of Encounter Diagnosis................................................................................... 152
5.8.
Family History Observation ............................................................................................... 153
5.8.1. Conformance for Family History Observation .............................................................. 153
5.8.2. Value Sets ...................................................................................................................... 154
5.8.3. Example of Family History Observation ........................................................................ 154
5.9.
Family History Organizer ................................................................................................... 154
5.9.1. Conformance Requirements for Family History Organizer ........................................... 155
5.9.2. Value Sets ...................................................................................................................... 156
5.9.3. Example of Family History Organizer ............................................................................ 156
5.10. Family History Death Observation .................................................................................... 157
5.10.1.
Conformance Requirements for Family History Death Observation ........................ 157
5.10.2.
Value Sets .................................................................................................................. 158
5.10.3.
Example of Family History Death Observation ......................................................... 158
5.11. Health Status Observation ................................................................................................ 159
5.11.1.
Conformance for Health Status Observation ............................................................ 159
5.11.2.
Value Sets .................................................................................................................. 160
5.11.3.
Example of Health Status Observation ..................................................................... 160
5.12. Hospital Admission Diagnosis ........................................................................................... 160
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5.12.1.
Conformance for Hospital Admission Diagnosis ....................................................... 160
5.12.2.
Value Sets .................................................................................................................. 161
5.12.3.
Example of Hospital Admission Diagnosis ................................................................ 161
5.13. Hospital Discharge Diagnosis ............................................................................................ 161
5.13.1.
Conformance for Hospital Discharge Diagnosis ........................................................ 161
5.13.2.
Value Sets .................................................................................................................. 162
5.13.3.
Example of Hospital Discharge Diagnosis ................................................................. 162
5.14. Immunization Activity ....................................................................................................... 162
5.14.1.
Conformance for Immunization Activity ................................................................... 162
5.14.2.
Value Sets .................................................................................................................. 165
5.14.3.
Example of Immunization Activity ............................................................................ 165
5.15. Indication .......................................................................................................................... 166
5.15.1.
Conformance for Indication ...................................................................................... 166
5.15.2.
Value Sets .................................................................................................................. 167
5.15.3.
Example for Indication .............................................................................................. 167
5.16. Instructions ....................................................................................................................... 167
5.16.1.
Conformance for Instructions ................................................................................... 168
5.16.2.
Example for Instructions ........................................................................................... 168
5.17. Medication Activity ........................................................................................................... 168
5.17.1.
Conformance for Medication Activity ....................................................................... 169
5.17.2.
Value Sets .................................................................................................................. 171
5.17.3.
Example of Medication Activity ................................................................................ 171
5.18. Medication Dispense......................................................................................................... 173
5.18.1.
Conformance for Medication Dispense .................................................................... 173
5.18.2.
Value Sets .................................................................................................................. 174
5.18.3.
Example of Medication Dispense .............................................................................. 174
5.19. Medication Information .................................................................................................... 175
5.19.1.
Conformance for Medication Information ............................................................... 175
5.19.2.
Value Sets .................................................................................................................. 175
5.19.3.
Example of Medication Information ......................................................................... 175
5.20. Medication Supply Order .................................................................................................. 176
5.20.1.
Conformance for Medication Supply Order.............................................................. 176
5.20.2.
Value Sets .................................................................................................................. 176
5.20.3.
Example of Medication Supply Order ....................................................................... 177
5.21. Non-Medicinal Supply Activity .......................................................................................... 177
5.21.1.
Conformance for Non-Medicinal Supply Activity...................................................... 177
5.21.2.
Value Sets .................................................................................................................. 178
5.22. PHCR Case Observation .................................................................................................... 178
5.22.1.
Conformance for PHCR Case Observation ................................................................ 178
5.23. PHCR Signs and Symptoms................................................................................................ 179
5.23.1.
Conformance for PHCR Signs and Symptoms ........................................................... 179
5.24. PHCR Treatment Given ..................................................................................................... 180
5.24.1.
Conformance for PHCR Treatment Given ................................................................. 180
5.25. PHCR Treatment Not Given............................................................................................... 180
5.25.1.
Conformance for PHCR Treatment Not Given .......................................................... 181
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5.26. PHCR Treatment Regimen................................................................................................. 181
5.26.1.
Conformance for PHCR Treatment Regimen ............................................................ 181
5.27. Precondition for Substance Administration...................................................................... 182
5.27.1.
Conformance for Precondition for Substance Administration ................................. 182
5.27.2.
Value Sets .................................................................................................................. 183
5.27.3.
Example for Precondition for Substance Administration ......................................... 183
5.28. Pregnancy Observation ..................................................................................................... 183
5.28.1.
Conformance for Pregnancy Observation................................................................. 183
5.28.2.
Value Sets .................................................................................................................. 184
5.28.3.
Example for Pregnancy Observation ......................................................................... 184
5.29. Problem Concern Act ........................................................................................................ 185
5.29.1.
Conformance for Problem Concern Act .................................................................... 185
5.29.2.
Value Sets .................................................................................................................. 185
5.29.3.
Example of Problem Concern Act ............................................................................. 186
5.30. Problem Observation ........................................................................................................ 186
5.30.1.
Conformance for Problem Observation .................................................................... 186
5.30.2.
Value Sets .................................................................................................................. 188
5.30.3.
Example of Problem Observation ............................................................................. 188
5.31. Problem Status .................................................................................................................. 189
5.31.1.
Conformance for Problem Status ............................................................................. 189
5.31.2.
Value Sets .................................................................................................................. 190
5.31.3.
Example of Problem Status ....................................................................................... 190
5.32. Procedure Activity Act....................................................................................................... 190
5.32.1.
Conformance for Procedure Activity Act .................................................................. 191
5.32.2.
Value Sets .................................................................................................................. 193
5.32.3.
Example of Procedure Activity Act ............................................................................ 193
5.33. Procedure Activity Observation ........................................................................................ 194
5.33.1.
Conformance for Procedure Activity Observation .................................................... 194
5.33.2.
Value Sets .................................................................................................................. 196
5.33.3.
Example of Procedure Activity Observation ............................................................. 196
5.34. Procedure Activity Procedure ........................................................................................... 198
5.34.1.
Conformance for Procedure Activity Procedure ....................................................... 198
5.34.2.
Value Sets .................................................................................................................. 200
5.34.3.
Example of Procedure Activity Procedure ................................................................ 201
5.35. Procedure Specimens Taken ............................................................................................. 202
5.35.1.
Conformance for Procedure Specimens Taken......................................................... 202
5.35.2.
Value Sets .................................................................................................................. 203
5.35.3.
Example of Procedure Specimens Taken .................................................................. 203
5.36. Product Instance ............................................................................................................... 203
5.36.1.
Conformance for Product Instance ........................................................................... 203
5.36.2.
Value Sets .................................................................................................................. 204
5.36.3.
Example of Product Instance .................................................................................... 204
5.37. Reaction Observation........................................................................................................ 204
5.37.1.
Conformance for Reaction Observation ................................................................... 204
5.37.2.
Value Sets .................................................................................................................. 206
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5.37.3.
Example of Reaction Observation ............................................................................. 206
5.38. Result Observation ............................................................................................................ 207
5.38.1.
Conformance for Result Observation ....................................................................... 207
5.38.2.
Value Sets .................................................................................................................. 208
5.38.3.
Example of Result Observation ................................................................................. 208
5.39. Result Organizer ................................................................................................................ 209
5.39.1.
Conformance for Result Organizer ........................................................................... 209
5.39.2.
Value Sets .................................................................................................................. 210
5.39.3.
Example of Result Organizer ..................................................................................... 210
5.40. Service Delivery Location .................................................................................................. 211
5.40.1.
Conformance for Service Delivery Location .............................................................. 211
5.40.2.
Value Sets .................................................................................................................. 211
5.40.3.
Example of Service Delivery Location ....................................................................... 211
5.41. Severity Observation ......................................................................................................... 212
5.41.1.
Conformance for Severity Observation .................................................................... 212
5.41.2.
Value Sets .................................................................................................................. 213
5.41.3.
Example of Severity Observation .............................................................................. 213
5.42. Smoking Status Observation ............................................................................................. 213
5.42.1.
Conformance for Smoking Status Observation ......................................................... 213
5.42.2.
Value Sets .................................................................................................................. 214
5.42.3.
Example of Smoking Status Observation .................................................................. 214
5.43. Social History Observation ................................................................................................ 214
5.43.1.
Conformance for Social History Observation............................................................ 215
5.43.2.
Value Sets .................................................................................................................. 215
5.43.3.
Example of Social History Observation ..................................................................... 215
5.44. Vital Signs Organizer ......................................................................................................... 216
5.44.1.
Conformance for Vital Signs Organizer ..................................................................... 216
5.44.2.
Value Sets .................................................................................................................. 217
5.44.3.
Example of Vital Signs Organizer............................................................................... 217
5.45. Vital Signs Observation ..................................................................................................... 217
5.45.1.
Conformance for Vital Signs Observation ................................................................. 217
5.45.2.
Value Sets .................................................................................................................. 218
5.45.1.
Example of Vital Signs Observation .......................................................................... 218
6.
Additional Implementation Guidance....................................................................................... 219
6.1.
Core Common Representation in HL7 Messaging – Recommendations .......................... 219
6.2.
Use of Open CDA Templates ............................................................................................. 219
6.3.
Program Extension of Templates ...................................................................................... 221
Appendix A: Interoperability Standards for Participating Public Health Domains ............................. 223
Appendix B: Reference Documents .................................................................................................... 225
Appendix C: Definitions and Acronyms .............................................................................................. 226
Appendix D: Recommended Value Sets and Vocabulary Summary ................................................... 228
Appendix E: Next Steps for PHRI ........................................................................................................ 230
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Table of Tables
Table 1 - Submitted PHRI User Stories ................................................................................................. 21
Table 2 - Key Terms in Public Health Reporting Specification - CDA .................................................... 25
Table 3 - Summary of Conformance Criteria ........................................................................................ 28
Table 4 - CDA Section Introduction ...................................................................................................... 30
Table 5 - Table Structure for CDA Sections .......................................................................................... 30
Table 6 - Table Structure for CDA Entries ............................................................................................. 31
Table 7 - CDA Header Structure and Suggested Values ....................................................................... 32
Table 8 - Patient Information – Overview ............................................................................................ 32
Table 9 - Patient Information - Header Elements ................................................................................ 33
Table 10 - CDA Header Value Sets (Patient Information) ..................................................................... 34
Table 11 - Patient Contact Information CDA Section Overview ........................................................... 35
Table 12 - Patient Contact Information – Types................................................................................... 36
Table 13 - Patient Contact Information - CDA Detail for Informant..................................................... 37
Table 14 - Patient Contact Information - CDA Detail for Participant ................................................... 37
Table 15 - Patient Contact Information - CDA Detail for Maternal Health .......................................... 37
Table 16 - Patient Contact Information Value Sets .............................................................................. 38
Table 17 - Template Structure for Adverse Event Report .................................................................... 44
Table 18 - Template Structure for Communicable Disease Case Report ............................................. 46
Table 19 – High Level PHRI to PHCR Template Alignment ................................................................... 47
Table 20 - Alignment of CDA to CSTE Recommendations .................................................................... 54
Table 21 - Allergy/Adverse Event CDA Section Overview .................................................................... 55
Table 22 - Allergy/Adverse Event - CDA Detail ..................................................................................... 57
Table 23 – Allergy/Adverse Event Example .......................................................................................... 59
Table 24 - Allergy/Adverse Event Value Sets........................................................................................ 60
Table 25 - Diagnosis/Health Problem CDA Section Overview .............................................................. 62
Table 26 - Diagnosis/Health Problem – CDA Detail .............................................................................. 63
Table 27 - Health Problem/Diagnosis Value Sets ................................................................................. 65
Table 28 - Health Problem/Diagnosis - Detailed Example.................................................................... 67
Table 29 - Employment Information (Social History) CDA Section Overview ...................................... 68
Table 30 - Employment Information - Social History - CDA Section Detail .......................................... 68
Table 31 - Employment Information - Social History - Value Set Conformance .................................. 69
Table 32 - Encounter CDA Section Overview ....................................................................................... 70
Table 33 - Encounter CDA Section - Detail ........................................................................................... 71
Table 34 - Encounter Value Sets ........................................................................................................... 72
Table 35 - Exposure - CDA Conceptual Overview ................................................................................. 77
Table 36 - Exposure Detail .................................................................................................................... 78
Table 37 - Proposed Exposure Vocabulary Constraints........................................................................ 79
Table 38 - Facility - CDA Conceptual Overview .................................................................................... 79
Table 39 - Facility Detail ....................................................................................................................... 80
Table 40 - Facility Type Value Sets ....................................................................................................... 80
Table 41 - Family History CDA Section Overview ................................................................................. 81
Table 42 - Family History CDA Section - Detail ..................................................................................... 83
Table 43 - Family History Value Sets .................................................................................................... 84
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Table 44 - Family History CDA Section - Detailed Example .................................................................. 85
Table 45 - Immunization CDA Section Overview .................................................................................. 88
Table 46 - Immunization - CDA Detail .................................................................................................. 89
Table 47 - Immunization Value Sets ..................................................................................................... 90
Table 48 - Medical Equipment Section - CDA – Overview.................................................................... 96
Table 49 - Medical Equipment CDA Detail ........................................................................................... 98
Table 50 - Medication CDA Section Overview ...................................................................................... 99
Table 51 - Medication CDA Detail ...................................................................................................... 100
Table 52 - Medication Value Sets ....................................................................................................... 101
Table 53 - Medication Detailed Example............................................................................................ 103
Table 54 - Order/Diagnostic Test CDA Section Overview ................................................................... 104
Table 55 - Order/Diagnostic Test CDA Detail ..................................................................................... 104
Table 56 - Payer Information CDA Section Overview ......................................................................... 105
Table 57 - Payer Information Value Sets ............................................................................................ 106
Table 58 - PHCR Clinical Information - CDA Section Overview........................................................... 106
Table 59 - PHCR Treatment Information – CDA Section Overview .................................................... 108
Table 60 - Physical Exam CDA Section – Overview ............................................................................. 111
Table 61 - Physical Exam CDA Section – Detail................................................................................... 111
Table 62 - Procedure CDA Section – Overview................................................................................... 113
Table 63 - Procedure CDA Section – Detail ........................................................................................ 114
Table 64 - Procedure CDA Section - Detailed Example ...................................................................... 115
Table 65 - Value Sets for Procedure CDA Section .............................................................................. 115
Table 66 - Provider Information - Overview ....................................................................................... 120
Table 67 - Provider Information - CDA Detail ..................................................................................... 120
Table 68 - Provider Information Value Sets....................................................................................... 121
Table 69 - Result CDA Section – Overview ......................................................................................... 123
Table 70 - Result Model - PHRI ........................................................................................................... 123
Table 71 - Result CDA Section - Detail ................................................................................................ 124
Table 72 - Result Value Sets ............................................................................................................... 125
Table 73 - Result - Detailed Example .................................................................................................. 127
Table 74 - Social History CDA Section Overview ................................................................................ 131
Table 75 - Social History Model - PHRI ............................................................................................... 131
Table 76 - Social History CDA Section – Detail ................................................................................... 133
Table 77 - Social History CDA Section - Detailed Example ................................................................. 133
Table 78 - Value Set Summary - Social History Section ...................................................................... 133
Table 79 - Summary of Available Codes for Social History ................................................................. 134
Table 80- Specimen CDA Section Overview ....................................................................................... 136
Table 81 - Specimen - CDA Section Detail .......................................................................................... 136
Table 82 - Specimen Value Sets .......................................................................................................... 137
Table 83 - Vital Sign Indicators CDA Overview ................................................................................... 138
Table 84 - Vital Sign Indicators - CDA Section Detail .......................................................................... 138
Table 85 - Vital Sign Indicator Value Sets ........................................................................................... 139
Table 86 - Vital Sign Indicator - Detailed Example ............................................................................. 141
Table 87 - Age Observation - Overview .............................................................................................. 141
Table 88 - Age Observation Value Set ................................................................................................ 142
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Table 89 - Allergy - Intolerance Observation Overview ..................................................................... 142
Table 90 - Allergy - Intolerance Observation Value Sets .................................................................... 145
Table 91 - Allergy Problem Act Overview ........................................................................................... 146
Table 92 - Allergy Problem Act Value Set ........................................................................................... 147
Table 93 - Allergy Status Observation Overview ................................................................................ 147
Table 94 - Allergy Status Observation Value Set ................................................................................ 148
Table 95 - Encounter Activities Overview .......................................................................................... 150
Table 96 - Encounter Activities Value Set........................................................................................... 151
Table 97 - Encounter Diagnosis Overview .......................................................................................... 152
Table 98 - Family History Observation Overview ............................................................................... 153
Table 99 - Family History Observation Value Sets.............................................................................. 154
Table 100 - Family History Organizer Overview ................................................................................. 154
Table 101 - Family History Organizer Value Sets ................................................................................ 156
Table 102 - Family History Death Observation Overview .................................................................. 157
Table 103 - Health Status Observation Overview .............................................................................. 159
Table 104 - Health Status Observation Value Set............................................................................... 160
Table 105 - Hospital Admission Diagnosis Overview.......................................................................... 160
Table 106 - Hospital Discharge Diagnosis Overview .......................................................................... 161
Table 107 - Immunization Activity Overview ..................................................................................... 162
Table 108 - Immunization Activity Value Sets .................................................................................... 165
Table 109 - Indication Overview......................................................................................................... 166
Table 110 - Indication Value Sets ....................................................................................................... 167
Table 111 - Medication Activity Overview ......................................................................................... 167
Table 112 - Medication Dispense Overview ....................................................................................... 169
Table 113 - Medication Dispense Value Sets ..................................................................................... 171
Table 114 - Medication Information Overview .................................................................................. 173
Table 115 - Medication Dispense Value Sets ..................................................................................... 174
Table 116 - Medication Information Overview .................................................................................. 175
Table 117 - Medication Information Value Sets ................................................................................. 175
Table 118 - Medication Supply Order Overview ................................................................................ 176
Table 119 - Medication Supply Order Value Sets ............................................................................... 176
Table 120 - Non-Medicinal Supply Activity Overview ........................................................................ 177
Table 121 - PHCR Case Observation Overview ................................................................................... 178
Table 122 - PHCR Signs and Symptoms Overview .............................................................................. 179
Table 123 - PHCR Treatment Given Overview .................................................................................... 180
Table 124 - PHCR Treatment Not Given Overview ............................................................................. 181
Table 125 - PHCR Treatment Regimen Overview ............................................................................... 181
Table 126 - Precondition for Substance Administration Overview .................................................... 182
Table 127 - Pregnancy Observation Overview ................................................................................... 183
Table 128 - Problem Concern Act Overview....................................................................................... 185
Table 129 - Problem Concern Act Value Sets ..................................................................................... 186
Table 130 - Problem Observation Overview ...................................................................................... 186
Table 131 - Problem Observation Value Sets ..................................................................................... 188
Table 132 - Problem Status Overview ................................................................................................ 189
Table 133 - Problem Status Value Sets ............................................................................................... 190
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Table 134 - Procedure Activity Act Overview ..................................................................................... 191
Table 135 - Procedure Activity Observation Overview ...................................................................... 194
Table 136 - Procedure Activity Observation Value Sets ..................................................................... 196
Table 137 - Procedure Activity Procedure Overview ......................................................................... 198
Table 138 - Procedure Activity Procedure Value Sets ........................................................................ 200
Table 139 - Procedure Specimens Taken Overview ........................................................................... 202
Table 140 - Product Instance Overview ............................................................................................. 203
Table 141 - Reaction Observation Overview ...................................................................................... 204
Table 142 - Reaction Observation Value Sets..................................................................................... 206
Table 143 - Result Observation Overview .......................................................................................... 207
Table 144 - Result Observation Value Sets......................................................................................... 208
Table 145 - Result Organizer Overview .............................................................................................. 209
Table 146 - Result Organizer Value Sets ............................................................................................. 210
Table 147 - Service Delivery Location Overview ................................................................................ 211
Table 148 - Service Delivery Location Value Sets ............................................................................... 211
Table 149 - Severity Observation Overview ....................................................................................... 212
Table 150 - Smoking Status Observation Overview ........................................................................... 213
Table 151 - Smoking Status Observation Value Sets .......................................................................... 214
Table 152 - Social History Observation Overview .............................................................................. 214
Table 153 - Social History Observation............................................................................................... 215
Table 154 - Vital Signs Organizer Overview ........................................................................................ 216
Table 155 - Vital Signs Observation Overview.................................................................................... 217
Table 156 - Vital Signs Observation Value Sets .................................................................................. 218
Table 157 - Additional Core Common Implementation Guidance - HL7 Messaging .......................... 219
Table 158 - Open CDA Templates Used in the PHRI CDA Specification ............................................. 221
Table 159 - Example of Program Extension of CDA Constraints ........................................................ 222
Table 160 - Interoperability Standards for Participating Public Health Domains .............................. 224
Table 161 - References ....................................................................................................................... 225
Table 162 - Definitions and Acronyms ............................................................................................... 227
Table 163 - Recommended Value Sets and Vocabulary Summary..................................................... 229
Table of Figures
Figure 1 - Generation of Public Health Report Types: Based on Jurisdictionally-Defined Local/State
Public Health Programs Reporting Requirements, Technical Implementation and Federal
Agencies Reporting.................................................................................................................. 17
Figure 2 - Examples of PHRI Public Health Reports .............................................................................. 21
Figure 3 - CDA Framework and Terminology ....................................................................................... 26
Figure 4 - Allergy Model - PHRI............................................................................................................. 56
Figure 5 - Encounter CDA Section – Visual Overview ........................................................................... 70
Figure 6 - Family History Model – PHRI ................................................................................................ 82
Figure 7 - Immunization Model - PHRI ................................................................................................. 88
Figure 8 - Laboratory Specialty Overview............................................................................................. 94
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Figure 9 - Medical Equipment Model - PHRI ........................................................................................ 97
Figure 10 - PHCR Clinical Information Model - PHRI .......................................................................... 107
Figure 11 - PHCR Treatment Information Model - PHRI..................................................................... 109
Figure 12 - Procedure Model - PHRI ................................................................................................... 113
Figure 13 - Vital Signs Model - PHRI ................................................................................................... 138
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1. Introduction
In support of the national objectives for healthcare reform, the Office of the National Coordinator for
Health Information Technology (ONC) Standards and Interoperability (S&I) Framework has sponsored
the development of harmonized interoperability specifications for public health reporting. These
specifications are designed to support national health initiatives and healthcare priorities, including
Meaningful Use (MU), the Nationwide Health Information Network (NwHIN), and the ongoing mission to
improve population health.
1.1. Purpose and Approach
The purpose of this document is to describe how to use the Health Level Seven (HL7) Clinical Document
Architecture Release 2 (CDA R2) specification to support the exchange of public health reports from
healthcare providers to public health entities. For the purpose of this document, the term “healthcare
provider” is used to describe a variety of healthcare provider settings (e.g., primary care physicians or
hospitals) that use Electronic Health Record (EHR) or Electronic Medical Record (EMR) technology. The
term “Intermediary” is used to describe a variety of systems (e.g., Health Information Exchanges (HIEs),
Incident Reporting Systems, Laboratory Information Systems) that are used to augment or facilitate the
EHR/EMR reporting function(s) for data exchange. Public health entities may be tribal, local, state,
jurisdictional, or federal agencies or other organizations involved in the execution, maintenance,
surveillance, or analysis of public health programs and/or public health reports.
The Public Health Reporting Specification - CDA focuses on the use of CDA R2 to support data exchanges
described in the Public Health Reporting Initiative (PHRI) Use Case document and representative
examples of different report types based upon submitted user stories. The inclusion of a specific report
type described in this document is based upon initial feedback from PHRI stakeholders about their
interest and readiness to support implementation pilots for Meaningful Use Stage III using this
specification. Readers should note that the examples referenced in this specification are not intended
to constrain the specification’s use for other report types or undermine ongoing efforts to finalize other
public health-related specifications. This document should be leveraged as a reference specification for
continued standards harmonization between Standards Development Organizations (SDOs) and to
support pilot testing or implementations that need to support a variety of public health data exchanges.
An important guiding principle when considering the use of this specification is to assess the need to
reduce overall reporting burdens for public health reporting. This specification provides a scalable CDA
R2-based approach to create various public health reports, and it is expected that subsequent releases
of this specification will support a wider variety of public health exchanges over time. Detailed
information about the PHRI Use Case and associated user stories referenced in this document can be
found at: http://wiki.siframework.org/PHRI+Use+Case+Materials.
The approach used to develop this specification supports multiple objectives:
1. Scalability: The specification is designed to provide a catalog of CDA templates that can be used
to generate a variety of implementation guides that can be applied to different public health
report types.
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2.
3.
4.
5.
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Maintenance and Reuse: Subsequent changes to the specification’s templates will be published
in a single source specification (which may also be referred to as a template library) and made
available to the public health community to update or develop implementation guides.
Translation: The specification can be used to create and maintain mapping tables for public
health reporting data elements and the Consolidated CDA specification. The mapping tables
would be built into the structure of the template, including future mapping from CDA R2 to HL7
2.x message specifications.
Familiarity: It is expected that public health stakeholders familiar with the Public Health
Reporting CDA Specification will be able to appropriately assess impacts and cross-walk between
the CDA and HL7 2.x specifications when considering alternatives for supporting public health
data exchanges.
Interoperability and Harmonization: Issues related to inconsistencies or incompatibilities
between different public health reports and/or data exchanges can be addressed in one
specification so that over time more public health reports and data exchanges can be supported
using a common set of templates, constraints, and value sets.
The approach used to develop this specification is consistent with the approach used to develop and
ballot HL7 CDA-based implementation guides. This specification uses a series of layered constraints to
CDA Sections and Entries used in public health reports. The CDA specification itself is a set of
constraints on the HL7 Reference Information Model (RIM) and is represented as a CDA R2 Refined
Message Information Model (RMIM).The Public Health Reporting specification adopts many of the
existing CDA R2 and Consolidated CDA constraints. Additional PHRI-specific constraints are applied and
expressed as conformance statements to further define and restrict the sequence and cardinality of CDA
objects and their associated vocabulary value sets for PHRI coded data elements. These conformance
statements would ultimately be further refined in implementation guides for specific public health
exchanges. The Consolidated CDA specification is a practical example of how this approach is used to
constrain CDA R2 to support clinical document exchanges.
This approach is predicated on submission to HL7 for formal balloting in May 2013.
1.2. Audience
The intended audience of this specification includes, but is not limited to, software developers, vendors,
pilot implementers, other HIT stakeholders, public health program staff (e.g., epidemiologists), and
public health informatics staff. Requisite knowledge for using this specification is outlined in Section
1.2.1.
1.2.1. Requisite Knowledge
Pre-requisites for understanding and using this specification include the following:


Implementers should have a strong knowledge of the Implementation Guide for CDA Release
2.0 Consolidated CDA Templates (US Realm) – may be referred to as Consolidated CDA
throughout this specification
Implementers should have a strong knowledge of HL7 CDA R2 and the Clinical Document
Architecture (CDA)
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

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Implementers should reference current CDA-based public health reporting implementation
guides that are noted in the References section of this document
Familiarity with the public health reporting functionality supported by this specification (e.g.,
PHRI Use Case and Functional Requirements)
For those implementers without requisite knowledge in these areas, it is HIGHLY RECOMMENDED to
read each of the documents defined in the References section of this document and consult with your
data exchange partners.
1.3. Scope
Figure 1 provides an overview of the scope and vision applicable to this specification. The PHRI Year 1
effort (started September 2011) was focused on defining the content for a provider-initiated Public
Health Report sent from the provider EHR to a local, state or federal public health information system.
The PHRI Data Harmonization Profile1 was used as a critical scoping artifact to set the boundaries and
structure of this specification.
Figure 1 - Generation of Public Health Report Types: Based on Jurisdictionally-Defined Local/State Public Health
Programs Reporting Requirements, Technical Implementation and Federal Agencies Reporting
1
The PHRI Data Harmonization Profile is available here: http://wiki.siframework.org/PHRI++Data+%26Terminology+Harmonization+Sub-Workgroup
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This specification is focused on specifying content of Public Health Reports. It does not specify the
transactions needed to send/receive/exchange the Reports between EHR systems (Content Creators)
and public health information systems (Content Consumer). It also does not define privacy and security
rules for submission/transmission/receipt of the Reports. The latters can be determined based on the
jurisdiction –specific implementation and regulations.
Figure 2 - Public Health Reporting Initiative: Public Health Reporting Approach
1.4. Summary of Key Technical Decisions
This section summarizes key technical decisions made to support the development of the Public Health
Reporting Specification. Decisions were based upon User Stories (individual reporting program use
cases) submitted to the PHRI (Table 1) and the identified common set of requirements, functions and
data elements across the use cases (referenced in the PHRI Use Case, Functional Requirements, and
Data Harmonization Profile). Common requirements are often referred to as “core common”
throughout this specification. Additional requirements determined to be unique to a specific report
type and/or reporting program are referred to as “extensions” to the common core requirements.
Conformance statements provided in this specification relate the mapping of the common core
requirements to applicable CDA R2 sections and/or entries. Conformance statements relevant to the
extensions for specific report types are either noted within the section/entry statements (sections 4 and
5) or provided in section 3.
1.4.1. PHRI User Stories, Consolidated Use Case, Common Requirements and
Standards
PHRI User Stories (Table 1) highlighting specific reporting scenarios/programs were submitted by
participating stakeholder organizations describing the content and data exchange requirements critical
to supporting EHR reporting to public health that could potentially be included in Meaningful Use Stage
III recommendations for public health reporting standards. These user stories were grouped by public
health domains (adverse events, child health, chronic disease, communicable disease, and
infrastructure, quality and research) and used to identify and define the types of reports and common
requirements for Public Health Reporting.2,3 User Stories were asked to complete a readiness
assessment to determine their readiness for inclusion in Meaningful Use Stage III based on a set of PHRIdefined criteria. Table 1 includes standards identified by the user story submitters for each report type
based on their responses to the PHRI Meaningful Use Stage III Readiness Assessment4. A comparison
2
Consolidated Public Health Reporting Use Case Documentation –
http://wiki.siframework.org/PHRI+Use+Case+Materials
3
PHRI Functional Requirements Document– http://wiki.siframework.org/PHRI+Use+Case+Materials
4
PHRI Meaningful Use Stage III Readiness Assessment - http://wiki.siframework.org/PHRI+Implementation+Guide
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between the user story requirements and the use of HL7 CDA R2 and Consolidated CDA (CCDA) standard
for specific reports across various stories was made to determine if CDA—designed for exchanging
clinical documents—is a suitable specification for exchanging public health reports. Please note that
several user stories utilized HL7 version 2.5.1 and other versions of the HL7 version 2 families of
message-based standards. The message-based data content was not reviewed by the PHRI participants
and therefore is not included in this specification.
The following table summarizes the User Stories submitted to the PHRI and used as a basis for the
consolidated PHRI Use Case, Functional Requirements, and Data Harmonization Profile which serve as
references for this specification. The table also includes standards referenced as part of the PHRI MU
Stage III Readiness Assessment.
User Story Name
FDA Spontaneous Triggered Event
Reporting (#1)
FDA Spontaneous Triggered Event
Reporting (#2)
Immunization Information Systems
Medical Device Reporting
Patient Safety Reporting – Agency
for Healthcare Research and
Quality (AHRQ) Common Formats
Birth and Fetal Death Registration
Birth Defects Reporting
Birth Event Reporting
Early Hearing Detection and
Intervention (EHDI)
Health Information Exchanges
(HIE) and Immunizations
Immunization
Immunization Information Systems
Submitter
Adverse Event
Food and Drug Administration
(FDA)
FDA
American Immunization Registry
Association (AIRA)
FDA
FDA
Child Health
CDC National Center for Health
Statistics (NCHS)
CDC National Center for Birth
Defects and Developmental
Disabilities (NCBDDD)
Ohio Department of Health
Oregon Health Authority
HL7 v3
HL7 v3
HL7 CDA R2
HL7 CDA R2
IHE EHCP
Software Partners, LLC
Newborn Hearing Screening
Minnesota Department of Health
American Immunization Registry
Association (AIRA)
Maine CDC, Data Research and
Vital Statistics (DRVS) office
CDC NCBDDD
Cancer Genetics
Chronic Disease
Michigan Department of
Data Research and Vital Statistics
HL7 v3
HL7 v2.5.1
HL7 CDA R2
IHE EHCP
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User Story Name
Cancer Reporting
Cardiovascular Disease
Impact of Work on Health
National Health Care Surveys
Patient Safety Reporting – AHRQ
Common Formats
Quality Reporting
Syndromic Measure Reporting
Communicable Disease Case
Reporting
Enteric Disease Reporting
Healthcare Associated Infections
Michigan Disease Surveillance
System
Minnesota Communicable Disease
Reporting
Oregon Health Authority
Mandated Disease Reporting
Patient Safety Reporting – AHRQ
Common Formats
Public Health Case Reporting
Submitter
Community Health
CDC National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP)
Nebraska Department of Health
and Human Services
CDC National Institute for
Occupational Safety and Health
(NIOSH)
CDC NCHS
FDA
Agilex
Communicable Disease
Agilex
Public Health Data Standards
Consortium (PHDSC)
Florida Department of Health
Council of State and Territorial
Epidemiologists (CSTE)
Michigan Department of Health
HL7 CDA R2
HL7 v2
Minnesota Department of Health
Oregon Health Authority
FDA
CDC Division of Notifiable Diseases
and Healthcare Information
(DNDHI)
South Dakota Communicable
South Dakota Department of
Disease Reporting
Health
Infrastructure, Quality, and Research5
Administrative Use of Health Data
PHDSC
PH Reporting User Story Model
Agilex
Public Health Data Quality
Agilex
Assurance
Registration for Public Health
Agliex
Reporting
HL7 CDA R2
5
Note that the user stories in the Infrastructure, Quality, and Research domain were not considered in scope for
this phase of the PHRI.
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User Story Name
University of Wisconsin Medical
Record (UW MED) Public Health
Information Exchange (PHINEX)
Submitter
University of Wisconsin
Table 1 - Submitted PHRI User Stories
Figure 2 provides examples of the Public Health Reports described in the user stories and a hierarchy
across these reports including examples of jurisdictional-specific reports.
Figure 2 - Examples of PHRI Public Health Reports
The current document is focused on public health reporting using HL7 CDA R2 for those domains where
the requirements comparison and analysis of standards revealed that CDA does provide the needed
report content sections and entries to support many user story requirements.
The format of this specification is based upon a modular approach for representing user story
requirements and can be used as building blocks (subject to underlying CDA R2 constraints) to further
enhance this specification over time and/or develop additional implementation guides for specific
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report types. The value of this approach supports the desire to reuse, to the best extent possible,
existing implementation guides that have already been developed using CDA R2.
1.4.2. Data Harmonization Profile - Core Common Requirements and Data
Elements
Leveraging the evaluation of CDA, analysis and mapping of data elements from each user story was
performed and reconciled to create a notion of a Public Health Report – a high level data model that
define the relationships between various user stories’ specific reports (Figure 2).
We further used this model to define common templates for the CDA-based Public Health Report
structures, i.e., common CDA sections and entries across various reports specified in this specification.
The data elements supported in this specification are a representative set of data elements across all
user stories that met the PHRI Use Case criteria and responses to the PHRI Meaningful Use Stage III
Readiness Assessment. These data elements are considered critical information that must be supported
in EHR/EMR systems in order to support a variety of public health reports. Further design
considerations identified in Data Harmonization Profile included ensuring consistency with Consolidated
CDA and other existing public health reporting CDA-based implementation guides.
1.4.3. Existing Interoperability Standards and Addressing Standards Gaps
This specification serves as a reference document to existing public health reporting implementation
guides and interoperability specifications (content profiles) developed to date by various public health
programs participated in the Initiative as user stories submitters and identified via the PHRI Meaningful
Use Stage III Readiness Assessment. The PHRI Interoperability Specification references the standards
documentation developed by the following public health programs/domains (in alphabetical order):






Adverse Events
Early Hearing Detection and Intervention
Immunization
Cancer
Communicable Diseases including Healthcare Associated Infections (HAI)
Vital Records
During the PHRI Data Harmonization process, the participants conducted harmonization of the data
content specified in various existing standards. For Communicable Disease reporting, participants also
identified gaps in the 2009 HL7 Implementation Guide (IG) for CDA Release 2 on Public Health Case
Reporting, Release 1. Even though this IG included section templates to meet the requirements of Public
Health Case Reports for all reportable conditions6, condition-specific templates were included only for
anthrax, acute hepatitis B, tuberculosis, and tularemia. Based on this guide, in May 2012 the Public
Health Data Standards Consortium (PHDSC) in partnership with the Council of State and Territorial
Epidemiologists (CSTE), and with support through a grant from the Centers for Disease Control and
Prevention (CDC) developed CDA-based Public Health Case Reports for an additional 11 conditions. The
6
The 2009 PHCR IG can be found here:
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=34
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case reports for these 15 conditions (including 4 conditions in the original 2009 IG) were developed in
the open source Open Health Tools Model Driven Health Tools (MDHT)7. In this work, the PHDSC-CSTECDC team documented gaps in the 2009 HL7 PHCR IG in terms of additional data elements and
document structures.
During the PHRI Interoperability Specification development process, the participants identified
additional data requirements for Communicable Disease Case Reports and Adverse Event Reports that
need to be added in the 2009 HL7 PHCR IG. Gaps between the C-CDA and the 2009 HL7 PHCR IG should
be identified and reconciled in the future to update the IG for a new ballot.
PHRI participants will work with the HL7 Public Health and Emergency Response (PHER) Workgroup and
the Structured Documents Working Group (SDWG) to update and re-ballot the 2009 HL7 PHCR IG using
the CDA structures defined in Section 4 below. We anticipate submitting to HL7 the Intent to Ballot the
PHCR IG in early March 2013 and the updated PHCR IG for the final ballot by the end of March 2013. The
ballot will take place during April 2013. We will participate in review of the public comments and
comments resolutions on the PHCR IG ballot in May 2013. We anticipate publishing the updated PHCR
IG by HL7 during the summer of 2013.
1.4.4.
PHRI Interoperability Specification Organization
Section 1 includes background and introductory information about this specification, including an
enumeration of User Stories submitted to the PHRI and background on the development of the PHRI
Consolidated Use Case, Functional Requirements, and Data Harmonization Profile. Section 1 also
includes pre-requisites for understanding this specification.
Section 2 describes the CDA Header as used by this specification. Section 3 describes recommendations
from the Adverse Event and Communicable Disease Case Reporting programs to express their content
through the templates described in this specification and other existing specifications.
Sections 4 and 5 describe the section and entry level templates specified as part of this document.
These sections are based on the core common data elements and requirements defined in the Data
Harmonization Profile. Section 6 includes additional implementation guidance to help implementers.
1.4.5. Use of Terms
The Public Health Reporting Initiative (PHRI) identified several terms that are used interchangeably or
inconsistently in multiple implementation guides. To assist PHRI specification implementers, the
definitions and context for terms used throughout this specification are provided as follows:
Key Term
Object
7
Definition within the Specification
Objects are defined in the Data Harmonization Profile (with details
provided in Section 3 of that document) as a foundational building block
for future public health reporting standardization. Each object is
defined as an information concept with associated data elements that
Open Health Tools Model Driven Health Tools Project for CDA. URL:
https://www.projects.openhealthtools.org/sf/projects/mdht/
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Key Term
Core Common
Report – also referred to as
Document Type
Specification – also referred
to as Template Library
Implementation Guide
Clinical Document
Architecture (CDA)
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Definition within the Specification
can be extended or used across multiple reporting domains or report
types. For example, Pregnancy status.
Objects referenced this specification can be used to reconcile or map to
other implementation specifications such as HL7 2.x messaging or CDA
R2.
Harmonized data elements that are widely shared across several public
health user stories and report types. The Public Health Reporting
Initiative expects EHR systems to support the capture and use of these
data elements to create and transmit public health reports. However,
public health systems may choose to receive all or a subset of these
data elements at their discretion.
A CDA-based public health report is analogous to a document-level
template, such as a procedure note or operative note, as defined within
the Consolidated CDA. A report may include one or more document
types (for example, an HAI Laboratory Identified Organism (LIO) report
together with supporting HAI Population Summary Report) and the
ultimate level of constraint for a specific reporting program is defined in
a CDA-based implementation guide.
For the purpose of this specification, the term report is a document
type
The Public Health Reporting specification is used to help generate
further refined CDA R2-based public health reporting implementation
guides. This specification represents a template library that serves as
the implementable CDA R2 representation of public health reporting
data elements defined in the Data Harmonization Profile.
The template library represents the common library of CDA section and
entry-level templates to be used to develop refined CDA R2-based
public health reporting implementation guides. The template library
defined in this specification contains specific structures and constraints
as defined through HL7. The PHRI template library will require ongoing
maintenance to support future adoption and release of CDA R3
An implementation guide developed under the S&I Public Health
Reporting Initiative based upon the collective artifacts (e.g., Data
Harmonization Profile and Public Health Reporting Specification. A
major characteristic for a PHRI Implementation Guide is that it
reuses/adds PHRI CDA-based templates and conforms to PHRI structure
and conformance requirements.
An HL7 data exchange standard which describes conformance
requirements in terms of three general levels corresponding to three
different, incremental types of conformance statements:
 Level 1 requirements impose constraints upon the CDA Header.
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Key Term


Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Definition within the Specification
The body of a Level 1 document may be XML or an alternate
allowed format. If XML, it must be CDA-conformant markup.
Level 2 requirements specify constraints at the section level of a
CDA XML document: most critically, the section code and the
cardinality of the sections themselves, whether optional or
required.
Level 3 requirements specify constraints at the entry level
within a section. A specification is considered “Level 3” if it
requires any entry-level templates.
Table 2 - Key Terms in Public Health Reporting Specification - CDA
1.5. HL7 CDA R2 Overview
The Health Level Seven (HL7) Clinical Document Architecture (CDA) standard was named in the
Meaningful Use of Health IT for data exchanges between clinical Electronic Health Record (EHR)
systems. In September 2011, the Health IT Standards Federal Advisory Committee recommended the
use of the HL7 CDA standard as a future direction for electronic data exchanges between clinical and
public health information systems (PH-IS) for public health reporting.8
Electronic Health Record systems that create, transmit, receive, and display Continuity of Care
Documents (CCD) as required under Meaningful Use9 have a framework - CDA - that can serve as the
basis for the creation of closely related documents that are needed within a document-based health
information exchange. CDA standard allows representation of clinical information of CCD in a structured
format (i.e., CDA templates) that is similar or identical to the paper form formats.10 Common data
elements found in various Public Health Reports (Table 2) can be modeled in a set of modular definitions
(CDA templates) reusable across reports and conformant with design patterns established for EHRs and
interoperable data exchanges. CDA templates (Figure 3) -- documents, document header and body of
the document and its sections and entries -- can be organized into documents, sections, and entries to
construct valid public health case report instances constraining certain templates as required and
optional based on the specific report content. Using CDA, the Public Health Report can leverage CCD
sections (e.g., social history, medications, results, encounters, immunization and others) to transmit
reportable information to public health entities as required under jurisdictional law. Each state and/or
local health department will determine which of that CDA templates/sections they require to assemble
the jurisdiction-specific CDA-based public health case report -- sent from EHRs directly to
8
Health IT Standards Federal Advisory Committee. Recommendations from the Public Health Surveillance Summer
Camp. September 28, 2011. URL:
http://healthit.hhs.gov/portal/server.pt?open=512&objID=1817&parentname=CommunityPage&parentid=28&mo
de=2&in_hi_userid=11673&cached=true#09281
9
US Department of Health and Human Services Washington (DC): Office of the National Coordinator for Health
Information Technology (US); 2010. Jul 13, Health information technology: initial set of standards, implementation
specifications, and certification criteria for electronic health record technology. Regulation Identification Number
0991-AB58.
10
R.H Dolin, L. Alschuler, S. Boyer, C. Beebe, F.M. Behlen, P.V. Biron, A. Shabo (2006). HL7 Clinical Document
Architecture, Release 2. Journal of the American Medical Informatics Association. 13(1): 30-39.
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local/state/federal public health information system or through the health information exchanges (HIEs)
-- for reporting these conditions from healthcare facilities/providers to the state and local public health
departments’ programs.
The HL7 CDA R2 format enables implementers to re-use common CDA section and entry level templates
for public health reports. Figure 3 shows a graphical depiction of a public health report created using
CDA templates.
Figure 3 - CDA Framework and Terminology
1.5.1. Use of Consolidated CDA
The Public Health Reporting Specification leverages the Consolidated CDA as a common reference
source for implementers when implementing CDA Sections and Entries. There are specific reasons for
this implementation choice:
 Conformance statements will be directly drawn from the Consolidated CDA as the starting point
for testable conformance. The Public Health Reporting Specification only introduces new
constraints when constraints defined in the Consolidated CDA do not meet the needs of public
health reporting
 This eliminates the possibility of conflicting conformance constraints between public health
reporting and Meaningful Use Stage 1 and Stage 2 regulatory requirements for reporting
 Leverages and ensures consistency with other S&I Framework Initiatives using CDA R2 as a
design basis
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The Public Health Reporting Specification, wherever possible, seeks to avoid the replication of material
directly. With HL7’s recent decision to make its standards available as free intellectual property (IP), the
burden of implementation should be significantly reduced. However, the overall maintenance of a
specification document can be highly burdensome if major changes are introduced, especially since the
Consolidated CDA is directly managed and controlled through the HL7 Structured Documents Working
Group (SDWG).
The PHRI anticipates that new templates at the section and entry level may be needed to support
broader adoption and use of this specification. These new templates may be one of two types:
 A proposed new template with new template ID will be created, with constraints and value sets
defined. This proposed new template would be offered for comment to implementers and
eventually balloted through HL7 as a proposed template for inclusion in existing or new CDAbased templates.
 Modification to an existing template to support a CDA-based public health report. For example,
a new template to represent patient status within a facility. This new template could then be
reused in other CDA-based public health reports and/or implementation guides in the future.
1.5.2. Conformance to this Specification
Conformance statements used in this specification follow commonly used statements characterized in
other CDA-based implementation guides:
 SHALL: an absolute requirement for all use of this template library
 SHALL NOT: an absolute prohibition against inclusion for all use of this template library
 SHOULD/SHOULD NOT: A best practice or recommendation to be considered by each use of this
template library within the context of their requirements; there may be valid reasons to ignore
an item, but the full implications must be understood and carefully weighed before choosing a
different course
 MAY/NEED NOT: This is truly optional language for use of this template library; can be included
or omitted as the domain decides with no implications
The Public Health Reporting Initiative used the Consolidated Conformance Verb Matrix included as part
of the HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1. This
matrix shown below, showing the chosen approach for conformance statements as being RFC 2119 and
the other approaches considered:
Chosen Approach for
Public Health
Conformance
RFC 2119
SHALL
Absolute
requirement of the
specification
Other Approaches Considered
HL7
SHALL
Required/Mandatory
IHE
R (Required)
HITSP
R (Required)
Element must be present
but can be NULL
Data elements must
always be sent. A NULL
can be sent.
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Other Approaches Considered
Chosen Approach for
Public Health
Conformance
RFC 2119
SHALL NOT
HL7
SHALL NOT
Absolute prohibition
of the specification
SHOULD
Not
Required/Mandatory
SHOULD
Recommended There may exist valid
reasons in particular
circumstances to
ignore a particular
item, but the full
implications must be
understood and
carefully weighed
before choosing a
different course.
Best Practice or
Recommendation
SHOULD NOT
IHE
-
HITSP
-
R2 (Required if known)
R2 (Required if known)
If the sending application
has data for the data
element, it is REQUIRED
to populate the data
element. If the value is
not known, the data
element need not be
sent
SHOULD NOT
The sending application
must be able to
demonstrate that it can
send all required if known
elements, unless it does
not in fact gather that
data. If the information
cannot be transmitted, the
data element shall contain
a value indicating the
reason for omission of the
data.
-
Not Recommended
MAY
Not Recommended
MAY
O (Optional)
O (Optional)
Optional
-
Accepted/Permitted
-
C (Conditional)
C (Conditional)
A conditional data element
is one that is required,
required if known or
optional depending upon
other conditions.
Required to be sent
when the conditions
specified in the HITSP
additional specifications
column are true
-
Table 3 - Summary of Conformance Criteria
For initial development of this specification, the proposed approach would rely on defining conformance
language at a high level, with a specific conformance statement defining high-level business
conformance and proposed cardinality. Conformance statements allow programs to append and / or
conformance statements to meet their needs so long as these updates do not change required elements
of a section or entry level template to a level that impedes interoperability, such as changing required
elements expected by a receiving system to optional.
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1.5.3. Constraints in this Specification
All of the CDA templates defined within the Public Health Reporting Specification are constrained as
open templates. This means that all of the features of the CDA R2 base standard are allowed except as
constrained by the templates in the Specification, versus closed templates which define template
constraints that specify everything that is allowed. Implementation guides developed from this
specification may decide to define templates as closed templates to support a particular reporting
program and/or report type.
1.5.4. Use of Value Sets in this Specification
This implementation guide defines a choice for usage of value sets for the PHRI common core data
elements in a CDA template as follows:
 Use approved ONC/MU corresponding value sets as a primary choice;
 In the absence of MU requirements, use PHRI recommendations regarding value sets and/or
coding systems
 In the absence of MU and PHRI recommendations, implementers may add value sets from
existing, incorporated by reference templates, and annotate this choice.
Existing value sets used by CDC programs, for example, may also serve as a choice for value set
implementation.
1.6. Organization of the Specification for Developing New Interoperability Standards
This guide is organized into several key sections and follows a similar format to the Consolidated CDA
document structure:
 CDA Header (defined in Section 2)
 Section Level Templates (defined in Section 4)
 Entry Level Templates (defined in Section 5)
Important differences in organization include:
 Document Level Templates (also referred to as report types) are included in Section 3 of this
Specification for Communicable Disease Case Reporting and Adverse Event Reporting
 General Public Health Reporting Constraints - Generic public health reporting requirements are
established to apply to any public health reporting CDA document. These constraints specifically
apply to constraints on the CDA header and sections, and also include the requirement that the
body of a public health CDA document be represented by a <structuredBody> element
1.6.1. Conventions Used in this Specification
The subsequent sections in 1.5.1 document the general structure of CDA Section-Level and Entry-Level
templates present in this specification.
1.6.1.1.
CDA Section Introduction
The initial table presented in the CDA Sections focuses on two elements:
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Inherits From
References
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Lists the specific CDA Sections and Entries that the CDA Section and/or Entry
specified in this specification will inherit constraints and optionality from.
In most cases, the Consolidated CDA will serve as the source for many of the
sections and entries used in this specification. There may be instances in
some sections of this specification where additional CDA Sections or Entries
may be referenced from outside the Consolidated CDA (specifically data
elements that are considered critical for public health reporting that are not
supported in an existing template.
Lists specific references from existing CDA-based public health reporting
implementation guides, and includes the relevant CDA Sections and/or
Entries that are reusable throughout this specification.
Table 4 - CDA Section Introduction
1.6.1.2.
Table Structure for CDA Sections
The purpose of the Table section in Section 4 (describing CDA Sections) is to show the XPATH (location)
of each content field and the priority of that field in relation of CDA standards and the public health
reporting needs. Table layouts are provided throughout this document to address CDA sections,
Content, and XML layout. The tables will define the following items related to public health report
implementation:
Section of Table
Description of this section
Core Common Mapping
The core common object name from the Public Health Reporting Initiative’s
Data Harmonization Profile is provided to show traceability of PHRI
requirements defined in the user stories and how they are represented using
CDA R2. These base requirements help define a Public Health Reporting
Domain for the Consolidated CDA
Field Name
The Field Name header is a defined section and content portion of the Public
Health Reporting Specification. This represents the Normal/Logical Name of
the CDA element and ties it to the core common data element name. These
names have been pulled directly from the Consolidated CDA to keep
consistent terms between the Consolidated CDA and PHRI specifications.
XPATH
The XPATH is the defined location path of each element and/or attribute
within the CDA R2 XML schema file. The PHRI specification uses these
XPATHs to help demonstrate the scalability of the PHRI specification to
support specific report types
Table 5 - Table Structure for CDA Sections
1.6.1.3.
Table Structure for CDA Entries
The purpose of the Table section in Section 5 (describing CDA Entries) is to show the specific section
level templates the entry level template applies to, list the other entry level templates that may be
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embedded within, and lists the specific core common data elements that may be contained within the
entry level template.
Section of Table
Used Within
May Embed
Core Common
Description of this section
Lists the specific section-level templates that the entry-level template can
apply to.
Lists other entry-level templates that may be embedded within this entrylevel template
Lists the specific public health core common data elements that may be
contained within this entry level template. When looked at within the
template structure of a document-level template, this row shows how many
of the core common data elements can be represented using CDA
Table 6 - Table Structure for CDA Entries
1.6.1.4.
Conformance Statements
Conformance clauses within the CDA Sections and Entries are listed in BOLD type. For the initial draft of
the Public Health Reporting Specification, the conformance statements used are draft, whereby they do
not include specific conformance IDs nor do they include specific cardinality. As the specification moves
from draft to final, these conformance statements will be updated to finalize the specific conformance
ID’s and cardinality for each CDA section and entry.
2. Public Health Reporting Specification – CDA Header
The CDA Header contains data elements that are to be included in a public health report, including
information on the patient, specific contact information for the patient, and associated provider
information. The header elements proposed in the Public Health Reporting Specification are specific to
CDA R2 and are specified to public health CDA documents. The header requirements within this section
are designed to be report-agnostic, as each public health reporting implementation guide would then
add further constraints to their CDA Header which would make those constraints report-specific.
An important note for CDA Header conformance is noted below:

Any public health implementation guide that is developed from this specification MUST include
the following CDA R2 Header elements within Table 2
Field Values
Suggested Values
classCode
moodCode
id
OID for HL7
RegisteredModel
DOCCLIN
EVN
0
Unique ID for CDA
POCD_HD000040
Notes for
Implementation
Core Common
Data Element
2.16.840.1.113883.1.3
CDA R2
document
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Field Values
Specific CDA Document
Type ID
LOINC Code
Suggested Values
Each public health report will
define specific document type
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Notes for
Core Common
Implementation
Data Element
Report Type
Example
displayName
“Adverse Event
Report – CDA”
Vocabulary OID
codeSystemName
title
2.16.840.1.113883.6.1
LOINC
Example
“Adverse Event
Report – FDA
CDA Template”
effectiveTime
confidentialityCode
confidentialityCodeSystem
languageCode
YYYYMMDDHHMMSS+0000
Code
Description
N
Normal
R
Restricted
V
Very Restricted
2.16.840.1.113883.5.25
en-US
Report Date/Time
HL7 v3 confidentiality
ISO-639-2
Table 7 - CDA Header Structure and Suggested Values
Additional header elements are included within the Patient Information and Patient Contact Information
sections of this document (shown below).
2.1. Patient Information
Patient information within a CDA-based public health report is represented in the CDA header through
the recordTarget element. The recordTarget element identifies the patient or patients whose health
history is/are described within this payload. A recordTarget is represented as a relationship between a
person and an organization, where the person is in a patient role (PatientRole class). The entity playing
the role is a patient (Patient class). The entity scoping the role is an organization (Organization class). A
patient is uniquely identified via the PatientRole.id attributes.
Inherits From
CDA Header
2.16.840.1.113883.10.20.22.1.1
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Table 8 - Patient Information – Overview
The following table describes the XPATH associated with the core common data elements aligned to
patient information:
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XPATH
Core Common Data Element
Patient ID
Patient Name
Address Usage
Patient Address
Patient Gender
Patient Marital Status
Patient Race
Patient Ethnicity
ClinicalDocument/recordTarget/patientRole/id
ClinicalDocument/recordTarget/patientRole/patient/name
ClinicalDocument/recordTarget/patientRole/addr/@use
ClinicalDocument/recordTarget/patientRole/addr
ClinicalDocument/recordTarget/patientRole/patient/
administrativeGenderCode
ClinicalDocument/recordTarget/patientRole/patient/
administrativeGenderCode
ClinicalDocument/recordTarget/patientRole /patient/raceCode
ClinicalDocument/recordTarget/patientRole/patient/
ethnicGroupCode
Patient Race Category
ClinicalDocument/recordTarget/patientRole /patient/raceCode
Patient Ethnicity Group
ClinicalDocument/recordTarget/patientRole/patient/
ethnicGroupCode
Patient Email
ClinicalDocument/recordTarget/patientRole/telecom
Patient Age
See Age Observation entry template
Language
Date of Birth
Patient Phone
ClinicalDocument/recordTarget/patientRole/patient/
languageCommunication
ClinicalDocument/recordTarget/patientRole/patient/
birthTime/@value
ClinicalDocument/recordTarget/patientRole/telecom/@use
Table 9 - Patient Information - Header Elements
2.1.1. Conformance of Patient Information

Unless otherwise noted in this section, implementers SHALL implement all conformance
requirements defined in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm)
Constraints for patient information are further divided into sections below:
For a patient’s name as noted in the CDA Header and when used in any part of a public health report,
the following constraints apply:

SHALL contain exactly one [1..1] name (CONF:9368).
o The content of name SHALL be either a conformant Patient Name
(PTN.US.FIELDED), or a string (CONF:9371).
o The string SHALL NOT contain name parts (CONF:9372).
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For a patient’s address as noted in the CDA Header and when used in any part of a public health report,
the following constraints apply:







SHOULD contain 1..1 @use, which SHALL be selected from ValueSet PostalAddressUse
2.16.840.1.113883.1.11.10637 STATIC 2005-05-01 (CONF:7290).
SHOULD contain 0..1 country, where the @code SHALL be selected from ValueSet
CountryValueSet 2.16.840.1.113883.3.88.12.80.63 DYNAMIC (CONF:7295).
SHOULD contain 0..1 state (ValueSet: StateValueSet 2.16.840.1.113883.3.88.12.80.1
DYNAMIC) (CONF:7293).
o State is required if the country is US. If country is not specified, its assumed to be
US. If country is something other than US, the state MAY be present but MAY be
bound to different vocabularies (CONF:10024).
SHALL contain 1..1 city (CONF:7292).
SHOULD contain 0..1 postalCode (ValueSet: PostalCodeValueSet
2.16.840.1.113883.3.88.12.80.2 DYNAMIC) (CONF:7294).
o PostalCode is required if the country is US. If country is not specified, its assumed to
be US. If country is something other than US, the postalCode MAY be present but
MAY be bound to different vocabularies (CONF:10025).
SHALL contain at least one and not more than 4 streetAddressLine (CONF:7291).
SHALL NOT have mixed content except for white space (CONF:7296).
2.1.2. Value Sets
The following value sets are applicable to the CDA Header for entering patient information:
Value Set Name
HL7 Marital Status
PHVS_Race_CDC
Value Set OID
2.16.840.1.113883.1.11.12212
2.16.840.1.114222.4.11.876
PHVS_Ethnicity_CDC
2.16.840.1.114222.4.11.877
PHVS_RaceCategory_CDC
2.16.840.1.114222.4.11.836
PHVS_EthnicityGroup_CDC
2.16.840.1.114222.4.11.837
PHVS_Language_ISO_639-2_Alpha3
2.16.840.1.114222.4.11.831
Telecom Use
2.16.840.1.113883.11.20.9.20
Language
2.16.840.1.113883.1.11.11526
PHVS_Gender_SyndromicSurveillance 2.16.840.1.114222.4.11.3403
Type
Defined by Meaningful Use
Specified by PHRI Data
Harmonization Profile
Specified by PHRI Data
Harmonization Profile
Specified by PHRI Data
Harmonization Profile
Specified by PHRI Data
Harmonization Profile
Specified by PHRI Data
Harmonization Profile
Specified by PHRI Data
Harmonization Profile
Defined by Meaningful Use
Specified by PHRI Data
Harmonization Profile
Table 10 - CDA Header Value Sets (Patient Information)
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2.1.3. Examples of Patient Information
<recordTarget typeCode="RCT" contextControlCode="OP">
<patientRole>
<id extension="#########"/>
<addr use="HP">
<streetAddressLine>15 New Kidney St. </streetAddressLine>
<city>Richmond</city>
<state>VA</state>
<postalCode>22222</postalCode>
</addr>
<telecom use="HP" value="tel:+1-703-555-1212"/>
<telecom use="WP" value="tel:+1-703-555-2323"/>
<patient>
<name use="L">
<given qualifier="CL">Jane</given>
<given qualifier="CL">M</given>
<family qualifier="BR">Snow</family>
</name>
<administrativeGenderCode code="F" displayName="Female" codeSystem="2.16.840.1.113883.5.1"
codeSystemName="HL7 AdministrativeGenderCode"/>
<birthTime value="19610821"/>
</patient>
</patientRole>
</recordTarget>
2.2. Patient Contact Information
Patient Contact Information is included within the CDA Header and can use multiple elements
depending on the type of relationship being established.
Inherits From
CDA Header
2.16.840.1.113883.10.20.22.1.1
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Table 11 - Patient Contact Information CDA Section Overview
It is expected that for a public health report, the following general rules may apply when defining
different patient contacts:
Type of Relationship (CDA
General Usage
Usage in Public Health Reports
Name)
Informant
Used for direct relationship types Informants can be used to
define specific relationships to
the patient that relate to their
most immediate family – i.e.
spouse
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Type of Relationship (CDA
Name)
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
General Usage
Usage in Public Health Reports
Custodian
Used for indirect relationship
types
Participant
Used for supporting relationships
Guardian
Used for legal relationships
For example, if a person is
diagnosed as exposed to a toxic
substance, immediate contact
information can be provided for
a spouse.
Custodians would not be
required at this time in public
health reports.
Support relationships can be
established using the HL7
Personal Relationship Type
value set, to identify the specific
type of supporting relationship.
For example, a public health
agency may wish to contact a
patient’s supporting relationship
to make further inquiries about
a specific diagnosis that has
been found.
Guardian can be defined where
the patient is a child or is
incapable of specific
communication.
For example, during a mass
casualty event, a public health
report may include information
about a specific child’s guardian
Table 12 - Patient Contact Information – Types
The following table summarizes data elements used to define an <informant> relationship:
CDA Element Name
typeCode
time
assignedEntity
classCode
id
Address
Telephone use
XPATH
ClinicalDocument/informant/@typeCode
ClinicalDocument/informant/time/@value
assignedEntity
assignedEntity/classCode
assignedEntity/id
assignedEntity/addr
assignedEntity/telecom/@use
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CDA Element Name
Telephone #
Person name
representedOrganization id
representedOrganization name
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
assignedEntity/telecom/@value
assignedEntity/assignedPerson/name
assignedEntity/representedOrganization/id@root
assignedEntity/representedOrganization/name
Table 13 - Patient Contact Information - CDA Detail for Informant
The following table summarizes data elements used to define a <participant> relationship
CDA Data Element Name
typeCode
templateId
classCode
codeCode
displayName
codeSystem
codeSystemName
Address use
Address
Telephone use
Telephone #
associatedPerson
XPATH
ClinicalDocument/participant/@typeCode
ClinicalDocument/participant/templateId/@root
@classCode
code/@code
code/@displayName
code/@codeSystem
code/@codeSystemName
addr/@use
addr
telecom/@use
telecom/@value
associatedPerson/name
Table 14 - Patient Contact Information - CDA Detail for Participant
The following table shows how patient contact information can be represented for maternal health:
CDA Data Element Name
Mother's name
Mother's place of residence
Mother's phone number
Mother's date of birth
Mother's birthplace
Mother's race
Mother's ethnicity
Mother's education
Mother's language
XPATH
recordTarget/patientRole/patient/guardian/guardianPerson/n
ame
recordTarget/patientRole/patient/guardian/addr
recordTarget/patientRole/patient/guardian/telecom
recordTarget/patientRole/patient/guardian/birthTime
recordTarget/patientRole/patient/guardian/birthplace/place
recordtarget/patientRole/patient/guardian/raceCode
recordTarget/patientRole/patient/guardian/ethnicGroupCode
recordTarget/patientRole/patient/guardian/
languageCommunication
Table 15 - Patient Contact Information - CDA Detail for Maternal Health
2.2.1. Conformance of Patient Contact Information
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Unless otherwise noted in this section, implementers SHALL implement all conformance requirements
defined in the Implementation Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm)
specific to the <Participant> element. These include the following:
 MAY contain 0..* participant (CONF:10003).
o The participant, if present, MAY contain 0..1 time (CONF:10004).
o Such participants, if present, SHALL have an associatedPerson or
scopingOrganization element under participant/associatedEntity (CONF:10006).
o Unless otherwise specified by the document specific header constraints, when
participant/@typeCode is IND, associatedEntity/@classCode SHALL be selected
from ValueSet 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes STATIC 2011-09-30
(CONF:10007).
2.2.2. Value Sets
The following value sets are specific to defining Patient Contact Information in a CDA document:
Value Set Name
Value Set ID
PHVS_PersonalRelationshipRoleType_HL7_V3 2.16.840.1.113883.1.11.19563
Specified by PHRI
Data Harmonization
Profile
Table 16 - Patient Contact Information Value Sets
2.2.3. Examples of Patient Contact Information
<participant typeCode="IND" contextControlCode="OP">
<templateId root="2.16.840.1.113883.3.88.11.32.3"/>
<time/>
<associatedEntity classCode="PRS">
<code code="DAU" displayName="Daughter" codeSystem="2.16.840.1.113883.5.111"
codeSystemName="HL7 RoleCode"/>
<addr use="HP">
<streetAddressLine>612 Wharf Ave.</streetAddressLine>
<city>Fairfax</city>
<state>VA</state>
<postalCode>20151</postalCode>
</addr>
<telecom use="HP" value="tel:+1-703-555-0033"/>
<telecom use="WP" value="tel:+1-703-555-3434"/>
<telecom value="mailto:Janet_Snow@email.com"/>
<associatedPerson>
<name>
<given>Janet</given>
<family>Snow</family>
<suffix/>
</name>
</associatedPerson>
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</associatedEntity>
</participant>
2.3. Representing Report Data Elements
The Public Health Reporting Initiative Data Harmonization Profile and CSTE both define data elements
specific to the concept of a “report” which represent the report metadata.
Report data elements specific to a CDA-based public health report may be represented in several
formats:




Use of metadata specific to a transport profile, such as IHE or Direct (outside the scope of this
implementation guide)
Use of the author component
Use of the dataEnterer component
Use of the legalAuthenticator component
2.3.1. Author within Public Health Report
The following conformance constraints apply to defining the author within a CDA-based public health
report:
 SHALL contain 1..* author (CONF:5444).
 Such authors SHALL contain 1..1 time (CONF:5445).
o The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.4) (CONF:16866).
 Such authors SHALL contain 1..1 assignedAuthor (CONF:5448).
o This assignedAuthor SHALL contain 1..1 id (CONF:5449) such that it
 SHALL contain 1..1 @root="2.16.840.1.113883.4.6" National Provider Identifier
(CONF:16786).
o This assignedAuthor SHOULD contain 0..1 code (CONF:16787).
 The code, if present, SHOULD contain 1..1 @code, which SHOULD be selected
from ValueSet Healthcare Provider Taxonomy (NUCC - HIPAA)
2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:16788).
o This assignedAuthor SHALL contain 1..* addr (CONF:5452).
 The content SHALL be a conformant US Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:16871).
o This assignedAuthor SHALL contain 1..* telecom (CONF:5428).
 Such telecoms SHOULD contain 1..1 @use, which SHALL be selected from
ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20
DYNAMIC (CONF:7995).
o This assignedAuthor SHALL contain exactly one [1..1] assignedPerson or
assignedAuthoringDevice (CONF:5430).
 The assignedPerson, if present, SHALL contain 1..* name (CONF:16789).
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 The content SHALL be a conformant US Realm Person Name
(PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:16872).
This assignedAuthor SHOULD contain 0..1 assignedAuthoringDevice (CONF:16783).
 The assignedAuthoringDevice, if present, SHALL contain 1..1
manufacturerModelName (CONF:16784).
 The assignedAuthoringDevice, if present, SHALL contain 1..1 softwareName
(CONF:16785).
There SHALL be exactly one assignedAuthor/assignedPerson or exactly one
assignedAuthor/assignedAuthoringDevice (CONF:16790).
2.3.2. DataEnterer within Public Health Report
The following conformance constraints apply to defining the dataEnterer within a CDA-based public
health report:


MAY contain 0..1 dataEnterer (CONF:5441).
The dataEnterer, if present, SHALL contain 1..1 assignedEntity (CONF:5442).
o This assignedEntity SHALL contain 1..* id (CONF:5443).
 Such ids SHOULD contain 0..1 @root="2.16.840.1.113883.4.6" National
Provider Identifier (CONF:16821).
o This assignedEntity SHALL contain 1..* addr (CONF:5460).
 The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10417).
o This assignedEntity SHALL contain 1..* telecom (CONF:5466).
 Such telecoms SHOULD contain 1..1 @use, which SHALL be selected from
ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20
DYNAMIC (CONF:7996).
o This assignedEntity SHALL contain 1..1 assignedPerson (CONF:5469).
 This assignedPerson SHALL contain 1..* name (CONF:5470).
 The content of name SHALL be a conformant US Realm Person Name
(PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10418).
o This assignedEntity MAY contain zero or one [0..1] code which SHOULD be selected
from coding system NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101
(CONF:9944).
2.3.3. LegalAuthenticator within Public Health Report
The following conformance constraints apply to defining the legalAuthenticator within a CDA-based
public health report:

SHOULD contain 0..1 legalAuthenticator (CONF:5579).

The legalAuthenticator, if present, SHALL contain 1..1 time (CONF:5580).
o The content SHALL be a conformant US Realm Date and Time (DTM.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.4) (CONF:16873).
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The legalAuthenticator, if present, SHALL contain 1..1 signatureCode (CONF:5583).
o This signatureCode SHALL contain 1..1 @code="S" (CodeSystem: Participationsignature
2.16.840.1.113883.5.89 STATIC) (CONF:5584).
The legalAuthenticator, if present, SHALL contain 1..1 assignedEntity (CONF:5585).
o This assignedEntity SHALL contain 1..* id (CONF:5586).
 Such ids MAY contain 0..1 @root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:16823).
o This assignedEntity MAY contain 0..1 code, which SHOULD be selected from ValueSet
Healthcare Provider Taxonomy (NUCC - HIPAA) 2.16.840.1.114222.4.11.1066 STATIC
(CONF:17000).
o This assignedEntity SHALL contain 1..* addr (CONF:5589).
 The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2) (CONF:10429).
o This assignedEntity SHALL contain 1..* telecom (CONF:5595).
 Such telecoms SHOULD contain 1..1 @use, which SHALL be selected from
ValueSet Telecom Use (US Realm Header) 2.16.840.1.113883.11.20.9.20
DYNAMIC (CONF:7999).
o This assignedEntity SHALL contain 1..1 assignedPerson (CONF:5597).
 This assignedPerson SHALL contain 1..* name (CONF:5598).
 The content of name SHALL be a conformant US Realm Person Name
(PN.US.FIELDED) (2.16.840.1.113883.10.20.22.5.1.1) (CONF:10430).
NOTE: The legalAuthenticator approach for report data elements is not the best method for
representing Report data elements, but may be needed specific to jurisdictional or program
requirements.
3. Public Health Reporting Specification – CDA Document Level Templates
Because this specification is intended to serve as a “template catalog” for use by public health, a specific
set of document-level templates and OIDs is not specified. Two examples for the structure of an
implementation guide derived from this specification are provided in this section. Each of the public
health reporting specifications in this section define a conformant CDA document that can be used to
exchange a specific public health report. For the use of CDA as the mechanism to exchange public health
reporting information, the following elements must be in place as part of the implementation guide.



Scope and intended use of the public health reporting document – for each report type, a clear
explanation
Description and explanatory narrative
Public Health Reporting Template metadata (e.g., templateId, etc.)
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In addition, as part of Sections 3.1 and 3.2, the following will be specified11:


Header constraints: this includes a reference to the US Realm Clinical Document Header
template and additional constraints specific to each document type
Required and optional section-level and entry-level templates for each public health reporting
type. Programs may choose “Entry” level templates that meet their requirements within the
Section template (which has template ID)
The approach used to identify and define report types is shown below. A summary of available reports
provided in this specification are documented in the table below, based on the following requirements:



Description of the report
What CDA sections MUST be included in the report type to make it compliant with this
specification
What CDA entries MUST be included in the report type to make it compliant with this
specification
To support compatibility between multiple versions of CDA templates, this specification has been
designed to be compatible with Consolidated CDA, which represents a catalog of templates that are
reused across many CDA-based implementation guides. Wherever possible, these reusable CDA sectionlevel and CDA entry-level templates will be used to develop document-level templates, such as an
adverse event report.
3.1. Adverse Event Report
For a CDA-based adverse event report, the proposed approach is to develop a Document-Level template
that contains the adverse event report information. This document-level template would be defined at a
high level with specific CDA Sections and CDA Entries that would be needed to conform to the
document-level template. Further details for the adverse event report would be outside the scope of
this specification and would be defined in a formal implementation guide.
3.1.1. High Level Conformance Requirements
The <structuredBody> of the Adverse Event Report Type SHALL conform to the following section
constraints below:
 SHALL contain one or more [1..] Allergies Section (templateId:2.16.840.1.113883.10.20.22.2.6.1)
 SHALL contain one or more [1..1] Medications Section
(templateId:2.16.840.1.113883.10.20.22.2.1.1)
 SHALL contain one or more [1..1] Problem Section
(templateId:2.16.840.1.113883.10.20.22.2.5.1)
 SHOULD contain exactly one [1..1] Procedures Section
(templateId:2.16.840.1.113883.10.20.22.2.7.1)
11
Note that draft examples of XML and HTML “reports” created using the specification for adverse event and
communicable disease case reporting are available on the PHRI wiki, here:
http://wiki.siframework.org/PHRI+Harmonization+and+Standards+Materials
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






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SHALL contain exactly one [1..1] Results Section (templateId:2.16.840.1.113883.10.20.22.2.3.1)
MAY contain zero or one [0..1] Encounters Section (entries optional)
(templateId:2.16.840.1.113883.10.20.22.2.22)
MAY contain zero or one [0..1] Family History Section
(templateId:2.16.840.1.113883.10.20.22.2.15)
MAY contain zero or one [0..1] Immunizations Section
(templateId:2.16.840.1.113883.10.20.22.2.2)
MAY contain zero or one [0..1] Medical Equipment Section
(templateId:2.16.840.1.113883.10.20.22.2.23)
MAY contain zero or one [0..1] Social History Section
(templateId:2.16.840.1.113883.10.20.22.2.17)
MAY contain zero or one [0..1] Vital Signs Section (templateId:2.16.840.1.113883.10.20.22.2.4)
3.1.2. Template Structure for Adverse Event Report
Template Name
Adverse Event Report
Allergies Section
Allergy Problem Act
Allergy Intolerance
Observation
Allergy Status Observation
Reaction Observation
Medication Activity
Drug Vehicle
Indication
Instructions
Medication Dispense
Immunization Medication
Information
Medication Information
Medication Supply Order
Immunization Medication
Information
Instructions
Medication Information
Encounter Section
Encounter Activity
Chief Complaint and Reason
for Visit
Family History Section
Family History Organizer
Family History Observation
Template Type
Document
Section
Entry
Entry
OID
To be defined
2.16.840.1.113883.10.20.22.2.6.1
2.16.840.1.113883.10.20.22.4.30
2.16.840.1.113883.10.20.22.4.7
Entry
Entry
Entry
Entry
Entry
Entry
Entry
Entry
2.16.840.1.113883.10.20.22.4.28
2.16.840.1.113883.10.20.22.4.9
2.16.840.1.113883.10.20.22.4.16
2.16.840.1.113883.10.20.22.4.24
2.16.840.1.113883.10.20.22.4.19
2.16.840.1.113883.10.20.22.4.20
2.16.840.1.113883.10.20.22.4.18
2.16.840.1.113883.10.20.22.4.54
Entry
Entry
Entry
2.16.840.1.113883.10.20.22.4.23
2.16.840.1.113883.10.20.22.4.17
2.16.840.1.113883.10.20.22.4.54
Entry
Entry
Section
Entry
Section
2.16.840.1.113883.10.20.22.4.20
2.16.840.1.113883.10.20.22.4.23
2.16.840.1.113883.10.20.22.2.22.1
2.16.840.1.113883.10.20.22.4.49
2.16.840.1.113883.10.20.22.2.13
Section
Entry
Entry
2.16.840.1.113883.10.20.22.2.15
2.16.840.1.113883.10.20.22.4.45
2.16.840.1.113883.10.20.22.4.46
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Template Name
Age Observation
Family History Death
Observation
Immunization Section
Immunization Activity
Immunization Refusal Reason
Medical Equipment Section
Non-Medicinal Supply Activity
Product Instance
Medication Section
Medication Activity
Problem Section
Problem Concern Act
Problem Observation
Age Observation
Health Status Observation
Problem Status Observation
Result Section
Result Organizer
Result Observation
Vital Signs Section
Vital Sign Organizer
Vital Sign Observation
Template Type
Entry
Entry
Section
Entry
Entry
Section
Entry
Entry
Section
Entry
Section
Entry
Entry
Entry
Entry
Entry
Section
Entry
Entry
Section
Entry
Entry
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
OID
2.16.840.1.113883.10.20.22.4.31
2.16.840.1.113883.10.20.22.4.47
2.16.840.1.113883.10.20.22.2.2.1
2.16.840.1.113883.10.20.22.4.52
2.16.840.1.113883.10.20.22.4.53
2.16.840.1.113883.10.20.22.2.23
2.16.840.1.113883.10.20.22.4.50
2.16.840.1.113883.10.20.22.4.37
2.16.840.1.113883.10.20.22.2.1.1
2.16.840.1.113883.10.20.22.4.16
2.16.840.1.113883.10.20.22.2.5.1
2.16.840.1.113883.10.20.22.4.3
2.16.840.1.113883.10.20.22.4.4
2.16.840.1.113883.10.20.22.4.31
2.16.840.1.113883.10.20.22.4.5
2.16.840.1.113883.10.20.22.4.6
2.16.840.1.113883.10.20.22.2.3.1
2.16.840.1.113883.10.20.22.4.1
2.16.840.1.113883.10.20.22.4.2
2.16.840.1.113883.10.20.22.2.4.1
2.16.840.1.113883.10.20.22.2.4.1
2.16.840.1.113883.10.20.22.4.27
Table 17 - Template Structure for Adverse Event Report
3.2. Communicable Disease Case Reporting (Public Health Case Report)
The CDA for PHCR of reportable conditions (diseases) is included in this section to closely align to the
2009 HL7 Implementation Guide for CDA Release 2: Public Health Case Reporting, Release 1 - US Realm.
This 2009 guide focused on the reporting flow from the provider to the local or state public health
departments and NOT the verification process or the reporting of a confirmed condition to the national
public health system (CDC). Furthermore, this section may serve as an update the 2009 guide to include
recent data harmonization updates by CSTE/CDC’s Case Report Standardization Workgroup and, more
recently, a pilot project by the Public Health Data Standards Consortium (PHDSC) and CSTE*. The
PHDSC and CSTE collaborative to develop CDA content modules for 15 reportable conditions is
referenced as part of creating a base “public health communicable disease model” for all reportable
conditions.
Specific information on piloting of reportable conditions by the States of Delaware, New York and
California, which are used as input to this specification, are available at the following location:
https://wiki.phdsc.org/index.php/CDA
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Upon completion of this specification, the catalog of templates in the base model for reportable
conditions will be uploaded into the Model Driven Health Tools (MDHT) for use in developing future
implementation guides based on reportable conditions.
3.2.1. High Level Conformance Requirements for Communicable Disease Case
Reporting
To support a base level of conformance for a reportable condition, the following high level conformance
requirements are proposed. These high level requirements apply to all public health case reports as a
common baseline of section-level templates:
 SHALL contain [1..1] Social History Section (templateId:2.16.840.1.113883.10.20.15.2.22)
 SHALL contain [1..1] PHCR Clinical information section
(templateId:2.16.840.1.113883.10.20.15.2.1)
 SHALL contain [1..1] PHCR Treatment information section
(templateId:2.16.840.1.113883.10.20.15.2.4)
 SHALL contain [1..1] Encounter Section (templateId:2.16.840.1.113883.10.20.15.2.2)
 SHALL contain [1..1] Result Section (templateId: 2.16.840.1.113883.10.20.22.2.3.1)
 SHALL contain [1..1] Immunizations Section (templateId:2.16.840.1.113883.10.20.1.6)
 MAY contain [1..1] Vital Signs Section (templateId: 2.16.840.1.113883.10.20.22.2.4.1)
3.2.2. Template Structure for Communicable Disease Case Reporting
This table outlines the base structure of a Communicable disease case report. This can then be extended
for individual communicable disease case reports and other types of communicable diseases. There are
two tables in this section – a table that provides a roadmap for communicable disease reports to use as
a baseline list of templates, and a table to define optional templates to include for communicable
disease case reports.
Template Name
Communicable disease case
report Case Report
PHCR Clinical Information
PHCR Treatment Information
Encounter Section
Encounter Activity
Immunization Section
Immunization Medication
Activity
Problem Section
Problem Concern Act
Problem Observation
Problem Status
Results Section
Result Organizer
Template Type
Document
OID
To be determined
Section
Section
Section
Entry
Section
Entry
2.16.840.1.113883.10.20.15.2.1
2.16.840.1.113883.10.20.15.2.4
2.16.840.1.113883.10.20.22.2.22.1
2.16.840.1.113883.10.20.22.4.49
2.16.840.1.113883.10.20.22.2.2.1
2.16.840.1.113883.10.20.22.4.52
Section
Entry
Entry
Entry
Section
Entry
2.16.840.1.113883.10.20.22.2.5.1
2.16.840.1.113883.10.20.22.4.3
2.16.840.1.113883.10.20.22.4.4
2.16.840.1.113883.10.20.22.4.6
2.16.840.1.113883.10.20.22.2.3.1
2.16.840.1.113883.10.20.22.4.1
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Template Name
Result Observation
Social History Section
Social History Observation
Vital Signs Section
Vital Signs Organizer
Vital Signs Observation
Template Type
Entry
Section
Entry
Section
Entry
Entry
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
OID
2.16.840.1.113883.10.20.22.4.2
2.16.840.1.113883.10.20.22.2.17
2.16.840.1.113883.10.20.22.4.38
2.16.840.1.113883.10.20.22.2.4.1
2.16.840.1.113883.10.20.22.2.4.1
2.16.840.1.113883.10.20.22.4.27
Table 18 - Template Structure for Communicable Disease Case Report
3.2.3. Alignment of PHRI to PHCR 2009
In preparation of the work for this high level alignment, an initial analysis of the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reports (US Realm) was generated. Through this analysis, a
high level view of how the work developed in 2009 for public health case reporting can be transitioned
to Consolidated CDA over time:
Proposed Template in PHRI CDA
Social History Section
2.16.840.1.113883.10.20.22.2.17
Corresponding Template in PHCR
2009
Social History Section
Reasoning Used
The current template was
deemed to represent data
elements correctly
Vital Signs Section
2.16.840.1.113883.10.20.22.2.4.1
Not present in PHCR 2009
Immunization Section
2.16.840.1.113883.10.20.22.2.2
Immunizations Section
Results Section
2.16.840.1.113883.10.20.22.2.3.1
PHCR Relevant Orders/Diagnostic
Tests
The current template was
deemed to represent data
elements correctly
PHCR Clinical Information
(proposed)
PHCR Clinical Information
The current template was
deemed to represent data
elements correctly
PHCR Treatment Information
(proposed)
PHCR Treatment Information
Current template supports
reportable condition
requirements
The current template was
deemed to represent data
elements correctly
Pilot testing will be needed to
ensure this template is
acceptable for inclusion in
PHRI CDA
The current template was
deemed to represent data
elements correctly
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Proposed Template in PHRI CDA
Encounters Section (entries
optional)
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Corresponding Template in PHCR
Reasoning Used
2009
Pilot testing will be needed to
ensure this template is
acceptable for inclusion in
PHRI CDA
Encounters Section
The consolidated CDA
template for Encounters will
work for capturing the
necessary information
Table 19 – High Level PHRI to PHCR Template Alignment
3.2.4. Alignment of CDA to CSTE
To support CSTE recommendations for public health case reporting, a mapping of CSTE data elements to
PHRI-defined CDA templates was generated. This analysis is included below:
CSTE Category
Report
CSTE Data
Element
Report
Date/Time
Alert creation
date/time
Reporting
system
CDA Template
Representation
Represented in the CDA
Header as the
<effectivetime> element
Represented in the CDA
Header as the
<effectiveTime> element
Can be represented in
the CDA Header using
multiple elements:
CDA XPath (listed for informative purposes)
/ClinicalDocument/effectiveTime
/ClinicalDocument/effectiveTime
/ClinicalDocument


Facility
Facility ID
Facility Name
Facility Address
<author>
legalAuthenticat
or
 custodian
 dataEnterer
The Facility ID is
represented in the
Service Delivery Location
Entry Template OR in the
<encompassingEncounte
r> element in the CDA
Header
The Facility Name is
represented in the
Service Delivery Location
Entry Template
The Facility Address is
/ClinicalDocument/componentOf/
encompassingEncounter/location/
healthCareFacility/id
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation/participant/
participantRole/playingEntity/name
/ClinicalDocument/component/
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CSTE Category
CSTE Data
Element
Facility Phone
Facility Email
Employment
information
Patient
Information
Occupation,
current
Occupation,
usual
Industry type,
current
Industry type,
usual
Employer name
Employer
address
Employer phone
Identifier
Name
Address
Phone
Email address
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
CDA Template
Representation
represented in the
Service Delivery Location
Entry Template
The Facility ID is
represented in the
Service Delivery Location
Entry Template
The Facility ID is
represented in the
Service Delivery Location
entry template
Can be represented using
the Social History Section
defined in a Social
History Observation
entry template
Represented in the CDA
Header as part of the
recordTarget element.
Represented in the CDA
Header as part of the
recordTarget element.
Represented in the CDA
Header as part of the
recordTarget element.
Represented in the CDA
Header as part of the
recordTarget element.
Defined within the
<telecom> element
Represented in the CDA
Header as part of the
recordTarget element.
structuredBody/component/section/
entry/observation/participant/
participantRole/addr
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation/participant/
participantRole/telecom
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation/participant/
participantRole/telecom
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation
/ClinicalDocument/recordTarget/
patientRole/id
/ClinicalDocument/recordTarget/
patientRole/patient/name
/ClinicalDocument/recordTarget/
patientRole/addr
/ClinicalDocument/recordTarget/
patientRole/telecom
/ClinicalDocument/recordTarget/
patientRole/telecom
Defined within the
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CSTE Category
CSTE Data
Element
Date of birth
Age
CDA Template
Representation
<telecom> element
(multiple elements
supported for phone
numbers and email
addresses)
Represented in the CDA
Header as part of the
recordTarget element.
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
Defined within the
<birthTime> element
Can be calculated using
the <birthTime> element
/ClinicalDocument/recordTarget/
patientRole/patient/birthTime
/ClinicalDocument/recordTarget/
patientRole/patient/birthTime
OR
Age units [code]
Can be represented using
an age Observation entry
template
Can be calculated using
the <birthTime> element
/ClinicalDocument/recordTarget/
patientRole/patient/birthTime
OR
Gender
Race
Ethnicity
Can be represented using
an age Observation entry
template
Represented in the CDA
Header as part of the
recordTarget element.
Within recordTagret,
defined using
<administrativeGenderCo
de>
Represented in the CDA
Header as part of the
recordTarget element.
Within recordTarget,
defined using
<raceCode>
Represented in the CDA
/ClinicalDocument/recordTarget/
patientRole/patient/
administrativeGenderCode
/ClinicalDocument/recordTarget/
patientRole/patient/raceCode
/ClinicalDocument/recordTarget/
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CSTE Category
CSTE Data
Element
Translator
needed
Language
spoken
Identifier
Provider
Information
Provider ID
Provider Name
Provider
Address
Provider Phone
Provider Email
CDA Template
Representation
Header as part of the
recordTarget element.
Within recordTarget,
defined using
<ehtnicityCode>
The PHRI initiative did
not specifically define
this element within CDA
as it was felt that the
Boolean value for the
need for a translator is
best determined by
policy, and is not needed
in a CDA document.
If an implementation
wishes to represent this
element, they may use
the preferenceInd
element.
Represented in the CDA
Header as part of the
recordTarget
Within recordTarget,
defined using the
<languageCommunicatio
n> element
Represented in the CDA
Header as part of the
recordTarget
Represented in the CDA
Header
Represented in the CDA
Header
Represented in the CDA
Header
Represented in the CDA
Header
Represented in the CDA
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
patientRole/patient/ethnicGroupCode
N/A
/ClinicalDocument/recordTarget/
patientRole/patient/
languageCommunication/
languageCode
/ClinicalDocument/recordTarget/
patientRole/id
/ClinicalDocument/recordTarget/
patientRole/providerOrganization/id
/ClinicalDocument/recordTarget/
patientRole/providerOrganization/name
/ClinicalDocument/recordTarget/
patientRole/providerOrganization/addr
/ClinicalDocument/recordTarget/
patientRole/providerOrganization/telec
om
/ClinicalDocument/recordTarget/
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CSTE Category
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CDA XPath (listed for informative purposes)
CSTE Data
Element
Address
CDA Template
Representation
Header
Provider Role
Represented in the CDA
Header
The Unique medical
record number can be
represented within the
CDA Header using the
setID element
The Diagnosis Code can
be represented in the
Problem Section as part
of a Problem Observation
entry template
The Chief
Complaint/Reason for
Visit can be represented
in the Chief
Complaint/Reason for
visit template
Triage Notes can be
represented in the Chief
Complaint/Reason for
Visit template
Clinical Impression can
be represented in the
Chief Complaint/Reason
for Visit template
The Diagnosis Type can
be represented within
the Problem Section as
part of a Problem
Observation template
The Discharge
Disposition is
represented within the
Encounter Section as part
of an Encounter Activities
template
The Disposition
Date/Time is represented
within the Encounter
Section as part of an
Health Record
Unique Medical
Record Number
Health
Problems
Diagnosis Code
Chief Complaint
/Reason for visit
Triage notes
Clinical
Impression
Diagnosis Type
Discharge
Disposition
Disposition
Date/Time
patientRole/providerOrganization/telec
om
/ClinicalDocument/setId
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation
/ClinicalDocument/component/
structuredBody/component
/ClinicalDocument/component/
structuredBody/component
/ClinicalDocument/component/
structuredBody/component
/ClinicalDocument/component/
structuredBody/component/section/
entry/observation
/ClinicalDocument/componentOf/
encompassingEncounter/
dischargeDispositionCode
/ClinicalDocument/componentOf/
encompassingEncounter/effectiveTime
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CSTE Category
CSTE Data
Element
Unique Visiting
ID
Visit date/time
Date of onset
Encounter
Encounter ID
Encounter Type
Encounter
Facility
Identifier
Unique Visiting
ID
Visit date/time
Date of onset
Patient class
Immunization
CDA Template
Representation
Encounter Activities
template
The Unique Visiting ID is
represented within the
Encounter Section
The Visit Date/Time is
represented within the
Encounter Section
The Discharge
Disposition is
represented within the
Encounter Section
The Encounter ID can be
represented in the
Encounter Section
The Encounter Type can
be represented in the
Encounter Section
The Encounter Facility
Identifier can be
represented in the
Encounter Section within
the Service Delivery
Location entry template
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
The Visit date/time can
be represented in the
<encompassingEncounte
r> element
The Date of Onset can be
represented in the
<encompassingEncounte
r> element
The Patient Class can be
represented in the
<encompassingEncounte
r> element
Immunization
information is included in
the immunization
Section. Each
Immunization can be
/ClinicalDocument/componentOf/
encompassingEncounter/effectiveTime/
/ClinicalDocument/componentOf/
encompassingEncounter/effectiveTime/
/ClinicalDocument/component/
structuredBody/component/section/id
/ClinicalDocument/component/
structuredBody/component/section/code
/ClinicalDocument/componentOf/
encompassingEncounter/location/
healthCareFacility/id
/ClinicalDocument/componentOf/
encompassingEncounter/effectiveTime
/ClinicalDocument/componentOf/
encompassingEncounter/effectiveTime
/ClinicalDocument/componentOf/
encompassingEncounter/code
/ClinicalDocument/component/
structuredBody/component/section
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CSTE Category
Primary
Contact
CSTE Data
Element
Name
Address
Phone
Family
Relationship
Procedure
Procedure Code
Procedure Type
Order
Result
Specimen
Specimen
Collection
Date/Time
Specimen
Parent ID
Specimen
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
CDA Template
Representation
represented using an
Immunization Activity
entry template
The Patient Contact
Name can be
represented in the CDA
Header
The Patient Contact
Address can be
represented in the CDA
Header
The Patient Contact
Phone can be
represented in the CDA
Header
The Patient Family
Relationship can be
represented in the
The Procedure Code can
be Represented in the
Procedure Section as part
of a Procedure Act
Activity entry template
The Procedure Type can
be represented in the
Procedure Section as part
of a Procedure Act
Activity entry template
Order codes are
represented using a
Medication Supply Order
entry template
The Result code is
represented in the Result
Section as part of a
Result Observation entry
Each of the specimen
elements are collected
using the Laboratory
Report Item entry
template.
/ClinicalDocument/recordTarget/
patientRole/patient/guardian
/ClinicalDocument/recordTarget/
patientRole/patient/guardian
/ClinicalDocument/recordTarget/
patientRole/patient/guardian
/ClinicalDocument/recordTarget/
patientRole/patient/guardian
/ClinicalDocument/component/
structuredBody/component/section/entry
/ClinicalDocument/component/
structuredBody/component/section/entry
/ClinicalDocument/component/
structuredBody/component/section/entry
/ClinicalDocument/component/
structuredBody/component/section/entry
/ClinicalDocument/component/
structuredBody/component/section/entry
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CSTE Category
Vital Signs
(Patient
Health
Indicators)
CSTE Data
Element
Received
Date/Time
Specimen Type
SpecimenSource
Site
Specimen Origin
Initial
Temperature
Initial Pulse
Oximetry
CDA Template
Representation
Represented in the Vital
Signs section as part of a
Vital Signs Observation
entry template
Represented in the Vital
Signs section as part of a
Vital Signs Observation
entry template
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
CDA XPath (listed for informative purposes)
/ClinicalDocument/component/
structuredBody/component/section/entry
/ClinicalDocument/component/
structuredBody/component/section/entry
Table 20 - Alignment of CDA to CSTE Recommendations
4. Public Health Reporting Specification – CDA Section Level Templates
The structure of this section was designed to follow a similar structure to other types of specifications
and implementation guides. The Federal Health Information Model (FHIM) may also be used in support
of Section 4.

Note that the explanations in Section 4 are not designed to be comprehensive. This section is
intended to provide an overview of CDA Sections that would be reused within public health
reporting implementation guides.
4.1. Allergy/Adverse Event
The Allergy/Adverse Event12 section supports public health reporting requirements to exchange
information about medicinal allergies, as well as allergic reactions to non-medicinal products. For public
health reporting using CDA, Allergy/Adverse Event Section with coded entries required is specified.
12
For the purposes of PHRI, a reaction, side effect or adverse effect to a medication or biologic product is defined
as one having a causal relationship to the product (i.e., exposure to the product caused or contributed to the
reaction, side effect or adverse effect). Adverse events, on the other hand, are characterized as events that occur
in temporal association with the product (i.e., exposure to the product preceded the event). Adverse events
following a medication or vaccine may or may not be causally associated. However, unlike a reaction, side effect
or adverse effect, in the case of an adverse event no causal relationship is implied. Due to historical naming
conventions, Value Set Codes involving vaccinations contain the term reaction. In this guidance, to specify that
health events occurring after receipt of vaccination may or may not be causally associated with a vaccine, Value
Set Name and Value set Description also contain the term “adverse event” to indicate that no causal association
between vaccination and the health outcome should be assumed.
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Inherits From
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
References
Allergy Section
2.16.840.1.113883.10.20.22.2.6.1
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Allergy Problem Act
2.16.840.1.113883.10.20.22.4.30
QRDA Category 1
Allergy – Intolerance Observation
2.16.840.1.113883.10.20.22.4.7
Allergy Status Observation
2.16.840.1.113883.10.20.22.4.28
Reaction Observation
2.16.840.1.113883.10.20.22.4.9
Severity Observation
2.16.840.1.113883.10.20.22.4.8
Allergy Intolerance Observation
Substance or Allergy Device – Intolerance
Observation
2.16.840.1.113883.10.20.24.3.90
Device Allergy
2.16.840.1.113883.10.20.24.3.6
Medication Allergy
2.16.840.1.113883.10.20.24.3.44
Table 21 - Allergy/Adverse Event CDA Section Overview
The following figure describes how the representation of an allergy would occur in a CDA document
level template (would include both Allergy Section and any supporting CDA Entries)
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Figure 4 - Allergy Model - PHRI
Core Common Data
Element
Allergy/Adverse Event
Date/Time
Allergy / Adverse Event
Causal Agent
Allergy/Adverse Event
Code
Severity Free Text
CDA Data Element Name
XPATH
effectiveTime
@effectiveTime
playingEntity
code #
code displayName
codeSystem
codeSystemName
Allergen name
playingEntity/@classCode
playingEntity/code/@code
playingEntity/code/@displayName
playingEntity/code/@codeSystem
playingEntity/code/@codeSystemName
playingEntity/name
Reaction code
Reaction name
Severity code
Severity name
value/@code
value/@displayName
value/@code
value/@displayName
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Core Common Data
Element
Patient Allergy /
Adverse Event Status
Allergy / Adverse Event
Type
Allergy/Adverse Event
Free Text
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
CDA Data Element Name
statusCode
code
value in Allergy –
Intolerance Observation
entry/value
Table 22 - Allergy/Adverse Event - CDA Detail
Field Values
section templateId
LOINC Code
Vocabulary OID
section displayName
codeSystemName
title
contentId
component/section/
Content Values
2.16.840.1.113883.10.20.22.2.6.1
48765-2
2.16.840.1.113883.6.1
Allergies, adverse reactions, alerts
LOINC
Allergies and Adverse Reactions
Allergy comment-x
Code
Description
DRIV
Is derived from
component/section/entry/act/
classCode
ACT
moodCode
Code
Description
EVN
Event
templatedId root
2.16.840.1.113883.10.20.22.4.30
component/section/entry/act/entryRelationship/
typeCode
SUBJ
component/section/entry/act/entryRelationship/observation/
classCode
Code
Description
OBS
An act that is
intended to
result in new
information
about a
subject.
moodCode
Code
Description
EVN
Event
templateId
2.16.840.1.113883.10.20.22.4.7
code and displayName
Code
Display Name
4200134006
Propensity to
adverse
reactions
typeCode
References
HL7v3 – ActRelationshipType
HL7 v3 – ActClass
HL7 v3 – ActMood
HL7v3 – ActRelationshipType
HL7 v3 – ActClass
HL7 v3 – ActMood
Initial set of SNOMED CT Allergy
codes proposed for Allergy/Adverse
Event Type
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Field Values
Content Values
References
418038807
Propensity to
Constrained by PHRI
adverse
reactions to
substance
419511003
Propensity to
adverse
reactions to
drug
418471000
Propensity to
adverse
reactions to
food
419199007
Allergy to
Substance
416098002
Drug Allergy
414285001
Food Allergy
59037007
Drug
intolerance
235719002
Food
intolerance
Vocabulary OID
2.16.840.1.113883.6.96
codeSystemName
SNOMED CT
component/section/entry/act/entryRelationship/observation/originalText/
reference value
#alert-x
component/section/entry/act/entryRelationship/observation/
statusCode
Code
Description
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
held
Held
New
New
suspended
Suspended
component/section/entry/act/entryRelationship/observation/participant
typeCode
CSM
HL7 v3 – ParticipationType
component/section/entry/act/entryRelationship/observation/participant/participantRole/
classCode
MANU
HL7 v3 – RoleClass
component/section/entry/act/entryRelationship/observation/participant/participantRole/
playingEntity
classCode
MMAT
HL7 v3 – EntityClass
component/section/entry/act/entryRelationship/observation/entryRelationship
typeCode
SUBJ
HL7 v3 – ParticipationType
inversion indication
true
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Field Values
Content Values
References
component/section/entry/act/entryRelationship/observation/entryRelationship/observation
classCode
Code
Description
HL7 v3 – ActClass
OBS
An act that is
intended to
result in new
information
about a
subject.
moodCode
Code
Description
HL7 v3 – ActMood
EVN
Event
entryRelationship typeCode
HL7 v3 – ActRelationshipType
Table 23 – Allergy/Adverse Event Example
4.1.1. Conformance for Allergy/Adverse Event
Unless otherwise noted in Section 4.1, implementers SHALL adopt all conformance statements present
for an Allergy Section (templateID 2.16.840.1.113883.10.20.22.2.6.1) in the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm). These conformance requirements are listed
below:
 Conforms to Allergies Section (entries optional) template (2.16.840.1.113883.10.20.22.2.6).
 SHALL contain exactly one [1..1] templateId (CONF:7527) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.6.1"
(CONF:10379).
 SHALL contain exactly one [1..1] code (CONF:15349).
o This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse
reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15350).
 SHALL contain exactly one [1..1] title (CONF:7534).
 SHALL contain exactly one [1..1] text (CONF:7530).
 SHALL contain at least one [1..*] entry (CONF:7531) such that it
o SHALL contain exactly one [1..1] Allergy Problem Act
(templateId:2.16.840.1.113883.10.20.22.4.30) (CONF:15446).
4.1.2. Value Sets
The following value sets are proposed for allergy and adverse event information:
Value Set Name
Allergy/Adverse Event Type
Ingredient
Value Set ID
Type
2.16.840.1.113883.3.88.12.3221.6.2 Consolidated CDA
May be constrained further for
environmental allergies
Specified by PHRI Data
Harmonization Profile
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Value Set Name
Medication Drug Class
Medication Clinical Drug
Medication Brand Name
Allergy Severity
Problem Status
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Value Set ID
Type
Constrained to UNII
2.16.840.1.113883.3.88.12.80.18
Specified by PHRI Data
Harmonization Profile
2.16.840.1.113883.3.88.12.80.17
Specified by PHRI Data
Harmonization Profile
2.16.840.1.113883.3.88.12.80.16
Specific to adverse events
caused by medications
2.16.840.1.114222.4.11.807
Consolidated CDA
2.16.840.1.113883.3.88.12.80.68
Consolidated CDA
Table 24 - Allergy/Adverse Event Value Sets

Implementations MAY further constrain allergies and adverse events associated with food
allergies using SNOMED-CT
4.1.3. Examples of Allergy
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.22.2.6.1"/>
<code code="48765-2" displayName="Allergies, adverse reactions, alerts"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
<title>Allergies and Adverse Reactions</title>
<text>
<content ID="allergy_comment-1">No known allergies. </content>
</text>
<entry typeCode="DRIV">
<act classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.27"/>
<templateId root="2.16.840.1.113883.3.88.11.32.6"/>
<id root="36e3e930-7b14-11db-9fe1-0800200c9a66"/>
<code nullFlavor="NA"/>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.40"/>
<templateId root="2.16.840.1.113883.3.88.11.32.12"/>
<code code="48767-8" displayName="Annotation Comment"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
<text>
<reference value="#allergy_comment-1"/>
</text>
<statusCode code="completed"/>
<author>
<time value="20080101"/>
<assignedAuthor>
<id root="2.16.840.1.113883.4.6.1013905751"/>
<assignedPerson>
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<name>
<prefix>Dr.</prefix>
<given>Randall</given>
<family>Ford</family>
</name>
</assignedPerson>
</assignedAuthor>
</author>
</act>
</entryRelationship>
</act>
</entry>
</section>
</component>
4.2. Diagnosis (Health Problem)
A diagnosis is included at this time due to inherent support within Consolidated CDA for defining and
structuring diagnoses to support clinical reporting needs. The Health Problem object takes information
commonly associated with diagnoses and problems, as well as risk factors and health concerns, and
merges them together to create high-level representation of health problem.


Usage of Diagnosis in this context is intended to be for setting-specific health problems, such as
those that may present at admission or be specific to a procedure like a surgery.
Usage of Problem in this context is intended to capture higher level health problems that may
be specifically tied to other problems, such as a communicable disease case report or adverse
event.
This distinction is given to provide flexibility to public health CDA implementations regarding the
reporting of problems.
A Health Problem/Problem Observation is required to be wrapped in an act wrapper in locations such as
the Problem Section, Allergies Section, and Hospital Discharge Diagnosis Section, where the type of
Problem needs to be identified or the condition tracked. A Problem Observation can be a valid
"standalone" template instance in cases where a simple Problem observation is to be sent.
Diagnosis
Inherits From
Encounter Diagnosis
2.16.840.1.113883.10.20.22.4.80
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Postoperative Diagnosis
2.16.840.1.113883.10.20.22.2.35
Preoperative Diagnosis
2.16.840.1.113883.10.20.22.2.34
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Inherits From
Hospital Discharge Diagnosis
2.16.840.1.113883.10.20.22.2.24
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
References
Hospital Admission Diagnosis
Section
2.16.840.1.113883.10.20.22.2.43
Hospital Admission Diagnosis
2.16.840.1.113883.10.20.22.4.34
Problem
Problem
2.16.840.1.113883.10.20.22.2.5.1
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Problem Concern Act
2.16.840.1.113883.10.20.22.4.3
Problem Observation
2.16.840.1.113883.10.20.22.4.4
Problem Status
2.16.840.1.113883.10.20.22.4.6
Table 25 - Diagnosis/Health Problem CDA Section Overview
Representation of a diagnosis in the CDA has similarities to the representation of an Allergy Section, but
would add detail for distinguishing different types of diagnoses that have been identified within the
public health report.
Value sets for Problem are not implicitly defined but a set of example values is provided under the
Problem Observation entry template. Generally, any SNOMED-CT, ICD-9 or ICD-10 value can be used for
reporting health problems.
Core Common
Data Element
Health
Problem/Diagnosis
Name
Health Problem
Name
Health Problem /
Diagnosis Free Text
Health Problem
Status
Health Problem
CDA Data Element Name
XPATH
code
code@code
displayName
code@displayName
text reference
text/reference/@value
Problem Status
value/@xsi:type
Problem Type
value/@code
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Core Common
Data Element
Type
Health Problem /
Diagnosis Onset
Date/Time
CDA Data Element Name
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
Problem date - low
effectiveTime/low/@value
Problem date - high
effectiveTime/high/@value
Treating Provider id
id/@root
Health Problem /
Diagnosis
Date/Time
Health Problem /
Diagnosis Onset
Date/Time
Health Problem /
Diagnosis
Date/Time
Provider ID
(Provider
Information
Provider Name
(Provider
Information)
assignedPerson/name
Treating Provider name
Table 26 - Diagnosis/Health Problem – CDA Detail
4.2.1. Conformance to Diagnosis Section
Unless otherwise noted in Section 4.2, implementers SHALL implement all conformance requirements
defined for a Problem Section (templateID 2.16.840.1.113883.10.20.22.2.5.1) in the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm).
If considered a health problem per the rules identified in Section 4.2, the following conformance
statements apply:
1. Conforms to Problem Section (entries optional) template (2.16.840.1.113883.10.20.22.2.5).
2. SHALL contain exactly one [1..1] templateId (CONF:9179) such that it
a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.5.1"
(CONF:10441).
3. SHALL contain exactly one [1..1] code (CONF:15409).
a. This code SHALL contain exactly one [1..1] @code="11450-4" Problem List
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15410).
4. SHALL contain exactly one [1..1] title (CONF:9181).
5. SHALL contain exactly one [1..1] text (CONF:9182).
6. SHALL contain at least one [1..*] entry (CONF:9183).
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a. Such entries SHALL contain exactly one [1..1] Problem Concern Act (Condition)
(templateId:2.16.840.1.113883.10.20.22.4.3) (CONF:15506).
If considered a diagnosis per the rules defined in Section 4.2, the specific location of where the diagnosis
was found is needed.
For diagnoses identified at admission to a hospital, the following constraints apply:





SHALL contain exactly one [1..1] templateId (CONF:9930) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.43"
(CONF:10391).
SHALL contain exactly one [1..1] code (CONF:15479).
o This code SHALL contain exactly one [1..1] @code="46241-6" Hospital Admission
Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15480).
SHALL contain exactly one [1..1] title (CONF:9932).
SHALL contain exactly one [1..1] text (CONF:9933).
SHOULD contain zero or one [0..1] entry (CONF:9934).
o The entry, if present, SHALL contain exactly one [1..1] Hospital Admission Diagnosis
(templateId:2.16.840.1.113883.10.20.22.4.34) (CONF:15481).
For diagnoses identified at discharge from a hospital, the following constraints apply:





SHALL contain exactly one [1..1] templateId (CONF:7979) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.24"
(CONF:10394).
SHALL contain exactly one [1..1] code (CONF:15355).
o This code SHALL contain exactly one [1..1] @code="11535-2" Hospital Discharge
Diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15356).
SHALL contain exactly one [1..1] title (CONF:7981).
SHALL contain exactly one [1..1] text (CONF:7982).
SHOULD contain zero or one [0..1] entry (CONF:7983).
o The entry, if present, SHALL contain exactly one [1..1] Hospital Discharge Diagnosis
(templateId:2.16.840.1.113883.10.20.22.4.33) (CONF:15489).
For diagnoses identified before a surgical procedure, the following constraints apply:



SHALL contain exactly one [1..1] templateId (CONF:8097) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.34"
(CONF:10439).
SHALL contain exactly one [1..1] code (CONF:15405).
o This code SHALL contain exactly one [1..1] @code="10219-4" Preoperative Diagnosis
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15406).
SHALL contain exactly one [1..1] title (CONF:8099).
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

SHALL contain exactly one [1..1] text (CONF:8100).
SHOULD contain zero or one [0..1] entry (CONF:10096) such that it
o SHALL contain exactly one [1..1] Preoperative Diagnosis
(templateId:2.16.840.1.113883.10.20.22.4.65) (CONF:15504).
For diagnoses identified after a surgical procedure, the following constraints apply:




SHALL contain exactly one [1..1] templateId (CONF:8101) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.35"
(CONF:10437).
SHALL contain exactly one [1..1] code (CONF:15401).
o This code SHALL contain exactly one [1..1] @code="10218-6" Postoperative Diagnosis
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15402).
SHALL contain exactly one [1..1] title (CONF:8103).
SHALL contain exactly one [1..1] text (CONF:8104).
4.2.2. Value Sets
The following value sets are proposed for defining information associated with a health problem:
Value Set Name
HL7ActRelationshipType
HITSP Problem Status
Value Set ID
2.16.840.1.113883.5.1002
2.16.840.1.113883.3.88.12.80.68
Type
Consolidated CDA
Specified in PHRI Data
Harmonization Profile
Problem Type
Constrained to Active, Inactive
and Resolved
2.16.840.1.113883.3.88.12.3221.7.2 Consolidated CDA
Table 27 - Health Problem/Diagnosis Value Sets
This specification generically supports all of the following controlled vocabularies when identifying
health problems. For each vocabulary, a specific value set has not been identified:



SNOMED-CT
ICD-9
ICD-10
For specifying additional attributes for a problem (specifically finality, certainty, and principality)
SNOMED-CT is recommended by PHRI.
4.2.3. Example of Diagnosis
Field Values
section templateId
Content Values
2.16.840.1.113883.10.20.22.2.5.1
Reference
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Field Values
LOINC code and displayName
Vocabulary OID
codeSystemName
title
textId
textContent
entry typeCode
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Content Values
Reference
Code
Display
Name
11450-4
Problem List
11348-0
Resolved
29299-5
Reason for Visit
10154-3
Chief Complaint
8646-2
Admission
Diagnosis
11535-2
Discharge
Diagnosis
10219-4
Preoperative
Diagnosis
10218-6
Postoperative
Diagnosis
2.16.840.1.113883.6.1
OIDs can be referenced here:
http://www.hl7.org/oid/index.cf
m
LOINC
Problems
Prob-x
“text”
Code
Description
HL7v3 – ActRelationshipType
DRIV
Is derived from
component/section/entry/act/
Class Code
ACT
classCode
moodCode
code
performer typeCode
Description
A record of
something that is
being done, has
been done, can
be done, or is
intended or
requested to be
done
Mood Code
Description
EVN
Event
UNK – cannot be blank
Type Code
Description
PRF
Performer - A
person,
nonperson
living subject,
organization or
device that who
HL7 v3 – ActClass
HL7 v3 – ActMood
HL7 v3 - ParticipationType
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Field Values
Content Values
Reference
actually and
principally carries
out the action.
component/section/entry/act/entryRelationship/observation/
xxxxxxxxx
SNOMED-CT used to record
code
problem
codeSystem
Diagnosis
codeSystemName
2.16.840.1.113883.6.96
displayName
SNOMED CT
text reference
#prob-x
Code
Description
A concern in the "active" state
represents one for which some
Completed
Completed
ongoing clinical activity is
Aborted
Aborted
expected, and that no activity is
Active
Active
expected in other states. Specific
Cancelled
Cancelled
statusCode
uses of the suspended and
held
Held
aborted states are left to the
New
New
implementation.
suspended
Suspended
Refers to template status
problemStatus
CD
problemType
xxx.x
displayName
Logical name
codeSystem
2.16.840.1.113883.6.2
codeSystemName
ICD9
problemDate – low
YYYYMMDD
problemDate – high
YYYYMMDD or UNK
component/section/entry/act/performer/assignedEntity/
Treating providerId
xxxxxxxxxxxxx…
Treating providerName
i.e. Dr. Shirley Jordan
representedOrganization
i.e. Smith Regional Hospital
MRN
xxxxxxxx…
Number provide by HIE/facility
Number provide by HIE/facility
Table 28 - Health Problem/Diagnosis - Detailed Example
4.3. Employment Information
The initial technical approach used for employment information will be to focus on defining
employment information using the CDA Social History Section. Employment Information would be
classified within the Social History by specifying Social History Type Code “Employment Information”
within the observation/code element of a Social History Observation.
Inherits From
Social History Section
2.16.840.1.113883.10.20.22.2.17
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
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References
Inherits From
Social History Observation
2.16.840.1.113883.10.20.22.4.38
Table 29 - Employment Information (Social History) CDA Section Overview
The Employment Information CDA Section would be developed by using the Social History CDA Section
and constraining it to only the Employment Detail Social History Type.
Code
364703007
Name
Employment detail (observable entity)
Required
R
Further work in developing an Employment Information CDA template is underway within NIOSH and
that template will supersede this approach, subject to change, in May 2013.
NOTE: because this is still in development, the language for XPath is limited to an explanation of how
the Social History Observation template will be used to
Core Common
CDA Data Element
XPATH
Name
Employer Name
Employer Address
Define as a performer for the observation
Employer Phone
Employment Status
Define as the status of the observation
Years of Employment
Define as an interval of time for an observation
Occupation and Industry
entry typeCode
component/entry/@typeCode
Codes
Table 30 - Employment Information - Social History - CDA Section Detail
4.3.1. Conformance for Employment Information

Implementers SHALL implement all conformance requirements defined for a Social History
Section (templateID 2.16.840.1.113883.10.20.22.2.17) in the Implementation Guide for CDA
Release 2.0 Consolidated CDA Templates (US Realm) . Specific constraints for social history
include:

SHALL contain exactly one [1..1] templateId (CONF:7936) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.17"
(CONF:10449).
SHALL contain exactly one [1..1] code (CONF:14819).
o This code SHALL contain exactly one [1..1] @code="29762-2" Social History
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:14820).
SHALL contain exactly one [1..1] title (CONF:7938).
SHALL contain exactly one [1..1] text (CONF:7939).
MAY contain zero or more [0..*] entry (CONF:7953) such that it




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o
Standards & Interoperability Framework
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SHALL contain exactly one [1..1] Social History Observation
(templateId:2.16.840.1.113883.10.20.22.4.38) (CONF:14821).
4.3.2. Value Sets
The following value sets are proposed for defining employment information. Note that these value sets
align to current NISOH development work on an Employment Information CDA template.
Value Set Name
Social History Type
Value Set ID
2.16.840.1.113883.3.88.12.80.60
Census Occupation Code
Census Industry Code
2.16.840.1.113883.6.240
2.16.840.1.113883.6.310
Type
Use 364703007 – Employment
Information (observable entity)
Census codes
Census codes
Table 31 - Employment Information - Social History - Value Set Conformance
4.3.3. Examples of Employment Information
The approach suggested is to use Social History as an initial example for implementation; an
“employment information” template is being defined in conjunction with HL7.
4.4. Encounter
The Encounters section is used to list and describe any healthcare encounters pertinent to the patient’s
current health status or historical health history within a public health report. An encounter can be a
hospitalization (acute, rehab, nursing facility, or long-term care), office or clinic visit, emergency room
visit, home health visit, or any treatment or therapy (physical, occupational, respiratory, or other), or
any interaction, even non face-to-face, between the patient and the healthcare system or a healthcare
provider.
Inherits From
PHCR Encounter Section
2.16.840.1.113883.10.20.15.2.2
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
CCD Encounter Activity
2.16.840.1.113883.10.20.1.21
HL7 Implementation Guide: CDA Release 2 –
Continuity of Care Document (CCD)
Encounters Section in an HAI Report
2.16.840.1.113883.10.20.5.5.24
HL7 Implementation Guide for CDA Release 2:
Healthcare Associated Infection (HAI) Reports,
DSTU Release 8 (US Realm)
Encounter Section
2.16.840.1.113883.10.20.22.2.22
Encounter Activity
2.16.840.1.113883.10.20.22.4.49
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References
Inherits From
Service Delivery Location
2.16.840.1.113883.10.20.22.4.32
Indication
2.16.840.1.113883.10.20.22.4.19
Chief Complaint and Reason for Visit
2.16.840.1.113883.10.20.22.2.13
Table 32 - Encounter CDA Section Overview
Figure 5 - Encounter CDA Section – Visual Overview
Core Common
Data Element
Admission Type
Encounter Type
CDA Data Element Name
XPATH
priorityCode
priorityCode
Encounter typeCode
codeSystem
codeSystemName
displayName
code/@code
code/@codeSystem
code/@codeSystemName
code/@displayName
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Core Common
Data Element
CDA Data Element Name
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
Reference value
code/originalText/reference/@value
Encounter date
effectiveTime
participant Name
participantRole/playingEntity/name
entryRelationship[@typeCode='RSON’]
Patient Visit
Date/Time
Admission
Date/Time
Discharge
Date/Time
Admission Source
Reason for Visit
Discharge Facility
Name
Discharge
Disposition
See Indication template
See Service Delivery
Location template
dischargeDispositionCode
participant[@typeCode='LOC'] OR
location/cda:healthCareFacility
componentOf/encompassingEncounter/
dischargeDispositionCode
Table 33 - Encounter CDA Section - Detail
4.4.1. Conformance for Encounter
Implementers SHALL adopt all conformance statements present for an Encounter Section (templateID
2.16.840.1.113883.10.20.22.2.22) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).
Specific to usage of the Encounters Section (2.16.840.1.113883.10.20.22.2.22.1):






Conforms to Encounters Section (entries optional) template
(2.16.840.1.113883.10.20.22.2.22).
SHALL contain exactly one [1..1] templateId (CONF:8705) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.22.1"
(CONF:10387).
SHALL contain exactly one [1..1] code (CONF:15466).
o This code SHALL contain exactly one [1..1] @code="46240-8" Encounters
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15467).
SHALL contain exactly one [1..1] title (CONF:8707).
SHALL contain exactly one [1..1] text (CONF:8708).
SHALL contain at least one [1..*] entry (CONF:8709) such that it
o SHALL contain exactly one [1..1] Encounter Activities
(templateId:2.16.840.1.113883.10.20.22.4.49) (CONF:15468).
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Implementers MAY use the Encounters Section in an HAI Report (templateID
2.16.840.1.113883.10.20.5.5.24) in reporting healthcare acquired infection. The constraints for the
Encounter section are as follows:



Conforms to HAI Section Generic Constraints template (2.16.840.1.113883.10.20.5.4.3).
SHALL contain 1..1 code (CONF:11471).
o This code SHALL contain 1..1 @code="46240-8" History of Encounters (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:4777).
SHALL contain 1..1 entry (CONF:4778).
o This entry SHALL contain 1..1 Prior Transfusion Encounter
(templateId:2.16.840.1.113883.10.20.5.6.72) (CONF:4779).
Specific to usage of the Chief Complaint and Reason for Visit Section (2.16.840.1.113883.10.20.22.2.13):




SHALL contain exactly one [1..1] templateId (CONF:7840) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.13"
(CONF:10383).
SHALL contain exactly one [1..1] code (CONF:15449).
o This code SHALL contain exactly one [1..1] @code="46239-0" Chief Complaint and
Reason for Visit (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15450).
SHALL contain exactly one [1..1] title (CONF:7842).
SHALL contain exactly one [1..1] text (CONF:7843).
4.4.2. Value Sets
The following value sets apply to the Encounter section template:
Value Set Name
PHVS_AdmitSource_HL7_2x
Value Set ID
2.16.840.1.114222.4.11.918
Type
Specified in PHRI Data
Harmonization Profile
PHVS_AdmissionType_HL7_2x
2.16.840.1.114222.4.11.913
Specified in PHRI Data
Harmonization Profile
Specified in PHRI Data
Harmonization Profile
Static – constrained to the
following codes:
PHVS_DischargeDisposition_HL7_2x 2.16.840.1.114222.4.11.915
Encounter Type
2.16.840.1.113883.3.88.12.80.32
Phone Call, Outpatient,
Inpatient, Other
Table 34 - Encounter Value Sets

Implementers MAY use CPT-4 for defining specific encounter codes, with recommended
constraints to 99200-99299
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4.4.3. Examples of Encounters
4.4.3.1.
Emergency Encounter in a Public Health Report
<section>
<templateId root="2.16.840.1.113883.10.20.22.2.22"/>
<code code="46240-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="History of encounters"/>
<title>Encounters</title>
<text>
<content ID="note-1">Name: SNOW, JANE Service Date: DOB: 03/29/1975
Sex: F Age: 33 Billing #: 112121212 Date of Adm: 12/18/2007
CLINICAL DIAGNOSIS: This is an echocardiogram ordered.
<br/><br/> Name: SNOW, JANE Service Date: DOB: 03/29/1975
<br/><br/></content><content ID="note-2"> Name: SNOW, JANE Service Date:
DOB: 03/29/1975 Sex: F Age: 33 Billing #: 112121212 Date of
Adm: 02/08/2008
DISCHARGE SUMMARY ADMISSION DIAGNOSES: 1. Diabetes type 2. 2.
Hypertension.
<br/><br/></content><content ID="note-3">"> Name: SNOW, JANE Service Date:
DOB: 03/29/1975 Sex: F Age: 33 Billing #: 112121212 Date of
Adm: 05/16/2008 OPERATIVE REPORT PROCEDURE: Upper endoscopy.
INDICATION: Anemia, history of heartburn. </content>
</text>
<entry typeCode="DRIV">
<encounter classCode="ENC" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.17"/>
<templateId root="2.16.840.1.113883.10.20.1.21"/>
<id root="8e6184b6-2321-4800-97e5-ccb487a104ff"/>
<code code="EMER" codeSystem="2.16.840.1.113883.5.4" codeSystemName="HL7
ActCode" displayName="Emergency"/>
<effectiveTime>
<low value="20080910"/>
<high nullFlavor="UNK"/>
</effectiveTime>
<performer typeCode="PRF">
<time>
<low value="20080910"/>
<high nullFlavor="UNK"/>
</time>
<assignedEntity>
<id extension="568a4e00-11e0-4194-8052-971e797080e2"
root="2.16.840.1.113883.4.6.1013905751"/>
<code code="280000000X" codeSystem="2.16.840.1.113883.6.101"
codeSystemName="ProviderCodes" displayName="Hospitals"/>
<addr/>
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<assignedPerson>
<name>
<family>Smith</family>
<given>John</given>
</name>
</assignedPerson>
<representedOrganization>
<id root="2.16.840.1.113883.3.190"/>
<name>Community Medical Center</name>
</representedOrganization>
<sdtc:patient>
<sdtc:id root="2.16.840.1.113883.3.190" extension="92709368"/>
</sdtc:patient>
</assignedEntity>
</performer>
<participant typeCode="LOC">
<templateId root="2.16.840.1.113883.10.20.1.45"/>
<participantRole classCode="SDLOC">
<code code="PC" codeSystem="2.16.840.1.113883.5.111" codeSystemName="RoleCode"
displayName="Primary Care Clinic"/>
<playingEntity classCode="PLC">
<name>Community Medical Center</name>
</playingEntity>
</participantRole>
</participant>
</encounter>
</entry>
</section>
4.4.3.2.
Inpatient Encounter in a Public Health Report
<section>
<templateId root="2.16.840.1.113883.10.20.22.2.22"/>
<code code="46240-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="History of encounters"/>
<title>Encounters</title>
<text>
<content ID="note-1">Name: SNOW, JANE Admitted: 03/27/2009 MR #:
123456789 DOB: 03/29/1975 Account#: 000012345678910 Age: 33
Physician: Smith, Jonnie, MD Location: 12-ee-12 HISTORY OF PRESENT ILLNESS:
This is a 33-year-old smoking female with a~long-standing history of asthma,
polycystic ovarian disease, and suspected~cervical cancer, currently being worked
up. The patient reports that she~took Advair for the first time today, but also took
a couple of other~medications today and had eaten. She then developed some
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tightness in her~chest and shortness of breath. She was concerned that she was
having an~anaphylactic type reaction and came into the ED. In the ED, the
patient~was not moving air very well. She was given 3 nebulizer treatments and
a~dose of Solu-Medrol, after which although she improved, she continued to~have
some difficulty breathing. Currently, she is breathing much more~relaxed. She
denies headache, vision changes, chest pain, or~palpitations. Her shortness of
breath has improved. She is having a~cough, nonproductive of sputum. No
nausea, vomiting, constipation,~hematemesis, or hematochezia. No new
rashes.~~PAST MEDICAL HISTORY:~1. Polycystic ovarian disease.~2. Possible
cervical cancer.~3. Asthma.~4. Hypertension.~5. Chronic lower extremity
edema.~6. Suspected diabetes.~~MEDICATIONS:~1. Vicodin on a daily basis.~2.
Advair 250/50.~3. Birth control pills.~4. Lisinopril 20 mg daily.~5. Prozac 40 mg
daily.~6. Cipro 500 mg b.i.d. for bronchitis.~7. Xanax 0.5 mg daily.~8. Restoril 30
mg daily.~9. Spironolactone 50 mg b.i.d.~10. Bentyl 20 mg 4 times a
day.~~ALLERGIES: BACTRIM, LEVAQUIN, and SEAFOOD.~~SOCIAL HISTORY: She
smokes 1-1/2 packs of cigarettes a day. Does not~drink alcohol. She is
unemployed.~~FAMILY HISTORY: Significant for mother with diabetes.~~REVIEW
OF SYSTEMS:~HEENT: No headache, vision changes, ear pain, or sore
throat.~CARDIOVASCULAR: No chest pain or palpitations.~RESPIRATORY: Positive
shortness of breath, but improved. A mild cough,~nonproductive of
sputum.~ABDOMEN: No nausea, vomiting, constipation, hematemesis,
or~hematochezia.~EXTREMITIES: No new edema.~~PHYSICAL
EXAMINATION:~VITAL SIGNS: Temperature is 98.2. Pulse 100. Blood pressure
132/79.~Respiratory rate 20. O2 saturation 96% on room air.~GENERAL: Obese
female, in no acute distress, lying in bed. She appears~comfortable.~HEENT:
Sclerae are anicteric. Mucous membranes are moist. Pharynx
is~________.~NECK: There is no lymphadenopathy.~CARDIOVASCULAR: Slightly
tachycardic. No murmurs, rubs, or gallops.~RESPIRATORY: Expiratory wheezes
noted bilaterally, but improved air~movement.~ABDOMEN: Bowel sounds are
positive. Nontender and nondistended. No~hepatosplenomegaly.~EXTREMITIES:
Trace bilateral lower extremity edema.~~LABORATORY DATA: Sodium 136,
potassium 4.2, chloride 102, bicarbonate 21,~BUN 19, creatinine 1.2, glucose 327.
White blood cell count 16.5. Please~note the patient has been on steroids.
Hemoglobin 12.1, hematocrit 38.3,~and platelets 338, with granulocytes 93%.
CPK is 99. Cardiac enzymes~negative x1.~~ASSESSMENT:~1. Acute asthma
exacerbation, possibly set off by food or some other~allergen.~2.
Hypertension.~3. Diabetes versus steroid-induced hyperglycemia.~~PLAN: At this
time, will start IV Solu-Medrol, jet nebulizers, and~Singulair. Will start sliding
scale insulin. Check a TSH and a hemoglobin~A1c, as well as a lipid panel. At this
point, I am going to go ahead and~continue her Cipro. Will obtain Physical
Therapy and Occupational Therapy~consults. Will provided gastrointestinal and
deep venous thrombosis~prophylaxis.~~
<br/><br/> Name: SNOW, JANE Service Date: DOB: 03/29/1975
<br/><br/></content><content ID="note-2"> Name: SNOW, JANE Service Date:
DOB: 03/29/1975 Sex: F Age: 33 Billing #: 112121212 Date of
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Adm: 02/08/2008
DISCHARGE SUMMARY ADMISSION DIAGNOSES: 1. Diabetes type 2. 2.
Hypertension.
<br/><br/></content><content ID="note-3">"> Name: SNOW, JANE Service Date:
DOB: 03/29/1975 Sex: F Age: 33 Billing #: 112121212 Date of
Adm: 05/16/2008 OPERATIVE REPORT PROCEDURE: Upper endoscopy.
INDICATION: Anemia, history of heartburn. </content>
</text>
<entry typeCode="DRIV">
<encounter classCode="ENC" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.17"/>
<templateId root="2.16.840.1.113883.10.20.1.21"/>
<id root="8e6184b6-2321-4800-97e5-ccb487a104ff"/>
<code code="IMP" codeSystem="2.16.840.1.113883.5.4" codeSystemName="HL7 ActCode"
displayName="Inpatient encounter"/>
<originalText>
<reference value="#note-1"/>
</originalText>
<effectiveTime>
<low value="20080910"/>
<high nullFlavor="UNK"/>
</effectiveTime>
<performer typeCode="PRF">
<time>
<low value="20080910"/>
<high nullFlavor="UNK"/>
</time>
<assignedEntity>
<id extension="568a4e00-11e0-4194-8052-971e797080e2"
root="2.16.840.1.113883.4.6.1013905751"/>
<code code="280000000X" codeSystem="2.16.840.1.113883.6.101"
codeSystemName="ProviderCodes" displayName="Hospitals"/>
<addr/>
<assignedPerson>
<name>
<family>Smith</family>
<given>John</given>
</name>
</assignedPerson>
<representedOrganization>
<id root="2.16.840.1.113883.3.190"/>
<name>Community Medical Center</name>
</representedOrganization>
<sdtc:patient>
<sdtc:id root="2.16.840.1.113883.3.190" extension="92709368"/>
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</sdtc:patient>
</assignedEntity>
</performer>
<participant typeCode="LOC">
<templateId root="2.16.840.1.113883.10.20.1.45"/>
<participantRole classCode="SDLOC">
<code code="PC" codeSystem="2.16.840.1.113883.5.111" codeSystemName="RoleCode"
displayName="Primary Care Clinic"/>
<playingEntity classCode="PLC">
<name>Community Medical Center</name>
</playingEntity>
</participantRole>
</participant>
</encounter>
</entry>
</section>
4.5. Exposure
The recommended approach for defining exposures is to use the Social History Section (templateID
2.16.840.1.113883.10.20.22.2.17) and to constrain the Social History Section to Social History Type
“Toxic exposure status” – using SNOMED-CT code 425400000.
This approach will also draw very heavily from existing domain analysis models (DAMs) related to
Exposure, developed using HL7 V3.
Inherits From
Social History Section
2.16.840.1.113883.10.20.22.2.17
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Social History Observation
2.16.840.1.113883.10.20.22.4.38
Table 35 - Exposure - CDA Conceptual Overview
The future approach recommended for defining exposure information is to propose the creation of a
new Exposure section-level template, and to create a new Exposure Observation template. This
template would support exposure types related to chemicals, physical exposures and environmental
exposures.
The template structure for Exposure information is in development. Current XPATH is not provided.
Core Common
CDA Data Element Name
XPATH
Exposure Type
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Core Common
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CDA Data Element Name
XPATH
Exposure / Injury Agent
Exposure Agent / Injury Cause
Exposure Duration
Place of Exposure / Injury
Activity at time of Exposure
/Injury
Exposure / Injury
Circumstances
Activity setting at time of
Exposure / Injury
Table 36 - Exposure Detail
4.5.1. Conformance for Exposure

To report toxic exposures, implementers MAY use the CDA Social History Section (templateID
2.16.840.1.113883.10.20.22.2.17), as defined in the Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm). If using the Social History template, the following
constraints apply:

SHALL contain exactly one [1..1] templateId (CONF:7936) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.17"
(CONF:10449).
SHALL contain exactly one [1..1] code (CONF:14819).
o This code SHALL contain exactly one [1..1] @code="29762-2" Social History
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:14820).
SHALL contain exactly one [1..1] title (CONF:7938).
SHALL contain exactly one [1..1] text (CONF:7939).
MAY contain zero or more [0..*] entry (CONF:7953) such that it
o SHALL contain exactly one [1..1] Social History Observation
(templateId:2.16.840.1.113883.10.20.22.4.38) (CONF:14821).




Note that these conformance statements apply to use of Social History as a template to capture
information about an exposure. This approach does not currently align to the core common data
elements in the PHRI Data Harmonization Profile.
4.5.2. Value Sets
No value sets have been defined for exposures as of time of publication. Further research will be needed
to establish specific coded values for exposures, which is expected to involve the formal definition of an
Exposure section-level template.
Specific vocabularies are defined for potential use in an Exposure template:
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Exposure Core Common Data Element
Exposure Type
Exposure / Injury Agent
Place of Exposure / Injury
Activity at time of Exposure / Injury
Activity setting at time of Exposure / Injury
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Vocabulary Constraints Proposed
No vocabulary defined, but proposed constraint is
limited to the following string values:
 chemical,
 physical,
 biological
 other agent
ICD-9-CM E-codes, ICD-10-CM V through Y-codes
ICD-9-CM E-849 codes , ICD-10-CM Y-92 codes
ICD-9-CM E-001 through E030 codes, ICD-10-CM Y93 through Y-99 codes
ICD-9-CM E-000 code, ICD-10-CM Y-99 code
Table 37 - Proposed Exposure Vocabulary Constraints
4.5.3. Example of Exposure
No examples have been defined for exposure at the time of publication.
4.6. Facility
The concept of a facility is not explicitly outlined in a CDA Section or Entry within the Consolidated CDA.
Facility information can be captured in different ways depending on the context of the facility
information being provided in the public health report:


Use of componentOf/encompassingEncounter/location to attach a facility to a specific encounter.
Facility information is ultimately constrained by the Encounter section.
Use of encounter/participant/associatedEntity where the public health report wishes to includes
facilities within a facility
Inherits From
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
componentOf
Table 38 - Facility - CDA Conceptual Overview
In the example shown below, the facility information is captured using the <documentationOf> data
element as part of a Service Delivery Location entry template. This is specific to defining the facility
associated with an encounter.
Core Common
Facility Address
Facility ID
Facility Name
CDA Data Element
Name
addr
id
name
XPATH
encompassingEncounter/location/healthcareFacility/
serviceProviderOrganization/addr
encompassingEncounter/location/healthcareFacility/id
encompassingEncounter/location/healthcareFacility/
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Core Common
Facility Phone
Facility Type
Standards & Interoperability Framework
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XPATH
CDA Data Element
Name
serviceProviderOrganization/name
encompassingEncounter/location/healthcareFacility/
serviceProviderOrganization/telecom
encompassingEncounter/location/healthcareFacility/code
telecom
code
Table 39 - Facility Detail
4.6.1. Conformance of Facility

Unless otherwise noted in this section, implementers SHALL implement all conformance
requirements defined in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm) specific to defining componentOf as an element. This includes the following
constraints:



The componentOf, if present, SHALL contain 1..1 encompassingEncounter (CONF:9956).
o This encompassingEncounter SHALL contain 1..* id (CONF:9959).
o This encompassingEncounter SHALL contain 1..1 effectiveTime (CONF:9958).
For any public health CDA-based document developed from this Specification, implementers MUST
use the Healthcare Service Location Value Set (finalize OID to be developed 9/20)
For the id element, a corresponding Assigning Authority for that id MAY be provided
4.6.2. Value Sets
The following value sets are proposed for defining facility information:
Value Set Name
Healthcare Service Delivery
Location
JCIH-EHDI NICU Service Delivery
Location
Value Set ID
2.16.840.1.113883.1.11.20275
1.3.6.1.4.1.19376.1.7.3.1.1.15.2.13
Table 40 - Facility Type Value Sets
4.6.3. Examples of Facility
The following example shows how a facility ID can be used to specific how an internal location for a
patient can be identified:
<participantRole classCode="SDLOC">
<id root="2.16.840.1.113883.3.117.1.1.5.1.1" extension="9W"/>
4.7. Family History
The Family History section contains data defining the patient’s genetic relatives in terms of possible or
relevant health risk factors that have a potential impact on the patient’s healthcare risk profile. Public
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health reports (for example, reports on the relationship between a mother and their child) would report
similar data elements for each family member, linked as a set of observations tied to the patient.
Inherits From
Family History Section
2.16.840.1.113883.10.20.22.2.15
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Family History Organizer
2.16.840.1.113883.10.20.22.4.45
Family History Observation
2.16.840.1.113883.10.20.22.4.46
Age Observation
2.16.840.1.113883.10.20.22.4.31
Family History Death Observation
2.16.840.1.113883.10.20.22.4.47
Table 41 - Family History CDA Section Overview
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Figure 6 - Family History Model – PHRI
As noted in Figure 2, the Family History section of a CDA Public Health Report is populated by creating a
Family History Organizer for each family member, with observations then being associated with that
Organizer.
The following table shows how each of the data elements defined in the Public Health Data
Harmonization Profile would be defined within a CDA Family History Section:
Core Common
Family Member
Relationship Type
Family Member Address
Family Member Name
Family History
CDA Element Name
XPATH
code
subject/relatedSubject/code/@code
address
name
statusCode
subject/relatedSubject/addr
subject/relatedSubject/subject/name
statusCode
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Core Common
Observation Status
Gender
CDA Element Name
Used to show the
observation is
completed
birthTime
subject/relatedSubject/subject/
administrativeGenderCode
subject/relatedSubject/subject/birthTime
effectiveTime
effectiveTime/@value
value
entryRelationship/observation/value/@code
raceCode
subject/relatedSubject/raceCode
subject/relatedSubject/ethnicityCode
GenderCode
Date of Birth
Family Member
Observation Start Time
Family Member
Observation End Time
Family Member
Observation Duration
Family History
Observation
Family Member Race
Family Member
Ethnicity
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
ethnicityCode
Table 42 - Family History CDA Section - Detail
4.7.1. Conformance of Family History

Implementers SHALL adopt all conformance statements present for a Family History Section
(templateID 2.16.840.1.113883.10.20.22.2.15) in the Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm).

SHALL contain exactly one [1..1] templateId (CONF:7932) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.15"
(CONF:10388).
SHALL contain exactly one [1..1] code (CONF:15469).
o This code SHALL contain exactly one [1..1] @code="10157-6" Family History
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15470).
SHALL contain exactly one [1..1] title (CONF:7934).
SHALL contain exactly one [1..1] text (CONF:7935).
MAY contain zero or more [0..*] entry (CONF:7955) such that it
o SHALL contain exactly one [1..1] Family History Organizer
(templateId:2.16.840.1.113883.10.20.22.4.45) (CONF:15471).




4.7.2. Value Sets
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The following value sets are proposed for family members that are defined in the Family History section
template:
Value Set Name
PHVS_Race_CDC
PHVS_Ethnicity_CDC
PHVS_RaceCategory_CDC
PHVS_EthnicityGroup_CDC
PHVS_Gender_SyndromicSurveillance
Value Set ID
2.16.840.1.114222.4.11.876
2.16.840.1.114222.4.11.877
2.16.840.1.114222.4.11.836
2.16.840.1.114222.4.11.837
2.16.840.1.114222.4.11.3403
Type
Dynamic
Dynamic
Dynamic
Dynamic
Dynamic
Table 43 - Family History Value Sets


For family history, observations about a family member SHOULD be recorded using SNOMEDCT.
For family history, the type of observation made for a family member SHOULD be recorded
using SNOMED-CT
4.7.3. Examples of Family History Section
Field Values
Recommend Content Values
for Public Health Reporting
section templateId
2.16.840.1.113883.10.20.22.2.15
LOINC Code
10157-6
displayName
History of Family
Vocabulary OID
2.16.840.1.113883.6.1
codeSystemName
LOINC
title
Family History
component/section/entry/organizer/
classCode
moodCode
Organizer templateId
statusCode
subject/relatedSubject/
classCode
code and displayName
codeSystem
codeSystemName
2.16.840.1.113883.10.20.1.23
Code
Description
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
held
held
New
New
suspended
suspended
HL7 RoleClass
HL7 RoleCode
Mapping to Data
Harmonization Profile
HL7 ActClass
HL7 ActMood
Refers to template status
Family Member Relationship
Type
2.16.840.1.113883.5.111
SNOMED- CT
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Field Values
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Recommend Content Values
Mapping to Data
for Public Health Reporting
Harmonization Profile
subject/subject
administrativeGenderCode
Vocabulary OID
codeSystemName
Code
Description
F
Female
M
Male
UN
Undifferentiated
2.16.840.1.113883.5.1
HL7 AdministrativeGenderCode
Family Member Gender
Table 44 - Family History CDA Section - Detailed Example
The following XML is an example of how to use the Family History section template can be used to
capture information about a deceased father:
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.22.2.15"/>
<!-- ******** Family history section template ******** -->
<code code="10157-6" codeSystem="2.16.840.1.113883.6.1"/>
<title>FAMILY HISTORY</title>
<text>
<paragraph>Father (deceased)</paragraph>
<table border="1" width="100%">
<thead>
<tr>
<th>Diagnosis</th>
<th>Age At Onset</th>
</tr>
</thead>
<tbody>
<tr>
<td>Myocardial Infarction (cause of death)</td>
<td>57</td>
</tr>
<tr>
<td>Diabetes</td>
<td>40</td>
</tr>
</tbody>
</table>
</text>
<entry typeCode="DRIV">
<organizer moodCode="EVN" classCode="CLUSTER">
<templateId root="2.16.840.1.113883.10.20.22.4.45"/>
<!-- ******** Family history organizer template ******** -->
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<statusCode code="completed"/>
<subject>
<relatedSubject classCode="PRS">
<code code="FTH" displayName="Father" codeSystemName="HL7 FamilyMember"
codeSystem="2.16.840.1.113883.5.111">
<translation code="9947008" displayName="Biological father" codeSystemName="SNOMED"
codeSystem="2.16.840.1.113883.6.96"/>
</code>
<subject>
<administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1"
displayName="Male"/>
<birthTime value="1910"/>
<!-- Example use of sdtc extensions included below in comments -->
<!-<sdtc:deceasedInd value="true"/>
<sdtc:deceasedTime value="1967"/>
-->
</subject>
</relatedSubject>
</subject>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.46"/>
<!-- Family History Observation template -->
<id root="d42ebf70-5c89-11db-b0de-0800200c9a66"/>
<code code="55561003" displayName="Active" codeSystemName="SNOMED CT"
codeSystem="2.16.840.1.113883.6.96"/>
<statusCode code="completed"/>
<effectiveTime value="1967"/>
<value xsi:type="CD" code="22298006" codeSystem="2.16.840.1.113883.6.96"
displayName="Myocardial infarction"/>
<entryRelationship typeCode="CAUS">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.47"/>
<!-- ******** Family history death observation template ******** -->
<id root="6898fae0-5c8a-11db-b0de-0800200c9a66"/>
<code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
<statusCode code="completed"/>
<value xsi:type="CD" code="419099009" codeSystem="2.16.840.1.113883.6.96"
displayName="Dead"/>
</observation>
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.31"/>
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<!-- ******** Age observation template ******** -->
<code code="445518008" codeSystem="2.16.840.1.113883.6.96" displayName="Age At Onset"/>
<statusCode code="completed"/>
<value xsi:type="PQ" value="57" unit="a"/>
</observation>
</entryRelationship>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.46"/>
<!-- ******** Family history observation template ******** -->
<id root="5bfe3ec0-5c8b-11db-b0de-0800200c9a66"/>
<code code="7087005" displayName="Intermittent" codeSystemName="SNOMED CT"
codeSystem="2.16.840.1.113883.6.96"/>
<statusCode code="completed"/>
<effectiveTime value="1950"/>
<value xsi:type="CD" code="46635009" codeSystem="2.16.840.1.113883.6.96"
displayName="Diabetes mellitus type 1"/>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.31"/>
<!-- ******** Age observation template ******** -->
<code code="445518008" codeSystem="2.16.840.1.113883.6.96" displayName="Age At Onset"/>
<statusCode code="completed"/>
<value xsi:type="PQ" value="40" unit="a"/>
</observation>
</entryRelationship>
</observation>
</component>
</organizer>
</entry>
</section>
</component>
4.8. Immunization
Immunization requirements will be drawn from the HL7 Immunization Domain Analysis Model (DAM)
and are specific to the administration of vaccinations.
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Figure 7 - Immunization Model - PHRI
Based on review of current structure for immunization information, it is not recommended to use CDA
for immunization reporting. The recommended specification in place for reporting immunization
information is HL7 Version 2.5.1 Implementation Guide: Immunization Messaging (Release 1.0)
The Immunization Section is a good approach when a point in time, authored and attested public health
document is required. Some examples might include reporting of immunizations with a communicable
disease, or an immunization history (like an immunization card).
Inherits From
Immunization Section
2.16.840.1.113883.10.20.22.2.2.1
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Immunization Activity
2.16.840.1.113883.10.20.22.4.52
Immunization Refusal Reason
2.16.840.1.113883.10.20.22.4.53
Table 45 - Immunization CDA Section Overview
Core Common Data
Element
Vaccination
Administration
Date/Time
Vaccination
Expiration
Date/Time
CDA Data Element Name
XPATH
Administered Date
entry/substanceAdministration/effectiveTime/
@value
effectiveTime
entry/substanceAdministration/effectiveTime/
@value
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Core Common Data
Element
Vaccine
Administering
Provider Name
Vaccine Product
Type Administered
Vaccine Lot Number
Vaccine Information
Statement (VIS)
Date
Vaccine Information
Statement (VIS)
Type
Vaccine Information
Statements (VIS)
Date given to
patient
Vaccine Event
Information Source
Vaccine
Manufacture Name
Vaccine Ordering
Provider Name
Vaccine
Administering
Provider Name
Exemption(s)/
Parent Refusal(s) of
Vaccine Product
Type Administered
Date/Time of
Exemption/Parent
Refusal of Vaccine
Product Type
Administered
CDA Data Element Name
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
Immunization Performer
entry/substanceAdministration/performer/
assignedEntity/assignedPerson/name
Medication name
entry/substanceAdministration/consumable/
manufacturedMaterial/code/@displayName
manufacturedMaterial/lotNumberText
lotNumber
manufacturerOrganization
manufacturerOrganization
performer/cda:assignedEntity
performer
entryRelationship[@typeCode=’RSON’]
See Immunization Refusal
Reason entry template
Align to Immunization Refusal Reason entry
template
entryRelationship[@typeCode=’RSON’]
See Immunization Refusal
Reason entry template
Align to Immunization Refusal Reason entry
template
Table 46 - Immunization - CDA Detail
4.8.1. Conformance for Immunization
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Implementers SHALL adopt all conformance statements present for an Immunization Section
(templateID 2.16.840.1.113883.10.20.22.2.2.1) in the Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm).
Conforms to Immunizations Section (entries optional) template
(2.16.840.1.113883.10.20.22.2.2).
SHALL contain exactly one [1..1] templateId (CONF:9015) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.2.1"
(CONF:10400).
SHALL contain exactly one [1..1] code (CONF:15369).
o This code SHALL contain exactly one [1..1] @code="11369-6" Immunizations
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15370).
SHALL contain exactly one [1..1] title (CONF:9017).
SHALL contain exactly one [1..1] text (CONF:9018).
SHALL contain at least one [1..*] entry (CONF:9019) such that it
o SHALL contain exactly one [1..1] Immunization Activity
(templateId:2.16.840.1.113883.10.20.22.4.52) (CONF:15495).
4.8.2. Value Sets
The following value sets apply to the Immunization section template:
Value Set Name
Value Set ID
PHVS_VaccinationReaction
2.16.840.1.114222.4.11.3289
PHVS_ImmunizationBodySite_CDC
2.16.840.1.114222.4.11.3023
PHVS_ManufacturersOfVaccinesMVX_CDC_NIP 2.16.840.1.114222.4.11.826
Type
Table 47 - Immunization Value Sets
4.8.3. Example for Immunization
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.1.6"/>
<code code="11369-6" displayName="History of immunizations"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
<title>Immunizations</title>
<text/>
<entry typeCode="DRIV">
<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
<templateId root="2.16.840.1.113883.3.88.11.32.14"/>
<id root="cevv5b05-6zae-11wq-0ve1-0822202c9a76"/>
<statusCode code="completed"/>
<effectiveTime value="20080108"/>
<approachSiteCode/>
<doseQuantity/>
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<consumable>
<manufacturedProduct classCode="MANU">
<templateId root="2.16.840.1.113883.10.20.1.53"/>
<templateId root="2.16.840.1.113883.3.88.11.32.9"/>
<manufacturedMaterial classCode="MMAT" determinerCode="KIND">
<code code="16" displayName="Influenza Virus Vaccine"
codeSystem="2.16.840.1.113883.6.59" codeSystemName="CVX">
<originalText/>
</code>
<name>TIV</name>
<lotNumberText>A1234-ddz</lotNumberText>
</manufacturedMaterial>
<manufacturerOrganization>
<name> GlaxoC3POKline Biologicals</name>
</manufacturerOrganization>
</manufacturedProduct>
</consumable>
<performer typeCode="PRF">
<time>
<low value="20070506"/>
</time>
<assignedEntity>
<id root="2.16.840.1.113883.4.6.332789877" extension="Provider ID"/>
<addr use="WP">
<streetAddressLine>227 Medical Court</streetAddressLine>
<streetAddressLine/>
<city>Annapolis</city>
<state>MD</state>
<postalCode>20497</postalCode>
<country>US</country>
</addr>
<telecom value="TEL:+1-301-555-7654"/>
<assignedPerson>
<name>
<prefix>Dr</prefix>
<given>Sarah</given>
<given/>
<family>Silvarmen</family>
</name>
</assignedPerson>
<representedOrganization>
<name>Orthopedic Associates of Annapolis</name>
</representedOrganization>
</assignedEntity>
</performer>
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<entryRelationship typeCode="SUBJ">
<observation classCode="OBS" moodCode="EVN">
<code nullFlavor="NA"/>
<text/>
<statusCode/>
<value xsi:type="INT" value="1"/>
</observation>
</entryRelationship>
<entryRelationship typeCode="CAUS">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.54"/>
<code nullFlavor="NA"/>
<text>
<reference value="#reaction"/>
</text>
<statusCode code="completed"/>
</observation>
</entryRelationship>
</substanceAdministration>
</entry>
</section>
</component>
4.9. Laboratory Report Item (IHE)
The Laboratory Report Item template is contained within a Laboratory Specialty section to include
specific information on a laboratory specimen. This template is specifically referenced for usage with
specimens, and has been identified through the IHE Laboratory (LAB) Technical Framework – Volume 3.
4.9.1. Conformance for Laboratory Report Item


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
A Laboratory Report Item Section under a Laboratory Specialty Section SHALL represent only one
Report Item.
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.2"/> - The templateId element identifies this section as
a Laboratory Report Item Section under a Laboratory Specialty Section. The templateId SHALL be
present with root="1.3.6.1.4.1.19376.1.3.3.2.2".
<code code=" " codeSystem=" " codeSystemName=" " displayName=" "/> - The Laboratory Report
Item Section SHALL identify the single Report Item uniquely using the <code> element. For example,
a LOINC test code. The code, codeSystem, and displayName SHALL be present. One MAY also
populate codeSystemName and orginalText.
<title/> - The Leaf Section title MAY be present, it is the local translation of the code@displayName.
<text/> - The Laboratory Report Item Section text SHALL be present and not blank. This narrative
block SHALL present to the human reader and represent the observations produced for this Report
Item, using the various structures available in the CDA Narrative Block schema (NarrativeBlock.xsd):
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tables, lists, paragraphs, hyperlinks, footnotes, references to attached or embedded multimedia
objects. The narrative block is fully derived from the entry containing the machine-readable result
data.
<entry typeCode="DRIV"> - The Laboratory Report Item Section SHALL contain a Lab Report Data
Processing Entry. This entry contains the machine-readable result data from which the narrative
block of this section is derived.
4.9.2. Example of Laboratory Report Item
<ClinicalDocument>
...
<component typeCode="COMP">
<structuredBody classCode="DOCBODY" moodCode="EVN">
<component typeCode="COMP">
<section classCode="DOCSECT">
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.1"/>
<!-- Example Specialty Section that holds two leaf sections. -->
<code code="18723-7" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="HEMATOLOGY STUDIES"/>
<title>Laboratory Hematology Results</title>
<component>
<section>
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.2"/>
<!-- Leaf Section that holds one Report Item. -->
<code code="16931-8" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="Hemoglobin/Hematocrit"/>
<text/>
<entry typeCode="DRIV">
<templateId root="1.3.6.1.4.1.19376.1.3"/>
<act classCode="ACT" moodCode="EVN">
...
</act>
</entry>
</section>
</component>
<component>
<section>
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.2"/>
<!-- Leaf Section that holds one Report Item. -->
<code code="14196-0" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="Reticulocytes"/>
<text/>
<entry typeCode="DRIV">
<templateId root="1.3.6.1.4.1.19376.1.3"/>
<act classCode="ACT" moodCode="EVN">
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...
</act>
</entry>
</section>
</component>
</section>
</component>
</structuredBody>
</component>
</ClinicalDocument>
4.10.
Laboratory Specialty (IHE)
The Laboratory Specialty template contains the Laboratory Report Item template, which will contain
information about the specimen, such as a single specimen battery, to support the requirements of
PHRI.
Figure 8 - Laboratory Specialty Overview
4.10.1. Conformance for Laboratory Specialty
Each of these conformance constraints is drawn directly from the IHE Laboratory Technical Framework.
 <templateId root="1.3.6.1.4.1.19376.1.3.3.2.1"/> - The templateId element identifies this
section as a Laboratory Specialty Section. The templateId SHALL be present with
root="1.3.6.1.4.1.19376.1.3.3.2.1".
 <code code=" " codeSystem=" " codeSystemName=" " displayName=" "/> - The Laboratory
Specialty Section SHALL identify the LOINC laboratory specialty. The code, codeSystem, and
displayName attributes SHALL be present. The codeSystemName MAY also be present.
 <title/> - The Laboratory Specialty Section <title> MAY be present. It is the local translation of
the code@displayName.
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A Laboratory Specialty Section SHALL contain EITHER a list of Laboratory Report Item Section(s)
OR a single text and entry element to represent the Report Items.
o Choice 1: Laboratory Report Item Section - With this option, this Laboratory Specialty
Section SHALL contain NEITHER a top level text NOR entry elements. Each Report Item is
contained in a corresponding Laboratory Report Item Section which contains the Lab
Report Data Processing Entry.
o Choice 2: Text and Entry - With this option, the Laboratory Specialty Section text SHALL
be present and not blank. This narrative block SHALL present to the human reader, all
the observations produced for this Specialty, using the various structures available in
the CDA Narrative Block schema (NarrativeBlock.xsd): tables, lists, paragraphs,
hyperlinks, footnotes, references to attached or embedded multimedia objects. The
narrative block is fully derived from the entry containing the machine-readable result
data. Additionally, a single Laboratory Report Data Processing Entry SHALL be present
with attribute typeCode="DRIV". This entry contains the machine-readable result data
from which the narrative block of this section is derived.
4.10.2. Example of Laboratory Specialty
<ClinicalDocument>
...
<component typeCode="COMP">
<structuredBody classCode="DOCBODY" moodCode="EVN">
<component typeCode="COMP">
<section classCode="DOCSECT">
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.1"/>
<!-- Example Specialty Section that holds a leaf section. -->
<code code="18723-7" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="HEMATOLOGY STUDIES"/>
<title>Laboratory Hematology Results</title>
<component>
<section>
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.2"/>
<!-- Example Leaf Section that holds one Report Item. -->
<code code="16931-8" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="Hemoglobin/Hematocrit"/>
<text/>
<entry typeCode="DRIV">
<templateId root="1.3.6.1.4.1.19376.1.3"/>
<act classCode="ACT" moodCode="EVN">
...
</act>
</entry>
</section>
</component>
</section>
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</component>
<component typeCode="COMP">
<section classCode="DOCSECT">
<templateId root="1.3.6.1.4.1.19376.1.3.3.2.1"/>
<!-- Example Specialty Section that holds Report Items directly as a
Laboratory Report Data Processing Entry-->
<code code="18719-5" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="CHEMISTRY STUDIES"/>
<title>Laboratory Chemistry Results</title>
<text/>
<entry typeCode="DRIV">
<templateId root="1.3.6.1.4.1.19376.1.3"/>
<act classCode="ACT" moodCode="EVN">
...
</act>
</entry>
</section>
</component>
</structuredBody>
</component>
...
</ClinicalDocument>
4.11.
Medical Equipment (Device)
The Medical Equipment section defines a patient’s implanted and external medical devices and
equipment that their health status depends on, as well as any pertinent equipment or device history.
For the purpose of adverse event reporting, initial selection was made within PHRI to use the Medical
Equipment Section within Consolidated CDA to support initial adverse event reporting requirements,
with the assumption that future piloting efforts may identify additional changes required to these
templates.
Inherits From
Medical Equipment
2.16.840.1.113883.10.20.22.2.23
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Non-Medicinal Supply Activity
2.16.840.1.113883.10.20.22.4.50
Product Instance
2.16.840.1.113883.10.20.22.4.37
Table 48 - Medical Equipment Section - CDA – Overview
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Figure 9 - Medical Equipment Model - PHRI
The mapping of the Medical Equipment section in Consolidated CDA to the core common data elements
defined for Medical Device in the PHRI Data Harmonization Profile is ongoing.
Core Common Data
Element
Device
Brand/Trade/Proprietary
Name
Device model number
Device catalog number
Device serial number
Device implant date
Device explant date
Reprocessed Device
Indicator
Reused Device Indicator
Device manufacturer
name
CDA Data Element
Name
XPATH
playingDevice
Included in the Product Instance template
playingDevice
playingDevice
playingDevice
Included in the Product Instance template
Included in the Product Instance template
Included in the Product Instance template
Included in the Non-Medicinal Supply Activity
template
Included in the Non-Medicinal Supply Activity
template
effectiveTime
effectiveTime
Not defined at this time – not supported by this template
Not defined at this time – not supported by this template
scopingEntity
Included in the Product Instance template
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Table 49 - Medical Equipment CDA Detail
4.11.1. Conformance for Medical Equipment
Implementers SHALL adopt all conformance statements present for a Medical Equipment Section
(templateID 2.16.840.1.113883.10.20.22.2.23) in the Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm).





SHALL contain 1..1 templateId (CONF:7944) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.2.23" (CONF:10404).
SHALL contain 1..1 code (CONF:15381).
o This code SHALL contain 1..1 @code="46264-8" Medical Equipment (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15382).
SHALL contain 1..1 title (CONF:7946).
SHALL contain 1..1 text (CONF:7947).
SHOULD contain 0..* entry (CONF:7948) such that it
o SHALL contain 1..1 Non-Medicinal Supply Activity
(templateId:2.16.840.1.113883.10.20.22.4.50) (CONF:15497).
4.11.2. Value Sets
Additional value sets will be defined for Medical Equipment in association with the FDA and their work
to establish an Adverse Event reporting document template (as initially defined in Section 3.1)
4.11.3. Example for Medical Equipment
<Section>
<templateId root="2.16.840.1.113883.10.20.22.2.23" />
<code code="46264-8" />
<title />
<text />
<entry>
<supply />
</entry>
</Section>
4.12.
Medication
Medication requirements for public health would center on the reporting of medications in the
following instances:


Medications that lead to an adverse event
Medications that may have been prescribed for a specific diagnosis
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As such, medication information is included in the Public Health Reporting Specification to support the
need for aligning medication to other sections within a public health implementation guide using CDA,
such as tying the Medication Section and associated Entries to an Allergy Section (and set of associated
observations) or tying the Medication Section to a specific diagnosis/problem Section.
Inherits From
Medications Section
2.16.840.1.113883.10.20.22.2.1.1
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Medication Activity
2.16.840.1.113883.10.20.22.4.16
Drug Vehicle
2.16.840.1.113883.10.20.22.4.24
Medication Dispense
2.16.840.1.113883.10.20.22.4.18
Medication Information
2.16.840.1.113883.10.20.22.4.23
Table 50 - Medication CDA Section Overview
Core Common
Data Element
Active Ingredient
Code
Active Ingredient
Code Description
Active Ingredient
Free Text
Medication Start
Date/Time
Dose Frequency
Administration
Timing
Dispense
Date/Time
CDA Data Element Name
XPATH
manufacturedProduct
manufacturedProduct
manufacturedProduct
effectiveTime -type
substanceAdministration/effectiveTime/@xsi:type
effectiveTime
substanceAdministration/effectiveTime
effectiveTime
substanceAdministration/effectiveTime
effectiveTime
See Medication Dispense
entry template
Route of
Administration
Dose and Dosage
Number
Site
routeCode
doseQuantity value
doseQuantity unit
approachSiteCode
substanceAdministration/routeCode/@code
substanceAdministration/doseQuantity/@value
substanceAdministration/doseQuantity/@unit
substanceAdministration/approachSiteCode/
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Core Common
Data Element
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XPATH
CDA Data Element Name
@code
Lot Number
Manufacturer
Name
Indication
Medication Series
Number
Medication Dosage
Form
Medication Code
lotNumber
manufacturedOrganization
See Indication entry level
template
manufacturedProduct
administrationUnitCode
Product Namecode
Product Name displayName
Product Name codeSystem
Product Name codeSystem
Name
Product text
Medication Type
Entry/manufacturedMaterial/lotNumber
entry/manufacturedMaterial/
manufacturedOrganization
@typeCode='RSON’
Type of Medication
administrationUnitCode/@code
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/
code/@code
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/
code/@displayName
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/
code/@codeSystem
substanceAdministration/consumable/
manufacturedProduct/ManufaturedMaterial/code
/@codeSystemName
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/
code/originalText/reference/@value
substanceAdministration/entryRelationship/
observation/value
Table 51 - Medication CDA Detail
4.12.1. Conformance for Medication

Implementers SHALL adopt all conformance statements present for a Medication Section
(templateID 2.16.840.1.113883.10.20.22.2.1.1) in the Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm).


Conforms to Medications Section (entries optional) template (2.16.840.1.113883.10.20.22.2.1).
SHALL contain exactly one [1..1] templateId (CONF:7568) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.1.1"
(CONF:10433).
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



SHALL contain exactly one [1..1] code (CONF:15387).
o This code SHALL contain exactly one [1..1] @code="10160-0" History of medication use
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15388).
SHALL contain exactly one [1..1] title (CONF:7570).
SHALL contain exactly one [1..1] text (CONF:7571).
SHALL contain at least one [1..*] entry (CONF:7572) such that it
o SHALL contain exactly one [1..1] Medication Activity
(templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15500).
o If medication use is unknown, the appropriate nullFlavor MAY be present (see unknown
information in Section 1) (CONF:10077).
4.12.2. Value Sets
The following value sets are proposed for the Medication section:
Value Set Name
PHVS_MedicationType_HITSP
Value Set ID
Type
2.16.840.1.113883.3.88.12.3221.8.19 Specified by PHRI Data
Harmonization Profile
Medication Clinical Drug
2.16.840.1.113883.3.88.12.80.17
Specified within
Consolidated CDA
Medication Drug Class
2.16.840.1.113883.3.88.12.80.18
Specified within
Consolidated CDA
PHVS_BodySite_HITSP
2.16.840.1.113883.3.88.12.3221.8.9 Specified by PHRI Data
Harmonization Profile
PHVS_RouteOfAdministration_HL7_2x 2.16.840.1.114222.4.11.816
Specified by PHRI Data
Harmonization Profile
PHVS_MedicationProductForm_HITSP 2.16.840.1.113883.3.88.12.3221.8.11 Specified by PHRI Data
Harmonization Profile
Table 52 - Medication Value Sets
The following additional constraints apply to the use of vocabularies with medication elements in the
Medication section template and associated entry templates:




UNII SHOULD be used when describing active ingredients
Medications SHOULD be coded using RxNORM.
ICD-9 Diagnosis codes SHOULD be used when describing indications for a medication
Federal Medication Terminology (FMT) names SHOULD be used for medication names
4.12.3. Example of Medication
Field Values
component templateId
Medication ID #
displayName
Vocabulary OID
Content Values
2.16.840.1.113883.10.20.22.2.1.1
10160-0
History of medication use
2.16.840.1.113883.6.1
References
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Field Values
codeSystemName
title
component/section/entry
typeCode
Content Values
LOINC
Medication
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
References
Code
DRIV
Description
HL7v3 – ActRelationshipType
Is derived
from
component/section/entry/substanceAdministration
classCode
SBADM
HL7 v3 – ActClass
moodCode
Code
Description
HL7 v3 – ActMood
EVN
Event
templateId
2.16.840.1.113883.10.20.1.24
templateId
2.16.840.1.113883.3.88.11.32.8
Medication activity template
text reference
#sig-1
statusCode
Code
Description
Refers to template status
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
held
held
New
New
suspended
suspended
component/section/entry/substanceAdministration/effectiveTime (Indicate Medication Stopped)
XSI Type
Code
Description
HL7 v3 – datatypes
IVL_TS
Interval Point
in Time
PIVL_TS
Periodic
Interval of
Time – Point
in Time
EIVL_TS
Event-Related
Periodic
Interval of
Time – Point
in Time
nullFlavor
UNK
component/section/entry/substanceAdministration/effectiveTime (Administration Timing)
type
Code
Description
HL7 v3 – datatypes
IVL_TS
Interval Point
in Time
PIVL_TS
Periodic
Interval of
Time – Point
in Time
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Field Values
EIVL_TS
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Content Values
References
Event-Related
Periodic
Interval of
Time – Point
in Time
institutionSpecified
True
timingOperator
A
periodValue
XX
timingPeriod unit
h
component/section/entry/substanceAdministration/routeCode
routeCode and displayName
Route codes would go here (FDA
SPL)
codeSystem
2.16.840.1.113883.3.26.1.1
codeSystemName
NCI Thesaurus
component/section/entry/substanceAdministration/approachSiteCode
Code
Description
code and displayName
21082005
Mouth
Vocabulary OID
2.16.840.1.113883.6.96
codeSystemName
SNOMED CT
component/section/entry/substanceAdministration/doseQuantity
value
X
unit
component/section/entry/substanceAdministration/maxDoseQuantity
xsi:type
RTO_PQ_PQ
component/section/entry/substanceAdministration/maxDoseQuantity/numerator
value
X
component/section/entry/substanceAdministration/maxDoseQuantity/denominator
value
X
component/section/entry/substanceAdministration/administrationUnitCode/
code and displayName
Unit codes would go here (FDA SPL)
codeSystem
2.16.840.1.113883.3.26.1.1
codeSystemName
NCI Thesaurus
Table 53 - Medication Detailed Example
4.13.
Order/Diagnostic Test
The Order/Diagnostic Test section represents information that may be included for a single order or set
of orders. There are currently multiple ways defined in the Public Health Reporting Specification- CDA
for representing an order/diagnostic test:
 Use a Medication Supply Order entry template to show information related to an order or
orders for medication. The exact location and structure of the Medication Supply Order entry
template within the CDA-based public health report would be constrained by the documentlevel and section-level templates associated with the Medication Supply Order entry template.
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Use the Provider Orders Section to capture a list of all pertinent orders made by a provider. This
approach draws heavily from the IHE Patient Care Coordination (PCC) - Technical Framework
Supplement - CDA Content Modules. The Provider Orders template can be used for medication
orders or other order types.
Inherits From
Medication Supply Order
2.16.840.1.113883.10.20.22.4.17
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Provider Orders
1.3.6.1.4.1.19376.1.5.3.1.1.20.2.1
Table 54 - Order/Diagnostic Test CDA Section Overview
Note that this table is detail provided for a medication order.
Core Common Data
Element
Diagnostic
Test/Order Code
CDA Data Element Name
Product Name code
Product Name displayName
Product Name codeSystem
Product Name
codeSystemName
Diagnostic
Test/Order
Date/Time
Order date/time
XPATH
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/c
ode/@code
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/c
ode/
@displayName
substanceAdministration/consumable/
manufacturedProduct/ManufacturedMaterial/c
ode/
@codeSystem
substanceAdministration/consumable/
manufacturedProduct/ManufaturedMaterial/co
de/
@codeSystemName
substanceAdministration/entryRelationship/sup
ply/author/time/@value
Table 55 - Order/Diagnostic Test CDA Detail
4.13.1. Conformance for Order/Diagnostic Test



For CDA-based public health reports, the Medication Supply Order Activity template SHALL be used
when listing specific medication orders
For CDA-based public health reports, the IHE Provider Orders Section SHALL be used to document a
list of medications and procedures that have been ordered
Implementers SHALL follow all constraints defined for the Provider Orders Section
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Implementers SHOULD use HL7 2.x messaging to send specific information about orders using
existing orders-based messaging implementation guides.
4.13.2. Value Sets
No specific value set is recommended.

The only vocabulary constraints currently applied is use of LOINC for laboratory order codes and
use of CPT to supporting diagnostic tests.
4.13.3. Examples of Order/Diagnostic Test
No specific examples provided at this time.
4.14.
Payer Information
The only attribute currently defined within the Public Health Reporting Specification related to payers is
the Insurance Type attribute. Further research will be needed to determine use of this data element
within a public health report.
Inherits from
Payers Section
2.16.840.1.113883.10.20.22.2.18
References
Payers Section and Coverage Entry
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Table 56 - Payer Information CDA Section Overview
4.14.1. Conformance of Payer Information Section






Implementers SHALL adopt all conformance statements present for a Payers Section
(templateID 2.16.840.1.113883.10.20.22.2.18) in the Implementation Guide for CDA Release
2.0 Consolidated CDA Templates (US Realm).
SHALL contain exactly one [1..1] templateId (CONF:7924) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.18"
(CONF:10434).
SHALL contain exactly one [1..1] code (CONF:15395).
o This code SHALL contain exactly one [1..1] @code="48768-6" Payers (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15396).
SHALL contain exactly one [1..1] title (CONF:7926).
SHALL contain exactly one [1..1] text (CONF:7927).
SHOULD contain zero or more [0..*] entry (CONF:7959) such that it
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o
Standards & Interoperability Framework
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SHALL contain exactly one [1..1] Coverage Activity
(templateId:2.16.840.1.113883.10.20.22.4.60) (CONF:15501).
4.14.2. Value Sets
Value Set Name
Value Set ID
PHVS_SourceOfPaymentTypology_PHDSC 2.16.840.1.114222.4.11.3591
Type
Specified by PHRI Data
Harmonization Profile
Table 57 - Payer Information Value Sets
4.14.3. Examples of Payer Information
Payer example will not be included as part of this release of the specification, as it was determined that
the representation of only 1 data element is not needed in an example.
4.15.
PHCR Clinical Information
Inherits From
Public Health Care Report
2.16.840.1.113883.10.20.15
References
HL7 Implementation Guide for CDA Release 2:
Public Health Case Reporting, Release 1
US Realm
PHCR Case Observation
2.16.840.1.113883.10.20.15.3.54
Patient condition – deceased
2.16.840.1.113883.10.20.15.3.17
Patient condition – alive
2.16.840.1.113883.10.20.15.3.42
Table 58 - PHCR Clinical Information - CDA Section Overview
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Figure 10 - PHCR Clinical Information Model – PHRI
4.15.1. Conformance of PHCR Clinical Information






All conformance statements for PHCR Clinical Information section template (templateID
2.16.840.1.113883.10.20.15.2.1) as specified in the HL7 Implementation Guide for CDA Release
2: Public Health Case Reporting, Release 1 - US Realm, SHALL be required.
SHALL contain exactly one [1..1] code="55752-0" Clinical Information with @xsi:type="CD"
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:540).
SHALL contain exactly one [1..1] title="Clinical Information" (CONF:541).
SHALL contain exactly one [1..1] text (CONF:542).
SHALL contain exactly one [1..1] entry (CONF:1891) such that it
o SHALL contain exactly one [1..1] @typeCode="DRIV" Is derived from (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1892).
o SHALL contain exactly one [1..1] PHCR Case observation
(templateId:2.16.840.1.113883.10.20.15.3.54) (CONF:1893).
MAY contain zero or one [0..1] entry (CONF:1915) such that it
o SHALL contain exactly one [1..1] @typeCode="DRIV" Is derived from (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1916).
o SHALL contain exactly one [1..1] Deceased Observation (templateId:
2.16.840.1.113883.10.20.22.4.79) (CONF:1917).
4.15.2. Value Sets
All value sets as specified in the HL7 Implementation Guide for CDA Release 2: Public Health Case
Reporting, Release 1 - US Realm are applicable.
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4.15.3. Examples of PHCR Clinical Information
Example of the use of the PHCR Clinical Information template and supporting clinical statements for
specific communicable disease case reports can be found within the HL7 Implementation Guide for CDA
Release 2: Public Health Case Reporting, Release 1 - US Realm. An XML snippet is provided from the
PHDSC New York Pilot:
<section>
<templateId root="2.16.840.1.113883.10.20.15.2.1"/>
<templateId root="2.16.840.1.113883.10.20.15.2.25"/>
<code code="55752-0" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Clinical Information"/>
<title>Clinical Information</title>
<text><list>
<caption>Pertussis Clinical Information Section</caption>
<item>Condition - Pertussis</item>
<item>Condition diagnosed 2011/12/15</item>
<item>Condition diagnosed by Dr Barry Smith</item>
<item>Problem remains active at time of report</item>
<item>Signs and Symptoms - Persistent Cough REPORTED starting on 2011/11/05</item>
<item>Signs and Symptoms - Whooping Respiration not reported</item>
<item>Signs and Symptoms - Paroxysms Of Coughing REPORTED starting on
2011/12/14</item>
<item>Signs and Symptoms - Post-tussive vomiting not reported</item>
<item>Patient is alive 2011/12/15</item>
</list></text>
4.16.
PHCR Treatment Information
Inherits From
Public Health Care Report
2.16.840.1.113883.10.20.15
References
HL7 Implementation Guide for CDA Release 2:
Public Health Case Reporting, Release 1
US Realm
PHCR Treatment Regimen
2.16.840.1.113883.10.20.15.3.57
Table 59 - PHCR Treatment Information – CDA Section Overview
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Figure 11 - PHCR Treatment Information Model - PHRI
4.16.1. Conformance of PHCR Treatment Information

All conformance statements for PHCR Treatment Information section template (templateID
2.16.840.1.113883.10.20.15.2.4) as specified in the HL7 Implementation Guide for CDA Release
2: Public Health Case Reporting, Release 1 - US Realm, SHALL be required.

SHALL contain exactly one [1..1] code="55753-8" Treatment Information with @xsi:type="CD"
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:663).
SHALL contain exactly one [1..1] title="Treatment Information" (CONF:664).
SHALL contain exactly one [1..1] text (CONF:665).
SHALL contain exactly one [1..1] entry (CONF:1959) such that it
o SHALL contain exactly one [1..1] @typeCode="DRIV" Is derived from (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1960).
o SHALL contain exactly one [1..1] PHCR Therapeutic regimen
(templateId:2.16.840.1.113883.10.20.15.3.57) (CONF:1961).



4.16.2. Value Sets
All value sets as specified in the HL7 Implementation Guide for CDA Release 2: Public Health Case
Reporting, Release 1 - US Realm are applicable.
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4.16.3. Examples of PHCR Treatment Information
Example of the use of the PHCR Treatment Information template and supporting clinical statements for
specific communicable disease case reports can be found within the HL7 Implementation Guide for CDA
Release 2: Public Health Case Reporting, Release 1 - US Realm. An XML snippet is provided below from
the PHDSC New York Pilot:
<section>
<templateId root="2.16.840.1.113883.10.20.15.2.4"/>
<templateId root="2.16.840.1.113883.10.20.15.2.26"/>
<code code="55753-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
displayName="Treatment Information"/>
<title>Treatment Information</title>
<text><list>
<caption>Pertussis Treatment Information Section</caption>
<item>Condition ID - NY214365</item>
<item>Prescribed Azithromycin on 2011/12/15 for 5 days</item>
</list></text>
<entry typeCode="DRIV">
<act classCode="ACT" moodCode="EVN" negationInd="false">
<templateId root="2.16.840.1.113883.10.20.15.3.57"/>
<templateId root="2.16.840.1.113883.10.20.15.3.67"/>
<code code="133877004" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMEDCT" displayName="Therapeutic regimen"/>
<statusCode code="completed"/>
<entryRelationship typeCode="REFR">
<observation classCode="OBS" moodCode="EVN" negationInd="false">
<id root="1.3.6.1.4.1.19376.1.3.4" extension="NY214365"/>
<code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"
codeSystemName="HL7ActCode"/>
<value xsi:type="CD" code="27836007" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMEDCT" displayName="Pertussis"/>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="false">
<templateId root="2.16.840.1.113883.10.20.15.3.55"/>
<templateId root="2.16.840.1.113883.10.20.15.3.68"/>
<statusCode code="active"/>
<effectiveTime xsi:type="IVL_TS">
<low value="20111215103000-0500"/>
<high value="20111220000000-0500"/>
</effectiveTime>
<routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1"
codeSystemName="NCI Thesaurus" displayName="Oral"/>
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<consumable>
<manufacturedProduct>
<manufacturedMaterial>
<code code="18631" codeSystem="2.16.840.1.113883.6.88" codeSystemName="RxNorm"
displayName="Azithromycin"/>
<name>Azithromycin 100 MG/ML [Zithromax]</name>
</manufacturedMaterial>
</manufacturedProduct>
</consumable>
</substanceAdministration>
</entryRelationship>
</act>
</entry>
</section>
4.17.
Physical Exam
Inherits From
Physical Exam Section
2.16.840.1.113883.10.20.2.10
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Table 60 - Physical Exam CDA Section – Overview
The following table contains an example of how the physical exam can be included using CDA for a
public health report:
Core Common
Data Element
Physical Exam
Observation
Physical Exam
Component/Device
Physical Exam
Section
Physical Exam
Observation Result
Physical Exam
Narrative
CDA Element Name
XPATH
Contained in narrative
methodCode
targetSiteCode
Self-contained – each exam section can be defined as its own Physical Exam
template
code
code/@code
title
title
Table 61 - Physical Exam CDA Section – Detail
Sections for physical exams such as foot, eye, and throat exams are covered by using one or more
Physical Exam section level templates, and the component/device used (dependent on exam) is tied to a
Procedure Activity.
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4.17.1. Conformance of Physical Exam Section
Implementers SHALL adopt all conformance statements present for a Physical Exam Section (templateID
2.16.840.1.113883.10.20.2.10) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).
1. SHALL contain exactly one [1..1] templateId (CONF:7806) such that it
a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.2.10"
(CONF:10465).
2. SHALL contain exactly one [1..1] code (CONF:15397).
a. This code SHALL contain exactly one [1..1] @code="29545-1" Physical Findings
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15398).
3. SHALL contain exactly one [1..1] title (CONF:7808).
4. SHALL contain exactly one [1..1] text (CONF:7809).
5. MAY contain zero or more [0..*] entry (CONF:17094) such that it
a. SHALL contain exactly one [1..1] Pressure Ulcer Observation
(templateId:2.16.840.1.113883.10.20.22.4.70) (CONF:17095).
6. MAY contain zero or more [0..*] entry (CONF:17096) such that it
a. SHALL contain exactly one [1..1] Number of Pressure Ulcers Observation
(templateId:2.16.840.1.113883.10.20.22.4.76) (CONF:17097).
7. MAY contain zero or more [0..*] entry (CONF:17098) such that it
a. SHALL contain exactly one [1..1] Highest Pressure Ulcer Stage
(templateId:2.16.840.1.113883.10.20.22.4.77) (CONF:17099).
4.17.2. Value Sets
No value sets are applicable at this time for a physical exam. Implementers should reference the CMS
Evaluation and Management Guidelines of 1997 for specific guidelines on physical exam information.
4.17.3. Examples of Physical Exam
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.2.10"/>
<code codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" code="29545-1"
displayName="PHYSICAL FINDINGS"/>
<title>PHYSICAL EXAMINATION</title>
<text>
<list listType="ordered">
<item>HEENT: All normal to examination.</item>
<item>Heart: RRR, no murmur.</item>
<item>THORAX &amp; LUNGS: Clear without rhonchi or wheeze.</item>
<item>ABDOMEN: No distension, tenderness, or guarding, obese, pos bowel sounds.</item>
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<item>BACK: Normal to inspection and palpation, without tenderness; no presacral edema.</item>
<item>EXTREMITIES: Doughy edema bilaterally, chronic stasis changes, no asymmetrical
swelling.</item>
</list>
</text>
</section>
</component>
4.18.
Procedure
Inherits From
Procedure Section
2.16.840.1.113883.10.20.22.2.7
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Procedure Activity Act
2.16.840.1.113883.10.20.22.4.12
Procedure Activity Observation
2.16.840.1.113883.10.20.22.4.13
Procedure Activity Procedure
2.16.840.1.113883.10.20.22.4.14
Table 62 - Procedure CDA Section – Overview
Figure 12 - Procedure Model - PHRI
Core Common Data Element
Procedure Code
CDA Element Name
procedure code
displayName
XPATH
procedure/code/@code
procedure/code/@displayName
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Core Common Data Element
Procedure Date/Time
Procedure Reason
CDA Element Name
codeSystem OID
codeSystemName
effectiveTime
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
procedure/code/@codeSystem
procedure/code/@codeSystemName
effectiveTime
Included in Indication @typecode = “RSON”
Procedure Not Performed Reason
Table 63 - Procedure CDA Section – Detail
The following table contains an example of how the different parts of a procedure would be
documented using CDA for a public health report:
Field Values
Content Values
Notes for Implementation
section OID
2.16.840.1.113883.10.20.1.12
code
47519-4
Vocabulary OID
2.16.840.1.113883.6.1
HL7 v3 – codeSystem
codeSystemName
LOINC
code/@displayName
History of Procedures
title
Procedures
content id
Proc-x
content text
#text
ClinicalDocument/component/structuredBody/component/section/entry/
typeCode
Code
Description
HL7 v3 ActRelationshipType
DRIV
Is derived from
ClinicalDocument/component/structuredBody/component/section/entry/procedure/
classCode
PROC
HL7 v3 - ActClass
moodCode
Code
Description
HL7 v3 - moodClass
EVN
Event
Procedure Activity Template ID 2.16.840.1.113883.10.20.1.29
id
code
xxx
codeSystemName
2.16.840.1.113883.6.104
displayName
ICD-9 Procedures
statusCode code
completed
Refers to template status
effectiveTime - low
YYYYMMDDHHMM
effectiveTime - high
YYYYMMDDHHMM
ClinicalDocument/component/structuredBody/component/section/entry/procedure/targetSiteCode
code
XXXXXXX
SNOMED-CT value set here
displayName
codeSystem
2.16.840.1.113883.6.96
SNOMED CT
codeSystemName
SNOMED CT
ClinicalDocument/component/structuredBody/component/section/entry/procedure/code/
originalText/
Reference value
Add procedure text here
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Table 64 - Procedure CDA Section - Detailed Example
4.18.1. Conformance of Procedure Section
Implementers SHALL adopt all conformance statements present for a Procedure Section (templateID
2.16.840.1.113883.10.20.22.2.7.1) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).









Conforms to Procedures Section (entries optional) template
(2.16.840.1.113883.10.20.22.2.7).
SHALL contain exactly one [1..1] templateId (CONF:7891) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.7.1"
(CONF:10447).
SHALL contain exactly one [1..1] code (CONF:15425).
o This code SHALL contain exactly one [1..1] @code="47519-4" History of Procedures
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15426).
SHALL contain exactly one [1..1] title (CONF:7893).
SHALL contain exactly one [1..1] text (CONF:7894).
MAY contain zero or more [0..*] entry (CONF:7895) such that it
o SHALL contain exactly one [1..1] Procedure Activity Procedure
(templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15512).
MAY contain zero or more [0..*] entry (CONF:8017) such that it
o SHALL contain exactly one [1..1] Procedure Activity Observation
(templateId:2.16.840.1.113883.10.20.22.4.13) (CONF:15513).
MAY contain zero or more [0..*] entry (CONF:8019) such that it
o SHALL contain exactly one [1..1] Procedure Activity Act
(templateId:2.16.840.1.113883.10.20.22.4.12) (CONF:15514).
There SHALL be at least one procedure, observation or act entry conformant to Procedure
Activity Procedure template, Procedure Activity Observation template or Procedure Activity
Act template in the Procedure Section (CONF:8021).
4.18.2. Value Sets
Additional value sets defined in Birth and Fetal Death Reporting have been identified and analyzed.
Value Set Name
MCH HBS Significant Birth Injury
Non-Laboratory Intervention
and Procedure
MCH HBS Seizure or Serious
Neurologic Dysfunction
Value Set OID
1.3.6.1.4.1.19376.1.7.3.1.1.13.8.9
2.16.840.1.114222.4.11.3204
1.3.6.1.4.1.19376.1.7.3.1.1.13.8.10
Table 65 - Value Sets for Procedure CDA Section
The following vocabulary constraints for the Procedure section also apply:
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
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Use of procedure codes SHOULD be constrained to SNOMED-CT, CPT-4, ICD-9 (volume 3) and/or
ICD-10 (PCS)
Use of procedure types SHOULD be constrained to SNOMED-CT, ICD-9 (volume 1&2), and ICD-10
4.18.3. Examples of Procedures
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.1.12" />
<code code="47519-4" displayName="History of procedures"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" />
<title>Procedures</title>
<entry typeCode="DRIV">
<procedure classCode="PROC" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.29" />
<id root="d512g451-9999-22ec-0gf2-1911311d0b77" />
<code code="V58.11" displayName="Encounter for antineoplastic chemotherapy
&#xD;&#xA; &#xD;&#xA;" codeSystem="2.16.840.1.113883.6.104" codeSystemName="ICD9
Procedures">
<originalText>
<reference value="#proc-3" />
</originalText>
</code>
<text></text>
<statusCode code="completed" />
<effectiveTime>
<low value="20070211" />
<high value="200609211030" />
</effectiveTime>
<!--Site where procedure was performed-->
<targetSiteCode code="302540006" displayName="Entire thumb"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"></targetSiteCode>
<time>
<low value="200702011000" />
<high value="200702011200" />
</time>
<assignedEntity>
<id root="78A150ED-B890-49dc-B716-5EC0027B3982" extension="ProviderID" />
<code code="280000000X" displayName="Hospitals"
codeSystem="2.16.840.1.113883.6.101" codeSystemName="ProviderCodes" />
<addr use="WP">
<streetAddressLine>145 Applecross Road</streetAddressLine>
<streetAddressLine></streetAddressLine>
<city>Southern Pines</city>
<state>NC</state>
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<postalCode>28388</postalCode>
</addr>
<assignedPerson>
<name>
<prefix>Dr. </prefix>
<given>Susan</given>
<given />
<family>Saltz</family>
</name>
</assignedPerson>
<representedOrganization>
<name>Southern Pines Women's Health Center</name>
</representedOrganization>
<sdtc:patient xmlns:sdtc="urn:hl7-org:sdtc">
<sdtc:id root="78A150ED-ZZ23-49dc-B716-5EC0027B3983"
extension="33445999" />
</sdtc:patient>
</assignedEntity>
</performer>
<!--Operative Report-->
</procedure>
</entry>
<entry typeCode="DRIV">
<procedure classCode="PROC" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.29" />
<id root="d512g451-9999-22ec-0gf2-1911311d0b77" />
<code code="V58.11" displayName="Encounter for antineoplastic chemotherapy
&#xD;&#xA; &#xD;&#xA;" codeSystem="2.16.840.1.113883.6.104" codeSystemName="ICD9
Procedures">
<originalText>
<reference value="#proc-3" />
</originalText>
</code>
<statusCode code="completed" />
<effectiveTime>
<low value="20060921000" />
<high value="200609211030" />
</effectiveTime>
<targetSiteCode code="302540006" displayName="Entire thumb"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"></targetSiteCode>
<time>
<low value="200701211000" />
<high value="200701211200" />
</time>
<assignedEntity>
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<id root="78A150ED-B890-49dc-B716-5EC0027B3982" extension="ProviderID" />
<code code="280000000X" displayName="Hospitals"
codeSystem="2.16.840.1.113883.6.101" codeSystemName="ProviderCodes" />
<addr use="WP">
<streetAddressLine>145 Applecross Road</streetAddressLine>
<streetAddressLine></streetAddressLine>
<city>Southern Pines</city>
<state>NC</state>
<postalCode>28388</postalCode>
</addr>
<assignedPerson>
<name>
<prefix>Dr. </prefix>
<given>Susan</given>
<given />
<family>Saltz</family>
</name>
</assignedPerson>
<representedOrganization>
<name>Southern Pines Women's Health Center</name>
</representedOrganization>
<sdtc:patient xmlns:sdtc="urn:hl7-org:sdtc">
<sdtc:id root="78A150ED-ZZ23-49dc-B716-5EC0027B3983"
extension="33445999" />
</sdtc:patient>
</assignedEntity>
</performer>
</procedure>
</entry>
<entry typeCode="DRIV">
<procedure classCode="PROC" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.29" />
<id root="d512g451-9999-22ec-0gf2-1911311d0b77" />
<code code="V58.11" displayName="Encounter for antineoplastic chemotherapy
&#xD;&#xA; &#xD;&#xA;" codeSystem="2.16.840.1.113883.6.104" codeSystemName="ICD9
Procedures">
<originalText>
<reference value="#proc-3" />
</originalText>
</code>
<statusCode code="completed" />
<effectiveTime>
<low value="200612291000" />
<high value="200612291030" />
</effectiveTime>
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<targetSiteCode code="302540006" displayName="Entire thumb"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"></targetSiteCode>
<time>
<low value="200702011000" />
<high value="200702011200" />
</time>
<!--Treating Physician-->
<assignedEntity>
<id root="78A150ED-B890-49dc-B716-5EC0027B3982" extension="ProviderID" />
<code code="280000000X" displayName="Hospitals"
codeSystem="2.16.840.1.113883.6.101" codeSystemName="ProviderCodes" />
<addr use="WP">
<streetAddressLine>145 Applecross Road</streetAddressLine>
<streetAddressLine></streetAddressLine>
<city>South Pine</city>
<state>NC</state>
<postalCode>55555</postalCode>
</addr>
<assignedPerson>
<name>
<prefix>Dr. </prefix>
<given>Susan</given>
<given />
<family>Saltz</family>
</name>
</assignedPerson>
<representedOrganization>
<name>Southern Pines Women's Health Center</name>
</representedOrganization>
<sdtc:patient xmlns:sdtc="urn:hl7-org:sdtc">
<sdtc:id root="78A150ED-ZZ23-49dc-B716-5EC0027B3983"
extension="33445999" />
</sdtc:patient>
</assignedEntity>
</performer>
</procedure>
</entry>
4.19.
Provider Information
Information for providers within the public health report is primarily reported in two ways:


Tied to the <participant> element
Tied to a specific service event through use of the <DocumentationOf> element
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References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Inherits From
CDA Header
2.16.840.1.113883.10.20.22.1.1
Table 66 - Provider Information - Overview
Core Common
Data Element
Provider ID
CDA Data Element
Name
id
Provider Name
name
Provider
Organization
Provider Address
name
Provider Phone
telecom
Provider Email
Address
Provider Role
telecom
Provider Type
code
addr
functionCode
XPATH
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/assignedPerson/id
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/assignedPerson/name
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/representedOrganization/name
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/representedOrganization/addr
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/representedOrganization/telecom
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/representedOrganization/telecom
documentationOf/serviceEvent[@classCode]/performer/
functionCode
documentationOf/serviceEvent[@classCode]/performer/
assignedEntity/assignedPerson/code
Table 67 - Provider Information - CDA Detail
4.19.1. Conformance of Provider Information
Implementers SHALL implement all conformance requirements defined in the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm) for a <performer> and <documentationOf>
element.
For an Encounter Activity, the following constraints apply for a provider:

MAY contain zero or more [0..*] performer (CONF:8725).
o The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8726).
 This assignedEntity MAY contain zero or one [0..1] code (CONF:8727).
For defining a performer, the following constraints apply in defining a provider:

MAY contain 0..* documentationOf (CONF:14835).
o The documentationOf, if present, SHALL contain 1..1 serviceEvent (CONF:14836).
o This serviceEvent SHALL contain 1..1 effectiveTime (CONF:14837).
o This effectiveTime SHALL contain 1..1 low (CONF:14838).
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o This serviceEvent SHOULD contain 0..* performer (CONF:14839).
o The performer, if present, SHALL contain 1..1 @typeCode="PRF" Participation physical
performer (CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC)
(CONF:14840).
The performer participant represents clinicians who actually and principally carry out the
serviceEvent. In a transfer of care this represents the healthcare providers involved in the
current or pertinent historical care of the patient. Preferably, the patient’s key healthcare care
team members would be listed, particularly their primary physician and any active consulting
physicians, therapists, and counselors (CONF:16753).
o The performer, if present, MAY contain 0..1 functionCode (CONF:16818).
o The functionCode, if present, SHOULD contain 0..1 @codeSystem, which SHOULD be
selected from CodeSystem participationFunction (2.16.840.1.113883.5.88) STATIC
(CONF:16819).
o The performer, if present, SHALL contain 1..1 assignedEntity (CONF:14841).
o This assignedEntity SHALL contain 1..* id (CONF:14846).
o Such ids SHOULD contain 0..1 @root="2.16.840.1.113883.4.6" National Provider
Identifier (CONF:14847).
o This assignedEntity SHOULD contain 0..1 code (CONF:14842).
o The code, if present, SHALL contain 1..1 @code, which SHOULD be selected from
CodeSystem NUCCProviderTaxonomy (2.16.840.1.113883.6.101) STATIC (CONF:14843).
4.19.2. Value Sets
The following value sets have been defined to constrain the provider role in Provider Information:
Value Set Name
PHVS_ProviderRole_HITSP
Value Set OID
Type
2.16.840.1.113883.3.88.12.3221.4.2 Specified by PHRI Data
Harmonization Profile
Table 68 - Provider Information Value Sets
4.19.3. Examples of Provider Information
<documentationOf>
<serviceEvent classCode="PCPR">
<effectiveTime>
<low value="20000101"/>
<high value="20080731"/>
</effectiveTime>
<performer typeCode="PRF">
<templateId root="2.16.840.1.113883.3.88.11.32.4"/>
<functionCode code="PP" displayName="Primary Care Provider"
codeSystem="2.16.840.1.113883.12.443" codeSystemName="Provider Role">
<originalText>Primary Care Provider</originalText>
</functionCode>
<time>
<low value="20020101"/>
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<high nullFlavor="UNK"/>
</time>
<assignedEntity>
<id root="2.16.840.1.113883.4.6.1013905751" extension="Provider ID"/>
<code code="280000000X" displayName="Hospitals"
codeSystem="2.16.840.1.113883.6.101" codeSystemName="ProviderCodes"/>
<addr use="WP">
<streetAddressLine>10 St. Sample Boulevard </streetAddressLine>
<city>Example</city>
<state>VA</state>
<postalCode>11111</postalCode>
</addr>
<addr use="WP">
<streetAddressLine>123 West Cove Alley</streetAddressLine>
<streetAddressLine>Suite #22</streetAddressLine>
<city>Richmond</city>
<state>VA</state>
<postalCode>11111</postalCode>
</addr>
<telecom use="WP" value="tel:+1-888-555-1111"/>
<telecom value="mailto:H.Cohen.MD@SFMC.com"/>
<assignedPerson>
<name>
<prefix>Dr.</prefix>
<given>Harry</given>
<given>R</given>
<family>Cohen</family>
</name>
</assignedPerson>
<representedOrganization>
<id root="2.16.840.1.113883.4.6.2649871"/>
<name>St. George Medical Center</name>
</representedOrganization>
<sdtc:patient>
<sdtc:id root="78A150ED-B890-49dc-B716-5EC0027B3983" extension="11224433"/>
</sdtc:patient>
</assignedEntity>
</performer>
</serviceEvent>
</documentationOf>
4.20.
Result
Current summary of research indicates that the Result section of the Consolidated CDA captures general
information about a result. Recommendation would be to allow implementers may then define specific
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Result Section templates that can be further constrained to meet the needs of public health programs.
This will be further discussed with the Public Health Reporting Initiative sprint team in the 9/27 meeting.
Inherits From
Results (IHE PCC Modules)
1.3.6.1.4.1.19376.1.5.3.1.3.27
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Results Section
2.16.840.1.113883.10.20.22.2.3.1
Result Organizer
2.16.840.1.113883.10.20.22.4.1
Result Observation
2.16.840.1.113883.10.20.22.4.2
Table 69 - Result CDA Section – Overview
Table 70 - Result Model - PHRI
Core Common
Data Element
Result ID
Result Status
CDA Data Element Name
Result id
statusCode
XPATH
id@root
statusCode
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Core Common
Data Element
Result
Date/Time
Result Type
Result Value
Result
Interpretation
Result
Reference
Range
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
CDA Data Element Name
effectiveTime
effectiveTime
code
codeSystem
code displayName
codeSystemName
value type
Result value
Result unit
interpretationCode
interpretationCodeSystem
interpretationCode
codeSystemName
interpretationCode
displayName
code@code
code/@codeSystem
code/@displayname
code/@codeSystemName
value/xsi:type
value/@value
value/@unit
interpretationCode/@code
interpretationCode/@codeSystem
interpretationCode/@codeSystemName
observationRange
referenceRange/observationRange/text
interpretationCode/@displayName
Table 71 - Result CDA Section - Detail
4.20.1. Conformance of Results Section
Implementers SHALL adopt all conformance statements present for a Result Section (templateID
2.16.840.1.113883.10.20.22.2.3.1) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).








Implementers SHALL use the Coded Entries Required constraints for the Result Section when
creating a CDA-based public health report
Implementers SHOULD use HL7 2.x messaging to report result information, to maintain
consistency with existing implementation guides, especially those focused on laboratory
reporting.
Conforms to Results Section (entries optional) template (2.16.840.1.113883.10.20.22.2.3).
SHALL contain exactly one [1..1] templateId (CONF:7108) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.3.1"
(CONF:9137).
SHALL contain exactly one [1..1] code (CONF:15433).
o This code SHALL contain exactly one [1..1] @code="30954-2" Relevant diagnostic tests
and/or laboratory data (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC)
(CONF:15434).
SHALL contain exactly one [1..1] title (CONF:8892).
SHALL contain exactly one [1..1] text (CONF:7111).
SHALL contain at least one [1..*] entry (CONF:7112) such that it
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o
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SHALL contain exactly one [1..1] Result Organizer
(templateId:2.16.840.1.113883.10.20.22.4.1) (CONF:15516).
4.20.2. Value Sets
Current value sets to be recommended for results information that are defined within a CDA public
health report include:
Value Set Name
PHVS_ValueType_HL7_2x
Value Set ID
2.16.840.1.114222.4.11.1059
PHVS_AbnormalFlag_HL7_2x
2.16.840.1.114222.4.11.800
Result Status
2.16.840.1.113883.11.20.9.39
Type
Specified within PHRI Data
Harmonization Profile
Specified within PHRI Data
Harmonization Profile
Specified within Consolidated
CDA
Table 72 - Result Value Sets
Supported vocabularies in this specification include the following:

LOINC for reporting of results

SNOMED for the observation value code, when reporting organism names or coded ordinal scale tests
4.20.3. Examples of Result Section
The following table outlines an example of capturing information for a result within the Results Section
Field Values
section templateId
code
codeSystem
codeSystemName
displayName
Vocabulary OID
codeSystemName
title
content id
content text
Entry/
typeCode
Entry/observation
classCode
Content Values
2.16.840.1.113883.10.20.1.14
30954-2
2.16.840.1.113883.6.1
LOINC
Relevant diagnostic tests and/or
laboratory data
2.16.840.1.113883.6.1
LOINC
Results
Lab-x
text
Code
DRIV
Description
Is derived from
Code
OBS
Description
An act that is
intended to
result in new
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Field Values
moodCode
Result Template ID
Results Module
templateId
code
codeSystem
codeSystemName
displayName
text reference value
statusCode
effectiveTime/low/@value
Result valueType
Result value
Result unit
interpretationCode
code and displayName
interpretationCode codeSystem
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Content Values
References
information
about a subject
Code
Description
HL7 v3 – ActMood
EVN
Event
2.16.840.1.113883.3.88.11.32.16
2.16.840.1.113883.10.20.1.31
NA
LOINC
2.16.840.1.113883.6.1
(i.e. SODIUM)
#lab-x
Code
Description
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
held
held
New
New
suspended
suspended
YYYYMMDD
XX
XX
Xx/xx
Code
Description
B
Better
D
Decreased
U
Increased
W
Worse
N
Normal
I
Intermediate
R
Resistant
S
Susceptible
VS
Very
Susceptible
A
Abnormal
AA
Abnormal Alert
HH
High Alert
LL
Low Alert
H
High
2.16.840.1.113883.5.83
Refers to template status
HL7 v3 ObservationInterpretation
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Field Values
interpretationCode
codeSystemName
observation range
Content Values
Observation Interpretation
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References
Text (i.e. 136-145)
Table 73 - Result - Detailed Example
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.22.2.3.1"/>
<code code="30954-2" displayName="Relevant diagnostic tests and/or laboratory data"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
<title>Results</title>
<text>
<content ID="lab-1">Patient has normal cholesteral</content>
<content ID="lab-2">Yellow</content>
</text>
<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.31"/>
<id root="57d07056-bd97-4c90-891d-eb716d3170c8"/>
<code code="2093-3" displayName="Cholesterol" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC"/>
<text>
<reference value="#lab-1"/>
</text>
<statusCode code="completed"/>
<effectiveTime>
<low value="20071022"/>
</effectiveTime>
<value xsi:type="PQ" value="98" unit="mg/dL"/>
<interpretationCode code="N" displayName="Normal"
codeSystem="2.16.840.1.113883.5.83" codeSystemName="Observation Interpretation"/>
<referenceRange>
<observationRange>
<text>55 - 115 mg/dL</text>
</observationRange>
</referenceRange>
</observation>
</entry>
<entry>
<organizer classCode="BATTERY" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.32"/>
<id root="zzz12320-67ad-11db-bd13-0800200c9a66"/>
<code code="24356-8" displayName="Urinalysis Panel"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
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<statusCode code="completed"/>
<effectiveTime value="20080918"/>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.31"/>
<id root="2a7cdfe6-13f5-4e36-92f0-9e174837eec1"/>
<code code="86192007" displayName="COLOR OF URINE"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
<text>
<reference value="#lab-2"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CV" nullFlavor="NA"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.31"/>
<id root="8616ca32-7b5c-4f1c-819a-3336dd61c8b4"/>
<code code="365828000" displayName="SPECIFIC GRAVITY URINE"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
<statusCode code="completed"/>
<value xsi:type="PQ" value="1.01" unit="g/ml"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
<observationRange>
<text>1.003-1.030</text>
</observationRange>
</referenceRange>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.31"/>
<id root="329a9130-3ba8-4306-b72f-a58678b8c452"/>
<code code="365723003" displayName="PH URINE" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"/>
<statusCode code="completed"/>
<value xsi:type="PQ" value="6.0"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
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<observationRange>
<text>5.0-8.0</text>
</observationRange>
</referenceRange>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.16"/>
<id root="8215896c-4f99-4e74-91ac-e52201c06a8d"/>
<code code="365799007" displayName="PROTEIN" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"/>
<text>
<reference value="#lab-82"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CV" nullFlavor="NA"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
<observationRange>
<text>NEG</text>
</observationRange>
</referenceRange>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.16"/>
<id root="908b849b-6eb9-448d-a9ec-708c469059ec"/>
<code code="365811003" displayName="GLUCOSE" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"/>
<text>
<reference value="#lab-83"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CV" nullFlavor="NA"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
<observationRange>
<text>NEG</text>
</observationRange>
</referenceRange>
</observation>
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</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.16"/>
<id root="1ddd48a3-2969-4293-9c25-2e0feefbe3a3"/>
<code code="365658008" displayName="KETONE" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"/>
<text>
<reference value="#lab-84"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CV" nullFlavor="NA"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
<observationRange>
<text>NEG</text>
</observationRange>
</referenceRange>
</observation>
</component>
<component>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.3.88.11.32.16"/>
<id root="a4f500b5-7309-405d-8432-c2269abf3487"/>
<code code="275778006" displayName="BILI" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"/>
<text>
<reference value="#lab-85"/>
</text>
<statusCode code="completed"/>
<value xsi:type="CV" nullFlavor="NA"/>
<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"
codeSystemName="Observation Interpretation" displayName="Normal"/>
<referenceRange>
<observationRange>
<text>NEG</text>
</observationRange>
</referenceRange>
</observation>
</component>
</organizer>
</entry>
</section>
</component>
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4.21.
Social History
Social History may also be used to capture specific risk factors as a set of observations.
Inherits From
Social History Section
2.16.840.1.113883.10.20.22.2.17
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Social History Observation
2.16.840.1.113883.10.20.22.4.38
Smoking Status Observation
2.16.840.1.113883.10.22.4.78
Pregnancy Observation
2.16.840.1.113883.10.20.15.3.8
Estimated Date of Delivery
2.16.840.1.113883.10.20.15.3.1
Table 74 - Social History CDA Section Overview
Table 75 - Social History Model - PHRI
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4.21.1. Conformance for Social History
Implementers SHALL adopt all conformance statements present for a Social History Section (templateID
2.16.840.1.113883.10.20.22.2.17) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).

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

The Social History section MAY include the following core common elements:
o Employment Information – defined using Social History Type
o Exposure – defined using Social History Type
o Smoking Status – defined using Social History Type
SHALL contain exactly one [1..1] templateId (CONF:7936) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.17"
(CONF:10449).
SHALL contain exactly one [1..1] code (CONF:14819).
o This code SHALL contain exactly one [1..1] @code="29762-2" Social History
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:14820).
SHALL contain exactly one [1..1] title (CONF:7938).
SHALL contain exactly one [1..1] text (CONF:7939).
MAY contain zero or more [0..*] entry (CONF:7953) such that it
o SHALL contain exactly one [1..1] Social History Observation
(templateId:2.16.840.1.113883.10.20.22.4.38) (CONF:14821).
MAY contain zero or more [0..*] entry (CONF:9132) such that it
o SHALL contain exactly one [1..1] Pregnancy Observation
(templateId:2.16.840.1.113883.10.20.15.3.8) (CONF:14822).
SHOULD contain zero or more [0..*] entry (CONF:14823) such that it
o SHALL contain exactly one [1..1] Smoking Status Observation
(templateId:2.16.840.1.113883.10.20.22.4.78) (CONF:14824).
MAY contain zero or more [0..*] entry (CONF:16816) such that it
o SHALL contain exactly one [1..1] Tobacco Use
(templateId:2.16.840.1.113883.10.20.22.4.85) (CONF:16817).
Core Common
Social History Type
Social History Start
Time
Social History End
Time
Social History
Duration
Social History Free
CDA Data Element Name
code
XPATH
component/section/code/@code
effectiveTime
component/entry/effectiveTime
content text
component/text/content
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Core Common
Text
Social History
Observed Value
CDA Data Element Name
entry typeCode
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
XPATH
component/entry/@typeCode
Table 76 - Social History CDA Section – Detail
Example social history values are contained in the following table:
Field Values
section templateId
code
displayName
Vocabulary OID
codeSystemName
title
content ID
context text
entry typeCode
Content Values
References
2.16.840.1.113883.10.20.1.15
29762-2
Social History
2.16.840.1.113883.6.1
LOINC
Social History
Socialhistory-x
Text
Code
Description HL7v3 – ActRelationshipType
DRIV
Is derived from
Table 77 - Social History CDA Section - Detailed Example
4.21.2. Value Sets
The following value sets are proposed for Social History information:
Value Set Name
PHVS_SocialHistoryType_HITSP
Value Set ID
2.16.840.1.113883.3.88.12.80.60
Table 78 - Value Set Summary - Social History Section
The primary value set used to report social history information within a public health report is the Social
History Type. This value set is available within the PHIN VADS value set repository at the following
location:
Code
229819007
256235009
160573003
364393001
364703007
425400000
363908000
Name
Tobacco use and exposure (observable
entity)
Exercise (observable entity)
Alcohol intake (observable entity)
Nutritional observable (observable
entity)
Employment detail (observable entity)
Toxic exposure status (observable
entity)
Details of drug misuse behavior
Required
R2
R2
R2
R2
R2
R2
R2
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Code
228272008
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Required
Name
(observable entity)
Health-related behavior (observable
entity)
R2
Table 79 - Summary of Available Codes for Social History
4.21.3. Examples of Social History Section
An example for how to capture a social history for a patient is shown below. In this example, additional
information about the patient’s employment history is included.
<component>
<section>
<templateId root="2.16.840.1.113883.10.20.1.15" />
<code code="29762-2" displayName="Social history"
codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" />
<title>Social History</title>
<text>
<content ID="socialhistory-1">Recently retired as a day care worker. Immigrated
from China 30 years ago. Husband passed away in 2003. 3 supportive children. Denies
current or history of tobacoo, EtOH, illicits. Exposed to second-hand smoke by
husband.</content>
</text>
<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.33" />
<id root="a13c6991-5c8b-11db-b0de-0800200c9a66" />
<code code="14679004" displayName="Occupation"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT">
<originalText>
<reference value="#socialhistory-1" />
</originalText>
</code>
<statusCode code="completed" />
<effectiveTime>
<low value="19971203" />
<high value="20001203" />
</effectiveTime>
<value xsi:type="CD" code=" 112271005 " displayName="Assembly Shipment"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" />
</observation>
</entry>
<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
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<templateId root="2.16.840.1.113883.10.20.1.33" />
<id root="a13c6991-5c8b-11db-b0de-0800200c9a66" />
<code code="257733005" displayName="Activity"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT">
<originalText>
<reference value="#socialhistory-2" />
</originalText>
</code>
<statusCode code="completed" />
<effectiveTime>
<low value="19990615" />
<high value="20060615" />
</effectiveTime>
<value xsi:type="CD" code="102393008" displayName="Child Care"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" />
</observation>
</entry>
<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.1.33" />
<id root="a13c6991-5c8b-11db-b0de-0800200c9a66" />
<code code="257733005" displayName="Activity"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT">
<originalText>
<reference value="#socialhistory-2" />
</originalText>
</code>
<statusCode code="completed" />
<effectiveTime>
<low value="19891101" />
<high value="19960415" />
</effectiveTime>
<value xsi:type="CD" code="102393008" displayName="Kitchen Help"
codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" />
</observation>
</entry>
</section>
</component>
4.22.
Specimen
Information on a specimen is included within a CDA-based public health report to provide detail to both
orders and results where a specimen or a collection of specimens have been gathered.
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The approach for using CDA to collect specimens is to use templates from the IHE Laboratory (LAB)
Technical Framework – Volume 3 – Content that can collect specimen information specified in the Public
Health Data Harmonization Profile.
Inherits From
Laboratory Report Item Section
1.3.6.1.4.1.19376.1.3.3.2.2
References
IHE Laboratory (LAB)
Technical Framework – Volume 3 - Content
Laboratory Data Processing Entry
1.3.6.1.4.1.19376.1.3.1
Specimen Collection
1.3.6.1.4.1.19376.1.3.1.2
Table 80- Specimen CDA Section Overview
Core Common Data
Element
Specimen ID
Specimen Collector ID
Specimen Description
Specimen origin
Specimen parent ID
CDA Element Name
id
id
XPATH
participantRole/id
performer/id
NOT APPLICABLE
participantRole/id
Id
Requires hierarchy
Specimen collection
date/time
Specimen received
date/time
Specimen source site
Specimen type
Specimen sent to PHL
effectiveTime
procedure/effectiveTime
effectiveTime
act/effectiveTime
targetSiteCode
code
procedure/targetSiteCode
participantRole/playingEntity/code
NOT APPLICABLE
Table 81 - Specimen - CDA Section Detail
4.22.1. Conformance for Specimen

For specimens within a CDA-based public health report, the Laboratory Report Item Section
(templateID 1.3.6.1.4.1.19376.1.3.3.2.2) SHOULD be used. The following constraints would apply:
o The templateId element identifies this section as a Laboratory Report Item Section under a
Laboratory Specialty Section. The templateId SHALL be present with
root="1.3.6.1.4.1.19376.1.3.3.2.2".
o The Laboratory Report Item Section SHALL identify the single Report Item uniquely using the
<code> element. For example, a LOINC test code. The code, codeSystem, and displayName
SHALL be present. One MAY also populate codeSystemName and orginalText. The Leaf
Section title MAY be present, it is the local translation of the code@displayName.
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o The Laboratory Report Item Section text SHALL be present and not blank. This narrative
block SHALL present to the human reader and represent the observations produced for this
Report Item, using the various structures available in the CDA Narrative Block schema
(NarrativeBlock.xsd): tables, lists, paragraphs, hyperlinks, footnotes, references to attached
or embedded multimedia objects. The narrative block is fully derived from the entry
containing the machine-readable result data.
o The Laboratory Report Item Section SHALL contain a Lab Report Data Processing Entry. This
entry contains the machine-readable result data from which the narrative block of this
section is derived.
To include specimens in a CDA-based public health report, implementers MAY use the Procedure
Specimens Taken Section (templateID 2.16.840.1.113883.10.20.22.2.31)
To include the Procedure Specimens Taken section, one or more procedures MUST have been
performed
A public health reporting implementation guide MAY define a CDA-based template to represent
information involved in a specimen collection.
4.22.2. Value Sets
All value sets specified in the IHE Laboratory (LAB)- Technical Framework Volume 3 - (LAB TF-3) Content ,
specific to a Laboratory Report Item Section, SHALL be utilized in conformance with that framework.
IHE does not constrain to a specific value set but allows for usage of the following vocabularies
In addition, the following value sets are proposed for implementation through the PHRI Data
Harmonization Profile (and drawn from existing HL7 data tables):
Value Set Name
PHVS_BodySite_CDC
Value Set ID
2.16.840.1.114222.4.11.967
PHVS_Specimen_CDC
2.16.840.1.114222.4.11.946
Type
Specified within PHRI Data
Harmonization Profile
Specified within PHRI Data
Harmonization Profile
Table 82 - Specimen Value Sets
4.22.3. Examples of Specimen
No examples are included at this time.
4.23.
Vital Sign Indicators
Inherits From
Vital Signs
2.16.840.1.113883.10.20.22.2.4.1
References
Implementation Guide for CDA Release 2.0
Consolidated CDA Templates (US Realm)
Vital Signs Organizer
2.16.840.1.113883.10.20.22.4.26
Vital Sign Observation
2.16.840.1.113883.10.20.22.4.27
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Table 83 - Vital Sign Indicators CDA Overview
Figure 13 - Vital Signs Model – PHRI
Core Common Data
Element
Vital Sign Type
Vital Sign Date/Time
Vital Sign Result ID
Vital Sign Free Text
Vital Sign Value
Result Interpretation
CDA Data Element Name
code
Vocabulary OID
title
effectiveTime
Vital code #
Vital code name
Result value
Result unit
interpretationCode
interpretationCodeSystem
interpretationCode
codeSystemName
interpretationCode
displayName
XPATH
code/@code
code/@codeSystem
code/@displayName
observation/effectiveTime
observation/code/@code
observation/code/@displayName
observation/value/@value
observation/value/@unit
interpretationCode/@code
interpretationCode/@codeSystem
interpretationCode/@codeSystemName
interpretationCode/@displayName
Table 84 - Vital Sign Indicators - CDA Section Detail
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4.23.1. Conformance for Vital Signs
Implementers SHALL adopt all conformance statements present for a Vital Signs Section (templateID
2.16.840.1.113883.10.20.22.2.4.1) in the Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm).







Implementers SHALL use the Coded Entries Required constraints for the Vital Signs Section
when creating a CDA-based public health report
Conforms to Vital Signs Section (entries optional) template (2.16.840.1.113883.10.20.22.2.4).
SHALL contain exactly one [1..1] templateId (CONF:7273) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.4.1"
(CONF:10452).
SHALL contain exactly one [1..1] code (CONF:15962).
o This code SHALL contain exactly one [1..1] @code="8716-3" Vital Signs (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15963).
SHALL contain exactly one [1..1] title (CONF:9967).
SHALL contain exactly one [1..1] text (CONF:7275).
SHALL contain at least one [1..*] entry (CONF:7276) such that it
o SHALL contain exactly one [1..1] Vital Signs Organizer
(templateId:2.16.840.1.113883.10.20.22.4.26) (CONF:15964).
4.23.2. Value Sets
The following value sets are recommended for usage within the Vital Signs section template:
Value Set Name
PHVS_VitalSignResult_HITSP
Value Set ID
2.16.840.1.113883.3.88.12.80.62
Type
Specified within PHRI Data
Harmonization Profile
Table 85 - Vital Sign Indicator Value Sets
4.23.3. Examples of Vital Signs
Field Values
Content Values
section templateId
2.16.840.1.113883.10.20.22.2.4.1
code
8716-3
Vocabulary OID
2.16.840.1.113883.6.1
title
Vital Signs
component/section/entry/organizer/
effectiveTime
YYYYMMDD
statusCode
Code
Description
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
References
Refers to template status
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Field Values
Content Values
References
held
held
New
New
suspended
suspended
component/section/entry/organizer/component/observation/
classCode
Code
Description
OBS
An act that is
intended to
result in new
information
about a subject
moodCode
Code
Description
EVN
Event
templateId
2.16.840.1.113883.10.20.1.31
code and displayName
Code
Description
9279-1
Respiration Rate
8867-4
Heart Beat
2710-2
Oxygen
Saturation
8480-6
Intravascular
Systolic
8462-4
Intravascular
Diastolic
8310-5
Body
Temperature
8302-2
Body Height
(Measured)
8306-3
Body Height
(Lying)
8287-5
Circumference
Occipital Frontal
(Tape Measure)
3141-9
Body Weight
(Measured)
Vocabulary OID
2.16.840.1.113883.6.1
codeSystemName
LOINC
statusCode
Code
Description
Refers to template status
Completed
Completed
Aborted
Aborted
Active
Active
Cancelled
Cancelled
held
held
New
New
suspended
Suspended
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Field Values
effectiveTime
Standards & Interoperability Framework
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Content Values
References
YYYYMMDD
Table 86 - Vital Sign Indicator - Detailed Example
5. Public Health Reporting Specification – CDA Entry Level Templates
An initial list of entries that have been identified as needed through analysis of the Public Health
Reporting Initiative Data Harmonization Profile are noted in this section as table headings. Note that this
list is not comprehensive and finalized – it only serves as a representative list of the CDA entries that will
need to be included in the Public Health Reporting Specification
5.1. Age Observation
Used In
May Embed
Core Common
Family History Observation
Problem Observation
Patient Age
Table 87 - Age Observation - Overview
5.1.1. Conformance for Age Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.31

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7613).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7614).
SHALL contain exactly one [1..1] templateId (CONF:7899) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.31"
(CONF:10487).
SHALL contain exactly one [1..1] code (CONF:7615).
o This code SHALL contain exactly one [1..1] @code="445518008" Age At Onset
(CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:16776).
SHALL contain exactly one [1..1] statusCode (CONF:15965).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:15966).
SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7617).
o This value SHALL contain exactly one [1..1] @unit="1", which SHALL be selected from
ValueSet AgePQ_UCUM 2.16.840.1.113883.11.20.9.21 DYNAMIC (CONF:7618).





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5.1.2. Value Sets
The following value sets are proposed for recording an age:
Value Set Name
AgePQ_UCUM
Value Set ID
2.16.840.1.113883.11.20.9.21
Type
Dynamic
Table 88 - Age Observation Value Set
5.1.3. Example of Age Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.31" />
<code code="445518008" />
<statusCode code="completed" />
<value unit="21" />
</Entry>
5.2. Allergy – Intolerance Observation
Used In
May Embed
Allergies Section
Allergy Problem Act
Allergy Status Observation
Reaction Observation
Severity Observation
Core Common
Table 89 - Allergy - Intolerance Observation Overview
5.2.1. Conformance for Allergy – Intolerance Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.7

Conforms to Substance or Device Allergy - Intolerance Observation template
(2.16.840.1.113883.10.20.24.3.90).
SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7379).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7380).
SHALL contain exactly one [1..1] templateId (CONF:7381) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.7"
(CONF:10488).
SHALL contain at least one [1..*] id (CONF:7382).
SHALL contain exactly one [1..1] code (CONF:15947).





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o This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem:
ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:15948).
SHALL contain exactly one [1..1] statusCode (CONF:19084).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19085).
SHALL contain exactly one [1..1] effectiveTime (CONF:7387).
o If it is unknown when the allergy began, this effectiveTime SHALL contain
low/@nullFLavor="UNK" (CONF:9103).
o If the allergy is no longer a concern, this effectiveTime MAY contain zero or one [0..1]
high (CONF:10082).
SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:7390).
o This value SHALL contain exactly one [1..1] @code, which SHALL be selected from
ValueSet Allergy/Adverse Event Type 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC
(CONF:9139).
o This value SHOULD contain zero or one [0..1] originalText (CONF:7422).
 The originalText, if present, MAY contain zero or one [0..1] reference
(CONF:15949).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15950).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:15951).
SHOULD contain zero or one [0..1] participant (CONF:7402) such that it
o SHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7403).
o SHALL contain exactly one [1..1] participantRole (CONF:7404).
 This participantRole SHALL contain exactly one [1..1] @classCode="MANU"
Manufactured Product (CodeSystem: RoleClass 2.16.840.1.113883.5.110
STATIC) (CONF:7405).
 This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:7406).
 This playingEntity SHALL contain exactly one [1..1]
@classCode="MMAT" Manufactured Material (CodeSystem: EntityClass
2.16.840.1.113883.5.41 STATIC) (CONF:7407).
 This playingEntity SHALL contain exactly one [1..1] code (CONF:7419).
o This code SHOULD contain zero or one [0..1] originalText
(CONF:7424).
 The originalText, if present, SHOULD contain zero or
one [0..1] reference (CONF:7425).
 The reference, if present, SHOULD contain zero
or one [0..1] @value (CONF:15952).
o This reference/@value SHALL begin
with a '#' and SHALL point to its
corresponding narrative (using the
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approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15953).
o This code MAY contain zero or more [0..*] translation
(CONF:7431).
o In an allergy to a specific medication the code SHALL be
selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16
Medication Brand Name DYNAMIC or the ValueSet
2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug
DYNAMIC (CONF:7421).
o In an allergy to a class of medications the code SHALL be
selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18
Medication Drug Class DYNAMIC (CONF:10083).
o In an allergy to a food or other substance the code SHALL be
selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20
Ingredient Name DYNAMIC (CONF:10084).
MAY contain zero or one [0..1] entryRelationship (CONF:7440) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7906).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7446).
o SHALL contain exactly one [1..1] Allergy Status Observation
(templateId:2.16.840.1.113883.10.20.22.4.28) (CONF:15954).
SHOULD contain zero or more [0..*] entryRelationship (CONF:7447) such that it
o SHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7907).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7449).
o SHALL contain exactly one [1..1] Reaction Observation
(templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:15955).
SHOULD contain zero or one [0..1] entryRelationship (CONF:9961) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9962).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9964).
o SHALL contain exactly one [1..1] Severity Observation
(templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15956).
5.2.2. Value Sets
The following value sets are proposed for the Allergy – Intolerance Observation template:
Value Set Name
Medication Brand Name
Medication Clinical Drug
Medication Drug Class
Ingredient Name
Allergy/Adverse Event Type
Value Set ID
2.16.840.1.113883.3.88.12.80.16
2.16.840.1.113883.3.88.12.80.17
2.16.840.1.113883.3.88.12.80.18
2.16.840.1.113883.3.88.12.80.20
2.16.840.1.113883.3.88.12.3221.6.2
Type
Dynamic
Dynamic
Dynamic
Dynamic
Dynamic
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Table 90 - Allergy - Intolerance Observation Value Sets
5.2.3. Example of Allergy – Intolerance Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.7" />
<id />
<code code="ASSERTION" />
<statusCode code="completed" />
<effectiveTime>
<!--PRIMITIVE:
If it is unknown when the allergy began, this effectiveTime SHALL contain
low/@nullFLavor="UNK"-->
<!--PRIMITIVE:
If the allergy is no longer a concern, this effectiveTime MAY contain zero or one
[0..1] high-->
</effectiveTime>
<value code="XXX">
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</originalText>
</value>
<participant typeCode="CSM">
<participantRole classCode="MANU">
<playingEntity classCode="MMAT">
<code>
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</originalText>
<translation />
<!--PRIMITIVE:
In an allergy to a specific medication the code SHALL be selected from the
ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet
2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC-->
<!--PRIMITIVE:
In an allergy to a class of medications the code SHALL be selected from the
ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC-->
<!--PRIMITIVE:
In an allergy to a food or other substance the code SHALL be selected from the
ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC-->
</code>
</playingEntity>
</participantRole>
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</participant>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation />
</entryRelationship>
<entryRelationship typeCode="MFST" inversionInd="true">
<observation />
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation />
</entryRelationship>
</Entry>
5.3. Allergy Problem Act
Used In
May Embed
Core Common
Allergies Section
Allergy – Intolerance Observation
Table 91 - Allergy Problem Act Overview
5.3.1. Conformance for Allergy Problem Act

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.30

SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7469).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7470).
SHALL contain exactly one [1..1] templateId (CONF:7471) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.30"
(CONF:10489).
SHALL contain at least one [1..*] id (CONF:7472).
SHALL contain exactly one [1..1] code (CONF:7477).
o This code SHALL contain exactly one [1..1] @code="48765-2" Allergies, adverse
reactions, alerts (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19158).
SHALL contain exactly one [1..1] statusCode (CONF:7485).
o This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from
ValueSet ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09
(CONF:19086).
SHALL contain exactly one [1..1] effectiveTime (CONF:7498).
o If statusCode/@code="active" Active, then effectiveTime SHALL contain [1..1] low
(CONF:7504).
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




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o If statusCode/@code="completed" Completed, then effectiveTime SHALL contain [1..1]
high (CONF:10085).
SHALL contain at least one [1..*] entryRelationship (CONF:7509) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7915).
o SHALL contain exactly one [1..1] Allergy - Intolerance Observation
(templateId:2.16.840.1.113883.10.20.22.4.7) (CONF:14925).
5.3.2. Value Sets
Value Set Name
ProblemAct
Value Set ID
2.16.840.1.113883.11.20.9.19
Type
Static
Table 92 - Allergy Problem Act Value Set
5.3.3. Example of Allergy Problem Act
<Entry classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.30" />
<id />
<code code="48765-2" />
<statusCode code="XXX" />
<effectiveTime>
<!--PRIMITIVE: If statusCode/@code="active" Active, then effectiveTime SHALL contain [1..1] low-->
<!--PRIMITIVE: If statusCode/@code="completed" Completed, then effectiveTime SHALL contain [1..1]
high-->
</effectiveTime>
<entryRelationship typeCode="SUBJ">
<observation />
</entryRelationship>
</Entry>
5.4. Allergy Status Observation
Used In
Allergies Section
Allergy – Intolerance Observation
May Embed
Core Common
Table 93 - Allergy Status Observation Overview
5.4.1. Conformance for Allergy Status Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.28
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




SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7318).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7319).
SHALL contain exactly one [1..1] templateId (CONF:7317) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.28"
(CONF:10490).
SHALL contain exactly one [1..1] code (CONF:7320).
o This code SHALL contain exactly one [1..1] @code="33999-4" Status (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19131).
SHALL contain exactly one [1..1] statusCode (CONF:7321).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19087).
SHALL contain exactly one [1..1] value with @xsi:type="CE", where the @code SHALL be
selected from ValueSet Problem Status Value Set 2.16.840.1.113883.3.88.12.80.68 DYNAMIC
(CONF:7322).
5.4.2. Value Sets
Value Set Name
HITSP Problem Status
Value Set ID
2.16.840.1.113883.3.88.12.80.68
Type
Dynamic
Table 94 - Allergy Status Observation Value Set
5.4.3. Allergy Status Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.28" />
<code code="33999-4" />
<statusCode code="completed" />
<value />
</Entry>
5.5. Drug Vehicle
Used In
Medication Activity
Immunization Activity
May Embed
Core Common
5.5.1. Conformance for Drug Vehicle
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Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)




SHALL contain exactly one [1..1] @classCode="MANU" (CodeSystem: RoleClass
2.16.840.1.113883.5.110 STATIC) (CONF:7490).
SHALL contain exactly one [1..1] templateId (CONF:7495) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.24"
(CONF:10493).
SHALL contain exactly one [1..1] code (CONF:19137).
o This code SHALL contain exactly one [1..1] @code="412307009" Drug Vehicle
(CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:19138).
SHALL contain exactly one [1..1] playingEntity (CONF:7492).
This playingEntity/code is used to supply a coded term for the drug vehicle.
o
o
This playingEntity SHALL contain exactly one [1..1] code (CONF:7493).
This playingEntity MAY contain zero or one [0..1] name (CONF:7494).
 This playingEntity/name MAY be used for the vehicle name in text, such as
Normal Saline (CONF:10087).
5.5.2. Value Sets
RxNORM is recommended as the terminology to use for coded values.
5.5.3. Example of Drug Vehicle
<Entry classCode="MANU">
<templateId root="2.16.840.1.113883.10.20.22.4.24" />
<code code="412307009" />
<playingEntity>
<code />
<name>
<!--PRIMITIVE:
This playingEntity/name MAY be used for the vehicle name in text, such as
Normal Saline-->
</name>
</playingEntity>
</Entry>
5.6. Encounter Activities
Used In
May Embed
Core Common
Encounters Section
Encounter Diagnosis
Indication
Service Delivery Location
Encounter Type
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Table 95 - Encounter Activities Overview
5.6.1. Conformance for Encounter Activities

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.49

SHALL contain exactly one [1..1] @classCode="ENC" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8710).
SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:8711).
SHALL contain exactly one [1..1] templateId (CONF:8712) such that it
SHALL contain at least one [1..*] id (CONF:8713).
SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet
EncounterTypeCode 2.16.840.1.113883.3.88.12.80.32 DYNAMIC (CONF:8714).
o The code, if present, SHOULD contain zero or one [0..1] originalText (CONF:8719).
 The originalText, if present, SHOULD contain zero or one [0..1] reference
(CONF:15970).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15971).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:15972).
 The originalText, if present, SHOULD contain zero or one [0..1]
reference/@value (CONF:8720).
SHALL contain exactly one [1..1] effectiveTime (CONF:8715).
MAY contain zero or more [0..*] performer (CONF:8725).
o The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8726).
 This assignedEntity MAY contain zero or one [0..1] code (CONF:8727).
MAY contain zero or more [0..*] participant (CONF:8738) such that it
o SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8740).
o SHALL contain exactly one [1..1] Service Delivery Location
(templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:14903).
MAY contain zero or more [0..*] entryRelationship (CONF:8722) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8723).
o SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:14899).
MAY contain zero or more [0..*] entryRelationship (CONF:15492) such that it
o SHALL contain exactly one [1..1] Encounter Diagnosis
(templateId:2.16.840.1.113883.10.20.22.4.80 ) (CONF:15973).
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







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MAY contain zero or one [0..1] sdtc:dischargeDispositionCode, which SHALL be selected from
ValueSet 2.16.840.1.113883.3.88.12.80.33 NUBC UB-04 FL17-Patient Status DYNAMIC or, if
access to NUBC is unavailable, from CodeSystem 2.16.840.1.113883.12.112 HL7 Discharge
Disposition. The prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of
the namespace provides a necessary extension to CDA R2 for the use of the
dischargeDispositionCode element (CONF:9929).
5.6.2. Value Sets
Value Set Name
EncounterType
Value Set ID
2.16.840.1.113883.3.88.12.80.32
Type
Dynamic
Table 96 - Encounter Activities Value Set
5.6.3.
Example of Encounter Activities
<Entry classCode="ENC" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.49" />
<id />
<code>
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
<reference value="XXX" />
</originalText>
</code>
<effectiveTime />
<performer>
<assignedEntity>
<code />
</assignedEntity>
</performer>
<participant typeCode="LOC">
<participantRole />
</participant>
<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<entryRelationship>
<act />
</entryRelationship>
<!--PRIMITIVE: MAY contain zero or one [0..1] sdtc:dischargeDispositionCode, which SHALL be selected
from ValueSet 2.16.840.1.113883.3.88.12.80.33 NUBC UB-04 FL17-Patient Status DYNAMIC or, if access
to NUBC is unavailable, from CodeSystem 2.16.840.1.113883.12.112 HL7 Discharge Disposition. The
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prefix sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a
necessary extension to CDA R2 for the use of the dischargeDispositionCode element-->
</Entry>
5.7. Encounter Diagnosis
Used In
May Embed
Core Common
Encounter Section
Encounter Activity
Problem Observation
Table 97 - Encounter Diagnosis Overview
5.7.1. Conformance for Encounter Diagnosis

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.80

SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:14889).
SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:14890).
SHALL contain exactly one [1..1] templateId (CONF:14895) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.80"
(CONF:14896).
SHALL contain exactly one [1..1] code (CONF:19182).
o This code SHALL contain exactly one [1..1] @code="29308-4" Diagnosis (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19183).
SHALL contain at least one [1..*] entryRelationship (CONF:14892) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:14893).
o SHALL contain exactly one [1..1] Problem Observation
(templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:14898).




5.7.2. Value Sets
Not applicable
5.7.3. Example of Encounter Diagnosis
<Entry classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.80" />
<code code="29308-4" />
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<entryRelationship typeCode="SUBJ">
<observation />
</entryRelationship>
</Entry>
5.8. Family History Observation
The Family History Observation is used to support inclusion of specific observations associated with a
family member within a public health report, such as the age of the family member, whether they are
deceased, and specific observations associated with their health.
Used In
May Embed
Family History Organizer
Age Observation
Family History Death Observation
Core Common
Table 98 - Family History Observation Overview
5.8.1. Conformance for Family History Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.46

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8586).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:8587).
SHALL contain exactly one [1..1] templateId (CONF:8599) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.46"
(CONF:10496).
SHALL contain at least one [1..*] id (CONF:8592).
SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type
2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:8589).
SHALL contain exactly one [1..1] statusCode (CONF:8590).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19098).
SHOULD contain zero or one [0..1] effectiveTime (CONF:8593).
SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be
selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC
(CONF:8591).
MAY contain zero or one [0..1] entryRelationship (CONF:8675) such that it








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o SHALL contain exactly one [1..1] @typeCode="SUBJ" Subject (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8676).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8677).
o SHALL contain exactly one [1..1] Age Observation
(templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15526).
MAY contain zero or one [0..1] entryRelationship (CONF:8678) such that it
o SHALL contain exactly one [1..1] @typeCode="CAUS" Causal or Contributory
(CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8679).
o SHALL contain exactly one [1..1] Family History Death Observation
(templateId:2.16.840.1.113883.10.20.22.4.47) (CONF:15527).
5.8.2. Value Sets
The following value sets are proposed for the Family History Observation template:
Value Set Name
Problem Type
Problem
Value Set ID
2.16.840.1.113883.3.88.12.3221.7.2
2.16.840.1.113883.3.88.12.3221.7.4
Type
Dynamic
Dynamic
Table 99 - Family History Observation Value Sets
5.8.3. Example of Family History Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.46" />
<id />
<code />
<statusCode code="completed" />
<effectiveTime />
<value />
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation />
</entryRelationship>
<entryRelationship typeCode="CAUS">
<observation />
</entryRelationship>
</Entry>
5.9. Family History Organizer
Used In
May Embed
Core Common
Family History Section
Family History Observation
Table 100 - Family History Organizer Overview
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The Family History Organizer is used to support inclusion of a family history section within a public
health report.
5.9.1. Conformance Requirements for Family History Organizer

Implementers SHALL adopt all constraints specified in the Implementation Guide for CDA
Release 2.0 Consolidated CDA Templates (US Realm) for template ID
2.16.840.1.113883.10.20.22.4.45

A public health implementation guide SHALL adopt the Family History Type Value Set specified
in Table 168 of the Implementation Guide for CDA Release 2.0 Consolidated CDA Templates (US
Realm) and defined as FamilyHistoryRelatedSubjectCode (2.16.840.1.113883.1.11.19579)
The Family History Organizer section MAY be included when adding a Family History section to a
public health report.
A public health report MAY include one or more Family History Observations as part of the
Family History Organizer
SHALL contain exactly one [1..1] @classCode="CLUSTER" Cluster (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8600).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:8601).
SHALL contain exactly one [1..1] templateId (CONF:8604) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.45"
(CONF:10497).
SHALL contain exactly one [1..1] statusCode (CONF:8602).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19099).
SHALL contain exactly one [1..1] subject (CONF:8609).
o This subject SHALL contain exactly one [1..1] relatedSubject (CONF:15244).
 This relatedSubject SHALL contain exactly one [1..1] @classCode (CodeSystem:
EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:15245).
 This relatedSubject SHALL contain exactly one [1..1] code (CONF:15246).
 This code SHALL contain zero or one [0..1] @code, which SHOULD be
selected from ValueSet FamilyHistoryRelatedSubjectCode
2.16.840.1.113883.1.11.19579 DYNAMIC (CONF:15247).
 This relatedSubject SHOULD contain zero or one [0..1] subject (CONF:15248).
 The subject, if present, SHALL contain exactly one [1..1]
administrativeGenderCode (CONF:15974).
o This administrativeGenderCode SHALL contain exactly one [1..1]
@code, which SHALL be selected from ValueSet Administrative
Gender (HL7 V3) 2.16.840.1.113883.1.11.1 STATIC
(CONF:15975).
 The subject, if present, SHOULD contain zero or one [0..1] birthTime
(CONF:15976).
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 The subject SHOULD contain zero or more [0..*] sdtc:id. The prefix sdtc:
SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the
namespace provides a necessary extension to CDA R2 for the use of the
id element (CONF:15249).
 The subject MAY contain zero or one sdtc:deceasedInd. The prefix sdtc:
SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of the
namespace provides a necessary extension to CDA R2 for the use of the
deceasedInd element (CONF:15981).
 The subject MAY contain zero or one sdtc:deceasedTime. The prefix
sdtc: SHALL be bound to the namespace “urn:hl7-org:sdtc”. The use of
the namespace provides a necessary extension to CDA R2 for the use of
the deceasedTime element (CONF:15982).
 The age of a relative at the time of a family history observation SHOULD
be inferred by comparing RelatedSubject/subject/birthTime with
Observation/effectiveTime (CONF:15983).
o This subject SHALL contain exactly one [1..1] relatedSubject/@classCode="PRS" Person
(CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:8610).
 This relatedSubject SHALL contain exactly one [1..1] code (CONF:8611)
(CONF:8611).
 This relatedSubject SHOULD contain zero or one [0..1] subject (CONF:8613).
 The subject, if present, SHALL contain exactly one [1..1]
administrativeGenderCode, where the @code SHALL be selected from
ValueSet Administrative Gender (HL7 V3) 2.16.840.1.113883.1.11.1
DYNAMIC (CONF:8614).
 The subject, if present, SHOULD contain zero or one [0..1] birthTime
(CONF:8615).
SHALL contain at least one [1..*] component (CONF:8607).
o Such components SHALL contain exactly one [1..1] Family History Observation
(templateId:2.16.840.1.113883.10.20.22.4.46) (CONF:16888).
o Such components SHOULD contain zero or more [0..*] Family History Observation
(templateId:2.16.840.1.113883.10.20.22.4.46) (CONF:8605).
5.9.2. Value Sets
Value Set Name
Value Set ID
Family History Related Subject
2.16.840.1.113883.1.11.19579
PHVS_Gender_SyndromicSurveillance 2.16.840.1.114222.4.11.3403
Type
Dynamic
Dynamic
Table 101 - Family History Organizer Value Sets
5.9.3. Example of Family History Organizer
<Entry classCode="CLUSTER" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.45" />
<statusCode code="completed" />
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<subject>
<relatedSubject classCode="XXX">
<code code="XXX" />
<subject>
<administrativeGenderCode code="XXX" />
<birthTime />
<!--PRIMITIVE: The subject SHOULD contain zero or more [0..*] sdtc:id. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the id element -->
<!--PRIMITIVE: The subject MAY contain zero or one sdtc:deceasedInd. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the deceasedInd element-->
<!--PRIMITIVE: The subject MAY contain zero or one sdtc:deceasedTime. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the deceasedTime element-->
<!--PRIMITIVE: The age of a relative at the time of a family history observation SHOULD be inferred
by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime-->
</subject>
</relatedSubject>
<relatedSubject classCode="PRS">
<!--PRIMITIVE: This relatedSubject SHALL contain exactly one [1..1] code (CONF:8611).-->
<!--PRIMITIVE: This relatedSubject SHOULD contain zero or one [0..1] subject-->
</relatedSubject>
</subject>
<component>
<observation />
<!--PRIMITIVE: -->
</component>
</Entry>
5.10.
Family History Death Observation
Used In
Family History Observation
May Embed
Core Common
Table 102 - Family History Death Observation Overview
5.10.1. Conformance Requirements for Family History Death Observation
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)
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SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8621).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:8622).
SHALL contain exactly one [1..1] templateId (CONF:8623) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.47"
(CONF:10495).
SHALL contain exactly one [1..1] code (CONF:19141).
o This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem:
ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:19142).
SHALL contain exactly one [1..1] statusCode (CONF:8625).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19097).
SHALL contain exactly one [1..1] value="419099009" Dead with @xsi:type="CD" (CodeSystem:
SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:8626).
5.10.2. Value Sets
No specific value sets are associated with the death of a family member and the Family History Death
Observation template.
5.10.3. Example of Family History Death Observation
<Entry classCode="CLUSTER" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.45" />
<statusCode code="completed" />
<subject>
<relatedSubject classCode="XXX">
<code code="XXX" />
<subject>
<administrativeGenderCode code="XXX" />
<birthTime />
<!--PRIMITIVE: The subject SHOULD contain zero or more [0..*] sdtc:id. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the id element -->
<!--PRIMITIVE: The subject MAY contain zero or one sdtc:deceasedInd. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the deceasedInd element-->
<!--PRIMITIVE: The subject MAY contain zero or one sdtc:deceasedTime. The prefix sdtc: SHALL be
bound to the namespace “urn:hl7-org:sdtc”. The use of the namespace provides a necessary extension
to CDA R2 for the use of the deceasedTime element-->
<!--PRIMITIVE: The age of a relative at the time of a family history observation SHOULD be inferred
by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime-->
</subject>
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</relatedSubject>
<relatedSubject classCode="PRS">
<!--PRIMITIVE: This relatedSubject SHALL contain exactly one [1..1] code (CONF:8611).-->
<!--PRIMITIVE: This relatedSubject SHOULD contain zero or one [0..1] subject-->
</relatedSubject>
</subject>
<component>
<observation />
<!--PRIMITIVE: -->
</component>
</Entry>
5.11.
Health Status Observation
Used In
Problem Observation
May Embed
Core Common
Table 103 - Health Status Observation Overview
5.11.1. Conformance for Health Status Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.5

SHALL contain 1..1 @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:9057).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:9072).
SHALL contain 1..1 templateId (CONF:16756) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.4.5" (CONF:16757).
SHALL contain 1..1 code (CONF:19143).
o This code SHALL contain 1..1 @code="11323-3" Health status (CodeSystem: LOINC
2.16.840.1.113883.6.1 STATIC) (CONF:19144).
SHOULD contain 0..1 text (CONF:9270).
o The text, if present, SHOULD contain 0..1 reference (CONF:15529).
 The reference, if present, SHOULD contain 0..1 @value (CONF:15530).
 SHALL begin with a '#' and SHALL point to its corresponding narrative
(using the approach defined in CDA Release 2, section 4.3.5.1)
(CONF:15531).
SHALL contain 1..1 statusCode (CONF:9074).
o This statusCode SHALL contain 1..1 @code="completed" Completed (CodeSystem:
ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19103).
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SHALL contain 1..1 value with @xsi:type="CD", where the @code SHALL be selected from
ValueSet HealthStatus 2.16.840.1.113883.1.11.20.12 DYNAMIC (CONF:9075).
5.11.2. Value Sets
The following value sets are proposed for the Health Status Observation template:
Value Set Name
Health Status
Value Set ID
2.16.840.1.113883.1.11.20.12
Type
Dynamic
Table 104 - Health Status Observation Value Set
5.11.3. Example of Health Status Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.5" />
<code code="11323-3" />
<text>
<reference value="XXX">
<!--PRIMITIVE: SHALL begin with a '#' and SHALL point to its corresponding narrative (using the
approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<value />
</Entry>
5.12.
Hospital Admission Diagnosis
Used In
May Embed
Core Common
Hospital Admission Diagnosis
Problem Observation
Table 105 - Hospital Admission Diagnosis Overview
5.12.1. Conformance for Hospital Admission Diagnosis

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.34

SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7671).
SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7672).
SHALL contain exactly one [1..1] templateId (CONF:16747) such that it
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o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.34"
(CONF:16748).
SHALL contain exactly one [1..1] code (CONF:19145).
o This code SHALL contain exactly one [1..1] @code="46241-6" Admission diagnosis
(CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19146).
SHALL contain at least one [1..*] entryRelationship (CONF:7674) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7675).
o SHALL contain exactly one [1..1] Problem Observation
(templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15535).
5.12.2. Value Sets
No specific value sets apply for this template – the Hospital Admission Diagnosis template does embed a
Problem Observation template, however, where specific value sets apply. Please see the Problem
Observation entry template for more details.
5.12.3. Example of Hospital Admission Diagnosis
<Entry classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.34" />
<code code="46241-6" />
<entryRelationship typeCode="SUBJ">
<observation />
</entryRelationship>
</Entry>
5.13.
Hospital Discharge Diagnosis
Used In
May Embed
Core Common
Hospital Discharge Diagnosis Section
Problem Observation
Table 106 - Hospital Discharge Diagnosis Overview
5.13.1. Conformance for Hospital Discharge Diagnosis

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.33

SHALL contain exactly one [1..1] @classCode="ACT" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7663).
SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7664).
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SHALL contain exactly one [1..1] templateId (CONF:16764) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.33"
(CONF:16765).
SHALL contain exactly one [1..1] code (CONF:19147).
o This code SHALL contain exactly one [1..1] @code="11535-2" Hospital discharge
diagnosis (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19148).
SHALL contain at least one [1..*] entryRelationship (CONF:7666) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7667).
o SHALL contain exactly one [1..1] Problem Observation
(templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15536).
5.13.2. Value Sets
No specific value sets apply for this template – the Hospital Discharge Diagnosis template does embed a
Problem Observation template, however, where specific value sets apply. Please see the Problem
Observation entry template for more details.
5.13.3. Example of Hospital Discharge Diagnosis
<Entry classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.33" />
<code code="11535-2" />
<entryRelationship typeCode="SUBJ">
<observation />
</entryRelationship>
</Entry>
5.14.
Immunization Activity
Used In
May Embed
Immunization Activity
Drug Vehicle
Immunization Medication Information
Immunization Refusal Reason
Indication
Instructions
Medication Dispense
Medication Supply Order
Reaction Observation
Core Common
Table 107 - Immunization Activity Overview
5.14.1. Conformance for Immunization Activity
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Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.52
SHALL contain exactly one [1..1] @classCode (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6
STATIC) (CONF:8826).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC (CONF:8827).
Use negationInd="true" to indicate that the immunization was not given.







SHALL contain exactly one [1..1] @negationInd (CONF:8985).
SHALL contain exactly one [1..1] templateId (CONF:8828) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.52"
(CONF:10498).
SHALL contain at least one [1..*] id (CONF:8829).
MAY contain zero or one [0..1] code (CONF:8830).
SHOULD contain zero or one [0..1] text (CONF:8831).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15543).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15544).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1 (CONF:15545).
SHALL contain exactly one [1..1] statusCode (CONF:8833).
SHALL contain exactly one [1..1] effectiveTime (CONF:8834).
In "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For
example, a repeatNumber of "3" means that the substance can be administered up to 3 times.
In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a
repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd. A
repeatNumber of "3" in a substance administration event means that the current administration
is the 3rd in a series.





MAY contain zero or one [0..1] repeatNumber (CONF:8838).
MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet Medication
Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:8839).
MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from
ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:8840).
SHOULD contain zero or one [0..1] doseQuantity (CONF:8841).
o The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit, which SHALL be
selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839
DYNAMIC (CONF:8842).
MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from
ValueSet Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC
(CONF:8846).
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SHALL contain exactly one [1..1] consumable (CONF:8847).
o This consumable SHALL contain exactly one [1..1] Immunization Medication
Information (templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:15546).
SHOULD contain zero or one [0..1] performer (CONF:8849).
MAY contain zero or more [0..*] participant (CONF:8850).
o The participant, if present, SHALL contain exactly one [1..1] @typeCode="CSM"
(CodeSystem: HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8851).
o The participant, if present, SHALL contain exactly one [1..1] Drug Vehicle
(templateId:2.16.840.1.113883.10.20.22.4.24) (CONF:15547).
MAY contain zero or more [0..*] entryRelationship (CONF:8853) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8854).
o SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15537).
MAY contain zero or one [0..1] entryRelationship (CONF:8856) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8857).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:8858).
o SHALL contain exactly one [1..1] Instructions
(templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15538).
MAY contain zero or one [0..1] entryRelationship (CONF:8860) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8861).
o SHALL contain exactly one [1..1] Medication Supply Order
(templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:15539).
MAY contain zero or one [0..1] entryRelationship (CONF:8863) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8864).
o SHALL contain exactly one [1..1] Medication Dispense
(templateId:2.16.840.1.113883.10.20.22.4.18) (CONF:15540).
MAY contain zero or one [0..1] entryRelationship (CONF:8866) such that it
o SHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8867).
o SHALL contain exactly one [1..1] Reaction Observation
(templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:15541).
MAY contain zero or one [0..1] entryRelationship (CONF:8988) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8989).
o SHALL contain exactly one [1..1] Immunization Refusal Reason
(templateId:2.16.840.1.113883.10.20.22.4.53) (CONF:15542).
MAY contain zero or more [0..*] precondition (CONF:8869) such that it
o SHALL contain exactly one [1..1] @typeCode (CodeSystem: HL7ActRelationshipType
2.16.840.1.113883.5.1002 STATIC) (CONF:8870).
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SHALL contain exactly one [1..1] Precondition for Substance Administration
(templateId:2.16.840.1.113883.10.20.22.4.25) (CONF:15548).
5.14.2. Value Sets
The following value sets are applicable to an Immunization Activity template:
Value Set Name
Medication Route FDA
Body Site
Units of Measure (UCUM)
Medication Product Form
Value Set ID
2.16.840.1.113883.3.88.12.3221.8.7
2.16.840.1.113883.3.88.12.3221.8.9
2.16.840.1.113883.1.11.12839
2.16.840.1.113883.3.88.12.3221.8.11
Type
Dynamic
Dynamic
Dynamic
Dynamic
Table 108 - Immunization Activity Value Sets
5.14.3. Example of Immunization Activity
<Entry classCode="XXX" moodCode="XXX" negationInd="XXX">
<templateId root="2.16.840.1.113883.10.20.22.4.52" />
<id />
<code />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1-->
</reference>
</text>
<statusCode />
<effectiveTime />
<repeatNumber />
<routeCode />
<approachSiteCode />
<doseQuantity unit="XXX" />
<administrationUnitCode />
<consumable>
<manufacturedProduct />
</consumable>
<performer />
<participant typeCode="CSM">
<participantRole />
</participant>
<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
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<entryRelationship typeCode="REFR">
<supply />
</entryRelationship>
<entryRelationship typeCode="REFR">
<supply />
</entryRelationship>
<entryRelationship typeCode="CAUS">
<observation />
</entryRelationship>
<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<precondition typeCode="XXX">
<criterion />
</precondition>
</Entry>
5.15.
Indication
Used In
Procedure Activity Procedure
Procedure Activity Observation
Procedure Activity Act
May Embed
Core Common
Table 109 - Indication Overview
5.15.1. Conformance for Indication
The following conformance constraints apply to the Indication entry template:






SHALL contain 1..1 @classCode="OBS" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6
STATIC) (CONF:7480).
SHALL contain 1..1 @moodCode="EVN" (CodeSystem: ActMood 2.16.840.1.113883.5.1001
STATIC) (CONF:7481).
SHALL contain 1..1 templateId (CONF:7482) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.4.19" (CONF:10502).
SHALL contain 1..1 id (CONF:7483).
o Set the observation/id equal to an ID on the problem list to signify that problem as an
indication (CONF:16885).
SHALL contain 1..1 code, which SHOULD be selected from ValueSet Problem Type
2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:16886).
SHALL contain 1..1 statusCode (CONF:7487).
o This statusCode SHALL contain 1..1 @code="completed" Completed (CodeSystem:
ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19105).
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

SHOULD contain 0..1 effectiveTime (CONF:7488).
SHOULD contain 0..1 value with @xsi:type="CD" (CONF:7489).
o The value, if present, MAY contain 0..1 @nullFlavor (CONF:15990).
 If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor
SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor
SHOULD be “OTH” and the other code SHOULD be placed in the translation
element (CONF:15991).
o The value, if present, SHOULD contain 0..1 @code (ValueSet: Problem Value Set
2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC) (CONF:15985).
5.15.2. Value Sets
Value Set Name
Problem Type
Problem
Value Set ID
2.16.840.1.113883.3.88.12.3221.7.2
2.16.840.1.113883.3.88.12.3221.7.4
Type
Consolidated CDA
Constrained from
Consolidated CDA but can be
extended by PHRI
Table 110 - Indication Value Sets
5.15.3. Example for Indication
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.19" />
<id>
<!--PRIMITIVE: Set the observation/id equal to an ID on the problem list to signify that problem as
an indication.-->
</id>
<code />
<statusCode code="completed" />
<effectiveTime />
<value nullFlavor="XXX" code="XXX">
<!--PRIMITIVE: If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor SHOULD
be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and the other
code SHOULD be placed in the translation element-->
</value>
</Entry>
5.16.
Instructions
Used In
May Embed
Core Common
Table 111 - Medication Activity Overview
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5.16.1. Conformance for Instructions
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)






SHALL contain 1..1 @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6
STATIC) (CONF:7391).
SHALL contain 1..1 @moodCode="INT" (CodeSystem: ActMood 2.16.840.1.113883.5.1001
STATIC) (CONF:7392).
SHALL contain 1..1 templateId (CONF:7393) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.4.20" (CONF:10503).
SHALL contain 1..1 code, which SHOULD be selected from ValueSet Patient Education
2.16.840.1.113883.11.20.9.34 DYNAMIC (CONF:16884).
SHOULD contain 0..1 text (CONF:7395).
o The text, if present, SHOULD contain 1..1 reference (CONF:15577).
 This reference SHOULD contain 1..1 @value (CONF:15578).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15579).
SHALL contain 1..1 statusCode (CONF:7396).
o This statusCode SHALL contain 1..1 @code="completed" Completed (CodeSystem:
ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19106).
5.16.2. Example for Instructions
<act classCode="ACT" moodCode="INT">
<templateId root="2.16.840.1.113883.10.20.22.4.20"/>
<code code="171044003"
codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"
displayName="Immunization Education"/>
<text>
<reference value="#sect1"/>
Patient may have low grade fever, mild joint pain and injection
area tenderness .
</text>
<statusCode code="completed"/>
</act>
5.17.
Medication Activity
Used In
Reaction Observation
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May Embed
Medications Section
Procedure Activity Procedure
Medications Administered Section
Procedure Activity Observation
Procedure Activity Act
Drug Vehicle
Indication
Instructions
Medication Dispense
Medication Information
Medication Supply Order
Reaction Observation
Core Common
Table 112 - Medication Dispense Overview
5.17.1. Conformance for Medication Activity

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for template ID
2.16.840.1.113883.10.20.22.4.16

SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7496).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:7497).
SHALL contain exactly one [1..1] templateId (CONF:7499) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.16"
(CONF:10504).
SHALL contain at least one [1..*] id (CONF:7500).
MAY contain zero or one [0..1] code (CONF:7506).
SHOULD contain zero or one [0..1] text (CONF:7501).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15977).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15978).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15979).
SHALL contain exactly one [1..1] statusCode (CONF:7507).
SHALL contain exactly one [1..1] effectiveTime (CONF:7508) such that it
o SHALL contain exactly one [1..1] low (CONF:7511).
o SHALL contain exactly one [1..1] high (CONF:7512).
SHOULD contain zero or one [0..1] effectiveTime (CONF:7513) such that it
o SHALL contain exactly one [1..1] @operator="A" (CONF:9106).








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










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o SHALL contain exactly one [1..1] @xsi:type=”PIVL_TS” or “EIVL_TS” (CONF:9105).
MAY contain zero or one [0..1] repeatNumber (CONF:7555).
o In "INT" (intent) mood, the repeatNumber defines the number of allowed
administrations. For example, a repeatNumber of "3" means that the substance can be
administered up to 3 times.In "EVN" (event) mood, the repeatNumber is the number of
occurrences. For example, a repeatNumber of "3" in a substance administration event
means that the current administration is the 3rd in a series (CONF:16877).
MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet Medication
Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:7514).
MAY contain zero or one [0..1] approachSiteCode, where the @code SHALL be selected from
ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:7515).
SHOULD contain zero or one [0..1] doseQuantity (CONF:7516).
o The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit="1", which
SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive
2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:7526).
o Pre-coordinated consumable: If the consumable code is a precoordinated unit dose (e.g.
"metoprolol 25mg tablet") then doseQuantity is a unitless number that indicates the
number of products given per administration (e.g. "2", meaning 2 x "metoprolol 25mg
tablet") (CONF:16878).
o Not pre-coordinated consumable: If the consumable code is not pre-coordinated (e.g. is
simply "metoprolol"), then doseQuantity must represent a physical quantity with @unit,
e.g. "25" and "mg", specifying the amount of product given per administration
(CONF:16879).
MAY contain zero or one [0..1] rateQuantity (CONF:7517).
o The rateQuantity, if present, SHALL contain exactly one [1..1] @unit="1", which SHALL
be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839
DYNAMIC (CONF:7525).
MAY contain zero or one [0..1] maxDoseQuantity (CONF:7518).
MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from
ValueSet Medication Product Form 2.16.840.1.113883.3.88.12.3221.8.11 DYNAMIC
(CONF:7519).
SHALL contain exactly one [1..1] consumable (CONF:7520).
o This consumable SHALL contain exactly one [1..1] Medication Information
(templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:16085).
MAY contain zero or one [0..1] performer (CONF:7522).
MAY contain zero or more [0..*] participant (CONF:7523) such that it
o SHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7524).
o SHALL contain exactly one [1..1] Drug Vehicle
(templateId:2.16.840.1.113883.10.20.22.4.24) (CONF:16086).
MAY contain zero or more [0..*] entryRelationship (CONF:7536) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7537).
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o






SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:16087).
MAY contain zero or one [0..1] entryRelationship (CONF:7539) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7540).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7542).
o SHALL contain exactly one [1..1] Instructions
(templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:16088).
MAY contain zero or one [0..1] entryRelationship (CONF:7543) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7547).
o SHALL contain exactly one [1..1] Medication Supply Order
(templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:16089).
MAY contain zero or more [0..*] entryRelationship (CONF:7549) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7553).
o SHALL contain exactly one [1..1] Medication Dispense
(templateId:2.16.840.1.113883.10.20.22.4.18) (CONF:16090).
MAY contain zero or one [0..1] entryRelationship (CONF:7552) such that it
o SHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7544).
o SHALL contain exactly one [1..1] Reaction Observation
(templateId:2.16.840.1.113883.10.20.22.4.9) (CONF:16091).
MAY contain zero or more [0..*] precondition (CONF:7546) such that it
o SHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7550).
o SHALL contain exactly one [1..1] Precondition for Substance Administration
(templateId:2.16.840.1.113883.10.20.22.4.25) (CONF:16092).
Medication Activity SHOULD include doseQuantity OR rateQuantity (CONF:7529).
5.17.2. Value Sets
Value Set Name
Medication Route FDA
Body Site
Units of Measure (UCUM)
Medication Product Form
Value Set ID
2.16.840.1.113883.3.88.12.3221.8.7
2.16.840.1.113883.3.88.12.3221.8.9
2.16.840.1.113883.1.11.12839
2.16.840.1.113883.3.88.12.3221.8.11
Type
Dynamic
Dynamic
Dynamic
Dynamic
Table 113 - Medication Dispense Value Sets
5.17.3. Example of Medication Activity
<Entry classCode="SBADM" moodCode="XXX">
<templateId root="2.16.840.1.113883.10.20.22.4.16" />
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<id />
<code />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode />
<effectiveTime>
<low />
<high />
</effectiveTime>
<effectiveTime operator="A">
<!--PRIMITIVE:
SHALL contain exactly one [1..1] @xsi:type=”PIVL_TS” or “EIVL_TS”-->
</effectiveTime>
<repeatNumber>
<!--PRIMITIVE: In "INT" (intent) mood, the repeatNumber defines the number of allowed
administrations. For example, a repeatNumber of "3" means that the substance can be administered up
to 3 times.In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a
repeatNumber of "3" in a substance administration event means that the current administration is the
3rd in a series.-->
</repeatNumber>
<routeCode />
<approachSiteCode />
<doseQuantity unit="1">
<!--PRIMITIVE: Pre-coordinated consumable: If the consumable code is a precoordinated unit dose
(e.g. "metoprolol 25mg tablet") then doseQuantity is a unitless number that indicates the number of
products given per administration (e.g. "2", meaning 2 x "metoprolol 25mg tablet").-->
<!--PRIMITIVE: Not pre-coordinated consumable: If the consumable code is not pre-coordinated (e.g.
is simply "metoprolol"), then doseQuantity must represent a physical quantity with @unit, e.g. "25" and
"mg", specifying the amount of product given per administration.-->
</doseQuantity>
<rateQuantity unit="1" />
<maxDoseQuantity />
<administrationUnitCode />
<consumable>
<manufacturedProduct />
</consumable>
<performer />
<participant typeCode="CSM">
<participantRole />
</participant>
<entryRelationship typeCode="RSON">
<observation />
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</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
<entryRelationship typeCode="REFR">
<supply />
</entryRelationship>
<entryRelationship typeCode="REFR">
<supply />
</entryRelationship>
<entryRelationship typeCode="CAUS">
<observation />
</entryRelationship>
<precondition typeCode="PRCN">
<criterion />
</precondition>
<!--PRIMITIVE: Medication Activity SHOULD include doseQuantity OR rateQuantity-->
</Entry>
5.18.
Medication Dispense
Used In
May Embed
Medication Activity
Immunization Activity
Immunization Medication Information
Medication Information
Medication Supply Order
Core Common
Table 114 - Medication Information Overview
5.18.1. Conformance for Medication Dispense

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.18

SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7451).
SHALL contain exactly one [1..1] @moodCode="EVN" (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7452).
SHALL contain exactly one [1..1] templateId (CONF:7453) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.18"
(CONF:10505).
SHALL contain at least one [1..*] id (CONF:7454).
SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet
Medication Fill Status 2.16.840.1.113883.3.88.12.80.64 DYNAMIC (CONF:7455).




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
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SHOULD contain zero or one [0..1] effectiveTime (CONF:7456).
SHOULD contain zero or one [0..1] repeatNumber (CONF:7457).
o In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a
repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd
(CONF:16876).
SHOULD contain zero or one [0..1] quantity (CONF:7458).
MAY contain zero or one [0..1] product (CONF:7459) such that it
o SHALL contain exactly one [1..1] Medication Information
(templateId:2.16.840.1.113883.10.20.22.4.23) (CONF:15607).
MAY contain zero or one [0..1] product (CONF:9331) such that it
o SHALL contain exactly one [1..1] Immunization Medication Information
(templateId:2.16.840.1.113883.10.20.22.4.54) (CONF:15608).
MAY contain zero or one [0..1] performer (CONF:7461).
o The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:7467).
 This assignedEntity SHOULD contain zero or one [0..1] addr (CONF:7468).
 The content of addr SHALL be a conformant US Realm Address
(AD.US.FIELDED) (2.16.840.1.113883.10.20.22.5.2) (CONF:10565).
MAY contain zero or one [0..1] entryRelationship (CONF:7473) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7474).
o SHALL contain exactly one [1..1] Medication Supply Order
(templateId:2.16.840.1.113883.10.20.22.4.17) (CONF:15606).
A supply act SHALL contain one product/Medication Information or one product/Immunization
Medication Information template (CONF:9333).
5.18.2. Value Sets
The following value sets are proposed for the Medication Dispense template:
Value Set Name
Medication Fill Status
Value Set ID
2.16.840.1.113883.3.88.12.80.64
Type
Dynamic
Table 115 - Medication Dispense Value Sets
5.18.3. Example of Medication Dispense
<Entry classCode="SPLY" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.18" />
<id />
<statusCode />
<effectiveTime />
<repeatNumber>
<!--PRIMITIVE: In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example,
a repeatNumber of "3" in a dispense act means that the current dispensation is the 3rd.-->
</repeatNumber>
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<quantity />
<product>
<manufacturedProduct />
</product>
<product>
<manufacturedProduct />
</product>
<performer>
<assignedEntity>
<addr>
<!--PRIMITIVE:
The content of addr SHALL be a conformant US Realm Address (AD.US.FIELDED)
(2.16.840.1.113883.10.20.22.5.2)-->
</addr>
</assignedEntity>
</performer>
<entryRelationship typeCode="REFR">
<supply />
</entryRelationship>
<!--PRIMITIVE: A supply act SHALL contain one product/Medication Information or one
product/Immunization Medication Information template-->
</Entry>
5.19.
Medication Information
Used In
Medication Dispense
Medication Supply Order
Medication Information
May Embed
Core Common
Table 116 - Medication Information Overview
5.19.1. Conformance for Medication Information

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm)
5.19.2. Value Sets
The following value sets are proposed for the Medication Information template:
Value Set Name
Medication Clinical Drug
Value Set ID
2.16.840.1.113883.3.88.12.80.17
Type
Dynamic
Table 117 - Medication Information Value Sets
5.19.3. Example of Medication Information
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<Entry classCode="MANU">
<templateId root="2.16.840.1.113883.10.20.22.4.23" />
<id />
<manufacturedMaterial>
<code>
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</originalText>
<translation>
<!--PRIMITIVE: Translations can be used to represent generic product name, packaged product
code, etc.-->
</translation>
</code>
</manufacturedMaterial>
<manufacturerOrganization />
</Entry>
5.20.
Medication Supply Order
Used In
May Embed
Medication Dispense
Medication Activity
Immunization Activity
Immunization Medication Information
Instructions
Medication Information
Core Common
Table 118 - Medication Supply Order Overview
5.20.1. Conformance for Medication Supply Order

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.17
5.20.2. Value Sets
The following value sets are proposed for the Medication Supply Order template:
Value Set Name
Medication Clinical Drug
Value Set ID
2.16.840.1.113883.3.88.12.80.17
Type
Dynamic
Table 119 - Medication Supply Order Value Sets
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5.20.3. Example of Medication Supply Order
<Entry classCode="SPLY" moodCode="INT">
<templateId root="2.16.840.1.113883.10.20.22.4.17" />
<id />
<statusCode />
<effectiveTime>
<high />
</effectiveTime>
<repeatNumber>
<!--PRIMITIVE: In "INT" (intent) mood, the repeatNumber defines the number of allowed fills. For
example, a repeatNumber of "3" means that the substance can be supplied up to 3 times (or, can be
dispensed, with 2 refills).-->
</repeatNumber>
<quantity />
<product>
<manufacturedProduct />
</product>
<product>
<manufacturedProduct>
<!--PRIMITIVE: A supply act SHALL contain one product/Medication Information or one
product/Immunization Medication Information template -->
</manufacturedProduct>
</product>
<author />
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
</Entry>
5.21.
Non-Medicinal Supply Activity
Used In
May Embed
Core Common
Medical Equipment Section
Product Instance
Table 120 - Non-Medicinal Supply Activity Overview
5.21.1. Conformance for Non-Medicinal Supply Activity
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)
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SHALL contain exactly one [1..1] @classCode="SPLY" (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8745).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8746).
SHALL contain exactly one [1..1] templateId (CONF:8747) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.50"
(CONF:10509).
SHALL contain at least one [1..*] id (CONF:8748).
SHALL contain exactly one [1..1] statusCode (CONF:8749).
SHOULD contain zero or one [0..1] effectiveTime (CONF:15498).
o The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:16867).
SHOULD contain zero or one [0..1] quantity (CONF:8751).
MAY contain zero or one [0..1] participant (CONF:8752) such that it
o SHALL contain exactly one [1..1] @typeCode="PRD" Product (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:8754).
o SHALL contain exactly one [1..1] Product Instance
(templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15900).
5.21.2. Value Sets
Not applicable
5.22.
PHCR Case Observation
Used In
PHCR Clinical Information
May Embed
Core Common
Table 121 - PHCR Case Observation Overview
5.22.1. Conformance for PHCR Case Observation
Implementers SHALL adopt all conformance statements as defined within the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reporting, Release 1





SHALL contain 1..1 @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:1868).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:1869).
MAY contain 0..* id (CONF:1870).
SHALL contain 1..1 code="ASSERTION" with @xsi:type="CD" (CodeSystem: ActCode
2.16.840.1.113883.5.4 STATIC) (CONF:1871).
SHALL contain 1..1 statusCode="completed" Completed (CodeSystem: ActStatus
2.16.840.1.113883.5.14 STATIC) (CONF:1872).
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SHOULD contain 0..1 effectiveTime/low (CONF:1873).
SHALL contain 1..1 value with @xsi:type="CD" (CONF:1874).
SHOULD contain 0..1 author (CONF:1875).


The author, if present, SHALL contain 1..1 time (CONF:1876).
The author, if present, SHALL contain 1..1 assignedAuthor (CONF:1877).
o
o
o
o
o
This assignedAuthor SHALL contain 1..* id (CONF:1878).
This assignedAuthor MAY contain 0..* addr (CONF:1879).
This assignedAuthor MAY contain 0..* telecom (CONF:1880).
This assignedAuthor MAY contain 0..1 assignedPerson (CONF:1881).
 The assignedPerson, if present, MAY contain 0..1 name (CONF:1882).
This assignedAuthor MAY contain 0..1 representedOrganization (CONF:1883).
 SHOULD contain 0..1 entryRelationship (CONF:1884) such that it


SHALL contain 1..1 @typeCode="REFR" Refers to (CodeSystem: HL7ActRelationshipType
2.16.840.1.113883.5.1002 STATIC) (CONF:1885).
SHALL contain 1..1 Problem Status (templateId: 2.16.840.1.113883.10.20.22.4.6) (CONF:1886).
 SHOULD contain 0..* entryRelationship (CONF:1887) such that it



SHALL contain 1..1 @typeCode="MFST" Is manifestation of (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1888).
SHALL contain 1..1 @inversionInd="true" (CONF:1889).
SHALL contain 1..1 PHCR Signs and symptoms (templateId:2.16.840.1.113883.10.20.15.3.53)
(CONF:1890).
5.23.
PHCR Signs and Symptoms
Used In
PHCR Case Observation
May Embed
Core Common
Table 122 - PHCR Signs and Symptoms Overview
5.23.1. Conformance for PHCR Signs and Symptoms
Implementers SHALL adopt all conformance statements as defined within the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reporting, Release 1
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SHALL contain 1..1 @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:1861).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:1862).
SHALL contain 1..1 @negationInd (CONF:1863).
SHALL contain 1..1 code="ASSERTION" with @xsi:type="CD" (CodeSystem: ActCode
2.16.840.1.113883.5.4 STATIC) (CONF:1864).
SHALL contain 1..1 statusCode="completed" Completed (CodeSystem: ActStatus
2.16.840.1.113883.5.14 STATIC) (CONF:1865).
SHOULD contain 0..1 effectiveTime (CONF:1866).
SHALL contain 1..1 value with @xsi:type="CD" (CONF:1867).
5.24.
PHCR Treatment Given
Used In
PHCR Treatment Regimen
May Embed
Core Common
Table 123 - PHCR Treatment Given Overview
5.24.1. Conformance for PHCR Treatment Given
Implementers SHALL adopt all conformance statements as defined within the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reporting, Release 1

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




SHALL contain 1..1 @classCode="SBADM" Substance administration (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:1919).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:1920).
SHALL contain 1..1 @negationInd="false" (CONF:1921).
SHALL contain 1..1 statusCode (CONF:1922).
SHOULD contain 0..1 effectiveTime (CONF:1923).
o The effectiveTime, if present, SHOULD contain 0..1 low (CONF:1924).
SHOULD contain 0..1 routeCode, where the @code SHALL be selected from ValueSet
Medication Route FDA Value Set 2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:1925).
SHALL contain 1..1 consumable (CONF:1926).
o This consumable SHALL contain 1..1 manufacturedProduct (CONF:1927).
 This manufacturedProduct SHALL contain 1..1 manufacturedMaterial
(CONF:1928).
 This manufacturedMaterial SHALL contain 1..1 code (CONF:1929).
o This code SHOULD contain 0..1 originalText (CONF:1930).
5.25.
PHCR Treatment Not Given
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Used In
PHCR Treatment Regimen
May Embed
Core Common
Table 124 - PHCR Treatment Not Given Overview
5.25.1. Conformance for PHCR Treatment Not Given
Implementers SHALL adopt all conformance statements as defined within the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reporting, Release 1





SHALL contain 1..1 @classCode="SBADM" Substance administration (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:1931).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:1932).
SHALL contain 1..1 @negationInd="true" (CONF:1933).
SHALL contain 1..1 statusCode="completed" Completed (CodeSystem: ActStatus
2.16.840.1.113883.5.14 STATIC) (CONF:1934).
SHALL contain 1..1 consumable (CONF:1935).
o This consumable SHALL contain 1..1 manufacturedProduct (CONF:1936).
 This manufacturedProduct SHALL contain 1..1 manufacturedMaterial
(CONF:1937).
 This manufacturedMaterial SHALL contain 1..1 code (CONF:1938).
o This code SHOULD contain 0..1 originalText (CONF:1939).
5.26.
PHCR Treatment Regimen
Used In
PHCR Treatment Information
May Embed
Core Common
Table 125 - PHCR Treatment Regimen Overview
5.26.1. Conformance for PHCR Treatment Regimen
Implementers SHALL adopt all conformance statements as defined within the HL7 Implementation
Guide for CDA Release 2: Public Health Case Reporting, Release 1



SHALL contain 1..1 @classCode="ACT" (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6
STATIC) (CONF:1940).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:1941).
SHALL contain 1..1 @negationInd (CONF:1942).
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SHALL contain 1..1 code="133877004" Therapeutic regimen with @xsi:type="CD" (CodeSystem:
SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:1943).
SHALL contain 1..1 statusCode="completed" Completed (CodeSystem: ActStatus
2.16.840.1.113883.5.14 STATIC) (CONF:1944).
SHALL contain 1..1 entryRelationship (CONF:1945) such that it
o SHALL contain 1..1 @typeCode="REFR" Refers to (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1946).
o SHALL contain 1..1 observation (CONF:1947).
 This observation SHALL contain 1..1 @classCode="OBS" Observation
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:1948).
 This observation SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem:
ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:1949).
 Observation/id SHALL be present, and SHALL equal case observation's
observation/id (CONF:1950).
 This observation SHALL contain 1..1 code="ASSERTION" with @xsi:type="CD"
(CodeSystem: ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:1951).
 This observation SHALL contain 1..1 value with @xsi:type="CD" (CodeSystem:
SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:1952).
SHOULD contain 0..* entryRelationship (CONF:1953) such that it
o SHALL contain 1..1 @typeCode="COMP" Has component (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1954).
o SHALL contain 1..1 PHCR Treatment given
(templateId:2.16.840.1.113883.10.20.15.3.55) (CONF:1955).
MAY contain 0..* entryRelationship (CONF:1956) such that it
o SHALL contain 1..1 @typeCode="COMP" Has component (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:1957).
o SHALL contain 1..1 PHCR Treatment not given
(templateId:2.16.840.1.113883.10.20.15.3.56) (CONF:1958).
5.27.
Precondition for Substance Administration
A criterion for administration can be used to record that the medication is to be administered only when
the associated criteria are met.
Used In
Immunization Section
May Embed
Core Common
Table 126 - Precondition for Substance Administration Overview
5.27.1. Conformance for Precondition for Substance Administration

SHALL contain 1..1 templateId (CONF:7372) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.4.25" (CONF:10517).
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

SHOULD contain 0..1 code (CONF:16854).
MAY contain 0..1 text (CONF:7373).
SHOULD contain 0..1 value with @xsi:type="CD" (CONF:7369).
5.27.2. Value Sets
No value sets apply for this template
5.27.3. Example for Precondition for Substance Administration
<precondition typeCode="PRCN">
<templateId root="2.16.840.1.113883.10.20.22.4.25"/>
<criterion>
<code code="ASSERTION"
codeSystem="2.16.840.1.113883.5.4"
codeSystemName="HL7ActCode"/>
<text>...</text>
<value xsi:type="CD" code="56018004"
codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT"
displayName="Wheezing"/>
</criterion>
</precondition>
5.28.
Pregnancy Observation
Used In
Social History Section
May Embed
Core Common
Table 127 - Pregnancy Observation Overview
5.28.1. Conformance for Pregnancy Observation
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)



SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:451).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:452).
SHALL contain exactly one [1..1] templateId (CONF:16768) such that it
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o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.15.3.8"
(CONF:16868).
SHALL contain exactly one [1..1] code (CONF:19153).
o This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem:
ActCode 2.16.840.1.113883.5.4 STATIC) (CONF:19154).
SHALL contain exactly one [1..1] statusCode (CONF:455).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19110).
SHOULD contain zero or one [0..1] effectiveTime (CONF:2018).
SHALL contain exactly one [1..1] value="77386006" Pregnant with @xsi:type="CD"
(CodeSystem: SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:457).
MAY contain zero or one [0..1] entryRelationship (CONF:458) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:459).
o SHALL contain exactly one [1..1] Estimated Date of Delivery
(templateId:2.16.840.1.113883.10.20.15.3.1) (CONF:15584).
5.28.2. Value Sets
No specific value set is proposed for a Pregnancy Observation template.

Implementers SHOULD use the SNOMED-CT code for pregnancy - 77386006
5.28.3. Example for Pregnancy Observation
<observation classCode="OBS" moodCode="EVN">
<!-- Pregnancy observation template -->
<templateId root="2.16.840.1.113883.10.20.15.3.8"/>
<id extension="123456789" root="2.16.840.1.113883.19"/>
<code code="ASSERTION" codeSystem="2.16.840.1.113883.5.4"/>
<statusCode code="completed"/>
<effectiveTime>
<low value="20110410"/>
</effectiveTime>
<value xsi:type="CD" code="77386006"
displayName="pregnant"
codeSystem="2.16.840.1.113883.6.96"/>
<entryRelationship typeCode="REFR">
<!-- Estimated Date of Delivery template -->
<templateId root="2.16.840.1.113883.10.20.15.3.1"/>
...
</entryRelationship>
</observation>
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5.29.
Problem Concern Act
Used In
May Embed
Core Common
Problem Section
Problem Observation
Table 128 - Problem Concern Act Overview
5.29.1. Conformance for Problem Concern Act
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)






SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:9024).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:9025).
SHALL contain exactly one [1..1] templateId (CONF:16772) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.3"
(CONF:16773).
SHALL contain at least one [1..*] id (CONF:9026).
SHALL contain exactly one [1..1] code (CONF:9027).
o This code SHALL contain exactly one [1..1] @code="CONC" Concern (CodeSystem:
HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:19184).
SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet
ProblemAct statusCode 2.16.840.1.113883.11.20.9.19 STATIC 2011-09-09 (CONF:9029).
The effectiveTime element records the starting and ending times during which the concern was
active on the Problem List.


SHALL contain exactly one [1..1] effectiveTime (CONF:9030).
o This effectiveTime SHALL contain exactly one [1..1] low (CONF:9032).
o This effectiveTime SHOULD contain zero or one [0..1] high (CONF:9033).
SHALL contain at least one [1..*] entryRelationship (CONF:9034) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9035).
o SHALL contain exactly one [1..1] Problem Observation
(templateId:2.16.840.1.113883.10.20.22.4.4) (CONF:15980).
5.29.2. Value Sets
Value Set Name
Problem Status
Value Set ID
2.16.840.1.113883.11.20.9.19
Type
Constrained to 3 proposed
codes for PHRI
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


Active
Inactive
Resolved
Table 129 - Problem Concern Act Value Sets
5.29.3. Example of Problem Concern Act
<Entry classCode="ACT" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.3" />
<id />
<code code="CONC" />
<statusCode />
<effectiveTime>
<low />
<high />
</effectiveTime>
<entryRelationship typeCode="SUBJ">
<observation />
</entryRelationship>
</Entry>
5.30.
Problem Observation
Used In
May Embed
Core Common
Hospital Discharge Diagnosis
Hospital Admission Diagnosis
Postoperative Diagnosis
Problem Concern Act (Condition)
Preoperative Diagnosis
Age Observation
Health Status Observation
Problem Status
Health Problem/Diagnosis Name
Table 130 - Problem Observation Overview
5.30.1. Conformance for Problem Observation
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.4


SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:9041).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:9042).
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MAY contain zero or one [0..1] @negationInd (CONF:10139).
o Use negationInd="true" to indicate that the problem was not observed (CONF:16880).
SHALL contain exactly one [1..1] templateId (CONF:14926) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.4"
(CONF:14927).
SHALL contain at least one [1..*] id (CONF:9043).
SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type
2.16.840.1.113883.3.88.12.3221.7.2 STATIC 2012-06-01 (CONF:9045).
SHOULD contain zero or one [0..1] text (CONF:9185).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15587).
 The reference, if present, SHALL contain exactly one [1..1] @value
(CONF:15588).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15589).
SHALL contain exactly one [1..1] statusCode (CONF:9049).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19112).
SHOULD contain zero or one [0..1] effectiveTime (CONF:9050).
o The effectiveTime, if present, SHALL contain exactly one [1..1] low (CONF:15603).
 This field represents the onset date (CONF:16882).
o The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:15604).
 This field represents the resolution date (CONF:16883).
o If the problem is known to be resolved, but the date of resolution is not known, then the
high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
Therefore, the existence of an high element within a problem does indicate that the
problem has been resolved (CONF:16881).
SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHOULD be
selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC
(CONF:9058).
o This value MAY contain zero or one [0..1] @nullFlavor (CONF:10141).
 If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor
SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor
SHOULD be “OTH” and the other code SHOULD be placed in the translation
element (CONF:10142).
o This value MAY contain zero or more [0..*] translation (CONF:16749).
 The translation, if present, MAY contain zero or one [0..1] @code (CodeSystem:
ICD10 2.16.840.1.113883.6.3 STATIC) (CONF:16750).
MAY contain zero or one [0..1] entryRelationship (CONF:9059) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9060).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9069).
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o SHALL contain exactly one [1..1] Age Observation
(templateId:2.16.840.1.113883.10.20.22.4.31) (CONF:15590).
MAY contain zero or one [0..1] entryRelationship (CONF:9063) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9068).
o SHALL contain exactly one [1..1] Problem Status
(templateId:2.16.840.1.113883.10.20.22.4.6) (CONF:15591).
MAY contain zero or one [0..1] entryRelationship (CONF:9067) such that it
o SHALL contain exactly one [1..1] @typeCode="REFR" Refers to (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:9064).
o SHALL contain exactly one [1..1] Health Status Observation
(templateId:2.16.840.1.113883.10.20.22.4.5) (CONF:15592).
5.30.2. Value Sets
Value Set Name
Problem Type
Problem
Value Set ID
2.16.840.1.113883.3.88.12.3221.7.2
2.16.840.1.113883.3.88.12.3221.7.4
Type
Dynamic
Constrained from
Consolidated CDA but can be
extended by PHRI
Table 131 - Problem Observation Value Sets
5.30.3. Example of Problem Observation
<Entry classCode="OBS" moodCode="EVN" negationInd="XXX">
<!--PRIMITIVE: Use negationInd="true" to indicate that the problem was not observed.-->
<templateId root="2.16.840.1.113883.10.20.22.4.4" />
<id />
<code />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<effectiveTime>
<low>
<!--PRIMITIVE: This field represents the onset date.-->
</low>
<high>
<!--PRIMITIVE: This field represents the resolution date.-->
</high>
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<!--PRIMITIVE: If the problem is known to be resolved, but the date of resolution is not known, then
the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'. Therefore, the
existence of an high element within a problem does indicate that the problem has been resolved.-->
</effectiveTime>
<value nullFlavor="XXX">
<!--PRIMITIVE:
If the diagnosis is unknown or the SNOMED code is unknown, @nullFlavor
SHOULD be “UNK”. If the code is something other than SNOMED, @nullFlavor SHOULD be “OTH” and
the other code SHOULD be placed in the translation element-->
<translation code="XXX" />
</value>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation />
</entryRelationship>
<entryRelationship typeCode="REFR">
<observation />
</entryRelationship>
<entryRelationship typeCode="REFR">
<observation />
</entryRelationship>
</Entry>
5.31.
Problem Status
Used In
May Embed
Core Common
Problem Observation
Table 132 - Problem Status Overview
5.31.1. Conformance for Problem Status

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.6

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7357).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7358).
SHALL contain exactly one [1..1] templateId (CONF:7359) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.6"
(CONF:10518).
SHALL contain exactly one [1..1] code (CONF:19162).
o This code SHALL contain exactly one [1..1] @code="33999-4" Status (CodeSystem:
LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:19163).



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


SHOULD contain zero or one [0..1] text (CONF:7362).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15593).
 The reference, if present, SHALL contain exactly one [1..1] @value
(CONF:15594).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15595).
SHALL contain exactly one [1..1] statusCode (CONF:7364).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19113).
SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be
selected from ValueSet Problem Status Value Set 2.16.840.1.113883.3.88.12.80.68 DYNAMIC
(CONF:7365).
5.31.2. Value Sets
Value Set Name
HITSP Problem Status
Value Set ID
2.16.840.1.113883.3.88.12.80.68
Type
Dynamic
Table 133 - Problem Status Value Sets
5.31.3. Example of Problem Status
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.6" />
<code code="33999-4" />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<value />
</Entry>
5.32.
Procedure Activity Act
Used In
May Embed
Procedures Section
Indication
Instructions
Medication Activity
Service Delivery Location
Core Common
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Table 134 - Procedure Activity Act Overview
5.32.1. Conformance for Procedure Activity Act
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)









SHALL contain exactly one [1..1] @classCode="ACT" Act (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8289).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8290).
SHALL contain exactly one [1..1] templateId (CONF:8291) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.12"
(CONF:10519).
SHALL contain at least one [1..*] id (CONF:8292).
SHALL contain exactly one [1..1] code (CONF:8293).
o This code SHOULD contain zero or one [0..1] originalText (CONF:19186).
 The originalText, if present, MAY contain zero or one [0..1] reference
(CONF:19187).
 The reference, if present, MAY contain zero or one [0..1] @value
(CONF:19188).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:19189).
o This code in a procedure activity observation SHOULD be selected from LOINC
(CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem:
2.16.840.1.113883.6.96) (CONF:19190).
SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet
ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8298).
SHOULD contain zero or one [0..1] effectiveTime (CONF:8299).
MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority
2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8300).
SHOULD contain zero or more [0..*] performer (CONF:8301).
o The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8302).
 This assignedEntity SHALL contain at least one [1..*] id (CONF:8303).
 This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8304).
 This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8305).
 This assignedEntity SHOULD contain zero or one [0..1] representedOrganization
(CONF:8306).
 The representedOrganization, if present, SHOULD contain zero or more
[0..*] id (CONF:8307).
 The representedOrganization, if present, MAY contain zero or more
[0..*] name (CONF:8308).
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 The representedOrganization, if present, SHALL contain exactly one
[1..1] telecom (CONF:8310).
 The representedOrganization, if present, SHALL contain exactly one
[1..1] addr (CONF:8309).
MAY contain zero or more [0..*] participant (CONF:8311).
o The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location
(CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8312).
o The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location
(templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15599).
MAY contain zero or more [0..*] entryRelationship (CONF:8314).
o The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP"
Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002
STATIC) (CONF:8315).
o The entryRelationship, if present, SHALL contain exactly one [1..1]
@inversionInd="true" true (CONF:8316).
o The entryRelationship, if present, SHALL contain exactly one [1..1] encounter
(CONF:8317).
 This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8318).
 This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event
(CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8319).
 This encounter SHALL contain exactly one [1..1] id (CONF:8320).
 Set the encounter ID to the ID of an encounter in another section to
signify they are the same encounter (CONF:16849).
MAY contain zero or one [0..1] entryRelationship (CONF:8322).
o The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="SUBJ"
Has Subject (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC)
(CONF:8323).
o The entryRelationship, if present, SHALL contain exactly one [1..1]
@inversionInd="true" true (CONF:8324).
o The entryRelationship, if present, SHALL contain exactly one [1..1] Instructions
(templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15600).
MAY contain zero or more [0..*] entryRelationship (CONF:8326).
o The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="RSON"
Has Reason (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC)
(CONF:8327).
o The entryRelationship, if present, SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15601).
MAY contain zero or one [0..1] entryRelationship (CONF:8329).
o The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP"
Has Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002
STATIC) (CONF:8330).
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The entryRelationship, if present, SHALL contain exactly one [1..1] Medication Activity
(templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15602).
5.32.2. Value Sets
Not applicable
5.32.3. Example of Procedure Activity Act
<Entry classCode="ACT" moodCode="XXX">
<templateId root="2.16.840.1.113883.10.20.22.4.12" />
<id />
<code>
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</originalText>
<!--PRIMITIVE: This code in a procedure activity observation SHOULD be selected from LOINC
(CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96).-->
</code>
<statusCode />
<effectiveTime />
<priorityCode />
<performer>
<assignedEntity>
<id />
<addr />
<telecom />
<representedOrganization>
<id />
<name />
<telecom />
<addr />
</representedOrganization>
</assignedEntity>
</performer>
<participant typeCode="LOC">
<participantRole />
</participant>
<entryRelationship typeCode="COMP" inversionInd="true">
<encounter classCode="ENC" moodCode="EVN">
<id>
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<!--PRIMITIVE: Set the encounter ID to the ID of an encounter in another section to signify they are
the same encounter.-->
</id>
</encounter>
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<entryRelationship typeCode="COMP">
<substanceAdministration />
</entryRelationship>
</Entry>
5.33.
Procedure Activity Observation
Used In
May Embed
Procedures Section
Indication
Instructions
Medication Activity
Service Delivery Location
Core Common
Table 135 - Procedure Activity Observation Overview
5.33.1. Conformance for Procedure Activity Observation
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)





SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8282).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:8237).
SHALL contain exactly one [1..1] templateId (CONF:8238) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.13"
(CONF:10520).
SHALL contain at least one [1..*] id (CONF:8239).
SHALL contain exactly one [1..1] code (CONF:19197).
o This code SHOULD contain zero or one [0..1] originalText (CONF:19198).
 The originalText, if present, SHOULD contain zero or one [0..1] reference
(CONF:19199).
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






Standards & Interoperability Framework
Public Health Reporting Specification - CDA
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:19200).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:19201).
o This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4
(CodeSystem: 2.16.840.1.113883.6.12), ICD9 Procedures (CodeSystem:
2.16.840.1.113883.6.4) (CONF:19202).
SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet
ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:8245).
SHOULD contain zero or one [0..1] effectiveTime (CONF:8246).
MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority
2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:8247).
SHALL contain exactly one [1..1] value (CONF:16846).
MAY contain zero or one [0..1] methodCode (CONF:8248).
o MethodCode SHALL NOT conflict with the method inherent in Observation / code
(CONF:8249).
SHOULD contain zero or more [0..*] targetSiteCode (CONF:8250).
o The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9
DYNAMIC (CONF:16071).
SHOULD contain zero or more [0..*] performer (CONF:8251).
o The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:8252).
 This assignedEntity SHALL contain at least one [1..*] id (CONF:8253).
 This assignedEntity SHALL contain exactly one [1..1] addr (CONF:8254).
 This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:8255).
 This assignedEntity SHOULD contain zero or one [0..1] representedOrganization
(CONF:8256).
 The representedOrganization, if present, SHOULD contain zero or more
[0..*] id (CONF:8257).
 The representedOrganization, if present, MAY contain zero or more
[0..*] name (CONF:8258).
 The representedOrganization, if present, SHALL contain exactly one
[1..1] telecom (CONF:8260).
 The representedOrganization, if present, SHALL contain exactly one
[1..1] addr (CONF:8259).
MAY contain zero or more [0..*] participant (CONF:8261).
o The participant, if present, SHALL contain exactly one [1..1] @typeCode="LOC" Location
(CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8262).
o The participant, if present, SHALL contain exactly one [1..1] Service Delivery Location
(templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15904).
MAY contain zero or more [0..*] entryRelationship (CONF:8264).
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o The entryRelationship, if present, SHALL contain exactly one [1..1] @typeCode="COMP"
Component (CodeSystem: HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC)
(CONF:8265).
o The entryRelationship, if present, SHALL contain exactly one [1..1]
@inversionInd="true" true (CONF:8266).
o The entryRelationship, if present, SHALL contain exactly one [1..1] encounter
(CONF:8267).
 This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:8268).
 This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event
(CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:8269).
 This encounter SHALL contain exactly one [1..1] id (CONF:8270).
 Set encounter/id to the id of an encounter in another section to signify
they are the same encounter (CONF:16847).
MAY contain zero or one [0..1] entryRelationship (CONF:8272) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8273).
o SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8274).
o SHALL contain exactly one [1..1] Instructions
(templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15905).
MAY contain zero or more [0..*] entryRelationship (CONF:8276) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8277).
o SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15906).
MAY contain zero or one [0..1] entryRelationship (CONF:8279) such that it
o SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:8280).
o SHALL contain exactly one [1..1] Medication Activity
(templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15907).
5.33.2. Value Sets
Value Set Name
Body Site
Value Set ID
2.16.840.1.113883.3.88.12.3221.8.9
Type
Dynamic
Table 136 - Procedure Activity Observation Value Sets
5.33.3. Example of Procedure Activity Observation
<Entry classCode="OBS" moodCode="XXX">
<templateId root="2.16.840.1.113883.10.20.22.4.13" />
<id />
<code>
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<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1).-->
</reference>
</originalText>
<!--PRIMITIVE: This @code SHOULD be selected from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (CodeSystem:
2.16.840.1.113883.6.12), ICD9 Procedures (CodeSystem: 2.16.840.1.113883.6.4).-->
</code>
<statusCode />
<effectiveTime />
<priorityCode />
<value />
<methodCode>
<!--PRIMITIVE: methodCode SHALL NOT conflict with the method inherent in Observation / code.-->
</methodCode>
<targetSiteCode code="XXX" />
<performer>
<assignedEntity>
<id />
<addr />
<telecom />
<representedOrganization>
<id />
<name />
<telecom />
<addr />
</representedOrganization>
</assignedEntity>
</performer>
<participant typeCode="LOC">
<participantRole />
</participant>
<entryRelationship typeCode="COMP" inversionInd="true">
<encounter classCode="ENC" moodCode="EVN">
<id>
<!--PRIMITIVE: Set encounter/id to the id of an encounter in another section to signify they are the
same encounter.-->
</id>
</encounter>
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
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<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<entryRelationship typeCode="COMP">
<substanceAdministration />
</entryRelationship>
</Entry>
5.34.
Procedure Activity Procedure
Used In
May Embed
Procedures Section
Reaction Observation
Indication
Instructions
Medication Activity
Service Delivery Location
Product Instance
Core Common
Table 137 - Procedure Activity Procedure Overview
5.34.1. Conformance for Procedure Activity Procedure
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.14





SHALL contain exactly one [1..1] @classCode="PROC" Procedure (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7652).
SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet
MoodCodeEvnInt 2.16.840.1.113883.11.20.9.18 STATIC 2011-04-03 (CONF:7653).
SHALL contain exactly one [1..1] templateId (CONF:7654) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.14"
(CONF:10521).
SHALL contain at least one [1..*] id (CONF:7655).
SHALL contain exactly one [1..1] code (CONF:7656).
o This code SHOULD contain zero or one [0..1] originalText (CONF:19203).
 The originalText, if present, SHOULD contain zero or one [0..1] reference
(CONF:19204).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:19205).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:19206).
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o This code in a procedure activity SHOULD be selected from LOINC (codeSystem
2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY
be selected from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12), ICD9 Procedures
(CodeSystem: 2.16.840.1.113883.6.104), ICD10 Procedure Coding System (CodeSystem:
2.16.840.1.113883.6.4) (CONF:19207).
SHALL contain exactly one [1..1] statusCode, which SHALL be selected from ValueSet
ProcedureAct statusCode 2.16.840.1.113883.11.20.9.22 DYNAMIC (CONF:7661).
SHOULD contain zero or one [0..1] effectiveTime (CONF:7662).
MAY contain zero or one [0..1] priorityCode, which SHALL be selected from ValueSet ActPriority
2.16.840.1.113883.1.11.16866 DYNAMIC (CONF:7668).
MAY contain zero or one [0..1] methodCode (CONF:7670).
o MethodCode SHALL NOT conflict with the method inherent in Procedure / code
(CONF:7890).
SHOULD contain zero or more [0..*] targetSiteCode (CONF:7683).
o The targetSiteCode, if present, SHALL contain exactly one [1..1] @code, which SHALL be
selected from ValueSet Body Site Value Set 2.16.840.1.113883.3.88.12.3221.8.9
DYNAMIC (CONF:16082).
MAY contain zero or more [0..*] specimen (CONF:7697).
o The specimen, if present, SHALL contain exactly one [1..1] specimenRole (CONF:7704).
 This specimenRole SHOULD contain zero or more [0..*] id (CONF:7716).
 If you want to indicate that the Procedure and the Results are referring
to the same specimen, the Procedure/specimen/specimenRole/id
SHOULD be set to equal an Organizer/specimen/ specimenRole/id
(CONF:7717).
o This specimen is for representing specimens obtained from a procedure (CONF:16842).
SHOULD contain zero or more [0..*] performer (CONF:7718) such that it
o SHALL contain exactly one [1..1] assignedEntity (CONF:7720).
 This assignedEntity SHALL contain at least one [1..*] id (CONF:7722).
 This assignedEntity SHALL contain exactly one [1..1] addr (CONF:7731).
 This assignedEntity SHALL contain exactly one [1..1] telecom (CONF:7732).
 This assignedEntity SHOULD contain zero or one [0..1] representedOrganization
(CONF:7733).
 The representedOrganization, if present, SHOULD contain zero or more
[0..*] id (CONF:7734).
 The representedOrganization, if present, MAY contain zero or more
[0..*] name (CONF:7735).
 The representedOrganization, if present, SHALL contain exactly one
[1..1] telecom (CONF:7737).
 The representedOrganization, if present, SHALL contain exactly one
[1..1] addr (CONF:7736).
MAY contain zero or more [0..*] participant (CONF:7751) such that it
o SHALL contain exactly one [1..1] @typeCode="DEV" Device (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7752).
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o SHALL contain exactly one [1..1] Product Instance
(templateId:2.16.840.1.113883.10.20.22.4.37) (CONF:15911).
MAY contain zero or more [0..*] participant (CONF:7765) such that it
o SHALL contain exactly one [1..1] @typeCode="LOC" Location (CodeSystem:
HL7ParticipationType 2.16.840.1.113883.5.90 STATIC) (CONF:7766).
o SHALL contain exactly one [1..1] Service Delivery Location
(templateId:2.16.840.1.113883.10.20.22.4.32) (CONF:15912).
MAY contain zero or more [0..*] entryRelationship (CONF:7768) such that it
o SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7769).
o SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:8009).
o SHALL contain exactly one [1..1] encounter (CONF:7770).
 This encounter SHALL contain exactly one [1..1] @classCode="ENC" Encounter
(CodeSystem: HL7ActClass 2.16.840.1.113883.5.6 STATIC) (CONF:7771).
 This encounter SHALL contain exactly one [1..1] @moodCode="EVN" Event
(CodeSystem: ActMood 2.16.840.1.113883.5.1001 STATIC) (CONF:7772).
 This encounter SHALL contain exactly one [1..1] id (CONF:7773).
 Set the encounter ID to the ID of an encounter in another section to
signify they are the same encounter (CONF:16843).
MAY contain zero or one [0..1] entryRelationship (CONF:7775) such that it
o SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7776).
o SHALL contain exactly one [1..1] @inversionInd="true" true (CONF:7777).
o SHALL contain exactly one [1..1] Instructions
(templateId:2.16.840.1.113883.10.20.22.4.20) (CONF:15913).
MAY contain zero or more [0..*] entryRelationship (CONF:7779) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" Has Reason (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7780).
o SHALL contain exactly one [1..1] Indication
(templateId:2.16.840.1.113883.10.20.22.4.19) (CONF:15914).
MAY contain zero or one [0..1] entryRelationship (CONF:7886) such that it
o SHALL contain exactly one [1..1] @typeCode="COMP" Has Component (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7887).
o SHALL contain exactly one [1..1] Medication Activity
(templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15915).
5.34.2. Value Sets
The following value sets are proposed for the Procedure Activity Procedure template:
Value Set Name
Body Site
Value Set ID
2.16.840.1.113883.3.88.12.3221.8.9
Type
Dynamic
Table 138 - Procedure Activity Procedure Value Sets
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5.34.3. Example of Procedure Activity Procedure
<Entry classCode="PROC" moodCode="XXX">
<templateId root="2.16.840.1.113883.10.20.22.4.14" />
<id />
<code>
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1).-->
</reference>
</originalText>
<!--PRIMITIVE: This code in a procedure activity SHOULD be selected from LOINC (codeSystem
2.16.840.1.113883.6.1) or SNOMED CT (CodeSystem: 2.16.840.1.113883.6.96), and MAY be selected
from CPT-4 (CodeSystem: 2.16.840.1.113883.6.12), ICD9 Procedures (CodeSystem:
2.16.840.1.113883.6.104), ICD10 Procedure Coding System (CodeSystem: 2.16.840.1.113883.6.4).-->
</code>
<statusCode />
<effectiveTime />
<priorityCode />
<methodCode>
<!--PRIMITIVE: methodCode SHALL NOT conflict with the method inherent in Procedure / code.-->
</methodCode>
<targetSiteCode code="XXX" />
<specimen>
<specimenRole>
<id>
<!--PRIMITIVE:
If you want to indicate that the Procedure and the Results are referring to the
same specimen, the Procedure/specimen/specimenRole/id SHOULD be set to equal an
Organizer/specimen/ specimenRole/id-->
</id>
</specimenRole>
<!--PRIMITIVE: This specimen is for representing specimens obtained from a procedure.-->
</specimen>
<performer>
<assignedEntity>
<id />
<addr />
<telecom />
<representedOrganization>
<id />
<name />
<telecom />
<addr />
</representedOrganization>
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</assignedEntity>
</performer>
<participant typeCode="DEV">
<participantRole />
</participant>
<participant typeCode="LOC">
<participantRole />
</participant>
<entryRelationship typeCode="COMP" inversionInd="true">
<encounter classCode="ENC" moodCode="EVN">
<id>
<!--PRIMITIVE: Set the encounter ID to the ID of an encounter in another section to signify they are
the same encounter.-->
</id>
</encounter>
</entryRelationship>
<entryRelationship typeCode="SUBJ" inversionInd="true">
<act />
</entryRelationship>
<entryRelationship typeCode="RSON">
<observation />
</entryRelationship>
<entryRelationship typeCode="COMP">
<substanceAdministration />
</entryRelationship>
</Entry>
5.35.
Procedure Specimens Taken
Note: the Procedure Specimens Taken template is a section-level template that can be embedded in
other sections and is used for Specimen information.
Used In
May Embed
Core Common
Procedures Section
Current template to use for representing specimens in public health
CDA-based reports
Table 139 - Procedure Specimens Taken Overview
5.35.1. Conformance for Procedure Specimens Taken
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm)

SHALL contain exactly one [1..1] templateId (CONF:8086) such that it
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o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.31"
(CONF:10446).
SHALL contain exactly one [1..1] code (CONF:15421).
o This code SHALL contain exactly one [1..1] @code="59773-2" Procedure Specimens
Taken (CodeSystem: LOINC 2.16.840.1.113883.6.1 STATIC) (CONF:15422).
SHALL contain exactly one [1..1] title (CONF:8088).
SHALL contain exactly one [1..1] text (CONF:8089).
The Procedure Specimens Taken section SHALL list all specimens removed or SHALL explicitly
state that no specimens were taken (CONF:8742).
5.35.2. Value Sets
There are no specific value sets applicable for the Procedure Specimens Taken template. This template is
focused on capturing specimen information as narrative information.
5.35.3. Example of Procedure Specimens Taken
<Section>
<templateId root="2.16.840.1.113883.10.20.22.2.31" />
<code code="59773-2" />
<title />
<text />
<!--PRIMITIVE: The Procedure Specimens Taken section SHALL list all specimens removed or SHALL
explicitly state that no specimens were taken-->
</Section>
5.36.
Product Instance
Used In
Procedure Activity Procedure
Non-Medicinal Supply Activity
May Embed
Core Common
Table 140 - Product Instance Overview
5.36.1. Conformance for Product Instance

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.37

SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem:
RoleClass 2.16.840.1.113883.5.110 STATIC) (CONF:7900).
SHALL contain exactly one [1..1] templateId (CONF:7901) such that it

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o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.37"
(CONF:10522).
SHALL contain at least one [1..*] id (CONF:7902).
SHALL contain exactly one [1..1] playingDevice (CONF:7903).
o This playingDevice SHOULD contain zero or one [0..1] code (CONF:16837).
SHALL contain exactly one [1..1] scopingEntity (CONF:7905).
o This scopingEntity SHALL contain at least one [1..*] id (CONF:7908).
5.36.2. Value Sets
Not applicable
5.36.3. Example of Product Instance
<Entry classCode="MANU">
<templateId root="2.16.840.1.113883.10.20.22.4.37" />
<id />
<playingDevice>
<code />
</playingDevice>
<scopingEntity>
<id />
</scopingEntity>
</Entry>
5.37.
Reaction Observation
Used In
May Embed
Allergy - Intolerance Observation
Medication Activity
Immunization Activity
Medication Activity
Procedure Activity Procedure
Severity Observation
Core Common
Table 141 - Reaction Observation Overview
5.37.1. Conformance for Reaction Observation
Implementers SHALL adopt all conformance statements as defined within the Implementation Guide for
CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.9

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7325).
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SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7326).
SHALL contain exactly one [1..1] templateId (CONF:7323) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.9"
(CONF:10523).
SHALL contain exactly one [1..1] id (CONF:7329).
SHALL contain exactly one [1..1] code (CONF:16851).
o The value set for this code element has not been specified. Implementers are allowed
to use any code system, such as SNOMED CT, a locally determined code, or a nullFlavor
(CONF:16852).
SHOULD contain zero or one [0..1] text (CONF:7330).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15917).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15918).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15919).
SHALL contain exactly one [1..1] statusCode (CONF:7328).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19114).
SHOULD contain zero or one [0..1] effectiveTime (CONF:7332).
o The effectiveTime, if present, SHOULD contain zero or one [0..1] low (CONF:7333).
o The effectiveTime, if present, SHOULD contain zero or one [0..1] high (CONF:7334).
SHALL contain exactly one [1..1] value with @xsi:type="CD", where the @code SHALL be
selected from ValueSet Problem Value Set 2.16.840.1.113883.3.88.12.3221.7.4 DYNAMIC
(CONF:7335).
MAY contain zero or more [0..*] entryRelationship (CONF:7337) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7338).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7343).
o SHALL contain exactly one [1..1] Procedure Activity Procedure
(templateId:2.16.840.1.113883.10.20.22.4.14) (CONF:15920).
 This procedure activity is intended to contain information about procedures
that were performed in response to an allergy reaction (CONF:16853).
MAY contain zero or more [0..*] entryRelationship (CONF:7340) such that it
o SHALL contain exactly one [1..1] @typeCode="RSON" Has reason (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7341).
o SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7344).
o SHALL contain exactly one [1..1] Medication Activity
(templateId:2.16.840.1.113883.10.20.22.4.16) (CONF:15921).
 This medication activity is intended to contain information about medications
that were administered in response to an allergy reaction (CONF:16840).
SHOULD contain zero or one [0..1] entryRelationship (CONF:7580) such that it
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SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem:
HL7ActRelationshipType 2.16.840.1.113883.5.1002 STATIC) (CONF:7581).
SHALL contain exactly one [1..1] @inversionInd="true" TRUE (CONF:10375).
SHALL contain exactly one [1..1] Severity Observation
(templateId:2.16.840.1.113883.10.20.22.4.8) (CONF:15922).
5.37.2. Value Sets
Value Set Name
Problem
Value Set ID
2.16.840.1.113883.3.88.12.3221.7.4
Type
Dynamic
Table 142 - Reaction Observation Value Sets
5.37.3. Example of Reaction Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.9" />
<id />
<code>
<!--PRIMITIVE: The value set for this code element has not been specified. Implementers are allowed
to use any code system, such as SNOMED CT, a locally determined code, or a nullFlavor-->
</code>
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<effectiveTime>
<low />
<high />
</effectiveTime>
<value />
<entryRelationship typeCode="RSON" inversionInd="true">
<procedure>
<!--PRIMITIVE: This procedure activity is intended to contain information about procedures that were
performed in response to an allergy reaction-->
</procedure>
</entryRelationship>
<entryRelationship typeCode="RSON" inversionInd="true">
<substanceAdministration>
<!--PRIMITIVE: This medication activity is intended to contain information about medications that
were administered in response to an allergy reaction -->
</substanceAdministration>
</entryRelationship>
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<entryRelationship typeCode="SUBJ" inversionInd="true">
<observation />
</entryRelationship>
</Entry>
5.38.
Result Observation
Used In
Results Organizer
May Embed
Core Common
Table 143 - Result Observation Overview
5.38.1. Conformance for Result Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.2

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7130).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7131).
SHALL contain exactly one [1..1] templateId (CONF:7136) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.2" (CONF:9138).
SHALL contain at least one [1..*] id (CONF:7137).
SHALL contain exactly one [1..1] code (CONF:7133).
o SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT
(CodeSystem: 2.16.840.1.113883.6.96) (CONF:19211).
o Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
other constrained terminology named by the US Department of Health and Human
Services Office of National Coordinator or other federal agency. Local and/or regional
codes for laboratory results are allowed. The Local and/or regional codes SHOULD be
sent in the translation element. See the Local code example figure (CONF:19212).
SHOULD contain zero or one [0..1] text (CONF:7138).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15924).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15925).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15926).
SHALL contain exactly one [1..1] statusCode (CONF:7134).
o This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from
ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC (CONF:14849).





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SHALL contain exactly one [1..1] effectiveTime (CONF:7140).
o Represents clinically effective time of the measurement, which may be when the
measurement was performed (e.g., a BP measurement), or may be when sample was
taken (and measured some time afterwards) (CONF:16838).
SHALL contain exactly one [1..1] value (CONF:7143).
SHOULD contain zero or more [0..*] interpretationCode (CONF:7147).
MAY contain zero or one [0..1] methodCode (CONF:7148).
MAY contain zero or one [0..1] targetSiteCode (CONF:7153).
MAY contain zero or one [0..1] author (CONF:7149).
SHOULD contain zero or more [0..*] referenceRange (CONF:7150).
o The referenceRange, if present, SHALL contain exactly one [1..1] observationRange
(CONF:7151).
 This observationRange SHALL NOT contain [0..0] code (CONF:7152).
5.38.2. Value Sets
The following value sets are proposed for the Result Observation template:
Value Set Name
Result Status
PHVS_AbnormalFlag_HL7_2x
Value Set ID
2.16.840.1.113883.11.20.9.39
2.16.840.1.114222.4.11.800
Type
Dynamic
Proposed by PHRI for result
interpretation
Table 144 - Result Observation Value Sets
5.38.3. Example of Result Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.2" />
<id />
<code>
<!--PRIMITIVE: SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or SNOMED CT
(CodeSystem: 2.16.840.1.113883.6.96)-->
<!--PRIMITIVE: Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
other constrained terminology named by the US Department of Health and Human Services Office of
National Coordinator or other federal agency. Local and/or regional codes for laboratory results are
allowed. The Local and/or regional codes SHOULD be sent in the translation element. See the Local code
example figure.-->
</code>
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
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</text>
<statusCode code="XXX" />
<effectiveTime>
<!--PRIMITIVE: Represents clinically effective time of the measurement, which may be when the
measurement was performed (e.g., a BP measurement), or may be when sample was taken (and
measured some time afterwards).-->
</effectiveTime>
<value />
<interpretationCode />
<methodCode />
<targetSiteCode />
<author />
<referenceRange>
<observationRange>
<code />
</observationRange>
</referenceRange>
</Entry>
5.39.
Result Organizer
Used In
May Embed
Core Common
Results Section
Result Observation
Table 145 - Result Organizer Overview
5.39.1. Conformance for Result Organizer

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.1

SHALL contain exactly one [1..1] @classCode (CodeSystem: HL7ActClass 2.16.840.1.113883.5.6
STATIC) (CONF:7121).
o SHOULD contain zero or one [0..1] @classCode="CLUSTER" Cluster (CodeSystem:
2.16.840.1.113883.5.6 HL7ActClass) OR SHOULD contain zero or one [0..1]
@classCode="BATTERY" Battery (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass)
(CONF:7165).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7122).
SHALL contain exactly one [1..1] templateId (CONF:7126) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.1" (CONF:9134).
SHALL contain at least one [1..*] id (CONF:7127).
SHALL contain exactly one [1..1] code (CONF:7128).
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o SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT
(codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem
2.16.840.1.113883.6.12) (CONF:19218).
o Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
other constrained terminology named by the US Department of Health and Human
Services Office of National Coordinator or other federal agency. Local and/or regional
codes for laboratory results SHOULD also be allowed (CONF:19219).
SHALL contain exactly one [1..1] statusCode (CONF:7123).
o This statusCode SHALL contain exactly one [1..1] @code, which SHALL be selected from
ValueSet Result Status 2.16.840.1.113883.11.20.9.39 STATIC (CONF:14848).
SHALL contain at least one [1..*] component (CONF:7124) such that it
o SHALL contain exactly one [1..1] Result Observation
(templateId:2.16.840.1.113883.10.20.22.4.2) (CONF:14850).
5.39.2. Value Sets
Value Set Name
Result Status
PHVS_ValueType_HL7_2x
Value Set ID
2.16.840.1.113883.11.20.9.39
2.16.840.1.114222.4.11.1059
Type
Dynamic
Proposed by PHRI for result
type
Table 146 - Result Organizer Value Sets
5.39.3. Example of Result Organizer
<Entry classCode="XXX" moodCode="EVN">
<!--PRIMITIVE:
SHOULD contain zero or one [0..1] @classCode="CLUSTER" Cluster
(CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) OR SHOULD contain zero or one [0..1]
@classCode="BATTERY" Battery (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass)-->
<templateId root="2.16.840.1.113883.10.20.22.4.1" />
<id />
<code>
<!--PRIMITIVE: SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT
(codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem
2.16.840.1.113883.6.12)-->
<!--PRIMITIVE: Laboratory results SHOULD be from LOINC (CodeSystem: 2.16.840.1.113883.6.1) or
other constrained terminology named by the US Department of Health and Human Services Office of
National Coordinator or other federal agency. Local and/or regional codes for laboratory results
SHOULD also be allowed.-->
</code>
<statusCode code="XXX" />
<component>
<observation />
</component>
</Entry>
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5.40.
Service Delivery Location
Used In
Procedure Activity Procedure
Procedure Activity Observation
Procedure Activity Act
Encounter Activities
May Embed
Core Common
Table 147 - Service Delivery Location Overview
5.40.1. Conformance for Service Delivery Location

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.32

SHALL contain exactly one [1..1] @classCode="SDLOC" (CodeSystem: RoleCode
2.16.840.1.113883.5.111 STATIC) (CONF:7758).
SHALL contain exactly one [1..1] templateId (CONF:7635) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.32"
(CONF:10524).
SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet
HealthcareServiceLocation 2.16.840.1.113883.1.11.20275 STATIC (CONF:16850).
SHOULD contain zero or more [0..*] addr (CONF:7760).
SHOULD contain zero or more [0..*] telecom (CONF:7761).
MAY contain zero or one [0..1] playingEntity (CONF:7762).
o The playingEntity, if present, SHALL contain exactly one [1..1] @classCode="PLC"
(CodeSystem: EntityClass 2.16.840.1.113883.5.41 STATIC) (CONF:7763).
o The playingEntity, if present, MAY contain zero or one [0..1] name (CONF:16037).

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5.40.2. Value Sets
The following value sets are proposed for the Service Delivery Location template:
Value Set Name
HealthcareServiceLocation
Value Set ID
2.16.840.1.113883.1.11.20275
Type
Dynamic
Consolidated CDA
Table 148 - Service Delivery Location Value Sets
5.40.3. Example of Service Delivery Location
<Entry classCode="SDLOC">
<templateId root="2.16.840.1.113883.10.20.22.4.32" />
<code />
<addr />
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<telecom />
<playingEntity classCode="PLC">
<name />
</playingEntity>
</Entry>
5.41.
Severity Observation
Used In
May Embed
Core Common
Reaction Observation
Allergy - Intolerance Observation
Severity Free Text
Table 149 - Severity Observation Overview
5.41.1. Conformance for Severity Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm)

SHALL contain 1..1 @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7345).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7346).
SHALL contain 1..1 templateId (CONF:7347) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.20.22.4.8" (CONF:10525).
SHALL contain 1..1 code (CONF:19168).
o This code SHALL contain 1..1 @code="SEV" (CodeSystem: ActCode
2.16.840.1.113883.5.4 STATIC) (CONF:19169).
SHOULD contain 0..1 text (CONF:7350).
o The text, if present, SHOULD contain 0..1 reference (CONF:15928).
 The reference, if present, SHOULD contain 0..1 @value (CONF:15929).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15930).
SHALL contain 1..1 statusCode (CONF:7352).
o This statusCode SHALL contain 1..1 @code="completed" Completed (CodeSystem:
ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19115).
SHALL contain 1..1 value with @xsi:type="CD", where the @code SHALL be selected from
ValueSet Problem Severity 2.16.840.1.113883.3.88.12.3221.6.8 DYNAMIC (CONF:7356).
SHOULD contain 0..* interpretationCode (CONF:9117).
o The interpretationCode, if present, SHOULD contain 0..1 @code, which SHOULD be
selected from ValueSet Observation Interpretation (HL7) 2.16.840.1.113883.1.11.78
DYNAMIC (CONF:16038).
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5.41.2. Value Sets
Not applicable as coded severity values not used
5.41.3. Example of Severity Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.8" />
<code code="SEV" />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<value />
<interpretationCode code="XXX" />
</Entry>
5.42.
Smoking Status Observation
Used In
May Embed
Core Common
Social History Section
Social History Type
Table 150 - Smoking Status Observation Overview
5.42.1. Conformance for Smoking Status Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.78


Conforms to Tobacco Use template (2.16.840.1.113883.10.20.22.4.85).
SHALL contain 1..1 @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:14806).
SHALL contain 1..1 @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:14807).
SHALL contain 1..1 templateId (CONF:14815) such that it
o SHALL contain 1..1 @root="2.16.840.1.113883.10.22.4.78" (CONF:14816).
SHALL contain 1..1 code (CONF:19170).
o This code SHALL contain 1..1 @code="ASSERTION" Assertion (CodeSystem: ActCode
2.16.840.1.113883.5.4 STATIC) (CONF:19171).
SHALL contain 1..1 statusCode (CONF:14809).
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o This statusCode SHALL contain 1..1 @code="completed" Completed (CodeSystem:
ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19116).
SHALL contain 1..1 effectiveTime (CONF:14814).
o This effectiveTime SHALL contain 1..1 low (CONF:14818).
SHALL contain 1..1 value with @xsi:type="CD" (CONF:14810).
o This value SHALL contain 1..1 @code, which SHALL be selected from ValueSet Smoking
Status 2.16.840.1.113883.10.22.4.78 DYNAMIC (CONF:14817).
5.42.2. Value Sets
The following value sets are applicable to a Smoking Status Observation template:
Value Set Name
Smoking Status
CDC Smoking
Status Recodes
Value Set ID
2.16.840.1.113883.10.22.4.78
Type
Proposed smoking
status value set
within Consolidated
CDA
No OID available
Value Set
modification to
http://www.cdc.gov/nchs/nhis/tobacco/tobacco_recodes.htm align to CDC
smoking status
reporting
requirements
Table 151 - Smoking Status Observation Value Sets
5.42.3. Example of Smoking Status Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.22.4.78" />
<code code="ASSERTION" />
<statusCode code="completed" />
<effectiveTime>
<low />
</effectiveTime>
<value code="XXX" />
</Entry>
5.43.
Social History Observation
Used In
May Embed
Core Common
Social History Observation
Social History Observed Value
Table 152 - Social History Observation Overview
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5.43.1. Conformance for Social History Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.38

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:8548).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:8549).
SHALL contain exactly one [1..1] templateId (CONF:8550) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.38"
(CONF:10526).
SHALL contain at least one [1..*] id (CONF:8551).
SHALL contain exactly one [1..1] code (CONF:8558).
o This code SHOULD contain zero or one [0..1] @code, which SHOULD be selected from
ValueSet Social History Type Set Definition 2.16.840.1.113883.3.88.12.80.60 STATIC
(CONF:19220).
o This code SHOULD contain zero or one [0..1] originalText (CONF:19221).
 The originalText, if present, SHOULD contain zero or one [0..1] reference
(CONF:19222).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:19223).
o This reference/@value SHALL begin with a '#' and SHALL point
to its corresponding narrative (using the approach defined in
CDA Release 2, section 4.3.5.1) (CONF:19224).
SHALL contain exactly one [1..1] statusCode (CONF:8553).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19117).
SHOULD contain zero or one [0..1] value (CONF:8559).
o Observation/value can be any data type. Where Observation/value is a physical
quantity, the unit of measure SHALL be expressed using a valid Unified Code for Units of
Measure (UCUM) expression (CONF:8555).

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



5.43.2. Value Sets
The following value sets are proposed for a Social History Observation. Implementers of public health
reporting using CDA may extend social history observation to support other codes as needed.
Value Set Name
Social History Type
Value Set ID
2.16.840.1.113883.3.88.12.80.60
Type
Dynamic
Table 153 - Social History Observation
5.43.3. Example of Social History Observation
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<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.38" />
<id />
<code code="XXX">
<originalText>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</originalText>
</code>
<statusCode code="completed" />
<value>
<!--PRIMITIVE: Observation/value can be any data type. Where Observation/value is a physical
quantity, the unit of measure SHALL be expressed using a valid Unified Code for Units of Measure
(UCUM) expression.-->
</value>
</Entry>
5.44.
Vital Signs Organizer
Used In
May Embed
Core Common
Vital Signs Section
Vital Signs Observation
Table 154 - Vital Signs Organizer Overview
5.44.1. Conformance for Vital Signs Organizer

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.26

SHALL contain exactly one [1..1] @classCode="CLUSTER" CLUSTER (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7279).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7280).
SHALL contain exactly one [1..1] templateId (CONF:7281) such that it
o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.26"
(CONF:10528).
SHALL contain at least one [1..*] id (CONF:7282).
SHALL contain exactly one [1..1] code (CONF:19176).
o This code SHALL contain exactly one [1..1] @code="46680005" Vital signs (CodeSystem:
SNOMED-CT 2.16.840.1.113883.6.96 STATIC) (CONF:19177).
SHALL contain exactly one [1..1] statusCode (CONF:7284).




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This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19120).
The effectiveTime represents clinically effective time of the measurement, which is most likely
when the measurement was performed (e.g., a BP measurement).


SHALL contain exactly one [1..1] effectiveTime (CONF:7288).
SHALL contain at least one [1..*] component (CONF:7285) such that it
o SHALL contain exactly one [1..1] Vital Sign Observation
(templateId:2.16.840.1.113883.10.20.22.4.27) (CONF:15946).
5.44.2. Value Sets
No value sets are applicable for a Vital Signs Organizer template.
5.44.3. Example of Vital Signs Organizer
<Entry classCode="CLUSTER" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.26" />
<id />
<code code="46680005" />
<statusCode code="completed" />
<effectiveTime />
<component>
<observation />
</component>
</Entry>
5.45.
Vital Signs Observation
Used In
May Embed
Core Common
Vital Signs Organizer
Table 155 - Vital Signs Observation Overview
5.45.1. Conformance for Vital Signs Observation

Implementers SHALL adopt all conformance statements as defined within the Implementation
Guide for CDA Release 2.0 Consolidated CDA Templates (US Realm) for templateID
2.16.840.1.113883.10.20.22.4.27

SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass
2.16.840.1.113883.5.6 STATIC) (CONF:7297).
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood
2.16.840.1.113883.5.1001 STATIC) (CONF:7298).
SHALL contain exactly one [1..1] templateId (CONF:7299) such that it
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o SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.27"
(CONF:10527).
SHALL contain at least one [1..*] id (CONF:7300).
SHALL contain exactly one [1..1] code (ValueSet: HITSP Vital Sign Result Type
2.16.840.1.113883.3.88.12.80.62 DYNAMIC) (CONF:7301).
SHOULD contain zero or one [0..1] text (CONF:7302).
o The text, if present, SHOULD contain zero or one [0..1] reference (CONF:15943).
 The reference, if present, SHOULD contain zero or one [0..1] @value
(CONF:15944).
 This reference/@value SHALL begin with a '#' and SHALL point to its
corresponding narrative (using the approach defined in CDA Release 2,
section 4.3.5.1) (CONF:15945).
SHALL contain exactly one [1..1] statusCode (CONF:7303).
o This statusCode SHALL contain exactly one [1..1] @code="completed" Completed
(CodeSystem: ActStatus 2.16.840.1.113883.5.14 STATIC) (CONF:19119).
SHALL contain exactly one [1..1] effectiveTime (CONF:7304).
SHALL contain exactly one [1..1] value with @xsi:type="PQ" (CONF:7305).
MAY contain zero or one [0..1] interpretationCode (CONF:7307).
MAY contain zero or one [0..1] methodCode (CONF:7308).
MAY contain zero or one [0..1] targetSiteCode (CONF:7309).
MAY contain zero or one [0..1] author (CONF:7310).
5.45.2. Value Sets
The following value sets are applicable to a Vital Signs Observation template:
Value Set Name
Vital Sign Result History Type
Value Set ID
2.16.840.1.113883.3.88.12.80.62
Type
Dynamic
Table 156 - Vital Signs Observation Value Sets
5.45.1. Example of Vital Signs Observation
<Entry classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.27" />
<id />
<code />
<text>
<reference value="XXX">
<!--PRIMITIVE: This reference/@value SHALL begin with a '#' and SHALL point to its corresponding
narrative (using the approach defined in CDA Release 2, section 4.3.5.1)-->
</reference>
</text>
<statusCode code="completed" />
<effectiveTime />
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<value />
<interpretationCode />
<methodCode />
<targetSiteCode />
<author />
</Entry>
6. Additional Implementation Guidance
Any additional implementation guidance can be included here. This may commonly include XML and
other examples of implementation. Analysis will be done based on the implementer audience that
participates in the sprint team on how detailed this level of additional guidance will need to be.
6.1. Core Common Representation in HL7 Messaging – Recommendations
Based on a review of the core common data elements, the following recommendations are provided:
Existing Core Common Concepts
Immunization
Recommendations for Implementation
Use the HL7 Version 2.5.1 - Implementation Guide for
Immunization Messaging (Version 1.4) for the reporting of
immunization information to an IIS.
Immunization within CDA can be used to support reporting of
immunization history
EHR-Laboratory Interoperability and Connectivity
Specification for Orders, ELINCS Orders, v1.0 June 28, 2011 is
the recommended format for laboratory orders.
Use the HL7 Version 2.5.1 Implementation Guide: Laboratory
Results Interface for US Realm, Release 1 is the recommended
format for laboratory results.
Order
Result
Table 157 - Additional Core Common Implementation Guidance - HL7 Messaging
6.2. Use of Open CDA Templates
The PHRI CDA Specification uses the following open templates from the Implementation Guide for CDA
Release 2.0 Consolidated CDA Templates (US Realm)
CDA Template Name
Admission Medication
Allergies
Allergy – Intolerance Observation
Allergy – Problem Act
Section or Entry
Entry
Section
Entry
Entry
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CDA Template Name
Allergy Status Observation
Chief Complaint and Reason for Visit
Discharge Medication
Drug Vehicle
Encounters
Encounter Activity
Family History Death Observation
Family History Observation
Family History Organizer
Hospital Admission Diagnosis
Hospital Admission Diagnosis
Hospital Admission Medications
Hospital Discharge Diagnosis
Hospital Discharge Diagnosis
Hospital Discharge Medications
Immunizations
Immunization Activity
Immunization Medication Information
Immunization Refusal Reason
Medical Equipment
Medication Activity
Medication Dispense
Medication Information
Medication Supply Order
Medications
Non-Medicinal Supply Activity
Payers
Postoperative Diagnosis
Postprocedure Diagnosis
Preoperative Diagnosis
Postprocedure Diagnosis
Preoperative Diagnosis
Problem
Problem Concern Act
Problem Status
Problem Observation
Procedure Description
Procedure Specimens Taken
Procedure Activity Act
Procedure Activity Observation
Procedure Activity Procedure
Procedures
Standards & Interoperability Framework
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Section or Entry
Entry
Section
Entry
Entry
Section
Entry
Entry
Entry
Entry
Section
Entry
Section
Section
Entry
Section
Section
Entry
Entry
Entry
Section
Entry
Entry
Entry
Entry
Section
Entry
Section
Section
Section
Section
Entry
Entry
Section
Entry
Entry
Entry
Section
Section
Entry
Entry
Entry
Section
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Section or Entry
CDA Template Name
Product Instance
Reaction Observation
Result Observation
Result Organizer
Results
Service Delivery Location
Severity Observation
Smoking Status Observation
Social History Observation
Social History
Vital Signs
Vital Sign Observation
Vital Signs Organizer
Entry
Entry
Entry
Entry
Section
Entry
Entry
Entry
Entry
Section
Section
Entry
Entry
Table 158 - Open CDA Templates Used in the PHRI CDA Specification
6.3. Program Extension of Templates
This specification includes specific XML examples for sections and entries and shows how they are
populated. CDC Programs may extend existing sections and entries to support implementation
requirements and constraints that they may wish to enforce on public health reports.
An example of this approach would be vital signs information. Current conformance language within
Consolidated CDA states the following for Vital Sign section and entry templates:
Vital Signs Organizer

Vital Signs Observation






SHALL contain at least one [1..*] entry (CONF:7276) such
that it
o SHALL contain exactly one [1..1] Vital Signs
Organizer
(templateId:2.16.840.1.113883.10.20.22.4.26)
(CONF:15964).
SHALL contain at least one [1..*] component (CONF:7285)
such that it
o SHALL contain exactly one [1..1] Vital Sign
Observation
(templateId:2.16.840.1.113883.10.20.22.4.27)
(CONF:15946).
MAY contain zero or one [0..1] interpretationCode
(CONF:7307).
MAY contain zero or one [0..1] methodCode (CONF:7308).
MAY contain zero or one [0..1] targetSiteCode
(CONF:7309).
MAY contain zero or one [0..1] author (CONF:7310).
SHALL contain exactly one [1..1] code (ValueSet: HITSP Vital
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Sign Result Type 2.16.840.1.113883.3.88.12.80.62
DYNAMIC) (CONF:7301).
Table 159 - Example of Program Extension of CDA Constraints
In this example, if a program does not wish to capture detailed vital sign observations, it may only
require the Vital Signs section and not require specific entries. This would mean relaxing the Vital Sign
Organizer and Vital Sign Observation constraints.
A program may also decide to require elements such as the target site for where the vital sign was
captured from, or an interpretation code, in which case, the program may author an implementation
guide that specifically uses SHALL to require this element, and constrains it using a value set.
Lastly, a program may take a specific value set constraint (such as the HITSP Vital Sign Result Type value
set requirement) and constrain to a different value set (such as one specific to a program) whereby a
different set of vital sign result types may be used.
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Appendix A: Interoperability Standards for Participating Public Health
Domains
The following table describes interoperability standards developed to support public health reporting
within specific domains. These standards were referenced to inform the development of this template
library document.
Reference Name
Implementation Guide
for Ambulatory
Healthcare Provider
Reporting to Central
Cancer Registries August
2012
Location
Cancer
http://www.cdc.gov/phin/library/gui
des/Implementation_Guide_for_Amb
ulatory_Healthcare_Provider_Reporti
ng_to_Central_Cancer_Registries_Au
gust_2012.pdf
IHE Maternal Health
Profiles
Vital Records
http://wiki.ihe.net/index.php?title=P
rofiles#IHE_Patient_Care_Coordinati
on_Profiles
IHE Immunization
Content Profile
Immunization
http://wiki.ihe.net/index.php?title=P
rofiles#IHE_Patient_Care_Coordinati
on_Profiles
HL7 Immunization
Domain Analysis Model
(DAM)
IHE Quality, Research
and Public Health
Technical Framework
Supplement
Quality Measure
Execution–Early Hearing
(QME-EH)
Trial Implementation
IHE Quality, Research
and Public Health
Technical Framework
Supplement
Early Hearing Care Plan
(EHCP)
How this reference was used in
development of the Public Health
Reporting Specification
The Cancer reporting guide is a
foundational document for the
reporting of cancer data and is used
as a source for several templates
within this specification
The IHE Maternal Health and
Newborn profiles were used to
support development of the Child
Health Domain.
The IHE – Immunization Content
Profile was used to support the
development of the Immunization
Domain
http://wiki.siframework.org/file/view The HL7 Immunization DAM is used
/HL7+Immunization+Domain+Analysi to help develop the immunization
s+Model.docx
Domain
Early Hearing Detection and Intervention
www.ihe.net/Technical_Framework/ QRDA document for quality measure
upload/IHE_QRPH_Suppl_QMEreporting
EH.pdf
www.ihe.net/Technical_Framework/
upload/IHE_QRPH_Suppl_EHCP_Rev1
-1_TI_2011-09-02.pdf
Content profile that contains data
related to patient demographics,
newborn hearing information, and
care plan
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Reference Name
Location
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
How this reference was used in
development of the Public Health
Reporting Specification
Trial Implementation
Healthcare Associated Infections (HAI)
HL7 Implementation
To be finalized as link to HL7 ballot
Guide for CDA Release 2: site
Healthcare Associated
Infection (HAI) Reports,
DSTU Release 8 (US
Realm)
Table 160 - Interoperability Standards for Participating Public Health Domains
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Appendix B: Reference Documents
The reference documents used in the creation of this template library are included below.
Reference Name
Location
Implementation Guide
for CDA Release 2.0
Consolidated CDA
Templates (US Realm)
HL7 Implementation
Guide: CDA Release 2 –
Continuity of Care
Document (CCD)
CSTE Recommendation
ISDS Recommendation –
Syndromic Surveillance
HITSP C83 Content
Modules
How this reference was used in
development of the Public Health
Reporting Specification
The base reference standard used to
define many of the sections and
entries included in this specification
CCD templates are also referenced
within this specification.
http://www.syndromic.org/uploads/f
iles/ISDSRecommendationPRELIMINARY_EHRDataReq4SS_vFIN
ALerratum-r2.pdf
http://wiki.hitsp.org/docs/C83/C831.html
Federal Health
Information Model
(FHIM)
http://www.fhims.org
S&I Framework Public
Health Reporting Use
Case
http://wiki.siframework.org/file/view
/PHRI+Use+Case.docx
The CSTE recommendations were
used to support development of the
Communicable Disease Domain
The ISDS recommendations were
used to support development of the
Communicable Disease Domain
HITSP C83 CDA Content Modules
were used as a reference source to
ensure alignment of this Data
Harmonization Profile to work done
within HITSP in developing HITSP
components in support of many of
the concepts expressed here.
The FHIM is the primary mechanism
for implementation alignment of
this Data Harmonization Profile to
possible implementation standards
The S&I Framework Public Health
Reporting Use Case serves as the
primary source of requirements for
this Data Harmonization Profile.
S&I Framework Data
Harmonization Profile
Table 161 - References
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Appendix C: Definitions and Acronyms
Acronym or Term
AIRA
CCD
CCDA
CDA
CMS
CSTE
CVX
DAM
DNDHI
DRVS
DSTU
EHCP
EHDI
EHR
EMR
FDA
FHIM
FMT
HAI
HCP
HIE
HIPAA
HIT
HITECH Act
HITSP
HL7
IG
IHE
IHTSDO
IP
IS
ISDS
JCIH
LIO
LIS
MDHT
MU
MVX
NCBDDD
NCCDPHP
Definition/Description
American Immunization Registry Association
Continuity of Care Documents
Consolidated CDA
Clinical Document Architecture
Content Management System
Council of State and Territorial Epidemiologists
HL7 Table 0292, Vaccine Administered (CVX)
Domain Analysis Model
Division of Notifiable Diseases and Healthcare Information
Data Research and Vital Statistics
Draft Standard for Trial Use
Easy Hosting Control Panel
Early Hearing Detection and Intervention
Electronic Health Record
Electronic Medical Record
Food and Drug Administration
Federal Health Information Model
Federal Medication Terminology
Healthcare Associated Infections
Healthcare Provider
Health Information Exchange
Health Insurance Portability and Accountability Act
Health information technology
Health Information Technology for Economic and Clinical Health Act of 2009
Health Information Technology Standards Panel
Health Level 7
Implementation Guide
Integrating the Healthcare Enterprise
Health Terminology Standards Development Organization
Intellectual Property
Information System
International Society for Disease Surveillance
Joint Committee on Infant Hearing
Laboratory Identified Organism
Laboratory Information System
Model Driven Health Tools
Meaningful Use
HL7 Table 0227, Manufacturers of Vaccines (MVX)
National Center for Birth Defects and Developmental Disabilities
National Center for Chronic Disease Prevention and Health Promotion
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Acronym or Term
NCHS
NICU
NIOSH
NwHIN
OID
ONC
PCC
PHCR
PHDSC
PHER
PH-IS
PHRI
QME
QRDA
RFC
RIM
RMIM
S&I Framework
SDOs
SDWG
UCUM
UNII
VIS
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Definition/Description
National Center for Health Statistics
Neonatal Intensive Care Unit
National Institute for Occupational Safety and Health
Nationwide Health Information Network
Object Identifier
Office of the National Coordinator for Health Information Technology
Patient Care Coordination
Public Health Clinicians and Researchers
Public Health Data Standards Consortium
Public Health and Emergency Response
Public Health Information Systems
Public Health Reporting Initiative
Qualified Medical Evaluation
Quality Reporting Document Architecture
Request for Comments
Reference Information Model
Refined Message Information Model
Standards & Interoperability Framework
Standards Development Organizations
Structured Documents Working Group
Unified Code for Units of Measure
Unique Ingredient Identifier
Vaccine Information Statement
Table 162 - Definitions and Acronyms
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Appendix D: Recommended Value Sets and Vocabulary Summary
This section contains a summary list of all value sets and vocabularies used in establishing the Public
Health Reporting Specification - CDA.
Core Common
Allergy/Adverse Event
Allergy/Adverse Event
Allergy/Adverse Event
Diagnosis (Health
Problem)
Diagnosis (Health
Problem)
Diagnosis (Health
Problem)
Employment
Information
Employment
Information
Employment
Information
Encounter
Exposure
Facility
Facility
Family History
Family History
Family History
Family History
Family History
Immunization
Immunization
Immunization
Medication
Medication
Medication
Medication
Medication
Order/Diagnostic Test
Patient Contact
Information
Value Set Name
Allergy/Adverse Event Type
Allergy Severity
Problem Status
Value Set OID
2.16.840.1.113883.3.88.12.3221.6.2
2.16.840.1.114222.4.11.807
2.16.840.1.113883.3.88.12.80.68
HL7ActRelationshipType
2.16.840.1.113883.5.1002
HITSP Problem Status
2.16.840.1.113883.3.88.12.80.68
Problem Type
2.16.840.1.113883.3.88.12.3221.7.2
Social History Type
2.16.840.1.113883.3.88.12.80.60
Census Occupation Code
2.16.840.1.113883.6.240
Census Industry Code
Encounter Type
None
Healthcare Service Delivery Location
JCIH-EHDI NICU Service Delivery
Location
PHVS_Race_CDC
PHVS_Ethnicity_CDC
PHVS_RaceCategory_CDC
PHVS_EthnicityGroup_CDC
PHVS_Gender_SyndromicSurveillance
PHVS_VaccinationReaction
PHVS_ImmunizationBodySite_CDC
PHVS_ManufacturersOfVaccinesMVX_
CDC_NIP
Medication Clinical Drug
Medication Drug Class
Medication Route
Medication Body Site
2.16.840.1.113883.6.310
2.16.840.1.113883.3.88.12.80.32
None
2.16.840.1.113883.1.11.20275
1.3.6.1.4.1.19376.1.7.3.1.1.15.2.13
2.16.840.1.114222.4.11.876
2.16.840.1.114222.4.11.877
2.16.840.1.114222.4.11.836
2.16.840.1.114222.4.11.837
2.16.840.1.114222.4.11.3403
2.16.840.1.114222.4.11.3289
2.16.840.1.114222.4.11.3023
Medication Product Form
None
2.16.840.1.114222.4.11.826
2.16.840.1.113883.3.88.12.80.17
2.16.840.1.113883.3.88.12.80.18
2.16.840.1.113883.3.88.12.3221.8.7
2.16.840.1.113883.3.88.12.3221.8.9
2.16.840.1.113883.3.88.12.3221.8.1
1
None
HL7 Role Class
2.16.840.1.113883.11.20.9.33
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Core Common
Patient Information
Patient Information
Patient Information
Patient Information
Patient Information
Patient Information
Patient Information
Patient Information
Patient Information
Payer Information
PHCR Clinical
Information
PHCR Treatment
Information
Physical Exam
Procedure
Procedure
Procedure
Provider Information
Result
Social History
Specimen
Specimen
Vital Sign Indicators
Standards & Interoperability Framework
Public Health Reporting Specification - CDA
Value Set Name
Value Set OID
HL7 Marital Status
2.16.840.1.113883.1.11.12212
PHVS_Race_CDC
2.16.840.1.114222.4.11.876
PHVS_Ethnicity_CDC
2.16.840.1.114222.4.11.877
PHVS_RaceCategory_CDC
2.16.840.1.114222.4.11.836
PHVS_EthnicityGroup_CDC
2.16.840.1.114222.4.11.837
PHVS_Language_ISO_639-2_Alpha3
2.16.840.1.114222.4.11.831
Telecom Use
2.16.840.1.113883.11.20.9.20
Language
2.16.840.1.113883.1.11.11526
PHVS_Gender_SyndromicSurveillance 2.16.840.1.114222.4.11.3403
PHVS_SourceOfPaymentTypology_PH
DSC
2.16.840.1.114222.4.11.3591
None
None
None
None
MCH HBS Significant Birth Injury
Non-Laboratory Intervention and
Procedure
MCH HBS Seizure or Serious
Neurologic Dysfunction
Provider Type
Result Status
PHVS_SocialHistoryType_HITSP
PHVS_BodySite_CDC
PHVS_Specimen_CDC
Vital Sign Result Type
None
None
1.3.6.1.4.1.19376.1.7.3.1.1.13.8.9
2.16.840.1.114222.4.11.3204
1.3.6.1.4.1.19376.1.7.3.1.1.13.8.10
2.16.840.1.113883.3.88.12.3221.4
2.16.840.1.113883.11.20.9.39
2.16.840.1.113883.3.88.12.80.60
2.16.840.1.114222.4.11.967
2.16.840.1.114222.4.11.946
2.16.840.1.113883.3.88.12.80.62
Table 163 - Recommended Value Sets and Vocabulary Summary
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Appendix E: Next Steps for PHRI
There are several steps defined for PHRI over the next 6-12 months, which are summarized in this
section.




Preparation for submission to HL7 Ballot
Detailed work on implementation guidance for reportable conditions
Detailed work to finalize any enhancements or changes to templates within the library
Identify any additional templates that are not included in the template library
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