Michigan Birth Defect Registry

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Report Title Here

Report Subtitle Here

Date

Michigan Birth

Defect Registry

Implementation Guide for Ambulatory

Healthcare Provider Reporting to Central

Birth Defect Registries, HL7 Clinical

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Version 1.2

G. Copeland, R. Humphrys, R. Kommareddi, R. May-Gentile, L. Rappleye, L. Simmons

Michigan Birth

Defect Registry

Implementation Guide for Ambulatory

Healthcare Provider Reporting to Central Birth

Defect Registries, HL7 Clinical Document

Architecture (CDA)

August, 2015

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Table of Contents

Table of Contents ... i

List of Figures ... iv

List of Tables ... v

Preface ...x

1.0

Introduction ... 1

1.1

Background ... 1

1.2

Legal Mandate for Michigan Birth Defects Reporting ... 2

1.2.1

Public Health Code as Amended ... 2

1.2.2

Data ... 2

1.2.3

Rules ... 2

1.3

Purpose... 3

1.4

Audience ... 3

1.5

Scope ... 3

1.6

Use Case, Scenarios, Diagrams ... 3

1.6.1

Scenario ... 3

1.6.2

Use Case Overview ... 4

1.7

Use of Vocabulary Standards... 7

1.8

HIPAA ... 7

1.9

Clinical Document Architecture Release 2 (CDA R2) ... 7

2.0

Ambulatory Healthcare Provider Birth Defects Report ... 9

2.1

Document Constraints ... 9

2.2

Parent Template ... 10

2.3

Specification ... 10

2.4

Birth Defects Header ... 10

2.5

Conventions Used in this Guide ... 11

2.5.1

Conformance (Optionality Constraints) ... 11

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2.7

Null Flavor ... 12

2.8

Birth Defects Specification Table ... 13

2.9

Organization of Implementation Guide ... 21

2.9.1

Conventions ... 21

2.9.2

Document Content Module ... 21

2.9.3

Sections ... 21

2.9.4

Entry Content ... 21

2.9.5

Vocabulary and Value Sets ... 21

2.10

Vocabulary Conformance ... 21

2.11

CDA Header Section Value Sets ... 22

2.11.1

Marital Status ... 22

2.11.2

Religious Affiliation ... 22

2.11.3

Race ... 24

2.11.4

Ethinicity ... 44

2.11.5

Personal Relation Role Type ... 44

2.11.6

Guardian ... 47

3.0

Document Level Templates ... 48

3.1

U.S. Realm Header ... 48

3.2

CDA Header Content Modules ... 49

3.3

Participants in Birth Defects Header ... 50

3.3.1

Record Target ... 50

3.3.2

Patient ... 51

3.3.3

Patient Contacts ... 52

3.3.4

Information Recipient ... 52

3.3.5

Address Constraints ... 53

3.3.6

Multiple Races ... 54

3.3.7

Provider Referred From ... 54

3.3.8

Birthplace ... 55

4.0

Section Level Templates ... 56

4.1

Birth Defect Diagnosis Section ... 56

4.1.1

Birth Defect Diagnosis Entry ... 57

4.2

Coded Results Section ... 61

4.2.1

Simple Observation Constraints Overview ... 62

4.3

Payers Section ... 64

4.3.1

Payer Type Vocabularies ... 65

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4.3.3

Payor Role Code Names ... 66

4.4

Cytogenetics Section ... 66

4.4.1

Genetic Testing Report ... 66

4.4.2

Clinical Genomic Statement Cytogenetics ... 67

4.4.3

Associated Observation Cells Analyzed Count ... 70

4.4.4

Associated Observation Cells Count ... 70

4.4.5

Associated Observation Cells Karyotyped Count ... 70

4.4.6

Associated Observation Colonies Count ... 71

4.4.7

Associated Observation International System for Human Cytogenetic

Nomenclature (ISCN) Band Level... 71

4.4.8

Chromosome Analysis Overall Interpretation ... 73

4.5

Labor and Delivery History and Physical ... 73

4.5.1

Pregnancy History Section ... 74

4.5.2

Social History Section ... 101

4.6

Labor and Delivery Events Section ... 103

4.6.1

Coded Detailed Physical Examination... 105

4.6.2

Procedures and Interventions ... 106

4.6.3

Coded Event Outcomes ... 134

4.6.4

Medications Administered ... 153

4.7

Newborn Delivery ... 167

4.7.1

Newborn Delivery Information Section... 167

4.7.2

Coded Detailed Physical Examination Section ... 169

4.7.3

Active Problems ... 175

4.7.4

Procedures and Interventions ... 179

4.7.5

Medications Administered ... 186

4.7.6

Coded Event Outcomes ... 192

4.8

Care Plan Section ... 200

4.9

Disposition Section ... 204

Appendix A – Reportable Birth Defect Conditions ... 1

Appendix B – Value Sets ... 4

Appendix C – Data Element and CDA Element Relationship Table ... 119

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List of Figures

Figure 1-1: Birth Defect Sequence Diagram ... 6

Figure 2-1: Birth Defects Header - Subject Type Code ... 10

Figure 2-2: Birth Defect Header – Participant Code Type ... 11

Figure 2-3: nullFlavor Examples ... 12

Figure 2-4: nullFlavor attribute required Example ... 13

Figure 2-5: Allowed nullFlavors when element is required example ... 13

Figure 2-6: nullFlavor explicitly disallowed example ... 13

Figure 2-7: Ambulatory Healthcare Provider Birth Defect Event Report Document Example ... 19

Figure 3-1: Example of a US Realm Header ... 49

Figure 3-2: Patient Contacts Example ... 52

Figure 3-3: Information Recipient Example ... 53

Figure 3-4: Address Example ... 54

Figure 3-5: sdtc:raceCode Example ... 54

Figure 3-6: Provider Referred From Example ... 55

Figure 3-7: Birthplace Example ... 55

Figure 4-1: Birth Defects Diagnosis Section Example ... 57

Figure 4-2: Birth Defects Diagnosis Template Example ... 60

Figure 4-3: Coded Results Section Example ... 61

Figure 4-4: Figure Simple Observation Example ... 64

Figure 4-5: Payers Section Example ... 65

Figure 4-6: Genetic Testing Report Example ... 67

Figure 4-7: Clinical Genomic Example ... 68

Figure 4-8: History of Pregnancies Example ... 75

Figure 4-9: Coded Social History Section Example ... 101

Figure 4-10: Labor and Delivery Events Section Example ... 104

Figure 4-11: Newborn Delivery Section Example ... 168

Figure 4-12: Active Problems Section Example ... 176

Figure 4-13: Procedures and Interventions Section Example... 179

Figure 4-14: Procedure Entry Example ... 179

Figure 4-15: Medications Administered Section Example ... 186

Figure 4-16: Care Plan Section Example ... 202

Figure 4-17: Encounter Entry Example ... 204

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List of Tables

Table 1-1:

Prepare and Transport Ambulatory Healthcare Provider Birth Defect Report for Michigan

Birth Defects Registry ... 5

Table 1-2: Use Case Flow ... 6

Table 2-1: Document Specification Table ... 13

Table 2-2: Marital Status Value Set ... 22

Table 2-3: Religious Affiliation Value Set ... 22

Table 2-4: Race Value Set ... 24

Table 2-5: Ethnicity Value Set ... 44

Table 2-6: Personal Relationship Role Type Value Set ... 44

Table 2-7: Guardian Value Set ... 47

Table 3-1: CDA Header Constraints ... 50

Table 3-2: Participants in Birth Defects Header ... 50

Table 4-1: Birth Defects Diagnosis Section ... 56

Table 4-2: Birth Defects Diagnosis Entry Template ... 58

Table 4-3: Coded Results Section ... 61

Table 4-4: Simple Observation Constraints Overview ... 62

Table 4-5: Payers Section ... 64

Table 4-6: Payer Type Vocabularies ... 65

Table 4-7: Payor Role Codes ... 66

Table 4-8: Role Code Names ... 66

Table 4-9: Cytogenetics Procedure Type Codes ... 72

Table 4-10: Chromosome Analysis Codes ... 73

Table 4-11: Labor and Delivery History and Physical Section ... 73

Table 4-12: Pregnancy History Section ... 74

Table 4-13: Pregnancy Observation Value Set... 75

Table 4-14: Pregnancy Observation Value Sets ... 75

Table 4-15: MCH HBS Date of Last Live Birth Metadata ... 77

Table 4-16: MCH HBS Date of Last Live Birth Value Set ... 78

Table 4-17: MCH HBS Date of Last Other Pregnancy Outcome Metadata ... 78

Table 4-18: MCH HBS Date of Last Other Pregnancy Outcome ... 79

Table 4-19: MCH HBS Number of Prior Pregnancies Metadata ... 79

Table 4-20: MCH HBS Number of Prior Pregnancies Value Set ... 80

Table 4-21: MCH HBS Number of Previous Live Births Now Living Metadata ... 80

Table 4-22: MCH HBS Number of Previous Live Births Now Living Value Set ... 81

Table 4-23: MCH HBS Number of Previous Live Births Now Dead Metadata ... 81

Table 4-24: MCH HBS Number of Previous Live Births Now Dead Value Set ... 82

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Table 4-26: BFDR Number of Preterm Births Value Set ... 83

Table 4-27: MCH HBS Poor Pregnancy Outcome History Metadata ... 84

Table 4-28: MCH HBS Poor Pregnancy Outcome History Value Set ... 84

Table 4-29: Maternal Risk Factors Value Set ... 85

Table 4-30: MCH HBS First Prenatal Care Visit Metadata ... 87

Table 4-31: MCH HBS First Prenatal Care Visit Value Set ... 87

Table 4-32: MCH HBS Last Prenatal Care Visit Metadata ... 88

Table 4-33: MCH HBS Last Prenatal Care Visit Value Set ... 88

Table 4-34: MCH HBS Number of Prenatal Care Visits Metadata... 89

Table 4-35: MCH HBS Number Prenatal Care Visits Value Set ... 90

Table 4-36: MCH HBS Pre-Pregnancy Weight Metadata ... 90

Table 4-37: MCH HBS Pre-Pregnancy Weight Value Set ... 91

Table 4-38: BFDR Date of Last Menses Metadata ... 91

Table 4-39: BFDR Date of Last Menses Value Set... 92

Table 4-40: BFDR Infertility Treatment Metadata ... 93

Table 4-41: BFDR Infertility Treatment Value Set ... 93

Table 4-42: BFDR Assistive Reproductive Technology Metadata ... 94

Table 4-43: BFDR Assistive Reproductive Technology Value Set ... 95

Table 4-44: BFDR Fertility Enhancing Drugs Metadata ... 96

Table 4-45: BFDR Fertility Enhancing Drugs Value Set ... 97

Table 4-46: BFDR Obstetric Estimate of Gestation Metadata ... 100

Table 4-47: BFDR Obstetric Estimate of Gestation

Value Set ... 101

Table 4-48: Coded Social History Section ... 101

Table 4-49: Coded Social History Observation Value Set ... 102

Table 4-50: Labor and Delivery Events Section ... 103

Table 4-51: Labor and Delivery Coded Detailed Physical Examination Value Set ... 105

Table 4-52: BFDR Mother’s Delivery Weight Metadata ... 105

Table 4-53: BFDR Mother’s Delivery Weight Value Set ... 106

Table 4-54: Labor and Delivery Procedures and Interventions Value Sets ... 106

Table 4-55: BFDR Unplanned Hysterectomy Metadata ... 107

Table 4-56: BFDR Unplanned Hysterectomy Value Set ... 108

Table 4-57: BFDR Facility Location OR Metadata ... 109

Table 4-58: BFDR Facility Location OR Value Set ... 109

Table 4-59: BFDR Delivery Metadata ... 110

Table 4-60: BFDR Delivery Value Set ... 111

Table 4-61: BFDR Unplanned Operation Metadata ... 113

Table 4-62: BFDR Unplanned Operation Value Set ... 114

Table 4-63: BFDR Transfusion Whole Blood or Packed Red Blood Metadata ... 115

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Table 4-65: BFDR Epidural Anesthesia – Procedure Metadata ... 116

Table 4-66: BFDR Epidural Anesthesia – Procedure Value Set ... 117

Table 4-67: BFDR Spinal Anesthesia – Procedure Metadata ... 118

Table 4-68: BFDR Spinal Anesthesia – Procedure Value Set ... 119

Table 4-69: BFDR Route and Method of Delivery – Spontaneous Delivery Metadata ... 120

Table 4-70:

BFDR Route and Method of Delivery – Spontaneous Delivery Value Set ... 120

Table 4-71: BFDR Route and Method of Delivery – Forceps Metadata ... 121

Table 4-72: BFDR Route and Method of Delivery – Forceps Value Set ... 122

Table 4-73: BFDR Route and Method of Delivery – Vacuum Metadata ... 123

Table 4-74: BFDR Route and Method of Delivery – Vacuum Value Set ... 124

Table 4-75: BFDR Route and Method of Delivery – Cesarean Metadata ... 125

Table 4-76: BFDR Route and Method of Delivery – Cesarean Value Set ... 126

Table 4-77: BFDR Route and Method of Delivery – Trial of Labor Metadata ... 127

Table 4-78: BFDR Route and Method of Delivery – Trial of Labor Value Set ... 127

Table 4-79: BFDR Route and Method of Delivery – Scheduled Cesarean Metadata ... 128

Table 4-80: BFDR Route and Method of Delivery – Scheduled Cesarean Value Set ... 128

Table 4-81: BFDR Augmentation of Labor – Procedure Metadata ... 129

Table 4-82: BFDR Augmentation of Labor – Procedure Value Set ... 130

Table 4-83: BFDR Induction of Labor Metadata ... 130

Table 4-84: BFDR Induction of Labor Value Set ... 131

Table 4-85: BFDR Cervical Cerclage Metadata ... 132

Table 4-86: BFDR Cervical Cerclage Value Set ... 132

Table 4-87: BFDR Tocolysis Metadata ... 133

Table 4-88: BFDR Tocolysis Value Set ... 134

Table 4-89: Labor and Delivery Coded Event Outcome Value Sets ... 134

Table 4-90: MCH HBS Number of Live Births Metadata ... 135

Table 4-91: MCH HBS Number of Live Births Value Set ... 136

Table 4-92: Pregnancy Outcome Value Set ... 136

Table 4-93: BFDR Birth Plurality of Delivery Metadata ... 137

Table 4-94: BFDR Birth Plurality of Delivery Value Set ... 137

Table 4-95: BFDR Fetal Presentation at Birth- Breech Metadata ... 138

Table 4-96: BFDR Fetal Presentation at Birth- Breech Value Set ... 138

Table 4-97: BFDR Fetal Presentation at Birth- Cephalic Metadata ... 139

Table 4-98: BFDR Fetal Presentation at Birth- Cephalic Value Set ... 140

Table 4-99: BFDR Fetal Presentation at Birth- Other Metadata ... 141

Table 4-100: BFDR Fetal Presentation at Birth- Other Value Set ... 142

Table 4-101: BFDR ICU Care Metadata ... 143

Table 4-102: BFDR ICU Care Value Set ... 144

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Table 4-104: BFDR Third Degree Perineal Laceration Value Set ... 145

Table 4-105: BFDR Fourth Degree Perineal Laceration Metadata ... 145

Table 4-106: BFDR Fourth Degree Perineal Laceration Value Set ... 146

Table 4-107: BFDR Ruptured Uterus Metadata ... 147

Table 4-108: BFDR Ruptured Uterus Value Set ... 147

Table 4-109: Meconium Staining Metadata ... 148

Table 4-110: Meconium Staining Value Set ... 149

Table 4-111: BFDR Premature Rupture Metadata ... 149

Table 4-112: BFDR Premature Rupture Value Set ... 150

Table 4-113: Precipitous Labor Metadata ... 151

Table 4-114: Precipitous Labor Value Set ... 151

Table 4-115: Prolonged Labor Metadata ... 152

Table 4-116: Prolonged Labor Value Set ... 153

Table 4-117: Labor and Delivery Medications Administered Value Set ... 153

Table 4-118: BFDR Antibiotics Metadata... 154

Table 4-119: BFDR Antibiotics Value Set ... 155

Table 4-120: BFDR Glucocortico Steroids Metadata ... 159

Table 4-121: BFDR Glucocortico Steroids Value Set ... 160

Table 4-122: BFDR Augmentation of Labor - Medication Metadata ... 161

Table 4-123: BFDR Augmentation of Labor - Medication Value Set ... 162

Table 4-124: BFDR Epidural Anesthesia – Medication Metadata ... 162

Table 4-125: BFDR Epidural Anesthesia – Medication Value Set ... 163

Table 4-126: BFDR Spinal Anesthesia – Medication Metadata ... 164

Table 4-127: BFDR Spinal Anesthesia – Medication Value Set ... 165

Table 4-128: Newborn Delivery Information Section ... 167

Table 4-129: Coded Detailed Physical Examination Section ... 169

Table 4-130: Newborn Coded Vital Signs Value Set ... 170

Table 4-131: MCH HBS Birth Weight Metadata ... 170

Table 4-132: MCH HBS Birth Weight Value Set ... 171

Table 4-133: MCH HBS Birth Height Metadata ... 171

Table 4-134: MCH HBS Birth Height Value Set ... 172

Table 4-135: Newborn General Appearance Value Set ... 172

Table 4-136: MCH HBS 5 Min Apgar Score Metadata ... 173

Table 4-137: MCH HBS 5 Min Apgar Score Value Set ... 173

Table 4-138: MCH HBS 10 Min Apgar Score Codes ... 174

Table 4-139: MCH HBS 10 Min Apgar Score Value Set ... 174

Table 4-140: Active Problems Section ... 175

Table 4-141: Newborn Delivery Information Active Problems Value Sets ... 176

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Table 4-143: MCH HBS Seizure or Serious Neurologic Dysfunction Value Set ... 177

Table 4-144: Procedures and Interventions ... 179

Table 4-145: Newborn Delivery Information Procedures and Interventions Value Sets ... 180

Table 4-146: MCH HBS Antibiotic Administration Procedure Metadata ... 181

Table 4-147: MCH HBS Antibiotic Administration Procedure Value Set ... 181

Table 4-148: MCH HBS Karyotype Determination Metadata ... 182

Table 4-149: MCH HBS Karyotype Determination Value Set ... 183

Table 4-150: MCH HBS Assisted Ventilation Immediately Following Delivery Metadata ... 183

Table 4-151: MCH HBS Assisted Ventilation Immediately Following Delivery Value Set ... 184

Table 4-152: BFDR Total Time on Ventilator Metadata ... 184

Table 4-153: BFDR Total Time on Ventilator Value Set ... 185

Table 4-154: Medications Administered Section ... 186

Table 4-155: Newborn Delivery Medications Administered Product Value Sets ... 187

Table 4-156: BFDR Newborn Receiving Surfactant Replacement Therapy Metadata ... 187

Table 4-157: BFDR Newborn Receiving Surfactant Replacement Therapy Value Set ... 188

Table

4-158: MCH HBS Intramuscular Medication Administration Route Metadata ... 189

Table 4-159: MCH HBS Intramuscular Administration Route Value Set ... 189

Table 4-160: BFDR IV Medication Administration Metadata ... 190

Table 4-161: BFDR IV Medication Administration Route Value Set ... 191

Table 4-162: BFDR Neonatal Sepsis Metadata ... 191

Table 4-163: BFDR Neonatal Sepsis Value Set ... 192

Table 4-164: Newborn Delivery Information Coded Event Outcome Value Sets ... 192

Table 4-165: BFDR NICU Care Codes ... 193

Table 4-166: BFDR NICU Care Value Set ... 194

Table 4-167: MCH HBS Significant Birth Injury Value Set Metadata ... 194

Table 4-168: MCH HBS Significant Birth Injury Value Set ... 195

Table 4-169: BFDR Birthplace Value Set Metadata ... 197

Table 4-170: BFDR Birthplace Value Set ... 198

Table 4-171: Cause of Death Codes Metadata ... 199

Table 4-172: Cause of Death Value Set Excerpt ... 200

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Preface

The Michigan Department of Health and Human Services (MDHHS) is supporting eligible

professionals meet the

Stage 2 Meaningful Use Specialized Registry Objective: Capability to Identify

and Report Specific Cases to a Specialized Registry

. Michigan’s birth defect registry will be

accepting birth defect case information in accordance to this implementation guide. For more

information on Michigan’s process to submit birth defect case reports to meet the specialized registry

objective, please contact Laura Rappleye at [email protected].

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1.0

Introduction

Birth defects are a serious public health problem across the nation. Every 4 ½

minutes, a baby is born with a major birth defect in the United States. Major birth

defects are conditions present at birth that cause structural changes in one or more

parts of the body. They can have a serious effect on health, development, or

functional ability.

About one in every 33 babies is born with a birth defect. Birth defects are a leading

cause of infant death, accounting for more than 1 of every 5 infant deaths. In

addition, babies born with birth defects have a greater chance of illness and long

term disability than babies without birth defects. Birth defects contribute

significantly to childhood mortality, morbidity, and long-term disability. Despite

the prevalence of birth defects, the reporting of them is lacking.

As ambulatory healthcare providers adopt modern electronic health record (EHR)

systems, the opportunity to automate and improve birth defect registry reporting is

increasing and becoming more feasible. This document provides clear and concise

specifications for electronic reporting from ambulatory healthcare provider EHR

systems to central birth defect registries) using Health Level Seven (HL7) Clinical

Document Architecture (CDA) based standards. This document is designed to

guide EHR vendors and public health central birth defect registries in the

implementation of standardized electronic reporting. It includes both business rules

and standardized specifications.

1.1

Background

In 1992, the Michigan Department of Health and Human Services (MDHHS),

Division of Vital Records and Health Statistics established the Michigan Birth

Defects Registry (MBDR). The MBDR is a confidential and secure registry that

relies on reports submitted by all Michigan hospitals and cytogenetic laboratories.

In addition to hospitals and cytogenetic laboratories, outpatient pediatric genetic

clinics, and other facilities, may report birth defects.

The MBDR maintains a file of case reports on children from birth to two years of

age born in Michigan or to Michigan residents and diagnosed with a reportable

condition in the state of Michigan. About 10,000 Michigan children are born

annually with birth defects or other reportable conditions. As of 2013, the MBDR

contains over 638,000 reports on more than 307,000 individual children born from

1992 to 2012 with statistical data on the prevalence of birth defects available

through the state website

1

. Epidemiology and vital records staff analyze registry

data and conduct special studies to better understand the impact of birth defects on

public health.

1_{Michigan Department of Health and Human Services, Birth Defects. January 15, 2014. Website:}

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The registry enables the collection and development of statistical data on birth

defects; surveillance of birth defects; studies of birth defect causes and prevention;

and ensures the families of children with birth defects receive appropriate support

services. Specifically, the MBDR provides the information needed to compute

baseline birth defects incidence and mortality rates and analyze trends; identify and

respond to potential clusters; formulate and test hypotheses of causation; plan and

develop relevant programs; coordinate assistance for long-term care and follow up;

evaluate programs and services; and further educate professionals and the

community at large.

These activities improve the knowledge concerning the prevention of birth defects

and to assure that Michigan children with birth defects have access to available

resources and assistance. The ability to meet these goals is largely dependent on the

successful functioning of a statewide registry and the quality of the data collected.

1.2

Legal Mandate for Michigan Birth Defects Reporting

1.2.1

Public Health Code as Amended

The MBDR was established as part of the Public Health Code (Act 368 of 1978) by

amending sections 5721 and 5805. Section 5721 of Part 57 stipulates that "(1) Each

diagnosed incidence of a birth defect, including a congenital or structural

malformation, or a biochemical or genetic disease, and any information relevant to

incidents of birth defects, shall be reported to the department. (2) The department

shall maintain comprehensive statewide records of all information reported to the

birth defects registry." The Rules governing reporting, the quality, manner,

collection and analysis of the data, and confidentiality regulations are proscribed by

the Code and the legislation. Confidentiality of all data is required by law and

strictly maintained by the Health Department staff. Section 2631 of the Public

Health Code regulates procedures protecting confidentiality and regulating

disclosure of data and records.

1.2.2

Data

The MBDR maintains a file of case reports on children diagnosed with a reportable

condition at birth through two years of age who were born in Michigan or to a

Michigan resident mother. This information is reported to the Registry by hospitals,

cytology laboratories, genetics counselors, physicians and others as is authorized

by Public Act 236 of 1988 which amended the Public Health Code, Act 368 of

1978. The Act directs the Michigan Department of Health and Human Services to

establish a comprehensive birth defects registry. The amendment is aimed at

improving statewide identification of children with birth defects and facilitating the

assessment of service and referral needs for these children.

1.2.3

Rules

The Michigan Birth Defects reporting rules, R 325.9071-9076, define a reportable

defect as "an abnormality of the body's structure or inherent function present at

birth, whether the abnormality is detected at the time of delivery or becomes

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apparent at a later date." A registrant is defined as "a child age birth to 2 years who

is diagnosed with a reportable birth defect in the state of Michigan." In addition,

the rules authorize the Director of the MDHHS to designate case reporting for

specific conditions up to the age of 12 years to assure complete case ascertainment.

The reports are required for children in an inpatient or outpatient setting or

diagnosed by clinical laboratories conducting cytogenetic tests or postmortem

examinations. R 325.9072 identifies reportable defects. Reports are to be submitted

within 30 days of diagnosis on the confidential Birth Defects Registry report forms

provided by the Department of Community Health or by electronic media.

1.3

Purpose

This Implementation Guide (IG) contains the necessary specifications for the

implementation of standardized data transmissions from an ambulatory healthcare

provider EHR to the MBDR. A single standardized method will allow efficient and

accurate transmission of birth defects information while reducing the burden on

EHR system-specific or registry-specific implementations.

1.4

Audience

This IG is designed to provide EHR vendors with the specifications for developing

the functionality of the EHR systems used by ambulatory healthcare providers to

report information on birth defects patients to the MBDR. The IG may also be

informative to ambulatory healthcare providers, MBDR staff, developers, analysts

and managers of public health information systems and/or data exchanges. This IG

is not intended for use for implementation of birth defects reporting from entities

other than ambulatory care settings.

1.5

Scope

This IG is intended to provide EHR developers and birth defect registry technical

staff with the operational context for use of the ambulatory care electronic birth

defect reporting.

1.6

Use Case, Scenarios, Diagrams

1.6.1

Scenario

There are a variety of scenarios in which a patient encounter includes activities

related to birth defects, including diagnosis, referral, treatment, and follow-up. For

purposes of this document, an encounter is defined as an interaction between a

patient and an ambulatory setting for the purpose of providing healthcare-related

service(s). The Use Case is triggered every time the encounter’s diagnosis is a birth

defect.

Scenario: Ambulatory Care Electronic Birth Defect Reporting to a Birth Defect

Registry

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User Story Summary: Of the more than 4 million infants born each year in the

United States, approximately 120,000 have birth defects. Major birth defects are

conditions that: 1) result from a malformation, deformation, or disruption in one or

more parts of the body; 2) are present at birth; and 3) have serious, adverse effects

on the affected person’s health, development, or functioning. Birth defects are a

leading cause of morbidity and infant death accounting for more than 20% of infant

deaths.

2

Surveillance of birth defects in a population is vital for quantifying the public

health impact of birth defects, monitoring trends, forming the basis for etiologic

and clinical studies, evaluating prevention strategies and interventions, planning for

services, and making informed policy decisions. Many birth defect surveillance

programs have instituted mandatory reporting requirements in an effort to receive

accurate and complete information about the suspected or diagnosed condition.

However, in the existing paper world of medical records, it has made reporting

complete and accurate information to public health registries difficult. Reporting

only occurs on a targeted basis. Hospitals and health care providers equipped with

an electronic means have the capability to submit the information needed.

Physicians in settings with limited electronic capabilities are presented with a

significant burden when required to report as they must screen for reportable cases

then gather and collate the paper documentation from the various testing and

diagnostic resources to complete the public health report. This leads to missed

cases and undercounting of many conditions. Underreporting of birth defect

conditions can slow down progress in measuring the prevalence and impact of

these conditions, complicate finding the underlying etiology and delay the

development of primary and secondary prevention and intervention strategies.

The purpose of the Ambulatory Care Electronic Birth Defect Reporting to a Birth

Defect Registry use case is to streamline birth defect reporting to improve the

timeliness and completeness of birth defect case information sent to a birth defect

or specialized registry while enabling healthcare providers achieve the Meaningful

Use Stage 2 Specialized Registry Objective.

1.6.2

Use Case Overview

Use Case Description: This use case describes the automated generation and

transmission of birth defects case information from an ambulatory healthcare

provider’s EHR to public health agencies birth defect or specialized registry. This

is intended to provide EHR developers and birth defect registry technical staff with

the operational context for use of the ambulatory care electronic birth defect

reporting implementation guide.

Pre-Conditions:



Business, legal and Health Insurance Portability and Accountability

Act (HIPAA) policy, procedures and agreements are in place

2_{Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control}

and Prevention (July 19, 2013). Facts About Birth Defects. Retrieved from

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

Reportable birth defect case information has been captured and stored

in the EHR using the data elements and vocabulary standards

referenced in this implementation guide



The EHR has the capability to trigger and transmit the generation of

electronic report in conformance with the structure and content

standards specified in this implementation guide



Connectivity to the transport network has been established

Table 1-1: Prepare and Transport Ambulatory Healthcare Provider Birth

Defect Report for Michigan Birth Defects Registry

Actors Description

Ambulatory Healthcare Provider EHR System

An electronic health record with the capability to capture and transform birth defect case information in accordance with the Michigan IG for Ambulatory Healthcare Provider Reporting to the Birth Defect Registry

Intermediary Systems A system performing vocabulary translations, structure and content validations

Public Health Agency Birth

Defect/Specialized Registry

A system collecting electronic birth defect case information

Transport Networks Systems providing secure document transport, i.e. Health Information Exchanges (HIE), DIRECT Health Information Service Providers (HISP)

Diagnosis and Problem List Triggers:



Clinical records of children under the age of 24 months, containing an

encounter diagnosis or a problem list

reportable birth defect

conditions documented in Appendix A



Clinical records of children greater than 24 months of age with a

previous encounter diagnosis or a problem list reportable birth defect

condition with an encounter for treatment for the existing birth defect

condition



Clinical records of children up to and including 12 years of age for

certain medical conditions which are commonly diagnosed after the

age of two years containing an

reportable birth defect conditions documented in Appendix A



Clinical records of deceased children under the age of 24 months,

containing an

reportable birth

defect conditions documented in Appendix A



Clinical records of deceased children up to and including 12 years of

age for certain medical conditions which are commonly diagnosed

after the age of two years containing an

encounter diagnosis or a

(18)

problem list

reportable birth defect conditions documented in

Appendix A

Table 1-2: Use Case Flow

Step Number Step Description

1 EHR captures and stores patient-level birth defect case information 2 EHR generates and transforms an electronic birth defect report in

accordance with the Implementation Guide for Ambulatory Healthcare Provider Reporting to the Birth Defect Registry

3 EHR prepares CDA for secure transport

4 CDA sent through a secure transport network

5 EHR logs the transmission information

6 Intermediary system performs translation and validation operations and transforms document into birth defect registry format

Figure 1-1: Birth Defect Sequence Diagram

Figure 1-3 illustrates the movement of the birth defects CDA from the EHR, to the

central birth defect registry. In the first band, the EHR generates and logs the

CDA, then securely passes the CDA through the transport network. An

intermediary system translates and transforms the CDA into a format readable by

the central birth defect registry.

Birth Defect CDA Basic Flow

T ra n s p o rt N e tw o rk E H R In te rm e d ia ry S y s te m B ir th D e fe c t R e g is tr y

1. Birth Defect Case Information Entered

2. Birth Defect CDA Generated 3. CDA Configured for Secure Transmission 4. CDA Transported 6. CDA validated, translated and transformed 5. Transmission Logged

7. Birth Defect Case Information Processed 8. Confirmation of receipt generated and logged 9. Confirmation Transported 10. Confirmation Logged

(19)

Flow Exceptions:



Transport network is unavailable



EHR, Intermediary system or registry is unavailable

Post Conditions:



Birth Defect/Specialized Registry surveillance team review case

information

1.7

Use of Vocabulary Standards

This guide calls for specific vocabulary standards for the exchange of birth defect

information. Standard vocabularies, particularly coded data items, enable

automated decision support for patient healthcare, as well as for public health

surveillance of populations.

1.8

HIPAA

Providing information on diagnosed birth defects is permitted under HIPAA and is

requested to enhance the ability of the MDHHS to effectively conduct public health

surveillance of birth defects. More specifically, 45 Code of Federal Regulations

164.512 stipulates that personal health information may be disclosed to public

health authorities authorized by law to collect or receive the information for the

purpose of preventing or controlling disease, injury, or disability, including but not

limited to public health surveillance, investigation, and intervention. MDHHS has

been authorized by Michigan Compiled Law (MCL) 333.5717 to establish a birth

defects registry to develop information on birth defects incidence, the causes of

birth defects and the prevention of birth defects.

1.9

Clinical Document Architecture Release 2 (CDA R2)

Clinical documents have two key functions: they need to communicate information

between health care providers, and they need to comply with local policies, laws

and regulations. There are six characteristics of clinical documents defined in the

CDA standard.



Persistence



Stewardship



Potential for authentication



Context



Wholeness



Human readability

The CDA standard also defines two major sections of a CDA document. The first

section of the document is the header, which is use for classification and

(20)

management. The second section is the document body which contains the

information from the clinical record.

(21)

2.0 Ambulatory Healthcare Provider Birth

Defects Report

The Ambulatory Healthcare Provider Birth Defects Event Report contains a

cumulative record of a patient’s encounters for diagnosis and/or treatment of Birth

Defects. This content module inherits from the Medical Documents content

module, and so must conform to the requirements of that template as well.

2.1

Document Constraints

The Ambulatory Healthcare Provider Birth Defects Event Report specification

collects information from several Integrating the Healthcare Enterprise (IHE)

Technical Frameworks and Profiles and the HL7 Continuity of Care Document

(CCD) IG

3

into one document. These include:



IHE Quality, Research, and Public Health (QRPH) Technical

Framework Supplements

o

Birth and Fetal Death Reporting

4

o

Health Birth Summary (HBS)

5

o

Maternal Child Health (MCH) – Birth and Fetal Death

Reporting (BFDrpt)

6

o

Mother and Child Health (MCH)

7



IHE Patient Care Coordination (PCC) Technical Framework

8



IHE PCC Technical Framework Supplement – CDA Content Modules

9



IHE Cardiology Technical Framework Supplement – Cardiac Imaging

Report Content (CIRC)

10



IG for CDA Release 2 – Genetic Testing Report (GTR)

11



IG for Ambulatory Healthcare Provider Reporting to Central Cancer

Registries

12

Additional constraints have been placed on certain sections and entries and one

new section has been created. All sections and further constraints are fully

described and specified in the Section Content Module section of the IG.

3_{HL7/ASTM Implementation Guide for CDA® R2 – Continuity of Care Document (CCD®) Release}

5_{IHE QRPH – HBS Draft for Public Comment}_{. Copyright: 2012: IHE International, Inc.}

8_{IHE Patient Care Coordination Technical Framework, Volume 2 (PCC TF-2): Transaction and}

9_{IHE PCC Technical Framework Supplement, CDA Content Module: Trial Implementation}_.

10_{IHE Cariology Technical Framework Supplement, CIRC Content: Trial Implementation}_.

11_{Implementation Guide for CDA Release 2 – GTR – Draft Standard for Trial Use – Second Ballot}_.

12_{Implementation Guide for Ambulatory Healthcare Provider Report to Central Cancer Registries}

(22)

2.2

Parent Template

The Ambulatory Healthcare Provider Birth Defects Event Report uses the Medical

Document template (1.3.6.1.4.1.19376.1.5.3.1.1.1) as its parent template and

inherits all of the constraints from that template.

2.3

Specification

This section references content modules using Template ID as the key identifier.

Definitions of the modules are found in either the:



IHE PCC Volume 2: Final Text



IHE PCC Content Modules 2010 Supplement

Note: It is important to notice that the BxDefects Report contains information

pertaining to a single newborn. In case of multiple births each newborn will be

assigned a new CDA if a birth defect is present. The subject participation identifies

the subject of a section or entry within a CDA document. This participation is used

to identify family members (e.g., in a family history observation), or mother (e.g.,

in a labor and delivery record) for the purpose of identifying who the particular

content in the document applies to when it is other than the patient.

2.4

Birth Defects Header

Birth Defects Header shall include the child as the unique patient Role element,

while the newborn’s mother, and the newborn's father shall be identified, for any

sections/entries concerned by means of a subject participation element.

Figure 2-1: Birth Defects Header - Subject Type Code

<sdtc:id extension"1234567891123" root="1.2.250.1.213.1.4.1"/> <name/>

Note: In order to avoid redundant data such as address and telecom to be defined

within a <subject> tag each time a section/entry will use it, the mother could be, as

well as the father, as a <participant> entity. In this case the related <subject>

elements shall refer to it, using the <participant> id for that purpose. In this case,

the ID element subject/relatedSubject[/code@code='MTH']/subject/[sdtc:id] shall

be the same as the one declared in the header for the related participant:

(23)

Figure 2-2: Birth Defect Header – Participant Code Type

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.4'/> The <templateId> element

identifies this person as a patient contact and must be recorded exactly as shown

below.

2.5

Conventions Used in this Guide

2.5.1

Conformance (Optionality Constraints)

The optionality constraints in this implementation guide use the HL7 Consolidated

The keywords SHALL, SHOULD, MAY, NEED NOT, SHOULD NOT, and

SHALL NOT in this document are to be interpreted as described in the HL7

Version 3 Publishing Facilitator's Guide.

13



SHALL: an absolute requirement



SHALL NOT: an absolute prohibition against inclusion



SHOULD/SHOULD NOT: best practice or recommendation. 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: truly optional; can be included or omitted as the

author decides with no implications

The keyword SHALL allow the use of nullFlavor unless the requirement is on an

attribute or the use of nullFlavor is explicitly precluded.

The subject of a conformance verb (keyword) in a top-level constraint is the

template itself. In nested constraints, the subject is the element in the containing

constraint.

14

13_{Health Level Seven International. Retrieved from}_{http://www.hl7.org}_{. January 2014.} 14_{HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1;}

(24)

2.6

Cardinality

Cardinality expresses the number of times an attribute or association may appear in

a CDA document instance that conforms to the specifications described within

section 4.0. Cardinality is expressed as a minimum and a maximum value separated

by ‘..’, and enclosed in ‘[ ]’, e.g., ‘[0..1]’.

Minimum cardinality is expressed as an integer that is equal to or greater than zero.

If the minimum cardinality is zero, the element need only appear in message

instances when the sending application has data with which to value the element.

Mandatory elements must have a minimum cardinality greater than zero.

The maximum cardinality is expressed either as a positive integer (greater than zero

and greater than or equal to the minimum cardinality) or as unlimited using an

asterisk (“*”).

The cardinality indicators may be interpreted as follows:



0..1 as zero to one present



1..1 as one and only one present



1..* as one or more present



0..* as zero to many present

2.7

Null Flavor

The nullFlavor definitions in this implementation guide use the HL7 Consolidated

CDA nullFlavor information technology solutions store and manage data, but

sometimes data are not available: an item may be unknown, not relevant, or not

computable or measureable.

15

In HL7, a flavor of null, or nullFlavor, describes the

reason for missing data. The following are nullFlavor examples.

Figure 2-3: nullFlavor Examples

Use null flavors for unknown, required, or optional attributes:

NI

No information. This is the most general and default null flavor.

NA

Not applicable. Known to have no proper value (e.g., last menstrual period

for a male.

NAV

Temporarily unavailable. Information is not available at this time, but it is

expected that it will be available later.

UNK Unknown. A proper value is applicable, but is not known.

15_{HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1;}

(US Realm) Draft Standard for Trial Use. December 2011.

(25)

Figure 2-4: nullFlavor attribute required Example

Figure 2-5: Allowed nullFlavors when element is required example

1.

SHALL

contain at least one [1..*]

id

2.

SHALL

contain exactly one [1..1]

code

3.

SHALL

contain exactly one [1..1]

effectiveTime

<entry>

<originalText>New Grading system</originalText> </code>

<originalText>Spiculated mass grade 5</originalText> </value>

</observation> </entry>

Figure 2-6: nullFlavor explicitly disallowed example

2.8

Birth Defects Specification Table

Table 2-1: Document Specification Table

Template ID TBD

Parent Template Medical Document 1.3.6.1.4.1.19376.1.5.3.1.1.1

General Description The Ambulatory Healthcare Provider BxDefects Event Report contains a record of a patient’s encounter for diagnosis and/or treatment of BxDefects. This content module inherits from the Medical Documents content module, and so must conform to the requirements of that template as well.

Document Code LOINC = TBD BxDefect Event Report

1.

SHALL contain exactly one [1..1] code/@code="11450-4" Problem List

(CodeSystem: LOINC 2.16.840.1.113883.6.1) or

2.

SHALL contain exactly one [1..1] effectiveTime/@value

1. SHALL contain exactly one [1..1] effectiveTime

(26)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification SHALL [1..1] Header Section 2.16.840.1.113883 .10.20.3 General Header Constraints for CDA R2

First Name recordTarget/patient Role/Patient/name/gi ven

Birth Name recordTarget/patient Role/patient/name/fa mily

Date and Time of Birth recordTarget/patient Role/patient/birthTim e Gender recordTarget/patient Role/patient/administ rativeGenderCode

[1..*] Address Useable Period element SHALL be present to indicate the beginning and ending dates the patient indicated that the address was used: ClinicalDocument/rec ordTarget/patientRole/ addr/useablePeriod Use attribute SHOULD be present to indicate the purpose of the address (e.g., mailing, home): ClinicalDocument/re cordTarget/patientR ole/addr/@use MAY [0..*] sdtc:raceCode 2.16.840.1.113883 .10.20.22.1.1 HL7 Implementatio n Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1 ClinicalDocument/rec ordTarget/patientRole/ patient/sdtc:raceCode /@* Newborn Medical Record Number recordTarget/patientR ole/id

(27)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification SHALL [1..1] Provider Referred From 1.3.6.1.4.1.19376. 1.4.1.3.1 Cardiac Imaging Report Content (CIRC) Supplement Provider Referred From element SHALL

be present. An appropriate distinction of “None” is permitted: ClinicalDocument/com ponentOf/encompassi ngEncounter/encount erParticipant//* SHALL [1..1] Birthplace Name, State, City, Town, County, or Location of Birth Birthplace element SHALL be present. An appropriate distinction of “None” is permitted: ClinicalDocument/rec ordTarget/patientRole/ patient/birthplace//* Birth Facility

Birth facility Id, name, address recordTarget/patientR ole/providerOrganizati on Child's Facility Address recordTarget/patientR ole/providerOrganizati on/addr

Child's Facility ID recordTarget/patientR ole/providerOrganizati on/id[1] Child Facility's National Provider Identification Number (NPI) recordTarget/patientR ole/providerOrganizati on/id[2] Where: id[2]@extension is the child facility's NPI id[2]@root is the NPI's OID Child's Facility Name recordTarget/patientR ole/providerOrganizati on/name Guardian 1.3.6.1.4.1.19376. 1.5.3.1.2.4 The guardians of a patient shall be recorded in the <guardian> element beneath the <patient> element.

Guardian element

SHALL be present when the patient is a minor child :

ClinicalDocument/rec ordTarget/patientRole/ patient/guardian//*

(28)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification Participant Other contacts are

recorded as <participant>

elements appearing in the document header. The classCode attribute shall be set to 'IND'.

The contacts can be agents of the patient, care givers,

emergency contacts, next of kin, or other relations like mother, father respectively. Participant element SHALL be present. An appropriate distinction of “None” is permitted: ClinicalDocument/Part icipant SHALL [1..1] Active Problems Section 1.3.6.1.4.1.19376. 1.5.3.1.3.6 PCC TF-2 No Further Constraints SHALL [1..1] BxDefects Diagnosis Section This section documents the ambulatory healthcare provider’s diagnosis of the BxDefect(s) after review of all relevant diagnostic examinations and studies. Includes information about the date of diagnosis, the location of the defect. TBD OID PCC Content Module Supplement

This is the key section for the Ambulatory Healthcare Provider BxDefects Event Report and therefore

(29)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification NEWBORN DETAILS SHALL [1..1] Newborn Delivery Information This section should contain information about: gestational age, size, birth order, Apgar scores, height, weight and cephalic circumference, and resuscitation measures. 1.3.6.1.4.1.19376. 1.5.3.1.1.21.2.4 PCC TF Supplement CDA Content Modules (TI) Vol 2: 6.3.3.2.40 SHALL [1..1] Labor and Delivery Events This section SHALL contain information pertinent to the labor and delivery process and outcome (e.g. type of labor, method of delivery, membrane detail, placenta detail, admission reason, gestational age at delivery, fetal surveillance, labor complications, and delivery complications). This section shall include the following sections: Problems, Procedures and Interventions, and Event Outcomes subsections. 1.3.6.1.4.1.19376. 1.5.3.1.1.21.2.3 PCC TF Supplement CDA Content Modules (TI) Vol 2: 6.3.3.2.39 SHALL [1..1] Labor and Delivery History and Physical 1.3.6.1.4.1.19376. 1.5.3.1.1.21.1.1

(30)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification SHALL [1..1] Coded Results Section 1.3.6.1.4.1.19376. 1.5.3.1.3.28 PCC TF-2

The Coded Results Section SHALL

contain at least one entry for a simple observation for the test result. An appropriate distinction of “None” is permitted. ClinicalDocument/com ponent/structuredBod y/component/section[t emplateId[@root=’1.3. 6.1.4.1.19376.1.5.3.1. 3.28’]]/entry/observati on[templateId[@root=’ 1.3.6.1.4.1.19376.1.5. 3.1.4.13’]] SHALL [1..1] Procedures Section 2.16.840.1.113883 .10.20.1.12 CCD 3.1.4 Procedures SHALL [1..1] Payers Section 1.3.6.1.4.1.19376. 1.5.3.1.1.5.3.7 PCC TF-2 No Further Constraints SHALL [1..1] Medications Administered The medications administered section shall contain a description of the relevant medications administered to a patient during the course of an encounter. It shall include entries for medication administration. 1.3.6.1.4.1.19376. 1.5.3.1.3.21 IHE PCC 2:6.3.3.2.10 An appropriate distinction of “None” is permitted. SHALL [1..1] Medications Section 1.3.6.1.4.1.19376. 1.5.3.1.3.19 PCC TF-2 An appropriate distinction of “None” is permitted. SHALL [1..1] Cytogenetics The Cytogenetic Section resides at the highest level of the Genetic Testing Report and consists of data related to cytogenetic testing such as FISH. 2.16.840.1.1138 83.10.20.20.1.4

(31)

Conf orm a nc e (O pti on a li lty ) Template Name Section Template Id Value Set Template Id Further Constraints applied by Ambulatory Healthcare Provider

Birth Defects Event Report Specification SHALL

[1..1] Care Plan

The care plan section shall contain a narrative description of the expectations for care including proposals, goals, and order requests for monitoring, tracking, or improving the condition of the patient. 1.3.6.1.4.1.19376. 1.5.3.1.3.31

PCC TF-2 The Care Plan

Section SHALL contain at least one entry for an encounter for the patient’s planned healthcare encounter(s). An appropriate distinction of “None” is permitted. ClinicalDocument/co mponent/structuredB ody/component/secti on[templateId[@root =’1.3.6.1.4.1.19376.1 .5.3.1.3.31’]]//entry/e ncounter/performer//*

Figure 2-7: Ambulatory Healthcare Provider Birth Defect Event Report

Document Example

<code code='XX-BxDefect' displayName='BxDefect Event Report' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title> Ambulatory Healthcare Provider Report to BxDefect Registry </title> <effectiveTime value='20080601012005'/>

<confidentialityCode code='N' displayName='Normal'

codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/>

<recordTarget>

<author> .. </author>

<participant> .. </ participant >

<custodian> .. </custodian>

<!—one or more health care providers who referred the patient to this provider for care -->

(32)

</encompas singEncounter> </componentOf> <informationRecipient></informationRecipient> <recordTarget> <patientRole> <patient> <birthplace> <place>..</place> </birthplace> </patient> </patientRole> </recordTarget>

<!—one or more birthplace observations --> <component>

</section>

</component> <component> <section>

</section>

</section>

</section> </component> </strucuredBody> </component> </ClinicalDocument>

(33)

2.9

Organization of Implementation Guide

2.9.1

Conventions

Conventions describe the rules adhered to in this specification.

2.9.2

Document Content Module

The Document Content Module describes the constraints for the CDA header, body

and entry sections.

2.9.3

Sections

The Section Content Module specifies section-level constraints. For example, the

Cytogenetics Genetic Testing Report Section contains a templateId element, a code

element, and the results and genetic testing observations.

2.9.4

Entry Content

The Entry Content Module defines the core semantic units of the ambulatory

healthcare provider birth defects event report—the conformance requirements for

CDA clinical statements including associated vocabularies and value sets.

2.9.5

Vocabulary and Value Sets

Vocabularies are groups of terms that are used to create the document. Some of the

vocabularies are in general use in the healthcare community; others have been

created by the birth defects registry community specifically for birth defects

reporting. A value set is a subset of the vocabulary chosen as appropriate for birth

defects reporting. Conformance statements indicate whether a specific vocabulary

or value is required.

2.10

Vocabulary Conformance

This guide calls for specific vocabulary standards for the exchange of BxDefect

information. Standard vocabularies, particularly coded data items, enable

automated decision support for patient healthcare, as well as for public health

surveillance of populations. Public Health Information Network (PHIN)

Vocabulary Services seeks to promote the use of standards-based vocabulary

within PHIN systems and foster the use and exchange of consistent information

among public health partners. These standards are supported by the PHIN

Vocabulary Access and Distribution System (VADS) for accessing, searching, and

distributing standards-based vocabularies used within PHIN to local, state and

national PHIN partner.

Furthermore, the templates in this document use terms from several code systems.

These vocabularies are defined in various supporting specifications and may be

maintained by other bodies, as is the case for the Logical Observation Identifiers

(34)

Names and Codes (LOINC®) and Systematized Nomenclature of Medicine

Clinical Terms (SNOMED CT®) vocabularies.

2.11

CDA Header Section Value Sets

The following are value sets used in the CDA Header Section, including marital

status, religious affiliation, race, ethnicity, personal relation role type, and guardian.

However, for a complete list of those value sets used in a CDA, see Appendix B.

2.11.1

Marital Status

Table 2-2: Marital Status Value Set

Value Set HL7 Marital Status

ID 2.16.840.1.113883.1.11.12212

Marital Status 2.16.840.1.113883.5.2

Code Print Name

A Annulled D Divorced T Domestic partner I Interlocutory L Legally Separated M Married S Never Married P Polygamous W Widowed

2.11.2

Religious Affiliation

Table 2-3: Religious Affiliation Value Set

Value Set HL7 2.16.840.1.113883.1.11.19185 DYNAMIC

Code System Religious Affiliation

ID 2.16.840.1.113883.5.1076

Description A value set of codes that reflect spiritual faith affiliation

Concept Code Concept Name

1001 Adventist 1002 African Religions 1003 Afro-Caribbean Religions 1004 Agnosticism 1005 Anglican 1006 Animism 1061 Assembly of God 1007 Atheism

1008 Babi & Baha'I faiths 1009 Baptist

(35)

Concept Code Concept Name

1062 Brethren 1011 Cao Dai 1012 Celticism

1013 Christian (non-Catholic, non-specific) 1063 Christian Scientist 1064 Church of Christ 1065 Church of God 1014 Confucianism 1066 Congregational 1015 Cyberculture Religions 1067 Disciples of Christ 1016 Divination 1068 Eastern Orthodox 1069 Episcopalian 1070 Evangelical Covenant 1017 Fourth Way 1018 Free Daism 1071 Friends 1072 Full Gospel 1019 Gnosis 1020 Hinduism 1021 Humanism 1022 Independent 1023 Islam 1024 Jainism 1025 Jehovah's Witnesses 1026 Judaism

1027 Latter Day Saints 1028 Lutheran 1029 Mahayana 1030 Meditation 1031 Messianic Judaism 1073 Methodist 1032 Mitraism 1074 Native American 1075 Nazarene 1033 New Age 1034 non-Roman Catholic 1035 Occult 1036 Orthodox 1037 Paganism 1038 Pentecostal 1076 Presbyterian 1039 Process, The 1077 Protestant 1078 Protestant, No Denomination 1079 Reformed 1040 Reformed/Presbyterian 1041 Roman Catholic Church 1080 Salvation Army

(36)

Concept Code Concept Name 1043 Scientology 1044 Shamanism 1045 Shiite (Islam) 1046 Shinto 1047 Sikism 1048 Spiritualism 1049 Sunni (Islam) 1050 Taoism 1051 Theravada 1081 Unitarian Universalist 1052 Unitarian-Universalism 1082 United Church of Christ 1053 Universal Life Church 1054 Vajrayana (Tibetan) 1055 Veda 1056 Voodoo 1057 Wicca 1058 Yaohushua 1059 Zen Buddhism 1060 Zoroastrianism

2.11.3

Race

Table 2-4: Race Value Set

Value Set Race 2.16.840.1.113883.1.11.14914 DYNAMIC

Code System(s) Race and Ethnicity - CDC 2.16.840.1.113883.6.238

Description A Value Set of codes for Classifying data based upon race. Race is always reported at the discretion of the person for whom this attribute is reported, and reporting must be completed according to Federal guidelines for race reporting. Any code descending from the Race concept (1000-9) in that terminology may be used in the exchange

http://phinvads.cdc.gov/vads/ViewCodeSystemConcept.acti on?oid=2.16.840.1.113883.6.238&code=1000-9

Concept Code Concept Name

1006-6 Abenaki 1579-2 Absentee Shawnee 1490-2 Acoma 2126-1 Afghanistani 2060-2 African 2058-6 African American 1994-3 Agdaagux 1212-0 Agua Caliente

1045-4 Agua Caliente Cahuilla 1740-0 Ahtna

(37)

Concept Code Concept Name 1993-5 Akhiok 1897-8 Akiachak 1898-6 Akiak 2007-3 Akutan 1187-4 Alabama Coushatta 1194-0 Alabama Creek 1195-7 Alabama Quassarte 1899-4 Alakanuk 1383-9 Alamo Navajo 1744-2 Alanvik 1737-6 Alaska Indian 1735-0 Alaska Native 1739-2 Alaskan Athabascan 1741-8 Alatna 1900-0 Aleknagik 1966-1 Aleut 2008-1 Aleut Corporation 2009-9 Aleutian 2010-7 Aleutian Islander 1742-6 Alexander 1008-2 Algonquian 1743-4 Allakaket 1671-7 Allen Canyon 1688-1 Alpine 1392-0 Alsea 1968-7 Alutiiq Aleut 1845-7 Ambler 1004-1 American Indian

1002-5 American Indian or Alaska Native 1846-5 Anaktuvuk 1847-3 Anaktuvuk Pass 1901-8 Andreafsky 1814-3 Angoon 1902-6 Aniak 1745-9 Anvik 1010-8 Apache 2129-5 Arab 1021-5 Arapaho 1746-7 Arctic

1849-9 Arctic Slope Corporation 1848-1 Arctic Slope Inupiat 1026-4 Arikara 1491-0 Ariz