| Submitted By: Andrea Fourquet / IHE USA | |
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| Data Element Information | |
| Rationale for Separate Consideration | Submitting this data element for consideration at a higher level within the USCDI with use cases and supporting information. |
| Use Case Description(s) | |
| Use Case Description | Gestational Age is a commonly used term across maternal health. This data element is captured in EHRs, are defined and endorsed by the American College of Obstetricians and Gynecologists (ACOG)2, and are represented in LOINC with Class=”OB.US/clinical”. It is used across all areas of care provision for a pregnant patient. It is important that the Gestational Age data element is captured and exchanged. According to the 2021 Aspen Health Strategy Group report on “Reversing the U.S. Maternal Mortality Crisis”, 700 women die each year as the result of pregnancy or delivery complications, and 50,000 more face short-term or long-term health consequences because of pregnancy or labor. The U.S. has the highest maternal mortality rate of any high-income nation in the world (17.4 maternal deaths per 100,000 live births) according to The Commonwealth Fund. While rates of maternal mortality have been decreasing in other countries, they have been rising in the United States since 1987. Maternal health data is not standardized, and data exchange is not interoperable across many settings, which impedes care and research on maternal morbidity, longitudinal maternal care, and associated impacts to infant and infant health. The United States Congress S.796 - Protecting Moms Who Served Act of 2021 includes support by the Department of Veterans Affairs for Maternity Care Coordination by carrying out the maternity care coordination program described in the Veterans Health Administration Directive 1330.03. The Veterans Health Administration Directive includes required coordination of maternity care which include provision of care across settings. Gestational age is a necessary data element required to be exchanged in support of care provision and care coordination. The following use cases demonstrate the exchange of information needed to support maternal care coordination and care provision. Personal access and control over perinatal information Frequency: Maintained and used Constantly by the person Personal Health data owned by the person and shared with perinatal providers that interact with the person throughout their pregnancy, birth, postpartum, and newborn care. The Person has the ability to share the following information as part their longitudinal record with providers with consent: encounter data, labs, vital signs, birth directives and birth plans SDOH assessments or screenings and associated interventions Self Reported biometrics Activities of daily living This concept has been described by the 2006 Independent Health Record Bank Act https://www.congress.gov/bill/109th-congress/house-bill/5559?s=1&r=5 Outpatient Care Frequency: Each Outpatient encounter The first prenatal visit taking place in the first trimester is vitally important Initial assessments, lab and documentation take place at this event The person’s preferences, cultural, and family support are considered Referral for routine or high-risk prenatal care Performance of Preventative Care encounters whenever there is confirmation of pregnancy. Completion of up to date relevant screenings. Psychosocial-risk assessment to identify the presence of a broad range of social, economic, psychological, and emotional problems. Screening includes but is not limited to: an assessment of barriers to care, unstable housing, communication barriers, nutrition, tobacco use, substance use, depression or other psychiatric illness, employment or financial status, safety, domestic abuse, sexual abuse, and stress. Performance of appropriate referrals based on screening results. Ensuring effective coordination of care between varying care settings and care providers and specialists such as endocrinology, cardiology, rheumatology, neurology, gynecology, mental health, social services, etc. The maternal patient is an active participant and is included as a key component of care provision use cases. Inpatient Care Frequency: Each Inpatient encounter Required inpatient medical, surgical, psychiatric, or residential care services. Care must be coordinated with the patient’s care providers and specialists (such as endocrinology, cardiology, rheumatology, neurology, gynecology, mental health, social services, etc.). Maternal patients need to be evaluated and referred or transferred from one inpatient setting to another based on consideration of the following factors: the stage of pregnancy, the patient’s health status, and the local resources available and needed to meet all of the patient’s medical and social needs. The maternal patient is an active participant and is included as a key component of care provision use cases. Obstetrical Emergencies Frequency: Each emergency and/or urgent care encounter The management of patients with obstetrical emergencies is normally directed toward the rapid evaluation, stabilization, and transfer to the nearest qualified facility. Mechanisms or processes need to be in place to initially triage obstetrics emergencies in the event this is necessary. It is imperative that the patient health information is available when the following occur: Performance of timely (i.e., stat or point of care) testing to diagnose pregnancy is needed when necessary. Timely access to diagnostic services, especially if this impacts the triaging of the patient’s care. Pregnancy information must be provided when seeking emergency care at the closest Emergency Department, Urgent Care Center or at the hospital the patient will be using for delivery. When a patient presents with a spontaneous abortion, the specialty provider may deem it medically necessary to provide care in the form of a procedure (i.e., dilation and curettage) or through medical management consistent with standard of care. Pregnancy information must be provided when seeking medically necessary procedures for the management of spontaneous abortion. Patients with complications such as preeclampsia or severe hypertension may be seen outside of routine visits. Information from these visits should be made available if a referral to a specialist is needed. The information should also be available when the patient returns to their primary care provider or any other provider caring for existing chronic conditions. The maternal patient is an active participant and is included as a key component of care provision use cases. Pregnancy Care Provision Frequency: Each care provision encounter Regular encounters with the patient’s care team is required. The maternal patient is an active participant and is included as a key component of care provision use cases. Frequency: Each postpartum encounter Postpartum visit with the patient’s maternity care provider at approximately 6-8 weeks following delivery (or earlier if recommended by that provider). Follow-up with the patient’s routine care provider (e.g., PCP and other routine care providers) after postpartum visit within 3 months (or earlier if comorbid conditions, e.g.,cardiovascular disease, Human immunodeficiency virus, acquired immunodeficiency syndrome, mental health condition, etc.). The maternal patient is an active participant and is included as a key component of care provision use cases. Travel Use Case Frequency: Each travel incidence that includes encounters with the health care system. It is not uncommon for expecting mothers to travel. If acute clinical conditions arise, the mother may seek treatment at a care setting remote from her normal place of care. The Gestational Age data element should be available to the new care team for the provision of safe and effective care. Additionally, A summary of the care provided by the remote provider should be available to the mother’s primary obstetrical provider for continuation and follow up care. Community Care Services Use Case Frequency: Each incidence where the barriers to care are identified and mitigated. Community Clinical Integration (CCI) involves creating an infrastructure for community collaboration to improve perinatal outcomes. The infrastructure is used to address barriers to care such as antepartum or postpartum care by working collaboratively with community partners (doulas, community-based organizations, community health workers, home visitation programs, etc.). The majority of preventable maternal morbidity/mortality occurs in community settings. Medical care, dental care, behavioral health care, substance use disorder care, material support, social support are all key components of whole-person care. High-value care activities should be coordinated across multiple sectors to ensure smooth transitions and handoffs among care team partners in order to share resources and accountability. Veterans Health Administration Directive 1330.03 https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4492813&FileName=36C24218R0013-006.pdf https://www.healthit.gov/playbook/specialists/#section-11-2 https://www.aimcci.org/ IHE USA Maternal Health Project https://drive.google.com/drive/u/0/folders/1Y5_iBEDalbFUTn_MKYr4yCmqo61jSdMe https://docs.google.com/document/d/1p0QS-O48Xcr1GZ1EFnz9S4gIvaL0cv8kkRv_RLOzgEQ/edit?usp=sharing Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) https://www.nichd.nih.gov/about/advisory/PRGLAC#:~:text=Lactating%20Women%20(PRGLAC)-,Task%20Force%20on%20Research%20Specific%20to%20Pregnant%20Women%20and%20Lactating,pregnant%20women%20and%20lactating%20women. The Gravity Consensus-driven Standards on Social Determinant of Health https://confluence.hl7.org/display/GRAV/The+Gravity+Project Institute for Healthcare Improvement http://www.ihi.org/ includes - Better Maternal Outcomes Rapid Improvement Network http://www.ihi.org/Engage/Initiatives/Better-Maternal-Outcomes-Rapid-Improvement-Network/Pages/default.aspx Maternal and Infant Health http://www.ihi.org/Topics/Maternal-Infant-Health/Pages/default.aspx Black Maternal Health: Reducing Inequities Through Community Collaboration http://www.ihi.org/resources/Pages/Publications/black-maternal-health-reducing-inequities-through-community-collaboration.aspx |
| Estimated number of stakeholders capturing, accessing using or exchanging | Maternal health data pertains to all maternal health patients, all providers providing care for maternal health patients and all requesters utilizing maternal health data to support applicable use cases such as research, public health and/or quality reporting. Anticipated stakeholder examples are: Patients Newborns Mothers Providers OB GYN Birthing Centers Doulas Midwives Community Health centers Community Health workers Fertility Clinics Public Health Insurance Providers Military Health System Veterans Administration Home Visitation Programs Dentists This list is not exclusive to the stakeholders that will capture, access or use this data element. |
| Use Case Description | Maternal Research Use Case Supports mapping maternal data across health records from specialty care and linking mother and child data harmonized across a broad set of use cases. This supports researchers in identifying root causes of maternal mortality and pediatric developmental problems, including SDOH such as limited income, poor nutrition, lack of medical coverage, etc. The goal is to provide standardization of data capture for comparative analysis over time to improve health outcomes and to define a framework for studying additional research populations in the future. Quality Improvement Use Case The Quality Improvement Ecosystem begins with information such as maternal care provision needs, information to support maternal care coordination, etc. Such information indicates existing status and knowledge about a given clinical topic. Stakeholders, such as professional societies, public health agencies, and governmental bodies, publish such information to assure awareness among consumers, healthcare practitioners, and healthcare organizations about what is known and suggested methods for managing the clinical topic as clinical guidelines. These clinical guidelines are translated into clinical decision support (CDS) artifacts to incorporate relevant, evidence based, and patient-specific clinical recommendations and actions directly within clinical workflow. To close the loop and enable continuous improvement, the results of such measurement analytics must be reported for aggregate review. “Reporting” serves the purpose of evaluating clinical performance and outcomes, whether it be internally for health care organizations, or for third parties such as public health or for payers. Public Health Reporting An expectant mother’s pregnancy attributes are crucial for providing the best possible prenatal care. As well, after delivery, Public Health needs to capture this data as part of birth certification, fetal death reporting and birth defect reporting. In particular, birth certification forms the basis of the patient census required by a large number of other Public Health programs including newborn screening, birth defect reporting and immunization registries making it critical that birth certification is as automated, timely and accurate as possible. Longitudinal Maternal & Infant Health Information for Research https://build.fhir.org/ig/HL7/fhir-mmm-ig/ Vital Records Birth and Fetal Death Reporting https://build.fhir.org/ig/HL7/fhir-bfdr/ Birth and Fetal Death Reporting https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf WHO Antenatal Care Guideline Implementation Guide https://build.fhir.org/ig/WorldHealthOrganization/smart-anc/index.html https://www.healthit.gov/playbook/specialists/#section-11-2 MATERNAL MORTALITY Factsheet https://docs.google.com/document/d/1p0QS-O48Xcr1GZ1EFnz9S4gIvaL0cv8kkRv_RLOzgEQ/edit https://www.aimcci.org/ https://hl7.org/fhir/us/ecr/2018sep/StructureDefinition-pregnancy-status.html https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_IPS.pdf https://www.healthit.gov/playbook/specialists/#section-11-2 |
| Estimated number of stakeholders capturing, accessing using or exchanging | Maternal health data pertains to all maternal health patients, all providers providing care for maternal health patients and all requesters utilizing maternal health data to support applicable use cases such as public health and/or quality reporting. Anticipated stakeholder examples are: Patients Newborns Mothers Providers OB GYN Birthing Centers Doulas Midwives Community Health centers Community Health workers Fertility Clinics Public Health Insurance Providers Military Health System Veterans Administration Home Visitation Programs Dentists This list is not exclusive to the stakeholders that will capture, access or use this data element. |
| Healthcare Aims |
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| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | LOINC: 18185-9 Gestational age SNOMED CT: 268477000 fetal gestation at delivery IHE 1.3.6.1.4.1.19376.1.5.3.1.4.13 HL7 : urn:hl7ii:2.16.840.1.113883.10.20.22.4.280:2018-04-01 https://loinc.org/18185-9/ https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_TF_Vol2.pdf (pg. 68) https://www.healthit.gov/isa/sites/isa/files/webform/uscid_webform/1966/CDAR2_IG_PREGNANCY_R1_DSTU_2019JAN.pdf (pg.46) |
| Additional Specifications | SDOH Clinical Care IG - https://hl7.org/fhir/us/sdoh-clinicalcare/ Longitudinal Maternal & Infant Health Information for Research IG - https://hl7.org/fhir/us/mihr/2022may/index.html WHO Antenatal Care Guideline Implementation Guide - https://build.fhir.org/ig/WorldHealthOrganization/smart-anc/guidance.html Antepartum Summary (APS) - https://www.ihe.net/Technical_Framework/upload/IHE_PCC_Suppl_AntepartumProfiles_Rev1-2_TI_2011-09-09.pdf Family Planning Version 2 (FPv2) - https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_FPv2.pdf Healthy Weight (HW) - https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_HW.pdf C-CDA R2.1 Supplemental Templates for Pregnancy Status - HL7 CDA® R2 Implementation Guide: C-CDA R2.1 Supplemental Templates for Pregnancy Status, Release 1 - US Realm Pregnancy Outcome List - https://nhsconnect.github.io/FHIR-Maternity-Record/explore_pregnancy_outcome.html NIH - https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DD9D34E3DC420E58DE0011417F4073B95E45E1C3F1FC HL7 CHOICE Project - Pregnancy History Model https://confluence.hl7.org/x/ptM7Bg https://www.hl7.org/implement/standards/product_brief.cfm?product_id=494 |
| Current Use | This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
| Supporting Artifacts |
ISA: https://www.healthit.gov/isa/representing-patient-pregnancy-status Blue Cross BLue Shield Pregnancy Risk assessment form: https://about.bcbstx.com/provider/pdf/3rd_trimester.pdf UnitedHealthcare Pregnancy Risk assessment form: https://www.uhcprovider.com/content/dam/provider/docs/public/commplan/multi/UHC-UHCCP-Obstetrics-Pregnancy-Risk-Assessment-Form.pdf https://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1399 CDAR2_IG_PREGNANCY_R1_DSTU_2019JAN.pdf |
| Number of organizations/individuals with which this data element has been electronically exchanged | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
This data is exchanged routinely as part of care provision and care coordination across multiple care settings and for informing patients. The preconception office visit https://www.uptodate.com/contents/the-preconception-office-visit?topicRef=446&source=see_link Prenatal care: Initial assessment https://www.uptodate.com/contents/prenatal-care-initial-assessment?topicRef=448&source=see_link Prenatal care: Second and third trimesters https://www.uptodate.com/contents/prenatal-care-second-and-third-trimesters?topicRef=112420&source=see_link Prenatal care: Patient education, health promotion, and safety of commonly used drugs https://www.uptodate.com/contents/prenatal-care-patient-education-health-promotion-and-safety-of-commonly-used-drugs?topicRef=446&source=see_link |
| Potential Challenges | |
| Restrictions on Standardization (e.g. proprietary code) | None |
| Restrictions on Use (e.g. licensing, user fees) | None |
| Privacy and Security Concerns | Pregnancy-related data, particularly pregnancy outcome, is sensitive and private information. It will be important to safeguard identifying information of individuals using current HIPAA policies and other relevant standards. Privacy and security should include statutes, regulations, and guiding principles to protect patient specific maternal health data because it is sensitive and private information. Privacy and security considerations associated with any health-related data should take appropriate action to mitigate the risk of compromise. The use of the following is highly encouraged: Security and Implementation Guidance; Security/Privacy Related Technologies Including Explicit Consent and Security Labels; Exchange Security; Additionally Protected Information. |
| Estimate of Overall Burden | Pregnancy-related data, particularly pregnancy outcome, is sensitive and private information. It will be important to safeguard identifying information of individuals using current HIPAA policies and other relevant standards. Privacy and security should include statutes, regulations, and guiding principles to protect patient specific maternal health data because it is sensitive and private information. Privacy and security considerations associated with any health-related data should take appropriate action to mitigate the risk of compromise. The use of the following is highly encouraged: Security and Implementation Guidance; Security/Privacy Related Technologies Including Explicit Consent and Security Labels; Exchange Security; Additionally Protected Information. |
| Other Implementation Challenges | N/A |
| ONC Evaluation Details Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI |
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| Maturity – Standards/Technical Specifications | Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification |
| Maturity - Current Use | Level 2 - Used at scale in more than 2 different production environments |
| Maturity - Current Exchange | Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Level 2 - Used by a majority of patients, providers or events requiring its use |
Submitted by RUy on 2022-09-30
Standards specified are insufficient. ICD-10-CM Z3A.X and others
ICD-10-CM Z3A and children codes represent weeks gestation of a pregnancy episode. Specific gestational age is fundamental in each pregnancy episode's encounters up until delivery. Having gestational age represented in the patient's diagnosis or problem list represented by specific ICD-10-CM Z3A codes or SNOMED-CT specific codes will assist OBGYN physicians and CDSS algorithms to use and recommend proper follow-ups, referrals and administration of screening tools (depression, gestational diabetes, preeclampsia/eclampsia, etc.).