Data Element

Information from the submission form
Pregnancy Status
Description
Indicator that a patient is currently pregnant, not pregnant, or that their pregnancy status is unknown currently, as it relates to potential risks and exposures.
Submitted By: Adam Bazer, MPD / Integrating the Healthcare Enterprise USA (IHE USA)
Data Element Information
Use Case Description(s)
Use Case Description A 24 year old female is being transported to a hospital for abdominal pains. During her transport she indicated that she is several weeks pregnant so the transport team makes sure to bring her to a hospital that has OBGYN capability. When she is in the hospital that pregnancy status indicator helps inform the providers to do some tests to make sure this pain is not related to her pregnancy and to avoid procedures that may have negative effects on the fetus.
Estimated number of stakeholders capturing, accessing using or exchanging This indication of pregnancy can be important for a variety of health care providers to help make informed decisions for the care of a patient. This would be captured and used in by any provider that creates or utilizes a patient electronic health record. This also may be populated by the patient in a personal record or at an appointment.
Link to use case project page https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_IPS.pdf
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) International Patient Summary (IPS) - https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_IPS.pdf


http://hl7.org/fhir/uv/ips/ValueSet/pregnancy-status-uv-ips
Additional Specifications Paramedicine Care Summary (PCS) - https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_PCS.pdf
Routine Interfacility Patient Transport (RIPT) - https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_RIPT.pdf
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts HL7 FHIR Connecathon has trested the FHIR Pregnancy Status for eCR and the International Patient Summary in September 2020
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 HL7 FHIR Connecathon has trested the FHIR Pregnancy Status for eCR and the International Patient Summary in September 2020
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) none
Restrictions on Use (e.g. licensing, user fees) none
Privacy and Security Concerns none
Estimate of Overall Burden This is regularly tracked as part of electronic medical records
Other Implementation Challenges none

Comment

Submitted by RUy on 2022-09-30

LOINC 10162-6 is referenced in IHE, but not 82810-3 or LL4129-4

This submission references IHE specifications that state LOINC 10162-6 "History of pregnancies Narrative", which is an unstructured, free-text note capture of the history of pregnancy, and not the status of the current pregnancy episode of the patient.  We advise transparency in the advised stated standard terminology, codes that represent pregnancy status at the patient level, captured as structured data, existing in multiple HL7/FHIR IGs and in production by government agencies, academia and community health centers. 

Submitted by nedragarrett_CDC on 2022-09-28

CDC's comment on behalf of CSTE

CSTE Comment:
  • CSTE strongly recommends that pregnancy status be included in USCDI v4. However, a single variable is not sufficient to capture critical data that are needed for a large variety of conditions affecting the public's health, including maternal mortality, Hepatitis B and C, COVID-19, Zika, syphilis, and influenza, to name only a few.
  • CSTE urges the inclusion of the following variables in the core data for exchange - as defined by the ONC Public Health Task Force on Capturing Pregnancy Data in Electronic Health Records and found here https://www.healthit.gov/sites/default/files/facas/HITJC_PHTF_Meeting_Slides_2017-03-30_0.pdf
  • https://www.healthit.gov/topic/federal-advisory-committees/collaboration-health-it-policy-and-standards-committees (See May 19 transmittal letter to the NC.  Click on charge 1 - Capturing Pregnancy Status, see MS Excel Spreadsheet)
  1. Pregnancy Status - Yes, No, Possible, Unknown
  2. Date pregnancy status recorded
  3. Estimated delivery date
  4. Pregnancy outcome
  5. Date of pregnancy outcome and optionally
  6. Postpartum status (this is important since if the mother recently gave birth and is diagnosed with a condition that could affect the neonate, public health action might be indicated).
  • Currently there are large gaps in the ability for data from electronic health records or ELR to capture sufficient pregnancy information to identify cases and measure the burden and outcome of medical conditions and infections in pregnancy on a population level. Standardizing these data for exchange would be a substantial step forward.
  • Finally, it is very important for electronic health records to develop a way to link the mother and infant records. A unique identifier for the mother which can be included in the infant's record, and a similar unique identifier for the infant which can be included in the mother's records would help to rectify this problem, which would be beneficial for both clinical care as well for public health when we receive data on mothers and infants but cannot link them (important for diseases such as HIV, listeria, Zika, syphilis, Hepatitis B, and others)

Submitted by Lantana Consul… on 2022-04-29

Lantana Consulting Group Comment

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. Minority mothers are enduring disparities in care and outcomes at this critical time. Data are not standardized and data exchange in not interoperable across many settings, which impedes research on maternal morbidity, longitudinal maternal care, and associated impacts to infant and infant health. Capturing data related to pregnancy in a standardized way will improve research and quality measurement by illuminating the causes of these failures in maternal health and allow for adjustments in treatment to improve outcomes and health equity. There are several important initiatives underway to improve maternal health, including the following: 
  • Office of the Assistant Secretary of Planning and Evaluation:  
    • Severe Maternal Morbidity and Mortality-Electronic Health Record (EHR) Data Infrastructure (National Institutes of Health)
    • MAT-LINK2: Expansion of MATernaL and Infant NetworK to Understand Outcomes Associated with Treatment for Opioid Use Disorder during Pregnancy (Centers for Disease Control)
    • Enhancing Surveillance of Maternal Health Clinical Practices and Outcomes with Federally Qualified Health Centers’ (FQHCs) Electronic Health Records Visit Data (Centers for Disease Control and Prevention)
  • Other projects include (but are not limited to):
    • Maternal Morbidity and Mortality Data and Analysis Initiative (Office of Women’s Health)
    • CMS Proposed Rule Hospital IPPS/LTCH PPS (Inpatient Prospective Payment System and Long Term Care Hospitals) Proposed Rule - CMS-1771-P includes consideration for establishing a publicly-reported hospital designation on Maternity Care.
Lantana recommends inclusion of Pregnancy Status, as well as BirthTime to improve standardized data for maternal healthcare, research, and quality measure.

Submitted by RUy on 2022-04-29

Review previous Pregnancy Status submissions from v1,v2.

Pregnancy Status was previously proposed and submitted by NACHC in coordination with ACOG for consideration in both USCDIv1 and USCDIv2. We fully support the previous comments from ACOG, CDC and IMO.  While NACHC agrees that there is a critical need for the pregnancy status data element, the currently submitted concept profile should not ideally be referenced from IPS as the submission is not harmonized with electronic case reporting (eCR) LOINC code for pregnancy status (LOINC 82810-3) with SNOMED-CT terminology bindings. The pregnancy status LOINC code that should be referenced is missing or not immediately transparent from the current USCDIv3 draft proposal. We appreciate the use case for reported pregnancy status in a patient-facing survey; however, for use in electronic health record systems (EHRs), we believe the intended concept should preferentially be the presence of a confirmed pregnancy status referenced by LOINC 82810-3, with its terminology bound answer codes (LOINC LL4129-4). This code is referenced in the federally supported Family Planning Annual Report (FPAR) program and data system from HHS, which we believe should be included as a reference in the version 3 draft proposal. NACHC is supportive of ACOG’s position supporting HL7’s CCDA “Pregnancy Status” and related women’s health data elements as its own data class listed in Appendix C in the attached document. 

2022-04-30 NACHC USCDIv3 Letter of Support_4.pdf

Submitted by aphillips@imoh… on 2022-04-28

Level 2 Data Element: Pregnancy Status

IMO supports the inclusion of Pregnancy Status in USCDI V3 but would like to note that the technical specifications cited in the proposal for inclusion in USCDI V3 as a level 2 data element are not currently implemented in production environments.
  • IHE International Patient Summary (IPS) Revision 1.1 – Trial Implementation
  • IHE PCC Technical Framework Supplement Paramedicine Care Summary (PCS) Revision 1.1 – Trial Implementation
  • IHE Patient Care Coordination Technical Framework Supplement Routine Interfacility Patient Transport (RIPT) Rev. 1.1 – Trial Implementation
The 3 technical specifications refer to the FHIR R4 International Patient Summary Implementation Guide (v1.0.0: STU 1) Observation for pregnancy status specified in LOINC with answer list codes from LL4129-4. The specifications do not reference LL4129-4, only the following codes:
  • Pregnant              LA15173-0          
  • Not pregnant     LA26683-5                         
  • Unknown            LA4489-6            
IMO agrees for the need for the Data Element for Pregnancy Status in USCDI V3 and would support the inclusion of a data element specified with LOINC coding for Pregnancy status 82810-3. The use of LOINC 82810-3 is aligned with the current version of FHIR R4 International Patient Summary Implementation Guide (v1.0.0 CI Build) as well as ISA recommendations for Representing Patient Pregnancy Status, which incorporates the LL4129-4 answer codes in the correct format. ONC certified HIT can exchange this data element.  

Submitted by nedragarrett_CDC on 2022-04-27

CDC's Consolidated Comment

General statement:
  • Viral Hepatitis case surveillance: Collected as part of routine case surveillance for acute Hepatitis A, B, C, and chronic Hepatitis B or C required at local level to prioritize investigations and interventions to minimize perinatal transmission.
  • Adult HIV case surveillance: Collected as part of routine case surveillance for HIV as 'Is this patient currently pregnant?"
  • STD case surveillance: "Collected as part of routine case surveillance for STDs as an indicator of whether the patient was pregnant at time of the reported event, with responses of Yes/No. For positive syphilis test, extremely important for determining whether female needs to be followed up immediately or can be triaged in regular way. Any pregnant female that has positive syphilis test needs to be contacted by the HD immediately. Syphilis in pregnancy is difficult: treatment must be started 30 days before delivery to prevent congenital syphilis in the infant, and syphilis causes premature birth.  So it’s imperative that labs report pregnancy status with the test results, so the HD can follow up.  "
Specific changes:
  • Recommend expansion of the value set to include: Yes; No; Unknown; Currently pregnant; not currently pregnant; possible
  • Also recommend adding a data element for pregnancy status date as pregnancy status can change over time for a given patient
CSTE Comment:  
  • CSTE strongly recommends that pregnancy status be included in USCDI v3. However, a single variable is not sufficient to capture critical data that are needed for a large variety of conditions affecting the public's health, including maternal mortality, Hepatitis B and C, COVID-19, Zika, syphilis, and influenza, to name only a few. CSTE urges the inclusion of the following variables in the core data for exchange - as defined by the ONC Public Health Task Force on Capturing Pregnancy Data in Electronic Health Records and found here https://www.healthit.gov/sites/default/files/facas/HITJC_PHTF_Meeting_Slides_2017-03-30_0.pdf https://www.healthit.gov/topic/federal-advisory-committees/collaboration-health-it-policy-and-standards-committees (See May 19 transmittal letter to the NC.  Click on charge 1 - Capturing Pregnancy Status, see MS Excel Spreadsheet)
 
  1. Pregnancy Status - Yes, No, Possible, Unknown
  2. Date pregnancy status recorded
  3. Estimated delivery date
  4. Pregnancy outcome
  5. Date of pregnancy outcome and optionally
  6. Postpartum status (this is important since if the mother recently gave birth and is diagnosed with a condition that could affect the neonate, public health action might be indicated).
  • Currently there are large gaps in the ability for data from electronic health records or ELR to capture sufficient pregnancy information to identify cases and measure the burden and outcome of medical conditions and infections in pregnancy on a population level. Standardizing these data for exchange would be a substantial step forward.
  • Finally, it is very important for electronic health records to develop a way to link the mother and infant records. A unique identifier for the mother which can be included in the infant's record, and a similar unique identifier for the infant which can be included in the mother's records would help to rectify this problem, which would be beneficial for both clinical care as well for public health when we receive data on mothers and infants but cannot link them (important for diseases such as HIV, listeria, Zika, syphilis, Hepatitis B, and others)
 

Submitted by nedragarrett_CDC on 2021-09-29

Unified Comment from CDC

  • CSTE supports inclusion of this measure into USCDI v3: It is not sufficient for pregnancy information to only be referenced in problem list or as snomed code as a condition

Submitted by nedragarrett_CDC on 2021-09-28

Unified Comment from CDC

General Comment: Recommend moving this element to a new Mother's Pregnancy Information USCDI Class (not in the Observation class). Exchange of data element: The Multiple Chronic Conditions eCare Plan project successfully tested this element at the Sep 2020 and Jan 2021 FHIR connectathons and has implemented it at the OHSU testing site. 

Submitted by nedragarrett_CDC on 2020-12-10

Recommendations for Updated Submission

We've reviewed and submitted feedback on the submission we've put forward for Pregnancy Status, and we believe the information provided differs from the submission here, which has been referenced when told we submitted a duplicate. After reviewing both our submission and this submission, we feel there is much more information that can be included here. We believe our submission should be revisited as it differs in some areas to the submission seen here.

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