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Observations

Data Element

Information from the submission form

Observation Value
The information determined as a result of making the observation. The information carried by Observation.value may take several forms, depending on the nature of the observation. For example, it could be a quantitative result, and ordinal scale value, nominal or categorial value, etc.

Data Type: variable. Possible data types include: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period

Terminology Standards: The appropriate terminology depends on the observation.

A few examples:
• If the observation is quantitative, then Observation.value.units SHALL be drawn from UCUM.
• If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC.
• If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc.
• If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology
• If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used.

Comment

MedMorph's Number of Prenatal Visits

In agreement of a common template structure for specifying observations and the mechanisms for creating subsets of key domains where there is value in doing so.  Additionally, USCDI could also provide a way for defining the concepts within the key domains (e.g. concepts associated with pregnancy, vital signs, labs).   While the proposed data class ‘Observation’ may capture elements that identify a value that support Number of Prenatal Visits, it is important to distinguish and define 'Number of Prenatal Visits' as those visits recorded in the most current records available. It should not include visits for laboratory and other testing in which a physician or health care professional did not examine or counsel the pregnant woman. It should not include classes, such as childbirth classes, where the physician or health care professional did not provide individual care to the pregnant woman. These types of nuances in reporting values are defined differently among other natality values reported such as Plurality and placing them within a general value in observation may lose the integrity of the information intended to capture.  While the proposed data class ‘Observation’ captures data elements for the specified pregnancy it is important to recognize that birth, fetal death and delivery events may be captured within specific areas of a healthcare system such as labor and delivery summaries and prenatal care records. To help lessen the burden of implementations and queries of these events we propose a new Delivery and Pregnancy Information class where data elements like the Number of Prenatal Visits may be appropriately captured in this specific life event. National worksheet for reporting of live birth and US standard birth certificate: https://www.cdc.gov/nchs/data/dvs/facility-worksheet-2016-508.pdf, https://www.cdc.gov/nchs/data/dvs/birth11-03final-ACC.pdf Additional relevant specification for this data element includes the following HL7 and IHE standards: HL7 Version 2.6 Implementation Guide: Vital Records Birth and Fetal Death Reporting, Release 1 STU Release 2 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=320 IHE Quality, Research and Public Health Technical Framework Supplement – Birth and Fetal Death Reporting-Enhanced (BFDR-E) Revision 3.1: https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf Vital Records Common Profiles Library FHIR IG: http://build.fhir.org/ig/HL7/fhir-vr-common-ig/branches/master/index.html Vital Records Birth and Fetal Death Reporting:  https://build.fhir.org/ig/HL7/fhir-bfdr/index.html Birth Defect Reporting FHIR IG: https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html HL7 CDA® R2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries Release 1 , STU 2 -US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=428 Below lists examples of artifacts of where this data element is collected. EPIC stork module (obstetrics) for birth reporting: https://www.epic.com/software#PatientEngagement EPIC FHIR APIs for patient, vitals, obstetric details: https://fhir.epic.com/Specifications?api=932 https://fhir.epic.com/Specifications?api=968 https://fhir.epic.com/Specifications?api=966 BFDR-E in ISA: https://www.healthit.gov/isa/reporting-birth-and-fetal-death-public-health-agencies

MedMorph's Plurality element

While the proposed data class ‘Observation’ may capture elements that identify a value that can capture plurality, it is important to distinguish and define 'Plurality' as the number of fetuses delivered live or death at any time in the pregnancy regardless of gestational age, or if the fetuses were delivered  at different dates.  This is specified as 1 (single), 2 (twin), 3 (triplet), 4 (quadruplet), 5 (quintuplet), 6 (sextuplet), 7 (septuplet), etc.).  This is different from other natality values that are reported such as 'If not single birth, specify number of infants in this delivery born alive'.  These nuances in values reported are defined differently and placing them within a general value may lose the integrity of the information intended to capture.  This item is captured on the national standard worksheets for jurisdictions to report a live birth and fetal death. As commented on other natality reporting data elements submitted to USCDI, it is important to recognize that birth and delivery events information may be captured within specific areas of a healthcare system such as labor and delivery summaries and prenatal care records. To help lessen the burden of implementations and queries of these events is the reason to propose a new Delivery and Pregnancy Information class where data elements like Plurality may be captured. National worksheets for reporting of live birth and fetal death: https://www.cdc.gov/nchs/data/dvs/facility-worksheet-2016-508.pdf, https://www.cdc.gov/nchs/data/dvs/fetal-death-facility-worksheet-2019-508.pdf Additional relevant specification for this data element includes HL7 and IHE standards listed below. HL7 Version 2.6 Implementation Guide: Vital Records Birth and Fetal Death Reporting, Release 1 STU Release 2 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=320 IHE Quality, Research and Public Health Technical Framework Supplement – Birth and Fetal Death Reporting-Enhanced (BFDR-E) Revision 3.1: https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf Vital Records Common Profiles Library FHIR IG: http://build.fhir.org/ig/HL7/fhir-vr-common-ig/branches/master/index.html Vital Records Birth and Fetal Death Reporting:  https://build.fhir.org/ig/HL7/fhir-bfdr/index.html Birth Defect Reporting FHIR IG: https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html HL7 CDA® R2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries Release 1 , STU 2 -US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=428 Below lists examples of artifacts of where this data element is collected. EPIC stork module (obstetrics) for birth reporting: https://www.epic.com/software#PatientEngagement EPIC FHIR APIs for patient, vitals, obstetric details: https://fhir.epic.com/Specifications?api=932 https://fhir.epic.com/Specifications?api=968 https://fhir.epic.com/Specifications?api=966 BFDR-E in ISA: https://www.healthit.gov/isa/reporting-birth-and-fetal-death-public-health-agencies

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