...
Data Element Name | Definition | Sample ValuesMustSupport | Cardinality | USCDI | USCDI Element | US Core Profile / FHIR Resource | US Core Profile / FHIR Element | eICR Profile.element | ||||||||||||||||
HCV Test |
| Anti-HCV, HCV RNA, HCV genotype | Laboratory | Tests | US Core Laboratory Result Observation Profile | code | US Core Laboratory Result Observation Profile.code | |||||||||||||||||
Hepatitis C Diagnosis | Acute, Chronic | Problems | n/a | US Core Condition Profile | code | eICR Condition.code | ||||||||||||||||||
HCV Treatment |
| Prescribed direct-acting antiviral (DAA) | Medication | Medication | US Core Medication Request Profile | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] | |||||||||||||||||
HCV Cure (SVR) | Negative HCV RNA level 6 months after starting treatment |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value | |||||||||||||||||
Pregnancy Status* | If pregnant, infants of HBV or HCV infected women should be tested for infection (see disease-specific guidelines) | HCG result positive | n/a |
| Pregnancy Status Observation | value[x] | Pregnancy Status Observation.value[x] | |||||||||||||||||
Last Menstrual Period |
|
| n/a |
| Last Menstrual Period | valueDateTime | Last Menstrual Period.valueDateTime | |||||||||||||||||
Pregnancy Outcome |
|
| n/a |
| Pregnancy Outcome Observation | valueCodeableConcept | Pregnancy Outcome Observation.valueCodeableConcept | |||||||||||||||||
Gestational Age at Outcome |
|
| n/a |
| Pregnancy Status Observation | component:sliceEstimatedGestationalAgeOfPregnancy.valueQuantity | Pregnancy Status Observation.component:sliceEstimatedGestationalAgeOfPregnancy.valueQuantity | |||||||||||||||||
Infant Born with Neonatal Abstinence Syndrome (NAS) |
|
| Problems | n/a | US Core Condition Profile | code | eICR Condition.code | |||||||||||||||||
Injected Drug Use (ever) |
|
| Clinical Notes? | History & Physical | US Core Document Reference Profile | text | Current Drug Use |
|
| Clinical Notes? | History & Physical | US Core Document Reference Profile | text | SUD/OUD Diagnosis |
| Date of diagnosis* | Date of test result confirming infection | Problems | n/a | US Core Condition Profile | onsetDateTime | eICR Condition.onset[x] | ||
Date of illness onset* | Date of the first sign or symptom of hepatitis | Problems | n/a | US Core Condition Profile | onsetDateTime | eICR Condition.onset[x] | ||||||||||||||||||
Presence of symptoms of acute hepatitis* | Verifies case definition | Problems | n/a | US Core Condition Profile | code | eICR Condition.code | ||||||||||||||||||
Presence of jaundice* | Verifies case definition | Problems | n/a | US Core Condition Profile | code | eICR Condition.code | ||||||||||||||||||
ALT level* | Verifies case definition | Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | ||||||||||||||||||
HCV Treatment | An RXNORM code for HCV medication is present | Medication | Medication | US Core Medication Request Profile | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] | ||||||||||||||||||
HCV Cure (SVR) | Negative HCV RNA level 6 months after starting treatment | Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value | ||||||||||||||||||
anti-HCV* | anti-HCV positive test results require confirmation by an additional more specific assay or for anti-HCV, a S/CO ratio ≥3.8. Verifies case definition. Determine all results (positive and negative). | Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | ||||||||||||||||||
Pregnancy Status* | If pregnant, infants of HBV or HCV infected women should be tested for infection (see disease-specific guidelines) | n/a |
| Pregnancy Status Observation | value[x] | Pregnancy Status Observation.value[x] | ||||||||||||||||||
SUD/OUD Diagnosis |
| Problems | n/a | US Core Condition Profile | code | eICR Condition.code | ||||||||||||||||||
MAT Prescribed |
|
| Assessment and Plan of Treatment? | n/a | US Core Medication Request Profile | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] | MAT Administered | RxNorm or NDC codes | |||||||||||||||
Patient Name | Medication | Patient Demographics |
| Medication Administration | medication[x] | Medication Administration.medication[x] | Patient Name |
|
| Patient Demographics | First Name Last Name | US Core First Name Last Name | US Core Patient Profile | name.given name.family | eCR Patient.name | |||||||||
Patient Address |
|
| Patient Demographics | Current Address | US Core Patient Profile | address | eCR Patient.addressPatient Age | |||||||||||||||||
Date of birth* | Core variables (NEDSS standards) |
| n/a |
| Calculated from | Patient Demographics | Date of Birth | US Core Patient Profile | birthDate | eCR Patient.birthDate | ||||||||||||||
Patient Sex | Core variables (NEDSS standards) | Patient Demographics | Birth Sex | US Core Patient Profile | us-core-birthsex | eCR Patient.us-core-birthsex | ||||||||||||||||||
Patient Race | Core variables (NEDSS standards) |
| Patient Demographics | Race | US Core Patient Profile | us-core-race | eCR Patient.us-core-race | |||||||||||||||||
Patient Ethnicity | Core variables (NEDSS standards) | Patient Demographics | Ethnicity | US Core Patient Profile | us-core-ethnicity | eCR Patient.us-core-ethnicity | ||||||||||||||||||
Origin of report* | Site requesting viral hepatitis testing | n/a |
| eICR Encounter.location.eICRLocation.name | ||||||||||||||||||||
State of report* | Core variables (NEDSS standards) | n/a |
| eICR Encounter.location.eICRLocation.address.state | ||||||||||||||||||||
County of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.eICRLocation.address.district | |||||||||||||||||||
Zip code of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.eICRLocation.address.postalCode | |||||||||||||||||||
Date of birth* | Core variables (NEDSS standards) |
| Patient Demographics | Date of Birth | US Core Patient Profile | birthDate | eCR Patient.birthDate | |||||||||||||||||
Date of illness onset* | First sign or symptom of hepatitis |
| Problems | n/a | US Core Condition Profile | onsetDateTime | eICR Condition.onset[x] | |||||||||||||||||
Presence of symptoms of acute hepatitis* | Verifies case definition |
| Problems | n/a | US Core Condition Profile | code | eICR Condition.code | |||||||||||||||||
Presence of jaundice* | Verifies case definition |
| Problems | n/a | US Core Condition Profile | code | eICR Condition.code | |||||||||||||||||
ALT level* | Verifies case definition |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
Hospitalization for hepatitis* | If yes, verify dates of hospitalization |
| n/a |
| US Core Encounter Profile | hospitalization | eICR Encounter.hospitalization | |||||||||||||||||
Hospitalization for hepatitis dates* |
|
| n/a |
| US Core Encounter Profile | period | eICR Encounter.period | Death from hepatitis* | If yes, review death certificate and medical records to rule out other potential causes of death and to confirm acute liver failure as the cause of death |
| n/a |
| Condition | outcome (extension) | ||||||||||
IgM anti-HAV* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
HBsAg* | HBsAg positive test results require confirmation by an additional more specific assay
Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
IgM anti-HBc* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
anti-HCV* | anti-HCV positive test results require confirmation by an additional more specific assay or for anti-HCV, a S/CO ratio ≥3.8. Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
anti-HDV* | Verifies case definition. Determine all results (positive and negative). |
| Laboratory | Values/ Results | US Core Laboratory Result Observation Profile | value[x] | US Core Laboratory Result Observation Profile.value[x] | |||||||||||||||||
Date of diagnosis* | Date of test result confirming infection |
| Problems | n/a | US Core Condition Profile | onsetDateTime | eICR Condition.onset[x].address.postalCode | |||||||||||||||||
Hospitalization for hepatitis* | If yes, verify dates of hospitalization | n/a |
| US Core Encounter Profile | hospitalization | eICR Encounter.hospitalization | ||||||||||||||||||
Hospitalization for hepatitis dates* |
| n/a |
| US Core Encounter Profile | period | eICR Encounter.period | ||||||||||||||||||
Death from hepatitis* | If yes, review death certificate and medical records to rule out other potential causes of death and to confirm acute liver failure as the cause of death | n/a |
| Condition | outcome (extension) | US Core Condition.category (coming soon) |
Table 3. Hepatitis C Data Elements
...