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User stories describe real-world observations including actors, events, systems, trigger events, and actions. We have included a two user story stories to describe the MedMorph hepatitis C use caseChronic Hepatitis C Surveillance Use Case.
User Story 1: Uncomplicated Adult Male - HCV Care Cascade
HCV Testing and Diagnosis
Patient X visits his primary care doctor, Dr. Y, for a non-emergent matter. Dr. Y notices that the EHR has flagged Patient X as eligible/due for a hepatitis C test. Dr. Y places/approves an order for FDA approved hepatitis C antibody test[3], with automatic reflex to an FDA-approved Nucleic Acid Testing (NAT) assay intended for detection of hepatitis C virus (HCV) RNA to confirm the diagnosis. An onsite lab tech draws a blood specimen from Patient X via venipuncture and sends it to an offsite lab.
The lab performs the recommended testing sequence. The anti-HCV test is reactive, so an FDA-approved NAT assay for HCV RNA is performed on the same specimen (reflex testing). The NAT assay is reactive, indicating that Patient X is currently infected with HCV. The lab sends results electronically to Dr. Y. Receipt of the HCV antibody and/or HCV RNA test result in the EHR automatically triggers an initial electronic case report (eICR) to public health, as well as any clinical registry affiliated with Dr. Y’s practice.
Hepatitis C Pretreatment Assessment
A member of Dr. Y’s office calls Patient X to schedule a follow-up appointment to review/discuss test results. During that follow-up appointment, Dr. Y orders a transient elastrography test (to evaluate the degree of hepatic fibrosis present), HCV genotype, HAV serology test, HBV serology test, complete blood count (CBC), HIV tests, and a complete metabolic profile including a hepatic function panel (i.e., albumin, total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), calculated glomerular filtration rate (eGFR)). The results of these will be used by Dr. Y to inform his recommended HCV treatment strategy. Dr. Y’s office receives the results from these follow-up tests.
Since HCV appears on Patient X’s problem list, an eICR will be sent to public health and/or the clinical registry after the encounter ends.
Patient X meets with Dr. Y to discuss treatment options. The results are shared with Patient X and indicate that there is no liver cirrhosis present and Patient X is infected with genotype 1b.
Treatment
Dr. Y performs a complete medication reconciliation to ascertain any potential drug-drug interactions and learns there is no risk. Dr. Y prescribes a daily fixed-dose combination of ledipasvir (90mg)/sofosbuvir (400mg) for twelve weeks as recommended by AASLD[4]. Patient X’s insurer has a PA process in place for the medication Dr. Y is recommending, so the clinical pharmacist assembles and submits the necessary paperwork. Patient X is called by the case manager in 2 weeks that the medication has been approved and follows up with the next available appointment with the clinical pharmacist. Patient X follows up with the clinical pharmacist and receives counseling about adherence to the medication and picks up the medication and starts to take it.
Since HCV appears on Patient X’s problem list, an eICR will be sent to public health and/or the clinical registry after the encounter ends.
Cured
Patient X follows up with the clinical pharmacist every 4 weeks after starting treatment. During each visit, the clinical pharmacist reviews any adverse events and or newly started prescriptions that may pose a risk of drug-drug interactions and discusses/reinforces the importance of adherence to the regimen. During the 3rd visit, which is the end of treatment visit (12 weeks after starting treatment), the clinical pharmacist orders an HCV RNA test for 3 months later for the post-treatment assessment of cure.
Patient X goes to the lab 3 months later to be tested and returns to Dr. Y’s office to confirm HCV RNA is undetectable (sustained virologic response (SVR)).
Since HCV appears on Patient X’s problem list, an eICR will be sent to public health and/or the clinical registry after the encounter ends.
User Story 2: Pregnant Woman and Exposed Infant – HCV Care Cascade
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Data Element Name | Definition | Sample Values | 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 | USCoreCondition | code | eICR Condition.code |
HCV Treatment |
| Prescribed direct-acting antiviral (DAA) | Assessment and Plan of Treatment? | n/a | US Core MedicationRequest | 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 DocumentReference Profile | text | |
Current Drug Use |
|
| Clinical Notes? | History & Physical | US Core DocumentReference Profile | text | |
SUD/OUD Diagnosis |
|
| Problems | n/a | USCoreCondition | code | eICR Condition.code |
MAT Prescribed |
|
| Assessment and Plan of Treatment? | n/a | US Core MedicationRequest | medication[x] | eICR Composition.section:slicePlanOfTreatmentSection.entry:sliceUSCoreMedicationRequest.medication[x] |
MAT Administered | RxNorm or NDC codes |
| Medication |
| Medication Administration | medication[x] | Medication Administration.medication[x] |
Patient Name |
|
| Patient Demographics | 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.address |
Patient Age | Core variables (NEDSS standards) |
| n/a |
| Calculated from 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.location.name | ||
State of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.address.state | ||
County of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.address.district | ||
Zip code of report* | Core variables (NEDSS standards) |
| n/a |
| eICR Encounter.location.location.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 | USCoreCondition | onsetDateTime | eICR Condition.onset[x] |
Presence of symptoms of acute hepatitis* | Verifies case definition |
| Problems | n/a | USCoreCondition | code | eICR Condition.code |
Presence of jaundice* | Verifies case definition |
| Problems | n/a | USCoreCondition | 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 |
| USCoreEncounter | hospitalization | eICR Encounter.hospitalization |
Hospitalization for hepatitis dates* |
|
| n/a |
| USCoreEncounter | 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 | USCoreCondition | onsetDateTime | eICR Condition.onset[x] |
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