Description

The purpose of the use case is to demonstrate how public health programs and research stakeholders can leverage and build upon current investments^[1] in electronic case reporting (eCR) to improve the availability of data that advance national public health priorities, in this case, eliminating hepatitis C as a public health threat in the United States^[2].

Problem Statement

Effective public health and research action depends on access to timely, relevant, and complete data. Unfortunately, the availability and quality of data to public health, particularly data captured in EHRs, remains limited: current data systems and exchange standards are siloed, and existing interoperability standards are administratively cumbersome, underutilized, or otherwise limited in application and scope. Many state and local programs do not have the data necessary to assess hepatitis C disease burden and its distribution in their communities, let alone monitor trends in key epidemiological parameters and health outcomes, like those captured in the HCV care cascade (as shown in Figure 1 below). In the absence of such situational awareness, public health programs lack the information necessary to efficiently and effectively direct public health action and population health research activities. The public health consequences of this current state are illustrated by, but certainly not unique to, hepatitis C surveillance. 

Figure 1. HCV Care Cascade

Goals of the Use Case

• Develop a use case to ensure the MedMorph architecture supports the electronic reporting of comprehensive hepatitis C data by health care providers and health systems to public health, researchers, and other potential users, such as clinical registries and quality reporting entities

• Improvde the efficiency and effectiveness of hepatitis c data throughout the HCV care cascade cycle from clinical settings/EHRs to public health

• Objectives to help guide this goal include:

  • Optimize access to hepatitis C data that are already captured within the EHR

  • Reduce the implementation and reporting burden on providers and health systems by automating electronic reporting and minimizing duplicative data demands whenever possible

  • Align with existing statutory/policy requirements

Scope of the Use Case

In-Scope

• Identify and report current HCV infection to public health and through bi-directional communication send information back to health care systems

• Improve data flow and retrieve relevant data out of EHRs in a timely, less burdensome, complete fashion

 Out-of-Scope

• Data captured outside the EHR and communicated directly to registries or public health

  • This includes electronic reporting from laboratories directly to public health, as well as data sent from pharmacy systems directly to clinical registries

• Policies of the clinical care setting to collect consent for data sharing

User Stories

User stories describe real-world observations including actors, events, systems, trigger events, and actions. We have included two user stories to describe the MedMorph hepatitis C 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.

Depending on registry protocols and state/local reporting requirements (e.g., around acute or chronic case reporting), receipt of these pretreatment test results triggers an additional report (following proper consent protocols) to public health and/or the clinical registry.

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.

When the electronic order for the prescription is entered by Dr. Y, it also triggers an additional report (following proper consent protocols) to public health and the clinical registry with which Dr. Y’s practice is affiliated.

Cured

Patient X follows up with the clinical pharmacist 4 weeks after starting treatment. During each visit, the clinical pharmacist reviews any adverse events and or newly started prescriptions that may pose risk of drug-drug interactions and discusses/reinforces the importance of adherence to the regimen. Patient X follows up every 4 weeks with the clinical pharmacist while being treated. During the 3^rd 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 (virologic cure).

Receipt of the HCV RNA test result in the EHR automatically triggers an additional report (following proper consent protocols) to public health, as well as any clinical registry with which Dr. Y’s practice is affiliated.

User Story 2: Pregnant Woman and Exposed Infant – HCV Care Cascade

Diagnostic Flow

Patient A, a pregnant woman (hereafter, “Mom”), visits her OBGYN, Dr. A, for her initial prenatal care visit. During this visit, Dr. A orders routine prenatal labs, including an FDA-approved hepatitis C antibody test^[5]. An onsite lab tech draws a blood specimen from Mom via venipuncture and sends the specimen to an offsite lab.

The lab performs the recommended testing. In this case, the anti-HCV test is reactive, so an FDA-approved NAT assay for HCV RNA is performed on the same specimen (reflex testing). This, too, is reactive, indicating that Mom is currently infected with HCV. The lab sends results electronically to Dr. A. Receipt of any HCV antibody and/or HCV RNA test result in the EHR automatically triggers an initial electronic case report to public health, as well as any clinical registry with which Dr. A’s practice is affiliated.  

NOTE: the report triggered should include information indicative of current pregnancy. Ideally, this information would be communicated using emerging standards for representing pregnancy status^[6]. Alternatively, and/or additionally, other information in the EHR could be defined as being a reasonably reliable proxy indicator of potential pregnancy and so included in the report if present (e.g., calculated time since last menstrual period, recent prenatal panel test ordered).

Because current HCV treatment regimens are not approved for use during pregnancy, Dr. A does not immediately initiate a referral for treatment.

Delivery Flow

Several months later, Mom goes into labor and arrives at the hospital. Mom’s HCV infection status is communicated to the hospital staff and captured in its EHR (e.g., in the problem list or medical history) so healthcare staff can take necessary additional precautions.

Mom delivers a healthy baby girl (hereafter “Baby”). Data on the delivery and its outcome are captured in the hospital’s EHR. The combination of information indicating a live birth, as well as Mom’s documented HCV infection status, triggers the hospital EHR to send an additional report (following proper consent protocols) to public health. That report includes information on Mom; her HCV infection status (diagnosis and/or test results and date); and her delivery (delivery date and outcome).

The delivery records are also forwarded to Baby’s pediatrician, Dr. P, where it also triggers a report (following proper consent protocols)  to public health that includes information on Baby and Baby’s exposure to HCV (recognized based on Mom’s HCV infection status).

NOTE: the hospital “delivery” and pediatrician “exposure” reports triggered under this flow allow for public health follow up to ensure the exposed infant receives appropriate care. In an ideal world, the “infant” flow outlined further below would itself ensure such follow up care. But reality is often far messier, especially when it comes to communication of data across different institutions and providers for different individuals (mom, baby). Adding these reporting steps better positions public health to help ensure those connections are made—and that providers like the pediatrician know what steps to take when caring for an exposed infant.

Post-Partum Treatment Flow for Mother

Mom has a post-delivery visit with Dr. A at 2 weeks, at which time Dr. A makes a referral for Mom to see Dr. Z, an HCV treatment provider.

At her first appointment with Dr. Z, he orders a transient elastrography test (to evaluate the degree of hepatic fibrosis present); HCV genotype; and a series of lab tests, including complete HAV serology, HBV serology, 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. Z to inform his recommended HCV treatment strategy. Dr. Z’s office receives the results from these follow up tests.

Depending on registry protocols and state/local reporting requirements (e.g., around acute or chronic case reporting), receipt of these pretreatment test results triggers an additional report (following proper consent protocols) to public health and/or the clinical registry.

Mom has a second appointment with Dr. Z to discuss options. The results, which are shared with Mom, indicate that there is no liver cirrhosis present and Patient X is infected with genotype 1b. Mom indicates that she is breast feeding and would like to continue to do so until Baby is at least 6 months old. Dr. Z and Mom thus decide to defer treatment for several months, until Baby has transitioned to bottle feeding.

Approximately 5 months later, Mom has a follow up visit with Dr. Z. Mom is no longer breast feeding, and she and Dr. Z agree to initiate treatment for her hepatitis C. From here, the flow for Mom is identical to User Story #1 (treatment and cure).

Testing, Diagnosis and Treatment Flow for Infant

Based on the records he received from the hospital, Dr. P knows that Baby was exposed to HCV. During Baby’s follow-up well child check, Dr. P orders an FDA-approved Nucleic Acid Test (NAT) intended for detection of hepatitis C virus (HCV) RNA. An onsite lab tech draws a blood specimen from Baby and sends the specimen to an offsite lab.

The lab performs the recommended test, and the results are reactive. The lab sends results electronically to Dr. P. Receipt of the HCV RNA test result in the EHR automatically triggers an electronic initial case report to public health.

Dr. P makes a referral for Baby to see Dr. G, a pediatric gastroenterologist. During Baby B’s first visit with Dr. G., Dr. G explains to Mom that it is too early to initiate treatment for Baby—and that there is a possibility that Baby’s viremia will prove transient.

Because HCV direct acting antivirals (DAAs) are not approved for use in children as young as Baby, Dr. G does not initiate treatment at this time. Instead, he will continue to monitor Baby’s health until she reaches age 3.

Once Baby is 3 years old, Dr. G will evaluate Baby and make a treatment recommendation. At this point, the flow for Baby is similar to User Story #1 (treatment and cure).

Use Case Actors

EHR^[7]:  An electronic health record (EHR) is a system used in care delivery for patients and captures and stores data about patients and makes the information available instantly and securely to authorized users. While an EHR does contain the medical and treatment histories of patients, an EHR system is built to go beyond standard clinical data collected in a provider’s provision of care location and can be inclusive of a broader view of a patient’s care. EHRs are a vital part of health IT and can:

• Contain a patient’s medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory and test results

• Allow access to evidence-based tools that providers can use to make decisions about a patient’s care

• Automate and streamline provider workflow

A FHIR Enabled EHR is one which exposes FHIR APIs for other systems to interact with the EHR and exchange data. FHIR APIs provide well defined mechanisms to read and write data. The FHIR APIs are protected by an Authorization Server which authenticates and authorizes users or systems prior to accessing the data. The EHR in this use case is a FHIR Enabled EHR.

Backend Services App: A system that resides within the clinical care setting and performs the reporting functions to public health and/or research registries. The system uses the information supplied by the PHA to determine when reporting needs to be done, what data needs to be reported, how the data needs to be reported and to whom the data should be reported. The term “Backend Service” is used to refer to the fact that the system does not require user intervention to perform reporting. The term “App” is used to indicate that it is similar to SMART on FHIR App which can be distributed to clinical care via EHR specified processes. The EHR specified processes are followed to enable the Backend Services App to use the EHR's FHIR APIs to access data. The healthcare organization is the one who is responsible for choosing and maintaining the Backend Services App within the organization.

Data/Trust Services: A set of services that can be used to pseudonymize, anonymize, de-identify, hash, or re-link data that is submitted to public health and/or research. These Data/Trust services are used as appropriate by the Backend Services App.

Trusted Third Party:  A system (e.g., HIE, RCKMS/AIMS Platform) at an intermediary organization that serves as a conduit to exchange data between healthcare organizations and PHAs. Trusted Third Parties perform the intermediary functions (e.g., apply business logic and informs the Reportability Response) using appropriate authorities and policies.

Public Health Authority (PHA) Data Store: A FHIR server or service that receives and stores the hepatitis C data.

Preconditions

Preconditions describe the state of the system, from a technical perspective, that must be true before an operation, process, activity, or task can be executed. Preconditions are what needs to be in place before executing the use case flow.

The preconditions for the hepatitis c use case include:

• Data use agreements are in place when needed

• Public Health uses allowed by HIPAA and other statutory authority have been defined and implemented

• All patient encounters required to initiate and move through the care cascade take place (i.e., the patient attends) with authorized providers, and requisite steps (e.g., tests ordered, tests performed, test results received, drug prescribed) are performed and captured in the EHR using approved standards

• Registry and state/local consent protocols are followed when sending supplemental reports for non-reportable conditions

• Provisioning workflows have been established. The provisioning workflow includes activities that publish the various metadata artifacts required to make EHR data available to public health and/or research. These activities include publishing value sets, trigger codes, reporting timing parameters, survey instruments, structures for reporting etc. These artifacts are used subsequently in data collection and reporting workflows.

Use Case Flows and Diagrams

The user stories described two workflows for reporting hepatitis C diagnosis (eICR) and treatment (reporting). The sections below highlight the abstract model, main flow, activity diagram and sequence diagram for each workflow.

Hepatitis C electronic Initial Case Reporting (eICR)

The electronic Initial Case Report (eICR) is termed “initial” because the report may be the first report made to public health from the clinical provider, containing just enough pertinent data for PHAs to initiate investigation or other appropriate public health activities as necessary.

eICR Process Abstract Model

Figure 2 below is the Abstract Model that illustrates the actors, activity, and systems involved in the eICR workflow when a patient has been diagnosed with hepatitis C.

Figure 2. Hepatitis C eICR Abstract Model

The EHR sends a notification to the Backend Services App when there has been activity in topics in which the app subscribes to. The Backend Services App then queries the EHR and the EHR returns the appropriate data. The Backend Service App receives and validates the data and sends the data to the Trusted Third Party. The Trusted Third Party checks the reportability of eICR, generates a Reportability Response RR), and sends the RR to the EHR, PHA/Research Organization/Data Repository, and Backend Services App. The Backend Services App may send the RR to the EHR and sends the report to the Public Health Authority (PHA).

eICR Main Flow

The table below illustrates each actor, role, activity, input, and output of each step of the hepatitis C electronic Initial Case Reporting (eICR) workflow.

Table 1. Hepatitis C electronic Initial Case Report (eICR) Main Flow

eICR Activity Diagram

Figure 3 below illustrates the flow of events and information between the actors for the hepatitis C eICR workflow.

Figure 3. Hepatitis C eICR Activity Diagram

eICR Sequence Diagram

Figure 4 below represents the interactions between actors in the sequential order that they occur in the hepatitis C eICR workflow.

Figure 4. Hepatitis C eICR Sequence Diagram

Hepatitis C Additional Reporting

The additional reporting workflow is used during the pre-treatment assessment, treatment, and cured stages of the HCV care cascade. The sections below expand on the abstract model, main flow, activity diagram and sequence diagram for the additional reporting workflow.

Additional Reporting Process Abstract Model

For the additional reporting of treatment and follow up of hepatitis C, use the workflow as illustrated in Figure 5 below.

Figure 5. Hepatitis C Reporting Abstract Model

The EHR sends a notification to the Backend Services App when there has been activity in topics in which the app subscribes to. The Backend Services App then queries the EHR and the EHR returns the appropriate data. The Backend Service App receives and validates the data and sends the data to the Data/Trust Services. The Data/Trust Services sends the deidentified/pseudonymized/anonymized data back to the Backend Services App. The Backend Services App sends the report to the Public Health Authority (PHA). 

Additional Reporting Main Flow

Table 2 below illustrates each actor, role, activity, input, and output of each step of the hepatitis C additional reporting workflow.

Table 2. Hepatitis C Chronic Additional Reporting Main Flow

Additional Reporting Activity Diagram

Figure 6 below illustrates the flow of events and information between the actors for the hepatitis C additional reporting workflow.

Figure 6. Hepatitis C Additional Reporting Activity Diagram

Additional Reporting Sequence Diagram

Figure 7 below represents the interactions between actors in the sequential order that they occur in the hepatitis C additional reporting workflow.

Figure 7. Hepatitis C Additional Reporting Sequence Diagram

Postconditions

Postconditions describe the state of the system, from a technical perspective, that will result after the execution of the operation, process activity, or task.

Postconditions for the hepatitis C use case include:

• A hepatitis C case report and longitudinal case information resides in a registry.

Alternate Flow(s)

The hepatitis C use case has identified flows that include alternate pathways for the exchange of hepatitis C data which include:

• Convey care cascade elements to clinical registries and HIEs to support population health management activities by healthcare providers and payer

• Transfer HCV data elements for research, augmented surveillance, and population health management

Data Requirements

The table below includes the data requirements for the hepatitis C use case based on the abstract model and the use case flows^[8].

A link to the detailed data requirements spreadsheet will be provided.

Table 3. Hepatitis C Data Elements

Policy Considerations

The policy considerations for the use case to be implemented in the real-world include:

Coming soon…

Non-Technical Considerations

The non-technical considerations for the use case to be implemented in the real-world include:

Coming soon…

Appendices

Related Use Cases and Links

References to Appropriate Documentation

Terms and Definitions

Direct Acting Antiviral (DAA) Therapy: Medications targeted at specific steps within the HCV life cycle.

electronic Case Reporting (eCR): The automated generation and electronic submission of reportable diseases and conditions from an electronic health record (EHR) to public health agencies.

HCV Antibody Test: Determines infection of the hepatitis C virus (HCV). The hepatitis C antibody test looks for antibodies that the body produces in response to the presence of HCV.

HCV Care Cascade: Includes a series of necessary and inter-linked steps including the following: HCV screening by antibody testing, HCV confirmation with HCV RNA testing, linkage to HCV care, retention in care, prescription of HCV therapy, adherence to treatment, and finally achievement of SVR.

HCV RNA Test: A blood test used to diagnose hepatitis C and measure the levels of virus in the bloodstream.

Hepatitis C: Hepatitis C is a liver infection caused by the hepatitis C virus. Hepatitis C can range from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is often described as “acute,” meaning a new infection or “chronic,” meaning lifelong infection.

• Acute hepatitis C occurs within the first 6 months after someone is exposed to the hepatitis C virus. Hepatitis C can be a short-term illness, but for most people, acute infection leads to chronic infection.

• Chronic hepatitis C can be a lifelong infection with the hepatitis C virus if left untreated. Left untreated, chronic hepatitis C can cause serious health problems, including liver damage, cirrhosis (scarring of the liver), liver cancer, and even death.

Hepatitis C Virus (HCV): Causes hepatitis C.

Nucleic Acid Test (NAT): a technique used to detect a particular nucleic acid sequence and thus usually to detect and identify a particular species or subspecies of organism, often a virus or bacteria that acts as a pathogen in blood, tissue, urine, etc.

Use Case: Document used to capture user (actor) point of view while describing functional requirements of the system. They describe the step by step process a user goes through to complete that goal using a software system. A Use Case is a description of the ways an end-user wants to "use" a system. Use Cases capture ways the user and system can interact that result in the user achieving the goal. (adapted from https://www.visual-paradigm.com/)

User Story: A User Story is a note that captures what a user does or needs to do as part of his/her work. Each User Story consists of a short description written from user's point of view, with natural language. (adapted from: https://www.visual-paradigm.com/)