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Table of Contents

Description

The purpose of the use case is to transmit cancer case information to state central cancer registries. The intent is to provide access to data not currently available, or available through non-standard and/or manual methods; it will not replace hospital registry reporting methods that are working well. The cancer use case will help assess how to address the gaps in workflow and triggers, and the ability to leverage MedMorph RA IG along with other existing HL7 FHIR® Implementation Guides to address the public health information needs.

Problem Statement

Cancer is a mandatory reportable disease; every state has public health law/regulation requiring information to be reported to a central cancer registry about all cancers diagnosed or treated within that state. Central cancer registries are population-based cancer registries that collect data on all cancer diagnosed in residents in a defined geographic area. The main sources of information include information from treatment facilities (e.g., hospitals, clinics/physician offices), diagnostic services (e.g., pathology laboratories) and vital statistics (e.g., death certificates). Central cancer registries have an emphasis on epidemiology and public health to determine patterns among various populations, monitor cancer trends over time, guide planning and evaluation of cancer control efforts, help prioritize health resource allocations and to advance clinical, epidemiologic and health services research 1. Even with reporting requirements, cancer surveillance is complex given the heterogeneous nature of the disease, numerous diagnostic and prognostic factors, and multiple medical encounters that produce data from a variety of non-harmonized data sources.

Challenges include:

  • Inability to identify which patient diagnoses and encounters require reporting

  • A lack of data in discrete fields (e.g., narrative blob text fields, PDF documents)

  • Issues with data flow

  • Delays in data availability

  • Managing proper timing of creating and transmitting reports

  • A lack of standardized systems for cancer data collection and reporting (in some cases)

These challenges make it difficult for registries to synthesize information in a timely and actionable way. Automation of cancer case registry reporting will reduce the burden of manual or other non-standardized data collection processes that currently exist.

Goals of the Use Case

The goal of this use case is to automate the capture of cancer cases and cancer treatment information not reported by other sources and provide incidence data faster for research and public health. It will leverage the Making Electronic Data More Available for Research and Public Health (MedMorph) Reference Architecture (RA) IG and other existing FHIR® infrastructure to transmit cancer case information primarily from ambulatory care practices to central cancer registries. This Use case will not replace hospital registry reporting methods which are working well. Additionally, this use case aims to identify data standards that allow for the collection and transmission of these data electronically from EHRs automatically rather than relying on labor-intensive manual processes and duplications of effort.

Scope of the Use Case

In-Scope

  • Collect standardized data on all types of reportable cancers diagnosed and/or treated

  • Define under what circumstances an EHR system must create and transmit a cancer report to the central cancer registry

  • Identify the data elements to be retrieved from the EHR to produce the cancer report

  • Use NAACCR Volume II data dictionary for standardized data collection

  • Include data collection along the longitudinal spectrum (Diagnosis -> Staging -> Initial Treatment -> Death)

Out-of-Scope

  • Validation of the EHR data

  • Data captured outside the EHR and communicated directly to registries

  • Changes to existing provider workflow or existing data entry

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

  • Integrating claims data into the trigger event to send a report to the cancer registries

Use Case Actors

Electronic Health Record (EHR): 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 Data Source 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.

Health Data Exchange (HDEA) (MedMorph’s 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 metadata repository 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 a SMART on FHIR App which can be distributed to clinical care via EHR vendor specified processes. The EHR vendor 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.

Central Cancer Registry: A data repository that receives and stores cancer case information.  Data Repositories are actively managed and are used to receive data, store data, and perform analysis as appropriate. These data repositories could be operated or accessed by PHA (or their designated organizations), research organizations with appropriate authorities and policies.

Central Cancer Registry Reporting Process Abstract Model

Figure 1 below is the Abstract Model that illustrates the actors, activity, and systems involved in the Central Cancer Registry Reporting Use Case workflow.

Figure 1: Central Cancer Registry Reporting Process Abstract Model

Use Case User Stories and Diagrams

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 need to be in place before executing the use case flow.

The preconditions for the cancer registry reporting use case include:

  • Use Case Trigger: A cancer diagnosis has been recorded in the EHR

  • EHR and central cancer registry systems support HL7 FHIR APIs

  • Pertinent data elements are captured discretely in the EHR

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

  • Provisioning workflows have been established. The 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.

User Stories

User Story Cancer Diagnosis and Treatment - Reporting based on Specific Criteria

A patient visits her primary care provider (PCP) because of a lump in her breast. The provider orders a mammogram and then a biopsy that is sent to the pathology laboratory for testing. The laboratory analyzes the biopsy specimen which indicates the patient has breast cancer. The pathology report is sent to the provider who ordered the biopsy. On January 20, 2022, the provider confirms the diagnosis of breast cancer. This information is integrated into the patient’s EHR. The patient is informed of her test results. The PCP clinic’s electronic reporting system determines that the patient has been diagnosed with a cancer that meets the criteria for reporting to the central cancer registry, as defined by the national standard Cancer Reportability List. These lists and other reportability criteria are contained in the Health Data Exchange App (HDEA), MedMorph’s backend services app. The HDEA handles all the trigger events for exchanging a patient’s EHR information across systems and is notified when the encounter is closed. The HDEA creates a standard report with the required data elements and sends it to the central cancer registry in the state where the patient resides, as required by state law. On February 2, 2022, the PCP orders a further workup and clinically stages the patient’s cancer. This information is also included in the patient’s EHR. The HDEA recognizes that this initial staging information does not meet the criteria for reporting because the information has been added within six months of the initial report transmitted to the central cancer registry (i.e., the initial report was sent January 20, 2022, and the staging information was done February 2, 2022). Thus, the staging information is in the EHR, but does not yet trigger the HDEA to report or exchange this information.

The patient has surgery on February 9, 2022, and the PCP refers her to a medical oncologist in the same clinic for further treatment. The medical oncologist sends the patient to the radiation therapy department to initiate radiation therapy as part of the first course of treatment for her breast cancer. Radiation therapy is given through September 29, 2022 and is documented in the EHR as the reason for the encounter/visit. The HDEA is notified of this update by the patient’s EHR and determines that the patient was seen for treatment of a cancer that meets the criteria for reporting to the central cancer registry and is more than six months after the initial diagnosis was transmitted to the central cancer registry. Thus, the HDEA creates a standard report with the required data elements and securely sends it to the central cancer registry in the state where the patient resides, as required by state law.

After radiation was completed on September 29, 2022, the medical oncologist initiates the chemotherapy regimen on October 10, 2022, as part of the first course of treatment for her breast cancer. The chemotherapy drugs are infused, and the chemotherapy treatment is documented in the EHR as the reason for the encounter/visit. The HDEA determines that the patient was seen for treatment of a cancer that meets the criteria for reporting to the central cancer registry; however, it does not meet the criteria for transmitting to the central registry because it has been added to the EHR between 6 months and 12 months of the initial diagnosis and transmission of a cancer report.

After 12 months from the initial diagnosis and transmission of a cancer report to the central cancer registry, the HDEA generates and sends a standard report with essential data elements to the central cancer registry in the state where the patient resides. At every subsequent 12 months after the initial diagnosis and transmission of a cancer report to the central cancer registry, the HDEA generates and sends a standard report with essential data elements to the central cancer registry in the state where the patient resides, until the patient is recorded as deceased or there have been no updates to the patient’s EHR record. These timed exchanges of a patient’s EHR information are triggered by criteria set up in the HDEA and run seamlessly in the background without human intervention, which eases mandatory reporting requirements.

Cancer Diagnosis and Treatment Main Flow

The table below illustrates each actor, role, activity, input, and output of each step of the Cancer Diagnosis and Treatment user story.

Step

Actor

Role

Activity

Input(s)

Output(s)

1

EHR System

Notifier

Notify the HDEA that criteria have been met

Trigger code

Notification message

2

HDEA

Evaluator

Evaluate notification message against criteria

Notification message content

Continuation decision based on available information

3

HDEA

Data Extractor

Query the EHR for cancer data

Notification message

FHIR query

4

EHR System

Query Responder

Return cancer data

FHIR query

FHIR resources

5

HDEA

Decision Logic Evaluator

Evaluate if a report needs to be sent

FHIR resources

FHIR resources

6

HDEA

Data Receiver

Receive FHIR resources and validate FHIR bundle

FHIR resources

FHIR validated bundle

7

HDEA

Data Sender

Send validated FHIR bundle to Central Cancer Registry

FHIR validated bundle

FHIR validated bundle

8

Central Cancer Registry

Data Receiver

Receive and validate FHIR bundle

FHIR bundle

Validated FHIR bundle

9

Repeat Steps 1-8 for any category notification that meets the reporting criteria as needed

 

Table 1: Cancer Diagnosis and Treatment Flow

Cancer Diagnosis and Treatment Activity Diagram

Figure 2 below illustrates the flow of events and information between the actors for the Cancer Diagnosis and Treatment workflow.

Figure 2: Cancer Diagnosis and Treatment Activity Diagram

Cancer Diagnosis and Treatment Sequence Diagram

Figure 3 below represents the interactions between actors in the sequential order that they occur in the Cancer Diagnosis Treatment workflow.

Figure 3: Cancer Diagnosis and Treatment Sequence Diagram

Alternate Flow – Reporting Every Encounter

Cancer - Reporting Every Encounter Alternate Flow

The Cancer Diagnosis and Treatment – Reporting Every Encounter user story remains the same as the Cancer Diagnosis and Treatment user story except instead of identifying a category of criteria that triggers a report, the “all reports” criteria are set.

The table below illustrates each actor, role, activity, input, and output of each step of the Alternate Cancer Diagnosis and Treatment Reporting Every Encounter user story

Step

Actor

Role

Activity

Input(s)

Output(s)

1

EHR System

Notifier

Notify the HDEA that criteria have been met

Trigger code

Notification message

2

HDEA

Evaluator

Evaluates notification message against criteria

Notification message content

Submittal decision based on available information

3

HDEA

Data Extractor

Query the EHR for cancer data

Notification message

FHIR query

4

EHR System

Query Responder

Return cancer data

FHIR query

FHIR resources

5

HDEA

Data Receiver

Receive and validate FHIR resources

FHIR resources

FHIR validated bundle

6

HDEA

Data Sender

Send validated FHIR bundle to Central Cancer Registry

FHIR validated bundle

FHIR validated bundle

7

Central Cancer Registry

Data Receiver

Receive and validate FHIR bundle

FHIR bundle

Validated FHIR bundle

8

Repeat Steps 1-7 for all reports

 

Table 2: Cancer - Reporting Every Encounter Alternate Flow

Cancer - Reporting Every Encounter Activity Diagram

Figure 4 below illustrates the flow of events and information between the actors for the Cancer Diagnosis and Treatment -  Reporting Every Encounter workflow.

Figure 4: Cancer - Reporting Every Encounter Activity Diagram

Cancer - Reporting Every Encounter Sequence Diagram

Figure 5 below represents the interactions between actors in the sequential order that they occur in the Cancer Diagnosis and Treatment – Reporting Every Encounter workflow.

Figure 5: Cancer - Reporting Every Encounter Sequence Diagram

Postconditions

  • The submitted cancer report resides in the central cancer registry.

Data Requirements

Cancer Data Elements: Note that these are pulled from NAACCR Version 21 Data Standards and Data Dictionary.

The table below illustrates the data element, definition, sample values or codes, USCDI, and USCDI element name for cancer reporting.

Click here for a detailed MS Excel version of the table below which includes mapping to US Core, USCDI, mCODE, and electronic Case Reporting (eCR).

NAACCR Data Item #

NAACCR Data Item Name

Use Case Data Element Name

Definition

USCDI V1 Data Class

USCDI V1 Data Element

US Core Profile / FHIR Resource

US Core / FHIR element

Sample Value

Sample Value Display Name

Code System OID

Code System Name

Value Set OID

2110

Date Case Report Exported

Date Report Generated

effectiveTime (Date Document was Generated)

 

 

 

 

 

 

 

 

 

 

 

?  

CDA Element: setId

 

 

 

 

 

 

 

 

 

 

Version Number

CDA Element: Version Number

 

 

 

 

1

 

 

 

2508

EHR Vendor Name

EHR Vendor Name

The name of the software vendor for the EHR that created the report

Provenance

us-core-provenance.agent:ProvenanceTransmitter.who(Device).manufacturer WHERE Provenance.agent:ProvenanceTransmitter.type=composer

Epic

2508

EHR Software Name

EHR Software Name 

The name of the software that created the report

Provenance

us-core-provenance.agent:ProvenanceTransmitter.who(Device).deviceName WHERE Provenance.agent:ProvenanceTransmitter.type=composer

Beacon

2508

EHR Software Version

EHR Software Version

The version number of the software that created the report

Provenance

us-core-provenance.agent:ProvenanceTransmitter.who(Device).version WHERE Provenance.agent:ProvenanceTransmitter.type=composer

V 1.4

Patient Information

2330

Name--Last

Patient Last Name

Last name of the patient.

Patient Demographics

Last Name

US Core Patient Profile

Patient.name.family

Shepherd

 

 

 

 

2240

Name--First

Patient First Name

First name of the patient.

Patient Demographics

First Name

US Core Patient Profile

Patient.name.given

Meredith

 

 

 

 

2250

Name--Middle

Patient Middle Name

Middle name or, if middle name is unavailable, middle initial of the patient.

Patient Demographics

Middle Name

US Core Patient Profile

Patient.name.given

Lynn

 

 

 

 

2390

2280

Name--Birth Surname 

Name--Alias

Patient Name Use

Identifies the purpose for this name

Patient Demographics

Previous Name

2270

Name--Suffix

Patient Suffix

Title that follows a patient's last name, such as a generation order or credential status (e.g., "MD," "Jr.").

Patient Demographics

Suffix

US Core Patient Profile

Patient.name.suffix

 

 

 

 

 

2350

2355

Addr Current--No & Street

Addr Current--Supplementl

Patient Street Address

The number and street address or the rural mailing address of the patient’s current usual residence. This can be used to generate a follow-up inquiry and must correspond to other fields in the current address. If the patient has multiple tumors, the current address should be the same. 

Patient Demographics

Current Address

US Core Patient Profile

Patient.address.line

111 Main Street

 

 

 

1810

Addr Current--City

Patient Address City

Name of city of the patient’s current usual residence. If the patient has multiple tumors, the current city of residence should be the same for all tumors.

Patient Demographics

Current Address

US Core Patient Profile

Patient.address.city

Seattle

 

2.16.840.1.113883.6.245

U.S. Board on Geographic Names (USGS - GNIS)

2.16.840.1.114222.4.11.973

1820

Addr Current--State

Patient Address State

USPS abbreviation for the state, territory, commonwealth, U.S. possession, or CanadaPost abbreviation for the Canadian province/territory of the patient’s current usual residence. If the patient has multiple tumors, the current state of residence should be the same for all tumors. 

Patient Demographics

Current Address

US Core Patient Profile

Patient.address.state

WA

 

2.16.840.1.113883.6.92

FIPS 5-2 (State)

2.16.840.1.113883.3.88.12.80.1

1830

Addr Current—Postal Code

Patient Address Zip Code

Postal code for the address of the patient’s current usual residence. If the patient has multiple tumors, the postal codes should be the same. For U.S. residents, use either the 5-digit or the extended 9-digit ZIP code. Blanks follow the 5-digit code. For Canadian residents, use the 6-character alphanumeric postal code. Blanks follow the 6-character code. When available, enter postal code for other countries.

Patient Demographics

Current Address

US Core Patient Profile

Patient.address.postalCode

98101

 

2.16.840.1.113883.6.231

USPostalCodes

2.16.840.1.113883.3.88.12.80.2

1832

Addr Current--Country

Patient Address Country

Country code for the address of patient’s current usual residence. If the patient has multiple tumors, the current country of residence should be the same for all tumors. 

Patient Demographics

Current Address

US Core Patient Profile

Patient.address.country

US

 

2.16.840.1.113883.3.88.12.80.63

Country

2.16.840.1.113883.3.88.12.80.63

 

Note: Doesn't map directly, but very important in determining current address vs. address at diagnosis

Patient Address Start Date

Address start date

Patient Demographics

Current Address or Previous Address?

US Core Patient Profile

Patient.address.period

June 23, 2005

 

 

 

 

 

Note: Doesn't map directly, but very important in determining current address vs. address at diagnosis

Patient Address End Date

address end date

Patient Demographics

Current Address or Previous Address?

US Core Patient Profile

Patient.address.period

nullFlavor="NA"

 

 

 

 

2360

Telephone

Patient Phone Number

Current telephone number with area code for the patient. Number is entered without dashes. Includes codes (in addition to valid telephone number).

Patient Demographics

Phone Number

US Core Patient Profile

Patient.telecom.value

(206)555-1313

 

 

 

 

220

Sex

Patient Gender

Administrative Gender - the gender that the patient is considered to have for administration and record keeping purposes.

US Core Patient Profile

Patient.gender

F

Female

2.16.840.1.113883.5.1

AdministrativeGender

2.16.840.1.113883.1.11.1

240

Date of Birth

Patient date of birth

Date of birth of the patient.

Patient Demographics

Date of Birth

US Core Patient Profile

Patient.birthDate

February 20, 1960

 

 

 

 

2300

Medical Record Number

Patient medical record number

Records medical record number used by the facility to identify the patient.

 

 

US Core Patient Profile

Patient.identifier.value

979746186

 

 

 

 

 

Patient identifier type

Patient Identifier System

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

 

 

US Core Patient Profile

Patient.identifier.type=MR

MR

 

 

 

 

2320

Social Security Number

Patient Social Security Number

Records patient’s social security number. The number is entered without dashes and without any letter suffix. This is not always identical to the Medicare claim number. 

 

 

US Core Patient Profile

Patient.identifier.value

333-44-5555

 

 

 

 

 

Patient identifier type

Patient Identifier System

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

 

 

US Core Patient Profile

Patient.identifier.type=?

 

 

 

 

 

2315

Medicare Beneficiary Identifier

Patient Medicare Beneficiary number

Congress passed the Medicare Access and CHIP Reauthorization ACT to remove Social Security Number (SSN) from Medicare ID card and replace the existing Medicare Health Insurance Claim Numbers with a Medicare Beneficiary Identifier (MBI). The MBI will be a randomly generated identifier that will not include a SSN or any personal identifiable information.

 

 

US Core Patient Profile

Patient.identifier.value

 

 

 

 

 

 

Patient identifier type

Patient Identifier System

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

 

 

US Core Patient Profile

Patient.identifier.type=SB

SB

 

 

 

 

160

Race 1

Patient first reported race

A person's self-identification with one or more social groups.
First reported race. (If the patient is multiracial, report all races using RACE 2 through RACE 5.) 

Patient Demographics

Race

US Core Patient Profile

Patient.extension:us-core-race

2054-5

Black or African American

2.16.840.1.113883.6.238

Race & Ethnicity - CDC

2.16.840.1.113883.1.11.14914

190

Spanish/Hispanic Origin

Patient Ethnicity

A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin regardless of race

Patient Demographics

Ethnicity

US Core Patient Profile

Patient.extension:us-core-ethnicity

2186-5

Not Hispanic or Latino

2.16.840.1.113883.6.238

Race & Ethnicity - CDC

2.16.840.1.114222.4.11.837

252

Birthplace--State

Patient State of Birth

USPS abbreviation for the state, territory or U.S. possession.

 

 

 

 

PA

 

2.16.840.1.113883.6.92

FIPS 5-2 (State)

2.16.840.1.113883.3.88.12.80.1

254

Birthplace--Country

Patient Country of Birth

The country in which the patient was born.

 

 

 

 

US

 

2.16.840.1.113883.3.88.12.80.63

Country

2.16.840.1.113883.3.88.12.80.63

150

Marital Status at DX

Patient Marital Status

Code for the patient’s marital status. (removed the NAACCR requirement that it's status at time of diagnosis)

 

 

US Core Patient Profile

Patient.maritalStatus 

M

Married

2.16.840.1.113883.5.2

MaritalStatus

2.16.840.1.113883.1.11.12212

1760

Vital Status

Vital Status

Vital status (dead or alive) of the patient as of the date entered in Date of Last Contact [1750]. If the patient has multiple tumors, vital status should be the same for all tumors.

 

 

Patient

Patient.deceasedBoolean

false

 

 

 

 

Date of First Contact

Date of Patient First Visit

Date of the patient's first visit with the reporting provider

 

 

eICR Encounter

period.start

 

 

 

 

 

1750

Date of Last Contact

Date of Death

Date of last contact with the patient, or date of death. If the patient has multiple tumors, Date of Last Contact should be the same for all tumors.

 

 

 

Patient.deceasedDateTime

 

 

 

 

 

 

Patient Smoking Status

Current smoking status

Smoking Status

Smoking Status

US Core Smoking Status Observation Profile

Observation.valueCodeableConcept.code

8517006

Former smoker

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.113883.11.20.9.38

 

 

Patient Smoking Status Date

Date patient's smoking status was recorded

 

 

US Core Smoking Status Observation Profile

Observation.effective[x]

<date of the encounter>

 

 

 

 

Encounter Information 

 

Note: Doesn't map directly, but important for context for other elements

Encounter period

The start and end times of the encounter.

 

 

US Core Encounter Profile

Encounter.period

 

 

 

 

 

 

 

Classification of Pt, Encounter

inpatient | outpatient | ambulatory | emergency +. 

 

 

US Core Encounter Profile

Encounter.class

 

 

 

 

 

 

 

Encounter subject

The patient or group present at the encounter.

 

 

US Core Encounter Profile

Encounter.subject

 

 

 

 

 

 

 

Encounter Identifier

Identifier(s) by which this encounter is known.

 

 

US Core Encounter Profile

Encounter.identifier.value

 

 

 

 

 

 

 

Encounter participant type

Role of participant in encounter.

 

 

US Core Encounter Profile

Encounter.participant.type

 

 

 

 

 

 

 

Primary participant  responsible for encounter 

Encounter principal  performer of service.

 

 

US Core Encounter Profile

Encounter.participant.type=PPRF

 

 

 

 

 

 

 

Participant  overseeing  the encounter 

Participant  overseeing  the encounter 

 

 

US Core Encounter Profile

Encounter.participant.type=ATND

 

 

 

 

 

 

 

Encounter participant individual

Persons involved in the encounter other than the patient. Reference(US Core Practitioner Profile)

 

 

US Core Encounter Profile

Encounter.participant.individual

 

 

 

 

 

 

 

Encounter primary performer NPI

NPI of encounter principal performer.

 

 

US Core Encounter Profile

Encounter.participant.individual.Practitioner.identifier:NPI

 

 

 

 

 

 

 

Encounter primary performer name

Name of encounter principal performer.

 

 

US Core Encounter Profile

Encounter.participant.individual.Practitioner.name

 

 

 

 

 

 

 

Encounter primary performer professional  role

Professional role of encounter principal performer.

 

 

?

Encounter.participant.individual.PractitionerRole.code

 

 

 

 

 

 

 

Encounter location address

The location where the encounter takes place.

 

 

US Core Encounter Profile

Encounter.location.location.address

 

 

 

 

 

 

 

Encounter location NPI

The NPI Number for the facility where the encounter takes place

 

 

 

 

 

 

 

 

 

630

Primary Payer at DX

Primary payer type

The type of coverage: social program, medical plan, accident coverage (workers compensation, auto), group health or payment by an individual or organization.

 

 

US Core Encounter Profile

Encounter.account.coverage.type

 

BC Managed Care or equivalent

 

 

 

580

Date of First Contact

Date of Patient First Visit

Date of the patient's first visit with the reporting provider

 

 

Encounter Diagnosis

Enounter diagnosis.

 

 

Encounter Service Provider

The organization (facility) responsible for this encounter

 

 

Encounter Reason Code

Coded reason the encounter takes place

 

 

Encounter Reason Reference

Reason the encounter takes place (reference)

Provider Information

 

 

Practitioner Name

The full name of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.name.text

Alex Karev, MD

 

 

 

 

 

 

Practitioner Last Name

The last name of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.name.family

Karev

 

 

 

 

 

 

Practitioner First Name

The first name of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.name.given

Alex

 

 

 

 

Practitioner Address

The address of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

 

Practitioner Street Address

The street address of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.address

999 Ellis Way

 

 

 

 

 

 

Practitioner Address City

The city of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.address

Seattle

 

2.16.840.1.113883.6.245

U.S. Board on Geographic Names (USGS - GNIS)

2.16.840.1.114222.4.11.973

 

 

Practitioner Address State

the State of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.address

WA

 

2.16.840.1.113883.6.92

FIPS 5-2 (State)

2.16.840.1.113883.3.88.12.80.1

 

 

Practitioner Address Postal Code

The postal code of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.address

98101

 

2.16.840.1.113883.6.231

USPostalCodes

2.16.840.1.113883.3.88.12.80.2

 

 

Practitioner Address Country

The country of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

USCorePractitionerProfile

Practitioner.address

US

 

2.16.840.1.113883.3.88.12.80.63

Country

2.16.840.1.113883.3.88.12.80.63

 

 

Practitioner Email Address

The email of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

Provenance and/or Care Team Members?

 

 

 

Akarev@GraceOnc.com

 

 

 

 

 

 

Practitioner Telephone Number

The telephone number of the physician playing a specific role for the patient during diagnosis and/or treatment for this cancer.

Care Team Members

 

 

 

(206) 555-3921

 

 

 

 

Provider Role

The role of the provider, which would apply to each of the individual provider types (above)

Care Team Members

 

 

 

 

 

 

 

 

2495

NPI--Physician 3

Practitioner Specialty NPI

The NPI (National Provider Identifier) code for another physician (e.g., managing provider, radiation oncologist, medical oncologist) involved in the care of the patient.

Care Team Members

 

 

 

 

 

 

 

 

Primary Cancer Condition 

1770

Cancer Status

Cancer Condition Clinical Status

The clinical status of the condition.

Problems

Problems

us-core-condition

us-core-condition.clinicalStatus

active

 

 

 

 

390

Date of Diagnosis

Cancer Date of Diagnosis

Date of initial diagnosis by a recognized medical practitioner

Problems

Problems

Document Reference or Diagnostic Report or Condition

 

January 26, 2018

 

 

 

 

 

Doesn't map to a SINGLE item

Cancer Diagnosis Code

Code for the cancer diagnosis being reported

Problems

Problems

Condition

 

408643008

Infiltrating duct carcinoma of breast (disorder)

2.16.840.1.113883.6.96

SNOMED CT

Needs to be developed

 

Doesn't map to a SINGLE item

Cancer Diagnosis Code

Code for the cancer diagnosis being reported

 

 

 

 

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

2.16.840.1.113883.6.90

ICD-10-CM

Have list of values in emarc; will need to publish as value set

522

Histologic Type ICD-O-3

Cancer Histologic Type

The histologic type of the tumor

Problems

Problems

Condition

 

8500/3 OR 8500

Infiltrating duct carcinoma, NOS

2.16.840.1.113883.6.43.1

ICD-O-3

Is there a way for us to create a VS to restrict these to only the Morphology codes? 

 

Histologic Type ICD-O-3

Cancer Histologic Type

 

 

 

 

 

82711006

Infiltrating duct carcinoma

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.114222.4.11.7256

523

Behavior Code ICD-O-3

Cancer Behavior

The behavior of the tumor (morphology)

Problems

Problems

Condition

 

3

Malignant, primary site

2.16.840.1.113883.3.520.3.14

NAACCR Behavior Code

2.16.840.1.113883.3.520.4.14

3843

Grade Clinical

Cancer Clinical Grade

The clinical grade of a solid primary tumor before any treatment (surgical resection or initiation of any treatment including neoadjuvant). 

Problems

Problems

Condition

 

1

Grade I

2.16.840.1.113883.3.520.3.15

NAACCR Grade

2.16.840.1.113883.3.520.4.15

3844

Grade Pathological

Cancer Pathological Grade

The pathological grade of a solid primary tumor that has been resected and for which no neoadjuvant therapy was administered

Problems

Problems

Condition

 

1

Grade I

TBD

TBD

TBD

3845

Grade Post Therapy Path (yp)

Cancer Post Treatment Grade

The post-treatment grade of a solid primary tumor that has been resected following neoadjuvant therapy

Problems

Problems

Condition

 

1

Grade I

TBD

TBD

TBD

490

Diagnostic Confirmation ICD-O-3

Cancer Diagnostic Confirmation Method

Code for the best method of diagnostic confirmation of the cancer being reported at any time in the patient’s history.

Problems

Problems

Condition

 

1

Positive histology

2.16.840.1.113883.3.520.3.3

NAACCR Diagnostic Confirmation

2.16.840.1.113883.3.520.4.3

400

Primary Site

Cancer Primary Site

Code for the primary site of the tumor being reported

Problems

Problems

Condition

 

C50.4

Upper-outer quadrant of breast

2.16.840.1.113883.6.43.1

ICD-O-3

Is there a way for us to create a VS to restrict these to only the Topography codes? 

 

Primary Site

Cancer Primary Site

 

 

 

 

 

110496004

Upper outer quadrant of right breast

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.113883.3.88.12.3221.8.9

 

Primary Site

Cancer Primary Site

 

 

 

 

 

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

2.16.840.1.113883.6.90

ICD-10-CM

 

410

Laterality

Cancer Laterality

The side of a paired organ, or the side of the body on which the reportable tumor originated

Problems

 

Condition

 

24028007

Right (qualifier value)

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.113883.3.520.4.22

1060

TNM Edition Number

Cancer TNM Stage Edition/Version Number

The edition of the AJCC manual used to stage the cancer

Problems

 

Condition

 

 

 

 

 

 

 

No mapping, but can be used to determine stage at diagnosis

Cancer Date TNM Clinical Stage Assigned

Date/time TNM clinical stage information was assigned

Problems

 

Condition

 

February 11, 2018

 

 

 

 

1004

AJCC TNM Clin Stage Group

Cancer TNM Clinical Stage Group

Detailed site-specific codes for the clinical stage group as defined by AJCC

Problems

 

Condition

 

IIIA OR 3A

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.30

980

TNM Clin Descriptor

Cancer TNM Clinical Descriptor

Identifies the AJCC clinical stage (prefix/suffix) descriptor as recorded by the physician. AJCC stage descriptors identify special cases that need separate data analysis. The descriptors are adjuncts to and do not change the stage group.

Problems

 

Condition

 

0

None

2.16.840.1.113883.15.6

TNM 7. Edition

2.16.840.1.113883.3.520.4.10

1001

AJCC TNM Clin T

Cancer TNM Clinical Tumor

Detailed site-specific codes for the clinical tumor (T) as defined by AJCC 

Problems

 

Condition

 

cT2 or c2

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.32

1002

AJCC TNM Clin N

Cancer TNM Clinical Nodes

Detailed site-specific codes for the clinical nodes (N) as defined by AJCC 

Problems

 

Condition

 

cN2 OR c2

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.33

1003

AJCC TNM Clin M

Cancer TNM Clinical Metastases

Detailed site-specific codes for the clinical metastases (M) as defined by AJCC 

Problems

 

Condition

 

cM0 OR c0

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.34

 

No mapping, but can be used to determine stage at diagnosis

Cancer Date TNM Pathological Stage Assigned

Date/time TNM pathological stage information was assigned

Problems

 

Condition

 

February 11, 2018

 

 

 

 

1014

AJCC TNM Path Stage Group

Cancer TNM Pathological Stage Group

Detailed site-specific codes for the pathologic stage group as defined by AJCC 

Problems

 

Condition

 

IIIA OR 3A

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.35

920

TNM Path Descriptor

Cancer TNM Pathological Descriptor

Identified the AJCC pathologic stage (prefix/suffix) descriptor as recorded by the physician. AJCC stage descriptors identify special cases that need separate data analysis. The descriptors are adjuncts to and do not change the stage group.

Problems

 

Condition

 

0

None

2.16.840.1.113883.15.6

TNM 7. Edition

2.16.840.1.113883.3.520.4.21

1011

AJCC TNM Path T

Cancer TNM Pathological Tumor

Detailed site-specific codes for the pathologic tumor (T) as defined by AJCC 

Problems

 

Condition

 

pT2 OR p2

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.37

1012

AJCC TNM Path N

Cancer TNM Pathological Nodes

Detailed site-specific codes for the pathologic nodes (N) as defined by AJCC 

Problems

 

Condition

 

pN2 OR p2

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.38

1013

AJCC TNM Path M

Cancer TNM Pathological Metastases

Detailed site-specific codes for the pathologic metastases (M) as defined by AJCC

Problems

 

Condition

 

cM0 OR c0

 

2.16.840.1.113883.3.520.3.18

TNM 8. Edition

2.16.840.1.113883.3.520.4.39

Medications (Treatment) 

 

Does not map, but might be similar concept in FHIR that we need to use.

Medication Status

Indicates whether the medication was prescribed, administered, etc. (Discuss with the WG--what do we want to capture for systemic therapy/meds?)

Medications

 

 

 

EVN

 

2.16.840.1.113883.5.1001

ActMood

2.16.840.1.113883.11.20.9.18

1220
1230
1240
1250

RX Date Chemo
RX Date Hormone
RX Date BRM
RX Date Other

Date medication prescribed

Date medication was prescribed

Medications

 

 

 

 

 

 

 

 

1390
1400
1410
1420

RX Summ--Chemo
RX Summ--Hormone
RX Summ--BRM
RX Summ--Other

Medication prescribed code

Code (with associated name) for the medication that was prescribed

Medications

Medications

 

 

1720960

26.3 ML gemcitabine 38 MG/ML Injection

2.16.840.1.113883.6.88

RxNorm

2.16.840.1.113762.1.4.1010.4

 

Does not map; ask WG whether to keep

Medication prescribed dose

Dose for the medication that was prescribed

 

 

 

 

2225

 

 

 

 

 

Does not map; ask WG whether to keep

Medication prescribed dose units

Units of measure for the medication that was prescribed

 

 

 

 

mg

 

2.16.840.1.113883.6.8

UCUM

2.16.840.1.113883.1.11.12839

 

RX Date Chemo
RX Date Hormone
RX Date BRM
RX Date Other

Date medication administered

A specific date/time or interval of time during which the medication administration took place.

 

 

 

 

 

 

 

 

 

 

RX Summ--Chemo
RX Summ--Hormone
RX Summ--BRM
RX Summ--Other

Medication administered code

Identifies the code (with associated name) for the medication that was administered. 

 

 

 

 

 

 

 

 

 

 

Does not map; ask WG whether to keep

Medication administered dose

Dose for the medication that was administered

 

 

 

 

 

 

 

 

 

 

Does not map; ask WG whether to keep

Medication administered dose units

Units of measure for the medication that was administered

 

 

 

 

 

 

 

 

 

 

 

Medication Reason

We need a way to link medications to the correct cancer diagnosis when there is more than one cancer diagnosis in the same report. Note: will there multiple cancer diagnoses in the same FHIR bundle, or would they each be sent in a separate bundle, in which case this linkage is not needed? (A code indicating why the medication was given.)

 

 

 

 

 

 

 

 

 

Problems 

 

 

Patient Problem Onset Date

Date of onset of the patient’s preexisting medical conditions, factors influencing health status, and/or complications for the treatment of this cancer

Problems

 

 

 

May 12, 1990

 

 

 

 

3780, 3782, 3784, 3786, 3788, 3790, 3792, 3794, 3796, 3798

Secondary Diagnosis 1-10

Patient Problem Code

Records the patient’s preexisting medical conditions, factors influencing health status, and/or complications for the treatment of this cancer. 

Problems

Problems

 

 

44054006

Diabetes mellitus type 2

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.113883.3.88.12.3221.7.4

3780, 3782, 3784, 3786, 3788, 3790, 3792, 3794, 3796, 3798

Secondary Diagnosis 1-10

Patient Problem Code

 

 

 

 

 

E11.9

Type 2 diabetes mellitus without complications

2.16.840.1.113883.6.90

ICD-10-CM

 

Procedures 

1290
670

RX Summ--Surg Prim Site
RX Hosp--Surg Prim Site

Procedure Code

Procedure to the primary site performed as part of the first course of treatment. 

Procedures

Procedures

 

 

442963006

Percutaneous needle biopsy of breast using ultrasound guidance

2.16.840.1.113883.6.96

SNOMED CT

Is there a value set for procedures? If not, should/can we create one? 

1290
670

RX Summ--Surg Prim Site
RX Hosp--Surg Prim Site

Procedure Code

 

Procedures

Procedures

 

 

19083

Biopsy, breast, with placement of breast localization device(s) (e.g., clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance

2.16.840.1.113883.6.12

CPT-4

We can't publish a CPT value set.

1290
670

RX Summ--Surg Prim Site
RX Hosp--Surg Prim Site

Procedure Code

 

Procedures

Procedures

 

 

0HBT3ZX

Excision of Right Breast, Percutaneous Approach, Diagnostic

2.16.840.1.113883.6.4

ICD10 PCS

See item in TFS for value set

1200
3170

RX Date Surg
RX Date Mst Defn Srg

Procedure Performed Date

Date/time of the procedure to the primary site performed as part of the first course of treatment. 

Procedures

 

 

 

January 26, 2018

 

 

 

 

 

 

Procedure Performed Facility

Facility (NPI/Name) where the procedure was performed

 

 

 

 

 

 

 

 

 

 

 

Procedure Reason

We need a way to link procedures to the correct cancer diagnosis when there is more than one cancer diagnosis in the same report. Note: will there multiple cancer diagnoses in the same FHIR bundle, or would they each be sent in a separate bundle, in which case this linkage is not needed?

 

 

 

 

 

 

 

 

 

1506

Phase 1 Radiation Treatment Modality

Radiation Code

Identifies the radiation modality administered during the first phase of radiation treatment delivered as part of the first course of treatment

Procedures?

Procedures?

 

 

77412

Radiation treatment delivery, ≥ 1 MeV; complex

2.16.840.1.113883.6.14

HCPCS

2.16.840.1.113883.3.520.4.23; but we can't publish the CPT codes in this value set.

1506

Phase 1 Radiation Treatment Modality

Radiation Code

 

 

 

 

 

448385000

Megavoltage radiation therapy using photons

2.16.840.1.113883.6.96

SNOMED CT

2.16.840.1.113883.3.520.4.23

1506

Phase 1 Radiation Treatment Modality

Radiation Code

 

 

 

 

 

DM011ZZ

Beam Radiation of Right Breast using Photons 1 - 10 MeV

2.16.840.1.113883.6.4

ICD10 PCS

2.16.840.1.113883.3.520.4.23

1210

RX Date Radiation

Radiation Administered Start Date

Date on which radiation therapy began at any facility that is part of the first course of treatment. 

Procedures?

 

 

 

09/14/2018

 

 

 

 

 

 

Radiation Reason

We need a way to link radiation procedures to the correct cancer diagnosis when there is more than one cancer diagnosis in the same report. Note: will there multiple cancer diagnoses in the same FHIR bundle, or would they each be sent in a separate bundle, in which case this linkage is not needed?

 

 

 

 

 

 

 

 

 

Lab Results 

 

 

Laboratory Test/Panel Code

The test (or panel of tests) that was performed relevant to the cancer diagnosis . A LOINC SHALL be used if the concept is present in LOINC.

Laboratory

Tests

 

 

10480-2

Estrogen+Progesterone receptor Ag [Presence] in Tissue by Immune stain

2.16.840.1.113883.6.1

LOINC

Value set to be developed to restrict to cancer-related (or can we do a "blacklist" approach--which tests are NOT wanted)

 

 

Laboratory Test Result Status

The status of the result value 

 

 

 

 

completed

 

2.16.840.1.113883.5.14

ActStatus

2.16.840.1.113883.11.20.9.39

 

 

Laboratory Test Performed Date

Date test was performed

Laboratory

 

 

 

January 26, 2018

 

 

 

 

 

 

Laboratory Result Value

The Laboratory result value.

Laboratory

Values/Results

 

 

Positive

 

2.16.840.1.113883.6.96

SNOMED CT

 

 

 

Laboratory Result Units of Measure

Units of measure for the laboratory result value.

Laboratory

Values/Results

 

 

 

 

2.16.840.1.113883.6.8

UCUM

2.16.840.1.113883.1.11.12839

Employment History 

 

 

Patient Industry Period

Date patient's industry code was recorded

 

 

 

 

April 1985-present

 

 

 

 

272

Census Ind Code 2010 CDC

Patient Industry Code

Code for the patient's usual industry, using U.S. Census Bureau codes and NIOSH non-paid worker codes

 

 

 

 

6570

Motion pictures and video industries

2.16.840.1.114222.4.5.315

Industry CDC Census 2010

2.16.840.1.114222.4.11.7187

 

 

Patient Occupation Period

Date patient's occupation code was recorded

 

 

 

 

April 1985-present

 

 

 

 

282

Census Occ Code 2010 CDC

Patient Occupation Code

Code for the patient's usual occupation, using U.S. Census Bureau codes and NIOSH non-paid worker codes

 

 

 

 

2700

Actors

2.16.840.1.114222.4.5.314

Occupation CDC Census 2010

2.16.840.1.114222.4.11.7186

Vital Signs 

 

 

Patient Height Code

Patient Height code

Vital Signs

Body height

 

 

8302-2

Height

2.16.840.1.113883.6.1

LOINC

2.16.840.1.113883.3.88.12.80.62

 

 

Patient Height Recorded Date

Date patient's height was recorded

 

 

 

 

<date of the encounter>

 

 

 

 

 

 

Patient Height Value

Patient Height value

Vital Signs

Body height

 

 

162.5

 

 

 

 

 

 

Patient Height Units

Patient Height units

Vital Signs

Body height

 

 

cm

 

2.16.840.1.113883.6.8

UCUM

2.16.840.1.113883.1.11.12839

 

 

Patient Weight Code

Patient Weight code

Vital Signs

Body weight

 

 

3141-9 or 29463-7

Weight Measured or Weight

2.16.840.1.113883.6.1

LOINC

2.16.840.1.113883.3.88.12.80.62

 

 

Patient Weight Recorded Date

Date patient's weight was recorded

 

 

 

 

<date of the encounter>

 

 

 

 

 

 

Patient Weight Value

Patient Weight value

Vital Signs

Body weight

 

 

72.5

 

 

 

 

 

 

Patient Weight Units

Patient Weight units

Vital Signs

Body weight

 

 

kg

 

2.16.840.1.113883.6.8

UCUM

2.16.840.1.113883.1.11.12839

Clinical Notes/Text Fields

 

TBD

Consultation Note Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Consultation Note

 

 

 

 

 

 

 

 

TBD

Discharge Summary Note Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Discharge Summary Note

 

 

 

 

 

 

 

2520

Text--DX Proc--PE

History & Physical Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

History & Physical

 

 

 

 

 

 

 

2530

Text--DX Proc--X-ray/Scan

Imaging Narrative Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Imaging Narrative

 

 

 

 

 

 

 

2550

Text--DX Proc--Lab Tests

Laboratory Report Narrative Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Laboratory Report Narrative

 

 

 

 

 

 

 

2570

Text--DX Proc--Path

Pathology Report Narrative Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Pathology Report Narrative

 

 

 

 

 

 

 

2560

Text--DX Proc--Op

Procedure Note Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Procedure Note

 

 

 

 

 

 

 

 

TBD

Progress Note Content

To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Progress Note

 

 

 

 

 

 

 

2630

RX Text--Radiation Other

Radiation Therapy Treatment Summary Content

Text area for manual documentation of information regarding treatment of the tumor being reported with beam radiation.
To be discussed with WG--do cancer registries want this? Are they allowed to receive it? 

Clinical Notes

Note: Flag for candidate for submission to ONDEC (new data element)?:
Radiation Therapy Treatment Summary

 

 

Patient received 5 MeV radiation treatment

 

 

 

 

Table 3: Cancer Reporting Data Elements

Policy Considerations

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

  • MedMorph will use existing frameworks (e.g., FHIR APIs) for the exchange of data.

  • When there is a third party, a data use or business use/associate agreement may be needed (e.g., Association of Public Health Laboratories (APHL)).

  • Public Health Agencies (PHAs) may have state-specific restrictions on collecting protected classes of data (e.g., AIDS status, mental health status, Substance Use Disorder/Opioid Use Disorder (SUD/OUD)).

    • If the patient gives consent for sharing of AIDs, mental health, etc. data the burden would be on the sending system.

    • For research use cases, there must be consent before the data is sent.

  • For jurisdictional restrictions on data that can not be collected, the MedMorph Reference Architecture will make provisions for defining actions (e.g., redaction, filtering, removal, validation) before submission. The actions could be triggered based on the content of specific data elements.

    • The MedMorph Reference Architecture will do an additional validation check on the data before the data leaves the healthcare organization. This is important in cases of a healthcare organization reporting to multiple jurisdictions.

  • What if more data is sent that what is requested?

    • —Registries may have restrictions on collecting certain information. For example, cancer registries collect comorbidity information, but some of them are restricted from collecting information about AIDS or mental health conditions as a comorbidity

    • This should be handled by policy and processes around the data received.

    • The data generator should be clear on what data is being requested and the data provided should only be the data requested.

    • The Reference Architecture IG will ask for feedback during the ballot process on if the MedMorph Reference Architecture should define an acknowledgment mechanism for notifications when additional data is received.

Technical Capabilities for Implementation of the Use Case

For the use case to be implemented successfully, the following technical capabilities must be considered:

  • EHRs and or tracking systems must be onboarded

  • The use, IT/data governance, and or versioning of FHIR between trading entities

  • Consent models for data exchange:

    • For public health purposes, existing authorities are sufficient, and no consent is required.

    • For research use cases:

      • Institutional Review Boards (IRB) approvals, intended purpose, and consent for the intended purpose is included

      • Other areas to investigate:

        • https://www.hl7.org/fhir/consent.html (e.g., FHIR ResearchSubject and ResearchStudy resources and their relationship to the Consent resource)

        • Patient-level data, Limited Data Set (LDS), Deidentified data sets, and relationships to consent

  • Data that is stored outside the EHR (e.g., Prescription Drug Monitoring Program (PDMP) data) may not be available

  • Activities that are not associated with a clinical order or clinical visit (e.g., drive-up COVID test, STD test, adult immunization at the pharmacy) may not be available

  • The reference architecture defines trigger events and timing offsets in relationship to trigger events, and actions to be performed based on trigger events to account for data lag vs. real-time (especially for research use cases)

  • Provenance should be supported as defined by USCDI and applied to all data classes being reported

  • State laws and standards can preempt/modify/exclude data that could occur in a content (use case) specific IG

Appendices

References to Appropriate Documentation

Terms and Definitions

  • Central Cancer Registry[3]:  an information system designed for the collection, storage, and management of data on persons with cancer.  Registries play a critical role in cancer surveillance, which tells us where we are in the efforts to reduce the cancer burden. Surveillance data may also serve as a foundation for cancer research and are used to plan and evaluate cancer prevention and control interventions.

  • Electronic Health Record (EHR)[4]: a real-time, patient-centered record that makes information available instantly and securely to authorized users. While an EHR contains 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

  • 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/)


[1] Menck, H., Gress, D. and Griffin, A., 2011. Cancer Registry Management Principles and Practices for Hospitals and Central Registries. 3rd ed. Dubuque, IA: Kendall Hunt.  ISBN: 978-0-7575-6900-5

[2] Adapted from https://www.healthit.gov/faq/what-electronic-health-record-ehr

[3] Adapted from: https://seer.cancer.gov/registries/cancer_registry/index.html

[4] Adapted from: https://www.healthit.gov/faq/what-electronic-health-record-ehr

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