| Submitted By: Maria Michaels / CDC | |
|---|---|
| Data Element Information | |
| Rationale for Separate Consideration | The current element of "Tests" does not specifically state that this is used to capture the code or name of the laboratory test performed. Suggest renaming the current element of "Tests" to "Laboratory Test/Panel Code". |
| Use Case Description(s) | |
| Use Case Description | Actively monitoring diseases, making decisions about public health threats, identifying trends in healthcare services utilization and other public health matters depend on accessible and accurate data. EHRs are a data source that can provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to more rapid disease detection, tracking, and treatment and innovation in healthcare delivery. Laboratory information, including the test code, test performed date, result status, result value and the result date, are important to multiple public health reporting and research use cases to track and analyze information about treatment for various health conditions. The Making EHR Data More Available for Research and Public Health (MedMorph) project's goal is to create a reliable, scalable, and interoperable method to get electronic health record data for multiple public health and research scenarios (use cases). MedMorph has identified Cancer Reporting, Healthcare Surveys, Hepatitis C Reporting, electronic Initial Case Reporting (eICR), PCORnet, and Birth Defect Reporting use cases that support the adoption of these data elements. These specific use cases are described in more depth on their respective web pages. |
| Estimated number of stakeholders capturing, accessing using or exchanging | All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements. All hospitals and physicians who diagnose or treat cancer are required to provide cancer related laboratory information to state cancer registries. Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here. Supporting Links: MedMorph Project Page: https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html Cancer Reporting: https://www.cdc.gov/cancer/npcr/ Healthcare Surveys: https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm Hepatitis C Reporting: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf eICR: https://www.cdc.gov/ecr/index.html PCORnet: https://pcornet.org/ Birth Defect Reporting: https://www.cdc.gov/nchs/nvss/births.htm |
| Link to use case project page | https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html; https://www.cdc.gov/cancer/npcr/; https://www.cdc.gov/nchs/dhcs/nhcs_registry_landing.htm; https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf |
| Supporting Attachments |
MedMorph-ChronicHepatitisCSurveillanceUseCase-DRAFT.pdf MedMorph-CancerReportingUseCase-DRAFT.pdf MedMorph-HealthCareSurveyReportingUseCase-DRAFT.pdf |
| Use Case Description | A foundational goal of MedMorph is generalizability beyond the 10 use cases that are actively informing the MedMorph project, in order to support many more public health and research use cases. Therefore, other public health and research use cases that use the MedMorph architecture will also benefit from the adoption of these data elements. |
| Estimated number of stakeholders capturing, accessing using or exchanging | All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements. All hospitals and physicians who diagnose or treat cancer are required to provide cancer related laboratory information to state cancer registries. Approximately 620,000 physicians in the US are active and have at least some component of ambulatory practice and thus are annually eligible to sampling and recruitment into the National Ambulatory Medical Care Survey (NAMCS), which samples from between 3,500 to 20,000 of these physicians annually. Presently each sampled physician submits one weeks' worth of patient encounters to NAMCS. Approximately 600 hospitals are in the National Hospital Care Survey (NHCS). 1/3 of that number are either in, or actively being recruited into, the EHR data submission mode for NHCS. NHCS is already receiving electronic CDA documents. When they reach their target of 200 hospitals submitting by this mode annually they will be receiving >1.2 million documents and sets including multiple sets of medication data annually. There were approximately 1,000,000 practicing physicians (as of 2020), approximately 120,000 certified physician assistants (as of 2019), and 290,000 licensed nurse practitioners (as of 2019). Most of these licensed clinicians interact with one of these public health use cases intermittently, annually. As of 2018, AHA reported 6,146 hospitals in the US experiencing 36,353,946 admissions. Almost all of those hospitals and at least half of the admissions interact with one or more of the public health use cases. The vast majority of these exchanges include full sets of medication data, including the data elements requested for USCDI consideration here. |
| Healthcare Aims |
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| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | Laboratory Test/Panel Code: LOINC Codes: http://loinc.org Laboratory Test Performed Date: FHIR dateTime, Period, Timing, Instant: http://hl7.org/fhir/observation-definitions.html#Observation.effective_x_ Laboratory Result Status: FHIR Observation Status: http://hl7.org/fhir/valueset-observation-status.html Laboratory Result Value: FHIR Quantity|CodeableConcept|string|boolean|integer|Range|Ratio|SampledData|time|dateTime|Period: http://hl7.org/fhir/observation-definitions.html#Observation.value_x_ http://loinc.org |
| Additional Specifications | HL7 FHIR US Core Implementation Guide v3.1.1 (https://www.hl7.org/fhir/us/core/index.html) HL7 FHIR US Core Laboratory Result Observation (http://hl7.org/fhir/us/core/StructureDefinition-us-core-observation-lab.html). MustSupport for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Status, Laboratory Result Value HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492). SHALL for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Value HL7 CDA ® Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398). SHALL for the following elements: Laboratory Test/Panel Code, Laboratory Test Performed Date, Laboratory Result Value HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385) HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm (http://hl7.org/fhir/us/ecr/STU1/) HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) HL7 FHIR® Implementation Guide: Common Data Models Harmonization FHIR Implementation Guide (Release 0.1.0) (http://hl7.org/fhir/us/cdmh/2019May/) HL7 CDA® R2 Implementation Guide: Ambulatory and Hospital Healthcare Provider Reporting to Birth Defect Registries Release 1, STU 2 -US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=428) HL7 FHIR® Implementation Guide: Birth Defect Reporting Implementation Guide 0.1.0 (https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html) |
| Current Use | Extensively used in production environments |
| Supporting Artifacts |
Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems. Widely available in EHR systems. These data elements exist in FHIR with a FHIR Maturity level of Normative for the Observation Resource. FHIR Observation Resource: http://hl7.org/fhir/observation.html LOINC is included in the ISA with an adoption level of 3 in production implementations for representing laboratory tests. SNOMED CT is included in the ISA with an adoption level of 1 in production implementations for representing laboratory tests. Laboratory in ISA: https://www.healthit.gov/isa/section/laboratory Part of Core EHR Certification since at least 2014 Specified in Meaningful Use/Promoting Interoperability since Stage 1 Part of EHR Certification for Transmission to Cancer Registries (2015 and 2014 Editions) Promoting Interoperability Programs Eligible Hospitals and Critical Access Hospitals are required to, and Merit-based Incentive Payment System (MIPS) participants may optionally, report on any two measures under the Public Health and Clinical Data Exchange objective of these programs. The § 170.315(f)(5) – Transmission to public health agencies – electronic case reporting certification criteria in the 2015 Edition Final Rule and the ONC Cures Act Final Rule, the § 170.315(f)(7) – Transmission to public health agencies – health care surveys, and the § 170.315 (f)(4) – Transmission to Cancer Registries are three such options to meet these measures. The current standard for § 170.315(f)(5), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: Public Health Case Report, Release 2: the Electronic Initial Case Report (eICR), Release 1, STU Release 1.1. ONC’s Certified Health IT Product List (CHPL) lists 73 EHR or HIT Module products certified to (f)(5) using this standard. eCR IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436 The current standard for § 170.315(f)(7), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 116 EHR or HIT Module products certified to (f)(5) using this standard. NHCS IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385 The current standard for § 170.315 (f)(4), as listed in ONC’s 2020 Interoperability Standards Advisory Reference Edition, is HL7 CDA® R2 IG: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, R1, DSTU Release 1.1 - US Realm. ONC’s Certified Health IT Product List (CHPL) lists 288 EHR or HIT Module products certified to (f)(4) using this standard. Cancer Reporting IG: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=398 These three widely adopted CDA standards have many of the Laboratory data elements contained on this form as Shall (required) or Should (best practice to include if available) conformance criteria, which demonstrates the maturity of these commonly exchanged data elements. Supporting Links: §170.315(f)(4) Transmission to cancer registries: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure 2014 Edition Test Methods: https://www.healthit.gov/sites/default/files/2014_test_methods/2014_edition_test_methods_archived.zip Observation API: https://fhir.epic.com/Specifications?api=998 Certified Health IT Product List: https://chpl.healthit.gov/#/search Certified Health IT Product List for Cancer: https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries) http://hl7.org/fhir/observation.html; https://www.healthit.gov/isa/section/laboratory; §170.315(f)(4) Transmission to cancer registries: https://www.healthit.gov/test-method/transmission-cancer-registries#test_procedure |
| Number of organizations/individuals with which this data element has been electronically exchanged | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
Level 2 – exchanged between 4 or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to the next draft version. HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436) - the Electronic Initial Case Report (eICR) is currently implemented in 5,400+ reporting sites nationally and exchanges Laboratory information including: Laboratory Test Code, Performed Date, Test Result Status, Result Value. As part of Cancer Reporting CDA IGs: IHE Connectathons 2010-2020 HIMSS Interoperability Showcase 2010-19 Public Health Informatics Conference Interoperability Showcase 2014, 2016, 2018 NACCHO 360X Interoperability Demonstrations, 2020 As part of National Health Care Surveys CDA IGs: IHE Connectathons 2019-2020 ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies. https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies Supporting Links: Certified Health IT Product List for Cancer: https://chpl.healthit.gov/#/search: 170.315 (f)(4): Transmission to Cancer Registries Retired | 170.314 (f)(5): Optional - ambulatory setting only - cancer case information Retired | 170.314 (f)(6): Optional - ambulatory setting only - transmission to cancer registries) IHE Connectathon: https://connectathon-results.ihe.net/ https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436 |
| Potential Challenges | |
| Restrictions on Standardization (e.g. proprietary code) | None |
| Restrictions on Use (e.g. licensing, user fees) | None |
| Privacy and Security Concerns | None |
| Estimate of Overall Burden | Low. All providers need to capture laboratory information as a basic component of patient care. Several existing IGs, as listed, require the exchange of this data element. The Promoting Interoperability Programs Objective 8 - Public Health and Clinical Data Registry Reporting, Measures 1: Immunization Registry Reporting, 2: Syndromic Surveillance Reporting, 3 -: Electronic Case Reporting and 4: Public Health Registry Reporting all require these data elements. This information is routinely communicated in HL7 CDA Documents and some FHIR API transactions. |
| Other Implementation Challenges | None |
| ONC Evaluation Details Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI |
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| Maturity – Standards/Technical Specifications | Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification |
| Maturity - Current Use | Level 2 - Used at scale in more than 2 different production environments |
| Maturity - Current Exchange | Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Level 2 - Used by a majority of patients, providers or events requiring its use |
Submitted by nedragarrett_CDC on 2022-10-07
CDC's Consolidated Comment for USCDI v4
CDC continues to recommend inclusion of this high priority data element in USCDI v4 CSTE agrees with CDC's recommendation for this data element.