Analysis of clinical specimens to obtain information about the health of a patient.

Data Element
Laboratory Test/Panel Code
Description

The test that was performed.
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.
Estimate the breadth of applicability of the use case(s) for this data element 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.
Estimate the breadth of applicability of the use case(s) for this data element 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
  • Improving the health of populations
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
Extent of exchange 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 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
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.

Comment

Submitted by nedragarrett_CDC on

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.

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