Description (*Please confirm or update this field for the new USCDI version*)
State or condition of a laboratory test.
Submitted By: Maria Michaels
/ CDC
Data Element Information
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.
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
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
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.
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
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)
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.
As previously commented the name of this data element should be more precise by indicating that it is the status of the performed test (and not the status of all the tests under an order, or of the entire report).
Updated name to: Performed Test Result Status. The definition could be updated to reflect the name change: The status of a laboratory performed test, which can include some workflow steps (specimen in lab, testing in process, results available, but not verified) as well as indicate the clinical uses for the results once reported (preliminary, final, corrected).
Referenced vocabulary shoud be HL7 product family specific: Iin v2 OBX-11 - with a link to this value set: https://terminology.hl7.org/4.0.0/ValueSet-v2-0085.html, in C-CDA observation.statusCode with a link to this value set: https://terminology.hl7.org/5.0.0/ValueSet-v3-ActStatus.html and in FHIR observation.status with a link to this value set: https://hl7.org/fhir/valueset-observation-status.html
As pointed out in the prior comment: https://www.healthit.gov/isa/comment/11631 APHL still suggests to be more specific which result status is meant here - the most important one would be the status of the performed test (in v2 OBX-11 - with a link to this value set: https://terminology.hl7.org/4.0.0/ValueSet-v2-0085.html, in C-CDA observation.statusCode with a link to this value set: https://terminology.hl7.org/5.0.0/ValueSet-v3-ActStatus.html and in FHIR observation.status with a link to this value set: https://hl7.org/fhir/valueset-observation-status.html) - suggested name would be Performed test result status
APHL repeats its comment from last year that further clarification of this data element is needed to ensure this is for each test (not the entire report). Once defined as for each test, then APHL proposes the following vocabulary bindings: In V2 this element is OBX-11 Observation Result Status; it is required in LRI with a required binding to HL70085 (https://terminology.hl7.org/4.0.0/CodeSystem-v2-0085.html) and in FHIR it is represented in Observation.status – this element is required for every observation resource with a required valueset binding to ObservationStatus (http://hl7.org/fhir/valueset-observation-status.html)
Result is a critical component to understanding and validating laboratory tests and results for both clinical care and public health. However, the submission here points to multiple standards relevant to electronic laboratory reporting. NACHC believes the submission here should first reference lab interoperability use cases for point of care delivery. This data element should first and foremost reference one or more value sets that consist of implemented and validated concepts used in the existing laboratory standards and then the appropriate HIT standards that use it.
While USCDI does provide a de facto data model and reference some existing standards in the point of care and laboratory reporting use cases, a coherent approach that takes the lab data from the manufacturer through point of care testing to electronic reporting is in development to pull all the relevant components of all the related use cases together in a project called SHIELD (Systemic Harmonization and Interoperability Enhancement of Laboratory Data). A long term approach that aligns all the use cases is optimal.
Clarifcation is needed as there are often 2 status elements used:
A status at the level of the performed test (in v2 OBX-11, in C-CDA observation.statusCode and in FHIR observation.status) - assuming that is the minimum element needed. It is a CLIA required element.
A status at the level of the order (in v2 OBR-25, in CDA Laboratory Battery Organizer.statusCode, in FHIR DiagnosticReport.status) indicating the status for all expected results for this battery. It is a CLIA required element.
I don't see Electronic Lab Reporting (ELR) mentioned in the above use case list - the v2 ELR R1 Implementation Guide (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=98) has been a PH MU measure since Stage1 and is widely implemented across the nation - both Result (Observation) Status (OBX-11 in v2) and Result Status (OBR-25 in v2) are requried elements.
HIV, STDs, Viral Hepatitis and Tuberculosis are nationally notifiable diseases for which diagnosis is dependent upon laboratory results. As such, laboratory test performed date, result value and result status are collected as part of CDC's routine surveilannce for these conditions. Additionally, beyond diagnostic tests, additional laboratory test information is collected to understand the health status of patients (e.g. HIV viral load, liver enzymes), and trends in drug susceptibility.
All of the laboratory data collected is used both for case management purposes within state, local, territorial and tribal health jurisdictions, and public health purposes at the national level. These data are integral to understanding disease transmission and to prioritize appropriate interventions for affecting communities.
Additional Use Case: This is a standard data item used by central cancer registries in all states. Data received through data exchange from pathology laboratories to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law.
Estimate number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of HIV Prevention, Division of TB Elimination, Division of STD Prevention, and Division of Viral Hepatitis flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.
Healthcare Aims: Improving patient experience of care, Improving health of populations, Reducing cost of care, provider experience of care.
Use of data element: Extensively used in production environments
This element is used by CMS Quality Reporting and is marked Required or Must Support in the FHIR QI Core IG
CSTE supports inclusion of this measure into USCDI v3
Submitted by Riki Merrick on
Update the name of this data element for clarity
As previously commented the name of this data element should be more precise by indicating that it is the status of the performed test (and not the status of all the tests under an order, or of the entire report).
Updated name to: Performed Test Result Status. The definition could be updated to reflect the name change: The status of a laboratory performed test, which can include some workflow steps (specimen in lab, testing in process, results available, but not verified) as well as indicate the clinical uses for the results once reported (preliminary, final, corrected).
Referenced vocabulary shoud be HL7 product family specific: Iin v2 OBX-11 - with a link to this value set: https://terminology.hl7.org/4.0.0/ValueSet-v2-0085.html, in C-CDA observation.statusCode with a link to this value set: https://terminology.hl7.org/5.0.0/ValueSet-v3-ActStatus.html and in FHIR observation.status with a link to this value set: https://hl7.org/fhir/valueset-observation-status.html