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
Data Element Description
The status of the laboratory result value.
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.
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
The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.
If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.
If you are only commenting on a single data class or element, you may leave this field blank.
2. Select the Data Class
To specify which data class your comment addresses:
In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
Note that the Data Class field will automatically populate based on your current location in the platform:
If you are on a data class page, the field will be set to that specific data class
If you are on a data element page, the corresponding data class will be pre-selected
3. Select the Data Element
To specify which data element your comment addresses:
In the "Data Element" drop-down menu, select the specific data element you want to comment on.
The drop-down menu will display only the elements available under the data class you selected in the previous step.
You can use the search function within the drop-down to quickly locate a specific data element.
If you are commenting on the data class itself rather than a specific element, you may leave this field blank.
Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
If you cannot find the appropriate data class or element for your comment:
Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
If you need to comment on multiple data classes or elements:
After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
The platform allows you to upload supporting documentation to enhance your comment:
Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.
Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.
Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
8. Optional: Save and Exit
If you need to pause your work and return to complete your comment later:
Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
Click this button to continue working on your draft.
You will be taken to a review page where you can:
Select "Submit Comment" to officially submit your feedback.
Click "Edit" to return to the comment form and make changes
Select "Discard Draft" to delete the saved draft and start fresh
Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.
9. Review and Submit
Once you have completed your comment:
Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
Click "Submit Comment" to officially submit your feedback
Click "Edit" to return to the comment form and make changes
Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by nedragarrett_CDC on
Unified Comment from CDC