Data Element
Submitted By: Daniel Vreeman / RTI International
Data Element Information
Data Element Description Who was responsible for asserting the observed value as "true".

Many observations will be asserted by a clinician in the care of a patient, but this data element also explicitly allows record of patients, caregivers, and other entities as the source. Such information is crucial for understanding context for observations derived from patient reported outcomes measures.

Data Type: Reference (Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson). This data element may be a pointer into a record in another table/structure that contains more metadata about the performer. In other contexts, it may be a data type that carries all of the requisite identifying information "inline", such as the XCN (Extended Composite ID Number and Name for Persons) data type used in HL7 v2 OBX-16.
Use Case Description(s)
Use Case Description Clinical observations are an essential structure for recording many kinds of health information. A laboratory test result, vital sign measurement, blood type, pain scale rating, or recording of exercise activity type that a person engaged in (e.g. running, walking, swimming, etc.) are all considered observations.

Billions of clinical observations have been exchanged in the current health information exchange ecosystem. All of the prevailing exchange (e.g. messages, documents, APIs) and common data model (e.g. OMOP, PCORnet, Sentinel, etc) paradigms represent these core data elements (code, value, date/time, subject) pertaining to observations.

For many reasons, it would be ill-advised for USCDI to enumerate the tens of thousands of specific observation “variables” (eye color, gait speed, shoulder flexion range of motion, etc) as separate Data Elements. Rather, USCDI needs a common template structure for specifying observations and then mechanisms for creating subsets of key domains where there is value in doing. Here we have proposed the essential data elements. Using this common pattern of essential data elements, key domain subsets (like the existing labs and vital signs classes) can be defined using the shared template with further specified through bindings to appropriate terminology standards and/or additional data elements.
Estimate the breadth of applicability of the use case(s) for this data element Most health IT systems with more than a few clinical variables use an entity-attribute-value (or name value pair) model similar to this proposed approach for storing and exchanging observations.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Reducing the cost of care
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Vocabulary Standard:
No single vocabulary covers the content necessary for representing all aspects of observation reporting (observation identifiers, coded observation values, computable units of measure, etc). Yet, the collection of core vocabularies needed are sufficiently mature.

[Observation: Code] LOINC was specifically designed to fulfill the need for a freely available standard for identifying observations. More than 25 years later, it now contains a rich catalog of variables, answer lists, and the collections that contain them.

[Observation: Value.units] UCUM was specifically designed to fulfill the need for a freely available standard of computable units of measure.

[Observation: Value.code]
• If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC.
• If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc.
• If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology
• If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used

Exchange and Analytic CDM specifications:
HL7 Version 2: Chapter 7
C-CDA: Results Section (entries required): 2.16.840.1.113883.10.20.22.2.3.1
FHIR: Observation
OMOP: Measurement, Observation
PCORnet CDM: LAB_RESULT_CM, PRO_CM, OBS_CLIN, OBS_GEN
Additional Specifications There are several implementation guides (e.g. for HL7 v2 and CDA) and FHIR profiles on Observation. Examples include those in the main FHIR spec (vital signs, genetics) and in US Core (smoking status) etc.
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts A few examples of documentation include:
Epic FHIR Documentation: https://fhir.epic.com/
Cerner FHIR Documentation: https://fhir.cerner.com/millennium/r4/diagnostic/observation/
Allscripts FHIR Documentation: https://developer.allscripts.com/FHIR?PageTitle=Resources
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 Three examples among many:
• the INPC clinical repository contains billions of discrete observations from about 100 institutions. https://www.ihie.org/popcare/#careweb
• Apple Health uses the FHIR Observation resource for labs and vital signs to interface with many institutions: https://support.apple.com/en-us/HT208647
• participating PCORNet institutions store billions of discrete observations represented in the PCORnet CDM structure
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Some, but not all observations in operational health IT systems are linked to vocabulary standards. So local codes still persist. At present, mappings to vocabulary standards are much more common for observation identifiers than for coded observation values.
Restrictions on Use (e.g. licensing, user fees) Licensing for some reference terminology standards is available at no cost worldwide: LOINC, UCUM, HPO.

SNOMED CT is available at no cost for use within the US via an affiliate license available from NLM (https://www.nlm.nih.gov/healthit/snomedct/snomed_licensing.html).

The FHIR exchange specification is available without copyright (i.e. it is declared to be Public Domain). Other HL7 exchange specifications are available under the terms described here http://www.hl7.org/legal/ippolicy.cfm?ref=nav.
Privacy and Security Concerns Some observations may carry sensitive information. Appropriate protections for addressing privacy and security concerns should be addressed in the surrounding technical infrastructure and policies.
Estimate of Overall Burden Unknown.

Comment

Submitted by erjones on

Please Include Observation Code in USCDI v5

Vizient recommends adding Observation Value, Observation Code, and Observation Performer to USCDI v5. These elements combined could be used to detail what kinds of observations took place, what the observations resulted in, and who ended up performing those observations during the visit.

Submitted by erjones on

Please Include Observation Performer in USCDI v4

The three elements Observation Value, Observation Code, and Observation Performer combined could be used to detail what kinds of observations took place, what the observations resulted in, and who ended up performing those observations during the visit.

Log in or register to post comments

FormGuide

Help

1. Optional: Background Text / Cover Letter

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:

  1. In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
  2. 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.
  3. Note that the Data Class field will automatically populate based on your current location in the platform:
    1. If you are on a data class page, the field will be set to that specific data class
    2. 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:

  1. In the "Data Element" drop-down menu, select the specific data element you want to comment on.
  2. The drop-down menu will display only the elements available under the data class you selected in the previous step.
  3. You can use the search function within the drop-down to quickly locate a specific data element.
  4. 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.
 

Data Class and Data Element

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:

  1. 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."
  2. This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
  3. In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
  4. Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Propose New Data Class or Element

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:

  1. After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
  2. A new comment section will appear, allowing you to enter details for your additional comment.
  3. For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
  4. Complete the Subject and Comment fields for your additional comment.
  5. 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.

Upload Supporting Files

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:

  1. Click the "Save and Exit" button at the bottom of the form.
  2. Your comment will be saved as a draft that you can access and complete later.
  3. 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.
  4. Click this button to continue working on your draft.
  5. You will be taken to a review page where you can:
    1. Select "Submit Comment" to officially submit your feedback.
    2. Click "Edit" to return to the comment form and make changes
    3. 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:

  1. Click the "Review and Submit" button at the bottom of the form.
  2. This will take you to a review screen displaying your comment(s) in full.
  3. Review all information for accuracy and completeness.
  4. On this review screen, you have three options: 
    1. Click "Submit Comment" to officially submit your feedback
    2. Click "Edit" to return to the comment form and make changes
    3. Click "Discard Draft" to delete the comment and start fresh
  5. The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records. 
  6. If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Review and Submit

Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

USCDI Comments

Close

Add a New Comment

Review comment and Submit

Edit
Comment #1