Findings or other clinical data collected about a patient during care.

Data Element

Applicable Vocabulary Standard(s)

Advance Directive Observation

Statement of presence and properties of patient or provider authored documents that record a patient’s goals, preferences and priorities should a patient be unable to communicate them to a provider.

Usage note: May include whether a person has one or more advance directives, the type of advance directive, the location of the current source document, and whether it has been verified.

Examples include but are not limited to indication that a living will is on file, reference to or location of durable medical power of attorney, and validating provider.

Sex Parameter for Clinical Use

Category based upon clinical observations typically associated with the designation of male and female.

Data Element




NACHC agrees that the Observation Data Class must be clarified to contain categories of observations much in the way that SDOH contains multiple data classes and is cross-cutting. We support the comment developed with HL7 below:

Observations (General) - [New Data Class]

HL7 notes that the distinction between the new Observations data class and other data classes such as Laboratory and Vital Signs, is unclear considering Laboratory Test Results are categorized as Observations, as are Vital Signs.  HL7 suggests that Vital Signs and Laboratory Test Results are included under Observations as references and also as specific data elements that are listed under Observations. This approach would provide greater clarity regarding to which other data classes they would apply.  

PACIO Comments on Advance Directive Observation

  • Data Class: Observations (Currently Draft V5)
  • Data Element: Advance Directive Observation (Currently Level 2)
  • Recommendation: Include the Advance Directive Observation data element in the USCDI V5 under the new Observations Data Class. Clarify that this observation does not supersede the Advance Directive data element.
  • Rationale: The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, with the goal of establishing a framework for the development of FHIR implementation guides to facilitate health information exchange. The PACIO community supports the inclusion of an Advance Directive data element in USCDI. With draft V5 we note that Advance Directive was changed to Advance Directive Observation. We believe that these two data elements do not reflect the same information. An Advance Directive Observation is a finding, such as “code status” or presence of an advance directive document. This is distinct from a data element that captures an advance directive document itself which we support in another comment. Both data elements are needed, but one cannot replace the other as they serve different purposes. We support the inclusion of an Advance Directive Observation data element but do not support it replacing the Advance Directive data element.

Observations more generally

We believe it would be beneficial to include all available observation data in USCDI (within valid privacy constraints, should any exist). There are many types of useful observations beyond vital signs, advance directive information (if correctly classified as an observation), and sex for clinical use that are available, useful, and should be a regular part of clinical data exchange. Having to enumerate and consider each one independently for inclusion in USCDI seems burdensome, slow, and against the idea that sharing clinical data among all relevant parties with a right to see it is good/the goal of this interoperability journey we're all on.

USCDI V5 Feedback

Advance Directive Observation - A single observation made by a person or provider about an Advance Directive Document or Provider-authored Medical Order form or the care experience preferences, treatment intervention preferences, personal healthcare goals, or orders contained within an Advance Healthcare Directive document/form, or an assertion made by a provider about a patient’s advance directive status, such as DNR Status.

The Advance Directive Observation data element is an observation about a person’s available advance healthcare directive information which is expressed in the form of a document. The document is a very important aspect of this data element’s nature because this data element requires “context” to be accurately understood and used. See prior comments about the need to include the Advance Directives data class and advance directive data element in USCDI v5.

Clarify this observation is recording the act of reading/verifying the existence of an advance healthcare directive document or form and identifying the content in the document considered relevant to the course of care for the patient.

APHL Comments on ISA 2022

APHL suggests that USCDI contain some clarification on how this class is expected to be used compared to these other classes, that all contain observations.

Clinical Tests

Clinical Test = Observation Code

Clinical Test Result/Report = Observation Value


Diagnostic Imaging   

Diagnostic Imaging Test = Observation Code

Diagnostic Imaging Report = Observation Value



Tests = Observation Code

Values/Results = Observation Value

Laboratory Test Performed Date = Observation Timing


Vital Signs

This class is slightly different, as it created a single element for the combination of Observation Code Observation Value; so for example: Systolic blood pressure  references as vocabulary Logical Observation Identifiers Names and Codes (LOINC®) version 2.67 to identify its respective Observation Code and The Unified Code of Units for Measure (UCUM), Revision 2.1 to define the units for the Observation Value, since in this case it will be a numeric value

Vizient comments

Vizient recommends adding to USCDI v3 Observation Value; Observation Code; and Observation Performer. These 3 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.

Level 2 Data Class: Observations

Level 2 Data Element: Observation Value

Level 2 Data Element: Observation Code

Level 2 Data Element: Observation Timing

Level 2 Data Element: Observation Subject

Level 2 Data Element: Observation Performer

IMO supports the inclusion of the proposed Level 2 Data Class: Observations and the specified data elements described above. CDA R2 C-CDA Templates for Clinical Notes R2.1 incorporates observations in mature and commonly implemented document types including Procedures and Progress notes. Numerous VSAC value sets specified in SNOMED CT, LOINC, ICD 10, HCPCS and CPT represent the data elements in this proposed Level 2 data class.  ONC certified HIT can support these data elements.

CMS-CCSQ Support for Observation Data Class for USCDI v3

CMS-CCSQ recommends adding to the USCDI v3 an observation data class with associated codes, values, and the performer, as a data capture structure that allows for exchange of standard clinical assessments and observations that routinely occur and are captured in discrete, structured fields.

  1. Data Element: Observation codes; CMS recommends adding observation codes related to clinician-administered assessments/observations to the USCDI. These include observations for screenings (i.e., depression screenings), clinical assessments, and risk assessments (i.e., pain intensity assessment, fall risk assessment) via standard assessment instruments.
  2. Data Element: Observation values; defined as the discrete values (results) of the observations

Rationale: In addition to lab and vital signs, many clinical observations assessed for patients shape quality patient care. Clinical observations are an essential structure for recording many kinds of health information, with results that inform clinical care and condition management decisions and are used extensively throughout CMS quality measurement. USCDI v2 added a data class for Clinical Tests, which includes some, but not all, of these observations/results. CMS specifically uses the following types of clinical assessments/observations in measurement and requests the observation code and value structure be added to the USCDI to support exchange: clinically-administered assessments, clinical screenings. These types of observations are administered and captured in discrete fields with specific associated codes and values, are exchanged via the FHIR Observation profile, and are specified by category codes in FHIR to distinguish between different types of observations.


  • Current standards:
    • Mature and standardized terminology exists via LOINC and SNOMED to represent clinical observations and assessments.
    • The Observation FHIR resource, included in the QI Core IG, is used to exchange this information.
      • Category is used, within the profile, to specify the type of observation.
  • Current uses, exchange, and use cases: These data are already extensively captured in EHRs by providers in discrete fields, and routinely exchanged for quality measurement and care coordination. For example, LOINC codes are used to define depression screening assessment tools used, and the results (or values) can take the form of quantitative results, ordinal scale values, or categorial values.


  1. Data Element: Performer; CMS recommends inclusion of patient-reported data, or structured data that comes directly from the patient related to the status of a patient’s health condition, in the USCDI. This data is typically captured via questionnaires and transformed into observations for storage and exchange. The observation performer data element (observation.performer in FHIR) is crucial for understanding context for observations derived directly from the patient.

Rationale: CMS is committed to an expanded use of patient generated data and recommends the inclusion of data in the USCDI that comes directly from the patient – in this specific case, patient reported outcome survey data with data captured in a structured way and can be exchanged as observations, with the performer specified as the patient. This is important not only to quality measurement but to advancing patient-centered clinical care, increasing patient access to data, and improving patient engagement. This data element has been identified by the USCDI Task Force as a priority area, and the standards around this concept have continued to mature and have continued to be tested in FHIR Connectathons (most recently in September 2021).


  • Current standards:
    • Argonaut Questionnaire Implementation Guide
    • FHIR Structured Data Capture (SDC) Implementation Guide
    • LOINC
  • Current uses, exchange, and use cases: Testing of FHIR resources continues in Connectathons, and CMS continues to capture patient reported data in quality measurement programs, as this is a priority area of focus across the healthcare ecosystem. This includes survey data captured from an instrument, such as PROMIS or HOOS and KOOS about mental or physical status. Use of PRO data is expanding nationally. Rapid technology advancements are simplifying mobile data collection and increasing integration of PRO data collection into clinical workflows and electronic medical records.

NCPDP Comment

NCPDP recommends the NCPDP SCRIPT Standard Version 2017071 be added to the list of standards.

Store the observation code with the results in the EHRs

The observation code is often stored in one of many mapping tables that researchers cannot find.  Suggest storing it as part of the result as defined in FHIR, CDA and HL7 V2.  Apple health does so, making it easy to find and to verify its correctness. 

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