Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s authorized representative, or patient’s healthcare provider that could identify a need, problem, or condition.

Data Element
Functional Status
Description (*Please confirm or update this field for the new USCDI version*)

Assessment of a patient’s capabilities, or their risks of development or worsening of a condition or problem. (e.g., fall risk, pressure ulcer risk, alcohol use)

Applicable Vocabulary Standard(s)

Applicable Standards (*Please confirm or update this field for the new USCDI version*)
  • Logical Observation Identifiers Names and Codes (LOINC®) version 2.72

View guidance on Applicable Vocabulary Standards and versioning.
Submitted By: Holly Miller, MD / MedAllies
Data Element Information
Data Element Description Assessment is a data class comprised of many tools used clinically to evaluate patient status, risks and capabilities.
Use Case Description(s)
Use Case Description We are proposing “Assessment” as a USCDI data class to serve as a repository for any standardized assessment instrument. There are thousands of assessment instruments in use across clinical settings, public health providers, payors, and researchers.
As one example, the CMS Data Element Library (DEL: Home - Data Element Library (cms.gov)) is an example of multiple standardized data elements used in the federally mandated assessment instruments by LTPAC (Long-Term and Post-Acute Care) providers who collectively provide care to over 7 million Medicare Beneficiaries per year. Because these assessments are required for payment and quality reporting, they are collected by the more than 15,000 Skilled Nursing Facilities (SNFs), 11,000 Home Health Agencies (HHAs), 4,600 Hospice Care agencies, 1,100 Inpatient Rehabilitation Facilities (IRFs), and 400 Long-Term Care Hospitals (LTCHs). These standardized data are collected and submitted to CMS as required by these entities. Most of these data elements are mapped to LOINC and some are mapped to C-CDA templates.
The DEL incorporates only a tiny percentage of standardized assessments currently in use; and the use of standardized assessments is universal in health care.
Estimate the breadth of applicability of the use case(s) for this data element This data class pertains to most or all patients, providers or requestors.
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) LOINC, SNOMED-CT
https://loinc.org/; https://www.snomed.org/
Additional Specifications N/A
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
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.
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 This would vary depending on the specific assessment instrument and how it is used.
Other Implementation Challenges Unknown

Comment

Submitted by ubackonja@mitre.org on

PACIO: Include FCMs in Functional & Mental/Cognitive Status

Recommendation: Expand the definitions of Functional Status data element to include the American Speech-Language-Hearing Association (ASHA) Functional Communication Measures (FCMs) that have assigned LOINC codes. Functional communication data are already standardized and electronically collectible and should be clearly recognized within USCDI so that they can participate in the federal interoperability infrastructure being implemented by ONC.

 

Rationale: The PACIO Project Community* recommends including Functional Communication Measures (FCMs), in the definitions of the Functional Status data element to demonstrate the capability in each of these domains for capturing communication-specific health information. FCMs address functional communication in real-world contexts, rather than simply documenting a diagnosis such as aphasia or a generic cognitive impairment. Therefore, inclusion of FCMs would help support patient- and caregiver-centered care as well as patient engagement. Also, adding FCMs to the definitions of Functional Status and Mental/Cognitive Status would make clinically meaningful communication-function information more readily recognizable as part of the standardized health information that should be available for interoperable exchange, rather than leaving it dependent on local implementation choices or narrative documentation. 

 

Current Standards:

Background: FCMs were created by the American Speech-Language-Hearing Association (ASHA) and are “used to describe an individual’s functional abilities over the course of speech-language pathology intervention in a given level of care,” according to an ASHA user guide. Eight FCMs have been endorsed by NQF for use in the Physician Quality Reporting System, including: Attention, Memory, Motor Speech, Reading, Spoken Language Comprehension, Spoken Language Expression, Swallowing, and Writing. Of note, an NQF-endorsed measure “tends to be one that is generally regarded as a high-quality measure” by CMS.

Practice: FCMs have been designed to support compliance with CMS requirements to “report all outcomes data on all Medicare Part B beneficiaries receiving speech-language services” (ASHA). In 2007, CMS recommended use of the NOMS, which includes FCMs, by speech-language pathologists.

Technical: Existing technically mature standards already capture functional communication data that cover a large portion of speech-language pathology (SLP) practice. LOINC includes FCM items, organized within a swallowing panel (99852-6), cognition panel (99788-2), Multi-Modal Functional Communication panel (99828-6), Spoken Language Comprehension panel (99836-9), and Spoken Language Expression panel (99844-3). These LOINC codes assigned to FCMs represent the collaboration between SLPs and other disciplines

Regulations:

 

Current Use:

  • Practice: The FCMs are the discipline standard for speech, language, and hearing assessments and are included in the National Outcomes Measurement System (NOMS). The purpose is to support longitudinal collection of speech, language, and hearing data to inform clinical care and support quality service provision (ASHA).
  • Technical: There is a NOMS "SMART on FHIR" app for Epic and Cerner customers and also supports collection of FCM data (NOMS includes FCM items). Epic includes the NOMS tool in its online showroom.

 

Current Exchange:

  • The NOMS is available via a “SMART on FHIR” app for Epic and Cerner customers also supports transmission of FCM data via its inclusion in NOMS. ASHA lists Net Health and IMS by MICA Information Systems as partnering vendors that have integrated the NOMS data collection tool into their speech-language pathology documentation systems that allows for FCM data transmission.
  • The FCM data are captured under both Functional Status and Cognitive Status as part of a published PACIO Personal and Functional Engagement (PFE) FHIR IG STU-2, compliant with US Core 6.1.0. 

 

Breadth of Applicability: 

  • FCM data are collected by clinicians, including Speech-Language Pathologists (SPLs) and audiologists, across various care settings, including post-acute care settings (ASHA). FCM data are not required to be collected, but they are collected by these specialties to support care (examples of FCM usage are available via ASHA NOMS data reports for 671,628 adults and 3,967 children ages 3–5).
  • FCM data can be electronically submitted to the NOMS system by participating organizations that integrate NOMS into their EHR systems.

 

Applicable Standards: 

  • The PACIO Community recommends including FCMs within the Functional Status and Mental/Cognitive Status data elements.

* The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, which aims to advance interoperable health information exchange between post-acute care (PAC) providers, patients, and other key stakeholders across health care.

Submitted by ubackonja@mitre.org on

PACIO: Add ICF to Functional Status

Recommendation: Add the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard for Functional Status, Health Concerns, and Mental/Cognitive Status, enabling standardized representation of functioning, activities, participation, and relevant environmental/contextual factors in addition to existing LOINC-based assessment representation.

Rationale: The PACIO Project Community* recommends the addition of the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Functional Status data element. The purpose would be to complement, not replace, use of other terminologies such as LOINC and SNOMED CT – ICF fills a specific interoperability gap in USCDI and is already an established federal, international, and HL7 standards ecosystem. USCDI currently has mechanisms for representing conditions and problems, but Functional Status and related health-status information require a vocabulary that describes what a person can do, how health conditions affect activities and participation, and what environmental factors influence functioning. ICF was specifically designed for that purpose and therefore complements, rather than duplicates, disease-oriented vocabularies such as ICD. The proposed ICF addition is a semantic complement to LOINC, rather than a replacement -- LOINC can identify the assessment/observation or instrument; ICF can provide a standardized functional-domain classification for what the observation represents. ICF is not an informal clinical terminology. It is an established, computable classification represented in HL7 Terminology. Its inclusion as an Applicable Vocabulary Standard would therefore build upon an existing standards infrastructure rather than require development of a new vocabulary or exchange mechanism.

 

Current Exchange:

Active Exchange: The ICD-API includes the ICF as a CodeSystem in FHIR.

Recent demonstration:

* The PACIO (Post-Acute Care Interoperability) Project, established February 2019, is a collaborative effort between industry, government, and other stakeholders, which aims to advance interoperable health information exchange between post-acute care (PAC) providers, patients, and other key stakeholders across health care.

Submitted by RebeccaB on

ASHA: Add ICF as Applicable Vocabulary Standard

On behalf of the American Speech-Language-Hearing Association (ASHA), I write to share ASHA’s support of PACIO's recommendation to add the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Functional Status, Health Concerns, and Mental/Cognitive Status data elements. . ASHA is the national professional, scientific, and credentialing association for 247,000 members, certificate holders, and affiliates who are audiologists; speech-language pathologists (SLPs); speech, language, and hearing scientists; audiology and speech-language pathology assistants; and students. Audiologists specialize in preventing and assessing hearing and balance disorders as well as providing audiologic treatment, including hearing aids. SLPs identify, assess, and treat speech, language, swallowing, and cognitive communication disorders. 

 

 Recommendation: Add the International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Functional Status, Health Concerns, and Mental/Cognitive Status data elements.

Rationale: The PACIO Project Community* recommends the addition of the World Health Organization’s International Classification of Functioning, Disability and Health (ICF) as an Applicable Vocabulary Standard to the Health Concern data element.

  • Background: The ICF was created in 2001 to classify functioning domains as a consequence of health conditions, which are not completely captured by any other codeable concept ontology. The ICF ontology allows data to be categorized as mental, cognitive, and functional factors, as well as health concerns in a machine-readable way.
  • Clinical utility: Research suggests that the ICF is useful in supporting clinical care related to functioning, cognition, and addressing health concerns, as demonstrated by evidence of its validation in post-acute physiotherapy, usefulness in assessing long-term psychiatric care, and utility in evaluating a telerehabilitation intervention.
  • Support: The ICF has been recommended or endorsed by The National Committee on Vital and Health Statistics (NCVHS) and the American Physical Therapy Association. The American Speech-Language-Hearing Association (ASHA) provides information on how to use the ICF. CMS and the CDC provide guidance on using the ICF.
  • The WHO developed the ICF to be ICD complementary, with ICF covering functioning and environmental factors and ICD covering diseases and other health problems. As described by the WHO, “ICF is based on the same foundation as ICD…and share the same set of extension codes that enable documentation at a higher level of detail.”
  • The PACIO Project makes extensive use of the ICF ontology in the Personal and Functional Engagement (PFE) FHIR IG STU-2 as category codes for several profiles. 

 

Current Standards

 

Current Use

  • All post-acute care (PAC) vendors can collect data pertaining to Functional Status and Mental/Cognitive Status given CMS requirements to collect such data required for PAC facilities to get reimbursement (e.g., Minimum Data Set for nursing facilities, Inpatient Rehabilitation Facility Patient Assessment Instrument [IRF-PAI]); therefore, all vendors have the potential to apply ICF to the volume of Functional Status and Mental/Cognitive Status data already collected.
    • Three vendors have deployed the PACIO PFE IG that integrates the ICF: Global Alliant, Open City Labs, and Patient Centric Solutions. 

 

Current Exchange

Submitted by RebeccaB on

ASHA: Include FCMs in Functional & Mental/Cognitive Status

 

On behalf of the American Speech-Language-Hearing Association (ASHA), I write to share ASHA’s support of PACIO's recommendation to expand the definitions of Functional Status and Mental/Cognitive Status data elements to include the American Speech-Language-Hearing Association (ASHA) Functional Communication Measures (FCMs) that have assigned LOINC codes. ASHA is the national professional, scientific, and credentialing association for 247,000 members, certificate holders, and affiliates who are audiologists; speech-language pathologists (SLPs); speech, language, and hearing scientists; audiology and speech-language pathology assistants; and students. Audiologists specialize in preventing and assessing hearing and balance disorders as well as providing audiologic treatment, including hearing aids. SLPs identify, assess, and treat speech, language, swallowing, and cognitive communication disorders. The services provided by ASHA members are medically necessary, evidence-based, and essential to the health and independence of Medicaid beneficiaries across the lifespan.

 

Recommendation: Expand the definitions of Functional Status and Mental/Cognitive Status data elements to include the American Speech-Language-Hearing Association (ASHA) Functional Communication Measures (FCMs) that have assigned LOINC codes.

 

Rationale: The PACIO Project Community* recommends including Functional Communication Measures (FCMs), in the definitions of the Functional Status and Mental/Cognitive Status data elements to demonstrate the capability in each of these domains for capturing communication specific health information. Inclusion of FCMs would help support patient- and caregiver-centered care as well as patient engagement.

 

Current Standards

  • Background: FCMs were created by the American Speech-Language-Hearing Association (ASHA) and are is “used to describe an individual’s functional abilities over the course of speech-language pathology intervention in a given level of care,” according to an ASHA user guide. Eight FCMs have been endorsed by NQF for use in the Physician Quality Reporting System, including: Attention, Memory, Motor Speech, Reading, Spoken Language Comprehension, Spoken Language Expression, Swallowing, and Writing. Of note, an NQF-endorsed measure “tends to be one that is generally regarded as a high-quality measure” by CMS.
  • Practice: FCMs have been designed to support compliance with CMS requirements to “report all outcomes data on all Medicare Part B beneficiaries receiving speech-language services” (ASHA). In 2007, CMS recommended use of the NOMS, which includes FCMs, by speech language pathologists.
  • Technical: LOINC includes FCM items, organized within a swallowing panel (99852-6), cognition panel (99788-2), Multi-Modal Functional Communication panel (99828-6), Spoken Language Comprehension panel (99836-9), and Spoken Language Expression panel (99844-3).

 

Current Use

  • Practice: The FCMs are the discipline standard for speech, language, and hearing assessments and are included in the National Outcomes Measurement System (NOMS). The purpose is to support longitudinal collection of speech, language, and hearing data to inform clinical care and support quality service provision (ASHA).
    • Technical: There is a NOMS "SMART on FHIR" app for Epic and Cerner Customers that supports collection of FCM data (NOMS includes FCM items).

 

Current Exchange

  • The NOMS is available via a “SMART on FHIR” app for Epic and Cerner Customers also supports transmission of FCM data via its inclusion in NOMS.
    • The FCM data are captured under both Functional Status and Cognitive Status as part of a published PACIO Personal and Functional Engagement (PFE) FHIR IG STU-2, compliant with US Core 6.1.0. 

 

Breadth of Applicability 

  • FCM data are collected by clinicians, including Speech Language Pathologists (SPLs) and audiologists, across various care settings, including post-acute care settings (ASHA). The FCM is not a required to be collected, but is collected by these specialties to support care (example of FCM usage available via ASHA NOMS data reports for 671,628 adults and 3,967 children ages 3-5).
  • FCM data can be electronically submitted to the NOMS system by participating organizations that integrate NOMS into their EHR systems.

 

Applicable standards: The PACIO Community recommends including FCMs within the Functional Status and Mental/Cognitive Status data elements.

Submitted by nachcinformatics on

Functional Status

Health Status – Functional Status

 

NACHC is supportive of the concept of functional status; however, it is not likely to support interoperability to solely create a terminology binding to support the concept. Because concepts in the draft version are in fact different types of functional status or causes of disability, we believe that creating a class for this concept will likely create larger transitions of care documents without being able to be processed by receiving systems. This approach creates liability for providers who at best can use this data as free text in this case and contributes to data overload and burnout. We strongly recommend providing either specific category of functional status with equivalent semantics and clear terminology bindings. NACHC encourages ONC to support work on a list of preferred instruments and mappings that will assist organizations in normalizing these types of data.

Submitted by yale-coredQMRoadmap on

CMS-CCSQ Support for Removing Pressure Ulcer Risk and Fall Risk

CMS suggests removing pressure ulcer risk and falls risk as examples under the Functional Status data element definition as they are not representative of functional status. Examples that can be added to this data element include self-care including activities of daily living, mobility, or use of a device. We agree that pressure injuries and falls risk information are important to exchange so we will address the placement of this information under the Problems data class in a future version of USCDI.

Submitted by HCapon on

PACIO Project Recommends Removal of Disability Status

  • Data Class: Health Status Assessments (Draft V4) 

  • Data Elements: Functional Status, Mental/Cognitive Status, Disability Status (Draft V4)  

  • Recommendation: Remove the Disability Status data element from the Health Status data class and instead add a new data element entitled, “Disability” to the patient demographic data class.  

  • 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 CMS and CDC submission, which reflect their view that identifying a person with a disability does not necessarily have any bearing on how healthy a person is or the status of one’s health. However, collecting and transmitting data on disability in a standardized way alongside other demographic factors is vital to recognition of disability as a key component of identity and allows analysis of outcomes and conditions in an intersectional way, incorporating race/ethnicity, age, sex, and disability together for a more comprehensive understanding of patient demographics. 

Submitted by HCapon on

PACIO Project Recommends Value Set Adoption

  • Data Class: Health Status Assessments (Draft V4) 

  • Data Elements: Functional Status, Mental/Cognitive Status, Disability Status (Draft V4) 

  • Recommendation: Adopt the value sets developed for the “Personal Functioning and Engagement” IG as part of the USCDI V3 updates to the U.S. Core IG to incorporate Functional Status and Cognitive Status data elements. 

  • 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. Functional and Mental/Cognitive Status are important data classes that have widespread use in all healthcare settings and sharing the content of standardized PAC assessments (some of which are federally required) with non-PAC providers (e.g., hospitals, physicians) would improve the quality of care and facilitate care coordination during transitions of care. These instruments use a consistent framework mapped to HIT standards for functional status, contain administrative and clinical patient data, can be considered as individual data elements (mobility, pressure ulcer, transportation, social isolation, etc.) or a “questionnaire” of grouped data elements together (MDS, OASIS, IRFPAI, FASI etc.) The PACIO Community wishes to update the ONC/USCDI with current efforts relating to several of the data elements under the proposed USCDI V4 data class of Health Status (Health Concerns, Functional Status, Disability Status, and Mental/Cognitive Status). The PACIO Community recognized the value of creating data models (like Gravity’s SDOH) that allow for expansion across multiple domains. As a result, PACIO created a new FHIR Implementation Guide (IG), “Personal Functioning and Engagement,” which consolidates PACIO’s prior published IGs (STU1) “Cognitive Status” and “Functional Status”. The PACIO group also is incorporating data elements of communication, swallowing, and hearing to the “Personal Functioning and Engagement” IG currently under development. Currently, the Personal Functioning and Engagement IG data structures focus on observation/ assessment data. However, the IG could include future expansion using additional resources as the work matures. The concept of “Personal Functioning and Engagement” encompasses both an individual’s abilities (positive strengths) and disabilities (impairments) across all types of functioning. The PACIO Community examined and incorporated the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework that underpins this new PACIO Personal Functioning and Engagement IG. PACIO’s current work focuses on ICF “Body Functions” including mental functions, sensory functions (including hearing), voice and speech functions, and ingestion functions (swallowing). Current PACIO focus for ICF “Activities and Participation” functions include Learning and Applying Knowledge, Communication, Mobility, and Self-care.  

Submitted by HCapon on

PACIO Project Comment on Pressure Ulcer Risk and Falls Risk

  • Data Class: Health Status Assessments (Draft V4) 

  • Data Elements: Functional Status (Draft V4)  

  • Recommendation: Remove the pressure ulcer risk and falls risk as examples under the Functional Status data element definition.  

  • 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 CMS submission, which suggests removing pressure ulcer risk and falls risk as examples under the Functional Status data element definition, as they are not directly representative of functional status. Examples that can be added to this data element include self-care including activities of daily living, mobility, or use of an assistive device. Under USCDI V3, activities of daily living currently is listed as an example under the “Disability Status” data element, which we have recommended be removed from the Health Assessments data class in a separate comment submission. Consistent with this recommendation, we recommend activities of daily living should be included as an example under the Functional Status data element. We agree that pressure injuries and falls risk information are important to exchange, so we recommend this information would be more appropriately captured under the Problems data class in a future version of USCDI. 

Submitted by PACIO-Project on

Support to Advance Functional Status

  • 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. Functional and Mental/Cognitive Status are important data classes that have widespread use in all healthcare settings and sharing the content of federally required PAC assessments with non-PAC providers (e.g., hospitals, physicians) would improve the quality of care and facilitate care coordination during transitions of care. These instruments use a consistent framework mapped to HIT standards for functional status, contain administrative and clinical patient data, can be considered as individual data elements (mobility, pressure ulcer, transportation, social isolation, etc.) or a “questionnaire” of grouped data elements together (MDS, OASIS, IRF-PAI, etc.)
  • The PACIO Community wishes to update the ONC/USCDI with current efforts relating to several of the data elements under the proposed USCDI v.4 data class of Health Status (Health Concerns, Functional Status, Disability Status, and Mental/Cognitive Status). The PACIO Community recognized the value of creating data models (like Gravity’s SDOH) that allow for expansion across multiple domains. As a result, PACIO created a new FHIR Implementation Guide (IG), “Personal Functioning and Engagement,” which consolidates PACIO’s prior published IGs (STU1) “Cognitive Status” and “Functional Status”. The PACIO group also is incorporating data elements of communication, swallowing, and hearing to the “Personal Functioning and Engagement” IG currently under development. Currently the Personal Functioning and Engagement IG data structures focus on observation/ assessment data. However, the IG could include future expansion using additional resources as the work matures. The concept of “Personal Functioning and Engagement” encompasses both an individual’s abilities (positive strengths) and disabilities (impairments) across all types of functioning. The PACIO Community examined and incorporated the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework that underpins this new PACIO Personal Functioning and Engagement IG. PACIO’s current work focuses on ICF “Body Functions” including mental functions, sensory functions (including hearing), voice and speech functions, and ingestion functions (swallowing). Current PACIO focus for ICF “Activities and Participation” functions include Learning and Applying Knowledge, Communication, Mobility, and Self-care.
    • The PACIO Community encourages ONC to consider adopting the value sets developed for the “Personal Functioning and Engagement” IG as part of the USCDI v.3 updates to the U.S. Core IG to incorporate Functional Status and Cognitive Status data elements.

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