Clinical Notes

USCDI V5 Feedback

USCDI guidance continues to confuse the industry by establishing the “Clinical Notes” Data Class without clarifying that the Data Elements defined within this class may represents a document which holds a collection of clinical notes expressed as narrative or structured data.  The clinical note Data Element may describe a collection of data elements, or it may describe an individual narrative clinical note that is expressed within the context of a clinical note document or may be expressed as a single clinical statement that can be understood on its own without the context provided by a document. 

This confusion created by the USCDI Clinical Notes Data Class I call the “Sheep, Sheep Problem”. USCDI has a “collective noun” problem in the way these Clinical Notes Data Elements are defined. This problem should be addressed sooner rather than later.

One option for addressing this problem is to clarify there are many more specific types of Clinical Documents or Clinical Forms each representing a collection of information with a single context and shared data Provenance information. An opportunity exists to define a hierarchy of Clinical Document and Form types, then the USCDI data elements can focus on just the highest tiers of this hierarchy. 

Clinical Notes, Clinical Documents, and Clinical Forms

Broaden the definition of this Data Class to include Documents and Forms

Clinical Document

A collection of narrative and structured data which is created at a point in time to establish a single context for understanding the meaning of the information. The collection of information shares a single Provenance in terms of who created it, signed it, shared it, etc. The collection needs to be human readable, has the potential for authentication, etc.  (See the 6 characteristics of a document as established in CDA and FHIR.)

The distinction between a Clinical Document and a Clinical Form is nuanced and differentiated by the format used to represent the information.

Consultation Note Document

Wouldn’t need to be a separate named Data Element. It is a type of Clinical Document and could be listed as such in the proposed “data element index list”.

Discharge Summary Note Document

Same comment as for Consultation Note Document

Emergency Department Note Document

Same comment as for Consultation Note Document

History & Physical Note Document

Same comment as for Consultation Note Document

Operative Note Document

Same comment as for Consultation Note Document

Procedure Note Document

Same comment as for Consultation Note Document

Progress Note Document

Same comment as for Consultation Note Document

Clinical Form

A collection of narrative and structured data which is created at a point in time to establish a single context for understanding the meaning of the information. The collection of information shares a single Provenance in terms of who created it, signed it, shared it, etc. The collection needs to be human readable, has the potential for authentication, etc.  (See the 6 characteristics of a document as established in CDA and FHIR.)

The distinction between a Clinical Form and a Clinical Document is nuanced and differentiated by the structural format used to represent the information. 

Clinical Note

A narrative finding expressed by a clinician in the context of documenting care provided to a patient or observations about a patient for whom care has been provided.

Consultation Note

Wouldn’t need to be a separate named Data Element. It is a type of Clinical Note and could be listed as such in the proposed “data element index list”.

Discharge Summary Note

Same comment as for Consultation Note

Emergency Department Note

Same comment as for Consultation Note

History & Physical Note

Same comment as for Consultation Note

Operative Note

Same comment as for Consultation Note

Procedure Note

Same comment as for Consultation Note

Progress Note

Same comment as for Consultation Note

THIA Prenatal Record Request

The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group recommends the inclusion of the Prenatal Record as an encounter-specific note in clinical notes. Various national initiatives have been formed to address relatively high maternal and fetal morbidity, including but not limited to, the Center for Medicare and Medicaid Services (CMS) Transforming Maternal Health Model (December 2023). Unfortunately, information exchange suffers from lack of standardization. An encounter-specific Prenatal Record would bolster availability of the right information at the right time to facilitate clinical efficiencies and empower tool development initiatives reliant on these critical data in the EHR vendor community.

THIA Policy & Standards WG - USCDI v5 Recommendation - Clinical Notes - Clinical Notes.pdf

Clinical Notes data class needs clarification

The Clinical Notes data class needs to include Encounter Summaries and Patient Summaries.  

Along the way, something got lost in translations for this data class.  The Consolidation CDA standard defines Clinical Note Templates for the document types named in the Clinical Notes Data Class.  It needs to be clarified that this data class covers support for Clinical Notes including support for “note activity” as well as wholly formed encounter summaries which are Clinical Notes of these types.  Specifically, the Clinical Notes data class needs to call out Clinical Notes, Clinical Note Encounter Documents, and Patient Summary Documents.  Patient Summary Documents are also known as Continuity of Care Documents (CCDs) they are a type of Clinical Note which covers a span of time which may cover multiple encounters.

Lisa Nelson Comments 20230221.pdf

AOTA's Comment on Clinical Notes

The American Occupational Therapy Association (AOTA) encourages USCDI to consider how notes from non-physician specialties, such as those created by occupational therapy practitioners, can be included in data exchange. AOTA believes the information captured by an occupational therapy practitioner is vital for holistic care. Occupational therapy documentation is typically captured in evaluation, progress, and discharge notes.  This field is for general comments on this specific data class. To submit new USCDI data classes and/or data elements, please use the USCDI ONDEC system: https://healthit.gov/ONDEC

USCDI 2022 Comments 9.22_1.pdf

Additional Clinical Notes

I recommend the next phase of clinical notes should include: 

Emergency Department Reports as a separate item from progress notes to make it easier to discern for the individual requesting their records.  Having as part of the progress notes creates confusion.

Back to school / Back to work notes

Rehabilitation Services records.

The recommendations are based on a survey completed by AHIMA in 2021 of their members requesting feedback on items most requested by patients, payers and providers.  

Occupational History

Occupational exposure to disease risk factors is part of the clinical information that needs to be regularly collected during clinical encounters. Having the occupational history available as part of the clinical notes helps with the clinical investigation and decision making for diagnosis of disease conditions.

The details recommended to be part of the occupational history are:

• Employment Status
• Jobs taken (Past and Present) and Voluntary Work done
• Retirement Dates
• Worked in Combat Zone (Periods, if any)

Work of Household Member(s), if a Minor

LOINC provides an ontology…

• LOINC provides an ontology of clinical reports which includes more than 3000 report names that can distinguish setting, e.g. Hospital, nursing home discharge, specialty, and other dictions at varying levels of specificity. These codes are currently called out in HL7’s CDA and HL7’s FHIR US Core as alternative codes to the few common ones that are enumerated. These are described as alternatives in an ONC guidance published in December 2020 (https://www.healthit.gov/sites/default/files/2020-08/2015EdCures_Update_CCG_USCDI.pdf). ONC should put a short statement or foot note on the clinical report section that calls attention to this larger set of LOINC code from the LOINC document ontology and provide a link to the December 2020 ONC guidance that says so.  For interested parties, the LOINC document ontology can be downloaded from: https://loinc.org/file-access/download-id/8994/
• This section lists general codes for five important kinds of reports. We presume procedure note code is meant to cover surgical operative notes. If not, LOINC 11504-8  Surgery Operation note should be included in the short list.
• Users should be aware of “11504-8 Surgical operation note panel” which includes most of the sections, e.g. blood loss, pre-op diagnosis, etc., and includes most of the sections defined in C-CDA for surgical notes.

Lab, Path, and Imaging narrative

The LOINC Document Ontology Subcommittee recommends removing the 3 rows for Laboratory narrative, Pathology narrative, and Imaging narrative. These three concepts represent narrative text from Clinical Reports, which capture information related to a lab test or imaging procedure (i.e., in response to an “order”) versus Clinical Notes, which are written by providers during the course of providing clinical care, and not in response to an order.

Value sets for each note type

Currently only the most generic LOINC term for each note type is listed, e.g., 11506-3 Progress note. However, for each note type, there is a larger set of more specific LOINC terms available, such as the following for progress notes: https://search.loinc.org/searchLOINC/search.zul?query=progress+note+scale%3Adoc. The LOINC Document Ontology Subcommittee recommends adding information about how to access the value set of more specific LOINC terms available for each note type to the Applicable Standard(s) column for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

Clinical notes explanatory text

The LOINC Document Ontology Subcommittee recommends adding the following explanatory text below the Clinical Notes header, following the existing explanatory text:

“LOINC document codes represent expected collections of information regardless of format (e.g., structured versus unstructured, electronic format versus PDF document). For each note type, there is a generic LOINC concept as well as more specific concepts that vary by setting, specialty, etc. In most clinical situations, use of a more specific code is encouraged.”