Data Element
Eating/drinking assistive device
Description
External devices that are designed, made, or adapted to assist a person with eating and/or drinking
Submitted By: Becky Gradl / Academy of Nutrition and Dietetics
Data Element Information
Data Element Description External devices that are designed, made, or adapted to assist a person with eating and/or drinking
Use Case Description(s)
Use Case Description Per 42 C.F.R. 482.28 (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-C/section-482.28) for hospitals and 42 C.F.R. 483.60 (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-483#483.60) for long-term care facilities, facilities must ensure patients’ or residents’ nutritional needs are met through therapeutic diets that meet any nutritional and special dietary needs. The data elements described in this submission for a new Nutrition and Diet class represent the minimum data elements that should be interoperable to support these regulations.

In the long-term care setting, therapeutic diets are defined (in Interpretive Guidelines for as "a diet ordered by a physician or other delegated provider that is part of the treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet (e.g., sodium or potassium), or to provide mechanically altered food when indicated." In the hospital setting, CMS stated (https://www.federalregister.gov/d/2014-10687/p-172) that they "consider all patient diets to be therapeutic in nature, regardless of the modality used to support the nutritional needs of the patient” given they are part of the totality of treatment. The data elements included are those necessary to define the care delivered and facilitate transitions.

Currently, most EHR systems are collecting the data elements described in this submission for a new Nutrition and Diet class and transmitting them to a food management system so that patients or residents may be provided with appropriate meals. Either a dietitian or a physician will enter the data elements in the EHR to create the diet order that is then sent to the food management system so the food and nutrition services can provide appropriate meals. Similarly, any changes to a patient or resident’s diet order is typically made in the EHR and transmitted again to the food management system; typically, only one diet order is active at a given time.
Estimate the breadth of applicability of the use case(s) for this data element All patients and residents are impacted by this new Nutrition and Diet class. This would also impact all healthcare facilities who provide meals to patients and residents, including, but not limited to hospitals, long term care, rehabilitation facilities, and home health. Practitioners such as physicians, nurses, and dietitians would capture, access, use and exchange this data and people who work to prepare and serve meals, including food service companies such as Sysco, Aramark, and Compass Group would also use the data elements.
Link to use case project page http://www.hl7.org/implement/standards/product_brief.cfm?product_id=289
Use Case Description Diet orders are also critical during transitions of care, smoothing the transition process and reinforcing discharge planning to help prevent hospital readmissions and improve quality of life across the continuum of care.

When there is a transition of care, nutrition and diet data elements are sometimes included, however should always be included to prevent any patient safety issues or unnecessary tests and costs associated with the need to reevaluate a patient for an appropriate therapeutic diet to meet their nutritional or special dietary needs. These proposed requirements to enhance communication between providers should reduce risks of complications and adverse events for patients and residents, for many of whom nutrition is a particularly essential part of the plan of care.
Estimate the breadth of applicability of the use case(s) for this data element Any patients who require a transition of care are impacted by this new Nutrition and Diet class. This would also impact those healthcare facilities who provide meals to patients and residents, including, but not limited to hospitals, long term care, rehabilitation facilities, and home health that the patient is transferred from and to. Practitioners such as physicians, nurses, and dietitians would also use this data related to the transition of care.
Link to use case project page http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492
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) HL7 Version 2 – ODS – Dietary orders, supplements, and preferences (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185)
HL7 Version 3 Standard: Orders; Diet and Nutrition, Release 1 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=317)
HL7 FHIR NutritionOrder (https://www.hl7.org/fhir/nutritionorder.html)

In addition, many there are many nutrition-related terms in SNOMED CT. Many of these terms have been put in value sets in VSAC or through HL7 terminology. Here are some examples:
Diet Type (OID 2.16.840.1.113883.4.642.3.385) – HL7 terminology
Nutrient Modifier (OID 2.16.840.1.113883.4.642.3.386) – HL7 terminology
Nutrition Supplement (OID 2.16.840.1.113883.4.642.3.390) – HL7 terminology
Enteral Nutrition Type (OID 2.16.840.1.113883.4.642.3.391) – HL7 terminology
Enteral Nutrition Additive (OID 2.16.840.1.113883.4.642.3.392) – HL7 terminology
Food Allergies and Intolerance (OID 2.16.840.1.113762.1.4.1186.3) - VSAC
Feeding Device Grouping (OID 2.16.840.1.113762.1.4.1095.87) - VSAC

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185
Additional Specifications Nutrition data is included in nine of the thirteen "transitions of care" documents between facilities in the HL7 Consolidated Clinical Document Architecture (C-CDA) Release 2. This should ensure (if implemented) that patients on a modified diet will have that data arrive at the hospital or other connected facility upon transition and admission. See section 2.40 in HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm is a Nutrition Section, including value sets, for Nutrition and Diet data elements. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492

There is also additional nutrition templates in HL7 CDA® R2 Implementation Guide: C-CDA R2.1 Supplemental Templates for Nutrition, Release 1 - US Realm. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=478
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts Per HL7, 95% of healthcare organizations in the US are using some form of the V2 standards. As examples of EHRs using the ODS for exchange of Nutrition and Diet data elements are EPIC, Cerner, and MatrixCare, while CBORD, Delegate, Computrition, and MealTracker are examples of food management systems.
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185
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 Per HL7, 95% of healthcare organizations in the US are using some form of the V2 standards. As examples of EHRs using the ODS for exchange of Nutrition and Diet data elements are EPIC, Cerner, and MatrixCare, while CBORD, Delegate, Computrition, and MealTracker are examples of food management systems.

While most organizations are using the ODS in HL7 V2 standards to exchange Nutrition and Diet data elements, the use of FHIR and the NutritionOrder resource (https://www.hl7.org/fhir/nutritionorder.html) should be encouraged as it better supports interoperability and a more complex structure for the exchange of the data. The NutritionOrder resource has a maturity of FMM3.

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are limited to no restrictions on the standardization of the data elements in the Nutrition and Diet class. The majority of data elements already have potential value sets through VSAC (with SNOMED CT), through HL7 terminology, or other open source terminologies.
Restrictions on Use (e.g. licensing, user fees) There are limited to no restrictions on the use of the data elements in the Nutrition and Diet class. The majority of data elements already have potential value sets through VSAC (with SNOMED CT), through HL7 terminology, or other open source terminologies.
Privacy and Security Concerns Since the data elements proposed in the new Nutrition and Diet class are currently being exchanged, they should continue to follow any existing privacy and security requirements, if any.
Estimate of Overall Burden Since the data elements in the proposed Nutrition and Diet class are currently being captured and exchanged through HL7 V2 standards in many systems, there should be limited to no burden to implement. This also applies to those systems using the C-CDA standards as well. If FHIR is not currently being utilized and is required as the standard to exchange the Nutrition and Diet class data elements, this may pose additional burden to implement.
Other Implementation Challenges There are no other known challenges to implement.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element represents a subset of Medical Devices used in clinical care.

Comment

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