ONC Standards Bulletin - July 2024 (original) (raw)

USCDI v5 includes two new data classes and 16 new data elements. One proposed data element in Draft USCDI v5, Test Kit Unique Device Identifier, was ultimately not included in the final version (see below for more information).

Observations

Observations are a common concept in healthcare and are used to support a variety of activities including diagnoses, test results, and screening assessments. ONC added Sex Parameter for Clinical Use (SPCU)and Advance Directive Observation to the new Observations data class. While there was overwhelming support for adding these elements in USCDI v5, ONC received comments recommending we create use-case specific data classes (e.g., SPCU and Advance Directive) for each of these data elements. ONC instead created a more general data class to include multiple elements that represent a similar concept. We reiterate that a data element’s placement in a particular data class does not limit its use to the context of that data class.

The SPCU data element was included as part of the HTI-1 Final Rule’s update to the “patient demographics and observations” certification criterion to which certified health IT will need to be updated by no later than January 1, 2026. SPCU provides sex specific context to observations, tests, procedures, and results. Individuals with SPCU attributes of female or male can have different reference ranges for a variety of laboratory test results (e.g., hormone levels, blood counts, renal function), different expected findings on diagnostic imaging studies (e.g., genitalia, solid organ sizes, skeletal variations), different recommended preventive screening recommendations (e.g., cervical, breast, or testicular cancer screenings), and different stages of gender-affirming treatment. SPCU can inform clinical decision making, treatment, and/or diagnostic tests. SPCU also aligns with the Administration’s Executive Order on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals. In the final version of USCDI v5, ONC added to the definition to clarify that there may be multiple instances of this data element for a single person, even though for the purpose of health IT certification in HTI-1 Final Rule, certified health IT must be able to record at least one value of SPCU.7 For example, depending on how the clinical observations (e.g., anatomic characteristics, recent hormone levels, or genetic testing) relate to or affect the clinical uses, such as laboratory tests and results, diagnostic imaging, or preventive screening measures, there may need to be multiple entries for a single patient. We also added LOINC as the applicable vocabulary standard to align with SPCU’s use in the “patient demographics and observations” certification criteria.8

An Advance Directive Observation describes various characteristics of an advance directive document, including its existence, location, content, and validity. Communicating and referencing advance directive information about a living will or a medical power of attorney has long been an issue in healthcare. This data element does not represent a specific advance directive document, but rather it provides information about such a document. For example, an Advance Directive Observation may state that the patient has a medical power of attorney, the date it was verified, and provide information about its location, such as a link. Advance Directive Observation builds on Care Experience Preferences and Treatment Intervention Preference, which were added in USCDI v4 to document patient goals and preferences in the care planning process, including advance care planning.

Patient Demographics/Information

The HTI-1 Final Rule also included Name to Use and Pronouns in the “patient demographics and observations” certification criterion updates.9 These two data elements further advance culturally competent care for lesbian, gay, bisexual, transgender, queer, intersex, asexual, and other sexual and gender minorities (LGBTQIA+) and align with President Biden’s Executive Order on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals.

Culturally competent care is critical to reducing disparities, promoting shared decision-making between providers and patients, and in improving access to healthcare that is respectful and responsive of diverse needs. Name to Use may represent a nickname or other name preferred by the patient. Pronouns refer to the preferred words to be used when communicating with or about an individual. ONC updated this data element name from Draft USCDI v5 to be plural, reflecting more common usage and understanding and addressing comments.

Interpreter Needed specifies a patient’s need for language services, regardless of their preferred language. Exchanging data on the need for interpreter services is critical to ensure all needed services are available during referrals and transfers. This promotes continuity and efficiency of care, reduces cancellation or delay of services, and enhances patient-centered care. As with other data elements representing clinical assessments, SNOMED CT and LOINC have been designated as applicable vocabulary standards. Interpreter Needed also aligns with two Executive Orders and supports the 2023 HHS Language Access Plan and Title IV of the Civil Rights Act of 1964.10,11

Orders

In Draft USCDI v5, ONC proposed to add a new Orders data class and one new general Order data element. An order represents a provider-authored request for the delivery of patient care services. Orders also indicate that certain aspects of care may be underway but the outcomes, such as a test result or report, aren’t yet available. This is particularly important when several providers are coordinating different aspects of care, as in the case of management of Multiple Chronic Conditions.

While ONC received support for adding this new class of data elements, we also received feedback that this single Orders data element was too broad to represent various types of orders, potentially creating confusion or ambiguity about how to implement them. In response, ONC added five elements representing the following specific order types: Medication, Laboratory, Diagnostic Imaging, Clinical Test, and Procedure.

By adding the Orders data class and five data elements to USCDI v5, ONC creates a minimum set of specific order types that should be exchanged to support patient care, care planning, and case management. The data elements Medication Order, Laboratory Order, and Diagnostic Imaging Order were included because they align with certification criteria for computerized order entry, which have been part of the ONC Certification Program since the publication of 2015 Edition Base Electronic Health Record Definition.12,13,14 ONC also added Clinical Test Order and Procedure Order, as these types of orders represent the majority of the remaining order types routinely used in most aspects of care.

Clinical Notes

As with other Clinical Notes data elements, Emergency Department Note and Operative Note convey narrative clinical content for coordination of patient care across the continuum and provide critical connections between inpatient and outpatient care settings. This is an important component of both acute and chronic disease management. These additional notes provide critical insight about a patient’s care that may not be available in other note types. This is particularly important for those who primarily rely on emergency departments for their care.

ONC received feedback at the data class level requesting clarification on if the included elements required only narrative information, structured information, or both. ONC clarifies that the intent of these data elements is to represent only narrative information. The ONC Certification Companion Guide for USCDI further clarifies this point that the data elements included in Clinical Notes data class should not be interpreted or associated with specific structured document templates that may share the same name. We also modified each definition to specify that the clinical notes represent narrative content.

Immunizations

Lot Number provides important vaccine information for patient care and safety, as well as for public health reporting, including adverse event tracking. Lot Number is a required component in the immunization messaging process and is critical for Vaccine Adverse Event Reporting System (VAERS) tracking in the event of a vaccine recall. The inclusion and availability of Lot Number also supports immunization inventory tracking. When ONC released Draft USCDI v5, we sought comment as to whether a new Lot Number data element should more broadly apply to other areas, such as medications or devices. Although ONC received some comments recommending Lot Number apply to medications, the expressed support was minimal. We therefore kept the focus on vaccine products, while recognizing lot number can be an important additional piece of information for those other concept areas. This means that systems implementing USCDI v5 in the future must at least be able to associate a lot number to a vaccine product.

Medications

In USCDI v4, ONC added the Medication data element Dose, which ONC believed to include the concept of route, or the way a medication enters the body to have its effect. We received numerous comments that Route is a distinctly valuable concept from Dose and should be its own separate data element. When considering this new data element, we saw potential confusion of this data element as something that could also represent other concepts, such as the approach to a certain procedure, or the way a device is used on or in the body. For this reason, we added this data element but changed its name to Route of Administration.

ONC also received feedback from the standards and implementer communities that an additional standard with widespread use should be added as an applicable vocabulary option: the National Cancer Institute (NCI) Thesaurus, which is used in the Structured Product Labeling implementation guide. To address the potential burden of a health IT developer having to add support for vocabulary standard where they have already implemented another standard in another workflow, ONC added the FDA Structured Product Labeling (SPL) Terminology (part of the National Cancer Institute Thesaurus (NCIt)), as a second applicable vocabulary standard. This means that certified health IT adopting USCDI v4 would only have to be able to represent Route of Administration with either SNOMED CT or the SPL Terminology.

Provenance

Author and Author Role provide insight into the source of health data and can be used to form assessments about its quality, reliability, or trustworthiness. These data elements can also indicate where to go to determine the origins of the information. These details can lead to better clinical decision making and support patient safety. Author Role may be a provider, a patient, a device, an outside medical record, or something else, while Author will provide additional details, such as the patient’s name, or the name and credentials of the documenting provider. The ability to identify data as coming originally from a patient can also help advance patient-centered care.

When these elements were proposed in Draft USCDI v5, ONC sought feedback from health IT developers and others as to their readiness to implement and exchange these data, given their feedback during the USCDI v1 cycle four years ago. We understand that much work has been done to exchange provenance data, and we received no concerns that the industry was not now ready to add these data elements.

Draft USCDI v5 Data Element Not Included

Laboratory

ONC added Test Kit Unique Device Identifier (UDI) to Draft USCDI v5 with the intent of advancing reliability, comparability, and interoperability of lab results data. ONC received feedback that while these data can be useful in post-marketing surveillance of home testing and other newly released devices, providers generally did not use this information to help interpret test kit derived lab results. Additionally, ONC received feedback that these device identifiers are not widely captured in the Laboratory Information Systems (LIS) or EHRs, and the infrastructure to exchange this data element is immature. The burden associated with implementing this data element would be significant, especially to laboratories and LIS developers. While ONC did not include Test Kit Unique Identifier in USCDI v5, it has been added to the USCDI+ Public Health (Laboratory Data Exchange) data set. USCDI+ is designed to support data element standardization beyond the core needs for standard clinical care. ONC believes this will help mature this data element through increased testing and use.

Other USCDI v5 Changes

ONC adopted the following updates to USCDI v5:

  1. Encounter Location: Added National Healthcare Safety Network (NHSN) Healthcare Facility Patient Care Location (HSLOC) and SNOMED CT® U.S. Edition as applicable vocabulary standards.
  2. Procedures: ONC clarified that Code on Dental Procedures and Nomenclature (CDT) is one of three applicable vocabulary standards that may be used to represent procedures, rather than limiting its use to only health IT primarily developed to record dental procedures.
  3. Immunizations: ONC changed the citations for two applicable vocabulary standards for vaccines:

ONC adopted the proposed changes to several other data elements, including definitions, examples, and usage notes: Current Address, Previous Address, Diagnostic Imaging Test, Discharge Summary Note, Procedure Note, Encounter Disposition, Result Unit of Measure, Mental/Cognitive Status, Functional Status, and Disability Status. ONC also updated the definition of the Care Team Members data class. For more detail, see the USCDI v5 change log.

In the Allergies and Intolerances data class, we also changed the names of the data elements to clarify the context for their use is to specifically represent agents that cause allergic reactions or other intolerances, rather than for therapeutic or other routine uses of these agents. The new names of the data elements are Medication Allergy Intolerance, Drug Class Allergy Intolerance, and Non-Medication Allergy Intolerance. The definitions of these data elements are unchanged.

As we have done in the past, we updated the applicable vocabulary standards for data elements to the latest versions as of the publication of USCDI v5.

Data Element Leveling Review

Many users of the USCDI platform will notice that the number of data elements in each level (0, 1, and 2) has significantly changed since ONC published Draft USCDI v5. This is a result of ONC conducting a thorough review of the level assigned to each data element to determine if these levels accuratefly reflected the technical maturity, extent of use and exchange, and applicability of these elements to a breadth of use cases. We found that in many cases upon more detailed analysis, data elements initially assigned to Level 2, for example, did not demonstrate evidence of significant use within health IT or exchange between different health IT modules, even in testing or pilot scenarios. These data elements are being reassigned to either Level 1 or 0 and will remain so unless additional information is obtained to demonstrate more extensive use, exchange, or applicability to indicate their feasibility to be considered for scaling to widespread national use. In other cases, some data elements were determined to represent a narrow use-case or a specialized use of other data elements, which may be more suitable to be considered for USCDI+ program.15

ONC looks to Level 2 data elements as the source for adding data elements to future versions of USCDI. We also maintain that Level 2 should contain only those data elements that are the most viable candidates for consideration. We encourage those whose submissions were reassigned to Level 1 or 0 to submit comments with additional evidence of use, exchange, and applicability to broader use cases. As we have done in the past, ONC will reconsider advancing data elements and adding them to future versions of USCDI.

USCDI v6 Submission Period

With the publication of USCDI v5, ONC begins the next cycle to update USCDI to Version 6. The ONDEC submission system is open and ready to collect recommendations for data elements to be considered for Version 6.

ONC is aware of the 2024 revision of the U.S. Office of Management and Budget Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (SPD 15). USCDI and ONC Certification Program criteria currently require the 1997 revision of SPD-15 but proposed to update to the newer version in the recently released HTI-2 proposed rule. ONC will consider updating how to represent race and ethnicity in a future version of USCDI.

ONC encourages the community to engage and collaborate to submit feedback for data elements previously submitted that are not included in USCDI v5. All submissions for new data elements and feedback on existing data elements must be received by Monday, September 30, 2024, at 11:59 pm ET.

An integral part of ONC’s process to update and expand USCDI is to identify concept areas that should be added to USCDI. This includes data elements that provide more detail in a given data class and those that represent areas not already addressed by past versions. ONC established the following prioritization criteria to guide these efforts and to signal to the community which data concepts ONC will focus on in future versions:

USCDI Prioritization Criteria

Stay tuned for the USCDI Roadmap to Future Versions

ONC continues to seek feedback from the community about the future of USCDI, even beyond which data elements should be included in the next version. To help guide this feedback, ONC plans to publish a roadmap which will outline our prioritization criteria, areas for improvement, and the lifecycle of data elements submitted for addition to USCDI or USCDI+. Frequently asked questions include the path of a data element that has been submitted for USCDI but not added to a past version, and whether data elements in USCDI+ could ever be added to a future USCDI version. We will provide answers to these questions and more in the roadmap, which we expect to publish later this year. ONC continues to work with the public and federal agencies to identify areas where more work is needed to inform future versions of USCDI. ONC recognizes there are specific but important use cases that require consistency and alignment on datasets that go beyond USCDI. For example, ONC has worked with federal partners to release draft USCDI+ data element lists for Quality, Maternal Health, Public Health, Cancer, and Behavioral Health to support quality measurement, research, and other healthcare activities.

For more information about ONC’s USCDI+ program please read ONC’s USCDI+ blog post and check out the USCDI+ website.

After the submission and comment period ends for USCDI v6, ONC will evaluate public feedback to determine which new data elements to include in Draft USCDI v6, which ONC expects to publish in early 2025. We look forward to working with the public to continue to improve USCDI for broader use.

ONC will consider all submissions from ONDEC and all feedback submitted through the USCDIwebsiteby September 30, 2024 11:59 pm ET.