USCDI Export for the Public

Classification Level Sort descending Data Class Data Class Description Data Element Data Element Description Applicable Standards Submitter Name Submitter Organization Submission Date
Level 0 Medical Devices

Instrument, machine, appliance, implant, software, or similar device intended to be used for a medical purpose.

Ventilator measured plateau pressure

The measured plateau pressure on the ventilator if the patient is receiving mechanical ventilation

Airway type LOINC LL5542-7
PEEP LOINC 20077-4
Pressure support LOINC 20079-0
Plateau Pressure LOINC 76259-1
Tidal Volume LOINC 76221-1
Respiratory Rate LOINC 33438-3

Ali Abbasi MD- on behalf of the I-SPY COVID investigators I-SPY COVID Trial Investigators
Level 0 Medical Devices

Instrument, machine, appliance, implant, software, or similar device intended to be used for a medical purpose.

Ventilator Mode

The mode of mechanical ventilation if the patient is receiving mechanical ventilation. Could refer to LOINV 20124-4 for options.

Airway type LOINC LL5542-7
PEEP LOINC 20077-4
Pressure support LOINC 20079-0
Plateau Pressure LOINC 76259-1
Tidal Volume LOINC 76221-1
Respiratory Rate LOINC 33438-3

Ali Abbasi MD- on behalf of the I-SPY COVID investigators I-SPY COVID Trial Investigators
Level 0 Genomics Molecular Consequence

Molecular consequence is a calculation of the effect of the sequence change if the allele is in a gene (source: NCBI, https://www.ncbi.nlm.nih.gov/clinvar/docs/details/).

The Sequence Ontology is a collaborative ontology project for the definition of sequence features used in biological sequence annotation.

May Terry MITRE Corporation
Level 0 Provenance

The metadata, or extra information about data, regarding who created the data and when it was created.

Case Report Version Number

An integer value used to version successive replacement documents of an electronic case report.

Sarah Gaunt The Association of Public Health Laboratories (APHL)
Level 0 Clinical Notes

Narrative patient data relevant to the context identified by note types.

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  • Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name. 
Colonoscopy

Narrative clinical assessment of the Colonoscopy results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Medical Devices

Instrument, machine, appliance, implant, software, or similar device intended to be used for a medical purpose.

Medical Device Name

The name of the medical device.

Sandi Mitchell J P Systems, Inc.
Level 0 Medications

Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Cannabinoids

As the use of medical cannabis, OTC cannabidiol (CBD), and adult use cannabis (medical marijuana), and recreational cannabis is more frequent - there is the potential for drug-drug interactions; and awareness for peri-operative elective or urgent surgical procedures and/or hospitalizations. It is not just the added sedation - and perhaps safer than opioids - but the emphasis here is that cannabinoids have the real potential to affect the metabolism of OTHER medications especially those that have a narrow therapeutic index or other medications that have high-protein binding. A standardized format will provide the foundation for drug-drug interaction screening - vs. a multitude of inconsistent entries. Although medical cannabis is technically DEA class-1; there is high probability that medical cannabis may be transitioned to DEA class-3 in the very near future (see recent CSR memo added to the 'Use Case' tab). Additionally, this idea is also for cannabidiol (CBD) which is over the counter (OTC) - so not just limited to prescription Epidiolex. Additionally, medical cannabis preparations often have unique dosage forms (e.g., badder, butter).

Paul T. Kocis, PharmD, MPH Dept of Pharmacology, Penn State College of Medicine
Level 0 Problems

Condition, diagnosis, or reason for seeking medical attention.

Date of First Noted/Documented

Date of first noted/documented by a qualified professional of the presence of a problem or condition affecting a patient.

Standard Date/Time formats

Tayler Williams American Medical Informatics Association (AMIA)
Level 0 Adverse Events

Unintended effects associated with clinical interventions.

Recorder Who recorded the adverse event

HL7.org FHIR R4 v4.0

Sandi Mitchell J P Systems, Inc.
Level 0 Clinical Tests

Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.

EKG/ECG Tracing Image

Narrative interpretation of the EKG/ECG Tracing Image.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Health Status Assessments

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.

Pain Assessment An assessment of a person’s pain, which could include assessment of acute and chronic pain using standardized assessment tools. Assessments of pain include but not limited to pain severity, interference of pain on activity, and pain impact on mood or sleep using unidimensional or multidimensional assessment tools.

LOINC and SNOMED CT

Level 0 Health Status Assessments

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.

Depression Screening

Assessment of clinical depression using standardized tools.

LOINC

Grace Glennon, on behalf of NCQA NCQA
Level 0 Patient Demographics/Information

Data used to categorize individuals for identification, records matching, and other purposes.

HL7-Identifier

Globally unique identifier assigned to a patient by an organization asserting compliance with the referenced HL7 FHIR Identify Matching IG

A system exists for using the identifier within HL7 FHIR transactions, particularly those invoking $match, but the standard also intends for the identifier to be used in other health information exchange transaction types as well as in non-healthcare specific transactions for example in OpenID Connect identity claims.

Julie Maas EMR Direct
Level 0 Health Status Assessments

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.

Mental Health Status

Assessment of or screening for the presence of a mental or behavioral health condition.

Various specific mental health status measures exist in LOINC, including the PHQ-9 for depression, the GAD-7 for anxiety, and the C-SSRS for suicide risk.

Michael Schoenbaum National Institute of Mental Health
Level 0 Health Status Assessments

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.

Care Team Member Completing Health Status Assessment

Care Team Member Conducting Health Status Assessment
Name
Identifier
Sequence of characters used to uniquely refer to a member of the care team.
Examples include but are not limited to National Provider Identifier (NPI) and National Council of State Boards of Nursing Identifier (NCSBN ID).
Role
Responsibility of an individual within the care team.
Examples include but are not limited to primary care physician and caregiver.

For the Care Team Member Identifier: National Provider Identifier (NPI) and National Council of State Boards of Nursing Identifier (NCSBN ID).

Tayler Williams American Medical Informatics Association (AMIA)
Level 0 Laboratory

Analysis of clinical specimens to obtain information about the health of a patient.

Test Result Harmonization Status

Harmonization status indicates equivalency of results across platforms and vendors, ie, a harmonized test for a particular analyte and specimen yield results equivalent to other harmonized tests for that analyte and specimen. Harmonization is required for full clinical interoperability of test results. Results from harmonized tests may be interpreted and trended together, and may use the same calculation and decision support rules. Machine learning models may be trained and applied to data sets from different test platforms and vendors if the tests are harmonized. Tests that are not harmonized do not yield comparable results and should be interpreted and processed separately, not in aggregate with other tests. Incorrect assumption of harmonization status is a serious patient safety risk, and lack of harmonization information impedes public health interpretation of test results.

These proposed elements are a work in progress and the CAP urges that the vocabulary standards listed be considered for a future version of USCDI:

Reference Range:
The CAP proposes that the content of this data element follow the OBX-7 field from the HL7 2.5.1 standard. The CAP supports the use of the HL7 2.5.1 standard because the standard was designed to help laboratories comply with CLIA requirements. For numerical values, the CAP also proposes the Unified Code for Units of Measure (UCUM) standard. The CAP supports the use of the UCUM standard because it is well-established and because a common standard for units of measure will reduce errors related to translation of units of measure from one system to another.

Name and Address of Laboratory Location:
In lieu of a non-standard and inefficient textual description of a name and address, the CAP is proposing the use of the CLIA identification number as the data element content. All laboratories performing clinical testing have a CLIA identification number and are required to be able to report it, so the use of this number is not burdensome. The name and location of a laboratory can be determined quickly from the CLIA number using available online resources (for example, https://www.cdc.gov/clia/LabSearch.html).

Condition & Disposition of Specimens:
The CAP proposes the use of SNOMED CT for data element content. SNOMED CT is a relatively complete, well-curated, and actively-managed medical ontology that has excellent coverage of concepts appropriate for description of laboratory specimens, specimen sources, and conditions, and supports a rich array of hierarchical and other concept relationships.

Test Result Harmonization Status:
This is the first proposal of a harmonization status data element, and examples do not exist in other health data standards. Recently the ISO defined standard methods for harmonizing laboratory tests (see ISO 17511:2020 and 21151:2020). The CAP proposes development of a standard representation of these methods as content for this data element.

Han Tran College of American Pathologists (CAP)
Level 0 Work Information Occupational Exposure/Hazard

A hazard that is specific to a person's work or work environment for a single job and with which the person might come in contact. A hazard is a source of potential harm to an individual's physical or mental health (e.g., biological, chemical, physical, psychological, radiological).

LOINC History of Occupational hazard | 87729-0

Sarah Gaunt The Association of Public Health Laboratories (APHL)
Level 0 Medical Devices

Instrument, machine, appliance, implant, software, or similar device intended to be used for a medical purpose.

Ventilator set positive end expiratory pressure

The set positive end expiratory pressure (PEEP) if the patient is receiving mechanical ventilation or a biphasic positive airway pressure.

Airway type LOINC LL5542-7
PEEP LOINC 20077-4
Pressure support LOINC 20079-0
Plateau Pressure LOINC 76259-1
Tidal Volume LOINC 76221-1
Respiratory Rate LOINC 33438-3

Ali Abbasi MD- on behalf of the I-SPY COVID investigators I-SPY COVID Trial Investigators
Level 0 Adverse Events

Unintended effects associated with clinical interventions.

Location Location where adverse event occurred

HL7.org FHIR R4 v4.0

Sandi Mitchell J P Systems, Inc.
Level 0 Pregnancy Information Gestational Age Determination Method

Method for estimating gestational age, e.g., ultrasound, date of LMP.

Value Set: Estimated Date of Delivery Including Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.81/expansion)
Value Set: Pregnancy Status Determination Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.80/expansion)
Postpartum Status (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.87/expansion)

Sarah Gaunt The Association of Public Health Laboratories (APHL)