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 Cancer Care Radiation Therapy Course Number Of Sessions in Course

Total number of sessions in the treatment course. A session is the period between when the patient enters the treatment room and when they leave it.

Elizabeth Covington University of Michigan
Level 0 Cancer Care Pathology Molecular Test Result

Score for the molecular test result identified. For example Pathology Molecular Test Name is ProMark, Result could be 30

American Joint Committee on Cancer e.g. AJCC8

Charles Mayo, PhD University of Michigan
Level 0 Cancer Care Pathology Molecular Test Name

Name of the molecular pathology test used as part of diagnosis and staging. There are a wide range of tests. In the case of prostate cancer values include:
DECIPHER
Prolaris
Oncotype DX Genomic Prostate Score
ProMark

American Joint Committee on Cancer e.g. AJCC8

Charles Mayo, PhD University of Michigan
Level 0 Cancer Care Provider Reported Toxicity Value

For each Cancer Patient - Provider Reported Toxicity record the Toxicity Value corresponding to the Toxicity Measure specified indicates the severity of the toxicity using the standardized table. specifies what value is measured. For example if CTCAE v5.0 (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…) the values in the standardized set are 0,1,2,3,4,5

The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) identified this as a high priority element supporting patient care, outcomes research and public policy

Common Terminology Criteria for Adverse Events
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…

Charles Mayo University of Michigan
Level 0 Cancer Care Provider Reported Toxicity Measure

For each Cancer Patient - Provider Reported Toxicity record the Toxicity Measure specifies what value is measured. For example if CTCAE v5.0 (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…) is used then the Toxicity Measure would correspond to CTCAE Term (e.g. Dry Mouth, or Dry Mouth)

The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) identified this as a high priority element supporting patient care, outcomes research and public policy

Common Terminology Criteria for Adverse Events
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…

Charles Mayo University of Michigan
Level 0 Cancer Care Radiation Therapy Outcome/Disease Status

Status of the disease treated with radiation therapy at the time of the record.
This is vital information both for clinical care and for public health policy
The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) noted a Delphi process to identify standard values recommended for classification. These were

Under Treatment

No evidence of disease (NED)

Stable Disease

Partial Response

Progressive Disease

Indeterminate (possible pseudo-progression)

Complete Response

Biochemical Recurrence

Primary Recurrence

Local Recurrence

Nodal Recurrence

Distant Recurrence

In OORO for each instance record of a Cancer Patient Treatment Outcome, multiple values of Disease Status can be selected e.g. Biochemical Recurrence, Nodal Recurrence

Charles Mayo University of Michigan
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 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 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 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 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 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 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 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