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 Genomics Variant Clinical Significance

Clinical significance is an assessment of the magnitude of a genetic variant's clinical effects as per estimates supplied by researchers and/or guidelines (source: HL7 Clinical Genomics Working Group).

LOINC is the reference terminology proposed by the HL7 Genomics Reporting FHIR IG (http://hl7.org/fhir/uv/genomics-reporting/index.html) for codifying the ACMG clinical significance categories (https://loinc.org/LL4034-6/)

May Terry MITRE Corporation
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. 
Physical Exam

Narrative clinical assessment of the Physical Exam results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
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 Outcomes Outcome

Outcome of the event – i.e. death, hospitalization, fever

HL7.org FHIR R4 v4.0

Sandi Mitchell J P Systems, Inc.
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. 
Psychological Testing

Narrative clinical assessment of the Psychological Testing results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Outcomes Mitigating action

Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm

HL7.org FHIR R4 v4.0

Sandi Mitchell J P Systems, Inc.
Level 0 Medications

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

Medication Start/End Date

The start and end date of a medication order.

Sandi Mitchell J P Systems, Inc.
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

Total Output The total volume that the patient put out during a calendar day, from all sources, including urine, stool, and drains like chest tubes, surgical drains, intrathecal catheters, external ventricular drains, peritoneal catheters.

LOINC 9097-7 Fluid balance 24hrs SNOMED CT 251856003 Fluid balance

Ali Abbas MD UCSF
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. 
Neuropsychological Testing

Narrative clinical assessment of the Neuropsychological Testing results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

Urine Output The total urine output during a calendar day, from all sources including voids, bladder catherization, urostomy, nephrostomy tubes.

LOINC 9097-7 Fluid balance 24hrs SNOMED CT 251856003 Fluid balance

Ali Abbas MD UCSF
Level 0 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.

Mental Status Evaluation

Narrative clinical assessment of the Mental Status Evaluation.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Clinical Notes

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

  •  
  • 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. 
Genetic Testing

Narrative clinical assessment of the Genetic Testing results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Cancer Care Secondary Cancer Condition

Also known as secondary malignant neoplasm, secondary cancer condition is used to describe either a new primary cancer or cancer that has spread from the place in which it started to other parts of the body (Source: NCI).

Three terminologies are commonly referenced for the exchange of secondary/metastatic cancer conditions:
• International Classification of Diseases, 10th version, Clinical Modification (ICD-10-CM) guidelines for coding and reporting and includes specific guidelines on inclusion of secondary codes needed to properly code a neoplasm.
• SNOMED CT, which includes dedicated codes for describing metastatic malignant neoplasms.
• International Classification of Diseases for Oncology version 3 (ICD-O-3), which includes codes that assert a neoplasm is metastatic.

May Terry MITRE Corporation
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 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.

Myelogram

Narrative clinical assessment of the Myelogram results.

Please see suggestions from attached Excel document

Melissa Ayres SSA
Level 0 Clinical Notes

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

  •  
  • 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 Cancer Care Staging System

A cancer staging system is used to describe the extent of cancer in the body. There are many staging systems. Some, such as the TNM staging system, are used for many types of somatic cancer. Others are specific to a particular type of cancer (Source: NCI). Examples of non-TNM staging systems include the Cotswolds Modifications of the Ann Arbor Staging Classification, Revised International Staging System (R-ISS), and Rai and Binet staging systems for chronic lymphocytic leukemia.

SNOMED CT specifies codes for describing different cancer staging systems.
mCODE further specifies a value set of SNOMED CT codes for cancer staging systems (http://hl7.org/fhir/us/mcode/ValueSet-mcode-cancer-staging-system-vs.ht…).

May Terry MITRE Corporation
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

Individual Administering Vital Signs

Identify the role of the individual taking the vital signs, differentiating between inputs that are from a care team member, patient or family/caregiver, as separate from an automated device or home monitoring system.

For care team members: Examples include but are not limited to National Provider Identifier (NPI) and National Council of State Boards of Nursing Identifier (NCSBN ID).

For FDA approved devices: FDA Unique Device Identification (UDI) System

Tayler Williams American Medical Informatics Association (AMIA)