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

The date and time at which the EHR system sends the report.

M3 Results is the output from an evidence-based, 27 question, patient rated cross cutting mental health assessment. The output is a score that is highly predictive of any mental health condition, 4 clusters for risk of anxiety, PTSD, bipolar disorder and depression and the responses to the 27 questions. Together the data elements provide clinicians and patients results that enable de-stigmatized care by providing scores and longitudinal monitoring based on those scores to hopefully drive better outcomes. M3 is used by LabCorp and others and qualifies for a Standard based on its interoperability through their network.

M3 has LOINC Codes M3 Score is an algorithm to allow a person to take a rated self-test and their clinician receive a structured report which includes a score that shows: 1) an assessment of an individuals risk of suffering from any mood disorder, and 2) a patient on a clinical map showing if they have a low, medium or high risk for each of the following: Depression, Anxiety, Bipolar, PTSD. In addition to the clusters, the report the answers for each report are included as structured data with all scores and responses having LOINC codes.

This data element captures the combined income of the patient and the family members he/she lives with.

ICD-10: Z59.5 Extreme poverty (100% FPL or below) Z59.6 Low income (200% FPL or below) Z59.7 Insufficient social insurance and welfare support Z72.4 Inappropriate diet and eating habits SNOMED-CT: 365553008 - Finding of household income (finding) 365556000 - Finding of pattern of income (finding) 365552003 - Finding of income details (finding) LOINC: 93025-5 - Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences [PRAPARE]

Patients may be their own data stewards, or have other data stewards able to authorize permissions on their data. This term, "Data Steward" is intended to describe an individual or organization authorized and accountable for permission decisions about the health data of the individual. While this may be a RelatedPerson or a member of a CareTeam (existing elements and classes in USCDI FHIR), it may also not be part of those groups. Data stewards may be needed for individual patients who are incapacitated or for minors who lack legal capacity to consent (although be able to assent). Data stewards may also have a critical role in stewardship of health data for deceased individuals, e.g. clinical genetic counseling, research studies. Individuals may also assign stewardship to multiple individuals and organizations. Data stewardship may also authorize designated organizations and/or individuals to determine data use permissions by specific segment (e.g. medication data vs. family history data).

FHIR has standards for Person and Organization resources: https://www.hl7.org/fhir/person.html https://www.hl7.org/fhir/organization.html However, role-specific terminology and standards may be needed to describe the specific role(s) of a Data Steward if considered as a separate element, or as a member of the CareTeam.

Structured data captured in a Medication Administration Report (usually for inpatients) showing each drug administered, who administered it, what time it was administered, etc.

LOINC has codes for flowsheet elements/structured clinical data including for prenatal, cancer staging, and medication administration (clinical LOINC), FHIR R4 Observation resource, MedicationAdministration, among others, can be used to communicate the information.

Study subject is part of

CDISC standards, HL7 FHIR researchstudy, researchsubject (formerly known as Data Access Framework (DAF))

Indicator of the progression of a study subject through a study.

CDISC standards, HL7 FHIR research-study-state, researchsubject (formerly known as Data Access Framework (DAF))

Date and timestamps associated with the completion of laboratory results, that are meta data associated with laboratory results

LOINC codes for labs—date and timestamps collected in standard format

The clinically relevant date/time of the observation. In the case of observations taken directly from a subject, it is the actual date and time the observation was obtained. In the case of a specimen-associated study, this field shall represent the date and time the specimen was collected or obtained.

Laboratory Test/Panel Code: LOINC Codes: http://loinc.org Laboratory Test Performed Date: FHIR dateTime, Period, Timing, Instant: http://hl7.org/fhir/observation-definitions.html#Observation.effective_x_ Laboratory Result Status: FHIR Observation Status: http://hl7.org/fhir/valueset-observation-status.html Laboratory Result Value: FHIR Quantity|CodeableConcept|string|boolean|integer|Range|Ratio|SampledData|time|dateTime|Period: http://hl7.org/fhir/observation-definitions.html#Observation.value_x_

A clinical trial protocol is a detailed document that outlines the objectives, design, and methodology of a trial, ensuring consistency and regulatory compliance. It includes the study rationale, participant eligibility criteria, interventions, outcomes, randomization and blinding methods, procedures for data collection, safety monitoring, and adverse event reporting. The protocol also addresses data management, ethical considerations, and trial administration, providing a comprehensive framework for conducting the study.

For a clinical trial protocol, the following terminology code systems are commonly used or may be used for greater interoperability:

1. SNOMED CT: Standardizes clinical concepts like medical conditions, procedures, and outcomes (e.g., inclusion/exclusion criteria).
2. LOINC: Standardizes lab tests, clinical measurements, and observations collected during the trial.
3. RxNorm: Used for medication coding, especially when the protocol involves drug interventions or dosing regimens.
4. ICD-10/ICD-11: Defines diagnoses and health conditions for eligibility or adverse event reporting.
5. MedDRA: Used to code adverse events, ensuring consistent reporting across trial sites.
6. CDISC Terminology: Supports standardization of clinical trial data elements (e.g., protocol design, trial outcomes) in regulatory submissions. Accessible via NCI terminology services.
7. WHODrug: Standardizes coding for medications in clinical trials, especially for drug safety and efficacy reporting in global trials.
8. NDC: Used to identify medications in the U.S. for protocol interventions or treatments.
9. CPT: Standardizes medical procedures and services for protocol-specified interventions, such as diagnostic tests or treatments.
10. UCUM: Standardizes units of measurement (e.g., mg, mL) used in clinical observations or lab results.
11. HCPCS: Complements CPT by coding medical products, services, and equipment used in U.S. trials.

These code systems ensure global semantic interoperability, consistency, compliance, and accuracy in clinical trial data collection and exchange.

The postpartum status of a patient, i.e. whether or not the patient is in the postpartum perio

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)

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)

Name of the job position held by an individual.

Same as above

LOINC

Same as above

LOINC

Same as above

LOINC

Same as above

LOINC

A refraction test is what the doctor uses to get your eyeglasses prescription. You look at a chart, usually 20 feet away, or in a mirror that makes things look like they’re 20 feet away. You’ll look through a tool called a phoropter. It lets the doctor move lenses of different strengths in front of your eyes. The test also helps your doctor spot presbyopia, hyperopia, myopia, and astigmatism. Source: WebMD Glossary of Eye Tests and Exams LOINC Panel 79895-9

LOINC Panel 79895-9 Subjective refraction measurements panel