USCDI Export for the Public

Defines if the radiation therapy structure a target structure (e.g. PTV, CTV, GTV) or an organ at risk.

Standard Values (List): Target; Organ at Risk

The number of radiation therapy treatment sessions delivered per week. Some radiation therapy protocols do not deliver treatment every day.

Who recorded the adverse event

HL7.org FHIR R4 v4.0

Research study that the subject is enrolled in

HL7.org FHIR R4 v4.0

HL7.org FHIR R4 v4.0

Used to capture BID, TID and other approaches intentionally treating more than one radiation therapy session per day to enhance biological effect.

The intended number of sessions over which the prescribed radiation therapy will be delivered

Name of the radiation therapy prescription used to distinguish it from other prescriptions.

Unit corresponding to numerical value of radiation dose (e.g. cGy)

Contributing factors suspected to have increased the probability or severity of the adverse event

HL7.org FHIR R4 v4.0

Radiation dose delivered to the target volume in fulfilling the prescription (e.g. 7200 cGy).

Name of target volume structure for radiation therapy (e.g. Prostate).

Identify targets and overall doses treated with the radiation therapy course. This supports systematic reporting what was done for treatment summaries. For example it enables identifying that the prostate received a dose of 7200 cGy. Where the prescription reflects intent, this element reflects what was delivered.

Does the radiation field for the current course overlap with radiation fields from prior courses of therapy?

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.

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

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).

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

Standard Date/Time formats

HL7 FHIR US Core ServiceRequest Category Codes HL7 Service Request Category

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.