USCDI Export for the Public

Narrative clinical assessment of the Holter monitor results.

Please see suggestions from attached Excel document

FHIR Resource: HL7 FHIR R4 MedicationStatement, aka R5 MedicationUsage Data element: MedicationStatement.status; MedicationUsage.takenAsOrdered Values in http://hl7.org/fhir/CodeSystem/medication-statement-status: {active | completed | entered-in-error | intended | stopped | on-hold | unknown | not-taken} These are defined in terms of taking; i.e., “active” in MedicationRequest means that the prescription can be filled, but in MedicationStatement, means that the patient is taking it. FHIR R5 target is to remove “status” and create “use,” with values { Taking | Taking as directed | Taking not as directed | Not Taking | Unknown (unable to obtain)} AVS/PVS system uses “I am taking this med {As written | Differently | Not taking | Unsure}”

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.

Documentation of a clinical encounter that takes place via telehealth.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

The tidal volume set 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

The diagnosis specifies a patient’s concern/problem after a series of diagnostic tests and screening procedures by the healthcare provider. Beyond the encounter diagnosis (existing USCDI data element), the Encounter Information should include the mode of diagnosis. The key to cancer treatment is the type of tumor and the encounter data must include how the diagnosis was assessed as well as the critical features on pathology (including modern molecular tumor profiling).

ICD-10 : https://www.cms.gov/Medicare/Coding/ICD10
SNOMED CT: https://www.snomed.org/

Assessment of a patient’s exposure to smoke emitted from tobacco products used by others.

Exposure to Second Hand Tobacco Smoke: SNOMED 16090371000119103 History of Exposure to Second Hand Tobacco Smoke: SNOMED 699009004 No Known Exposure to Second Hand Tobacco Smoke: SNOMMED 711563001 Second hand smoke exposure CPHS (Children’s preventive health services) LOINC: 39243-1

Highest level of education obtained. This is important for research and health care policy using social determinants of health (SDOH). Value should be as identified by patient. The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) identified this element as high priority for routine collection.

Reference for value set items selected was American Community Survey https://www.census.gov/data/tables/2020/demo/educational-attainment/cps… .

Standard values identified are
None

Elementary School

High School Or GED

College no degree

Associates degree vocational

Associates degree academic

Bachelor's degree

Master's degree

Professional degree

Doctorate degree

American Community Survey
https://www.census.gov/data/tables/2020/demo/educational-attainment/cps…

Narrative clinical assessment of the Visual Fields evaluation.

Please see suggestions from attached Excel document

Documentation of a clinical encounter that takes place in an outpatient setting. Reason to consider separately (including this here because the "Reason" field for additional elements is truncating my text): This data element has some overlap with other existing and proposed Clinical Notes data elements Outpatient is a setting versus a type of service (Consultation, History & Physical, Discharge Summary, Transfer Summary, etc.). For example, Outpatient consultation notes span the “Consultation Note” and “Outpatient Note” data elements. However, we feel it is important to specify this particular setting because the vast majority of LOINC terms representing outpatient clinical notes aren’t captured in the data elements that represent particular types of service.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

According to the HHS implementation guide there are six-item set of questions used on ACS and other major surveys to gauge disability is the data standard for survey questions on disability. (HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status | ASPE). https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0 The prompt for this data element should be consistent with HHS implementation guide: “Do you have serious difficulty walking or climbing stairs?” https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0

HL7 FHIR: US Public Health Disability Status HL7 CDA: Disability Status Observation VSAC Value Set: Disability Status (LOINC)

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

According to the HHS implementation guide there are six-item set of questions used on ACS and other major surveys to gauge disability is the data standard for survey questions on disability. (HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status | ASPE). https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0 The prompt for this data element should be consistent with HHS implementation guide: “Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?”

HL7 FHIR: US Public Health Disability Status HL7 CDA: Disability Status Observation VSAC Value Set: Disability Status (LOINC)

HL7 Version 2 – ODS – Dietary orders, supplements, and preferences (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185) HL7 Version 3 Standard: Orders; Diet and Nutrition, Release 1 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=317) HL7 FHIR NutritionOrder (https://www.hl7.org/fhir/nutritionorder.html) In addition, many there are many nutrition-related terms in SNOMED CT. Many of these terms have been put in value sets in VSAC or through HL7 terminology. Here are some examples: Diet Type (OID 2.16.840.1.113883.4.642.3.385) – HL7 terminology Nutrient Modifier (OID 2.16.840.1.113883.4.642.3.386) – HL7 terminology Nutrition Supplement (OID 2.16.840.1.113883.4.642.3.390) – HL7 terminology Enteral Nutrition Type (OID 2.16.840.1.113883.4.642.3.391) – HL7 terminology Enteral Nutrition Additive (OID 2.16.840.1.113883.4.642.3.392) – HL7 terminology Food Allergies and Intolerance (OID 2.16.840.1.113762.1.4.1186.3) - VSAC Feeding Device Grouping (OID 2.16.840.1.113762.1.4.1095.87) - VSAC

Clinical notes information for a newborn may include the Labor and delivery summary record under–Infant data, and maternal progress note. Example information will include breastfeeding information at time of discharge.

LOINC codes exist for each of the proposed data elements The clinical notes of an new born should capture information such as: 73756-9 | Infant is being breastfed at discharge

The unique identifier for a single instance of a specimen received by a laboratory and its analysis.

According to the HHS implementation guide there are six-item set of questions used on ACS and other major surveys to gauge disability is the data standard for survey questions on disability. (HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status | ASPE). https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0

HL7 FHIR: US Public Health Disability Status HL7 CDA: Disability Status Observation VSAC Value Set: Disability Status (LOINC)

Audiometry/Audiology Audiograms: (68635-2 Audiology Diagnostic study note) Psychology Reports Mental Status Evaluation: (94798-6 Psychology Diagnostic study note) Neuropsychological Testing: (94798-6 Psychology Diagnostic study note) Psychological Testing: (94798-6 Psychology Diagnostic study note) Cardiac Reports Angiogram: (75425-9 Cardiology Diagnostic study note) Cardiac Catheterization: (75425-9 Cardiology Diagnostic study note) Doppler Test (75425-9 Cardiology Diagnostic study note) Electrocardiograph, electrocardiogram (EKG/ECG) result/interpretation: (75425-9 Cardiology Diagnostic study note) EKG/ECG Tracing Image: (75425-9 Cardiology Diagnostic study note) Echocardiogram result/interpretation: (75425-9 Cardiology Diagnostic study note) Stress Testing (exercise, pharma): (83539-7 Cardiology Risk assessment & screening note) Holter monitor: (83539-7 Cardiology Risk assessment & screening note) Neurology Electroencephalogram (EEG): (68556-0 Neurology Diagnostic study note) Electromyogram/nerve conduction (EMG): (68556-0 Neurology Diagnostic study note) Myelogram: (68556-0 Neurology Diagnostic study note) Ophthalmology/Optometry Visual Acuity: (78573-3 Ophthalmology Diagnostic study note) Visual Fields: (78573-3 Ophthalmology Diagnostic study note) Radiology (Interpretations Only; No Images) CT: (68604-8 Ophthalmology Diagnostic study note) MRI: (68604-8 Ophthalmology Diagnostic study note) PET: (68604-8 Ophthalmology Diagnostic study note) X-Ray: (68604-8 Ophthalmology Diagnostic study note) Respiratory DLCO Study: (80792-5 Pulmonary Diagnostic study note) Pulmonary Function Study: (80792-5 Pulmonary Diagnostic study note) Spirometry Test result/interpretation: (80792-5 Pulmonary Diagnostic study note) Spirometry Tracing Image: (80792-5 Pulmonary Diagnostic study note) Surgical Diagnostics Bone Marrow (Biopsy/Aspiration): (48807-2 Bone marrow aspiration report) Colonoscopy: (18746-8 Colonoscopy study report) Endoscopy: (18751-8 Endoscopy study report) Additional Procedures Ultrasound (exclude Doppler): (59282-4 Stress cardiac echo study report) Genetic Testing: (51969-4 Genetics analysis report) Physical Exam: (29545-1 Physical findings narrative)

LOINC—although we would like to see the set of codes constrained as suggested above. In Data Element Description above, we have the suggested LOINC code (showing also the Long Common Name) for each Note in our list. Such constraints are needed in order to allow for semantic interoperability.

Documentation sent to a consultant, for example, by a primary care provider, summarizing the patient’s clinical history and reason for consult.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.