CAP Comment on Laboratory Result Value

Laboratory Result Value

• Corresponding CLIA Reporting Requirement: The test result and, if applicable, the units of measurement or interpretation, or both
• Description: The College of American Pathologists (CAP) supports replacing the Laboratory Result/Value element in USCDI with this Level 2 data element. This data element aligns with CLIA’s requirement to report the test result and, if applicable, the units of measurement or interpretation, or both. The CLIA requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards.
• Vocabulary Standard: The CAP suggests replacing the listed standards with the UCUM standard for quantitative results units and the SNOMED CT standard for qualitative results. 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. The CAP supports the use of the SNOMED CT standard for qualitative data because it is a relatively complete, well-curated, and actively-managed medical ontology that has excellent coverage of concepts appropriate for qualitative laboratory results and supports a rich array of hierarchical and other concept relationships.

APHL Comments on ISA 2022

APHL suggests to remove this element, as it is really covered under the existing V3 element Values/Results; if it is included it should just function as the new label/name to the existing element rather than being added, which would cause undue confusion.

CDC's comment on behalf of CSTE for USCDI v4

CSTE agrees with CDC that laboratory result value is a critical field to include in USCDI v4. Many test results for conditions of public health importance cannot be interpreted without a value – these include serologic tests, tests which measure antibiotic susceptibility, Hepatitis C viral RNA, HIV, Hepatitis B viral DNA among many others.

CDC's Consolidated Comment for USCDI v4

CDC continues to recommend inclusion of this high priority data element in USCDI v4

CDC's Consolidated Comment

Additional use case:

• Use case background: For cardiovascular disease prevention and treatment, particularly cholesterol management, laboratory-related data elements are vitally important for quality improvement related to clinical treatment as well as public health surveillance. Patients who have LDL-C values of ≥190 mg/dL are considered to have severe hypercholesterolemia and are recommended to be on a high-intensity statin. They are at high risk for having an atherosclerotic cardiovascular disease (ASCVD) event. Having information about their LDL-C values is critically important for understanding level of risk and for monitoring the impact that statin treatment (or other lipid-lowering agents) has on their LDL levels. Moreover, both laboratory result value and the date/timestamps are important for ensuring patients have LDL-C screening done in accordance with clinical guidelines. These data elements are currently in or will be part of future proposed iterations of CMS347, Statin Therapy for the Prevention and Treatment of Cardiovascular Disease, currently used in multiple CMS quality reporting programs, HRSA’s Uniform Data System, and the CDC/NACDD Multistate EHR-based Network for Disease Surveillance (MENDS). Chronic disease surveillance for diabetes (A1c), and chronic kidney disease (estimated glomerular filtration rate [eGFR] and/or urine albumin-to creatinine ratio [uACR]) also rely on the use of laboratory result values
• Link to use case:

https://chronicdisease.org/page/MENDSINFO/

• Implementation Guide:

1. HL7 FHIR Quality Measure STU2 for FHIR R4 Implementation Guide - Quality Measure STU2 for FHIR R4 Implementation Guide (hl7.org)
2. HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm 2.0.0 - STU 2 - HL7.FHIR.US.ECR\Home Page - FHIR v4.0.1 (http://build.fhir.org/ig/HL7/case-reporting/)
3. HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 2, STU Release 3.0 - HL7 Standards Product Brief - HL7 CDA® R2 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=436)
4. HL7 FHIR Health Care Surveys Content Implementation Guide (http://hl7.org/fhir/us/health-care-surveys-reporting/2022Jan/);
5. HL7 FHIR Central Cancer Registry Reporting Content Implementation Guide (http://hl7.org/fhir/us/central-cancer-registry-reporting/2022Jan/).
6. 17 message mapping guides (MMGs) used for under the National Notifiable Diseases Surveillance System (NNDSS) (https://ndc.services.cdc.gov/message-mapping-guides/)

CSTE Comment:

• CSTE agrees that laboratory result value is a critical field to include in USCDI v3. Many test results for conditions of public health importance cannot be interpreted without a value – these include serologic tests, tests which measure antibiotic susceptibility, Hepatitis C viral RNA, HIV, Hepatitis B viral DNA among many others.

Unified Comment from CDC

• Additional Use Case:  HIV, STDs, Viral Hepatitis and Tuberculosis are nationally notifiable diseases for which diagnosis is dependent upon laboratory results. As such, laboratory test performed date, result value and result status are collected as part of CDC's routine surveilannce for these conditions. Additionally, beyond diagnostic tests, additional laboratory test information is collected to understand the health status of patients (e.g. HIV viral load, liver enzymes), and trends in drug susceptibility.
   
• Additional Use Case: This is a standard data item used by central cancer registries in all states. Data received through data exchange from pathology laboratories to central cancer registries for CDC and NCI’s national cancer surveillance systems, as required by law. 
   
• All of the laboratory data collected is used both for case management purposes within state, local, territorial and tribal health jurisdictions, and public health purposes at the national level. These data are integral to understanding disease transmission and to prioritize appropriate interventions for affecting communities.
   
• Estimate number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of HIV Prevention, Division of TB Elimination, Division of STD Prevention, and Division of Viral Hepatitis flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.
   
• Healthcare Aims: Improving patient experience of care, Improving health of populations, Reducing cost of care, provider experience of care.
   
• Use of data element: Extensively used in production environments
   
• Suggested starter set: Service order for isolation precautions, Service order for contact precautions, Service order for droplet precautions, Service order for airborne precautions, Service order for isolation precautions not further specified
   
• This element is used by CMS Quality Reporting and is marked Required or MustSupport in the FHIR QI Core IG
   
• CSTE supports inclusion of this measure into USCDI v3.