Data Element

Information from the submission form

Comment

APHL Comments on ISA 2022

APHL repeats its comment from last year that further clarification of this data element is needed to ensure this is for each test (not the entire report). Once defined as for each test, then APHL proposes the following vocabulary bindings: In V2 this element is OBX-11 Observation Result Status; it is required in LRI with a required binding to HL70085 (https://terminology.hl7.org/4.0.0/CodeSystem-v2-0085.html) and in FHIR it is represented in Observation.status – this element is required for every observation resource with a required valueset binding to ObservationStatus (http://hl7.org/fhir/valueset-observation-status.html)

Submission references multiple standards

NACHC supports the comments of APHL and CDC. Result is a critical component to understanding and validating laboratory tests and results for both clinical care and public health. However, the submission here points to multiple standards relevant to electronic laboratory reporting. NACHC believes the submission here should first reference lab interoperability use cases for point of care delivery. This data element should first and foremost reference one or more value sets that consist of implemented and validated concepts used in the existing laboratory standards and then the appropriate HIT standards that use it.    Possible Relevant Value Sets: HL7 v2 approach: Result status https://hl7-definition.caristix.com/v2/HL7v2.3/Tables/0123   Observation Result Status https://hl7-definition.caristix.com/v2/HL7v2.3/Tables/0085   Possible Relevant Value Sets: FHIR approach: Diagnostic Report Status https://build.fhir.org/valueset-diagnostic-report-status.html Observation Status https://fhir-ru.github.io/valueset-observation-status.html   While USCDI does provide a de facto data model and reference some existing standards in the point of care and laboratory reporting use cases, a coherent approach that takes the lab data from the manufacturer through point of care testing to electronic reporting is in development to pull all the relevant components of all the related use cases together in a project called SHIELD (Systemic Harmonization and Interoperability Enhancement of Laboratory Data). A long term approach that aligns all the use cases is optimal. https://mdic.org/program/systemic-harmonization-and-interoperability-enhancement-for-lab-data-shield/   Please see attached NACHC letter, documenting this comment and other feedback for v3 accepted draft data elements.

2022-04-30 NACHC USCDIv3 Letter of Support_0.pdf

Suggest to include in USCDI v3 - with clarification

Clarifcation is needed as there are often 2 status elements used: A status at the level of the performed test (in v2 OBX-11, in C-CDA observation.statusCode and in FHIR observation.status) - assuming that is the minimum element needed. It is a CLIA required element. A status at the level of the order (in v2 OBR-25, in CDA Laboratory Battery Organizer.statusCode, in FHIR DiagnosticReport.status) indicating the status for all expected results for this battery. It is a CLIA required element.

Additional Use Cases

I don't see Electronic Lab Reporting (ELR) mentioned in the above use case list - the v2 ELR R1 Implementation Guide (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=98) has been a PH MU measure since Stage1 and is widely implemented across the nation - both Result (Observation) Status (OBX-11 in v2) and Result Status (OBR-25 in v2) are requried elements.

Unified Comment from CDC

  • Additional Use Cases:
  • 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.  
  • 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.
  • 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.  
  • 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  
  • This element is used by CMS Quality Reporting and is marked Required or Must Support in the FHIR QI Core IG  
  • CSTE supports inclusion of this measure into USCDI v3

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