Strategy Alignment Legend | |
|---|---|
User Experience and Functionality Strategy for how stakeholders and end-users engage with the SHIELD tooling and available knowledge. | |
Infrastructure and Integration Strategy for how the tooling and knowledge management environment will operate and integrate with external systems and standards. | |
Knowledge Management and Analytics Strategy for how LIVD knowledge will be captured, versioned, and curated over time in a highly reliable and patient-safe way. | |
Strategy for ensuring the quality, fit-for-purpose, and usefulness of available knowledge. | |
Use cases
What are the data elements necessary to determine Determine whether you can trend two tests on the same line in an EHR flowsheet?What are the data elements necessary to support
Alignment ------
Comments
data aggregation can hide quality issues
Support laboratory public health reporting and data aggregation with minimal manual curation?What are the data elements necessary to detect
Alignment ---
Detect quality issues at an arbitrary point in the laboratory analytic workflow (e.g. a given reagent lot)?What are the data elements necessary to determine
Alignment ------
Comments
Where does quality discussion take place?
Ensure historical accuracy of critical data elements as standards and specifications change over time
How do we create the necessary ones
Quality can depend on external groups
Determine the comparability of two laboratories’ data for use as real-world evidence?What are the data elements necessary to evaluate
Alignment ---
Evaluate the likely transferability of a clinical decision support model between hospitals?
Alignment ---
Identify laps in currently used nomenclatures that are not comprehensive enough.
Create comprehensive interoperable nomenclatures by using similar novel NLP as google does
Identify the frequency of the presence of differing unidentical longitudinal mapping within the same Health Information System and version, across a 6 month period, across the still not interoperable nomenclatures.
Integrate differing nomenclatures LOINC, LIVID, etc. into a full interoperable system that will avoid unnecessary mapping.
Need to identify the frequency of non-calibrated results for equivalent analytes
Integrate clinical information specialists that can help integrate the necessary pieces and evaluate the resulting outputs
Make it accessible to a person reading it and support manual mapping by providing guided support where multiple mappings are possible per the IVD manufacturer
Make it accessible to a computer for automatic mapping suggestions as much as possible
Help the IVD vendor to create the content for the LIVD file
Support upload of IVD vendor created content to the LIVD file repository
Support review of submitted content, with workflow support for further clarification and official publication after review
...
Would tooling include tools needed to map the vendor LOINCs (and SCT qualifier values) from IVD vendors? (i.e. an authoring tool)?
Is another part the maintenance of the LIVD maps (to changes in IVD vendor product info, instruments, UDIs, as well as to code systems like LOINC and SCT)?
Assuming "highly reliable semantic interoperability" is defined so we know when it is achieved? Hopefully the source of truth for the definition for a lab test is also defined and where in the information flow (see VRE example below). Is it the test in the EHR? Is it the test in the performing lab's CLIA/CAP specimen collection manual? Is it the test in the performing lab's LIS build? The answer will dictate the coding and semantic meaning needs.
Provide data to support a pathway for approval of EUAs, and to monitor performance of EUAs and approved IVDs
Identify the data elements early (even though we know we will need more) so we can approach the industry early to start working towards adding support for elements they are NOT yet supporting
Functionality | Host | Notes | In scope ? |
UDI repository | FDA | CAP to provide advisory Cte? | At GUDID? |
LIDR “file” DB for EUAs & IVDs | FDA?, CAP?, NLM? | UDIs are not strictly required here, temporary ID placeholder is probably OK. | yes |
Semantic resources | VA?, CAP? | Could be hosted with LIDR data | ? |
Lab data dictionaries and calibration/harmonization documentation files Alignment ------ | Local (lab) only vs centralized (CAP?) | Labs would submit data dictionaries, or make them available via API. QC data records could be available as well. Also hosts a canonical standard data dictionary for LIVD datasets in a standard format TBD. Labs could optionally submit LDT data here or provide via API (arguable). | ? |
Harmonization algorithms and organization hub | CAP? | This is a place to store harmonization/normalization rules/SOPs, where to get reagents, methods, etc. | ? |
RWE Data Hub | CAP? | enough said… | likely |
QC/harmonization national program similar to PT | CAP? | Same… | ? |
Implementation help portal | CAP? | Training for harmonization, workflow integration and data exchange for clinical and RWE hub purposes. Includes auto-population tools for labs, reference implementation for testing messages and message validators. HL7 v2 and FHIR support. | likely |
Portal/API linking all of the above resources | CAP? |
| likely |
...
A reference repository for a manufacturer, device model, test code/result code/standardization or harmonization status
A unified terminology server for test/result/specimen names and codes
IVD data hub: There are many outstanding questions, including patient identifiers, whether it would attempt to gather disease/outcome information, etc. A practical approach would be to limit the data hub to IVD results and rely on linkages to other existing registries, studies, or other data sources.