Infrastructure and Integration
Strategy for how the tooling and knowledge management environment will operate and integrate with external systems and standards.
Detailed Description
The knowledge management systems will need to present their information in a digestible way for local use. For their part, outside systems will also need to adjust in order to use the knowledge resources to their full effectiveness. Laboratory information systems (LISs), instruments, and electronic health records (EHRs) do not universally have the ability to either store or transmit the necessary data elements that a national clinical interoperability effort would require. It is necessary to involve vendors early in the process so that they can develop new functionality to support this effort.
Because the knowledge repositories serve as a single source of truth for IVD mapping and manufacturer information, they must be highly available and secure systems. They must be enforce authorization and authentication of users for the editing and maintenance of repository information, but they must also be able to present information for users in public and open formats. The repositories should also offer application programming interfaces (APIs) for this information and be able to publish notifications of changes to interested parties. Abundant educational materials regarding implementation must also be available.
Supporting Tactics
Tactic | Impact |
|---|---|
Application programming interfaces | When possible, data sources should offer programmatic interfaces |
LIS/EHRs' ability to store and exchange needed data elements | Not all necessary elements (e.g. UDI) are supported in current systems |
Third party search | If a third party (i.e. not the laboratory or the original result destination) received a subset of result data, would they be able to quickly obtain missing data elements from LIDR or re: harmonization status? |
Supporting Use Cases
Use Case |
|---|
A laboratory information system is able to store all necessary details about a test, its results, the UDI of the device and kit that performed it, and its harmonization status. It is able to transmit these data via HL7 v2 message or FHIR message to a second party. |
A health information exchange (HIE) receives laboratory data including results and the device that produced it, but does not know the traceability. Via an API, it is able to query the LIDR to determine the traceability. |
An EHR receives laboratory results but no further information about the result. Via an API, it is able to query the laboratory menu to learn what IVD performed the test and its traceability status. If the lab does not provide a traceability status, the EHR is then able to query the LIDR for this information. |
Key Initiatives & Action Items
Involve vendors in areas that require new functionality
Define necessary requirements for data platforms housing all necessary resources