|Submitted By: Riki Merrick / Association of Public Health Laboratories|
|Data Element Information|
|Rationale for Separate Consideration||This qualifies the Performed Test (currently called Tests) - in order to fully understand, if lab results in a patient's record (or across different patient records for a research study) can be safely intermingled in the flow sheet or the analysis it is important to know, what specific test was done (and if the test was harmonized against an international standard) - this is a patient safety issue.|
|Use Case Description(s)|
|Use Case Description||For COVID-19 pandemic HHS released the following guidance about how t report COVID-19 test results and what elements need to be included - this is representing #7 Device Identifier on the list.
Reporting requirement under What to report: https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html
Implementation guidance: https://www.hhs.gov/sites/default/files/hhs-guidance-implementation.pdf
|Estimated number of stakeholders capturing, accessing using or exchanging||For the COVID-19 use case it would be ANY lab that provides testing under HHS guidance.
|Link to use case project page||https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html|
|Use Case Description||Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) = In 2016, the FDA sponsored the creation of the Systematized Harmonization and Interoperability for Laboratory Data (SHIELD) project as a public-private partnership to address the critical area of laboratory data availability and interoperability for IVD devices - the simple title: "Name the same test the same way across the healthcare ecosystem."
The URL link is to the highest level of the current work to draft the strategic plan - see the following pages for a bit more detail:
|Estimated number of stakeholders capturing, accessing using or exchanging||This is a 70-organization joint operation, involving federal agencies, in vitro diagnostics (IVD) organizations, standards development orgnanizations, EHR and LIS vendors, medical associations, and other professional laboratory organizations.|
|Link to use case project page||https://aphlinformatics.atlassian.net/wiki/spaces/SC/overview?homepageId=986579060|
|Maturity of Use and Technical Specifications for Data Element|
|Additional Specifications||AS part of the response HL7 created this guidance page for implementation of HHS elements: https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification; See specifcially this section for the Device Identification: https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification
This guidance has been written up as the LAB_HHS_ELR_Guidance_Component for LOI and LRI for pre-adoption with ANY HL7 v2 order or reslt message (in ballot Sept 2021), so not currenlty linkable publically
|Current Use||In limited use in production environments|
Since this is a NEW requirement (effective Aug 1, 2020) most every system: LIS, EHR-s and Public Health Surveillance System had to create a place for this element - most of the test kits for COVID-19 (under EUA) and instruments do NOT yet have a UDI assigned to them, so accommodations for a syntax of __ was created (https://confluence.hl7.org/display/OO/Proposed+HHS+ELR+Submission+Guidance+using+HL7+v2+Messages#ProposedHHSELRSubmissionGuidanceusingHL7v2Messages-DeviceIdentification) - it is being exchanged in some ELR messages currently
|Number of organizations/individuals with which this data element has been electronically exchanged||4|
I picked 4, even though I assume it has probably been sent to more than 4 PHAs nationwide, BUT the last statement, that is is widely in production certainly does not apply to it at this time (outside of the COVID-19 reporting to PH use case)
|Restrictions on Standardization (e.g. proprietary code)||none, though it requires a request for assignment of the device ID by the FDA, so has a process step needed to get to the desired format for this data element.|
|Restrictions on Use (e.g. licensing, user fees)||none|
|Privacy and Security Concerns||none|
|Estimate of Overall Burden||Need to add new fields to each system in the healthcare ecosystem that uses the lab results and ensure the integrity of all related elements.
The manufacturer needs to request assignment of a DI from FDA, so that it can be accessible via the GUUID, which may take some time.
The systems need to suport two possible formats for this device ID, as not every test kit may have a device ID (it is more likely to be able to have device IDs for all instruments).
|ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
|Maturity – Standards/Technical Specifications||Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification|
|Maturity - Current Use||Level 2 - Used at scale in more than 2 different production environments|
|Maturity - Current Exchange||Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems|
|Breadth of Applicability - # Stakeholders Impacted||Level 2 - Used by a majority of patients, providers or events requiring its use|