FH: Race and Ethnicity have an extra value not in the 2018 Lab Value spreadsheets: "PHC1175^Refused to answer^CDCPHINVS", do we need an action item to update the Value Set spreadsheets? (I was not successful updating the spreadsheet so added question here) HJB: Agreed.
2020-06-16 FH: SPM-4 in ELR R1, Section 6 Vocabulary Constraints references Specimen Type Value Set, description is "Specimen Type - Union of HL70487 and SNOMED CT Specimen sub-tree (12303009)." The Mapping Spreadsheet references LIVD with comment: "LIVD provides SCT codes for SPM-4." For ELR can we use the value set defined in ELR?
- Is there expectation that LDTs would have a UDI and how would that be acquired? If not, what is entered when there is no UDI? N/A? Is field blank?
- May wish to distinguish LDTs using IVD reagents for a different non 510 k /EUA approved specimen type versus a LDT with totally different reagents, such as own reaggents created from scratch.
- UDI for manual test kits and LDTs (non analyzer performed tests)?
Do we need multiple test kits? Ed will check if 1 or 2 UDIs
ROMA is a 2 step immunoassay. see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4996955/
- On LIVD, would those be multiple IVD Test Codes? Multiple devices/test kits?
If only device identifier, OBX-18 can handle multiple
If UDI Carrier or UDI, multiple PRTs can handle that.
- Roche also has a ROMA Assay on the Elecsys anlayzer: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153607.pdf
- Since ELR is subject to certification and the provider is supposed to use the certified version, there must be clarity that pre-adoption of the AOEs according to the latest LRI IG sections is permissible. (AP: What is meant by certification? ELR for non hospital labs has not required use of 2015 vendor certification products. In fact it can still be sent on paper, flat file or via portals. Also ELR and LRI guides/messages are separate and go to different places. Some LISs have fields in their database and send ELR messages with fields they don't send back to ordering provider via LRI.)
- Some of the AOEs may be able to be answered based on knowledge in the system (e.g. is patient hospitalized = Patient class is inpatient in encounter)
- We should do an analysis of which of these HHS questions are available in the EHR-s (and in what format) and then decide on the best way to share that data, e.g., use PID/PD1/PV1/PV2/NK1 (occupation) - I got some feedback, that UNLESS the element is already in ELR R1 (like PV1-2), OBX segments will be easiest in the short term to add to the surveillance system.
- Understanding is some drive up/drive through COVID testing sites are using paper requisitions for ordering, so data elements would be required on paper req to performing lab, who would enter them into their results reporting to PHA ELR message (if provided!).
- Options for differentiating OBX for AOE vs OBX for results: (AP Note: The AOE question and response, would be represented as a result and result value. The LOINC is likely the same for the AOE question and result in most cases. However, they may have an order ID/identifier for the AOE, and a result ID for the result field to distinguish the two uses of the same data item. Also is this question on the ELR/LRI?)
- LOINC code
- ELR R1 expects OBX after SPM for patient age - could put others there
- Use a separate OBR for EPI important information
- OBX-29 in LOI/LRI
- In eDOS, AOE is represented in XXX field
- In LOI, AOE is represented in
- While communication of a .csv or flat file from performing lab to PHA, if the above guidance cannot be implemented in time, is out of scope of HL7 to define format, we could make some suggestions on what to include to match with the ELR transaction that it needs to match up with.
- APHL is creating a flatfile format for this purpose (not csv, but rather tab delimited) - the elments in this flatfile are all mapped to the respective ELR R1 location, so that transformation could occur at the sender or receiver side (conversion tooling for the PHAs is being discussed)
- Suggest to allow for Direct Messaing to convey the file. Riki: need to check with the PHA, what transport mechanism they allow, but I don;t see why it shouldn't be an option
- Why not just use ELR in xml format via Direct? Riki: Becasue this is for manual data entry
- What shall we point to for LIVD latest guide? Riki: Unfortunately the IICC link is the only one official, right?