Stream: genomics / eMerge Pilot
Topic: CLIA# capture
Larry Babb (Apr 14 2019 at 18:35):
Where do we assign the CLIA information to the organization (lab) performing the assay and taking responsibility for the report. I looked through the "performer" options (see related performer topic in the #genomics / eMerge Pilot stream). The performer Reference to Organization does not seem to allow for linking or associating the CLIA# which is a pretty critical bit of information that clinical testing labs are required to display and associate with their reports. This is not the same as a practitioner's qualifications where are available within the Practitioner resource.
Please advise where the CLIA# should be captured.
Bret H (Apr 15 2019 at 12:10):
use Organization.identifier
within this element you can identify the system that provided the identifier.
see https://www.hl7.org/fhir/datatypes.html#Identifier
might be useful to view https://www.hl7.org/fhir/observation-mappings.html ,specifically the V2 section.
Bret H (Apr 15 2019 at 12:21):
ps the IG is international in scope. As EMERGE is based in the US, you will have other US specific requirements. Should note where these occur and how you are addressing them. @Nathan Davis do you have an example snippet of observation with the labs CLIA id referenced that you could share?
Andrea Pitkus, PhD, MLS(ASCP)CM, CSM (Apr 15 2019 at 20:33):
Great question. See https://confluence.hl7.org/pages/viewpage.action?pageId=39160393
MSH 4.2-4.3 in V2.
FHIR
MessageHeader.sender(Organization.identifier.value)
MessageHeader.sender(Organization.identifier.system)
The performing laboratory would be the sender....
What'll get interesting and haven't tested yet, are use cases where one lab does some initial genomics testing and sends results/orders for bioinformatics testing of raw data to another lab. There are specific CLIA and/or CAP accreditation requirements and may have more than one performing laboratory contributing to an "integrated diagnostic report" as indicated on today's call. @Bret H & @Larry Babb
Larry Babb (Apr 16 2019 at 19:24):
got it. We will use the performer(Organization)'s identifier system/value fields to share the CLIA# information. The LMM/Broad labs work together to produce one side of the results, but I believe the LMM takes full responsibility for the contents and therefore the Broad's CLIA# is not needed. if it is I will simply add two performer's (I think). Again, not worried as I have not seen the need for this, so we will presume 1 at this point. Plenty of other issues to resolve that have much more value.
Last updated: Apr 12 2022 at 19:14 UTC
