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Meeting Details

Date: July 21, 2023

Time: 1PM ET

Coordinates:  Join Zoom meeting: https://zoom.us/j/5100467805 | Meeting ID: 510 046 7805 | +1 929-436-2866-US (New York)

Attendees:

Rob Hausam, Ralf Herzog, Andrea Pitkus, Dan Rutz, Joan Kegerize (ACLA), Joellen Carter, Kath Walsh, Sara Armson (ONC), Sheryl Taylor (NIST), Marti Velezis

Chair: Hans Buitendijk

Scribe: Hans Buitendijk

  • Quorum (Co-Chair + 4) Met 

AGENDA

  • Standing Topics 
    • Special Topics
    • COW/FOE updates
  • Micro (Craig)
  • Panel/Micro and discoverable Observations in FIHR
  • Coordination with HL7 Europe/Australia
    • Panel approach
  • DeviceAssociation - Impact Assessment
  • DiagnosticReport.status
  • Other JIRAs form Triage Inventory below
  • Other agenda items?

Meeting Resources

JIRA Dashboards:

JIRA Grouping Tags:

  • OO-Lab - to indicate when the JIRA Ticket should be reviewed by the OO Lab SMEs, especially when the issue is not assigned to the Resource owner.

Meeting Minutes

Previous Meeting Notes

Standing Topics

eSignature Update

  • Follow-up date  


eSignature Update

2023-02-24 OO - LAB/LIVD

From Chat (2023-06-23 LAB)  Andrea Pitkus:  Regarding e-sig, I came across this CLIA doc (see #5):  https://www.cms.gov/files/document/qso-21-10-clia-revised.pdf

New Rule on Race/Ethnicity from OMB/CDC

  • Follow-up date  

New Rule on Race/Ethnicity from OMB/CDC

CPT-PLA

  • Follow-up date August 11, 2023 to review draft

Meeting Notes

  • CPT-PLA
    • Hans, Nancy, and Kathy will draft a proposal on where to relocate the reference in ISA in a better context, and then review in this group before submitting with PAC input on process.
    • The recommendation to ONC will be drafted here: OO Lab and CPT PLA - Orders & Observations - Confluence (hl7.org) in the ONC Recommendation section.
    • We are not planning re-discuss the topic, rather to establish a crisp recommendation on where to represent CPT-PLA instead of its current location with a focused rationale.
  • COW/FOE Updates
    • Focusing on potassium workflow including how to communicate using Task.
    • The team noted that some of these flows are not well addressed in v2.
  • Micro
  • Panel/Micro and discoverable Observations in FIHR
    • Hans/Fran to create an initial proposal, focusing on the micro scenario, on how to approach this in FHIR / FHIR US Core.
      • No update




JIRA Triage Inventory

V2 Lab JIRAs (link)

The following JIRA Tickets need to be reviewed by the Lab members as carry over from May 2023 WGM:

FHIR Lab JIRA (link)

The following JIRA Tickets need to be reviewed by the Lab members as carry over from May 2023 WGM:


Chat History

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:13 PM)
In response to Hans' email on more info on micro I also provided more examples from CDC/APHL that would reflect the different responses/types of parent-child test patterns
Here are the different types of tests that may occur for a stool https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441030/figure/Fig1/

 
Craig Newman (Altarum) to Everyone (Jul 21, 2023, 1:28 PM)
MID - This term identifies any other observations about the isolate
MOD - This terms identifies observations about the culture (not individual isolates) other than the culture status
 
Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:41 PM)
Craig, not sure if you have read the paper too and the APHL requirements
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441030/

https://www.aphl.org/aboutAPHL/publications/Documents/FS_SalmonellaSustainabilityWhitePaper_Nov2014.pdf

Hans to Everyone (Jul 21, 2023, 1:41 PM)
@Andrea: While I can see these references are helpful background, but would be great to contribute specific examples and languages to include.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:42 PM)
/https://www.bio-rad.com/webroot/web/pdf/fsd/literature/FSD_14-0699.pdf
https://www.aphl.org/aboutAPHL/publications/Documents/FS-Campylobacter-Diagnosis-Recommendations.pdf
 
Dan Rutz to Everyone (Jul 21, 2023, 1:45 PM)
the ex-xE-health?
 
Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:45 PM)
Here's an example as requested, "Several FDA-cleared CIDTs are available from commercial sources for the direct detection of Campylobacter spp. in human stool specimens. These tests are immunologically based assays or nucleic acid amplification tests (NAAT), formatted as either microwell-plates or lateral flow immunoassays, and designed to detect specific Campylobacter spp" from APHL campylobacter guidance
However, an important limitation of CIDTs is that they do not yield an isolate for characterization, public health surveillance, outbreak detection and antibiotic susceptibility testing.

Table 2. NAAT-based Assays for Detection of Campylobacter spp.*

bioMérieux BioFire® FilmArray® Gastrointestinal Panel
Luminex® Verigene® Enteric Pathogens (EP)
Qiagen QIAstat-Dx® Gastrointestinal Panel
Quidel® EntericBio Dx GI Panel
Hologic® Prodesse ProGastro, Salmonella, Shigella, Campylobacter, STEC (SSCS

BD Max™ Enteric Bacterial Panel

The use of a direct immunoassay on clinical specimens provides a result one to two days sooner than culture.
(similar to what Ralf described)

Hans to Everyone (Jul 21, 2023, 1:48 PM)
Can we use non-vendor specific test names based on LOINC/SNOMED?

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:48 PM)

https://www.aphl.org/aboutAPHL/publications/Documents/FS-Campylobacter-Diagnosis-Recommendations.pdf

It depends on whether LOINCs are available.

you'd have to do more research
https://loinc.org/57768-4

https://loinc.org/100867-1

https://loinc.org/82196-7

(this is common assay )

Hans to Everyone (Jul 21, 2023, 1:53 PM)
Perhaps, but for HL7 documentation referencing vendor names would be challenging.
 
Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:53 PM)
and most highly ranked of campy direct stool tests

we gave you more generic info on direct stool testing by pcr, but you didn't want to include it.  If there is another way you want to describe it while being clear to all, especially the lab and developer community, feel free to let us know

there are Antigen and immunoassay tests above if you want to highlight those instead

If you read the LOINC descriptions they also provide insight:  https://loinc.org/82196-7 indicates it was created for the Verigene tests, but not limited to that as LOINC doesn't include vendor names

Hans to Everyone (Jul 21, 2023, 1:57 PM)
Can you turn that into specific suggestions on updates to the draft?
 
Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:57 PM)
In the right examples: antigen, immunoassay tests
in case it wasn't clear above

Hans to Everyone (Jul 21, 2023, 1:58 PM)
Can you put that in the right row in the sheet where you believe it is most clear?
 
Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone (Jul 21, 2023, 1:59 PM)
Hans you have the sheet open.  I do not.  It would be much faster for you to do so.
 
Hans to Everyone (Jul 21, 2023, 1:59 PM)
These sheets are collaborative.  You can update at the same time.

Follow-up Next time: