/
2026-03-03 LIDR Meeting Notes
Edit

2026-03-03 LIDR Meeting Notes

Date

Mar 3, 2026

Attendees

Bolded names indicates attendance

 Name

Organization

 Name

Organization

Hung Luu - regrets

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

University of Wisconsin

Pam Banning

3M - Solventum

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Rob Hausam

Hausam Consulting

Stan Huff

University of Utah

Ed Heierman

Abbott / IICC

Carmen Pugh

long term lab professional

Laurent Lardin

Biomerieux

Ralf Herzog

Roche

Christina Gallegos

APHL

 

 

 

 

Follow up on UDI representation

Adding Conclusion here: UDI Background

Will keep filling this page out to collect all solutions there.

 

Vison 2030 work considerations

Answers to the questions around UDI:

  • How many 510k tests have UDI? You would have to query the database using FDA product code and hopefully trap the entire list of IVD tests - i.e., there are many product codes and I am sure an office level search will result in too many non-test products (i.e., instruments, etc).I think that is a requirement for getting the 510k - Yes, most 510K submissions fall under the UDI Rule.

  • what is the request process for UDIs? FDA does not issue UDI-DIs.  They are created by the Labeler (US) based on the requirements of the Issuing Agency (e.g., GS1, HIBCC, ICCBBA).  

     

  • what the best way is to find them in the FDA GUDID?  Same response as finding 510Ks - you will need to either search by FDA product code or GMDN code to see if you could locate all of the products you are looking for -- I do not think this is an easy process to ensure you have 100% of the tests.

    As you may remember -- even finding the test kit and analyzer was difficult.

I am not sure even AI could make sense of this one yet....but it is worth a try if someone has time to create some prompts.

USCDI V7 Draft review

USCDI Draft-V7 Feedback

CDC requested elements = see publications that support collection / use of some of these: UCSDI V7 Element Support

We should update the mapping here to include the new elements: https://confluence.hl7.org/spaces/OO/pages/256515226/US+-+CLIA+Elements+mapping+to+HL7+data+elements

Discussed:

Reviewed against comments from HL7 OO WG https://confluence.hl7.org/spaces/OO/pages/413056613/USCDI+V7+Draft+Feedback and addressed these elements today:

Device Type

Laboratory Order

Reason Not Performed

Adverse Event Class

Follow up email from Andrea: As a follow up to the Adverse Events items in USCDI, I saw USCDI + has a number of other items listed in the USCDI+ Data Class for Adverse Events:  https://uscdiplus.healthit.gov/uscdiplus?id=uscdi_record&table=x_g_sshh_uscdi_uscdi_class&sys_id=318085628745b95098e5edb90cbb35ce&view=sp

 Some of these include the "Adverse Event Suspect Entity" or "Adverse Event Category" or "Adverse Event Identification" which may provide the details and/or linkage Stan inquired about.

 They list CTCAE terms and grading.  In looking this up, I find https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events  "An AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the drug or intervention that may or may not be considered to be related to the drug or intervention."

 There's a CTCAE terms pdf that lists the term and criteria for grading.  Some of these include laboratory result value criteria.  Carmen asked about hemolysis and I see it on page 4.  Anemia, DIC, Eosinophilia are also mentioned on this page.  Page 84 Investigations lists increased or decreased specific lab result values. Infections and hematuria are also indicated.  It doesn't appear that they use any standardized terminologies/codesystems. 

We may wish to look at USCDI + items related to laboratory data needs.  If there, it may good to reference them or request their promotion to USCDI, etc.

https://www.medpagetoday.com/publichealthpolicy/fdageneral/120265

https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool - Looks like FDA has a new Adverse events database/dashboard.

Specimen Collection Method

Decided not to rehash comments we already made on V6, they are still true, but does it help to keep making the same comment? - we can ask Sara on the SC call; applies to overarching comments, vocabulary comments and Medical Devices class

LIDR Patterns

  • Biomerieux culture plates

  • Toxicology screening vs confirmatory

  • challenge tests

  • urine dipstick variations

  • required specimen pre-processing before running on instrument?

Action Item Follow up

Next call

Tuesday Mar 10, 2026 9 - 10 AM ET

Chat

Andrea Pitkus 9:23 AM
from a google search, "Lab test adverse event reporting requires prompt, detailed documentation of any unexpected or serious adverse events (SAEs) linked to testing, including patient/product details and corrective actions. Serious, unexpected reactions must be reported to the FDA within 15 calendar days (7 days for fatal/life-threatening), while IRB reports for research require immediate or specific, expedited timelines"

https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf

Andrea Pitkus 9:31 AM
Per your hemolysis question, here is a FDA recall with customer reported unexpected hemolysis: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5580975&pc=CAK

Andrea Pitkus 9:32 AM
" alleged hemolysis was observed in the plasma post-centrifugation"

Andrea Pitkus 9:33 AM
For this item they also indicate, "Hemolysis is commonly caused by the following factors: characteristics of blood.Bacterial contamination.Excessively cooling.Filter clogging."

Andrea Pitkus 9:34 AM
CLIA also has adverse event reporting requirements:  "CLIA-certified laboratories must report adverse events related to laboratory-developed tests (LDTs) to the FDA within 30 calendar days if they suggest the test caused or contributed to death/serious injury, or malfunctioned. Events posing a serious public health risk require reporting within 5 working days. Laboratories must also report, investigate, and implement corrective actions for nonconforming events to comply with quality regulations."

Andrea Pitkus 9:35 AM
Key Aspects of CLIA/FDA Adverse Event Reporting:

  • Reporting Requirements: Laboratories are treated as manufacturers for their LDTs and must report events (death, serious injury, or malfunction) to the FDA via their website within 30 days of becoming aware of the event.

  • Urgent Reports: Events requiring immediate remedial action to prevent, serious public health risks must be reported within 5 working days.

  • What to Report: Events include, but are not limited to, test kit/reagent failures, instrument malfunctions, and issues with specimen collection or results that affect patient safety.

  • Report Contents: Reports should include a detailed description of the incident, patient details, product information (if applicable), and the investigation/corrective action taken.

 

  • CMS Compliance: While the FDA handles device-related adverse events, CMS oversight involves reporting "Rapid Response" issues, such as those that could affect a wide range of patient results, directly to CMS Regional Offices.

 

Given it's part of CLIA, but reporting is via FDA pathways per CDC website, we may wish to ask ASTP ONC if they intend USCDI element to include or exclude this reporting and to communicate that to all.

Action items