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Date

07 Aug 2023

Attendees

...

Name	Organization	Role
Scott Campbell	UNMC	Co-Chair Steering Committee member
Raj Dash	College of American Pathologists (CAP)	Co-Chair Steering Committee member
Dan Rutz	Epic	Steering Committee member
Muktha Natrajan	CDC
Sandy Jones (Secondary)	CDC Cancer Surveillance
Anne Peruski (Secondary)	CDC
Andrea Pitkus	University of Wisconsin-Madison	Steering Committee member
Xavier Gansel	bioMérieux	Steering Committee member
Stan Huff	Graphite Health	Steering Committee member
John Snyder	NLM	Steering Committee member
Rob Hausam	Hausam Consulting
Marjorie Rollins	Regenstrief	Steering Committee member
Amy McCormick (secondary)	Epic
Nanguneri Nirmala	Tufts Medical Center	Steering Committee member
Mehdi Nassiri	Indiana University/Indiana University Health/Association for Molecular Pathology	Steering Committee member
Eza Hafeza	Regenstrief	Steering Committee member
Jim Case	Snomed International	Steering Committee member
Mary Kennedy	CAP

Discussion topics

Item

Notes

Identify tangible activities for this working group

What role does standards play and what gaps are we looking to close? What are the known limitations and/or areas that standards cannot address currently?
Span of tests: for chemistry, microbiology, etc. order and result (LOINC), AOE question (LOINC), specimen type, specimen source and/or body site (SCT), specimen collection method (SCT).
How the test was performed, describe the result → interoperability gaps exist today even with standards in place today
Limitation: no agreement on coding HL7 value sets & specimens with the standards
How to address issue of free text vs discrete data capture vs discrete coded data capture?
In SCT, the specimen hierarchy is suboptimal. HL7 specimen domain analysis model has been mapped to SCT with some improvements suggested.
- For cancer, the specimen hierarchy does not follow editorial guidelines and has not been well-maintained. Proximal primitive parenting has not been widely applied.
- Example: for “how is tissue removed?” Is biopsy considered an excision? (in a machine classifiable model this is not computable).
- Missing content.
- Do we need to establish concrete use cases of these challenges?
- Share challenges and gaps with SCT to propose a quality improvement effort.
- Define interoperability challenges and create prototypes / pilots that works in the real world and demonstrate value of going to the effort?
- Lab systems don't have to store the exchange standards, but their local values stored need to be structured so they can be mapped to the national terminology standards. Many laboratory systems store their local data in a free-form text fields for specimen source and specimen type.
- EHRs today don’t make best use of standards today (e.g. using UCUM to normalize units).
- There is no place in information models that standardizes how laboratory device information is stored and transmitted.
  - Is there a standard for laboratory device nomenclature?
  - LOINC describes methods but not specific devices
  - LIVD assigns LOINC codes for in vitro devices (industry defined format to facilitate publication and exchange of LOINC codes for IVD test results)
  - How to include UDIs (CLSI AUTO-16 / LAW discussion today)?
How do we prevent effort in building HL7 laboratory interfaces and minimize miscommunications?
- There are multiple ways to represent information; establishing equivalence or normalizing data from multiple sources is not trivial.
- LOINC methodology is optional (can choose a valid method-less LOINC code but this does not support interoperability unless the method is provided elsewhere [e.g., post-coordinated expression])
- We may not need new standards but we need agreement on how to use existing standards so similar data is transmitted similarly.
- We are missing guidelines for standard implementation of standards!
  - HL7 implementation guides not followed
  - How do we help implementors of standards
- Agree that we need to identify what standards should be used and how. We need to eliminate the need for so many mappings/translations to exchange data.
- IHE (IHE.net) attempts to provide guidance (through use cases) on how to solve interoperability challenges through proper use of existing standards.
We need laboratories at the table to discuss what the issues are on their side with using the standards.
- These issues could be documented as use cases.
Prioritize data elements we need, publishing how standards need to work together, versus focus on incentivizing adoption of standards. We need to articulate the short- and long-term value proposition so that it’s clear what the benefits are to all stakeholders.
- This can serve as a mechanism for prioritizing this project team’s effort.
Change management and maintenance is a burden on labs too
Need $$ for labs to help them.
Technical standards and capabilities are not perfect but likely sufficient. There are gaps in transmission implementations (where to get and put the UDI vs device type vs both) and vocabulary standard gaps but is that the best place to start (versus describing the problem and value proposition for doing it the right way).
What are the options we have to make the situation better?
Maybe list top 10 standards issues and rank them to start working on them?

Cloud Recording: https://duke.zoom.us/rec/share/77b_ijthaXJDozyMcfUJcT4JZIdABMH26FSJdDfXUD1A2k3Q80ALTxo4oS47VFlQ.v75jDbiSTQBVICNE

From Chat:

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:34 PM
What lab test areas are you talking about? as it depends

Scott Campbell to Everyone 1:35 PM
"what role should standards play? What are the known limitations and/or areas that standards cannot address currently?"

Xavier Gansel to Everyone 1:37 PM
limitation : no agreement on coding HL7 value sets & specimens with the standards

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:43 PM
Agree Sandy,. Would love surgeons and others to use specimen standards for what they collect and send to labs (academic, reference, PH, etc.) so it is received/used whether pathology, genomics, clinical lab, micro, etc.
One misunderstanding in implementing standards is belief that they should be used in place of "local codes" or LOINC names used for naming a test. or a pipeline . Lab mapping is not dynamic like clinician use/notions in their heads. Lab mappings are set (for the most place)
Dan, pre/post coordination
upper left lung can be represented with about 40 different combinations of SCT cods (specimen type, source, specimen collection procedure). Highly dependent on health IT functionality and what is mapped/used in those systems
scott's points assume implementers know the difference between specimen type, source, procedure.
many say lung biopsy as a specimen source or specimen type and don't understand "meaning" per SCT/HL7 use.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:51 PM
Raj, are you suggesting to ask what terms folks are using/receiving in EHR/LIS or look across the CAP Cancer protocols for different specimen type, source, collection procedure (resection, etc.) and add those to the existing CDC cross Map table project?

You to Everyone 1:51 PM
Not necessarily cancer. Look at most common interoperability issues...
By result volume that's probably chemistry
Or by public health need.

Sandy Jones, CDC to Everyone 1:52 PM
lab systems don't have to store the exchange standards, but their local values stored need to be structured so they can be mapped to the national terminology standards. Many laboratory systems store their local data in a free-form text fields for specimen source and specimen type.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:52 PM
How are you defining interoperability issues? (where folks are not using standards, where standards content gaps occur, both, other)
DO we need to review standards use/adoption in lab areas (chem first, hem, micro, bb, path, genomics, etc.)

You to Everyone 1:55 PM
I define interoperability challenges as the barriers that impede clinical data sharing.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:55 PM
Do we want to call out Health IT systems support (or lack thereof) for standards? some lab results can't be encoded....
thanks Raj.
which devices
most think about instruments and test kits per LIVD, but Rob is describing other device usage
devices cultured too like EKG leads, cath tips

Xavier Gansel to Everyone 1:58 PM
UDI was the subject today in the LIDR wg : how to include UDI support in IHE LAW / CLSI AUTO 16

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 1:59 PM
+Xavier and also when a single UDI instrument/UDI kit is used for multiple individual result items from an instrument on a patient. (10+ antibiotics on a single device card)
Other CLSI standards like MIC and labs reporting the same items differently.
significant PH implications too
another area is using standards correctly. related to modeling/building results (and orders), is meaning, whereby some labs do not build challenge tests the same and have a generic LOINC used across different time frames/suppression/stimulant results comingling values requiring different interpretations.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 2:05 PM
Speaking of interpretations, there are a lot of generic interpretation terms for panels, pathology, genomics, etc. built as a test result and mapped to the same generic "interpretation" or "comment loinc" thus lacking any semantic meaning as to the contenxt.
context
Another usage issue is folks apply the SCT view of the work with lab results/LOINC/don't realize LOINC doesn't support subsumption (parent-child inheritance) and try to use generic LOINCs to do queries, calculations, etc as though it does giving unexpected results at times
+Stan on use

Sandy Jones, CDC to Everyone 2:06 PM
Agree that we need to identify what standards should be used and how.

Sandy Jones, CDC to Everyone 2:07 PM
We need to eliminate the need for so many mappings/translations to exchange data.

Sandy Jones, CDC to Everyone 2:08 PM
YES!!

Sandy Jones, CDC to Everyone 2:10 PM
We need laboratories at the table to discuss what the issues are on their side with using the standards.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 2:11 PM
regulations to help standardize?

Sandy Jones, CDC to Everyone 2:11 PM
Laboratories are overburdened with trying to map their data in so many different ways.

Sandy Jones, CDC to Everyone 2:12 PM
Maybe laboratories could identify the carrots.

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 2:13 PM
Where standards are adopted is another piece. many labs don't create CDAs, while EHRs do
A cancer biomarker/tumor marker may be LOINC encoded on the LIS (CP) and EHR, but when used for cancer reporting, desire is to use SCT. Then FHIR, mCode, cancer registry reporting requires LOINC again

Dan Rutz to Everyone 2:20 PM
https://isitreadonlyfriday.com/

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 2:21 PM
Change management and maintenance is a burden on labs too
Need $$ for labs to help them.
Not everyone has a Duke Pathology Informatics team. Critical Access Hospital IT support may be the computer store on Main strett
street
Next steps?
There are large labs still on HL7 2.3.1 too
and not able to support complete specimen info.
Maybe list top 10 standards issues and rank them to start working on them?
or 5?

Andrea Pitkus, PhD, MLS(ASCP)CE, FAMIA. UW-Madison to Everyone 2:27 PM
+Sandy 😂

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