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Attendees

Present	Name	Organization
X	Nancy Cornish	CDC
X	Manjula Gama-Ralalage	CDC
X	Riki Merrick	APHL
X	Christina Gallegos	APHL
X	Amy Lui	Inductive Health / APHL
	Raj Dash	Duke / CAP
X	John Snyder	National Library of Medicine (SNOMED CT)
X	Andrea Pitkus	UW
X	Kathy Walsh	Labcorp
-	Rob Hausam	Hausam Consulting
X	Doug Franklin	APHL
X	Pam Banning	3M

Discussion topics

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Notes

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Item
Notes
Upcoming OOO
Riki 3/21-3/24
John 3/31-4/6
Pam 3/31-4/7
Rob 3/31-4/6
Nancy 3/30
TRUU-Lab follow up
Support for educational offerings
SHIELD involvement
Dr. Sing will provide update on TRUU Lab for CLIAC April 12- update to this presentation from 2018
https://www.cdc.gov/cliac/docs/addenda/cliac0919/13_TRUU-LAB_Singh.pdf
Also present to Clinical Lab Partners Forum - not scheduled yet (Heather at CDC organizing)
SHIELD might put up a Test Naming topic call in May
Some questions from SHIELD:
Are TRUU Lab calls happening? - the time has changed - need to find out if calls are open
Wednesdays
Also a question on the website ?link
Riki/Nancy to Follow up with Dr. Singh on getting this the TRUU LAB call information out there to get added to the calls
Reporting Biomarkers to Cancer registries
NOT DISCUSSED
Specimen CMT - Progress
44 more terms need to be added
Many terms have not been finalized yet - discouraged, duplicates (with some differences), fields not finalized, 150 terms will need additional work (missing definition, term not decided, etc.) - may need to assign them
Schema diagrams - John to request access from Riki to search the database to see what attributes are assigned to different concepts
https://app.smartsheet.com/sheets/h6JWqw5v9pwvrqWMq9r4g85CXjv9M8VvVqvHRwc1?view=grid
Specimen CMT - Hosting Optionshttps://app.smartsheet.com/sheets/h6JWqw5v9pwvrqWMq9r4g85CXjv9M8VvVqvHRwc1?view=grid
Reviewing the discouraged terms without comments on why they are discouraged
·       Endometrium tissue by hysterectomy
o   This is listed as discouraged, but in the text for the preferred term we list this term – and the others as what folks should be using, but then we call these discouraged.
o   Swab is discouraged for all domains
o   Tissue is split between pathology and micro domain, so should be the same for both
o   Issue here is that we have mixed how we have used usage:
§ #1 for the specimen in the domain
§ #2 for the way we have applied the coding
o   We have the rule to use precoordinated code (though long term we would like type to be more clean – but that can be done based on the modeling of the pre-coordinated term, so ensure we use ONLY the specimen use in the lab domain here
o   Make sure we have all pre-coordinated terms for both domains
o   EndometriumTissueBiopsy is missing – need to add for both domains
·       Andrea is reviewing cancer dictionary at UW – lots of pre-coordinated terms
o   She will provide additional content she finds missing
·       Lochia
o   Discouraged for micro – not good to culture
o   Preferred specimen is vaginal discharge
·       Bone
o   Discouraged as NHSN, but preferred otherwise – we may not have reviewed the NHSN terms, so it may
o   Reach out to them when we are done with term review
DID ANYOME ELSE TAKE MORE NOTES?
Specimen CMT - Hosting Options
From last call:
JTG Consulting (Jamel Giuma)- would be willing to host the CMT and TRUU Lab
Contact info:
Email: jamel@jtg.group
Direct #: 1-786-598-2540,
Mobile: 1-305-301-5074
Specimen CMT - education
  NOT DISCUSSED
Specimen CMT - potential pilot sites
Goal is to have some implementers lined up by April - so who to reach out to?
Review where we are: Vendor Connections
Onepager: https://aphlinformatics.atlassian.net/wiki/download/attachments/1853947928/20200601_CBR_SCM_OnePager_v04_final_cleared.pdf?api=v2
Specimen CMT - tracking implementation impact
Setting baseline
Define metrics
  NOT DISCUSSED
Specimen CMT - Compare to NHS Medical Terminology testing
NOT DISCUSSED
Andrea review and thoughts
Sent via email:
Not very far yet (A-E terms done) in reviewing/mapping Specimen Source Site terms for cancer patients. I'm searching the Cross Map Table and a few are in there, but many are not. It might be good for me to see if I can share terms in the future so they can be added/addressed either in the cross map table or if SCT requests are needed, etc.

Some patterns I'm seeing.
Specimen Source and Procedure pre coordinated term (i.e. Site and Biopsy)
Many disorders such as Site and Tumor, or Site and Mass, or Site and Lesion
Pre Coordinated terms with Site and multiple lateralities such as (left and posterior and Site) or (Right and Distal and Site), whereby there's a Specimen Source Site with one laterality pre coordinated and a qualifier is needed for the other.

I plan to investigate more on our end the information sources as they may be internal and external from our systems. If these are from clinicians, it further emphasizes a need for education/requirements/assistance for physicians as documentation/select of these terms often begins with them.

Given the impacts on pathology/cancer, PH, genetics, microbiology, and need for accurate/quality info/encoding, it might be good within SHIELD to discuss strategies (when we get our agency folks onboard)..

How can correct specimen terms/codes be available in EHRs at the point of order entry (labs, radiology, procedures, etc.)? Then at point procedures are performed/documented (radiology, lab specimen collection, surgical procedure/reports, etc.) (also in discrete interoperable manner to be transmitted to downstream systems)
Laboratory Medicine/Pathology/Genomics/Microbiology, etc. How can the terms/codes (including derived specimens) be available in all LISs/EHRs/PH systems (also in discrete interoperable manner to be transmitted to downstream systems)?
How can the terms/codes be used in all PH systems from ELR, eCR, Cancer Reporting, HAI, and at all levels: jurisdiction (state, local), central cancer registry, National CDC, NIH SEER, etc.
Specimen CMT - review of terms with questions

How can terms/codes be used in all research, RWD/RWE, 510(k) approvals, FDA, and research common data models like OMOP, PCORI/PCORNET, i2b2, etc. PCORNET uses radiology LOINC system for lab specimens (uggh)
I should add EHR receipt, and transmission too whether within a system, to HIEs, other EHRs, Long term care facilities, SNFs, clinic, non traditional settings, etc.
We have it in USCDI for labs, but should be expanded to all above.
ONC certification is for SCT functionality, but should be for all the systems to support not only SCT encoding of all specimen items (like lab), but in all areas of workflow in the EHR, LIS or other information system. facilitate said functionality.
The good news is the Specimen Call (HL7) has worked through many of the complexities, but it might be good to see if HL7 can support all the messaging in all the use cases above (i.e. radiology, procedures, surgery, pathology, genomics) especially when developed by other WGs. Including v2, FHIR, CDA. Most will likely be ok, but may find gaps/needs. It's in mCode multiple times too.
It might be good to have "searchability" function too, especially for things like biobanking. Need to think about more, but this ties on to the add on order functionality.
10. Would ask federal agencies to review regulations/policies where specimen requirements exist (i.e. CLIA), NIH, to see if any regs need tweaking of terms/functionality to support.
11. IVD vendors with LIVD, LIDR, 510K, RWD, etc.
12. Possible other areas that may benefit: forensic testing, autopsies,
13. Education like Xavier's inquiries for micro. What's the difference between specimen type/source/procedure. How to map. Nancy mentioned CDC education. That would be good for laboratories, but what about providers, nurses, etc.? Robyn may have ideas from AMP members/testing. Is there an AMA quality area that might target their members? Medical School Education? of course the immediate pushback is physician/clinical burden.
14. Could expand to include device vendors for containers, additives too.

For CAP eCP, it would reduce pathologist burden/error potential with manual selecting in eCP. If surgeon provided and it autofilled (with allowed physician override to correct, etc.) for pathologists, radiology, etc. Wouldn't it be great if PH, cancer registry, etc. autofilled ;)

Anyhow, a few thoughts around impact in this area. Theoretically a SHIELD workgroup especially with path, micro, PH, vendors might work on the needs in each part of the process, solutions, means to adopt, policy/reg wish list, etc.
Future projects for this call after CMT
Result value sets (Xavier) or may do this at SHIELD as a WG
Recording: https://www.aphlweb.org/aphl_departments/Strategic_Initiatives_and_Research/IPMG/ConfigMgt/LabMCoP/Meeting Notes/20230316_LabMCoP_Zoom.zip

From Chat:

Action items

Quick decisions not requiring context or tracking

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Discussion topics

From Chat:

Action items

Quick decisions not requiring context or tracking

Item	Notes
Upcoming OOO	Riki 3/21-3/24 John 3/31-4/6 Pam 3/31-4/7 Rob 3/31-4/6 Nancy 3/30
TRUU-Lab follow up Support for educational offerings SHIELD involvement	Dr. Sing will provide update on TRUU Lab for CLIAC April 12- update to this presentation from 2018 https://www.cdc.gov/cliac/docs/addenda/cliac0919/13_TRUU-LAB_Singh.pdf Also present to Clinical Lab Partners Forum - not scheduled yet (Heather at CDC organizing) SHIELD might put up a Test Naming topic call in May Some questions from SHIELD: Are TRUU Lab calls happening? - the time has changed - need to find out if calls are open Wednesdays Also a question on the website ?link Riki/Nancy to Follow up with Dr. Singh on getting this the TRUU LAB call information out there to get added to the calls
Reporting Biomarkers to Cancer registries	NOT DISCUSSED
Specimen CMT - Progress	44 more terms need to be added Many terms have not been finalized yet - discouraged, duplicates (with some differences), fields not finalized, 150 terms will need additional work (missing definition, term not decided, etc.) - may need to assign them Schema diagrams - John to request access from Riki to search the database to see what attributes are assigned to different concepts https://app.smartsheet.com/sheets/h6JWqw5v9pwvrqWMq9r4g85CXjv9M8VvVqvHRwc1?view=grid	Specimen CMT - Hosting Optionshttps://app.smartsheet.com/sheets/h6JWqw5v9pwvrqWMq9r4g85CXjv9M8VvVqvHRwc1?view=grid Reviewing the discouraged terms without comments on why they are discouraged · Endometrium tissue by hysterectomy o This is listed as discouraged, but in the text for the preferred term we list this term – and the others as what folks should be using, but then we call these discouraged. o Swab is discouraged for all domains o Tissue is split between pathology and micro domain, so should be the same for both o Issue here is that we have mixed how we have used usage: § #1 for the specimen in the domain § #2 for the way we have applied the coding o We have the rule to use precoordinated code (though long term we would like type to be more clean – but that can be done based on the modeling of the pre-coordinated term, so ensure we use ONLY the specimen use in the lab domain here o Make sure we have all pre-coordinated terms for both domains o EndometriumTissueBiopsy is missing – need to add for both domains · Andrea is reviewing cancer dictionary at UW – lots of pre-coordinated terms o She will provide additional content she finds missing · Lochia o Discouraged for micro – not good to culture o Preferred specimen is vaginal discharge · Bone o Discouraged as NHSN, but preferred otherwise – we may not have reviewed the NHSN terms, so it may o Reach out to them when we are done with term review DID ANYOME ELSE TAKE MORE NOTES?
Specimen CMT - Hosting Options	From last call: JTG Consulting (Jamel Giuma)- would be willing to host the CMT and TRUU Lab Contact info: Email: jamel@jtg.group Direct #: 1-786-598-2540, Mobile: 1-305-301-5074
Specimen CMT - education	NOT DISCUSSED
Specimen CMT - potential pilot sites	Goal is to have some implementers lined up by April - so who to reach out to? Review where we are: Vendor Connections Onepager: https://aphlinformatics.atlassian.net/wiki/download/attachments/1853947928/20200601_CBR_SCM_OnePager_v04_final_cleared.pdf?api=v2
Specimen CMT - tracking implementation impact Setting baseline Define metrics	NOT DISCUSSED
Specimen CMT - Compare to NHS Medical Terminology testing	NOT DISCUSSED
Andrea review and thoughts	Sent via email: Not very far yet (A-E terms done) in reviewing/mapping Specimen Source Site terms for cancer patients. I'm searching the Cross Map Table and a few are in there, but many are not. It might be good for me to see if I can share terms in the future so they can be added/addressed either in the cross map table or if SCT requests are needed, etc. Some patterns I'm seeing. Specimen Source and Procedure pre coordinated term (i.e. Site and Biopsy) Many disorders such as Site and Tumor, or Site and Mass, or Site and Lesion Pre Coordinated terms with Site and multiple lateralities such as (left and posterior and Site) or (Right and Distal and Site), whereby there's a Specimen Source Site with one laterality pre coordinated and a qualifier is needed for the other. I plan to investigate more on our end the information sources as they may be internal and external from our systems. If these are from clinicians, it further emphasizes a need for education/requirements/assistance for physicians as documentation/select of these terms often begins with them. Given the impacts on pathology/cancer, PH, genetics, microbiology, and need for accurate/quality info/encoding, it might be good within SHIELD to discuss strategies (when we get our agency folks onboard).. How can correct specimen terms/codes be available in EHRs at the point of order entry (labs, radiology, procedures, etc.)? Then at point procedures are performed/documented (radiology, lab specimen collection, surgical procedure/reports, etc.) (also in discrete interoperable manner to be transmitted to downstream systems) Laboratory Medicine/Pathology/Genomics/Microbiology, etc. How can the terms/codes (including derived specimens) be available in all LISs/EHRs/PH systems (also in discrete interoperable manner to be transmitted to downstream systems)? How can the terms/codes be used in all PH systems from ELR, eCR, Cancer Reporting, HAI, and at all levels: jurisdiction (state, local), central cancer registry, National CDC, NIH SEER, etc.
Specimen CMT - review of terms with questions
How can terms/codes be used in all research, RWD/RWE, 510(k) approvals, FDA, and research common data models like OMOP, PCORI/PCORNET, i2b2, etc. PCORNET uses radiology LOINC system for lab specimens (uggh) I should add EHR receipt, and transmission too whether within a system, to HIEs, other EHRs, Long term care facilities, SNFs, clinic, non traditional settings, etc. We have it in USCDI for labs, but should be expanded to all above. ONC certification is for SCT functionality, but should be for all the systems to support not only SCT encoding of all specimen items (like lab), but in all areas of workflow in the EHR, LIS or other information system. facilitate said functionality. The good news is the Specimen Call (HL7) has worked through many of the complexities, but it might be good to see if HL7 can support all the messaging in all the use cases above (i.e. radiology, procedures, surgery, pathology, genomics) especially when developed by other WGs. Including v2, FHIR, CDA. Most will likely be ok, but may find gaps/needs. It's in mCode multiple times too. It might be good to have "searchability" function too, especially for things like biobanking. Need to think about more, but this ties on to the add on order functionality. 10. Would ask federal agencies to review regulations/policies where specimen requirements exist (i.e. CLIA), NIH, to see if any regs need tweaking of terms/functionality to support. 11. IVD vendors with LIVD, LIDR, 510K, RWD, etc. 12. Possible other areas that may benefit: forensic testing, autopsies, 13. Education like Xavier's inquiries for micro. What's the difference between specimen type/source/procedure. How to map. Nancy mentioned CDC education. That would be good for laboratories, but what about providers, nurses, etc.? Robyn may have ideas from AMP members/testing. Is there an AMA quality area that might target their members? Medical School Education? of course the immediate pushback is physician/clinical burden. 14. Could expand to include device vendors for containers, additives too. For CAP eCP, it would reduce pathologist burden/error potential with manual selecting in eCP. If surgeon provided and it autofilled (with allowed physician override to correct, etc.) for pathologists, radiology, etc. Wouldn't it be great if PH, cancer registry, etc. autofilled ;) Anyhow, a few thoughts around impact in this area. Theoretically a SHIELD workgroup especially with path, micro, PH, vendors might work on the needs in each part of the process, solutions, means to adopt, policy/reg wish list, etc.
Future projects for this call after CMT	Result value sets (Xavier) or may do this at SHIELD as a WG