2021-09-01
- riki.merrick
Agenda
Review Section 5 of strategic plan document (Riki)
Instructions:
Riki will share the full document with committee members via email - do NOT share outside this group!
For the next 2 weeks review and improve the document - due back to Co-Chair Committee by 9/13/2021, so that a new draft can be created by 9/20/2021
Focus on the committee’s specific section
If you have feedback on content of other committees, please reach out directly to their co-chairs
Focus specifically on content and flow - in the strategic section could be higher level, but do include detail, if you have it - we can always move that detail into an appendix
Are there gaps or mis-representations?
Identify any items that will need funding (vs those that could be dealt with by in-kind SHIELD member contributions)
If you have $$ ideas for budgeted items, please include
Also include the timeline (where in the phase of SHIELD activity this would fit and also how long it would take and consider any dependencies) to help create the roadmap
Longer timeline for SHIELD:
After the 3 weeks will share plan with the larger SHIELD community
work on funding (FDA and ONC both have requested CARES ACT funding
plan to launch at national level in January 2022
in person meeting (COVID permitting) / media etc
would need funding in place by then
Will re-orgnaizae the SHIELD groups after that to implement the strategic plan
Discussion:
Over the next 3 weeks the alignment committee will work out the vetting process for governmental agencies and also try to figure out, if we can get endorsements from private orgnaizations / companies as well as the final authorship and distribution (depends on clearance in the federal agencies for example)
Do we need to include details around cell lines for cultures or substances details for antibodies etc?
for FDA submission all of these things: critical reagents, cell lines, poly-clonal vs mono-clonal AB are tracked - have not really looked at all the CDHR elements
we clearly state that inclusion of LDTs is OUT OF SCOPE for this effort, because they are NOT tracked in LIVD files / LIDR
yes, but we should still provide for a mechanism to convey on the instance data that the test was an LDT (to avoid co-mingling its results with commercially available)
For LDTs would have to include a lot more detail to be truly useful for FDA purposes - this is TBD and not in scope here
Do we need to track software that created translation / transformations?
This can be s source of error
fits into the data provenance section
is not somethign that woudl be in the LIVD file - this is for instance data
some specs already cover that (e.g. SFT segment in Hl7 V2.x messages)
Need to consider how to include (if in scope) the creation of the infrastructure to create and distribute low and high ranges, positive controls etc to support test harmonization activities (related to the topic of Ana and Jack Bloom’s conversation from last week’s call notes).
Need differnt approaches:
build infrastructure then we can quickly identify the most important problems using the different approaches that needs to be address - share knowledge across solutions
HOMEWORK: ALL to review and edit this wiki page: Strategies - Section 5
Any more thoughts on these diagrams? - not discussed
https://aphlinformatics.atlassian.net/wiki/download/attachments/1167425547/SHIELD_Flows.pptx?api=v2
LIVD File Normalization to Third Normal Form Update (Jerry)
Created the individual tables and relationships, have the documentation around the linkages, but no UI - this is a FIRST DRAFT, but would like to get feedback on the approach.
Please review: COVID_LIVD_ContentDB_v1
https://drive.google.com/file/d/1DCr9V4hb6gUQOsObSRnD-Vft8Uf4Et7r/view?usp=sharing
Leave comments about it here:
Update on Budget estimate for LIDR?
Will identify elements that will need funding vs which elements will be able to be provided in-kind.
FDA has worked with NLM on the GUUID, but we have not formally talked about that (part of strategic alignment to staff up internally and inform leadership - FDA to NLM and ONC to NLM) - this will be part of vetting the strategic plan.