Move “Phenotypic DST (pDST) is recommended to be performed in conjunction with sequencing-based DST, unless pDST has already been performed or will be conducted elsewhere. Please choose pDST test below (leave blank if not needed)” to appear as part of the Additional Test Option(s).
Insert space b/w elsewhere and Please
Update: Updated!
Sequencing-Based DST (performed by default)
Please see detailed testing algorithm on test information webpage.
Please choose a pDST test below (leave blank if not needed)” to appear as part of the Additional Test Option(s).
Logic Updated: Display ALL three test options, but apply condition logic:
If First-line pDST (RIF, INH, PZA, EMB) is chosen, then First-line pDST for 4-month RPT-MOX regimen (RIF, INH, PZA, MOX) should be removed
Second-line pDST (MOX, AMK, CAP, ETA, KAN, RFB)
If First-line pDST for 4-month RPT-MOX regimen (RIF, INH, PZA, MOX) is chosen, then First-line pDST (RIF, INH, PZA, EMB) should be removed
All test options should be displayed if any material (sediment, culture, etc) is selected
Update needed: If material selected is sediment, only 1 test option is displayed [First-line pDST for 4-month RPT-MOX regimen (RIF, INH, PZA, MOX)]
Update needed: display all test options
Add title: “Additional Test Option” to each test option
Please confirm that you would like TB DST Reference Center to perform WGS Genotyping *
OPTION SHOULD be defaulted/auto-selected: Yes, please perform default testing
Update: Has sequencing-based DST been performed by CDPH or CDC on a sample from this patient previously?
Update text:
Phenotypic DST (pDST)
pDST is recommended to be performed in conjunction with sequencing-based DST, unless pDST has already been performed or will be conducted elsewhere. Please choose a pDST test below (leave blank if not needed).
WGS Genotyping
WGS Genotyping is performed by default on culture submissions or isolates obtained from submitted sediments and data will be submitted to the CDC for analysis/National Surveillance.
Submitting Lab Results Section:
Update needed: Pop-up text should be changed to: "Sample should be sent to CDC for MDDR and not to MDL for sequencing-based DST"
Change text “Indicate reason(s) for sequencing-based DST below, if applicable” to “Please select any that apply”
Remove “Other reason(s), please specify” from list
11/8/23: Updates Identified:
Under WGS Genotyping:
Yes, please perform default testing >>This radio button should be defaulted/auto selected
Ask Olga: Under order test tile, the tile is now capturing the date--is this automatically updated based on the version; If so, can we include the format [DATE] version?
Additional TRF Changes
Changes to sediments/specimens:
CDPH Proposed Updates:
Modifications:
Move “Sediment-AFB Negative” from “Other” to “Sediment”
a. if “Sediment-AFB Negative” selected:
i. show selection “*Material approved by CDPH”: Yes/No
AND
ii. display message:
Under “Other” add additional options:
a. Processed tissue
b. Mixed culture
c. Non-viable culture
d. Other (add comment field, if selected)
Rename “Other” to “Other (e.g. tissue, mixed culture)”
Need to discuss with APHL/CDC: Some of these proposed changes are not allowable sediments
If user selects Culture, maps to WGS panel
If user instead selects mixed culture, could instead map to tNGS
Option: If user selects “Culture” AND IN Submitting Lab Results AOE the user selects Mixed Culture OR (and/or) Non-Viable Culture then the panel ordered should be to Add “M_TBDST_tNGS” Panel and “M_TBtNGS_Aux” Panel.
N.B.: Currently AOEs are not stored in SL
Ideally Mixed Culture or non-viable culture should be stored in SL
Potentially use Materials Comments to store or misc comments field in other tabs (user would need to search in SL)
Potentially concatenate all AOEs data and store in Comments 1 tab?
Long-term: Would be good to capture and store this information discretely for tracking/auditing purposes (storing as comment tab would make it difficult to discretely parse)
About 7% of tests ordered fall under this use case
Next step:
APHL will discuss with CDC to determine if options are allowable; will then determine next steps for development/which option should be implemented
Questions
Next Steps & Action Items
ICC: Provide current list of TB Specimen Sources and any associated mappings for review: 11/8
APHL: ICC to provide summary of universal changes which may be applied to both MDL/VRDL AND TB LWPs for review to Steven/TB Team prior to applying to TB LWP so we have consensus and awareness of changes, potential impact, and historic documentation
Next:
CDPH/GG will review in QC1, identify any additional changes needed
Sarah N Buss Will follow up with CDC to determine if additional specimen types/material type modifiers are allowable for testing (will determine development option if allowable)
ICC/Catherine: Provide current list of TB Specimen Sources and any associated mappings for review: 11/8
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