2019-05-29 Meeting notes

• • TSTMOD discussion (or on the 29^th) – Jordan has invited Joleen White and others to discuss the new variable to house values such as: detection, screening, confirmatory, screen to confirm, etc.
    • Jordan reviews the ADA Tiered Testing cmap (get link)
    • US FDA recommends a 3-tiered testing approach. First tier is screening (with results positive/negative). Second tier is confirmatory (again with values positive/negative). Third tier is characterization; most companies do titration tests to determine quantities of ADAs in the sample (with result values of numbers with unit of ‘Titer’.)
    • They need a variable that captures the tiers (screening, confirmatory, etc). The team considered TSTMOD.

•                                                                                  i.            Team agrees that we need a new variable for LB, MB, and IS.

                                                                                 ii.            Concern with what the third value should be? Characterization or something else?

  1. What is the variable name? This should come last….
  2. What are the values that should go in there?

                                                                                                                                         i.      Team agrees on Screen and Confirm

                                                                                                                                       ii.      We are unsure what the third tier name is.

  1. What is the description/definition?

                                                                                iii.            Jordan wants confirmation that Quasi-quantitative does not belong with ‘Screening’ and ‘Confirmatory’ -> Team agrees that Quasi-Quantitative is better suited for the –RSLSCL NSV that is being proposed with the LOINC mapping.

                                                                               iv.            Jordan wants feedback on whether ‘Test Mode’ is really the appropriate name for the variable or whether another name is more appropriate?

  • Manjula reports that this might also be useful for MRD testing; e.g. reflex testing.
  • MB team actions:

                                                                                   i.            Consider variable name and definition

                                                                                 ii.            Define two values ‘Screen’ and ‘Confirm’

                                                                                iii.            Consider third value name and definition.

                                                                               iv.            Jordan asks for input from lab team members  for use cases for that third tier type data in the LB domain.

                                                                                 v.            MB team will prep all of this over the next two weeks and we’ll discuss it on the

• LB to MB move – Jordan: We are looking at 154 terms pending moving. There are 19 terms the MB team would like to seek consultation from the LB team as to whether they should remain in the LB domain.
  • Move is being done as per the SDTMIG publications. SDTMIG3.3 has all microbial tests in MB. SDMIG3.4 has many of these tests further going to IS.
  • The original decision was that all microbial-based tests would go into the MB domain.

                                                                                 i.            Allergy testing is a special grey area however because of context for why you do the test. You are not looking for the bug but rather asking whether the subject is allergic to the bug.

                                                                               ii.            Do we need an additional rule that all microbial allergy testing should also go into MB with this first move?

1. Team agrees that all should go to MB, regardless of whether they are for lab or allergens.

                                                                              iii.            Jordan presents the PR draft write-up. Team re-considers short list of published LBTEST values that are generic microbes (usually part of a urinalysis panel) that the Lab team wanted kept in the list the last time we talked at a F2F.

1. Team considers whether we can make a rule that all generic type tests like these (Yeast, Fungi, Bacteria, Trichomonas, etc.) should stay in LB. MB team has not seen this generic tests come through as potential MBTEST values. The first generic test is ‘Microbial Identification’ with further identification and characterization.
2. Alternatively we could just say this is the finite list that occurs in both domains and be done with it. Team agrees to go with this approach.

                                                                             iv.            Jordan asks about C92241, M. tuberculosis IFN Gamma Response LBTEST. The MB domain is for microbial identification.

1. Erin to check into why we have both C92241 and C81996.
2. Team agrees to move C92241 to the MB codelist.