Statistics Meeting Book (May 15, 2019)

III. CURRENT METHOD CONFORMITY ASSESSMENT PROJECTS (All– 10:45AM‐11:05AM) Progress updates a. Statistics for Microbiology Methods Validation - Paul Wehling & Robert LaBudde (Leads) 1. Word copies of the Annexes for Appendix J, provided, to be able to work with equations easily: a. Robert LaBudde b. Paul Wehling Discussions and action items: Delia: This meeting is being recorded. (and this is new) We have a quorum today; BTW, Jimmy Yuk has discontinued serving as a committee member, so the quorum total number has changed. Google Doc is no longer working for our group so we will explore other options to share the workings files, such as SharePoint. Committee members approved the draft agenda and the meeting minutes.

Volunteers to check equations modified by Paul: a) Qian Graves b) Jane Weitzel

c) Hilde Skår Norli d) Sidney Sudberg

b. Changes to Appendix J (in progress) - Paul Wehling & Robert LaBudde (Leads) 1. ISPAM being ‘reactivated’ to discuss quantitative methods 2. Qualitative methods need changes (performed during &/or after validation) a. Homogeneity? (Robert to write a TR?) b. Paul to update Committee on Progress of changes c. Candidate minus Reference d. New method of calculating the CI for the paired dPod e. Use of Z (n) vs. t (n-1) f. Removal of reference to Welch/Satterthwaite t-test? g. Chi-Square Test Calculator (Robert/Paul) http://lcfltd.com/AOAC/aoac‐binary‐v2‐5.xlsx i. To be discussed with Appendix J changes

Discussions and action items: From last teleconference, this working group has found more work what needs to be done on the App. J. The tables in ANNEX G have the results from the old formulae before the updates so we will need to recalculate the results and update the tables. Some of the columns are not needed so we will remove them, and there is an ICC section we will need to add to the document. Some of the formulae in ANNEX F is not in the proper order so we will need to review them and reorder them. Action items: Robert will write up the short iCC section and email it to Paul to be added in ANNEX F. Paul will recompute the results and update the tables, also delete some columns and do more editing, and to reorder the formulae in ANNEX F. The current version of the file is called V1.0 so we will be tracking the changes with this as a beginning. Next subgroup meeting is scheduled on May 8 th at 10:30am (Eastern time)

c. Statistics Committee’s Terms of Reference (ToR) Update – All, ToR Subcommittee 1. Latest version – v8 has been approved by OMB a. Board of Directors to vote via e-Ballot?

version