Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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Attachment 1 

Summary: “Reviewed and Recognized” (R 2 ) certification program  Concept:

Review the procedures and claims application notes just like we would review a package  insert in the Performance Tested Methods  (PTM) program and license the use of a  “Reviewed and Recognized” (R 2 ) certification mark (shown below). 

Process:

This is essentially the PTM process.  1. Consulting (optional) 2.

Technology Provider (TP) submit R 2  application.

3.

AOACRI assigns a Technical Consultant (TC) to assist TP in process and development of internal data study report and proposed independent lab protocol.

4.

TC recruits two AOACRI reviewers plus an AOAC Voluntary Expert.

5.

AOACRI Reviewers and AOAC Voluntary Expert review: application note, internal data study report, and proposed independent lab protocol.

6.

Independent lab protocol approved.

7.

TC recruits independent lab using the Onsite Method Validation model. *

8.

Onsite Method Validation data collected.

9.

Onsite Method Validation data integrated into Validation Study Report by the TP with assistance of TC. AOACRI Reviewers and AOAC Voluntary Expert review the Validation Study Report and Application Notes. If Validation Study Report and Application Notes approved, then TP provider licensed to use R 2  certification mark.

10.

11.

* Onsite Method Validation model – AOACRI instituted the Onsite Method Validation model in 2018. This model allows a proprietary method to be evaluated onsite.  Samples are prepared and blind coded by an independent lab, and then shipped to the method developer, in this case the TP.  The independent lab also provides a technician who goes to the TP laboratory to carry out the independent study.  The independent study is monitored by an AOACRI TC to ensure the integrity of the study.  This process would eliminate a lot of potential liability and the need to ship, set up, and qualify expensive equipment from TP to an independent testing laboratory.

04/05/2019