Proposal to Clarify Data Submission Reporting and Documentation Requirements (Resolution 22) Membership & Professional Standards Committee (MPSC) Jonathan Chen, MD, Chair November 12-13, 2014

 The current policy does not specify what has always been implied  Data submitted through OPTN forms must be accurate  Members must provide documentation to verify data accuracy  Other policies explicitly state members must maintain or provide certain documentation The Problem

#6 – Promote the efficient management of the OPTN Clearly communicate with members Strategic Plan

 Improve readability of OPTN rules and requirements  Clarify policy to alleviate confusion  Reduce resources required to obtain documentation and review potential noncompliance issues  Only applies to standardized forms required by Policy 18 Goal of the Proposal

 Clarifies member obligations to provide documentation, when requested, to verify data accuracy How will the Proposal Achieve its Goal

Product Bylaw Addition Target Population Impact: Transplant Hospitals, OPOs, & Histocompatibility Laboratories Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 80/17,885 Overall Project Impact

 Should not have to change policies or procedures  Will not be required to provide additional documentation during routine site surveys  UNOS will not change how it monitors compliance  May be asked to gather and provide relevant documentation upon request for MPSC review What Members will Need to Do

 Non-discussion agenda at regional meetings  Generally supported in Committee and individual comments  Primary source documentation  Maintain documentation for regular audits Public Comment

 Add “upon request” to address concerns that members must maintain all documentation in central location for routine audits Post-Public Comment Changes

RESOLVED, that Policy 18.1 (Data Submission Requirements) is modified as set in Resolution 22, effective February 1, 2015 Resolution22 (page 85)