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Proposal to Clarify Data Submission Reporting and
Documentation Requirements (Resolution 22)
Membership & Professional Standards Committee (MPSC)
Jonathan Chen, MD, ChairNovember 12-13, 2014
The current policy does not specify what has always been impliedData 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
0 1000 2000 3000 4000 5000
Series1
0 1000 2000 3000 4000 5000 6000
Se-ries1
Should not have to change policies or procedures
Will not be required to provide additional documentation during routine site surveysUNOS 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
Resolution 22 (page 85)
