OPTN BylawsSubstantive Rewrite of the Bylaws

Addressing Review, Actions, and Due Process

Sponsored by the Membership and Professional Standards Committee

(MPSC)

Public Comment Period February 3, 2012 – April 6, 2012

The Rewrite Process

This rewrite represents Part 2 of Phase I: Part 1: Plain language changes and re-

organization WITHOUT any changes to substance

Part 2: Plain language and reorganization WITH substantive changes to the due process section (current Appendix A)

Project Overview Started March 2011 Review Teams with Extensive

Collaboration• MPSC Bylaws Due Process Substantive

Rewrite work group • HRSA representatives• UNOS staff, including legal & subject

matter experts

Project Goals The goals of the substantive rewrite were to:Rewrite in plain languageReorganize the bylaws logicallyClarify Members’ rights and responsibilitiesClarify OPTN responsibilities and actions

Project Goals – continued (2) Define three possible review pathways

for potential violations, including an option that allows for the speedy, agile handling of threats to patient health and public safety• Imminent Threat Review• Expedited Review (New!)• Routine Review

Project Goals – continued (3) Clarify the period in which the Secretary of HHS should

be notified of a potential violation or non-compliance issue

Clarify when potential violations will be referred to the Secretary of HHS

Clarify when and how the OPTN Contractor will perform special Secretary-directed reviews as permitted under the Final Rule, especially in cases where there is no OPTN policy violation

Project Goals – continued (4)

Add a monitoring tool to aid Members who may need time and assistance to come into compliance

Provide increased opportunities to Members for quality improvement

Comments on this proposal were received through

Online survey

Live Meeting presentations to the Regions• Approved by 10 regions. • 1 region did not comment.

Education sessions to OPTN/UNOS Committees

Public Comment

Public Comment Tally

Public Comment Response Tally

Type of Response Response Total In Favor

In Favor as Amended

OpposedNo Vote/

No Comment/ Did Not Consider

Individual 10 7 (70%) 0 (0%) 2 (20%) 1 (10%)

Regional 11 10 (91%) 0 (0%) 0 (0%) 1 (9%)

Committee 5 4(80%) 0 (0%) 1 (20%)

Post Public Comment Changes

Please refer to the full language for the new Appendix L: Reviews, Actions, and Due Process (Exhibit K).

Based on comments received from ASTS and AOPO, several revisions were made that changed responsibility and authority given to the Executive Director and correctly assigns it to the MPSC Chair or the OPTN.

Clarified language regarding hearing panel members and their responsibility to avoid conflicts of interest.

Post Public Comment Changes (2)

Clarified notification requirements by adding definition for Transplant Hospital Patients.

Corrected typos and formatting errors where found.

In response to numerous requests, will work with staff to provide concrete examples and diagrams to be included in the OPTN Evaluation Plan for Member guidance.

Questions?

Comments?