OPTN/UNOS Thoracic Organ Transplantation Committee Dr. Joe Rogers Clarification to Policy 10.1.G: Reporting Additional Data for Candidates with an LAS of 50 or Higher (Resolution 26) OPTN/UNOS Thoracic Organ Transplantation Committee Dr. Joe Rogers

Background Policy 10.1.G: Reporting Additional Data for Candidates with an LAS of 50 or Higher effective February 1, 2012 Every 14 days, for candidates with LAS of 50 or higher, transplant programs must report: Assisted Ventilation Supplemental Oxygen PCO2 *

Policy 10.1.G cannot be monitored as written The Problem Policy 10.1.G cannot be monitored as written

#6: Promote the Efficient Management of the OPTN Strategic Plan #6: Promote the Efficient Management of the OPTN Clearly communicate with members

Work with DEQ to: Clarify LAS variables that must be reported Goal of the Proposal Work with DEQ to: Clarify LAS variables that must be reported Clarify timing of reporting requirements

How the Proposal Will Achieve Its Goal Changes to policy language Current policy: “any observed changes” Proposed policy: removes reference to “any observed changes” Monitoring: Candidate’s data must be assessed and reported every 14 days even if no changes Current policy: “three key variables” Proposed policy: removes reference to “three” Monitoring: DEQ will review all fields related to supplemental oxygen (frequency and amount), and PCO2 (venous, capillary, or arterial)

Overall Project Impact Product Policy Modification Target Population Impact: Lung transplant candidates with an LAS of 50 or higher Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 20/17,885

Resolution 26 (page 111) RESOLVED, the modifications to Policy 10.1.G (Reporting Additional Data for Candidates with an LAS of 50 or Higher), as set forth in Exhibit C, are hereby approved, effective February 1, 2015.

Proposed Policy Within 14 days of the date a candidate’s LAS becomes 50 or higher, A the candidate’s transplant program must assess and report data for three key variables to the OPTN Contractor the following variables no more than 14 days after a candidate’s LAS becomes 50 or higher:   Assisted ventilation Supplemental oxygen Current PCO2 The transplant program is only required to report an updated PCO2 value if the test was performed within those 14 days. While the candidate’s LAS score remains 50 or higher, the transplant program must continue to assess and report any observed changes in the three clinical key variables assisted ventilation and supplemental oxygen every 14 days. The transplant program is only required to report updated PCO2 data if the assessment was performed during the previous 14 day interval. The transplant program must maintain documentation of each assessment in the candidate’s medical chart.