Proposal to Change the OPTN/UNOS Bylaws to Better Define Notification
Requirements for Periods of Functional Inactivity
Membership and Professional Standards CommitteeFall 2012
Bylaws do not clearly outline Member actions for functional inactivity, including:
Periods of waiting list inactivation Cessation of a transplant program component
(e.g. Living Donor/adult-peds)
Since the Bylaws do not specifically address notification content or timing, programs have been inconsistent in how they notify patients
The Problem
Detailed, timely patient information regarding periods when organ offers will not be made on their behalf
More guidance for MPSC to monitor functional inactivity
Goal of the Proposal
Clearly define Member responsibilities: Clarify patient notification content and timing
requirements for periods of waiting list inactivation in UNetsm
Specify Member actions for notifying patients when a program voluntarily ceases performing a specific type of transplant
Goal of the Proposal (cont.)
Current bylaw requires programs to provide written notice to potential candidates and candidates of waiting list inactivity Proposed modifications: waiting list
inactivity notifications must contain the following: Reason Expected length Explanation organs cannot be accepted during
this time
How the Proposal will Achieve its Goal WL Inactivation
Notification content requirements (cont): Options available to the candidates, including
multiple listing/transfer Mechanism for notifying candidates when WL is
reactivated or if the expected length of inactivation is extended
Copy of Patient Information Letter Cumulative notice must include dates for each
instance of WL inactivation
How the Proposal will Achieve its Goal WL Inactivation II
When to send notifications:
How the Proposal will Achieve its Goal WL Inactivation III
Periods at least 30 days in advance
Periods less than 30 days in
advance
Cumulative Periods
Notification Must Be Sent
30 days prior to WL inactivation
No later than 7 days following WL inactivation
No later than 7 days after last date of period that exceeded threshold
Example: Program reaching cumulative waiting list inactivation of 28 days or more in one 365 day Period
How the Proposal will Achieve its Goal WL Inactivation IV
Instances of Inactivation at
Program AStart Date
Consecutive # of Days Inactive
# of Days WL inactive for Review
Period
Running total: Cumulative # of
days
1 1/10/11 3 3 3
2 3/15/11 7 7 10
3 6/27/11 7 7 17
4 8/20/11 4 4 21
5 11/22/11 13 13 34
6 12/22/11 7 7 41
Total # of Cumulative Days WL Inactivated in Period 1 41
Members must: Notify all patients affected by the
cessation at least 30 days prior to, but no later than 7 days after cessation
How the Proposal will Achieve its GoalProgram Component Cessation
Patient notifications must include: Reason for cessation Explanation that organs cannot be accepted
on the candidate’s behalf during period of cessation
Patient options Phone number for the transplant program’s
administrative office
How the Proposal will Achieve its GoalProgram Component Cessation (cont.)
12 programs met WL inactivation thresholds in 2011
4 programs ceased a component in 2011 Proposed requirements could result in
additional financial burden to send notifications, increase in patient calls/questions, submission of responses to MPSC inquiries
Impact
Anticipated Date of Board Consideration: June 2013
Anticipated Effective Date: September 1, 2013
Expected Implementation
WL inactivation: Include required elements in patient notifications Send within specified timeframe
Cessation: Include all required elements Send within specified timeframes
MPSC will continue to monitor periods of WL inactivation and will request confirmation that you notified patients
What Members Will Need to Do
Is the term ‘affected patients’ clear enough?
Should adult candidates be notified of the cessation of a pediatric component and vice-versa?
Should transplant recipients be notified of the cessation of living donor, deceased donor, or age-specific components?
Should there be different patient notification timelines for living versus deceased donor program components?
Proposed Bylaw language on pgs. 10-11 of public comment proposal document
Specific Requests for Comment
MPSC Chair: Kenneth Andreoni, MD
MPSC Vice Chair: Alan Reed, MD
Staff LiaisonsHeather [email protected]
Sally [email protected]
Questions?