ad hoc disease transmission advisory committee spring 2015
TRANSCRIPT
Ad Hoc Disease Transmission Advisory Committee
Spring 2015
Board approved proposal to align OPTN Policy with PHS Guideline in Nov. 2014 Most policies effective Feb. 1, 2015 NAT requirements -- not effective until programming for
data collection fields and screening is complete (watch for System Notice, expected late Summer 2015)
PHS Guideline education available! Recorded town hall meeting on applying increased risk
criteria on TransplantPro February 3, 2015 webinar covered policy changes
passed by Board in Nov. FAQ sheet on OPTN website
DTAC Update
Improving Patient Safety Portal Update Upgrading portal for reporting potential donor-derived
disease transmission events Easier to use less free text more pull down menus
Programming scheduled for completion this spring
DTAC Update
Proposal to Require Re-Execution of the Match Run when a Deceased
Donor’s Infectious Disease Results Impact Potential Recipients based
upon Screening Preferences
Ad Hoc Disease Transmission Advisory CommitteeSpring 2015
Large number of organ allocations take place based on match runs executed before receiving certain infectious disease results
Presents a potential patient safety concern Organs could unintentionally be allocated to a candidate
who is not willing to accept offers from specific diseased donors
Increases opportunity for unintended donor-derived disease transmission!
The Problem
Enhance patient safety by outlining specific requirements for when a match run must be re-executed prevents unintentional allocation that may lead to
unintended donor-derived disease transmission
Goal of the Proposal
If the donor tests positive for… Then candidates may choose not to receive offers on the following match runs:
Cytomegalovirus (CMV) Intestine
Hepatitis B core antibody (HBcAb)
Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas
Hepatitis B Nucleic Acid Test (NAT)*
Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas
Hepatitis C (HCV) Antibody Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas
Hepatitis C Nucleic Acid Test (NAT)*
Heart, Intestine, Kidney, Liver, Lung, Pancreas, Heart-Lung, Kidney-Pancreas
Current Infectious Disease Screening Options
*approved by the Board in Nov 2014, but not yet implemented
The DTAC requested data to better understand how often match runs are executed without the relevant infectious disease results
Reviewed all donor matches executed from January 2012-December 2013
Supporting Evidence
Deceased Donor Matches 2012-2013Percent with Ambiguous Results
Percent of Deceased Donor Matches with Result of Pending: 2009-2013
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 1 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 2 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 3 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 4 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 5 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 6 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 7 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 8 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 9 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 10 Highlighted)
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO (Region 11 Highlighted, One OPO with 0%))
No Elimination of Pathway for Urgent Allocation WHEN test results are received plays a roll in
executing the match run
Stringent requirements preventing match run execution could lead to loss of potential organ donors or organ discard
REQUESTED: OPO community feedback on appropriate expectations in this area
How the Proposal will Achieve its Goal
How the Proposal will Achieve its Goal
Host OPOs: For new positive HBV, HCV, or CMV results with (provisional) organ acceptance
• Report new test result to first tx hospital on match that accepted each organ as soon as possible, but within 1 hr of receiving result
• Report updated donor result in DonorNetSM
• Re-execute match run if potential recipient declines the offer after learning this new information
• Re-allocate the organ using the updated match run
How the Proposal will Achieve its Goal
TX Hospitals with (provisional) organ acceptance, once notified by Host OPO of positive HBV, HCV, or CMV result:
• Inform potential recipient (or agent) of the positive donor test result
• Notify the host OPO whether organ will be accepted or declined within an hour of receipt of this new information
• If accepted, meet requirements for informed consent in Policy 15.3.A: Deceased Donors with Additional Risk Identified Pre-Transplant
How the Proposal will Achieve its Goal
Host OPOs: For new positive HIV result with or without (provisional) organ acceptance for a potential recipient
• STOP allocation on original match run• Report updated donor result in
DonorNetSM
• Re-execute only kidney and liver match runs to include only HIV-pos candidates at centers participating in IRB approved research protocol that meet OPTN Final Rule requirements
• Allocate organs using updated match run
• Withdraw all pending offers to candidates who are not HIV pos and on new match runs
The Solution- a recap
Enhance patient safety without eliminating or limiting options for match run execution
With the exception of HIV, honor primary offer and allow opportunity for medical judgment and informed consent based upon new test result
Review requirements for when re-execution of a match run is required based upon new donor infectious disease results
Report new donor information in DonorNetSM before re-executing match to appropriately screen candidates from appearing on match run
Communicate with first accepting transplant hospital for an organ regarding these new findings within an hour of receiving positive test result
What OPOs will Need to Do
Review new requirements for OPOs to re-execute the match run (some back up offers may be withdrawn based upon new information)
Inform potential recipient (or agent) of new positive donor test results
Notify host OPO if organ will be accepted or declined within an hour of receiving new donor information
If accepting organ, meet requirements for informed consent in Policy 15.3.A
What Transplant Hospitals will Need to Do
Dan Kaul, MDCommittee [email protected],edu Presenter name (RA will complete)
email address
Shandie Covington Committee Liaison [email protected]
Questions?
Extra slides… if needed
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) HCV Serology Results for Liver Matches Run 2012-2013 By OPO
Percent of Match Runs (with Final Acceptance) Having Ambiguous (not Positive or Negative) CMV Serology Results for Intestine Matches Run 2012-2013 By OPO