1 National Webinar to Review Non-Discussion Agenda Fall 2015 Public Comment If you are logged into...

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National Webinar to Review Non-Discussion Agenda

Fall 2015 Public Comment

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Webinar Objectives

Review non-discussion agenda process

Present and discuss proposals on the non-discussion agenda

Review methods to submit feedback to sponsoring committees

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Regional Meeting Goals Discuss and comment on proposed policies and bylaws

Collect feedback and provide to sponsoring committees Advisory to the councillor during Board deliberations

Executive Update on OPTN/UNOS activities

Receive updates on OPTN committee activities and projects

Discuss regional business

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Regional Meeting Agenda Discussion Agenda

8 proposals presented, discussed, and voted on during meeting

Non-Discussion Agenda 4 proposals presented today No discussion at the regional meeting Regional Vote

Process for moving a proposal to the Discussion Agenda 15% of member institutions within a region submit a request All requests must be received one week prior to the regional meeting date If the 15% threshold is met, proposal will be presented and discussed during

regional meeting

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Non-Discussion Agenda Proposals Proposed Changes to Transplant Program Key Personnel Procurement

Requirements (Membership and Professional Standards Committee)

Revising Kidney Paired Donation Pilot Program Priority Points (Kidney Transplantation Committee)

Proposal to Update the Human Leukocyte Antigen (HLA) Equivalency Tables (Histocompatibility Committee)

Proposal to Reduce the Documentation Shipped with Organs (Organ Procurement Organization Committee)

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Changes to Transplant Program Key Personnel Procurement Requirements

Membership and Professional Standards CommitteeFall 2015

Update key personnel procurement Bylaws to: Correct unexplained inconsistencies Clearly establish requirements that are currently viewed as optional Remove unnecessary specificity Accommodate applications that the MPSC generally believes are acceptable,

but that it must reject due to current Bylaws requirements

Thereby, Simplifying the key personnel application process for members and the MPSC

What is the goal of the proposal?

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Inconsistent primary surgeon procurement requirements

Solution: Delete primary kidney transplant surgeon multi-organ procurement

requirement Delete primary liver transplant surgeon donor selection and management

requirement

What problem will the proposal solve?

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The word “should” means Primary transplant physician aren’t required to observe organ procurements

Solution: Use the word “must”


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Questionable necessity of specifying primary transplant physicians must observe multi-organ donor procurements

Solution: Delete primary transplant physician multi-organ procurement

observation requirement

Exposure to multi-organ donors will likely occur without an explicit OPTN Bylaws requirement considering:

Proposed change that primary transplant physicians must observe at least three organ procurements

Multiple organs procured from the overwhelming majority of donors


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Surgeons applying through fellowship pathway sometimes meet all requirements, but didn’t perform the requisite number of procurements during fellowship

Solution: Allow applying surgeons to cite procurements performed both

during their fellowship and 2 years after completion Otherwise, must apply through clinical experience pathway


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Proposal stems directly from recommendations developed by a Joint Societies Working Group (JSWG)

Collaborative effort between: American Society of Transplantation (AST) American Society of Transplant Surgeons (ASTS) North American Transplant Coordinators Organization (NATCO) MPSC

Supporting Evidence

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No immediate action required of members upon implementation

Membership and key personnel change applications submitted on or after the implementation date will be evaluated based on these requirements

Anticipated board review date – December 2015

Anticipated implementation date – March 2016

How will members implement this proposal?

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Promote the efficient management of the OPTN

Proposal addresses key personnel procurement requirements that are: inconsistent unnecessarily specific needing additional flexibility

How does this proposal support the OPTN Strategic Plan?

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Questions

Questions – click hand button

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Questions?Committee Chair Jonathan Chen, MD [email protected]

Committee Liaison Chad Waller [email protected]

Region 1 Rep David Axelrod, MD, MBA [email protected]

Region 2 Rep Matthew Cooper, MD [email protected]@gunet.georgetown.edu

Region 3 Rep Thomas Pearson, MD, D.Phil. [email protected]

Region 4 Rep Adam Bingaman, MD, PhD [email protected]

Region 5 Rep Lisa Stocks, RN, MSN, FNP [email protected]

Region 6 Rep Christian Kuhr, MD [email protected]

Region 7 Rep David Cronin II, MD, PhD, MHCM [email protected]

Region 8 Rep Timothy Schmitt, MD, FACS [email protected]

Region 9 Rep Lewis Teperman, MD [email protected]

Region 10 Rep Todd Pesavento, MD [email protected]

Region 11 Rep Kenneth Brayman, MD, PhD, FACS [email protected]

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mailto:[email protected]














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Revising Kidney Paired Donation Pilot Program Priority

PointsKidney Transplantation Committee

Fall 2015

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How does the proposal address the problem statement?

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Supporting Evidence

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Increased the # of matching opportunities for 99% and 100% CPRA candidates

Prioritizing by pair characteristics increased the # of matching opportunities for hard to match pairs Blood type O candidates Candidate’s whose paired donor is non-O

Supporting Evidence – Overall Trends

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Members participating in KPDPP will need to communicate the changes as a part of informed consent, particularly about the remedy for a failed exchange

Proposal does not require additional data collection

No changes to current routine site surveys

Anticipated Board Date: December 2015

Implementation Date: Pending programming


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Increase the number of transplants Increase # of matches found Incentivize transplant hospitals to participate Use data to improve chance of timely offers to candidates most likely to

accept

Improve equity in access to transplants Addresses increased difficulty in matching certain blood types and CPRA

levels Improves access for candidates in failed exchanges


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Questions


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Questions?Committee Chair Mark Aeder, MD [email protected]

Committee Liaison Melinda Woodbury [email protected]

Region 1 Rep Reginald Gohh, MD [email protected]

Region 2 Rep Alexander Gilbert, MD [email protected]

Region 3 Rep Truman Earl, MD, MSCI [email protected]

Region 4 Rep Steven Potter, MD, FACS [email protected]

Region 5 Rep Jonathan Fisher, MD, FACS [email protected]

Region 6 Rep Eric Langewisch, MD [email protected]

Region 7 Rep Didier Mandelbrot, MD [email protected]

Region 8 Rep Clifford Miles, MD [email protected]

Region 9 Rep Vinay Nair, DO [email protected]; [email protected]

Region 10 Rep Joshua Augustine, MD [email protected]

Region 11 Rep Vincent Casingal, MD [email protected]

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Proposal to Update the HLA Equivalency Tables

Histocompatibility CommitteeFall 2015

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What problems will the proposal solve? Some equivalences have changed since last update

Proposed solution - update equivalency tables based on: advances in HLA typing the frequencies of antigens reported for donors and antigens and unacceptable

antigens reported for candidates

Some HLA antigen dropdowns in UNetSM disadvantage candidates with antibodies against some alleles but not all of them Proposed solution - update dropdowns in UNet

Policy references to HLA DPB, DQA, and DQB are out of date Proposed solution – change policy references to these loci to DPB1, DQA1, and DQB1

Increase opportunities for candidates to receive offers Compatible donors will not be excluded based on outdated or broad

HLA typing constraints of prior equivalency tables

Reduce risk of positive crossmatch after shipping kidneys nationally and regionally


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Supporting Evidence

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Broad antigens reported for deceased donors (2013-2014)

* C3 was reported by 33 labs for 264 donors. Note: Labels show the number of labs for each broad antigen.

Transplant Programs: Request updated HLA typing using molecular methods for existing

candidates who may be affected by the changes to the equivalences tables

Review/modify unacceptable antigens reported for candidates with antibodies against alleles that are being added

Labs: Assign split (not broad) antigens to candidates


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Strategic Goal ImpactIncrease the number of transplants Improve efficiency of allocation for sensitized

candidates

Improve equity in access to transplants

Allow members to enter more specific data to ensure candidates are not excluded from donors against whom they don’t have UAs

Improve waitlisted patient, living donor, and transplant recipient outcomes

• Table updates will lead to better compatibility and decrease probability of post-transplant rejection

• Allocation to candidates less likely to have a positive crossmatch reduces cold ischemia time

Promote living donor and transplant recipient safety

Reduce risk of organ discards due to futile shipments


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Questions


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Questions?Committee Chair Dolly Tyan, PhD [email protected]

Committee Liaison Geoffrey Zindren [email protected]

Region 1 Rep Indira Guleria, PhD [email protected]

Region 2 Rep Julie Houp, MS [email protected]; [email protected]

Region 3 Rep Gabriella Wheeler, PhD [email protected]

Region 4 Rep Chantale Lacelle, PhD [email protected]

Region 5 Rep Dolly Tyan, PhD [email protected]

Region 6 Rep Diane Kumashiro, MS, CHS, CLS [email protected]

Region 7 Rep Manish Gandhi, MD [email protected]

Region 8 Rep Brian Freed, PhD, D(ABHI) [email protected]

Region 9 Rep Allen Norin, PhD [email protected]

Region 10 Rep Sam Ho, PhD, D(ABHI) [email protected]

Region 11 Rep Peter Lalli, PhD, D(ABHI) [email protected]

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Proposal to Reduce the Documentation Shipped with

OrgansOrgan Procurement Organization Committee

Fall 2015

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What problem will the proposal solve? Current policy requires OPOs to send complete donor record with

each organ

Requirement originated before OPOs could upload information into DonorNet®

During the TransNetsm project, UNOS staff members observed attempts to make copies of documentation, often interrupting donor management

Free up OPO staff to concentrate on donor management and packaging and shipping quality by eliminating requirements to include documentation they have already provided to transplant centers


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Reduces the need to copy and ship documentation already provided to transplant programs Blood type documentation (including subtype if used for allocation) and

infectious disease testing results will still be packaged with each organ Death pronouncement source documentation, authorization for donation source

documentation, human leukocyte antigen (HLA) type, donor evaluation and management, donor medical and behavioral history, and organ intraoperative findings will be provided in DonorNet upon receipt

Transplant programs can accurately and completely evaluate donor suitability using information provided in DonorNet

How does the proposal address the problem statement?

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OPOs must: Submit deceased donor information to UNOS upon receipt so transplant

programs can evaluate donor suitability Still include source documentation for blood type and infectious disease testing

with each organ

Transplant hospitals must: Be aware that deceased donor information is available in DonorNet and can

print copies if necessary

The proposed language will not change the way UNOS conducts its routine site surveys


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Strategic Goal: Promote the efficient management of the OPTN Allow for more efficient and timely communication of donor

information using DonorNet instead of paper documentation that gets packaged and shipped with each organ.


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Questions


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Questions?Committee Chair Sean Van Slyck, MPA, HAS, CPTC [email protected]

Committee Liaison Robert Hunter [email protected]

Region 1 Rep Jill Stinebring, RN [email protected]

Region 2 Rep Debbie Williams, MBA, BSN, RN, CPTC [email protected]

Region 3 Rep Giridhar Vedula, MD [email protected]

Region 4 Rep Janice Whaley, MPH, CPTC [email protected]

Region 5 Rep Sindhu Chandran, MD [email protected]

Region 6 Rep Stephen Kula, PhD, NHA [email protected]

Region 7 Rep J. Kevin Cmunt, BS, MS [email protected]

Region 8 Rep Diane Brockmeier, RN, BSN, MA [email protected]

Region 9 Rep Rebecca Milczarski, MSN, MBA, CPTC [email protected]

Region 10 Rep Daniel Lebovitz, MD [email protected]; [email protected]

Region 11 Rep Dwayne Jolly [email protected]

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Opened August 14

Closes October 14

Proposals are posted on the OPTN website under “Governance” tab

http://optn.transplant.hrsa.gov/governance/public-comment/

Fall 2015 Public Comment

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Submit comments on the OPTN website http://optn.transplant.hrsa.gov/governance/public-comment/

Communicate with your regional representative http://optn.transplant.hrsa.gov/converge/members/committees.asp

Providing Feedback

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Regional Meeting Information

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http://transplantpro.org

Region Regional Administrator Phone Number Email

1,4,9 Shannon Edwards 804-782-4759 [email protected]

2,6,8 Betsy Gans 804-782-4814 [email protected]

3,11 Cliff McClenney 804-782-4742 [email protected]

5,7,10 Chrystal Graybill 804-782-4631 [email protected]

Regional Administrators Contacts

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