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Clarifications on reporting maintenance dialysis

Proposal Overview

Status: Implemented

Sponsoring Committee: Living Donor

Strategic Goal: Promote the efficient management of the OPTN

View the policy notice (PDF; 6/2019)

View the Board report (PDF - 510 K; 6/2019)

Read the proposal (PDF; 1/2019)

Contact: Justin Moore

Executive Summary

Members have raised questions regarding the meaning of the phrase “begins dialysis” in Organ Procurement and Transplantation Network (OPTN) Policy 18.6: Reporting of Living Donor Events. Currently, it is not clear whether the phrase “begins dialysis” requires reporting chronic dialysis representing end-stage renal failure (ESRD), acute dialysis, or both under OPTN Policy 18.6. In addition, there are several other areas within policy language, the Transplant Information Electronic Data Interchange (TIEDI®), and the OPTN Patient Safety Portal, which refer to the decrease or loss of renal function in a living donor using inconsistent terminology.

This proposal clarifies when transplant hospitals should report chronic versus acute dialysis in the sections of OPTN policy and harmonizing terminology on OPTN forms. This will help hospitals accurately report living donor events. In addition, greater clarity in reporting will improve safety reviews and the understanding of clinical events after living donation.


Anonymous | 03/26/2019

Vote: 6 strongly support, 16 support, 0 abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/22/2019

As a practicing social worker, I often work with clients that's been diagnosed with chronic kidney disease and end stage renal disease; and in most cases, these individuals are receiving dialysis treatment. Although, it sometimes depend on the severity of the disease and other health conditions. In my opinion, there should be a clarification on reporting maintenance dialysis because each individual kidneys function differently. Chronic Kidney Disease (CKD) doesn't automatically mean a person's kidneys are failing, but instead "damaged". End Stage Renal Disease(ESRD)is severe which means the kidneys have stopped working and dialysis and/or a kidney transplant is needed in order to survive. Hospitals need to specify whether the phrase "begin dialysis" is absolutely necessary because "chronic" and "end stage" are two different terms.

Anonymous | 03/22/2019

The Transplant Coordinators Committee reviewed the proposal during a meeting on February 19, 2019. The members expressed their support for this proposal, noting it will provide much needed clarity for transplant coordinators. Further, members recommended this clarifying language should extend to all other instances in OPTN data that document maintenance dialysis. The Committee appreciates the opportunity to provide feedback to the Living Donor Committee.

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) supports this proposal.

Anonymous | 03/22/2019

Vote: 9 strongly support, 13 support, 1 abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/22/2019

13 strongly support, 12 support, 3 abstain

Anonymous | 03/22/2019

25 strongly support, 17 support, 1 abstain

National Kidney Foundation | 03/21/2019

The National Kidney Foundation supports this proposal with suggested modifications. We agree the most important clinical outcome to capture is end-stage renal disease (ESRD) following a unilateral nephrectomy. While this event is extremely rare, appropriate documentation is critical to ensuring subsequent priority on the transplant waitlist. However, documentation should not be defined by the start of dialysis or the number of dialysis sessions and instead based on diagnosis of ESRD or an eGFR of less than 20 ml/min/1.73m2, which is when an individual is eligible for to be listed for a transplant. The Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines and the U.S. Kidney Disease Outcomes Quality Initiative (KDOQI) commentary on CKD evaluation and management recommends a diagnosis of CKD when two laboratory values at least 90 days apart confirm a sustained reduction in eGFR, with stage 5 or ESRD defined as an eGFR of

American Society of Transplant Surgeons | 03/21/2019

The American Society of Transplant Surgeons (ASTS) supports this policy proposal to clarify and streamline data when reporting on living donor events. While rare, a complication in a living donor can present significant consequences for transplant centers under the current system. Namely, providers have not been able to properly distinguish between donors who have experienced an acute temporary event post-donation versus those with End-Stage Renal Disease (ESRD) when reporting to the OPTN/UNOS Patient Safety Portal. Inconsistent terminology has also been a barrier to accurately gauging center performance. ASTS welcomes the opportunity to encourage measures leading to improved clinical outcomes and reductions to additional regulatory burdens.

Anonymous | 03/19/2019

To Whom it May Concern, On behalf of the American Nephrology Nurses Association (ANNA), thank you for allowing us the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Public Comment Proposals 01/22/19- 03/22/19. Our comments for several of the current policy proposals are as follows: OPTN Standards for Public Comment 01/22/19 – 03/22/19 Clarifications on reporting maintenance dialysis: ANNA supports.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation supports this proposal in concept, and offers the following comments for consideration: • The need for temporary dialysis in a living donor within 2 years of donation to be considered a major adverse event, which can be made a part of the reporting requirements through the Patient Safety Portal. • The current event phrasing “begins dialysis” is unclear in whether if means acute dialysis, chronic dialysis. There is other inconsistent language that makes it difficult to determine which living donors have met the criteria for ESRD, which is the original intent.

Anonymous | 03/15/2019

Vote: 16 strongly support, 12 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/28/2019

Region 10 Vote: 14 strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/25/2019

Region 8 vote: 8 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/21/2019

Region 2 Vote: 11 strongly support, 15 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/21/2019

Region 5 Vote: 13 strongly support, 20 support, 1 abstain

Anonymous | 02/18/2019

Region 1 vote-8 Strongly support, 6 support, 0 abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/08/2019

Region 7 vote-6 strongly support, 4 support, 3 abstentions