Project to update refusal codes
Board approved June 14, 2021; implemented December 2, 2021
The OPTN Final Rule requires transplant programs to provide to the OPTN “reasons for refusal” of organ offers made to candidates registered at their programs (see 42 C.F.R. §121.7(b)(4)), and OPTN Policy 18.3: Recording and Reporting the Outcomes of Organ Offers accordingly requires these reasons to be reported to the OPTN.
The OPTN received community feedback that refusal codes were too vague, needed clarification, and were outdated. Additionally, some codes covered multiple reasons for refusal, such as “age or quality.” To address these concerns, and in light of the recommendations of the Systems Performance Committee (PDF), the OPTN Data Advisory Committee (DAC) collaborated with OPTN committee members and various stakeholders to develop a revised list of codes to indicate why a specific organ offer was not accepted for a specific candidate. This revised list was approved by the OPTN Board of Directors during its June 2021 meeting.
Revising the list of refusal codes supports increased efficiency of the OPTN through better understanding of refusal behaviors. Offering members more options for reporting why an offered organ is refused provides more robust data to develop improved allocation strategies to:
- Reduce cold ischemic time
- Reduce number of discards
- Increase the number of transplants
These revisions do not change or add data collection, but provide an updated list of options under the primary refusal and secondary refusal drop downs in the offer details form section of DonorNet®.
- Mini Brief (PDF)
- Policy Notice (PDF)
- Update to Refusal Codes Three-Month Post-Implementation Monitoring Report (PDF)
- Update to Refusal Codes Nine-Month Post-Implementation Monitoring Report (PDF)
- Update to Refusal Codes Twelve-Month Post-Implementation Monitoring Report (PDF)
Opportunity to provide input now closed
The opportunity to provide input was open March 8-21, 2021.
Thank you to all who provided their thoughts and recommendations. The feedback submitted was used to inform the final list of refusal codes reviewed and approved by the OPTN Board of Directors.
About refusal codes
OPOs and transplant programs strive to place the right organ with the right candidate. On occasion, this means that a transplant program may choose to refuse certain organ offers for reasons related to the candidate, the donor, or OPO or transplant hospital operational issues. When this occurs, a refusal reason is entered into DonorNet®. These reasons are labeled with numerical values that are referred to as refusal codes.
Refusal codes are used by transplant programs and OPOs when reviewing their acceptance practices as well as in research analysis to better understand:
- Why an organ was declined
- Identify trends in acceptance behaviors
- Inform proposed solutions to increase acceptance rates
Until implementation of this revised list, refusal codes had not been updated since 2004 and data showed the majority of the codes were underutilized. In 2018, 17 of 23 refusal codes accounted for less than 4% of refusals while 70% of all refusal reasons were listed as “830 Donor Age or Quality.” To promote more specific collection for refusal reasons associated with Donor Age or Quality, several codes have been added to include:
- DCD donor
- Donor age
- Donor instability/ high vasopressor usage
- Prolonged downtime/CPR
Ensuring the codes are relevant and discrete, or mutually exclusive, allows for the data to be more actionable.
| Proposed Category | Proposed Refusal Reason |
|---|---|
| Candidate Specific Reasons | Candidate refused |
| Candidate requires different laterality | |
| Candidate requires multiple organ transplant | |
| Candidate temporarily medically unsuitable | |
| Candidate transplanted or pending transplant | |
| Candidate unavailable | |
| Candidate's condition improved, transplant not needed | |
| Crossmatch Related Reasons | No candidate serum for crossmatching |
| No donor serum for crossmatching | |
| Positive physical crossmatch | |
| Positive virtual crossmatch/unacceptable antigens | |
| Disease Transmission Risk | Donor infection/positive culture |
| PHS risk criteria or social history | |
| Positive infectious disease screening test: HCV, HBV, CMV, etc. | |
| Donor and Candidate Matching | DCD donor |
| Donor age | |
| Donor size – height | |
| Donor size – weight | |
| Number of HLA mismatches unacceptable | |
| Donor Specific Reasons | Donor instability/high vasopressor usage |
| Donor medical history, specify | |
| Prolonged downtime/CPR | |
| Logistics | Donor family time constraint |
| Exceeded policy defined response time | |
| Recovery team availability | |
| Resource time constraint (OPO, TXC, Donor Hospital, etc.) | |
| Transplant team or facility availability | |
| Transportation not available | |
| Organ Specific Reasons | Actual or projected cold ischemic time too high |
| Biopsy not available | |
| Malignancy or suspected malignancy | |
| Organ anatomical damage or defect | |
| Organ biopsy results unsatisfactory | |
| Organ preservation (pumping issue, not pumped, etc.) | |
| Organ specific test results not available | |
| Unsatisfactory organ specific test results | |
| Warm ischemic recovery time too high | |
| Other | Disaster/Emergency/Epidemic/Pandemic – Candidate |
| Disaster/Emergency/Epidemic/Pandemic – Donor | |
| Other, specify |
Collaborators
Feedback was solicited from various stakeholders to develop the updated refusal codes list including:
- OPTN Heart Transplantation Committee
- OPTN Kidney Transplantation Committee
- OPTN Liver & Intestinal Organ Transplantation
- OPTN Lung Transplantation Committee
- OPTN Membership and Professional Standards Committee
- OPTN Operations and Safety Committee
- OPTN Organ Procurement Organizations Committee
- OPTN Pancreas Transplantation Committee
- OPTN Transplant Administrators Committee
- OPTN Transplant Coordinators Committee
- OPTN Vascularized Composite Allograft Transplantation Committee
- Transplant community members