CLEVELAND — University Hospitals initiated a “14-day voluntary inactivation” of its kidney transplant program on Sept. 2, days after the United Network for Organ Sharing (UNOS) conducted an on-site review of the program in relation to the transplantation of a kidney into the wrong patient in July, according to an internal communication obtained by News 5. A hospital spokesperson on Tuesday confirmed that the program is on pause.
The document, sent to employees on Sept. 2 from UH's Chief Quality and Clinical Transformation Officer Dr. Peter Pronovost, states that for the previous two days, a team from UNOS conducted a “detailed, on-site review related to a recent error in our kidney transplant program” where they “met with multiple individuals connected to the transplant program, carefully examined the facts of the situation, as well as the changes we have made in caregiver training protocols, pre-procedural checklists, processes and other aspects of the program.”
The UNOS visit comes nearly two months after July 2, the day of the incident, when there were two kidney transplants happening at UH. The health system confirmed a kidney meant for one patient was mistakenly transplanted into the wrong person. The person who received the wrong kidney appeared to be accepting it and recovering, according to the last update from UH. Sources inside the hospital said the blood types were compatible.
According to records provided by UNOS, UH did a total of 74 kidney transplants in 2016, and by 2020 it had more than doubled to 194.
News 5 also learned that the mistake wasn’t noticed until the second transplant operation. UH would not confirm how far along the surgery was when the transplant team realized they had the kidney intended for the first patient. UH said the second patient was back on the transplant list awaiting another organ, as of July 14. News 5 has not yet confirmed whether that patient has received a new kidney yet.
Back in July, UH told News 5 investigators that they were unable to comment further on the incident while investigations by outside agencies were being conducted. The Ohio Hospital Association said they were not investigating UH’s kidney mix-up. UH confirmed that it did report the problem to UNOS, and the Centers for Medicare and Medicaid Services told us they were aware of the incident and will take appropriate action after review.
The message from UH obtained this week states that “although UNOS expressed no concern with our program improvements, they did make some additional recommendations that we are committed to implementing as quickly and carefully as possible.”
UH made the decision to pause the kidney transplant program for no more than 14 days beginning Sept. 2, to “best prepare the team to focus on a culture of safety, trust and belonging, as well as to begin integration of the UNOS recommendations.”
“This pause is one more step in UH’s effort to prevent this kind of error from ever happening again and is designed to strengthen our safety culture,” the message states. “We fully understand how important the kidney transplant program is to the community, and we look forward to resuming full transplant procedures within the next two weeks.”
The message states that they will also be welcoming back two colleagues who had been on administrative leave. News 5 had previously reported that two caregivers were put on leave pending an investigation, but UH did not disclose their positions with the hospital system.
UH officials expect patient impact during the two-week pause “to be minimal,” the message states. While transplant surgeries are suspended, clinic visits will proceed as normal, and they will identify and work directly with any patients who are directly affected.
Officials with UH's transplant program provided the following statement after News 5 presented them with the internal document:
The Transplant Institute update sent to staff on Thursday was an important update regarding the next step in our expansive response to the unfortunate error that occurred in July in our kidney program.
That voluntary, temporary pause in kidney transplant surgeries enables us to fully implement protocols and processes that will enhance quality of care. We do not anticipate any significant delays in patient care as a result of the pause because no kidney transplant surgeries had been scheduled during the 14 days.
We fully understand how important the kidney transplant program is to the community. The actions we are taking build on more than 50 years of transplant experience and more than 3,000 kidney transplants. We look forward to resuming full transplant procedures within the next two weeks.
UH respects strict standards of compliance for patient privacy and cannot comment on the patients involved or any patients in our care at any time. We continue to work directly with them on their serious health care illnesses and needs.
The Organ Procurement and Transplantation Network provided this statement when News 5 inquired about their investigation into UH:
As you know, the OPTN operates under a confidential medical peer review process, with the goal of working with members to ensure that member institutions maintain high quality and safety standards. We are not able to provide or confirm any details about any organization that may be subject to a review.
During periods of transplant program inactivity organs cannot be accepted. OPTN bylaws (D.12.B – p. 79) require transplant programs to notify their waiting list candidates if they inactivate for 15 or more consecutive days or 28 or more cumulative days during a calendar year.
RELATED
- UH confirms it's being investigated after kidney transplant mistake
- UH kidney transplant mistake not noticed until second patient was in operating room, sources say
- In letter to employees, UH CEO addresses transplant error and lists actions taken
- Despite mix-up at University Hospitals, experts assure organ donation still safe
- UH transplant patient receives kidney intended for another, hospital official confirms