Gulf Coast living kidney donor transplant program placed on probation!

[Clark]

http://www.naplesnews.com/news/health/gulf-coast-kidney-transplant-program-placed-on-probation-25f3551a-e612-37c3-e053-0100007f8dc1-360190471.html


Gulf Coast kidney transplant program placed on probation
By Liz Freeman

Gulf Coast Medical Center's kidney transplant program with live donors was placed on probation Wednesday after an investigation into the death of a 40-year-old Cape Coral donor this past spring, according to an organ transplant oversight panel.

The probation — for an indeterminate length of time — is for failure to follow policies "or a serious lapse in patient safety or quality of care," according to the Organ Procurement and Transplantation Network, OPTN.

Hospital officials consented to the probation, which involves close supervision, even though Gulf Coast will not reinstate its kidney transplant program with living donors until a laparoscopic transplant surgeon joins the staff, likely in the spring, said Mary Briggs, spokeswoman for the publicly-operated Lee Memorial Health System.

Lee Memorial operates Gulf Coast in Fort Myers, which operates the only kidney transplant program involving living and deceased donors in the region. Only the living donor transplant program is on probation by the OPTN board, which is based in Richmond, Virginia.

Lee Memorial voluntarily suspended its kidney transplant program with living donors on April 21, five days after the death of John "Jamie" Donaldson, 40, who was donating a kidney to his ailing father.

Donaldson bled to death because a clamp or staple that should have sealed the renal artery stump after his left kidney was removed for the transplant failed, according to the July autopsy report.

In addition, there was a small cut to the aorta just below the left renal artery, but it had been closed by a staple. The Lee County Medical Examiner said the death was accidental.

Frank Donaldson, 70, who received his son's kidney and is doing well today, said Wednesday he wants Gulf Coast's program to be reinstated in order to help other kidney patients. He said the surgeon who removed his son's kidney was fired.

"I think they need to start the program again but they have to have the surgeon replaced who made the mistake," Donaldson said. "One guy made a mistake and he has to live with it.”

Donaldson said he is feeling great, can work in his garage and drive, but his daughter-in-law, Christine Donaldson, has to cope with what should not have happened.

"She's got me. I'm doing the best I can to support her right now," he said.

Gulf Coast canceled four scheduled transplants with living donors after the death of the younger Donaldson and another 21 patients were on hold.

Since then, two patients received transplants at other centers and 23 patients are waiting to potentially have transplants at Gulf Coast, Briggs said in a statement.

The probation oversight is with the United Network for Organ Sharing, UNOS, a private, nonprofit organization that manages the nation's transplant program under contract with the federal government.

"Over the past several months, Lee Memorial has been cooperating with UNOS in a comprehensive review of our transplant related procedures and protocols," Briggs said in a statement. "During the review process, we have been responsive and open to UNOS recommendations for improvement. Our plans for improvement include recruiting a fellowship trained laparoscopic transplant surgeon, refining clinical communications and coordination of care between the hospital and transplant care providers, and enhanced patient evaluation standards.”

After Gulf Coast suspended its kidney transplant program with living donors, a peer review "revealed concerns with its processes for evaluation of potential living donors," according to OPTN.

The OPTN professional standards committee interviewed hospital staff on Oct. 27 and concluded the hospital requires additional monitoring as it continues its quality improvement plan.

Gulf Coast waived its right to a hearing with the OPTN professional standards committee, according to OPTN.

Gulf Coast is working on its corrective action plan and intends to present it at the OPTN's next board meeting on March 15, Briggs said.

Complications for living kidney donors can include infection, problems with anesthesia, blood loss, blood clot, injury to other organs or surrounding tissue.

There have been 16 living kidney donor deaths within 30 days of the organ donation from 1999 to this past January, where 12 of the deaths were medical in nature, according to the U.S. Department of Health and Human Services.