RCA of transplant case reveals lack of redundancy
Redundant validation put in place
A root-cause analysis points to a lack of redundancy as the critical failure that allowed organs to be transplanted into a patient with the wrong blood type, according to information from Duke University in Durham, NC, the site of a recent notorious sentinel event. The public immediately wondered how such a tragic mistake could occur, but quality improvement professionals knew the root cause had to be more than a surgeon’s mistake. Duke launched a root-cause analysis immediately and reports that a lack of redundant steps for confirming blood type and other compatibility factors in the hospital’s organ transplant process contributed to the death of Jesica Santillan, 17.
Separate news releases from Duke and the organ donor bank described the series of events this way: When the heart and lungs became available, Carolina Donor Services found two potential recipients, and both were at Duke. Both had blood type A, the same as the organs. They contacted a Duke surgeon on call for adult heart transplantations. When he realized the first organ-matched Duke patient was a child, he referred the call to James Jaggers, MD, the surgeon in charge of pediatric heart transplants. Carolina Donor Services maintains that it gave Jaggers all the necessary information about the organ, including blood type.
Jaggers told Carolina Donor Services that the child suggested was not medically ready for the transplant, but according to a Duke statement, "He inquired as to whether the heart and lungs might be available for Jesica Santillan." Since the original offer was for only a heart, and Santillan needed lungs also, the donor bank caller had to check on the availability of lungs before giving Jaggers an answer.
Santillan was not the second potential recipient that the donor service had identified at Duke. The second potential donor with Type A blood was not discussed with Jaggers because the patient was an adult, and Jaggers handled pediatric transplants. Jaggers says he inquired about Santillan receiving the organs because she needed the transplant so badly, and he was hoping the organs were a match. Santillan had O-positive blood.
Jaggers gave Santillan’s name to Carolina Donor Services and thought it would look up pertinent information on the national list of patients awaiting transplants, says Jeff Molter, spokesman for Duke University Hospital. The donor bank proceeded on the assumption that Jaggers knew the organ blood type was A. Jaggers thought the bank would confirm compatibility through its database before getting back to him with an answer.
The donor bank contacted the physician of the second patient it had identified at Duke, but the organs were not a size match for that patient. The bank then called Jaggers back regarding Santillan. The donor bank confirmed that the lungs also were available, which Jaggers took as a confirmation that organs were a match in every way because he had thought they were checking their database for the match. The transplant was put in motion despite the blood type mismatch.
Carolina Donor Services said the organs arrived with paperwork and labels that clearly indicated the blood type. Duke said the blood type match was not confirmed at that point because the team thought all compatibility had been checked already. A statement from Duke said, "Jaggers does not recall blood-type matching being discussed with CDS, but does recall the discussion including the donor’s height, weight, organ function, and cause of death. Dr. Jaggers assumed that they wouldn’t have called back and released the organs if they weren’t a match. This was a wrong assumption on his part."
Hospital Peer Review obtained a copy of a letter from William J. Fulkerson, MD, vice president and chief executive officer at Duke University Hospital, to Deanna Sampson, director of policy compliance at the United Network for Organ Sharing in Richmond, VA, which oversees the organ transplant system. In the letter, Fulkerson wrote, "We have concluded that human error occurred at several points in the organ placement process that had no structured redundancy. The critical failure was absence of positive confirmation of ABO compatibility of the donor organs and the identified recipient patient."
The letter continued, "Duke University Hospital has conducted a thorough root-cause analysis of the event and the organ procurement process followed in the pediatric thoracic transplant program. During that review, the lack of redundancy was recognized as a weakness. Validation of the ABO compatibility and other key data elements regarding the donor and recipient will now be performed by: the transplant surgeon, the transplant coordinator, and the procuring surgeon. The transplant surgeon will actively confirm the donor and recipient key data elements verbally. During the notification call to the transplant surgeon, the donor key data elements will be communicated. These data elements will be compared to the information in the transplant program’s database to confirm blood type compatibility, size compatibility, and if there are issues regarding anti-HLA antibodies.
"An additional verification will be accomplished via telephone contact with the organ procurement organization placement coordinator by the transplant coordinator." In addition to the redundant validation put in place, Duke University Hospital is evaluating the information technology supporting access to recipient information. Technology improvements may result, the letter stated.
Ralph Snyderman, MD, chancellor for health affairs at Duke University and president and CEO of Duke University Health System, released a statement: "The response to the tragedy, however, was a true test of our institution. When the surgeon, Dr. Jim Jaggers, understood the problem of the mismatch, he immediately assumed responsibility for his role, informed the family, and placed the patient on the priority list for a second heart-lung transplant. He signaled the problem to the institution, which immediately initiated a sentinel review process and instituted corrective actions to prevent such mishaps in the future."
Santillan’s initial transplant operation took place Feb. 7. A second heart-lung transplant procedure, using blood group-compatible organs, was conducted Feb. 20. Santillan died two days later.
[For more information, contact:
• Duke University Hospital, 3000 Erwin Road, Durham NC 27710. Telephone: (919) 684-4148.
• Carolina Donor Services, 3622 Lyckan Parkway, Suite 6002, Durham, NC 27707. Telephone: (919) 489-8404.]