Assumptions and a lack of redundancy led to trouble

The 2003 transplant error at Duke University Hospital in Durham, NC, that led to the appointment of Karen Frush, MD, as the new patient safety officer at Duke University Hospital System (DUHS) in Durham,, was traced to a lack of redundancy in the system that ensured donor organs matched the patient.

The problem began when a surgeon misinterpreted a message from the organ donor bank, mistakenly assuming that he was being told the organ was a blood-type match when in fact the donor bank was only informing him that the heart and lungs were available for his patient. That error went uncorrected until the surgery was under way, apparently because the Duke system did not have adequate steps in place to require checking the blood type.

In several statements describing the incident and the results of its root-cause analysis, the hospital cited a lack of redundancy as the critical failure. Duke added "multiple confirmations of donor match by members of the care team before the transplantation process begins and improved communications between Duke and the organ procurement organization," according to a statement by William Fulkerson, MD, CEO of Duke Hospital.

Duke’s root-cause analysis determined that Jesica Santillan, 17, died because the hospital’s organ transplant process lacked redundant steps for confirming blood type and other compatibility factors.

Duke and the organ donor bank describe 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 called 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.

Jaggers gave Jesica’s name to Carolina Donor Services and thought it would look up pertinent information on the national list of patients awaiting transplants. The donor bank proceeded on the assumption that Jaggers knew the organ blood type was A since he had been told in the phone call and had suggested Jesica. Jaggers thought the bank would confirm compatibility through its database before getting back to him with an answer.

Blood type match not confirmed

Carolina Donor Services says the organs arrived with paperwork and labels that clearly indicated the blood type. Duke says the blood type match was not confirmed at that point because the team thought all compatibility had already been checked.

In a letter from Fulkerson to Deanna Sampson, director of policy compliance at the United Network for Organ Sharing in Richmond, VA, which oversees the organ transplant system, he says, "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 goes on to say, "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."