In the wake of Jésica Santillán's mismatched organ transplant, Duke University Hospital implemented a series of safety measures targeted at the organ transplant procedure to ensure that such medical mishaps do not reoccur.
In addition, the United Network for Organ Sharing, the national non-profit organization that coordinates the matching process between organ donors and recipients, reevaluated its matching system over the past year and has added additional checks to minimize the potential for incompatible transplants.
Many of DUH's changes for its organ transplant procedure, however, came into effect within a month of Santillán's death on Feb. 21, 2003.
"Basically, we implemented a large number of changes immediately so we weren't reliant upon a third party to do the match," said Chief of Cardiovascular and Thoracic Surgery Dr. Peter Smith, who led a multidisciplinary team that designed the new changes. The additional measures were a result of root cause analysis and process analysis conducted by the team, which included surgeons, nurses, transplant coordinators and administrators, among others.
As were most hospitals, Smith added, at the time of the Santillán mishap, DUH was relying on the fact that a match precluded the organs being offered to an institution. To eliminate the possibility of a mismatch, DUH has now implemented redundant checks for blood type compatibility--two timeouts where the healthcare professionals agree on the match, once before the patient is anesthetized and once after the organ arrives at DUH. The final step is to type the donor's blood at the time of transplantation.
To facilitate the checks, posters have been affixed in the thoracic surgery operating rooms reminding the staff of blood compatibility relationships.
"Whereas there was not much redundancy [in the procedure], there is a tremendous redundancy introduced subsequently," said Dr. Duane Davis, associate professor of thoracic surgery. He added these repetitive protocols were reasonable due to the high stakes involved with a human life. "There's been continuous improvement because of the 100 percent auditing of each transplant," said Smith, qualifying the audits as being primarily internal. Another significant change is the incorporation of the Pediatric Heart Transplant program into its Adult Heart Transplant counterpart to achieve greater consistency of treatment. Only the adult program is to be responsible for coordination between DUH and the regional organ procurement organization. With its safeguards, DUH has led the way for UNOS and its Organ Procurement and Transplantation Network, as well as transplant centers nationwide, to institute their own changes, Smith said. For UNOS, the modifications have primarily been procedural to ensure a blood type match. The software that coordinates the match now must display the donor's blood type on every screen--information entered into the system by two separate UNOS staff members, another redundant procedure. Furthermore, UNOS is requiring every hospital capable of transplant surgeries to have a protocol ensuring the match, to conduct routine audits of transplants and to produce documentation asserting the validity of its protocol. "One of the specific statements in the [new] policy is to make it extremely explicit that it is the transplant center's responsibility to compare information about the patient and blood type of the donor," said Joel Newman, assistant director of communications of UNOS. Yet to be evaluated is a proposal to draw two independent blood samples from the donor and recipient and individually enter the blood type results into the UNOS system. Also during this past year, DUH has reemphasized patient safety hospital-wide, creating safety task forces, updating information technology systems and instituting additional checks for pediatric services. DUH chief executive officer Dr. Bill Fulkerson said medical errors occur because of inadequate systems. The Hospital's "concrete" actions are thus oriented at strengthening current systems to safeguard all healthcare professionals from committing serious errors, he added. Duke University Health System is in the process of finding a Patient Safety Officer, a newly created position that would have oversight across the entire organization. Furthermore, DUH and DUHS are constantly working on improving and deploying various information technology systems, such as eBrowser, a common database able to be accessed by a large host of hospital and outpatient clinic staff, and the Computerized Physician Order Entry system, which will replace handwritten prescriptions when it is implemented this spring. Fulkerson also pointed to the need to emphasize a culture that "embraces safety" and said his role was to promote such a culture and encourage hospital staff to report all possible sources of error. "We're going to fix the things that are broken and fix them for the last time," he said.
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