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Duke Health News

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William J. Fulkerson, M.D.
Vice President and Chief Executive Officer
Duke University Hospital

February 21, 2003

Ms. Deanna Sampson
Director, UNOS Policy Compliance Department
United Network for Organ Sharing
Post Office Box 2484
Richmond, Virginia 23218

Dear Ms. Sampson,

Duke University Hospital has completed the initial phase
review of the events related to the heart/lung transplant from
donor ------. We provide the following to promote our joint
efforts in the peer review of this incident and for the purpose
of performance improvement. 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 transplant
surgeon does not recall receiving or requesting information
regarding the donor's ABO type from the procurement
coordinator, who released the organs for the specific
recipient.

Jesica Santillan is a 17 y/o female with restrictive
cardiomyopathy and secondary nonreactive pulmonary
hypertension. She had been listed with UNOS for heart
transplant in January 2002, but following a cardiac
catheterization that showed non-reactive pulmonary hypertension
and a CT scan that showed no intrinsic lung disease, she was
then listed for heart/lung transplantation in May 2002. Patient
had a progression of symptoms with frequent syncope with any
exertion.

An offer from Carolina Donor Services (CDS) of organs was
made in the evening on 2/6/03. The organs were offered to Dr.
Milano, the adult heart transplant surgeon on call, for a
pediatric heart transplant recipient. Because the potential
recipient was a pediatric patient Dr. Milano referred CDS to
Dr. Jaggers, the pediatric heart transplant surgeon on call.
Dr. Jaggers declined for the specified patient because that
patient was not ready for transplant. Dr. Jaggers inquired
about heart/lung availability for Jesica Santillan, specifying
the patient by name. Dr. Jaggers inquired about the status of
the lungs. The organ procurement coordinator stated that he
would check this and call back. On the return call, Dr. Davis,
the lung and heart/lung adult transplant surgeon on call, then
was offered a heart/lung block from this donor for an adult
recipient. He declined due to size incompatibility. The organs
were then offered by CDS to Dr. Jaggers for Jesica Santillan.
Dr. Jaggers accepted the offer. He does not recall ABO typing
being discussed with CDS but does recall a discussion of
height, weight and cause of death. Arrangements were made for
Jesica Santillan to be admitted to the Pediatric ICU and for
the harvest team to travel to the donor site to retrieve the
organs.

On arrival at the donor site, the harvesting physician, Dr.
Lin, examined the organs of the donor and reviewed the donor
packet. Dr. Lin judged the organs to be of good quality. He
called Dr. Jaggers and reported the condition of the organs and
was directed to harvest the heart and lungs. The organs were
transported back to Duke University Hospital following a delay
due to bad weather.

Once the organs arrived at the Duke University Hospital
operating room #7 the recipient's heart and lungs were removed
and the donor organs were implanted. Total ischemic time was
six hours. This included 30 minutes of warm ischemic time. The
organs functioned well for approximately 30-40 minutes after
she was removed from bypass. Then the organ function
deteriorated and the patient was placed back on cardiopulmonary
bypass. Moments later, the OR received a call from the Duke
University Hospital Clinical Transplant Immunology Laboratory
reporting the transplant was ABO incompatible with the
recipient. The team was able to stabilize cardiopulmonary
function and again separate from bypass. The patient was closed
and transported to the Pediatric Intensive Care Unit.

In response, 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.

The procuring surgeon will receive information including but
not limited to the ABO type and size about the intended
recipient. In the review of the donor packet, the procuring
surgeon will verify the ABO compatibility as well as other key
elements used to evaluate the suitability of the donor and the
organs for the targeted recipient. In addition, the procuring
surgeon will complete a verbal verification of the ABO
compatibility with the transplant surgeon. This call will be
placed, as per current standard, prior to the organ
procurement.

The verification processes outlined above were effectively
implemented during the re-transplant of the recipient of donor
------'s organs on February 20, 2003.

In addition to the redundant validation put in place, Duke
University Hospital is evaluating the information technology
supporting access to recipient information. Should that
evaluation reveal a need for additional support, resources will
be dedicated to meet those needs.

We will continue to examine the organ procurement process
for opportunities for additional safeguards. We will monitor
the effectiveness of the process changes through our
performance improvement program. We believe that the changes we
have put in place enhance the safety of the procurement process
and should be considered as a national guideline.

Should you require additional information please do not
hesitate to contact us.

Sincerely,

William J. Fulkerson, MD

R. Duane Davis, MD