FROM: Gail Shulby, Director, Accreditation & Regulatory
Affairs

DATE: March 21, 2003

RE: Update on Sentinel Event Review and CMS/JCAHO

Immediately following the Jesica Santillan organ transplant
mismatch, Duke University Hospital launched a sentinel event
review to analyze what had happened and what could be done to
enhance the safety of organ transplantation at Duke. As a
result of our own internal review, many changes were
immediately made. As part the sentinel event process, we also
notified the Division of Facilities Services (DFS) and the
Joint Commission on the Accreditation of Health Care
Organizations (JCAHO). Surveyors from both DFS and JCAHO
visited Duke University Hospital recently, and we now have
received their reports which identified many of the same areas
for improvement that we found and for which corrective action
had already been taken.

The general areas identified by the reviews included a lack
of redundancies to ensure compatibility of organ transplants,
the need for improved coordination between Duke and the organ
procurement organization, and documentation of the competencies
of certain members of the transplant team.

Below are some of the actions taken as a result of our own
review as well as input from CMS and JCAHO.

• Following Jesica's first transplant on Feb. 7, we
  immediately put in place procedures for redundant
  verifications of blood type compatibility by: (1) the
  surgeon, (2) the transplant coordinator, (3) the procuring
  surgeon and (4) the circulating nurse in the operating room.
  Furthermore, we continue to work with Carolina Donor Services
  (CDS) and the United Network for Organ Sharing (UNOS) to
  enhance the collaboration across entities.
• The surgeon who procures donor organs will now have blood
  type information concerning the donor and recipient and will
  be in communication with the transplanting surgeon at various
  times during the organ procurement.
• Pediatric and adult transplant review have been merged to
  ensure uniform administrative and medical oversight as well
  as consistent standards of care for both adults and children.
  By combining the pediatric and adult transplant programs, we
  can more easily ensure that an experienced, well-trained
  coordinator is part of each transplant.
• Processes for documenting the qualifications and
  certifications of transplant team members will be
  improved.
• Both CMS and JCAHO raised questions about the level of
  experience and training of the procuring surgeon. We will
  document for CMS and JCAHO that the procuring surgeon was
  trained in thoracic organ procurement, has experience in
  procuring thoracic organs, was deemed competent to procure
  organs and was board certified in general surgery.)
• Both reports questioned the level of training of the
  pediatric transplant coordinator. Both CMS and JCAHO will be
  notified that we believe this individual does, indeed, have
  the proper training but that unfortunately, this was not
  documented in the files.
• To further enhance our transplantation program, we will
  continue to work with CDS to improve communication and
  coordination between entities.

We will voluntarily provide the Centers for Medicare and
Medicaid Services (CMS), which requested the DFS survey, a
written outline of our corrective actions. JCAHO informed us
that our accreditation status will be changed from
"Accreditation with Full Standards Compliance" to
"Accreditation with Requirements for Improvement." Following
JCAHO requirements, we will soon respond to their report and
follow that with a statement of our corrective actions.

We continue to review the circumstances surrounding Jesica's
care and welcome the input from these agencies to further
enhance our programs. Both agencies also will be returning for
further inspections. DFS, we believe, will return Monday, March
24 for a full validation survey. JCAHO will return within three
months for a focused survey. We will continue to cooperate
fully in future reviews. We are confident that we will be able
to demonstrate the high quality, safe care that we provide at
Duke University Hospital. Thank you for your continued
cooperation.