National Agency Lowers Duke Hospital Rating

By Jim Shamp

The Herald-Sun

jshamp@heraldsun.com

DURHAM -- Duke University Hospital has been downgraded by a national health care regulatory agency pending proof that it's made necessary changes since the Feb. 22 death of heart-lung transplant patient Jesica Santillan.

According to Charlene Hill, spokeswoman for the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), the agency reduced Duke's status from "Accreditation with Full Standards Compliance" to "Accreditation with Requirements for Improvement."

Duke was cited Wednesday, and the change was announced to Duke employees Friday in a memo from Gail Shulby, director of accreditation and regulatory affairs. Duke's medical news office made the memo public.

Another inspection report, from the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS), was sent to Duke and to the federal office in Atlanta last week by inspectors from the state Division of Facility Services in Raleigh. Working on behalf of the federal agency, they spent several days scouring Duke Hospital after Santillan's death.

Ralph Snyderman, chief executive officer of the Duke University Health System and Duke's chancellor for health affairs, said he expected to complete Duke's review of that analysis next week. Meanwhile, he pledged Friday to use Duke's experience with Santillan as a springboard to put the Durham institution in the forefront of a national patient safety movement.

"This could have happened anywhere," Snyderman said. "But it happened here." He said Duke would use what it has learned to become "a strong voice to improve the safety of transplantation."

JCAHO is private and paid for by the organizations it serves. It considers major medical errors to be "sentinel events," which must be reported to the nonprofit organization that inspects member hospitals at least every three years, Hill said. Sentinel events such as the hospital's report of the Santillan death also trigger special on-site JCAHO inspections. Duke's was conducted March 6.

Hill said Duke surgeon James Jaggers' Feb. 7 transplant of a type A donor's heart and lungs into Santillan, the 17-year-old Mexican girl with type O-positive blood, was a sentinel event because it had "an unanticipated outcome resulting in permanent loss of function or death."

Santillan died after her body rejected the excessively "foreign" organ tissue.

This isn't the first time the Duke facility has missed the top-level accrediting standards. It received the "Accreditation with Requirements for Improvement" rating after its regular triennial inspection in March 2001. A February 2002 review found necessary changes, so Duke Hospital was elevated to the "Full Standards" status.

Perhaps the university's greatest embarrassment came May 10, 1999, when federal officials put the brakes on tens of millions of dollars in funding for some 2,000 Duke medical research studies.

In one of the largest actions of its kind, the U.S. Department of Health and Human Services' Office for Protection from Research Risks issued the temporary shutdown to get the medical center to beef up institutional review boards' oversight of research projects.

Hill said JCAHO will probably give Duke at least six months to prove that it's meeting the agency's requirements for improving six defined "performance areas" in the most recent review. They include such factors as planning, governance and assessing competence of staff to meet their job expectations.

JCAHO accreditation matters because medical insurers and officials of government programs such as Medicare and Medicaid expect hospitals to meet the agency's minimal quality standards for their clients.

Shulby said both CMS and JCAHO raised questions about the level of experience and training of Shu Lin, the surgeon who harvested Santillan's first, ill-fated organs from a donor in Boston.

"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," said Shulby in the memo to Duke personnel.

Both reports also questioned the level of training of the pediatric transplant coordinator, said Shulby. "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."

Snyderman said he has appointed a new review committee to examine where Duke Hospital might be exposed to errors. One possible focus could be procedures not commonly done, such as Santillan's heart-lung transplant, he said.

He also said a computerized physician's order entry system was started Thursday, after several years of preparation. The system will rely on computerized ordering of drugs and procedures, to help eliminate errors from reading doctors' handwriting and to red-flag possible drug interactions and overdoses.

Copyright © 2003 The Durham Herald Company.

This article posted March 22, 2003.