The Centers for Medicare and Medicaid Services accepted Duke University Hospital's corrective plan of action to assure patient safety in the hospital following an Aug. 31 incident in which a premature infant in the Intensive Care Nursery at DUH suffered burns from heated air from an incubator.
DUH was in jeopardy of losing its status as Medicare- and Medicaid-certified hospital on Oct. 17 if it did not produce an adequate response to the problems CMS found in the ICN. Duke has been certified since 1977, and only twice has CMS issued letters threatening to revoke DUH's certification--once following Jésica Santillán's mismatched organ transplant and once following this latest incident.
"In this case, [CMS] found what they thought were serious enough errors that they were prepared to revoke the eligibility of Medicare and Medicaid patients to come to Duke and have the hospital reimbursed for care," said John Burness, vice president of public affairs and government relations.
Patient safety, especially in pediatrics, has come into question two other specific times in the last year--once in the wake of the Santillán tragedy and again in June following an incident in the Pediatric Intensive Care Unit where a baby suffered first-, second- and third-degree burns due to a flash fire during a critical procedure.
In response to the most recent incident, the Division of Facility Services investigated DUH Sept. 5 on behalf of CMS after the hospital self-reported the incident the previous day. The survey pinpointed several errors in the infant's care--the nursing staff in the ICN was inadequately trained in the proper use of the incubator and had failed to address the critical needs of the infant. They did not promptly assess the baby's condition after the procedure was performed, failing to note that one of the incubator's air vents had become uncovered, projecting the heated air on the infant's right side and causing burns.
Burness, DUHS Compliance Officer Gail Shulby and Chief Executive Officer of DUH Dr. William Fulkerson created Duke's response and presented it to CMS officials Monday in response to this report. "Had Duke not given us a credible plan of correction, one that we could have accepted, that's where [they] would have been in terms of their losing their certificate," said Pat Harris, deputy administrator for CMS.
Salient features from the corrective plan include the institution of a Pediatric Patient Safety Program and a collaboration with the Medical Review of North Carolina, Inc., the state's medical quality improvement organization.
The plan also calls for reviewing and revising various ICN policies such as patient monitoring and vital signs monitoring. It also requires the hospital to educate ICN staff on these revised policies and retrain staff on the safe use of incubators, the insertion of catheters and endotracheal tubes and the role delineation of staff in the ICN.
"[The incidents] led the leadership to say, 'We need simply to do a better job,'" Burness said. DUHS had already been discussing instituting more stringent patient safety standards, he said, but this last incident prompted the immediate action.
Although CMS accepted the current plan of action, the federal organization nevertheless plans to conduct subsequent visits to ensure the hospital complies with its own plan and addresses the problematic issues.
"I think [it was] a plan that was developed through mutual agreement," Harris said. "They came prepared with the proposal in hand. I would say the piece we suggested was the ongoing quality aspect, where they would continue to work with other organizations." Harris said Duke plans to collaborate with outside sources instead of just relying on internal staffing.
The Pediatric Patient Safety Program will be headed by Dr. Karen Frush, chief medical director for children's services, and Dr. Marlene Miller, director of quality and safety initiatives at Johns Hopkins Children's Center, will serve as the outside counselor to the group. Harris said pediatrics was where Duke had its most significant issues and that it was the primary area addressed by the corrective plan of action. She added she was unaware of an adult safety program being established at this time.
"We need to do more, immediately, to ensure the safety of every single patient we treat," wrote Snyderman, also chancellor for health affairs, in a memo to all DUHS employees.
Kevin Sowers, newly appointed chief operating officer of the hospital and currently acting CEO of Durham Regional Hospital, has been charged with reviewing all operations throughout the hospital that might affect patient safety--especially in nursing services, clinical engineering and other recent trouble. He assumes his new leadership role next month.
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