The federal Centers for Medicare and Medicaid Services (CMS) found Duke Hospital in full compliance with all of its Conditions of Participation after reviewing a corrective action plan from the hospital. The plan was initiated to ensure safety in the hospital's Intensive Care Nursery. CMS directed Duke to make patient-safety changes following an August 31 incident in which a premature infant suffered burns from heated air in an incubator.
After Duke officials reported the incident, CMS initiated a review of the hospital on September 4. The infant is no longer at Duke and has a favorable prognosis, Duke officials report. Following a survey by CMS, Duke Hospital was notified in October that it had been found in compliance.
CMS had informed hospital officials in September that it would terminate its eligibility for Medicare and Medicaid reimbursement unless Duke Hospital addressed issues the agency had identified. After accepting Duke's corrective action plan, CMS agreed to allow the hospital to continue to participate in the Medicare and Medi-caid programs, pending a regulatory follow-up visit.
Duke and CMS agreed that the hospital will make significant changes to strengthen its patient-safety programs, particularly in pediatric care. Duke officials said the hospital is establishing a Pediatric Safety Program, headed by physician Karen Frush, chief medical director for children's services, and advised by physician Marlene Miller, director of quality and safety initiatives at Johns Hopkins Children's Center.
Duke is proposing to collaborate with North Carolina's medical quality improvement organization, Medical Review of North Carolina, Inc. (MRNC), to develop a continuous, comprehensive pediatric safety-monitoring program, which will be shared with CMS. Duke officials said that, over time, they expect that the MRNC/Duke partnership will be expanded to other clinical services. Duke has agreed to commit the necessary resources to make the MRNC collaboration effective.
In addition, the hospital's newly appointed chief operating officer, Kevin Sowers, will review all operations that might affect patient safety throughout the hospital. The Duke University Health System (DUHS) also will take steps to increase safety throughout the Duke health-care network. DUHS is aggressively recruiting a physician to fill a new position overseeing patient safety across the entire health system. And, the DUHS board of directors will invite outside experts to serve on its Patient Safety and Quality Asurance Committee.
CMS's review of the August 31 incident identified several problems in the infant's treatment: Nursing staff was inadequately trained in the proper use of the incubator; the infant was not properly monitored during the crucial time period after the procedure was done; and staff failed to notice that sterile covers had fallen over one of the incubator's warm air outlet vents, which channeled the heated air directly onto the infant's right side and caused the burns.
A team of senior Duke Hospital and Health System officials led by hospital Chief Executive Officer William J. Fulkerson Jr. presented the hospital's detailed corrective plan to CMS in Atlanta on September 22. After reviewing the plan and other actions Duke is taking, CMS accepted Duke's corrective plan and removed the threat to revoke Medicare and Medicaid payments to Duke. On October 16, CMS notified Duke Hospital that it was found to be in full compliance with all of its Conditions of Participation.
The ICN incidents followed two other reported cases at the hospital involving children this year, including a heart/lung transplant case in February and an accidental flash fire in the Pediatric Intensive Care Unit in June that resulted in burns to a child.