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DURHAM, N.C. -- The federal Centers for Medicare & Medicaid Services (CMS) has accepted a corrective action plan from Duke University Hospital to ensure safety in the hospital's Intensive Care Nursery. CMS directed Duke to make patient safety changes following an Aug. 31 incident in which a premature infant suffered burns from heated air in an incubator.

Duke and CMS have agreed that Duke University Hospital will make significant changes that strengthen the hospital's patient safety programs, particularly in pediatric care. Duke officials said the hospital is establishing a Pediatric Safety Program, headed by Karen Frush, M.D., chief medical director for children's services, and advised by Marlene Miller, M.D., 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 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 intensively review all operations that might affect patient safety throughout the hospital. Sowers, who previously served as interim chief executive officer at Durham Regional Hospital, this week succeeds Robert Clapp, who is returning to a senior position with the Duke University Health System.

The Health System also will take several steps that increase safety protections throughout the Duke health care network. DUHS has created a new position and is aggressively recruiting for a physician to oversee 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 Assurance Committee. Joe and Terry Graedon, the syndicated columnists who host "The People's Pharmacy" on National Public Radio and are known for their advocacy of patient safety, have agreed to join the DUHS board's Patient Safety and Quality Assurance Committee.

"Traditionally, CMS would be issuing notices proposing to revoke Duke's hospital certification, Duke would appeal, and a long, cumbersome process would begin," said CMS Administrator Tom Scully. "Instead, we have avoided that normal bureaucratic dance and engaged in a real workout plan with Duke. This will more quickly improve patient safety -- and result in real change at Duke Hospital -- which is what this is all about. We appreciate the constructive approach that Dr. Snyderman and his team have taken to resolving some major issues," continued Scully.

"We are pleased that CMS agrees that we are implementing the steps needed to further improve patient safety and to ensure the public that the highest quality care they expect from Duke is provided with the highest possible commitment to patient safety," DUHS President and CEO Ralph Snyderman, M.D., said. "It is not good enough that our statistical record of protecting patients, especially tiny, premature infants like the one involved in this incident, is among the best in the country," Snyderman said in a message to employees. "We need to do more, immediately, to ensure the safety of every single patient we treat."

CMS initiated a review involving Duke University Hospital on Sept. 4, after the hospital self-reported an incident in which a premature infant received a burn from heated air in an incubator in its Intensive Care Nursery (ICN). The infant is no longer at Duke and has a favorable prognosis, Duke officials report.

Following its review, CMS informed hospital officials on Sept. 19 that it would terminate its eligibility for Medicare and Medicaid reimbursement unless Duke University Hospital addressed issues the agency had identified. By accepting Duke's corrective action plan, CMS continues the hospital's participation in the Medicare and Medicaid programs, pending a regulatory follow-up visit.

CMS's review of the Aug. 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 note 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., M.D., presented the hospital's detailed corrective plan to CMS in Atlanta on Monday, Sept. 22. After reviewing the plan and other actions Duke is taking, CMS accepted Duke's corrective plan describing how the hospital would ensure safe conditions at Duke Hospital and removed the threat to revoke Medicare and Medicaid payments to Duke, pending a follow-up site review.

Duke's corrective plan includes the following corrective actions: reviewing and revising various ICN policies such as the monitoring of patients, vital signs monitoring, thermoregulation and documentation guidelines; educating ICN staff on these revised policies prior to their next shift assignment; and re-educating ICN staff on the safe use of incubators, insertion of umbilical artery catheters and endotracheal tubes, and role delineation of staff in the ICN.

Additionally, Duke will strengthen policies and guidelines on where procedures may be performed in the ICN, actions to be taken should a procedure need to be performed in an incubator in the ICN, insertion of umbilical artery catheters and endotracheal tubes, actions to be taken should a portable X-ray not be performed within the expected time frame, and delineation of the roles of the care nurse and neonatal nurse practitioner while performing a procedure in the ICN. Finally, the ICN will have temperature alarms on monitors used in the unit defaulted to the "on" position.

The ICN incident 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. Snyderman said that while the incidents were in different units of the hospital, they all involved children, and together, "they inevitably raise concerns about whether we have a systemic problem."

Snyderman outlined Duke's new patient-safety procedures in a message to all Health System employees, saying that at Duke, "Everyday, we care for patients who are too sick to be treated elsewhere, with procedures that didn't exist a few years ago. We measure our success in the lives we improve every day. No health care facility can guarantee success, and both humans and technology are imperfect, but we and the public expect much more of us. We will not let our patients down." The full text of Snyderman's message can be found above.

Below is the text of two letters from Duke Hospital CEO William Fulkerson to CMS officials about Duke's safety plans.

# # #

September 21, 2003

Ms. Sandra Pace
Associate Regional Administrator
Division of Survey and Certification
Centers for Medicare and Medicaid Services
Sam Nunn Atlanta Federal Center, Suite 4T20
61 Forsyth Street
Atlanta, Georgia 30303-8909

Dear Ms. Pace:

Re: Hospital Provider Number 34-0030

Thank you for your letter of September 19. My colleagues and I at Duke University Hospital and the Duke University Health System recognize the critical role the Centers for Medicare and Medicaid Services play in ensuring the public that the patients at our nation's hospitals receive the highest quality care in the safest possible environment. We look forward to working with CMS not only to remedy the problems you identified associated with our voluntary report of the August 31 incident in our ICN, but to working with you to assure the public that we are doing everything we can to ensure patient safety.

Enclosed is our corrective plan of action. We believe it addresses the concerns CMS has identified and look forward to working with you to address any deficiencies you may identify in our plan. In addition to these specific corrective actions, we want you to know that we are taking or have taken the following additional actions to improve patient safety in Duke University Hospital and the Duke University Health System:

• Duke Hospital's chief operating officer is being assigned to intensively review all aspects of nursing services, clinical engineering and other operations that have been identified in recent incidents at Duke Hospital. He will be free -- indeed is being encouraged -- to investigate any area(s) that he believes might pose a safety problem and implement necessary changes in these operations;

• We have established a Pediatric Safety Center. Dr. Karen Frush, M.D., medical director for children's services, will lead the center which will carry out a comprehensive review of all pediatric care services delivered across Duke University Hospital. She has full authority to take any steps she and her team deem necessary to protect the safety of our pediatric patients. Dr. Marlene Miller, M.D., who has earned a national reputation in the field of quality and safety initiatives at the Johns Hopkins Children's Center, will serve as consultant to Dr. Frush and her team;

• Looking beyond the care of children and Duke University Hospital specifically, we have established and are currently recruiting a patient safety officer to oversee care across the entire Duke University Health System. This is a new position which will report directly to the Patient Safety and Quality Assurance Committee of the Health System Board of Directors and to the President and CEO of the Health System;

• The Health system Board of Directors will invite outside experts to serve on its Patient Safety and Quality Assurance Committee. Joe and Terry Graedon, the syndicated columnists who host "The People's Pharmacy" on National Public Radio and are well known for their advocacy of patient safety, have already agreed to serve on this important committee.

We hope to have an opportunity to discuss our corrective action plan with you at your earliest convenience. To that end, at the request of Dr. Ralph Snyderman, M.D., President and CEO of the Duke University Health System, I will be leading a senior team from Duke that will fly to Atlanta tomorrow morning to personally deliver our corrective plan to you. We hope to review any concerns you may have and to plan next steps. Our team will consist of myself as CEO of Duke University Hospital, Dr. Gary L. Stiles, M.D., chief medical officer of the Duke University Health System, Ms. Gail A. Shulby, director of accreditation and regulatory affairs for our Hospital and Health System, and Mr. John F. Burness, senior vice president of Duke University.

We look forward to working with you and your associates at CMS to enhance safety at Duke University Hospital and the Duke University Health System.

Sincerely,

William J. Fulkerson, M.D.
Chief Executive Officer

September 22, 2003

Ms. Sandra Pace
Associate Regional Administrator
Division of Survey and Certification
Centers for Medicare and Medicaid Services
61 Forsyth Street
Atlanta, Georgia 30303-8909

Dear Ms. Pace:

We have appreciated the opportunity to meet with you today to review Duke University Hospital's detailed corrective action plan in response to CMS' letter of September 19 concerning the August 31 incident in our ICN. This letter supplements my letter of September 21 which accompanied our corrective plan and emphasized our desire to partner with CMS to ensure the highest quality care and safety for our patients. We are pleased you have accepted our corrective action plan. In my letter and in our meeting, I reported a number of additional actions we are taking to monitor the level of care and safety across all of our pediatric units, our hospital and health system.

We reviewed today an additional opportunity that can strengthen Duke's ongoing patient safety program. We propose a partnership with North Carolina's quality improvement organization, Medical Review of North Carolina (MRNC), to collaborate on a continual monitoring program to assist us in reviewing, assessing, and developing a comprehensive plan for patient safety across the many pediatric services at our hospital. Under this proposal, MRNC would work closely with the new Pediatric Patient Safety Program we are launching. Pediatric services will be the initial focus of our collaboration. We expect that over time MRNC and Duke University Hospital will expand this partnership to other clinical services. We are initiating discussions with MRNC and are prepared to commit the necessary resources to implement a successful partnership.

As part of this proposal, we will suggest that Duke and MRNC regularly inform and seek advice from CMS on the programs and initiatives we are undertaking. It is our hope that this partnership can become a model for both North Carolina and the nation to ensure the public of the quality of care and commitment to safety of our health care delivery system.

As I indicated in my letter of September 21 and our conversation today, we recognize the critical role CMS plays in ensuring the public that patients at our nation's hospitals receive high quality care in a safe environment. We believe that today's conversation has moved that important agenda forward.

Sincerely,

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