The latest report from a series of probes into the Duke University Hospital found deficiencies in the Hospital's dialysis division, medication administering procedure and infection control, according to a memo issued Friday by Dr. William Fulkerson, CEO of Duke Hospital.
The Hospital's shortcomings in these areas caused it to be noncompliant with the Centers for Medicare and Medicaid Services' conditions of participation and placed it in "immediate jeopardy" of losing participation rights in Medicare and Medicaid services.
An audit conducted by the CMS was initiated in response to the case of Jesica Santillan, who died from complications resulting from a mismatched heart-lung transplantation. The first audit occurred Feb. 24, two days after SantillA¡n passed away. The CMS always undertakes reviews after hospitals have committed errors of such gravity to ensure they comply with the conditions of participation for Medicare and Medicaid.
Richard James, chief of the CMS survey and certification operations branch in Atlanta, said the results of the February partial survey of the Hospital prompted a week-long, comprehensive "full validation" examination of the entire Hospital, the results of which were released Wednesday.
CMS officials were unable to provide the detailed report as of press time, and James refused to comment on the specifics of the report, which delineated the particular deficiencies of the Hospital.
Specifically, the report noted problem areas in dialysis water testing for chemical makeup and bacteria, dialysis machine testing and oversight of the water treatment process. Updated equipment was installed in April, according to Fulkerson's memo.
In reviewing 84 records, the North Carolina Division of Facility Services, which conducted the in-hospital study on behalf of CMS, found one instance in which a patient was administered the wrong medicine. However, Fulkerson's memo made clear that the patient's life was not endangered by the mistake.
Another problem described in the memo was the inconsistency in contact isolation protocols the hospital must follow - a problem area the hospital addressed by conducting a skills blitz for nurses.
Dr. Michael Cuffe, vice chair of medicine for clinical affairs, said the results of the CMS survey pertain only to minor issues in the hospital. "Apart from [Santillan's] pediatric transplant, I don't think things have gone wrong," he said. "[patient safety] is more of a global problem in medicine."
Cuffe pointed to the hand off of information within the hospital as having the greatest potential for error, emphasizing that steps had to be taken to close the gaps created by middlemen. He cited the Computerized Physician Order Entry system, in which physicians type prescriptions directly into a computer, as an easy way to eliminate one of the hand offs.
Fulkerson's memo also cited the placement of internal checks in known problem areas, primarily pertaining to the transfer of information. SantillA¡n's botched transplantation was a direct result of miscommunication somewhere between the donor service and Santillan's physician.
Simply complying with the directives of the CMS, Cuffe said, does not result in better patient safety. Instead, he advocated that Hospital take additional steps to reform pathways of communication within the hospital - steps that might eventually serve as a model for other hospitals nationwide.
Cuffe drew a parallel between a four-day suspension the Hospital faced four years ago in human subject research. Following the suspension, the hospital changed its human research methods and became an example for other hospitals also conducting human testing, he said.
"The Santillan case may have been the impetus for the Hospital to improve its communication plan [regarding patient safety]," he said. Now, Cuffe said, the Hospital is prioritizing safety differently.
The Hospital is preparing for the DFS to return for a follow-up inspection in mid-July and for a visit in late June by the Joint Commission for the Accreditation of Healthcare Organizations, which originally downgraded the accreditation of the hospital in March.
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