In an investigation stemming from Duke University Hospital's treatment of Jésica Santillán, the federal Centers for Medicare and Medicaid Services issued a report Wednesday citing multiple deficiencies in the Hospital's conduct.
Noting about 50 problem areas, the 54-page report - written by the North Carolina Division of Facility Services - concluded the Hospital "failed to provide medical leadership in transplant surgical services that would ensure a consistent and safe solid organ transplant program."
If no changes are made, the findings threaten the Hospital's ability to collect reimbursements for treating Medicare and Medicaid patients.
Among the most significant charges, the report questioned the qualifications of two participants in the Feb. 7 transplant of a heart and lungs of incorrect blood type into Jésica - a pediatric nurse practitioner who served as transplant coordinator and the surgical resident who retrieved the donor organs in Boston. Investigators said they found no documentation that the nurse had training in transplantation or that the resident had appropriate credentials.
The report also noted the following deficiencies: Hospital staff failed to keep track of blood type and other information about Jésica donor, both before and during surgery; Jésica's medical records failed to mention her known allergy to the antibiotic Vancomycin and documentation of a pre-surgical evaluation by the anesthesiologist; and the Hospital failed to monitor the quality of its contracted services with the regional transplant office, Carolina Donor Services.
DFS called the problems "serious" and noted that they do not happen often. Investigators now plan to complete a thorough investigation of the Hospital.
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