State Health Department Cites Stony Brook University Hospital for Serious Patient Care Violations

State Investigation Finds 36 Violations at SUNY Hospital in Multiple Programs, Hospital Faces Maximum Fine of $72,000

ALBANY, November 3, 2006 - The New York State Health Department today announced that Stony Brook University Hospital's pediatric cardiac surgery program will remain closed until further notice. Further investigations of the Pediatric and several other hospital programs that concluded in October led to citations for 36 violations, 17 of which were cited in the most recent investigation.

The citations were in four main areas: the credentialing and privileges of physicians, reappointment of physicians without documentation of appropriate training, performance issues such as quality assurance, and post surgical infection control rates. Patient care issues were found in the Departments of Pediatrics, Pharmacy, Emergency, Vascular Surgery, Urology and HIV/AIDS. The Hospital is assessed a civil penalty of $72,000, the maximum allowable under law, and shall pay the entire amount of that sum within fifteen (15) days of the effective date of this Stipulation and Order.

Earlier this year, the Department initiated a comprehensive on-site investigation into the deaths of three pediatric patients who experienced post-surgical complications following surgical procedures. Major breakdowns in patient care were attributed to the hospital's failure to ensure the availability of a full-time pediatric cardiac surgeon to oversee each patient's care during their hospital stays, particularly as it related to appropriate medical response regarding emergencies in the post-surgical period.

"The Department is deeply concerned about the lack of system controls in Stony Brook. It is clear from the investigative findings that Stony Brook University Hospital not only had administrative problems but failed to ensure the delivery of quality health care to patients, with potentially life threatening consequences," Dr. Novello said.

Dr. Novello further stated, "We will not permit the cardiac surgery program at Stony Brook University Hospital to resume until we are satisfied that all of the violations regarding the program have been addressed including the presence of a full-time pediatric cardiac surgeon on staff. We will be closely monitoring the hospital in all of the other areas where violations were cited. We want to ensure that appropriate corrective actions are implemented, maintained, and approved by the Department of Health in order to prevent further breakdowns in patient care."

The Department's investigations also determined that the hospital: failed to conduct basic pre-operative assessments; failed to follow New York State protocol for reporting incidents; failed to ensure that surgeons were adequately trained for the surgery they conducted; failed to follow medication preparation regulations so as to be able to ensure safety in medication administration to pediatric patients; and failed to communicate changes in patient clinical conditions to the physician.

The following is a summary of the Department's investigative findings against Stony Brook University Hospital:

  • The hospital did not have a full-time pediatric cardiac surgeon on-site to ensure response to emergencies and to perform timely surgeries on pediatric patients.
  • The hospital's credentialing process does not ensure that physicians requesting privileges have the qualifications needed for appointment.
  • The credentialing process does not ensure that physicians requesting reappointment for other privileges have proof of training, experience or have provided quality care.
  • Patterns of delay in providing pediatric surgical care to patients were identified on multiple occasions.
  • The hospital failed to take appropriate steps to transfer Pediatric Cardiac Surgery patients to another hospital when the surgeon was not immediately available.
  • The hospital was cited for violations related to a medication overdose including three pediatric patients, one of which resulted in a patient death.
  • The hospital does not have systems in place to ensure correct medication administration in the operating room.
  • The hospital was cited for allowing staff to practice outside their scope and qualifications.
  • The hospital was cited for failure to appropriately monitor and notify the attending physician of a change in a patient's status that resulted in the patient's death.
  • There is no quality plan for the Designated AIDS Center. A routine system of communicating emergency services reports on known or suspected HIV infected patients to the AID Center has not been established.

As a result of the actions taken by the Department:

  • Stony Brook University Hospital will not be permitted to reopen the pediatric cardiac surgery program or cardiac catheterization program, until a full-time pediatric cardiac surgeon is retained, approved by the Department, and an affiliation agreement with a medical institution with expertise in pediatric cardiac surgery is in place as well.
  • The hospital is required to develop, submit and implement an acceptable plan of correction for all violations cited. The plan must demonstrate how the violations will be addressed and highlight the actions that will be developed to prevent similar deficient practices from happening in the future. The plan of correction is due to the Department of Health on November 15, 2006.
  • Once the plan is accepted by the Department, the hospital will be afforded time to fully implement those corrections. An on-site re-visit by Department inspectors to ensure compliance with state requirements will follow.

The findings by the State Department of Health have prompted CMS to authorize a Federal Survey of the Conditions of Participation for the Medicare/Medicaid program at Stony Brook University Hospital.

Dr. Novello said, "The Department wants to ensure that Stony Brook University Hospital is held accountable for their inability to provide quality care to their patients. Stony Brook should secure the services of appropriate consultants, approved by the Department, to review and make written recommendations to the Hospital for the purpose of improving and strengthening the policies, procedures and operations of the Hospital regarding: credentialing and the granting of privileges to physicians; the pediatrics department; the preparation, administration and dispensing of pharmaceuticals in all departments, including operating rooms; and the organization and operation of the emergency department."