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FLORIDA HOSPITAL WATERMAN 1000 WATERMAN WAY TAVARES, FL 32778 March 5, 2013
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0021
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on staff interview, medical record review and facility document review the facility failed to provide the State Agency, (surveyor), information related to a Federal complaint investigations of an Adverse Incident resulting in a patient death.
Findings:
Review of the Agency for Health Care Administration, (AHCA), 15 Days Report - Hospital, filed by the facility on 02/15/2013 revealed the following reportable Adverse Patient Incident, (#5211), suffered by patient #1 while undergoing open heart surgery on 12/10/2012. Section A. Circumstances of the incident (narrative): revealed " The patient underwent surgery for mitral valve repair on 12/10/2012. There was a failure in the heart lung machine intra-operatively requiring the use of a manual hand crank for approximately 30 minutes. During the post-operative period, the patient was diagnoses with anoxic brain injury. The family made the decision to withdraw the patient from life support and he expired on [DATE]. " The Report revealed under section IV ANALYSIS AND CORRECTIVE ACTIONS letter A: Analysis (apparent cause) of this incident revealed " The investigation ruled out many of the components of the heart lung bypass machine. The observed flow issues may well have been related to an obstruction in the oxygenator, which may have been present after its onset for the duration of the procedure. The exact etiology of this obstruction remains uncertain. " Under letter B: Describe corrective or proactive action(s) taken revealed only " Maquet if performing an extensive preventive maintenance on the heart ling machine to be done prior to placing it back into service. "
Interview during the entrance conference on 03/05/2013 at 9:30 AM with the Risk Manager the following items were requested, evidence of the facility ' s investigation of the adverse incident, Results of the Quality Assurance Performance Improvement (QAPI) activities, QAPI minutes, equipment maintenance, (testing), records, and medical staff records. The interview revealed that the Risk Manager stated that she would have to get with " legal " and get back with the surveyor. Several times throughout the complaint investigation the surveyor was told that she was waiting on legal and would let the surveyor k now what they said. Interview on 03/05/2012 at 2:45 PM, the Risk Manager revealed she would not provide any information related to the investigation of the equipment failure that resulted in the adverse incident.
The Risk Manager provided the survey with the following document that stated: " Florida Hospital Waterman is dedicated to encouraging a culture of safety and quality health care. Under the federal law, Florida Hospital Waterman reports to a federally-designated Patient Safety Organization. Under federal law, patient safety reports and other patient safety work product can be used only for patient safety activities and may not be disclosed except as provided by that law."
"Patient safety work product does not include information that Florida Hospital Waterman is required to report as an adverse event to the Agency for Health Care Administration."
"If any responsive documents exist that were not required to be reported to the Agency for Health Care Administration as an adverse event, such as documents would be privileged as patient safety work product pursuant to the Patient safety and Quality Improvement Act of 2005 as having been created in the context of a comprehensive PSES."
Review of the medical record for patient #1, interview with the contacted profusion company (including the perfusionist), and review of equipment records from the contracted biomedical company responsible to the heart-lung bypass machine could not determine the cause of the equipment failure and what steps the facility had taken to prevent a re-occurrence of the adverse incidence.