State Health Department Cites Mt. Sinai Medical Center for Seriously Deficient Patient Care - Investigation Continues
$66,000 Fine Levied Following The Department's Expanded Investigation
NEW YORK CITY, August 30, 2002 - New York State Commissioner of Health Antonia C. Novello, M.D., M.P.H., Dr.P.H. today announced fines totaling $66,000 - the maximum permitted by law - against Mt. Sinai Medical Center for 33 violations identified as part of the State Health Department's (the Department's) investigation of 92 patient care complaints filed against the medical center. The Department's investigation confirmed problems in 53 (or 58 percent) of the 92 cases.
As part of the investigation, state inspectors found serious quality of care violations in 11 cases. Nine of the cases involved the liver transplant program, including one patient who donated part of his liver to a relative. The other two cases involved a patient whose emergency surgery was delayed causing an adverse outcome, and a patient who was prematurely discharged despite experiencing complications following a kidney transplant.
Dr. Novello, who today met with Mt. Sinai Medical Center's leadership to discuss the Department's investigative findings, said, "Due to the severity and widespread impact of these latest violations, which negatively affected 53 patients entrusted in its care, at this time, I cannot allow Mt. Sinai Medical Center to reopen its living donor adult liver transplant program. The Medical Center and the liver transplant program must devote all their efforts to correcting the problems that have been identified before any consideration is given to re-starting the living donor program."
Mt. Sinai Medical Center's living donor adult liver transplant program will remain suspended by the Department until the hospital corrects all of the deficiencies and successfully passes a State re-inspection.
The Hospital is required to submit a Plan of Correction (POC) to the Department by Friday, September 13, 2002. The POC must state what the hospital will do to correct the individual findings, what steps will be implemented to address broader issues and what long-range plans the hospital intends to implement to monitor the effectiveness of the care it provides.
As part of the POC, Mt. Sinai Medical Center must develop a prior approval process to assure that liver transplantation is performed on patients without contraindications. Transplantation should only be performed on patients whose health conditions at the time of surgery do not pose an additional risk for complications.
The hospital must also develop a retrospective assessment process, including the use of independent clinical experts who will be approved by the Department, to review all liver transplant cases to assure that the surgical procedures were performed on patients without apparent contraindications. The hospital's POC must include provisions for submitting monthly reports to the Department on the results of the retrospective assessments.
The Department will determine the appropriateness of the hospital's plan for both the prior approval process and the retrospective assessment process as part of the Department's overall review of the hospital's POC.
The thoroughness of the Department's complaint investigations and the Statement of Deficiencies issued to Mt. Sinai Medical Center as a result of its investigative findings demonstrate the importance that this Department places on each and every patient care complaint it receives. Dr. Novello said, "The Department takes all patient care complaints seriously and will investigate each and every complaint to identify deficiencies when they exist. Hospitals found with violations will be held accountable and will be required to take immediate actions to correct the violations."
The Department's expanded focus into the care provided to patients in Mt. Sinai Medical Center's Liver Transplant Unit began in March of this year, just days after the Department issued an inspection report and fined the hospital $48,000 for deficiencies identified during an investigation into the death of a patient who underwent surgery to donate a portion of his liver to his ailing brother.
The Department has since broadened its investigation beyond the hospital's liver transplant unit after receiving patient care complaints regarding other units of the hospital. To date, 92 of the total 158 patient care complaints received have been fully investigated. The Department continues to aggressively investigate the remaining 66 cases.
The Department is now in the process of responding directly to the families who came forward with complaints about the care their loved ones received at Mt. Sinai Medical Center. Each family soon will receive a detailed letter explaining the outcome of their specific case with a copy of the Department's August 29, 2002 Statement of Deficiencies (SOD) issued to the hospital.
The Department's August 29 Statement of Deficiencies (SOD) cited a total of 33 deficiencies against Mt. Sinai Medical Center under the categories of Governing Body, Administration, Medical Staff, Nursing Services, Patient Rights, Admission and Discharge, Infection Control, Surgical Services, and Environmental Health. New York State law permits a maximum fine of $2,000 per deficiency for the 33 deficiencies identified.
In addition to the 11 serious violations identified above, the Department's investigation found the following deficiencies:
- Medical staff violated hospital policy by proceeding with liver transplant surgery on three patients despite determinations during pre-operative assessments that each patient was experiencing complications from a pre-existing health condition - i.e. cancer, sepsis (an infection).
- There was no evidence that the care provided to three patients by the physician assistants was adequately supervised by attending physicians.
- There was no evidence in 25 cases that the attending transplant surgeon evaluated the patient post-operatively. In one of those cases there is no evidence that the resident caring for the patient informed the attending physician of the patient's deteriorating health condition.
- The Hospital failed to ensure that two adverse incidents involving patients were reported to the State Health Department as required by State law - via the New York Patient Occurrence Reporting and Tracking System.
- The hospital allowed private patient care associates and "companions" to perform functions that are required to be performed only by a licensed nurse, contributing to adverse patient outcomes.
- There was lack of assessment and supervision of patients at risk for falls. Two patients experienced life-threatening injuries and one of which died after sustaining severe head trauma from falls.
- There were four instances in which the hospital failed to notify the family of a patient who sustained injuries after a fall.
- The hospital failed to ensure that adequate nurse staffing was available to provide care to patients in the liver transplant unit. The Department found violations related to staffing in 23 of the patient complaint cases.
- There was no evidence in some cases that follow-up care was provided by nurses to patients experiencing significant changes in their health condition, nor that the attending physician was notified of such changes.
- The hospital, before fully addressing their acute health care needs, discharged three patients prematurely without proper planning and support.
- In 10 cases, the attending surgeon specified on the original consent was replaced by another qualified surgeon who actually performed the surgery without the patient's knowledge or informed consent.
- Hospital policies and procedures for infection control, including sanitation and isolation measures, were inadequate, and in some instances not developed.
- The hospital did not ensure that the entire facility was kept clean and maintained in good repair.
Since initially being cited by the Department in March of this year for violations related to the death of a live liver donor on January 13, 2002, Mt. Sinai Medical Center has been cooperative in the investigations and continues to develop and implement measures to address the violations already identified.
Dr. Novello met with Mt. Sinai Hospital President, Larry Hollier, M.D., – who is set to begin leading the hospital in his new position on September 3 – to discuss the Department's latest investigative findings and to make it clear that the hospital must remain diligent in its efforts to correct all of the violations cited by the Department.
"After our conversation today, I am confident that Dr. Hollier and Mt. Sinai Medical Center are committed to correcting the problems identified in our report," Dr. Novello said. "The new leadership understands the importance of learning from the hospital's past mistakes and they have dedicate themselves and are committed to improving the quality of care patients receive."