Health Department Fines Manhattan Hospital $20,000 for Serious Breakdowns in Patient Care

Albany, May 14, 2004 — The New York State Health Department today announced it has fined Manhattan Eye, Ear and Throat Hospital (MEETH) in New York City $20,000 for serious breakdowns in patient care in its anesthesia and plastic surgery departments.

Earlier this year, the Department initiated a comprehensive on-site investigation into the deaths of two patients who experienced complications during elective cosmetic procedures at MEETH. State Health Commissioner Antonia C. Novello, M.D., M.P.H., Dr.P.H., said the investigation identified 10 violations which have resulted in fines against the hospital. New York State law permits a maximum fine of $2,000 per violation for the 10 deficiencies identified, for a total of $20,000.

Specifically, the Department's investigation determined that MEETH failed to conduct basic pre-operative assessments, failed to adequately monitor changes in the patients' vital signs and failed to effectively respond to the adverse incidents.

"We are deeply concerned with the severity of the violations cited, particularly with the hospital's failure to ensure that the safeguards required by the State Hospital Code were in place to monitor the status of patients undergoing elective surgery. Furthermore, the hospital's response to these emergency situations was not effective. These egregious violations will require the full and immediate attention of the hospital to assure that they are never repeated," Commissioner Novello said.

"Patients who are administered anesthesia during any surgical procedure require close monitoring - a universally accepted standard of care that the hospital did not meet in these cases," the Commissioner said.

In addition to the fine against MEETH, the Department is taking the following action:

  1. Requiring the hospital to obtain an independent expert consultant to conduct a comprehensive review of its anesthesia department. The review must include an analysis of the hospital's administration of anesthesia, the pre- and post-monitoring of patients under anesthesia and the response to emergency situations when there is a failure in the system.
  2. Requiring the hospital to continue implementing a prior approval process for the administration of anesthesia for all elective surgical procedures. MEETH's affiliate, Lenox Hill Hospital, must review the type and dosage of anesthesia to be administered to patients prior to the start of any and all elective surgeries and document the review in the medical record.
  3. Requiring the hospital to continue to maintain a ratio of one anesthesiologist to every two certified registered nurse anesthetists (CRNAs). In addition, while supervising the CRNAs, the anesthesiologist may not be assigned to any other ongoing case and must be immediately available to the CRNAs.
  4. Requiring the hospital to document the training and continuing education of surgical staff in cardiopulmonary resuscitation.
  5. Requiring the hospital to submit quarterly reports to the Department for a period of one year on the implementation of the Plan of Correction (POC), as well as an assessment of the effectiveness of those actions. Also:
  6. The Department will obtain the services of an independent expert consultant to conduct monthly assessments of the MEETH's anesthesia services, including a review of the effectiveness of the prior approval process for the next year.
  7. The Department will review the hospital's independent consultant's report on the anesthesia services at MEETH and will solicit the input of the American Society of Anesthesiologists.
  8. The Department will conduct unannounced inspections of MEETH's anesthesia and plastic surgery departments during the coming year to assure the hospital is in compliance with the State Hospital Code.

Specifically, the Department's investigation found:

  • Failure in the first case to complete a thorough pre-operative work-up to thoroughly identify the patient's risk factors.
  • A lack of adequate monitoring of the patients' respiration and vital signs during the surgical procedures involved in the two cases.
  • Failure to ensure that the devices monitoring the patients were functioning at full capacity during surgery. The alarms, which should have alerted medical personnel of the significant changes in the conditions of the patients, were not audible in either case.
  • The administration of the quantity and dose of anesthesia to the patient in the first case was not thoroughly documented in the patient's medical record.
  • A lack of communication in the first case between the surgeon and nurse anesthetist during the surgical procedure.
  • Significant delay by hospital staff in responding appropriately to emergency situations. In the two cases, the hospital staff did not quickly identify sudden changes in the patients' health conditions which precluded their ability to take prompt and effective remedial action.

The hospital is required to submit a written Plan of Correction (POC) to the Department by Friday, May 28, 2004. The POC must indicate what the hospital will do to correct the specific violations and the systemic issues which led to them, and what long-range plans the hospital intends to implement to monitor the effectiveness of the care it provides.