DOH NEWS

State of New York
Department of Health

ALBANY, September 28, 2001 – The New York State Health Department today announced that Westchester Medical Center (WMC) in Valhalla, New York will be fined $22,000 for its failure to ensure patient safety during MRI procedures. The State Health Department (the Department) cited WMC for eleven violations that occurred on July 27, 2001, leading to the tragic death of a sedated six-year-old patient. The child sustained fatal injuries after being struck in the head by a ferrous oxygen canister that was pulled into the magnetic resonance imaging (MRI) scanner.

The Department's investigation determined that Westchester Medical Center failed to implement and maintain necessary policies, practices and safeguards, including the ongoing evaluation of the services and care provided to patients in the MRI suite. The Department has taken appropriate actions to ensure that the WMC addresses the violations and implements policies and procedures that protect the health and lives of all patients in their care.

On July 27, 2001 a ferrous oxygen canister was introduced into the MRI suite by an anesthesiologist after he determined that the piped-in oxygen flow to the sedated patient was not sufficient. The two technicians responsible for the supervision of the patient left the procedure room to address concerns relating to the inadequate oxygen flow, thereby leaving the scanner and the related equipment unsupervised. When introduced into the room, the ferrous oxygen canister became a deadly projectile fatally striking the patient in the head as he lay sedated in the MRI scanner.

The Department cited WMC for deficiencies related to staff's failure to ensure that an adequate flow of oxygen was being provided through a piped-in system to the sedated patient prior to initiating the procedure; maintain a safe environment for patients while in the MRI procedure room; appropriately store ferrous oxygen canisters safely away from the proximity of the MRI suite; implement and maintain safeguards to prevent a magnetic object (ferrous oxygen canister) from being introduced into the MRI suite; and assess the need for additional safeguards as a result of a previous incident in 1997. The 1997 incident was not appropriately reported within WMC.

After the tragic incident, Westchester Medical Center responded in a responsible manner by conducting an internal investigation of the incident, identifying deficiencies and taking appropriate steps to correct them. The hospital has fully cooperated with the Department during the investigation, and has said that they will immediately respond to the deficiencies.

As a result of the Department's investigation, WMC was cited for eleven violations of the State Hospital Code, resulting in a maximum fine of $22,000. Deficiencies were cited in the areas of: Governing Body; Medical Staff; Quality Assurance; Anesthesia Services; Radiological and Nuclear Medicine Services; and Environmental Health.

The Medical Center is required to submit a Plan of Correction (POC) to the Department by October 10, 2001 describing how each of the identified deficiencies will be addressed, what corrective actions will be taken and the protocols to be implemented to insure that similar violations do not recur. These reports must specifically describe the corrective actions taken and assess the effectiveness of those measures.

Specifically, the Department's investigation found:

• Adequate safety precautions were not implemented and maintained on July 27, 2001 when a ferrous oxygen canister was introduced into the magnetic resonance imaging (MRI) procedure room;
• A previous incident occurred in the same MRI suite in 1997, wherein a ferrous oxygen canister was introduced into the procedure room by an anesthesiologist. The canister was magnetically drawn into the MRI unit striking the imaging device. This incident was not appropriately reported within the Medical Center and, therefore, was not properly assessed by administrative staff to determine if additional safeguards should have been taken. No patients were involved in the incident;
• The Medical Center did not provide services to the patient in a safe and protective manner. Staff did not review and confirm that an adequate amount of oxygen was available to the sedated patient prior to starting the procedure. The tank connected to the piped-in oxygen system emptied during the beginning of the procedure;
• The MRI technicians left the control room to attend to the oxygen problem, thereby leaving the scanner and related equipment unsupervised. In effect, staff were not present to prevent the introduction of the oxygen tank into the procedure room;
• The Medical Center's policies related to the oxygen supply were not written, resulting in potential for inconsistent understanding and administration of oxygen to sedated patients in the MRI unit; and
• The safety zone around the scanner area, to designate the area within which metallic items must not be introduced, was not clearly identified. There was no automatic indicator or alarm for alerting staff to low oxygen levels being supplied from the piped-in system.

9/28/01–104 OPA