The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

NEW YORK UNIVERSITY LANGONE MEDICAL CENTER 550 FIRST AVENUE NEW YORK, NY 10016 Jan. 5, 2015
VIOLATION: ANESTHESIA SERVICES Tag No: A1000
Based on record review, review of policies and procedures and interviews, it was determined that the hospital failed to provide anesthesia services that conform to current standards of practice. Specifically, the hospital failed to formulate and implement interdepartmental policies and procedures to ensure that patients are protected against operating room fires. This finding was noted in 1 of 10 patient records that were assigned a high fire safety risk by operating room staff (Patient #1 / MR #1).

Cross reference is made to Tag A 951 482.51(b).


Findings include:

Review of MR #1 on 12/29/14 at approximately 2:30 PM, found that on 12/18/14 the anesthesiologist administered between 40% to 75% oxygen at 6 liters per minute via face mask and failed to suspend the oxygen flow when the plastic surgeon used an electrocautery during the course of an excision of a nevus on the left face which was approximately 5 centimeters (cm.) away from the border of the face-mask.

Review of Anesthesia policies and procedures, Reference # 2011 subtitle "Electrosurgical Units (ESU)", on 12/30/14 at approximately 10:00 AM, states "Stop supplemental Oxygen at least one (1) minute before and during use of the ESU, if possible, especially during head, neck, or upper chest surgery." Further policy states that "staff should question the need for 100% oxygen for open delivery during facial surgery. As a general policy, use air or FiO2 at less than or equal to 30% for open delivery, consistent with patient needs." Note: FiO2 - fraction of inspired oxygen - is the fraction or percentage of oxygen in the space being measured, for example, patient wearing a nasal cannula or a simple face mask.

At interview with the anesthesiologist (employee #1) on 12/30/14 at approximately 11:00 AM, it was stated that he was never made aware that an electrocautery was to be used for this case and that he never actually saw the device in the OR for this case prior to its use. He further stated that he did not hear any time out called by the nurse or anyone else. He further stated that he would have proceeded anyway even if he had known of the plan to use an electrocautery. He stated the use of electrocauteries are under the purview of the surgeon. He also stated that he was using a face mask attached to an auxiliary oxygen flow meter which was delivering oxygen at 6 liters per minute which can yield 100% oxygen.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on record review, review of policies and interviews, it was evident that the hospital failed to provide surgical services that conformed to current standards of practice. Specifically, the hospital failed to follow interdepartmental policies and procedures to ensure that patients are protected against operating room fires. This finding was noted in 1 of 10 patient records that were assigned a high fire safety risk by operating room staff (Patient #1 / MR #1).

Cross reference is made to Tag A 951 482.51(b).


Findings include:

Review of MR#1 found that the patient sustained 2nd and 3rd degree burns to the face when an electrocautery was used by the plastic surgeon (employee #2) in an unsafe manner. Specifically, on 12/18/14 at approximately 9 AM, the plastic surgeon used an electrocautery in the process of excision of a nevus (a superficial skin growth) from the left side of the face while the patient was wearing an oxygen mask delivering between 40% and 75% oxygen through a plastic tube connected to the wall oxygen outlet. This was the auxiliary line which can deliver 100% oxygen. The mask had been applied by the anesthesiologist (employee #1). The surgical site on the left side of the face was approximately 5 centimeters (cm) to the left of the border of the oxygen mask. No incise draping or tenting was done. There was no interruption of the oxygen during the cautery application. When the surgeon used the cautery in the presence of the oxygen, there was a spark escalating to a surgical fire that involved the oxygen mask and the drape and the patient sustained 2nd and 3rd degree burns to the face.

Review of Hospital Policy and Procedure (Anesthesia - Fire Safety in an Oxygen Rich Environment-OR Reference #2201) on 12/30/14 at 9:00 AM indicated that oxygen must be turned off for 1 minute prior to and during use of the electrocautery if there is a high fire risk rating (1 = Low Risk, 2 = Medium Risk, 3 = High Risk).

Interview with the anesthesiologist (employee #1) on 12/30/14 at approximately 11:00 AM found that he was not aware of the intended use of the cautery and he did not participate or hear any time out. He stated that he is responsible for anesthesia administration, not the actions of surgeons.

Interview with the plastic surgeon (employee #2) on 12/30/14 at 11:30 AM found that he did not notice if the oxygen was on or off and he did not request that the oxygen be interrupted. He stated that he does not regularly observe the anesthesiologist during surgery. He stated that he draped the patient, but there was no incise draping or tenting of the drapes.

Telephone interview with the circulating RN (employee #3) on 01/05/15 at approximately 11:00 AM found that she performed a time out and notified staff of the presence of the electrocautery, but she wasn't certain if the anesthesiologist responded to it.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on record review, review of hospital policy and interviews, it was evident that the hospital failed to follow its "time out" policy and procedure and to have in place a policy and procedure that addresses how to regulate the percentage of oxygen provided patients, both of which would reduce the risk of surgical fires. This finding was noted in 1 of 10 patient records that were assigned a high fire safety risk by operating room staff (Patient #1 / MR #1).


Findings include:

Review of MR #1 on 12/29/14, at approximately 2:30 PM, it was determined that although the patient was rated as "Highest Risk of Fire", level 3 (out of 3) by the circulating RN (employee #3), a surgical fire occurred in which the patient sustained 2nd and 3rd degree facial burns.

During interview with the anesthesiologist (employee #1) on 12/30/14 at approximately 11:00 AM the surveyor questioned how much oxygen would be delivered if there was a face mask attached to an auxiliary oxygen outlet. The anesthesiologist was uncertain as to how much oxygen would be delivered.

The OR nursing management/education staff (employee #4) stated on 12/30/14 at approximately 3:30 PM that the time out process always includes the fire risk rating. During telephone interview on 01/05/15 at approximately 11 AM with the RN (employee #3), who performed the time out for the case referenced in MR #1, it was stated that she informed the surgical and anesthesia staff of the high fire risk rating and the intended use of the electrocautery with no response. She placed the cautery on 20/20 mode and attached the grounding pad to the patient's leg. Nursing staff was present as the cautery was being used concurrently with the use of oxygen. There was no evidence that nursing attempted to stop the use of the electrocautery while the patient was on high flow oxygen.

Review of the "time out" form on 12/30/14 at approximately 4:00 PM indicates that pre-procedure and pre-anesthesia time out was done by the RN (employee #5) on 12/18/14 at 8:47 AM. The fire-safety risk component, however, is entered by another RN (employee #3) and was timed 12/18/14 at 10:09 AM approximately 1 hour after the OR fire. During a telephone interview with RN (employee #3) on 01/05/15 at approximately 11:00 AM it was determined that RN (employee #5) and RN (employee #3) relieved each other during the course of the procedure. It was not known if all other persons listed on the OR assignment log for this case were present during the "time out", however, the "time out" form lists the Surgeon, Anesthesiologist and one additional nurse.

The OR nursing management/education staff (employee #4) was unable to provide evidence that there were drills for OR fires where the fire directly involves the patient.

The policy and procedure for "time out" (Element 9-A,1 ) did not include any reference to fire risk assessments as part of the time out.