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QUEENS HOSPITAL CENTER 82-68 164TH STREET JAMAICA, NY 11432 Feb. 4, 2011
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility did not ensure that anesthesia service was delivered in a consistent and safe manner.

Findings include:
Review of MR #1 noted that this [AGE] year old patient presented in the Emergency Department (ED) on 1/12/11 with complaints of vomiting and abdominal pain. The patient was admitted with diagnosis of acute pancreatitis. This patient had an ERCP (Endoscopic Retrograde Cholangio Pancreatography) on 1/18/11. After or during the course of the procedure, the patient who was accidently extubated went into cardiac arrest, became unresponsive, was coded and eventually died .

It was noted that the procedure ended on 1/18/11 at 9:35 AM. Sometime after the procedure, it was discovered that the patient was accidently extubated. The event around the patient's extubation was documented on the Anesthesia record. Review of the anesthesia record noted that around 9:40 AM -10:00 AM the patient was asystolic (this anesthesia record documentation was unclear). It was noted that the documentation was done after the events and could not be completed accurately per the facility's position as it is impossible to document while trying to re-intubate and run a code.

There was inconsistent documentation in the medical record as it was noted that the Surgical/Invasion Procedure Form dated 1/18/11 indicated that the procedure ended at 9:35 AM while the Anesthesia Record indicated that the procedure ended on 1/18/11 at 10:35 AM. Additionally, the Resuscitation Flow Sheet form indicated that the code started at 9:45 AM and ended at 10:05 AM. However, it was noted that 200 joules was given at 10:07 AM.

-The Anesthesiologist, who was monitoring the patient, was interviewed on 2/4/11 at 3:08 PM. The Anesthesiologist reported that he turned the patient so that he could "flip" her from the OR table to the stretcher when he noticed that the patient's left hand was in the ET tube; he looked in the mouth and both balloons were in the mouth. He also stated that he did not know the actual time the patient self extubated.
- A copy of the monitoring strip from the anesthesia machine was requested and surveyor was informed that this machine did not have memory. The facility was unable to determine the time the patient was extubated.

-The failure of the staff to immediately recognize the extubation or to determine the circumstances surrounding the event limit the ability to QA the events.

The Gastroenterology (GI), who performed the ERCP, was interviewed on 2/4/11 at 2:19 PM. The GI reported that although she was in the OR when the patient was extubated she was doing her paperwork but her back was turned and she did not know there was a problem until the anesthesiologist asked for help. The anesthesiologist also reported that before the patient was moved from the OR table to the stretcher the anesthesia machine was disconnected. The anesthesia machine should have had battery back-up system and the alarm should have alerted the staff when the patient extubated.

The patient was at high risk for unplanned extubation in that she had been intubated endotracheally for a period prior to surgery and had self extubated only 2 days prior to ERCP during which time there was a potential for erosion of structures in and around the trachea. This would require that anesthesia collaborate with the endoscopist to ensure safe esophogeal access and removal. The fact that that there was a history of self extubation was a risk of a repeat event and required a higher level of surveillance.

The procedure involved the use of an endoscope concurrent with endotracheal intubation and the time of the removal of the endoscope represents a period of high risk of dislodgement of the ET tube. This is a point in the procedure where the type of extubation in which the balloon is not out of the mouth but not in the proper site is likely. There is no evidence that the facility formulated a policy and procedure to ensure that anesthesia and GI collaborate at these crucial points in the procedures where a duodenoscope is passed, advanced, and eventually retracted in close proximity to an ET tube.

There is no evidence that cuff pressure (balloon) was taken pre operatively to assure that the ET tube was secure so that ERCP could proceed safely.

The observation of the balloon in the oral cavity was evidence that there was an extubation that might not be immediately noticeable as there would be only a partial extrusion of the ET tube. Only an alarm could alert staff to this event.

The rhythm identified as asystole was one that is a terminal dysrhythmia that is found in events where there is more protracted de-oxygenation than the seconds without oxygenation described in the notes.

While on site, a copy of the Department of Anesthesia Emergency Protocol was requested but this was not received. A copy of Nursing Policy was submitted instead.
-- Hospital Wide QA that was reviewed noted the Department of Anesthesia was not properly represented.
-The Department of Anesthesia monthly QA for the year 2010 was reviewed. The monthly minutes were incomplete as some minutes (4/14/10 & 12/17/10) consisted of memos to staff. The minutes did not include attendance of staff and cases or issues discussed.