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Tag No.: A1000
Based on medical record review, document review, and interview, in one (1) of four (4) medical records reviewed, the facility failed to ensure that a patient who underwent an endoscopy was appropriately assessed and monitored and that a timely code was called in accordance with the hospital's policies and procedures and standards of anesthesia care (Patient # 1).
Findings include:
See Tag A-1002
Tag No.: A1002
Based on medical record review, document review, and interview, in one (1) of four (4) medical records reviewed, the facility failed to ensure that a patient who underwent an endoscopy was appropriately assessed and monitored and that a timely code was called in accordance with the hospital's policies and procedures and standards of anesthesia care (Patient # 1).
Findings include:
A review of the medical record for Patient #1 identified that the patient presented on 12/20/24 for an endoscopy procedure. The anesthesia start time was at 3:19 PM with the following vital signs: Respiration Rate (RR) 13 (Normal range 11-18 breaths per minute); Blood Pressure (BP) 160/70 (Normal range=120/80 mm Hg); Pulse 50s (Adult Range is 60-100 bpm); EKG - Normal Sinus Rhythm (NSR), Paced rhythm (An electrocardiographic finding in which the cardiac rhythm is controlled by an electrical impulse from an artificial cardiac pacemaker); SpO2 (oxygen saturation, percentage of oxygen in the blood) 99% (Normal range is 95-100%); ETCO2 (a noninvasive technique which measures the partial pressure of carbon dioxide in exhaled air) 30 (Normal range is 35-45 millimeters of mercury (mm Hg).
At 3:25 PM, the vital signs were as follows: B/P 140s/80; pulse in the 50s.
At 3:26 PM, Staff A, Certified Registered Nurse Anesthetist (CRNA) documented that they administered the following medication and fluids to the patient: Docaine (Anesthetic) 100 mg (milligram) given IV (intravenous); Propofol 100 mg (Anesthetic) 100 mg IV; Propofol new bag 200 mcg/kg/minute (Microgram per kilogram per minute) IV; Isolyte (Source of electrolyte and hydration) 100cc IV.
The procedure began at 3:29 PM. Staff A documented changes in the rate of Propofol administration at 3:34 PM to 150 mcg/kg/min and at 3:41 PM to 80 mcg/kg/min. At 3:40 PM, Staff A administered Phenylephrine (A medication used to increase blood pressure)120 mcg IV and Isolyte 100 IV.
At 3:51 PM, Staff C, the Attending Anesthesiologist, was called to the bedside to evaluate the patient. At 4:01 PM, the patient had no palpable pulse; staff initiated Advanced Cardiovascular Life Support (ACLS) on the patient, and a code was called. The Return of Spontaneous Circulation was documented at 4:04 PM. The patient required intubation and management in the Intensive Care Unit. Imaging studies of the brain revealed evidence of hypoxic-ischemic encephalopathy (lack of oxygen in the brain). The patient subsequently expired on 1/9/2025 at 2:51 AM after the facility implemented a Do Not Resuscitate (DNR) order and palliative care at the request of the patient's family.
A review of the Anesthesia Policy and Procedure titled "Intra-operative Care, and the Standards for Basic Anesthetic Monitoring from the American Society of Anesthesiologists (ASA)," last affirmed on December 13, 2020, states "2. Standard II: During all anesthetics, the patient's oxygenation, ventilation, circulation, and temperature shall be continuously evaluated.
2.1 Oxygenation-
2.1.2-Methods-
Blood oxygenation: During all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed. When the pulse oximeter is utilized, the variable pitch pulse tone and the low threshold alarm shall be audible to the anesthesiologist or the anesthesia care team personnel. Adequate illumination and exposure of the patient are necessary to assess color.
2.3 Circulation-
2.3.2 Methods-
Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from the beginning of anesthesia until preparing to leave the anesthetizing location.
Every patient receiving anesthesia shall have arterial blood pressure and heart rate determined and evaluated at least every five minutes."
Review of the Medical Staff Rule and Regulation revised 7/2/2024, #214 - Rules Pertaining to Surgery and Invasive Procedures revised 8/16/2023 states "Intra-operative Anesthesia/Sedation Monitoring: The anesthesiologist or other individual qualified to administer anesthesia or sedation is to maintain records of all pertinent events taking place during the induction of, maintenance of, and emergence from anesthesia ...Vital signs will be recorded at a minimum of every 5 minutes ...
Medical Staff Rule and Regulation # 207-A states: The Code Team is available at all times to assist and provide support in the care of patients, visitors, and employees who are unconscious and not breathing and/or have no discernable pulse. Any staff member may activate a code call. The Code Team will be responsible for responding to medical emergencies ... Medical emergencies occurring in the operating room (OR), the Intensive Care Unit (ICU), and the Post-Anesthesia Care Unit (PACU) will be managed by the medical and nursing staff of those units as per their standards. If further assistance is deemed necessary, a code may be called."
There was no documented evidence of continuous assessment of the patient's vital signs during the procedure. Vital signs documented at a minimum every five (5) minutes did not include all parameters for oxygenation and circulation as per the Anesthesia policy on Intra-operative Care, the Standards for Basic Anesthetic Monitoring, and the Medical Staff Rules and Regulations.
There was no documented evidence that vital signs were monitored and recorded at appropriate intervals:
-No Blood Pressure from 3:45 PM to 4:01 PM (16 minutes)
-No Respiration from 3:42 PM to 3:55 PM (13 minutes)
-No Pulse (paced) from 3:45 PM to 4:01 PM (16 minutes)
-No Oxygen saturation from 3:49 PM to 4:01 PM(12 minutes)
There was no body temperature from the beginning of the procedure at 3:31 PM until 4:25 PM after the code. The body temperature at 4:25 PM was abnormal at 35.5 degrees Celsius (Normal 37o C).
Documentation in the MR revealed Staff A did not timely initiate a code when the patient manifested significant changes in their medical condition. Prior to calling a code at 4:01 PM and initiating Advanced Cardiovascular Life Support (ACLS) for the absence of palpable pulse, there was no respiration rate recorded for the patient at 3:42 PM; three minutes later, at 3:45 PM, the pulse oximeter reading was unobtainable, and at 3:54 PM, mask ventilation was applied to the patient.
At an interview on 1/8/2025 at 10:07 AM, Staff A, in the presence of Staff I, Director of CRNAs, reported the following: The patient was stable preoperatively, with vascular issues. After the procedure ended (Staff could not recall the specific time), the oxygen saturation and blood pressure machines were not picking up readings. Interventions provided to the patient included relocating the pulse oximeter and the blood pressure cuff, repositioning the patient, and administering Phenylephrine to increase the patient's blood pressure. Staff A, when asked how they confirmed the patient had a pulse, reported that the cardiac monitors showed some activities [Paced rhythm] but did not palpate for a pulse. Staff C, Attending Anesthesiologist, responded to a call for assistance, and a mask ventilation was placed on the patient. Shortly afterward, the patient was coded, and they were successfully resuscitated. Staff A reported they did not ask the GI (Gastroenterologist) provider for help when they had difficulty waking the patient after the procedure.
As per the interview on 1/8/2025 at 11:07 AM, Staff B, a Gastrologist, reported that after they completed the procedure, they returned to the procedure room and found the patient being resuscitated by the anesthesiologist, CRNA, and nurses.
During an interview with Staff C, the Attending Anesthesiologist, on 1/8/2025 at 11:33 AM, they reported they were called by CRNA [Staff A] to the procedure room as the patient was unarousable post-procedure. On the first encounter, the patient had a paced rhythm and tidal volume [The amount of air that moves in or out of the lungs with each respiratory cycle], and B/P was unobtainable. The patient was unresponsive to sternal rub. Staff C stated that their initial clinical assessment revealed the patient had some degree of carbon dioxide retention. The patient lost pulse and was resuscitated and managed in the Critical care Unit.
An Immediate Jeopardy (IJ) situation was identified on 1/14/2025 at 12:06 PM due to the facility's failure to ensure an endoscopy patient was appropriately assessed and monitored, and a code was timely activated when the patient developed significant changes in their medical condition.
On 1/14/2025, at 5:29 PM, the facility provided the survey staff with an acceptable IJ Removal Plan.
The IJ Removal Plan indicated that all pertinent staff would be reeducated to the Anesthesia Policy and Procedure Manual on Standards for Basic Anesthetic Monitoring and procedural endoscopy assessment, monitoring, and code activation.
The IJ was removed on 1/15/2025 at 3:32 PM based on onsite verification of the facility's implementation of the IJ Removal Plan through observations, interviews, and document reviews.