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201 CHESTNUT HILL ROAD

STAFFORD SPRINGS, CT 06076

PATIENT RIGHTS

Tag No.: A0115

The Condition of Participation of Patient Rights has not been met.

Based on clinical record reviews, review of facility documentation, and interviews for one sampled patient (Patient #1) who was reviewed for patient rights, the hospital failed to ensure that the patient received care in a safe setting when staff failed to use electrocautery equipment in accordance with manufacturer's recommendations, and failed to ensure that staff activated the fire alarm when a fire was noted in the operating room resulting in a determination of Immediate Jeopardy.

Please see A144

Based on clinical record reviews, review of facility documentation, and interviews for one of three patients reviewed for restraints (Patient #9), the hospital failed to ensure that the patient's restraints were removed in a timely manner and consistant with the physician order.

Please see A174

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on clinical record reviews, review of facility documentation, and interviews for one sampled patient (Patient #1) who was reviewed for patient rights, the hospital failed to ensure that the patient received care in a safe setting when staff failed to use electrocautery equipment in accordance with manufacturer's recommendations, and failed to ensure that staff activated the fire alarm when a fire was noted in the operating room resulting in a determination of Immediate Jeopardy. The findings include:

Patient #1's diagnoses included an ongoing lung infection and empyema.

Review of Patient #1's operative note dated 4/21/22 identified that Patient #1 underwent a complete decortication (removal of fibrous tissues) with repair of a fistula and wedge resection, and drainage of 1500 milliters of fluid. The operative note identified that an incision between the fourth and fifth intercostal space was made with electrocautery and indicated that during dissection, ventilation was withheld. Further review of the operative note identified that due to a difficult and challenging procedure, a decision was made to convert the procedure from laparoscopic to an open surgical procedure. The operative note identified that when the electrocautery device was removed from the patient's chest, flame sparks were observed when the cautery device touched gauze that was in the surgical field. The operative note indicated that the patient did not sustain any injury or burn.

The Hospital Event Document dated 4/20/22 identified that when the surgeon was using the electrocautery pencil, he asked the CRNA to ventilate the patient. The report indicated that during cauterization, there was as an air leak in Patient #1's lung and that a lap sponge below the cautery pencil caught fire.

Interview with RN #1 (circulating nurse) on 4/21/22 at 11:30 AM identified that she did not activate the fire alarm when she identified that there was a fire and stated she should have pulled the fire alarm.

The hospital failed to ensure that the fire alarm was activated when a fire was noted in the operating room.

Interview with Surgical Technician (ST) #1 on 4/21/22 at 12:02 PM indicated that after the surgeon opened Patient #1's chest, she placed dry lap pads on the sterile field. ST #1 indicated that MD #1 had his finger on the tip of the Bovie (cautery pencil) as he was removing it from the wound and at that time, the lap pad caught fire. ST #1 indicated that she doused the lap pad and surrounding area with normal saline and MD #1 pushed the lap pad to the floor. In a subsequent interview with ST #1 on 4/27/22 at 1:30 PM ST #1 indicated she was not aware that dampened lap pads were to be used.

Although the Surgeon's operative note identified that Patient #1's procedure posed a risk for fire and indicated that wet lap pads were used for mitigation, ST #1 identified that the lap pads provided to the surgeon (placed on the surgical field) were dry.

The hospital failed to ensure that fire mitigations were employed resulting in a fire on the surgical field.

Interview with MD #1 (surgeon) on 4/21/22 at 3:00 PM indicated that after he withdrew the cautery pencil from the patient's surgical site, he noticed sparks from the pencil land on the lap pad/gauze located on the drapes that were covering the patient. The surgeon indicated that there may have been a possible air leak from the patient's lung which escaped, causing the sparks. MD #1 indicated that after the incident, he examined the patient and identified no that there were no injuries to the patient. MD #1 indicated that the fire risk for Patient #1's procedure was determined to be a 2, which meant there was a degree of fire risk due to the location of the surgical procedure (chest). MD #1 indicated that to mitigate a fire risk, staff have a container of water available, use suction during the procedure, and use wet gauze. An interview with MD #1 on 5/4/22 at 12:15 PM identifed MD #1 was not aware of whether the lap sponge was damp or dry at the time of the fire. MD #1 indicated the suction was set up and available at the time of the procedure and stated he communicated with the CRNA not to provide ventialtion when he was in the process of using the electrocautery equipment.

Interview with Certified Registered Nurse anesthetist (CRNA) #1 on 4/21/22 at 4:14 PM identified that he did not observe when or how the fire started because he was sitting in a chair behind the surgical drapes. CRNA #1 identified that during Patient #1's procedure, there were issues with the ventilator equipment identifying that there was a "circuit leak-not delivering volume", which required him to manually ventilate the patient periodically with 100% oxygen to keep the patient's oxygen saturations up. The CRNA indicated he was unable to see what was going on at the operative site but heard the surgeon yell and when he got up from his chair, he saw a flame of approximately 1 inch on the corner of the lap pad. The CRNA stated that he turned off the oxygen flow, secured an ambu bag and restarted ventilating the patient when he was told by the surgeon that it was safe to do so. The CRNA stated that although the operative note identified that electrocautery was used and that during dissection ventilation was withheld, CRNA #1 indicated that at no time was it communicated to him that electrocautery equipment was in use. In a subsequent interview with CRNA #1 on 4/27/22 at 2:30 PM CRNA #1 indicated that his attention was focused on ventilating the patient and was not in tune with what was going on with the surgigal procedure. CRNA #1 indicated that in cases when there was a closed circuit ventilation, as was the case with Patient #1, if it was communicated that a Bovie was in use, the CRNA stated he would have attempted to lower the oxygen concentration to the lowest level to which the patient maintained acceptable oxygen saturations.

Interview with MD #2 (Chief of Surgery) on 4/27/22 at 2:45 PM identified that maximum safety is promoted when there is optimal communication among staff in the operating room. MD #2 further identified that the surgeon was also responsible to request a damp sponge when using electrocautery equipment.

Review of the hospital's Electrosurgical Unit Safety policy directed that hospital personnel are provided with detailed instructions from the electrosurgical unit's manufacturer.

Review of the electrocautery operations manual identified that for combustion supporting gasses as in oxygen, the gas can accumulate in materials like cotton, wool or gauze and the materials become highly flammable causing risk of fire to patient, medical personnel, and damage to property. The operations manual identified do not use combustion supporting gasses when an operation is being performed on the head and thorax. If use is unavoidable, you must extract the combustion supporting gases before performing electrosurgery, remove any jeopardized materials (cotton, wool or gauze) and before performing electrosurgery, check oxygen carrying tubes and connections, endotracheal tubes and cuffs for leaks.

Review of the Association of Perioperative Registered Nurses (AORN) Guidelines for perioperative practice Electrosurgical safety identified fire prevention interventions when using an electrocautery device included use of radiopaque sponges moistened with non- inflammatory liquid near the ignition source.

The hospital policy for Fire safety in the Operating Room identified that in response to a fire, the Circulating RN overhead pages within the department and identifies that there is a fire in the operating room. The policy further directed that any personnel outside the affected operating room will pull the fire alarm.

The facility did not have polices in place that addressed Perioperative fire risk assessment and use of electrocautery equipment in surgery.

On 4/26/22 at 2:00 PM the hospital's corrective action plan was reviewed and the Immediate Jeopardy was removed. The plan included inspection of equipment used during the fire, education to all surgical staff related to fire mitigation and response, communication in the operating room, created a fire safety tool kit and policies addressing electrosurgery use in surgical services, perioperative fire risk assessment, and QAPI monitoring of the action plan.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on clinical record reviews, review of facility documentation, and interviews for one of three patients reviewed for restraints (Patient #9), the hospital failed to ensure that the patient's restraints were removed in a timely manner and consistant with the physician order. The findings include:

Patient #9 was admitted with chief complaints of alcohol use and schio-affective disorder.

Review of Patient #9's clinical record dated 3/5/22 identified that Patient #9 exhibited behaviors of yelling, cursing, agitation, restlessness, physically aggressive and spitting. Staff attempted less restrictive alternatives to restraints which were ineffective, and restraints were initiated at 10:10 PM.

Review of Patient #9's restraint monitoring documentation identified that Patient #9 was placed in 4- point restraint on 3/5/22 at 10:10 PM and the restraints were discontinued on 3/5/22 at 11:27 PM.

A physician's order dated 3/5/22 at 10:16 PM directed Restraint: violent or self- destructive continuous x 4 hours. Restraint type -double secured locked wrist/ankle, Justification: harmful to self and others. Release parameters: when exhibiting calm behaviors, when not a threat to self and others, when not physically agitated, and when not verbally aggressive.

The physician's violent restraint note dated 3/5/22 at 10:24 PM identified a restraint was warranted due to Patient #9 being harmful to self and others. The physician notes further identified the restraints would be discontinued when the patient was able to maintain safety without this intervention.

A behavioral health progress note dated 3/5/22 at 10:54 PM identified that 4- point restraints were applied due to Patient #9 displaying physical aggression towards others/self and was highly agitated.

The restraint monitoring flowsheet identified that on 3/5/22 between 10:41 PM and 11:27 PM (46 minutes) Patient #9 was identified as drowsy but arousable with minimal stimulation with no other behaviors identified. However, the patient remained restrained for 46 minutes before being released.

Interview with Manager #1 (Behavioral Health) on 4/26/22 at 2:15 PM identified that she was unable to determine if there were reasons staff did not remove Patient #9's restraint when the patient stopped displaying behaviors that precipitate the initiation of the restraints.

Subsequent to the observation the Director of Quality identified a restraint audit tool was initiated to assess restraint use. The Director indicated that deviations or "fall outs" would trigger an email to the staff entering the documentation as well as to Quality and the Chief Nursing Officer so actions could be taken timely.

PHYSICAL ENVIRONMENT

Tag No.: A0700

The Condition of Participation of Physical Environment has not been met.

Based on a review of hospital documentation, review of hospital policies and procedures and staff interviews, the hospital failed to execute the Fire Safety Plan as required by 2012 NFPA 101 "Life Safety Code" 19.7.2.1, 19.7.2.3 and facility policy resulting in a finding of Immediate Jeopardy.

Please see A701


Based on review of facility training documentation, and a review of facility policies and procedures, the facility did not ensure that Life Safety from Fire was provided.

Please see A709

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on a review of hospital documentation, review of hospital policies and procedures and staff interviews, the hospital failed to execute the Fire Safety Plan as required by 2012 NFPA 101 "Life Safety Code" 19.7.2.1, 19.7.2.3 and facility policy resulting in a finding of Immediate Jeopardy. The findings include:

On 04/20/2022 at approximately 5:20 PM a flash fire occurred on the operative site of a patient in Operating Room #3. During the flash fire, staff failed to activate the fire alarm to notify emergency forces and to warn other building occupants promptly. The operative notes indicated that MD #1 advised the staff in the operating room of a fire and the staff failed to initiate the hospital's fire plan as required, which calls the announcement of the code word Dr. Red, the location of the fire, and that the fire alarm be activated.

Interview with RN #1 (circulating nurse) on 4/21/22 at 11:30 AM identified that she did not activate the fire alarm when she identified that there was a fire and stated she should have pulled the fire alarm.

On 4/26/22 at 2:00 PM the hospital's corrective action plan was reviewed and the Immediate Jeopardy was removed. The plan included inspection of equipment used during the fire, education to all surgical staff related to fire mitigation and response, communication in the operating room, created a fire safety tool kit and policies addressing electrosurgery use in surgical services, perioperative fire risk assessment, and QAPI monitoring of the action plan.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on review of facility training documentation, and a review of facility policies and procedures, the facility did not ensure that Life Safety from Fire was provided. The findings include:


On 04/20/2022 at approximately 5:20 PM a flash fire occurred on the operative site of a patient in Operating Room #3. During the flash fire, staff failed to activate the fire alarm to notify emergency forces and to warn other building occupants promptly, as called for by the facility policy (reference 2012 NFPA 101 "Life Safety Code" 19.7.2.1, 19.7.2.3). On 04/21/2022 at approximately 11:00 AM and times throughout the day, documentation was reviewed that indicated that all operating room staff had not been reeducated as to their specific responsibilities in the event of a surgical fire. Interview of the facilities manager identified that the equipment involved with the surgical fire on 4/20/22 were never sequestered and checked for proper function/operation by facility Biomedical Engineering Department prior to use on 04/21/2022. The facilities manager identified that between April 20, 2022, and April 21,2022 there were two (2) additional surgeries performed in Operating Room #3. The facility provided for review, prior training from RPA/Jenson Hughes, a Fire & Emergency Management for Health Care Facilities Consultant that had provided training on April 11, 2021. The training included surgical fire prevention, suppression and evacuation. However, documentation of personnel who attended the training was not provided or available on the day of survey.

On 4/26/22 at 2:00 PM the hospital's corrective action plan was reviewed and the Immediate Jeopardy was removed. The plan included inspection of equipment used during the fire, education to all surgical staff related to fire mitigation and response, communication in the operating room, created a fire safety tool kit and policies addressing electrosurgery use in surgical services, perioperative fire risk assessment, and QAPI monitoring of the action plan.

SURGICAL SERVICES

Tag No.: A0940

The Condition of Participation for Surgical Services has not been met.

Based on clinical record reviews, review of facility documentation, and interviews for one sampled patient (Patient #1) who was reviewed for operative services, the hospital failed to ensure that fire reduction measures were followed resulting in a fire during a surgical procedure, and failed to ensure that hospital policies were in place and followed to ensure that the fire alarm was activated when a fire was noted resulting in a determination of Immediate Jeopardy.

Please see A951

OPERATING ROOM POLICIES

Tag No.: A0951

Based on clinical record reviews, review of facility documentation, and interviews for one sampled patient (Patient #1) who was reviewed for surgical services safety from fire, the hospital failed to ensure that policies were in place and followed to ensure high standards of medical practice and patient care safety when staff failed to employ fire safety measures and failed to respond appropriately to a surgical fire resulting in a determination of Immediate Jeopardy. The findings include:

Patient #1's diagnoses included an ongoing lung infection and empyema.

Review of Patient #1's operative note dated 4/21/22 identified that Patient #1 underwent a complete decortication (removal of fibrous tissues) with repair of a fistula and wedge resection, and drainage of 1500 milliters of fluid. The operative note identified that an incision between the fourth and fifth intercostal space was made with electrocautery and indicated that during dissection, ventilation was withheld. Further review of the operative note identified that due to a difficult and challenging procedure, a decision was made to convert the procedure from laparoscopic to an open surgical procedure. The operative note identified that when the electrocautery device was removed from the patient's chest, flame sparks were observed when the cautery device touched gauze that was in the surgical field. The operative note indicated that the patient did not sustain any injury or burn.

The Hospital Event Document dated 4/20/22 identified that when the surgeon was using the electrocautery pencil, he asked the CRNA to ventilate the patient. The report indicated that during cauterization, there was as an air leak in Patient #1's lung and that a lap sponge below the cautery pencil caught fire.

Interview with RN #1 (circulating nurse) on 4/21/22 at 11:30 AM identified that she did not activate the fire alarm when she identified that there was a fire and stated she should have pulled the fire alarm.

The hospital failed to ensure that the fire alarm was activated when a fire was noted in the operating room.

Interview with Surgical Technician (ST) #1 on 4/21/22 at 12:02 PM indicated that after the surgeon opened Patient #1's chest, she placed dry lap pads on the sterile field. ST #1 indicated that MD #1 had his finger on the tip of the Bovie (cautery pencil) as he was removing it from the wound and at that time, the lap pad caught fire. ST #1 indicated that she doused the lap pad and surrounding area with normal saline and MD #1 pushed the lap pad to the floor. In a subsequent interview with ST #1 on 4/27/22 at 1:30 PM ST #1 indicated she was not aware that dampened lap pads were to be used.

Although the Surgeon's operative note identified that Patient #1's procedure posed a risk for fire and indicated that wet laparoscopic pads were used for mitigation, ST #1 identified that the laparoscopic pads provided to the surgeon (placed on the surgical field) were dry.

The hospital failed to ensure that fire mitigations were employed resulting in a fire on the surgical field.

Interview with MD #1 (surgeon) on 4/21/22 at 3:00 PM indicated that after he withdrew the cautery pencil from the patient's surgical site, he noticed sparks from the pencil land on the lap pad/gauze located on the drapes that were covering the patient. The surgeon indicated that there may have been a possible air leak from the patient's lung which escaped, causing the sparks. MD #1 indicated that after the incident, he examined the patient and identified no that there were no injuries to the patient. MD #1 indicated that the fire risk for Patient #1's procedure was determined to be a 2, which meant there was a degree of fire risk due to the location of the surgical procedure (chest). MD #1 indicated that to mitigate a fire risk, staff have a container of water available, use suction during the procedure, and use wet gauze. An interview with MD #1 on 5/4/22 at 12:15 PM identifed MD #1 was not aware of whether the lap sponge was damp or dry at the time of the fire. MD #1 indicated the sucrtion was set up and available at the time of the procedure and stated he communicated with the CRNA not to provide ventialtion when he was in the process of using the electrocautery equipment.

Interview with Certified Nurse anesthetist (CRNA) #1 on 4/21/22 at 4:14 PM identified that he did not observe when or how the fire started because he was sitting in a chair behind the surgical drapes. CRNA #1 identified that during Patient #1's procedure, there were issues with the ventilator equipment identifying that there was a "circuit leak-not delivering volume", which required him to manually ventilate the patient periodically with 100% oxygen to keep the patient's oxygen saturations up. The CRNA indicated he was unable to see what was going on at the operative site but heard the surgeon yell and when he got up from his chair, he saw a flame of approximately 1 inch on the corner of the laparoscopic pad. The CRNA stated that he turned off the oxygen flow, secured an ambu bag and restarted ventilating the patient when he was told by the surgeon that it was safe. The CRNA stated that although the operative note identified that electrocautery was used and that during dissection ventilation was withheld, CRNA #1 indicated that at no time was it communicated to him that electrocautery equipment was in use. In a subsequent interview with CRNA #1 on 4/27/22 at 2:30 PM CRNA #1 indicated that his attention was focused on ventilating the patient and was not in tune with what was going on with the surgigal procedure. CRNA #1 indicated that in cases when there was a closed circuit ventilation, as was the case with Patient #1, if it was communicated that a Bovie was in use, the CRNA stated he would have attempted to lower the oxygen concentration to the lowest level to which the patient maintained acceptable oxygen saturations.

Interview with MD #2 (Chief of Surgery) on 4/27/22 at 2:45 PM identified that maximum safety is promoted when there is optimal communication among staff in the operating room. MD #2 further identified that the surgeon was also responsible to request a damp sponge when using electrocautery equipment.

Review of the hospital's Electrosurgical Unit Safety policy directed that hospital personnel are provided with detailed instructions from the electrosurgical unit's manufacturer.

Review of the electrocautery operations manual identified that for combustion supporting gasses as in oxygen, the gas can accumulate in materials like cotton, wool or gauze and the materials become highly flammable causing risk of fire to patient, medical personnel, and damage to property. The operations manual identified do not use combustion supporting gasses when an operation is being performed on the head and thorax. If use is unavoidable, you must extract the combustion supporting gases before performing electrosurgery, remove any jeopardized materials (cotton, wool or gauze) and before performing electrosurgery, check oxygen carrying tubes and connections, endotracheal tubes and cuffs for leaks.

Review of the Association of Perioperative Registered Nurses (AORN) Guidelines for perioperative practice Electrosurgical safety identified fire prevention interventions when using an electrocautery device included use of radiopaque sponges moistened with non- inflammatory liquid near the ignition source.

The hospital policy for Fire safety in the Operating Room identified that in response to a fire, the Circulating RN overhead pages within the department and identifies that there is a fire in the operating room. The policy further directed that any personnel outside the affected operating room will pull the fire alarm.

The facility did not have polices in place that addressed Perioperative fire risk assessment and use of electrocautery equipment in surgery.


On 4/26/22 at 2:00 PM the hospital's corrective action plan was reviewed and the Immediate Jeopardy was removed. The plan included inspection of equipment used during the fire, education to all surgical staff related to fire mitigation and response, communication in the operating room, created a fire safety tool kit and policies addressing electrosurgery use in surgical services, perioperative fire risk assessment, and QAPI monitoring of the action plan.