HospitalInspections.org

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

Based on medical record reviews, review of hospital policies and interviews for one of eleven patients reviewed for patient rights (P #10), the facility failed to ensure that the grievance policy was followed, and based on medical record review, review of hospital policies, review of hospital documentation, review of manufacturer's recommendations, observations and interviews for one of twelve patients reviewed for patient rights (P #1) and for one of nine surgical patients (P #1), the facility failed to ensure a safe environment during an operative procedure.


Please see A123 and A144


On 4/5/21 IJ was identified starting on 4/3/21 when staff failed to properly respond to a fire in the operating room during a surgical procedure, and failed to immediately remove and/or perform a risk assessment of other equipment once a safety concern was identified. An Immediate Action Plan was submitted on 4/5/21 at 3:20 PM. The action plan was reviewed on 4/6/21 and identified that the hospital implemented the plan as written. IJ was removed on 4/6/21.

The hospital submitted an immediate action plan dated 4/5/21 to include equipment recall with system- wide notification, delivery of replacement equipment, and device and emergency response education. The facility was found to be compliant with the plan as submitted on 4/6/21.

The hospital submitted an addendum to the action plan on 4/7/21 to include education for expected procedural operator and security response to fire notification.

Based on medical record reviews, review of hospital policies and interviews for one of eleven patients reviewed for patient rights (P #10), the facility failed to ensure that the grievance policy was followed. The finding includes:


P #10 had a family history of cerebral aneurysm rupture. A physician order dated 12/17/19 by MD #3 (from Clinic #1) directed a CTA (computed tomography angiogram) of the head on 12/17/19 to rule out aneurysm. The radiology report of the head CTA dated 12/17/19 also contained CTA results of the neck. The neck results identified an occlusion at the origin of the right vertebral artery. The radiology results were read by Radiology Resident #1 and the report was signed by Attending Radiologist #1 on 12/17/19.

An addendum to the radiology report dated 12/31/19 identified that the original report of 12/17/19 correctly identified that the head CTA did not identify a cerebral aneurysm (original reason for the ordered head CTA). However, the 12/17/19 report mistakenly contained an unrelated CTA of the neck.

A physician order by MD #4 dated 1/30/20 directed P #10 to have a stress echocardiogram with exercise with complete Doppler and color flow imaging due to right vertebral artery occlusion.

P #10 presented to the radiology department (approximately one year later) on 1/20/21 to have the aforementioned test and the test was subsequently canceled.

An email to the Hospital from the Director of Clinic #1 dated 2/26/21 identified that MD #5 planned a surgical intervention for P #10 as a result of the erroneous results in the 12/17/19 CTA report. MD #5 realized the images were that of another patient and called the Hospital radiology department. An addendum was made to P #10's radiology report by Radiologist #2 and identified P #10's correct CTA reading. The email further indicated that P #10 was concerned that the addendum was not enough, and that s/he could mistakenly have an unnecessary procedure because of the misdiagnosis on the chart.

An email from MD #5 dated 3/2/21 noted that P #10 was angry over the original radiology mix up.

The grievance (filed on 3/1/21 on behalf of P #10) identified that the Hospital spoke with P #10 on 3/25/21 at 3:10 PM and P #10 was to receive documents to be completed in order for the medical record to be amended.

The hospital failed to provide a written response to P #10's grievance regarding the radiology mix- up.

Interview with the Director of Patient Relations on 4/7/21 at 12:47 PM noted that she would have expected Patient Grievance Coordinator #1 to send a written response to P #10 when Patient Grievance Coordinator #1 sent P #10 the paperwork for the amended record.

The hospital policy entitled Patient Rights and Responsibilities identified a right to receive prompt response to a complaint or grievance. The hospital policy entitled Patient Complaint and Grievance Management Policy identified that a written response to a grievance will be provided to the patient within thirty (30) business days.

Based on medical record review, review of hospital policies, review of hospital documentation, review of manufacturer's recommendations, observations and interviews for one of twelve patients reviewed for patient rights (P #1) and for one of nine surgical patients (P #1), the facility failed to ensure a safe environment during an operative procedure. The finding includes:


a. P #1 was admitted to the hospital on 4/3/21 following multiple stab wounds to the torso, left flank, left arm, left posterior chest and head. P #1 required emergent surgery and was taken to OR (operating room) #12 at 10:51 PM on 4/3/21.

The anesthesia record identified that Anesthesiologist #1 was the responsible anesthesia provider. P #1 was anesthetized and subsequently intubated at 11:07 PM. The anesthesia record further noted that P #1 was transported from OR #12 to OR #9 at 11:20 PM due to an OR fire. P #1's surgery continued in OR #9 and was completed without further incident. P #1 did not sustain injury as a result of the fire and procedure relocation.

An equipment/medical device report dated 4/4/21 identified that while P #1 was intubated, a pop noise was heard and flames were observed coming from the rapid infuser (used to warm and rapidly infuse fluids) that was located in the right corner of the OR room. The report further indicated that the fire would start again following use of the extinguisher and "would not go out until it was unplugged from the wall". The equipment/medical device report dated 4/4/21 noted that a call was placed to "155" (hospital emergency line), the OSAM (off shift administrative manager) and the fire department was subsequently called.

The OR staff failed to follow their fire safety plan that identified to immediately pull the fire alarm in order to ensure a timely notification of the local fire department and to ensure timely assessment of the scene and patient safety.

Observation of the involved rapid infuser (RI-2) on 4/5/21 at 11:05 AM in the Biomedics department identified that a 1000 cc IV (intravenous) bag of solution was spiked and hanging from the RI IV pole. The observation also identified that the electrical plug at the back of the RI-2 and the back panel of the RI-2 were charred and the laminated instruction card that hung at the back of the device was also burned and had melted onto the cord connected to the back of the device.

Observation of OR #9 on 4/6/21 at 10:43 AM identified a CO2 fire extinguisher on the right wall and the closest fire alarm pull station was located outside OR #12, which was around the corner and approximately 61 feet away from OR #12's entry doors.

Interview with Assistant Manager #1 on 4/5/21 at 11:33 AM and/or 1:51 PM identified that RN #1 (circulator) phoned her at 11:23 PM on 4/3/21 to inform her of the OR fire. She further identified that she instructed RN #1 to call the OASM.

Interview with RN #1 (circulator) on 4/7/21 at 9:18 AM identified that she should have pulled the fire alarm and was unsure of the pull station location at the time of the fire.

Interview with the OSAM on 4/7 /21 at 2:37 PM identified that she was in the hospital, went to the OR department, and was informed that the fire alarm was not pulled and the fire department had not yet been notified. The OSAM called security to instruct SO (security officer) #1 to call the fire department. The OSAM further indicated that Engineer #1 informed her there was no need to call the fire department after checking OR #12 and the equipment. However, the OSAM disagreed and educated both RN #1 and Electrician #1 of the need to notify the fire department to ensure safety.

The hospital policy entitled fire safety in a procedural area identified that all team members will be familiar with the locations of the pull stations. The policy further identified that the circulating nurse/procedural assistant will, in part, pull the fire alarm box, delegate if necessary.

The hospital policy entitled Patient Rights and Responsibilities identified that the patient had the right to receive care in a safe and secure environment.




b. A hospital email dated 4/4/21 at 6:30 AM identified that Biomed Tech #1 came and inspected the RI-2 that had caught on fire, brought the device to the Biomed office and recommended that all other RI-2's in the OR be unplugged.

A MAUDE (manufacturer and user device experience) data base report accessed by the hospital on 4/5/21 and dated 3/29/19 identified that the RI-2 device had a similar fire at another facility attributed to the electrical cord at the device.

Observation on 4/5/21 at 11:05 AM in the Biomedics department of the involved RI-2 identified that a 1000 cc IV (intravenous) bag of solution spiked and hanging from the RI IV pole. The observation also identified that the electrical plug at the back panel of the RI-2 and the back of the RI-2 were charred and the laminated instruction card that hung at the back of the device was also burned and had melted onto the cord connected to the back of the device. Additional RI-2 devices were not observed in the Biomed department.

Interview with the Manager of Clinical Engineering on 4/5/21 at 11:20 AM noted that the hospital had 4 additional RI-2's, 2 were located in the OR, one in the ED (emergency department) and one in either L&D (labor and delivery) or the ICU (intensive care unit). He further indicated that they were not removed from service because they may be needed in an emergency. Subsequently, the four additional RI-2 devices were removed from service and taken to the Biomed office per the direction of the Department of Public Health Building and Fire Safety Investigator.

The hospital failed to ensure that the additional RI-2 devices were removed from service and thoroughly inspected immediately after the fire allowing for available use and possible risk to patient safety from 4/4/21 at 12:40 AM to 4/5/21 at 11:30 AM.

The hospital policy entitled 2021 Medical Equipment Management Plan noted an objective to identify and respond appropriately to equipment hazards in a timely manner and to implement processes designated to further reduce the risks associated with medical equipment throughout the facility. The policy further noted that the hospital, in part, inspects and tests medical equipment and performs safety checks.

The hospital policy entitled Patient Rights and Responsibilities identified that the patient had the right to receive care in a safe and secure environment.


The hospital submitted an immediate action plan dated 4/5/21 to include equipment recall with system- wide notification, delivery of replacement equipment, and device and emergency response education. The facility was found to be compliant with the plan as submitted on 4/6/21.





c. Additional staff interviews identified the following:

Interview with RN #1 (circulator) on 4/7/21 at 9:18 AM identified that on 4/3/21, she went into the hall when the fire was extinguished in the OR and called the 155 emergency number. She further indicated that the operator told her that 155 was only for "codes" (cardiac arrests) and would transfer her call to the boiler room.

Interview with the Manager of Clinical Operations on 4/7/21 at 2:21 PM identified that she spoke with the operator who received the 155 call and the operator understood that the fire had been extinguished, clean- up was needed and therefore she was going to transfer RN #1's call to the boiler room.

Interview with the Security Manager on 4/7/21 at 2:25 PM identified that when 155 is called, the phone call is picked up by desk security (dispatch) as well as the operator and security would then call to the fire department by dialing 911.

An interview with SO #1, initiated on 4/7/21 and completed on 4/8/21 at 12:38 PM, identified that he was trained to call maintenance with a report of a fire and maintenance would decide whether or not to notify the fire department. SO #1 further noted that his trainer taught him this procedure and a written policy or procedure was not available.

The operator at the 155 emergency call failed to follow the hospital 155 procedure to call the security dispatch when a fire was reported. The hospital lacked a written procedure for dispatch security to follow in the event of a reported fire. Operator and Security failures delayed local fire department notification and the insurance of patient safety.

The hospital's posted procedure for hospital operators directed that they contact hospital security for any fire activity at extension 3466.

The hospital did not have a policy directing dispatch security responsibilities following notification of a fire.

The hospital submitted an addendum to the action plan on 4/7/21 to include education for expected procedural operator and security response to fire notification.




d. Additional observations and staff interviews identified the following:

Observation in the Biomedics department of the involved RI-2 on 4/5/21 at 11:05 AM identified that a 1000 cc IV (intravenous) bag of solution spiked and hanging from the RI IV pole. The observation also identified that the electrical plug at the back of the RI-2 and the back panel of the RI-2 were charred and the laminated instruction card that hung at the back of the device was also burned and had melted onto the cord connected to the back of the device. Observation of the intake fan cover on the underside of the device identified a build- up of dust and debris in a small area of the fan cover.

Anesthesiologist #1 was interviewed on 4/6/21 at 11:42 AM and was asked to give an exact accounting of the RI-2 setup that he performed on 4/3/21. Anesthesiologist #1 indicated the following 1. He was notified of a "class 1" (emergency case) the night of 4/3/21 and prepared the RI-2 in case it would be needed; 2. The RI-2 was already in OR #12 with the tubing attached and was unplugged; 3. He spiked the IV bag, plugged in the machine and pressed the device power button; 4. Anesthesiologist #1 pressed the prime button on the device, primed the tubing with IV fluid and the device was left on in "standby mode". Anesthesiologist #1 identified that when he initially powered the device on, he heard a short lasting unusual humming noise but attributed this to be like the noise when starting an engine. Anesthesiologist #1 did not identify that he inspected/cleaned the RI-2 device prior to use.

Interview with the Clinical Engineer Manager on 4/7/21 at 12:13 PM noted that the RI devices do not receive preventive maintenance/inspection from his staff other than the annual preventive maintenance and in the event of a reported issue The Clinical Engineer Manager indicated that additional cleaning would not be performed by his staff.

The manufacturer's preventive maintenance schedule for the RI-2 directed, in part, to check/clean the fan guard and check power cord before and after each use.

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

Based on staff interviews, inspection of physical evidence, and training records provided to the surveyor by the Director of Accreditation and Regulatory Affairs, facility staff failed to follow the established policies and procedures for response to a fire incident within an operating room, and failed to follow the established policies and procedures for the physical integrity, resistance, leakage current, and touch current tests for fixed and portable patient-care related electrical equipment is performed as required by section # 10.3 of NFPA 99.



Please see A701 and A724



On 4/5/21 IJ was identified starting on 4/3/21 when staff failed to properly respond to a fire in the operating room during a surgical procedure, and failed to immediately remove and/or perform a risk assessment of other equipment once a safety concern was identified. An Immediate Action Plan was submitted on 4/5/21 at 3:20 PM. The action plan was reviewed on 4/6/21 and identified that the hospital implemented the plan as written. IJ was removed on 4/6/21.

The hospital submitted an immediate action plan dated 4/5/21 to include equipment recall with system- wide notification, delivery of replacement equipment, and device and emergency response education. The facility was found to be compliant with the plan as submitted on 4/6/21.

The hospital submitted an addendum to the action plan on 4/7/21 to include education for expected procedural operator and security response to fire notification.

Based on staff interviews, inspection of physical evidence, and training records provided to the surveyor by the Director of Accreditation and Regulatory Affairs, facility staff failed to follow the established policies and procedures for response to a fire incident within an operating room. The findings include:


a. Review of hospital documentation and staff interviews identified the following evidence: On 04/03/21 at approximately 11:08 PM, as a patient was being prepared for a surgical procedure within Operating Room #12 (O.R. #12), staff witnessed smoke and visible two (2) foot high flames emitting from a Belmont Rapid Infuser pump that was plugged into a wall electrical receptacle in direct proximity to the patient in O.R. #12. Staff utilized a nearby fire extinguisher to suppress the fire. After discharging the extinguisher on the appliance that was on fire, staff observed that the appliance was continuing to emit smoke and burn. Staff again discharged the fire extinguisher on the appliance that was on fire. Simultaneously, staff called an internal telephone number (155) to report the fire at 11:18 PM. This number connected the caller to facility staff in the boiler room. The caller was instructed by the boiler room staff to contact the facility security department. O.R. staff then called the facility security department to report the fire. Security Department staff called 911 to report the fire to the local fire department. The patient was removed from O.R. #12 by staff at 11:20 PM. Bridgeport Fire Department personnel arrived on location of the fire at 11:45 PM.

Facility staff failed to activate a fire alarm pull station as specified in the facility Fire Response Plan Policy.

During a physical inspection of the Operating Room suite that was involved in the incident, the surveyor observed two (2) fire alarm pull stations near O.R. #12. One fire alarm pull station was sixty-one (61) feet from O.R. #12, the other was seventy-eight (78) feet from O.R. #12. Neither was utilized during the fire incident of 04/03/21.



b. On 04/05/21 the surveyor, accompanied by facility staff, toured the Clinical Engineering Department work space to investigate the appliance involved in the fire which was being held in a secure location by facility staff. During the course of the examination of the pump involved in the fire, the surveyor asked facility Clinical Engineering staff that were present in the same room how many other of these pumps were in the facility and their locations. The Director of Clinical Engineering informed the surveyor that the pumps were in the operating rooms on a stand by basis if needed, as there were no other pumps that could replicate the function that these pumps do, and these pumps are integral in the event of an emergency with patient care in the operating rooms. The Director of Clinical Engineering then informed the surveyor that a conference call had just been completed with the manufacturers and their representatives, and it was relayed to all on the call by manufacturer representatives that similar fire events involving these types of pumps had occurred in the past in other facilities, with no defined reason why these fires had occurred but the suspicion was saline solution being dripped onto the power cord that energizes the pump started these fires. At this time, the surveyor informed the Director of Clinical Engineering to remove all Belmont Feed pumps from service immediately throughout all surgical facilities in the Yale New Haven Health network (5 pumps at this hospital) until a definite answer could be obtained on the cause of the fires with these types and styles of pumps by this manufacturer. The Director of Clinical Engineering agreed and started the process to inform his network to immediately remove these pumps from service.



On 4/5/21 IJ was identified starting on 4/3/21 when staff failed to properly respond to a fire in the operating room during a surgical procedure, and failed to immediately remove and/or perform a risk assessment of other equipment once a safety concern was identified. An Immediate Action Plan was submitted on 4/5/21 at 3:20 PM. The action plan was reviewed on 4/6/21 and identified that the hospital implemented the plan as written. IJ was removed on 4/6/21.

The hospital submitted an immediate action plan dated 4/5/21 to include equipment recall with system- wide notification, delivery of replacement equipment, and device and emergency response education. The facility was found to be compliant with the plan as submitted on 4/6/21.

The hospital submitted an addendum to the action plan on 4/7/21 to include education for expected procedural operator and security response to fire notification.

Based on staff interviews, inspection of physical evidence, and review of training records provided to the surveyor by the Director of Accreditation and Regulatory Affairs, facility staff failed to follow the established policies and procedures for the physical integrity, resistance, leakage current, and touch current tests for fixed and portable patient-care related electrical equipment is performed as required by section # 10.3 of NFPA 99. The findings include:


Review of hospital documentation and staff interviews identified the following evidence: On 04/03/21 at approximately 11:08 PM, as a patient was being prepared for a surgical procedure within Operating Room #12 (O.R. #12), staff witnessed smoke and visible two (2) foot high flames emitting from a Belmont Rapid Infuser pump that was plugged into a wall electrical receptacle in direct proximity to the patient in O.R. #12. Staff utilized a nearby fire extinguisher to suppress the fire. After discharging the extinguisher on the appliance that was on fire, staff observed that the appliance was continuing to emit smoke and burn. Staff again discharged the fire extinguisher on the appliance that was on fire.

Records provided to the surveyor indicated that the last documented inspection and service to the unit was conducted in September 2020.

After the incident of a Belmont Infuser Pump (serial # 2019011501) catching fire within Operating Room #12 on 04/03/21, the surveyor was not provided with records that did indicate that anesthesia or biomedical staff was inspecting the pump at the intervals described within the device operating manual. An inspection of this device post fire incident by the surveyor showed that the fire began at the exterior rear of the device where the power cord female end is inserted onto the male receptacle on the unit.

The manufacturer's preventive maintenance schedule for the RI-2 directed, in part, to check/clean the fan guard and check power cord before and after each use.