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Based on observation, interview and document review, the hospital was found to be out of compliance with the Condition of Participation (COP) 482.41 Physical Environment due to failure of ensuring annual preventative maintenance was completed on patient care equipment according to hospital policy; and the failure to develop and implement a system to provide appropriate stop-gap measures to prevent continued hazards and accidents while incidents involving potentially malfunctioning patient care equipment were investigated.

The cumulative effect of these systemic issues resulted in the hospital's inability to ensure safety for patients and therefore did not meet the COP.

Findings include:

Refer to A701; Based on observation, interview and document review, the hospital failed to develop and implement a system to provide immediate, stop-gap measures when potentially defective and/or malfunctioning patient care equipment was identified. This increased the risk of continued incidents and/or accident hazards while using these devices and had potential to affect all patients receiving care in the hospital.

Refer to A710; Based on observation, interview, and documentation review, the hospital was found to be out of compliance with Life Safety Code (LSC) requirements. These findings have the potential to affect all patients in the hospital.

Refer to F724; Based on observation, interview and document review, the hospital failed to ensure preventative maintenance (PM) was performed on 2 of 78 capnography machines, in accordance with hospital policy, to prevent malfunction and/or accidents. This had potential to affect all patients using these machines.

Based on observation, interview and document review, the hospital failed to develop and implement a system to provide immediate, stop-gap measures when potentially defective and/or malfunctioning patient care equipment was identified. This increased the risk of continued incidents and/or accident hazards while using these devices and had potential to affect all patients receiving care in the hospital.

Findings include:

A provided Current Summary report, dated 7/29/20, identified a fire had happened in the Birth Center of the hospital on 7/29/20, in a patient room. The report identified a capnography machine (used in monitoring the concentration or partial pressure of carbon dioxide of a patient) had caught fire while in use on a patient that caused them to evacuate the area and the local fire department to respond. The patient (P1) was uninjured in the incident.

On 8/3/20, at 9:47 a.m. the patient room where the fire happened was toured with registered nurses (RN)-C and RN-D present. The room had been sealed off from the hallway and other patient rooms using a hard-plastic barrier, and several air filtration devices remained in place to reduce the smoke odor. The patient bed remained in the room and was positioned with the headboard along the outside wall; approximately five feet away from a small counter which had been built-in to the wall. The counter had a visible black scorch mark present which measured approximately 8 to 10 inches (") in diameter. RN-D verified the bed was likely in the same position it would have been while the incident happened in real-time. There was no visible burn marks or damage to the patient bed; however, a similar black-colored burn and/or scorch mark was present on the floor of the patient room. RN-D explained, to her understanding, the machine had been pulled to the floor as the staff were trying to evacuate the patient from the room, and while it was on the floor, the machine had continued to spark and display flames. RN-D verified the burn markings were not present prior to the capnography machine fire on 7/29/30. RN-D was interviewed at this time, and explained the use of the capnography machines on the birthing unit happened very infrequently; however, she voiced the nurses were all trained in their use upon orientation to the hospital.

On 8/3/20, at 12:14 p.m. P1 was interviewed and explained the incident in detail. P1 and her husband were in the room and P1 was hooked up to several machines, including the capnography machine, when suddenly they heard "a pop sound" from the machine and it immediately following "burst into flames." P1 described the flames as "two or three feet high" when the machine initially ignited. P1 and her husband immediately began to yell into the hallway for help, and a series of staff members including nurses and maintenance personnel responded with fire extinguishers as the room started to fill with smoke. P1 affirmed the capnography machine was attached to her when it started on fire, however, verified she was uninjured during the event.

When interviewed on 8/3/20, at 10:06 a.m. RN-E stated she worked as a float nurse between several units around the hospital. RN-E stated she had just been made aware of a fire which happened involving a capnography machine that morning, on 8/3/20, however, voiced she did not know any specifics aside from something had happened. RN-E expressed she had not been given any re-education or instructions on the capnography machines since the incident.

When interviewed on 8/3/20, at 1:56 p.m. the director of clinical engineering (DCE) explained the machine used at the time of the incident was an Oridion Capnostream20 capnography machine and provided the burned unit for review to the surveyor and the Deputy State Fire Marshal. The unit was visibly melted and burned with gray and black-colored burn markings present on nearly it's entire surface. The device smelled of burned plastic and smoke. DCE explained the hospital had 78 total capnography machines (77 remaining post-incident) and stated this model had been subject to a battery-related recall in 2016 which "had potential to cause fires." DCE verified the recall(s) were completed and the batteries for the devices had since been changed, as per the recall directions. The machines had potential to be used on "any of the medical floors," and when questioned on procedures in place for review of the other-like machines to ensure they were in good working condition and reduce the risk of fire and/or similar malfunction, DCE voiced the hospital had not yet started to review or inspect any of the other machines since the incident; nor had the hospital contacted the device manufacturer for input on the malfunction since they were still investigating the situation. DCE explained the hospital was currently reviewing their sequester process for equipment, however, acknowledged they currently did not have a process to "go back and test like equipment" or a process to determine when to notify staff to potential concerns surrounding pieces of equipment when malfunctions occur. DCE expressed, in hindsight, an email or message could have been relayed to staff to be aware of the incident and subsequent monitoring of the machines, or a physical check of the equipment to ensure no visible battery-related issues (i.e. swelling) were present.

On 8/3/20, at 3:01 p.m. the vice president of performance excellence and the regulatory officer for the hospital were interviewed. They explained many of their systems to provide stop-gap measures depend on "what happens around the patient" and if harm occurs. P1 was unharmed during the fire event on 7/29/20, so the hospital viewed the incident as more of a critical event rather than reportable and/or sentinel event (any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not related to the natural course of the patient's illness). As a result of the incident, they outlined a critical event review would be completed which would help determine the follow-up actions, if any, the hospital would take to prevent continued similar incidents. This process included completing "a huddle" of involved staff with 48 hours of the incident, however, they expressed this had not been done. Further, they expressed this incident provided them "an opportunity" to review their processes, including equipment stop-gap measures and when to notify staff of equipment alerts, which was important to do as the hospital "want[s] to make sure our equipment is functioning and safe for the patient's it's being used on."

A provided Medical Equipment Management Plan policy, dated 2/2020, identified a purpose of supporting a safe patient care and treatment environment by managing risks associated with the use of clinical equipment. A scope was listed which directed the program was designed to assure continual availability of safe, effective equipment through a program of planned maintenance, timely repair, and evaluation of all events that could have an adverse impact on the safety of patients and staff. Further, a section labeled, "Hazard Notices and Recalls," identified the clinical engineering director, among others, would be notified who would then, " ... screen known equipment for matches and by evaluating the relative severity of the risk. When conditions warrant, equipment is remove from service and replaced with a safe effective substitute if available." The policy lacked any directions or guidance on how the director makes the determination regarding which pieces are removed or how/when users would be notified to be alert to potential concerns pertaining to a piece of equipment.

Based on observation, interview, and documentation review, the hospital was found to be out of compliance with Life Safety Code (LSC) requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to LSC deficiencies cited at K711 and K921 for additional information.

Based on observation, interview and document review, the hospital failed to ensure preventative maintenance (PM) was performed on 2 of 78 capnography machines, in accordance with hospital policy, to prevent malfunction and/or accidents. This had potential to affect all patients using these machines.

Findings include:

A provided Current Summary report, dated 7/29/20, identified a fire had happened in the Birth Center of the hospital on 7/29/20 in a patient room. The report identified a capnography machine (used in monitoring the concentration or partial pressure of carbon dioxide of a patient) had caught fire while in use on a patient causing them to evacuate the area and the local fire department to respond. The patient (P1) was uninjured in the incident.

On 8/3/20, at 12:14 p.m. P1 was interviewed and explained the incident in detail. P1 and her husband were in the room and P1 was hooked up to several machines, including the capnography machine, when suddenly they heard "a pop sound" from the machine and it immediately following "burst into flames." P1 described the flames as "two or three feet high" when the machine initially ignited. P1 and her husband immediately began to yell into the hallway for help, and a series of staff members including nurses and maintenance personnel responded with fire extinguishers as the room started to fill with smoke. P1 affirmed the capnography machine was attached to her when it started on fire, however, verified she was uninjured during the event.

When interviewed on 8/3/20, at 1:56 p.m. the director of clinical engineering (DCE) explained the machine used at the time of the incident was an Oridion Capnostream20 capnography machine and provided the burned unit for review to the surveyor and the Deputy State Fire Marshal. The unit was visibly melted and burned with gray and black-colored burn markings present on nearly it's entire surface. The device smelled of burned plastic and smoke, and a visible sticker was affixed to the top which read, "FBC 1450328." DCE explained the hospital' system for completing preventative maintenance (PM) included monthly rounding to patient rooms and soiled utility rooms to check equipment and place new stickers when the PM is completed. However, DCE acknowledged there was still a "certain amount" of equipment which does get missed as they skip occupied rooms on these rounds. DCE voiced the hospital used 78 total capnography machines (77 remaining post-incident) similar to P1's which had caught fire, and they were to have annual PM completed per hospital policy and their assigned risk score. DCE provided a report demonstrating the PM completed on these machines.

A Biomedical Engineering report, dated 8/3/20, identified all the capnography machines used along with their last completed PM. The device attached to P1 when it ignited was listed with the same matching tracking number as the machine had been labeled with; however, the last required PM, which was dated to be done in September 2019, was recorded as, "Unable to Locate." Further, one additional unit (Control 2030368) was also recorded with the same findings of, "Unable to locate," despite it's PM being due in July 2020.

DCE explained the annual PM for the machines included a visual inspection, calibration of the unit, performing a safety check and replacing the batteries every two years. DCE verified P1's capnography machine which had caught fire on 7/29/20, did not have the annual PM completed, with his records last showing it done in 2018. Further, DCE expressed those particular machines had been subject to a safety recall in 2016 due to an issue with their batteries; however, added these had all been completed since the recall.

On 8/3/20, at 3:01 p.m. the vice president of performance excellence and the regulatory officer for the hospital were interviewed. They expressed the incident involving P1's capnography machine provided them "an opportunity" to review their processes, including the preventative maintenance procedures, which was important as the hospital "want[s] to make sure our equipment is functioning and safe for the patient's it's being used on."

A provided Medical Equipment Management Plan policy, dated 2/2020, identified the purpose of the plan was to support a safe patient care and treatment environment. A section labeled, "Inspection, Testing, and Maintenance," directed the clinical engineering department was responsible for managing, testing and maintenance processes. Further, a computer system would be used to establish a PM program which addressed the needs of each piece of equipment, along with each piece' specific frequency of inspection. Further, the policy directed clinical engineering assured all scheduled testing of life support and non-life support equipment would be " ... performed in a timely manner."

A provided Oridion Capnostream 20p Operator's Manual, dated 2017, identified the machine required no routine service " ... other than any performance testing mandated by the operator's institution." However, the monitor required period calibration to ensure proper operating limits.