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707 EAST MAIN STREET

MIDDLETOWN, NY 10940

QAPI

Tag No.: A0263

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Based on medical record review, document review and interview, the facility failed to utilize its hospital-wide quality assessment and performance improvement program to identify actual or potential problems concerning patient care and clinical performance and develop courses of actions to address problems identified.

These findings were noted in one (1) of five (5) incident reports reviewed (Patient #1).

The failure to identify problems and implement corrective actions may result in negative patient outcomes.

Findings include:

Review of Quality Assessment and Performance Improvement for an incident dated 9/26/22 for Patient #1 revealed a 69-year-old female with a history of Chronic Obstructive Pulmonary Disease who presented to the ED on 9/26/22 at 6:30 AM with difficulty breathing and was placed on BIPAP (Bi-level Intermittent Positive Airway Pressure) for oxygenation. On 9/26/22 at 10:51 AM, the patient was found unresponsive with BIPAP tube dislodged. The patient was successfully resuscitated but suffered anoxic brain injury. The facility failed to conduct a thorough review of the incident, identify areas of improvement, and implement corrective actions.

See A-0286
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PATIENT SAFETY

Tag No.: A0286

Based on medical record review, document review and interview, the facility failed to utilize its hospital-wide quality assessment and performance improvement program to identify actual or potential problems concerning patient care and clinical performance and develop courses of actions to address problems identified.
These findings were noted in one (1) of five (5) incident reports reviewed (Patient #1).

This failure prevents identification and resolution of problems that could result in potential harm to patients.

Findings include:

Review of the facility's "Risk Events" from September 2022 to February 2023 revealed an incident dated 9/27/22 that occurred in the Emergency Department on 9/27/22 involving Patient #1. The patient was a 69-year-old female with a medical history of Chronic Obstructive Pulmonary Disease (on home oxygen) who was brought to the Emergency Department (ED) for severe shortness of breath. The patient was placed on BIPAP (Bilateral -Level Positive Airway Pressure) as per physician order and her vital signs as recorded by the automated electronic monitor were Blood Pressure (BP) 120/70, Pulse (P) 92, Respiratory Rate (RR) 22, and SpO2- 97%. At 10:51 AM, the patient was found by a nurse in bed slumped over to the left side with BIPAP mask on, and BIPAP tubing disconnected and on the floor. The patient was successfully resuscitated but suffered catastrophic brain injury consistent with Brain Death secondary to anoxia. The patient expired on 10/07/22 at 1:27 PM.

Quality review of incident dated 3/23/23, noted the event for Patient #1 occurred in the Emergency Department during a period of high acuity and high census. The report noted "there was also an incidental finding in the review where the RN orientee accidentally and erroneously validated a false oxygen saturation at 15% before the event [cardiac arrest] occurred."

The review concluded the following:
No problems with the BIPAP equipment
No lapses in documentation surrounding the event
No delay in communication
No omission of services.

The review of medical record for Patient #1 identified that there were significant changes in the patient's vital signs on 9/27/22 that were not timely recognized and managed.
On 9/27/22 at 10:08 AM, patient's vital signs as recorded by the automated electronic monitor were Blood Pressure (BP) 120/70, Pulse (P) 92, Respiratory Rate (RR) 22, and SpO2- 97%.
At 10:39 AM, automated vital signs readings were BP 121/95, P 95, RR 33, SpO2 15%.

There was a significant delay in responding to the patient's BIPAP alarms and the SpO2 of 15%. At 10:51 am, 12 minutes from the last recorded vital signs, the patient was found unresponsive with a dislodged BIPAP tube.

During the tour of the ED on 3/23/23 at approximately 10:12 AM, equipment alarms were not centrally monitored and there was no system in place to alert a nurse who may be busy with other patients.

During a second tour of the ED on 3/28/23 at approximately 10:34 AM, in the presence of the respiratory care team and Chief Nursing Officer and Chief Operating Officer, ventilator and BIPAP alarms were audible in the Nurses' Station, in rooms 36 and 37 but not in room 34 where the patient's nurse was caring for another patient during the incident.

The quality review of the incident did not identify any problems and no corrective actions were implemented.

On 03/28/2023 at 4:00 PM, these findings were brought to the attention of facility's administrative personnel Staff A (Vice President of Quality and Patient Safety), Staff C (ED, Nursing Administrator), Staff R (Chief Operating Officer), and Staff S (Chief Nursing Officer).
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EMERGENCY SERVICES

Tag No.: A1100

Based on medical record review, document review, and interview, in one (1) of eighteen (18) medical records reviewed, the Emergency Department staff failed to monitor, respond timely, and manage a patient with critical levels of oxygen saturation.

These failures resulted in the death of Patient #1 and placed other patients at risk for harm.

Findings include:

The Emergency Department staff failed to monitor and respond timely to Patient #1 who was on BIPAP (A bilevel positive airway pressure), a non-invasive ventilation machine, and whose oxygen saturation level dropped to 15% (normal oxygen saturation is 95-100%). The patient was found unresponsive with BIPAP oxygen tube disconnected. The patient suffered an anoxic brain injury (brain injuries caused by lack of oxygen to the brain, which results in the death of brain cells), and subsequently died.

See Tag A-1104.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on medical record review, document review, and interview, in one (1) of eighteen (18) medical records reviewed, the Emergency Department staff failed to monitor, respond timely, and manage a patient in critical condition.

These failures caused harm to Patient #1 and placed other patients at risk for harm.

Findings include:

Patient #1 was a 69-year-old female, Assisted Living resident, with a medical history of Chronic Obstructive Pulmonary Disease (on home oxygen) who was brought to the Emergency Department (ED) by EMS on 9/26/22 at 6:30 AM for severe shortness of breath. As per EMS report, the patient desaturated to the 70s (normal oxygen saturation is 95-100%) and she required a non-rebreather mask that was upgraded to CPAP (Continuous Positive Airway Pressure) which increased the patient's oxygen saturation to the 90s on arrival to the ED. In the ED, the patient was immediately triaged and medically evaluated.

At 6:54 AM, the patient was placed on BIPAP (Bi-Level Intermittent Positive Airway Pressure) as per physician order. At 10:08 AM, patient's vital signs as recorded by the automated electronic monitor were Blood Pressure (BP) 120/70, Pulse (P) 92, Respiratory Rate (RR) 22, and SpO2- 97%.

At 10:39 am, automated vital signs readings were BP 121/95, P 95, RR 33, SpO2 15%.

There was no indication or documented evidence that Staff G and O (nurses) reviewed the patient's vital signs and escalated the patient's medical condition to the provider.

At 10:51 AM, 12 minutes after the last vital sign reading, the patient was found by Staff G (Registered Nurse Orientee) in bed slumped over to the left side with BIPAP mask on, and BIPAP tubing disconnected and on the floor. The patient was successfully resuscitated and admitted to the Intensive Care Unit.

On 09/29/2022, head CT scan revealed cerebral and cerebellar [Brain] edema. A physician noted that CT scan showed "catastrophic brain injury consistent with Brain Death secondary to anoxia." The patient underwent Brain Death Protocol - she was extubated and pronounced dead on 10/07/22 at 1:27 PM.

Review of the policy titled, "Emergency Department and Assessment/Reassessment" (Revised 05/12/2021) revealed that "...For any change in in the patient's condition, the ED provider must be notified immediately ...Reassessments are also performed: (1) When there is a clinically significant change in the patient's status. (2) When there is a clinically significant change in the patient's vital signs. (3) As indicated by the patient's condition and/or treatments/procedures ..."

On 03/24/2023, at 11:29 AM, an interview was conducted with Staff O (ED, Registered Nurse Orientee Preceptor) who stated, "the patient was alert and oriented x 3 the entire time. She [Patient #1] tried to pull off her mask several times. I [Staff O] was delivering care to another patient with chest pain when I received a call from Staff G over Vocera (Device used for clinical communication) asking me to come to bay 37. When I [Staff O] went in, the patient's mask was on, and the BIPAP tubing was disconnected."
Staff O reported that the BIPAP alarm could only be heard close to Patient #1's room, and she was unable to hear the alarm while attending to a patient in another room.

During interview on 03/27/2023 at 11:29 AM, Staff G (ED, Registered Nurse Orientee) recalled that the patient arrived at the ED in respiratory distress. Patient was placed on BIPAP. Staff G said, "I was in another room (#36) where we had three patients with COVID. Nebulizers were going off in the room, I could not hear the alarm in room 36, where the patient [patient #1] was located. As I walked out, I heard the BIPAP going off. The doctor and I went into patient's room where I found the patient's tubing was disconnected. It was laying on top of the bed. It was not connected. We checked for pulse, and I grabbed the cart."

During the tour of the ED on 3/23/23 at approximately 10:12 AM, monitors were observed at the nursing station.
During a concurrent interview, Staff C (Nurse Administrator), reported that no one is assigned to observe the monitors at the nurses' station, but they are located there so that nurses can view the monitors when they are at the station.

During a second tour of the ED on 3/28/23 at approximately 10:34 AM, in the presence of the respiratory care team and Chief Nursing Officer and Chief Operating Officer, ventilator and BIPAP alarms were audible in the Nurses' Station, in rooms 36 and 37 but not in room 34 where Staff O was caring for another patient during the incident with Patient #1.

On 03/28/2023 at 4:00 PM, an Immediate Jeopardy (IJ) situation was announced due to the facility's failure to monitor and respond timely to medical equipment alarms resulting in delayed recognition of the patient's emergency and prompt medical evaluation and treatment of the patient. The patient went into cardiac arrest and was successfully resuscitated but suffered irreversible brain injury and death.

The facility provided an IJ removal plan to survey staff on 03/29/2023 at 06:04 pm.
The plan included:
(1) A revised policy (effective 03/2023) titled, "Telemetry Admission and Discontinuation -Adult and Pediatric" that notes "...Emergency Room Provider (Physician, NP/PA} will determine that the patient requires telemetry monitoring...
(2) ED RN assigned to the patient will notify ED Central Monitoring of the new telemetry order...
(3) Telemetry rhythms and pulse oximetry will be monitored continuously...
(4) Events, ectopy, and arrhythmias are reported by the ED Central Monitoring immediately to the patient's primary RN. If the primary RN is unavailable, it is reported to the Charge RN. If the Charge RN is not reachable, it is reported to the ED manager then nursing unit director.
(5) An assessment of the patient experiencing a significant change is conducted by the RN...
(6) The nurse calls the responsible practitioner using the SBAR format with the assessment results, changes in condition and rhythm interpretation and documents findings and MD notification in Epic...
(7) Continuous Pulse Ox Monitoring: RN or LIP will notify Telemetry Tech parameters for O2 sat limits
Telemetry Tech will notify primary RN if O2 sat falls below designated low parameter
(8) RN is responsible for documentation of O2 Sat within EMR
Same escalation for cardiac alarms will be followed with O2 sat notification to RN/Charge Nurse/Nurse Leader...."

The IJ was removed on 03/29/2023 at 3:15 PM based on onsite verification of the implementation of the IJ removal plan.
Surveyors conducted tours and interviews with ED staff on 3/29/23 to verify staff re-education and observe staff monitoring and response to equipment alarms.
Based on interview with nursing staff and telemetry technicians on duty, 100 % of staff reported they have been re-education to the revised policies on assessment and reassessment of patients, Cardiac and Oxygen Saturation Monitoring-Alarm Response Plan. Review of the training log revealed 56% of staff working in the Emergency Department had been trained. Interviews conducted with senior leadership confirmed that facility staff members that have not been in-serviced would be trained on the revised policies before the start of their shift.
Observation in the ED revealed two (2) staff members, an ED RN and a Telemetry Technician were assigned to monitor cardiac and oxygen saturation alarms. Interviews with senior leadership confirmed that qualified personnel would be assigned to continuously monitor cardiac and oxygen saturation alarms 24/7.