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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance.

A-0144 CARE IN SAFE SETTING The patient has the right to receive care in a safe setting. Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring (monitoring a patient's heart rhythm) and continuous pulse oximetry (a medical device used to measure the saturation of oxygen carried in red blood cells) were provided in accordance with the providers' orders, facility policies, and facility-adopted educational references. This failure was identified in two of ten observations of patients on pulse oximetry and in one of five telemetry patients' medical records reviewed.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM was out of compliance.

A-286 Program Scope. (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ...identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ....§482.21(c) Standard: Program Activities ...(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. §482.21(e) Standard: Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ...(3) That clear expectations for safety are established. Based on interviews, and record review, the facility failed to ensure the quality assurance and performance improvement (QAPI) committee implemented a quality control process which addressed failures in patient care related to patient monitoring in two of two events reviewed.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 INFECTION PREVENTION AND CONTROL AND ANTIBIOTIC STEWARDSHIP PROGRAMS was out of compliance.

A-749 - The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews, and record review, the facility failed to ensure staff followed infection control practices and policies in two of two observations of patients on ventilators, in two of two observations of patients with tube feedings, and in three of three observations of patients in contact isolation.

Based on observations, document reviews, and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry monitoring (monitoring a patient's heart rhythm) and continuous pulse oximetry (a medical device used to measure the saturation of oxygen carried in red blood cells) were provided in accordance with the providers' orders, facility policies, and facility-adopted educational references. This failure was identified in two of ten observations of patients on pulse oximetry and in one of five telemetry patients' medical records reviewed. (Patient #1).

Findings include:

Facility policies:

The Digital Diagnostics Remote Telemetry policy read, telemetry is monitored 24 hours a day, 7 days a week with an external telemetry monitoring company. In the event of a significant cardiac rhythm disturbance, the external telemetry monitoring company will call the primary number provided at go-live to inform the staff of the change. In case of no answer, the external telemetry monitoring company will contact all subsequent numbers provided in the facility's escalation tree. The external telemetry monitoring company will fax or email a rhythm strip to the nurse's station.

The Telemetry Monitoring policy read, alarms may not be silenced or turned off at any time, during monitoring. Every shift, or per order, review the monitor strips, trends, and alarms. Ongoing care: reassess the patient for signs of hemodynamic compromise with any significant changes in cardiac rate or rhythm (i.e. BP, oxygen saturation, respiratory rate, signs of myocardial ischemia, etc.). The cardiac rhythm will be interpreted and documented in the patient chart at the initiation of cardiac monitoring, every shift, or per MD order, and with any rhythm change.

The Patient Safety Hand Off Communication policy read, the primary objective of a "hand-off" of information between staff is to provide accurate information about a patient's care, treatment, services, current condition, and any recent and anticipated changes. The information communicated during a handoff must be accurate to meet patient safety goals. Information handoffs regarding patients should occur if temporary responsibility for staff leaving the unit for a short time. Handoffs require verification of the received information, including repeat back or read back as appropriate to the information being communicated.

Reference:

The Lippincott Mechanical ventilation, humidification, and respiratory therapy procedure, revised on 12/10/23 and provided by the facility, read, the Joint Commission issued a sentinel event alert concerning medical device alarm safety because alarm-related events have been associated with permanent loss of function or death. Among the major contributing factors were improper alarm settings, alarm settings turned off inappropriately, and alarm signals that were inaudible to staff. Make sure alarm limits are set appropriately and that alarms are turned on, functioning properly, and audible to staff.

1. The facility failed to ensure adequate telemetry monitoring and continuous pulse oximetry as ordered in order to detect any changes in condition for patients including a patient who experienced cardiac arrest and was subsequently diagnosed with an anoxic brain injury (a complete lack of oxygen to the brain which results in the death of brain cells).

A. Observations

i. On 9/9/24 at 1:07 p.m., observations were conducted in the intensive care unit (ICU). The observations revealed a telemetry monitoring log with multiple blank entries. Registered Nurse (RN) #1 stated that the telemetry monitoring log had been put in place to audit the external telemetry monitoring company. RN #1 also stated that the facility had experienced issues with the monitoring company calling the facility regarding changes in vital signs and cardiac rhythms. Further observations revealed an entry at 8:35 a.m. for the patient in room 208, indicating a rhythm of sinus tachycardia (a cardiac rhythm where the heart beats faster than normal). The telemetry call log also revealed the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility and informed them of the rhythm change.

Further observations revealed an entry at 8:47 a.m. for the patient in room 313, indicating the patient was off of telemetry monitoring. The telemetry call log also revealed that the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility and informed them the patient was off of telemetry monitoring.

ii. On 9/10/24 at 9:53 a.m., observations were conducted in the ICU. The observations revealed a telemetry monitoring log with multiple blank entries. Further observations revealed an entry at 7:35 a.m. for the patient in room ICU #1, indicating a pulse oximetry of 84%. The telemetry call log also revealed that the external telemetry monitoring company did not call the facility. RN #1 stated that the external telemetry monitoring company should have contacted the facility of the patients low pulse oximetry.

This observation was in contrast to the external telemetry monitoring company contract which read, the external monitoring company's role was limited to remote surveillance of telemetry monitors and providing immediate notification to providers in cases of cardiac rhythm changes, patients going offline, or battery depletion. There was no evidence in the contract listing monitoring pulse oximetry as a responsibility of the contracted services provided.

B. Document Review

i. A live medical record review for Patient #1 was completed on 9/11/24 with chief nursing officer (CNO) #5. The medical record revealed Patient #1 was admitted to the ICU on 7/25/24 for acute respiratory failure with hypoxia (when the air sacs of the lungs cannot release enough oxygen into the blood). Further review of the medical record revealed, on 7/29/24 at 5:26 p.m., the restraint management documentation reported Patient #1 could not understand or follow directions to avoid activities that might have caused self-harm. Impulsive behaviors were noted, such as disconnecting or removing medical devices, which disrupted treatment.

On 7/29/24 at 6:58 p.m., Patient #1's ICU nursing assessment reported the patient was alert and disorientated times four (person, place, time, and situation). Further review of the nursing assessment revealed Patient #1's restraints were removed.

Medical record review revealed, on 7/30/24 at 8:10 a.m., RT #11 changed Patient #1's ventilator setting to PSV wean (a procedure that helped patients transition from mechanical ventilation to spontaneous breathing). Further review of the medical record revealed RT #11 removed the Patient #1 from the ventilator and placed the patient on a tracheostomy collar (a medical device used to deliver oxygen to patients with a tracheostomy by providing oxygen directly to the tracheostomy tube). Further review of the medical record revealed at 9:05 a.m., RT #11 stated they walked by Patient #1's room and saw the tracheostomy pulled out and pressed against the wall of the trachea (tube in the neck and chest that carries air to and from the lungs) and occluded the airway. RT #11 stated they heard the alarms and saw the patient was in an asystolic cardiac rhythm (a condition where the heart's electrical and mechanical activity stops). RT #11 stated they pushed the code blue button, placed the trach back into the patient's airway, inflated the cuff, and started ventilations with a bag valve mask.

ii. A review of Patient #1's medical record revealed a late entry nursing note on 7/30/24 at 2:39 p.m., five hours and 33 minutes after the incident. RN #12's nursing note reported at 9:06 a.m., they were passing medications to another patient when RT #11 alerted them that Patient #1 had an asystolic cardiac rhythm. RN #12 stated the staff immediately called a code (an overhead page to alert staff of a medical emergency), started cardiopulmonary resuscitation (CPR), and initiated advanced cardiac life support (ACLS) protocol. RN #12 also stated that the external monitoring company called the facility at 9:09 a.m., three minutes after the code was called. Further review of the medical record revealed the patient was transferred to a local level one trauma center for further evaluation and treatment.

iii. Review of the external monitoring company's call log revealed the only calls placed to the facility during the events that led up to Patient #1's emergency code on 7/30/24 were at 8:26 a.m. and 9:47 a.m.

This was in contrast to the Digital Diagnostics Remote Telemetry policy which read, telemetry was monitored 24/7 by an external company. In the event of a significant cardiac rhythm disturbance, the company would call the primary number provided and, if unanswered, proceed through the facility's escalation contacts.

iv. Review of Patient #1's resuscitation record showed an asystolic cardiac rhythm, with CPR and the code starting at 9:10 a.m. Further review of the resuscitation record revealed the patient was already intubated at that time.

This was in contrast to RT #11's note, which stated that at 9:05 a.m., Patient #1 was found in asystole with their tracheostomy pulled out and pressed against the tracheostomy wall, occluding the airway.

This was in contrast to RN #12's note, which stated that CPR began at 9:06 a.m., and the external monitoring company called the facility at 9:09 a.m., three minutes after the code was initiated.

v. Review of an external level one trauma center medical record, provided by the facility, revealed Patient #1 was transferred to an acute care hospital, presented to the ED, and admitted to the ICU with a diagnosis of hypoxic brain injury secondary to hypoxic cardiac arrest. Further review of the external medical record revealed a provider note from ICU resident (Provider) #7. Provider #7 documented the patient had an unwitnessed arrest for approximately seven minutes prior to the initiation of CPR. Further review of the external medical record revealed an electroencephalogram (EEG) was done on 7/30/24. The EEG (a test that measured the electrical activity of the brain) showed moderate to severe cerebral dysfunction (impairment of the brain's normal functioning) related to an anoxic injury.

C. Interviews

i. On 9/10/24 at 2:38 p.m., an interview was conducted with RT #11. RT #11 stated they changed Patient #1's ventilator setting to PSV wean, which the patient tolerated well without distress. RT #11 then removed the patient from the ventilator and placed them on a tracheostomy collar. After five minutes, they left the room, informed RN #12 at 9:00 a.m. that they were leaving the floor and noted the patient was not restrained. RT #11 returned to the ICU at 9:05 a.m., heard alarms, and found the patient in asystolic cardiac rhythm, with gray skin and blue lips. RT #11 pushed the code blue button, reinserted the trach, inflated the cuff, and began bag valve mask ventilations. RT #11 stated the external telemetry company called during the code and after the patient went into cardiac arrest.

RT #11 stated before Patient #1's event, the facility monitored telemetry patients in-house. RT #11 stated they believed that if in-house monitoring had been in place, the alarms would have been recognized, preventing the code.

ii. On 9/12/24 at 11:33 a.m., an interview was conducted with CNO #5. CNO #5 stated the survey triggered the facility to complete a second root cause analysis (RCA) regarding Patient #1's event. CNO #5 stated the findings of the second RCA revealed RT #11 removed the Patient #1 from the ventilator, applied the trach collar, and remained at the bedside for approximately five minutes before leaving. CNO #5 stated a staff member was expected to be at the bedside for 30 minutes during the trach trial. However, upon request, the facility was unable to provide a policy or national guidance showing the expectation of staff to be at the bedside for 30 minutes.

CNO #5 stated RT #11 notified RN #12 that they needed to leave the floor and would not be at the patient's bedside. CNO #5 stated RN #12 did not report to the patient's bedside for one-on-one monitoring as expected. CNO #5 stated RN #12 did not pause their medication pass to observe the patient during the trach trial.

CNO #5 stated the second RCA revealed Patient #1's alarm for oxygen saturation sounded, and hospital staff failed to respond for approximately 10-12 minutes. CNO #5 stated at the time of Patient #1's event, staff and administration believed the external telemetry monitoring company was responsible for monitoring the patient's vital signs, including oxygen saturation. CNO #5 stated they were unaware that the company was not responsible for monitoring oxygen saturation, which contributed to failures leading up to Patient #1's event.

The interview with CNO #5 was in contrast to the Patient Safety Hand Off Communication policy which read, the primary objective of a "hand-off" of information between staff was to provide accurate information about a patient's care, treatment, services, current condition, and any recent or anticipated changes. The information communicated during a handoff had to be accurate to meet patient safety goals. Information handoffs regarding patients were required if temporary responsibility for staff leaving the unit for a short time.

The interview with CNO #5 was in contrast to the Lippincott Mechanical ventilation, humidification, respiratory therapy procedure read which read, The Joint Commission (TJC) had issued a sentinel event alert concerning medical device alarm safety due to alarm-related events being associated with permanent loss of function or death.

iii. On 9/11/24 at 12:34 p.m., an interview was conducted with medical director (Director) #14. Director #14 stated the facility's first RCA revealed staff were present when the patient went into asystole, the code started immediately, the airway was reestablished without issue, two rounds of ACLS were administered, including administration of one milligram of epinephrine and the patient regained a pulse. Director #14 stated the original RCA for Patient #1 did not match the patient's current clinical presentation and diagnosis of anoxic brain. Director #14 stated after further review it was determined the patient was in a pulseless electrical activity (PEA) rhythm (electrical activity present in the heart with an absence of a pulse), and the patient was found after the patient went into cardiac arrest. Director #14 stated they did not know how long the patient was in cardiac arrest before staff started CPR. Director #14 stated there were gaps in documentation and the timeline that the facility could not answer for. Director #14 stated they were concerned when the facility took away in-house telemetry monitoring. Director #14 stated staff shared concerns with the external telemetry monitoring company's ability to safely monitor patients.

2. The facility failed to provide adequate continuous pulse oximetry as ordered to monitor for changes in condition.

A. Observations

i. On 9/10/24 at 9:22 a.m., observations were conducted in the medical surgical unit on the second floor. Observations revealed Patient #3 was on continuous pulse oximetry with the door closed. Further observations revealed the continuous pulse oximetry monitor was not hardwired or centrally monitored.

B. Document Review

i. A live medical record review for Patient #3 was completed on 9/11/24 with licensed practical nurse (LPN) #15. Medical record revealed Patient #3 had an active order for continuous pulse oximetry placed on 9/10/24.

C. Interviews

i. On 9/10/24 at 9:30 a.m., an interview was conducted with LPN #15. LPN #15 stated the continuous pulse oximetry monitors were not centrally monitored and were only monitored by the staff on the floor. LPN #15 stated patients on continuous pulse oximetry should not have closed doors, as staff would not hear the alarms. LPN #15 stated if the alarms were not heard, patients could have gone into respiratory distress and potentially die without treatment.

ii. On 9/10/24 at 9:38 a.m., an interview was conducted with RT #11. RT #11 stated patients who were on continuous pulse oximetry should have their doors open at all times for patient safety. RT #11 stated if the patient's door was closed staff would not be able to hear the alarms. RT #11 stated that if staff did not hear and respond to continuous pulse oximetry alarms, the patient could go into respiratory distress, leading to respiratory arrest and possible death.

iii. On 9/10/24 at 9:45 a.m., an interview was conducted with CNO #5. CNO #5 stated for safety, patients on continuous pulse oximetry should have their doors open, as closed doors prevented staff from hearing alarms. CNO #5 stated the facility did not have a policy addressing door status or proximity to the nursing station for alarm monitoring. However, CNO #5 stated they were updating their policy to centrally monitor pulse oximetry for high-risk patients. CNO #5 stated missed alarms could have resulted in significant events, like decannulation (the process of removing a breathing tube), which, if untreated, could have been fatal.

Based on interviews, and record review, the facility failed to ensure the quality assurance and performance improvement (QAPI) committee implemented a quality control process which addressed failures in patient care related to patient monitoring in two of two events reviewed (Patients #1 and #4) (Cross-reference A-0144).

Findings include:

Facility policy:

The Sentinel Event and Root Cause Analysis policy read, a sentinel event is a patient safety event that reached a patient and resulted in a death, permanent harm, or severe temporary harm. The policy of the facility was to identify sentinel events and conduct investigations of such events in accordance with accrediting body standards. The purpose was to focus the attention of the sentinel event on understanding factors which contributed to the event, and to change the culture, system, and processes to reduce the probability of future events. To be thorough and credible, a root cause analysis included an analysis that determined where redesign might reduce risks, inquiry in all areas related to the event, and a determination of potential improvements that led to a decrease in the likelihood of future events. Once improvement plans were developed and actions implemented, the effectiveness of the changes was evaluated.

Reference:

The Quality Assurance and Performance Improvement (QAPI) Plan read, the plan monitored every aspect of patient care as it related to the treatment of disease and disability, in order to identify and resolve any breakdowns that could result in suboptimal patient care and safety. The overall objectives improved performance on an ongoing basis. The function of the QAPI committee acted expeditiously to remove barriers when improvement suggestions were identified and ensured the monitoring and follow-up of corrective action plans.

1. The facility failed to ensure the QAPI committee implemented a process that addressed failures in patient monitoring.

A. Medical record review

i. A live medical record review for Patient #1 was completed on 9/11/24 with chief nursing officer (CNO) #5. The medical record revealed Patient #1 was admitted to the ICU on 7/25/24 for acute respiratory failure with hypoxia (when the air sacs of the lungs cannot release enough oxygen into the blood). Further review of the medical record revealed, on 7/29/24 at 5:26 p.m., the restraint management documentation reported Patient #1 could not understand or follow directions to avoid activities that might have caused self-harm. Impulsive behaviors were noted, such as disconnecting or removing medical devices, which disrupted treatment.

On 7/29/24 at 6:58 p.m., Patient #1's ICU nursing assessment reported the patient was alert and disorientated times four (person, place, time, and situation). Further review of the nursing assessment revealed Patient #1's restraints were removed.

Medical record review revealed, on 7/30/24 at 8:10 a.m., RT #11 changed Patient #1's ventilator setting to PSV wean (a procedure that helped patients transition from mechanical ventilation to spontaneous breathing). Further review of the medical record revealed RT #11 removed the Patient #1 from the ventilator and placed the patient on a tracheostomy collar (a medical device used to deliver oxygen to patients with a tracheostomy by providing oxygen directly to the tracheostomy tube). Further review of the medical record revealed at 9:05 a.m., RT #11 stated they walked by Patient #1's room and saw the tracheostomy pulled out and pressed against the wall of the trachea (tube in the neck and chest that carries air to and from the lungs) and occluded the airway. RT #11 stated they heard the alarms and saw the patient was in an asystolic cardiac rhythm (a condition where the heart's electrical and mechanical activity stops). RT #11 stated they pushed the code blue button, placed the trach back into the patient's airway, inflated the cuff, and started ventilations with a bag valve mask.

ii. Medical record review revealed Patient #4 was admitted to room 414 on 7/11/24 for post acute physical, occupational, and speech therapy after an acute hospitalization for acute myeloblastic leukemia (a type of blood cancer), and myocarditis (an inflammation of the heart muscle). Patient #4 developed intermittent episodes of chest heaviness and shortness of breath during their hospitalization. The medical team performed diagnostic tests on Patient #4 which ruled out cardiac complications. Medical record review revealed Patient #4 desired full cardiopulmonary resuscitation if their heart stopped for any reason.

Medical record review of the resuscitation log revealed on 7/19/24 at 4:36 p.m., staff called a rapid response (a team which responded to a patient's deteriorated condition) because staff found Patient #4 unresponsive with agonal breathing (an abnormal breathing pattern which indicated a severe medical emergency). Medical record review of a provider note, written on 7/20/24 at 6:02 p.m. read, the patient became unconscious while talking to the RN. This was in contrast to the resuscitation log which read staff found Patient #4 unresponsive.

Medical record review revealed a late entry nurse's note entered on 7/26/24 (seven days after the event) at 5:31 p.m. which read, Patient #4's telemetry box (a heart rhythm monitor) read ventricular tachycardia (a condition where the lower chambers of the heart beat too fast and cause a lack of oxygenated blood to the rest of the body) and the leads needed replacement. The nurse notified Patient #4's primary nurse who replaced one lead and stated they planned to replace all the leads. Staff called a rapid response approximately two minutes later for the unresponsive patient.

B. Document review

i. A document review of the QAPI committee meeting minutes was completed. The review revealed the meeting minutes for 5/13/24 and 8/19/24 were identical for the nursing services discussion for staffing for patient safety, new monitors for patients, rapid response, codes, and effectiveness of resuscitation. When asked, chief executive officer (CEO) #8 stated Director #7 did not complete meeting minutes for all meetings and frequently cut and pasted materials for quality meetings from month to month without updates.

ii. A document review of the RCA done on 8/5/24 for Patient #1's code blue event was completed. The review revealed four pages on handwritten notes taken on notebook paper and one page of a portion of an RCA formatted guide. The RCA notes included limited information about the patient admission condition and a few events which led up to and occurred during the code blue. The document lacked the elements outlined in the sentinel event and root cause analysis policy including analysis, inquiry, explanation, identification of risks and actions plans which decreased the likelihood of future events.

C. Interviews

i. An interview was conducted on 9/12/24 at 11:33 a.m. with director of quality management (Director) #7, chief nursing officer (CNO) #5, and corporate quality director (Director) #10. Director #10 stated the facility had concerns that the root cause analysis (RCA) completed on 8/5/24 for a code blue event (an event that required cardiopulmonary resuscitation for a stopped heart beat) on Patient #1 had missed some elements, so they reviewed and re-assessed the RCA on 9/11/24. Director #10 stated the re-evaluation revealed gaps in the original RCA which showed the failure to evaluate facility staff and monitor alarms. Director #10 stated the original RCA did not include a deeper investigation of the event and the reassessment revealed additional opportunities for improvements in the process for patient monitoring.

Director #7 stated the original RCA revealed inconsistencies between the services offered by the contracted company hired to remotely monitor patients and what staff believed the contracted services provided to monitor patients. Director #7 stated the contracted services monitored only heart rhythms, but staff believed the contracted services also monitored patients' blood pressure, respirations, heart rates, and oxygen saturation (SPO2). Director #7 stated the facility completed RCAs when there were difficulties with situations and not all code blue events had RCAs.

Director #7 stated there was a code blue event with Patient #4 which resulted in the patient being transferred to a higher level of care but the decision was made to forego the RCA due to unidentified concerns with monitoring. Director #7 stated they later reviewed the circumstances around the code blue event and discovered Patient #4 had an episode of approximately 20 minutes in which staff did not have a consistent connection of their heart monitoring leads. Director #7 stated in retrospect, the facility should have completed an RCA because they later identified issues with patient monitoring. Director #7 stated they did not confirm if Patient #4 coded while they did not have the monitor leads attached to their chest.

CNO #5 stated no one made them aware of the current inconsistencies of patient monitoring between staff and contracted services. CNO #5 stated staff logged phone calls made to the unit by contracted services and handed off to CNO #5 for review. CNO #5 stated they reviewed the logs, but made no changes to practice as a result of the data collected. CNO #5 stated the internal process for quality and process improvement contained flaws and no processes changed as a result of the phone logs collected which showed the inconsistencies of patient monitoring.

ii. An interview was conducted on 9/19/24 at 11:55 a.m. with registered nurse (RN) #9. RN #9 stated the facility's RCA process lacked a nurse driven approach which allowed for a deeper investigation into issues. RN #9 stated education provided to staff lacked information from the quality department that encouraged understanding and compliance with a new process. RN #9 stated the RCA for Patient #1 completed on 8/5/24 was not a formalized process which identified all barriers to safe patient care.

iii. On 9/19/24 at 7:07 a.m., an interview was conducted with CNO #5. CNO #5 stated they learned the contracted services did not monitor patients completely during the RCA on 8/5/24. CNO #5 stated they changed the process for staff to monitor patients in addition to the contracted services, however, the facility did not use a formal auditing tool to ensure staff compliance with patient monitoring. CNO #5 stated staff monitored the monitors and alarms in the rooms of medical surgical patients on the unit and not monitored by contract services. CNO #5 stated staff did not hear the monitors alarm when patients chose to shut their doors. CNO #5 stated there was no protocol in place to ensure staff heard and responded to monitor alarms.

CNO #5 stated a quality plan, which included process improvement, looked at the risks and trends and made improvements for increased patient safety. CNO #5 stated a lack of follow-up for process improvement projects resulted in patient harm and adverse outcomes for patients.

Interviews and document review were in contrast to the sentinel event and root cause analysis policy which read, RCAs focused on factors which contributed to events, and to change culture, system, and processes to reduce the probability of future events. Once the team developed improvement plans and implemented action plans, the team then evaluated the effectiveness of the changes.

Furthermore, interviews and document review were in contrast to the QAPI plan which read, the plan monitored every aspect of patient care to identify and resolve breakdowns that resulted in suboptimal patient care and safety and improved performance on an ongoing basis. The function of the QAPI committee was to remove barriers of identified improvement suggestions and ensure staff monitored and followed up on corrective action plans.

Based on observations, interviews, and record review, the facility failed to ensure staff followed infection control practices and policies in two of two observations of patients on ventilators, in two of two observations of patients with tube feedings, and in three of three observations of patients in contact isolation.

Findings include:

Facility policies:

The Standard Precautions policy read, all staff would practice standard precautions. Precautions included hand hygiene and the use of personal protective equipment (PPE) depending on the anticipated exposure.

The Transmission Based Precautions policy read, the facility's policy was to prevent the transmission of infectious agents among patients and healthcare personnel in all settings. Contact precautions (actions taken by staff and visitors to prevent the spread of germs) were intended to prevent transmission of infectious agents by direct or indirect contact with the patient or the patient's environment. Healthcare personnel who cared for patients on contact precautions wore a gown and gloves for all interactions that involved contact with the patient or contaminated areas. Staff donned PPE upon room entry and discarded before they exited the patient's room to contain and prevent the spread of germs.

The Donning and Removal of Personal Protective Equipment policy read, PPE was to be used to provide a protective barrier and reduce the risk of transmission of organisms.

References:

The Infection Prevention and Control Plan read, the infection prevention and control program was to ensure the facility had a functioning coordinated process in place to minimize the risks of hospital associated infection (HAI) in patients and health care workers. The program was aimed at reducing the risk of nosocomial infections and designed to reduce the risk of transmission of the infections among patients, employees, and visitors. Policies and procedures of the plan included hand hygiene, personal protective equipment, exposure, and isolation precautions.

The Tube Feeding protocol, approved by the Medical Executive Committee on 2/26/24, read, to prevent tube feeding contamination, staff were to label and date the formula and tubing and were to be changed every 24 hours.

The Breathing Circuit Ventilator manufacturer's instructions for use (IFU) read, ensure that all unused ports are capped.

1. The facility failed to ensure equipment used for patients on ventilators were used in a way to prevent infection.

A. Observations

i. Observations were conducted on the intensive care unit (ICU) on 9/11/24. At 9:42 a.m. in ICU room #3, the observation revealed the ventilation circuit was left uncapped, open to air, and hung on the oxygen regulator.

ii. Observations were conducted on the intensive care unit (ICU) on 9/11/24. At 9:55 a.m. in ICU room #6, the observation revealed the ventilation circuit was left uncapped, open to air, and hung on the oxygen regulator.

This was in contrast to the breathing circuit ventilator IFU which instructed to cap all unused ports to the ventilator.

B. Interviews

i. On 9/11/24 at 10:04 a.m., an interview was conducted with respiratory therapist (RT) #4. RT #4 stated the ventilator circuit should not have been left open to air and should have been capped when not in use. RT #4 stated a ventilator circuit left open to air allowed bacteria or viruses into the ventilator circuit and could have caused patient respiratory infections.

ii. On 9/11/24 at 9:42 a.m., an interview was conducted with chief nursing officer (CNO) #5. CNO #5 stated ventilator circuits should not have been left open to air and should have been capped when not in use. CNO #5 stated a ventilator circuit left open to air allowed bacteria to get into the tubing and had the potential to cause infections.

2. The facility failed to ensure tube feedings were labeled in order to ensure they were not expired.

A. Observations

i. Observations were conducted on the ICU on 9/11/24. At 9:42 a.m. in ICU room #10, observations revealed a feeding bottle of formula was hung, running, and not dated. Additionally, staff in the room stated they did not date the tube feeding tubing.

ii. Observations were conducted on the medical-surgical unit on 9/12/24 at 9:22 a.m. In room #320, observations revealed a tube feeding bottle was hung, running, and not dated. Additionally, staff in the room stated they did not date the tube feeding tubing.

B. Interviews

i. On 9/11/24 at 10:15 a.m., an interview was conducted with licensed practical nurse (LPN) #6. LPN #6 stated tube feeding containers needed an open date label. LPN #6 stated tube feeding bottles expired after 24 hours and the tube feeding tubes expired after 48 hours. LPN #6 stated bacteria grew in the bottle and tubing after the expiration date and a patient could experience nausea, vomiting, or an infection if exposed to an expired product.

ii. On 9/11/24 at 9:42 a.m., an interview was conducted with CNO #5. CNO #5 stated nurses were responsible to date the tube feeding bottles and tubing prior to patient administration. CNO #5 stated nurses changed the tube feedings every 24 hours and patients could have experienced gastrointestinal (stomach and colon) upset if staff used expired formula to tube feed patients.

This was in contrast to the tube feeding protocol which instructed staff to label and date formula and tubing to prevent tube feeding contamination.

3. The facility failed to ensure staff wore the appropriate PPE in accordance with facility policy when caring for patients in contact isolation.

A. Observations

i. Observations were conducted on 9/11/24 at 10:15 a.m. in ICU room #1. Observations revealed a contact isolation sign on the door of room #1. Registered nurse (RN) #1 entered room #1 to hang an intravenous medication and wore only a simple face mask. Additionally, RN #1 did not perform hand hygiene upon exit of the room.

ii. Observations were conducted on 9/11/24 at 10:47 a.m. in medical surgical room #412. Observations revealed a contact isolation sign on the door of room #412. Observations revealed RN #2 entered the room to silence an IV medication pump alarm with no personal protective equipment (PPE).

iii. Observations were conducted on 9/11/24 at 10:53 a.m. in medical surgical room #412. Observations revealed a contact isolation sign on the door of room #412. Observations revealed RT #3 entered room #412 to care for the patient without PPE.

This was in contrast to the standard precautions policy which read, all staff practiced standard precautions which included hand hygiene and PPE. Additionally, it was in contrast to the donning and removal of personal protective equipment policy which read PPE was used to provide a protective barrier and reduce the risk of transmission of organisms. Furthermore, this was in contrast to the transmission based precautions policy which read staff who cared for patients in contact precautions wore a gown and gloves for all interactions that involved contact with the patient or contaminated area and was put on upon room entry and discarded before they exited the patient room to contain and prevent the spread of germs.

B. Interviews

i. On 9/11/24 at 10:15 a.m., an interview was conducted with RN #1. RN #1 stated the patient in room #1 was in contact isolation for extended-spectrum beta-lactamase (ESBL), a bacteria resistant to certain antibiotics. RN #1 stated they had to administer an IV medication and did not have time to put PPE on. RN #1 stated it was important to wear PPE to prevent the spread of infection. RN #1 stated when they did not wear PPE, an infection could have spread to other patients.

ii. On 9/11/24 at 10:47 a.m., an interview was conducted with RN #2. RN #2 stated they forgot to put on PPE before they entered contact isolation ICU room #1 to silence the IV pump alarm. RN #2 stated PPE was important because it prevented the spread of infection. RN #2 stated there was a risk of infection to staff and other patients when they did not wear PPE.

iii. On 9/11/24 at 10:53 a.m., an interview was conducted with RT #3. RT #3 stated they did not see the contact isolation sign on the door of room #412. RT #3 stated PPE was important and prevented the spread of infection. RT #3 stated there was a risk of infection to staff and other patients when they did not wear PPE.

iv. On 9/11/24 at 10:23 a.m. an interview was conducted with CNO #5. CNO #5 stated staff received infection control and PPE education multiple times in the last six months. CNO #5 stated they expected and required staff to wear PPE in isolation rooms. CNO #5 stated when staff did not wear PPE, they increased patients' and staffs' risk of infection.

C. Document review

i. The 2024 infection control committee meeting minutes were reviewed and revealed the benchmark for PPE compliance was 95%. The review revealed the facility had a PPE compliance rate of 82% for January, 2024 with 112 observations and 95.9% for July, 2024 with 73 observations.

This was in contrast to the observations on 9/11/24 which revealed three staff members entered into three patient rooms without PPE or infection control compliance.

ii. The infection prevention and control plan was reviewed and read, the facility had a functioning coordinated process in place to minimize the risks of hospital associated infection (HAI) in patients and health care workers.

This was in contrast to observations on 9/11/24 and 9/12/24 which revealed staff did not follow IFUs, protocols, or policies for ventilators, tube feedings, or PPE for isolation.