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Based on observation, interview, and record review, the facility's Governing Body (responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to ensure the Condition of Participation for Governing Body was met as evidenced by:

1. The facility's Governing Body failed to ensure adequate oversight for the Nursing Services Department in the Intensive Care Department/Unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), to ensure the facility's policy and procedure regarding the use of sitters (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety) including fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) prevention, was followed, and to ensure that the QAPI (Quality Assessment and Performance Improvement- a data driven and proactive approach to quality improvement) team effectively tracked patient adverse events (an undesirable outcome that happens during medical care), analyzed their causes, and implemented preventive actions and mechanisms to ensure patient safety for two of 30 sampled patients (Patient 1 and Patient 6), who both fell on the floor while in the ICU. Patient 1 fell on 11/28/2024 and Patient 6 fell on 2/2/2025.

This deficient practice resulted in two separate instances of fall involving Patients 1 and 6, which had the potential to result in complications such as fracture (break in the bone), brain bleed, etc., and may result in prolonged hospitalization and delayed recovery for Patients 1 and 6. (Refer to A-0063)

2. The facility's Governing Body failed to ensure the sterile processing department (SPD, the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place), provided services and competent staff that met current national standard practice regarding reprocessing and sterilization process and adhered to facility's policies and procedures regarding the reprocessing (the specific process of cleaning, disinfecting [the process of eliminating or reducing harmful germs on surfaces to a level that does not pose a risk of infection], and sterilizing [the process of completely destroying all forms of germs through methods ensuring that medical instruments and equipment are free from any living microbes (germs) before use] reusable medical equipment to ensure it is safe to reuse between patients) of surgical instruments and infection control (practices and procedures implemented to prevent the spread of infections by minimizing the transmission of germs in a healthcare setting).

This deficient practice had the potential for improper processing of surgical instruments potentially resulting in increased risk of infection, organ failure, disfigurement, and/or death for patients undergoing surgical procedures. (Refer to A-0063)

3. The facility's Governing Body failed to ensure its contracted service staff adhered to infection control and prevention practice to disinfect (killing germs and bacteria) one of three sampled hemodialysis (HD, the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machine (HDM 2) with heat or bleach at the end of day use, after hemodialysis was completed for one of 30 sampled patients (Patient 16), in accordance with the contracted service's policy and procedure and hemodialysis machine operator manual.

This deficient practice had the potential to result in bacterial contamination within the hemodialysis machine and had the potential to introduce bacteria to other patients' bloodstream who may use the same machine (HDM 2) thus causing infection to patients from hemodialysis treatment. (Refer to A-0083)

4. The facility's Governing Body failed to ensure that contracted dialysis services adhered to the facility's "Dialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) Services," policy and procedure when one of one sampled dialysis machine (HDM 1) was left unattended in a public area, containing intravenous (IV, administered into the vein) fluids, chemical reagents (solutions, typically containing electrolytes used to create the "dialysate" fluid which is circulated through a dialysis machine to filter waste products from a patient's blood), and patient-identifiable information.

This deficient practice had the potential to result in unauthorized access to medical records (the HDM 1 contained patient-identifiable information), contamination, and breaches of patient confidentiality, etc. (Refer to A-0083)

5. The facility's Governing Body failed to ensure that contracted dialysis services adhered to safe practices and the facility's policy and procedure regarding safe handling and storage protocols for dialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machines, when one of one sampled dialysis machine (HDM 1) was left unattended in a public area, containing intravenous (IV, administered into the vein) fluids, chemical reagents (solutions, typically containing electrolytes used to create the "dialysate" fluid which is circulated through a dialysis machine to filter waste products from a patient's blood), and patient-identifiable information.

This deficient practice had the potential to result in unauthorized access to medical records (the HDM 1 contained patient-identifiable information), contamination, and breaches of patient confidentiality, etc. (Refer to A-0084)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by:

1. The facility failed to ensure that one of 30 sampled patients (Patient 25) was properly provided adequate information regarding refusal of blood product transfusion as well as be provided with alternative options to blood transfusion (a medical procedure where blood or blood components from a donor are transferred into the bloodstream of a recipient), as part of the informed consent process (a process that involves discussing treatment options with the patient, including risks and benefits, and getting their agreement to proceed), in accordance with the facility's policy and procedure regarding informed consent.

This deficient practice resulted in Patient 25 receiving three (3) units of packed red blood cells (PRBC- used to increase the oxygen-carrying capacity of the blood in patients with anemia [when the body does not have enough health red blood cells], blood loss, or other conditions that cause a low red blood cell count) during a surgical procedure emergency, which violated Patient 25's rights regarding informed consent. (Refer to A-0131)

2. The facility failed to follow the physician's order for one of 30 sampled patients (Patient 1) to provide a bedside sitter (a trained individual, often a healthcare worker or sitter, assigned to provide continuous, one-on-one supervision of a patient to ensure their safety, especially if the patient is at risk of falls [an unexpected, unintentional descent of a patient to the ground or another lower surface], disorientation, or self-harm) for constant supervision to monitor Patient 1's safety, when:

2.a. On 11/28/2024, in the Intensive Care Unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), Registered Nurse (RN 1) left Patient 1 unattended while retrieving medications from the medication room resulting in Patient 1 falling to the floor.

This deficient practice resulted in Patient 1 experiencing a fall in the ICU on 11/28/2024. This deficient practice also had the potential to result in complications such as fracture (break in the bone), etc. (Refer to A-0144)

2.b. On 12/6/2024, a sitter was not assigned to Patient 1 when Patient 1 was transferred to the Step-Down Unit (SDU, an intermediate care unit for patients who no longer require intensive care but still need close monitoring). From 12/6/2024 through 12/11/2024, Patient 1 remained without a sitter. On 12/11/2024, Patient 1 was found disconnected from the Bilevel Positive Airway Pressure (BIPAP, a non-invasive ventilator that assist patients with breathing difficulties) machine and suffered cardiac arrest (when the heart suddenly stops beating) in the SDU.

This deficient practice resulted in a cardiac arrest in the SDU on 12/11/2024 due to Patient 1's disconnection from the BiPAP machine. In addition, this deficient practice had the potential to place other patients with physician-ordered bedside sitters at risk for similar sentinel event (a patient safety event that results in death, permanent harm, or severe temporary harm) due to inadequate supervision. (Refer to A-0144)

3. The facility failed to protect the confidentiality of information, in accordance with the facility's policy and procedure regarding Patient Rights (a subset of human rights) and Responsibility, for twenty of twenty sampled patients (who were receiving dialysis for the month of February 2025), when a binder containing medical record numbers (MRNs) was left unattended on a dialysis machine (HDM 1) in a public area (on the East Tower ground floor in front of the elevator).

This deficient practice violated patient confidentiality and compromised compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA, is a federal law that protects patients' health information) regulations. This deficient practice also increased the risk of unauthorized access to protected health information (PHI, any individually identifiable health information about a patient that is held by a covered entity, like a healthcare provider or health plan, and is subject to privacy regulations under the Health Insurance Portability and Accountability Act [HIPAA]), failing to uphold patients' rights to privacy and confidentiality of their clinical records. (Refer to A-0147)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Quality Assessment and Performance Improvement (QAPI) was met as evidenced by:

1. The facility failed to identify, analyze, and address deficiencies in ICU (Intensive Care Unit- ward that provides the critical care and life support for acutely ill and injured patients) equipment availability through its Quality Assessment and Performance Improvement (QAPI, a systematic approach to improving the quality of care and safety in a healthcare setting. QAPI combines Quality Assurance [QA] and Performance Improvement [PI] to create a comprehensive, data-driven program) program, resulting in inadequate monitoring for four of 30 sampled Patients (Patient 5, Patient 7, Patient 8, and Patient 9), with an arterial line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) to ensure they each have a leveler (a device used to ensure proper positioning of the A-line relative to the patient's photostatic axis [atomical reference point at the 4th intercostal space, mid-axillary line]) at the bedside, to use each time the patient was repositioned to ensure accurate reading of the patient's blood pressure (the force of blood against artery walls as the heart pumps blood throughout the body), in accordance with the facility's policy and procedure regarding Monitoring Arterial Blood using a Pressure Transducer (a device that converts the pressure fluctuations of blood within the artery into an electrical signal) System and the policy regarding QAPI.

This deficient practice resulted in delays in recalibration of the A-line, and had the potential for inaccurate blood pressure readings which may lead to delays in the implementation of timely interventions, thus compromising patient safety due to complications of unidentified elevated, uncontrolled blood pressure such as stroke (a clot in the brain), damage to vital organs such as kidneys, etc. (Refer to A-0273)

2. The facility failed to track, analyze, and implement preventive actions for adverse patient events (a negative or harmful result experienced by a patient as a consequence of medical care), specifically recurrent patient falls (an unexpected, unintentional descent of a patient to the ground or another lower surface) in the Intensive Care Unit (ICU, specialist hospital wards that provide treatment and monitoring for people who are very ill). The Quality Assessment and Performance Improvement (QAPI, a systematic approach to improving the quality of care and safety in a healthcare setting. QAPI combines Quality Assurance [QA] and Performance Improvement [PI] to create a comprehensive, data-driven program) program team did not conduct a Root Cause Analysis (RCA, a systematic process used to identify and analyze the underlying causes of a medical error or adverse event, with the goal of preventing similar incidents from happening again by addressing the root issues rather than just the symptoms; it typically involves a multidisciplinary team to thoroughly investigate the event and develop corrective actions) or established an effective action plan to prevent falls among high-risk patients, in accordance with the facility's policy and procedure regarding QAPI.

This deficient practice resulted in repeated falls in the ICU, including:
-Patient 1, who fell on 11/28/2024 unwitnessed while sedated, and was identified as a high fall risk.
-Patient 6, who had an unwitnessed fall on 2/2/2025 after heart surgery.
The failure to implement an effective fall prevention strategy placed patients at risk for serious harm and compromised patient safety. (Refer to A-0286)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by:

1. The facility failed to ensure that four of 30 sampled Patients (Patient 5, Patient 7, Patient 8, and Patient 9), with an arterial line (A-line, a thin, flexible tube that's inserted into an artery to measure blood pressure and to collect blood samples) had a leveler (a device used to ensure proper positioning of the A-line relative to the patient's photostatic axis [atomical reference point at the 4th intercostal space, mid-axillary line]) at the bedside to use each time the patients (Patients 5, 7, 8, and 9) were repositioned, to ensure accurate reading of the patient's blood pressure (the force of blood against artery walls as the heart pumps blood throughout the body), in accordance with the facility's policy and procedure regarding Monitoring Arterial Blood using a Pressure Transducer (a device that converts the pressure fluctuations of blood within the artery into an electrical signal) System.

This deficient practice resulted in delays in recalibration of the A-line, and had the potential for inaccurate blood pressure readings which may lead to delays in the implementation of timely interventions, thus compromising patient safety due to complications of unidentified elevated, uncontrolled blood pressure such as stroke (a clot in the brain), damage to vital organs such as kidneys, etc. (Refer to A-0395)

2. The facility failed to ensure two of two sampled staff (Registered Nurse [RN] 6 and Charge Nurse [CN] 5) were competent and able to implement hemodialysis (HD, the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency take off (a procedure to quickly disconnect a dialysis patient from the dialysis machine in a critical situation) procedure, in accordance with the facility policy and procedure regarding hemodialysis emergency take off procedure, in case of emergency and when a hemodialysis nurse (HD nurse, a Registered Nurse who specialized performing hemodialysis) becomes incapacitated, for one of 30 sampled patients (Patient 13).

This deficient practice had the potential to result in Patient 13 being left on hemodialysis machine running with no proper supervision and/or improperly disconnecting Patient 13 from the hemodialysis machine during an emergency, thus causing harm or even death during hemodialysis. (Refer to A-0397)

3. The facility failed to follow its "Utilization of Safety Attendants for Patients" policy and procedure and the physician's order to provide a bedside sitter (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety, especially if the patient is at risk for falls [a sudden, unintentional descent of a patient to the ground or another lower surface] , disorientation [the condition of having lost one's sense of direction], or self-harm) for constant supervision for one of 30 sampled patients (Patient 1).

This deficient practice resulted in Patient 1 experiencing a fall in the ICU on 11/28/2024, and a cardiac arrest (a sudden loss of heart function, leading to a lack of blood flow to the brain and vital organs) in the SDU (Step Down Unit, specialist hospital wards that serve as a transition point for patients who are no longer critically ill enough to remain in ICU but still require more intensive monitoring and care than a general ward can provide) on 12/11/2024, due to accidentally being disconnected from the Bilevel Positive Airway Pressure (BIPAP machine, a non-invasive ventilator that assist patients with breathing difficulties) machine. In addition, this deficient practice had the potential to place other patients with physician-ordered bedside sitters at risk for similar sentinel events (a patient safety event that results in death, permanent harm, or severe temporary harm) due to inadequate supervision. (A-0398)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Infection Prevention, Control and Antibiotic Stewardship Program was met as evidenced by:

1. The facility failed to ensure staff adhered to infection control and prevention practices when:

1.a. One of one sampled staff (Patient Access Representative [PAR1, acts as the first point of contact for patients at a healthcare facility, responsible for greeting them, registering them for appointments, verifying insurance information, collecting necessary paperwork, and generally managing the patient check-in process]) did not perform hand hygiene (the practice of cleaning one's hands to remove dirt and germs by using soap and water or alcohol-based sanitizer) upon entry and exit from a patient's room for one of 30 sampled patients (Patient 21), in accordance with the facility's policy and procedure regarding hand hygiene.

This deficient practice had the potential to result in the spread of germs and bacteria from Patient 21 to others including other patients, staff and/or visitors. (A-0749)

1.b. The facility's one of one sampled contracted service staff (HDN 3) did not disinfect (killing germs and bacteria) one of three sampled hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machine (HDM 2) with heat or bleach at the end of day use, after hemodialysis was completed for one of 30 sampled patients (Patient 16), in accordance with the contracted service's policy and procedure and hemodialysis machine operator manual.

This deficient practice had the potential to result in bacterial contamination within the hemodialysis machine and introduce bacteria to other patients' bloodstream, who may end up using the same HD machine (HDM 2), thus causing infection from a hemodialysis treatment. (Refer to A-0749)

2. The facility failed to ensure infection control policies and procedures regarding Employee Health Services were implemented when the facility failed to:

2.a. Ensure that one of two sampled Special Processing Technician (SPT 4, responsible for sterilizing and maintaining medical equipment and instruments), had completed a mandatory N-95 (a disposable mask that filters airborne particles) fit test (a procedure used to evaluate how well a respirator fits am individual, ensuring that it effectively filters out airborne particles to provide adequate respiratory protection), in accordance with the facility's Employee Health Services Infection Prevention Policies and Employee health testing.

This deficient practice had the potential to result in increased risk of exposure to airborne pathogens which could lead to infection for both the employee, the patients, and other staff. (Refer to A-0772)

2.b. Ensure that four out of six employees (E1, E3, E4, E5) had annual screening for tuberculosis (TB, a chronic bacterial infection that primarily affects the lungs) infection by QuantiFERON laboratory test (a blood test used to detect latent or active tuberculosis infection by measuring the immune response to specific TB antigens), in accordance with the regulatory requirements set by the [State] Department of Public Health (DPH) regarding TB testing (checks to see if someone was infected with tuberculosis).

This deficient practice increases the risk of tuberculosis transmission among staff, patients and visitors due to inadequate testing/monitoring. (Refer to A-0772)

3. The facility failed to ensure that personnel training and education on the practical applications of infection prevention and control guidelines, policies and procedures were provided, completed and documented when:

3.a. Proof of completion of annual competencies (specific set of skills, knowledge, and abilities required to perform job functions effectively and safely within a particular field) verification and completion of skills check for three of six sampled employee records (Sterile Processing Technicians- responsible for sterilizing [free of germs] and maintaining medical equipment and instruments [SPT 1, SPT 4], and Surgical Scrub technicians- assists the surgeon during surgical procedures [SST 1]), were found to be incomplete with missing signatures from a preceptor (provides supervision during training) to indicate/verify staff competency.

This deficient practice had the potential to result in improper training which has the potential for patient safety risks due to improperly sterilized instruments, increased infection rates, etc. (Refer to A-0775)

3.b. Proof of completion of orientation (refers to the process of introducing new employees to an organization, including its policies, procedures, culture, and specific job responsibilities) upon hire, and access to oneSOURCE (a platform commonly used in healthcare settings to provide access to essential information, such as manufacturer's instructions for use [IFUs], policy documents, and compliance-related materials), were not provided for one of one sampled employee (Sterile Processing Technician- responsible for sterilizing [free of germs] and maintaining medical equipment and instruments [SPT 4]). The facility was also not able to provide copies of completed orientation checklist for SPT 4 for surveyor review.

This deficient practice had the potential to result in non-compliance with job related requirements due to lack of knowledge from training and inability to access resources which may lead to potential patient safety risks due to errors in cleaning and sterilization processes (free of germs) for surgical instruments. (Refer to A-0775)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview, and record review, the facility's governing body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to:

1. Ensure adequate oversight for the Nursing Services Department in the Intensive Care Department/Unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), to ensure the facility's policy and procedure regarding the use of sitters (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety) including fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) prevention, was followed, and to ensure that the QAPI (Quality Assessment and Performance Improvement- a data driven and proactive approach to quality improvement) effectively tracked patient adverse events (an undesirable outcome that happens during medical care), analyzed their causes, and implemented preventive actions and mechanisms to ensure patient safety for two of 30 sampled patients (Patient 1 and Patient 6), who both fell on the floor while in the ICU. Patient 1 fell on 11/28/2024 and Patient 6 fell on 2/2/2025.

This deficient practice resulted in two separate instances of fall involving Patients 1 and 6, which had the potential to result in complications such as fracture (break in the bone), brain bleed, etc., and may result in prolonged hospitalization and delayed recovery for Patients 1 and 6.

2. Ensure the sterile processing department (SPD, the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place), provided services and competent staff that met current national standard practice regarding reprocessing and sterilization process and adhered to facility's policies and procedures regarding the reprocessing (the specific process of cleaning, disinfecting [the process of eliminating or reducing harmful germs on surfaces to a level that does not pose a risk of infection], and sterilizing [the process of completely destroying all forms of germs through methods ensuring that medical instruments and equipment are free from any living microbes (germs) before use] reusable medical equipment to ensure it is safe to reuse between patients) of surgical instruments and infection control (practices and procedures implemented to prevent the spread of infections by minimizing the transmission of germs in a healthcare setting).

This deficient practice had the potential for improper processing of surgical instruments potentially resulting in increased risk of infection, organ failure, disfigurement, and/or death for patients undergoing surgical procedures.

Findings:

1.a. During a review of Patient 1's "History and Physical (H&P, a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 11/25/2025, the "H&P" indicated, Patient 1 was brought in by ambulance from home and presented with tachycardia (an abnormally fast heart rate exceeding 100 beats per minutes). The H&P also indicated that Patient 1 had a history of dementia (a disorder causing memory loss and confusion) and atrial fibrillation (a-fib, an irregular and often rapid heart rhythm that increases the risk of stroke [blood clot in the brain], heart failure [a condition where the heart muscle is stiff or weakened, making it unable to pump blood effectively], and other complications). Neurological (relating to the nervous system, which includes the brain, spinal cord, and nerves) assessment indicated: "Unable to assess mental status, patient unable to follow commands."

During a concurrent interview and record review on 2/19/2025 at 3:00 p.m. with the Director of Medical Surgical unit (DIR) 3, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Nursing Documentation-Flowsheet (a form that records a patient's clinical observations over time)," dated 11/28/2024, was reviewed. The flowsheet indicated, on 11/28/2024 at 12:11 a.m., Patient 1 was "found on the floor, lying flat." DIR 3 stated that the cause of the fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) remained unknown.

During an interview on 2/21/2025 at 1:00 p.m. with ICU (Intensive Care Unit. specialist hospital wards that provide treatment and monitoring for people who are very ill) Registered Nurse (RN) 1, RN 1 confirmed that Patient 1 was receiving continuous sedation (a state of relaxation or drowsiness) with Precedex (Dexmedetomidine, an injectable sedative given through the vein) and was being monitored using the Richmond Agitation-Sedation Scale (RASS, is a 10-point scale used to assess a patient's level of sedation or agitation, ranging from +4 [combative] to -5 [unarousable]), with a target RASS score of 0 to -2. RN 1 stated Patient 1 was at -1 (drowsy, a state of sleepiness and wakeness) on 11/28/2024. RN 1 stated Patient 1 was high risk for falls and was left sleeping while RN 1 retrieved medications from the medication room. Upon returning, RN 1 found Patient 1 on the floor with other staff present. The fall was unwitnessed, and the reason for the fall was unknown.

During a concurrent interview and record review on 2/21/2025 at 2:30 p.m. with Registered Nurse (RN) 2, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled "Order," report dated 11/26/2024, was reviewed. The physician (MD 5) ordered bedside sitter for Patient 1 from 11/26/2024 at 12:59 p.m. to 12/17/2024 at 1:02 a.m. RN 2 confirmed that there was no documented evidence that a sitter was monitoring Patient 1 on 11/28/2024.

During an interview on 2/21/2025 at 12:33 p.m. with the Co-Chair of the Falls Performance Improvement (PI) Team (RM), RM stated the Falls PI team communicates directly with QAPI (Quality Assurance Performance Improvement- a data driven and proactive approach to quality improvement) and was responsible for fall prevention measures, system assessment, collaboration with other department leaders. RM was unaware of Patient1's falls until the day of the interview, stating, "I did not review this case (Patient 1's fall on 11/28/2024) unit this morning."

During an interview on 2/21/2025 at 2:00 p.m. with the Director of ICU (DIR) 2, DIR 2 stated that after a patient fall, a post-fall huddle (a meeting held after a patient falls to determine the cause and prevent future falls) was conducted, but nursing staff were not included in these discussions. Instead, one leader from the unit where the fall occurred, such as the charge nurse, unit manager, or unit representative, will attend. DIR 2 also stated that they did not participate in the post-fall huddle for Patient 1's fall on 11/28/2024.

During an interview on 2/21/2025 at 9:20 p.m. with the Chief Executive Officer (CEO), the CEO stated Governing Body relies heavily on the QAPI department to report on current issues and outline action plan taken in response. CEO emphasized that ultimately, the Governing Body holds the responsibility for ensuring oversight of an ongoing quality improvement plan focused on patient safety, quality of care, organization-wide quality assessment.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement," dated 12/1/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient centered systems to improve quality of care and patient safety in alignment with regulatory standards... As part of performance Improvement, leaders (including governing body) will:
1. Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines
2. Identify frequency of data collection for performance improvement
3. Prioritize performance improvement in response to changes within the internal and external environment
4. Proactively identify processes needing improvement to prevent medical errors
5. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes...
Structure and Accountability:
1. The Community Board (GB) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectations for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

During a review of the facility's policy and procedure (P&P) titled, "Performance Improvement Team Charter: 2025 Falls PI Team," dated 1/10/2012, the P&P indicated, "Define the Issues: Non-compliant behaviors (e.g., patient/family turning off bed alarm, don't call/wait for assistance).Inconsistencies with bed alarms and zone settings activation (e.g., staff do not set bed in moderate sensitivity setting, do not activate the bed alarm after turning off). Falls from chairs (including commode, wheelchair) because of inconsistencies with using chair alarms. Inconsistent yellow gown and gait belt usage. Reinforce bedside charting, especially for high fall risk patients. Goals of the Process Improvement: Analyze monthly falls and initiate immediate corrective actions to improve performance and compliance with designated interventions. Lead processes that support full compliance with Fall Prevention Policy. Strategize fall prevention measures specific to patient needs and continue to evaluate and modify strategies as appropriate ... How Does This Process Support the Hospital's Overall Strategic Plan? By working to reduce the number and rate of falls we are focusing on patient safety, patient satisfaction, and prevention of hospital acquired conditions."

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients" dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury ... Safety attendant will accompany the patient at all times."

1.b. During a review of Patient 6's "Progress Notes (a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 2/3/2025, the note indicated, Patient 6 "The patient presented to the emergency room following the acute (sudden and severe) onset of severe abdominal and chest pain. He (Patient 6) was complaining that he (Patient 6) could not move his right leg. The patient (Patient 6) underwent a CT angiogram (computed tomography angiography, is a medical imaging test that uses X-rays to create pictures of blood vessels and blood flow) which demonstrated evidence of a type A thoracic aortic dissection (a tear in the inner layer of the aorta, the main artery that carries oxygenated blood from the heart to the body)." The Progress Notes also indicated that Patient 6 had undergone emergency heart surgery.

During a concurrent interview and record review on 2/20/2025 at 11:30 a.m. with the Nurse Manager (MN) 3 of the Step-Down Unit (SDU, a hospital unit that provides intermediate care for patients who are not ready for general ward care but don't need intensive care), Patient 6's EMR (Electronic Medical Record) document titled, "Fall Post Event Summary," dated 2/2/25, was reviewed. The Fall Post Event Summary indicated Patient 6 had an unwitnessed fall while in the ICU. Patient 6 was found sitting on the floor with a urinal (a container used by patients who are unable to get out of bed to collect their urine).

During an interview on 2/21/2025 at 12:33 p.m. with the Co-Chair of the Falls Performance Improvement (PI) Team (RM), RM stated the Falls PI team communicates directly with QAPI (Quality Assurance Performance Improvement- a data driven and proactive approach to quality improvement) and was responsible for fall prevention measures, system assessment, collaboration with other department leaders. RM was unaware of Patient 1's falls and Patient 6's fall until the day of the interview (2/21/2025), stating, "I did not review this case (Patient 1's fall on 11/28/2024) unit this morning."

During an interview on 2/21/2025 at 2:00 p.m. with the Director of ICU (DIR) 2, DIR 2 stated that after a patient fall, a post-fall huddle was conducted, but nursing staff were not included in these discussions. Instead, one leader from the unit where the fall occurred, such as the charge nurse, unit manager, or unit representative, will attend. DIR 2 also stated that they did not participate in the post-fall huddle for Patient 1's fall on 11/28/2024.

During an interview on 2/21/2025 at 9:20 p.m. with the Chief Executive Officer (CEO), the CEO stated Governing Body relies heavily on the QAPI department to report on current issues and outline action plan taken in response. CEO emphasized that ultimately, the Governing Body holds the responsibility for overseeing all services in the facility, and ensuring oversight of an ongoing quality improvement plan focused on patient safety, quality of care, organization-wide quality assessment.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement " dated 12/1/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient centered systems to improve quality of care and patient safety in alignment with regulatory standards... As part of performance Improvement, leaders (including governing body) will:
1. Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines
2. Identify frequency of data collection for performance improvement
3. Prioritize performance improvement in response to changes within the internal and external environment
4. Proactively identify processes needing improvement to prevent medical errors
5. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes...
Structure and Accountability:
1. The Community Board (GB) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectations for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

During a review of the facility's policy and procedure (P&P) titled, "Performance Improvement Team Charter: 2025 Falls PI Team, " dated 1/10/2012, the P&P indicated, "Define the Issues: Non-compliant behaviors (e.g., patient/family turning off bed alarm, don't call/wait for assistance).Inconsistencies with bed alarms and zone settings activation (e.g., staff do not set bed in moderate sensitivity setting, do not activate the bed alarm after turning off). Falls from chairs (including commode, wheelchair) because of inconsistencies with using chair alarms. Inconsistent yellow gown and gait belt usage. Reinforce bedside charting, especially for high fall risk patients. Goals of the Process Improvement: Analyze monthly falls and initiate immediate corrective actions to improve performance and compliance with designated interventions. Lead processes that support full compliance with Fall Prevention Policy. Strategize fall prevention measures specific to patient needs and continue to evaluate and modify strategies as appropriate ... How Does This Process Support the Hospital's Overall Strategic Plan? By working to reduce the number and rate of falls we are focusing on patient safety, patient satisfaction, and prevention of hospital acquired conditions."

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients" dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

2. During an interview on 2/18/2025 at 2:32 p.m. with the Sterile Processing Technician - Lead (LSPT), LSPT stated that the ultrasonic machine (a cleaning device that uses high frequency sound waves to remove contaminants from surgical instruments) must be tested daily (a test solution that is inserted inside the machine to assess for color changes in the solution after the test and to ensure that the ultrasonic cleaning process effectively utilizes cavitation [powerful cleaning effect, helping to dislodge dirt, debris, and contaminants from surfaces] to decontaminate and clean instruments properly by examining the changes in dosimeters [testing solution] after a cleaning cycle, operators can gauge the effectiveness of the cavitation process]) by the graveyard shift (the overnight work shift), but the log was nowhere to be found.

During an interview on 2/18/2025 at 2:32 p.m. with the following staff: Sterile Processing Technician -Lead (LSPT) and Sterile Processing Technician (SPT 1), in the decontamination room (a specific section or designated space where contaminated or soiled items are received, sorted, and prepared for the decontamination process), the staff (LSPT and SPT 1) were not able to answer questions about the ultrasonic machine, including how it worked, what the daily tests were for, and where the log for the daily testing was located.

During a concurrent observation and interview on 2/18/2025 at 4:38 p.m. with the Director of Operative Services (Dir 1), Dir 1 was observed using an alcohol pad to wipe the brown marks present on the sterile surgical instruments (the Narrow Deaver [retractor 1, a surgical retractor used to hold back tissue and provide access to deeper surgical sites], and the Sweetheart retractor [retractor 2, a surgical instrument used to hold back tissues and provide stability in the surgical field]). Brown staining of the alcohol pad was noted after Dir 1 wiped down the instruments (retractor 1 and 2). Dir 1 then stated that these instruments should not be used for patients in the operating rooms and should be sent back for reprocessing (a special process or treatment in preparation for reuse) due to the presence of brown stains.

During a concurrent observation and interview on 2/19/2025 at 10:27 a.m. with the Administrative Director (AD 1) and the Sterile Processing Technician-Lead (LSPT), in the Assemble Room (a designated area where surgical instruments and supplies are organized, assembled, and prepared for sterilization [the process of eliminating all living microorganisms from an object or surface] and subsequent use in surgical procedures), surgical tray preparation for sterilization, was observed. Multiple trays were observed to contain green towels (a type of fabric used to cover and wrap surgical instruments and trays to provide protection and maintain sterility during surgical procedures) covering the trays with surgical instruments on top. AD 1 stated that trays that lack a liner (a protective material or insert, such as sterile wrap, intended to create a barrier between the instruments and the tray, ensuring proper sterilization and preventing contamination) must be wrapped with green towels to protect the instruments. Both AD 1 and LSPT stated that they were not aware if this practice (using green towels to cover trays) was in accordance with the facility's policy and procedures.

During a concurrent observation and interview on 2/19/2025 at 11:11 a.m. with the Sterile Processing Technician-Lead (LSPT), LSPT demonstrated a cart (a cart with enclosed compartments and secure doors that transports surgical instruments and supplies) that would typically be used for the transport of dirty instruments from the Operating Room (OR) to the decontamination room (a specific section or designated space where contaminated or soiled items are received, sorted, and prepared for the decontamination process). LSPT also demonstrated how the biohazard sign (a biological material or substance that can cause disease or illness in humans) on top of the cart can be switched to a clean cart sign whenever necessary. LSPT stated that the same cart(s) was(were) used for the transport of clean/sterile instruments ; the cart would have to be cleaned with [Brand] enzymatic solution (a cleaning product that contains enzymes to break down stains and soils) before re-use and then the sign would be changed to "clean cart" on top, allowing the cart to be used for the transport of clean and sterile instruments.

During the same interview on 2/19/2025 at 10:27 a.m. with the Sterile Processing Technician-Lead (LSPT), LSPT was not able to provide information regarding the enzymatic [Brand] wipes used for cleaning carts.

During an interview on 2/19/2025 at 3:00 p.m. with the Manager of the Operating Room (MOR), MOR stated that the facility's policy regarding stored sterile packages (sealed containers that contain surgical instruments or supplies used in sterile procedures, designed to maintain the sterility of their contents until they are opened for use, ensuring safety and minimizing the risk of infection) indicated that sterile packages shelf life was indefinite if the temperature and humidity were maintained within range and sterile items had no tear in the package, then it should be okay to continue storing sterile packages. The MOR also stated there were no routine inspections conducted to inspect the integrity of sterile packages in sterile supply room and there was no log.

During a concurrent observation and interview on 2/19/2025 at 3:22 p.m. with the Director of Operative Services (Dir 1) in the central supply room in the Surgical Department, a Gelpi retractor (a surgical instrument used for holding back tissue in a surgical procedure) was observed with brown-colored deposits like rust after instrument was removed from a sterile total hip tray (a collection of instruments specifically prepared and sterilized for use during total hip replacement surgeries). Dir 1 stated the following: "The brown deposit in the middle section of the Gelpi retractor could be rust. The water exposure could lead to damage of the instrument. When we identify issues like this one, the instrument gets treated by the contracted company that would either polish the instrument or replace it."

During an interview on 2/21/2025 at 9:30 a.m. with the Sterile Processing Technician (SPT 4), SPT 4 stated the following: "I am from registry (temporarily hired employee), and I have been working at this place since November 2024. I have been doing this job for a very long time, and I am very familiar with the processes. In this hospital, the setup is different, the sinks are much smaller and do not allow submergence of bigger surgical instruments and trays. We only recently received brushes. And before that, I did not have the brushes to clean the scopes (a medical instrument used for viewing or performing procedures). I also have never really been oriented to any of the policies here. I only had general orientation when I was shown where everything is. There are no visual guidelines regarding what to do with instruments and how to clean them. Staff can look up the manufacturer guidelines by logging into a portal, called oneSOURCE (a leading healthcare management solution that enables facilities to stay in compliance 24/7 through its robust online platform equipped with the world's most updated IFUs (instructions for use) and PM (preventative maintenance) Service Manuals), but I am registry, and I don't have access to oneSOURCE. We do get a lot of rusty instruments which I send back to decontamination room. As to the tape on instruments, I never received instructions that instruments with tape should not be used."

During an interview on 2/21/2025 at 3:11 p.m. with the Infection Prevention Manager (IPM), IPM stated that carts used for transport of dirty and clean/sterile instruments could be reused once they were cleaned with bleach (disinfectant that kills germs) in between use. The IPM then stated that questions regarding cleaning carts should be addressed with the SPD (Special Processing Department, the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place) manager or director.

During a concurrent interview and record review on 2/21/2025 at 5:35 p.m. with the Director of Education (DE) and Manager of Education (MED), three employee files (Special Processing Technician (SPT 1, SPT 4, and Surgical Scrub technicians [SST 1]) were reviewed for professional competencies (the specific requirements and knowledge required to perform job functions effectively and safely). All competencies provided for the three employees for the years 2023 and 2024 contained missing signatures that were required to be signed by the verifier of competencies upon evaluation. The DE was not able to provide a list of required items by the facility annual educational requirements and competencies for Special Processing Department (SPD, a hospital department that cleans, disinfects [clean and safe for use], and sterilizes [free of germs] medical instruments and devices) employees and Surgical Scrub Technicians working in the Surgical Department (the area in a hospital where surgical procedures are performed, and where procedural staff must be properly trained and competent in their roles).

During the same record review on 2/21/2025 at 5:35 p.m., the Facility did not provide any pertinent documents regarding the employees' required annual competencies and annual educational requirements (HealthStream assignments, educational and training modules or courses assigned to healthcare employees such as continuing education, compliance training, competency assessments that are essential for enhancing staff knowledge, skills and performance in their role) specific to the department of employment, including copies of employee competency records, and relevant policies.

During a concurrent interview and record review on 2/21/2025 at 5:35 p.m. with the Director of Education (DE) and the Manager of Education (MED), the Sterile Processing Technician's (SPT 4) employee file, was reviewed. SPT 4's employee file contained no documented orientation with introduction to the facility's policies, procedures, and specific job responsibilities. SPT 4's file also contained no documented granted access to oneSOURCE upon the start date of 11/27/2024.

During an interview on 2/21/2025 at 6:24 p.m. with the Director of Quality (DQ), DQ stated the facility conducted internal self-reassessment for the sterile processing department (SPD) on 10/7/2024 and identified problems including but not limited to ripped sterile packs in the central supply room and SPD staff being unable to speak to the process of cleaning. DQ stated there was an action plan in place including reprocessing problem items, training SPD staff and validating their competencies in response to the problems identified in SPD.

During an interview on 2/21/2025 at 9:27 p.m. with the Chief Executive Officer (CEO), CEO stated the following: governing body oversee the overall quality and safety of the facility. The issues in sterile processing department were escalated to quality committee to ensure there was action taken. The governing body delegated to subcommittee and quality committee to oversee all quality and safety activities for patients.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/2024, the P&P indicated, "Scope: As part of performance improvement, leaders (including governing body) will: 1. Set priorities (ie high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines. 2. Identify frequency of dada collection for performance improvement. 3. Prioritize performance improvement in response to changes within the internal and external environment. 4. Proactively identify processes needing improvement to prevent medical errors. 5. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performances of process improvement/deficiencies, and monitoring/sustaining processes ... Structure and Accountability ... 1. The Community Board (governing body [GB]) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectation for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective [the facility's] committees/ teams."

During a review of the facility's policy and procedure (P&P) titled, "Infection Control Guidelines for Sterile Processing Department," dated 9/2023, the P&P indicated the following: The sterile Processing Department (SPD) is recognized as a high risk for infection prevention. To protect patients and other personnel from unnecessary exposure to potentially pathogenic organisms, Sterile Processing employees will be expected to abide by the following: Basic training in aseptic technique for all new sterile processing employees much be presented and documented. Personnel are expected to have general orientation to the hospital infection prevention program and periodic in-service of infection prevention policies and procedures.

During a review of the facility's policy and procedure (P&P) titled, "Wrapped Packaging," dated 12/6/2024, the policy indicated that the facility recognizes the important role of sterility...

During a review of the facility's policy and procedure (P&P) titled, "Sterilization of Equipment Supplies," dated 9/27/2021, the policy indicated that sterile items must be received, stored, and distributed in a manner which ensure sterility and integrity.

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines doe the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines titled, "Standards of Sterilization," dated 2021, the guidelines indicated that steam sterilization cannot be assured unless proper cleaning of the device and reduced bioburden (define) and soil was achieved. Verification and documentation of automated cleaning processes through objective means is an important aspect of quality control. Cleaning encompasses the removal of organic residue and microorganisms from the patient, from handling, or from water exposure during reprocessing. Inspection using enhanced visualization tools such as lighted magnification and video borescopes might identify residues not observable by the unaided eye.

During a review of the facility's policy and procedure (P&P) titled, "Event-Related Sterile Package Shelf Life," the P&P indicated the following: 6. Trays

Based on observation, interview and record review, the facility's governing body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) failed to:

1. Ensure its contracted service staff adhered to infection control and prevention practice to disinfect (killing germs and bacteria) one of three sampled hemodialysis (HD, the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machine (HDM 2) with heat or bleach at the end of day use, after hemodialysis, was completed for one of 30 sampled patients (Patient 16), in accordance with the contracted service's policy and procedure and hemodialysis machine operator manual.

This deficient practice had the potential to result in bacterial contamination within the hemodialysis machine and had the potential to introduce bacteria to other patients' bloodstream who may use the same machine (HDM 2) thus causing infection to patients from hemodialysis treatment.

2. Ensure that contracted dialysis services adhered to the facility's "Dialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) Services," policy and procedure when one of one sampled dialysis machine (HDM 1) was left unattended in a public area, containing intravenous (IV, administered into the vein) fluids, chemical reagents (solutions, typically containing electrolytes used to create the "dialysate" fluid which is circulated through a dialysis machine to filter waste products from a patient's blood), and patient-identifiable information.

This deficient practice had the potential to result in unauthorized access to medical records (the HDM 1 contained patient-identifiable information), contamination, and breaches of patient confidentiality, etc.

Findings:

1. During a review of Patient 16's "(H&P, a formal and complete assessment of the patient and the problem)," dated 2/11/2025, Patient 16 was admitted to the facility with diagnoses including but not limited to acute renal failure (the sudden and rapid loss of kidney's ability to filter waste and balance fluid in blood), acute (new onset) exacerbation (worsening of a disease or an increase in its symptoms) of congestive heart failure (CHF, a chronic condition in which a weakness of the heart leads to a buildup of fluid in the lungs), and electrolyte (minerals in the blood) abnormality.

During an interview on 2/20/2025 at 2:59 p.m. with the Chief Executive Officer (HDD) of the facility's hemodialysis contracted service (HDC), HDD stated hemodialysis nurses were responsible to use either heat or bleach at the end of day use to disinfect the hemodialysis machine to prevent infection and keep the machine clean per manufacturer's guideline.

During a concurrent interview and record review on 2/20/2025 at 3:15 p.m. with HDD, Patient 16's hemodialysis record titled, "Dialysis Nurses Notes (HD note)," dated 2/14/2025, was reviewed. The HD note indicated Patient 16 received hemodialysis on 2/14/2025 from 1:35 p.m. to 4:35 p.m. using HD machine (HDM 2). The HD note also indicated Hemodialysis Nurse (HDN 3) rinsed HDM 2 after hemodialysis was completed. HDD stated HDN 3 did not disinfect HDM 2 with heat or bleach at the end of hemodialysis treatment.

During a concurrent interview and record review on 2/20/2025 at 3:20 p.m. with HDD, hemodialysis machine (HDM 2)'s "Equipment Log Sheet (HD log)," dated from 2/12/2025 to 2/16/2025, was reviewed. The HD log indicated, Patient 16's hemodialysis treatment was the last treatment for day (2/14/2025). The HD log also indicated next HD treatment was on 2/16/2025. HDD stated HDN 3 should have disinfected HDM 2 after completing hemodialysis for Patient 16 with heat or bleach. HDN 3 did not disinfect HDM 2 at the end of the day (2/14/2025).

During an interview on 2/21/2025 at 9:27 p.m. with the Chief Executive Officer (CEO), CEO stated the facility's governing body was responsible to oversee the quality and safety of the facility. CEO stated the contracted service was required to follow policy and procedure to make sure services provided meet requirement to provide quality care to patients.

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Service," dated 2/2020, the P&P indicated, "Each contracted dialysis service is responsible for serving, maintaining, and upgrading the equipment, including safety checks."

During a review of the facility's hemodialysis contracted service (HDC)'s policy and procedure (P&P) titled, "Single Pass Dialysis Machine - Cleaning & Disinfection and Documentation," dated 12/2024, the P&P indicated, "It is the policy of [the contracted service] to follow the cleaning and disinfectant procedures outlined below per manufacturer's guidelines ... The single pass dialysis machine is to be heat or bleach disinfected at the end of each day (end of day per individual nurse assignment) when machine is used for treatment. Document cleaning and/or disinfection for every treatment in provided machine logbook."

During a review of the hemodialysis machine (HDM 2) manufacturer's guidelines titled, "[brand] Hemodialysis Machine Operator's Manual Rev P," undated, the manufacturer's guidelines indicated, "Heat Disinfect or Chemical/Rinse is recommended daily when the machine is used for treatment."

During a review of the facility's contract agreement with the HDC titled, "Dialysis Services Agreement (HD contract)," dated 11/20/2023, the HD contract indicated, "1.5 Nursing Services ...Dialysis Company shall ensure ... said nursing personnel shall perform the following nursing services pursuant to this Agreement ... demonstrate responsible handling of waste, sterilization and disinfection of equipment."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/2024, the P&P indicated, "Structure and Accountability ... 1. The Community Board (governing body [GB]) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectation for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective [the facility's] committees/ teams."

During a review of the facility's GB bylaws (legal guidelines for an organization) titled, "Bylaws of [the facility]," dated 5/ 2023, the GB bylaws indicated, "The Community Boar bylaws shall specify the exact functions of the Community Board, consistent with these bylaws. Subject to the Board's ultimate oversight and authority to take action, the Board delegates the following responsibilities to the Community Board... (b) determining that the Corporation's hospital, its employees, and the appointees of the medical staff will conduct their activities so as to conform with the requirements and principles of all applicable laws and regulations... (d) establishing and approving policies and procedures for those functions of the Corporation's hospital that have been delegated to the Community Board... (e) assuring a safe environment within the Corporation's hospital for employees, medical staff, patients, and visitors..."

2. During a concurrent observation and interview on 2/18/2025 at 3:15 p.m. with Infection Control Manager (IPM) on the East Tower ground floor in front of the elevator, the dialysis machine (HDM 1) was observed to be left unattended. IPM stated, "The dialysis machine should never be left unattended. The machine should be stored in the storage area in the basement." The machine contained:
-Two normal saline (is a solution of 0.9% sodium chloride [salt] in water) intravenous (IV,) fluid bags hanging
- Four bottles of reagent (chemical solutions used in dialysis treatment)
-A bottle of vinegar
-A binder containing patient medical records numbers (MRN, unique identifier used to tack patient medical records).

During an interview on 2/18/2025 at 3:20 p.m. with Hemodialysis Nurse (HDN) 1, HDN1 stated, "I usually leave the dialysis machine there (referring to the location at the East Tower ground floor in front of the elevator) to go for lunch."

During an interview on 2/21/2025 at 3:20 p.m. with Chair Executive Officer (HDD) of the Dialysis contracted services. HDD stated, "Leaving the dialysis machine unattended is unacceptable and not safe practice." HDD confirmed that unattended dialysis machine poses a risk of cross-contamination (the transfer of harmful bacteria [a tiny living thing that can cause infection and illness], viruses [a tiny germ that can cause illness], chemicals, or other contaminations from one person, object, or surface to another), as unauthorized individuals may tamper with the machine. HDD further stated, "Dialysis nurses have keys to the storage room and are required to store the dialysis machine in the designated storage area before taking breaks.

During an interview on 2/21/2025 at 9:27 p.m. with the Chief Executive Officer (CEO), CEO stated the facility's governing body was responsible to oversee the quality and safety of the facility. CEO stated the contracted service was required to follow policy and procedure to make sure services provided meet requirement to provide quality care to patients.

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Services," dated 6/16/2023, the P&P indicated, "The purpose of this policy is to define the process of the provision of dialysis services to patients. Patient's dialysis needs will be met through the utilization of competent contracted services ... Rooms are available for storage of dialysis equipment and supplies. Dialysis equipment is to be placed in storage rooms whenever not in use. The dialysis company(s) assigned to the storage room is responsible for maintaining it in orderly fashion. The dialysis nurse will notify the Nursing Resource Office before leaving if housekeeping is needed for cleaning the room. Note: If the storage room key is not returned to the Nursing Resource Office in a timely manner, the dialysis company will be billed for the lock being re-keyed or replacement. No copies are to be made of the keys ...Dialysis equipment is not to be left unattended in any area. There are no exceptions. If the patient is on isolation, the equipment must be wiped down with an appropriate disinfectant and stored in the assigned locked storage area after each treatment."

During a review of the facility's policy and procedure (P&P) titled, "Infection Prevention and Control Plan," dated 4/9/2024, the P&P indicated, "Infection Prevention and Control (IPC) program assists patient care by reducing the risk of infection in patients, visitors, associates and others through education, surveillance, prevention, control, and continuous review and evaluation of infection prevention practices. The scope of service includes surveillance, prevention, and control of infections in patients, healthcare workers, volunteers, and visitors...Responsibilities: Oversees the organization-wide Infection Prevention and Control Program... The Infection Control committee - Standard and transmission-based precautions monitoring through active rounding by IP..."

During a review of the facility's policy and procedure (P&P) titled, "Patient Rights and Responsibility," dated 9/9/2024, the P&P indicated, "Have personal privacy respected ... Confidential treatment of all communications and records pertaining to your care and stay in the hospital. You will receive a separate "Notice of Privacy Practices· that explains your privacy rights in detail and how we may use and disclose your protected health information."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/2024, the P&P indicated, "Structure and Accountability ... 1. The Community Board (governing body [GB]) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectation for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective [the facility's] committees/teams."

During a review of the facility's GB bylaws (legal guidelines for an organization) titled, "Bylaws of [the facility]," dated 5/ 2023, the GB bylaws indicated, "The Community Boar bylaws shall specify the exact functions of the Community Board, consistent with these bylaws. Subject to the Board's ultimate oversight and authority to take action, the Board delegates the following responsibilities to the Community Board... (b) determining that the Corporation's hospital, its employees, and the appointees of the medical staff will conduct their activities so as to conform with the requirements and principles of all applicable laws and regulations... (d) establishing and approving policies and procedures for those functions of the Corporation's hospital that have been delegated to the Community Board... (e) assuring a safe environment within the Corporation's hospital for employees, medical staff, patients, and visitors..."

Based on observation, interview, and record review, the facility's governing body (is a group of people who are legally responsible for the hospital's operations. This group is also responsible for ensuring the hospital's compliance with regulations and the provision of high-quality care) failed to ensure that contracted dialysis services adhered to safe practices and the facility's policy and procedure regarding safe handling and storage protocols for dialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machines, when one of one sampled dialysis machine (HDM 1) was left unattended in a public area, containing intravenous (IV, administered into the vein) fluids, chemical reagents (solutions, typically containing electrolytes used to create the "dialysate" fluid which is circulated through a dialysis machine to filter waste products from a patient's blood), and patient-identifiable information.

This deficient practice had the potential to result in unauthorized access to medical records (the HDM 1 contained patient-identifiable information), contamination, and breaches of patient confidentiality, etc.

Findings:

During a concurrent observation and interview on 2/18/2025 at 3:15 p.m. with the Infection Control Manager (IPM) on the East Tower ground floor in front of the elevator, the dialysis machine (HDM 1) was observed to be left unattended. IPM stated, "The dialysis machine should never be left unattended. The machine should be stored in the storage area in the basement." The machine contained:

-Two normal saline (is a solution of 0.9% sodium chloride [salt] in water) intravenous (IV, a method of delivering fluids or medicine directly into a vein) fluid bags hanging
- Four bottles of reagent (chemical solutions used in dialysis treatment)
-A bottle of vinegar
-A binder containing patient medical records numbers (MRN, unique identifier used to tack patient medical records).

During an interview on 2/18/2025 at 3:20 p.m. with Hemodialysis Nurse (HDN) 1, HDN1 stated, "I usually leave the dialysis machine there (referring to the location at the East Tower ground floor in front of the elevator) to go for lunch."

During an interview on 2/21/2025 at 3:20 p.m. with the Chair Executive Officer (HDD) of the Dialysis contracted services, HDD stated, "Leaving the dialysis machine unattended is unacceptable and not safe practice." HDD confirmed that unattended dialysis machine poses a risk of cross-contamination (the transfer of harmful bacteria [a tiny living thing that can cause infection and illness], viruses [a tiny germ that can cause illness], chemicals, or other contaminations from one person, object, or surface to another), as unauthorized individuals may tamper with the machine. HDD further stated, "Dialysis nurses have keys to the storage room and are required to store the dialysis machine in the designated storage area before taking breaks.

During an interview on 2/21/2025 at 9:27 p.m. with the Chief Executive Officer (CEO), CEO stated the facility's governing body was responsible to oversee the quality and safety of the facility. CEO stated the contracted service was required to follow policy and procedure to make sure services provided meet requirement to provide quality care to patients.

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Services," dated 6/16/2023, the P&P indicated, "The purpose of this policy is to define the process of the provision of dialysis services to patients. Patient's dialysis needs will be met through the utilization of competent contracted services ... Rooms are available for storage of dialysis equipment and supplies. Dialysis equipment is to be placed in storage rooms whenever not in use. The dialysis company(s) assigned to the storage room is responsible for maintaining it in orderly fashion. The dialysis nurse will notify the Nursing Resource Office before leaving if housekeeping is needed for cleaning the room. Note: If the storage room key is not returned to the Nursing Resource Office in a timely manner, the dialysis company will be billed for the lock being re-keyed or replacement. No copies are to be made of the keys ...Dialysis equipment is not to be left unattended in any area. There are no exceptions. If the patient is on isolation, the equipment must be wiped down with an appropriate disinfectant and stored in the assigned locked storage area after each treatment.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement " dated 12/1/2024, the P&P indicated, "The Community Board (GB) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectations for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

During a review of the facility's policy and procedure (P&P) titled, "Infection Prevention and Control Plan," dated 4/9/2024, the P&P indicated, "Infection Prevention and Control (IPC) program assists patient care by reducing the risk of infection in patients, visitors, associates and others through education, surveillance, prevention, control, and continuous review and evaluation of infection prevention practices. The scope of service includes surveillance, prevention, and control of infections in patients, healthcare workers, volunteers, and visitors...Responsibilities: Oversees the organization-wide Infection Prevention and Control Program... The Infection Control committee - Standard and transmission-based precautions monitoring through active rounding by IP..."

During a review of the facility's policy and procedure (P&P) titled, "Patient Rights and Responsibility," dated 9/9/2024, the P&P indicated, "Have personal privacy respected ... Confidential treatment of all communications and records pertaining to your care and stay in the hospital. You will receive a separate "Notice of Privacy Practices· that explains your privacy rights in detail and how we may use and disclose your protected health information."

Based on interview and record review the facility failed to ensure that one of 30 sampled patients (Patient 25) was properly provided adequate information regarding refusal of blood product transfusion as well as be provided with alternative options to blood transfusion (a medical procedure where blood or blood components from a donor are transferred into the bloodstream of a recipient), as part of the informed consent process (a process that involves discussing treatment options with the patient, including risks and benefits, and getting their agreement to proceed), in accordance with the facility's policy and procedure regarding informed consent.

This deficient practice resulted in Patient 25 receiving three (3) units of packed red blood cells (PRBC- used to increase the oxygen-carrying capacity of the blood in patients with anemia [when the body does not have enough health red blood cells], blood loss, or other conditions that cause a low red blood cell count) during a surgical procedure emergency, which violated Patient 25's rights regarding informed consent.

Findings:

During a record review on 2/19/2025 at 11:00 a.m. with the Information Technology Manager (ITM), the Risk Management Specialist (RMS) and the Director of Risk Management (DRM), Patient 25's history and physical (H&P, a complete and formal assessment of the patient and the problem), dated 7/31/2024, at 11:20 a.m., was reviewed. The H&P indicated Patient 25 was admitted for Bradycardia (heartbeat less than 60 beats per minute) and difficulty breathing.

During further record review on 2/19/2025, Patient 25's cardiology (a branch of medicine that focuses on the diagnosis, treatment, and prevention of heart and blood vessel diseases) consultation note, dated 7/31/2024, at 11:06 p.m., completed by MD (Medical Doctor) 7, was reviewed. In the same cardiology consultation note, MD 7 documented recommendation of a pacemaker device system (a small device that prevents the heart from beating slow) and documented indications for the procedure and that the risks and the benefits regarding the pacemaker placement were explained to Patient 25 and family member. However, there was no documentation that Blood Transfusion refusal or other alternative options to blood transfusion, was discussed with Patient 25 and/or family member. Likewise, a record review of Patient 25's Advance directive (a legal document that lets you specify your medical care wishes if you are unable to make decisions for yourself) indicated "No Blood." These lack of documentation, in the MD notes, regarding MD discussion about blood transfusion and/or alternatives to blood transfusion were confirmed by the ITM and the RMS during an interview.

During a review of Patient 25's record of Consent to Surgery/Special Procedure, dated 8/1/2024, signed by Registered Nurse (RN) 10 and the second RN witness (RN 11), the Consent to Surgery/Special Procedure form, indicated Patient 25's refusal to permit Blood and Blood Products. However, Patient 25's Main EP (Electro Physiology- a report that contains details of the results of a test used to assess the electrical activity of the heart) Report indicated Patient 25 received three units of blood despite a documented refusal by Patient 25 to receive blood and blood products.

During a review of Patient 25's medical record titled, pre-anesthesia (a medical intervention that temporarily blocks pain and sensation during surgical procedures and other medical treatments) evaluation informed consent (a process that involves discussing treatment options with the patient, including risks and benefits, and getting their agreement to proceed), the record indicated "Consent (referring to consent for blood transfusion) not obtained due to emergency circumstances."

During a review of Patient 25's Operative report, dated 8/1/2024, documented by MD 7, the Operative Report indicated MD 7 had several conversations with Patient 25's family members regarding Patient 25's status during surgery. However, there was no documentation in the Operative report regarding Patient 25's Family member's notification pertaining to Patient 25 having received three units of blood.

During a concurrent interview and record review on 2/20/2025 at 1:50 p.m. with the Catheterization Surgical Laboratory (area that uses technology to diagnose and treat heart conditions) Director (CSLD) and the ITM, Patient 25's Procedure note, dated 8/1/2024, and the Main EP Report, dated 8/1/2024, were reviewed. CSLD was asked if there was documentation of discussion or plan for Patient 25's refusal of Blood Products in the OR record time out (a brief pause before a surgical procedure where the entire surgical team verbally confirms critical patient details like their identity, the intended procedure, and the surgical site, ensuring everyone is on the same page and minimizing the risk of errors before making an incision; it's a crucial patient safety check considered a standard practice in modern surgery) and in the Operative report. Both the ITM and the CSLD confirmed there was no plan, or any alternatives to blood transfusion presented and discussed with Patient 25, when Patient 25 refused blood transfusion nor was there any communication documented addressing Patient 25's refusal of Blood Products in preparation for the procedure (pacemaker placement). CSLD stated MD 7 was in communication with the Family member during the procedure. However, there was no documentation to indicate that alternative options to Blood transfusion were discussed with Patient 25's family member during the procedure (Pacemaker placement).

During an interview on 2/20/2025 at 9 :35 a.m. with the Risk Management Specialist (RMS) and the Director of Risk Management (DRM), the RMS and the DRM stated that the event involving Patient 25's documented refusal of Blood transfusion which was reflected in the consent form, and yet during surgery, received three (3) units of blood (PRBC, Packed Red Blood Cells- used to increase the oxygen-carrying capacity of the blood in patients with anemia, blood loss, or other conditions that cause a low red blood cell count), was reviewed by the facility. The review was completed on 9/16/2024 and included a need for communication with MD when a patient verbalizes Blood transfusion refusal including a need for patient informed consents to be reviewed during Operation room time outs. In addition, the Medical Staff Director (MSD) stated the Department chair, and a designated medical staff member were also reviewing the case and their review will be completed in March 2025.

During a review of the facility's Policy and Procedure (P&P) titled, "Informed Consent," dated 12/4/2024, the P&P indicated "the physician will document the information specified in the following procedures and the patient medical record whenever the following diagnostic and therapeutic interventions are to be performed which included blood transfusion."

During a review of the facility's document titled, "Massive Transfusion Protocol," dated 2/2/2022, the protocol indicated "physician to obtain consent for blood product transfusion from patient or patient surrogate ..." The protocol also indicated "provider must document the medical determination that an emergency exists."

Based on interview and record review, the facility failed to follow the physician's order for one of 30 sampled patients (Patient 1) to provide a bedside sitter (a trained individual, often a healthcare worker or sitter, assigned to provide continuous, one-on-one supervision of a patient to ensure their safety, especially if the patient is at risk of falls, disorientation, or self-harm) for constant supervision to monitor Patient 1's safety, when:

1. On 11/28/2024, in the Intensive Care Unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), Registered Nurse (RN 1) left Patient 1 unattended while retrieving medications from the medication room resulting in Patient 1 falling to the floor.

This deficient practice resulted in Patient 1 experiencing a fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) in the ICU on 11/28/2024. This deficient practice also had the potential to result in complications such as fracture (break in the bone), etc.

2. On 12/6/2024, a sitter was not assigned to Patient 1 when Patient 1 was transferred to the Step-Down Unit (SDU, an intermediate care unit for patients who no longer require intensive care but still need close monitoring). From 12/6/2024 through 12/11/2024, Patient 1 remained without a sitter. On 12/11/2024, Patient 1 was found disconnected from the Bilevel Positive Airway Pressure (BIPAP, a non-invasive ventilator that assist patients with breathing difficulties) machine and suffered cardiac arrest (when the heart suddenly stops beating) in the SDU.

This deficient practice resulted in a cardiac arrest in the SDU on 12/11/2024 due to Patient 1's disconnection from the BiPAP machine. In addition, this deficient practice had the potential to place other patients with physician-ordered bedside sitters at risk for similar sentinel event (a patient safety event that results in death, permanent harm, or severe temporary harm) due to inadequate supervision.

On 2/21/2025 at 4:44 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements have caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Chief Executive Officer (CEO), System Chief Medical Officer (SCMO), Chief Nursing Officer (CNO), Chief Operating Officer (COO), Director of Quality (DQ), Senior Director for Risk Management (DRM), System Director for Accreditation and Licensing (SDAL), and Regulatory Specialist (RS). The facility failed to follow physician order to provide a bedside sitter (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety, especially if the patient is at risk for falls [an unexpected, unintentional descent of a patient to the ground or another lower surface], disorientation [the condition of having lost one's sense of direction], or self-harm) for constant supervision to monitor Patient 1's safety thus resulting in Patient 1 having an unwitnessed fall in the Intensive Care Unit (ICU, specialist hospital wards that provide treatment and monitoring for people who are very ill). Subsequently, Patient 1 was found having disconnected self from a BIPAP (bilevel positive airway pressure, provide pressurized air to patient's airway to assist with breathing) machine which led to a cardiac arrest (when the heart stops beating) in the Step Down Unit (specialist hospital wards that serve as a transition point for patients who are no longer critically ill enough to remain in ICU but still require more intensive monitoring and care than a general ward can provide).

Patient 1 was brought to the facility's emergency department (ED, hospital department provides unscheduled outpatient services to patients whose condition requires immediate care) for tachycardia (high heart rate) and generalized weakness on 11/24/2024. On 11/26/2024, there was a physician order to have a sitter for Patient 1. On 11/28/2024 at 12:10 a.m., Patient 1 was found on the floor in the Intensive Care Unit (ICU) when Registered Nurse (RN 1) left Patient 1 to get medications. Patient 1 was then transferred to the facility's Step Down Unit on 12/6/2024. There was no sitter in place from 12/6/2024 to 12/11/2024 despite an existing order which was never discontinued by the physician. On 12/11/2024, Patient 1 pulled out BIPAP machine which led to cardiac arrest. Code Blue (hospital emergency code use to summon help when a patient is in need of resuscitation [to revive a patient]) was called. Patient 1 was intubated (placement of a flexible plastic tube into the trachea to maintain an open airway) and sent back to ICU.

On 2/21/2025 at 9:20 p.m., the IJ was removed in the presence of the Chief Executive Officer (CEO), System Chief Medical Officer (SCMO), Chief Nursing Officer (CNO), Director of Quality (DQ), Senior Director for Risk Management (DRM), System Director for Accreditation and Licensing (SDAL), and Regulatory Specialist (RS). The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed through observation, interview and record review. The IJ Removal Plan indicated that for immediate action taken by the facility, on 2/21/2025, nursing leaders conducted facility-wide validations to ensure that every high fall-risk patient with a sitter order had a sitter present and that 15-minute observation were properly documented. Education began with nursing staff that were on duty on 2/21/2025 and covered the following: nurses must follow physician orders for a sitter when a patient is identified as high risk for falls, patients must be observed if a sitter order is in place regardless of patient's sedation status, nurse must call charge nurse or lead nurse to provide constant observation, uninterrupted observation must be documented every 15 minutes and there must be hand-off communication between unit to unit and sitter to sitter. The IJ Removal Plan also included nursing leaders or designated staff would conduct observations and record review to confirm sitter order and compliance of sitter implementation and documentation.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 11/25/2025, the "H&P" indicated, Patient 1 was brought in by ambulance from home and presented with tachycardia (an abnormally fast heart rate exceeding 100 beats per minutes). The H&P also indicated that Patient 1 had a history of dementia (a disorder causing memory loss and confusion) and atrial fibrillation (a-fib, an irregular and often rapid heart rhythm that increases the risk of stroke [blood clot in the brain], heart failure [a condition where the heart muscle is weakened or stiff, making it unable to pump blood effectively], and other complications). Neurological (relating to the nervous system, which includes the brain, spinal cord, and nerves) assessment indicated: "Unable to assess mental status, patient unable to follow commands."

During a concurrent interview and record review on 2/19/2025 at 3:00 p.m. with the Director of Medical Surgical unit (DIR) 3, Patient 1's "Nursing Documentation-Flowsheet (a form that records a patient's clinical observations over time)," dated 11/28/2024, was reviewed. The flowsheet indicated, at 12:11 a.m., Patient 1 was "found on the floor, lying flat." DIR 3 stated that the cause of the fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) remained unknown.

During a concurrent interview and record review on 2/20/2025 at 10:00 a.m. with the Nurse Manager (NM) 3 of the Surgical Treatment Unit (STU, a hospital area where surgeries are performed and patients are cared for before and after) Patient 1's Medication Administration Record (MAR), from 11/26/2024 through 11/28/2024, was reviewed. The MAR indicated, Patient 1 was administered continuous infusion of Precedex (dexmedetomidine, a sedation used to reduce anxiety [an emotion that can feel like fear, or uneasiness] and agitation [feeling extremely restless, tense, or irritated] without suppressing breathing) on 11/26/2024 at 11:59 p.m., which continued until 12/11/2024, when Patient 1's BiPAP (Bilevel Positive Airway Pressure machine, a non-invasive ventilator that assist patients with breathing difficulties) machine was accidentally disconnected.

During an interview on 2/21/2025 at 1:00 p.m. with ICU Registered Nurse (RN) 1, RN 1 confirmed that Patient 1 was receiving continuous sedation with Precedex and was being monitored using the Richmond Agitation-Sedation Scale (RASS, a 10-point scale used to assess a patient's level of sedation [a state of relaxation or drowsiness] or agitation, ranging from +4 [combative] to -5 [unarousable]), with a target RASS score of 0 to -2. RN 1 stated Patient 1 was at -1 (drowsy, a state of sleepiness and wakeness) on 11/28/2024. RN 1 stated Patient 1 was high risk for falls and was left sleeping while RN 1 retrieved medications from the medication room. Upon returning, RN 1 found Patient 1 on the floor with other staff present. The fall was unwitnessed, and the reason for the fall was unknown.

During a concurrent interview and record review on 2/21/2025 at 2:30 p.m. with Registered Nurse (RN) 2, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Order" report, dated 11/26/2024, was reviewed. The physician (MD 5) ordered bedside sitter for Patient 1 from11/26/2024 at 12:59 p.m. to 12/17/2024 at 1:02 a.m. RN 2 confirmed that there was no documented evidence that a sitter (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety, especially if the patient is at risk for falls [an unexpected, unintentional descent of a patient to the ground or another lower surface], disorientation [the condition of having lost one's sense of direction], or self-harm) was monitoring Patient 1 on 11/28/2024 (when Patient 1 fell in the ICU). RN 2 further stated, "As long as there is an order from the physician for a sitter, they need to have a sitter for constant observation. If they do not have a sitter, it can lead to fall, or accidental extubation (removal of the tube from the patient's throat that helps them breathe)."

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients" dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

During a review of the facility's policy and procedure (P&P) titled, "Fall Prevention Program," dated 6/30/2022, the P&P indicated, "Assessment may only be conducted by a licensed clinical individual. When a patient has been identified as being at risk for falling, interventions implemented to reduce falls are specific to the patient's assessed needs and risk level."

2. During a concurrent interview and record review on 2/20/2025 at 10:00 a.m. with the Nurse Manager (MN) 3 of the Step-Down Unit (SDU, a hospital unit that provides intermediate care for patients who are not ready for general ward care but don't need intensive care), Patient 1's "transfer Summary," dated 12/6/2024, was reviewed. The summary indicated Patient 1 was transferred to the SDU on 12/6/2024. MN 3 confirmed that Patient 1 was transferred to SDU without a sitter.

During a concurrent interview and record review on 2/20/2025 at 10:30 a.m. with Nurse Manager (MN) 3, Patient 1's "Clinical Note Nursing," was reviewed. The note indicated on 12/11/2024 at 1:30 a.m. the Telemetry Monitor Technician (MT, a healthcare worker who monitors a patient's heart rate remotely) observed that Patient 1's heart rate was at 30s and notified any RN to check on Patient 1. RN 9 found that Patient 1 had pulled out the BiPAP's tubing resulting in a cardiac arrest (heart stop). Code Blue (a hospital emergency response for a patient in a cardiac arrest or respiratory arrest [when a person stops breathing or breathes inadequately]) was called, and Patient 1 was intubated (a medical procedure where a tube is inserted into the airway to assist with breathing) before being sent back to the ICU.

During a concurrent interview and record review on 2/21/2025 at 2:30 p.m. with Registered Nurse (RN) 2, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Order Summary," report dated 11/26/2024, was reviewed. The physician (MD 5) ordered bedside sitter for Patient 1 from 11/26/2024 at 12:59 p.m. to 12/17/2024 at 1:02 a.m. RN 2 confirmed that there was no documented evidence that a sitter was monitoring Patient 1 on 12/11/2024.

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients" dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

During a review of the facility's policy and procedure (P&P) titled, "Fall Prevention Program," dated 6/30/2022, the P&P indicated, "Assessment may only be conducted by a licensed clinical individual. When a patient has been identified as being at risk for falling, interventions implemented to reduce falls are specific to the patient's assessed needs and risk level."

Based on observation, interviews, and record review the facility failed to protect the confidentiality of information, in accordance with the facility's policy and procedure regarding Patient Rights (a subset of human rights) and Responsibility, for twenty of twenty sampled patients (who were receiving dialysis for the month of February 2025), when a binder containing medical record numbers (MRNs) was left unattended on a dialysis machine (HDM 1) in a public area (on the East Tower ground floor in front of the elevator).

This deficient practice violated patient confidentiality and compromised compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA, is a federal law that protects patients' health information) regulations. This deficient practice also increased the risk of unauthorized access to protected health information (PHI, any individually identifiable health information about a patient that is held by a covered entity, like a healthcare provider or health plan, and is subject to privacy regulations under the Health Insurance Portability and Accountability Act [HIPAA]), failing to uphold patients' rights to privacy and confidentiality of their clinical records.

Findings:

During a concurrent observation and interview on 2/18/2025 at 3:15 p.m. with the Infection Control Manager (IPM) on the East Tower ground floor in front of the elevator, the dialysis machine (HDM 1) was observed to be left unattended. IPM stated, "The dialysis machine should never be left unattended. The machine should be stored in the storage area in the basement." The machine contained:
-Two normal saline (a solution of 0.9% sodium chloride [salt] in water) intravenous (IV, a method of delivering fluids or medicine directly into a vein) fluid bags hanging
- Four bottles of reagent (chemical solutions used in dialysis treatment)
-A bottle of vinegar
-A binder containing patient medical records numbers (MRN, unique identifier used to tack patient medical records).

During an interview on 2/18/2025 at 3:20 p.m. with Hemodialysis Nurse (HDN) 1, HDN 1 stated, "I usually leave the dialysis machine there (referring to the location East Tower ground floor in front of the elevator) to go for lunch."

During an interview on 2/21/2025 at 3:20 p.m. with the Chair Executive Officer (HDD) of the Dialysis contracted services. HDD stated, "Leaving the dialysis machine unattended is unacceptable and not safe practice." HDD further stated, "Dialysis nurses have keys to the storage room and must take the dialysis machine to the storage room prior to taking breaks."

During a review of the facility's policy and procedure (P&P) titled, "Patient Rights and Responsibility," dated 9/9/2024, the P&P indicated, "Have personal privacy respected ... Confidential treatment of all communications and records pertaining to your care and stay in the hospital. You will receive a separate "Notice of Privacy Practices· that explains your privacy rights in detail and how we may use and disclose your protected health information.

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Services," dated 6/16/2023, the P&P indicated, "The purpose of this policy is to define the process of the provision of dialysis services to patients. Patient's dialysis needs will be met through the utilization of competent contracted services ... Rooms are available for storage of dialysis equipment and supplies. Dialysis equipment is to be placed in storage rooms whenever not in use. The dialysis company(s) assigned to the storage room is responsible for maintaining it in orderly fashion. The dialysis nurse will notify the Nursing Resource Office before leaving if housekeeping is needed for cleaning the room. Note: If the storage room key is not returned to the Nursing Resource Office in a timely manner, the dialysis company will be billed for the lock being re-keyed or replacement. No copies are to be made of the keys ...Dialysis equipment is not to be left unattended in any area. There are no exceptions. If the patient is on isolation, the equipment must be wiped down with an appropriate disinfectant and stored in the assigned locked storage area after each treatment."

Based on observation, interview, and record review, the facility failed to identify, analyze, and address deficiencies in ICU (Intensive Care Unit- ward that provides the critical care and life support for acutely ill and injured patients) equipment availability through its Quality Assessment and Performance Improvement (QAPI, a systematic approach to improving the quality of care and safety in a healthcare setting. QAPI combines Quality Assurance [QA] and Performance Improvement [PI] to create a comprehensive, data-driven program) program, resulting in inadequate monitoring for four of 30 sampled Patients (Patient 5, Patient 7, Patient 8, and Patient 9), with an arterial line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) to ensure they each have a leveler (a device used to ensure proper positioning of the A-line relative to the patient's photostatic axis [atomical reference point at the 4th intercostal space, mid-axillary line]) at the bedside, to use each time the patient was repositioned to ensure accurate reading of the patient's blood pressure (the force of blood against artery walls as the heart pumps blood throughout the body), in accordance with the facility's policy and procedure regarding Monitoring Arterial Blood using a Pressure Transducer (a device that converts the pressure fluctuations of blood within the artery into an electrical signal) System and the policy regarding QAPI.

This deficient practice resulted in delays in recalibration of the A-line, and had the potential for inaccurate blood pressure readings which may lead to delays in the implementation of timely interventions, thus compromising patient safety due to complications of unidentified elevated, uncontrolled blood pressure such as stroke (a clot in the brain), damage to vital organs such as kidneys, etc.

Findings:

1. During a review of Patient 5's "ED (emergency department, hospital department that treats patients in need of immediate care upon arrival to the hospital) Physician Notes," dated 2/17/2025, the note indicated, Patient 5 "presents to the emergency department by ambulance from home for sudden and significant change in mental function, nausea (the urge to throw-up), vomiting and diarrhea (loose stools), profuse diarrhea tonight and family stated she (Patient 5) has been more confused than usual, low oxygen saturation (the amount of oxygen in the blood)." Diagnostic studies indicated Patient 5 had an acute (sudden and severe onset) intracranial hemorrhage (a brain bleed).

During a concurrent observation and interview on 2/19/2025 at 12:05 p.m. with the charge nurse (CN 3, charge nurse responsible for overseeing ICU nursing staff) in the intensive care unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients) in room ABC on 2/19/2025 at 12:05 p.m., Patient 5 was observed with an A-Line in the left wrist. There was no A-line leveler (a device used to ensure the A-line is correctly positioned for accurate blood pressure readings. If the transducer [a device that converts the pressure fluctuations of blood within the artery into an electrical signal], is too high, it underestimates blood pressure, if the transducer is too low, it overestimates blood pressure. The leveler helps maintain correct alignment to prevents errors) in the room. CN 3 stated that the ICU only had two levelers available for all ICU patients. CN 3 said that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During a review of Patient 5's "Arterial Line Group," flowsheet (document used to track clinical observations for Patients over time), dated 2/18/2025, the flowsheet indicated, an Arterial line was inserted for Patient 5 on 2/18/2025 at 7:53 a.m. and remained current.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2, a member of the QAPI subcommittee, stated that QAPI team and ICU leadership discussed this issue (regarding inadequate number of available levelers) earlier that morning and were in the process of ordering a leveler for each ICU room.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/13/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient¿-centered systems to improve quality of care and patient safety in alignment with regulatory standards...As part of performance Improvement, leaders (including governing body) will: Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes ... Performance Improvement Committee Functions: Patient Safety Program (Refer to Patient Safety Program Plan): Patient safety integrates with all quality assessment and performance Improvement activities. Proactive Risk Assessments, such as FMEA (Failure Mode Effect Analysis), will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact to patient care outcomes ..."

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

2. During a review of Patient 7's "Face sheet (a document within a patient's medical chart that summarizes key information)," dated 2/12/2025, the face sheet indicated, Patient 7 was admitted for symptomatic bradycardia (a slow heart rate that causes symptoms like dizziness, fatigue [a feeling of extreme tiredness], or shortness of breath. A normal heart rate for adults is faster than 60 beats per minute), hyperkalemia (a higher-than-normal level of potassium [an essential mineral for nerve and muscle function] in the bloodstream), and acute renal failure (a condition characterized by a sudden and significant decline in kidney function).

During a review of Patient 7's "Operation/Procedure Report," dated 2/13/2025, the note indicated, Patient 7 had a procedure to insert an Arterial line into the femoral artery (a large blood vessel located in the upper thigh) at 10:25 a.m. on 2/13/2025.

During an interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN) 3 in the ICU, CN 3 stated that the ICU only had two levelers available for all ICU patients. CN3 stated that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN 3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2, a member of the QAPI subcommittee, stated that QAPI team and ICU leadership discussed this issue earlier that morning and are in the process of ordering a leveler for each ICU room.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/13/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient ¿centered systems to improve quality of care and patient safety in alignment with regulatory standards...As part of performance Improvement, leaders (including governing body) will: Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes ... Performance Improvement Committee Functions: Patient Safety Program (Refer to Patient Safety Program Plan): Patient safety integrates with all quality assessment and performance Improvement activities. Proactive Risk Assessments, such as FMEA (Failure Mode Effect Analysis), will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact to patient care outcomes ..."

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

3. During a review of Patient 8's "Operation/Procedure Report, dated 2/17/2025, the Report indicated, Patient 8 was scheduled for a mitral valve (one of four valves in your heart that regulates blood flow) replacement. The Operation/Procedure Report also indicated Patient 8 "past medical history include endocarditis (an inflammation of the inner lining of the heart chambers and heart valves) ...Patient (Patient 8) did undergo cardiology (the branch of medicine that deals with diseases and abnormalities of the heart) evaluation including an echocardiogram (a test of the action of the heart), which demonstrated evidence of severe mitral regurgitation (a valve in the heart, called the mitral valve, doesn't close properly, allowing blood to leak backwards instead of flowing smoothly forward) with a flail posterior mitral valve leaflet (is a flap of tissue in the heart valve that opens and closes to allow blood to flow through the heart)." The report also indicated an A-line was inserted to the wrist of Patient 8.

During an interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN) 3 in the ICU, CN 3 stated that the ICU only had two levelers available for all ICU patients. CN 3 stated that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN 3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2, a member of the QAPI subcommittee, stated that QAPI team and ICU leadership discussed this issue earlier that morning and are in the process of ordering a leveler for each ICU room.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/13/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient ¿centered systems to improve quality of care and patient safety in alignment with regulatory standards...As part of performance Improvement, leaders (including governing body) will: Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes ... Performance Improvement Committee Functions: Patient Safety Program (Refer to Patient Safety Program Plan): Patient safety integrates with all quality assessment and performance Improvement activities. Proactive Risk Assessments, such as FMEA (Failure Mode Effect Analysis), will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact to patient care outcomes ..."

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

4. During a review of Patient 9's "Face sheet," dated 2/12/2025, the face sheet indicated, Patient 9 was admitted to the facility for gastrointestinal (GI, bleeding is bleeding in the digestive tract [is a long, continuous tube-like pathway through which food travels from the mouth to the anus, where it is broken down, absorbed for nutrients, and ultimately expelled as waste]).

During a record review of Patient 9's "Operative/Procedure Report," dated 2/13/2025, the Report indicated Patient 9 had a procedure to insert a A-line to the left wrist.

During an interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN) 3 in the ICU, CN 3 stated that the ICU only had two levelers available for all ICU patients. CN 3 stated that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2, a member of the QAPI subcommittee, stated that QAPI team and ICU leadership discussed this issue earlier that morning and are in the process of ordering a leveler for each ICU room.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/13/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient ¿centered systems to improve quality of care and patient safety in alignment with regulatory standards...As part of performance Improvement, leaders (including governing body) will: Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes ... Performance Improvement Committee Functions: Patient Safety Program (Refer to Patient Safety Program Plan): Patient safety integrates with all quality assessment and performance Improvement activities. Proactive Risk Assessments, such as FMEA (Failure Mode Effect Analysis), will be utilized to assess actual and potential risk, failure, points of vulnerability, and prioritized areas for improvement based on impact to patient care outcomes ..."

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

Based on interview and record review, the facility failed to track, analyze, and implement preventive actions for adverse patient events (a negative or harmful result experienced by a patient as a consequence of medical care), specifically recurrent patient falls (an unexpected, unintentional descent of a patient to the ground or another lower surface) in the Intensive Care Unit (ICU, specialist hospital wards that provide treatment and monitoring for people who are very ill). The Quality Assessment and Performance Improvement (QAPI, a systematic approach to improving the quality of care and safety in a healthcare setting. QAPI combines Quality Assurance [QA] and Performance Improvement [PI] to create a comprehensive, data-driven program) program team did not conduct a Root Cause Analysis (RCA, a systematic process used to identify and analyze the underlying causes of a medical error or adverse event, with the goal of preventing similar incidents from happening again by addressing the root issues rather than just the symptoms; it typically involves a multidisciplinary team to thoroughly investigate the event and develop corrective actions) or established an effective action plan to prevent falls among high-risk patients, in accordance with the facility's policy and procedure regarding QAPI.

This deficient practice resulted in repeated falls in the ICU, including:
-Patient 1, who fell on 11/28/2024 unwitnessed while sedated, and was identified as a high fall risk.
-Patient 6, who had an unwitnessed fall on 2/2/2025 after heart surgery.
The failure to implement an effective fall prevention strategy placed patients at risk for serious harm and compromised patient safety.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 11/25/2025, the "H&P" indicated, Patient 1 was brought in by ambulance from home and presented with tachycardia (an abnormally fast heart rate exceeding 100 beats per minutes). The H&P also indicated that Patient 1 had a history of dementia (a disorder causing memory loss and confusion) and atrial fibrillation (a-fib, an irregular and often rapid heart rhythm that increases the risk of stroke [blood clot in the brain], heart failure [a condition where the heart muscle is weakened or stiff, making it unable to pump blood effectively], and other complications). Neurological (relating to the nervous system, which includes the brain, spinal cord, and nerves) assessment indicated: "Unable to assess mental status, patient unable to follow commands."

During a concurrent interview and record review on 2/19/2025 at 3:00 p.m. with the Director of Medical Surgical unit (DIR) 3, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history), was reviewed. The document titled "Nursing Documentation-Flowsheet (a form that records a patient's clinical observations over time)," dated 11/28/2024, was reviewed. The flowsheet indicated, on 11/28/2024 at 12:11 a.m., Patient 1 was "found on the floor, lying flat." DIR 3 confirmed that Patient 1 had been identified as high fall (an unexpected, unintentional descent of a patient to the ground or another lower surface) risk and stated that the cause of the fall remained unknown.

During an interview on 2/21/2025 at 1:00 p.m. with ICU Registered Nurse (RN)1, RN 1 confirmed that Patient 1 was receiving continuous sedation with Precedex (dexmedetomidine, a sedation used to reduce anxiety [an emotion that can feel like fear, or uneasiness] and agitation [feeling extremely restless, tense, or irritated] without suppressing breathing) and was being monitored using the Richmond Agitation-Sedation Scale (RASS, is a 10-point scale used to assess a patient's level of sedation or agitation, ranging from +4 [combative] to -5 [unarousable]), with a target RASS score of 0 to -2. RN 1 stated Patient 1 was at -1 (drowsy, a state of sleepiness and wakeness) on 11/28/2024. RN 1 stated Patient 1 was high risk for falls and was left sleeping while RN 1 retrieved medications from the medication room. Upon returning, RN 1 found Patient 1 on the floor with other staff present. The fall was unwitnessed, and the reason for the fall was unknown.

During a concurrent interview and record review on 2/21/2025 at 2:30 p.m. with Registered Nurse (RN) 2, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Order" report, dated 11/26/2024, was reviewed. The physician (MD 5) ordered bedside sitter for Patient 1 from 11/26/2024 at 12:59 p.m. to 12/17/2024 at 1:02 a.m. RN 2 confirmed that there was no documented evidence that a sitter was monitoring Patient 1 on 11/28/2024.

During an interview on 2/21/2025 at 12:33 p.m. with the Co-Chair of the Falls Performance Improvement (PI) Team (RM), RM stated the Falls PI team communicates directly with QAPI (Quality Assurance Performance Improvement- a systematic approach to improving the quality of care and safety in a healthcare setting. QAPI combines Quality Assurance [QA] and Performance Improvement [PI] to create a comprehensive, data-driven program) and was responsible for fall prevention measures, system assessment, collaboration with other department leaders. RM was unaware of Patient 1's fall until the day of the interview (2/21/2025), stating, "I did not review this case (Patient 1's fall on 11/28/2024) until this morning."

During an interview on 2/21/2025 at 2:00 p.m. with the Director of ICU (DIR) 2, DIR 2 stated that after a patient fall, a post-fall huddle was conducted, but nursing staff were not included in these discussions. Instead, one leader from the unit where the fall occurred, such as the charge nurse, unit manager, or unit representative, would attend. DIR 2 also stated that they did not participate in the post-fall huddle for Patient 1's fall on 11/28/2024.

During an interview on 2/21/2025 at 9:20 p.m. with the Chief Executive Officer (CEO), the CEO stated Governing Body relies heavily on the QAPI department to report on current issues and outline action plan taken in response. CEO emphasized that ultimately, the Governing Body holds the responsibility for ensuring oversight of an ongoing quality improvement plan focused on patient safety, quality of care, organization-wide quality assessment.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement," dated 12/1/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient centered systems to improve quality of care and patient safety in alignment with regulatory standards...As part of performance Improvement, leaders (including governing body) will: Set priorities (high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes... Structure and Accountability: The Community Board (GB) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectations for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

During a review of the facility's policy and procedure (P&P) titled, "Performance Improvement Team Charter: 2025 Falls PI Team, " dated 1/10/2012, the P&P indicated, "Define the Issues: Non-compliant behaviors (e.g., patient/family turning off bed alarm, don't call/wait for assistance).Inconsistencies with bed alarms and zone settings activation (e.g., staff do not set bed in moderate sensitivity setting, do not activate the bed alarm after turning off). Falls from chairs (including commode, wheelchair) because of inconsistencies with using chair alarms. Inconsistent yellow gown and gait belt usage. Reinforce bedside charting, especially for high fall risk patients. Goals of the Process Improvement: Analyze monthly falls and initiate immediate corrective actions to improve performance and compliance with designated interventions. Lead processes that support full compliance with Fall Prevention Policy. Strategize fall prevention measures specific to patient needs and continue to evaluate and modify strategies as appropriate ... How Does This Process Support the Hospital's Overall Strategic Plan? By working to reduce the number and rate of falls we are focusing on patient safety, patient satisfaction, and prevention of hospital acquired conditions."

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients," dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

2. During a review of Patient 6's "Progress Notes (a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 2/3/2025, the note indicated, Patient 6 "The patient (Patient 6) presented to the emergency room following the acute (sudden and severe in onset) onset of severe abdominal and chest pain. He (Patient 6) was complaining that he (Patient 6) could not move his right leg. The patient (Patient 6) underwent a CT angiogram (computed tomography angiography [CTA], is a medical imaging test that uses X-rays to create pictures of blood vessels and blood flow) which demonstrated evidence of a type A thoracic aortic dissection (a tear in the inner layer of the aorta, the main artery that carries oxygenated blood from the heart to the body)." The Progress Notes also indicated Patient 6 had undergone emergency heart surgery.

During a concurrent interview and record review on 2/21/2025 at 11:30 a.m. with the Nurse Manager (MN) 3 of the Step-Down Unit (SDU, a hospital unit that provides intermediate care for patients who are not ready for general ward care but don't need intensive care), Patient 6's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Fall Post Event Summary," dated 2/2/25, was reviewed. The Fall Post Event Summary indicated Patient 6 had an unwitnessed fall while in the ICU. Patient 6 was found sitting on the floor with a urinal (a container used by patients who are unable to get out of bed to collect their urine).

During an interview on 2/21/2025 at 12:33 p.m. with the Co-Chair of the Falls Performance Improvement (PI) Team (RM), RM stated the Falls PI team communicates directly with QAPI and was responsible for fall prevention measures, system assessment, and collaboration with other department leaders. RM was unaware of Patient 1's falls and Patient 6's fall until the day of the interview (2/21/2025), stating, "I did not review this case (Patient 1's fall on 11/28/2024) until this morning."

During an interview on 2/21/2025 at 2:00 p.m. with the Director of ICU (DIR) 2, DIR 2 stated that after a patient fall, a post-fall huddle (a meeting held after a patient falls to determine the cause and prevent future falls) was conducted, but nursing staff were not included in these discussions. Instead, one leader from the unit where the fall occurred, such as the charge nurse, unit manager, or unit representative, would attend. DIR 2 also stated that they did not participate in the post-fall huddle for Patient 1's fall on 11/28/2024.

During an interview on 2/21/2025 at 9:20 p.m. with the Chief Executive Officer (CEO), the CEO stated Governing Body relies heavily on the QAPI department to report on current issues and outline action plan taken in response. CEO emphasized that ultimately, the Governing Body holds the responsibility for ensuring oversight of an ongoing quality improvement plan focused on patient safety, quality of care, organization-wide quality assessment.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement " dated 12/1/2024, the P&P indicated, "The quality assessment and performance improvement plan (QAPI) is a proactive, interdisciplinary, systematic approach to designing or redesigning patient centered systems to improve quality of care and patient safety in alignment with regulatory standards ... As part of performance Improvement, leaders (including governing body) will: Set priorities (le high volume, high risk, problem prone processes) for performance improvement and patient health outcomes in alignment with regulatory guidelines ...Prioritize performance improvement in response to changes within the internal and external environment. Proactively identify processes needing improvement to prevent medical errors. Ensure methods (ie improvement tools) are implemented for identifying causes of variation, measuring performance of process improvement/deficiencies, and monitoring/sustaining processes... Structure and Accountability: The Community Board (GB) is responsible for assuring oversight of an ongoing quality improvement plan for patient safety, quality of care, organization-wide quality assessment, and contracted services. The GB is responsible for evaluating through periodic review and establishing clear expectations for quality of care and patient safety. The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually. The GB will delegate the development, implementation, and evaluation of QAPI to respective AHGL committees/teams ..."

During a review of the facility's policy and procedure (P&P) titled, "Performance Improvement Team Charter: 2025 Falls PI Team, " dated 1/10/2012, the P&P indicated, "Define the Issues: Non-compliant behaviors (e.g., patient/family turning off bed alarm, don't call/wait for assistance).Inconsistencies with bed alarms and zone settings activation (e.g., staff do not set bed in moderate sensitivity setting, do not activate the bed alarm after turning off). Falls from chairs (including commode, wheelchair) because of inconsistencies with using chair alarms. Inconsistent yellow gown and gait belt usage. Reinforce bedside charting, especially for high fall risk patients. Goals of the Process Improvement: Analyze monthly falls and initiate immediate corrective actions to improve performance and compliance with designated interventions. Lead processes that support full compliance with Fall Prevention Policy. Strategize fall prevention measures specific to patient needs and continue to evaluate and modify strategies as appropriate ... How Does This Process Support the Hospital's Overall Strategic Plan? By working to reduce the number and rate of falls we are focusing on patient safety, patient satisfaction, and prevention of hospital acquired conditions."

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients" dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

Based on observation, interview, and record review, the facility failed to ensure that four of 30 sampled Patients (Patient 5, Patient 7, Patient 8, and Patient 9), with an arterial line (A-line, a thin, flexible tube that's inserted into an artery to measure blood pressure and to collect blood samples) had a leveler (a device used to ensure proper positioning of the A-line relative to the patient's photostatic axis [atomical reference point at the 4th intercostal space, mid-axillary line]) at the bedside to use each time the patients (Patients 5, 7, 8, and 9) were repositioned, to ensure accurate reading of the patient's blood pressure (the force of blood against artery walls as the heart pumps blood throughout the body), in accordance with the facility's policy and procedure regarding Monitoring Arterial Blood using a Pressure Transducer (a device that converts the pressure fluctuations of blood within the artery into an electrical signal) System.

This deficient practice resulted in delays in recalibration of the A-line, and had the potential for inaccurate blood pressure readings which may lead to delays in the implementation of timely interventions, thus compromising patient safety due to complications of unidentified elevated, uncontrolled blood pressure such as stroke (a clot in the brain), damage to vital organs such as kidneys, etc.

Findings:

1. During a review of Patient 5's "ED (emergency department, hospital department that provides services to patients whose condition requires immediate care) Physician Notes," dated 2/17/2025, the note indicated, Patient 5 "presents to the emergency department by ambulance from home for sudden and significant change in mental function, nausea (the urge to throw-up, vomiting and diarrhea (loose stools), profuse diarrhea tonight and family stated she (Patient 5) has been more confused than usual, low oxygen saturation (amount of oxygen in the blood)." Diagnostic studies indicated Patient 5 had an acute (sudden and severe in onset) intracranial hemorrhage (a brain bleed).

During a concurrent observation and interview on 2/19/2025 at 12:05 p.m. with the charge nurse (CN 3, charge nurse responsible for overseeing ICU nursing staff) in the intensive care unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), in room ABC, on 2/19/2025 at 12:05 p.m., Patient 5 was observed with an Arterial Line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) in the left wrist. There was no A-line leveler (a device used to ensure the A-line is correctly positioned for accurate blood pressure readings) in the room. CN 3 explained that the ICU only had two levelers available for all ICU patients. CN3 said that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN 3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2 stated they were in the process of ordering more.

During a review of Patient 5's "Arterial Line Group," flowsheet (document used to track clinical observations for Patients over time), dated 2/18/2025, the flowsheet indicated, an Arterial line was inserted for Patient 5 on 2/18/2025 at 7:53 a.m. and remained current.

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/22/2022, the P&P indicated, "The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually."

During a review of the facility's policy and procedure (P&P) titled, "Standard of Nursing Practice," dated 3/22/2022, the P&P indicated, "The Standards of Nursing Practice provide guidelines to our Registered Nurses (RN) and establish the framework for the evaluation of our practice. Standards are written in measurable terms and describe the responsibilities for which nurses are accountable. The American Nurse's Association (ANA) has two distinct categories: Standards of Practice and Standards of Professional Performance ... The Standards of Practice describe a competent level of nursing care according to the critical thinking model known as the nursing process ...The standards of Professional Performance describe a competent level of behavior in the professional role that includes the following: Resource Utilization: The RN utilizes appropriate resources to plan, provide, and sustain evidence-based services that are safe, effective, and fiscally responsible."

2. During a review of Patient 7's "Face sheet (a hospital is a document within a patient's medical chart that summarizes key information)," dated 2/12/2025, the face sheet indicated, Patient 7 was admitted for symptomatic bradycardia (a slow heart rate that causes symptoms like dizziness, fatigue [a feeling of extreme tiredness], or shortness of breath. A normal heart rate for adults is faster than 60 beats per minute), hyperkalemia (a higher-than-normal level of potassium [an essential mineral for nerve and muscle function] in the bloodstream), and acute renal failure (a condition characterized by a sudden and significant decline in kidney function).

During a review of Patient 7's "Operation/Procedure Report," dated 2/13/2025, the note indicated, Patient 7 had a procedure to insert an Arterial line into the femoral artery (a large blood vessel located in the upper thigh) at 10:25 a.m. on 2/13/2025.

During a concurrent observation and interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN 3, charge nurse responsible for overseeing ICU nursing staff) in the intensive care unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), in room ABC, on 2/19/2025 at 12:05 p.m., Patient 5 was observed with an Arterial Line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) in the left wrist. There was no A-line leveler (a device used to ensure the A-line is correctly positioned for accurate blood pressure readings) in the room. CN 3 explained that the ICU only had two levelers available for all ICU patients. CN 3 said that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN 3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During a review of Patient 7's "Arterial Line Group," flowsheet (document used to track clinical observations for Patients over time), dated 2/18/2025, the flowsheet indicated, an Arterial line was inserted for Patient 7 on 2/18/2025 at 7:53 a.m. and remained current.

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/22/2022, the P&P indicated, "The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually."

During a review of the facility's policy and procedure (P&P) titled, "Standard of Nursing Practice," dated 3/22/2022, the P&P indicated, "The Standards of Nursing Practice provide guidelines to our Registered Nurses (RN) and establish the framework for the evaluation of our practice. Standards are written in measurable terms and describe the responsibilities for which nurses are accountable. The American Nurse's Association (ANA) has two distinct categories: Standards of Practice and Standards of Professional Performance ... The Standards of Practice describe a competent level of nursing care according to the critical thinking model known as the nursing process ...The standards of Professional Performance describe a competent level of behavior in the professional role that includes the following: Resource Utilization: The RN utilizes appropriate resources to plan, provide, and sustain evidence-based services that are safe, effective, and fiscally responsible."

3. During a review of Patient 8's "Operation/Procedure Report, dated 2/17/2025, the report indicated, Patient 8 was scheduled for a mitral valve (one of four valves in your heart that regulates blood flow) replacement. Patient 8 "past medical history include endocarditis (an inflammation of the inner lining of the heart chambers and heart valves) ...Patient (Patient 8) did undergo cardiology (the branch of medicine that deals with diseases and abnormalities of the heart) evaluation including an echocardiogram (a test of the action of the heart), which demonstrated evidence of severe mitral regurgitation (a valve in the heart, called the mitral valve, doesn't close properly, allowing blood to leak backwards instead of flowing smoothly forward) with a flail posterior mitral valve leaflet (is a flap of tissue in the heart valve that opens and closes to allow blood to flow through the heart)." The report indicated an A-line was inserted to the wrist.

During a concurrent observation and interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN 3, charge nurse responsible for overseeing ICU nursing staff) in the intensive care unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), in room ABC, on 2/19/2025 at 12:05 p.m., Patient 8 was observed with an Arterial Line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) in the left wrist. There was no A-line leveler (a device used to ensure the A-line is correctly positioned for accurate blood pressure readings) in the room. CN 3 explained that the ICU only had two levelers available for all ICU patients. CN 3 said that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2 stated they were in the process of ordering more.

During a review of the facility's policy and procedure titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/22/2022, the P&P indicated, "The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually."

During a review of the facility's policy and procedure (P&P) titled, "Standard of Nursing Practice," dated 3/22/2022, the P&P indicated, "The Standards of Nursing Practice provide guidelines to our Registered Nurses (RN) and establish the framework for the evaluation of our practice. Standards are written in measurable terms and describe the responsibilities for which nurses are accountable. The American Nurse's Association (ANA) has two distinct categories: Standards of Practice and Standards of Professional Performance ... The Standards of Practice describe a competent level of nursing care according to the critical thinking model known as the nursing process ...The standards of Professional Performance describe a competent level of behavior in the professional role that includes the following: Resource Utilization: The RN utilizes appropriate resources to plan, provide, and sustain evidence-based services that are safe, effective, and fiscally responsible."

4. During a review of Patient 9's "Face sheet," dated 2/12/2025, the face sheet indicated, Patient 9 was admitted to the facility for gastrointestinal (GI, bleeding is bleeding in the digestive tract [is a long, continuous tube-like pathway through which food travels from the mouth to the anus, where it is broken down, absorbed for nutrients, and ultimately expelled as waste]).

During a record review of Patient 9's "Operative/Procedure Report," dated 2/13/2025, the report indicated Patient 9 had a procedure to insert an A-line to the left wrist.

During a concurrent observation and interview on 2/19/2025 at 12:05 p.m. with the Charge Nurse (CN 3, charge nurse responsible for overseeing ICU nursing staff) in the intensive care unit (ICU, ward that provides the critical care and life support for acutely ill and injured patients), in room ABC, on 2/19/2025 at 12:05 p.m., Patient 9 was observed with an Arterial Line (A-line, a catheter placed in an artery to monitor blood pressure and obtain blood samples) in the left wrist. There was no A-line leveler (a device used to ensure the A-line is correctly positioned for accurate blood pressure readings) in the room. CN 3 explained that the ICU only had two levelers available for all ICU patients. CN 3 said that each time a patient was repositioned (for bathing, hygiene care, wound care, transfer to chair or off the unit, and scheduled repositioning every two hours), the nurse must leave the room to retrieve the leveler from the medication room, causing a delay in care. CN 3 confirmed that the lack of sufficient levelers could result in potential delays in patient care and monitoring.

During an interview on 2/21/2025 at 7:30 p.m. with the Director of ICU (DIR) 2, DIR 2 confirmed that the ICU had only two levelers stored in the medication room and stated there should be one leveler per patient room. DIR 2 stated they were in the process of ordering more.

During a review of the facility's policy and procedure (P&P) titled, "Monitoring Arterial Blood using a Pressure Transducer System, dated 2025, the P&P indicated:
-"Level transducer (a pressure sensor that converts pressure into electrical signals) with the patient's phlebostatic axis (an anatomical reference point at the fourth intercostal space at the mid-axillary line (an imaginary line that runs vertically down the torso from the armpit), used for accurate readings."
-"Level Transducer to the patient's phlebostatic axis and zero transducers to atmospheric pressure (calibrating the transducer to eliminate the effects of ambient air pressure) each time the patient is repositioned to ensure accuracy and consistency of arterial BP (blood pressure) measurements."

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment, Performance Improvement Plan (QAPI)," dated 3/22/2022, the P&P indicated, "The GB will ensure adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and determine the number of distinct improvement projects annually."

During a review of the facility's policy and procedure (P&P) titled, "Standard of Nursing Practice," dated 3/22/2022, the P&P indicated, "The Standards of Nursing Practice provide guidelines to our Registered Nurses (RN) and establish the framework for the evaluation of our practice. Standards are written in measurable terms and describe the responsibilities for which nurses are accountable. The American Nurse's Association (ANA) has two distinct categories: Standards of Practice and Standards of Professional Performance ... The Standards of Practice describe a competent level of nursing care according to the critical thinking model known as the nursing process ...The standards of Professional Performance describe a competent level of behavior in the professional role that includes the following: Resource Utilization: The RN utilizes appropriate resources to plan, provide, and sustain evidence-based services that are safe, effective, and fiscally responsible."

Based on observation, interview and record review, the facility failed to ensure two of two sampled staff (Registered Nurse [RN] 6 and Charge Nurse [CN] 5) were competent and able to implement hemodialysis (HD, the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency take off (a procedure to quickly disconnect a dialysis patient from the dialysis machine in a critical situation) procedure, in accordance with the facility policy and procedure regarding hemodialysis emergency take off procedure in case of emergency and when a hemodialysis nurse (HD nurse, a Registered Nurse who specialized performing hemodialysis) becomes incapacitated, for one of 30 sampled patients (Patient 13).

This deficient practice had the potential to result in Patient 13 being left on hemodialysis machine running with no proper supervision and/or improperly disconnecting Patient 13 from the hemodialysis machine during an emergency, thus causing harm or even death during hemodialysis treatment.

Findings:

During a review of Patient 13's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 2/9/2025, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to bilateral lower extremities (both legs) cellulitis (an infection of the deeper layers of skin and the underlying tissue), hyperkalemia (a condition where the potassium [an essential mineral for nerve and muscle functions] level in the blood is abnormally high), and end stage renal disease (ESRD, a stage where the kidneys can no longer support the body's needs for waste removal and fluid balance) on hemodialysis (HD, the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly).

During a concurrent observation and interview on 2/19/2025 at 12:29 p.m. with Registered Nurse (RN) 6, in Patient 13's room, Patient 13 was receiving hemodialysis with hemodialysis nurse (HDN [HD nurse, a Registered Nurse who specialized performing hemodialysis] 3) at bedside. RN 6 stated HDN 3 would stay with Patient 13 during hemodialysis. RN 6 also stated he (RN 6) did not know how to shut off the hemodialysis machine in case of the HD nurse passed out or became incapacitated.

During an interview on 2/19/2025 at 12:31 p.m. with Charge Nurse (CN) 5, CN 5 stated nursing staff was not trained how to perform dialysis emergency take off procedure (a procedure to quickly disconnect a dialysis patient from the dialysis machine in a critical situation). CN 5 stated she (CN 5) would not touch the hemodialysis machine.

During an interview on 2/19/2024 at 12:34 p.m. with the hemodialysis nurse (HDN 3), HDN 3 stated nursing staff should know how to clamp Patient 13's dialysis tubing and turn off the hemodialysis machine in case of emergency.

During an interview on 2/19/2024 at 12:40 p.m. with the Director (DIR 3) of Medical Surgical Unit (Med-Surg, general patient population hospitalized for various causes such as illness and surgery), DIR 3 stated nursing staff did not receive training with regards to dialysis emergency take off procedure. DIR 3 stated it would be a good opportunity to train the nursing staff.

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Service," dated 6/2023, the P&P indicated, "In the event of an emergency (power failure, earthquake, or fire) and the patient's safety is of concern, the staff RN in the absence of the dialysis nurse will clamp the dialysis tubing, both tubes separately, closet to the patient turn off the dialysis unit (machine) and cut the tubing on the side closet to the dialysis unit (machine) beyond the clamps."

Based on interview and record review, the facility failed to follow its "Utilization of Safety Attendants for Patients" policy and procedure and the physician's order to provide a bedside sitter (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety, especially if the patient is at risk for falls [a sudden, unintentional descent of a patient to the ground or another lower surface] , disorientation [the condition of having lost one's sense of direction], or self-harm) for constant supervision for one of 30 sampled patients (Patient 1).

This deficient practice resulted in Patient 1 experiencing a fall in the ICU on 11/28/2024, and a cardiac arrest (a sudden loss of heart function, leading to a lack of blood flow to the brain and vital organs) in the SDU (Step Down Unit, specialist hospital wards that serve as a transition point for patients who are no longer critically ill enough to remain in ICU but still require more intensive monitoring and care than a general ward can provide) on 12/11/2024, due to accidentally being disconnected from the Bilevel Positive Airway Pressure (BIPAP machine, a non-invasive ventilator that assist patients with breathing difficulties) machine. In addition, this deficient practice had the potential to place other patients with physician-ordered bedside sitters at risk for similar sentinel events (a patient safety event that results in death, permanent harm, or severe temporary harm) due to inadequate supervision.

Findings:

During a review of Patient 1's "History and Physical (H&P, a documented comprehensive formal assessment by a healthcare provider who examines the patient and their presenting problem)," dated 11/25/2025, the "H&P" indicated, Patient 1 was brought in by ambulance from home and presented with tachycardia (an abnormally fast heart rate exceeding 100 beats per minute). The H&P also indicated that Patient 1 had a history of dementia (a disorder causing memory loss and confusion) and atrial fibrillation (a-fib, an irregular and often rapid heart rhythm that increases the risk of stroke [blood clot in the brain], heart failure [a condition where the heart muscle is weakened or stiff, making it unable to pump blood effectively], and other complications). The physical examination indicated : Neurological (relating to the nervous system, which includes the brain, spinal cord, and nerves): "Unable to assess mental status, patient unable to follow commands."

During a concurrent interview and record review on 2/19/2025 at 3:00 p.m. with the Director of Medical Surgical unit (DIR) 3, Patient 1's "Nursing Documentation-Flowsheet (a form that records a patient's clinical observations over time)," dated 11/28/2024, was reviewed. The flowsheet indicated, at 12:11 a.m., Patient 1 was "found on the floor, lying flat." DIR 3 stated that Patient 1 did not have a sitter (a trained individual, often a healthcare worker, assigned to provide continuous, one-to-one supervision of a patient to ensure their safety, especially if the patient is at risk for falls [a sudden, unintentional descent of a patient to the ground or another lower surface] , disorientation [the condition of having lost one's sense of direction], or self-harm) at this time (12:11 a.m. on 11/28/2024) and the cause of the fall remained unknown.

During a concurrent interview and record review on 2/20/2025 at 10:00 a.m. with the Nurse Manager (MN) 3 of the Surgical Treatment Unit (STU, a hospital area where surgeries are performed and patients are cared for before and after), Patient 1's Medication Administration Record (MAR), from 11/26/2024 through 11/28/2024, was reviewed. The MAR indicated, Patient 1 was started on continuous infusion of Precedex (dexmedetomidine, a sedation [a state of relaxation or drowsiness] used to reduce anxiety [an emotion that can feel like fear, or uneasiness] and agitation [feeling extremely restless, tense, or irritated] without suppressing breathing) on 11/26/2024 at 11:59 p.m., which continued until 12/11/2024, when Patient 1's BiPAP (Bilevel Positive Airway Pressure machine, a non-invasive ventilator that assist patients with breathing difficulties) machine was accidentally disconnected.

During an interview on 2/21/2025 at 1:00 p.m. with ICU Registered Nurse (RN) 1, RN 1 confirmed that Patient 1 was receiving continuous sedation with Precedex and was being monitored using the Richmond Agitation-Sedation Scale (RASS, is a 10-point scale used to assess a patient's level of sedation or agitation, ranging from +4 [combative] to -5 [unarousable]), with a target RASS score of 0 to -2. RN 1 stated Patient 1 was at -1 (drowsy, a state of sleepiness and wakeness) on 11/28/2024. RN 1stated Patient 1 was high risk for falls and was left sleeping while RN 1 retrieved medications from the medication room. Upon returning, RN 1 found Patient 1 on the floor with other staff present. The fall was unwitnessed, and the reason for the fall was unknown.

During a concurrent interview and record review on 2/20/2025 at 10:00 a.m. with the Nurse Manager (MN) 3, Patient 1's "transfer Summary," dated 12/6/2024, was reviewed. The summary indicated Patient 1 was transferred to the SDU (Step Down Unit, specialist hospital wards that serve as a transition point for patients who are no longer critically ill enough to remain in ICU but still require more intensive monitoring and care than a general ward can provide), on 12/6/2024. MN 3 confirmed that Patient 1 was transferred to SDU without a sitter.

During a concurrent interview and record review on 2/20/2025 at 10:30 a.m. with the Nurse Manager (MN) 3, Patient 1's "Clinical Note Nursing, was reviewed. The note indicated on 12/11/2024 at 1:30 a.m., the Telemetry Monitor Technician (MT, a healthcare worker who monitors a patient's heart rate remotely) observed that Patient 1's heart rate was at 30s and notified any RN to check on Patient 1. RN 9 found that Patient 1 had pulled out the BiPAP's tubing resulting in a cardiac arrest (when the heart stops beating). Code Blue (a hospital emergency response for a patient in a cardiac arrest or respiratory arrest [when a person stops breathing or breathes inadequately]) was called, and Patient 1 was intubated (a medical procedure where a tube is inserted into the airway to assist with breathing) before being sent back to the ICU.

During a concurrent interview and record review on 2/21/2025 at 2:30 p.m. with Registered Nurse (RN) 2, Patient 1's electronic medical record (EMR, a digital version of a patient's paper chart that contains their medical history) document titled, "Order," report, dated 11/26/2024, was reviewed. The Order indicated the physician (MD 5) had ordered bedside sitter for Patient 1 from 11/26/2024 at 12:59 p.m. until 12/17/2024 at 1:02 a.m. RN 2 confirmed that there was no documented evidence that a sitter was monitoring Patient 1 on 11/28/2024, the date Patient 1 fell, or on 12/11/2024, when Patient 1 was accidentally disconnected from the BiPAP and went into cardiac arrest.

During a review of the facility's policy and procedure (P&P) titled, "Utilization of Safety Attendants for Patients," dated 6/10/2022, the P&P indicated, "The purpose of this policy is to provide guidelines for safety attendant placement for patients with high risk behaviors, high fall risk, or other behaviors that place the patient at risk for injury... Safety attendant will accompany the patient at all times."

Based on observation, interview and record review, the facility failed to ensure staff adhered to infection control and prevention practices when:

1. One of one sampled staff (Patient Access Representative [PAR1, acts as the first point of contact for patients at a healthcare facility, responsible for greeting them, registering them for appointments, verifying insurance information, collecting necessary paperwork, and generally managing the patient check-in process]) did not perform hand hygiene (the practice of cleaning one's hands to remove dirt and germs by using soap and water or alcohol-based sanitizer) upon entry and exit from a patient's room for one of 30 sampled patients (Patient 21), in accordance with the facility's policy and procedure regarding hand hygiene.

This deficient practice had the potential to result in the spread of germs and bacteria from Patient 21 to others including other patients, staff and/or visitors.

2. The facility's one of one sampled contracted service staff (HDN 3) did not disinfect (killing germs and bacteria) one of three sampled hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) machine (HDM 2) with heat or bleach at the end of day use, after hemodialysis was completed for one of 30 sampled patients (Patient 16), in accordance with the contracted service's policy and procedure and hemodialysis machine operator manual.

This deficient practice had the potential to result in bacterial contamination within the hemodialysis machine and introduce bacteria to other patients' bloodstream, who may end up using the same HD machine (HDM 2), thus causing infection from a hemodialysis treatment.

Findings:

1. During a review of Patient 21's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 2/18/2025, Patient 21 was admitted to the facility with diagnoses including but not limited to urinary tract infection (UTI, an infection in any part of the urinary system), positive blood cultures (suggests a systemic infection requires prompt medical attention), and hypertension (high blood pressure).

During a concurrent observation and interview on 2/19/2025 at 11:04 a.m. with the Clinical Educator (CED 2) of the Medical-Surgical (Med-Surg, general patient population hospitalized for various causes such as illness and surgery) Unit, outside Patient 21's room, the Patient Access Representative (PAR 1- acts as the first point of contact for patients at a healthcare facility, responsible for greeting them, registering them for appointments, verifying insurance information, collecting necessary paperwork, and generally managing the patient check-in process) walked into Patient 21's room without performing hand hygiene (the practice of cleaning one's hands to remove dirt and germs by using soap and water or alcohol based sanitizer). PAR 1 later left Patient 21's room without performing hand hygiene. CED 2 stated all staff were required to perform hand hygiene, "foam in and foam out (using alcohol-based hand sanitizer when entering and exiting of patient room)," upon entry and exit of a patient's room.

During an interview on 2/19/2025 at 11:08 a.m. with Patient Access Representative (PAR 1, acts as the first point of contact for patients at a healthcare facility, responsible for greeting them, registering them for appointments, verifying insurance information, collecting necessary paperwork, and generally managing the patient check-in process), PAR 1 stated she (PAR 1) forgot to "foam in and foam out" at Patient 21's room. PAR 1 stated, "it was my fault. I forgot."

During an interview on 2/21/2025 at 7:08 p.m. with the Infection Prevention Manager (IPM), IPM stated the following: the facility followed World Health Organization (WHO)'s "5 Moments of Hand Hygiene." Staff was required to perform hand hygiene upon entry and exit of a patient's room. It was important to perform hand hygiene so no one would move germs from one patient to people including other patients, staff and/or visitors.

During a review of the facility's policy and procedure (P&P) titled, "Hand Hygiene," dated 9/2024, the P&P indicated, "[the facility] recognizes that hand hygiene is the single most important measure for preventing and controlling infections. The medical center follows Centers for Disease Control and Prevention (CDC, agency that helps protect the public's health) and World Health Organization (WHO) guidelines for hand hygiene the risk of infection from potential pathogens on the hands of healthcare workers (HCWs)."

During a review of the World Health Organization (WHO) guidelines for hand hygiene titled, "Your 5 Moments for Hand Hygiene," dated 5/2009, the guidelines indicated, "1. Before touching a patient ... clean your hands before touching a patient when approaching him/her ... 5. After touching patient surroundings ... clean your hands after touching any object or furniture in the patient's immediate surroundings, when leaving - even if the patient had not been touched."

2. During a review of Patient 16's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 2/11/2025, Patient 16 was admitted the facility with diagnoses including but not limited to acute renal failure (the sudden and rapid loss of kidney's ability to filter waste and balance fluid in blood), acute (new onset) exacerbation (worsening of a disease or an increase in its symptoms) of congestive heart failure (CHF, a chronic condition in which a weakness of the heart leads to a buildup of fluid in the lungs), and electrolyte (minerals in the blood) abnormality.

During an interview on 2/20/2025 at 2:59 p.m. with the Chief Executive Officer (HDD) of the Hemodialysis Contracted Service (HDC), HDD stated hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) nurses were responsible to use either heat or bleach at the end of day use to disinfect the hemodialysis machine to prevent infection and keep the machine clean per manufacturer's guideline.

During a concurrent interview and record review on 2/20/2025 at 3:15 p.m. with the Chief Executive Officer (HDD), Patient 16's hemodialysis record titled, "Dialysis Nurses Notes (HD note)," dated 2/14/2025, was reviewed. The HD note indicated Patient 16 received hemodialysis on 2/14/2025 from 1:35 p.m. to 4:35 p.m. using HD machine (HDM 2). The HD note also indicated Hemodialysis Nurse (HDN 3) rinsed HDM 2 after hemodialysis was completed. HDD stated HDN 3 did not disinfect HDM 2 with heat or bleach at the end of hemodialysis treatment.

During a concurrent interview and record review on 2/20/2025 at 3:20 p.m. with the Chief Executive Officer (HDD), hemodialysis machine (HDM 2)'s "Equipment Log Sheet (HD log)," dated from 2/12/2025 to 2/16/2025, was reviewed. The HD log indicated, Patient 16's hemodialysis treatment was the last treatment for day (2/14/2025). The HD log also indicated next HD treatment was on 2/16/2025. HDD stated HDN 3 should have disinfected HDM 2 after completing hemodialysis for Patient 16 with heat or bleach. HDN 3 did not disinfect HDM 2 at the end of the day (2/14/2025).

During a review of the facility's policy and procedure (P&P) titled, "Dialysis Service," dated 2/2020, the P&P indicated, "Each contracted dialysis service is responsible for serving, maintaining, and upgrading the equipment, including safety checks."

During a review of the facility's hemodialysis contracted service (HDC)'s policy and procedure (P&P) titled, "Single Pass Dialysis Machine - Cleaning & Disinfection and Documentation," dated 12/2024, the P&P indicated, "It is the policy of [the contracted service] to follow the cleaning and disinfectant procedures outlined below per manufacturer's guidelines ... The single pass dialysis machine is to be heat or bleach disinfected at the end of each day (end of day per individual nurse assignment) when machine is used for treatment. Document cleaning and/or disinfection for every treatment in provided machine logbook."

During a review of the hemodialysis machine (HDM 2) manufacturer's guidelines titled, "[brand] Hemodialysis Machine Operator's Manual Rev P," undated, the manufacturer's guidelines indicated, "Heat Disinfect or Chemical/Rinse is recommended daily when the machine is used for treatment."

During a review of the facility's contract agreement with the HDC titled, "Dialysis Services Agreement (HD contract)," dated 11/20/2023, the HD contract indicated, "1.5 Nursing Services ...Dialysis Company shall ensure ... said nursing personnel shall perform the following nursing services pursuant to this Agreement ... demonstrate responsible handling of waste, sterilization and disinfection of equipment."

Based on interview and record review the facility failed to ensure infection control policies and procedures regarding Employee Health Services were implemented when the facility failed to:

1. Ensure that one of two sampled Sterile Processing Technician (SPT 4, responsible for sterilizing and maintaining medical equipment and instruments), had completed a mandatory N-95 (a disposable mask that filters airborne particles) fit test (a procedure used to evaluate how well a respirator fits am individual, ensuring that it effectively filters out airborne particles to provide adequate respiratory protection), in accordance with the facility's Employee Health Services Infection Prevention Policies and Employee health testing.

This deficient practice had the potential to result in increased risk of exposure to airborne pathogens which could lead to infection for both the employee, the patients, and other staff.

2. Ensure that four of six employees (E1, E3, E4, E5) had annual screening for tuberculosis (TB, a chronic bacterial infection that primarily affects the lungs) infection by QuantiFERON laboratory test (a blood test used to detect latent or active tuberculosis infection by measuring the immune response to specific TB antigens), in accordance with the regulatory requirements set by the [State] Department of Public Health (DPH) regarding TB testing (checks to see if someone was infected with tuberculosis).

This deficient practice increases the risk of tuberculosis transmission among staff, patients and visitors due to inadequate testing/monitoring.

Findings:

1. During an interview on 2/21/2025 at 5:57 p.m. with the Director of Human Resources (DHR), the DHR stated that one personnel file for a Sterile Processing Technician (SPT 4, responsible for sterilizing [free of germs] and maintaining medical equipment and instruments) that was reviewed to ensure compliance with accepted Employee Health Infection Control Policies, had no current completed mandatory annual N-95 (a disposable mask that filters airborne particles) fit test on file (N-95 fit test determines if an N-95 respirator fits a person's face and provides adequate protection).

During the same interview on 2/21/2025 at 5:57 p.m. with the Director of Human Resources (DHR), the DHR stated that N-95 fit test was required for all employees upon hire and annually in accordance with the facility's policy.

During a review of the facility's policy and procedure (P&P) titled, "Infection Control Guidelines for Sterile Processing Department," dated 9/2023, the P&P indicated the following: The sterile Processing Department (SPD) is recognized as a high risk for infection prevention. To protect patients and other personnel from unnecessary exposure to potentially pathogenic organisms, Sterile Processing employees will be expected to abide by the following:
I. Personnel are expected to comply with accepted Employee Health Services Infection Prevention Policies with particular emphasis to annual physician examination, Rubella immunity, and annual TB skin testing.
III. Basic training in aseptic technique for all new sterile processing employees much be presented and documented. Personnel are expected to have general orientation to the hospital infection prevention program and periodic in-service of infection prevention policies and procedures.

During a review of the facility's policy and procedure (P&P) titled, "Pre-Employment Health and Physical Screening," dated 3/24/2023, the P&P indicated that 12. Complete N-95 fit test and fit test questionnaire in accordance with the facility's respiratory protection policy as defined by OSHA (Occupational Safety and Health Administration, federal agency that sets and enforces workplace safety standards) for all accepted post-offer candidates ...

2. During a review of the facility's personnel files, four (4) out of six (6) employee ( E1, E3, E4, E5) health files reviewed had no annual tuberculosis (TB, a chronic bacterial infection that primarily affects the lungs) infection screening by QuantiFERON laboratory (lab) test (a blood test used to detect latent or active tuberculosis infection by measuring the immune response to specific TB antigens), in accordance with the regulatory requirements set by the [State] Department of Public Health (DPH).

During a review of the four employee (E1, E3, E4, and E5) health files, the Health Files indicated the following:
-E1 had last annual TB infection screening by QuantiFERON lab test done on 7/22/2022 and it was negative.
-E3 had last annual TB infection screening by chest X-ray (a test that creates an image of lungs) done on 1/21/2016 and was negative.
-E4 had last annual TB infection screening by QuantiFERON lab test done on 2/28/2023 and was negative.
-E5 had last annual TB infection screening by QuantiFERON lab test done on 6/8/2021 and was negative.

During an interview on 2/21/2025 at 6:20 p.m. with the Director of Human Resources (DHR), the DHR stated that the facility's current practice was to screen employees for tuberculosis infection only upon hire and every four years thereafter. The DHR also stated that the practice for TB screening for employees with a positive history of TB screening is to verify the presence or absence of active tuberculosis infection by obtaining a chest Xray every 10 years.

During an interview on 2/21/2025 at 6:20 p.m. with the Infection Prevention Manager (IPM), the IPM stated that the facility had been using a FLEX (a temporary modification or exemption allowed by the regulatory bodies that permits an alternative approach to standard protocols, in this case, for tuberculosis screening). The IPM then stated that the FLEX has expired, but the facility has applied for a new FLEX. However, it has not been approved yet.

During a review of the tuberculosis (TB) testing [State] regulatory requirements, the guidelines for tuberculosis screening require an annual TB test that shall be done on those individuals with a previously documented negative tuberculosis test ... Less frequent testing for tuberculosis, but never less than every four years, may be adopted as hospital policy when documented in writing as approved by the Infection Control Committee, the medical staff and the health officer of the health jurisdiction in which the facility is located.

Based on interview and record review, the facility failed to ensure that personnel training and education on the practical applications of infection prevention and control guidelines, policies and procedures were provided, completed and documented when:

1. Proof of completion of annual competencies (specific set of skills, knowledge, and abilities required to perform job functions effectively and safely within a particular field) verification and completion of skills check for three of six sampled employee records (Sterile Processing Technicians- responsible for sterilizing [free of germs] and maintaining medical equipment and instruments [SPT 1, SPT 4], and Surgical Scrub technicians- assists the surgeon during surgical procedures [SST 1]), were found to be incomplete with missing signatures from a preceptor (provides supervision during training) to indicate/verify staff competency.

This deficient practice had the potential to result in improper training which has the potential for patient safety risks due to improperly sterilized instruments, increased infection rates, etc.

2. Proof of completion of orientation (refers to the process of introducing new employees to an organization, including its policies, procedures, culture, and specific job responsibilities) upon hire, and access to oneSOURCE (a platform commonly used in healthcare settings to provide access to essential information, such as manufacturer's instructions for use [IFUs], policy documents, and compliance-related materials) were not provided for one of one sampled employee (Sterile Processing Technician- responsible for sterilizing [free of germs] and maintaining medical equipment and instruments [SPT 4]). The facility was also not able to provide copies of completed orientation checklist for SPT 4 for surveyor review.

This deficient practice had the potential to result in non-compliance with job related requirements due to lack of knowledge from training and inability to access resources which may lead to potential patient safety risks due to errors in cleaning and sterilization processes (free of germs) for surgical instruments.

Findings:

1. During a concurrent interview and record review on 2/21/2025 at 5:35 p.m. with the Director of Education (DE) and the Manager of Education (MED), three employee files (Special Processing Technician- responsible for sterilizing [free of germs] and maintaining medical equipment and instruments [SPT 1, SPT 4,] and Surgical Scrub technician [SST 1]), were reviewed for professional competencies (the specific requirements and knowledge required to perform job functions effectively and safely). All competencies provided for the three employees (SPT 1, SPT 4, and SST 1) for the years 2023 and 2024 contained missing signatures that were required to be signed by the verifier of competencies upon evaluation. The DE was not able to provide a list of items required by the facility's annual educational requirements and competencies for the Special Processing Department's (SPD, a hospital department that cleans, disinfects [clean and safe for use], and sterilizes [free of germs] medical instruments and devices) employees and Surgical Scrub Technicians working in the Surgical Department (the area in a hospital where surgical procedures are performed, and where procedural staff must be properly trained and competent in their roles).

During the same record review on 2/21/2025 at 5:35 p.m. with the Director of Education (DE) and the Manager of Education (MED), the Facility was not able to provide any pertinent documents regarding the employees' required annual competencies and annual educational requirements (HealthStream assignments, educational and training modules or courses assigned to healthcare employees such as continuing education, compliance training, competency assessments that are essential for enhancing staff knowledge, skills and performance in their role) specific to the department of employment (SPD), including copies of employee competency records, and relevant policies.

2. During an interview on 2/21/2025 at 9:30 a.m. with the Sterile Processing Technician (SPT 4, responsible for sterilizing [free of germs] and maintaining medical equipment and instruments, and stores medical equipment), the SPT 4 stated the following: "I only had general orientation when I started working here (referring to the facility under survey) in November 2024. I was shown where everything is. There are no visual guidelines regarding what to do with instruments and how to clean them. Staff can look up the manufacturer guidelines by logging into a portal, called OneSource (a web-based solution allowing all healthcare departments and staff easy access to Instructions For Use [IFUs], cleaning protocols, service manuals, and Safety Data Sheets [SDS- a detailed document provided by a chemical manufacturer that outlines the properties, hazards, and safety precautions related to any chemicals used in the sterilization process]), but I am registry (staff personnel provided by a placement service on a temporary or on a day -to- day basis), and I don't have access to OneSource.

During a concurrent interview and record review on 2/21/2025 at 5:35 p.m. with the Director of Education (DE) and the Manager of Education (MED), the Sterile Processing Technician's (SPT 4) employee file, was reviewed. SPT 4's employee file contained no documented orientation with introduction to the facility's policies, procedures, and specific job responsibilities. SPT 4's file also contained no documented granted access to oneSOURCE upon the start work date of 11/27/2024.

During a review of the facility's policy and procedure (P&P), titled "Infection Control Guidelines for Sterile Processing Department," dated 9/2023, the P&P indicated the following: The sterile Processing Department (SPD) is recognized as a high risk for infection prevention. To protect patients and other personnel from unnecessary exposure to potentially pathogenic organisms, Sterile Processing employees will be expected to abide by the following: Basic training in aseptic technique for all new sterile processing employees much be presented and documented. Personnel are expected to have general orientation to the hospital infection prevention program and periodic in-service of infection prevention policies and procedures.

Based on observation, interview and record review, the facility failed to ensure that the staff adhered to its policies and procedures regarding the reprocessing (the specific process of cleaning, disinfecting [the process of eliminating or reducing harmful germs on surfaces to a level that does not pose a risk of infection], and sterilizing [the process of completely destroying all forms of germs through methods ensuring that medical instruments and equipment are free from any living microbes (germs) before use] reusable medical equipment to ensure it is safe to reuse between patients) of surgical instruments and infection control (practices and procedures implemented to prevent the spread of infections by minimizing the transmission of germs in a healthcare setting) when:

1.Adhesive tape, placed in the decontamination room (the first stop for instruments that make it to the basement is the decontamination room, where the instruments are soaked and precleaned) in the sink, to measure the water fill amount (serves as an informal guideline for staff), was not replaced when it (adhesive tape) started showing signs of degradation (peeling, edges darkened and curling, and residue on the sink surface).

This deficient practice had the potential for the tape residue to accumulate organic matter (biological material derived from living organisms, including blood, tissue, body fluids and can serve as a medium for microbial growth, interfering with the effectiveness of disinfection and sterilization processes) and bacteria (germs that can spread through contaminated surfaces, instruments, and improper infection control practices), which can facilitate the spread of bacteria through surfaces.

2.a. In a Gelpi retractor (a surgical instrument used for holding back tissue in a surgical procedure), the middle part of the instrument between each fork, referred to as the shank (the connecting section between the two pointed tips), it was observed with brown-colored deposits similar to rust (presence of rust on surgical instruments may compromise the integrity of the instrument and its sterility) after instrument was removed from a sterile total hip tray (a collection of instruments specifically prepared and sterilized for use during total hip replacement surgeries).

This deficient practice had the potential to compromise the Gelpi retractor's integrity and sterility, placing patients' safety during surgical procedures at risk.

2.b. Two sterile instruments: the Narrow Deaver (a surgical retractor used to hold back tissue and provide access to deeper surgical sites), and the Sweetheart retractor (a surgical instrument used to hold back tissues and provide stability in the surgical field), inside a sterile major tray ( a tray containing a collection of essential instruments prepared and sterilized for surgical procedures), were found to have brown spots that left brown staining on the alcohol pad after cleaning.

This deficient practice had the potential to result in compromised sterility of the instruments increasing the risk of infection for all the facility's surgical patients.

3. Sterile packages (sealed containers that contain surgical instruments or supplies or use in sterile procedures, designed to maintain the sterility of their contents until they are opened for use, ensuring safety and minimizing the risk of infection) were not inspected quarterly (the scheduled review process to ensure compliance with established standards), in accordance with the facility's policy. Additionally, audits of supplies and shelf life (the process of varying the expiration dates and integrity of medical supplies) was not performed and no orderly system of rotation of supplies in place for stored sterilized items was routinely conducted, in accordance with the facility's policy regarding sterile package shelf-life.

This deficient practice had the potential to increase the risk of infection for all patients undergoing surgical procedures when regular audits and inspections were not performed to ensure that all materials used in patient care meet regulatory standards.

4. An enzymatic solution (a cleaning agent specifically designed to break down organic material, such as blood, tissue, or other bodily fluids) in the decontamination process to facilitate the cleaning of surgical instruments, was not used in accordance with the manufacturer's instructions for use (MIFU).

This deficient practice had the potential to diminish the effectiveness in breaking down organic material leading to ineffective cleaning and sterilization of surgical instruments increasing the risk for surgical site infections and other complications with a potential to compromise patient safety and well-being.

5. Carts marked as biohazard (designated carts intended for the transportation of contaminated materials, that are handled in a manner that minimizes the risk of exposure to infectious agents), used for transportation of dirty and contaminated surgical instruments, were wiped down with a multi-enzymatic cleaner (formulated to breakdown organic matter such as blood, tissue, and other biological materials) and subsequently used for the transport of clean and sterile items.

This deficient practice has the potential to compromise patient safety, increase surgical site infection and other healthcare associated infections for patients due to a potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) of sterile items.

6. A towel was observed to be positioned at the bottom of the tray within the sterile minor surgical tray packaging (minor tray is a sterile, single-use tray of instruments used for minor surgical procedures).

This deficient practice had the potential to compromise the sterility of the instruments, (towels can harbor bacteria and may not be sterilized to the same standards), and compromise patient safety and well-being by increasing surgical site infections.

7. Log containing records of daily testing of ultrasonic machine (an ultrasonic cleaning device useful for washing hard-to-reach- areas on a medical device) to ensure that the device was functioning properly and effectively cleaning items by verifying the presence of cavitation (when proper cavitation is occurring, indicating the machine is generating sufficient ultrasonic energy to clean effectively), was not located.

This deficient practice had the potential to harm surgical patients as there was no assurance that the ultrasonic machine had been properly maintained or functioning effectively, which could compromise the cleaning process for surgical instruments in the facility leading to increased risk of infections.

8. Updated preventive maintenance (PM) stickers (adhesive labels that indicate when maintenance has been performed on equipment, along with the next scheduled maintenance date) were not available for staff on equipment, such as washers, sterilizers, and other reprocessing equipment, in accordance with the facility's policy regarding preventive maintenance.

This deficient practice had the potential to pose risk to patient safety by using equipment that may not meet safety and performance standards.

Findings:

1. During an observation on 2/18/2025 at 2:05 p.m. in the decontamination room (a designated area within the facility where contaminated surgical instruments and equipment are cleaned, disinfected [methods to eliminate or reduce harmful organisms], and prepared for sterilization [the process of eliminating all forms of microbial life, including bacteria, viruses, fungi, spores, from surfaces, instruments, or materials), three (3) sinks numbered (#) 1, 2, and 3 were observed. Sink # 2 was filled with blue colored solution. Adhesive tape was observed in sink # 2, attached to the side [surface] of the sink. The tape was observed showing signs of degradation, including peeling, darkened and curling edges, and residue on the sink surface.

During an interview on 2/18/2025 at 2:13 p.m. with the Sterile Processing Technician -Lead (LSPT), the LSPT stated that sink 2 was used for enzymatic soak (a cleaning process involving immersion of surgical instruments in a solution containing enzymes that break down organic material such as blood and tissue to facilitate effective cleaning) with lukewarm water. The LSPT then stated that the tape was the marker for the water line, but it should be replaced as it does not look good and should have been replaced.

During an interview on 2/21/2025 2:51 p.m. with the Infection Prevention Manager (IPM), the IPM stated the following regarding the adhesive tape residue in the sink: "The adhesive tape has been already replaced; it was used to define the fill line as a marker for the technicians to know how much water is required." The IPM also stated that the facility follows the AAMI guidelines (Association for the Advancement of Medical Instrumentation guidelines) which provide standards and best practices for the cleaning, disinfection, and sterilization of medical instruments and then presented printed guidelines for the decontamination process, dated 2017. The IPM also stated they (the IPM) were not certified in Special Processing (systemic procedure of cleaning, disinfecting, sterilizing, and preparing surgical instruments and medical devices for safe use in healthcare setting).

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines for the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines, titled "Standards of Sterilization," dated 2021, the recommendation was for the sinks to be disinfected after each use. Additionally, AAMI guidelines emphasize that all surfaces should be kept clean and free from contaminants, including residues and materials that can harbor microorganisms. Regular cleaning and disinfection of sinks contribute to effective infection control practices and support sterilization process.

2.a. During an observation on 2/19/2025 at 3:22 p.m. in the central supply room in the Surgical Department a Gelpi retractor (a surgical instrument used for holding back tissue in a surgical procedure) was observed with brown-colored deposits like rust after the instrument was removed from a sterile total hip tray (a collection of instruments specifically prepared and sterilized for use during total hip replacement surgeries).

During an interview on 2/19/2025 at 3:22 p.m. with the Director of Operative Services (Dir 1), the Dir 1 stated the following: "The brown deposit in the middle section of the Gelpi retractor could be rust. The water exposure can lead to damage of the instrument. When we identify issues like this one, the instrument gets treated by the contracted company that would either polish the instrument or replace it."

During an interview on 2/19/2025 at 3:26 p.m. with the Director of Operative Services (Dir 1), the Dir 1 stated that the reprocessing process (the systematic procedure of cleaning instruments for safe reuse) should begin with Sterile Processing Department (SPD), and the instruments should be checked by the Special Processing Technicians (SPTs). The last and final check was done in the operating room (OR) by the surgical scrub technician (a specialized technologist who assists the surgeon during procedures by managing instruments and ensuring a sterile environment), who can identify any issues and will tag the instrument and send it back to reprocessing. The Dir 1 then said that that the facility was also contracted with a company that comes every Thursday to inspect surgical instruments and their quality.

During a review of the facility's policy and procedure (P&P) titled, "Wrapped Packaging," dated 12/6/2024, the policy indicated that the facility recognizes the important role of sterility...

During a review of the facility's policy and procedure (P&P) titled, "Sterilization of Equipment Supplies," dated 9/27/2021, the policy indicated that sterile items must be received, stored, and distributed in a manner which ensure sterility and integrity.

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines doe the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines titled, "Standards of Sterilization," dated 2021, the guidelines indicated that steam sterilization cannot be assured unless proper cleaning of the device and reduced bioburden (define) and soil was achieved. Verification and documentation of automated cleaning processes through objective means is an important aspect of quality control. Cleaning encompasses the removal of organic residue and microorganisms from the patient, from handling, or from water exposure during reprocessing. Inspection using enhanced visualization tools such as lighted magnification and video borescopes might identify residues not observable by the unaided eye.

2.b. During an observation on 2/18/2025 at 4:35 p.m., in the Surgery Department, in the main Operating Room (OR), the major tray (a tray containing a collection of essential instruments prepared and sterilized for surgical procedures) was selected to be opened for an inspection of its contents: sterilized surgical instruments. Two sterile surgical instruments (the Narrow Deaver [a surgical retractor used to hold back tissue and provide access to deeper surgical sites], and the Sweetheart retractor [a surgical instrument used to hold back tissues and provide stability in the surgical field]) were inspected and observed with marks on both surgical instruments.

During a concurrent observation and interview on 2/18/2025 at 4:38 p.m. with the Director of Operative Services (Dir 1), the Dir 1 was observed using an alcohol pad to wipe the brown marks on the surgical instruments (the Narrow Deaver [a surgical retractor used to hold back tissue and provide access to deeper surgical sites], and the Sweetheart retractor [a surgical instrument used to hold back tissues and provide stability in the surgical field]), were inspected and observed with marks on both surgical instruments. Brown staining of the alcohol pad was noted after Dir 1 cleaned the retractors. Dir 1 then stated that these instruments should not be used for patients in the operating rooms and should be sent back for reprocessing (a special process or treatment in preparation for reuse) due to the presence of brown stains.

During an interview on 2/19/2025 at 3:26 p.m. with the Director of Operative Services (Dir 1), the Dir 1 stated that the reprocessing process (the systematic procedure of cleaning instruments for safe reuse) should begin with Sterile Processing Department (SPD), and the instruments should be checked by Special Processing Technicians (SPTs). The last and final check was done in the operating room (OR) by the surgical scrub technician (a specialized technologist who assists the surgeon during procedures by managing instruments and ensuring a sterile environment), who can identify any issues and will tag the instrument and send it back to reprocessing. The Dir 1 then said that that the facility is contracted with a company that comes every Thursday to inspect surgical instruments and their quality.

During a review of the facility's policy and procedure (P&P) titled, "Wrapped Packaging", dated 12/6/2024, the policy indicated that the facility recognizes the important role of sterility...

During a review of the facility's policy and procedure (P&P) titled, "Sterilization of Equipment Supplies," dated 9/27/2021, the policy indicated that sterile items must be received, stored, and distributed in a manner which ensure sterility and integrity.

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines for the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines titled, "Standards of Sterilization," dated 2021, the guidelines indicated that steam sterilization cannot be assured unless proper cleaning of the device and reduced bioburden (define) and soil was achieved. Verification and documentation of automated cleaning processes through objective means is an important aspect of quality control. Cleaning encompasses the removal of organic residue and microorganisms from the patient, from handling, or from water exposure during reprocessing. Inspection using enhanced visualization tools such as lighted magnification and video borescopes (optical devices used for inspection of areas that are otherwise difficult to access) might identify residues not observable by the unaided eye.

3. During an interview on 2/19/2025 at 10:30 am with the Sterile Processing Technician-Lead (LSPT), the LSPT stated that technicians from the Sterile Processing Department (SPD, a hospital department that prepares medical devices and instruments for use in surgical procedures), did not inspect stored sterile supplies and did not routinely conduct rotation of stored sterilized items.

During an observation on 2/19/2025 at 2:41 p.m. in the central supply storage room (a designated area with controlled temperature and humidity, where sterile supplies, instruments, and equipment is organized, stored, and maintained), in the OR (Operating Room, the specialized area in the hospital where surgical procedures are performed), a Shunt Passer (a surgical instrument used to facilitate the placement of shunts or catheters), processed on 2/17/2024, was found in a sterile peel pack with a label (attached to the instrument, inside the sterile peel pack) containing printed physician's name on it, along with another label reading a "Peritoneal Passer(a surgical instrument used to facilitate placement of catheters into the peritoneal [abdominal] cavity) right below the physician name's sticker.

During an interview on 2/19/2025 at 2:45 p.m. with the Nurse Manager for Operating Room (MOR), the MOR looked at the peel pack containing a Shunt Passer and stated the following: "There should not be any labels or tickers inside sterile packing on sterilized instruments."

During a concurrent observation and interview on 2/19/2025 at 2:45 p.m. with the Nurse Manager for Operating Room (MOR), a punctured peel pack (when a peel pack is punctured, it indicates that the sterility of the packing has been compromised, which can lead to potential contamination) containing a Hemlock clip applier (a surgical instrument used to apply clips to tissue during surgical procedures), processed on 1/14/2025, was found in the central supply room. The MOR stated that sharp instruments should have protectors, and perhaps the protector fell off, resulting in the instrument puncturing the peel pack. The MOR also stated that the punctured peel pack compromised the sterility of the instrument (Hemlock clip applier) and was no longer sterile.

During a concurrent observation and interview on 2/19/2025 at 2:46 p.m. with the Nurse Manager for Operating Room (MOR), a peel pack containing a clip applier (a surgical instrument used to apply clips to tissue during surgical procedures), processed on 10/22/2018, was observed with red surgical tape and brown residue at the handle. The MOR stated that the tape and residue should have been removed during reprocessing (a special process or treatment in preparation for reuse) before being sterilized on 10/22/2018.

During an interview on 2/19/2025 at 3:00 p.m. with the Manager of the Operating Room (MOR), the MOR stated that the facility's policy regarding stored sterile packages (sealed containers that contain surgical instruments or supplies used in sterile procedures, designed to maintain the sterility of their contents until they are opened for use, ensuring safety and minimizing the risk of infection) indicated that sterile packages' shelf life was indefinite if the temperature and humidity were maintained within range and sterile items have no tear in the package, then it should be okay to continue storing sterile packages. The MOR also stated there were no routine inspections conducted to inspect the integrity of sterile packages in sterile supply room and there was no log.

During an observation on 2/19/2025 at 3:10 p.m. in the sterile supply room in the main OR, a peel pack containing skin hooks tray (a surgical instrument used to hold or retract skin), processed on 12/09/2022, were observed. Two hooks inside the tray contained attached instrument tape. The top of the tray contained blue adhesive tape, and a label with the handwritten name on it.

During an interview on 2/19/2025 at 3:15 p.m. with the Director of Surgical Services (Dir 1), the Dir 1 stated that this sterile plastic peel pack containing a tray with skin hooks should not be used because sterility might have been compromised since the tape was not removed during reprocessing.

During a review of the facility's policy and procedure (P&P) titled, "Care and Cleaning of Instruments," dated 9/2022, the P&P indicated that the guidelines for the care and cleaning of instruments in Sterile Processing require the instrument technician to use tip protectors before placing cutting instruments and knives into appropriate trays and place instruments into appropriate packaging ...

During a review of the facility's policy and procedure (P&P) titled, "Event-Related Sterile Package Shelf Life," the P&P indicated the following: 6. Trays/supplies (in the central supply room) should be rotated with the "first in/first out" rule (is a management principle commonly used in inventory control that dictates that the first items placed in storage should be the first ones to be used, to ensure that items are used in the order they were received or processed). 9. Inspect all stored items quarterly to monitor compliance with this policy regarding storage and condition of the sterile product. This inspection will ne performed by the Qualified Special Processing technician. All packing that looks worn or handled will be discarded if disposable or returned to SPD for reprocessing if re-usable. 10. Document all the findings of the inspection on each departmental Environmental Rounds Report. Send a copy to SP who will report findings through their Quality Assurance (QA) quarterly report and to Infection Prevention who will report the findings at their meetings. 11. Evaluate all items found at inspection time to exceed 12 months of inactivity with the department head as to the need to maintain sterile. 14. Training will be interdisciplinary for persons responsible for handling storage, cleaning, and inspecting of sterile supplies. The training will be documented.

During a review of the facility's policy and procedure (P&P) titled, "Sterilization of Equipment Supplies," dated 9/2021, the P&P indicated that 1. Sterile items must be received, stored, and distributed in a manner which ensures sterility and integrity. 2.An orderly system of rotation of supplies must be used so items stored first are used first.

During a review of the facility's policy and procedure (P&P) titled, "Manual Cleaning Process," dated 9/2023, the P&P indicated that instrument tape and plastic dipping material, when used properly, are ways of identifying specific instruments. These types of marking products wear out over time and staff need to inspect them each time the instrument is processed and should be checked for wear according to the IFU of the product used.

4. During an observation on 2/18/2025 at 2:05 p.m. in the decontamination room (the designated area where soiled medical instruments were initially received, sorted, and cleaned of gross debris before further processing), a sink (sink number [#] two (2), was observed filled with light, blue-colored solution.

During an interview on 2/18/2025 at 2:05 p.m. with the Sterile Processing Technician (SPT 1), the SPT 1 stated that the solution (the enzymatic cleaner, removes bioburden- refers to the quantity of live germs present on a surface, medical device, or material before sterilization [free of germs] or disinfection [clean]) was used for cleaning instruments to remove bioburden. The SPT 1 also stated that the SPT 1 would change the solution only when the solution gets dirty.

During an interview on 2/21/2025 at 10:02 a.m. with the Sterile Processing Technician (SPT 4), the SPT 4 stated the following: "Sink # 2 is used for soaking and should not typically be used for scrubbing instruments. The point of soaking instruments is to reduce the bioburden or to loosen it up. I change the solution when it starts getting cloudy and drain the sink completely before going to lunch or a break. We don't have any visual guidelines available for us in the decontamination room. The soaking should be for about 5 minutes. The solution for soaking has been changed twice since I started here, and I never got the guidelines for brushing either. I am registry (temporary hired worker) and I have started working here in November 2024. I have never received access to the facility's portal where I can access all the manufacturer's recommendations and instructions for use (IFUs, detailed guidelines provided by manufacturers on how to properly use and maintain medical devices and equipment)."

During a review of the facility's policy and procedure (P&P) titled, "Manual Cleaning Process: Inspection and Non-Submergible Items," dated 9/2023, the P&P indicated the following:
A. Sterile processing and Operating Services staff are to follow manufacturer recommendation to properly decontaminate contaminated non-submersible items (any object that cannot be fully submerged in water during the cleaning process). 3. Clean luminated items with a brush of the recommended type, size, material, cleaning solution. 9. Change the solution after every use.

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines doe the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines titled, "Standards of Sterilization," dated 2021, the guidelines indicated that 7.4.1.c. To begin decontamination process as soon as possible after the items have been used. 7.4.1.h. The importance of using a cleaning solution compatible with the device and following manufacturer's cleaning guidelines for proper dilution, concentration, and contact time. 7.4.1.i. Before manual cleaning, the cleaning solution should be ensured to be clean and changed when appears soiled, which could be after one use. 7.6.4.2.i. Monitor the water temperature as required in the manufacturer's written IFUs; Change the solution after every use (a use should be defined in the health care facility's policies and procedure).

During a review of the facility's policy and procedure (P&P) titled, "Manual Cleaning Process: Inspection and Washing of Submersible Instrumentation," dated 9/2023, the P&P indicated the following:
A. 2nd sink: all items that are deemed submersible by manufacturer's written instructions should be submerged in 2nd sink with enzyme solution. Follow manufacturer written instructions for use (IFU) which indicate the amount of contact time required between the submersible instruments in the 2nd sink with enzyme solution.
IV. 1. Instruments with dried blood, bone pieces and debris should be presoaked in 1st sink with enzymatic solution following IFUs.

During a review of the Association for the Advancement of Medical Instrumentation (AAMI, is a nonprofit organization that develops standards and guidelines doe the safe and effective use of medical devices and equipment, advocating for best practices in healthcare and medical technology) guidelines titled, "Standards of Sterilization," dated 2021, the guidelines indicated that the healthcare organization should establish policies and procedures for all methods of cleaning and decontamination of reusable items. Process audits to monitor compliance with the various policies and procedures should be performed on a scheduled basis, with appropriate follow-up to address problems. Additionally, the device manufacturer's current written instructions for Use (IFUs) should be accessible, reviewed, and followed.

5. During an interview on 2/18/2025 at 2:05 p.m. with the Infection Prevention Manager (IPM), the IPM stated the following: "Surgical instruments are transported from OR (Operating Room, area where surgical procedures take place) to decontamination room (a specific section or designated space where contaminated or soiled items are received, sorted, and prepared for the decontamination process). Clean instruments are transported in the same cart that is used for dirty instruments ...Technicians clean the carts with wipes and re-use the same carts for transporting clean instruments and then sterile instruments ..." The IPM then said, "it's an acceptable practice, there is no facility policy regarding this practice."

During a concurrent observation and interview on 2/19/2025 at 11:11 a.m. with the Sterile Processing Technician-Lead (LSPT), the LSPT demonstrated a cart (a cart with enclosed compartments and secure doors that transports surgical instruments and supplies) that would typically be used for the transport of dirty instruments from the Operating Room (OR) to the decontamination room. The LSPT also demonstrated how the biohazard sign (a biological material or substance that can cause disease or illness in humans) on top of the cart can be switched to a clean cart sign whenever necessary. The LSPT also stated that the same cart(s) is(are) used for the transport of clean/sterile instruments ; the cart will have to be cleaned with [Brand] enzymatic solution (a cleaning product that contains enzymes to break down stains and soils) before re-use and then the sign will be changed to "clean cart" on top, allowing the cart to be used for the transport of clean and sterile instruments.

During the same interview on 2/19/2025 at 10:27 a.m. with the Sterile Processing Technician-Lead (LSPT), the LSPT was not able to provide information regarding the enzymatic [Brand] wipes used for cleaning carts.

During an interview o 2/20/2025 at 3:11 p.m. with the Infection Prevention Manager (IPM), the IPM stated that carts used for transport of dirty and clean/sterile instruments can be reused once they are cleaned with bleach (disinfectant that kills germs) in between use. The IPM then stated that questions regarding cleaning carts should be addressed to the SPD (Sterile Processing Department, the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place) manager or director.

During a review of the facility's policy and procedure (P&P) titled, "Instruments, Scopes, and Equipment Processing, dated 10/2021, the P&P indicated the following regarding A. Handling of sterile instruments and supplies: all wrapped sterile instrument trays and supplies processed in Special Processing Department (SPD) will be transported to the OR in a covered cart after the sterilization process is completed and the packages are dry and properly labeled. Covered carts will be used for transport and ONLY sterile items will be placed and transported on these carts. Never any soiled or dirty items. B. Handling of used instruments: Operating Room (OR) case carts will be used to transport contaminated instruments to the decontamination room in the Operating Room. The cart will be wiped down with germicidal solution (a substance that kills germs, like bacteria and viruses, that can cause disease) after it is unloaded in the instrument room and before being re-used.

During a review of the facility's policy and procedure (P&P) titled, "Containment and Transport of Soiled Items," dated 9/15/2023, the P&P indicated that: all container or carts used for containing contaminated items be marked with a biohazard label ...Containers with biohazard labels are to be dedicated for soiled transport and storage. Soiled biohazard labeled containers are never to transport clean equipment. Soiled case carts must be cleaned after each use. Transportation equipment/carts should be disinfected after each use. Decontamination of transportation equipment after each use helps prevent cross-contaminati