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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 the Nursing Department implemented policies regarding timely assessment and basic life support interventions as well as ensure the Respiratory Department develop an updated policy and procedure to be implemented and followed by staff regarding the appropriate use of respiratory devices per manufacturer's guideline when:

1.a. The nursing staff failed to follow basic life support (BLS, a set of medical procedures that are used to help patients experiencing medical emergencies) guideline, in accordance with the facility's protocol regarding basic life support, when one of 30 sampled patients (Patient 1) was found non-responsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and pulseless (no heart rate).

This deficient practice resulted in a delay of initiating chest compressions (a part of cardiopulmonary resuscitation [CPR], which is a first aid technique that keeps the heart pumping until emergency help arrives) on Patient 1 by two minutes and had the potential to put other patients' safety at risk when life saving measures are not provided immediately during Code Blue (hospital emergency code use to summon help when a patient is in need of resuscitation) situation. (Refer to A-0063)

1.b. The facility failed to ensure the appropriate use of respiratory device for three of 30 sampled patients (Patients 10, 12 and 13) when the facility staff used Ballard closed suction system (inline suction catheter to remove secretion from airway) beyond the manufacturer's instruction of 24 hours use. The staff used the Ballard closed suction system for 7 days. This deficient practice had the potential to put Patients 10, 12 and 13 at risk for respiratory infection and malfunction of the device. (Refer to A-0063)

2. The facility's governing body failed to ensure its contracted laboratory service comply with the facility's policy and procedure regarding reporting of critical values (diagnostic result that could be life-threatening and requires immediate medical attention) when a positive blood culture (a microbiology test that checks blood sample for bacteria or fungi [microorganisms that can cause infection]) was not reported by the contracted service in a timely manner for one of 30 sampled patients (Patient 10). The positive blood culture result was not reported until after 7.5 hours.

This deficient practice had the potential to result in a delay of treatment for Patient 10 which may result in complications such as sepsis (a serious condition in which the body responds improperly to an infection). This deficient practice also had the potential to result in prolonged hospitalization for Patient 10. (Refer to A-0083)

3. 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 evaluate and maintain its contracted services record to ensure contracted services are in compliance with the facility's requirement, in accordance with facility's policy and procedure regarding contracts management, for one of three sampled contracted services (CS 1).

This deficient practice had the potential to result in having unqualified contracted services providing services to patients and compromise patients' safety. (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 for four of 30 sampled patients (Patients 24, 26, 27, and 29) the following:

1.a. Patient 24 was provided a copy of the "Conditions of Admission (COA - a contract between a patient and a hospital that outlines the patient's responsibilities for the hospital services they receive)" and the Important Message from Medicare (IMM - a notice that hospitals provide to Medicare patients to explain their rights as inpatients) letter upon admission to the facility.

1.b. Patient 26 was provided a copy of the COA and the Important Message from Medicare letter upon admission to the facility.

1.c. Patient 27 was provided a copy of the COA and the IMM letter upon admission to the facility.

1.d. Patient 29 was provided the IMM letter upon admission to the facility.

These deficient practices resulted in Patients 24, 26, 27, and 29, and/or the patients' representatives, to not be informed of their rights as a patient and their rights to appeal for discharge from the hospital, which may lead in Patient 24, 26, 27, and 29's inability to effectively make decisions regarding their care and treatment. (Refer to A-0117)

2. The facility failed to identify one of 30 sampled patient's (Patient 1) abnormal heart rhythm and loss of oxygen saturation (measures the amount of oxygen in the blood) reading and notify the Registered Nurse (RN) or the Respiratory Care Practitioner (RCP) in a timely manner, in accordance with the facility's policy and procedure regarding Telemetry monitoring (a technique that allows healthcare providers to continuously track a patient's heart rhythm and electrical activity).

This deficient practice resulted in a delay in life-saving measures such as CPR (cardiopulmonary resuscitation- an emergency life-saving procedure performed when the heart stops beating), which may have contributed to Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells). (Refer to A-0144)

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 treatment.

Based on interview and record review the facility failed to ensure the Condition of Participation for Quality Assurance Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital program) was met as evidenced by:

1. The facility failed to analyze and track an adverse event (a harmful or negative outcome) and also failed to formulate and implement a corrective action plan or preventive action, when the facility did not identify a delay in Cardiopulmonary Resuscitation (CPR, an emergency lifesaving procedure performed when the heart stops beating), when Patient 1 was found to be unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways), pulseless (no heartbeat), and not breathing which resulted in Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells), and implement a corrective action plan for follow-ups.

This deficient practice had the potential for staff's inability to respond appropriately during a medical emergency such as in cases of patients who may be pulseless or not breathing, which may result in patient harm (such as brain damage) and/or death. (Refer to A-0286)

2. 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 its antimicrobial stewardship program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance) met monthly, in accordance with the facility's policy and procedure regarding antimicrobial stewardship program, and to report its data to hospital QAPI (Quality Assurance Performance Improvement, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee and the Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) leadership since 11/2023.

This deficient practice resulted in lack of QAPI oversight over the facility's antimicrobial stewardship program for its performance and compliance since 11/2023. This deficient practice also had the potential to result in increased rates of antibiotic resistance among bacteria, potentially leading to more difficult to treat infections, poorer patient outcomes, and a greater risk of spreading resistant organisms within the hospital due to unnecessary and inappropriate antibiotic usage. (Refer to A-0308)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment.

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 initiate Cardiopulmonary Resuscitation (CPR, an emergency lifesaving procedure performed when the heart stops beating) in a timely manner, per policy and procedure regarding BLS (Basic Life Support- a set of medical procedures that are used to help patients experiencing medical emergencies), for one of 30 sampled patient (Patient 1), when Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways), pulseless (no heartbeat), and not breathing.

This deficient practice resulted in a delay in life-saving measures, which may have contributed to Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells). (Refer to A-0395)

2. The facility failed to ensure nursing staff identified a patient's change in respiratory status (how well a patient is producing air exchange), communicate with the interdisciplinary team and report to physician in a timely manner, in accordance with the facility's policy and procedures regarding vital signs (includes the heart rate, respiratory rate, temperature, and blood pressure) clinical monitoring and physician notification, for one of 30 sampled patients (Patient 13) leaving Patient 13's respiratory rate at 39 breaths per minute (normal range 16 to 20 breaths per minute) for 16 hours (from midnight to 4:30 p.m.).

This deficient practice had the potential to delay treatment and care and put Patient 13 at risk for hyperventilation (breathing too quickly) and respiratory distress (difficulty breathing). (Refer to A-0395)

3. The facility failed to ensure for two of 30 sampled patients (Patients 22 and 27), nursing care was provided, the facility's policy and procedure regarding patient reassessment post (after) interventions when:

3.a. Patient 22's pain was not reassessed (re-evaluate) after Tylenol (can be used as pain medication), ordered as needed (PRN) for mild pain, was given.

This deficient practice had the potential to cause delayed treatment of Patient 22's pain which may worsen Patient 22's pain and may also result in psychological distress due to inadequately managed pain. (Refer to A-0395)

3.b. Patient 27 was not reassessed (reevaluated) after administering Midodrine (medication used for raising blood pressure), ordered as needed (PRN), for SBP (systolic BP, maximum amount of pressure the blood uses to move through the body) less than 100 mmHg (millimeters of mercury, a unit of measure).

This deficient practice had the potential to cause a delay in determining the effectiveness of treatment for Patient 27 and/or a delay the provision of necessary intervention/adjustment in treatment if the previous intervention was ineffective. (Refer to A-0395)

3.c. Patient 27 was not reassessed after Hydromorphone (narcotic pain medication), ordered PRN for moderate pain, was given.

This deficient practice had the potential to cause delayed treatment of Patient 27's pain which may worsen Patient 27's pain and may also result in psychological distress due to inadequately managed pain. (Refer to A-0395)

4. The facility failed to ensure for one of three sampled crash carts (Crash cart 1, wheeled container carrying medicine and equipment for use in emergency resuscitations), Crash cart 1 was checked daily in accordance with the facility's policy and procedure regarding Crash cart maintenance.

This deficient practice had the potential to delay critical emergency care if the crash cart was not properly stocked potentially leading to worsened patient outcomes and/or patient death. (Refer to A-0398)

5. The facility failed to ensure for four of 30 sampled patients (Patients 21, 22, 23, and 27), Patients 21, 22, 23 and 27's medications were administered in accordance with the physician's order.

These deficient practices had the potential to cause adverse health outcomes which could negatively affect Patients 21, 22, 23 and 27's health and safety due to unsafe medication administration and may lead to prolonged hospitalization and/or death of the patient. (Refer to A-0405)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Infection Prevention/Control/Antibiotic Stewardship Pr0gram (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance) was met as evidenced by:

1. The facility failed to ensure Contact isolation precaution (steps that prevent the spread of germs from patients to others through direct or indirect contact. Example: use of gloves during patient care) interventions were properly implemented, in accordance with the facility's policy and procedure regarding contact precaution, for one of 30 sampled patients (Patient 10), when there was no isolation signage posted outside Patient 10's room to inform staff and visitors of what to do. This deficient practice resulted in Patient 10's visitor entering the patient's room and touching Patient 10 without the proper PPE (Personal Protective equipment such as gloves, gowns, etc.). This deficient practice also had the potential to result in spreading infection to other patients, visitors or staff. (Refer to A-0749)

2. The facility failed to ensure the Ballard closed suction systems (inline suction catheter to remove secretion from airway) were not used beyond manufacturer's instruction (user manual) for three of 30 sampled patients (Patients 10, 12, and 13). The Ballard suction systems were replaced after seven days instead of after 24 hours. This deficient practice had the potential to result in respiratory infection for Patients 10, 12 and 13. (Refer to A-0749)

3. The facility failed to ensure the water bag (deliver water to patients enterally through gastrostomy [an artificial external opening into the stomach for nutritional and medication administration]) was not being used more than 24 hours, beyond manufacturer's instruction for one of 30 sampled patients (Patient 12). This deficient practice had the potential to deliver contaminated (dirty) water to Patient 12 and make Patient 12 sick. (Refer to A-0749)

4. The facility failed to ensure Patient 25's tube feeding set (device used to administer feeding formula and water flush to the patient) was changed in accordance with the facility's policy and procedure regarding replacement of tube feeding sets after 24 hours. This deficient practice had the potential to result in Patient 25's tube feeding set to be contaminated and may transmit bacterial infection to the patient (Patient 25). (Refer to A-0749)

5. The facility failed to ensure Patient 24's tube feeding set had a label date, of when the set was hung, in accordance with the facility's policy and procedure and the manufacturer's guideline. This deficient practice had the potential to result in Patient 24's tube feeding set to be contaminated and may transmit bacterial infection to the patient (Patient 24). (Refer to A-0749)

6. The facility's antimicrobial stewardship program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance) failed to meet monthly in accordance with the facility's policy and procedure regarding antimicrobial stewardship program (ASP), and to report its data to hospital Quality Assurance and Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee and the Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) leadership on a regular basis.

This deficient practice resulted in lack of QAPI oversight over the facility's antimicrobial stewardship program for its performance and compliance. This deficient practice also had the potential to result in increased rates of antibiotic resistance among bacteria, potentially leading to more difficult to treat infections, poorer patient outcomes, and a greater risk of spreading resistant organisms (Bacteria that are not controlled or killed by antibiotics) within the hospital due to unnecessary and inappropriate antibiotic usage. (Refer to A-0771)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

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

1. The facility failed to ensure its clinical staff (Respiratory Care Practitioner) identify change in respiratory status (how well a patient is producing air exchange), communicate with the nursing staff, and to report change of condition to physician in a timely manner, in accordance with the facility's policy and procedure regarding vital signs clinical monitoring and physician notification, for one of 30 sampled patients (Patient 13), when Patient 13's respiratory rate of 39 breaths per minute was not addressed and remained at about the same rate for 16 hours (from midnight to 4:30 p.m.).

This deficient practice had the potential to delay treatment and care and put Patient 13 at risk for hyperventilation (breathing too quickly) and respiratory distress (difficulty breathing), which can also prolong Patient 13's recovery. (Refer to A-1160)

2. The facility failed to ensure a complete oxygen therapy order, to include an order for FiO2 (percentage amount of oxygen delivered), was documented, when one of 30 sampled patients (Patient 13) was placed on mechanical ventilator (an appliance for artificial respiration) with Assist Control (AC, a mode of mechanical ventilator that provides support for each breath a patient takes) setting.

This deficient practice had the potential for clinical staff to not be clear on how much oxygen to provide for Patient 13 and put Patient 13 at risk for receiving too little or too much oxygen which can lead to complications such as difficulty breathing, chest pain, dangerously low heart rate due to oxygen toxicity, etc. (Refer to A-1164)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

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 Nursing Department implemented policies regarding timely assessment and basic life support interventions as well as ensure the Respiratory Department develop an updated policy and procedure to be implemented and followed by staff regarding the appropriate use of respiratory devices per manufacturer's guideline when:

1. The nursing staff failed to follow basic life support (BLS, a set of medical procedures that are used to help patients experiencing medical emergencies) guideline, in accordance with the facility's protocol regarding basic life support, when one of 30 sampled patients (Patient 1) was found non-responsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and pulseless (no heart rate).

This deficient practice resulted in a delay of initiating chest compressions (a part of cardiopulmonary resuscitation [CPR], which is a first aid technique that keeps the heart pumping until emergency help arrives) on Patient 1 by two minutes and had the potential to put other patients' safety at risk when life saving measures are not provided immediately during Code Blue (hospital emergency code use to summon help when a patient is in need of resuscitation) situation.

2. The facility failed to ensure the appropriate use of respiratory device for three of 30 sampled patients (Patient 10, 12 and 13) when the facility staff used Ballard closed suction system (inline suction catheter to remove secretion from airway) beyond the manufacturer's instruction of 24 hours use. The staff used the Ballard closed suction system for 7 days. This deficient practice had the potential to put Patients 10, 12 and 13 at risk for respiratory infection and malfunction of the device.

Findings:

1. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/1/2024, the H&P indicated, Patient 1 was admitted to the facility with diagnoses including but not limited to non-ST-elevation myocardial infarction (NSTEMI, a type of heart attack that occurs when the heart's need for oxygen can't be met), and respiratory failure (a medical condition in which the lungs are not working properly and oxygen blood levels are too low) requiring mechanical ventilation (a life-support technique that helps someone breathe when they are unable to do so on their own) status post tracheostomy (a surgically created hole in the throat that provides an alternative airway for breathing).

During an interview on 10/16/2024 at 4:24 p.m. with the Chief Nursing Officer (CNO) and the Clinical Nurse Director (CND), the CND stated the following: On 3/8/2024 at approximately 2:43 a.m., Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and a Rapid Response Team (RRT, a system implemented in hospitals designed to identify and respond to patients with early signs of clinical deterioration) was initiated, followed by a code blue (hospital emergency code use to summon help when a patient is in need of resuscitation) at 2:45 a.m. Patient 1 suffered pulseless electrical activity (PEA, a condition where the heart was electrical activity but is unable to pump blood, resulting no pulse) and coded (when someone requires an immediate life-saving measure). The CNO stated the following: Clinical staff who work at the bedside are required to have Basic Life Support (BLS, a set of medical procedures that are used to help patients experiencing medical emergencies) training. Staff required to have BLS training are Charge Nurses (CN), Registered Nurses (RN), Certified Nursing Assistants (CNA) and Respiratory Care Practitioners (RCP). If a staff is the first person to find a patient unresponsive, they should follow BLS guidelines to check for pulse then breathing. If a patient is unresponsive, not breathing, and pulseless, the staff who found the patient should stay with the patient and start cardiopulmonary resuscitation (CPR, emergency lifesaving procedure performed when the heart stop beating) with chest compressions (a part of cardiopulmonary resuscitation [CPR], which is a first aid technique that keeps the heart pumping until emergency help arrives) first.

During an interview on 10/16/2024 at 5:33 p.m. with the Respiratory Care Practitioner (RCP 1), RCP 1 stated the following: On 3/8/2024, he (RCP 1) was in the hallway on Medical Surgical Unit 1 (Unit 1) and was notified by Charge Nurse (CN) 1 to check on Patient 1. When he (RCP 1) responded to Patient 1's room, Patient 1 was unresponsive and not breathing. He (RCP 1) immediately initiated bagging (providing ventilation) Patient 1 with a bag and mask (a device that helps someone breath when not breathing on own). No staff was providing chest compressions to Patient 1 when he (RCP 1) entered Patient 1's room.

During an interview on 10/16/2024 at 5:59 p.m. with the Charge Nurse (CN) 1, CN 1 stated the following: She (CN 1) found Patient 1 was pale with no chest rise and fall in Patient 1's room. She (CN 1) called RCP 1 into Patient 1's room. RCP 1 started bagging Patient 1. CN 1 checked Patient 1's pulse and determined there was no pulse. She (CN 1) called a code blue and stayed with Patient 1. Chest compressions were performed by another Respiratory Care Practitioner who entered Patient 1's room at a later time. CN 1 did not perform chest compressions on Patient 1. CN 1 also said when a patient was found pulseless, CPR should be initiated right away so there was no delay. There are better patient outcomes if CPR was initiated immediately.

During a concurrent interview and record review on 10/17/2024 at 8:36 a.m. with CNO, Patient 1's "Code Blue Record," dated 3/82024, was reviewed. The Code Blue Record indicated, Manual ventilation begun at 2:43 a.m. and chest compression started at 2:45 a.m. (two minutes apart). CNO stated staff should call Code Blue and initiate chest compressions first when Patient 1 was found unresponsive and pulseless. CNO stated chest compressions was to help with circulation for the patient.

During an interview on 10/18/2024 at 8:12 p.m. with the Certified Nursing Assistant (CNA) 2, CNA 2 stated she (CNA 2) would verify patient's code status (a document that outlines the type of medical treatment a patient wants to receive if his or her heart or breathing stops) first before initiating chest compressions even if the patient was found unresponsive with no pulse.

During an interview on 10/18/2024 at 8:14 p.m. with the Charge Nurse (CN) 5, CN 5 stated the following: she (CN 5) would not initiate chest compressions until knowing patient's code status when she (CN 5) found a patient unresponsive and pulseless (no heart rate). There was no identifier to indicate a patient's code status at bedside. Someone would need to go to the computer or patient's medical chart to find the patient's code status. There could be delay in initiating chest compressions, but she (CN 5) would stay with the patient and bag the patient while waiting for the information regarding a patient's code status.

During a review of a document provided by the facility titled, "Basic Life Support (BLS) Reference," dated 10/2020, the document indicated the following: "Compressions, Airway, Breathing (C-A-B); Critical Concepts: High-quality CPR improves a victim's chances of survival. The critical characteristics of high-quality CPR include the following: Start compressions within 10 seconds after recognizing cardiac arrest ... Adult BLS Algorithm (a set of instructions that are followed in order to complete a task) for Healthcare Providers: verify scene safety, check responsiveness, shout for help, activate emergency response system via mobile device (if appropriate), Get AED (Automated External Defibrillator- a medical device that can help people experiencing sudden cardiac arrest by analyzing the heart's rhythm and delivering an electric shock to the heart) and emergency equipment (or send someone to do so); Look for no breathing or only gasping and check pulse (simultaneously), Is pulse definitely felt within 10 seconds?; no breathing or only gasping, pulse not felt; Start CPR: perform cycles of 30 compressions and 2 breaths, use AED as soon as it is available ..."

During a review of the facility's policy and procedure (P&P) titled, "Code Blue," dated 6/2022, the P&P indicated the following: " ...Definitions: ...A Code Blue may be called for any patients with an absent pulse, apnea (when breathing stops or becomes very shallow), agonal breathing (irregular, labored breathing that can sound like gasping, snorting, or moaning), or life-threatening arrythmias ... 1. Any staff who finds a person in cardiopulmonary arrest will initiate a Code Blue. This person must stay with the victim and summon help by whatever means are available ..."

2.a. During a review of Patient 12's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 10/6/2024, the H&P indicated, Patient 12 was admitted to the facility with diagnoses including but not limited to acute (new onset) on chronic hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood) status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), and dysphagia (difficulty swallowing) with status post gastrotomy (an artificial external opening into the stomach for nutritional and medication administration).

During a concurrent observation and interview on 10/15/2024 at 2:57 p.m. with the Respiratory Care Practitioner (RCP) 2 in Patient 12's room, Patient 12's Ballard closed suction systems (Ballard, inline suction catheter to remove secretion from airway) was observed dated 10/13/2024 with a day sticker "Change Sunday." RCP 2 stated Patient 12 had a lot of secretion and Ballard was changed on 10/13/2024 (Sunday). RCP 2 stated Ballard was changed on an as needed basis.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview and record review on 10/16/2024 at 12:01 p.m., ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. It should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022 was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated."

During the same interview on 10/16/2024 at 12:04 p.m., ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a concurrent interview and record review on 10/18/2024 at 8.57 p.m. with the Chief Executive Officer (CEO), Medical Director (MDR), Chief Nursing Office (CNO), Associate Chief Nursing Officer (ACNO), Clinical Nurse Director (CND), Director of Respiratory Therapy and Rehabilitation Services (DTRS) and Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/18/2024 at 8:57 p.m., MDR stated the governing body (responsible for guiding the hospital's long-term goals and policies and assists with strategic planning and decision-making) was aware the manufacturer's instruction was not followed. MDR stated the risk of using product beyond recommended time would be product malfunction and infection. CND stated the manufacturer would not be responsible for the product if it was used beyond the recommended time, the facility would be liable.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."

During a review of the facility's governing body bylaws (GB bylaws) titled, "Amended and Restated Bylaws of [the facility]," dated 8/2017, the GB bylaws indicated, "the Board responsibility for patient care. The Board will require an organization-wide process with specific review and evaluation policies to assess, preserve, and improve the overall quality and effectiveness of patient care and safe delivery of care given by staff, including Medical Staff in the hospital, consistent with the scope of services provided. The Board will manage and oversee the establishment of organizational expectations for improving patient care and safety ... the Board will provide administrative assistance reasonably necessary."


2.b. During a review of Patient 13's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 9/21/2024, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to acute (new onset) hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), pneumonia (lung infection) and septic shock (a body's overwhelming and life-threatening response to infection).

During a concurrent observation and interview on 10/15/2024 at 3:09 p.m. with Registered Nurse (RN) 16 in Patient 13's room, Patient 13's Ballard closed suction systems (Ballard, inline suction catheter to remove secretion from airway) had a day sticker "change Friday" with no date. RN 16 stated she (RN 16) did not know when Patient 13's Ballard was changed.

During an interview on 10/15/2024 at 3:15 p.m. with the Director of Respiratory Therapy and Rehabilitation Services (DTRS), DTRS stated Ballard was changed every seven (7) days and as needed when soiled. DTRS stated the sticker of "Change Friday" without the date was not clear which Friday was it.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/16/2024 at 12:01 p.m., ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. It should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022 was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated."

During the same interview on 10/16/2024 at 12:04 p.m., ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a concurrent interview and record review on 10/18/2024 at 8.57 p.m. with the Chief Executive Officer (CEO), Medical Director (MDR), Chief Nursing Office (CNO), Associate Chief Nursing Officer (ACNO), Clinical Nurse Director (CND), Director of Respiratory Therapy and Rehabilitation Services (DTRS) and Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/18/2024 at 8:57 p.m., MDR stated the governing body (responsible for guiding the hospital's long-term goals and policies and assists with strategic planning and decision-making) was aware the manufacturer's instruction was not followed. MDR stated the risk of using product beyond recommended time would be product malfunction and infection. CND stated the manufacturer would not be responsible for the product if it was used beyond the recommended time, the facility would be liable.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."

During a review of the facility's governing body bylaws (GB bylaws) titled, "Amended and Restated Bylaws of [the facility]," dated 8/2017, the GB bylaws indicated, "the Board responsibility for patient care. The Board will require an organization-wide process with specific review and evaluation policies to assess, preserve, and improve the overall quality and effectiveness of patient care and safe delivery of care given by staff, including Medical Staff in the hospital, consistent with the scope of services provided. The Board will manage and oversee the establishment of organizational expectations for improving patient care and safety ... the Board will provide administrative assistance reasonably necessary."

2.c. During a review of Patient 10's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 6/22/2024, the H&P indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), pneumonia (lung infection), cerebral vascular accident (CVA - stroke; damage to the brain from interruption of its blood supply), and endocarditis (inflammation of the heart's inner lining).

During a concurrent interview and record review on 10/16/2024 at 12 p.m. with the Respiratory Therapy Manager (RTM), Patient 10's "Respiratory Miscellaneous Billing (billing)," dated from 10/11/2024 to 10/16/2024, was reviewed. The billing indicated, Ballard was changed on 10/11/2024, 10/13/2024 and 10/16/2024. RTM stated the Ballard was not changed daily. RTM stated the Ballard was changed every seven (7) days and as needed per facility's policy and procedure.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/16/2024 at 12:01 p.m., ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. It should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022 was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated."

During the same interview on 10/16/2024 at 12:04 p.m., ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a concurrent interview and record review on 10/18/2024 at 8.57 p.m. with the Chief Executive Officer (CEO), Medical Director (MDR), Chief Nursing Office (CNO), Associate Chief Nursing Officer (ACNO), Clinical Nurse Director (CND), Director of Respiratory Therapy and Rehabilitation Services (DTRS) and Infection Control Preventionist (ICP), the manufacturer's instructions titled, "Ballard Closed Suction System manufacturer's instructions for use," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/18/2024 at 8:57 p.m., MDR stated the governing body (responsible for guiding the hospital's long-term goals and policies and assists with strategic planning and decision-making) was aware the manufacturer's instruction was not followed. MDR stated the risk of using product beyond recommended time would be product malfunction and infection. CND stated the manufacturer would not be responsible for the product if it was used beyond the recommended time, the facility would be liable.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."

During a review of the facility's governing body bylaws (GB bylaws) titled, "Amended and Restated Bylaws of [the facility]," dated 8/2017, the GB bylaws indicated, "the Board responsibility for patient care. The Board will require an organization-wide process with specific review and evaluation policies to assess, preserve, and improve the overall quality and effectiveness of patient care and safe delivery of care given by staff, including Medical Staff in the hospital, consistent with the scope of services provided. The Board will manage and oversee the establishment of organizational expectations for improving patient care and safety ... the Board will provide administrative assistance reasonably necessary."

Based on 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 its contracted laboratory service (CS 1) comply with the facility's policy and procedure regarding reporting of critical values (diagnostic result that could be life-threatening and requires immediate medical attention) when a positive blood culture (a microbiology test that checks blood sample for bacteria or fungi) was not reported by the contracted service in a timely manner for one of 30 sampled patients (Patient 10). The positive blood culture result was not reported until after 7.5 hours.

This deficient practice had the potential to result in a delay of treatment for Patient 10 which may result in complications such as sepsis (a serious condition in which the body responds improperly to an infection). This deficient practice also had the potential to result in prolonged hospitalization for Patient 10.

Findings:

During a review of Patient 10's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 6/22/2024, the H&P indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), pneumonia (lung infection), cerebral vascular accident (CVA/stroke, damage to the brain from interruption of its blood supply), and endocarditis (inflammation of the heart's inner lining).

During a concurrent interview and record review on 10/18/2024 at 9:16 a.m. with the Infection Control Preventionist (ICP), Patient 10's blood culture (a microbiology test that checks blood sample for bacteria or fungi) report, dated 10/10/2024, was reviewed. The blood culture report indicated Patient 10 was positive for Klebsiella Pneumoniae (a type of bacteria causing bloodstream infections). ICP stated the following: Klebsiella Pneumoniae on blood culture was considered as critical value (diagnostic result that could be life-threatening and requires immediate medical attention). Laboratory staff should communicate with nursing staff promptly and log down which nursing staff was contacted for the critical value.

During an interview on 10/18/2024 at 9:20 a.m. with the Wound Care Specialist Registered Nurse (WCS 1), WCS 1 stated nursing staff must report any critical value to a physician within sixty (60) minutes.

During a concurrent interview and record review on 10/18/2024 at 11:34 a.m. with the Laboratory Coordinator (LC 1), Patient 1's blood culture report, dated 10/10/2024, was reviewed. The blood culture reported indicated, Klebsiella Pneumoniae was detected at 1:36 p.m.

During the same interview on 10/18/2024 at 11:34 a.m., LC 1 stated the following: blood culture was a send-out test completed by the facility's contracted service (CS 1). Results were automatically uploaded to Patient 10's electronic medical record (EMR, digital version of paper chart) system by CS 1. CS 1 should have informed the facility's laboratory department via fax when the blood culture resulted positive at 1:36 p.m. then laboratory staff could inform nursing staff per facility's policy. CS 1 did not call or fax the positive blood culture result to the facility's laboratory department. LC 1 stated there was a delay in reporting critical value to the physician for Patient 10 which could cause delay in treatment.

During a review of Patient 10's "Critical Call Log (documentation for all critical values)," dated 10/10/2024, the Critical Call Log indicated, CS 1 called to the facility at 9:01 p.m. (7.5 hours after the original result time) to report critical value of the blood culture test which turned positive for Klebsiella Pneumoniae.

During an interview on 10/18/2024 at 2:52 p.m. with the Chief Executive Officer (CEO), CEO stated he (CEO) oversees the laboratory department and was aware CS 1 was used for send-out tests including blood culture. CEO stated all contracted services were required to comply with the facility's policy and procedures.

During an interview on 10/18/2024 at 8:52 p.m. with the CEO, CEO stated the governing body was ultimately responsible for the facility's overall performance and to provide oversight for everything including contracted services.

During a review of Contracted Service 1's "Contract Addendum - April 2, 2003," dated 6/20/2003, the contract addendum indicated, "Regulatory Compliance ... each party hereto shall adopt, implement, and maintain appropriate compliance policies, procedures, and practices necessary to comply with all laws and regulations applicable to the party's respective business."

During a review of the facility's policy and procedure (P&P) titled, "Critical Results of Tests and Diagnostic Procedures," dated 6/2022, the P&P indicated, "to ensure that results of critical testes and diagnostic procedures results considered critical to patient care will be immediately communicated by the Licensed caregiver to appropriate providers in a timely manner in order to provide subsequent patient treatment decisions ...critical results of diagnostic tests will be communicated, acknowledged and will receive a physician response with one (1) hour. Critical results are to be called by the laboratory staff to the Registered Nurse (RN) ... Critical results for [the facility]: microbiology - positive blood culture. Microbiology services are provided by a contracted laboratory service and when critical values are found they notify the organization to report the findings."

During a review of the facility's governing body bylaws (GB bylaws) titled, "Amended and Restated Bylaws of [the facility]," dated 8/2017, the GB bylaws indicated, "the Board responsibility for patient care. The Board will require an organization-wide process with specific review and evaluation policies to assess, preserve, and improve the overall quality and effectiveness of patient care and safe delivery of care given by staff, including Medical Staff in the hospital, consistent with the scope of services provided. The Board will manage and oversee the establishment of organizational expectations for improving patient care and safety ... the Board will provide administrative assistance reasonably necessary."

Based on 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 evaluate and maintain its contracted services record to ensure contracted services are in compliance with the facility's requirement, in accordance with facility's policy and procedure regarding contracts management, for one of three sampled contracted services (CS 1).

This deficient practice had the potential to result in having unqualified contracted services providing services to patients and compromise patients' safety.

Findings:

During a concurrent interview and record review on 10/18/2024 at 2:54 p.m. with the Chief Executive Officer (CEO), contracted service (CS) 1's "Contract Checklist Annual Evaluation and Renewal (contract eval form)," dated 8/9/2022 was reviewed. The contract evaluation form indicated contract review date was on 8/9/2022. CEO stated the contracted services need to be reviewed by the facility to ensure they provided quality care. CEO stated there was no other updated contract evaluation form found in CS 1's file.

During a concurrent interview and record review on 10/18/2024 at 2:54 p.m. with the Chief Executive Officer (CEO), contracted service (CS) 1's "Certificate of Liability Insurance," dated 12/16/2020. The Certificate of Liability Insurance indicated policy expired on 12/31/2021. CEO acknowledged there was no other updated Certificate of Liability Insurance found in CS 1's file.

During an interview on 10/18/2024 at 8:52 p.m. with CEO, CEO stated the governing body was ultimately responsible for the facility's overall performance and to provide oversight for everything including contracted services.

During a review of the facility's policy and procedure (P&P) titled, "Contracts Management - Outside Services," dated 7/2022, the P&P indicated, "to assure care, treatment, and services provided through contractual agreements are provided safely and effectively ... Administrative/ Management staff is responsible for monitoring outside contract services, ascertaining compliance to contract agreements, maintaining records, and assuring conditions for compliance with laws, regulations, and [the facility's] policies ... contracts renewals, renegotiations, or terminations should be completed timely so that continuity of patient care is maintained ... Request the following documents from the outside service provider: the insurance certificates must be updated annually or upon expiration. All certificates are entered into the contract manager application (CM) so that CM can be the definitive source for expiration dates ... Contracts must be reviewed on the annual renewal date or at a minimum of every two years ... Contract requirements are checked annually per the contract update checklist, completing the Contract Evaluation checklist."

Based on interview and record review, the facility failed to ensure for four of 30 sampled patients (Patients 24, 26, 27, and 29) the following:

1. Patient 24 was provided a copy of the "Conditions of Admission (COA - a contract between a patient and a hospital that outlines the patient's responsibilities for the hospital services they receive)" and the Important Message from Medicare (IMM - a notice that hospitals provide to Medicare patients to explain their rights as inpatients) letter upon admission to the facility.

2. Patient 26 was provided a copy of the COA and the Important Message from Medicare letter upon admission to the facility.

3. Patient 27 was provided a copy of the COA and the IMM letter upon admission to the facility.

4. Patient 29 was provided the IMM letter upon admission to the facility.

These deficient practices resulted in Patients 24, 26, 27, and 29, and/or the patients' representatives, to not be informed of their rights as a patient and their rights to appeal for discharge from the hospital, which may lead in Patient 24, 26, 27, and 29's inability to effectively make decisions regarding their care and treatment.

Findings:

1. During a review of Patient 24's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 9/11/2024, the H&P indicated Patient 24 was admitted to the facility for recent respiratory failure (a serious condition that occurs when not enough oxygen passes from your lungs to your blood) with the need for ventilator (a medical device to help support or replace breathing).

During a review of Patient 24's face sheet (front page of the chart that contains a summary of basic information about the resident), dated 9/9/2024, the face sheet indicated Patient 24 had an emergency contact listed.

During an interview on 10/15/24 at 4:02 p.m., with the Charge Nurse (CN 4), CN 4 stated it was the bed side nurse's responsibility to ensure the patient's admission forms, including the COA (Conditions of Admission- a contract between a patient and a hospital that outlines the patient's responsibilities for the hospital services they receive) and IMM (Important Message from Medicare- a notice that hospitals provide to Medicare patients to explain their rights as inpatients) letter, were signed upon admission or as soon as possible. CN 4 stated, if the patient cannot sign the form, the patient's emergency contact listed on the face sheet should be contacted.

During a concurrent interview and record review on 10/15/2024 at 4:21 p.m. with the Associate Chief Nursing Officer (ACNO), the ACNO verified Patient 24's record had no documentation that a copy of the COA and IMM letter was provided to the patient and/or patient's representative.

During a review of the facility's policy and procedure (P&P) titled, "Conditions of Admission," dated 07/2022, the P&P indicated, "The 'Conditions of Admission' form is to be signed by the patient or their legal representative at the time of admission or at the earliest possible opportunity after the patient arrives at the Hospital. The form is to be dated and timed with the date the form was signed not the date and time of admission. If the form cannot be signed at the time of admission, the medical record should reflect documentation as to why a signature could not be obtained. Subsequent attempts to obtain a signature should also be completed and documented in the record...At the time of admission a hospital representative such as an RN, Unit Clerks, or Admissions staff will present the form to patient and/or patient's legal representative/surrogate decision maker for signature."

During a review of the facility's policy and procedure (P&P) titled, "Utilization Management Plan," dated 09/2024, the P&P indicated, "Case managers are responsible for presenting an Important Message from Medicare (IMM) to the patient and or patient twice during the hospital stay ..."

2. During a review of Patient 26's "History and Physical (H&P)," dated 8/9/2024, the H&P indicated Patient 26 was admitted to the facility on 8/8/2024, for respiratory failure (serious lung condition that causes difficulty breathing) and aspiration pneumonia (lung infection caused by inhaling food, liquids or other materials).

The H&P also indicated Patient 26 was a functional quadriplegia (individual has no brain or spinal cord injury but is completely unable to move). Patient 26's neurologic (relating to the nervous system which includes the brain, the spinal cord, and the nerves) exam indicated he (Patient 26) was alert and oriented to self, place and time.

During a concurrent interview and record review on 10/16/2024 at 10:55 a.m. with Registered Nurse 5 (RN 5), RN 5 stated Patient 26's "Social Worker Consultation Note," dated 8/12/2024, indicated Patient 26's family member was designated as a surrogate decision maker.

During a concurrent interview and record review on 10/17/2024 at 9:55 a.m., with the Clinical Nurse Director (CND), the CND verified Patient 26's record had no documentation that the COA and IMM Letter was given to the patient and/or the patient's representative upon admission.

During an interview on 10/17/2024 at 3:43 p.m., with Wound Care Specialist 1 (WCS 1), WCS 1 stated she was familiar with the process regarding COA and IMM. WCS 1 stated the COA and IMM Letter should be given to the patient and signed on the day of admission or the day after. WCS 1 stated there should be documentation of an attempt to have the documentation (COA and IMM letter) signed.

During a concurrent interview and record review on 10/18/2024 at 8:57 a.m. with WCS 1, WCS 1 verified Patient 26's record had no documentation that an attempt was made to provide a copy of the COA and IMM letter to Patient 26 and/or the patient's representative.

During a review of the facility's policy and procedure (P&P) titled, "Conditions of Admission," dated 07/2022, the P&P indicated, "The 'Conditions of Admission' form is to be signed by the patient or their legal representative at the time of admission or at the earliest possible opportunity after the patient arrives at the Hospital. The form is to be dated and timed with the date the form was signed not the date and time of admission. If the form cannot be signed at the time of admission, the medical record should reflect documentation as to why a signature could not be obtained. Subsequent attempts to obtain a signature should also be completed and documented in the record...At the time of admission a hospital representative such as an RN, Unit Clerks, or Admissions staff will present the form to patient and/or patient's legal representative/surrogate decision maker for signature."

During a review of the facility's policy and procedure (P&P) titled, "Utilization Management Plan," dated 09/2024, the P&P indicated, "Case managers are responsible for presenting an Important Message from Medicare (IMM) to the patient and or patient twice during the hospital stay ..."


3. During a review of Patient 27's "History and Physical (H&P)," dated 8/30/2024, the H&P indicated, Patient 27 was admitted for respiratory failure (serious lung condition that causes difficulty breathing) and ventilator (a medical device to help support or replace breathing) weaning (decrease amount of assistance from the breathing machine). The H&P further indicated Patient 27 was awake, alert, and had periods of confusion.

During a review of Patient 27's "Facesheet (front page of the chart that contains a summary of basic information about the patient)," the record indicated Patient 27 had two emergency contacts listed.

During a concurrent interview and record review on 10/17/2024 at 9:55 a.m. with the Clinical Nurse Director (CND), the CND verified Patient 27's record had no documentation that a copy of the COA and the IMM Letter were provided to Patient 27 and/or the patient's representative.

During an interview on 10/17/2024 at 3:43 p.m. with Wound Care Specialist 1 (WCS 1), WCS 1 stated she was familiar with the process regarding COA and IMM. WCS 1 stated the COA and the IMM Letter should be given to the patient and signed on the day of admission or the day after. WCS 1 stated there should be documentation of an attempt to have the documentation signed.

During a concurrent interview and record review on 10/18/2024 at 8:57 a.m. with WCS 1, WCS 1 verified Patient 27's record had no documentation that an attempt was made to provide a copy of the COA and IMM letter to Patient 27 and/or the patient's representative.

During a review of the facility's policy and procedure (P&P) titled, "Conditions of Admission," dated 07/2022, the P&P indicated, "The 'Conditions of Admission' form is to be signed by the patient or their legal representative at the time of admission or at the earliest possible opportunity after the patient arrives at the Hospital. The form is to be dated and timed with the date the form was signed not the date and time of admission. If the form cannot be signed at the time of admission, the medical record should reflect documentation as to why a signature could not be obtained. Subsequent attempts to obtain a signature should also be completed and documented in the record...At the time of admission a hospital representative such as an RN, Unit Clerks, or Admissions staff will present the form to patient and/or patient's legal representative/surrogate decision maker for signature."

During a review of the facility's policy and procedure (P&P) titled, "Utilization Management Plan," dated 09/2024, the P&P indicated, "Case managers are responsible for presenting an Important Message from Medicare (IMM) to the patient and or patient twice during the hospital stay ..."


4. During a review of Patient 29's "History and Physical (H&P)," dated 10/5/2024, the H&P indicated Patient 29 was admitted on 10/4/2024 for respiratory failure (serious lung condition that causes difficulty breathing). The H&P also indicated Patient 29 had a history of Parkinson's Disease (a progressive disease of the nervous system marked by tremor, muscular rigidity, and slow, imprecise movements), cerebrovascular accident (stroke, loss of blood flow to a part of the brain), and high blood pressure (BP, amount of force blood uses to move through the body).

During a concurrent interview and record review on 10/16/2024 at 2:35 p.m. with Registered Nurse 5 (RN 5), RN 5 stated Patient 29's "Electronic Medical Record (EMR, digital version of the paper chart)," indicated Patient 29's family member was listed as the Durable Power of Attorney (DPOA, a legal document that gives someone the right to make decisions for someone else).

During an interview on 10/17/2024 at 3:43 p.m. with Wound Care Specialist 1 (WCS 1), WCS 1 stated she was familiar with the process regarding IMM Letters. The WCS 1 stated the IMM Letter should be given to the patient and signed on the day of admission or the day after. WCS 1 stated there should be documentation of an attempt to have the documentation signed.

During a concurrent interview and record review on 10/18/2024 at 8:57 a.m. with WCS 1, WCS 1 verified Patient 29's record had no documentation that an attempt was made to provide a copy of the IMM letter to Patient 29 and/or the patient's representative.

During a review of the facility's policy and procedure (P&P) titled, "Conditions of Admission," dated 07/2022, the P&P indicated, "The 'Conditions of Admission' form is to be signed by the patient or their legal representative at the time of admission or at the earliest possible opportunity after the patient arrives at the Hospital. The form is to be dated and timed with the date the form was signed not the date and time of admission. If the form cannot be signed at the time of admission, the medical record should reflect documentation as to why a signature could not be obtained. Subsequent attempts to obtain a signature should also be completed and documented in the record...At the time of admission a hospital representative such as an RN, Unit Clerks, or Admissions staff will present the form to patient and/or patient's legal representative/surrogate decision maker for signature."

During a review of the facility's policy and procedure (P&P) titled, "Utilization Management Plan," dated 09/2024, the P&P indicated, "Case managers are responsible for presenting an Important Message from Medicare (IMM) to the patient and or patient twice during the hospital stay ..."

Based on observation, interview and record review, the facility failed to identify one of 30 sampled patient's (Patient 1) abnormal heart rhythm and loss of oxygen saturation (measures the amount of oxygen in the blood) reading and notify the Registered Nurse (RN) or the Respiratory Care Practitioner (RCP) in a timely manner, in accordance with the facility's policy and procedure regarding Telemetry monitoring (a technique that allows healthcare providers to continuously track a patient's heart rhythm and electrical activity).

This deficient practice resulted in a delay in life-saving measures such as CPR (cardiopulmonary resuscitation- an emergency life-saving procedure performed when the heart stops beating), which may have contributed to Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells).

On 10/17/2024 12:47 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has 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), Chief Nursing Officer (CNO), Assistant Chief Nursing Officer (ACNO), Clinical Nurse Director (CND), Director of Respiratory and Rehab Services (DRRS), and Clinical Educator and Staff Development Coordinator (CESD).

The facility was informed that they failed to identify Patient 1's abnormal heart rhythm and loss of oxygen saturation reading (measures the amount of oxygen in the blood) and notify the Registered Nurse (RN)/Respiratory Care Practitioner (RCP), which resulted in a delay in addressing Patient 1's change of condition and implementation of medical emergency response that led to Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells).

On 10/18/2024 at 5:45 p.m., in the presence of the CNO, the facility submitted an Immediate Jeopardy Removal Plan (IJRP, interventions to correct the deficient practice). The IJRP included the following:

1. Immediate implementation of a Monitor Tech (MT) Audit Tool to assess the competency and performance of monitor technicians responsible for cardiac monitoring and rhythm interpretation at the main ICU (Intensive Care unit- responsible for the provision of care to critically ill patients) telemetry monitor (a device that tracks a patient's heart rhythm and electrical activity) station on a shift-to-shift basis. The MT is overseen by the Charge Nurse who makes rounds to the main ICU telemetry monitoring station every two hours with a checklist identifying that no unusual activity is found with the telemetry strips (a recording of the patient's heart's electrical activity). The audit tool will be reviewed daily by the Clinical Director/Clinical Supervisor. The Audit Tool will assess the following: Heart rate alarms at the Central Monitoring Station in the ICU are set appropriately to the patient's baseline heart rate, rhythm, clinical condition, treatment plan, and per physician orders. The default heart rate alarm settings are 50-120. If a monitor alarm (e.g., Inoperative, "LEAD OFF," LOW SpO2 [oxygen saturation- measures the amount of oxygen in the blood] 90 percent, SpO2 not measurable, lethal arrhythmia [abnormal heart rhythm], etc.) occurs, the patient must be checked immediately. The clinical staff must assess the patient for the level of consciousness (a person's awareness and understanding of their surroundings), palpable pulses (the sensation of blood flowing through an artery that can be felt by pressing on it with the fingertips), blood pressure, capillary refill (assesses circulatory system functioning), skin temperature, etc. The MT communicates with the RN/Respiratory Care Practitioner (RCP) when the above occurs through the following mechanisms:

" Calling the nurses station and relaying the message to the unit secretary or charge nurse that telemetry monitor indicates a need to review patient status and follow-up. The unit secretary or charge nurse sends the RN/RCP into the patient's room and notifies the MT that someone is checking the patient. If no one is available at the nurse's station MT/Unit Clerk Assistant (UCA) will do overhead paging.

" Overhead paging for immediate response by nursing or respiratory to attend to patient by stating "Please check Pulse Ox (Pulse oximeter- device that measures the amount of oxygen in the blood) in room XXX" or "Please check leads off in Room XXX". The MT reviews the monitor and notices that the monitor issues have been resolved and/or RN/RCP notifies the MT that they are at the patient bedside addressing the problem. If there is an indication on the monitor that the issue is not resolved or there is no response within 2 minutes from the clinical staff to the MT alert, the MT is to activate an RRT (Rapid Response Team- a group of healthcare professionals trained to provide immediate care to patients who are becoming unstable or critically ill)/Code Blue (a hospital emergency code that indicates a patient is in critical condition and requires immediate medical attention).


2. Immediate implementation of an in-service of all [facility] clinical staff to all changes and to respond immediately when the MT alerts them to check on a patient and that when a patient is found unresponsive and pulseless (absence of a heartbeat) that chest compressions (to push down hard and fast in a specific way on a person's chest) are to be started immediately without delay following the American Heart Association (AHA) guidelines until all clinical staff have been educated. These guidelines include the following: Staff who find a patient unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) will shout "Are you OK" then check the pulse; Shout for help or activate the Code Blue button located inside the room; Once pulselessness is established, begin chest compression immediately; The crash cart (a cart stocked with emergency medical equipment [oxygen tank, etc.], drugs, and devices used in a medical emergency) is brought into the room, the defibrillator pads are applied to the patient to determine if the patient has a shockable rhythm (an irregular heart rhythm that can be corrected by an electric shock from a defibrillator [device that restores normal heart rhythm]).

3. Immediate implementation of re-training of all MT staff to ensure that all monitor techs are fully trained on equipment, alarms and emergency protocols. Ongoing competency assessment will be implemented to evaluate the effectiveness of the training program. Training program includes the following: Overview of the role of the MT including an overview of the responsibilities and scope of practice of monitor techs and understanding of the importance of continuous cardiac monitoring in patient care; Rhythm recognition; Rhythm strip interpretation practice and written test; Alarm management for cardiac and SpO2; Emergency response policy including RRT or Code Blue activation and Closed loop communication (a method of communication that includes confirming that a message was received and understood correctly); Documentation and reporting including accurate documentation of the Call Log and Shift hand¿off communication (a basic health care practice designed to provide continuity of care from one healthcare team to another); Case studies (involves an in-depth examination of a patient's situation to improve patient outcomes and the quality of care) and simulation training (a training method that involves realistic, immersive replications of work processes, scenarios and tools); Proper functioning of central monitoring equipment including failure of equipment response.

4. Immediate update to the Code Blue Evaluation Form and Code Blue Record to include timeliness that staff responded to a call from the MT immediately and that chest compressions began immediately following the establishment of pulselessness. Review of these documents by the Clinical Director/Clinical Supervisor.

5. Immediate implementation of more frequent mock codes (a simulation exercise that helps medical professionals learn how to respond to a critically ill patient) monthly to validate competency of staff involved in the code blue process.

On 10/18/2024 at 8:26 p.m., in the presence of the CEO, CNO, CND, ACNO, Medical Director (MD), CESD, Wound Care Specialist (WCS 1), Director of Therapy and Rehab Services (DTRS), and Infection Control Preventionist (ICP), the facility was informed that the elements of the IJ Removal Plan cannot be verified and confirmed through observations, interviews, and record reviews. The facility was unable to demonstrate staff could appropriately respond to a code blue emergency without delay. During staff interviews, multiple staff stated they would verify code status in the patient's chart or with the patient's primary nurse, prior to performing CPR, when a patient was found unresponsive, not breathing, and pulseless. The facility was placed on a 23-day fast track (a process that places a hospital or other provider on a termination track if deficiencies are found that pose an immediate jeopardy to patient health and safety).

On 10/28/2024, an onsite visit was conducted to verify the implementation of the facility's IJ Removal Plan. The surveyor was able to verify implementation of the IJRP through observation, interview, and record review. The IJ was removed on 10/28/2024 at 11:25 a.m. in the presence of the facility's Chief Nursing Officer, the Clinical Educator, and the Wound Care Specialist.

Findings:

During a review of Patient 1's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 3/1/2024 at 7:38 p.m., the H&P indicated Patient 1 who had diagnoses including but not limited to non-ST-elevation myocardial infarction (NSTEMI, a type of heart attack that occurs when the heart's need for oxygen can't be met), and respiratory failure (a medical condition in which the lungs are not working properly and oxygen blood levels are too low) requiring mechanical ventilation (a life-support technique that helps someone breathe when they are unable to do so on their own) status post tracheostomy (a surgically created hole in the throat that provides an alternative airway for breathing), presented to the facility on 2/29/2024 at 8:05 p.m.

During a review of Patient 1's Physician's Orders (a written set of instructions from a doctor that medical staff must follow), dated 2/29/2024, the orders indicated the following: Patient 1 had orders for continuous pulse oximeter (noninvasive test that measures the amount of oxygen in a person's blood) and telemetry monitoring (a device that allows healthcare providers to continuously track a patient's heart rhythm and electrical activity).

During a review of Patient 1's "Electroencephalogram (EEG, a test or record of brain activity)," dated 3/8/2024, the EEG indicated the following: " ...3/8/2024 ...Procedure performed: STAT (immediately) Electroencephalogram evaluate for anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells) ... Impression ... severe metabolic encephalopathy (any brain disease, disorder, or damage that affects the brain's structure or function), clinical correlation (relationship between clinical findings and the underlying pathological [physical or mental] processes in a patient) advised ..."

During an observation and interview on 10/15/2024 at 1:48 p.m. with the Monitor Technician 1 (MT 1), the following was observed: There were 3 monitors in the Intensive Care Unit (a hospital ward that provides specialized care and monitoring for patients with life-threatening injuries or illnesses) with telemetry monitoring for patients. There was a corresponding "Telemetry/Oximetry Call Log (a record of events that include a timestamp and explanation of events)," with a date of 10/15/2024 used by MT 1.

During the same interview on 10/15/2024 at 1:48 p.m., the MT 1 stated the following: It is the responsibility of the Monitor Technician to continuously monitor all patients on telemetry. If the pulse oximeter is not reading or reading less than 90%, or the heart rhythm is abnormal, there is an audible alarm and visual cue on the telemetry monitor. If the pulse oximeter is not reading or the heart rhythm is abnormal (not in sinus rhythm), there should be a call to notify the staff at the nurse's station on the floor so a nurse can check on the patient. Any significant events, including Rapid response Team (RRT, a team of healthcare professionals that identify and respond to patients with early signs of clinical deterioration) and code blue (a medical emergency, usually cardiac or respiratory arrest), require a phone call to notify staff and must be logged on the "Telemetry/Oximetry Call Log". The log includes the following: patient and room number, reason for call, name of caller, time called, info given, and action taken.

During a concurrent interview and record review on 10/16/2024 at 11:30 a.m. with the Clinical Nurse Director (CND), the CND verified Patient 1's telemetry strips, dated 3/8/2024, indicated the following: On 3/8/2024 from 2:30 a.m. through 2:45 a.m., Patient 1 had an abnormal paced heart rhythm (an electrocardiogram finding where an artificial cardiac pacemaker control's the heart's rhythm with an electrical impulse).

During the same interview on 10/16/2024 at 11;30 a.m., the CND stated the following: Patient 1 was on the telemetry monitor. The telemetry strips show the QRS (represents the electrical impulse spreading through the ventricles [the two lower chambers of the heart] of the heart) was abnormal when Patient 1 was pacing. When a pulse (indicates a heartbeat) was checked by staff (CN 1) at 2:43 a.m., Patient 1 was pulseless (absence of a heartbeat). Due to the abnormal heart rhythm on the telemetry strips and lack of pulse, it was determined Patient 1 was in PEA (Pulseless Electrical Activity- a life-threatening heart rhythm that occurs when the heart stops beating despite electrical activity) for approximately 13-16 minutes. There was electrical activity on the telemetry monitor, but Patient 1 did not have a pulse.

During a concurrent interview and record review on 10/16/2024 at 4:24 p.m. with the Chief Nursing Officer (CNO) and the Clinical Nurse Director (CND), the CND stated the following: On 3/8/2024 at approximately 2:43 a.m., Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and an RRT was initiated, followed by a code blue at 2:45 a.m. Patient 1 suffered pulseless electrical activity (PEA) and coded (when someone requires an immediate life-saving measure).

During the same interview on 10/16/2024 at 4:24 p.m., the CND stated, upon review, it was noted that there were irregularities with the telemetry call log. Patient 1's pulse oximeter was unreadable, and Patient 1 had an abnormal heart rhythm for 13 minutes before Patient 1 was checked by staff (CN 1). The CNO and CND verified the following: The "Telemetry/Oximetry Call Log" did not have any logged notifications from MT 2 to staff for Patient 1, from 2:30 a.m. until 2:43 a.m. on 3/8/2024, when the RRT was called. The next entry on the telemetry log for Patient 1 was on 3/8/2024 at 2:45 a.m. for the code blue. There were only two entries on 3/8/2024 for Patient 1 on the telemetry log.

During the same interview and record review on 10/16/2024 at 4:24 p.m., the CND also stated the following: The MT 2 was supposed to call staff immediately when Patient 1's pulse oximetry monitor was unreadable, and heart rhythm was abnormal. MT 2 did not notify staff that Patient 1's pulse oximeter was unreadable and Patient 1's heart rhythm was abnormal. There should have been continuous telemetry monitoring of Patient 1 by MT 2. Because Patient 1 was not monitored appropriately by MT 2, this caused a delay in care for Patient 1. It is important for the monitor technician (a healthcare professional who monitors and analyzes a patient's heart activity and other vital signs) to call and notify staff immediately when there is an event on the telemetry monitor (a device that tracks a patient's pulse oximetry, heart rate, heart rhythm and electrical activity while they are in the hospital) to ensure patient safety and to prevent adverse events (an undesirable or harmful outcome).

During an interview on 10/16/2024 at 5:33 p.m. with the Respiratory Care Practitioner 1 (RCP 1), RCP 1 stated the following: On 3/8/2024, he (RCP 1) was in the hallway on Medical Surgical Unit 1 (Unit 1) and was notified by CN 1 to check on Patient 1. CN 1 asked him (RCP 1) "Can you look at this patient?" and CN 1 stated Patient 1 was unresponsive. When he (RCP 1) responded to Patient 1's room, Patient 1 was unresponsive and not breathing. He (RCP 1) immediately initiated bagging Patient 1 with a bag and mask (a device that helps someone breath when not breathing on own). He (RCP 1) does not remember hearing a RRT or Code Blue called overhead, while in the room. No staff was providing chest compressions to Patient 1 when he (RCP 1) entered Patient 1's room.

During an interview on 10/16/2024 at 5:59 p.m. with CN 1, CN 1 stated the following: She (CN 1) was rounding on patients in the early morning on 3/8/2024, when she (CN 1) noticed Patient 1 was not as active that she (Patient 1) normally was. Patient 1 was pale and there was no chest rise and fall. She (CN 1) called RCP 1 into the room from the doorway. RCP 1 started bagging the patient. CN 1 checked Patient 1's pulse, determined there was no pulse, but did not begin chest compressions at this time. She (CN 1) called an RRT and checked a pulse. She (CN 1) called a code blue and stayed with Patient 1. Chest compressions were performed by another Respiratory Care Practitioner (not RCP 1), whom she (CN 1) does not remember the name. CN 1 did not perform chest compressions on Patient 1 during the code blue. Patient 1's pulse oximetry probe was attached to her (Patient 1's) finger. When a Patient is found pulseless, CPR should have been initiated right away so there was no delay. There are better outcomes if CPR is initiated immediately.

During an interview on 10/16/2024 at 6:39 p.m. with Registered Nurse 2 (RN 2), RN 2 stated the following: As an ICU nurse (RN 2), was a part of the code blue team on 3/8/2024. He (RN 2) was sitting next to MT 2 in the Intensive Care Unit (Unit 3). He (RN 2) looked at the telemetry monitors and noticed Patient 1's pulse oximeter was not reading, Patient 1 was pacing, and he (RN 2) was not sure for how long. There should have been a number reading on the pulse oximeter, and there was none. He (RN 2) did not hear an audible alarm indicating Patient 1 was off the monitor or had an arrythmia (abnormal heart rhythm). Unless the alarm is silenced, you would hear an alarm. A code blue was called, and he (RN 2) responded. If the pulse ox is off or an arrythmia, there should be a call from the MT to the unit nurse's station to notify staff.

During an interview on 10/16/2024 at 7:05 p.m. with Registered Nurse 1 (RN 1), RN 1 stated the following: She (RN 1) was the primary nurse for Patient 1 on 3/8/2024. She (RN 1) was at the nurse's station and CN 1 was checking on patients. CN 1 came back to the nurse's station because something was not right with Patient 1 and stated to call a RRT. Patient 1's room was near the end of the hallway in comparison to the nurse's station. MT 2 did not call the nurse's station prior to the RRT. If a patient is unresponsive, the patient's breathing and a pulse should be checked immediately.

During an interview and record review on 10/17/2024 at 8:30 a.m. with the CNO, the CNO verified the following information on Patient 1's "Code Blue Record:" Manual ventilation begun at 2:43 a.m. and CPR (compressions) started at 2:45 a.m. The CNO acknowledged mechanical ventilation started 2 minutes before compressions were started on Patient 1 and that this was a delay in the care. The CNO stated the following: Clinical staff who work at the bedside are required to have Basic Life Support (BLS) training. Staff required to have BLS are Charge Nurses (CN), Registered Nurses (RN), Certified Nursing Assistants (CNA) and Respiratory Care Practitioners (RCP). If a staff is the first person to find a patient unresponsive, they should follow American Heart Association BLS guidelines and check a pulse then breathing. If a patient is unresponsive, not breathing, and pulseless, the staff who found the patient should stay with the patient and start CPR with compressions first. The staff should call for help immediately using the code blue button in the patient's room.

During an interview and record review on 10/18/2024 at 10:10 a.m. with the Medical Director (MDR) and the Medical Doctor 1 (MD 1), the MD 1 stated the following: He (MD 1) was consulted to see Patient 1 for Neurology (a medical specialty that studies and treats disorders of the nervous system [includes the brain and spine]). Patient 1 suffered a cardiac arrest (when the heart stops beating) and had brain encephalopathy (brain dysfunction or damage) from the anoxia (an absence of oxygen reaching the tissues). If there is anoxia, the brain cells get damaged or die. Due to the cardiac arrest, Patient 1 was cognitively (anything related to thinking, learning, and understanding) impaired, not moving or waking up. He (MD 2) diagnosed Patient 1 with an anoxic brain injury based on clinical presentation. She (Patient 1) did not improve neurologically during her stay in the ICU.

During a review of a document provided by the facility titled, "Basic Life Support (BLS) Reference," dated 10/2020, the document indicated the following: "Compressions, Airway, Breathing (C-A-B); Critical Concepts: High-quality CPR improves a victim's chances of survival. The critical characteristics of high-quality CPR include the following: Start compressions within 10 seconds after recognizing cardiac arrest ... Adult BLS Algorithm (a set of instructions that are followed in order to complete a task) for Healthcare Providers: verify scene safety, check responsiveness, shout for help, activate emergency response system via mobile device (if appropriate), Get AED (Automated External Defibrillator- a medical device that can help people experiencing sudden cardiac arrest by analyzing the heart's rhythm and delivering an electric shock to the heart) and emergency equipment (or send someone to do so); Look for no breathing or only gasping and check pulse (simultaneously.), Is pulse definitely felt within 10 seconds; no breathing or only gasping, pulse not felt; Start CPR: perform cycles of 30 compressions and 2 breaths, use AED as soon as it is available ..."

During a review of the facility's policy and procedure (P&P) titled, "Code Blue," dated 6/2022, the P&P indicated the following: " ...Definitions: ...A Code Blue may be called for any patients with an absent pulse, apnea (when breathing stops or becomes very shallow), agonal breathing (irregular, labored breathing that can sound like gasping, snorting, or moaning), or life-threatening arrythmias ... 1. Any staff who finds a person in cardiopulmonary arrest will initiate a Code Blue. This person must stay with the victim and summon help by whatever means are available ..."

During a review of the facility's policy and procedure (P&P) titled, "Telemetry Monitoring," dated 6/2019, the P&P indicated the following: " ...Communication: the central monitoring monitor technician (MT, a healthcare professional who monitors and analyzes a patient's heart activity and other vital signs) will communicate with the bedside nurse/ respiratory therapist immediately when: an acceptable ECG tracing or SpO2 (Oxygen saturation) reading is not observed ... A change from the patient's baseline occurs. i. Potential life-threatening arrhythmias occurs. ii. Non-life threatening rhythms/rates occur that are a significant change from the previous monitoring signals ... if MT does not receive any response from the staff or the problem continues to exist, he/she may elect to activate RRT or Code Blue ... anyone receiving the call from MT needs to ensure that the responsible staff member gets notified. All the assigned staff (nursing, unit clerk monitor technician, respiratory technician) are expected to respond to patients' needs ...Documentation: MT documents each patient call to the Call Log (see attachment C) including the response and resolution times ..."

Based on interview and record review, the facility failed to analyze and track an adverse event (a harmful or negative outcome) and also failed to formulate and implement a corrective action plan or preventive action, when the facility did not identify a delay in Cardiopulmonary Resuscitation (CPR, an emergency lifesaving procedure performed when the heart stops beating), when Patient 1 was found to be unresponsive, pulseless, and not breathing which resulted in Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells), and implement a corrective action plan for follow-ups.

This deficient practice had the potential for staff's inability to respond appropriately during a medical emergency such as in cases of patients who may be pulseless or not breathing, which may result in patient harm (such as brain damage) and/or death.

Findings:

During a review of Patient 1's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 3/1/2024 at 7:38 p.m., the H&P indicated Patient 1 who had diagnoses including but not limited to non-ST-elevation myocardial infarction (NSTEMI, a type of heart attack that occurs when the heart's need for oxygen can't be met), and respiratory failure (a medical condition in which the lungs are not working properly and oxygen blood levels are too low) requiring mechanical ventilation (a life-support technique that helps someone breathe when they are unable to do so on their own) status post tracheostomy (a surgically created hole in the throat that provides an alternative airway for breathing), presented to the facility on 2/29/2024 at 8:05 p.m.

During a concurrent interview and record review on 10/16/2024 at 11:30 a.m. with the Clinical Nurse Director (CND), the CND verified Patient 1's telemetry strips (a recording of the patient's heart's electrical activity), dated 3/8/2024, indicated the following: On 3/8/2024 from 2:30 a.m. through 2:45 a.m., Patient 1 had an abnormal paced heart rhythm (an electrocardiogram finding where an artificial cardiac pacemaker control's the heart's rhythm with an electrical impulse).

During the same interview on 10/16/2024 at 11:30 a.m., the CND stated the following: Patient 1 was on the telemetry monitor (a device that tracks a patient's heart rhythm and electrical activity). When a pulse (indicates a heartbeat) was checked by staff (CN 1) at 2:43 a.m., Patient 1 was pulseless (absence of a heartbeat). Due to the abnormal heart rhythm on the telemetry strips and lack of pulse, it was determined Patient 1 was in PEA (Pulseless Electrical Activity- a life-threatening heart rhythm that occurs when the heart stops beating despite electrical activity) for approximately 13-16 minutes. There was electrical activity on the telemetry monitor, but Patient 1 did not have a pulse.

During a concurrent interview and record review on 10/16/2024 at 4:24 p.m. with the Chief Nursing Officer (CNO) and the Clinical Nurse Director (CND), the CND stated the following: On 3/8/2024 at approximately 2:43 a.m., Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and a RRT (Rapid Response Team- a group of healthcare professionals trained to provide immediate care to patients who are becoming unstable or critically ill) was initiated, followed by a code blue (a hospital emergency code that indicates a patient is in critical condition and requires immediate medical attention) at 2:45 a.m. Patient 1 suffered pulseless electrical activity (PEA) and coded (when someone requires an immediate life-saving measure).

During the same interview on 10/16/2024 at 4:24 p.m., the CNO stated the following: Clinical staff who work at the bedside were required to have Basic Life Support (BLS, a set of medical procedures that are used to help patients experiencing medical emergencies) training. Staff required to have BLS were Charge Nurses (CN), Registered Nurses (RN), Certified Nursing Assistants (CNA) and Respiratory Care Practitioners (RCP). If a staff was the first person to find a patient unresponsive, they should follow the American Heart Association BLS guidelines and check for a pulse and breathing. If a patient was unresponsive, not breathing, and pulseless, the staff who found the patient should stay with the patient and start CPR (Cardiopulmonary Resuscitation, an emergency lifesaving procedure performed when the heart stops beating) with compressions first.

During an interview and record review on 10/17/2024 at 8:30 a.m. with the CNO, the CNO verified the following information on Patient 1's "Code Blue Record:" Manual ventilation begun at 2:43 a.m. and CPR (compressions) started at 2:45 a.m. The CNO acknowledged mechanical ventilation started 2 minutes before compressions were started on Patient 1 and that this was a delay in the care.

During the same interview on 10/17/2024 at 8:30 a.m., the CNO stated that a Root Cause Analysis (RCA, the process of discovering the root causes of problems in order to identify appropriate solutions) was performed after Patient 1's sentinel event (a patient safety incident that results in death, severe or permanent harm, or requires intervention to sustain life), but it was not identified during the RCA that there was a delay in CPR to Patient 1. The CNO further stated that the facility did not have a Root Cause Analysis policy as indicated in the "Event/Occurrence Reported" facility policy.

During an interview on 10/18/2024 at 8:26 p.m. with the CNO, the CND, the Associate Chief Nursing Officer (ACNO), the Chief Executive Officer (CEO), the Medical Director (MDR), Clinical Educator and Staff Development Coordinator (CESD), Wound Care Specialist 1 (WCS 1), and the Director of Respiratory Therapy and Rehab Services (DTRS), the CEO state the following: A Root Cause Analysis (RCA, the process of discovering the root causes of problems in order to identify appropriate solutions) was performed with any adverse or sentinel event. Patient 1's event on 3/8/2024 was identified as a sentinel event (a patient safety incident that results in death, severe or permanent harm, or requires intervention to sustain life). Quality Assurance & Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital program) was responsible for the quality of care. The purpose of QAPI was to identify facility failures related to patient safety issues. QAPI must address how to maintain patient safety. QAPI oversees the RCA process.

The CNO stated the following: The RCA was started on 3/11/2024 and ended 3-4 weeks later.

The MDR stated the following: All adverse and sentinel events were reported to QAPI, and RCA findings are also reported to QAPI. The RCA did not identify there was a delay by facility staff providing CPR to Patient 1. This delay was not reported to QAPI. The MDR acknowledged no actions were taken by QAPI, such as implementation of an action plan (the plan outlines the specific steps to be taken to address the identified problem) and follow-up, because the delay was not identified during the RCA.

The ACNO stated the following: It was important to identify the delay in CPR to Patient 1 to start chest compressions immediately and improve patient outcomes.

During a review of the document provided by the facility titled, "Code Blue Evaluation," dated 3/8/2024, the document indicated the following: Code blue evaluation for Patient 1 ...; Time Response and BLS/ACLS (Advanced Cardiac Life Support- a set of clinical guidelines for the urgent and emergent treatment of life-threatening conditions) Performance: ...4. CPR: Met ...; Procedure conducted per protocol: Yes; Recommendations: None ..."

During a review of the document provided by the facility on 10/18/2024 at 5:55 p.m., untitled, no date, the document indicated the following: " ...An Action Plan shall be issued upon completion of the Root Cause Analysis. The Action Plan must: 1. Identify changes that can be implemented to reduce risk or formulate a rationale for not undertaking changes. Identify at least on stronger or intermediate strength action for each root cause identified. 2. Where improvement actions are planned, identify who is responsible for implementation, when the action will be implemented, including any pilot testing, and how and by whom the effectiveness of the action will be evaluated. 3. Monitor the effectiveness of the intervention implemented to assure they are effective and sustained ..."

During a review of the facility's "Organizational Performance Improvement Plan (a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital)," dated 2/2024, the plan indicated the following: "The purpose of the Organizational Performance Improvement Plan is to promote a culture of safety and provide a systematic, coordinated and continuous approach for creating and maintaining focus on reliable process and best clinical outcome. The plan is structured to ensure that there is measurable improvement in quality indicators with a demonstrated link to improved health outcomes ... Goals and Objectives: ... 3. Collect standardized clinically relevant information about patient safety events and close calls that adversely impacts patients ...; Performance Improvement: ... Specific Evaluation Processes- B. Root Cause Analysis (RCA)- A root cause analysis (RCA) is one of the most universally used set of steps during the investigation of an adverse event and is often used to identify performance issues, related causes and needed improvements. The RCA's strength, when done correctly, leads to the identification of the primary cause of the problem and related secondary causes ... (Refer to Performance Improvement (Pl) Policy #7, Root Cause Analysis: Conducting Of) ..."

During a review of the facility's policy and procedure (P&P) titled, "Event/Occurrence Reporting," dated 9/2022, the P&P indicated the following: " ...For possible sentinel events, near-misses or significant occurrences the CEO or CNO will assemble the appropriate team to complete a determination meeting to ascertain if the event is a sentinel event requiring a Root Cause Analysis team to be formed ... Refer to the RCA policy ..."

Based on 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 its antimicrobial stewardship program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance) met monthly, in accordance with the facility's policy and procedure regarding antimicrobial stewardship program, and to report its data to the hospital QAPI (Quality Assurance Performance Improvement, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee and the Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) leadership since 11/2023.

This deficient practice resulted in lack of QAPI oversight over the facility's antimicrobial stewardship program for its performance and compliance since 11/2023. This deficient practice also had the potential to result in increased rates of antibiotic resistance among bacteria, potentially leading to more difficult to treat infections, poorer patient outcomes, and a greater risk of spreading resistant organisms within the hospital due to unnecessary and inappropriate antibiotic usage.

Findings:

During a concurrent interview and record review on 10/18/2024 at 3:47 p.m. with the Director of Pharmacy (DP), the facility's policy and procedure (P&P) titled, "Antimicrobial Stewardship Program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance)," dated 11/2022, was reviewed. The P&P indicated, "the antimicrobial stewardship committee is collaboration between several disciplines as follows: Core Group: Infection Disease Physician, Director of Infection Prevention and Control, Microbiology, and Pharmacy. Additional representatives from nursing administration, respiratory therapy, clinical laboratory, environmental services, and Information Services will attend the monthly meetings as needed ... other quality improvement initiatives will be discussed at the monthly meeting." DP stated the antimicrobial stewardship program (ASP) committee did not meet monthly. DP stated the ASP committee met three to four times a year, at least quarterly.

During an interview on 10/18/2024 at 3:56 p.m. with DP, DP stated the following: The antimicrobial stewardship 2023 first and second quarters (first quarter: January to March, second quarter: April to June) data was last reported to Quality Assurance and Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) on 11/30/2023. The facility's ASP committee used to report to Infection Control/Pharmacy and Therapeutics/ Clinical Nutrition Committee then to QAPI, but it was changed to Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) in 2024.
The antimicrobial stewardship 2024 first and second quarters 2024 data was presented to Infection Control/Pharmacy and Therapeutics/ Clinical Nutrition Committee on 9/26/2024 but not yet presented to facility's MEC this year (2024). Due to various reasons, there was no reporting to QAPI and MEC since 11/2023. She (DP) was planning to report to MEC during December 2024 meeting. It was important to report and share data to QAPI and MEC to ensure there was constant monitoring (monitoring of antibiotic prescribing practices, infection types, antibiotic resistance patterns, etc.) and compliance.

During a concurrent interview and record review on 10/18/2024 at 6:01 p.m. with the Associate Chief Nursing Officer (ACNO), the facility's "Antimicrobial Stewardship Program (ASP) Committee Minutes (ASP minutes, summary of meeting)," dated 11/28/2023 and "Antimicrobial Stewardship Program (ASP) Committee Agenda (ASP agenda, items to be discussed in the meeting)," dated 6/4/2024, were reviewed.
The ASP minutes indicated, the ASP meeting was held on 11/28/2023 and the ASP agenda indicated, the ASP meeting was on 6/4/2024. ACNO stated that was all the ASP meetings minutes/ agenda from November 20023 to date (2 meetings total) given to her (ACNO) by DP. ACNO stated there was no ASP meeting minutes for 6/4/2024 ASP meeting.

During an interview on 10/18/2024 at 8:51 p.m. with the Medical Director (MDR), MDR stated any highlight from the facility's Quality Forum (Facility's QAPI meeting) would be brought to MEC, after that he (MDR) would report any highlight to the board of directors.
During an interview on 10/18/2024 at 8:52 p.m. with the CEO, CEO stated the governing body (responsible for guiding the hospital's long-term goals and policies and assists with strategic planning and decision-making) was ultimately responsible for the facility's overall performance and to provide oversight for everything.

During a review of the facility's "Minutes of [the facility] Board of Directors (meeting minutes)," dated 12/14/2023, 3/14/2024, and 6/20/2024, the meeting minutes did not indicate any reporting or discussion regarding the facility's antimicrobial steward program.

During a review of the facility's policy and procedure (P&P) titled, "Antimicrobial Stewardship Program (ASP)," dated 11/2022, the P&P indicated, "to optimize the use of antimicrobial agents in order to improve patient outcomes, minimize toxicity, decrease the potential emergency of antimicrobial resistance, and provide cost effective, quality care ... ASP activities are routinely reported to the hospital quality improvement committees."

During a review of the facility's policy and procedure (P&P) titled, "Organizational Performance Improvement Plan," dated 2/2024, the P&P indicated, "the purpose of the organizational performance improvement plan is to promote a culture safety and provide a systemic, coordinated and continuous approach for creating and maintaining focus on reliable process and best clinical outcome ... Medical Executive Committee as a representative of the medical staff, makes key leadership decisions related to medical staff policies, procedures, and rules with an emphasis on patient safety and quality improvement initiatives ... managers oversee programs, services ... are responsible for implementing and maintaining a system for continuous improvement, measurement activities and reporting for their areas of accountability. Selected results of quality measures activities and analyses are presented in Quality Forum per reporting calendar, and at designated clinical committees .... The Quality Forum Committee is responsible for implementing the objectives of the organization wide performance improvement and patient safety program. Department Reports to Quality Forum: Pharmacy ...Infection Prevention."

During a review of the facility's governing body bylaws (GB bylaws) titled, "Amended and Restated Bylaws of [the facility]," dated 8/2017, the GB bylaws indicated, "the Board responsibility for patient care. The Board will require an organization-wide process with specific review and evaluation policies to assess, preserve, and improve the overall quality and effectiveness of patient care and safe delivery of care given by staff, including Medical Staff in the hospital, consistent with the scope of services provided. The Board will manage and oversee the establishment of organizational expectations for improving patient care and safety ... the Board will provide administrative assistance reasonably necessary."

Based on observation, interview and record review, the facility failed to:

1. Initiate Cardiopulmonary Resuscitation (CPR, an emergency lifesaving procedure performed when the heart stops beating) in a timely manner, per policy and procedure regarding BLS (Basic Life Support- a set of medical procedures that are used to help patients experiencing medical emergencies), for one of 30 sampled patient (Patient 1), when Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways), pulseless (no heartbeat), and not breathing. This deficient practice resulted in a delay in life-saving measures, which may have contributed to Patient 1's anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells).

2. Ensure nursing staff identify a patient's change in respiratory status (how well a patient is producing air exchange), communicate with the interdisciplinary team (Example: Respiratory Care Practitioner) and report to physician in a timely manner, in accordance with the facility's policy and procedures regarding vital signs (includes the heart rate, respiratory rate, temperature, and blood pressure) clinical monitoring and physician notification, for one of 30 sampled patients (Patient 13) leaving Patient 13's respiratory rate at 39 breaths per minute (normal range 16 to 20 breaths per minute) for 16 hours (from midnight to 4:30 p.m.).

This deficient practice had the potential to delay treatment and care and put Patient 13 at risk for hyperventilation (breathing too quickly) and respiratory distress (difficulty breathing).

3. Ensure for two of 30 sampled patients (Patients 22 and 27), nursing care was provided, in accordance with the facility's policy and procedure regarding patient reassessment post (after) interventions when:

3.a. Patient 22's pain was not reassessed (re-evaluate) after Tylenol (can be used as pain medication), ordered as needed (PRN) for mild pain, was given.

This deficient practice had the potential to cause delayed treatment of Patient 22's pain which may worsen Patient 22's pain and may also result in psychological distress due to inadequately managed pain.

3.b. Patient 27 was not reassessed (reevaluated) after administering Midodrine (medication used for raising blood pressure), ordered as needed (PRN), for SBP (systolic BP, maximum amount of pressure the blood uses to move through the body) less than 100 mmHg (millimeters of mercury, a unit of measure).

This deficient practice had the potential to cause a delay in determining the effectiveness of treatment for Patient 27 and/or a delay the provision of necessary intervention/adjustment in treatment if the previous intervention was ineffective.

3.c. Patient 27 was not reassessed after Hydromorphone (narcotic pain medication), ordered PRN for moderate pain, was given.

This deficient practice had the potential to cause delayed treatment of Patient 27's pain which may worsen Patient 27's pain and may also result in psychological distress due to inadequately managed pain.

Findings:

1. During a review of Patient 1's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 3/1/2024 at 7:38 p.m., the H&P indicated Patient 1 who had diagnoses including but not limited to non-ST-elevation myocardial infarction (NSTEMI, a type of heart attack that occurs when the heart's need for oxygen can't be met), and respiratory failure (a medical condition in which the lungs are not working properly and oxygen blood levels are too low) requiring mechanical ventilation (a life-support technique that helps someone breathe when they are unable to do so on their own) status post tracheostomy (a surgically created hole in the throat that provides an alternative airway for breathing), presented to the facility on 2/29/2024 at 8:05 p.m.

During a review of Patient 1's "Electroencephalogram (EEG, a test or record of brain activity)," dated 3/8/2024, the EEG indicated the following: " ...3/8/2024 ...Procedure performed: STAT (immediately) Electroencephalogram evaluate for anoxic brain injury (a complete lack of oxygen to the brain, which results in the death of brain cells) ... Impression ... severe metabolic encephalopathy (any brain disease, disorder, or damage that affects the brain's structure or function), clinical correlation (relationship between clinical findings and the underlying pathological [physical or mental] processes in a patient) advised ..."

During a review of Patient 1's "Shift Note (Code Blue- a hospital emergency code that indicates a patient is in critical condition and requires immediate medical attention))," dated 3/8/2024, the code blue note documented by Registered Nurse 1 (RN 1) indicated: "During charge nurse rounding, Charge Nurse 1 (CN 1) notified me (RN 1) that patient (1) needed RRT (Rapid Response Team- a group of healthcare professionals trained to provide immediate care to patients who are becoming unstable or critically ill) called. Respiratory Therapists (RT's) and Registered Nurses (RN's) attended patient's room when Code Blue was called at 2:45 a.m."

During a concurrent interview and record review on 10/16/2024 at 11:30 a.m. with the Clinical Nurse Director (CND), the CND verified Patient 1's telemetry strips (a recording of the patient's heart's electrical activity), dated 3/8/2024, indicated the following: On 3/8/2024 from 2:30 a.m. through 2:45 a.m., Patient 1 had an abnormal paced heart rhythm (an electrocardiogram finding where an artificial cardiac pacemaker control's the heart's rhythm with an electrical impulse).

During the same interview on 10/16/2024 at 11:30 a.m., the CND also stated the following: Patient 1 was on the telemetry monitor (a device that tracks a patient's pulse oximetry, heart rate, heart rhythm and electrical activity while they are in the hospital). When a pulse (indicates a heartbeat) was checked by staff (CN 1) at 2:43 a.m., Patient 1 was pulseless (absence of a heartbeat). Due to the abnormal heart rhythm on the telemetry strips and lack of pulse, it was determined Patient 1 was in PEA (Pulseless Electrical Activity- a life-threatening heart rhythm that occurs when the heart stops beating despite electrical activity) for approximately 13-16 minutes. There was electrical activity on the telemetry monitor, but Patient 1 did not have a pulse.

During a concurrent interview and record review on 10/16/2024 at 4:24 p.m. with the Chief Nursing Officer (CNO) and the Clinical Nurse Director (CND), the CND stated the following: On 3/8/2024 at approximately 2:43 a.m., Patient 1 was found unresponsive (not reacting in a normal way when spoken to, touched, or stimulated in other ways) and an RRT was initiated, followed by a code blue at 2:45 a.m. Patient 1 suffered pulseless electrical activity (PEA) and coded (when someone requires an immediate life-saving measure).

During an interview on 10/16/2024 at 5:33 p.m. with the Respiratory Care Practitioner 1 (RCP 1), RCP 1 stated the following: On 3/8/2024, he (RCP 1) was in the hallway on Medical Surgical Unit 1 (Unit 1) and was notified by CN 1 to check on Patient 1. CN 1 asked him (RCP 1) "Can you look at this patient?" and CN 1 stated Patient 1 was unresponsive. When he (RCP 1) responded to Patient 1's room, Patient 1 was unresponsive and not breathing. He (RCP 1) immediately initiated bagging (providing ventilation) Patient 1 with a bag and mask (a device that helps someone breath when not breathing on their own). He (RCP 1) does not remember hearing a RRT or Code Blue called overhead, while in the patient's (Patient 1) room. No staff was providing chest compressions to Patient 1 when he (RCP 1) entered Patient 1's room.

During an interview on 10/16/2024 at 5:59 p.m. with CN 1, CN 1 stated the following: She (CN 1) was rounding (a process whereby nurses carry out regular checks on patients) on patients in the early morning on 3/8/2024, when she (CN 1) noticed Patient 1 was not as active as Patient 1 normally was. Patient 1 was pale and there was no chest rise and fall. She (CN 1) called RCP 1 into the room from the doorway. RCP 1 started bagging the patient. CN 1 checked Patient 1's pulse, determined there was no pulse, but did not begin chest compressions at this time. She (CN 1) called an RRT and checked for a pulse (there was no pulse). She (CN 1) then called a code blue and stayed with Patient 1. Chest compressions were performed by another Respiratory Care Practitioner (not RCP 1), whom she (CN 1) does not remember the name. CN 1 did not perform chest compressions on Patient 1 during the code blue. Patient 1's pulse oximetry probe was attached to her (Patient 1's) finger. CN 1 also said when a patient was found pulseless, CPR should have been initiated right away so there was no delay. CN 1 further said there were better outcomes if CPR was initiated immediately.

During an interview on 10/16/2024 at 7:05 p.m. with RN 1, RN 1 stated the following: She (RN 1) was the primary nurse for Patient 1 on 3/8/2024. She (RN 1) was at the nurse's station and CN 1 was checking on patients. CN 1 came back to the nurse's station because something was not right with Patient 1 and stated to call a RRT. Patient 1's room was near the end of the hallway in comparison to the nurse's station. RN 1 also said if a patient was unresponsive, the patient's breathing and a pulse should be checked immediately.

During an interview and record review on 10/17/2024 at 8:30 a.m. with the CNO (Chief Nursing Officer), the CNO verified the following information on Patient 1's "Code Blue Record:" Manual ventilation begun at 2:43 a.m. and CPR (compressions) was started at 2:45 a.m. The CNO acknowledged mechanical ventilation started 2 minutes before compressions were started on Patient 1 and that this was a delay in the care.

During the same interview on 10/17/2024 at 8:30 a.m., the CNO stated the following: Clinical staff who work at the bedside were required to have Basic Life Support (BLS) training. Staff required to have BLS were Charge Nurses (CN), Registered Nurses (RN), Certified Nursing Assistants (CNA) and Respiratory Care Practitioners (RCP). If a staff was the first person to find a patient unresponsive, they should follow the American Heart Association BLS guidelines and check a pulse then breathing. If a patient was unresponsive, not breathing, and pulseless, the staff who found the patient should stay with the patient and start CPR with compressions first. Staff did not have a facility-issued cell phone or device to communicate with other staff. If there was a RRT or code blue, staff should shout for help or press the code blue button within the patient's room.

During a concurrent interview and record review on 10/18/2024 at 10:10 a.m. with the Medical Director (MDR) and the Medical Doctor 1 (MD 1), the MD 1 stated the following: He (MD 1) was consulted to see Patient 1 for Neurology (a medical specialty that studies and treats disorders of the nervous system [includes the brain and spine]). Patient 1 suffered a cardiac arrest (when the heart stops beating) and had brain encephalopathy (brain dysfunction or damage) from the anoxia (an absence of oxygen reaching the tissues). If there was anoxia, the brain cells get damaged or die. Due to the cardiac arrest, Patient 1 was cognitively (anything related to thinking, learning, and understanding) impaired, not moving or waking up. He (MD 2) diagnosed Patient 1 with an anoxic brain injury based on clinical presentation. She (Patient 1) did not improve neurologically during her stay in the ICU.

During a review of a document provided by the facility titled, "Basic Life Support (BLS) Reference," dated 10/2020, the document indicated the following: "Compressions, Airway, Breathing (C-A-B); Critical Concepts: High-quality CPR improves a victim's chances of survival. The critical characteristics of high-quality CPR include the following: Start compressions within 10 seconds after recognizing cardiac arrest ... Adult BLS Algorithm (a set of instructions that are followed in order to complete a task) for Healthcare Providers: verify scene safety, check responsiveness, shout for help, activate emergency response system via mobile device (if appropriate), Get AED (Automated External Defibrillator- a medical device that can help people experiencing sudden cardiac arrest by analyzing the heart's rhythm and delivering an electric shock to the heart) and emergency equipment (or send someone to do so); Look for no breathing or only gasping and check pulse (simultaneously.), Is pulse definitely felt within 10 seconds; no breathing or only gasping, pulse not felt; Start CPR: perform cycles of 30 compressions and 2 breaths, use AED as soon as it is available ..."

During a review of the facility's policy and procedure (P&P) titled, "Code Blue," dated 6/2022, the P&P indicated the following: " ...Definitions: ...A Code Blue may be called for any patients with an absent pulse, apnea (when breathing stops or becomes very shallow), agonal breathing (irregular, labored breathing that can sound like gasping, snorting, or moaning) , or life-threatening arrythmias ... 1. Any staff who finds a person in cardiopulmonary arrest will initiate a Code Blue. This person must stay with the victim and summon help by whatever means are available ..."

2. During a review of Patient 13's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 9/21/2024, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to acute (new onset) hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), pneumonia (lung infection) and septic shock (a body's overwhelming and life-threatening response to infection).

During a concurrent observation and interview on 10/15/2024 at 3:09 p.m. with Registered Nurse (RN) 16 in Patient 13's room, Patient 13 was observed to be on mechanical ventilator (an appliance for artificial respiration). RN 16 stated Patient 13 was previously on T piece (an instrument used in weaning of a patient from mechanical ventilator during spontaneous [instant] breath trials) for thirteen (13) hours but had an episode of throwing up, then she (Patient 13) was put back on mechanical ventilator.

During a concurrent interview and record review on 10/16/2024 at 4:19 p.m. with the Wound Care Specialist Registered Nurse (WCS 1), Patient 13's "Mechanical Ventilation Assessment (assessment completed by Respiratory Care Practitioner [RCP] documenting type/mode of mechanical ventilator use, respiration rate, amount of oxygen delivered and overall patient's respiratory status)," dated from 10/14/2024 to 10/15/2024, was reviewed. The Mechanical Ventilation Assessment indicated Respiratory Care Practitioner (RCP) 5 documented the following Ventilator Support Mode (T-piece [an instrument used in weaning of a patient from ventilator during spontaneous [instant] breath trials], CPAP [continuous positive airway pressure, a mode of mechanical ventilator setting that assists patient breaths], AC [Assist Control, a mode of mechanical ventilator that provides support for each breath a patient takes] / Fraction of Inspired Oxygen (FiO2, percentage amount of oxygen delivered)/ Respiration Rate (RR, breaths per minute [BPM] normal range 16 to 20 per minutes)/ Pulse Rate (PR, pulse normal range 60 to 100 beats per minute)/ Bedside Pulse Oximetry (O2Sat, oxygen saturation in blood normal range 90 to 100%):

10/14/2024 at 11:25 p.m.: T-piece, FiO2 40%, RR 18, PR 124, O2Sat 94%
10/15/2024 at 12:08 a.m.: CPAP, FiO2 50%, RR 42, PR 123, O2Sat 91% Comments: "increased heart rate and labor breathing (working hard to breathe)"
10/15/2024 at 3:41 a.m.: CPAP, FiO2 40%, RR 39, PR 114, O2Sat 100% Comments: "increased heart rate and labor breathing"
WCS 1 stated there was a change in Patient 13's respiratory status after Patient 13 was put on the mechanical ventilator. WCS 1 stated respiratory rate of 39 - 42 was not Patient 13's baseline. WCS 1 also said the RCP and nursing staff should communicate and notify the physician on call at night about the elevated heart rate and respiratory rate.

During a review of Patient 13's Nurses Notes, dated 10/15/2024, the nurses notes, documented by Registered Nurse (RN) 17, indicated, at 12:00 a.m. (Patient 13's) heart rate sustained at 120 - 125 beat per minute, patient (Patient 13) was put back on CPAP ventilator setting and physician (MD) 2 notified ... intravenous (IV - administered into a vein) fluid infused. Heart rate regulated post treatment to 100 - 110s beat per minute."

During an interview on 10/16/2024 at 4:28 p.m. with WCS 1, WCS 1 stated RN 17 did not report to MD 2 about Patient 13's elevated respiratory rate after Patient 13 was put back on CPAP per nursing documentation.

During an interview on 10/17/2024 at 3:16 p.m. with the Respiratory Care Practitioner (RCP) 3, RCP 3 stated there was physician order to wean Patient 13 off from mechanical ventilator per facility's TIPS (Therapist Implemented Patient Specific) protocol (an individualized, step-by-step method implemented and monitored by respiratory care practitioners to recover independent breathing).

During a concurrent interview and record review on 10/17/2024 at 3:50 p.m. with RCP 3, Patient 13's "Mechanical Ventilation Assessment (assessment completed by RCP documenting type/mode of mechanical ventilator use, respiration rate, amount of oxygen delivered and overall patient's respiratory status)," dated from 10/14/2024 to 10/15/2024, was reviewed. The Mechanical Ventilation Assessment indicated Respiratory Care Practitioner (RCP) 4 and 5 documented the following Ventilator Support Mode (T-piece [an instrument used in weaning of a patient from ventilator during spontaneous [instant] breath trials], CPAP [continuous positive airway pressure, a mode of mechanical ventilator setting that assists patient breaths, AC [Assist Control, a mode of mechanical ventilator that provides support for each breath a patient takes]) / Fraction of Inspired Oxygen (FiO2, percentage amount of oxygen delivered)/ Respiration Rate (RR, breaths per minute [BPM] normal range 16 to 20 per minutes)/ Pulse Rate (PR, pulse normal range 60 to 100 beats per minute)/ Bedside Pulse Oximetry (O2Sat, oxygen saturation [amount of oxygen in the blood] in blood normal range 90 to 100%):

10/14/2024 at 12:58 p.m.: T-piece FiO2 40% RR 16 PR 108 O2Sat 93% by RCP 4
10/14/2024 at 3:40 p.m.: T-piece FiO2 40% RR 16 PR 102 O2Sat 96% by RCP 4
10/14/2024 at 9:07 p.m.: T-piece FiO2 40% RR 18 PR 118 O2Sat 96% by RCP 5
10/14/2024 at 11:25 p.m.: T-piece FiO2 40% RR 18 PR 124 O2Sat 94% by RCP 5
10/15/2024 at 00:08 a.m.: CPAP FiO2 50% RR 42 PR 123 O2Sat 91% Comments: "increased heart rate and labor breathing (working hard to breathe)" by RCP 5
10/15/2024 at 3:41 a.m.: CPAP FiO2 40% RR 39 PR 114 O2Sat 100% Comments: "increased heart rate and labor (having difficulty) breathing" by RCP 5
10/15/2024 at 8 a.m.: CPAP FiO2 40% RR 37 PR 109 O2Sat 100% by RCP 4
10/15/2024 at 1:08 p.m.: CPAP FiO2 40% RR 38 PR 113 O2Sat 100% by RCP 4
10/15/2024 at 4:25 p.m.: AC FiO2 70% RR 38 PR 123 O2Sat 91% Comments: "Patient (Patient 13) placed on AC setting due to increased work of breathing and low blood pressure. Patient using accessory muscles and mouth breathing. Orange yellow discharge from stoma (opening from the body) site noted." By RCP 4

During the same interview on 10/17/2024 at 3:50 p.m. with RCP 3, RCP 3 stated the following: Patient 13 was off ventilator and on T-piece with FiO2 40% on 10/14/2024. Patient 13 was put back on mechanical ventilator with CPAP setting on 10/15/2024 at 00:08 a.m. due to increased heart rate and labored breathing. Patient 13's respiration rate increased to 38 to 39 BPM (breaths per minute) since on CPAP. There should be communication with the physician on call at night to report Patient 13's change of respiratory status. Patient 13 was in TIPS (Therapist-Implemented Patient-Specific) protocol (an individualized, step-by-step method implemented and monitored by respiratory care practitioners to recover independent breathing) and anytime when respiratory rate was higher than 35 BPM, the physician should be notified. Patient with prolonged high respiratory rate could have hyperventilation (breathing too quickly) and could get tired and have respiratory distress (difficulty breathing). There was a delay in communicating Patient 13's change of respiratory status to a physician. There should be collaboration between RCP and nursing staff in identifying Patient 13's change of condition. The staff should report to the physician so that the physician could give further instruction such as putting Patient 13 on AC setting (a breathing mode that helps patients by delivering support for each breath they take) to help her (Patient 13) breathe easier.

During an interview on 10/17/2024 at 3:55 p.m. with the Director of Respiratory Therapy and Rehab Services (DTRS), DTRS stated RCP 5 should have performed another respiratory assessment within an hour after Patient 13 was put back on CPAP on 10/15/2024 at 00:08 a.m. to evaluate her (Patient 13's) response to the ventilator. DTRS stated RCP 5 did not reassess Patient 13 until 3:41 a.m. (almost four [4] hours later).

During an interview on 10/18/2024 at 10:26 a.m. with the Medical Director (MDR), MDR stated the clinician could have notified the physician on call at night for any further instruction or recommendation by physician to address Patient 13's elevated (high) respiratory rate on 10/15/2024.

During a review of the facility's policy and procedure (P&P) titled, "Therapist Implemented Patient Specific (TIPS-2) Protocol (Version-2) for Weaning from Mechanical Ventilation," dated 3/2022, the P&P indicated, "Weaning of the mechanical ventilator is the gradual withdrawal of ventilatory support ... even though the patient may meet the criteria to begin weaning, he/she may not be able to maintain stability over an extended period of time while weaning. If any of the following adverse effects occur, return the patient to the ventilator at the settings used prior to the weaning ...respiratory rate greater than 35 per minute ... if weaning parameter results are poor, contact the pulmonologist or attending physician."

During a review of the facility's policy and procedure (P&P) titled, "Vital Signs, Clinical Monitoring," dated 7/2022, Vital signs: temperature, pulse, respirations, and blood pressure ... may reveal sudden changes in patient's condition as well as, changes that occurs progressively over a period of time ... Patient can expect the nursing staff and interdisciplinary team to interpret the significance of vital signs and weight and communicate this to the physician.

During a review of the facility's "Vital Signs/ Weight Measurement/ Clinical Monitoring Quick Reference Guide," dated 6/2021, the reference guide indicated, "[the facility] policy for normal range of vital signs:
Temperature (oral 98.6/ rectal 99.6/ axillary 97.6)
Blood Pressure (120/80 to 139/89)
Respiration (16 to 20)
Heart rate (60 to 100)
Pulse Oximetry (90 to 100%)
Vital signs that fall outside the above referenced normal range are abnormal and must be verbally reported to the primary Registered Nurse or Charge Registered Nurse immediately."

During a review of the facility's policy and procedure (P&P) titled, "Assessment and Reassessment, Interdisciplinary," dated 9/2022, the P&P indicated, "the purpose of the reassessment is to determine the effectiveness of the treatment and care interventions in achieving established goals for the patient and to assist in the ongoing planning, coordination and supervision of the care of the patient ... Nursing: as frequently during the shift as the patient's condition warrants ... in general, reassessment addresses the following: review of physical and psychosocial status, changes in clinical condition, response to treatment and medical interventions ... need for additional referrals/communication to members of the multidisciplinary care team ... Respiratory Therapy Services: Patient will be reassessed when there are changes in their condition ... in general, reassessment addresses the following: response to treatment and medical interventions/ orders, response to interventions noted in the patient's plan of care, need for communication to members of the multidisciplinary care."

3.a. During a review of Patient 22's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 9/29/2024, the H&P indicated Patient 22 was admitted to the facility for respiratory failure (a serious condition that makes it difficult to breathe on your own), and was on mechanical ventilation (a medical device to help support or replace breathing).

During concurrent interview and record review on 10/16/2024 at 3:20 p.m. with the Clinical Educator and Staff Development Coordinator (CESD), the CESD verified Patient 22's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 10/5/2024 to 10/10/2024, included a physician's order of Tylenol 650 milligram (mg -metric unit of measurement, used for medication dosage and/or amount) via gastrostomy (G-tube, a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems), every four hours, PRN (as needed) for mild pain.

During the same interview and record review on 10/16/2024 at 3:20 p.m., the CESD verified Patient 22's MAR on 10/10/2024 at 2:58 p.m., Patient 22 was given Tylenol 650 mg via G-tube for pain. The CESD stated there was no documentation Patient 22's pain was reassessed after the patient (Patient 22) was administered Tylenol. The CESD further stated Patient 22's pain should have been reassessed an hour after receiving the Tylenol to know if the pain medication was effective in reducing Patient 22's pain.

During a review of the facility's policy and procedure (P&P) titled, "Patient Rights and Responsibilities," dated 6/2022, indicated, "[Name of the Facility] patients have the right to ...Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions."

During a review of the facility's policy and procedure (P&P) titled, "Pain management," dated 5/2022, the P&P indicated, "Re-assess pain intensity after each pain management intervention ...30 - 60 minutes for any pain intervention."

3.b. During a review of Patient 27's "History and Physical (H&P)," dated 8/30/2024, the H&P indicated Patient 27 was admitted for respiratory failure (serious lung condition that causes difficulty breathing) and ventilator (a medical device to help or support breathing) weaning (decrease amount of assistance from the breathing machine). Patient 27 had a history of high blood pressure (BP-amount of force blood uses to move through the body), cerebrovascular accident (CVA-stroke, loss of blood flow to a part of the brain), and anxiety (a feeling of dread or uneasiness).

1. During a review of Patient 27's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient )," dated 9/19/2024, the MAR indicated a physician's order for Patient 27 to be given Midodrine (medication used for raising blood pressure) 10 milligrams (mg, metric unit of measurement, used for medication dosage and/or amount) orally every six hours PRN (as needed) for SBP (Systolic Blood Pressure- maximum amount of pressure the blood uses to move through the body) less than 100 mmHg (millimeters of Mercury- a unit of measurement).

During a concurrent interview and record review on 10/16/2024 at 11:20 a.m. with Registered Nurse 5 (RN 5), RN 5 verified Patient 27's MAR, dated 9/26/2024 at 1:43 a.m., indicated Patient 27 was given Midodrine 10 mg orally PRN for BP (Blood Pressure) of 92/55 (Normal Blood Pressure range is 120/80).

During the same interview and record review on 10/16/2024 at 11:20 a.m., RN 5 verified Patient 27 had no documentation of the patient's BP reassessment after Midodrine 10 mg oral was given on 9/26/2024 at 1:43 a.m. RN 5 stated the nurse should have rechecked Patient 27's BP because if the patient's BP becomes too low, it could become critical and would need to include other interventions.

During a review of the facility's "Policy and Procedure (P&P)," titled "Assessment and Reassessment, Interdisciplinary," dated 09/2022, the P&P indicated, "The purpose of the reassessment is to determine the effectiveness of the treatment and care interventions in achieving established goals for the patient and to assist in the ongoing planning, coordination and supervision of the care of the patient."

During a review of the facility's "Policy and Procedure (P&P)" titled, "Vital Signs (temperature, pulse, respirations, and blood pressure), Clinical Monitoring," dated 07/2022, the P&P indicated, "Vital signs will be obtained ... As necessary, when patients condition warrants."

2. During a review of Patient 27's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 08/30/2024, the MAR indicated a physician's order for Patient 27 to be given Hydromorphone (medication for pain) 0.5 milligrams (mg, metric unit of measurement, used for medication dosage and/or amount) intravenously (IV, through the vein), every six hours PRN (as needed) for severe pain.

During a concurrent interview and record review on 10/16/2024 at 11:20 a.m. with Registered Nurse 5 (RN 5), RN 5 verified Patient 27's MAR indicated the following:

-On 10/06/2024 at 4:56 p.m., Patient 27 was given Hydromorphone 0.5 mg IV.
The corresponding pain reassessment of Patient 27 was taken on 10/06/2024 at 7:30 p.m. (2 hours and 34 minutes after Patient 27 received the pain medication).

-On 10/14/2024 at 12:37 p.m., Patient 27 was given Hydromorphone 0.5 mg IV. The corresponding pain reassessment of Patient 27 was taken on 10/14/2024 at 4:36 p.m. (3 hours and 59 minutes after Patient 27 received the pain medication).

-On 10/16/2024 at 7:42 a.m., Patient 27 was given Hydromorphone 0.5 mg IV. The corresponding pain reassessment of Patient 27 was taken on 10/16/2024 at 9:42 a.m. (2 hours after Patient 27 received the pain medication).

During the same interview and record review on 10/16/2024 at 11:20 a.m., RN 5 stated the patient's pain should be reassessed within the hour after PRN pain medication was given to know if the pain medication was effective, and/or if any changes are needed for the patient, and/or to watch for adverse reactions.

During a review of the facility's "Policy and Procedure (P&P)" titled, "Pain Management," dated 05/2022, the P&P indicated, "Re-assess pain intensity after each pain management intervention ...30-60 minutes for any pain intervention ...Monitor for common side effects of opioid/other pain medication when used which may include oversedation (excessive drowsiness), slurred speech, respiratory depression (slow or shallow breathing), nausea (the sensation of having to throw-up)/vomiting, pruritus (itching) and acute (sudden and severe in onset) confusion."

During a review of the facility's "Policy and Procedure (P&P)" titled, "Assessment and Reassessment, Interdisciplinary," dated 09/2022, the P&P indicated, "The purpose of the reassessment is to determine the effectiveness of the treatment and care interventions in achieving established goals for the patient and to assist in the ongoing planning, coordination and supervision of the care of the patient."

Based on observation and interview, the facility failed to ensure for one of three sampled crash carts (Crash cart 1, wheeled container carrying medicine and equipment for use in emergency resuscitations), Crash cart 1 was checked daily in accordance with the facility's policy and procedure regarding Crash cart maintenance.

This deficient practice had the potential to delay critical emergency care if the crash cart was not properly stocked potentially leading to worsened patient outcomes and/or patient death.

Findings:

During a concurrent observation, interview, and record review on 10/15/2024 at 3:40 p.m. with the Clinical Nurse Director (CND), Crash cart 1 in the medical-surgical unit (a hospital ward where patients are treated for a variety of medical conditions, including illnesses, injuries, and post-surgery recovery) was observed by the hallway with the crash cart binder on top of the cart. Crash cart 1's daily checklist log (list of essential equipment and medications that would be required to treat a patient for the first 30 minutes of a medical emergency) for the month of October 2024 was reviewed with the CND. The CND verified Crash cart 1's daily check on 10/4/2024 and 10/5/2024 were not completed.

During the same interview on 10/15/2024 at 3:40 p.m., the CND stated all the crash carts in the facility were being checked daily using the daily checklist log. The CND stated daily crash cart check were important to ensure equipment and supplies were ready for use in a medical emergency.

During a review of the facility's policy and procedure (P&P) titled, "Crash Cart Maintenance," dated 06/2023, the P&P indicated the following:

"Charge registered nurse (RN) or designated RN shall be responsible for:
a. Checking external contents of cart and operation of the defibrillator monitor and the portable suction machine.
b. Completing the crash cart checklist (see Appendix II) each shift, verifying that locks are intact and filling the required logs."

Based on interview and record review, the facility failed to ensure for four of 30 sampled patients (Patients 21, 22, 23, and 27), Patients 21, 22, 23 and 27's medications were administered in accordance with the physician's order.

These deficient practices had the potential to cause adverse health outcomes which could negatively affect Patients 21, 22, 23 and 27's health and safety due to unsafe medication administration and may lead to prolonged hospitalization and/or death of the patient.

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 6/24/2024, the H&P indicated Patient 21 was admitted to the facility for respiratory failure (a serious condition that makes it difficult to breathe on your own) with required mechanical ventilator (a medical device to help support or replace breathing), end stage renal disease (ESRD - irreversible kidney failure) on hemodialysis (a treatment to cleanse the blood of wastes and extra fluids artificially through a machine when the kidney(s) have failed), aspiration (occurs when oral or gastric contents are inhaled into the lungs) pneumonia (lung infection) and urinary tract infection (UTI - an infection in the bladder/urinary tract).

¿During a concurrent interview and record review on 10/16/2024 at 4:11 p.m. with the Clinical Educator and Staff Development Coordinator (CESD), the CESD verified Patient 21's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 10/8/2024 to 10/9/2024, included a physician's order of Meropenem (antibiotic for treatment of infection) 1 gram (gm- a unit of measurement), intravenous (IV, through the veins) infusion, every twelve hours.

During the same interview and record review on 10/16/2024 at 4:11 p.m., the CESD stated Patient 21's MAR indicated Meropenem 1 gram IV was given on the following dates and times:

- On 10/8/2024 at 6:07 p.m.; and,

- On 10/9/2024 at 1:56 a.m. (8 hours after the last dose of Meropenem was given to Patient 21).

The CESD stated the dose was given 4 hours early from the physician's order (Meropenem 1 gm IV to be given every 12 hours). The CESD stated antibiotics being given early than the scheduled dose was concerning because the patient could have an overdose of the medication in their blood stream.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 8/2023, indicated:

- "Medications will be administered upon the written, telephone/read back or verbal order ..."

- "Antimicrobial agents will be administered within 1 hour of a physician's order, unless otherwise indicated by the physician."

- "Medications eligible for scheduled dosing times ... The goal of this scheduling is to achieve and maintain therapeutic blood levels of the prescribed mediation over a period of time."

2. During a review of Patient 22's "History and Physical (H&P)," dated 9/29/2024, the H&P indicated Patient 22 was admitted to the facility for respiratory failure (a serious condition that makes it difficult to breathe on your own), mechanical ventilation (a medical device to help support or replace breathing) required.

During a concurrent interview and record review on 10/16/2024 at 3:33 p.m. with the Clinical Educator and Staff Development Coordinator (CESD), the CESD verified Patient 22's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 10/10/2024, included a physician's order of Ciprofloxacin (antibiotic for treatment of infection) 500 milligram (mg - metric unit of measurement, used for medication dosage and/or amount), via Gastrostomy (G-tube, a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems) twice a day (BID), with a start date of 10/10/2024 at 11:10 a.m..

During the same interview and record review on 10/16/2024 at 3:33 p.m., the CESD stated Patient 22's MAR indicated Ciprofloxacin 500 mg via G-tube was given on 10/10/2024 at 1:58 p.m. (three hours after the initial dose was ordered). The CESD stated the Ciprofloxacin dose ordered for 11:10 a.m. was given late. The CESD said it was important to give antibiotics as scheduled to maintain a steady stream of antibiotics in the blood stream.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 8/2023, indicated:

- "Medications will be administered upon the written, telephone/read back or verbal order ..."

- "Antimicrobial agents will be administered within 1 hour of a physician's order, unless otherwise indicated by the physician."

- "Medications eligible for scheduled dosing times ... The goal of this scheduling is to achieve and maintain therapeutic blood levels of the prescribed mediation over a period of time."

3. During a review of Patient 23's "History and Physical (H&P)," dated 10/9/2024, the H&P indicated Patient 23 was admitted to the facility for ongoing care for chronic hypoxic (low oxygen) respiratory failure (a serious condition that makes it difficult to breathe on your own), relapsing multiple sclerosis (MS - a chronic, progressive disease involving damage to the nerve cells in the brain and spinal cord) with functional quadriparesis (a condition that causes muscle weakness in all four limbs, or both arms and both legs), aspiration (occurs when oral or gastric contents are inhaled into the lungs) pneumonia (lung infection) and recurrent urinary tract infections (UTI - an infection in the bladder/urinary tract).

During a concurrent interview and record review on 10/16/2024 at 2:38 p.m. with Registered Nurse (RN 8), RN 8 verified Patient 23's "Medication Administration Record (MAR, a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 10/14/2024 to 10/15/2024, included a physician's order of Meropenem (antibiotic for treatment of infection) 1 gram, intravenous (IV, through the veins) infusion to be given every eight hours, with a start date of 10/14/2024 at 1:00 p.m.

During the same interview and record review on 10/16/2024 at 2:38 p.m., RN 8 stated Patient 23's MAR indicated Meropenem 1 gram IV was given on 10/14/2024 at 3:17 p.m. (2 hours and 17 minutes after the initial dose was ordered). RN 8 stated Patient 23's antibiotic should have been given within an hour of scheduled order time. RN 8 stated the patient's antibiotic should be given on time for effective treatment.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 8/2023, indicated:

- "Medications will be administered upon the written, telephone/read back or verbal order ..."

- "Antimicrobial agents will be administered within 1 hour of a physician's order, unless otherwise indicated by the physician."

- "Medications eligible for scheduled dosing times ... The goal of this scheduling is to achieve and maintain therapeutic blood levels of the prescribed mediation over a period of time."

4. During a review of Patient 27's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/30/2024, the H&P indicated Patient 27 was admitted for respiratory failure (serious lung condition that causes difficulty breathing) and was on ventilator (a medical device to help support or replace breathing) weaning (decrease amount of assistance from the breathing machine). Patient 27 had a history of high blood pressure (BP, amount of force blood uses to move through the body) and cerebrovascular accident (CVA-stroke, loss of blood flow to a part of the brain).

During a review of Patient 27's "Medication Administration Record (MAR - a daily documentation record used by a licensed nurse to document medications and treatments given to a patient)," dated 9/19/2024, the MAR indicated a physician's order for Patient 27 to be given Midodrine (medication used for raising blood pressure) 10 milligrams (mg- metric unit of measurement, used for medication dosage and/or amount) orally every six hours as needed (PRN) for Systolic (SBP, maximum amount of pressure the blood uses to move through the body) less than 100 mmHg (millimeters of mercury, a unit of measure).

During a concurrent interview and record review on 10/16/2024 at 11:20 a.m. with Registered Nurse 5 (RN 5), RN 5 verified Patient 27's "Blood Pressure-History," indicated the following:

- On 9/21/2024 at 4:00 a.m., Patient 27's BP was 94/64.

- On 9/23/2024 at 12:00 a.m., Patient 27's BP was 95/55.

- On 9/25/2024 at 8:00 a.m., Patient 27's BP was 96/55; at 2:00 p.m., Patient 27's BP was 90/55; at 3:35 p.m., Patient 27's BP was 93/51; and, at 8:00 p.m., Patient 27's BP was 95/55.

During the same interview and record review on 10/16/2024 at 11:20 a.m., RN 5 verified Patient 27's MAR did not have documentation that the PRN Midodrine was given to Patient 27 when Patient 27's SBP was less than 100:

-on 9/21/2024 at 4:00 a.m.;

-on 9/23/2024 at 12:00 a.m.; and,

- on 9/25/2024 at 8:00 a.m., 2:00 p.m., 3:35 p.m., and 8:00 p.m.

RN 5 stated PRN Midodrine should have been given based on the order parameters (range), to give if SBP was less than 100. RN 5 stated the BP was low and Midodrine should have been given.

During a review of the facility's "Policy and Procedure (P&P)" titled, "Medication Administration," dated 08/2023, the P&P indicated, "Medications will be administered upon the written, telephone/read back or verbal order ...The following be confirmed prior to each administration of medication/radiopharmaceutical ...The appropriate time, to ensure adherence to the prescribed frequency and time of administration."

Based on observation, interview and record review, the facility failed to ensure its staff adhered to the facility's infection control program to prevent and control the transmission of infections within the hospital when:

1. Contact isolation precaution (steps that prevent the spread of germs from patients to others through direct or indirect contact. Example: use of gloves during patient care) interventions were not properly implemented, in accordance with the facility's policy and procedure regarding contact precaution, for one of 30 sampled patients (Patient 10), when there was no isolation signage posted outside Patient 10's room to inform staff and visitors of what to do. This deficient practice resulted in Patient 10's visitor entering the patient's room without the proper PPE (Personal Protective equipment such as gloves, gowns, etc.). This deficient practice also had the potential to result in spreading infection to other patients, visitors or staff.

2. Ballard closed suction systems (inline suction catheter to remove secretion from airway) were used beyond manufacturer's instruction (user manual) for three of 30 sampled patients (Patient 10, 12, and 13). The Ballard suction systems were replaced after seven days instead of after 24 hours. This deficient practice had the potential to result in respiratory infection for Patients 10, 12 and 13.

3. The water bag (deliver water to patients enterally through gastrostomy [an artificial external opening into the stomach for nutritional and medication administration]) was being used more than 24 hours, beyond manufacturer's instruction for one of 30 sampled patients (Patient 12). This deficient practice had the potential to deliver contaminated (dirty) water to Patient 12 and make Patient 12 sick.

4. Patient 25's tube feeding set (device used to administer feeding formula and water flush to the patient) was changed in accordance with the facility's policy and procedure regarding replacement of tube feeding sets after 24 hours.

This deficient practice had the potential to result in Patient 25's tube feeding set to be contaminated and may transmit bacterial infection to the patient (Patient 25).

5. Patient 24's tube feeding set had a label date, of when the set was hung, in accordance with the facility's policy and procedure and the manufacturer's guideline.

This deficient practice had the potential to result in Patient 24's tube feeding set to be contaminated and may transmit bacterial infection to the patient (Patient 24).

Findings:

1. During a review of Patient 10's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 6/22/2024, the H&P indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), pneumonia (lung infection), cerebral vascular accident (CVA - stroke; damage to the brain from interruption of its blood supply), and endocarditis (inflammation of the heart's inner lining).

During an observation on 10/15/2024 at 2:14 p.m. in Patient 10's room, Patient 10's family member was observed sitting next to Patient 1 holding his (Patient 10) left hand. Patient 10's family member did not wear any personal protective equipment (PPE, equipment worn to prevent or minimize exposure to hazards. Example: gloves).

During a concurrent observation and interview on 10/15/2024 at 2:19 p.m. in Patient 10's room with Registered Nurse (RN) 14, there was no isolation signage posted outside or inside Patient 1's room. RN 14 stated Patient 10 was in contact isolation precaution (steps that prevent the spread of germs from patients to others through direct or indirect contact. Example: use of gloves during patient care). RN 14 stated the signage could be lost when Patient 10 was moved to this current room.

During an interview on 10/15/2024 at 2:25 p.m. with the Clinical Nurse Director (CND), CND stated there should be a signage posted outside Patient 10's room for contact isolation to notify staff and visitors to wear PPE prior to entering the room. CND stated there would be risk for spreading infection to others if the isolation precaution was not followed.

During a concurrent interview and record review on 10/18/2024 at 9:16 a.m. with the Infection Control Preventionist (ICP), Patient 10's blood culture (a microbiology test that checks blood sample for bacteria or fungi) report, dated 10/10/2024, was reviewed. The blood culture report indicated Patient 10 was positive for Klebsiella Pneumoniae (a type of bacteria causing bloodstream infections). ICP stated patients whose blood culture was positive for Klebsiella Pneumoniae should be placed in contact isolation precaution.

During a review of the facility's policy and procedure (P&P) titled, "Contact Precaution," dated 8/2022, the P&P indicated, "Contact Precautions are used to reduce the risk of transmissions of microorganisms from patient to patient, patient to employee, employee to patients, visitors to patient and patient to visitors ... Notification: A contact sign must be placed on patient's door."

2.a. During a review of Patient 12's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 10/6/2024, the H&P indicated, Patient 12 was admitted to the facility with diagnoses including but not limited to acute (new onset) on chronic hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood) status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), and dysphagia (difficulty swallowing) with status post gastrotomy (an artificial external opening into the stomach for nutritional and medication administration).

During a concurrent observation and interview on 10/15/2024 (Tuesday) at 2:57 p.m. with the Respiratory Care Practitioner (RCP) 2 in Patient 12's room, Patient 12's Ballard closed suction systems (Ballard, inline suction catheter to remove secretion from airway) was observed dated 10/13/2024 (Sunday) with a day sticker "Change Sunday." RCP 2 stated Patient 12 had a lot of secretion and Ballard was changed on 10/13/2024 (Sunday). RCP 2 stated Ballard was changed on an as needed basis.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instruction (user manual) titled, "Ballard Closed Suction System Manufacturer's Instructions for Use (manufacturer's instruction)," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same interview on 10/16/2024 at 12:01 p.m., ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. Ballard should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022, was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated." ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."

2.b. During a review of Patient 13's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 9/21/2024, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to acute (new onset) hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), pneumonia (lung infection) and septic shock (a body's overwhelming and life-threatening response to infection).

During a concurrent observation and interview on 10/15/2024 (Tuesday) at 3:09 p.m. with Registered Nurse (RN) 16 in Patient 13's room, Patient 13's Ballard had a day sticker "change Friday" with no date. RN 16 stated she (RN 16) did not know when Patient 13's Ballard was changed.

During an interview on 10/15/2024 at 3:15 p.m. with the Director of Respiratory Therapy and Rehabilitation Services (DTRS), DTRS stated Ballard was changed every seven (7) days and as needed when soiled. DTRS stated the sticker of "Change Friday" without the date was not clear which Friday it was changed.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instruction (user manual) titled, "Ballard Closed Suction System Manufacturer's Instructions for Use (manufacturer's instruction)," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve." ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. Ballard should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022 was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated." ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."


2.c. During a review of Patient 10's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 6/22/2024, the H&P indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), pneumonia (lung infection), cerebral vascular accident (CVA - stroke; damage to the brain from interruption of its blood supply), and endocarditis (inflammation of the heart's inner lining).

During a concurrent interview and record review on 10/16/2024 (Wednesday) at 12 p.m. with the Respiratory Therapy Manager (RTM), Patient 10's "Respiratory Miscellaneous Billing (billing)," dated from 10/11/2024 to 10/16/2024, was reviewed. The billing indicated, the Ballard was changed on 10/11/2024, 10/13/2024 and 10/16/2024. RTM stated the Ballard was not changed daily. RTM stated Ballard was changed every seven (7) days and as needed per facility's policy and procedure.

During a concurrent interview and record review on 10/16/2024 at 12 p.m. with the Director of Respiratory Therapy and Rehabilitation Services (DTRS), the manufacturer's instruction (user manual) titled, "Ballard Closed Suction System Manufacturer's Instructions for Use (manufacturer's instruction)," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, place the Tuesday sticker on thumb control valve." DTRS stated she (DTRS) was aware the manufacturer's instructions was not being followed. Their practice was to change Ballard every seven (7) days and as needed when it was soiled and there was leakage.

During a concurrent interview and record review on 10/16/2024 at 12:01 p.m. with the Infection Control Preventionist (ICP), the manufacturer's instruction (user manual) titled, "Ballard Closed Suction System Manufacturer's Instructions for Use (manufacturer's instruction)," undated, was reviewed. The manufacturer's instructions indicated, "Ballard Closed Suction Systems are intended to be used 24 hours before changing. Change more frequently if catheter becomes heavily soiled during use ... Day Sticker Usage: apply the appropriate day sticker to the thumb control valve. Example: If Ballard system is opened on Monday, placed the Tuesday sticker on thumb control valve."

During the same onterview on 10/16/2024 at 12:01 p.m., ICP stated the following: manufacturer's instruction should be the first thing for the facility to follow. Ballard should be changed after 24 hours. Patients would be at risk for respiratory infection when the manufacturer's instruction was not being followed.

During a concurrent interview and record review on 10/16/2024 at 12:04 p.m. with ICP, the facility's policy and procedure (P&P) titled, "Disposable Circuit Changes," dated 2/2022 was reviewed. The P&P indicated, "to ensure that all respiratory care supplies are changed in a timely manner by complying with the CDC (Centers for Disease Control and Prevention, an organization that protects the public's health) guidelines ... Procedures for changes of closed-suction system catheters: 1. Closed-suction system catheters must be changed every seven (7) days by the night shift therapist assigned to each patient or clinically indicated." ICP stated she (ICP) was not aware it was the current practice (referring to changing the closed- suction system catheters after 24 hours per manufacturer's guideline that should be reflected in the facility's P&P). ICP stated the P&P should be updated and follow manufacturer's guideline.

During a review of the facility's Infection Control Program titled "Guidelines for Selected Clinical Syndromes or Conditions," dated 8/2022, the Infection Control Program indicated, "patient care equipment and instruments/devices must be cleaned and maintained according to the manufacturer's instruction to prevent patient-to-patient transmission of infectious agent."

3. During a review of Patient 12's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 10/6/2024, the H&P indicated, Patient 12 was admitted to the facility with diagnoses including but not limited to acute (new onset) on chronic hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood) status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), and dysphagia (difficulty swallowing) with status post gastrotomy (an artificial external opening into the stomach for nutritional and medication administration).

During a concurrent observation and interview on 10/15/2024 (Tuesday) at 2:50 p.m. with Registered Nurse (RN) 15 in Patient 12's room, there was a water bag (deliver water to patients enterally through gastrostomy [an artificial external opening into the stomach for nutritional and medication administration]) dated 10/13/2024 (two days ago- Sunday) connected to a feeding pump with setting at 150 milliliters (ml, unit of measure) every four (4) hours with tubing connected to Patient 12. RN 15 stated the water bag should be changed every day by night shift. RN 15 stated there could be bacterial growth in the water bag that could make Patient 12 sick.

During an interview on 10/15/2024 at 4:35 p.m. with Registered Nurse (RN) 4, RN 4 stated night shift nursing staff was responsible to change the water bag every night. RN 4 stated giving old water more than 24 hours could put patients at risk for infection.

During an interview on 10/15/2024 at 4:40 p.m. with the Clinical Nurse Director (CND), CND stated water bag should be changed daily by night shift.

During a review of the manufacturer's instruction titled, "Feeding Set with Flush Bag and ENPlus Spike," dated 4/2021, the manufacturer's instruction indicated, "Do not use for greater than 24 hours ... Precaution ... Due to the risk of bacterial contamination (dirty) and overall system accuracy, do not use feeding set for greater than 24 hours."

4. During a concurrent observation and interview on 10/15/2024 at 2:50 p.m., with Charge Nurse 2 (CN 2), Patient 25 was observed in bed, awake and alert. Patient 25 had a Percutaneous Endoscopic Gastrostomy (PEG- a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems) and was receiving tube feeding formula through the PEG at the rate of 60 milliliters per hour (mL/hr, a unit of measure) and 40 mL of water every four hours from the water flush bag. CN 2 verified Patient 25's tube feeding set had a label on the water flush bag, with a date and time of 10/13/2024 (Sunday), at 6:00 a.m. CN 2 stated Patient 25's tube feeding set had been in use for 48 hours (the date of observation was 10/15/2024- Tuesday), and the tube feeding set should be changed every 24 hours.
During a review of Patient 25's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 9/5/2024, the H&P indicated Patient 25 was admitted for respiratory failure (serious lung condition that causes difficulty breathing). Patient 25 had a medical history of tracheostomy (surgical hole in the neck for air to the lungs) on a ventilator (a medical device to help support or replace breathing), a PEG, and functional quadriplegia (individual has no brain or spinal cord injury but is completely unable to move).

During a concurrent interview and record review on 10/16/2024 at 10:16 a.m. with Registered Nurse 5 (RN 5), RN 5 verified Patient 25's "Electronic Medical Record," indicated a physician's order, dated 9/5/2024, of Jevity 1.2 tube feeding at 60 mL/hr, with a 40 mL water flush to be given every four hours. RN 5 stated Patient 25's tube feeding set should be changed every 24 hours to prevent growth of bacteria that could cause an infection to the patient.

During an interview on 10/18/2024 at 4:09 p.m. with Infection Control Preventionist (ICP), the ICP stated the tube feeding set should be changed every 24 hours. The ICP stated it was important to change the tube feeding set to prevent infections and should be labeled with the date and time the set was changed.

During a review of the manufacturing guidelines titled, "Kangaroo OMNI Feeding Set with Flush Bag and ENPlus Spike," dated 2021, the guidelines indicated, "Kangaroo OMNI Feeding Set with Flush Bag and ENPlus Spike ...Do not use for greater than 24 hours. Medical Device...Due to the risk of bacterial contamination and overall system accuracy, do not use feeding sets for greater than 24 hours."

5. During a review of Patient 24's "History and Physical (H&P)," dated 9/11/2024, the H&P indicated Patient 27 was admitted to the facility for respiratory failure (a serious condition that occurs when not enough oxygen passes from your lungs to your blood) with the need for ventilator (a machine or device used medically to support or replace the breathing of a person).

During a concurrent observation and interview on 10/17/2024 at 11:15 a.m. with Registered Nurse 10 (RN 10), Patient 24 was observed awake in bed, receiving Nepro (feeding formula) at 50 milliliters per hour (ml/hr, unit of measurement) with 200 ml of free water flush every four hours via gastrostomy (G-tube, a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems). RN 10 verified Patient 24's tube feeding bag and water flush bag did not have a date and time on when it was hung. RN 10 stated tube feeding bag and water flush bag should have a written date and time on when it was hung.

During an interview on 10/16/2024 at 12:28 p.m. with Registered Nurse (RN 8), RN 8 verified that Patient 24 had a physician's orders for Nepro tube feeding at 50 ml/hr with 200 ml free water flush every four hours.

During an interview on 10/18/2024 at 4:09 p.m. with the Infection Control Preventionist (ICP), the ICP stated, the feeding set including the tubing, the water flush bags, and tube feed containers were to be changed every 24 hours to prevent a risk for bacterial infection. The ICP also stated all bags and feed containers should be dated and timed with the time it was administered.

During a review of the manufacturer's guide titled, "Kangaroo OMNI Feeding Set with Flush Bag and ENPlus Spike," dated 2021, the reference guide indicated, "the feeding set with flush bag and spike should not be used for greater than 24 hours."

Based on interview and record review, the facility's antimicrobial stewardship program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance) failed to meet monthly in accordance with the facility's policy and procedure regarding antimicrobial stewardship program (ASP), and to report its data to hospital Quality Assurance and Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee and the Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) leadership on a regular basis.

This deficient practice resulted in lack of QAPI oversight over the facility's antimicrobial stewardship program for its performance and compliance. This deficient practice also had the potential to result in increased rates of antibiotic resistance among bacteria, potentially leading to more difficult to treat infections, poorer patient outcomes, and a greater risk of spreading resistant organisms (bacteria that are not controlled or killed by antibiotic) within the hospital due to unnecessary and inappropriate antibiotic usage.

Findings:

During a concurrent interview and record review on 10/18/2024 at 3:47 p.m. with the Director of Pharmacy (DP), the facility's policy and procedure (P&P) titled, "Antimicrobial Stewardship Program (ASP, a set of practices that aims to improve the use of antibiotics to treat infections and reduce the risk of antibiotics resistance)," dated 11/2022, was reviewed. The P&P indicated, "the antimicrobial stewardship committee is collaboration between several disciplines as follows: Core Group: Infection Disease Physician, Director of Infection Prevention and Control, Microbiology, and Pharmacy. Additional representatives from nursing administration, respiratory therapy, clinical laboratory, environmental services, and Information Services will attend the monthly meetings as needed ... other quality improvement initiatives will be discussed at the monthly meeting." DP stated the antimicrobial stewardship program (ASP) committee did not meet monthly. DP stated the ASP committee met three to four times a year, at least quarterly.

During an interview on 10/18/2024 at 3:56 p.m. with DP, DP stated the following: The antimicrobial stewardship 2023 first and second quarters (first quarter: January to March, second quarter: April to June) data was last reported to Quality Assurance and Performance Improvement (QAPI, a process by which a hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) on 11/30/2023. The facility's ASP committee used to report to Infection Control/Pharmacy and Therapeutics/ Clinical Nutrition Committee then to QAPI, but it was changed to Medical Executive Committee (MEC, responsible for making important medical and clinical decisions, overseeing medical staff and addressing various healthcare-related issued within the hospital) in 2024. The antimicrobial stewardship 2024 first and second quarters 2024 data was presented to Infection Control/Pharmacy and Therapeutics/ Clinical Nutrition Committee on 9/26/2024 but not yet presented to facility's MEC this year (2024). Due to various reasons, there was no reporting to QAPI and MEC since 11/2023. She (DP) was planning to report to MEC during December 2024 meeting. DP stated it was important to report and share data to QAPI and MEC to ensure there was constant monitoring and compliance.

During a concurrent interview and record review on 10/18/2024 at 6:01 p.m. with the Associate Chief Nursing Officer (ACNO), the facility's "Antimicrobial Stewardship Program (ASP) Committee Minutes (ASP minutes, summary of meeting)," dated 11/28/2023 and "Antimicrobial Stewardship Program (ASP) Committee Agenda (ASP agenda, items to be discussed in the meeting)," dated 6/4/2024, were reviewed. The ASP minutes indicated, the ASP meeting was held on 11/28/2023 and the ASP agenda indicated, the ASP meeting was on 6/4/2024. ACNO stated that was all the ASP meetings minutes/ agenda from November 20023 to date (2 meetings total) given to her by DP. ACNO stated there was no ASP meeting minutes for 6/4/2024 ASP meeting.

During an interview on 10/18/2024 at 8:51 p.m. with the Medical Director (MDR), MDR stated any highlight from the facility's Quality Forum (Facility's QAPI meeting) would bring to MEC, after that he (MDR) would report any highlight to the board of directors.

During a review of the facility's policy and procedure (P&P) titled, "Organizational Performance Improvement Plan," dated 2/2024, the P&P indicated, "the purpose of the organizational performance improvement plan is to promote a culture safety and provide a systemic, coordinated and continuous approach for creating and maintaining focus on reliable process and best clinical outcome ... Medical Executive Committee as a representative of the medical staff, makes key leadership decisions related to medical staff policies, procedures, and rules with an emphasis on patient safety and quality improvement initiatives ... managers oversee programs, services ... are responsible for implementing and maintaining a system for continuous improvement, measurement activities and reporting for their areas of accountability. Selected results of quality measures activities and analyses are presented in Quality Forum per reporting calendar, and at designated clinical committees .... The Quality Forum Committee is responsible for implementing the objectives of the organization wide performance improvement and patient safety program. Department Reports to Quality Forum: Pharmacy ...Infection Prevention."

Based on observation, interview, and record review, the facility failed to ensure its clinical staff (Respiratory Care Practitioner) identify change in respiratory status (how well a patient is producing air exchange), communicate with the nursing staff, and to report change of condition to physician in a timely manner, in accordance with the facility's policy and procedure regarding vital signs clinical monitoring and physician notification, for one of 30 sampled patients (Patient 13), when Patient 13's respiratory rate of 39 breaths per minute was not addressed and remained at about the same rate for 16 hours (from midnight to 4:30 p.m. on 10/15/2024).

This deficient practice had the potential to delay treatment and care and put Patient 13 at risk for hyperventilation (breathing too quickly) and respiratory distress (difficulty breathing), which can also prolong Patient 13's recovery.

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 9/21/2024, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to acute (new onset) hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), pneumonia (lung infection) and septic shock (a body's overwhelming and life-threatening response to infection).

During a concurrent observation and interview on 10/15/2024 at 3:09 p.m. with Registered Nurse (RN) 16 in Patient 13's room, Patient 13 was on mechanical ventilator (an appliance for artificial respiration). RN 16 stated Patient 13 was on T piece (an instrument used in weaning [(decrease amount of assistance from the breathing machine] of a patient from mechanical ventilator during spontaneous [instant] breath trials) for thirteen (13) hours but had an episode of throwing up, then she (Patient 13) was put back on the mechanical ventilator.

During an interview on 10/17/2024 at 3:16 p.m. with the Respiratory Care Practitioner (RCP) 3, RCP 3 stated there was physician order to wean Patient 13 off from mechanical ventilator per facility's TIPS (Therapist Implemented Patient Specific) protocol.

During a concurrent interview and record review on 10/17/2024 at 3:50 p.m. with RCP 3, Patient 13's "Mechanical Ventilation Assessment (assessment completed by RCP documenting type/mode of mechanical ventilator use, respiration rate, amount of oxygen delivered and overall patient's respiratory status)," dated from 10/14/2024 to 10/15/2024, was reviewed. The Mechanical Ventilation Assessment indicated Respiratory Care Practitioner (RCP) 4 and 5 documented the following Ventilator Support Mode (T-piece [an instrument used in weaning of a patient from ventilator during spontaneous [instant] breath trials], CPAP [continuous positive airway pressure, a mode of mechanical ventilator setting that assists patient breaths, AC [Assist Control, a mode of mechanical ventilator that provides support for each breath a patient takes]) / Fraction of Inspired Oxygen (FiO2, percentage amount of oxygen delivered)/ Respiration Rate (RR, breaths per minute [BPM] normal range 16 to 20 per minutes)/ Pulse Rate (PR, pulse normal range 60 to 100 beats per minute)/ Bedside Pulse Oximetry (O2Sat, oxygen saturation [amount of oxygen in the blood] in blood normal range 90 to 100%):

10/14/2024 at 12:58 p.m.: T-piece FiO2 40% RR 16 PR 108 O2Sat 93% by RCP 4
10/14/2024 at 3:40 p.m.: T-piece FiO2 40% RR 16 PR 102 O2Sat 96% by RCP 4
10/14/2024 at 9:07 p.m.: T-piece FiO2 40% RR 18 PR 118 O2Sat 96% by RCP 5
10/14/2024 at 11:25 p.m.: T-piece FiO2 40% RR 18 PR 124 O2Sat 94% by RCP 5
10/15/2024 at 00:08 a.m.: CPAP FiO2 50% RR 42 PR 123 O2Sat 91% Comments: "increased heart rate and labor breathing (working hard to breathe)" by RCP 5
10/15/2024 at 3:41 a.m.: CPAP FiO2 40% RR 39 PR 114 O2Sat 100% Comments: "increased heart rate and labor (having difficulty) breathing" by RCP 5
10/15/2024 at 8 a.m.: CPAP FiO2 40% RR 37 PR 109 O2Sat 100% by RCP 4
10/15/2024 at 1:08 p.m.: CPAP FiO2 40% RR 38 PR 113 O2Sat 100% by RCP 4
10/15/2024 at 4:25 p.m.: AC FiO2 70% RR 38 PR 123 O2Sat 91% Comments: "Patient (Patient 13) placed on AC setting due to increased work of breathing and low blood pressure. Patient using accessory muscles and mouth breathing. Orange yellow discharge from stoma (opening from the body) site noted." By RCP 4

During the same interview on 10/17/2024 at 3:50 p.m. with RCP 3, RCP 3 stated the following: Patient 13 was off ventilator and on T-piece with FiO2 40% on 10/14/2024. Patient 13 was put back on mechanical ventilator with CPAP setting on 10/15/2024 at 00:08 a.m. due to increased heart rate and labored breathing. Patient 13's respiration rate increased to 38 to 39 BPM since on CPAP. There should be communication with the physician on call at night to report Patient 13's change of respiratory status.
Patient 13 was in TIPS (Therapist-Implemented Patient-Specific) protocol (an individualized, step-by-step method implemented and monitored by respiratory care practitioners to recover independent breathing) and anytime when respiratory rate was higher than 35 BPM, the physician should be notified. Patient with prolonged high respiratory rate could have hyperventilation (breathing too quickly) and could get tired and have respiratory distress (difficulty breathing). There was a delay in communicating Patient 13's change of respiratory status to a physician. There should be collaboration between RCP and nursing staff in identifying Patient 13's change of condition. The staff should report to the physician so that the physician could give further instruction such as putting Patient 13 on AC setting (a breathing mode that helps patients by delivering support for each breath they take) to help her (Patient 13) breathe easier.

During an interview on 10/17/2024 at 3:55 p.m. with the Director of Respiratory Therapy and Rehab Services (DTRS), DTRS stated RCP 5 should have performed another respiratory assessment within an hour after Patient 13 was put back on CPAP on 10/15/2024 at 00:08 a.m. to evaluate her (Patient 13's) response to the ventilator. DTRS stated RCP 5 did not reassess Patient 13 until 3:41 a.m. (almost four [4] hours later).

During an interview on 10/18/2024 at 10:26 a.m. with the Medical Director (MDR), MDR stated the clinician (RCP) could have notified the physician on call at night for any further instruction or recommendation by physician to address Patient 13's elevated (high) respiratory rate on 10/15/2024.

During a review of the facility's policy and procedure (P&P) titled, "Therapist Implemented Patient Specific (TIPS-2) Protocol (Version-2) for Weaning from Mechanical Ventilation," dated 3/2022, the P&P indicated, "Weaning off the mechanical ventilator is the gradual withdrawal of ventilatory support ... even though the patient may meet the criteria to begin weaning, he/she may not be able to maintain stability over an extended period of time while weaning. If any of the following adverse effects occur, return the patient to the ventilator at the settings used prior to the weaning ...respiratory rate greater than 35 per minute ... if weaning parameter results are poor, contact the pulmonologist or attending physician."

During a review of the facility's policy and procedure (P&P) titled, "Vital Signs, Clinical Monitoring," dated 7/2022, the P&P indicated "Vital signs: temperature, pulse, respirations, and blood pressure ... may reveal sudden changes in patient's condition as well as, changes that occurs progressively over a period of time ... Patient can expect the nursing staff and interdisciplinary team to interpret the significance of vital signs and weight and communicate this to the physician."

During a review of the facility's "Vital Signs/ Weight Measurement/ Clinical Monitoring Quick Reference Guide," dated 6/2021, the reference guide indicated, "[the facility] policy for normal range of vital signs:

Temperature (oral 98.6/ rectal 99.6/ axillary 97.6)
Blood Pressure (120/80 to 139/89)
Respiration (16 to 20)
Heart rate (60 to 100)
Pulse Oximetry (90 to 100%)
Vital signs that fall outside the above referenced normal range are abnormal and must be verbally reported to the primary Registered Nurse or Charge Registered Nurse immediately."

During a review of the facility's policy and procedure (P&P) titled, "Assessment and Reassessment, Interdisciplinary," dated 9/2022, the P&P indicated, "the purpose of the reassessment is to determine the effectiveness of the treatment and care interventions in achieving established goals for the patient and to assist in the ongoing planning, coordination and supervision of the care of the patient ... Nursing: as frequently during the shift as the patient's condition warrants ... in general, reassessment addresses the following: review of physical and psychosocial status, changes in clinical condition, response to treatment and medical interventions ... need for additional referrals/communication to members of the multidisciplinary care team ... Respiratory Therapy Services: Patient will be reassessed when there are changes in their condition ... in general, reassessment addresses the following: response to treatment and medical interventions/ orders, response to interventions noted in the patient's plan of care, need for communication to members of the multidisciplinary care."

Based on observation, interview and record review, the facility failed to ensure a complete oxygen therapy order, to include an order for FiO2 )percentage amount of oxygen delivered), was documented, when one of 30 sampled patients (Patient 13) was placed on mechanical ventilator (an appliance for artificial respiration) with Assist Control (AC, a mode of mechanical ventilator that provides support for each breath a patient takes) setting.

This deficient practice had the potential for clinical staff to not be clear on how much oxygen to provide for Patient 13 and put Patient 13 at risk for receiving too little or too much oxygen which can lead to complications such as difficulty breathing, chest pain, dangerously low heart rate due to oxygen toxicity, etc.

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 9/21/2024, the H&P indicated, Patient 13 was admitted to the facility with diagnoses including but not limited to acute (new onset) hypoxic (deficiency in the amount of oxygen reaching the tissues) respiratory failure (condition in which not enough oxygen passes from the lungs into the blood), status post tracheostomy (an artificial opening through the neck usually for the relief of difficulty in breathing), pneumonia (lung infection) and septic shock (a body's overwhelming and life-threatening response to infection).

During a concurrent observation and interview on 10/15/2024 at 3:09 p.m. with Registered Nurse (RN) 16 in Patient 13's room, Patient 13 was on mechanical ventilator (an appliance for artificial respiration). RN 16 stated Patient 13 was on T piece (an instrument used in weaning of a patient from mechanical ventilator during spontaneous [instant] breath trials) for thirteen (13) hours but had an episode of throwing up, then she (Patient 13) was put back on mechanical ventilator.

During a concurrent interview and record review on 10/17/2024 at 3:24 p.m. with the Respiratory Care Practitioner (RCP) 3, Patient 13's physician order, dated 10/15/2024, was reviewed. The physician order indicated the following:

Indication: respiratory failure
Vent Mode (mechanical ventilator setting): AC (Assist Control, a mode of mechanical ventilator that provides support for each breath a patient takes)
Rate (a set rate in which the mechanical ventilator would deliver breaths per minute): 12
TV (Tidal Volume, the amount of air that moves into and out of the lungs during each breath): 350
FiO2 (Fraction of inspired [breath in] oxygen, the amount and percentage oxygen being delivered): blank
Peep (Positive end-expiratory [breathing out] pressure, to maintain airway pressure above atmospheric level): 5

During the same interview on 10/17/2024 at 3:24 p.m., RCP 3 stated the following: the physician order was missing FiO2 amount. The RCP should clarify with the physician how much oxygen to give to Patient 13. Without an ordered amount of FiO2, there would be concern of giving too much oxygen to the patient and could result in hyperoxygenation (a condition where the body is exposed to higher -than- normal levels of oxygen which leads to oxygen toxicity).

During an interview on 10/18/2024 at 10:35 a.m. with the Medical Director (MDR), MDR stated a mechanical ventilator order would include the following: mode of ventilator, back up rate (a set rate in which the mechanical ventilator would deliver breaths per minute), tidal volume, FiO2 and PEEP. MDR stated if the RCP saw an incomplete order, he or she could call the physician to clarify.
During a review of the facility's policy and procedure (P&P) titled, "Oxygen Therapy Weaning Guidelines," dated 2/2022, the P&P indicated, "Oxygen is considered a drug and is therefore to be ordered, dispensed and controlled as a drug. Excess or deficiency of this substance may have negative impact upon patient outcome."