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

1. The facility failed to maintain its physical plant and overall hospital environment in a manner that the safety and well-being of patients were assured by having no documented evidence of temperature and relative humidity readings in the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) and failing to include the NICU in the Annual Crucial Area Validation (air balance test - a test to ensure the HVAC [Heating, Ventilation, and Air Conditioning] system is circulating air evenly and effectively to all areas).

This deficient practice had the potential to eliminate detection of an abnormal environmental condition conducive to bacterial and fungal growth which could cause infection to immunocompromised (immune system not working properly) and vulnerable patients (individuals at risk for greater harm and poor health outcomes) especially NICU newborns, which could lead to death. (Refer to A-0063)

2. The facility failed to follow manufacturer's guidelines for proper disinfection and sterilization for five of five sampled medical equipment (NICU isolette [a clear, enclosed incubator designed to provide a controlled, warm, and germ-free environment for premature or ill newborns, maintaining their body temperature and protecting them from the outside environment], Autoclave (a sterilization machine that uses high pressure to kill microorganisms [living thing too small to see]) 1, Autoclave 2, neonatal expiratory valve (a part of a ventilator [a machine that provides breathing support for patients who cannot breathe adequately on their own], surgical instruments).

This deficient practice had the potential to lead to the spread and growth of infection to a group of vulnerable and immunocompromised NICU patients. (Refer to A-0063)

3. The facility failed to ensure its infection preventionist professionals implemented infection control measures in the NICU and Sterile Processing Department (SPD - part of a healthcare facility responsible for the thorough cleaning, disinfection, inspection, sterilization, and storage of reusable medical instruments and devices to ensure they are safe for patient use).

This deficient practice had the potential to create and develop an environment conducive for bacterial and fungal growth which could cause severe infection and death to immunocompromised and vulnerable patients. (Refer to A-0063)

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 (CoP) for Quality Assurance and Performance Improvement (QAPI - a process used to ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services, including those services furnished under contract or arrangement; and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors) was met, as evidenced by:

1. The facility failed to ensure its QAPI (a process used to ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services) maintained effective quality improvement programs for an improved health outcomes when:

a. Daily cleaning for Autoclave (a machine that utilize high-temperature steam and pressure to kill germs [living thing that can cause disease]) 1 and 2 were not conducted by Sterile Processing Department (SPD) staff per manufacturer's guidelines. Weekly cleaning and flushing for Autoclave 1 and 2 were not conducted by SPD staff per manufacturer's guidelines. Deep cleaning/scaling for Autoclave 1 and 2 in SPD were not conducted by vendor annually per manufacturer ' s guidelines.

b. Temperature and humidity monitoring in the NICU (Neonatal Intensive Care Unit - a specialized hospital unit that provides intensive, around-the-clock care for newborns who are premature, of low birth weight, or have serious health conditions requiring expert treatment and specialized equipment) unit was not done prior to 8/8/2025 per facility's policy and procedures. Annual air balancing test (a test to ensure the HVAC [Heating, Ventilation, and Air Conditioning] system is circulating air evenly and effectively to all areas) was not conducted for each units in the facility per facility's policy and procedures.

c. Infection preventionist oversight of the infection prevention program in the facility and report to QAPI concern with stains in the ceiling in neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers), missing air-balancing test in NICU, missing autoclaves annual deep cleaning, no humidity and temperature monitoring in NICU prior to 8/8/25, improper disinfectant method for isolettes (a transparent enclosed crib designed to maintain a controlled environment for newborns), in NICU, and stains in sterilized medical instruments tray in Sterilization Processing Department (SPD).

This deficient practice resulted in the facility's inability to assess and monitor necessary testing and procedures required in the facility policy and procedures and manufacturer ' s guidelines for equipment which most likely led to the development of an environment conducive for bacterial and fungal growth which could cause severe infection and even death to the immunocompromised and vulnerable patients. (Refer to A-0273)

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

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

1. The facility failed to ensure that one of 39 sampled patients (Patient 1) received timely assessment after being admitted to the hospital at the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers).

This deficient practice resulted in a delay in initial assessment of a very low birth weight extremely premature infant, who was a twin. (Refer to A-0395)

2. The facility failed to ensure three of 39 sampled patients (Patient 21, Patient 25, and Patient 29) were assessed or reassessed for pain before and after administration of pain medication per policy & procedure.

This deficient practice had the potential for ineffective pain management. (Refer to A-0398)

3. The facility failed to ensure one of two crash carts (a cart stocked with emergency medical equipment, supplies, and drugs for use by licensed health care staff when trying to resuscitate [revive someone who has lost consciousness] a patient) in the Labor & Delivery (L&D - a hospital department offering specialized care for pregnant individuals during labor, childbirth, and the immediate period after childbirth) unit were checked daily per policy & procedure.

This deficient practice had the potential for life-saving emergency equipment to be unavailable or to work incorrectly when needed. (Refer to A-0398)

4. Based on interview and record review, the facility failed to ensure documentation of a medication administered for one of 39 sampled patients (Patient 1) was done according to facility policies and procedures and current standards of care.

This deficient practice resulted in inaccurate documentation of Patient 1, who was an extremely low birth weight (a birth weight of less than 5 pounds and 8 ounces) and extremely premature newborn (born before 28 weeks when the normal length of pregnancy is 40 weeks) receiving a time critical medication for a very low blood sugar. (Refer to A-0405)

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

Based on interview and record review, the facility failed to ensure the Condition of Participation (CoP) for Physical Environment was met, as evidenced by:

1. The facility failed to ensure it maintained its physical plant (building and equipment used in the operation of the facility) and overall hospital environment in a manner that the safety and well-being of patients were assured by having water stain signs, no documented evidence of temperature and relative humidity readings in the neonatal intensive care unit (NICU), and failing to include the NICU in the Annual Crucial Area Validation (Air Balance Test - a process that involves measuring adjusting the airflow in a building's heating, ventilation, and air conditioning system to ensure correct amount of conditioned air is delivers to each space). Water intrusion and/or water leaks, as evidenced by ceiling stains, creates a favorable environment for mold to grow, mold spores can become airborne and compromise indoor air quality, exposure to mold spores can exacerbate respiratory problems, particularly in vulnerable individuals with weakened immune systems. Temperature and humidity control in hospitals is vital for preventing the spread of infections. Proper air balancing helps control the spread of airborne pathogens by ensuring adequate ventilation rates and pressure differentials.

This deficient practice resulted in the facility's failure to monitor and record the temperature, relative humidity and adequate air exchanges in one of one neonatal intensive care unit (NICU 1) which likely eliminated detection of abnormal environmental conditions conducive to bacterial and fungal growth which could cause infection to the immuno-compromised (immune system not working properly) and vulnerable patients (individuals at risk for greater harm and poor health outcomes) especially NICU newborns which can lead to death. (Refer to A-0701)

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 (CoP) for Infection Prevention and Control and Antibiotic Stewardship (a set of coordinated strategies aimed at optimizing antibiotic use to improve patient outcomes, reduce antibiotic resistance, and minimize healthcare costs) Programs was met, as evidenced by:

1. The infection prevention and control program (IPP) failed to establish and implement (carry out) facility wide policies and procedures (P&P) on methods to prevent and control infections as evidenced by,

a. The IPP did not ensure eyewash stations were not installed in locations that required employees to perform emergency flushing of the eyes in decontamination (the process of removing or neutralizing germs) sinks for one of three sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) workrooms (Sterile Processing Department decontamination workroom, SPD- an area within a health care facility that processes and controls medical supplies, devices, and equipment);

b. The IPP did not ensure hand-held cleaning brushes (a special brush used to clean reusable surgical instruments) were cleaned after each use in accordance with the manufacturer's instruction for use (IFU), for one of two sampled brushes (Brush 2).

c. The IPP did not ensure that soil linen and clean linen were stored in separate rooms in accordance with the hospital's P&P for one of one sampled nursing unit (Neonatal Intensive Care Unit, [NICU] a unit for critically ill newborn patients).

d. The IPP did not ensure reusable medical equipment was reprocessed in accordance with the manufacturer's IFU, for one of two sampled endoscopes (Endoscope 2, a reusable instrument used to inspect and treat the interior portions of the body).

e. The IPP did not ensure terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were implemented in accordance with the hospital's P&P for one of three reprocessing workrooms (SPD clean work workroom).

f. The IPP did not ensure hand hygiene was performed during patient care or handling patient equipment for three of three sampled employees (Registered Nurse 5, Registered Nurse 14 and Environmental Service Staff 1).

g. The IPP did not ensure semi-critical equipment (a device that carries breathing gas or come in contact with mucous membranes) was properly stored for three of three sampled medical devices (Semi-Critical Medical Device 1, Semi-Critical Medical Device 2, and Semi-Critical Medical Device 3).

h. The IPP did not ensure proper personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) were worn when using CaviWipes XL (the brand name for the germicidal towelettes) to clean OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) in accordance with the manufacturer's IFU for one of one sampled employee (Environmental Service Staff 1).

These failures increased the risk for injury and cross-contamination (the transfer of harmful germs from one person, object or place to another) thereby adversely affecting the health and safety of patients, visitors, and hospital personnel. (Refer to A-0749)

2. The facility failed to provide and maintain a facility wide safe and sanitary (clean) environment (what surrounds us) to avoid the potential of transmission (transferring) of infections and communicable diseases (illness spread from one person or animal to another) as evidenced by:

a. The autoclaves (Sterilizer ,a machine that utilize high-temperature steam and pressure to kill germs (living thing that can cause disease)) were not maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining(mark that is difficult to remove), black matter(material), green matter, greyish-brown matter, and debris (remains of something destroyed)were observed throughout the chamber (the internal portion of the sterilizer) for two of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 1 and Sterilizer 2).

b. Previously reprocessed (a process used to remove soil and germs and/or inactivate germs) instruments were observed with orange/red matter, brown staining, discoloration(change in color), scratches, water spots, pitting (small holes or indentation on the surface of surgical instruments), green stains, black spots, and white residue (something left over) for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2).

c. Medical devices were not reprocessed in accordance with the manufacturer's instruction for use (IFU) for one of one sampled reusable Neonatal Expiratory Valve (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components).

d. Giraffe OmniBeds (isolette- a transparent enclosed crib designed to maintain a controlled environment for newborns) were not cleaned and disinfected (clean by destroying germs) after each use in accordance with the manufacturer's IFU for two of two sampled isolettes (Giraffe OmniBed 1 and Giraffe OmniBed 2).

These failures resulted in unsafe healthcare practices and had the potential to cause further harm and prolonged hospitalization thereby increasing the risk of death to patients being cared for in the hospital. (Refer to A-0750)

3. The Infection Control Leadership (ICL) failed to perform active hospital-wide infection prevention and control rounds (routine assessments to monitor and ensure compliance with nationally recognized standards, infection prevention policies, identify potential risk, and promote patient and staff safety) when infection prevention and control rounds were not implemented, for two of two sampled departments (the Neonatal Intensive Care Unit [NICU, a unit for critically ill newborn patients] and the sterile processing department [SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment]) as evidence by,

a. The ICL did not ensure the autoclaves (steam sterilizer, a machine that utilize high-temperature steam and pressure to kill germs) were maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, green matter, greyish-brown matter, and debris were observed throughout the chamber (the internal portion of the sterilizer) for two of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 1 and Sterilizer 2);

b. The ICL did not ensure previously reprocessed instruments were not observed with orange/red matter, brown staining, discoloration, scratches, water spots, pitting (small holes or indentation on the surface of surgical instruments), green stains, black spots, and white residue for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2);

c. The ICL did not ensure medical devices were reprocessed in accordance with the manufacturer's IFU for one of one sampled reusable Neonatal Expiratory Valve (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components); and

d. The ICL did not ensure Giraffe OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) were cleaned and disinfected after each use in accordance with the manufacturer's IFU for two of two sampled isolettes (OmniBed 1 and OmniBed 2).

e. The ICL did not ensure proper personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) were worn when using CaviWipes XL (the brand name for the germicidal towelettes) to clean OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) in accordance with the manufacturer's IFU for one of one sampled employee (Environmental Service Staff 1).

f. The ICL did not ensure semi-critical equipment (a device that carries breathing gas or come in contact with mucous membranes) was properly stored for three of three sampled medical devices (Semi-Critical Medical Device 1, Semi-Critical Medical Device 2, and Semi-Critical Medical Device 3).

g. The ICL did not ensure that soil linen and clean linen were stored in separate rooms in accordance with the hospital's P&P for one of one sampled nursing unit (NICU).

This failure resulted in inadequate infection prevention program oversight of the NICU and the SPD thereby increasing the risk of avoidable disease transmission for patients and staff within the departments. (Refer to A-0772).

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 (GB - responsible for guiding the hospital ' s long-term goals and policies, and assists with strategic planning and decision-making) failed to provide oversight to ensure the facility ' s staff protects patients and provides safe and quality patient care when:

1. The facility failed to maintain its physical plant and overall hospital environment in a manner that the safety and well-being of patients were assured by having no documented evidence of temperature and relative humidity readings in the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) and failing to include the NICU in the Annual Crucial Area Validation (air balance test - a test to ensure the HVAC [Heating, Ventilation, and Air Conditioning] system is circulating air evenly and effectively to all areas).

This deficient practice had the potential to eliminate detection of an abnormal environmental condition conducive to bacterial and fungal growth which could cause infection to the immunocompromised (immune system not working properly) and vulnerable patients (individuals at risk for greater harm and poor health out come), especially NICU newborns, which could lead to death.

2. The facility failed to follow manufacturer's guidelines for proper disinfection and sterilization for five of five sampled medical equipment (NICU isolette [a clear, enclosed incubator designed to provide a controlled, warm, and germ-free environment for premature or ill newborns, maintaining their body temperature and protecting them from the outside environment], Autoclave (a sterilization machine that uses high pressure to kill microorganisms [living thing too small to see]) 1, Autoclave 2, neonatal expiratory valve (a part of a ventilator [a machine that provides breathing support for patients who cannot breathe adequately on their own], surgical instruments).

This deficient practice had the potential to lead to the spread and growth of infection to a group of vulnerable and immunocompromised NICU patients.

3. The facility failed to ensure its infection preventionist professionals implemented infection control measures in the NICU and Sterile Processing Department (SPD - part of a healthcare facility responsible for the thorough cleaning, disinfection, inspection, sterilization, and storage of reusable medical instruments and devices to ensure they are safe for patient use).

This deficient practice had the potential to create and develop an environment conducive for bacterial and fungal growth which could cause severe infection and death to immunocompromised and vulnerable patients.

Findings:

1. During a review of the "Daily (Manual) Temperature & Humidity Log," dated 8/2025, the Log indicated that the relative humidity in the NICU must be 30-60%. The Log further indicated:
a. On 8/14/2025, the humidity in the NICU was 61.4%.
b. On 8/15/2025, the humidity in the NICU was 62.8%.

During a concurrent interview and record review on 8/13/2025 at 10:54 a.m. with the Director of Facilities (DIR 2), the "Air Balance Report," dated 8/6/2025, was reviewed. The Report indicated NICU and NICU Isolation #2 did not meet the California Mechanical Code minimum for air changes per hour (ACH - how many times the air in a room or building is completely replaced with fresh outside air in one hour). The NICU had an Actual ACH of 5.41, instead of the required minimum of 6 ACH, and NICU Isolation #2 had an Actual ACH of 0, instead of the required ACH of 12. DIR 2 confirmed that NICU Isolation #2 having an Actual ACH of 0 was "basically saying" there was no air exchange in that area.

During an interview on 8/13/2025 at 11:34 a.m. with DIR 2, DIR 2 stated that NICU Isolation #2 having an Actual ACH of 0 was because of the exhaust fan in that area not working. DIR 2 further stated that the NICU was not included in the manual "Temperature, Humidity, and Air Pressure Daily Logs" until 8/2025, and that the Facilities team began physically rounding daily in the NICU on 8/8/2025. DIR 2 confirmed there was no in-house log of temperature or humidity readings in the NICU prior to 8/8/2025.

During an interview on 8/13/2025 at 3:15 p.m. with DIR 2, DIR 2 stated that he discovered the NICU was not included in the 12/ 2024 annual air balance testing when a third-party construction team requested the report for pre-construction planning on 5/8/2025. The next annual air balance test would not occur until 12/2025.

During an interview on 8/14/2025 at 1:51 p.m. with the Senior Manager of Infection Prevention (SMIP), the SMIP stated it was important to monitor temperature and humidity because high humidity creates a moist environment which promotes fungus and mold growth; additionally, high temperatures could increase humidity. The SMIP further stated it was important to monitor hourly air changes to ensure air was being filtered effectively through the HVAC system due to the "microbial contaminants"(an unwanted microorganism introduced into a culture, specimen, or environment where it is not intended to be) in the air.

During an interview on 8/15/2025 at 3:33 p.m. with the Chief Executive Officer (CEO), the CEO stated that the function of the Governing Body (GB) was to ensure that the facility provided safe and quality patient care. The CEO confirmed that the GB ensured the facility was compliant with all the Conditions of Participation. The CEO stated he was unaware of the infection control and physical environment issues until this week and there was a breakdown in reporting up to the GB. The CEO further stated that the GB was ultimately responsible for the entire facility.

During a review of the facility ' s policy and procedure (P&P), titled "Critical Air Environments," last revised 4/2023, the P&P indicated, "Facilities and/or clinical staff shall monitor and record temperature, relative humidity, and verify the pressure relationship in areas designated as high risk by this policy and documented by the individual ministry daily. ... Facilities shall at a minimum conduct annual testing and balancing of critical areas for air change rates and pressurization."

During a review of the facility ' s "Plan for the Provision of Care and Organization Performance Improvement," dated 2021, the Plan indicated, "The Governing Body, Senior Management, Medical Staff Officers, and the Nurse Executive of [Facility Name] have the overall responsibility and accountability for the quality of care and services provided by the Medical Center."

2. a. During an observation on 8/13/2025 at 1:58 p.m. in the Neonatal Intensive Care Unit (NICU), Environmental Services Staff (EVS) 1 cleaned a Giraffe OmniBed (isolette - a clear, enclosed incubator designed to provide a controlled, warm, and germ-free environment for premature or ill newborns, maintaining their body temperature and protecting them from the outside environment) in the NICU with CaviWipesXL disinfecting towelettes in preparation for the next newborn NICU patient. EVS 1 used one wipe to clean the isolette.

During an interview on 8/13/2025 at 3:05 p.m. with EVS 1, EVS 1 stated he had cleaned and disinfected the OmniBeds and the equipment was ready for patient use.

During an interview on 8/13/2025 at 3:12 p.m. with the SMIP and IP 2, the SMIP stated she did not identify a breach in the Caviwipes XL use. The SMIP was observed reading the towelette label and stated that the manufacturer's IFU indicated CaviWipes XL was a two-step disinfectant product. The SMIP stated the first wipe was for cleaning the Omnibed and a second wipe should have been used to disinfect the Omnibed. The SMIP stated she was unaware that the CaviWipes were a two-step disinfection process. The SMIP stated the Infection Prevention Program (IPP) was responsible for ensuring safe infection prevention and control practices and she did not review the cleaning and disinfection procedures for patient safety prior to implementing the practice.

During an interview on 8/15/2025 at 3:33 p.m. with the Chief Executive Officer (CEO), the CEO stated that the function of the Governing Body (GB) was to ensure that the facility provided safe and quality patient care. The CEO confirmed that the GB ensured the facility was compliant with all the Conditions of Participation. The CEO stated he was unaware of the infection control and physical environment issues until this week and there was a breakdown in reporting up to the GB. The CEO further stated that the GB was ultimately responsible for the entire facility.

During a review of the manufactuerer's instructions for use (IFUs) titled "Giraffe OmniBed User Manual," dated 2016-2014, the User Manual indicated, "Before you use the device for the first time and after each patient use, clean and disinfect the device and accessories as specified in the instructions that follow ... Cleaning and disinfecting the device is required between each patient use ... Follow manufacturer ' s instructions for solution concentration, method of surface application, and contact time required to achieve disinfection. Validated cleaning and disinfecting solutions are chemically compatible and have been validated to be effective in cleaning and/or disinfecting the device:
CaviCide / CaviWipes / CaviWipesXL
- Purpose: Cleaning for all parts, Disinfectant for all parts
- Disinfection contact duration: 3 or 6 minutes depending on the part"

During a review of the manufacturer's IFUs titled "CaviWipes XL," dated 4/18/2023, the IFU indicated, "For use as a disinfectant: CaviWipes XL is a two-step disinfectant product. One wipe is required to preclean then the second wipe is required to disinfect."

During a review of the facility's policy and procedure (P&P) titled "Infection Prevention: Infection Prevention Program Plan and Risk Assessment," last reviewed 5/2024, the P&P indicated, "Responsibilities include, but are not limited to: Coordinating with Infection Prevention to plan and implement educational or in-service programs on the prevention of infections ... Assuring that healthcare workers use safe and effective practices for all cleaning, disinfection, and sterilization, as appropriate for their job functions ... [Facility Name] has developed specific policies and procedures to address the hospital environment including:
...
3. Techniques for safely cleaning and disinfecting the environment.
...
5. Sterile processing and evaluation of failures."

During a review of the facility ' s "Plan for the Provision of Care and Organization Performance Improvement," dated 2021, the Plan indicated, "The Governing Body, Senior Management, Medical Staff Officers, and the Nurse Executive of [Facility Name] have the overall responsibility and accountability for the quality of care and services provided by the Medical Center."

b. During an observation on 8/14/2025 at 8:29 a.m. in the Sterile Processing Department (SPD - part of a healthcare facility responsible for the thorough cleaning, disinfection, inspection, sterilization, and storage of reusable medical instruments and devices to ensure they are safe for patient use), SPD Tech 1 was standing at the decontamination sink and placing the medical device (neonatal expiratory valve) into an enzymatic solution (a special cleaner used in healthcare settings). SPD Tech 1 was observed fully submerging the device into the solution before proceeding with the cleaning process. SPD Tech 1 proceeded to turn and reposition the device in the solution. SPD Tech 1 removed the device from the solution and proceeded to rinse the solution off the device. SPD Tech 1 was observed preparing the medical device for the washer-disinfector (a machine that uses a combination of mechanical, chemical, and thermal processes to reprocess surgical instruments) process. SPD 1 was not observed using a syringe to flush the enzymatic solution through the valve's ports.

During an observation on 8/14/2025 at 10:52 a.m. in the SPD, the following were observed:
a. Autoclave 1 had green matter on the inside of the door and was visibly dirty inside with brown and white matter throughout the chamber.
b. Autoclave 2 had grayish-brown residue throughout the chamber and debris in the chamber door.
c. Multiple surgical instruments contained brown staining, scratches, pitting, green stains, black stains, and water stains.

During an interview on 8/15/2025 at 9:15 a.m., the Director of Surgical Services (DIR 5) stated that the SPD staff performed tests to ensure effectiveness of the autoclaves and to confirm instruments were sterile, and they had met those parameters. DIR 5 also stated the SPD followed AAMI (Association for the Advancement of Medical Instrumentation - an organization that focuses on improving patient safety and healthcare outcomes by advancing the safety and effectiveness of medical technology and develops and publishes standards, guidance, and other resources for the entire lifecycle of medical devices) standards for sterilizing the instruments.

In the same interview, DIR 5 stated the autoclave manufacturer's "Instructions For Use" (IFUs) indicated there were daily and weekly cleaning tasks for the autoclaves to be done by the SPD technicians; however, DIR 5 confirmed there was no log documenting that these tasks were completed and they were unable to prove that they were done. The autoclaves were also scheduled for an annual deep clean every January to be done by the vendor; however, the vendor did not perform the deep cleaning January 2025. DIR 5 stated they failed to follow up with the vendor on their end and it was their responsibility to do so.

In the same interview, DIR 5 stated there was no documentation that showed the SPD staff were trained in reprocessing the neonatal expiratory valve. DIR 5 stated the product was introduced to the hospital four years ago and the SPD staff did not receive formal training on reprocessing the neonatal expiratory valve. DIR 5 stated SPD staff were instructed to follow the manufacturer's IFU accessed through a third-party database. DIR 5 stated that the manufacturer's IFU available in the database did not specify that an enzymatic solution should be flushed through the expiratory valve port using a 20 milliliter (ml, unit of measurement) syringe. DIR 5 stated the manual provided with the valve indicated that the valve ports should be cleaned with a syringe. DIR 5 stated she was not aware that the IFU provided in the database differed from the manual that was delivered with the product. DIR 5 stated the enzymatic solution should have been flushed through the valve ports in accordance with the manufacturer's manual that was delivered with the product.

During an interview on 8/15/2025 at 3:33 p.m. with the Chief Executive Officer (CEO), the CEO stated that the function of the GB was to ensure that the facility provided safe and quality patient care. The CEO confirmed that the GB ensured the facility was compliant with all the Conditions of Participation. The CEO stated he was unaware of the infection control and physical environment issues until this week and there was a breakdown in reporting up to the GB. The CEO further stated that the GB was ultimately responsible for the entire facility.

During a review of the manufacturer's instructions for use (IFUs) of the Amsco EAGLE Series 3000 sterilizer, dated 3/26/1998, the IFUs indicated, "Daily clean chamber ... wash inside of chamber and loading equipment with a mild detergent solution such as ... weekly flush chamber drain strainer ... Rinse drain with hot solution of trisodium phosphate ... Yearly descaling (minimum recommended frequency). Have a qualified service person perform these procedures."

During a review of the manufacturer's manual of the neonatal expiratory valve titled, "Infinity Acute Care System," dated 2017, the manual indicated, "Before the contact time begins and after it has elapsed, fit a syringe (A) containing 20 mL of solution to the ejector channel (B) [opening in the valve]. Inject and extract the solution several times with the syringe."

During a review of the facility's policy and procedure (P&P) titled "Infection Prevention: Infection Prevention Program Plan and Risk Assessment," last reviewed 5/2024, the P&P indicated, "Responsibilities include, but are not limited to: Coordinating with Infection Prevention to plan and implement educational or in-service programs on the prevention of infections ... Assuring that healthcare workers use safe and effective practices for all cleaning, disinfection, and sterilization, as appropriate for their job functions ... [Facility Name] has developed specific policies and procedures to address the hospital environment including:
...
3. Techniques for safely cleaning and disinfecting the environment.
...
5. Sterile processing and evaluation of failures."

During a review of the facility's "Plan for the Provision of Care and Organization Performance Improvement," dated 2021, the Plan indicated, "The Governing Body, Senior Management, Medical Staff Officers, and the Nurse Executive of [Facility Name] have the overall responsibility and accountability for the quality of care and services provided by the Medical Center."

3. During an observation on 8/12/2025 at 2:20 p.m. in the Neonatal Intensive Care Unit (NICU - a hospital ward equipped and staffed to provide intensive care to dangerously ill or premature newborn babies), there were brown/orange-colored stains on the interior cabinet surface next to the black cast iron drainpipe in the handwashing sink located between Bay 18 and 19.

During an observation on 8/12/2025 at 2:45 p.m. in the NICU Supply and Equipment Storage Room, there were water stains on four ceiling tiles.

During an observation on 8/13/2025 at 1:58 p.m. in the Neonatal Intensive Care Unit (NICU), Environmental Services Staff (EVS) 1 cleaned a Giraffe OmniBed (isolette) in the NICU with CaviWipesXL disinfecting towelettes in preparation for the next newborn NICU patient. EVS 1 used one wipe to clean the isolette. The instructions on the label of the CaviWipesXL container indicated, "CaviWipesXL is a two-step disinfectant product. One wipe is required to pre-clean then a second wipe is required to disinfect. Repeated use of the product may be required to ensure that the surface remains visibly wet for 3 minutes at room temperature."

During an interview on 8/13/2025 at 3:47 p.m. with the Senior Manager of Infection Prevention (SMIP), the SMIP stated she had not reviewed the manufacturer's guidelines for disinfecting the isolettes prior to implementing training for the EVS staff.

During an interview on 8/13/2025 at 5:16 p.m. with the SMIP, the SMIP stated the EVS Manager was assigned to put the education material together on 8/11/2025 for the EVS staff on how to clean the isolette with the CaviWipesXL without being provided with resource materials. The expectation was that the EVS Manager was responsible for giving education material to the Senior Manager to review, and the Senior Manager stated she failed to review and approve the educational content prior to roll out to the EVS staff. The Senior Manager also stated she did not follow up with the EVS Manager related to the cleaning process.

During an interview on 8/14/2025 at 1:51 p.m. with the SMIP, the SMIP stated it was important to monitor temperature and humidity because high humidity creates a moist environment which promotes fungus and mold growth; additionally, high temperatures could increase humidity. The SMIP further stated it was important to monitor hourly air changes to ensure air was being filtered effectively through the HVAC system due to the microbial contaminants in the air.

During an interview on 8/18/2025 at 10:44 a.m. with Infection Preventionist (IP) 2, IP 2 stated that the IP team performed daily rounds in the facility focusing on things such as hand hygiene (the practice of cleaning hands to remove dirt, germs, and pathogens), PPE (personal protective equipment), Foley catheter (a flexible tube inserted through the urethra into the bladder to drain urine continuously) and central line (a thin flexible tube that is inserted into a large vein, typically in the neck, chest, or groin, and threaded into a central vein near the heart) audits. The IP team participated in Environment of Care rounds with Facilities and EVS every week but focused only on one unit during each round; NICU was audited during these rounds two to three times a year. The environment concerns such as the staining on the ceilings and sinks were noted during Environment of Care rounds and given to the Patient Safety Officer to create work orders for, but she stated it was not the IP team's responsibility to follow up on whether the work orders were completed. The environmental concerns identified were not followed up for resolution.

During an interview on 8/15/2025 at 3:33 p.m. with the Chief Executive Officer (CEO), the CEO stated that the function of the GB was to ensure that the facility provided safe and quality patient care. The CEO confirmed that the GB ensured the facility was compliant with all the Conditions of Participation (CoPs). The CEO stated he was unaware of the infection control and physical environment issues until this week and there was a breakdown in reporting up to the GB. The CEO further stated that the GB was ultimately responsible for the entire facility.

During a review of the facility ' s job description (JD) for the "Infection Preventionist" position, the JD indicated, "All Infection Preventionists (IPs) are accountable for implementation of and compliance with policies, practices, and processes of the infection prevention program at the facility, region, division and system level. ... Conducts routine infection prevention tasks (surveillance, rounding, consultation, education) independently. ... Identify and address complex infection prevention concerns, escalating issues as appropriate for decision making. ... Develops infection prevention educational content and educates caregivers regarding infection prevention topics."

During a review of the facility ' s job description (JD) for the "Senior Manager, Infection Prevention" position, the JD indicated, "The Senior Manager of Infection Prevention is the subject matter expert in the epidemiology and natural history of infectious processes and pathogens, recognition of clusters and risk factors for infection, and methods of breaking the chain of infection ... Responsible for facility level prevention decision making."

During a review of the facility ' s policy and procedure (P&P) titled "Infection Prevention: Infection Prevention Program Plan and Risk Assessment," last reviewed 5/2024, the P&P indicated, "Surveillance and monitoring includes but not limited to: ... Monitoring construction/renovation projects in conjunction with Plant Operations, Environment of Care, Safety, and Risk Management ... Conducting or facilitating Infection Prevention and Control environmental and isolation rounds ... Reviewing ongoing and regular review of surveillance data ... [The facility] has developed specific policies and procedures to address the hospital environment including:
1. Ventilation, temperature, humidification, and water control issues, including measures taken to maintain a safe environment during internal or external construction or renovation.
2. Maintaining safe air handling systems in areas of special ventilation such as operating rooms, airborne isolation rooms.
3. Techniques for safely cleaning and disinfecting the environment.
...
5. Sterile processing and evaluation of failures."

During a review of the facility ' s "Plan for the Provision of Care and Organization Performance Improvement," dated 2021, the Plan indicated, "The Governing Body, Senior Management, Medical Staff Officers, and the Nurse Executive of [Facility Name] have the overall responsibility and accountability for the quality of care and services provided by the Medical Center."

Based on observation, interview, and record review, the facility failed to ensure its Quality Assurance and Performance Improvement (QAPI, a process used to ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services, including those services furnished under contract or arrangement; and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors) maintained effective quality improvement programs for an improved health outcomes when:

1. Daily cleaning for autoclave,(a machine that utilize high-temperature steam and pressure to kill germs [living thing that can cause disease]) 1 and 2 were conducted by Sterile Processing Department (SPD) staff per manufacturer's guidelines. Weekly cleaning and flushing for autoclave 1 and 2 were conducted by SPD staff per manufacturer's guidelines. Deep cleaning/scaling for autoclave 1 and 2 in SPD were conducted by vendor annually per manufacturer's guidelines

2. Temperature and humidity monitoring in neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) unit prior to 8/8/2025 per facility's policy and procedures. Annual air balancing test were conducted for each unit in the facility per facility's policy and procedures.

3. Infection preventionist oversight of the infection prevention program in the facility and report to QAPI concern with stains in the ceiling in NICU unit, missing air-balancing test in NICU, missing autoclaves annual deep cleaning, no humidity and temperature monitoring in NICU prior to 8/8/25, improper disinfectant method for isolettes (a transparent enclosed crib designed to maintain a controlled environment for newborns) in NICU, and stains in sterilized medical instruments tray in Sterilization Processing Department (SPD).

This deficient practice resulted in the facility's inability to assess and monitor necessary testing and procedures required in the facility policy and procedures and manufacturer's guidelines for equipment which most likely led to the development of an environment conducive for bacterial and fungal growth which can cause severe infection and even death to the immuno-compromised and vulnerable patients.

Findings:

1. During an observation on 8/14/25 at 10:52 a.m., in the Sterile Processing Department (SPD), the following were observed:
a. Autoclave 1 (a machine that utilize high-temperature steam and pressure to kill germs (living thing that can cause disease) had green matter on the inside of the door and was visibly dirty inside with brown and white matter throughout the chamber.
b. Autoclave 2 had grayish-brown residue throughout the chamber and debris in the chamber door.

During an interview on 8/15/25 at 9:15 a.m., with the Director of Surgical Services (DSS) stated that they ensured effectiveness of the autoclaves and confirm instruments were sterile (clean) and they have met those parameters. They followed the Association for the Advancement of Medical Instrumentation (AAMI) standards for sterilizing (to make it free from living microorganisms) the instruments. The Instructions for Use (IFU)s for the autoclaves indicated there were daily and weekly cleaning tasks for the autoclaves to be done by the instrument technicians.There was no documentation that these tasks were completed, and they could not prove that they were done. The autoclaves were also scheduled for an annual deep clean every January to be done by the vendor (company that sells good or services); however, the vendor did not perform the deep cleaning on January 2025. The Director stated they failed to follow up with the vendor on their end and it was their responsibility.

During an interview on 8/15/25 at 3:15 p.m., with the Senior Manager of Infection Prevention (IP1) stated that the cleaning of the autoclaves was not reported to the Infection Control committee by the Director of Facilities. The Infection Preventionist (IP) would report to Quality Assurance and Performance Improvement (QAPI- a process used to ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services), on cleaning and infection control issues with the environment and equipment in the facility. The Infection Control committee was not made aware that the vendor had not done its annual deep cleaning which could have pushed the issue with the QAPI for action.

During an interview on 8/18/25 at 10:44 a.m., with Infection Preventionist (IP2) stated that the that the IP team would perform daily rounds (tour of the facility to assess staff following infection control guidelines) focusing on things such as hand hygiene, Personal Protective Equipment (PPE-equipment use to minimize exposure to hazards), Foley (tube use to drain urine from the bladder) and central line (long thin tube use to insert into vein that provides long-term access for administering medication)audits.

IP participated in Environment of Care (EOC) rounds with facilities and Environmental Services (EVS) every week but focus only on one unit; neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) was audited during these rounds 2-3 times a year. IP2 also stated that they did not look into the autoclaves or look at the instruments in the SPD, that she missed the staining (mark that is difficult to remove), and scratches on the instruments, and no one notified them of these issues, so they did not investigate.

During an interview on 8/18/25 at 10:46 a.m., with the Senior Manager of Infection Prevention (IP1) stated ultimately she had an oversight of the infection prevention program in the facility. The Senior Manager of Infection Prevention confirmed that these issues fall under the infection prevention program and they had not been discussed by the Infection Control committee yet.

A review of manufacturer guideline of Amsco (Brand that supplies medical equipment) EAGLE@ Series 3000, dated 3/26/98 Rev.10, indicated:
"1. Daily clean chamber ...wash inside of chamber and loading equipment with a mild detergent solution such as...
2. Weekly flush chamber drain strainer ... ...Rinse drain with hot solution of trisodium phosphate..
3. Yearly descaling (minimum recommended frequency). Have a qualified service person perform these procedures."

2. During an interview on 8/13/25 at 3:15 p.m., the Director of Facilities (DF) stated the testing Air Balance Scope changed in 2024, that a few areas were not included in the annual air balancing test (process to test and adjusting the heat, ventilation, and air conditioning (HVAC) system). Neonatal intensive care unit (NICU- a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) was one of the areas not included. It was discovered on 5/8/25 that the NICU was not included in the December 2024 annual Air Balance Testing.

During an interview on 8/15/25 at 5:55 p.m., with the Director of Facilities (DF), DF stated an Air Balance Test was done by a general contractor at close of project for NICU approximately the end of 2023; the next Air Balance Test should be done by December 2024 with the oversight of NICU. Currently, the Air Balance not being done was not reported to QAPI. DF stated that his role with QAPI was to insure they were maintaining infection control. DF stated he reported to the Infection Preventionist (IP) on infection control issues, that would include Air Balance Temperature and Humidity.

During an interview on 8/13/25 at 11:34 a.m. with the DF stated that Temperature and Relative Humidity(measure how much moisture in the air) in house rounding was supposed to be done three times a day in NICU all Operating Room (OR)s, Labor and Delivery (L&D-provide care for pregnant women in childbirth),Cath Lab (specialized area equipped to perform procedures related to the heart and blood vessels), and Electro-physiology (EP- diagnosis and treat problem with the heart electrical system). Concurrently, NICU was not included in the Temperature, Humidity, and Air Pressure Daily Logs that the daily physical rounding did not start in the NICU until 8/8/25.

During an interview on 8/13/25 at 3:14 p.m. with the DF stated there was no in house log of temperature or humidity in NICU before 8/8/25.

During an interview on 8/15/25 at 2:59 p.m., with the Executive Director of Quality (EDQ) of Quality stated that the QAPI committee was not notified of the missing air balance tests since December 2024, the monitoring of temperature and humidity, and the cleaning of the autoclaves. The QAPI Committee has not required from the Director of facilities the results of the air balance test, monitoring of temperature and humidity in the NICU and the cleaning of the Autoclaves in the Sterilizing Processing Department (SPD). The Director of Facilities is in charge of the Environment of Care Committee who reports to QAPI for what are mandated monitoring, testing annually and cleaning of equipment on a regular basis per manufacturer's guidelines. The Director of Facilities failed to report up to QAPI regarding the issues with the air balance tests, during the Environment of Care committee reporting during QAPI's meeting in June 2025. Because of this failure of the Director of Facilities to update and report to QAPI the issues, he was not aware of those issues until today.

Review of facility's policy Technical Standards 480, titled Critical Air Environments, with an implementation Date of October, 2020 and last revised April 2023 indicated, Facilities shall at a minimum conduct annual testing and balancing of critical areas for air change rates and pressurization.

Reviewed facility's policy and procedure, titled, Critical air Environments, policy number PSJHRESO1400, indicated that Facilities and/or clinical staff shall monitor and record temperature, relative humidity, and verify the pressure relationship in area designated as high risk by this policy and documented by the individual ministry daily..... Facilities shall at minimum conduct annual testing and balancing of critical areas or air change rates and pressurization.

3. During observation and records review from 8/12/25-8/14/25, the following infection control concerns were identified:
1. Multiple water stains on ceiling and sinks in NICU, L&D, and Mother/Baby.
2. EVS staff not cleaning the Giraffe OmniBed isolettes (infant incubator, a clear plastic-enclosed crib used in a Neonatal Intensive Care Unit (NICU) to provide a warm, controlled, and protective environment for premature and critically ill newborns) in the NICU per both the isolette manufacturer's instructions as well as the disinfectant product manufacturer's instructions.
3. Autoclave 1 in the Sterile Process Department (SPD) had green matter on the inside of the door and was visibly dirty inside with brown and white matter throughout the chamber.
4. Autoclave 2 in the SPD had grayish-brown residue throughout the chamber and debris in the chamber door.
5. Reprocessing in the SPD for the neonatal expiratory valve from a ventilator in the NICU was not performed correctly according to manufacturer's guidelines.
6. Multiple surgical instruments in the SPD contained brown staining, scratches, pitting, green stains, black stains, and water stains that IP did not conduct surveillance, rounding for infection prevention.
7. Neonatal intensive care unit (NICU); Cardio-Vascular unit, Operation Room 1 and Operation Room 2 in Cardiac catheterization lab, and Electrophysiology room were missing the annual air balancing testing that was last conducted in the rest of the facility in December 2024.
8. 2 areas in the NICU failed the air balance test in 8/2025. The actual reading of air change per hour from NICU isolation 2 is 0. IP should monitor the temperature and humidity in NICU.
9. There was no documentation that temperature and humidity was documented in the NICU prior to 8/6/25, which should be done 3 times per day using the FLUKE (manual device to check temperature and humidity).

A review of the job description for the "Infection Preventionist" indicated, "All Infection Preventionists (IPs) are accountable for implementation of and compliance with policies, practices, and processes of the infection prevention program at the facility, region, division and system level. ... Conducts routine infection prevention tasks (surveillance, rounding, consultation, education) independently. ... Identify and address complex infection prevention concerns, escalating issues as appropriate for decision making. ... Develops infection prevention educational content and educates caregivers regarding infection prevention topics."

A review of the job description for the "Senior Manager, Infection Prevention" indicated, "The Senior Manager of Infection Prevention is the subject matter expert in the epidemiology and natural history of infectious processes and pathogens, recognition of clusters and risk factors for infection, and methods of breaking the chain of infection ... Responsible for facility level prevention decision making."

During an interview on 8/13/25 at 3:47 p.m., with the Senior Manager of Infection Prevention (IP1) stated she had not reviewed the manufacturer's guidelines for disinfecting the isolettes prior to implementing training for the Environmental Services (EVS) staff.

During an interview on 8/13/25 at 5:16 p.m., with the Infection Preventionist (IP1) stated the EVS Manager was assigned to put the education material together on 8/11/25 for the EVS staff on how to clean the isolette with the CaviWipesXL (extra-large premoistened towelette for cleaning) without being provided with resource materials. The expectation was that the EVS Manager was responsible for giving education material to the Senior Manager to review, and the Senior Manager stated she failed to review and approve the educational content prior to roll out to the EVS staff The Senior Manager also stated she did not follow up with the EVS Manager related to the cleaning process.

During an interview on 8/14/25 at 2:02 p.m., with the IP1 stated it was important to monitor humidity because high humidity and moisture promoted fungus and growth. The air was getting filtered thru the HVAC is important since the air can be filtered in order to have safe environment because the microbial contaminants in the air can be filtered out. High temperature was also important to monitor because it can increase the humidity levels. But the facility failed to monitor if humidity and high temperature were within normal ranges.

During an interview on 8/18/25 at 10:44 a.m., with Infection Preventionist (IP2) stated that the that the IP team performs daily rounds focusing on things such as hand hygiene, PPE, Foley and central line audits. IP participates in Environment of Care (EOC) rounds with facilities and EVS every week but focus only on one unit; NICU is audited during these rounds 2-3 times a year. IP2 also stated that they did not look into the autoclaves or look at the instruments in the SPD, that she missed the staining and scratches on the instruments, and no one notified them of these issues so they did not investigate.

During an interview on 8/18/25 at 10:46 a.m., with the Senior Manager of Infection Prevention (IP1) stated ultimately she has an oversight of the infection prevention program in the facility. The Senior Manager of Infection Prevention confirmed that these issues fall under the infection prevention program and they had not been discussed by the Infection Control committee yet.

During an interview on 8/15/25 at 2:59 p.m., with the Executive Director of Quality, EDQ stated the function of QAPI was to have quality and patient safety oversight of the organization and identify gaps in quality and patient safety to ensure they are addressed and corrected. The Director confirmed QAPI provided surveillance over the entire hospital and its services and that they should have had oversight over the issues identified with infection control and environment of care and ensure that there is monitoring in place for these issues.

During an interview on 8/15/25 at 3:33 p.m., with the Chief Executive Officer (CEO) confirmed there was a breakdown in reporting of these issues up through the committees to QAPI.

A review of the facility's policy and procedure titled "Quality Assurance Performance Improvement and Patient Safety Plan", last approved 6/2025, indicated, "To establish a planned, systematic, and interdisciplinary approach to improving the care, treatment and services provided .....the quality committee of the board bears ultimate accountability, authority, and responsibility for the quality, safety, experience, and value of all patient care services ...collecting data on performance for processes as defined in the organization's infection control program, environment of care program, and patient safety program ....the organization will prioritize those performance improvement activities that address processes that focus on ....affect health outcomes, patient safety, and quality of care ..."

Based on interview and record review, the facility failed to ensure that one of 39 sampled patients (Patient 1) received timely assessment (evaluate) after being admitted to the hospital at the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers).

This deficient practice resulted in a delay in initial assessment of a very low birth weight extremely premature infant, who was a twin.

Findings:

During a review of Patient 1's "Face Sheet" (a document that summarizes key information about a patient), dated 7/9/2025, the Face Sheet indicated Patient 1 was admitted with a diagnosis, which included newborn twin.

During a concurrent interview and record review on 8/14/2025 at 9:57 a.m. with the Assistant Nurse Manager of NICU (ANM 1), Patient 1's delivery record, dated 7/9/2025, was reviewed. ANM 1 stated the following:
1. Patient 1 was delivered by cesarean section (a surgical procedure that involves delivering a baby through incisions in the birth parent ' s abdomen and uterus) and born on 7/9/2025 at 3:46 p.m.
2. Patient 1's APGAR scores (a test given to newborns soon after birth, using a 0 to 10 point scale based on heart rate, respiratory effort, muscle tone, response to stimulation, and skin color) were 8/10 at one minute, 9/10 at five minutes, and 9/10 at 10 minutes of life.
3. Patient 1 received resuscitation (a set of emergency procedures used to support newborns with a goal to establish and maintain adequate ventilation and oxygenation) by the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) team, which included delivery of continuous positive airway pressure (CPAP - delivery of pressurized air through a mask over the nose and/or mouth to keep the lungs open), positive pressure ventilation (PPV - a crucial technique used in neonatal resuscitation when a baby is not breathing effectively or has a low heart rate), oxygen, and intubation (the process of inserting an endotracheal tube to deliver oxygen to the lungs).

During a review of Patient 1's nursing flowsheet (document used to record assessments), dated 7/9/2025, the flowsheet indicated Patient 1 was admitted to the NICU at 4:30 p.m.

During a review of Patient 1's nursing note, dated 7/10/2025, the nursing note indicated Patient 1 was admitted to the NICU intubated (there was a tube inserted into the windpipe through the mouth to keep the lungs open) from delivery (birth) and was placed on a ventilator (breathing machine).

During a concurrent interview and record review on 8/14/2025, at 4:30 p.m. with ANM 1, Patient 1's nursing flowsheet for initial assessment, dated 7/15/2025, was reviewed. ANM 1 stated the following:
1. Patient 1 was born on 7/9/2025 at 3:46 p.m.
2. Patient 1 was transferred from the Labor and Delivery (L&D - a hospital department offering specialized care for pregnant individuals during labor, childbirth, and the immediate period after childbirth) unit to NICU at 4:30 p.m.
3. Patient 1's initial assessment was done at 8:00 p.m.

ANM 1 further stated initial assessment was normally done within two hours of admission. Patient 1's initial assessment should have been done around 6:30 p.m., but it was not done until the next shift at 8:00 p.m.

During a review of Patient 1's head-to-toe assessments (full body examination), dated 7/10/2025, ANM 1 stated head-to-toe assessments were done every three hours if stable. ANM 1 stated if the patient is unstable, head-to-toe assessments were done every six hours, according to the Tiny Baby Bundle protocol (practices for caring for a very small bay in the NICU).

During an interview and record review on 8/15/2025 at 9:20 a.m. with Registered Nurse (RN) 10, Patient 1's nursing flowsheet, dated 7/10/2025, was reviewed. RN 10 stated Patient 1 was assessed at 8:00 a.m. and 9:00 p.m. Patient 1 was not assessed every six hours in accordance with the Tiny Baby Bundle Protocol.

A review of the facility's Tiny Baby Bundle Protocol, dated 10/31/2024, indicated the following:
1. From birth to the tenth day of life, goals included preventing bleeding in the head, supporting lung transition/protection, heart stability, initiate feedings, temperature stability, prevent infection, and promoting family bonding.
2. Cluster (group) the care every six hours with examinations done at 8 am and 8 pm.
3. Do not remove the thermal (heat) mattress and plastic wrap used in the delivery room, until the temperature is normal.
4. Ensure skin protection with full skin inspection every six hours.
5. Position changes, according to nursing standards of care, for infants using the log roll method.

A review of the facility's NICU Standards of Care, dated 7/2024, indicated the following:
1. The NICU follows the standards of patient care from the American Academy of Pediatrics (AAP - organization that provides evidence-based recommendations for pediatric health) and American College of Obstetricians and Gynecologists (ACOG - organization that provides evidence-based guidance for obstetric and gynecologic care to promote optimal patient care).
2. All infants shall receive a physical assessment by a registered nurse within two hours of admission and reassessments every shift, with vital signs (physiologic measurements that indicate a person's basic bodily functions, including temperature, pulse rate, breathing rate, blood pressure, and oxygen saturation).

Based on interview and record review, the facility failed to ensure its licensed nurses adhered to the facility's policies and procedures when:

1. The facility failed to ensure three of 39 sampled patients (Patients 21, Patient 25, and Patient 29) were assessed (evaluate) or reassessed for pain before and after administration of pain medication per policy & procedure.

This deficient practice had the potential for ineffective pain management.

2. The facility failed to ensure one of two sampled crash carts (a cart stocked with emergency medical equipment, supplies, and drugs for use by licensed health care staff when trying to resuscitate [revive someone who has lost consciousness] a patient) in the Labor & Delivery (L&D - a hospital department offering specialized care for pregnant individuals during labor, childbirth, and the immediate period after childbirth) unit were checked daily per policy & procedure.

This deficient practice had the potential for life-saving emergency equipment to be unavailable or to work incorrectly when needed.

Findings:

1. a. During a review of Patient 21's "History & Physical" (H&P - a formal and complete assessment of the patient and the problem), dated 7/28/2025 at 10:09 p.m., the H&P indicated Patient 21 was admitted to L&D for decreased fetal movement (not feeling the baby move while the person is pregnant) and repeat Cesarean section (a surgical procedure to deliver a baby through incisions in the mother's abdomen and uterus).

During a review of 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 7/29/2025, the MAR indicated Patient 21 was given ibuprofen (a type of pain medication) orally (through the mouth) at 11:09 a.m. for a reported pain intensity of three out of 10 on the numeric pain scale (a method of measuring pain intensity by asking a patient to rate their pain on a scale from zero, which is no pain, to ten, which is the worst possible pain).

During a concurrent interview and record review on 8/13/2025 at 2:39 p.m. with Registered Nurse (RN) 1, Patient 21's "Vital Signs" (measurements that provide essential information about a person's basic bodily functions, including body temperature, heart rate, breathing rate, blood pressure, oxygen saturation [amount of oxygen in the blood], and pain) flowsheet (a form in an electronic medical record that collects all the necessary data and displays it for easier review), dated 7/29/2025, was reviewed. The flowsheet indicated that Patient 21's pain was not reassessed until 3:40 p.m. RN 1 stated that pain must be reassessed 60 to 90 minutes after medication administration if the medication was given orally. RN 1 confirmed that Patient 21's pain was reassessed four hours and 31 minutes later.

In the same interview, RN 1 stated that it was important to reassess pain on time to make sure the pain medication worked and to ensure that they are managing their patients' pain effectively.

During a review of the facility's policy & procedure (P&P), titled "Pain Assessment and Management - Adult," last revised 10/2024, the P&P indicated, "The pain management process includes: 1. Pain management, reassessment, planning, and intervention ... Pain Reassessment: Pain intensity and pain relief/comfort as reported by the patient will be reassessed and documented: c. Reassessment following a PO (by mouth), SQ (subcutaneous [beneath the skin]), rectal [in the rectum], IM (intra-muscular [in the muscle]) medication, or non-medication therapeutic treatment: 1. 60 to 120 minutes."

b. During a review of Patient 25's H&P, dated 7/30/2025 at 11:41 p.m., the H&P indicated Patient 25 was admitted to the facility for left foot cellulitis (a bacterial infection of the skin and tissues beneath the skin).

During a review of Patient 25's MAR, dated 8/13/2025, the MAR indicated Patient 25 was given hydromorphone (a type of pain medication) intravenously (IV - into the veins) at 3:23 p.m. for a reported pain intensity of seven out of 10 on the numeric pain scale.

During a concurrent interview and record review on 8/14/2025 at 10:15 a.m. with Assistant Nurse Manager (ANM) 2, Patient 25's "Vital Signs" flowsheet, dated 8/13/2025, was reviewed. The flowsheet indicated that Patient 25's pain was not reassessed until 4:59 p.m., one hour and 36 minutes later. ANM 1 stated that if pain medicine was given IV, then pain must be reassessed within 30-60 minutes. ANM 1 confirmed that Patient 25's pain reassessment was not done within that timeframe.

During a review of the facility's policy & procedure (P&P), titled "Pain Assessment and Management - Adult," last revised 10/2024, the P&P indicated, "The pain management process includes: 1. Pain management, reassessment, planning, and intervention ... Pain Reassessment: Pain intensity and pain relief/comfort as reported by the patient will be reassessed and documented: d. Reassessment following an IVP (IV Push) medication or continuous epidural: 1. 30 to 60 minutes."

c. During a review of Patient 29's H&P, dated 8/5/2025 at 2:09 p.m., the H&P indicated Patient 29 was admitted to the facility for appendicitis (an infection of the appendix [a small pouch attached to the large intestine]).

During a review of Patient 29's MAR, dated 8/10/2025, the MAR indicated Patient 29 had an order for 30 milligrams (mg - metric unit of measurement, used for medication dosage and/or amount) of ketorolac (a type of pain medication) IV to be given as needed every six hours for "moderate pain." Patient 29 received one dose of ketorolac at 6:35 p.m.

During a concurrent interview and record review on 8/15/2025 at 3:15 p.m. with RN 6, Patient 29's "Vital Signs" flowsheet, dated 8/10/2025, was reviewed. The flowsheet did not show any documentation that Patient 29's pain was assessed prior to the pain medication being given at 6:35 p.m. RN 6 confirmed there was no record of any pain assessment prior to administration of the pain medication at 6:35 p.m. when there should have been.

In the same concurrent interview and record review, Patient 29's "Vital Signs" flowsheet, dated 8/11/2025, was reviewed. The flowsheet indicated Patient 29 reported a pain intensity of seven out of 10 on the numeric pain scale at 12:38 p.m.; however, the quality of the pain was not documented. RN 6 stated when assessing pain, it was important to assess pain level, pain location, quality of the pain, and any interventions performed.

During a review of the facility's policy & procedure (P&P), titled "Pain Assessment and Management - Pediatrics," last revised 9/2022, the P&P indicated, "C. The pain management process includes: 1. Pain assessment. 2. Planning and intervention. ... D. A pain assessment includes: 1. Location; onset/pattern; radiation; intensity in regard to pain scale; description/quality; sedation."

2. During a concurrent interview and record review with Registered Nurse (RN) 1, on 8/12/2025, at 3:07 p.m., the "Crash Cart Checklist", dated from 8/1/2025 to 8/12/2025, for the L&D unit was reviewed. The Checklist indicated that facility staff had checked the Crash Cart on the following days:
a. 8/1/2025,
b. 8/2/2025,
c. 8/3/2025,
d. 8/4/2025,
e. 8/5/2025,
f. 8/6/2025,
g. 8/7/2025,
h. 8/9/2025,
i. 8/10/2025,
j. 8/11/2025,
k. 8/12/2025.

There was no documentation that the crash cart was checked on 8/8/2025. RN 4 stated that the crash carts are checked daily and confirmed that there was no documentation the crash cart was checked on 8/8/2025. RN 1 further stated, "If it was not filled out, then it was not done, and it should have been done."

During a review of the facility's policy & procedure (P&P), titled "Administration: Crash Carts/Emergency Carts," last revised 4/2022, the P&P indicated, "The purpose of this policy is to: Assure that all emergency carts are in a state of readiness for use in an emergency situation ... Staff on the unit are responsible for checking crash carts daily."

Based on observation, interviews and record reviews, the facility failed to ensure documentation of a medication administered for one of 39 sampled patients (Patient 1) was done according to facility policies and procedures and current standards of care.

This deficient practice resulted in inaccurate documentation of Patient 1, who was an extremely low birth weight (a birth weight of less than 5 pounds and 8 ounces) and extremely premature newborn (born before 28 weeks) receiving a time critical medication for a very low blood sugar.

Findings:

During a review of Patient 1's face sheet (a document that summarizes key information about a patient), dated 7/9/2025, the face sheet indicated Patient 1 was admitted with a diagnosis, which included a newborn twin.

During a concurrent interview and record review on 8/14/2025 at 9:57 a.m. with Assistant Nurse Manager of NICU (ANM 1), Patient 1's delivery record, dated 7/9/2025, was reviewed. ANM 1 stated the following:
1. Patient 1 was an extremely premature twin with a gestational (how far along the pregnancy is) age of 25 2/7 weeks (normal term is 40 weeks gestational age) with a birth weight of 1 pound and 11 ounces.
2. Patient 1 was delivered by emergency cesarean section (a surgical procedure that involves delivering a baby through incisions in the birth parent's abdomen and uterus) and was born on 7/9/2025 at 3:46 p.m.
3. Patient 1 received resuscitation (a set of emergency procedures used to support newborns with a goal to establish and maintain adequate ventilation and oxygenation) by the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) team, which included delivery of continuous positive airway pressure (CPAP - delivery of pressurized air through a mask over the nose and/or mouth to keep the lungs open), positive pressure ventilation (PPV - a crucial technique used in neonatal resuscitation when a baby is not breathing effectively or has a low heart rate), oxygen, and intubation (the process of inserting an endotracheal tube to deliver oxygen to the lungs).
4. Patient 1's APGAR scores (a test given to newborns soon after birth using a 0 to 10 point scale based on heart rate, respiratory effort, muscle tone, response to stimulation, and skin color) were 8/10 at one minute, 9/10 at five minutes, and 9/10 at 10 minutes of life.
5. Patient 1 was transported to the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) for further stabilization, evaluation, and care.

During a concurrent interview and record review on 8/15/2025 at 9:47 a.m. with Registered Nurse (RN) 10, Patient 1's nursing flowsheet (a document used to record assessments), dated 7/9/2025, was reviewed. RN 10 stated Patient 1's initial (beginning) blood sugar was low - 34 milligrams per deciliter (mg/dl - a unit of measurement of mass). RN 10 stated normal blood sugar is 45 mg/dl and higher.

During a concurrent interview and record review on 8/15/2025 at 9:47 a.m. with RN 10, Patient 1's Medication Administration Record (MAR- a daily documentation record used by a licensed nurse to document medications and treatments given to a patient), dated 7/9/2025, was reviewed. RN 10 stated there was no documentation of an order for dextrose 10% (provides the body extra water and sugar) by vein (carry blood from body's tissue to the heart) for Patient 1. RN 10 stated there was documentation of a cabinet override (to go around the system to get a single dose of medication) for dextrose 10% infusion(administration of fluid or medication directly into the body) for Patient 1 on 7/9/2025 at 5:38 p.m. done by one of the NICU nurses (RN 12).

In the same interview, RN 10 stated the Admitting Physician (MD 1) must have given a verbal order for dextrose 10% infusion for Patient 1's low blood sugar to RN 11, and RN 11 forgot to document a verbal order in Patient 1's Electronic Medical Record (EMR) Subsequently (later), because a verbal order was not documented in Patient 1's EMR, by RN 11, the admitting physician (MD 1) failed to document and authenticate (verify) the verbal order for an IV bolus (large dose) of dextrose 10%.

During a record review of RN 11's nursing note for Patient 1, dated 7/9/2025, Patient 1 was given a dextrose bolus for a blood sugar of 34 mg/dl.

During a review of the facility's policy and procedure (P&P) titled "Medication Administration and Monitoring," dated 5/2025, the P&P indicated the following:
1. The registered nurse (RN) is responsible for the accurate administration and documentation of medications, consistent with their professional practice standards and in accordance with applicable laws and regulations.
2. All medication orders must be entered by electronic health record (eHR) to appear in the patient's medication profile on the electronic medication administration record (eMAR - a digital system used to track and manage medication administration).

During a review of the facility's P&P titled "Verbal/Telephone Orders," dated 4/2021, the P&P indicated the following:
1. Orders are accepted only from licensed providers with documented privileges at the facility receiving the orders.
2. Verbal orders may be accepted only as permitted by facility policy.
3. Verbal and telephone orders may be received and recorded by licensed nurses.
4. The licensed nurse who takes a verbal or telephone order will read the verbal or telephone order back to the licensed provider and request confirmation the order has been received correctly.
5. All verbal or telephone orders are entered directly into the electronic health records and read back aloud to the prescriber for clarification and verification of accuracy.
6. Documentation of the verbal or telephone orders are documented electronically to indicate verbal or telephone order with read back and the name of the licensed provider.
7. All verbal and telephone orders must be authenticated by the licensed provider within 48 hours.
8. The RN is responsible for reviewing and acknowledging all orders prior to implementation.

Based on observation, interview, and record review, the facility failed to ensure it maintained its physical plant (building and equipment used in the operation of the facility) and overall hospital environment in a manner that the safety and well-being of patients were assured by having water stain signs, no documented evidence of temperature and relative humidity readings in the neonatal intensive care unit (NICU), and failing to include the NICU in the Annual Crucial Area Validation (Air Balance Test - a process that involves measuring adjusting the airflow in a building's heating, ventilation, and air conditioning system to ensure correct amount of conditioned air is delivers to each space). Water intrusion and/or water leaks, as evidenced by ceiling stains, creates a favorable environment for mold to grow, mold spores can become airborne and compromise indoor air quality, exposure to mold spores can exacerbate respiratory problems, particularly in vulnerable individuals with weakened immune systems. Temperature and humidity control in hospitals is vital for preventing the spread of infections. Proper air balancing helps control the spread of airborne pathogens by ensuring adequate ventilation rates and pressure differentials.

This deficient practice resulted in the facility's failure to monitor and record the temperature, relative humidity and adequate air exchanges in one of one neonatal intensive care unit (NICU 1) which likely eliminated detection of abnormal environmental conditions conducive to bacterial and fungal growth which could cause infection to the immuno-compromised (immune system not working properly) and vulnerable patients (individuals at risk for greater harm and poor health outcomes) especially NICU newborns which could lead to death.

On 8/15/2025 at 1:33 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements have caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient), in the presence of the Executive Director for Quality/Performance Excellence (EDQ) and the Director of Risk Management.

The facility failed to maintain its physical plant and overall hospital environment in a manner that the safety and well-being of patients were assured by having no documented evidence of temperature and relative humidity readings in the neonatal intensive care unit (NICU - a specialized unit equipped with staff trained to care for medically fragile newborns who are dangerously ill or too premature to be with their mothers) and failing to include the NICU in the Annual Crucial Area Validation (air balance test - a test to ensure the HVAC [Heating, Ventilation, and Air Conditioning] system is circulating air evenly and effectively to all areas). This deficient practice resulted in the facility ' s failure to monitor and record the temperature, relative humidity and adequate air exchanges has most likely eliminated detection of abnormal environmental condition conducive (promote) to bacterial (tiny living life form)and fungal growth which can cause infection to the immuno-compromised (immune system not working properly) and vulnerable patients (individuals at risk for greater harm and poor health out come) especially NICU newborns which can lead to death.

On 8/13/2025 at 3:15 p.m., the Director of Facilities (DIR 2) stated that that on 5/8/2025, he discovered that the NICU, Cardiovascular Unit (a hospital unit providing specialized medical care for patients with heart and blood vessel conditions), Operating Room (OR) 1 and OR 2 in the Cardiac Catheterization Lab (an area in the hospital where they perform minimally invasive procedures used to diagnose and treat heart conditions), and Electrophysiology (a field of medicine that studies the electrical activity of the body, most often focusing on the heart) room, was missing the air balance testing which was supposed to be conducted on 12/19/2024 for annual testing by the vendor. It was discovered accidentally during the pre-construction planning in May 2025. The air balance report from the vendor (company offering something for sale), dated 8/6/2025, indicated that two areas in the NICU failed the balance test and that one of the fans in the NICU was broken. Concurrently, the actual reading of air change per hour (how many times the air in a room or building is completely replaced with fresh outside air in one hour) from NICU Isolation 2 (a specialized room designed to separate a patient from others to prevent the spread of infection or to protect them from potential infections) was zero. There was no documentation of any temperature or humidity monitoring in the NICU prior to 8/8/2025. DIR 2 stated that they began manually logging temperature and humidity in the NICU on 8/8/2025.

On 8/19/2025 at 5:14 p.m., the IJ was removed in the presence of the Executive Director for Quality/Performance Excellence (EDQ). The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed by the survey team while onsite through observation, interview, and record review. The IJ Removal Plan indicated:
The plan for correcting each specific deficiency cited:
- Facilities Engineer will take manual temperature and humidity readings once per shift daily and will document the readings on a log.
- The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
- If the temperature and humidity are out of range the Facility Engineer will place a work order to correct the issue and once corrected will re-monitor to ensure it is within range.
- Monitoring temperature and humidity will be added to the Environment of Care rounds for the NICU and will be done on a weekly basis.
- Temperature and humidity monitoring and proper documentation will be included in new hire orientation and annual competency for the Facilities team.
The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
- The Facilities Team were educated on NICU proper temperature and humidity readings including proper documentation and record keeping requirements.
- A temperature and humidity documentation log to record the readings was created.
- Digital hygrometers were installed in the NICU.
A completion date for correction of each deficiency cited:
- 08/15/25
The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
- Temperature and humidity readings will be monitored and will be reviewed by the Director of Facilities. The temperature and humidity log will be reviewed monthly for 90 days. The audits will be reported to the Environment of Care Committee, Infection Control Committee, Performance Improvement Patient Safety Committee, Medical Executive Committee, and the Governing Board.
The title of the person(s) responsible for implementing the acceptable IJ Removal Plan:
- Director of Facilities
The plan for correcting each specific deficiency cited:
- The fan was replaced on 8/14/25. The air balancing testing was completed in the NICU on 8/15/25 by the third-party vendor.
The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
- The NICU has been added to the annual testing scope of work. This requirement has been added to the work order system. The work order system is the notification system to trigger the testing to be done.
The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
a. The fan was replaced.
b. The air balancing testing was conducted by a third party contracted vendor.
c. The air balancing testing will be conducting annually.
d. If the air balancing fails, the contracted vendor will be contacted for repair and a rebalancing will be conducted to ensure it is corrected.
A completion date for correction of each deficiency cited:
- 08/15/25
The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
- The annual air balance testing will be included in the Environment of Care annual evaluation. The annual report will be presented to the Environment of Care Committee, Infection Control Committee, Performance Improvement Patient Safety Committee, Medical Executive Committee, and the Governing Board.
The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
- Director of Facilities
- Executive Director of Operations
- Refer to #5 above.

Findings:

1. During an observation 8/12/2025 at 2:20 p.m. in the neonatal intensive care unit (NICU - a hospital ward equipped and staffed to provide intensive care to dangerously ill or premature newborn babies [babies born before 37 weeks completed pregnancy]) accompanied by the Director of Facilities, the Safety Officer, and the Senior Facility Manager, the hand wash sink located between bay (space for patient care) 18 and 19 was covered with plastic from top of the sink to the floor.

Once the plastic was removed and the cabinet cover removed, there were brown/orange-colored stains on the interior cabinet surface next to the black cast iron drainpipe. The cove base (trim [edge] at the bottom of the wall where it meets the floor) in front of the cabinet was separated from the cabinet, creating a gap between the cabinet and the cove base.

During a concurrent interview on 8/12/2025 at 2:20 p.m. with the Director of Facilities (DIR 2), DIR 2 stated the handwash sink was covered because it was being repaired for a leaking P-trap (U-shaped plumbing pipe located under the sink), that it was first covered last week and that it was still being worked on, that the leak was at the brass fitting (use to connect pipes), and that the P-trap has already been changed.

During a concurrent observation and interview on 8/12/2025 at 2:45 p.m. with DIR 2 in the NICU Supply and Equipment Storage Room, there was water staining on four ceiling tiles. When asked what was above the ceiling tiles, DIR 2 stated he would have to pull the drawing to give a definite (exact) answer on what was above the tiles.

During a concurrent observation and interview on 8/13/2025 at 9:55 a.m. with DIR 2 in the Labor & Delivery (L&D) unit, a corner of air supply register in Clean Supply Room had chipped paint 1" X 1 1/2" in size, exposing a brown rust-like surface. Next to the same register, there was water staining at the corner of the ceiling tile. Also, observed another stained ceiling tile near the wall of the same room. DIR 2 stated it was chipped paint, and that the water staining at the ceiling tile was a dry leak otherwise it would be dark.

During an observation on 8/13/2025 at 10:30 a.m. in the first floor of the facility accompanied by DIR 2 and the Senior Manager of Facilities (FM 1), there was water staining at two ceiling tiles at the 1st floor corridor (aisle) by the chapel and air supply diffuser (part of heating, ventilation, and air conditioning system spread heat or cool air evenly into a room).

During a concurrent interview on 8/13/2025 at 10:30 a.m. with DIR 2, DIR 2 stated new ceiling tiles were ordered and that the order was placed yesterday. DIR 2 stated the stains were caused by a leak from a vertical (upright) hairline crack (thin, narrow crack) on the black drain line, the same cast iron line under the covered sink in the NICU. The crack was located about 2 1/2 feet below the pan (the floor separation), and the crack was 7 inches long. DIR 2 stated the leak was mitigated (reduced) by a third-party mechanical vendor on 7/10/2025.

During a concurrent interview on 8/13/2025 at 10:30 a.m. with FM 1, FM 1 stated now that testing (of the stains under the sink) was done they could get a work order to get the covering put back and the stains removed. FM 1 stated the facility did not repair that (covering separated from the sink cabinet base) because they were testing.

During a review of the third-party mechanical vendor report, dated 7/25/2025, the report indicated the scope of work to perform the replacement of 2-inch cast iron piping serving the NICU drain line for the scrub sink. On 7/10/2025, a 2-inch cast-iron sanitary sewer line was picking up sink in the NICU. Isolate drain piping feeding broken section. Cut out damaged 2-inch cast iron piping - replaced inch cracked cast-iron servicing floor sink in the boiler room used for boiler blow downs. Returned to site the next day to perform a broken piping repair. Isolated piping serving broken section of 2-inch cast iron drain line serving the NICU scrub-in sink drain line.

During a review of photos provided by the Director of Facilities on 8/13/2025 at 10:45 a.m., the photos showed Heating, Ventilation, Air and Conditioning (HVAC) ducting, and fire sprinkler pipes, fittings and heads located above the Labor and Delivery (L&D) supply room. Photos or drawings were not provided of what was above the ceiling tiles of the NICU Supply and Equipment Storage Room.

2. During an interview on 8/12/2025 at 2:12 p.m. with the Director of Facilities (DIR 2), DIR 2 stated that on the hospital policy, the relative humidity range (the percentage of water vapor in the air compared to the maximum amount of water vapor the air could hold at its current temperature; comfortable indoor range 40%-60%) in the neonatal intensive care unit [(NICU), a hospital ward equipped and staffed to provide intensive care to dangerously ill or premature newborn babies] should be 30% to 60%.

During an interview on 8/13/2025 at 9:20 a.m. with DIR 2, DIR 2 stated a handheld device was used by Engineering to measure temperature and humidity in Operating Room (OR) 1 and 2 and all other ORs throughout the hospital.

During an interview on 8/13/2025 at 11:34 a.m. with DIR 2, DIR 2 stated that temperature and relative humidity in-house rounding was done three times a day in NICU, all ORs, L&D, Cath Lab, and Emergency Department (ED). The NICU was not included in the Temperature, Humidity, and Air Pressure Daily Logs. The daily physical rounding did not start in the NICU until 8/8/2025. DIR 2 stated that the computerized temperature and humidity trend tracking from the vendor for Air Handler 5 should have the humidity and temperature for the NICU on it and that he was waiting for it from the vendor.

During an interview on 8/13/2025 at 3:14 p.m. with DIR 2, DIR 2 stated there was no in-house log of temperature or humidity in NICU before 8/8/2025, other than the electronic Building Management System (BMS), that "if anything is out of parameter we get pinged on cell phone and computer. The building is in the management system not the In-House Log because the In-House log is for areas that is not in this system (BMS system)."

During an interview on 8/14/2025 at 1:51 p.m. with the Senior Manager of Infection Prevention (SMIP), SMIP stated that high humidity (amount of water vapor [substance in gas phase] present in the air) would promote fungus (living organism [living thing that can function on its own] that is not a plant or animal) and mold (tiny spores [cell that can develop into a new one] that grow in damp spaces), that it would create a moist environment. SMIP further stated temperature and humidity were related and high temperature could increase humidity. SMIP also stated, "When we investigated with the NICU, [the nurses] had stated they had noticed the bedding and the linens to be wet and damp. And when [the nurses] noticed, they changed them." SMIP confirmed it was not usual for the bedding to be wet.

During a review of the Building Management System (BMS) 3-month trend report from 5/1/2025 to 7/12/2025, the report indicated the HVAC (Heating, Ventilation, and Air Conditioning) Mechanical Vendor among other non-temperature and non-humidity reading lists Discharge Air Temp (Air Supply at the ceiling air register) in NICU, Discharge Air Humidity at the Supply Register in the NICU, Return Air Temperature at the ceiling Air return at the NICU, and Return Air Humidity were at the Air Return at the NICU.

During a concurrent interview on 8/15/2025 at 9:15 a.m. with DIR 2, DIR 2 stated they were not able to determine what the temperature and humidity was in the NICU room. DIR 2 further stated they started taking the temperature manually 8/8/2025. DIR 2 further stated the air balancing issues and an incident in the NICU involving a patient developing aspergillosis (an infection caused by a type of mold) triggered the change to take temperature and humidity readings in the NICU with a handheld hygro-thermometer tester (used to measure the humidity and temperature of the air) three times per day.

During a review of the new "Daily (Manual) Temperature & Humidity" log for 8/2025 taken with a handheld hygro-thermometer tester by the Stationary Engineer (operates, maintains, and repair mechanical and electrical equipment), the log indicated the Relative Humidity (amount of water vapor present in the air express as a percentage of the amount needed to achieve saturation at the same temperature,) parameters to be 30% to 60%. The Daily (Manual) Temperature & Humidity log also indicated the Relative Humidity parameters readings (normal range 30% to 60%) that were outside their parameters as indicated below:

8/14/2025 Humidity 61.4% NICU
8/15/2025 62.8%

8/10/2025 Humidity 62% L&D OR#1
8/11/2025 60.2%
8/12/2025 62.8%
8/13/2025 60.4%

8/10/2025 Humidity 64% L&D OR#2
8/11/2025 60.7%
8/12/2025 63.1%
8/13/2025 61.2%

Further review of the Daily (Manual) Temperature & Humidity log revealed there was only one entry per day instead of three times per day.

During a concurrent interview on 8/15/2025 at 10:46 a.m. with DIR 2, DIR 2 stated, "We round (routine inspections) three times per day, there is only one form (Daily (Manual) Temperature & Humidity log), we need to improve on the form, so it shows the three rounds. Our shifts are 6:00 a.m. - 2:30 p.m., 2 p.m. - 10:30 p.m., 10 p.m. - 6:30 a.m. Not all shifts are shown on the form; the form needs to be improved. I can't prove to you that they are doing (readings) three shifts per day."

During a review of the facility's policy and procedure (P&P) titled, "Critical Air Environments," last revised 4/2023, the P&P indicated, "Facilities and/or clinical staff shall monitor and record temperature, relative humidity, and verify the pressure relationship in areas designated as high risk by this policy and documented by the individual ministry daily."

3. During a review of the facility's "Air Balance Report (document record the results of the HVAC system ensuring proper air flow)," dated 8/6/2025, the Report indicated NICU Isolation (a separated area to prevent spread infection) #2 and main NICU failed the air balance test. The Air Balance Report indicated that the NICU did not meet the California Mechanical Code (CMC) (minimum standards for the design, installation, and maintenance of mechanical systems in buildings) for Air Changes per Hour (ACH) (measure how many times the total volume of air in a room is replaced with new air in one Hour) had an ACH of 5.41 instead of the required minimum of 6.00 ACH, and that NICU Isolation 2 (Rooms 8 and 9) did not meet the CMC minimum 12 ACH, meaning the NICU did not have any exhaust airflow required to maintain a negative pressure relationship or ACH.

Upon further investigation, it was determined that the motor of Exhaust Fan (EF - removes unwanted air, such as moisture from enclose area transferring it outdoors) 21, located on the second floor roof which serves this space, had a motor hum (motor trying to start but is stopped by some issue) and did not operate. The required ACH for the NICU was 6 ACH and the Actual ACH was 5.41, and that the required ACH for NICU Isolation 2 was 12 ACH and the Actual ACH was 0.00 ACH.

During a concurrent interview on 8/13/2025 at 10:54 a.m. with DIR 2, DIR 2 stated the two areas appear as "Fail" because they were unable to test the areas because there were patients in the area. DIR 2 stated the vendor (Air Balance vendor) was back on-site 8/11/2025 to test the two areas, but he did not have the reports and should have it this week. DIR 2 further stated "We were slightly off we did not reach the required 6.00 we were 5.51. We needed to do adjustments which were adjusted 8/11/2025 by the vendor (Air Balance vendor)."

DIR 2 also stated, "I communicated with the vendor (Air Balance vendor) that stated there was a wiring issue with EF-21. On 8/11/2025, the vendor (Air Balance vendor) corrected the wiring on exhaust fan 21 and tried to rebalance the room. There would be another revisit for additional corrections to reach the minimum requirement. I don't know what those corrections are." DIR 2 further stated more air changes meant more air crossing through air filtration systems. Low air changes could be caused by a plugged filter or a damper partially closed off. That the more air changes the cleaner the air, the less air changes the opposite the less clean the air because the air does not run through the filter. DIR 2 confirmed that NICU Isolation 2 having an Actual ACH of 0.0 in the report was basically saying there was no air exchange.

During an interview on 8/13/2025 at 11:34 a.m. with DIR 2, DIR 2 stated the data of 0.0 Actual ACH on the first page of the Air Balance report for NICU Isolation 2 was recorded because of the wiring of the exhaust fan that was not working.

During an interview on 8/13/25 at 3:15 p.m. with DIR 2, DIR 2 stated the scope of the Air Balance testing changed in 2024 and that a few areas were not included in the annual air balancing. NICU was one of the areas. It was not included in the 2024 Annual Certification. The Annual 2024 happened 12/2024. The next Annual Air Balance Test would not have occurred until 12/2025, and the Air Balance Test vendor came out and tested the areas that were not tested on 12/2024.

In the same interview, DIR 2 stated on 5/8/2025, it was discovered that the NICU was not included in the 12/2024 Air Balance Testing. On 5/8/2025, a dialogue (exchange of spoken or written words between two or more people) was started to correct this. The areas that were missing were tested on 8/6/2025. Areas not tested in the 12/2024 testing were NICU, Cardiovascular (heart and blood vessels) Unit (CVU), Operating Room (OR)1 and 2 (in the Cath Lab(specialized area equipped to perform procedures related to the heart and blood vessels), Electro-physiology (EP) Labs (specialize room equipped to treat the heart's electrical system), and Cath Lab (specialized area equipped to perform procedures related to the heart and blood vessels).

DIR 2 further stated, "I was working with a construction team that wanted to do some preconstruction work, and the Director of Facilities sent them the 12/9/2024 Air Balance Test report and it was then when the construction team discovered the areas that were not included. The exhaust fan (EF21) was dedicated to the NICU Isolation 2 room."

During an interview on 8/14/2025 at 1:51 p.m., with the Senior Manager of Infection Prevention (SMIP), SMIP stated that Hourly Air Changes were important so that air would get filtered. The SMIP further stated, "We want it filtered to have a safe environment the microbial contaminants (small living things that cause diseases) in the air are filtered out."

During an interview on 8/15/2025 at 9:40 a.m., with DIR 2, DIR 2 stated he was in error that exhaust fan (EF21) serving Isolation-2 in NICU was not repaired on 8/11/2025. The fan was repaired yesterday 08/14/2025 at 7:00 p.m., by replacing the motor, and that he was in communication with the Air Balance Test vendor to revisit on the two outstanding items indicated in the 8/6/2025 Air Balance Test report.

During an interview on 8/15/2025 at 4:55 p.m. with DIR 2, DIR 2 stated the Air Balance Tester would be at the hospital today (8/15/25) to conduct an air balance test in NICU by 5 p.m. The HVAC Mechanical would be arriving to do any mechanical changes needed to HVAC servicing NICU and the Building Management System (BMS) vendor would be remotely standing by to assist - verbal response to set point adjustments if needed.

During an interview on 8/15/2025 at 5:55 p.m. with DIR 2, DIR 2 stated that construction ended at the end of 2023. An Air Balance Test was done by a general contractor at close of project for NICU and it passed; the next Air Balance Test was done 12/2024 with the oversight of NICU. It was just NICU that wasn't added to the scope. The Air Balance testing not being done in NICU was not reported to Quality Assurance and Performance Improvement (QAPI - a group that identify areas for improvement, developing strategies to address those areas, implementing changes and continuously monitor progress).

In the same interview, DIR 2 stated his role with QAPI was to ensure they were maintaining infection control. DIR 2 reported to the Infection Preventionist (IP) on infection control issues, that would include Air Balance Temperature and Humidity. The Dir 2 stated he did not attend any QAPI meetings.

During a review of the facility's policy and procedure (P&P), titled "Critical Air Environments," last revised 4/2023, the P&P indicated, "Facilities shall at a minimum conduct annual testing and balancing of critical areas for air change rates and pressurization."

Based on observation, interview, and record review, the infection prevention and control program (IPP) failed to establish and implement hospital wide policies and procedures (P&P) on methods to prevent and control infections as evidenced by,

1. The IPP did not ensure eyewash stations were not installed in locations that required employees to perform emergency flushing of the eyes in decontamination (the process of removing or neutralizing germs) sinks for one of three sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) workrooms (Sterile Processing Department decontamination workroom, SPD- an area within a health care facility that processes and controls medical supplies, devices, and equipment);

2. The IPP did not ensure hand-held cleaning brushes (a special brush used to clean reusable surgical instruments) were cleaned after each use in accordance with the manufacturer's instruction for use (IFU), for one of two sampled brushes (Brush 2).

3. The IPP did not ensure that soil linen and clean linen were stored in separate rooms in accordance with the hospital's P&P for one of one sampled nursing unit (Neonatal Intensive Care Unit, [NICU] a unit for critically ill newborn patients).

4. The IPP did not ensure reusable medical equipment was reprocessed in accordance with the manufacturer's IFU, for one of two sampled endoscopes (Endoscope 2, a reusable instrument used to inspect and treat the interior portions of the body).

5. The IPP did not ensure terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were implemented in accordance with the hospital's P&P for one of three reprocessing workrooms (SPD clean work workroom).

6. The IPP did not ensure hand hygiene was performed during patient care or handling patient equipment for three of three sampled employees (Registered Nurse 5, Registered Nurse 14 and Environmental Service Staff 1).

7. The IPP did not ensure semi-critical equipment (a device that carries breathing gas or come in contact with mucous membranes) was properly stored for three of three sampled medical devices (Semi-Critical Medical Device 1, Semi-Critical Medical Device 2, and Semi-Critical Medical Device 3).

8. The IPP did not ensure proper personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) were worn when using CaviWipes XL (the brand name for the germicidal towelettes) to clean OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) in accordance with the manufacturer's IFU for one of one sampled employee (Environmental Service Staff 1).

These failures increased the risk for injury and cross-contamination (the transfer of harmful germs from one person, object or place to another) thereby adversely affecting the health and safety of patients, visitors, and hospital personnel.

Findings:

An interview was conducted with the Senior Manager, Infection Prevention (SMIP) and the Infection Control Preventionist (IP 2), on August 13, 2025, at 11:05 a.m., in the neonatal intensive care unit (NICU, a unit for critically ill newborn patients). The SMIP stated the hospital followed the following nationally recognized infection control and prevention guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guideline for perioperative areas),

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor),

D. ANSI/AAMI ST79, American National Standards/Association for the Advancement of Medical Instrument: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities, and

E. The Association for Professionals in Infection Control (APIC, a professional association for individuals working in the field of infection prevention).

1. During a tour of the sterile processing department with the SMIP and the Surgery Manager (NM 4) on 8/14/2025, at 8:10 a.m., the emergency eyewash station was observed attached to the decontamination sink.

During an interview with the SPD Technician (SPD Tech 1) and NM 4 on 8/14/2025, at 8:13 a.m., in the SPD decontamination workroom, SPD Tech 1 confirmed the sink was used for decontaminating and cleaning potential infectious surgical instruments. SPD Tech 1 stated if he needed to use the emergency eyewash station and washed his eyes over the decontamination sink, potential infectious material could accidentally splash into his eyes. NM 4 stated she was not aware that the emergency eyewash station should not have been installed in locations that required SPD staff to perform emergency flushing of the eyes in the decontamination sink.

The review of the ANSI/AAMI ST79: 2017, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" was conducted. The standard indicated the following, "...3.3.7 Emergency eyewash/shower equipment... Eyewash stations should not be in a location that requires flushing of the eyes in a decontamination sink..."

2. During a tour with the SMIP and NM 4 on 8/14/2025, at 8:18 a.m., in the SPD decontamination workroom, the decontamination sink was observed. Two toothbrush-style cleaning brushes were observed on top of the decontamination sink. SPD Tech 1 was observed picking up Brush 2 from the sink and brushing debris from the surface of a surgical instrument.

During an interview with SPD Tech 1 on 8/14/2025, at 8:22 a.m., in the SPD decontamination workroom, SPD Tech 1 stated cleaning brushes were not cleaned between cases. SPD Tech 1 stated brushes were used throughout the day and discarded or disinfected at the end of the day.

During an interview with the SMIP on 8/14/2025, at 8:25 a.m., in the SPD decontamination workroom, the SMIP stated the cleaning brushes should be either cleaned or discarded after each use to prevent cross-contamination. The SMIP stated the hospital did not have a P&P in place for the reprocessing of cleaning brushes. The SMIP stated staff should have followed the manufacturer's IFU.

The review of the hospital's undated document titled, "Toothbrush-Style Cleaning Brushes," indicated, "Cleaning & Disinfection [a cleaning process using chemicals to kill germs]: Clean brushes after each use and disinfect between cases or daily, at a minimum..."

3. During a tour of the NICU with the SMIP and the Assistant Nurse Manager (ANM 1) on 8/13/2025 at 11:30 a.m., there was one linen hamper, and one linen cart observed in the corridor (hallway) between Room 10 and Room 11.

During an interview with ANM 1 and the SMIP on 8/13/2025, at 11:40 a.m., in the NICU corridor, ANM 1 stated the linen hamper contained soiled NICU scrubs (hospital issued uniform) and the linen cart contained clean NICU scrubs. The SMIP stated the clean and soiled linen should not be stored together to prevent cross-contamination.

During a follow-up interview with IP 2 and the NICU Manager (NM 2) on 8/18/2025, at 10:20 a.m., in the NICU, NM 2 stated the clean linen cart, and the soiled linen hamper had been stored in the NICU's corridor between Room 10 and Room 11 for the past year. IP 2 stated that she had conducted daily infection control rounds in the NICU, and she had not identified that soiled linen was being stored in the same area as clean linen. IP 2 stated, "I missed it."

The review of the hospital's P&P titled, "Hospital Laundry and Linen Handling, Storage, Transportation and Disposal," revised 11/2022, indicated " ...C. Washing Linen: ...Storing Clean Linen: ...3. Separate rooms shall be maintained in the hospital for storage of clean linen and for storage of soiled linen to prevent contamination."

4. During a tour of the gastroenterology (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) reprocessing (a process used to remove soil and germs and/or inactivate germs) workroom, with NM 4 and IP 2, on 8/15/2025 at 12:15 p.m., the GI Technician (GI Tech 1) was observed reprocessing Endoscope 2.

During an interview with GI Tech 1 and NM 4 on 8/15/2025 at 12:30 p.m., in the GI reprocessing workroom, NM 4 stated the GI department followed the manufacturer's IFU for reprocessing endoscopes. GI Tech 1 stated that endoscopes could be stored for up to seven days before they could no longer be considered safe for patient use. GI Tech 1 stated that when the endoscope had not been used within seven days, the endoscope was removed from the storage cabinet and placed directly into the automatic endoscope reprocessor (AER, a machine used for disinfecting endoscopes). NM 4 stated she was unsure of the appropriate procedure to follow when an endoscope had been stored for the maximum allowable storage time without being used. A request was made for the hospital's policy and procedure on cleaning, processing, and storing flexible endoscopes.

During an interview with IP 2 and GI Tech 1 on 8/15/2025 at 12:35 p.m., in the GI reprocessing workroom, IP 2 stated when an unused endoscope had been stored for seven days, the GI technician must repeat the entire reprocessing cycle from the beginning in accordance with the manufacturer's IFU. GI Tech 1 stated he was not aware that an unused endoscope that was either expired or had been potentially contaminated (harmful germs) in the storage cabinet should be cleaned using the entire endoscope reprocessing cycle.

An interview was conducted with the Director, Risk Management (DRM) on 8/18/2025 at 3:25 p.m., in the conference room. A request was made for the hospital's policy and procedure on cleaning, processing, and storing flexible endoscopes. The DRM stated the hospital did not have a policy and procedure in place for the reprocessing and storing endoscopes. The DRM stated staff were expected to follow the manufacturer's IFU for reprocessing and storing endoscopes.

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2018, indicated the following instructions for use, "...1.2 Importance of Cleaning, Disinfection, and Sterilization: The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals for all ancillary equipment, and have a thorough understanding of the following items: Instruction manuals for the endoscope, accessories, and all the other reprocessing equipment..."

The review ANSI/AAMI ST91:2021: "Flexible and semi-rigid endoscope processing in health care facilities," indicated "13 Quality control: 13.2 Establishing policy and procedures for quality assurance and safety program. The health care facility should establish a multidisciplinary, comprehensive, written quality assurance and safety program for all aspects of endoscope processing."

5. A concurrent observation and interview were conducted on 8/14/2025, at 11:12 a.m., with the SMIP and NM 4, in the SPD clean workroom. Black and dark brown spots were observed scattered throughout the floor; multiple black and grey adhesive labels were observed attached to the floor; several orange stains were observed on the floor; the processing tables were observed held together with medical tape; black matter and grey fuzzy matter was observed throughout the floor; and reddish-brown matter was observed on the floor in front of Sterilizer 1 (autoclave, a machine that utilize high-temperature steam and pressure to kill germs) and Sterilizer 2. NM 4 stated the reddish-brown matter was "rust." The SMIP stated the medical tape must be removed from the processing tables and the stickers should have been removed from the floor during the terminal cleaning process. SPD Tech 2 stated the black matter was debris and the grey fuzzy matter was dust. NM 4 confirmed the floor should have been terminally cleaned each day that the SPD workroom had been used.

The review of the hospital's document titled, "Environmental Services: Daily/Weekly Terminal Cleaning Log" dated 7/2025 and 8/2025, indicated the SPD clean workroom had been terminally cleaned daily from 7/1/2025 to 8/12/2025.

During an interview with the Environmental Service Manager (EVS Mgr) on 8/14/2025, at 2:50 p.m., in the SMIP office, the EVS Mgr confirmed that the SPD workrooms should be terminally cleaned daily. The EVS Mgr stated he had inspected the SPD clean workroom, and the air vents were dusty, and floor was not clean. The EVS Mgr stated he could not explain why the floor and air vents were not clean. The EVS Mgr stated the SPD workroom floor should have been washed with flooded water in accordance with the daily terminal cleaning procedures and the air vents should have been cleaned in accordance with the weekly terminal cleaning procedures.

The review of the hospital's P&P titled "Cleaning of the Sterile Processing Department," revised 9/2023, indicated " ...Terminally clean sterile processing areas each day the areas are used ..."

6a. During a tour of the NICU with the SMIP, IP 2, and ANM 1 on 8/13/2025 at 1:58 p.m., in the NICU utility room, the environmental service staff (EVS 1) was observed wiping down an OmniBed (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) with a large white towelette. EVS 1 was not observed to change his gloves or perform hand hygiene prior to replacing the removeable parts back onto the OmniBed. There were no hand hygiene products observed in the NICU utility room.

During an interview with EVS 1 and the SMIP on 8/13/2025 at 3:05 p.m., in the NICU utility room, EVS 1 confirmed that he did not perform hand hygiene during the cleaning process or prior to replacing the accessories back onto the OmniBed. EVS 1 stated there were no hand hygiene products in the NICU utility room accessible to him. EVS 1 stated he changed his gloves when they were torn or felt sticky and dirty. EVS 1 stated he did not know that he had to perform hand hygiene if he wore gloves to clean the equipment. The SMIP stated hand hygiene was required before and after glove use.

The review of the hospital's P&P titled, "Hand Hygiene Policy," revised 10/2024, indicated " ...Requirements: ...5. Access to hand hygiene products is provided in all work units ...Gloves: ...c. Gloves should not be used as a substitute for hand hygiene ..."

6b. During a tour of the NICU with the SMIP and IP 2 on 8/13/2025 at 11:15 a.m., in Room 10, the Registered Nurse (RN 5) was observed reviewing the electronic medical record and a pair of soiled gloves were observed on the counter.

During an interview with RN 5 on 8/13/2025 at 11:17 a.m., outside of Room 10, RN 5 confirmed the gloves were soiled and had been used. RN 5 stated she had provided care for the patient including a diaper change and she did not have time to dispose of the gloves because the trash receptacle was on the other side of the room. The SMIP stated RN 5 should have promptly and properly disposed of her soiled gloves.

6c. During a tour of the NICU with the SMIP and IP 2 on 8/13/2025 at 11:22 a.m., RN 14 was observed in Room 17 holding Patient 32's soiled diaper in her left hand. RN 14 exited Patient 32's room and was observed going into Room 16. RN 14 was observed assisting Patient 33's family member into a wheelchair. After assisting Patient 33's family member into the wheelchair, RN 14 was observed returning to Patient 32's room holding the soiled diaper in her left hand. RN 14 was not observed performing hand hygiene after providing care to Patient 32's or performing hand hygiene between patients.

During an interview with RN 14 and the SMIP, on 8/13/2025 at 11:40 a.m., outside of Room 17, RN 14 confirmed she was holding Patient 32's soiled diaper in her left hand when she had assisted Patient 33's family member into the wheelchair. RN 14 stated she did not touch "anything" with her left hand. The SMIP stated RN 14 should have performed hand hygiene after providing care to Patient 32 and RN 14 should have performed hand hygiene between patients.

The review of the hospital's P&P titled, "Hand Washing-NICU," revised 7/2025, indicated "Policy: ...H. Perform hand hygiene routinely and thoroughly before entering the NICU and before and after contact with the neonate (newborn) or the neonate's environment ..."

7. During an observation in the NICU clean storage room with the SMIP and the respiratory care practitioner (RCP 2) on 8/15/2025 at 11:15 a.m., three ventilator machines (a machine used medically to support or replace the breathing of a person) were observed and the neonatal expiratory valves (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components) were fitted to the ventilator. Semi-Critical Medical Device 1 was dated 7/13/2025, Semi-Critical Medical Device 2 was dated 8/13/2025, and Semi-Critical Medical Device 3 was dated 8/8/2025. Semi-Critical Medical Device 1, 2, and 3 were covered with opened plastic bags.

During an interview with RCP 2 and the SMIP on 8/15/2025 at 11:20 a.m., RCP 2 confirmed that the neonatal expiratory valves were reusable semi-critical medical devices. RCP 2 stated the semi-critical medical devices were removed from the ventilators after use and transported to the SPD for cleaning. RCP 2 stated that after the semi-critical medical devices were cleaned the devices were returned to the department in a peel pack (a germ-free pouch that is used as a barrier to prevent contamination of the germ-free items from dust, moisture, and other environmental factors). RCP 2 stated the semi-critical medical devices were either stored in the respiratory closet or the peel packs were removed, and the semi-critical medical devices were fitted to the ventilator for storage. RCP 2 stated she did not know if the hospital's ventilator machines had been validated for storing semi-critical medical devices. RCP 2 stated the date shown on the ventilators were not the dates that the semi-critical medical devices were reprocessed. RCP 2 stated the dates shown on the ventilators identified when the ventilators were cleaned. RCP 2 stated the department did not have a system in place to verify the traceability or the processing status of the device after the device had been fitted to the ventilator for storage. RCP 2 stated she did not know if the ventilator had been validated to protect reprocessed semi-critical items from cross-contamination. The SMIP stated that she was not sure and she would need to review the process for transporting, reprocessing, and storage of the semi-critical medical device.

The review of the Manufacturer's Manual titled Drager: Evita V Series/Babylog VN series: Reprocessing Instructions," dated Edition 4: 1/2025, indicated "2.3: Safety instructions: Reusable products: reusable products must be reprocessed; otherwise, there is an increased risk of infection.
-Use validated procedures for reprocessing
-Follow the infection prevention policies and reprocessing regulations including the reprocessing intervals, of the health-care facility.
-Follow the national infection prevention policies and reprocessing regulations
3.45 Storage and transport: After reprocessing, there are no special requirements for storage and transport of the product. However, the following must be observed:
-Store dry and free of dust
-Avoid recontamination and damage during transport

8. During a tour of the NICU with the SMIP, IP 2, and ANM 1 on 8/13/2025 at 1:58 p.m., in the NICU utility room, EVS 1 was observed wiping down an OmniBed with CaviWipes XL. EVS 1 was not observed to wear eye protection.

During an interview with EVS 1 and the SMIP on 8/13/2025 at 3:05 p.m., in the NICU utility room. EVS 1 stated he did not know that he needed to wear eye protection. EVS 1 stated eye protection was not included in the CaviWipes XL training. The SMIP stated she had not reviewed the education and training prior to implementing the CaviWipes XL to clean and disinfect the OmniBeds.

The review of the hospital's document titled "CaviWipes Safety Sheet," dated 6/29/2022, indicated, " ... Personal Protective Equipment: Eye protection: Wear safety goggles or other eye protection to prevent eye contact ..."

Based on observation, interview, and record review, the hospital failed to provide and maintain a hospital wide safe and sanitary environment to avoid the potential of transmission of infections and communicable diseases as evidenced by:

1. The autoclaves (steam sterilizer, a machine that utilize high-temperature steam and pressure to kill germs) were not maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, green matter, greyish-brown matter, and debris were observed throughout the chamber (the internal portion of the sterilizer) for two of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 1 and Sterilizer 2);

2. Previously reprocessed instruments were observed with orange/red matter, brown staining, discoloration, scratches, water spots, pitting (the formation of small localized depressions or holes), green stains, black spots, and white residue for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2);

3. Medical devices were not reprocessed in accordance with the manufacturer's IFU for one of one sampled reusable Neonatal (the period immediately after birth) Expiratory Valve (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components); and

4. Giraffe OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) were not cleaned and disinfected after each use in accordance with the manufacturer's IFU for two of two sampled isolettes (OmniBed 1 and OmniBed 2).

These failures resulted in unsafe healthcare practices and had the potential to cause further harm and prolonged hospitalization thereby increasing the risk of death to patients being cared for in the hospital.

Findings:

On August 15, 2025, at 12:15 p.m., an immediate jeopardy (IJ- a situation that had threatened or was likely to threaten the health and safety of a patient) situation was called in the presence of the Executive Director, Quality/Performance Excellence (EDQ) and the Director, Risk Management (DRM). The EDQ and the DRM were verbally notified of failure of the hospital not implementing safe infection control and prevention practices when the autoclaves (steam sterilizer, a machine used to kill germs on surgical instruments) were not clean and maintained in accordance with the manufacturer's IFU; multiple reusable surgical instruments were not clean and/or damaged and the instruments were available for patient use; the Giraffe OmniBeds were not clean and disinfected between patients in accordance with the manufacturer's IFU; and neonatal expiratory valves were not reprocessed (a process carried out on a used device in order to allow its safe reuse) in accordance with the manufacturer's IFU.

On August 19, 2025, at 1:23 p.m., the hospital provided an IJ removal plan (RP). The RP included the following components:

"[Giraffe OmniBed/Isolette Cleanliness]
1. The plan for correcting each specific deficiency cited:
The Giraffe OmniBed will be cleaned per the manufacturer guidelines for cleaning and disinfection. CaviWipes XL (the brand name for the germicidal towelettes) will be used on the entire Giraffe except for the humidifier (a device used to add moisture to dry air), CaviCide (the brand name of the germicidal liquid solution) will be used on the humidifier. The revised cleaning and disinfection guidelines were approved by the Senior Manager of Infection Prevention and Infection Prevention Medical Director on 8/15/25. It will be submitted for approval to the Infection Control Committee (a committee responsible for preventing and controlling infections) on 09/16/25.
2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
All Giraffe OmniBed cleaning and disinfection process practices will be reviewed and approved by the Senior Manager of Infection Prevention, the Infection Prevention Medical Director, and the Infection Control Committee prior to implementing the practice.
3. The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
a. The Environmental Services (EVS) staff responsible for cleaning and infection of the Giraffe OmniBed were educated on the correct cleaning and disinfectant solutions as per the manufacturer's guidelines on 8/18/25. The training included each EVS staff viewing a video provided by the manufacturer and return demonstration to validate competency (the ability for EVS staff to demonstrate the required knowledge and skills needed to maintain a safe and healthy environment, particularly in infection control).
b. A standard operating procedure outlining the cleaning process was posted in the cleaning area.
4. A completion date for correction of each deficiency cited:
08/18/25
5. The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
The Sr. Manager of Infection Prevention obtained a training video from the manufacturer and developed a step-by-step cleaning and disinfection competency based on the Manufacturer's Instructions for Use recommended by the vendor. The EVS Manager watched the video and reviewed the step-by-step cleaning and disinfection process. The staff cleaning and disinfection was observed by the EVS Manager on 8/18/25.
The cleaning and disinfection of the Giraffe OmniBed will be monitored. Each EVS staff member will be observed to ensure the correct process is followed. Five (5) [Giraffe OmniBed] cleanings will be observed per month for 90 days. The audits will be reported to the Infection Control Committee, Performance Improvement Patient Safety Committee (a committee that is responsible for overseeing and improving the quality of care provided by the hospital), Medical Executive Committee (a committee responsible for making important medical and clinical decisions, overseeing medical staff, and addressing various healthcare-related issues within the hospital) and the Governing Board (a committee that manages or controls the hospital's activities). .
6. The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
Manager, Environmental Services
Senior Manager, Infection Prevention

[Autoclaves/Sterilizers Cleanliness]
1. The plan for correcting each specific deficiency cited:
Autoclave 1 and Autoclave 2 were both deep cleaned (a special cleaning performed by the manufacturer) to remove the residue and debris. The Manufacturer was notified on 8/14/25 of the deficiency. The Manufacturer completed the deep cleaning on 8/15/25 and a completion report was provided to the Director of Surgical Services.
2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
a. Annual deep cleaning was added [to] the Biomed preventative maintenance schedule. Biomed will coordinate with Steris (vendor) and Director of Perioperative and Cardiovascular Services or designee.
b. Autoclave daily, weekly, and annual cleaning will be reported to the Infection Control Committee on a quarterly basis.
c. The Surgical Services Director or designee will review the annual quality of autoclave cleaning from the vendor.
3. The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
a. Added daily autoclave drain cleaning to the daily opening department checklist. Added weekly autoclave drain and chamber routine cleaning to the daily opening department checklist. Added daily cleaning of the outside and inside of the autoclave to the daily opening department checklist.
i. Implemented tasks in SPM application (Strategic Portfolio Management, the name of the hospital's data system) to digitally document/monitor.
b. Received 2024 "AMSCO Steam Sterilization Routine Cleaning Procedure Instructions for Use" received from manufacturer. Though specific frequency interval is not mentioned and "routine chamber cleaning" is recommended, in addition to daily drain, outside and inside of the autoclave, we are implementing weekly auto drain and chamber routine cleaning.
c. On 8/15/2025, Steris technician in-serviced all employees in the SPD on how to perform daily & weekly routine cleaning of the autoclave.
i. Edu-gram (an educational program) for daily and weekly Autoclave Cleaning created to have all employees sign off.
d. Received quote and ordered the manufacturer-recommended chamber cleaning kit on 08/15/25.
e. The Steris manufacturer will complete the annual cleaning which will be done first quarter and records will be kept with Biomed (Biomedical, a department responsible for maintaining, repairing, and ensuring the safe operation of medical equipment within the hospital). The cleaning was done on 8/15/2025 and the next cleaning will be done on 08/15/2026.
4. A completion date for correction of each deficiency cited:
08/15/25
5. The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
a. Competencies (the ability for SPD staff to demonstrate the required knowledge and skills needed to reprocess medical devices and equipment safely) will be checked for all employees each quarter, starting on 8/15/2025.
b. The daily and weekly cleaning audits will be reviewed by Director of Perioperative and Cardiovascular Services or designee.
c. Annual deep cleaning records will be documented on the written and digital department records and reviewed by Director of Perioperative (the period surrounding a surgical procedure) and Cardiovascular (the system that transports blood throughout the body) Services or designee.
The monitoring requirements will be reported to the Infection Control Committee, Surgical Services Committee, Performance Improvement Patient Safety Committee, Medical Executive Committee, and the Governing Board.
6. The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
Director of Perioperative and Cardiovascular Services

[Surgical Instruments Integrity]
1. The plan for correcting each specific deficiency cited:
a. The surgical instruments containing staining, scratches, pitting (small holes or indentation on the surface of surgical instruments), and water stains were removed from service.
b. The SPD staff were in-serviced on how to inspect instruments and trays throughout the workflow on 08/18/25 pending supplement training with Steris on 08/21/25.
c. Third-party contracted service provider (IMS) [instrument management service] notified on 8/15/2025 of the deficiency.
d. Third-party contracted service provider (IMS) to come on-site and review and in-service the trays (specifically the long and major instrument trays pulled aside from 8/14/2025), 08/15/25, and 08/18/25. Provider to share the most recent service records of these trays.
2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
a. Providers will update the weekly service from twice a week to three times a week, so the trays are serviced more frequently.
b. Surgical Services Director or [the] designee will monitor the third-party contracted service provider (IMS) reports for the condition of the instruments, removal, and replacement instruments.
c. End of cycle (the final stages where the sterilized items are prepared for removal and use) instrument tray inspection audit was implemented.
d. SPD staff will inspect instruments throughout their workflow.
3. The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
a. Third-party contracted service providers on-site on 8/15/2025.
b. Providers will in-service all employees in the SPD on how to inspect instruments and trays throughout the workflow.
c. Providers will update the weekly service from twice a week to three times a week, so the trays are serviced more frequently.
4. A completion date for correction of each deficiency cited:
08/15/25
5. The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
a. Verify competencies for all employees each quarter, starting on 8/15/2025
b. Monthly audits from the third-party contracted service provider (IMS) regarding the condition of the instruments, removal and replacement instruments.
The monitoring requirements will be reported to the Infection Control Committee, Surgical Services Committee, Performance Improvement Patient Safety Committee, Medical
6. The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
Director of Perioperative and Cardiovascular Services

[Neonatal Expiratory Valve]
1. The plan for correcting each specific deficiency cited:
The neonatal expiratory ventilator valve cleaning and disinfection process was revised to follow the manufacturer's guidelines.
2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
The Policy and procedure will be created so the staff can access cleaning and disinfection processes.
3. The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
Sterile Processing Staff have been educated on the revised cleaning and disinfection process including the policy and procedure.
4. A completion date for correction of each deficiency cited:
08/15/25
5. The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:
The cleaning and disinfection of the expiratory valve will be monitored. Staff competencies will be monitored for all employees each quarter. Five (5) [Neonatal Expiratory Valve] cleanings will be observed per month for 90 days. The audits will be reported to the Infection Control Committee, Surgical Services Committee, Performance Improvement Patient Safety Committee, Medical Executive Committee, and the Governing Board.
6. The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
Director of Perioperative and Cardiovascular Services."

On August 19, 2025, at 1:35 p.m., the RP for the IJ was reviewed and was found acceptable.

On August 19, 2025, at 5:13 p.m., the immediate jeopardy situation was removed onsite in the presence of the EDQ, after the RP was verified onsite as implemented through observation, interviews, and record reviews, as evidenced by the cleanliness of the sterilizer, cleanliness and integrity of the surgical instruments, implementation of cleaning procedures and maintenance for the Giraffe OmniBed, implementation of cleaning procedures for the neonatal expiratory valve, staff knowledge of the manufacturer's IFU, and a tracking system designed to prevent future breaches in infection control and prevention practices.

An interview was conducted with the Senior Manager, Infection Prevention (SMIP) and Infection Control Preventionist 2 (IP 2), on August 13, 2025, at 11:05 a.m., in the NICU. The SMIP stated the hospital followed the following nationally recognized guidelines:
A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States); B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guidelines for perioperative areas); C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor); D. ANSI/AAMI ST79, American National Standards/Association for the Advancement of Medical Instrument: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and E. The Association for Professionals in Infection Control (APIC, a professional association for individuals working in the field of infection prevention).

1. The review of the hospital's document titled, "Field Service Report" (a service report) dated 1/28/2024, indicated a preventative maintenance visit was scheduled on 10/4/23. The Field Service Report showed chamber cleaning was completed for Sterilizer 1 on 1/28/2024.

The review of the hospital's document titled, "Field Service Report" dated 1/28/2024, indicated a preventative maintenance visit was scheduled on 10/4/23. The Field Service Report showed chamber cleaning was completed for Sterilizer 2 on 1/27/2024.

During a tour of the sterile processing department (SPD, an area within the hospital that processes and controls medical supplies, devices, and equipment) with the SMIP, Surgery Manager (NM 4), and Sterile Processing Technician 2 (SPD Tech 2) on 8/14/2025, at 10:52 a.m., two autoclaves were observed. Autoclave 1 was labeled as "Sterilizer 1" and Autoclave 2 was labeled as "Sterilizer 2." Sterilizer 1 and Sterilizer 2 were inspected, and the following were observed:

-Sterilizer 1 contained green matter on the inside of the door; greyish-brown matter throughout the chamber; and the chamber drain strainer was filled with debris.

-Sterilizer 2 contained black matter and brown staining throughout the chamber.

During a concurrent observation and interview with SPD 2 and NM 4 on 8/14/2025, at 10:59 a.m., SPD Tech 2 stated Sterilizer 1 and Sterilizer 2 had "some discoloration and should be cleaner." SPD Tech 2 stated the SPD technicians were not trained to clean the inside of the sterilizer nor were the technicians responsible for cleaning the inside of the sterilizer machines. SPD Tech 2 stated the inside of the sterilizers were cleaned by the manufacturer and he was not aware of routine cleaning activities that were expected to be performed by the SPD technician. SPD Tech 2 was observed to be inspecting Sterilizer 1's drain strainer. SPD Tech 2 stated the drain strainer was filled with debris (lint, paper, and residue) and needed to be cleaned. SPD Tech 2 stated, "I did not check the drain strainer today" (8/14/25). SPD Tech 2 stated he should have checked the strainer for cleanliness prior to running the sterilizer. NM 4 stated daily, and weekly cleaning and maintenance activities were entered into the hospital's SPM system, and she did not have access to the system to review the documentation. SPD Tech 2 stated he did not know how to use the SPM system, and he had not entered data into the SPM system related to daily or weekly cleaning for the sterilizers.

The review of the hospital's document titled, "AMSCO Stem Sterilization Routine Cleaning Procedure: Instruction for Use" dated 2024, indicated, "...Drain Strainer Cleaning Frequency: The chamber drain strainer should be cleaned at least once a day...Drain Routine Cleaning: The chamber drain should be cleaned once a week if liquid media are processed in the sterilizer; drain should be cleaned following chamber cleaning; and drain should be cleaned whenever it becomes clogged....Chamber Routine Cleaning Procedure: Clean Chamber under the following conditions: Spills and routinely to maintain sterilizer cleanliness and appearance ....NOTE: Routine Chamber Cleaning conducted by equipment operators does not replace the STERIS-recommended annual professional cleaning ..."

During an interview with the Director of Perioperative and Cardiovascular Services (DIR 5), on 8/15/25 at 9:15 a.m., in the conference room, DIR 5 stated the hospital did not have a policy and procedure on reprocessing reusable instruments or reprocessing equipment in the SPD. DIR 5 stated the hospital followed AAMI standards and the manufacturer's IFU for reprocessing instruments and equipment. DIR 5 stated she had reviewed the manufacturer's IFU on autoclave care and maintenance and the IFU indicated routine cleaning activities should be performed by the hospital staff. DIR 5 stated the hospital did not have documentation that showed staff had performed routine cleaning and maintenance activities. DIR 5 stated the autoclaves were routinely scheduled in January for the professional deep cleaning service and the professional deep cleaning service scheduled for January 2025 (seven months ago) was not performed in accordance with the manufacturer's IFU. DIR 5 stated, "It was the hospital's responsibility to follow up with the manufacturer and ensure that the deep cleaning service was done."

The review of the manufacturer's manual titled, "AMSCO Stem Sterilization Routine Cleaning Procedure: Instruction for Use" dated 2024, indicated, "All personnel involved in the use of this equipment must carefully review and comply with the warnings, cautions, and instructions contained in this manual."

2. A concurrent interview and inspection of surgical trays were conducted with SPD Tech 2, the SMIP, and NM 4, on 8/14/2025, at 9:35 a.m., in the SPD's clean workroom. Two surgical tray sets were inspected. SPD Tech 2 stated the surgical tray sets contained reusable surgical instruments that had been "previously reprocessed and were ready for patient use." The following were observed:

-Tray Set 1 contained 100 surgical instruments, dated 8/13/2025. 15 of 100 sampled instruments were of concern upon inspection of the surgical tray set. Three instruments had multiple scratches; five instruments contained scattered water spots; one instrument contained pitting (indentation); four instruments were discolored; and two instruments contained brown staining; and

-Tray Set 2 contained 37 surgical instruments, dated 8/7/2025. 10 of 37 sampled instruments were of concern upon inspection of the tray set. Three instruments had water stains; two instruments contained white residue; one instrument contained orange/red matter; one instrument contained green stains; one instrument had black spots; one instrument had scratches; and two instruments had brown stains.

SPD Tech 2 stated the instruments with pitting and scratches should have been removed from the tray set for repair. SPD Tech 2 stated the orange/red matter was "rust" and the rust was "missed" during the inspection process. SPD Tech 2 nor NM 4 did not provide an explanation for the multiple brown stained instruments. SPD Tech 2 stated if one reprocessed instrument in a tray set was potentially contaminated, the entire tray set would not be acceptable for patient use and the surgical tray set would have to be returned to the SPD's decontamination (the process of removing or neutralizing germs) workroom for reprocessing. SPD Tech 2 did not provide an explanation for the identified black spots or green stained instruments.

During an interview with DIR 5, on 8/15/25, at 9:15 a.m., in the conference room, DIR 5 stated, "During the instrumentation inspection process, all damaged instruments should have been removed from the tray set prior to the sterilization process."

The review of the ANSI/AAMI ST79: 2017, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" indicated, "7.6 Cleaning: 7.6.1 General Considerations ...g) Instruments should be carefully inspected for flaws [defects], damage, debris, detergent residue, and completeness, then dried ..."

3. An observation was conducted with the SMIP and NM 4 on 8/14/2025, at 8:29 a.m., of the manual instrument cleaning process, in the SPD decontamination workroom. SPD Tech 1 was observed standing at the decontamination sink and placing the medical device (neonatal expiratory valve) into an enzymatic solution (a special cleaner used in healthcare settings). SPD Tech 1 was observed fully submerging the device into the solution before proceeding with the cleaning process. SPD Tech 1 proceeded to turn and reposition the device in the solution. SPD Tech 1 removed the device from the solution and proceeded to rinse the solution off the device. SPD Tech 1 was observed preparing the medical device for the washer-disinfector (a machine that uses a combination of mechanical, chemical, and thermal processes to reprocess surgical instruments) process. SPD 1 was not observed using a syringe to flush the enzymatic solution through the valve's ports.

During an interview with SPD Tech 1 on 8/14/2025, at 8:45 a.m., in the decontamination workroom, SPD Tech 1 stated he followed the manufacturer's IFU for reprocessing the medical device. SPD Tech 1 stated the manufacturer's IFU did not mention cleaning the valve ports with a syringe.

During an interview with DIR 5, on 8/15/2025, at 9:15 a.m., in the conference room, DIR 5 stated there was no documentation that showed the SPD staff were trained in reprocessing the neonatal expiratory valve. DIR 5 stated the product was introduced to the hospital four years ago and the SPD staff did not receive formal training on reprocessing the neonatal expiratory valve. DIR 5 stated SPD staff were instructed to follow the manufacturer's IFU accessed through a third-party database. DIR 5 stated that the manufacturer's IFU available in the database did not specify that an enzymatic solution should be flushed through the expiratory valve port using a 20 milliliter (ml, unit of measurement) syringe. DIR 5 stated the manual provided with the valve indicated that the valve ports should be cleaned with a syringe. DIR 5 stated she was not aware that the IFU provided in the database differed from the manual that was delivered with the product. DIR 5 stated the enzymatic solution should have been flushed through the valve ports in accordance with the manufacturer's manual that was delivered with the product.

The review of the manufacturer's manual titled, "Infinity Acute Care System," dated 2017, indicated "Before the contact time begins and after it has elapsed, fit a syringe (A) containing 20 mL of solution to the ejector channel (B) [opening in the valve]. Inject and extract the solution several times with the syringe,"

4. During a tour of the neonatal intensive care unit (NICU, a unit for critically ill newborn patients) with the SMIP, Infection Preventionist (IP 2), and Assistant Nurse Manager 1 (ANM 1) on 8/13/2025 at 1:58 p.m., in the NICU utility room, the environmental service staff (EVS 1) was observed wiping down OmniBed 1 with a large white towelette. EVS 1 labeled OmniBed 1 as "clean" and transferred OmniBed 1 onto the unit. EVS 1 was observed gathering supplies to clean OmniBed 2. EVS 1 proceeded to wipe down OmniBed 2 using one large towelette, applied a clean label, and transferred OmniBed 2 onto unit.

During an interview with EVS 1 on 8/13/2025 at 3:05 p.m., in the NICU utility room, EVS 1 stated he had cleaned and disinfected the OmniBeds, and the equipment was ready for patient use.

During an interview with the SMIP and IP 2 on 8/13/2025 at 3:12 p.m., in the nurse station, the SMIP stated she did not identify a breach in the Caviwipes XL use. The SMIP was observed reading the towelette label and stated that the manufacturer's IFU indicated CaviWipes XL was a two-step disinfectant product. The SMIP stated the first wipe was for cleaning the Omnibed and a second wipe should have been used to disinfect the Omnibed. The SMIP stated she was unaware that the CaviWipes were a two-step disinfection process. The SMIP stated the infection Prevention Program (IPP) was responsible for ensuring safe infection prevention and control practices and she did not review the cleaning and disinfection procedures for patient safety prior to implementing the practice.

The review of the hospital's document titled "Infection prevention: Infection Prevention Program Plan and Risk Assessment," revised 5/2024, indicated "Purpose: the purpose of the Infection Prevention program (IPP) plan is to identify infections and reduce the risks of disease transmission through the development and implementation of preventative measures ...VIII Education and Training of Caregivers: ...I. Infection prevention prepares and/or assist with departmental-specific in-services

The review of the manufacturer's IFU titled "CaviWipes XL," dated 4/18/2023, indicated "For use as a disinfectant: CaviWipes XL is a two-step disinfectant product. One wipe is required to preclean then the second wipe is required to disinfect."

The review of the manufacturer's IFU titled "Giraffe OmniBed: User Manual," dated 2016-2024, indicated ... "Cleaning and disinfection frequency: Before you use the device for the first time and after each patient use, clean and disinfect the device and accessories as specified in the instructions that follow."

Based on observation, interview, and record review, the Infection Control Leadership (ICL) failed to perform active hospital-wide infection prevention and control rounds (routine assessments to monitor and ensure compliance with nationally recognized standards, infection prevention policies, identify potential risk, and promote patient and staff safety) when infection prevention and control rounds were not implemented, for two of two sampled departments (the Neonatal Intensive Care Unit [NICU, a unit for critically ill newborn patients] and the sterile processing department [SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment]) as evidence by,

1. The ICL did not ensure the autoclaves (steam sterilizer, a machine that utilize high-temperature steam and pressure to kill germs) were maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, green matter, greyish-brown matter, and debris were observed throughout the chamber (the internal portion of the sterilizer) for two of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 1 and Sterilizer 2);

2. The ICL did not ensure previously reprocessed instruments were not observed with orange/red matter, brown staining, discoloration, scratches, water spots, pitting (the development of small holes or indentation on the surface of surgical instruments), green stains, black spots, and white residue for two of two sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2);

3. The ICL did not ensure medical devices were reprocessed in accordance with the manufacturer's IFU for one of one sampled reusable Neonatal Expiratory Valve (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components);

4. The ICL did not ensure Giraffe OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) were cleaned and disinfected after each use in accordance with the manufacturer's IFU for two of two sampled isolettes (OmniBed 1 and OmniBed 2).

5. The ICL did not ensure proper personal protective equipment (PPE, equipment used to protect healthcare workers and prevent the spread of germs to others) were worn when using CaviWipes XL (the brand name for the germicidal towelettes) to clean OmniBeds (isolette, a transparent enclosed crib designed to maintain a controlled environment for newborns) in accordance with the manufacturer's IFU for one of one sampled employee (Environmental Service Staff, EVS 1).

6. The ICL did not ensure semi-critical equipment (a device that carries breathing gas or come in contact with mucous membranes) was properly stored for three of three sampled medical devices (Semi-Critical Medical Device 1, Semi-Critical Medical Device 2, and Semi-Critical Medical Device 3).

7. The ICL did not ensure that soil linen and clean linen were stored in separate rooms in accordance with the hospital's P&P for one of one sampled nursing unit (NICU).

8. The ICL did not ensure temperature and relative humidity readings and the Annual Crucial Area Validation (Air Balance Test - a process that involves measuring adjusting the airflow in a building ' s heating, ventilation, and air conditioning system to ensure correct amount of conditioned air is delivers to each space) were conducted in accordance with the hospital's P&P for one of one sampled nursing unit (NICU).

This failure resulted in inadequate infection prevention program oversight of the NICU and the SPD thereby increasing the risk of avoidable disease transmission for patients and staff within the departments.

Findings:

On 8/18/2025, at 3:53 p.m., an immediate jeopardy (IJ - a situation that had threatened or was likely to threaten the health and safety of a patient) situation was called in the presence of the Executive Director, Quality/ Performance Excellence (EDQ) and the Director, Risk Management (DRM). The EDQ and the DRM were verbally notified of failure of the infection control and prevention leadership not implementing safe infection control and prevention practices when the autoclaves were not clean and maintained in accordance with the manufacturer's IFU; multiple reusable surgical instruments were not clean or were damaged and the instruments were available for patient use; the Giraffe OmniBeds were not clean and disinfected between patients in accordance with the manufacturer's IFU; and neonatal expiratory valves (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components) were not reprocessed (a process carried out on a used device in order to allow its safe reuse) in accordance with the manufacturer's IFU; temperature and humidity was not being documented in the NICU prior to 8/6/2025.

On August 19, 2025, at 1:35 p.m., the hospital provided an IJ removal plan (RP). The RP was reviewed and was found acceptable. The RP included the following components:

1. The plan for correcting each specific deficiency cited:
a. On 08/18/25, the Infection Control Committee (ICC) [a committee responsible for preventing and controlling infections] meeting schedule was revised from a quarterly cadence to monthly schedule. This change is intended to support more timely reporting and improved oversight of infection prevention activities. The ICC reporting calendar was revised to include the following reports:
" Annual Infection Prevention Appraisal
" IP [Infection Prevention] risk assessment and IP plan/goals
" Infection Prevention Policies and Procedures
" Infection Prevention /HAI [hospital acquired infection, infections acquired during the process of receiving health care that was not present during the time of admission] Report:
" Infection Prevention Surveillance Audits
" Infection Prevention: Inpatient Observational Audit/EOC [environment of care rounds, regular inspections conducted by a healthcare facility to ensure that the facility is safe, clean, and working properly for patients and staff] high risk areas.
" Facilities: Temperature, Humidity, and Air Pressure Relations
" Constructions/ICRA [infection control risk assessment] Report
" HLD [high level disinfection, a process that kills most germs]/Scope Reprocessing
" Sterile Processing Department (SPD)
" Dialysis Report
" Caregiver Health
" Lab [laboratory]/Microbiology
" Pharmacy: Antimicrobial Stewardship
" Environmental Services (EVS)
" Kitchen
" Water Management Program
" Regulatory Audits
This change was approved by the Sr. Manager of Infection Prevention and Medical Director of Infection Prevention on 08/18/25.

b. Effective August 18, 2025, a formalized Infection Prevention (IP) Surveillance process has been established to strengthen oversight and ensure proactive infection control measures.

As part of this process, the Infection Preventionist and/or the Senior Manager of Infection Prevention will conduct weekly Infection Control (IC) rounds in designated high-risk areas, including the Neonatal Intensive Care Unit (NICU), Intensive Care Unit (ICU), Sterile Processing Department (SPD), and Operating Rooms (OR).

In addition, annual IC tracers will be performed in high-risk reprocessing areas (e.g., SPD, GI [gastroenterology, the study, diagnosis, and treatment of disorders within the digestive system] Lab, and High-Level Disinfection; ensure reprocessing instructions are current and accurate and are correctly implemented; sterilized maintenance contract with records for service; visual inspection of packaging materials and traceability of load contents. Findings and unresolved issues identified during these rounds will be escalated to the respective core leader and department director for immediate attention and corrective action.

Critical findings requiring broader organizational support will be reported during the Safety Huddle. All trends, patterns, and recurring issues will be compiled and presented to the Infection Control Committee (ICC) to facilitate the development and implementation of effective corrective action plans. These interventions will be continuously evaluated for both effectiveness and sustainability.
c. The daily organizational safety huddle was updated to include a section to report IC concerns on 08/19/25.
d. A memo was emailed to the Leadership outlining the expectations to notify the Sr. Manager of IP about any new or revised processes impacting IC on 08/18/25. The examples included:
" Construction, renovation, maintenance, demolition, repair of any area
" Caregiver training and competency assessments
" Introduction of new products or equipment
" Equipment failures or supply shortages
" Updates to manufacturer's instructions for use
" New or updated policy and procedures
" Unit/departmental standard operating procedures
" Environmental concerns (e.g., air balance, temperature, humidity out of range according to policy)
" Changes in personnel (e.g., hand hygiene auditor or person responsible for HLD)
e. Effective 08/19/23, The Environment of Care (EOC) rounding process has been revised to incorporate a multidisciplinary team approach. Rounds will now be conducted by representatives from the following departments:
" Safety
" Infection Prevention
" Pharmacy
" Food and Nutrition Services
" Environmental Services (EVS)
" Facilities
" Biomedical Engineering
" Security
" Caregiver Health
" Chief Medical Officer (ad hoc) [for this]
" Chief Nursing Officer (ad hoc)
" Executive Director, Operations (ad hoc)
" Executive Director, Quality (ad hoc)
" Unit Leadership
The EOC rounds will be conducted on a weekly basis with the entire team starting 08/20/25. Upon completion of each round, the team will debrief with the respective unit leadership to
review observations and share findings. Unit leadership will be responsible for ensuring that all identified issues are addressed and resolved.
2. The plan for improving the processes that led to the deficiency cited, including how the hospital is addressing improvements in its systems in order to prevent the likelihood of recurrence of the deficient practice:
The Sr. Manager of IP and IP Medical Director will have increased oversight of the IP program and will ensure the program has surveillance rounds, prevention and control of health care associated infections (HAIs) and other infectious diseases. The program will also demonstrate adherence to nationally recognized infection prevention and control guidelines. IP issues identified in the program will be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) [a hospital committee that is responsible for a set of focused activities to improve healthcare outcomes] program.
3. The procedure for implementing the IJ Removal Plan, if found acceptable, for each deficiency cited:
a. The Chief Medical Officer (CMO) met with the IP Chair to discuss the need for increased oversight and more frequent meetings. The IP Chair approved on 08/18/25. The CMO notified the Sr. Manager of Medical Staff Services to schedule the meeting monthly effective 09/16/25. The Sr. Manager of IP reviewed the ICC agenda items and revised the reporting schedule to include additional high-risk areas and more frequent reporting on 08/18/25.
b. The Sr. Manager of IP developed a surveillance rounding calendar and a tracer tool to track IC compliance. The surveillance activities have been scheduled starting the week of 08/18/25.
c. The Safety Huddle standard operating procedure was updated and the process change was announced at the 08/19/25 huddle.
d. The Leadership memo was emailed on 08/18/25.
e. The multidisciplinary team was notified about the revised process on 08/19/25. The team will be trained on 08/20/25 and rounding will begin on 08/20/25.
4. A completion date for correction of each deficiency cited:
08/22/25
5. The monitoring and tracking procedures that will be implemented to ensure that the IJ Removal Plan is effective, and that the specific deficiency(ies) cited remain corrected and in compliance with the regulatory requirements:

a. The ICC monthly meetings will be monitored to ensure the updated reporting criteria have been included in the meeting.
b. The ICC will monitor the IP surveillance rounding reports to ensure findings are resolved.
c. Findings and action plans resulting from Environment of Care (EOC) rounds related to infection control will be formally reported to the ICC.

The monthly results of all EOC rounds and ICC oversight will be reported to the Performance Improvement Patient Safety Committee [a committee that is responsible for overseeing and improving the quality of care provided by the hospital], Medical Executive Committee [a committee responsible for making important medical and clinical decisions, overseeing medical staff, and addressing various healthcare-related issues within the hospital] , Quality Board, and the Governing Board [a committee that manages or controls the hospital's activities].
6. The title of the person(s) responsible for implementing the acceptable IJ Removal Plan.
Senior Manager, Infection Prevention
Executive Director, Quality
Principle Safety Officer, Safety and EOC
Chief Nursing Officer
Executive Director, Operations
Chief Medical Officer
Medical Director, IP

On August 19, 2025, at 5:15 p.m., the immediate jeopardy situation was removed onsite in the presence of the EDQ, after the RP was verified onsite as implemented through observation, interviews, and record reviews, Managers/Directors knowledge of assuring compliance with infection prevention policies and procedures, and a tracking system designed to prevent future breaches in infection control and prevention practices.

An interview was conducted with the Senior Manager, Infection Prevention (SMIP) and Infection Control Preventionist 2 (IP 2), on August 13, 2025, at 11:05 a.m., in the neonatal intensive care unit (NICU, a unit for critically ill newborn patients). The SMIP stated the hospital followed the following nationally recognized infection control and prevention guidelines:

A. Centers for Disease Control and Prevention (CDC, the national public health agency of the United States);

B. Association of periOperative Registered Nurses (AORN, a nationally recognized infection control guideline for perioperative areas);

C. Occupational Safety and Health Administration (OSHA, a large regulatory agency of the United States Department of Labor);

D. ANSI/AAMI ST79, American National Standards/Association for the Advancement of Medical Instrument: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities; and

E. The Association for Professionals in Infection Control (APIC, a professional association for individuals working in the field of infection prevention).

1. The review of the hospital's document titled, "Field Service Report" (a service report) dated 1/28/2024, indicated a preventative maintenance visit was scheduled on 10/4/23. The Field Service Report showed chamber cleaning was completed for Sterilizer 1 on 1/28/2024.

The review of the hospital's document titled, "Field Service Report" dated 1/28/2024, indicated a preventative maintenance visit was scheduled on 10/4/23. The Field Service Report showed chamber cleaning was completed for Sterilizer 2 on 1/27/2024.

During a tour of the SPD with the SMIP, Surgery Manager (NM 4), and Sterile Processing Technician 2 (SPD Tech 2) on 8/14/2025, at 10:52 a.m., two autoclaves were observed. Autoclave 1 was labeled as "Sterilizer 1," and Autoclave 2 was labeled as "Sterilizer 2." Sterilizer 1 and Sterilizer 2 were inspected, and the following were observed:

-Sterilizer 1 contained green matter on the inside of the door; greyish-brown matter throughout the chamber; and the chamber drain strainer was filled with debris.

-Sterilizer 2 contained black matter and brown staining throughout the chamber.

During an interview with the SMIP on 8/15/2025 at 3:15 p.m., in the conference room, the SMIP stated she had not performed infection prevention and control rounds in the SPD for 2025. The SMIP stated the infection prevention program plan was to perform two tracers per year, but the tracers were not completed due to other infection prevention activities performed on the other units. The SMIP stated she was not aware that the autoclaves were not clean nor that the annual deep cleaning had not been done by the manufacturer.

2. A concurrent interview and inspection of surgical trays were conducted with SPD Tech 2, the SMIP, and NM 4, on 8/14/2025, at 9:35 a.m., in the SPD's clean workroom. Two surgical tray sets were inspected. SPD Tech 2 stated the surgical tray sets contained reusable surgical instruments that had been "previously reprocessed and were ready for patient use." The following were observed:

-Tray Set 1 contained 100 surgical instruments, dated 8/13/2025. 15 of 100 sampled instruments were of concern upon inspection of the surgical tray set. Three instruments had multiple scratches; five instruments contained scattered water spots; one instrument contained pitting; four instruments were discolored; and two instruments contained brown staining; and

-Tray Set 2 contained 37 surgical instruments, dated 8/7/2025. 10 of 37 sampled instruments were of concern upon inspection of the tray set. Two instruments had water stains; two instruments contained white residue; one instrument contained orange/red matter; one instrument contained green stains; one instrument had black spots; one instrument had scratches; and two instruments had brown stains.

During an interview with IP 2 and the SMIP on 8/15/2025 at 3:15 p.m., in the conference room, the SMIP stated she had not performed infection prevention and control rounds in the SPD for 2025. The SMIP stated the ICP program should have performed ICP rounds in the SPD.

3. An observation was conducted with the SMIP and NM 4 on 8/14/2025, at 8:29 a.m., of the manual instrument cleaning process, in the SPD decontamination (the process of removing or neutralizing germs) workroom. SPD Tech 1 was observed standing at the decontamination sink and placing the medical device (neonatal expiratory valve) into an enzymatic solution (a special cleaner used in healthcare settings). SPD Tech 1 was observed fully submerging the device into the solution before proceeding with the cleaning process. SPD Tech 1 proceeded to turn and reposition the device in the solution. SPD Tech 1 removed the device from the solution and proceeded to rinse the solution off the device. SPD Tech 1 was observed preparing the medical device for the washer-disinfector (a machine that uses a combination of mechanical, chemical, and thermal processes to reprocess surgical instruments) process.

During an interview with SPD Tech 1 on 8/14/2025, at 8:45 a.m., in the SPD decontamination workroom, SPD Tech 1 stated he followed the manufacturer's IFU for reprocessing the medical device. SPD Tech 1 stated the manufacturer's IFU did not mention cleaning the valve ports with a syringe.

During an interview with IP 2 and the SMIP on 8/15/2025 at 3:15 p.m., in the conference room, the SMIP stated she had not performed infection prevention and control rounds in the SPD for 2025. The SMIP stated she did not know that the manufacturer's IFU available in the database did not specify that an enzymatic solution should be flushed through the expiratory valve port using a 20 milliliter (ml, unit of measurement) syringe. The SMIP stated the Infection Prevention Program did not know that the manual provided with the valve indicated that the valve ports should be cleaned with a syringe. The SMIP stated it was identified during this survey that the IFU provided in the database differed from the manual that was delivered with the product. The SMIP stated the ICP program was responsible for infection prevention and control activities. IP 2 stated she had not observed the staff reprocessing neonatal expiratory valves.

4. During a tour of the NICU with the SMIP, IP 2, and the Assistant Nurse Manager (ANM 1) on 8/13/2025 at 1:58 p.m., in the NICU utility room, the environmental service staff (EVS 1) was observed wiping down OmniBed 1 with a large white towelette. EVS 1 labeled OmniBed 1 as "clean" and transferred OmniBed 1 onto the unit. EVS 1 was observed gathering supplies to clean OmniBed 2. EVS 1 proceeded to wipe down OmniBed 2 using one large towelette, applied a clean label, and transferred OmniBed 2 onto unit.

During an interview with EVS 1 on 8/13/2025 at 3:05 p.m., in the NICU utility room, EVS 1 stated he had cleaned and disinfected the OmniBeds, and the equipment was ready for patient use.

During an interview with the SMIP and IP 2 on 8/13/2025 at 3:12 p.m., in the nurse station, the SMIP stated she did not identify a breach in the Caviwipes XL use. The SMIP was observed reading the towelette label and stated that the manufacturer's IFU indicated CaviWipes XL was a two-step disinfectant product. The SMIP stated the first wipe was for cleaning the Omnibed and a second wipe should have been used to disinfect the Omnibed. The SMIP stated she was unaware that the CaviWipes were a two-step disinfection process. The SMIP stated the Infection Prevention Program was responsible for ensuring safe infection prevention and control practices and she did not review the cleaning and disinfection procedures for patient safety prior to implementing the practice.

5. During a tour of the NICU with the SMIP, IP 2, and ANM 1 on 8/13/2025 at 1:58 p.m., in the NICU utility room, EVS 1 was observed wiping down an OmniBed with CaviWipes XL. EVS 1 was not observed to wear eye protection.

During an interview with EVS 1 and the SMIP on 8/13/2025 at 3:05 p.m., in the NICU utility room. EVS 1 stated he did not know that he needed to wear eye protection. EVS 1 stated eye protection was not included in the CaviWipes XL training. The SMIP stated she did not have knowledge of the required PPEs. The SMIP stated she had not reviewed the education and training prior to implementing the CaviWipes XL to clean and disinfect the OmniBeds. The SMIP stated the infection program was responsible for ensuring the training was accurate and safe.

6. During an observation in the NICU clean storage room with the SMIP and the respiratory care practitioner (RCP 2) on 8/15/2025 at 11:15 a.m., three ventilator machines (a machine used medically to support or replace the breathing of a person) were observed and the neonatal expiratory valves (a medical device that prevents the newborn's exhaled air, which may contain germs, from entering the breathing machine's internal components) were fitted to the ventilator. Semi-Critical Medical Device 1 was dated 7/13/2025, Semi-Critical Medical Device 2 was dated 8/13/2025, and Semi-Critical Medical Device 3 was dated 8/8/2025. Semi-Critical Medical Device 1, 2, and 3 were covered with opened plastic bags.

During an interview with RCP 2 and the SMIP on 8/15/2025 at 11:20 a.m., RCP 2 confirmed that the neonatal expiratory valves were reusable semi-critical medical devices. RCP 2 stated the semi-critical medical devices were removed from the ventilators after use and transported to the SPD for cleaning. RCP 2 stated that after the semi-critical medical devices were cleaned the devices were returned to the department in a peel pack (a germ-free pouch that is used as a barrier to prevent contamination of the germ-free items from dust, moisture, and other environmental factors). RCP 2 stated the semi-critical medical devices were either stored in the respiratory closet or the peel packs were removed, and the semi-critical medical devices were fitted to the ventilator for storage. RCP 2 stated she did not know if the hospital's ventilator machines had been validated for storing semi-critical medical devices. RCP 2 stated the date shown on the ventilators were not the dates that the semi-critical medical devices were reprocessed. RCP 2 stated the dates shown on the ventilators identified when the ventilators were cleaned. RCP 2 stated the department did not have a system in place to verify the traceability or the processing status of the device after the device had been fitted to the ventilator for storage. RCP 2 stated she did not know if the ventilator had been validated to protect reprocessed semi-critical items from cross-contamination (the transfer of harmful germs from one person, object, or place to another). The SMIP stated that she was not sure, and she would need to review the process for transporting, reprocessing, and storage of the semi-critical medical device.

The review of the hospital's P&P titled "Stand by Equipment-Respiratory Therapy NICU" Revised 8/2025 indicated that the semi- critical medical devices can be fitted to the ventilator and stored for 70 days. There were no nationally recognized infection prevention and control guidelines observed to reference the policy.

During an interview with the SMIP on 8/15/25 at 3:15 p.m., in the conference room, the SMIP stated the respiratory department did not have a policy and procedure for storing and transporting semi-critical medical devices that included infection prevention precautions. The SMIP stated the Infection prevention program did not perform a risk assessment for the device and she did not know if the semi-critical valve storage closet required humidity and temperature monitoring. The SMIP stated she would need to perform a risk assessment to determine the maximum allowable time the valve could safely be fitted to the ventilator for storage. The SMIP stated the semi-critical medical device storage system must be in accordance with the national infection and prevention standards including traceability standards.

7. During a tour of the NICU with the SMIP and the Assistant Nurse Manager (ANM 1) on 8/13/2025 at 11:30 a.m., there was one linen hamper, and one linen cart observed in the corridor (hallway) between Room 10 and Room 11.

During an interview with ANM 1 and the SMIP on 8/13/2025, at 11:40 a.m., in the NICU corridor, ANM 1 stated the linen hamper contained soiled NICU scrubs (hospital issued uniform) and the linen cart contained clean NICU scrubs. The SMIP stated the clean and soiled linen should not be stored together to prevent cross-contamination.

During a follow-up interview with IP 2 and the NICU Manager (NM 2) on 8/18/2025, at 10:20 a.m., in the NICU, NM 2 stated the clean linen cart, and the soiled linen hamper had been stored in the NICU's corridor between Room 10 and Room 11 for the past year. IP 2 stated that she had conducted daily infection control rounds in the NICU, and she had not identified that soiled linen was being stored in the same area as clean linen. IP 2 stated, "I missed it." IP 2 stated she performed rounds, but the rounds were focused on tasks which included daily isolation procedures and hand hygiene audits.

The review of the hospital document titled "Infection Prevention: Infection Prevention Program Plan and Risk Assessment," revised 5/2024, indicated Purpose: The purpose of the infection Prevention program (IPP) is to identify infections and reduce the risks of disease transmission through the development and implementation of preventative measures ... C. Responsibilities of the Infection Prevention Department ... 2. The Manager of Infection Prevention has been given the authority of the IPP and is responsible for: i implementing policies concerning the management of infections and communicable disease ...iii Developing a system for identifying reporting, investigating, and controlling infections and communicable diseases iv. Coordinating
infection prevention activities and projects within the hospital. Facilitating ongoing monitoring of the program activities and interventions effectiveness ..."

8. During a review of the facility ' s Air Balance Report (document record the results of the HVAC system ensuring proper air flow)," dated 8/6/2025, the Report indicated NICU Isolation (separate place to prevent spread infection) #2 and Main NICU failed. The "Air Balance Report" indicated that the NlCU did not meet the California Mechanical Code (CMC) (minimum standards for the design, instillation, and maintenance of mechanical systems in buildings) for Air Changes per Hour (ACH) (measure how many times the total volume of air in a room is replaced with new air in one hour) had an ACH of 5.41 instead of the required minimum of 6.00 ACH, and that NICU Isolation 2 (Room 8 and 9) did not meet the CMC minimum 12 ACH, meaning the NICU did not have any exhaust airflow required to maintain a negative pressure (a condition where the air pressure inside a space is lower than the surrounding areas) relationship or ACH. That upon further investigation, it was determined that Exhaust Fan (removes unwanted air, such as moisture from enclosed area transferring it outdoors)(EF)-21, located on the 2nd floor roof which serves this space, exhaust fan motor has a motor hum (motor trying to start but is stop by some issue)and does not operate. That the Required ACH for the NICU was 6 ACH and the Actual ACH was 5.41, and that Required ACH for NICU Isolation 2 was 12 ACH and the Actual ACH was .00 ACH.

During an interview on 8/13/2025 at 11:34 a.m. with DIR 2, DIR 2 stated that NICU Isolation #2 having an Actual ACH of 0 was because of the exhaust fan in that area not working. DIR 2 further stated that the NICU was not included in the manual "Temperature, Humidity, and Air Pressure Daily Logs" until 8/2025, and that the Facilities team began physically rounding daily in the NICU on 8/8/2025. DIR 2 confirmed there was no in-house log of temperature or humidity readings in the NICU prior to 8/8/2025.

During an interview on 8/13/2025 at 3:15 p.m. with DIR 2, DIR 2 stated that he discovered the NICU was not included in the 12/ 2024 annual air balance testing when a third-party construction team requested the report for pre-construction planning on 5/8/2025. The next annual air balance test would not occur until 12/2025.

During an interview on 8/14/2025 at 1:51 p.m. with the Senior Manager of Infection Prevention (SMIP), the SMIP stated it was important to monitor temperature and humidity because high humidity creates a moist environment which promotes fungus and mold growth; additionally, high temperatures could increase humidity. The SMIP further stated it was important to monitor hourly air changes to ensure air was being filtered effectively through the HVAC system due to the "microbial contaminants" (an unwanted microorganism introduced into a culture, specimen, or environment where it is not intended to be) in the air.

During a review of the facility ' s policy and procedure (P&P), titled "Critical Air Environments," last revised 4/2023, the P&P indicated, "Facilities and/or clinical staff shall monitor and record temperature, relative humidity, and verify the pressure relationship in areas designated as high risk by this policy and documented by the individual ministry daily. ... Facilities shall at a minimum conduct annual testing and balancing of critical areas for air change rates and pressurization."