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Based on observations, interviews, and record reviews, the hospital failed to ensure the hospital had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by:

1. Clean Gastrointestinal endoscopes (GI scopes - thin flexible tubes with a light and a camera used to examine the inside of the digestive tract) (number of scopes varied) were not stored in a clean environment and not compliant with the National Infection Control Standards (American National Standards Institute [ANSI]/Advancement of Medical Instrumentation [AAMI] - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry) the hospital followed. This failure had the potential for clean scopes to become contaminated by bacteria (living cells that can make one sick) and viruses (tiny infectious agent) which can result in infection to a patient. (Refer to A-0749 finding 1).

2. There was no documented evidence to demonstrate that three of three storage cabinets used to store clean flexible GI scopes were cleaned and maintained according to the manufacturer's instructions for use (IFUs). This failure had the potential for dust and debris, or microbial contaminants (bacteria, viruses) to accumulate inside the cabinets which can transfer to the clean scopes leading to infection when used on a patient. (Refer to A-0749 finding 2).

3. One of one Central Services Technician (CST 1) did not clean and decontaminate soiled surgical instruments according to procedures and the National Standards the hospital followed (ANSI/AAMI). This failure resulted in surgical instruments to not be clean prior to entering the sterilizer, resulting in un-sterile surgical instruments and the potential to cause infection in the surgical patient. (Refer to A-0749 finding 3).

4. One of one CST (CST 1) reused single-use instrument cleaning sponges multiple times. This failure had the
potential to cross-contaminate instruments and surgical trays. (Refer to A-0749 finding 4).

5. There was no documented evidence to demonstrate the hospital cleaned three of three instrument washers according to manufacturer's IFU. This failure had the potential for improperly cleaned instrument washers and the potential for surgical patients to become infected. (Refer to A-0749 finding 5).

6. The Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings) failed to monitor and track infections for five of six sampled patients (Patient 31, Patient 32, Patient 33, Patient 22 and Patient 23) in the Neonatal (newborn) Intensive Care Unit (NICU - specialty care unit) with infections. This failure had the potential to result in an increased risk of spreading infections to all patients receiving care in the NICU. (Refer to A-0750 finding 1)

7. The IP failed to follow the requirements of All Facilities Letter (AFL) 23-08," to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO) when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures (laboratory test for disease) for Pseudomonas aeruginosa (P. aeruginosa - bacteria commonly found in the environment that cause severe infections to those individuals who have a weakened immune system). This failure resulted in the IP not utilizing outside resources to control an unusual infection. (Refer to A-0750 finding 2)

8. The IP failed to Follow the Policy and Procedure (P&P) titled "Outbreak Investigation" when the IP did not follow the procedure outlined in the P&P to conduct an investigation of an outbreak of P. aeruginosa when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures for P. aeruginosa (the bacteria was grown and detected in a sample). This failure resulted in the hospital to not be aware of the source of the infection, how the infection spread and had the potential to result in an increased risk of spreading P. aeruginosa. to all patients receiving care in the NICU. (Refer to A-0750 finding 3)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide Infection Control Program resulting in the hospital's inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services.

Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. Clean Gastrointestinal endoscopes (GI scopes - thin flexible tubes with a light and a camera used to examine the inside of the digestive tract) (number of scopes varied) were not stored in a clean environment and not compliant with the National Infection Control Standards (American National Standards Institute [ANSI]/Advancement of Medical Instrumentation [AAMI] - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry) the hospital followed. This failure had the potential for clean scopes to become contaminated by bacteria (living cells that can make one sick) and viruses (tiny infectious agent) which can result in infection to a patient.

2. There was no documented evidence to demonstrate that three of three storage cabinets used to store clean flexible GI scopes were cleaned and maintained according to the manufacturer's instructions for use (IFUs). This failure had the potential for dust and debris, or microbial contaminants (bacteria, viruses) to accumulate inside the cabinets which can transfer to the clean scopes leading to infection when used on a patient.

3. One of one Central Services Technician (CST 1) did not clean and decontaminate soiled surgical instruments according to procedures and the National Standards the hospital followed (ANSI/AAMI). This failure resulted in surgical instruments to not be clean prior to entering the sterilizer, resulting in un-sterile surgical instruments and the potential to cause infection in the surgical patient.

4. One of one CST (CST 1) reused single-use instrument cleaning sponges multiple times. This failure had the
potential to cross-contaminate instruments and surgical trays.

5. There was no documented evidence to demonstrate the hospital cleaned three of three instrument washers according to manufacturer's IFU. This failure had the potential for improperly cleaned instrument washers and the potential for surgical patients to become infected.

Findings:

1. During a concurrent observation and interview on 8/20/25 at 9:15 a.m., with the Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings), the Central Sterile Department was observed. IP stated the hospital follows the national infection control standards from AAMI, among others.

During a concurrent observation and interview on 8/20/25 at 11:10 a.m., with IP and Endoscopy Technician (ET) 1, the scope storage room was observed. The following concerns were identified: the scopes were located in a room used to perform high level disinfection (HLD - the strongest form of disinfection, effectively killing all microorganisms, making the scopes safe to use) of reusable GI scopes. ET 1 was in the process of performing high level disinfection of a GI scope. In a room without a door and adjacent to her workspace, were three GI scope cabinets. One of the cabinets was left open which contained clean GI scopes, exposing the clean GI scopes. The IP was asked if the room storing the clean GI scopes was considered a clean room, the IP stated no because they perform HLD of GI scopes.

During a review of the National Standards the hospital followed, "ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities" the standards indicated, "11.2.2 Storage Cabinets, cabinets used for storage of flexible endoscopes should be situated in a secure location such as in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room (AORN, 2018e, IX.a [39]). Situating the storage cabinet in a secure location helps protect inventories of flexible endoscopes and supplies that are vulnerable to misappropriation. Locating the storage cabinet in the clean workroom or in a clean area outside of the procedure room helps prevent contamination of processed endoscopes..."

2. During a concurrent observation and interview on 8/20/25 at 11:15 a.m., with ET I, the scope storage cabinet room was observed, ET 1 stated they (ETs) wipe the cabinets every week using a hospital disinfectant wipe. ET 1 stated the clean scopes remain in the cabinets while the cabinets are wiped out. ET 1 stated ETs do not remove the scopes when they clean the cabinets or the drip trays.

The hospital was unable to provide documented evidence to demonstrate the three scope cabinets were cleaned routinely.

During a review of the cabinet manufacturer's IFU provided by ET 1, the IFU indicated, "Maintenance and Cleaning...(provided detailed instructions on how to clean the cabinets) ...Removable Drip Tray, remove scopes from the cabinet. Then remove drip tray [removable tray or basin located at the bottom of the cabinet that collects any residual moisture or liquid that may drip from the endoscopes during the drying process] and clean the drip tray with a non-abrasive liquid cleaner..."

3. During a concurrent observation and interview on 8/20/25 at 2:45 p.m., in the hospital sterile processing decontamination room, with the Central Sterile Processing Supervisor (CSPS), a Central Sterile Technician (CST 1) was cleaning soiled surgical instruments in a 3-compartment sink. Sink one was labeled "Rinse Sink", sink two was labeled "Enzymatic Soak" and Sink three was labeled "Last Rinse". The following concerns were identified: CST 1 removed soiled instruments from the "Enzymatic Soak sink", took them over to the "Rinse Sink", proceeded to brush the instruments above the water and over the soiled instruments that were in the "Rinse Sink". CST 1 did not immerse the immersible instruments beneath the water level and did not use sink number three "Last Rinse" for the final rinse of the instruments. CST 1 performed the final rinse in sink one over soiled surgical instruments that were in sink one. CSPS stated that CST 1 should have brushed the soiled instruments beneath the water level in sink two "Enzymatic Soak", not in sink one and CST should have utilized sink 3 "Last Rinse" for the final rinse prior to taking the instruments to the washers. According to CSPS, the water used for cleaning and rinsing the instruments was critical water (reverse osmosis - treated water).

During a review of the National Standards the hospital followed, "ANSI/AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" the Standards indicated, "7.6.4.2 Manual cleaning ... (d) clean immersible devices under water to minimize aerosolization ..."

During a review of a document provided by the hospital titled, "One Source Cleaning/Decontamination manual cleaning" the document indicated, "8. Rinse the device by completely immersing it in treated water ..."

4. During a concurrent observation and interview on 8/20/25 at 3 p.m., with CSPS, a tour of the sterile processing decontamination room (a room used to clean and decontaminate reusable patient equipment) was conducted. CST 1 was observed cleaning soiled surgical trays that were used to hold patient surgical instruments. CST 1 used tubular sponges to clean the trays and when asked how often she replaced the sponges, CST 1 stated she used the tubular sponges throughout the day and then disposed of tubular sponges at the end of her day or after three or four uses "sometimes". CST 1 stated was not sure if the sponges were single-use or if they could be used multiple times. CSPS was asked how the sponges get cleaned and if they were single-use. CSPS stated, "Currently we [the hospital] don't have a practice in place of how many times the sponges get used and replaced." CSPT was unsure if the sponges were single-use.

During a review of a document provided by the hospital, titled "Medline [Medical Supplier] ...SPONGES: TUBULAR SPONGE DRY" the document indicated the sponges the hospital used as multiuse were SINGLE USE.

5. During a concurrent observation and interview on 8/20/25 at 3:10 p.m., with CSPS, a tour of the hospital sterile processing decontamination room, CSPS was asked how they cleaned and maintained three of three instrument washers. One washer that was not in use contained white substances on the internal chamber. CSPS stated, "We currently only change the filters daily and perform a descaling." CSPS was asked to provide documentation to demonstrate their cleaning schedule of the washers. CSPS stated they did not have documentation. CSPS was asked to provide the manufacturer's instructions for the washers.

During a review of the washer IFU, the IFU indicated, "Chamber components: 5.1 inspect rotary spray arm assemblies for free movement and clogged holes once a week...5.2 clean debris screen in chamber once a day...5.3 remove hard water deposits from interior of chamber using decontamination cycle once a week ..5.5 clean water outlet connection in chamber once a week..." "6.6 cleaning door gasket once a month." The IFU provided detailed instructions on the frequency and the method for cleaning the washers. The facility did not have any documentation to indicate they followed the manufacturer's instructions for cleaning and maintaining the three washers.

Based on interview and record review, the hospital failed to ensure the Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings):

1. Monitored and tracked infections for five of six sampled patients (Patient 31, Patient 32, Patient 33, Patient 22 and Patient 23) in the Neonatal (newborn) Intensive Care Unit (NICU - specialty care unit) with infections. This failure had the potential to result in an increased risk of spreading infections to all patients receiving care in the NICU.

2. Followed the requirements of All Facilities Letter (AFL) 23-08," to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO) when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures (laboratory test for disease) for Pseudomonas aeruginosa (P. aeruginosa - bacteria commonly found in the environment that cause severe infections to those individuals who have a weakened immune system). This failure resulted in the IP not utilizing outside resources to control an unusual infection.

3. Followed the Policy and Procedure (P&P) titled "Outbreak Investigation" when the IP did not follow the procedure outlined in the P&P to conduct an investigation of an outbreak of P. aeruginosa when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures for P. aeruginosa (the bacteria was grown and detected in a sample). This failure resulted in the hospital to not be aware of the source of the infection, how the infection spread and had the potential to result in an increased risk of spreading P. aeruginosa. to all patients receiving care in the NICU.

Findings:

1. During an interview on 8/21/25, at 8:11 a.m., with IP, IP stated her process for the surveillance of infections within the hospital was to pull up the hospital isolation list every morning. IP stated she looked at each patient with an infection for the reason the patient was on isolation precautions (method of controlling the spread of infections). IP did not explain her surveillance process for patients with infections who were not on isolation precautions. IP stated she was alerted when Patient 31 in the NICU had multi-drug resistant (MDR, does not respond to three or more antibiotic categories) Pseudomonas. IP stated she was concerned and placed both Patient 31 and Patient 32 on isolation precautions. IP stated Patient 32 had the first infection of Pseudomonas in his eye and then Patient 31 had MDR Pseudomonas pneumonia. IP stated she did not want the Pseudomonas infection to spread to other babies in the NICU.

During a review of Patient 31's "Medical Record (MR)" admission date 7/21/25, with Quality and Patient Safety Manager (QPSM), the "Microbiology [study of organisms] Results (MIR)," dated 8/9/25, at 5:30 p.m., and Order Information for Isolation, dated 8/12/25, at 7:34 a.m., were reviewed. The MIR indicated Culture Sputum (saliva and mucus from the lungs), Collection Date: 8/9/25, Preliminary Results dated 8/11/25 "Many Pseudomonas aeruginosa Susceptibility (antibiotics effective against bacteria) to follow." Final Results dated 8/12/25 "Many Pseudomonas aeruginosa******Multi-drug resistant organism******." The Order Information for Isolation indicated "Entered and electronically signed by SYSTEM, SYSTEM ...Start Date/Time 08/12/2025 7:34 PDT [Pacific Daylight Time] Type of Isolation Contact [key practices include using gown and gloves for all interactions, dedicated medical equipment, and placing the patient in a private room when possible] reason for Isolation MDR Pseudomonas ...Comment This isolation order was auto-generated by the System. The patient met criteria for isolation based on clinical lab findings."

During a review of Patient 32's MR, admission date 7/21/25, with QPSM, the MIR, dated 8/5/25, at 8 p.m., the Physician Note, dated 8/12/25, at 3:54 p.m., and the Order Information for Isolation, dated 8/12/25, at 11:14 a.m., were reviewed. The MIR indicated Test: Eye Culture, Collection Date: 8/5/25, at 8 p.m., Preliminary Results dated 8/6/25 Few Pseudomonas aeruginosa. Susceptibility (antibiotics effective against bacteria) to follow. Final Results dated 8/7/25 Few Pseudomonas aeruginosa. The Order Information for Isolation indicated Registered Nurse (RN) 1 entered and electronically signed an order for contact isolation due to MDR Pseudomonas Special instructions Precaution.

During a review of Patient 33's MR, admission date 7/15/25, with QPSM, the MIR, dated 8/12/25, at 6:10 a.m., and the IP documentation was reviewed. The MIR indicated Test: Eye Culture, Collection Date: 8/10/25, at 6:20 p.m., Infection Rare (few) Pseudomonas.

During a review of Patient 22's MR, admission date 7/24/25, with QPSM, the MIR, dated 7/30/25, and the IP documentation were reviewed. The MIR indicated Test: Respiratory (lungs and airways) Culture, Collection Date: 7/30/25, Infection Escherichia coli (bacteria commonly found in the lower intestine).

During a review of Patient 23's MR, admission date 7/14/25, with QPSM, the MIR, dated 8/14/25 was reviewed. The MIR indicated Test eye culture Collection Date 8/14/25, Result date 8/16/25 Infection Staphylococcus aureus (common bacterial infection in NICU).

During an interview on 8/21/25 at 1:46 p.m., with IP, IP was unable to provide documented evidence of monitoring or tracking of patients with infections in the hospital including Patient 31, Patient 32, Patient 33, Patient 22, and Patient 23. IP stated Pseudomonas was not a normal occurrence in the NICU. Occurrences of Pseudomonas was not the hospital's baseline (starting point). IP stated, "If I did not document [referring to monitoring of infections], it did not happen."

During a review of the facility's P&P titled "Outbreak Investigation," dated 5/22/25 the P&P indicated "Purpose: To identify probable contributing factors in order to control an outbreak and to prevent similar outbreaks in the future. Guidelines/Policy Statement: Outbreak may be suspected when healthcare-associated infections (HAIs) occur above the background rate or when an unusual microbe is recognized ... Initiate surveillance ..."

2. During a current interview and record review on 8/21/25 at 1:46 p.m. with IP, "All Facilities Letter (AFL) 23-08," dated 1/18/23 was reviewed. The "AFL" indicated "Requirements to Report Outbreaks and Unusual Disease Occurrences (AFL 23-08): Health facilities licensed by CDPH [California Department of Public health] Licensing and Certification (L&C) are required to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO)...this AFL refers to recommended pathogen-specific outbreak reporting thresholds, definitions and other resources provided by the Council for Outbreak response-Healthcare Associated Infections and Antimicrobial Resistant (CORHA), where available ...Definitions: Outbreak-The occurrence of cases of a disease or condition above the expected or baseline level, usually over a given period of time, in a geographic area or facility, or in a specific populations group...the designation of an outbreak is relative to the usual frequency of the disease or condition in the same facility or community, among the specified population, over a comparable period of time...
Examples of Reportable Incidents...Single case of colonization or infection with an MDRO [multiple drug resistant organism] if it was never previously or only rarely encountered in the facility, region or LHJ [local health jurisdiction]...outbreak or increased incidence of any MDRO...or infection on a neonatal intensive care unit (NICU)...Upon receipt of a report of an outbreak or unusual occurrence, the LHD [local Health Department] recommends control actions and may conduct an epidemiologic investigation..." IP stated pseudomonas was neither the baseline nor a normal occurrence in the hospital's NICU. IP stated she reviewed the AFL, but the AFL was unclear to her. IP stated she decided not to report because there was only one case of MDR pseudomonas.

During a review of the facility's P&P titled, "Event Reporting and Management," dated 10/24/23, the P&P indicated "E. Reporting Requirements to Regulatory Agencies 1. Patient Safety Leader, Regulatory Leader, or other designee will report to regulatory agencies in accordance with state-specific reporting requirements or other reporting as required. Reportable Events defined by either the State Department of Public Health or other applicable regulatory agency, will be reported within the required reporting timeframes.

3a. During a review of Patient 31's MR, dated 7/21/25, the MR indicated, Patient 31 was admitted to the NICU on 7/21/25.

During a review of Patient 31's "Physician Note (PN)," dated 8/9/25, the PN indicated, "Problems by Systems: 1. Respiratory ...Last x-ray [a picture of the bones and other parts inside of the body] on 8/8 had revealed bilateral [involving both sides] ...hazy lung fields ..."

During a review of Patient 31's MIR, dated 8/12/25, the MIR indicated, "Order: Culture Sputum [mucous from the lower airways] Collect Date/Time: 8/9/2025 17:30 [5:30 p.m.] Last update Date/Time: 8/12/2025 07:41 [7:41 a.m.] ...[result]Many Pseudomonas aeruginosa ******Multi-drug resistant organism******."

During a review of Patient 31's "Isolation Order (IO)," dated 8/12/25, the "IO" indicated, "Requested start date/Time" 8/12/25 at 7:34 am. Type of Isolation: Contact. Reason for Isolation: MDR-Pseudomonas. Comment: This isolation order was auto-generate by the System. The patient met criteria for isolation based on clinical lab findings."

3b. During a review of Patient 32's MR, dated 7/21/25, the MR indicated, Patient 32 was admitted to the NICU on 7/21/25.

During a review of Patient 32's MIR, dated 8/7/25, the MIR indicated, "Order: Eye Culture. Collect Date/Time: 8/5/2025 00:20 [12:20 a.m.] Last update Date/Time: 8/7/2025 06:49 [6:49 a.m.] ...[result] Pseudomonas aeruginosa ..."

During a review of Patient 32's "IO," dated 8/12/25, the IO indicated, "Requested start Date/Time: 8/12/25 at 11:13 am Type of Isolation: Contact Reason for isolation: MDR-Pseudomonas Special Instructions: Precaution."

During a review of Patient 32's PN, dated 8/12/25 at 3:54 p.m., the PN indicated, "The other twin [Patient 31] was recently diagnosed with MDR pseudomonal sepsis [life threatening condition]/pneumonia [infection in the lungs]. On 8/5 developed conjunctivitis [infection in the eye]. Eye culture was positive for pseudomonas. Is on tobramycin [antibiotic] ointment ..."

3c. During a review of Patient 33's MR, dated 7/15/25, the MR indicated, Patient 33 was admitted to the NICU on 7/15/25 for respiratory distress [difficulty breathing]."

During a review of Patient 33's PN, dated 8/10/25 at 9:06 p.m., the PN indicated, "7. Infection. On 8/10 noted to have eye discharge. Eye culture will be followed. Was placed on tobramycin eyedrops for conjunctivitis [pink eye caused by a virus or bacteria]."

During a review of Patient 33's PN, dated 8/11/25 at 10:21 p.m., the PN indicated, "7. Infection. On 8/10 noted to have eye discharge. Eye culture is positive for Pseudomonas aeruginosa. Was placed on tobramycin eyedrops for conjunctivitis ..."

During a review of Patient 33's MIR, dated 8/12/25, the MIR indicated, "Eye Culture ...[result] Pseudomonas aeruginosa ..."

During an interview on 8/21/25 at 8:00 a.m. IP, IP stated Pseudomonas could be transmitted through water, environment, previous infections, or visitors/family. IP stated pseudomonas could be removed by hand hygiene (washing hands or sanitizing rub) and environmental cleaning. IP stated on 8/12/25, Patient 31 had multi-drug-resistant pseudomonas pneumonia and was placed on contact isolation. IP stated on 8/7/25, Patient 32 already had a positive pseudomonas eye culture. IP stated she did not document interventions implemented to prevent the spread of the pseudomonas. IP stated she should have documented these interventions because "if you do not document it did not happen." IP stated her risk assessment for the pseudomonas outbreak infections were to place both patients (Patient 31 and Patient 32) on contact isolation to prevent the spread of infection in the NICU. IP stated, "I did not document the risk assessment, but I should have documented."

During an interview on 8/21/25 at 8:45 a.m. with IP, IP was unable to provide documentation of action she took to prevent the spread of the infection. IP was unable to provide documentation she reviewed Patient 31, Patient 32, or Patient 33's MR to obtain data. IP stated she did not document her process or any surveillance of the pseudomonas infection.

During an interview on 8/21/25 at 9:29 a.m. with IP, IP could not provide any documentation she investigated the cause of the pseudomonas Patient 31 and Patient 32 contracted or that she implemented measures to prevent the further spread of the infection. No documented evidence she conducted a Root Cause Analysis (RCA - a systemic, data-driven problem-solving method used to identify the underlying, fundamental causes)

During an interview on 8/21/25 at 9:38 a.m. with Director of Quality and Patient Safety (DQPS) 1, DQPS 1 stated the IP reported to her. DQPS 1 stated the RCA was not done.

During a review of the New England Journal of Medicine (a prestigious peer reviewed medical journal) the article titled "Endemic Pseudomonas aeruginosa Infection in a Neonatal Intensive Care Unit" dated 9/7/2000 indicated "Nosocomial infections [hospital acquired infection] due to Pseudomonas aeruginosa have been well described, but the environmental reservoir [location] of the organism [germ] varies [changes] ...All potential reservoirs should be identified, including environmental sources, equipment used in patient care, and the hands of health care workers."

During a review of "Cases Journal" (a peer reviewed medical journal), the article titled "Endogenous endophthalmitis caused by Pseudomonas aeruginosa in a preterm infant: a case report" dated 12/10/2009, indicated "Endophthalmitis is an infection of the vitreous [clear gel in the eye] or aqueous humor [a water-like fluid in the eye] of the eye. Although it rarely occurs in the neonatal period [first four weeks of a child's life] it has been previously diagnosed in preterm infants. Endogenous endophthalmitis is when eye infection is secondary to septicemia and represent 20% of the cases of endophthalmitis. Pseudomonas aeruginosa is responsible for more than 75% of invasive neonatal eye infections. The course of pseudomonal endophthalmitis is typically fulminant [severe and sudden onset], developing over hours even in early diagnosis. For survivors, the usual result is blindness of the affected eye ... Pseudomonas aeruginosa is an aggressive gram-negative bacillus and is responsible for more than 75% of invasive neonatal eye infections. Acute bacterial endophthalmitis is a vision-threatening condition and must be managed as an emergency ... Premature infants are particularly vulnerable to Pseudomonas infections. They are immunocompromised and they often have multiple systemic problems related to prematurity. Moreover they are dependent on a range of different equipments (humidifiers, incubators, respirators and suction apparatus) that are required to keep them alive but that can also be a source of nosocomial [hospital acquired] infection (when contaminated)."

During a review of the facility's P&P titled, "Event Reporting and Management," dated 10/24/23, the P&P indicated "C. Event Analysis: For Sentinel Events and Reportable Events, an Event Analysis must begin as soon as possible with completion of the analysis and implementation of any action plans not to exceed 45 calendar days from knowledge of the event ... An Event Analysis team will meet to: a. Identify the contributing and causal factors that led to the outcome. b. Contribute to a full understanding of the event and compare it to a prescribed or expected course under the same or similar circumstances. c. Identify system and process-based solutions ....Definitions ...Event Analysis - A structured method used to analyze patient safety or quality related events. It may be a Root Cause Analysis, Event Investigation and Analysis, Apparent Cause Analysis, Common Cause Analysis, or any other type of investigation related to an Event as defined above. An Event Analysis is led by the Patient Safety Leader or Quality Leader and includes a variety of executive and department leaders dependent upon the event in question.

During a review of the facility's P&P titled "Multi-Drug Resistant Organisms (MDRO)," dated 1/25/23 the P&P indicated "Prevention of MDRO infections is multifaceted and evidenced based. Strategies for infection prevention include ...prevention of transmission ..."

During a review of the facility's P&P titled "Outbreak Investigation," dated 5/22/25 the P&P indicated "Purpose: To identify probable contributing factors in order to control an outbreak and to prevent similar outbreaks in the future. Guidelines/Policy Statement: Outbreak may be suspected when healthcare-associated infections (HAIs) occur above the background rate or when an unusual microbe is recognized ...Epidemiologic investigations must be conducted in a standardized way that assesses the contributing factors: source, pathogen, host and mode of transmission. Ending an outbreak involves modifying one or more of these factors. Procedure: Recognition of an Outbreak Surveillance is the basic tool necessary to identify endemic and epidemic HAIs ...Epidemic (outbreak) investigations represent an excess over the expected (endemic) level of a disease within a geographic area. However, one case of an unusual disease (e.g. botulism) may constitute an epidemic ... Reporting Healthcare-associated outbreaks should be reported to local and state health departments as soon as they are suspected. Conducting an Outbreak Investigation The importance and sequence of the various steps will vary, depending on the nature of the problem ... Prepare for the investigation. Notify administration, Infection Control Committee Chair, Microbiology Department, regulatory officials as required and other pertinent individuals of the suspected outbreak ...2. Confirm the existence of an outbreak. Develop a case definition and use it to estimate the magnitude of the problem. This may change as information is gathered. Compare the current incidence with unusual or baseline incidence ...4. Search for additional cases; collect critical data; develop a line listing; collect specimens if indicated. Encourage immediate reporting of new cases by laboratory, physicians, nursing staff and others as appropriate (e.g. radiology in cases of pneumonia). Search for other cases that may have occurred retrospectively or concurrently through laboratory reports, medical records, patient charts, physicians and nursing staff, and public health data. Use a specific data collection form ... Person - Characteristics of the case patients help in defining the most likely risk factors for infections. Factors to assess include: Patient characteristics (e.g. age, sex, underlying disease) Possible exposures (i.e. surgery, nursing and medical staff, infected patients) Therapeutic modalities (i.e. invasive procedures, medications, antibiotics) Use of all of the above to develop an accurate description of the population at risk ...6. Take immediate control measures, if indicated. Institute control measures such as increased attention to hand hygiene, additional use of barriers (i.e. gowns, gloves), or confiscating suspected product (e.g. patient care item). 11. Implement and evaluate control and preventative measure. 12. Initiate surveillance ... The efficacy [ability to produce desired result] of the intervention can be measured by further surveillance to determine if cases cease to occur or return to endemic level. Use the opportunity of an outbreak to correct other practices related to the current situation that may contribute to an outbreak in the future. 13. Communicate findings and summarize investigation for stake holders."

Based on interview and record review, the hospital failed to have a policy and procedure in place to track all surgical equipment to a specific surgical patient. This failure resulted in the inability of the hospital to determine precisely which surgical instruments were used on a high-risk tissue and high-risk patient surgical case.

Findings:

On 8/20/25, a complaint validation survey was initiated which included investigation of a case where surgical instruments were used on a possible Creutzfeldt-Jakob disease (CJD - a rare and fatal neurodegenerative disease caused by abnormal proteins called prions, which trigger normal proteins in the brain to misfold causing brain cell damage and death) patient.

During an interview on 8/20/25 at 9:05 a.m., with Chief Medical Officer (CMO), CMO stated the CJD case was not confirmed and the craniotomy (a procedure that involves removing a piece of the skull to access the brain) surgical tray (a sterile collection of specialized instruments and tools used by surgeons during a craniotomy) were sequestered (isolated) and removed from use until further notice.

During an interview on 8/20/25 at 9:10 a.m., with Central Sterile Processing Supervisor (CSPS). CSPS stated that the instruments were pulled, cleaned, sterilized, sequestered (isolated) and were out of service (no longer being used).

During an interview on 8/20/25 at 9:15 a.m., with Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings), IP stated the hospital followed the national infection control standards from the Association for the Advancement of Medical Instrumentation (AAMI - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry), among others.

During a concurrent observation and interview on 8/20/25 at 10:20 AM, with CSPS, CSPS escorted the surveyor to the office where the possible CJD craniotomy set was sequestered. CSPS stated the hospital sequestered two craniotomy sets because on the same day the possible CJD was operated on, there was a second craniotomy case. CSPS was asked why both had to be sequestered. CSPS stated "Currently the Operating Room Department (OR) does not scan instrument sets to patients, so to play it safe, both trays were sequestered." CSPS was asked why OR did not scan instrument sets to patients, in which CSPS responded, "I don't know."

During a review of the National Standards the hospital followed, "ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities" the Standards indicated the following:
"C.2 Processing devices contaminated with high-risk tissue ... 6) A tracking system should be in place that permits recall of devices used on high-risk tissue and high-risk patients. This tracking system should permit identification of the patient on which the devices were used, the date they were used, the procedure performed, and the surgeon's name. Facilities that do not have a commercially available or automated tracking system should create a manual system. A simple system can be created using a steam-sterilizable two-part card, with an external CI that is affixed to the outside of instrument trays. When the tray is used, the bottom part of the card is removed and affixed to the patient's chart to identify all items used on the patient. To ensure accurate tracking of sets and devices, all items should be given a unique number. For example, if the facility has four craniotomy trays, they should be numbered #1, #2, #3, and #4 to identify the specific tray used on the patient."

During an interview on 8/21/25 at 3 PM, with Operating Room Director (ORD) and the CMO, were asked if they had a method of tracking that would allow them to recall surgical devices used on high-risk tissue and high-risk patients. The ORD and CMO stated the hospital currently did not have a method of tracking surgical devices but moving forward the hospital will start tracking surgical devices.