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Based on interview and record review, the Governing Body (GB) failed to provide adequate oversight to ensure a safe and effective quality of patient care for 303 of 303 patients admitted on May 15, 2025, when:

The GB did not ensure an effective quality improvement program and provide effective oversight of Infection Control practices and processes when Sterilizer 2 (a machine used to kill germs on surgical instruments) was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer's Instructions for use. Patient care rooms were not appropriately cleaned between patients use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries and the infection preventionist did not implement an active surveillance activity when there were allegations of mold in the obstetric patient care rooms. (Refer to A049).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15,2025 when:

1. the facility failed to monitor, collect and analyze quality data when Sterilizer 2 was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer's Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries. (Refer to A 273)

2. The facility failed to identify the collected data to utilize the opportunities for improvement of the issues regarding the Sterile processing department cleaned (Pre & Pack) areas floor contained tape, stickers and scattered black spots the infection preventionist did not implement surveillance activities when there were allegations of mold in the obstetric patient care rooms in accordance with the policy and procedure. (Refer to A 283).


The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality care and patient safety and had the potential to cause adverse health outcomes (potentially harmful effects on health resulting from various factors such as medication, exposure to chemicals) which could interfere with the patient's medical care and may jeopardize the health and safety in a safe environment.

Based on observation, interview, and record review, the facility failed to provide a sanitary environment and an active infection control program as evidenced by:

1. The facility failed to implement an effective and facility-wide infection prevention and control plan for preventing and controlling the transmissions of infections within the hospital for one of one sampled operating room. Cross reference to A0749.

2. The facility failed to ensure the infection prevention and control program included the prevention and control of hospital acquired infections (HAI, an infection that develops in a hospital while a patient is receiving treatment for a different condition), including maintaining a clean and sanitary environment for seven of seven sampled surgical patients, and jeopardize the health and welfare of other patients experiencing surgical procedures. Cross reference to A0750.

3. The facility failed to ensure infection prevention and control leadership responsibilities were implemented for an allegation of toxic mold (a highly dangerous germ that can cause a range of health problems) infestation on the Maternal Child Health Unit (a unit used to care for mother and baby) for six of six sampled Patients (Patients 3, 31, 32, 34, 36, and 37) and jeopardized the health and welfare of other patients admitted to one of four sampled rooms (Room A). Cross reference to A0772.

The cumulative effect of these systemic failures resulted in the facility's inability to provide quality healthcare in a safe and sanitary environment for the facility's patients in accordance with §482.42 Condition of Participation for Infection Control Services.

Based on interview and record review, the Governing Body (GB) failed to ensure the quality of care was provided for 303 of 303 patients admitted on May 15, 2025, when the GB did not have an effective oversight of Infection Control Practices and processes which resulted in Sterilizer 2 (a machine used to kill germs on surgical instruments) was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and readily available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer's Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period(period after childbirth)) unit Operating room was not appropriately cleaned between surgeries and the infection preventionist did not implement an active surveillance activity when there were allegations of mold in the obstetric patient care rooms.

These failures had resulted in the facility's failure to identify the problem prone areas and deliver care with the GB oversight and to provide a safe patient care environment causing risk for acquiring hospital infection which could jeopardize the health and safety of the patients and prolonged the hospitalization.

Findings:

During an interview on May 21, 2025, at 10:16 AM, in the conference room, with two members of the Governing Board (GB): the Chief Executive officer (CEO) and the Chief of staff (COS), the survey findings were discussed including, Sterilizer 2 was found to contain greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer's Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics unit Operating room was not appropriately cleaned between surgeries. The GB stated the Quality Department report to the board each meeting as noted in the GB minutes. Improvement opportunities and interventions are discussed at each GB meeting. The COS stated the, these findings are the responsibility of the governing body, it starts by making sure staff are reporting everything, the facility would have this as part of our governing board going forward and follow up to make sure it comes back because the GB should know about this.

During a concurrent interview and record review on May 21, 2025, at 10:20 AM, with the CEO and COS, the facility's document "Board of Trustees agenda," dated April 24, 2025, was reviewed. The "Board of Trustees agenda" indicated, "Quality report was presented, by the COS". The COS stated, "I presented the quality report to the board of trustees, I present what was discussed in the quality committee meeting, if quality issues were not in the quality meeting, the board would not have likely been aware."

During a review of the facility's policy and procedure (P&P) titled, "Governing Body Bylaws," dated March 5, 2019, the P&P indicated, "The powers of the corporation shall be exercised, its property controlled, and its affairs conducted by or under the direction of the Board of Directors to be known as the board of trustees ...
5.5(6) Quality Committee
The Quality committee shall provide assistance to the board of trustees in fulfilling their oversight responsibilities to assure the highest quality of clinical care, patient safety and customer service provided to patients of [facility name]. The committee also assists the Board in exercising its responsibilities to maintain a relationship with medical staff and to approve and oversee medical policies and professional staff appointments, reappointments and clinical privileges ..."

Based on interview and record review, the hospital failed to maintain an effective and ongoing hospital wide data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15, 2024, to monitor, collect and analyze quality data when Sterilizer 2 was found with greyish white residue throughout the chamber, multiple reusable surgical instruments were not clean and/or were damaged and available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes (an instrument which can be introduced into the body to give a view of its internal parts) were not stored in a clean storage cabinet in accordance with the manufacturer's Instructions for use. Patient care rooms were not appropriately cleaned between patient use, the Obstetrics (a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period) unit Operating room was not appropriately cleaned between surgeries.

These failures resulted in the hospital's inability to identify the problem prone (likely to cause errors) areas and create changes to improve patients' health outcomes and had the potential to cause preventable adverse patient outcomes that could negatively affect patients' health and safety.

Findings:

During a interview on May 21, 2025, at 9:20 AM, with the Chief Operating Officer (COO) and Chief executive officer (CEO) the survey team's following findings were discussed:
Sterilizer 2 was found to contain greyish white residue throughout the chamber, multiple reusable surgical instruments were not cleaned and/or were damaged and was readily available for patient use, cleaning cloths used to clean reusable instruments were not made of non-linting material. Endoscopes were not stored in a clean storage cabinet in accordance with the manufacturer's instructions for use. Patient care rooms in the maternity unit were not appropriately cleaned between patient use, the Obstetrics unit Operating room was not appropriately cleaned between surgeries were discussed. The COO acknowledged these findings and stated, the facility will work to correct these findings.

During a concurrent interview and record review on May 21, 2025, at 9:25 AM, with the COO, the facility's "Board of Quality Committee Minutes," dated March 24, 2025, was reviewed. The "Board of Quality Committee Minutes" did not show any data regarding the cleanliness of the sterilizers in the sterile processing department, the tracking of reusable surgical instruments, and the used of wrong cleaning cloth material. The COO acknowledged and stated, the facility should have identified these issues with the tracking system.

During a follow-up concurrent interview and record review on May 21, 2025, at 9:27 AM, with the COO, the facility's "Infection Control Committee Meeting Minutes," dated February 12, 2025, was reviewed. The "Infection Control Committee Meeting Minutes" did not show any data regarding the tracking of Endoscopes and monitoring of the cleanliness of patient care rooms and the Obstetrics unit. The COO verified and stated, the facility was not tracking the issues.


During a review of the facility's document titled "Infection control Committee meeting minutes" dated February 12, 2025, the "Infection control Committee meeting minutes" indicated, "EVS Room Cleaning q4 [quarter 4] 2024: Surfaces that fell below 95% were :Chair arms, paper towel dispenser, soap dispenser, IV pole, IV pump, Door knob, Light switch, telephone, bathroom handrail, bathroom doorknob, bathroom light switch, bathroom sink, bathroom faucet, soap dispenser, toilet flush handle, heal wall switches."


During a concurrent interview and record review on May 21, 2025, at 9:30 AM, with the COO, the facility's "Quality management Plan," dated 2025 indicated, " II. Hospital and medical staff leaders have the authority and responsibility for ensuring high quality, safe patient care services ... They are responsible for ensuring that there is a planned, systemic hospital wide approach for designing, measuring, assessing and improving patient care, patient safety and services. III. The goal of the Quality Management program is the provide a framework for improving performance, which is collaborative and systematic ...IV. The Quality management program monitors the performance of important functions/ processes and significant issues which are linked to and integrated with the QM Program though reporting processes, committee participation or oversight including: Clinical pertinence, Pharmacy and therapeutic function, Operative and other procedures, medication usage, patient safety, environmental safety, infection prevention, efficiency of clinical practice patterns, monitoring of significant departures from establish clinical patterns." The COO stated, the quality team has the overall responsibility for evaluating the problems, and making plans to improve, the hospital has things we need to improve on.

Based on interview, and record review, the hospital failed to maintain an effective and an ongoing hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for 303 of 303 patients admitted on May 15, 2025, when the facility failed to identify the collected data of the facility's issues and work on the opportunities for improvement when:

1. the sterile processing department clean (Pre & Pack) areas floor contained tape, stickers and scattered black spots.
2. the infection preventionist did not implement surveillance activities when there were allegations of mold in the obstetric (area of medicine that deals with pregnancy and the birth of babies) patient care rooms in accordance with the policy and procedure.

These failures resulted in the hospital's inability to focus and improve the problem prone areas to ensure the provision of quality care and patient safety and had the potential to cause adverse health outcomes which could interfere with the patient's medical care and may jeopardize the health and safety.

Findings:


1. During an interview on May 21, 2025, at 9:23 AM with the Chief Operations Officer (COO), the findings regarding the tape, stickers and black spots on the floor of the sterile processing department was discussed. The COO confirmed that the floor of the sterile processing room was not cleaned to infection prevention control standard.

During a concurrent interview and record review on May 21, 2025, at 9:25 AM with the COO, the facility's, "Infection control Committee meeting minutes" dated February 12, 2025, indicated, "Sterile Processing Department Monitoring and Evaluation 4th Quarter 2024 no positive spore tests (a biological indicator used to assess the effectiveness of a sterilization process, specifically by testing the ability of the process to kill highly resistant microbial spores) on steam sterilization and no positive spore tests on the Hydrogen Peroxide sterilization process." There was no further data presented regarding the Sterile processing department. The COO stated, the facility's environmental rounds should have been more detailed, this issue was not identified prior.

2. During a concurrent interview and record review on May 21,2025, at 9:30 AM, with the COO, the facility's "Quality management Plan," dated 2025,was reviewed. The "Quality management Plan," indicated, " II. Hospital and medical staff leaders have the authority and responsibility for ensuring high quality, safe patient care services ... They are responsible for ensuring that there is a planned, systemic hospital wide approach for designing, measuring, assessing and improving patient care, patient safety and services. III. The goal of the Quality Management program is the provide a framework for improving performance, which is collaborative and systematic ...IV. The Quality management program monitors the performance of important functions/ processes and significant issues which are linked to and integrated with the QM Program though reporting processes, committee participation or oversight including: Clinical pertinence, Pharmacy and therapeutic function, Operative and other procedures, medication usage, patient safety, environmental safety, infection prevention, efficiency of clinical practice patterns, monitoring of significant departures from establish clinical patterns." The COO stated, the quality team has the overall responsibility for evaluating the problems, and making plans to improve, the hospital has things to improve on.


During an interview on May 21, 2025, at 9:45 AM with the COO and Chief Executive Officer (CEO) regarding the findings that the infection preventionist did not implement surveillance activities when there were allegations of mold on April 22,2025 in the obstetric patient care rooms in accordance with policy. The COO stated that the infection preventionist were told by Environment Services (EVS) there was no infection problem, Infection control should have checked for them self, Infection control needed to evaluate it so it could be brought to the quality committee and this was not done. The CEO stated that the hospital should trust what EVS told them, but they should also validate the report.

During a review of the facility policy and procedure (P&P) titled, "Infection prevention and control Admi Manual, Environmental cultures", dated May 2023, the P&P indicated, "" ...c. Outbreak [higher than usual number of cases of a disease] investigations
1 appropriate environmental culture will be collected if the environment is implicated as a source of nosocomial infection outbreak conditions.
2. the environment should be tested only after establishing,
i. A common microbial agent
ii. Role of the person-to- person transmission via patients or personnel has been ruled out epidemiologically.
iii. mode of transmission is not apparent.
iv. Epidemiologic investigation implicates a specific environmental source as a risk factor.
3 Environmental culturing will be conducted when recommended by the infection prevention committee chair (designee) and in coordination with the microbiology department."

Based on observation, interview, and record review, the facility failed to ensure the Obstetrics (OB- a medical specialty focused on the care of women during pregnancy, childbirth, and the postpartum period (time after childbirth)) Operating room was cleaned according to the policy between surgical procedures. This failure had the potential to expose patients to unsafe operating conditions with increased risk of hospital acquiring the infection, surgical complication and prolonged hospitalization.

Findings:

During a concurrent observation and interview on May 15,2025, at 11:25 AM, with the Infection Control Preventionist Manager (ICPM), the OB Unit Operating room (OR) was observed. The OB OR was observed to be ready for use, the operating table base was covered with a white blanket, when lifted the operating room table base was observed to have streaks on it, when wiped with a facility provided cleaning wipe, the wipe had brown residue on it after being wiped on the OR table base. The ICPM stated "I don't believe the table base was cleaned as well as it should have."

During a concurrent observation and interview on May 15,2025, at 11:27 AM, with the ICPM, the OB Operating room was observed. The air conditioning vent located in the ceiling above the Operating room table, was observed to be dirty and dusty. The ICPM stated, this would be a concern for infection especially in the operating room.

During a review of the facility's "Operating room terminal cleaning [a thorugh cleaning process after a patient is moved out to ensure a clean and safe healthcare environment to prevent the spread of infections] log- Labor and Delivery May 2025" the "Operating room terminal cleaning log- Labor and Delivery May 2025" indicated, " EVS [Environmental Service] staff please date time and initial that the daily OR terminal cleaning has been performed as follows: Clean and disinfect all surfaces (overhead lights/switches, ceiling vents, hoses, walls ... OR bed/ attachments positioning/ transfers devices, mobile/ fixed equipment ..." A further review of the record indicated the log was last dated and signed on May 14, 2025 at 8:30AM.

During a review of the facility's policy and procedure (P&P) titled "Area cleaning- Surgical areas- Terminal cleaning 8440.40000.12" undated, the P&P indicated, "This procedure covers the terminal or end of day cleaning instructions for surgical/invasive areas and delivery rooms and meets AORN [Association of Perioperative (around the time of surgery) Nursing] requirements. Guidelines I. Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily when the areas are being used ...Procedure ...5. After the last case, a more thorough cleaning may be needed. The table should be disassembled and cleaned with a disinfectant. 6. Spot wash walls and wall vents with hospital approved disinfectant."

During an interview on May 20,2025, at 3:00 PM, with Obstetrician-Gynecologist (OBGYN1) (a medical doctor who focuses on the health and care of women), OBGYN 1 stated, if dust or debris from a vent entered the sterile field during a procedure, it would contaminate the sterile field (area created and maintained as free from microorganisms as possible to reduce the risk of infection during surgery) which is an infection risk.

Based on observation, interview, and record review, the facility failed to ensure the infection prevention and control needs of all patients requiring surgical services and gastroenterology services (GI, the study, diagnosis, and treatment of disorders that deal with the digestive system) including the storage of flexible endoscopes (a reusable instrument used to inspect and treat the interior portions of the body) were met when:

1. The steam sterilizer (autoclave, a machine used to kill germs on surgical instruments) was not maintained in accordance with the manufacturer's instruction for use (IFU) and brown staining, black matter, and whitish/grey residue were observed throughout the chamber (the internal portion of the sterilizer) for one of two sampled reprocessing (a process used to remove soil and germs and/or inactivate germs) machines (Sterilizer 2).

2. Previously reprocessed instruments were observed with black spots, brown staining, discoloration, scratches, etching (an engraving on the surface of the instrument), flawed (defected), and white residue for two of three sampled surgical instrument tray sets (Tray Set 1 and Tray Set 2).

3. Hand-held cleaning cloths were not made of lint-free material and were used to clean reusable surgical instruments for seven of seven sampled surgical patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36).

4. The facility's policy and procedure (P&P) on the manual cleaning process (the physical removal of visible soil and debris from instruments using hand-held cloth, hand-held brushes, detergents, and water) did not clearly outline the critical steps on cleaning reusable surgical instruments for one of two sampled surgical cases (Surgical Case 1).

5. Terminal cleaning procedures (a thorough environmental cleaning procedure that is performed at the end of each day when the area is being used) were not implemented in accordance with the hospital protocol and black spots, adhesive labels (stickers), and pieces of medical plastic tape were observed throughout the floor for one of two sampled reprocessing workrooms (Sterile Processing Department Workroom-SPD, an area within a health care facility that processes and controls medical supplies, devices, and equipment).

6. The facility's P&P was not implemented on cleaning and brushing soiled (potentially infectious) instruments submerged (underwater) in the enzymatic solution (a cleaning detergent used to help prepare instruments for cleaning) for one of four sampled Sterile Processing Technicians (SPDT 1).

7. Thick grey fuzzy matter, debris, and a brown bug were observed under the endoscope's drip tray (a removable tray designed to collect residual moisture that may drip during the storage process), and the endoscope cabinet's drip tray contained black matter and debris for one of two sampled endoscope storage cabinets (Scope Cabinet 2).

8. Terminal cleaning procedures were not implemented in the surgical scrub area (a designated area for surgeons and other operating room staff to scrub their hands and arms before a surgical procedure) and the water did not drain from the sink properly (water drained slowly) for one of two sampled surgical scrub stations (Scrub Station 2).

9. Hand hygiene (the practice of cleaning one's hand to remove dirt and germs to prevent the spread of infections) was not performed after handling soiled surgical instruments in accordance with the hospital's P&P, for one of four sampled Sterile Processing Technicians (SPDT 4).

These failures had the potential for cross-contamination (the unintentional transfer of harmful germs or other from one surface or object to another), injury, and prolonged hospitalization, for seven of seven sampled surgical patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36), and jeopardize the health and welfare of other patients experiencing surgical procedures.

Findings:

On May 19, 2025, at 4:47 PM, 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 Chief Operating Officer (COO). The COO was verbally notified of failure of the facility not implementing safe infection prevention and control practices when the steam sterilizer was not clean and maintained in accordance with the manufacturer's IFU; Multiple reusable surgical instruments were not clean and/or damaged and were available for patient use; there was no written policy and procedure that clearly outlined the critical (important) steps in instrument cleaning; and hand-held cleaning cloths used to clean reusable surgical instruments were not made of non-linting material in accordance with the Association for the Advancement of Medical Instrument (AAMI, nationally recognized infection prevention and control standards).

These failures had the potential for cross-contamination, injury, and prolonged hospitalization, for seven of seven sampled patients (Patient 3, Patient 6, Patient 7, Patient 31, Patient 34, Patient 35, and Patient 36), and jeopardize the health and welfare of other patients experiencing surgical procedures.

On May 20, 2025, at 1:44 PM, the facility provided a corrective action plan (CAP). The CAP included the following components:

"1. Sterilizer 2 not clean and the routine cleaning procedures were not performed per manufacturer's guidelines.

CAP:
-Phenix (an equipment cleaning vendor) performed a deep clean (a process used to clean the steam sterilizer machine which involves removing persistent stains and other chemical material that regular cleaning may not address). Date completed: 5/18/25.
-All trays (containers that hold a variety of surgical instruments) processed in Sterilizer 2 prior to it being deep cleaned by the Vendor, were reprocessed. Date completed: 5/18/25.
-Staff re-education on routine cleaning of Sterilizer per manufactures guidelines started on 5/17/25. Education will be completed for all staff as they come to work by: 6/2/25.
-Log created to document the cleaning (chamber, door/gasket, clean drain, printer, and external wipe down). Date completed: 5/17/25.
-SPD Leadership will audit Logs on a daily basis for compliance.
- IP (infection prevention) Environment rounds (a systematic assessment of a healthcare facility's environment to ensure it's safe and sanitary, preventing the spread of infections) to include checking (monitoring) for compliance.
-Responsible Person: Chief Nursing Office/Director for SPD.

2. Surgical instruments were found to be contaminated with brown/black spots, white residue, and stains after sterilization (a process used to kill germs) and ready for patient use.

CAP:
-SPD water source connected to soft water so that the Sterilization is fed with soft steam, upon investigation found out that it was bypassed and hooked up directly to city water. Date completed: 5/19/25
-Steris (manufacturer/vendor) will proactively verify the drain on the cool can (a reservoir used to cool down the hot water produced during sterilization) is functioning properly.
-Steris will conduct an inspection bi-monthly to verify proper drain function to prevent any water or steam from backing up into the sterilizer.
-Water source tested on 5/19/25.
-Plant Operations will continue to test water on a daily basis.
-Water will continue to be tested by Vendor on a monthly basis.
-Steris will continue to monitor for stains, spots, and white residue after sterilization three times a month.
-Any instruments found with stains, spots and white residue after sterilization will be re-processed, refurbished or taken out of service by the SPD staff.
-Responsible person: Chief Nursing Officer/Director for SPD.

3. Cleaning cloths used to clean reusable patient surgical instruments, were not non-linting in accordance with AAMI Standards.

CAP:
-Non Linting (lint-free) cloths ordered, delivered, and implemented in SPD. Date: 5/19/25.
-Staff re-education started for the use of Lint Free cloths to be used in SPD on 5/19/25.
-Education will be completed for all SPD staff as they come to work by 6/2/25.
-SPD leadership will monitor on a weekly basis to ensure that only non-linting cloth is used for cleaning instruments.
-IP Environment rounds to include checking for compliance.
-Responsible person: Chief Nursing Officer/Director for SPD.

4. Policies and procedure did not clearly outline critical steps for instrument cleaning.

CAP:
-Instrument cleaning policy for SPD # 8380.50800 (policy reference number) updated to include critical steps for instrument cleaning based on AAMI guidelines. Policy approved by Medical Chair of Surgery and Medical Director of Infection Prevention Committee on 5/20/25.
-Staff re-education for the updated policy started on 5/20/25.
-Education will be completed for all SPD staff as they come to work by 6/2/25.
-Responsible person: Chief Nursing Officer/Director for SPD."

On May 20, 2025, at 3:01 PM, the CAP for the IJ was reviewed and was found acceptable.

On May 21, 2025, at 11:34 AM, the immediate jeopardy situation was removed onsite in the presence of the COO, after the CAP 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 the lint-free cleaning cloth, staff knowledge of the critical steps for instrument cleaning, and a tracking system to prevent future reprocessing breeches.

1. An interview was conducted with the Infection Control Preventionist Manager (ICPM) and the Infection Control Preventionist (ICP), on May 15, 2025, at 10:55 AM, in the conference room. The ICP 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 (2017) 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).

A concurrent observation and interview were conducted with the Sterile Processing Manager (SPDM) and the Infection Control Preventionist (ICP) on May 16, 2025, at 8:17 AM, in the SPD clean workroom. Two sterilizer machines were observed. There was brown staining, black matter, and whitish/grey residue observed throughout Sterilizer 2's chamber wall (internal portion of the sterilizer). The SPDM stated, Sterilizer 2 "have some discoloration and needs a deep cleaning."

An interview and record review were conducted with the SPDM on May 19, 2025, at 10:16 AM, in the conference room. The facility's document titled, "AMSCO 400 Series Medium Steam Sterilizers: Operator Manual," dated 2019, indicated, "...8.3.1 Clean Chamber Drain Strainer: Recommended Frequency: The chamber drain strainer must be cleaned at least once a day...8.3.2 Flush Chamber Drain...The chamber drain should be cleaned once a week...Drain Cleaning Method...6. Rinse the bottom of the chamber with a small amount of water to prevent detergent residue from baking onto the surface..." The SPDM stated she had reviewed the manufacturer's IFU, and the facility performs daily cleaning of the sterilizer's chamber drain filter. The SPDM stated the staff did not clean the sterilizer's internal chamber daily and the facility did not have documentation to show that staff had provided daily inspection or cleaning of the sterilizer's door gasket, the internal chamber, or the machine's external surfaces. The SPDM stated there was room for additional education on routine cleaning of the steam sterilizers.

The review of the facility's P&P titled, "Sterilization and Disinfection Methods," reviewed June 2023, was conducted. The P&P indicated, "...Procedure I. Steam Sterilization: A. Sterilizers will be inspected and cleaned daily according to the manufacturer's IFU. Examples of items requiring daily inspection and cleaning are door gaskets, chamber drain screens (filters), the internal chamber, and external surfaces ..."

2. A concurrent interview and inspection of surgical trays were conducted with SPDT 2 and the SPDM, on May 16, 2025, at 8:25 AM, in the SPD clean workroom. Two surgical tray sets were inspected. SPDT 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 24 surgical instruments, dated May 15, 2025. 11 of 24 sampled instruments were of concern upon inspection of the surgical tray set. Two instruments had multiple scratches; three instruments were discolored; four instruments had brown staining, and two instruments contained etchings; and

-Tray Set 2 contained 78 surgical instruments, dated May 8, 2025. 19 of 78 sampled instruments were of concern upon inspection of the tray set. Two instruments were damaged; six instruments had brown staining; three instruments had multiple scratches; one instrument had white residue; one instrument had black spots; two instruments had etchings; two instruments had orange/red matter; and two instruments were flawed.

The SPDM stated the facility has been discarding all instruments containing etching. The SPDM stated the instruments with etchings should have been removed from the tray set prior to the sterilization process. SPDT 2 stated the orange/red matter was "rust" and the rust was "missed" during the inspection process. SPDT 2 nor the SPDM did not provide an explanation for the multiple brown stained instruments. SPDT 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. SPDT 2 did not provide an explanation for the identified damaged and/or stained instruments.

An interview and record review were conducted with the Director of Perioperative (the care provided to patients before, during, and after a surgical procedure) Services (DSS) on May 21, 2025, at 9:30 AM, in the conference room. The DSS stated, "During the instrumentation inspection process, all damaged instruments should have been removed from the tray set prior to the sterilization process." The facility's document titled, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities," dated 2017, was reviewed. The document indicated, 7.6 Cleaning: 7.6.1 General Considerations ...g) Instruments should be carefully inspected for flaws, damage, debris, detergent residue, and completeness, then dried ..." The facility's P&P was requested on the instrumentation inspection process. The DSS stated the facility did not have a P&P on inspecting surgical instruments and the facility followed the infection control national standards from ANSI/AAMI on inspecting instruments.

3. The review of surgical procedures performed for Patients 3, 6, 7, 31, 34, 35, and 36 was conducted. The findings were as follows:

-For Patient 3, Patient 3's "Discharge Summary" (a document that summarizes patient care events during hospitalization) dated May 16, 2025, indicated Patient 3 was admitted to the facility on May 12, 2025, and a C-section (cesarean birth, a surgical procedure used to deliver a baby) was performed on May 14, 2025.

-For Patient 6, Patient 6's "Discharge Summary" dated May 15, 2025, indicated Patient 6 was admitted to the facility on May 12, 2025, and a C-section was performed on May 12, 2025.

-For Patient 7, Patient 7's "Discharge Summary" dated May 16, 2025, indicated Patient 7 was admitted to the facility on May 13, 2025, and a C-section was performed on May 14, 2025.

-For Patient 31, Patient 31's "Discharge Summary" dated May 4, 2025, indicated Patient 31 was admitted to the facility on May 1, 2025, and a C-section was performed on May 1, 2025.

-For Patient 34, Patient 34's "Progress Note-Physician" dated May 17, 2025, indicated Patient 34 was admitted to the facility on May 16, 2025, and a C-section was performed on May 17, 2025.

-For Patient 35, Patient 35's "Discharge Summary" dated May 2, 2025, indicated Patient 35 was admitted to the facility on April 30, 2025, and a repeat C-section and a bilateral salpingectomy (a surgical procedure used to prevent pregnancy) were performed on May 1, 2025.

-For Patient 36, Patient 36's "Discharge Summary" dated April 26, 2025, indicated Patient 36 was admitted to the facility on April 19, 2025, and a C-section was performed on April 22, 2025.

An observation was conducted with the ICPM and the SPDM on May 19, 2025, at 10:37 AM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 1 was observed standing at the decontamination sink and wiping debris off the surface of the surgical instrument with the hand-held cleaning cloth.

A concurrent interview and observation were conducted with SPDT 1 and the SPDM on May 19, 2025, at 10:43 AM, in the SPD decontamination workroom. SPDT 1 stated she was performing manual instrument cleaning, and she did not know if the cleaning cloth was made of non-linting material. The cleaning cloth label was viewed, and the label indicated the cleaning cloth was made of 100 percent (unit of measurement) cotton material. The SPDM stated cleaning supplies were supplied by the facility, and she was not aware the "washcloth" needed to be made of lint-free material.

An interview and record review were conducted with the ICPM on May 19, 2025, at 11:50 AM, in the conference room. The ICPM stated she had contacted the linen/washcloth vendor, and the following document was provided by the linen vendor. The facility's document titled, "Washcloths" dated May 19, 2025, indicated the washcloths used in the facility were "100% (percent, unit of measurement) cotton white. They (linen/washcloth) are designed to be very low-linting." The ICPM stated the "washcloths" used to clean Patients 3, 6, 7, 31, 34, and 35's surgical instruments were not lint-free. The ICPM stated lint-free cloths were designed to help minimize the spread of germs on surgical instruments during the cleaning process and the cleaning cloth should have been lint-free in accordance with AAMI standards.

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, "7.4 Decontamination: 7.6.1 General considerations ...d) Cloths and towels used in decontamination should be clean and nonlinting (e.g., microfiber cloth or cellulose sponge) and should be changed at regular established intervals and when they are soiled or wet ..."

4. An observation was conducted with the SPDM and the ICP on May 16, 2025, at 10:25 AM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 1 was observed standing at the decontamination sink. SPDT 1 placed an instrument tray into the enzymatic solution and proceeded to clean the instrument.

An interview was conducted with SPDT 1 and the SPDM on May 16, 2025, at 10:30 AM, in the SPD decontamination room. SPDT 1 stated she was not sure of the manual cleaning steps, and she could not recall the steps. The SPDM stated the surgical instruments should have been rinsed in water prior to placing the instruments into the enzymatic solution. The SPDM stated she was not sure if instruments should have been soaked in the enzymatic solution.

A follow up interview was conducted with the SPDM on May 16, 2025, at 4:20 PM, in the conference room. The SPDM stated the facility did not have a P&P which clearly outlined the manual cleaning process. A request was made for the facility's surgical instrument cleaning competency-based performance checklist (a specific set of skills, knowledge, abilities, and behaviors an employee must possess to perform instrument cleaning effectively) which outlined the manual cleaning process. The SPDM stated the facility did not have a competency-based checklist which clearly outlined the steps of the manual cleaning process.

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, "M.3 Resources and training: Facility-specific written policies and procedures that are both general and instrument-specific should clearly outline the important steps in instrument cleaning and sterilization ..."

5. A concurrent observation and interview were conducted on May 16, 2025, at 8:15 AM, with the ICP and SPDM, 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; and pieces of medical tape was covered with grey fuzzy matter were observed throughout the floor. The ICP stated the tape, and stickers should have been removed during the terminal cleaning process. The SPDM confirmed the floor should have been cleaned each day the SPD workroom was used.

An interview and review of the facility's document titled, "Sterile Processing Cleaning Logs," dated May 2025, was conducted with the Director of Environmental Service (EVSD) on May 16, 2025, at 3:20 PM, in the conference room. The terminal cleaning log indicated the SPD workrooms were cleaned daily from May 1, 2025, to May 15, 2025. The EVSD stated the facility's expected the EVS staff to perform terminal cleaning in accordance with the terminal cleaning procedure. The EVSD stated the SPD's clean workroom and the SPD's decontamination workroom should have been terminally cleaned.

The review of the facility's P&P titled "Area Cleaning-Sterile Processing Department," reviewed June 2023, was conducted. The P&P indicated "I. Terminal Cleaning: A. Perform terminal cleaning and disinfection of sterile processing areas daily when the areas are used ...F. Disinfect all floors with a single-use mop, including areas under mobile equipment, starting with the perimeter and working around the room toward the center ..."

6. A concurrent interview and observation of the manual cleaning process was conducted with the SPDM and the ICP on May 16, 2025, at 10:35 AM, in the SPD's decontamination workroom. SPDT 1 was observed performing manual cleaning on a reusable surgical instrument. SPDT 1 was observed using a hand-held brush to scrub debris from the surfaces of the instrument. During the brushing process, the instrument was not completely submerged in the enzymatic solution water. SPDT 1 confirmed the instrument was not completely submerged in the cleaning solution when she had scrubbed the instrument surfaces to remove the excess debris. SPDT 1 stated, "I understand, I should have scrubbed the instrument under water to remove the debris." The SPDM stated instruments should be completely submerged in the cleaning solution during the brushing process to prevent splashing and the risk of aerosolization (turning into a fine mist or spray containing minute [very small] particles) of chemicals and contaminates (harmful germs).

The review of the facility's P&P titled, "General Cleaning and Decontamination Policy," reviewed June 2023, was conducted. The P&P indicated, " ...Procedure: I. Instruments: D. ...Submerge instruments when cleaning to reduce aerosolized particles in the air."

7. An observation was conducted on May 16, 2025, at 8:05 AM, of the endoscope storage workroom with the Gastroenterology Technician (GI Tech) and the ICP. Scope Cabinet 2's drip tray contained black matter and debris. The GI Tech wiped the drip tray with a wet cloth and the black matter and debris were easily removed. The GI Tech proceeded to remove the drip tray from the cabinet and thick grey fuzzy matter, debris, and a brown insect were observed. Twelve endoscopes were observed hanging freely in the cabinet and were labeled "Clean."

An interview was conducted with the GI Tech, the ICP, and the SPDM on May 16, 2025, at 8:14 AM, in the endoscope storage workroom. The SPDM stated the endoscopes had been cleaned and were ready for patient use. The GI Tech stated the grey fuzzy matter was dust and the black matter was dirt and debris. The GI Tech confirmed the brown insect was "a dead bug." The GI Tech stated he did not clean under the drip tray and did not know who was responsible for cleaning under the scope's drip tray. The SPDM confirmed the endoscopes were potentially contaminated. The ICP stated the scopes needed to be reprocessed and the scope cabinet and storage room needed to be clean to prevent cross-contamination.

The review of the manufacturer's manual titled, "Olympus Reprocessing Manual," dated 2014, was conducted. The manual indicated the following instructions for use, "...8.2 Storing the disinfected (to cleanse or treat something to destroy or prevent the growth of harmful germs) endoscope and accessories: Warning: Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices...Be sure the endoscope storage cabinet is properly maintained, clean, dry, and well ventilated..."

8. An observation was conducted with the ICPM and the Maternal Child Health (MCH, mother and baby care unit) Director on May 15, 2025, at 12:25 PM, in the scrub area. Scrub Station 2 was observed discolored and contained brownish/yellow residue. The MCH Director was observed using a leg handle to turn the faucet on, and the running water was observed to flow into the scrub sink. The MCH Director turned the water valve off and the water was observed to slowly drain from the scrub sink.

An interview was conducted with the ICPM and the MCH Director, on May 15, 2025, at 12:33PM, in the scrub area. The MCH Director stated she did not know when Scrub Station 2 had been cleaned but the sink should have been cleaned when the operating room was terminally cleaned. The MCH Director stated she did not know why the water was draining slow from the sink and she was not aware if a work order had been created to repair the sink. The ICPM stated the sink should be cleaned and Scrub Station 2's drain should be cleaned to prevent cross-contamination of potential waterborne germs from the sink, faucet, or drain to the surrounding environment including the hands and clothing of the perioperative personnel.

The review of the facility's P&P titled "Area Cleaning-Surgical Areas-Terminal Cleaning," reviewed June 2023, was conducted. The P&P indicated, " ...Guidelines: I. Surgical and invasive procedures room and scrub/utility areas should be terminally cleaned daily when the areas are being used ..."

9. An observation was conducted with the SPDM and ICPM on May 20, 2025, at 3:40 PM, of the manual instrument cleaning process, in the SPD decontamination workroom. SPDT 4 was observed standing at the decontamination sink and brushing debris off the surface of the surgical instrument. SPDT 4 was observed to be wearing two pairs of gloves. SPDT 4 walked toward the SPD's clean supply shelf and was observed removing his blue gloves. SPDT 4 was not observed to remove his off-white gloves or perform hand hygiene. SPDT 4 gathered the supplies and was observed walking back to the decontamination sink.

An interview was conducted with SPDT 4 on May 20, 2025, at 3:45 PM, in the SPD decontamination workroom. SPDT 4 stated he was performing manual instrument cleaning, and the red soil on the instrument was blood. SPDT 4 confirmed he did not perform hand hygiene after handling the soiled instrument. SPDT 4 stated he did not know that he should have removed the second pair of gloves or perform hand hygiene after removing his first pair of gloves. SPDT 4 stated he thought the second pair of gloves were considered clean.

An interview was conducted with the ICPM on May 20, 2025, at 3:50 PM, in the SPD decontamination workroom. The ICPM stated SPDT 4 should have removed both pairs of gloves and perform hand hygiene to prevent cross-contamination to the clean supplies.

The review of the hospital's P&P titled, "Handling of Contaminated Items," reviewed June 2023, was conducted. The P&P indicated, " ...Procedure: Hands should always be washed between glove changes or before donning (to put on) and upon removal of gloves ..."

The review of the facility's P&P titled, "Hand Hygiene," reviewed May 2023, was conducted. The P&P indicated, "...111. Hand Decontamination using an alcohol-based hand rub is indicated: ...C. After contact with bloody fluids or excretions ...Note: If hands are visibly soiled, use soap and water ...H. After removing gloves or other personal protective equipment. Note: Gloves do not replace handwashing/hand decontamination ..."

Based on observation, interview, and record review the facility failed to investigate an allegation of mold infestation on the Maternal Child Health Unit (a unit for mother and baby care) for one of 37 sampled Patients (Patient 36).

This failure resulted in no infection prevention activities thereby increasing the risk of harm for six of six sampled Patients (Patients 3, 31, 32, 34, 36, and 37) and jeopardized the health and welfare of other patients admitted to one of four sampled rooms (Room A).

An observation was conducted with the Maternal Child Health Director (MCH Director) and the Infection Preventionist Manager (ICPM) on May 15, 2025, at 11:37 AM, in Room A. The findings were as follows: There was black/greyish fuzzy matter observed along the shower door; there was black fuzzy matter observed in the hinges of the shower door; multiple tiles were observed broken, cracked, or missing; the grout around the shower's door was observed broken and discolored. The shower's handrail was observed covered with an orange/brownish substance; the wall was observed with scattered black circular spots; and the tile that surrounded the upper portion of the shower area was observed to have layers of thick black matter.

An interview was conducted with the ICPM and the MCH Director on May 15, 2025, at 11:47 AM, in Room A. The MCH Director stated she could not identify the orange/brownish substance, the black fuzzy matter, the black/greyish fuzzy matter, or the black spots. The ICPM stated Room A needed to be cleaned.

The review of Patient 36's clinical record was conducted. The findings were as follows:
Patient 36's "Discharge Summary," dated April 26, 2025, indicated Patient 36 developed a febrile illness (fever/elevated body temperature) and a rash on the abdomen (the front part of the body between the chest and the pelvis) during the hospital course that did not resolve with medication. Patient 36's physician indicated Patient 36 had body aches, lethargy (tiredness/sleepiness), and severe headaches while in Room A and Patient 36 symptoms did not resolve until after Patient 36 was moved out of the "moldy (germ) room of [room number]."

Significant Findings: "Mold in Room A likely Toxic Mold (highly dangerous germ) which affected patient's care."

The review of the "Laboratory Preliminary Report" dated May 19, 2025, was conducted. The findings were as follows:
Procedure: Environmental Culture (a sample of the black fuzzy matter)
Collected: May 15, 2025
Preliminary Report: Possible rare fungus (mold/germ) identification to follow. Moderated bacteria (germ) present to date.

An interview was conducted with the ICPM on May 19, 2025, at 9:45 AM, in the conference room. The ICPM stated she was not aware of the condition of Room A until the survey team arrived at the facility on May 15, 2025. The ICPM stated someone (she could not recall) had informed her that "the mold issue had been resolved." The ICPM stated she did not observe Room A or investigate the allegation of potential for mold infestation.

On May 19, 2025, 11:20 AM, an interview with the Infection Preventionist Manager (ICPM) and a concurrent telephone interview were conducted with the Infectious Disease Medical Doctor (MD 1), in the conference room. MD 1 stated the final culture results were needed before he could make an informed diagnoses of the germs that were obtained from Room A. MD 1 viewed the photographs of Room A restroom and stated the shower, wall, floor, grout, and the tile needed to be "fixed" and were not cleanable." MD 1 stated the tile surfaces and wall surfaces should not have been cracked or damaged. MD 1 stated the surfaces should have been durable, smooth, and cleanable to prevent cross-contamination (the unintentional transfer of harmful germs or other from one surface or object to another).

The review of the facility's "Admission List," dated April 27, 2025, to May 19, 2025, was conducted. The findings were as follows:
-For Patient 31, Patient 31 was admitted to Room A on May 1, 2025.
-For Patient 32, Patient 32 was admitted to Room A on May 5, 2025.
-For Patient 37, Patient 37 was admitted to Room A on May 8, 2025.
-For Patient 3, Patient 3 was admitted to Room A on May 12, 2025.
-For Patient 34, Patient 34 was admitted to Room A on May 16, 2025.

An interview was conducted with the Chief Nursing Officer (CNO) on May 20, 2025, at 8:15 AM, in the conference room. The CNO stated the allegation of mold in Room A was reported to her the following morning after the patient had been moved to another room. The CNO stated she did not observe the room. The CNO stated "the mold allegation was resolved when the patient was moved to another room."

A follow-up interview was conducted with the ICPM, on May 20, 2025, at 8:55 AM, in the conference room. The policy and procedure (P&P) on the facility's infection prevention program was requested. The ICPM stated if she had been involved in the allegation process, the outcome would have looked a lot different. The ICPM stated she should have been included in the investigation process.

The review of the facility's P&P titled, "Infection Prevention Program Elements," reviewed May 2023, was conducted. The P&P indicated, " ...Policy: I. The hospital develops, implements and maintains an active, hospital wide program for the prevention, control and investigation of infections and communicable disease .... III The infection prevention program includes essential elements designed to identify and reduce risks of patients, staff, and visitors acquiring and/or transmitting infections. V. Elements on the infection prevention program include: A. A hospital wide active surveillance system that covers both hospital patients and staff working in the hospital which includes documentation of infection detection, data collection and analysis, monitoring, implementing evaluation of preventions and reporting findings/results ..."