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Based on observation, interview, and record review, the hospital failed to provide the sanitary environment and an active infection control program in the perioperative area as evidenced by:

1. The hospital failed to ensure the infection control program implemented the hospital's P&Ps and professional standards and employed methods for preventing and controlling the transmission of infection within the hospital. Cross reference to A749.

2. The hospital failed to ensure the infection control staff provided sufficient oversight of the perioperative services. Cross reference to A750.

The cumulative effect of these systemic failures resulted in the hospital's inability to minimize the risk of spread of infections in the hospital.

Based on interview and record review, the hospital failed to ensure services provided under contracted vendors were provided in a safe and effective manner by establishing complete and regularly scheduled contract evaluations for the vendors in the hospital. This failure had the potential for the risk of substandard services being provided in the hospital.

Findings:

The hospital was unable to provide a policy and procedure on evaluation of contract services when requested.

On 9/18/25, a review of the hospital's vendor contract evaluation was initiated.

On 9/18/25 at 1500 hours, a request was made to review the contract evaluations for Vendors A and B.

The VP of Business Development/Interim CNO was unable to provide the contract evaluations for Vendors A and B. The VP of Business Development/Interim CNO stated the hospital only had contract evaluations on vendors that provided direct patient care.

On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.

Based on interview and record review, the hospital failed to ensure the contract list was site-specific within the hospital's health system to include a complete list of all contracted services for the hospital. This failure had the potential for the risk of substandard services being provided in the hospital.

Findings:

On 9/18/25 at 1500 hours, a review of the hospital's contracted services was conducted with the VP of Business Development/Interim CNO.

Review of the hospital's contracted list showed Vendor A was missing from the list provided during the survey.

The VP of Business Development/Interim CNO acknowledged Vendor A was not listed on the hospital's contracted services list as required.

On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.

Based on observation, interview, and record review, the hospital failed to ensure the QAPI program included an ongoing program related to infection control in the perioperative area. This failure created an increased risk of poor health outcomes for the patients receiving care in the hospital.

Findings:

During an interview with the VP of Business Development/Interim CNO on 9/18/25 at 1300 hours, the VP of Business Development/Interim CNO provided the 2023 Hospital Performance Improvement Plan and stated that it was also the plan used for 2025.

Review of the 2023 Hospital Performance Improvement Plan showed "The Performance Improvement Plan describes the systematic, organization-wide approach to quality that is used to plan, design, measure, assess, and improve organizational performance...

4. Measurement and Evaluation...
- Departmental quality improvement activities...
- Regulatory and compliance standard...

Performance Improvement Priorities...
A. Priorities are based on:
1. Strategic planning priorities;
2. The needs identified for major patient populations served;
3. The needs identified in operational processes;
4. Consideration of the entire scope of services and operations;
5. High risk, high/low volume, or problem prone areas;
6. Consideration of prevalence and severity of problems and impact on patient safety
7. Patient care and organizational functions;
8. The overall resources available..."

Review of the hospital's Quality Performance Improvement Report for Operating Room for the year 2025, showed the following performance measures:
* Universal Protocol followed
* H&P 24 hours update on file
* Consent signed by Patient and MD
* Unexpected surgical complication
* Labeling of fluids on sterile field
* Prophylactic antibiotic timing

During observation, interview, and record review from 9/16/25 to 9/19/25, the following deficient practice was identified:

* The hospital failed to provide the sanitary environment and an active infection control program in the perioperative area. Cross reference to A 0747.

During an interview and concurrent record review with the VP of Business Development/Interim CNO, Infection Preventionist, OR Charge Nurse, and Facility Director on 9/19/25 at 1037 hours, the CNO stated staff who was in charge of the QAPI program, was off. The OR Charge Nurse and Facility Director stated two department worked so closely and no work order needed to be filed. The Facility Director stated there was no tracking system to follow up with issues. The VP of Business Development/Interim CNO verified that the QAPI program did not include infection control issues within the surgical department. The QAPI lacked a system to track, measure, and analyze infection control issues, including issues with rusty equipment, the physical environment, and out-of-range temperature and humidity levels that were previously identified.

Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity was maintained in the dry food storage area of the kitchen. These failures created a potential risk for an unsafe food storage environment.

Findings:

Review of the hospital's provided document titled Serving Safe Food Certification Coursebook, Page 92 (undated) showed under Dry Storage: Keep packages of dried fruits and vegetables, cereals and other grain products, sugar, flour, and rice intact and dry. These foods may be stored for long time periods, but water and high humidity may cause bacterial growth. Storage area temperatures should be 50 degrees to 70 degrees Fahrenheit with a relative humidity of 50-60%.

On 9/17/25 at 1042 hours, an observation and concurrent interview was conducted with the Director of Dietary Services in the hospital's dry food storage area. A posting was noted on the wall of the dry food storage area showing: Temperature: between 50-70 degrees Fahrenheit; Humidity: at 50-60%.

On observation of the digital thermometer in the dry food storage area it showed the temperature to be 75.7 degrees Fahrenheit and the humidity at 45%. The Director of Dietary Services acknowledged the temperature in the dry food storage area should be between 50 and 70 degrees Fahrenheit and humidity should be between 50-60%. The Director of Dietary Services acknowledged the temperature and humidity of the dry food storage area were both out of range.

On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings.

Based on observation, interview, and record review, the hospital failed to ensure the infection control program implemented the hospital's P&Ps and professional standards, and employed methods for preventing and controlling the transmission of infection within the hospital as evidenced by:

1. Soft water was not available for the instrument washer from 7/31/25 to 9/16/25.

2. The routine maintenance for the instrument washer and sterilizers was not conducted as per the manufacturer's IFU.

3. The air exchange was not tested annually.

4. The Rapicide PA (a high-level disinfectant) Minimum Required Concentration (MRC) Test Strips was not used as per the manufacturer's IFU.

5. Instruments were soaked in saline (a mixture of salt ans water) after the procedure and before being transported to the decontamination area, a method not in compliance with AORN's guidelines.

6. Sterile supplies were not stored as per AORN's Guidelines.

7. There was no cleaning verification test conducted to confirm the effectiveness of manual cleaning on high-risk scopes as per AORN's guidelines.

8. There is no lighted magnification inspection of scopes prior to the HLD as per AORN's guidelines.

9. The physical environment in the peri-operative area was not maintained in a sanitary condition.

10. For two sterilizers, the manual was not readily available to review when to perform sterilizer inspection, routine maintenance, and cleaning.

11. Surgeon 1 failed to perform surgical scrubbing as per the manufacturer's IFU.

12. There was no clock or timer to ensure surgical scrub followed the manufacturer's IFU.

13. Hinged instruments were not sterilized in an open position as per AORN's Guidelines.

These failures had the potential for spread of infections and negative impacts to the patients' health conditions.

Findings:

During an interview on 9/16/25 at 0835 hours, the Infection Control Preventionist and OR Charge Nurse stated the hospital followed the AORN's Guidelines as their practice for the perioperative services.

1. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Instrument Cleaning 2025 edition showed under 3. Water Quality. 3.2. Water should be monitored and controlled to the values. Chloride is damaging to stainless steel and can cause pitting corrosion.

During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the communication board was observed. The board showed "both water tanks out 7/31/25."

During an interview with the Instrument Technician and Senior Instrument Technician in the presence of the OR Charge Nurse on 9/17/25 at 1019 hours, the Instrument Technician and Senior Instrument Technician stated two soft water tanks were used for the instrument washer. When the first soft water tank was empty, the second tank was used. The Senior Instrument Technician stated that both soft water tanks were empty on 7/31/25. The soft water tanks were replaced on 9/16/25 around 3 or 4 PM.

On 9/19/25 at 1037 hours, an interview with the VP of Business Development/Interim CNO, Infection Preventionist, Facility Director, OR Charge Nurse, and Instrument Technician was conducted. The Infection Preventionist stated the Infection Preventionist was aware of the lack of soft water from 7/31/25 to 9/16/25. The Infection Preventionist also stated there was no random inspection and monitoring of the surgical tray. The VP of Business Development/Interim CNO verified the above findings.

2. Review of the hospital's P&P titled Autoclave Testing, Cleaning and Maintenance dated August 2023 showed the following:

* Chamber drain will be flushed weekly following the manufacturer's IFU. See attachment "A" for IFU step by step directions and cleaning product to be used and how to dilute.

* Check Control and Status Signals will be performed weekly following the manufacturer's IFU. See attachment "A" for IFU step by step directions.

* Float Switch Assembly will be checked quarterly following the manufacturer's IFU. See attachment "A" for IFU step by step direction. Float switch assembly will be performed by company that performs preventative maintenance.

Review of Attachment A under 4.2 Recommended Periodic Maintenance showed the following:

* 4.2.2 Weekly.

- 1. Flush chamber drain as follows:
a. Turn off steam supply valve. Wait until jacket pressure is zero. Wait until chamber has cooled to room temperature
b. Remove chamber drain strainer
c. Rinse drain with a solution of one quart of hot water and 1/2 cup of STERIS Liqui- Jet instrument detergent
d. Wait five minutes.
e. Flush drain with one quart of hot water
f. Place strainer back in drain
g. Turn Manual control to off
h. Turn steam supply valve back on
- 2. Check control and status signals as follows:
a. Select and start a short cycle
b. Observe gauges, display and printed tape for proper functioning
- 3. Flush Steam Generator, if sterilizer is equipped with optional steam generator

Review of the AMSCO 3000 Series Operator Manual under Table 6-1. Routine Maintenance Guide showed the following:

* 5.0 Chamber Components
- 5.1 Inspect rotary spray arm assemblies for free movement and clogged holes once a week.
- 5.3 Remove hard water deposits from interior of chamber using decontamination cycle once a week.
- 5.4 Clean washer/disinfector exterior once a week.
- 5.5 Clean water outlet connection in chamber once a week.

* 9.0 Manifold Racks
- Inspect rotary spray arm assemblies of manifold racks for free movement and clogged holes once a week

During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the Instrument Technician stated there were two sterilizers and one instrument washer. The Instrument Technician stated the Instrument Technician performed cleaning outside of the sterilizer daily.

During an interview with the Instrument Technician and Senior Instrument Technician on 9/17/25 at 1014 hours, the Instrument Technician and Senior Instrument Technician stated the drainer was cleaned daily but the vendor cleaned the inside of the chambers for the sterilizers. For the instrument washer, the cleaning process was followed when the washer prompted to clean. The Instrument Technician and Senior Instrument Technician verified there was no weekly routine maintenance performed for the sterilizers and washer.

On 9/19/25 at 1037 hours, the VP of Business Development/Interim CNO verified the above findings.

3. During an entrance conference on 9/16/25 at 0850 hours, the air exchange report for the surgery department was requested. On 9/17/25, the air exchange report was provided. Review of the Air Balance report dated 9/17/25, showed the air exchange was tested in surgical department.

During an interview with the Facility Director on 9/17/25 at 1209 hours, the Facility Director stated the air exchanges would be performed annually. The previous air exchange report was requested. Review of the Annual Crucial Area Validation showed the air exchange test was performed on 12/12/23.

On 9/19/25 at 1037 hours, the VP of Business Development/Interim CNO verified the above findings.

4. Review of the manufacturer's IFU for Rapicide PA Minimum Required Concentration (MRC) Test Strip showed to dip the strip into the solution for one second; shake off the excess solution; wait for 30 seconds and then compare the strip color to the color chart on the bottle. Ready within one minute of testing to determine if the result matches PASS or FAIL.

During an interview with the Instrument Technician on 9/16/25 at 1010 hours, the Instrument Technician stated the test strip was used to validate the HLD's efficacy. The Instrument Technician stated to dip in a couple seconds like eight to 10 seconds.

On 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings.

5. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Instrument Cleaning 2025 edition showed under 6. Point-of-Use Treatment. 6.4 Keep instruments moist until they are cleaned by using either saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments. Do not use saline.

During an observation in the OR on 9/17/25 at 1300 hours, the dirty instrument soaked in clean solution were observed in the basket. Surgical Technician 1 stated the dirty instruments were soaked in saline.

On 9/17/25 at 1340 hours, the OR Charge Nurse acknowledged the findings.

6. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Sterilization. 2025 edition showed under 4. Storage of Sterile Items. 4.1.3. Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts.

During a tour of the OR area on 9/17/25 at 1329 hours, with the OR Charge Nurse, the sterile supplies were observed stored in the OR hallway. The sterile supplies were stored in the closed cabinet, and some sterile supplies were stored in the open cart in the OR hallway. It was observed the door of the closed cabinet was open.

The OR Charge Nurse verified the above findings.

7. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2025 edition showed under 9. Cleaning Verification and Inspection. 9.5 Use cleaning verification tests to verify manual cleaning of flexible endoscopes before sterilization or HLD when new endoscopes are purchased and at established intervals (e.g., after each use, daily). 9.5.1. For flexible endoscopes that are identified as high risk by the health care organization (e.g., duodenoscopes, bronchoscopes), verify manual cleaning efficacy with a cleaning verification test after each use. 9.5.2. Cleaning effectiveness may be evaluated by testing for one or more of following: ATP, protein, carbohydrate, and hemoglobin.

During a tour of GI Reprocessing room with the Instrument Technician and OR Charge Nurse on 9/16/25 at 1010 hours, the Instrument Technician and OR Charge Nurse stated there were no cleaning verification tests after the manual scope cleaning and prior to the HLD.

During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings.

8. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2025 edition showed under 9. Cleaning Verification and Inspection. 9.3. Use lighted magnification to inspect the external surfaces of flexible endoscopes and accessories before sterilization or HLD.

During an interview with the Instrument Technician and Senior Instrument Technician on 9/17/25 at 1041 hours, the Instrument Technician stated the Instrument Technician inspected the external surfaces of scopes with bare eyes, not with the lighted magnification.

During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings.

9. During a tour of the surgical department with the OR Charge Nurse on 9/17/25 at 1329 hours, the following were identified:

* Rusty wheels of the back table and stainless-steel kick bucket in OR 3.
* Worn out OR table mattress in OR 3.
* A rectangular plastic seal, black tape on the ceiling next to sprinkler in OR 3.
* The fluorescent light fixture on the ceiling with translucent plastic cover displayed irregular blotchy discoloration in the decontamination room.

During an interview with the OR Charge Nurse on 9/18/25 at 0912 hours, the OR Charge Nurse verified the above findings.

10. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Sterilization 2025 edition showed under 10. Quality. 10.15.2. Perform sterilizer inspection and routine maintenance including cleaning as specified in the manufacturer's written IFU.

During a tour of the SPD on 9/16/25 at 0930 hours, with the VP of Business Development/Interim CNO and Instrument Technician, the Instrument Technician stated there were two sterilizers and one instrument washer. The Instrument Technician stated the Instrument Technician performed cleaning outside of the sterilizer daily and no routine maintenance for inside of the chamber.

During an interview with Biomedical Technician 3 on 9/16/25 at 1330 hours, Biomedical Technician 3 stated the Biomedical Technician 3 did not have manuals for the two sterilizers at the hospital.

On 9/17/25, the hospital provided manuals for the sterilizers. During an interview with the OR Charge Nurse on 9/17/25 at 1034 hours, the OR Charge Nurse stated the manuals for the sterilizers were prepared on 9/16/25.

11. Review of the manufacturer's IFU for BD E-Z Scrub 107 (4% CHG) showed the following:
* Wet hands and forearms to the elbows with warm water.
* Use nail cleaner and apply scrub solution from sponge side.
* Scrub nails, cuticles, and interdigital spaces thoroughly for three minutes with brush side and hands and forearms with the sponge side.
* Rinse with warm water.
* Repeat scrub for three more minutes, use the sponge side only.
* Rinse hands and arms thoroughly.

On 9/17/25 at 1002 hours, Surgeon 1 was observed performing surgical scrub with the BD E-Z Scrub 107. It was observed the OR Charge Nurse dialed the timers. At 1003 hours, Surgeon 1 rinsed both forearms and hands. At 1005 hours, Surgeon 1 opened another BD E-Z Scrub 107 and started to scrub the forearms and hands. At 1006 hours, Surgeon 1 rinsed the forearms and hands. At 1007 hours, the OR Charge Nurse told Surgeon 1 to wait until the timer rang. At 1009 hours, Surgeon 1 opened another BD E-Z Scrub 107 and repeated the surgical scrub. At 1013 hours, Surgeon 1 rinsed the scrubbed forearms and hands. At 1014 hours, Surgeon 1 entered the OR.


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12. Review of the manufacturer's IFU for BD E-Z Scrub 107 (4% CHG) showed the following directions:
* Wet hands and forearms to the elbows with warm water
* Use nail cleaner and apply scrub solution from sponge side
* Work up lather
* Scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side
* Rince with warm water
* Repeat scrub for three more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds.
* Rinse hands and arms thoroughly
* Dry thoroughly

During a tour of the OR area on 9/16/25 at 0928 hours, hand scrub sinks were observed in the OR hallway. There was no clock or timer observed around hand scrub sinks.

On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings.

13. Review of the AORN's Guidelines for Perioperative Practice: Packaging Systems dated 2025, showed under section 3.9.2, place items to be sterilized in an open or unlatched position within the sterilization package. The open or unlatched position facilitates sterilant contact of all surfaces of the item.

During a concurrent observation and interview on 9/16/25 at 1005 hours, with the Instrument Technician in the sterile surgical instrument storage area in the main hallway of the OR, several hinged sterilized packaged instruments were found sterilized and packaged in the closed position. The Instrument Technician acknowledged the sterile surgical instruments should have been placed in the sterilization pouch and sterilized in the open position.

On 9/18/25 at 1515 hours, the VP of Business Development/Interim CNO was notified and acknowledged the above findings.

Based on observation, interview, and record review, the hospital failed to ensure the Infection Control Preventionist provided sufficient oversight of the surgical services when the deionized water filtration system was not functional, increasing the risk of compromised surgical instrument integrity during reprocessing and patient harm.

Findings:

Review of the hospital's P&P titled Infection Prevention and Control Program dated April 2025 showed the goal of the program is to facilitate the prevention of hospital-acquired infections. The Infection Control Preventionist, with the guidance of the Chairperson has the responsibility for the daily management of infection prevention and control activities. The Infection Control Preventionist has the authority to take steps to prevent or control acquisition and transmission of infectious agents.

During an observation, interview, and record review from 9/16/25 to 9/19/25, the following deficient practice was identified:

* The hospital failed to ensure deionized water was available for the processing of soiled surgical instruments. Cross reference to A749, example # 1.

On 9/19/25 at 1038 hours, an interview and record review were conducted with the Infection Control Preventionist, the Instrument Technician, the OR Charge Nurse, and the VP of Business Development/Interim CNO. The Infection Control Preventionist stated the water filtration system, responsible for providing deionized water for surgical instrument processing, was due for preventive maintenance and had not been functional since 7/31/25.

The Instrument Technician mentioned that during this period, instruments were inspected more closely and specially cleaned with a chemical to safely remove any build-up, as well as another chemical for lubricating them. The Instrument Technician also showed pictures of the instruments to the Infection Control Preventionist. The OR Charge Nurse added that any rusty instruments were always removed from service at any point during processing and before use on a patient during surgery.

The Infection Control Preventionist stated the primary concern in getting the water filtration system operational was addressing the credit hold, which required a balance and service payment before the vendor could provide the service.

Review of the vendor receipt showed the water filtration system was serviced and functional as 9/17/25.

However, a more comprehensive and proactive oversight of infection prevention related to the non-functional water filtration system was not performed by the Infection Control Preventionist. For example, the Infection Preventionist failed to instruct to open sample trays for inspection of the surgical instruments or considered alternative methods to ensure surgical instruments were processed using deionized water while the system was down. Rather, the Infection Preventionist stated a responsive approach for overseeing the post-surgical complications from an infection prevention standpoint was to review post-surgical patient cultures for any potential contaminants or return-to-surgery rates.

The above concerns were shared and acknowledged by the Infection Control Preventionist, the Instrument Technician, the OR Charge Nurse, and the VP of Business Development/Interim CNO.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services were provided in a safe manner. This failure could result in the potential for poor health outcomes to patients receiving surgical services in the hospital.

Findings:

1. The hospital failed to ensure the infection control program implemented the hospital's P&Ps and professional standards and employed methods for preventing and controlling the transmission of infection within the hospital. Cross reference to A749.

2. The hospital failed to ensure the Infection Control Preventionist provided sufficient oversight of the surgical services when the deionized water filtration system was not functional from 7/31/25 to 9/16/25. Cross reference to A750.

Based on interview and record review, the hospital failed to provide rehabilitation services as ordered by the physician for two of five sampled patients (Patients 4 and 5). This failure created the risk of substandard health outcomes for patients.

Findings:

Review of the hospital provided document titled Rehab Services Department (undated) showed under the section titled, Patient Assessment/Reassessment, Initial evaluations of inpatients will be performed within 24 hours of the department notified of the referral.

During an interview on 9/17/25 at 1345 hours, the Director of Rehabilitation Services stated that the contracted rehabilitation service provider was unable to provide enough staff at times to provide all rehabilitation services ordered by the hospital's providers for inpatients.

1. Review of Patient 5's medical record initiated on 9/19/25 at 0855 hours, showed Patient 5 was admitted to the hospital on 8/19/25 and was discharged on 9/2/25.

Review of the orders for Patient 5 showed an order for a physical therapy evaluation and treatment was entered on 8/25/25. The orders also showed an order for occupational therapy evaluation and treatment ordered on 8/28/25.

During a concurrent interview and record review on 9/18/25 at 0855 hours, with LVN 1, LVN 1 was unable to locate any documentation showing Patient 5 was evaluated and/or treated by a Physical Therapist or an Occupational Therapist during their hospitalization.

2. Review of Patient 4's medical record initiated on 9/19/25 at 0920 hours, showed Patient 4 was admitted to the hospital on 9/3/25 and was discharged on 9/5/25.

Review of the orders for Patient 4 showed an order for a physical therapy evaluation and treatment was entered on 9/4/25. The orders also showed an order for occupational therapy evaluation and treatment ordered on 9/5/25.

During a concurrent interview and record review on 9/18/25 at 0920 hours, with LVN 1, LVN 1 was unable to locate any documentation showing Patient 4 was evaluated and/or treated by a Physical Therapist or an Occupational Therapist during their hospitalization.

On 9/18/25 at 1515 hours, the above findings were shared and acknowledged by the VP of Business Development/Interim CNO.