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Based on observation, interview, and record review, the GB failed to assume full responsibility for determining, implementing, and monitoring policies governing the hospital's functions to ensure compliance with CoPs under 482.21 (QAPI) and 482.42 (Infection Control) as evidenced by:

1. Failure to ensure the hospital - wide, data-drive, effective QAPI program was implemented and maintain. Cross reference to A263.

2. Failure to ensure the sanitary environment and the active IC program. Cross reference to A747.

3. The GB failed to ensure that consistent temperature and humidity parameters were defined in the hospital's P&P for the perioperative services.

Review of the hospital's P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 showed the temperature and humidity within all operative and invasive procedure areas will be monitored daily and maintained as follows:

* Clean workrooms: 68 to 73 degrees F.
* Decontamination Areas: 60 to 73 degrees F.
* SPD/OR sterile storage areas: 75 degrees maximum.

Review of the hospital's P&P titled Temperature, Humidity, and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range and air cycle and pressure relationship requirement. Further review of the hospital's P&P showed the temperature range levels are as follows:

* Clean workrooms: 72 to 78 degrees F.
* Soiled or decontamination room: 72 to 78 degrees F.
* Sterile storage: 72 to 78 degrees F.

Review of the SPD Clean Workroom Daily Temperature Record showed the temperature level should be between 68 degrees F to 73 degrees F.

Review of the SPD Decontamination Area Daily Temperature Record showed the temperature level should be between 60 to 73 degrees F.

Review of the SPD Sterile Storage Daily Temperature Record showed the temperature level should be less than 75 degrees maximum.

On 9/9/24 at 1411 hours, the IC Manager was interviewed with the presence of the Director of Quality. When asked, the IC Manager stated the new P&P titled Temperature, Humidity, and Ventilation Requirement in Health Care Facility dated 8/23/24 was for the hospital-wide, but the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 was for the perioperative areas. The SPD staff followed the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 when monitoring the temperature level in the SPD. The IC Manager stated the old P&P titled Temperature and Humidity Monitoring under Perioperative Services dated December 2022 was in the process of removing it and new P&P should have been adopted in the SPD. The IC Manager and Quality Director verified the above findings.

During the meeting with the GB, the CEO and Chief Quality and Patient Safety Officer on 9/11/24 at 1004 hours, the CEO and Chief Quality and Patient Safety Officer verified the above findings were ultimately GB's responsibility.

The cumulative effect of these systemic practice resulted in the GB's inability to provide high quality healthcare to the patients in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure the hospital - wide, data-drive, effective QAPI program was implemented and maintain as evidenced by:

1. Failure to ensure the QAPI program included an ongoing program related to the IC in the perioperative area. Cross reference to A273.

2. Failure to ensure the sanitary environment and the active IC program. Cross reference to A747.

The cumulative effect of these systemic failures resulted in the hospital's inability to implement and maintain a QAPI program designed to maximize the quality healthcare in a safe environment.

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

Findings:

Review of the hospital's P&P titled Organization-Wide Quality Assessment and Performance Improvement Program dated March 2024 showed the following:

* The Quality and Regulatory Compliance department shall be responsible to be support the organization's Quality Improvement principles, strategies, priorities, approach, and methodologies, which includes but is not limited to the following tasks:

- To maintain the database for all QAPI activities including quality improvement teams, departmental quality measures, medical staff quality and peer review activities.

- To provide reports using statistical tools & techniques to analyze and display data.

-To compares internal data over time to identify patterns, trends and variations.

* The Department Leaders are accountable for the quality and safety of care/services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the quality and safety of care provided in their departments.

- Directors will communicate opportunities for improvement for prioritization.

- Directors will promote the development of standards of care and criteria to objectively measure the quality and safety of care/services rendered in their departments.

- Report QAPI data and actions taken as appropriate.

- Communicate the status of departmental quality, patient safety, and survey readiness initiatives regularly to departmental staff members.

During an observation, interview, and record review from 9/9/24 to 9/11/24, the following deficient practice was identified:

1. The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle due to unavailability of the sterilizers. Cross reference to A749, example #8.

On 9/10/24 at 1129 hours, the Director for Cardiology and Perioperative Services and IC Manager were interviewed. When asked, the Director for Cardiology and Perioperative Services stated he reported to the facility department for the unavailability of the sterilizers. However, the Director for Cardiology and Perioperative Services did not communicate with IC or QAPI committees. When asked, the Director for Cardiology and Perioperative Services stated he was not aware of the inappropriate transporting surgical equipment to Hospital A.

2. The temperature in SPD decontamination area was not monitored and maintained as per the hospital's P&P. Cross reference to A749, example #11.

On 9/9/24 at 1411 hours, the IC Manager verified the temperature of the SPD decontamination area had been consistently out of range. However, the IC Manager was not aware of it.

Review of the Quality/Patient Safety Council dated 8/27/24, failed to show the above issues were addressed.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's environment and equipment were maintained in a safe and sanitary manner as evidenced by:

1. The physical environment in the SPD was not in good repair at all times.

2. The broken equipment were observed in the OR hallway. And there was no action taken when the work orders for those broken equipment were placed on 8/24/24 and 9/3/24.

3. The surgical equipment in OR 3 was not maintained in a sanitary condition.

These failures could create the increased risk of unsafe environment and safety for patients, staff, and visitors.

Findings:

1. On 9/10/24 at 1031 hours, the SPD Clean work area was toured with the SPD Supervisor, IC Manager, Quality PI/Review RN, and Director of Quality. The followings were identified:

a. The flooring in front of Sterilizer #3 was stripped off in two vertically parallel lines, exposing the subflooring beneath.

b. The vent and the surrounding wall below Sterilizer #3 had matted collections of dark dust matter.

c. The inside door of the Sterilizer #3's chamber was observed with residual burnt and dry tape.

d. The dust accumulation was observed on the margin between the door and the door jamb for Sterilizer #3.

e. The pipe underneath of Sink #2 in the decontamination room was observed with green substances.

f. In SPD clean work area, Sterilizer # 4 was observed with rust and dust accumulation. When asked, the SPD Supervisor stated Sterilizer # 4 was not functioning more than five years. The IC Manager stated she recommended to put the barrier over Sterilizer #4 when she performed EOC round in August 2024.

2. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager and OR Charge Nurse 1. The following was observed:

* Three Mayo stands were observed in the OR hallway behind the red line (semi-restricted area). The work order was posted on the Mayo Stands.

Review of the Work Order Details dated 8/26/24 at 1400 hours, showed "Biomed: Please print this for your records, reference, or attach it to the equipment needing repair." The Work Order Details showed the problem description was the three mayo stands not going up or down.

* Three stepping stools were observed in the OR hallway behind the red line (semi-restricted area). The work order was posted on one of the stepping stools.

Review of the Work Order Details dated 9/3/24 at 1856 hours, showed "Biomed: Please print this for your records, reference, or attach it to the equipment needing repair." The Work Order Details showed the problem description was three stepping stools with uneven/unbalanced bottom.

The IC Manager and OR Charge Nurse 1 verified the above findings.

3. During a tour of OR 3 with the IC Manager and OR Charge Nurse 1 on 9/10/24 at 1005 hours, the following were observed to be rusty.

* Three ring stands wheels
* Back table wheels
* IV pole wheels
* Two stools wheels

The IC Manager and OR Charge Nurse 1 verified the above findings.

Based on observation, interview, and record review, the hospital failed to provide the sanitary environment and the active IC program as evidenced by:

1. The hospital failed to ensure the IC 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 IC staff provided sufficient oversight the IC issues related to the perioperative services. Cross reference to A772.

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 observation, interview, and record review, the hospital failed to ensure the IC 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. The GI staff performed the endoscope cleaning by manually flushing channels and HLD without documented competency. In addition, the hospital's P&P related to the endoscope cleaning did not address the manual HDL to guide the staff on how to perform the manual HLD for the endoscopes.

2. The GI cleaning room did not have the minimum two decontamination sinks as per AORN's guidelines.

3. The GI staff failed to verbalize the drying step for the scope cleaning prior to the HLD as per the hospital's P&P.

4. The Wavicide-01 (a high-level disinfectant) MEC Strips Indicator was not used as per the manufacturer's IFU.

5. The Wavicide-01 solution temperature was not maintained as per manufacturer's IFU.

6. The GI staff did not wear appropriate PPE during the scope cleaning as per the AORN's Guidelines.

7. There was no cleaning verification test to verify the manual cleaning efficacy for the scopes that were identified as high risk as per AORN's guidelines.

8. The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle.

9. There was limited quantity of surgical equipment that was frequently used for surgical procedure.

10. The SPD physical environment was not maintained in sanitary condition.

11. Temperature in SPD decontamination area was not monitored and maintained as per the hospital's P&P.

12. OR 6's humidity level was not maintained as per the hospital's P&P.

13. There no clock or timers for surgical scrub sinks between OR 1 and OR 2.

14. Staff crossed the red line in OR area without appropriate attires.

15. The surgical equipment in OR 3 was not maintained in a sanitary condition.

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

Findings:

On 9/9/24 at 0915 hours, the Director for Cardiology and Perioperative Services was interviewed. When asked, Director for Cardiology and Perioperative Services stated the hospital followed the AORN's Guidelines as their practice for the perioperative services including OR and GI services.

1. On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated the GI department had 10 scopes, including four scopes used for upper GI procedure, three scopes used for colonoscopy procedure, one scope used for ERCP procedure, one scope used for pediatric, and one bronchoscope to be reprocessed in GI cleaning room. When asked, GI Tech 1 stated two AER machines were not in use since June of 2024 and the Scope Buddy was not in function since July of 2024. When asked, GI Tech 1 stated he performed manual flushing into the scope chambers and manual HLD.

Review of the hospital's P&P titled Endoscopes-Cleaning of Flexible dated March 2022 showed the procedure includes the automated reprocessing-high level disinfection. However, the P&P did not address the manual HLD to guide the staff on how to perform the manual HLD.

Review of the Olympus's OnTrack Reprocessing In-Service/Customer Competency for the Endoscope showed the steps of manual HLD were not demonstrated because GI technicians would be using a non-Olympus automated endoscope reprocessing unit to perform these steps.

When requested the documented competency for the manual HDL for three GI technicians, the hospital was not able to provide it.

2. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 3. Sterile Processing Area, endoscope processing areas should have a minimum of two decontamination sinks or sink basins, preferably three, that are deep and wide enough to allow complete submersion of the endoscope without tight coiling.

On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. The following was observed:

* The Endoscope Cleaning Guide was observed posted on the wall next to the sink. Review of the Endoscope Cleaning Guide showed precleaning, leakage testing, manual cleaning, rinsing are steps to clean an endoscope. The steps for rinsing include to immerse the entire instrument in clean water and gently agitate to rinse after the manual cleaning.

* It was observed there was only one compartment sink in the GI cleaning room. When GI Tech 1 was asked to demonstrate how to clean the used scope, GI Tech 1 demonstrated it with one compartment sink. GI Tech 1 stated he drained all the water from the sink after the manual cleaning the scopes and filled up the water in the same sink to rinse the scopes. When asked, GI Tech 1 stated he did not clean the sink after draining water for the manual cleaning steps and before filling up the water for the rinsing steps.

On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

3. Review of the hospital's P&P titled Endoscopes- Cleaning of Flexible dated March 2022 showed the procedure of cleaning an endoscope include precleaning, transporting, leak testing, manual cleaning, inspection, and automated reprocessing - HDL. The manual cleaning section showed to dry the exterior surfaces of the endoscope with a soft, lint-free cloth and purge all channels with instrument air.

On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated he performed manual scope cleaning prior to HLD. GI Tech 1 was asked to demonstrate the manual scope cleaning in the sink. GI Tech 1 stated after the rinsing the scope in the sink, the scope would be transferred for HLD. When asked, GI Tech 1 stated he did not dry the exterior surfaces of the scope prior to the HLD.

On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

4. Review of the manufacturer's IFU for Wavicide-01 MEC Strips Indicator showed to dip the strip in the test solution for one second, remove the excess solution by gently shaking the strip. compare the strip color with the color blocks at 30 seconds.

Review of Wavicide MEC Indicator Log for September 2024 showed 30 seconds between the test start time and test end time.

On 9/10/24 at 1344 hours, the area for HLD GI cleaning was toured with the CN in PACU and GI Tech 1 in the presence of the Director of Quality, Quality PI/Review RN, and IC Manager. GI Tech 1 was asked to demonstrate how to use Wavicide-01 MEC strips indicator. GI Tech 1 demonstrated dipping the Wavicide - 01 MEC strip into the solution for 30 second. GI Tech 1 stated he was checking the time with his own watch. When asked, GI Tech 1 stated he was told to dip the Wavicide - 01 MEC strip in the solution for 30 seconds.

The CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

5. Review of the manufacturer's IFU for Wavicide-01 showed the Wavicide-01 is a high level
disinfectant when used according to directions at full strength and 22 degrees C with an immersion time of at least 45 minutes.

Review of the Wavicide MEC Indicator Log for September 2024 showed the solution temperature would be from 20 to 22.5 degrees C. the following:

* On 9/3/24, the solution temperature was 23.5 degrees C.
* On 9/4/24, the solution temperature was 24.2 degrees C.
* On 9/5/24, the solution temperature was 25.2 degrees C.
* On 9/6/24, the solution temperature was 25.0 degrees C.
* On 9/7/24, the solution temperature was 25.9 degrees C.
* On 9/8/24, the solution temperature was 23.9 degrees C.
* On 9/9/24, the solution temperature was 24.2 degrees C.
* On 9/10/24, the solution temperature was 24.0 degrees C.

Further review of the Wavicide MEC Indicator Log failed to show if there was any action taken when the above tested solution temperature level was higher than the temperature level instructed by the manufacturer.

On 9/11/24 at 1100 hours, the Director of Quality and IC Manager verified the above findings.

6. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 4. Personal Protective Equipment, personnel working in the decontamination area of the endoscope processing room should wear PPE that corresponds with the degree of anticipated exposure, including general purpose utility gloves with fitted cuffs that extend beyond the cuff the gown and preferably that extend to the elbow. Examination gloves may be worn underneath the decontamination gown and utility gloves with extended cuffs.

On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. GI Tech 1 was asked to demonstrate the manual scope cleaning. GI Tech 1 demonstrated the PPE that he would wear prior to the manual scope cleaning. GI Tech 1 stated he would use regular disposable Nitrile gloves.

7. Review of the AORN's Guidelines for Perioperative Practice, Guidelines for Flexible Endoscopes 2024 edition showed under 9. Cleaning Verification and Inspection, using cleaning verification tests to verify manual cleaning of flexible endoscopes before sterilization of HLD when new endoscopes are purchased and at established intervals (eg, after each use, daily). 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. Cleaning effectiveness may be evaluated by testing for one or more of following: ATP, protein, carbohydrate, and hemoglobin.

On 9/10/24 at 1344 hours, the GI cleaning room was toured with the CN in PACU and GI Tech 1. When asked, the CN in PACU stated she oversaw the GI services and there were three GI technicians. When asked, GI Tech 1 stated there was no such cleaning verification tests to verify manual cleaning of endoscopes.

On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

8. On 9/10/24 at 1129 hours, the Lead SPD Technician was interviewed in the presence of the Director for Cardiology and Perioperative Services, Director of Quality, and IC Manager. When asked, the Lead SPD Technician stated she had transported the packaged items to be sterilized via her private vehicle, sterilized them at Hospital A, and transported back to the hospital via her private vehicle when three low temperature sterilizers could not use due to lack of proper cassettes. When asked, the Lead SPD Technician stated OR Charge Nurse 2 instructed to do so. The Director for Cardiology and Perioperative Services stated OR Charge Nurse 2 was no longer working in the hospital.

On 9/11/24 at 1110 hours, SPD Tech 1 was interviewed in the presence of the Director of Quality, Quality PI/Review RN, and IC Manager. When asked, SPD Tech 1 stated she had transported the packaged items to be sterilized via her private vehicle, sterilized them at Hospital A, and transported back to the hospital via her private vehicle on 9/7/24. When asked, SPD Tech 1 stated OR Charge Nurse 3 instructed to do so. When asked, SPD Tech 1 stated the sterilizer at Hospital A was not the same sterilizer she used at the hospital. SPD Tech 1 stated there was no one at Hospital A's SPD clean work area. SPD Tech 1 stated that she had to follow the steps showing on the sterilizer monitor.

Review of the Multi-Record Envelope dated 9/7/24, showed Hospital A's Sterilizer #3 was used to sterilize four Stryker HD Camera, seven Stryker batteries, and one Olympus Lens tray.

On 9/11/24 at 1400 hours, the Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

9. On 8/21/24, the hospital reported to the CDPH that an unprocessed power drill was used during the surgical procedure for Patient 5.

On 9/9/24, Patient 5's medical record was reviewed. Patient 5's medical record showed Patient 5 was admitted to the hospital on 8/19/24.

Review of the Operative Report dated 8/19/24, showed Patient 5 presented as critical trauma with multiple injuries including a traumatic amputation of his left leg. The patient was brought emergently to the OR after being informed of need for emergent surgery.

Review of the IntraOp Record dated 8/19/24 at 0454 hours, showed Patient 5's surgical procedure was started on 8/19/24 at 0415 hours and ended on 8/19/24 at 0531 hours. The form showed "All sterile supply packaging verified as acceptable condition for use in a surgical procedure."

On 9/9/24 at 0828 hours, the Director for Cardiology and Perioperative Services was interviewed. When asked, the Director for Cardiology and Perioperative Services stated there were two large power head drill; but being a trauma center, the head drill was frequently used at the hospital. One power head drill was broken and there was only one large power head drill was available. The Director for Cardiology and Perioperative Services stated on 8/19/24,
the OR Nurse picked up the surgical tray including the large power head drill, which was not sterilized yet and used it for the patient's surgical procedure.

On 9/9/24 at 0846 hours, the SPD clean work area was toured with the SPD Supervisor, Lead SPD Technician, Director for Cardiology and Perioperative Services, and Quality PI/Review RN. When asked, the SPD Supervisor stated the surgical tray which included the large power head drill, was placed on the table to be sterilized next morning.

On 9/11/24 at 1110 hours, SPD Tech 1 was interviewed. When asked, SPD Tech 1 stated only one large power head drill was available at the hospital. SPD Tech 1 sated the drill was sterilized almost every day due to high frequent usage.

On 9/10/24 at 1310 hours, the Chief Quality and Patient Safety Officer was interviewed with the Director of Quality. When asked, the Chief Quality and Patient Safety Officer stated only one available large power head drill was one of the contributing factors for the event.

10. The SPD physical environment was not in sanitary condition at all time. Cross Reference to A 724, example #1.

11. Review of the hospital's P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range, and air cycle and pressure relationship requirement. The local department will adjust the thermostat and humidistat. After 30 minutes, if not resolved, a work order will be created through the intranet. Record the work order number in the Temperature and Humidity form. If immediate resolution is needed, call facilities and reference the work order number. Record the temperature and humidity one hour after facilities repair and follow-up as needed. Individual departments are responsible to record accurate relative temperature and humidity readings and corrective actions responses. The P&P showed the temperature of the soiled or decontamination room should be between 72 to 78 degrees F.

During a tour of the decontamination area on 9/9/24 at 1413 hours with the Quality PI/Review RN, it was observed the temperature level was 80.4 degrees F in the decontamination room.

Review of the SPD Decontamination Area Daily Temperature Record for August and September 2024 showed the temperature level was out of range, the temperature level was too high, notified the facilities, and order was placed. Further record review showed there was no temperature level documented at all for whole month of August and September 2024.

Review of the Work Order Details dated 6/25 and 7/12/24, showed the temperature level was too high in decontamination area.

During an interview with the Lead SPD Technician on 9/10/24 at 1129 hours in the presence of the Director for Cardiology and Perioperative Services, Director of Quality, and IC Manager, the Lead SPD Technician stated the SPD decontamination was operated when the temperature level was out of range for August and September 2024.

On 9/11/24 at 1400 hours, the CN in PACU, Director of Quality, Quality PI/Review RN, and IC Manager verified the above findings.

12. Review of the hospital's P&P titled Temperature, Humidity and Ventilation Requirement in Health Care Facility dated August 2023 showed the hospital follows the 2008 ASHRAE 170 temperature and humidity range, and air cycle and pressure relationship requirement. The P&P showed the OR's humidity level should be 20 to 60%.

On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, Director of Quality, and OR Charge Nurse 1. OR 6 was in use. OR Charge Nurse 1 was asked to verify the temperature and humidity levels in OR 6. OR Charge Nurse 1 stated OR 6's humidity level was 71.6%.

13. Review of the manufacturer's IFU for BD E-Z Scrub 205 (Providone-Iodine) showed the following:
* Clean under nails with nail pick.
* Wet hands and forearms.
* Scrub thoroughly for three minutes paying particular attention to the nails, cuticles, and interdigital spaces.
* Rinse thoroughly.
* Repeat scrub for three more minutes.
* Rinse thoroughly.

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 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, Director of Quality, and OR Charge Nurse 1. The double scrub sinks were observed between OR 1 and OR 2. Two types of scrubs (BD E-Z Scrub 205 and 107) were observed above the sink. When asked, OR Charge Nurse 1 stated the physicians and scrub techs were to manually scrub for the first surgical case, but they could use Avagard Antiseptic Surgical Hand Scrub between cases. It was also observed no timer or clock near or on the sinks. When asked how the physicians and scrub techs were ensure for three minutes scrub times as per the manufacturer's IFU, OR Charge Nurse 1 was not able to answer.

14. Review of the hospital's P&P titled Dress Code-Surgical dated June 2024 showed the purpose is to maintain environmental control and promote a high level of cleanliness and hygiene within the surgical setting. Further review of the P&P showed the following:

* Surgical attire in the surgical semi restricted and restricted areas.
* Scrub Clothes: Approved, clean and freshly laundered surgical attire will be donned daily and will be changed whenever they become soiled or wet.
* Masks: Disposable masks must be worn at all times in the restricted area when there are open sterile items and equipment present.
* Surgical Hats/Hoods: A clean, low-lint surgical head cover or hood that confines all hair should be worn.

On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager, OR Charge Nurse 1 in the presence of the Director of Quality. When asked, OR Charge Nurse 1 stated behind redline was the restricted area that required appropriate attire. The following was observed:

* Broken equipment was placed in the OR hallway (semi-restricted area). Cross Reference to A724, example # 2.

* Two hospital staff were observed walking behind the red line (semi-restricted area) and picking up the broken equipment located behind red line. Two hospital staff did not wear the approved scrub clothes and surgical hats.

The IC Manager and OR Charge Nurse 1 verified the above findings.

15. On 9/10/24 at 1005 hours, the surgical areas were toured with the IC Manager and OR Charge Nurse 1 in the presence of the Director of Quality.

The surgical equipment in OR 3 was not maintained in a sanitary condition. Cross Reference to A724, example # 3.

Based on observation, interview, and record review, the hospital ensure the IC staff provided sufficient oversight the IC issues related to the perioperative services. This failure created the risk for substandard of care for patients receiving the care in the hospital.

Findings:

During the observation, interview, and record review from 9/9/24 to 9/11/24, the following deficient practice was identified:

* The SPD staff performed inappropriate transporting surgical supply/equipment via their private vehicle. Cross Reference to A749, example #8.

* The GI staff performed the endoscope cleaning by manually flushing channels and HLD without documented competency. Cross reference to A749, example # 1.

* The GI cleaning room did not have the minimum two decontamination sinks as per AORN's guidelines. Cross reference to A749, example # 2.

* The GI staff failed to verbalize the drying step for the scope cleaning prior to the HLD as per the hospital's P&P. Cross reference to A749, example # 3.

* The Wavicide-01 MEC Strips Indicator was not used as per the manufacturer's IFU. Cross reference to A749, example # 4.

* The Wavicide-01 solution temperature was not maintained as per manufacturer's IFU. Cross reference to A749, example # 5.

On 9/9/24 at 1402 and 1413 hours, the IC Manager was interviewed. When asked, the IC Manager stated she was not aware of the inappropriate transporting surgical supply/equipment. When asked, the IC Manager stated she was not aware that the machines in GI Cleaning room were not in use. The IC Manager stated she was not able to provide guidelines or recommendations for manual cleaning process.