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Based on observation, interview, and record review, the hospital failed to have an effective GB to be responsible for the conduct of the hospital as evidenced by:

1. The hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Cross reference to A263.

2. The GB failed to have the systems in place for tracking, surveillance, and prevention and control of infection. Cross reference to A770.

3. The hospital failed to have an active hospital-wide programs for the surveillance, prevention, and control of the HAIs. The programs failed to demonstrate adherence to nationally recognized infection prevention and control guidelines. In addtion, the program failed to ensure the infection prevention and control issues identified in the programs must be addressed in collaboration with the hospital-wide QAPI program. Cross reference to A747.

4. The hospital failed to ensure the surgical services were organized and provided in accordance with the acceptable standards of practice. Cross reference to A940.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services in a safe and effective manner.

Based on record review and interview, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as evidenced by:

1. The hospital failed to ensure the QAPI program incorporated quality indicator data to monitor the effectiveness and safety of the services. Cross reference to A273.

2. The hospital failed to ensure the QAPI program tracked medical errors and adverse events to implement preventive actions and mechanisms that include feedback throughout the hospital. Cross reference to A286.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services in a safe and effective manner.

Based on interview and record review, the hospital failed to ensure the QAPI program incorporated quality indicator data to monitor the effectiveness and safety of the services as evidenced by:

1. Failure to identify the IUSS as a high risk, high volume, problem-prone practice in the Surgical Services.

2. Failure to perform the comprehensive and collaborative case studies for SSI to identify future improvements to the Perioperative Services and the patients health outcomes.

These failures increased the risk for substandard outcomes for the patients in the hospital.

Findings:

Review of the hospital's QAPI Program Plan dated 2020 showed the goal of the QAPI program is to identify and reduce the risk of medical errors and improve health outcomes. The focus of the QAPI program is to identify high-risk problem prone opportunities and take action to reduce the likelihood of medical errors.

- Attachment A - QAPI Hospital wide Indicators showed the SSI HAI rate with a benchmark goal of "0".

During the Complaint Validation survey conducted on 8/2/21 to 8/27/21, the following concerns were identified:

* Failure to monitor, track, analyze, and create collaborative performance improvement projects regarding the frequency of IUSS use in the Surgical Services. Cross reference A751, examples #1 and #2.

* Failure to ensure comprehensive analytics the SSIs to identify possible breaks in the infection control. Cross reference to A751, example #3.

Review of the Quality/Patient Safety Council Report dated 6/21 failed to show the meeting discussion of the infection control issues for the past quarter.

Review of the MEC meeting minutes from 7/14/21, showed the MEC had identified an SSI with no further recommendation.

The CEO stated the Infection Prevention was reported to the MEC, and then to the GB. The Infection Prevention Committee was no longer reporting to the QAPI. When asked why the reporting structure was changed, the CNO stated the medical staff in the MEC was responsible now to oversee the Infection Prevention Committee. The CNO stated the hospital committees were expected to bring any unresolved issues to the GB if the committees and sub-committees were unable to do so.

Based on interview and record review, the hospital failed to ensure the QAPI program tracked medical errors and adverse events to implement preventive actions and mechanisms that included feedback throughout the hospital.

Findings:

On 8/26/21 at 1040 hours, an interview was conducted with the Employee Health/Infection Prevention.

During the Complaint Validation survey conducted on 8/2/21 to 8/27/21, the following concerns were identified:

* Failure to monitor, track, analyze, and create collaborative performance improvement projects regarding the frequency of the IUSS use in Surgical Services. Cross reference to A751, examples #1 and #2.

* Failure to ensure comprehensive analytics for the SSIs to identify possible breaks in infection control. Cross reference to A751, example #3.

The Employee Health/Infection Prevention acknowledged the above concerns and stated they were not performing the data collection on the IUSS. The Employee Health/Infection Prevention stated the Manager of Surgery was taking care of the IUSS data collection, and it was not communicated to the Employee Health/Infection Prevention.

Based on interview, observation, and record review, the hospital failed to maintain the hospital environment for the safety and well-being of the patients in the patients' rooms, the Pre-op Overflow, OR rooms, and GI Procedure room. These failures put the patients, patient families, and staff at risk for infection.

Findings:

1. During a tour of the hospital on 8/24/21 beginning at 0900 hours, with the Employee Health/Infection Prevention, Engineering Supervisor (ES), Environment & Safety Coordinator (ESC), National Director IC, and VP of Facilities Development, the following was observed:

* Room 101 - Rusted plumbing in the bathroom

* Room 102 - Scraped paint on wall

* Room 106 - Peeling paint on the windowsill and wall. The bathroom showed an exposed plumbing cleanout (a pipe with a cap that provides access to the sewer line so that blockages can be removed). Additionally, the bathroom overhead light had multiple pieces of foreign matter inside the cover.

* Room 115 - The window had debris and multiple spider webs between the window and screen. There was rusty plumbing in the bathroom behind the toilet.

* Tub room #2 (200 unit) - The supply cabinet inside the tub room was seen. The laminate covering on the edge of the top drawer was missing leaving exposed wood.

* Room 206 - Cracked paint on the windowsill and wall.

* Room 208 - The sink was loose, and the caulking (a waterproof filler and sealant) was cracked.

* Room 213 - Tile at threshold was raised and loose.

* Room 214 - Blue tape covering missing tile at threshold.

The VP of Facilities Development, ES, ESC, and Employee Health/Infection Prevention all concurred with these findings.


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2. On 8/24/21 at 1046 hours, a tour of the Pre-op Overflow was conducted with the Manager of Surgery. The following concerns were identified:

* The wall adjacent to the work counter had scattered areas of chipped paint.
* The base board adjacent to the work counter was broken off.

The Manager of Surgery acknowledged the above findings.


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3. The hospital failed to show evidence of maintaining perioperative care of the HVAC. Cross references to A951, examples #1, #2, and #3.

The hospital's P&P titled Safety Management Plan last reviewed 2/21 showed the fundamentals of the safety program stated the safety is dynamic. Regular evaluation of the environment for work practices and hazards is required to maintain a current relevant safety management program. The program should be changed as needed to respond to identify the risk, hazards, and regulatory compliance. The hospital Safety Officer and Security Supervisor manages the safety risk assessment process for the hospital. The Safety Officer is designated to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information and disseminate summaries of actions and results. The risk assessment implement is used to evaluate the impact of the environment of care on the ability of the organization to perform clinical activities.

The hospital's documentation showed the SPD areas used a portable AC unit in 2020 (Cross reference to A724, example #1) and the document indicated the air flow and pressure did not meet the standards. On 8/25/21, the portable AC unit was again used in the SPD. The hospital ECO rounds Schedule 2021 review showed the patient care areas (ED, OR, GI, and ICU) were visited twice a year.

On 8/27/21 at 0835 hours, an interview and document review was conducted with the Coordinator of EVS. The EOC rounds schedule was reviewed; however, the Coordinator of EVS was not able to provide a documented evidence showing the hospital had assessed the risk of the clinical care area for the scheduling of visits.

Based on observation, interview, and record review, the hospital failed to ensure the supplies and equipment were maintained as evidenced by:

1. The SPD and OR Hallway were not maintained at the temperatures or air pressure recommended by the AORN Guidelines. This created the potential for spreading of infection.

2. The hospital failure to ensure the crash carts in the OR Hallway and the 100 unit were without the expired items and readily available for emergency use . This failure created the potential for expired medical supplies to be used during a Code Blue.

These failures created the risk of poor health outcomes to the patients receiving surgical services in the hospital.

Findings:

1. The AORN's Guidelines for Perioperative Practice, 2021 edition, Guidelines for Perioperative Practice: Design and Maintenance of the Surgical Suite showed the following:

* The sterile processing clean workroom should have a positive pressure relationship to adjacent areas.

* The sterile storage room should have a maximum relative temperature of 75 degrees F, and relative humidity level of no more than 60%.

* Do not use free standing fans, portable humidifiers, air conditioners, or dehumidifiers. These devices all contain a fan that when running can disrupt the planned airflow within the room and may transfer unwanted particles from the floor to the surgical site.

a. On 8/25/21 at 1010 hours, a tour of the sterile processing clean workroom was observed with the SPD Supervisor. Two large portable air conditioners were placed near each other in the room. One of them was directed toward the small hallway leading to the SPD wrapping station. The other portable air conditioner was directly in front of the peel packaging counter with both of the air blow tubes blowing directly on the work counter.

Review of the air balance validation testing was conducted on 9/20 showed the SPD Clean Workroom had a portable AC unit which was noted to change the space pressurization due to the additional heat exhaust of the unit to the space. Further review showed the recommendation was to address the issue with a permanent solution to prevent changes to the air balance of the space. The report showed the SPD Clean room was not able to maintain positive pressure. When the AC unit was on, the pressure was negative at -0.021 WC.

During an interview with the Infection Prevention on 8/25/21 at 1544 hours, the Infection Prevention stated the Surgery Service requested the portable AC units independently and then it was approved by the administration. The Infection Prevention stated she was not involved in the oversight of the installation of the portable AC units in the SPD Clean Workroom.

On 8/26/21 at 1230 hours, an interview and concurrent review of facility documents was conducted with the HVAC staff. The HVAC staff stated the pressure was not measured on a daily basis in the SPD.

b. On 8/24/21 at 1330 hours, an inspection of the SPD area was conducted with the Manager of Sterile Processing. The Manager of Sterile Processing used a fluke temperature probe to take the temperature of the room. The temperature reading was at 78.8 degrees F.

c. On 8/24/21 at 1429 hours, an inspection of the temperature reading was conducted with the Manager of Sterile Processing. The Manager of Sterile Processing took the temperature of the OR Hallway with a fluke temperature probe, which showed the temperature reading was 77.4 degrees F.

The Manager of Sterile Processing acknowledged the above findings.

2. Review of the hospital's P&P titled Crash Carts Emergency Medications: In section, Maintenance and Exchange dated 2/21 showed exchangeable fully stocked and sealed crash carts are maintained by the Central Supply and Pharmacy and available for exchange on demand. After the Central Supply has processed and secured its portion of the cart, the cart is then brought to the pharmacy where the pharmacist replaces and certifies the cart with a new medication tray.

a. On 8/25/21 at 1038 hours, an inspection of the crash cart in the OR Hallway was conducted with the Director of Clinical OP & Improvement. The following was identified:

* Four IV start kits had expired on 5/31/20.
* Two IV infusion sets had expired on 9/30/20, and 4/30/21, respectively
* Two IV extension sets had expired on 9/30/20.
* Two 18g IV needles had expired on 7/21.
* Two 24g IV needles had expired on 6/21.
* One 22g IV needle had expired on 7/20.
* One NS 1 L bag had expired on 5/20 and two expired on 4/20.
* One LR 1 L bag had expired on 3/20.
* One NS 500 ml bag had expired on 6/20.
* One LR 500 ml bag had expired on 1/21.
* One D5 500 ml bag had expired on 3/21.
* One NS 250 ml bag had expired on 7/20.
* One central venous catheter kit had expired on 2/28/21.
* Two arterial blood sample kits had expired on 4/30/21.
* One laryngoscope blade with an oily thick substance on the packaging.

On 8/25/21 at 1357 hours, an interview was conducted with the Interim Director of Materials. The Interim Director of Materials stated the Central Supply was responsible for restocking and ensuring all expired or unsanitary items were removed from the crash carts. The Interim Director of Materials stated the date when the crash cart was last checked was unknown as the Crash Cart Check sticker was missing from the cart. The Interim Director stated the sticker showed when the supplies were checked, by whom it was checked, and the date the supplies expired.

The Interim Director of Materials was informed of the above findings.


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b. During a tour of the 100 unit with the CNO on 08/26/2021 at 1045 hours, the crash cart was inspected. Review of Drawer #3 of the crash cart showed two expired IV start kits. The CNO stated, "That is the responsibility of the SPD...they should not be there...they should have been replaced."


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Based on observation, interview, and record review, the hospital failed to have the active hospital-wide programs for the surveillance, prevention, and control of the HAIs. The programs failed to demonstrate adherence to nationally recognized infection prevention and control guidelines. In addtion, the programs failed to ensure the infection prevention and control issues identified in the programs must be addressed in collaboration with the hospital-wide QAPI program as evidenced by:

1. The hospital failed to ensure the infection control practices as per the hospital's P&P, manufacturer's guidelines, and AORN's guidelines. Cross reference to A749.

2. The hospital failed to ensure the Infection Prevention Program reflected the scope and complexity of the services provided in the hospital. Cross reference to A751.

3. The hospital failed to ensure the GB had systems in place for tracking, surveillance, and prevention and control of infection. Cross reference to A770.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services in a safe and effective manner.

Based on observation, interview, and record review, the hospital failed to ensure the infection control practices as per the hospital's P&P, manufacturer's guidelines, and AORN's guidelines as evidenced by:

1. Failure to ensure the electronic shaver was maintained in a sanitary condition.

2. Failure to maintain the refrigerators in the Pre-Op and Pre-Op Overflow in a sanitary condition.

3. The expired surgical items were stored in the supply storage area in the SPD and OR hallway.

4. SPD Tech 1 had exposed arms when wrapping a surgical tray in the SPD clean work area.

5. The SPD and OR Hallway was not maintained at the acceptable temperatures or air pressure recommendations by the AORN's guidelines.

6. Failure to ensure the enzymatic detergent was properly diluted for decontamination of the surgical instruments.

7. Expired washer test strips were used in the Decontamination Room.

8. Instrument peel packs had no load stickers in the SPD as per the hospital's P&P.

9. RN 1 failed to wear PPE properly in the ICU COVID-19 isolation room.

These accumulative failures placed patients and staff at risk for infection.

Findings:


1. Review of the Medline Electrical Clipper with Charging Base IFU showed care and cleaning of the clipper body included:

* Remove the loose hair and other gross debris from the clipper by placing it under the running water or soaking in a water bath.

* Wipe the clipper with a damp cloth containing a non-corrosive disinfectant.

* Dry the clipper with a clean towel.

* Return the clipper to either the charging adapter or storage area.

On 8/24/21 at 1046 hours, a tour of the Pre-Op Overflow area was conducted with the Manager of Surgery. A Medline Electrical Clipper was observed on the charging base on top of the work counter. Hair particles were observed scattered inside the device's crevices. When asked, the Manager of Surgery stated the shaver should have been cleaned and disinfected after each use.

2. Review of the hospital's P&P titled Refrigerator - Patient's Nutrition and Medication dated 2/20 showed the nutrition refrigerator is not to be used to store food brought in from outside. It is only for food supplied by the hospital dietary department. The temperature of the food refrigerator must be kept between 32 degrees and 41 degrees F. All the refrigerators should be cleaned and disinfected once a month by the Department. The refrigerator will be defrosted as needed.

a. On 8/24/21 at 1046 hours, a tour of the Pre-Op Overflow area was conducted with the Manager of Surgery. A small refrigerator was observed on top of the work counter. Inside the refrigerator compartment was a Physical Therapy device. The compartment had a large build-up of ice formation. The Manager of Surgery stated the refrigerator was for the Physical Therapy and would be removed from the patient care area.

b. On 8/24/21 at 1109 hours, a tour of the Pre-Op room was conducted with the Manager of Surgery. A small refrigerator was observed in the office area of the Pre-Op room. The Manager of Surgery stated the refrigerator was for the patients nourishment. The following was identified:

- The temperature reading was at 42 degrees F.
- One opened bottle of soda.
- One opened bottle of water.
- Ice build-up in the freezer compartment.

The Manager of Surgery verified the opened water and soda bottles should be removed immediately.

3. Review of the hospital's P&P titled Sterilization Standards dated 2/23/20, showed the sterility of items will be applicable unless the integrity of the packaging has become damaged or compromised in any way. Rotation of sterile supplies will be rotated using the first in, first out principle. Items newly sterilized are placed at the back or the left side of the shelf.

a. On 8/24/21 at 1330 hours, a tour of the SPD was conducted with the Manager of Sterile Processing. An inspection of the SPD refrigerator showed four packages of UltraSnap ATP Tests dated 5/28/21. The Manager of Sterile Processing stated the items should be immediately discarded.

b. On 8/24/21 at 1445 hours, a tour of the OR Hallway was conducted with the Manager of Sterile Processing. Inspection of the OR Hallway sterile supply area showed two packages of Allograft Human Tissue with the expiration date of 7/29/21. The Manager of Sterile Processing acknowledged the findings and stated the items should be removed.

On 8/25/21 at 1010 hours, an interview was conducted with the SPD Supervisor. The SPD Supervisor stated she was responsible for expired sterile supplies in the SPD and OR Hallway. The visual check was done when there was available time, and the recent operations were slow.

4. The AORN's Guidelines for Perioperative Practice, 2021 edition, Guidelines for Perioperative Practice: Surgical Attire showed the sterile processing team member should wear scrub attire that covers the arm while preparing and packaging items in the clean assembly section of the sterile processing area.

On 8/25/21 at 1010 hours, a tour of the SPD clean work Area was conducted with the SPD Supervisor. The SPD Supervisor stated the area was designated for wrapping surgical instrument trays. SPD Tech 1 had both arms exposed. The SPD Supervisor stated SPD Tech 1 just completed wrapping a surgical instrument tray for sterilization. When asked if SPD Tech 1 wrapped the surgical instruments with the arms were covered, SPD Tech 1 stated not doing so. The SPD Supervisor acknowledged the above findings.

5. The SPD and OR Hallway were not maintained at the temperatures or air pressure recommendations by the AORN's guidelines. Cross references to A0724, example #1.a, b, and c.

6. Review of the IFU for the Dual Enzymatic Detergent and Presoak showed the water temperatures between 90 to 110 degrees will optimize enzyme performance. Use 1/2 to 1 ounce of concentrated solution per gallon of water for manual scope cleaning. For the ultrasonic cleaner, dispense at 1/2 to 1 ounce of concentrated solution per gallon of water.

a. On 8/24/21 at 1459 hours, SPD Tech 1 was observed in the Decontamination Room preparing the Dual Enzymatic Detergent in the sink for manual washing. SPD Tech 1 turned on the water to fill up the sink to the line sticker. A temperature probe was emerged in the sink water showing 92 degrees F. While the water was still filling to the water line, SPD Tech 1 dispensed the enzymatic solution from the dosing machine. The water turbulence coming from the sink spout caused the temporary formation of suds. The suds obscured the water demarcation line. SPD Tech 1 placed the soiled instruments into the enzymatic preparation and began to scrub the instruments. However, when asked if the water was at the appropriate level, SPD Tech 1 acknowledged the water was below the demarcation line as the suds had dissipated. SPD Tech 1 filled the sink basin with more water.

b. On 8/25/21 at 1250 hours, an observation of the instrument cleaning was conducted with SCT 2 and the Director of Clinical Operation and Improvement. SCT 2 was observed in the Decontamination Room preparing to wash the dirty surgical instruments. The ultrasonic cleaner was on the counter adjacent to the two-basin wash sink. SCT 2 stated the detergent solution prepared in the ultrasonic washer was a preparation of the Dual Enzymatic Detergent and water. When asked for the dilution ratio, SCT 2 stated it was 1/2 ounce to 1 ounce of detergent to one gallon of water. SCT 2 stated there was about two gallons of water in the washer basin with one ounce of water. When asked how to measure two gallons of water, SCT 2 stated there was no demarcation sticker but a staining on the ultrasonic basin showed the approximate amount. When asked how it was ensured the enzymatic solution was maintained at 90 degrees to 110 degrees F as per the IFU, SCT 2 stated it was not maintained at the recommended temperature per the IFU.

On 8/25/21 at 1324 hours, the above findings were shared with the SPD Supervisor. The SPD Supervisor acknowledged the findings.

7. Review of the manufacturer's IFU for the Wash-Checks U Cleaning Monitor showed it is designed to monitor cleaning efficiency during the washing process. The expiry date is printed on the product packaging.

On 8/25/21 at 1324 hours, an inspection of the Decontamination Room was conducted with SCT 2 and the SPD Supervisor. A Wash Check test strips package was on the storage rack next to the automatic washer. The SPD Supervisor stated the washer was tested everyday using the Wash Check Strips. Inspection of the packaging for the Wash-Checks U showed an expiration date of 3/21. Additionally two unopened packages of Wash- Checks U strips had the expiration date of 11/20.

Review of the Wash-Checks U Cleaning Record for the month of August showed the test strips were used through the whole month of August.

The SPD Supervisor acknowledged the above findings.

8. Review of the hospital's P&P titled Instrument Cleaning and Processing dated 5/21/21, showed a date/load sticker will be applied to the outside of the pouch and labeled with the name of the contents written on the bottom sealed edge using a sterilization marker.

The AORN's Guidelines for Perioperative Practice, 2021 edition, Guideline for Perioperative Practice: Sterilization, showed sterilization and include the following:

* The sterilizer number.
* The cycle or load number.
* The date of sterilization.
* A description of the package contents.
* Identification of the assembler.

- Package labels should be visible and remain securely fixed to the package throughout processing, storage, and distribution to the point of use.

On 8/24/21 at 1330 hours, a tour of the SPD was conducted with the Manager of Sterile Processing. Inspection of the sterile stroage shelving showed the following:

- Two sterile peel packs with McCabe dissectors had no the load stickers as per the hospital's P&P.

- One peel pack with a osteotome chisel had no load sticker and had small flecks of brown-colored staining within the peel pack.

The Manager of Sterile Processing acknowledged the findings and stated the above instruments should have labels and be reprocessed.


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9. Review of the hospital's P&P titled Personal Protective Equipment (PPE) - Gowns, Gloves, Mask, Eye Protection dated 04/2021 showed in part:

IV. Procedure

B. Gowns

1. Isolation gowns are used in Standard and Transmission-Based Precautions to protect arms and exposed body areas and prevent contamination of clothing with blood, body fluids and other potentially infectious material.

5. Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back. Fasten in back at neck and waist.

During a tour of the ICU with the CNO, RN 1 was seen in the COVID-19 isolation room rendering care to the patients. RN 1's gown was not tied in the back, leaving the back, shoulders and upper arms exposed. When asked if this was the proper procedure, the CNO stated, "No, RN 1's gown should be completely closed."

Based on observation, interview, and record review, the hospital failed to ensure the Infection Prevention Program reflected the scope and complexity of the services provided in the hospital as evidenced by:

1. The IUSS were performed with incomplete sterilization records and the tracking for frequency of use was not reported to the Infection Control Committee and QAPI. Additionally, the IUSS documentation for processing was incomplete.

2. The Infection Control Plan failed to identify IUSS as a quality indicator as a high risk, high volume, problem-prone occurrence.

3. The Infection Control Committee failed to comprehensively analyze Patient 5's SSI with collaboration with the MEC and QAPI.

These failures created the risk for persistent of poor practices and not identifying the possible cause of SSI.

Findings:

1. The CMS, Center for Clinical Standards and Quality/Survey & Certification Group 14-44-Hospital/CAH/ASC dated 8/29/14, showed the availability of IUSS is not considered an appropriate substitute for maintaining a sufficient inventory of instruments. IUSS also entails an increased risk of inadvertent contamination during the transfer to the sterile field and burns. Even when all steps are performed properly, IUSS should be limited to the situations in which there is an urgent need and insufficient time to process an instrument by using a terminal sterilization.

The AORN's Guidelines for Perioperative Practice, 2021 edition, Guidelines for Perioperative Practice, Sterilization showed to transport devices using IUSS to the point of use in a manner that minimizes the risk of contamination of the item and thermal injury to patients or personnel. The guidelines also showed to document cycle information to provide a means of tracking items that are processed using IUSS to individual patients and for quality monitoring.

Review of the hospital's P&P titled Immediate Use Steam Sterilization dated 2/23/20, showed IUSS should only be used when the patient care would be negatively impacted.

1.a. Review of the hospital's surgery schedule from 9/20 to 8/24/21, showed the surgeries performed at the hospital were as follows:

- 9/20, a total of 131 surgeries.
- 10/20, a total of 147 surgeries.
- 11/20, a total of 123 surgeries.
- 12/20, a total of 142 surgeries.
- 1/21, a total of 114 surgeries.
- 2/21, a total of 126 surgeries.
- 3/21, a total of 165 surgeries.
- 4/21, a total of 129 surgeries.
- 5/21, a total of 162 surgeries.
- 6/21, a total of 156 surgeries.
- 7/21, a total of 141 surgeries.
- From 8/1 to 8/24/21, a total of 112 surgeries.

Review of the hospital's IUSS Daily Log from 9/20 to 8/24/21, showed the IUSS were performed the following amount of times:

- For 9/20, three surgical instruments were processed by IUSS. Two of three instruments sterilized were documented as "Multiple Cases" for the reason for IUSS. The IUSS rate was at 2.2% for 9/20.

- For 10/20, seven surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for three instruments, "Terminal Sterilize" for three instruments, and "Outside instrument arrived late" for one instrument. The IUSS rate for 10/20 was at 4.8%.

- For 11/20, 13 surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for 10 instruments, "Contaminated Tray" for one instrument, and "Terminal Tray" for two instruments. The IUSS rate for 11/20 was at 10.6%.

- For 12/20, five surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for four instruments and "Dropped Instrument" for one instrument. The IUSS rate for 12/20 was 3.5%.

- For 1/21, one surgical instrument was processed by IUSS due to "Dropped Instrument." The IUSS rate was at 0.8% for 1/21.

- For 2/21, three surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for two instruments and "Terminal Sterilize" for one instrument. The IUSS rate for 2/21 was 2.3%.

- For 3/21, nine surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for six instruments, "Terminal Sterilize" for two instruments, and "Dropped Instrument" for one instrument. The IUSS rate for 3/21 was 5.5%.

- For 4/21, there was no documentation of IUSS for the surgical instruments The IUSS rate was 0% for 4/21.

- For 5/21, five surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for four instruments and "Terminal Sterilize" for one instrument. The IUSS rate for 5/21 was 3.0%.

- For 7/21, nine surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for seven instruments and "Dropped Instrument" for two instruments. The IUSS rate for 7/21 was 6.4%.

- From 8/1/21 to 8/24/21, seven surgical instruments were processed by IUSS. The reasons for IUSS were "Multiple Cases" for six instruments and "Terminal Sterilize" for one instrument. The IUSS rate for 8/1/21 to 8/24/21 was 6.3%.

On 8/27/21 at 0924 hours, an interview was conducted with the Employee Health/Infection Prevention and the Manager of Surgery regarding the above findings. The Employee Health/Infection Prevention stated she was not involved with the tracking or quality monitoring of IUSS in the hospital. The Manager of Surgery stated the IUSS was tracked in Perioperative Services; however, the data collection was not analyzed further and there was no plan. When asked why the IUSS was performed for multiple cases, the Manager of Surgery stated additional surgeons were recently hired. The Manager of Surgery stated more surgical instruments were purchased to accommodate the increased surgeries; however, the plan was not escalated or communicated to the Infection Prevention or QAPI.

b. Review of the random selection on the 3M Steam Sterilization Record Keeping for the date of 8/3/21, showed the "Cysto Tray" and "Elik Elevator" were processed by IUSS. However, the column showing "RH" or relative humity was blank.

On 8/27/21 at 1410 hours, an interview was conducted with the OR Charge Nurse and Manager of Surgery. When asked who responsible for ensuring the IUSS device parameters and end product evaluation was safe for patient use, the OR Charge Nurse stated the circulating nurse was responsible. However, when asked if the relative humidity was checked in the room, the Charge Nurse stated it was not done.

The above findings were shared with the Manager of Surgery.

2. Review of the hospital's Infection Prevention Program Plan dated 3/15 showed the Infection Prevention Program Plan uses sound epidemiologic principles to plan, implement, evaluate, and improve infection prevention and control strategies. The prevention control efforts will include monitoring medical and surgical services that have a high volume of procedures and/or have a population at high risk for developing infection. The Infection Prevention Committee is responsible for analyzing risks, reviewing surveillance data, and recommending intervention strategies. The Infection Prevention Committee reviews the P&Ps used throughout the organization that address infection prevention and control practices.

On 8/26/21 at 1026 hours, an interview and concurrent review of the facility documents was conducted with the Employee Health/Infection Prevention.

Review of the above Infection Prevention Program Plan failed to include the goals for the 2020/2021 year for the use of IUSS in Surgical Services. The Employee Health/Infection Prevention stated the benchmark for IUSS was met in 2018 so it was not included in the current Infection Prevention Program Plan. The Employee Health/Infection Prevention stated the collecting IUSS data was not part of the duties in the committee. The Employee Health/Infection Prevention stated Surgical Services was responsible for taking care of the IUSS program.

Review of the hospital's P&P for Immediate Use Steam Sterilization failed to include oversight and quality monitoring of IUSS in a collaborative manner with the Infection Control. The P&P showed it was for Surgical Services. When asked, the Employee Health/Infection Prevention stated she did not have any involvement with the quality monitoring for IUSS.

3. The AORN's Guidelines for Perioperative Practice, 2021 edition, Sterile Technique, showed if a patient develops an SSI, have an interdisciplinary team that includes an infection preventionist evaluates sterile technique practices that may have contributed to the development of the infection, including intraoperative delays; adherence to surgical attire policies; performance of hand hygiene or surgical antisepsis; use of items that are not sterile, not labeled as sterile, or not packaged from sterile delivery to the sterile field; number of personnel and their roles during the procedure; and movement of personnel around and within the sterile field.

- Effective management and collection of healthcare information that accurately reflects the patient's care, treatment and services is a regulatory and accreditation requirement for the hospital. Clear and concise perioperative documentation is essential for the continuity of outcome-focused nursing care and for effective comparison of realized versus anticipated patient outcomes.

Review of the hospitals' P&P titled Surgical Site Infection dated 6/21/20, showed the scope of the P&P is for Surgical Services Personnel and physicians. The owner of the P&P is the Director of Surgical Services. Operation specific SSI are calculated monthly and reported to Quality, Infection Control, and Surgery Committee. Utilize other surgical infection prevention methods in accordance with the patient's specific clinical situation include aseptic technique and application, proper surgical attire, surgical hand scrub, wound classification, and testing of sterilizers.

Review of the hospital's P&P titled Specimens, Handling Pathological and Bacteriological dated 6/21/20, showed all foreign bodies removed from a patient must be labeled, recorded on the operative record, on the pathology form, and in the specimen log; and placed in the pathology office, unless otherwise specified by the surgeon.

On 8/26/21 at 1310 hours, an interview and concurrent review of the facility documents and Patient 5's medical record was conducted with the Employee Health/Infection Prevention, Manager of Surgery, and OR Charge Nurse. The medical record showed Patient 5 was admitted to hospital on 9/25/20, with complaints of abdominal pain, nausea, and vomiting. The medical impression showed small bowel obstruction.

a. Review of the Physician Consult Note dated 9/25/20 at 1819 hours, showed MD 1 planned to perform a laparoscopic versus open ventral hernia repair with mesh for Patient 5's incarcerated ventral hernia.

* Review of Patient 5's Intraoperative Nursing Record dated 9/25/20, showed the following concerns:

- The "Time In Room" was documented as "1030" hours. The "Anesthesia Start" showed, "1030" hours. The "Surgery Start" showed, "1045" hours. However, the "Surgery End" showed, "0022" hours. The "Anesthesia End" showed, "0051" hours, and the "Time Out of Room" showed, "0035" hours.

- The surgical team composition included the anesthesiologist, surgeon, circulating RN, and scrub. However, there was no documentation of "In/Out" times for team members to show movement in the OR.

- The "Medication" section showed Patient 5 was administered 0.5% Marcaine (local anesthetic). However, there was no documentation of the amount administered.

* Review of Patient 5's Implant Tracking Log dated 9/25/20 (no time), showed incomplete documentation of the "Surgical Procedure" as it showed only "Laparoscopic."

* Review of Patient 5's Intraoperative Nursing Record dated 9/29/20, showed Patient 5 would have a diagnostic laparoscopic exploratory removal of herniated mesh, washout, and small bowel resection. However, the following concerns were identified:

- The surgical team composition included the anesthesiologist, surgeon, circulating RN, and scrub. However, there was no documentation of "In/Out" times for team members to show movement in the OR.

- The "Specimens Sent to Pathology" section did not have documented evidence showing the removed mesh implant sent to the pathology as per the hospital's P&P.

* Review of Patient 5's Implant Tracking Log dated 9/29/20 (no time), showed incomplete documentation of the "Surgical Procedure" with the description showing only "Diagnostic Laparoscopic."

* Review of the Physician Surgical Operative Report dated 9/29/20 at 2338 hours, showed Patient 5 had a diagnostic laparoscopy and open sigmoid colectomy. However, there was no documentation of the removal of mesh.

Review of Patient 5's laboratory Patient Results showed the body fluid from Patient 5's JP drain from the abdominal wound was positive for the fungal and bacterial infection.

The Employee Health/Infection Prevention, Manager of Surgery, and OR Charge Nurse acknowledged the above findings.

b. When asked what the Infection Prevention's role in the SSIs monitoring, the Employee Health/Infection Prevention stated reviewing the medical record for a complete history of the patient's hospital course, the surgeries. Then the data reporting was completed on the NHSN and a report prepared for the MEC. In the case of Patient 5, the patient was at high risk due to underlying comorbidities.

However, when asked, the Employee Health/Infection Prevention stated the above concerns were not identified during the review of Patient 5's medical record. When asked if the Employee Health/Infection Prevention reviewed the aseptic technique and application, and testing of sterilizers in the SSI review for Patient 5, the Employee Health/Infection Prevention stated it was not. When asked how the Employee Health/Infection Prevention identified if the surgical instruments used for Patient 5 were appropriately sterilized, the Employee Health/Infection Prevention stated the hospital did not keep the record to identify which tray was used for Patient 5. When asked what type of guidance was available for the Employee Health/Infection Prevention to use for investigating the SSI, the Employee Health/Infection Prevention stated one was not used other than the NHSN.

The Employee Health/Infection Prevention stated the SSIs were reported to the Infection Control Committee on 3/21. The conclusion of findings showed the patient's ages, comorbidities, and severity of disease were the contributing factors for infection risk. The Employee Health/Infection Prevention would continue the daily audits in the SPD to address barriers and issues. Education would be done on proper aseptic technique, cleaning, and practices in the OR for compliance.

When asked how the Employee Health/Infection Prevention addressed the audit recommendations, the Employee Health/Infection Prevention stated doing the daily rounds in the Perioperative Department. However, the Employee Health/Infection Prevention stated an audit tool was still being developed. When asked how the identified concerns were addressed, the Employee Health/Infection Prevention stated it was done verbally with each department.

On 8/26/21 at 1046 hours, and interview and concurrent review of the facility documents was conducted with the Director of Medical Staff.

Review of the Peer Review Worksheet for MD 1 dated 3/5/21, showed the MEC determined MD 1 had "questionable utilization of resources." However, further review of the document failed to show the MEC had any further recommendations for MD 1. Additionally, the MEC failed to identify the above documentation errors in Patient 5's medical record, as well as identify any further analysis of Patient 5's case for other possible cause of SSI.

Based on observation, interview, and record review, the hospital failed to ensure the GB had systems in place for tracking, surveillance, and prevention and control of infection as evidenced by:

1. Failure to provide oversight of the temperature and humidity in the Perioperative Space, and the use of portable AC units in restricted areas of the Perioperative Space.

2. Failure to monitor, track, analyze and create collaborative performance improvement projects regarding the frequency of IUSS use in Surgical Services.

3. Failure to ensure the comprehensive analysis of the SSIs to identify possible breaks in infection control.

These failures created substandard outcomes for the patients in the hospital.

Findings:

Review of the Quality Assessment and Performance Improvement Program Plan dated 2020, showed the Governing Board retains overall responsibility and accountability for the quality of patient care, including safety of patients, staff and visitors and the appropriate utilization of resources. The Board remains responsible for establishing clear expectations for safety, allocating adequate resources for measuring, assessing, improving, and sustaining hospital performance and reducing risk to patients; and enhancing the efficiency and quality of care through an appropriate number of performance improvement projects.

On 8/27/21 at 1525 hours, an interview and concurrent review of the hospital documents was conducted with the CNO and CEO. The following concerns were shared with them:

* Failure to ensure the temperature and humidity level were maintained in the SPD and OR Hallway, and failure to ensure the maintenance of positive pressure in the SPD Clean Work room. Cross references to A724, example #1; and A951, example #3.

* Failure to monitor, track, analyze, and create collaborative performance improvement projects regarding the frequency of IUSS used in Surgical Services. Cross reference to A751 examples #1 and #2.

* Failure to ensure the comprehensive analysis of the SSIs to identify possible breaks in infection control. Cross reference to A751, example #3.

The CNO stated the GB was involved in the operation of Infection Control and Surgical Services. However, the details were discussed in the committees and sub-committees before it came to the GB. The CEO stated the Infection Prevention reported to the MEC, and then to the GB. The Infection Prevention was no longer reporting to the QAPI. The CNO stated the hospital committees were expected to bring any unresolved issues to the GB if the committees and sub-committees were unable to do so.

The CNO stated the hospital leadership was out on the units daily to see the function and overall maintenance of the hospital. However, when asked if the above infection control concerns were brought to the GB's attention, the CNO stated it was not documented. The CNO stated most issues were resolved personally and verbally. The CNO presented the document showing the Local Governing Board shall not have the authority of the Board, but shall be subject in all respects to the direction of the board. Subject to the foregoing the Local Governing Board's responsibilities shall include the following:

- Make determination whether to add or substantially change any material services, program, type or level of care offered by the hospital , after reviewing a medical needs assessment concerning the service involved.

- Advise, direct and support the mission and community relations activities of the hospital.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services was organized and provided in accordance with acceptable standards of practice as evidenced by:

1. Failure to ensure the hospital leadership had oversight for the use of IUSS in the SPD. Cross reference to A941.

2. Failure to ensure the surgical service was provided in consistence with patient's needs and standards of practice. Cross reference to A951.

3. Failure to ensure to Patient 5's Operative Report included describing techniques and tissues removed by the surgeon. Cross reference to A959.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide surgical services in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Surgical Services.

Based on observation, interview, and record review, the hospital failed to ensure the hospital leadership had oversight for the use of IUSS in the SPD, creating the risk for substandard outcomes for the surgical patients in the hospital.

Findings:

1. The use of IUSS was performed with incomplete sterilization records; and tracking of frequency of IUSS use was not reported to the Infection Control and QAPI. Additionally, the IUSS documentation for processing was incomplete. Cross references to A751, example #1 and A770, example #2.

2. The Infection Control Plan failed to identify the use of IUSS as a quality indicator as a high risk, high volume, problem-prone occurrence. Cross references to A751 example #2; and A770, example #2.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services were provided in consistence with the patient's needs and standards of practice as evidenced by: .

1. Failure to develop and implement a comprehensive P&P for humidity and temperature of the perioperative area.

2. Failure to follow the AORN's guidelines for maintaining the integrity of structural surfaces and repairing the surfaces when damaged for three ORs (ORs 1, 2, and 3) and the GI procedure room.

3. Failure to ensure the humidity levels were maintained in the ORs.

4. Failure to ensure the OR staff using the Fluke meter (a meter used to check the room's temperature and humidity) properly and consistently.

5. Failure to ensure the portable air purifier and AC units were not used in the perioperative area as per the AORN's guidelines.

6. Failure to ensure the MH cart contents were consisted with the content list.

7. Failure to ensure the use of disinfectant was implemented as per the hospital's P&P and manufacturer's IFU.

8. Failure to implement the hospital's P&P related to the fire risk score assessment for one of two time-out observations.

9. Failure to ensure the GI endoscope cabinets were maintained as per the AORN's guidelines and the PD Team performed an assessment when adding the GI endoscope cabinets.

10. Failure to ensure the crash carts in the OR Hallway and the 100 unit were maintained to provide safe and effective emergency services.

11. Failure to ensure the IUSS sterilization records were completed and tracking of the frequency of use was reported to the Infection Control and QAPI.

12. Failure to identify the use of IUSS as a quality indicator as a high risk, high volume, problem-prone occurrence.

13. Failure to ensure the Pre-op Overflow was maintained in a sanitary manner.

14. Failure to ensure the electronic shaver was maintained in a sanitary condition.

15. Failure to maintain the refrigerators in Pre-Op and Pre-Op Overflow in a sanitary condition.

16. Failure to ensure the expired surgical items was not available to the patient use.

17. Failure to ensure SPD Tech 1 had not exposed arms when wrapping a surgical tray in the SPD Clean Work Area.

18. Failure to ensure the SPD and the OR Hallway's temperature or air pressure was maintained as per the AORN's guidelines.

19. Failure to ensure the enzymatic detergent was at the appropriate dilution and temperature for decontamination of surgical instruments.

20. Failure to ensure the expired washer test strips was removed in the Decontamination Room.

21. Instrument peel packs were missing load stickers in the SPD.

22. Failure to ensure the comprehensively analyzing of SSI for one of six sampled patients (Patient 5).

23. Failure to ensure the GI endoscope processing room setting was maintained as per the AORN's guidelines.

24. Failure to ensure the OR staff was trained for manually processing the GI endoscopes.

These failures created unsafe patient care in surgical services.

Findings:

1. Review of the AORN's Guideline for Perioperative Practice: Design and Maintenance of the Surgical Suite, 2021 edition, showed to create and implement a systematic process for monitoring and maintaining the structural surfaces and HVAC system performance.

Review of the hospital's P&P tilted Humidity and Temperature in the Operating Room dated 7/2020 showed the perioperative team will reinforce good maintenance and operational practices, assess the risks, and enact appropriate responses. The perioperative team will make scheduling decisions based on observable conditions likely to pose SSI risks. Reliable evidence suggests that very high humidity (above 75%) for extended time may present a challenge to maintaining environmental cleanliness. Relative humidity greater than 60% will be reported to perioperative supervisory team. Relative humidity greater than 60% requires that the OR team notify the appropriate clinical supervisor promptly.

On 8/2/21 at 1335 hours, during an interview with the Manager of Surgery, the Manager of Surgery stated the daily monitoring of temperature and humidity levels in the perioperative areas excluded the PACU. However, they placed a portable AC unit in the PACU because the PACU was hot in the afternoon. The Manager stated she was aware of the AORN's requirements for the temperature in the PACU and would start to measure it. It was observed two patients in the PACU for recovery.

On 8/9/21 at 0911 hours, an interview and concurrent review of the Operating Room Suite Daily Humidity Record and the Operating Room Suite Daily Temperature Record was conducted.

The Operating Room Suite Daily Humidity Record showed the following information:
- The required humidity range is 30-60 %.
- To enter time and initials in the corresponding box for the observed humidity daily
- If initials are recorded above or below the bolded range box, a work order must be submitted to the engineering and documented in the space provided.

Further review of this form showed the sections to document the date, problem, work order number, and engineering resolution.

Further review of the Operating Room Daily Humidity Record showed the following:

- On 6/30/21, OR 4's humidity level was between 67-69 %. The work order number for the problem of high humidity level was 367437. However, the section for engineering resolution was left blank.

On 8/9/21 at 1229 hours, the follow-up interview and record review was conducted with the Engineering Supervisor.

Review of the Engineering Dept. Work Order Summary for the work order number of 367437 showed the problem was the hallway and OR 4's humidity levels were high. The solution section showed, "Project Completed, replaced exhaust belt. RPMs are up, removing heat and humidity." The solution documentation did not include the parameter fixed humidity levels, time of repair, and name of staff who was informed of the repair completed.

The Engineering Supervisor stated the work order summary would not record the humidity level after repaired, the engineering would either send out an email or call the staff to inform the work order was completed and the humidity level returned to the acceptable range.

Further interview with the Manager of Surgery was conducted, the Manager of Surgery stated the OR staff was responsible to update the Operating Room Daily Humidity/Temperature Record for Engineering Resolution. The Manager of Surgery stated the OR staff did not recheck the room humidity level after the engineering fixing. An interview was conducted with the Employee Health/Infection Prevention for the out-of -range OR humidity and temperature events notification, the Employee Health/Infection Prevention stated she trusted the Engineering Supervisor for repair; and when problem was fixed, there would be nothing for Employee Health/Infection Prevention to do.

When asked about reporting the out-of-range temperature and humidity levels to the engineering by the OR staff during any off business hours, the Manager of Surgery stated it was done verbally and the Engineering Resolution would not be documented on the record.

The Manager of Surgery was not able to provide a list of perioperative supervisory team as per the P&P indicated. There was no mechanism to report or coordinate with the infection control prevention for the out-of-range humidity levels in the ORs.

2. The AORN's Guideline for Perioperative Practice: Design and Maintenance of the Surgical Suite, 2021 edition, showed maintaining the integrity of structural surfaces (e.g., doors, floors, walls, ceilings, and cabinets) and have surfaces repaired when damaged. Report damage to floors, walls, ceilings, cabinets, and other structural surfaces according to the health care organization's policy. Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning. Damage to floor surfaces may create a trip or fall hazard.

a. On 8/9/21 at 1110 hours, the ORs were inspected with the Manager of Surgery and Employee Health/Infection Prevention. The following was observed:

* ORs 1, 2, and 3 were observed with missing paints on the side of the built-in cabinets frames. The metal frames were observed with dark brown to black marks.

* In OR 3, one section of the baseboard near the entrance was detached from the wall generating a visible gap with collected dust.

The concurrent interview was conducted with the OR Charge Nurse and Manager of Surgery. The Employee Health/Infection Prevention stated the EOC round was done in June and she toured the ORs that time. She could not recall they noticed the rusty or the baseboard problem during that EOC round.

b. On 8/25/21 at 1007 hours, a GI procedure was observed in the GI Lab (procedure room). A floor drain was observed nearby the anesthesia cart. The floor drain was covered with an opened drain cover. It was observed with the unsealed rusty drainpipe and spider webs. In addition, a spider was observed along the pipe edge. The concurrent interview was conducted with CST 1, he confirmed the observation and stated he was not aware of it.

3. The AORN's Guideline for Perioperative Practice: Design and Maintenance of the Surgical Suite, 2021 edition, showed the following:

* 12.3. Maintain the operational values for HVAC setting at either the settings described in recommendation 2.6.1 or the setting that applied at the time of design or the most recent renovation of the HVAC system and as stated local regulations.

* 12.4. Develop a method for reporting a variance in HVAC system parameters.

- 12.4.1. Establish a reporting system that enables two-way conversation between perioperative personnel and plant operations personnel.

* 12.6. Designed perioperative team members in collaboration with the interdisciplinary team should performed a risk assessment of the surgical suite if a variance in the parameter.

a. On 8/9/21 at 0954 hours, during the OR tour with the OR Charge Nurse, the OR Charge Nurse checked the OR hallway's temperature and humidity levels with the Fluke (a temperature humidity meter). The humidity level was registered 78.1 degrees F. The OR hallway was observed to have two wheeled supply cart stored the surgical sterile and non sterile supplies. One sterile item or "Ventralex ST Hernia Patch" was found on the cart. The product was instructed to be stored between 36 to 77 degrees F. During the concurrent interview with the OR Charge Nurse, she confirmed the finding and stated they did not monitor the OR hallway's temperature and humidity levels.

b. The ASHRAE 2019 Humidity Control Events in Perioperative Care Areas indicated the facility should designate a Perioperative Decision Team (PD Team) to periodically review the specifics of the perioperative case types, mechanical system capabilities, standards, infection control statistics and recent research and trends in indoor RH levels. A PD Team typically includes the facility's management and infection control personnel. As a suggested minimum, the PD Team should include a facility engineer, an infection control professional, and a perioperative professional.

The designated PD Team should be available to respond to humidity control events and assessed the severity and consistency of the RH deviation; infection risk to patients of the scheduled procedures; level of the clinical staff, patient, and support family members' comfort; confidence of the facility engineer in a timely resolution; occupied or unoccupied status of the perioperative space.

Areas of infection risk that are associated with low of high RH for the PD Team to consider include the development of mold and mildew in high RH air; loss of healthy immune system functioning in vulnerable patients and in on-site hospital staff; shelf life and integrity of sterile supplies and equipment calibration; transmission of airborne and droplet disease; survival rate of pathogens; decreased effectiveness of hand hygiene and surface cleaning because if surface recontamination; discomfort of the surgical team.

When the upper RH limit is exceeded, there are two responses for the PD Team to take if the RH is more than 10 % (66% for this hospital ) above the upper limit for more than 8 hours, it is very likely the mechanical system needs repair. The PD Team should consider halting operations until the issue is resolved. Traffic limiting, enhanced cleaning between cases and perspiration controls should be added where appropriate.

On 8/2/21 at 1335 hours, during an interview with the Manager of Surgery, the Manager of Surgery stated the OR staff monitored the OR's temperature and humidity levels once a day in the morning. The staff documented the temperature and humidity levels readings in the Operating Room Daily Temperature Record and contact the engineering department for the any out-of-range temperature and humidity levels. The details would show on the records and include the date, problem, work order numbers, and engineering resolution.

The Manager of Surgery provided an incident report under "Infection" regarding OR 4's high humidity level on 7/30/21. The document showed on 7/30/21, the circulating nurse reported the room humidity level was inordinately high when the OR Change Nurse entering OR 4. The OR floor was slippery from condensation. The condensation covered the glass door panels of the built-in cabinets where the sterile supplies were stored. The condensations also presented on the OR equipment in the room. The vascular supply cart was in the OR suite and all its contents were discarded. The humidity level was read as 75% at approximately at 0645 hours. The Manager of Surgery stated the engineering fixed the humidity level, EVS 1 did terminal cleaning OR 4 at 0730 hours. The room was returned for use at 0942 hours. The Manager of Surgery stated a procedure was performed on Patient 6 in OR 4 after OR 4 was fixed by the engineering. The OR staff had checked the room temperature and humidity level for an acceptable range before taking the patient to the room. However, Patient 6's medical record review showed Patient 6 entered OR 6 at 0942 hours and OR Nurse 2 was the circulator nurse. There was no documented evidence OR Nurse 2 checked the temperature and humidity level before starting the case. The Intraoperative Nursing Record for the circulator RN to document showed the in/out section was left blank.

On 8/2/21 at 1417 hours, the Engineering Supervisor stated the engineering department checked the perioperative area daily for those rooms that required air pressure control. The engineering department responded to the surgical services staff when they entered the work order request regarding the out-of-range temperature and humidity level. The engineering worked on the HVAC units on the roof. The engineers would call the surgical staff when the work was completed but did not document the information related to notification to the surgery staff or the feedback from them. The engineers expected the OR staff to check the temperature and humidity level to ensure the temperature and humidity level were back to the range after being fixed. The Engineering Supervisor provided the document of Engineering Dept Work Order Summary for the 7/30/21 incident. The document showed on 7/30/21 at 0600 hours, the HVAC staff noticed the OR humidity level was at 96%. The HVAC staff turned on to 74 degrees F to bind the humidity level to drop. At 0625 hours, the temperature was adjusted to 68 degrees F. At 0645 hours, the engineering got a call that ORs 1 and 4 had condensation in the rooms. At 0645 hours, the humidity level dropped to 55%; ORs 1 and 4 with half damper opened. The outside humidity level was 95 % at 0600 hours. The humidity recovered to unit due to return blower on at 67 degrees F.

On 8/9/21 at 0915 hours, during the interview with the OR Charge Nurse, she stated the OR staff checked the ORs' temperature and humidity levels and reached out to the engineers for any out -of- range temperature and humidity levels. The OR Charge Nurse stated the request and repairs were mostly done verbally. The OR staff did not formally documented the rechecked of the temperature and humidity levels after the engineers' works were done. The OR Charge Nurse stated on 7/30/21, OR Nurse 2 should have rechecked the OR temperature and humidity levels before bought the patient to the room for surgery. But the OR Charge Nurse could not locate the notes to show the temperature and humidity levels were rechecked on 7/30/21.

On 8/9/21 at 1229 hours, during interview with the Employee Health/Infection Prevention for her input and feedback about the OR high humidity incident occurred on 7/30/21. The Employee Health/Infection Prevention stated she believed the engineering department would be able to handle it. The Employee Health/Infection Prevention was informed during the hospital's all department morning huddle. When asked about the guidelines for preventing SSI, that excessive humidity was listed on various mechanism for intraoperative contamination that could lead to occur a post-operative SSI. The Employee Health/Infection Prevention stated she was not aware of it.

On 8/9/21 at 1320 hours, the Operating Room Daily Humidity Record was reviewed with the Manager of Surgery and Engineering Supervisor. The record for humidity levels showed the required range of the humidity level was 30 to 60%; the lowest humidity level was less (<) than 21 %; and the highest humidity level was above (>) 70 %.

Review of the Operating Room Daily Humidity Record for June, July and August, 2021 showed the following:

* June 2021:

- OR 1: humidity level was > 60%, or 67-69 % on 6/30/21.

* July 2021:

- OR 1: the humidity level was > 60% for nine days including three days (7/1, 7/28, and 7/31) with the humidity levels greater than 70%.
- OR 2: the humidity level was > 60% for three days.
- OR 3: the humidity level was > 60% for three days.
- OR 4: the humidity level was > 60% for five days including three days (7/28, 7/30, and 7/31) with the humidity levels greater than 70 %.

* August 2021:

- OR 1: the humidity level was > 60% on 8/1 and 8/2/21.
- OR 2: the humidity level was > 60% on 8/1 and 8/3/21.
- OR 4: the humidity level was > 60% on 8/1 and 8/2/21.

The documents showed the "work order number" was documented as "verbally" on 7/30, 7/31, 8/1, and 8/2/21.

During a concurrent interview, the Engineering Supervisor who generated the work orders for the above out-of-range days, stated the engineer adjusted the temperature level to adjust the humidity level to be back to the range but did not document the time when the work was completed and/or the OR staff was notified. The Manager of Surgery stated the OR staff did not document when the engineer called for the completion of the repair. There was no log to show the staff rechecked the ORs' temperature and humidity levels for the return to the acceptable range.

The Manager of Surgery stated the Operating Room Daily Humidity Record would not record when the humidity level was higher than 70 %. There was no method to verify the accurate humidity level when the humidity level was out of range.

During an interview with the Employee Health/Infection Prevention, she stated she was not aware of the ORs humidity levels that were out of range in consecutive days for July & August.

4. On 8/2/21 at 1408 hours, during an interview with the Manager of Surgery, she stated the OR Charge Nurse and Manager of Sterile Processing checked the ORs' temperature and humidity levels in the morning. The temperature and humidity levels were recorded in the Operating Room Daily Temperature/ Humidity Record. The Manager of Surgery asked CST 1 to check the current ORs' temperature and humidity levels. CST 1 checked with the Fluke and returned with a handwritten report. The report showed OR 3's temperature was 63.5 degrees F which was out of the acceptable range, 68-75 degrees F. OR 3 had an ongoing surgery. The Manager of Surgery went back and rechecked the room's temperature and it showed 71.3 degrees F which was in the acceptable range. The Manager of Surgery stated the reading on the Fluke would not be accurate if the user did not hold the Fluke correctly. The Manager of Surgery stated the OR staff especially OR RNs would be responsible to check the temperature and humidity levels from now on, they would be in-service for the use of Fluke.

Review of the Fluke's operation note showed to allow time for the meter to stabilize when moving from one temperature/humidity extreme to another.

On 8/9/21 at 0915 hours, the OR Charge Nurse used the Fluke to check OR 1's temperature and humidity levels. The OR Charge Nurse hold the Fluke on her hand and the reading numbers on the Fluke's screen kept changing. The Manager of Surgery recommended the OR Charge Nurse to set the Fluke on the OR table and wait for three minutes to read the numbers. The OR Charge Nurse stated she had not received the in-service for the use of Fluke. At 1135 hours, during an interview, the Manager of SPD stated he checked the morning temperature and humidity levels for the ORs, he learned the use of Fluke from the engineering, he had no in-service training for the use of the Fluke.

5. According to the AORN's Guideline for Perioperative Practice, 2021 edition, do not use free-standing fans, portable humidifiers, air- conditioners, and dehumidifiers. These devices all contain a fan that when running can disrupt the planned airflow within the room and may transfer unwanted particles from the floor to the surgical site. The increased mixing of the room air and the alterations to the air pattern that were created when a portable air conditioner was used. This disruption in the airflow pattern could cause contaminants from the floor to become airborne, leading to potential contamination of the surgical site.

The hospital's P&P titled Medical Equipment -Identification Tags and Inspection Stickers reviewed 6/17 showed any new piece of medical equipment that passes an incoming inspection shall be labeled with a biomedical equipment control number. The biomedical equipment control number shall be recorded in the medical equipment database along with all other pertinent information regarding the medical equipment. This will allow for the proper tracking, inspection scheduling and reporting of the equipment.

- On 8/9/21 at 0915 hours, OR 1 was unoccupied and the room was inspected with the Manager of Surgery and Employee Health/Infection Prevention. A portable unit Air Purifier "WINIX model C545" was observed in OR 1. The Air Purifier had a hospital electricity check sticker "Jan 2021." The concurrent interview with the OR Charge Nurse, Manager of Surgery, Bio Med, Engineering Supervisor, Employee Health/Infection Prevention, they all stated they were not aware when and how this air purifier got into OR 1 and the hospital had no IFU or maintenance record for this equipment. The Employee Health/Infection Prevention stated their most recently ECO round in the OR was in June, she did not recall the air purifier unit was in the room.

- On 8/24/21 at 1034 hours, the perioperative area was toured with the Manager of Surgery. Five units of spot cooler MovinCool Classic Plus 14 were observed used in the perioperative services areas including the pre-op, pre-op overflow, OR hallway, PACU, and SPD cleaning room. During interview with the OR staff, they stated the spot coolers were used since the summer was hot. During the concurrent interview with the Manager of Surgery, she stated she was not sure a specific date when the engineering bought those units in. It was between surgery and engineering department that talked about the use those spot coolers.

On 8/26/21 at 0835 hours, the Coordinator of EVS provided the documents showing the portable AC units, MovinCool Classic Plus 14, came into the hospital between June and July. But she did not have a specific date when those were deployed to the perioperative area as responding to the surgical staff's request.

6. The hospital's P&P titled Malignant Hyperthermia reviewed 6/2020 showed the operating room should have the emergency equipment necessary for management of MH are always available.

On 8/24/21 at 1532 hours, the MH cart was inspected with Anesthesiologist 1. The Surgical Malignant Hyperthermia cart Meds/Supplies List showed the cart should have one each of Nasogastric Tube 16F/#10. During the inspection, there were Salem Sump nasal gastric tube 16F and 18F, one each. During the concurrent interview with Anesthesiologist 1, he stated the MH cart should have the Salem Sump nasal gastric tube. The supplies list was not corrected.

7. The hospital's P&P titled Disinfectants revised 04/2018 showed all mixing and diluting of solution used for disinfectant/decontamination are to be done according to the manufacturer's direction.

On 8/9/21 at 1048 hours, EVS 1 was observed performing the turnover cleaning in OR 3. EVS 1 used the lint free clothes which was saturated with Virex Plus disinfecting solution to wipe the door handle, Workstation on Wheel, anesthesia cart, and Mayo stands. The contacted time on those surfaces were various between 2 minutes 30 seconds to three minutes.

Review of the Virex Plus's product label showed a sign of "5."

During the concurrent interview with the Employee Health/Infection Prevention, she confirmed the contact time of Virex Plus disinfecting solution should be five minutes and EVS 1 did not follow the Virex Plus's IFU.

8. The hospital's P&P titled Universal Protocol dated 3/2020 showed the time-out is to be conducted in the location where the procedure will be performed just prior to starting the procedure. The time out must document in the patient's record. The Fire Risk Score Assessment includes the following:

- Standard fire precautions for all fire risk assessment levels, prep solution is dry prior to draping.

- If cautery or other ignition source is in use but risk level assessment is 2, follow the ESU and equipment Safety recommendations. Provides for ready availability of saline or water. For Medium Risk (rating 2), follow standard for safety precautions and environment risk assessment.

On 8/24/21 at 1439 hours, during an observation of Patient 2's surgery, OR Nurse 1 was observed using a ChloraPrep applicator to disinfect Patient 2's operative site. The patient was under a general anesthesia with LMA. During the surgical time out with the surgical team, OR Nurse 1 did not include the fire score assessment.

Review of Patient 2's Intraoperative Nursing Record dated 8/24/21, showed OR Nurse 1 documented the Fire Risk Assessment Score was "2." The "notes" section showed OR Nurse 1 listed the patient's past medical history such as Osteoporosis, AV fistula, and dialysis.

Review of the label for ChloraPrep Applicator showed the product is flammable, to reduce risk of fire, prep carefully.

9. The AORN's Guidelines for Flexible Endoscopes showed to store flexible endoscopes in the cabinets that are situated in a secure location in a separate clean area close to, but not within the endoscopy procedure room.

Review of the MFR for Secure-A-Scope, the Maintenance and Cleaning instruction for cleaning indicated interior components should be cleaned by hand using a non-abrasive liquid cleaner, germicides, mild detergent and water, standard disinfectants, and detergents.

On 8/25/21 at 1007 hours, three MASS Secure-A-Scope cabinets in the GI procedure room were observed. Each cabinet stored the upper and low GI scopes. During a concurrent interview with CST 1, he stated they started with one endoscope cabinet at least three years ago, then the hospital added the other two endoscope cabinets last years due to the needs. CST 1 stated the CSTs cleaned the exterior and interior of the endoscope cabinets with the disinfecting wipes.

On 8/27/21 at 1048 hours, the GI procedure room was toured with the Manager of Surgery. Three Secure-A-Scope cabinets were inspected for the interior cleanliness. While removing of the drip tray, there were light brown and black particles remaining at the bottom of those cabinets. The Manager of Surgery stated she started one Secure-A-Scope cabinet was here before 2019 and two more cabinets were added in 2020 due to the volume of GI procedures increased. The Manager of Surgery stated the process for adding the cabinets in 2020, she discussed with the Supervisor of Sterile Processing; requested the capital budget and GB approval; then the material department purchased the cabinets. The Manager of Surgery did not recall the infection control prevention involved with this project.


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10. The crash carts in the OR Hallway and the 100 unit were not maintained to provide safe and effective emergency services. Cross reference to A724.

11. The IUSS was performed with incomplete sterilization records and the tracking for the frequency of use was not reported to Infection Control and QAPI. In addition, the use of IUSS documentation for processing was incomplete. Cross reference to A751, example #1.

12. The Infection Control Plan failed to identify the use of IUSS as a quality indicator as a high risk, high volume, problem-prone occurrence. Cross reference to A751, example #2.

13. The Pre-op Overflow was maintained in a sanitary manner. Cross reference to A701, example #2.

14. The electronic shaver was not maintained in a sanitary condition. Cross reference to A749, example #1.

15. The refrigerators were not maintained in a sanitary condition in the Pre-Op and Pre-Op Overflow. Cross reference to A749, example #2.

16. The SPD and OR Hallway had the expired surgical items. Cross reference to A749, example #3.

17. SPD Tech 1 had exposed the arms when wrapping a surgical tray in the SPD Clean Work Area. Cross reference to A749, example #4.

18. The SPD and OR Hallway were not maintained at the temperatures or air pressure recommendations as per the AORN's guidelines. Cross references to A749, example #5; and A 724, example # 1.

19. The enzymatic detergent was not maintained at the appropriate dilution and temperature for decontamination of the surgical instruments. Cross reference to A749, example #6.

20. The expired washer test strips were found in the Decontamination Room. Cross reference to A749, example #7.

21. The instrument peel packs had no load stickers in the SPD. Cross reference to A749 example #8.

22. The hospital Infection Control failed to comprehensively analyze one of six sampled patient's SSI (Patient 5). Cross reference to A751, example # 3.

23. According to the AORN's Guidelines for Flexible Endoscopes, 2021 edition, the minimum standard for design and construction of an endoscopy processing room containing both decontamination and clean areas.

- The endoscopy processing room should include a door that provides access to and from the decontamination room and a separate door that provides access to and from the clean area.

- An endoscopy processing room with one room design should provide a minimum of 3 feet (0.9 m) between the decontamination area and the clean work area and either a separating wall or a barrier that extends a minimum of 4 feet (1.2 m) above the sink rim to separate soiled work area from clean area. Cross contamination can result when soiled items are placed in close proximity to clean items and on the surfaces upon which clean items are later placed.

- The endoscope processing room should be designed in facilitate a unidirectional workflow from the contamination area or decontamination room to the clean area or clean work room.

On 8/25/21 at 1249 hours, the endoscope processing room (Utility) was toured. This room was located next to the pre-op room. Upon entering the room, the left side of the room was occupied by the lab services and the right side of the room was used for GI endoscopy processing. During an observation and concurrent interview with SCT 2, the lab technicians came in with gloved hands and processed the COVID sealed specimen under a hood. There was no removing of the gloves and hand hygiene performed by the lab technicians before and after processing those specimens. There was a 6 ft high x 15 feet long retractable plastic screen separated the Lab service area and GI scope cleaning.

In the GI endoscope cleaning area, one AER (Auto Endo

Based on interview and record review, the hospital failed to ensure the operative report was completed for one of six sampled patients (Patient 1) when there was no documented evidence Patient 5's Operative Report included describing techniques and tissues removed by the surgeon. This failure posed the potential of unsafe care.

Findings:

The operative report was not completed for Patient 5. Cross reference to A751, example #3.a.