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Based on observation, interview, and record review, the GB failed to ensure the safe and effective operation of surgical services as evidenced by:

1. The GB failed to ensure the contracted services provided in a safe and effective manner. Cross reference to A084.

2. The hospital-wide, data-driven, effective QA program was not implemented and maintained. Cross reference to A0263.

3. The faciliyt and equipment used for patient care were not maintained to ensure the safety of patients and staff. Cross reference to A0700.

4. The infection prevention program was not implemented and maintained to minimize the spread of infections in the OR, endoscopy, Cath lab, and radiology areas. Cross reference to A0747.

5. The surgical services were not provided and organized to ensure the health and safety of patients. Cross reference to A0940.

The cumulative effect of these systemic practices resulted in the failure of the hospital's GB to ensure the provision of quality healthcare in a safe manner.

Based on interview and record review, the hospital failed to ensure the contracted services were provided in a safe and effective manner. This failure created the risk of substandard services to the patients in the hospital.

Findings:

Review of the hospital's Performance Improvement Plan FY 2023 for 7/1/22 to 6/30/23, showed the GB will require reports and mechanisms for monitoring and evaluating the quality and safety of patient care services, including care provided by contract services, and staffing effectiveness.

On 5/17/23 at 1018 hours, an interview and concurrent review of hospital documents was conducted with the CEO regarding contracted services.

Review of the Facility Contract Directory showed all of the hospital's active clinical and non-clinical contracts had no renewal terms or when each contract had to be evaluated for performance.

When asked how the GB knew which contracts were due for renewal and performance evaluation, the CEO stated each department head was responsible to know when the contracts were due. The hospital's corporate team would then review the contract approvals to determine the continuation of services.

When asked if all contracts had performance evaluations as per the terms of the contracts, the CEO stated only the clinical contracts and selected non-clinical contracts were evaluated. The CEO stated the hospital was in the process of standardizing the performance evaluation process which could also meet the specific criteria for each contract.

Review of the Sodexo contract for EVS services showed the contracted service would conduct quarterly patient surveys and semi-annual employee surveys as a component of the contracted services' self-evaluation program. The results of the surveys and action plans were reviewed with the hospital administration.

When asked, the CEO stated Sodexo's performance evaluation was not done.

No additional documents to support Sodexo had met the contract obligation to perform the self-evaluation was provided during the survey.

The above findings were acknowledged by the CEO.

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

The hospital failed to ensure the GB and executive officials prioritized the quality improvement and patient safety related to the physical environment, infection control, and surgical services to determine the performance improvement projects. Cross reference to A309.

The cumulative effect of these systemic practices resulted in the failure of the hospital's QAPI program to ensure the safety and quality of the services provided.

Based on observation, interview, and record review, the hospital failed to ensure the GB and executive officials prioritized the quality improvement and patient safety related to the physical environment, infection control, and surgical services to determine the performance improvement projects. This failure created the risk of performance issues not being addressed by the performance improvement activity.

Findings:

Review of the hospital's Bylaws dated 4/21/10, 8.2 showed the GB is responsible for assuring the healthcare services provided are of high quality, safe, effective, efficient, and consistent with community standards. The GB will be responsible for ongoing quality assessment, performance improvement, patient safety and utilization of management activities of the hospital, for assuring the quality assessment and performance improvement, patient safety and utilization management activities of the hospital are consistent with standards, policies and procedures established by the Board.

Review of the Infection Prevention Program dated 5/25/22 showed the GB had the overall responsibility and oversight of the infection prevention program at the hospital.

Review of the hospital's Performance Improvement Plan FY 2023 for 7/1/22 to 6/30/23, showed the GB has ultimate responsibility and authority to ensure the hospital develops, executes, and enforces a planned, systematic process whereby the quality and safety of patient care and services provided are prioritized, measured, evaluated, and improved. The Performance Improvement Patient Safety Committee will identify, study, and improve clinical performance and patient safety as it relates to specific patient populations, problem prone areas, patient care services which are provided a contractual entity, and overall systems and processes that affect patient care and safety.

During the Complaint Validation survey from 5/15/23 through 5/17/22, the following deficient practices were identified:

* The hospital failed to ensure the facility and equipment used for patient care were not maintained to ensure the safety of patients and staff. Cross reference to A0700.

* The hospital failed to provide a sanitary environment and an active infection control program. Cross reference to A0747.

* The hospital failed to ensure surgical services were provided organized to ensure the health and safety of patients. Cross reference A0940.

On 5/17/23 at 1423 hours, the CEO, MD 2, CMO, Director of Quality, and IPD were informed of the deficient practices identified during the Complaint Validation survey affecting surgical services related to the temperature and humidity concerns in the ORs, endoscopy, Cath Lab, and radiology areas; state of the physical environment in these areas; and infection control concerns in these areas.

a. When asked how the performance improvement projects were selected by the Performance Improvement Patient Safety Committee, the CEO stated the projects were selected based on if deficiencies were identified and reported.

The Director of Quality verified there were no performance improvement projects related to the concerns identified during the survey, including the temperature and humidity concerns which were known to the hospital as the ongoing concerns.

b. Review of the 2022/2023 EOC Rounds Schedule showed the ORs was scheduled for inspection on 9/21/22, and again on 4/26/23. The endoscopy area or GI lab was scheduled for inspection on 10/5/22 and 5/10/23. The radiology area was scheduled for inspection on 10/12/22 and 5/17/23. However, the IPD confirmed the rounding data was not found, and no EOC rounds were done in the hospital for 2023.

c. When asked how the GB ensured oversight of the existing concerns identified during the Complaint Validation survey, the CMO stated any problems reported to the GB was moved forward with a plan of action presented from the MEC and GB members. MD 2 stated the OR concerns were known for a while and recommendations from the GB was given to the hospital.

However, review of the GB meeting minutes on 10/26 and 12/7/22; and 1/25 and 2/22/23 failed to show documented evidence these concerns identified on survey were addressed. Additionally, the Director of Quality verified no OR physical environment and HVAC concerns were reported on the 9/21/22.

The CEO stated the HVAC concern in the OR was ongoing. The CEO stated it was important to establish the protocols and procedures in all the departments to ensure the ongoing problems in the OR were communicated consistently and acted on in a manner, which was consistent between all employees and departments. The CEO stated there were improvement opportunities concerning the reporting of problems.

Based on interview and record review, the hospital failed to ensure the dressing for PICC line was changed as per the hospital's P&P for one of 13 sampled patients (Patient 4), creating the risk of not providing necessary care and services to meet the care needs for this patient.

Findings:

Review of the hospital's P&P titled Intravenous Therapy Policy; Vascular Access Devices dated 8/8/18, showed for the Central (short-term) line- Transparent dressing change with chlorahexidine impregnatedatch (a disinfectant and antiseptic) is changed every seven days and prn if soiled, lose or damp using sterile technique by RN.

On 5/16/23, an interview and concurrent review of Patient 4's medical record was conducted with the Director of Inpatient Services.

Patient 4's medical record showed the PICC line was placed for the patient on 4/24/23. Review of the physician's order dated 4/28/23 at 1730 hours, showed to administer Rocephin (antibiotic medication) 1 gm IVPB daily from 4/29 to 5/20/23. When asked, the Director of Inpatient Services stated the dressing for PICC line should be changed every seven days.

Review of the Outpatient/Short Stay Nursing Care Record dated 5/4 and 5/11/23, failed to show the dressing was changed every seven days for Patient 4.

The Director of Inpatient Services verified the above findings.

Based on observation, interview, and record review, the hospital failed to ensure the facility and equipment used for patient care was maintained to ensure the safety of patients and staff as evidenced by:

1. The hospital failed to ensure the facilities, supplies, and equipment maintained in an acceptable level of safety and quality in the cath lab, CT room, US 2, endoscopy, and OR areas. Cross reference to A0724.

2. The hospital failed to ensure the ventilation, temperature, and humidity control in the surgical and procedural areas were properly maintained. Cross reference to A0726.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide quality healthcare in a safe and sanitary environment for the hospital's patients.

Based on observation, interview, and record review, the hospital failed to ensure the facilities, supplies, and equipment maintained in an acceptable level of safety and quality in the Cath Lab, CT room, US 2, endoscopy, and OR areas. This failure had the potential to result in poor health outcomes to the patients in the hospital.

Findings:

1. On 5/15/23 at 0921 hours, an inspection of the Cath Lab was conducted with the Director of Quality and Cath Lab Lead. The following was observed:

- Cath Lab B had a large dent with a cracked surface. The humidity level was at 73.3%. There was paint chipping off the door into Cath Lab B.

- The Sterile Storage Room in the Cath Lab had a stained ceiling tile with a dried brown stain.

The Cath Lab Lead and the Director of Quality verified the above findings.

2. On 5/15/23 at 1030 hours, an inspection of the CT room and US 2 was conducted with the Director of Imaging Services and the Director of Quality. The following were identified:

* The CT room had a cabinet shelving with supplies on it. The shelf was missing the bracket to keep it secure.

* The CT control room had ceiling tiles with brown staining on them.

* US 2 had a large area of ceiling tile with brown staining on it. The supply drawer was heavily dented, and the door threshold border came off the middle section of the entryway.

The Director of Imaging Services acknowledged the above concerns.

3. The environment of the endoscopy area was not maintained in a sanitary and clean condition. Cross reference to A0749, Example #4.

4. Medical equipment was not maintained in ORs 1, 3, 4, and Cath Lab area in a sanitary manner. Cross reference to A0749, Example #12.

5. The HMS was not maintained as per the manufacturer's IFU and the OSHA requirements on bloodborne pathogen. Cross reference to A0749, Example #16.

6. The corrugated boxes were stored in the OR, clean, and sterile storage. Cross reference to A0750, Example #1.

7. The food storage room was not maintained in the sanitary environment. Cross reference to A0750, Example #2.

8. The SPD was not maintained in a sanitary condition. Cross reference to A0750, Example #3.

9. A heart-lung machine was not maintained in a sanitary condition. Cross reference to A0951, Example #3.


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10. On 5/15/23 at 1039 hours, the pre-op and post-op areas were toured with the Director of Inpatient Services. The counter top's laminate at nursing station and patients' care areas (Bays 5, 6, and 7 in the post-op area) were chipped, exposing the wood underneath. The Director of Inpatient Services verified the above findings.

Based on observation, interview, and record review, the hospital failed to ensure the proper ventilation, temperature, and humidity control in the surgical and procedural areas as evidenced by:

1. Failure to ensure the temperature and humidity levels were maintained in the OR as per the hospital's P&P and AORN's guidelines.

2. Failure to ensure the HVAC annual air balance and ACH evaluation were completed for procedure rooms and sterile storage areas per the AORN's guidelines.

3. Failure to ensure the temperature and humidity levels were monitored in US 2 and the humidity level was monitored in the CT room as per the AORN's guidelines.

4. Failure to ensure the temperature level, humidity levels, and air exchanges were monitored and maintained in the hospital's endoscopy area as per the AORN's guidelines.

5. Failure to ensure the temperature and humidity levels were monitored in sterile storage of the Cath Lab area as per the AORN's guidelines.

These failures had the potential to result in poor health outcomes to the patients receiving care in the hospital

Findings:

1. The ORs' temperature and humidity levels were not maintained as per the hospital's P&P and AORN's guidelines. Cross reference to A0951, Example #5.

2. The AORN's Guidelines for Perioperative Practice, 2018 edition, Guideline for Design and Maintenance, Design Concepts, Recommendation 2.6.1 showed the following:

* Procedure Rooms will have a temperature range of 70 to 75 °F, humidity of 20% to 60%, a minimum ACH of 15, and have positive pressure in relation to adjacent areas.

* Sterile Storage Rooms will have a maximum temperature of 75 degrees F, a maximum humidity of 60%, a minimum ACH of 4, and have positive pressure in relation to adjacent areas.

On 5/17/23 at 0955 hours, an interview and concurrent review of the Annual Crucial Area Validation dated 9/22/22 was conducted with the Engineering Supervisor and the Director of Quality.

There was no documented evidence to show the ACH and pressure requirment was evaluated for US 2 and the Cath Lab Sterile Storage Room.

The above concern was shared with the Director of Quality. The Director of Quality verified sterile supplies were stored in the Cath Lab Sterile Storage Room, and US 2 was used for US guided needle biopsies requiring a sterile field.

3. The temperature and humidity levels were not monitored in US 2 and the humidity level was monitored in the CT room as per the AORN's guidelines. Cross reference to A0749, Example #14.

4. The temperature level, humidity levels, and air exchanges were not monitored and maintained in the hospital's endoscopy area as per the AORN's guidelines. Cross reference to A0749, Example #1.

5. The temperature and humidity level were not monitored in the sterile storage of the Cath Lab area as per the AORN's guidelines. Cross reference to A0749, Example #13.

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

1. The hospital failed to implement an effective and facility-wide IC plan for preventing and controlling the transmissions of infections within the hospital. Cross reference to A0749.

2. The hospital failed to ensure the IC program included the prevention and control of HAI, including maintaining a clean and sanitary environment. Cross reference to A0750.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe and sanitary environment for the hospital's patients.

Based on observation, interview, and record review, the hospital failed to implement an effective and facility-wide IC plan for preventing and controlling the transmissions of infections in the hospital as evidenced by:

1. Failure to ensure the temperature levels, humidity levels, and air exchanges were monitored and maintained in the endoscopy area as per the AORN's guidelines.

a. The bronchoscopy procedure was performed for a patient when the temperature level of the bronchoscopy room was out of range.

b. The temperature levels were not maintained for the bronchoscopy room as per the AORN's guidelines.

c. The temperature levels were not maintained for Scope Room 1 (or a GI procedure room) as per the AORN 's guidelines.

d. The temperature levels were not maintained for Scope Room 2 (or a GI procedure room) as per the AORN 's guidelines.

e. The Room Temperature Monitoring Logs for Bronchoscopy Room, Scope Rooms 1 and 2 were not created with the acceptable temperature ranges as per the AORN's guidelines.

f. The temperature and humidity levels were not monitored for the endoscopy reprocessing room as per the AORN's guidelines.

g. The air balance or a minimum of air exchange per hours were not reported for Scope Room 2 and the endoscopy processing room.

2. Failure to ensure the portable air conditioner was not used in the patient care area and procedure room as per the AORN's guidelines.

3. Failure to ensure the programmed enzymatic dispensing machine dispensed an accurate dilution of the enzymatic solution as per the manufacturer's IFU.

4. Failure to ensure the environment of the endoscopy area was maintained in a sanitary and clean condition.

5. Failure to ensure the decontamination sink in the endoscopy processing room was set up as per the AORN's Guidelines.

6. Failure to ensure the endoscope was cleaned as per the manufacturer's IFU.

7. Failure to ensure Anesthesiologist 1 disinfected the rubber septum of the vial prior to withdrawing the medication from the vial as per the AORN's guidelines.

8. Failure to ensure Anesthesiologist 1 disinfected Patient 1's IV port prior to accessing the IV port for IV medication administration as per the hospital's P&P.

9. Failure to ensure Anesthesiologist 1 used pre-filled normal saline (an IV sulution) syringe when flushing the IV line after administering medication.

10. Failure to ensure RN 1 performed hand hygiene and donning gloves prior to inserting an IV for Patient 5 as per the hospital's P&P.

11. Failure to ensure the Cath Lab Lead and the Lead CT stated the correct wet time for using the Super Sani Cloth (a disinfectant) to disinfect medical equipment after patient use.

12. Failure to ensure medical equipment which had had ready-to-use in ORs 1, 3, 4 and Cath Lab area were maintained in sanitary condition.

13. Failure to ensure the temperature and humidity level of the Sterile Storage in the Cath Lab area was monitored as per the AORN's Guidelines and failure to ensure the environment of Cath Lab area was maintained in a sanitary manner.

14. Failure to ensure the temperature and humidity levels were monitored in US 2 and the humidity levels were monitored in the CT room as per the AORN's guidelines.

15. Failure to ensure the temperature and humidity levels were maintained in the OR as per the hospital's P&P and AORN's guidelines.

16. Failure to ensure the HMS was maintained as per the manufacturer's IFU and the OSHA requirements on bloodborne pathogens.

17. Failure to ensure the scope was sterilized as per the manufacturer's IFU.

These failures created the increased risk of transmission of infections and further compromised the acutely ill patients' clinical conditions.

Findings:

Review of the hospital's P&P titled, "Infection Prevention Program," revised 9/9/16, indicated the following: "...Purpose: The purpose of this policy is to provide surveillance, prevention, and control of communicable disease within the hospital environment for the protection of both the patients and the hospital employee...Policy: All department employees understand the importance of specific infection control practices such as: ...11. Surgery suite cleaning procedures ...12. Different disinfecting chemicals ...13. Cross-contamination [the transfer of harmful germs from one person, object, or place to another] ...15. HIV virus [human immunodeficiency virus-blood borne pathogen] is transmitted: a. Through blood and body fluids, b. Through contaminated needles ..."

On 5/15/23 at 0849 hours, during the entrance conference with the CEO, CNO/DSS, and IPD, the IPD stated the hospital followed the AORN's guidelines and the AAMI's guidelines as their hospital's standards of practice for the perioperative services. The CNO/DSS stated the position of the director of GI services had been vacant, and she oversaw the GI services as an interim director of endoscopy services.

1. The AORN's Guidelines for Perioperative Practice, 2022 edition, Guideline for Flexible Endoscopes, Recommendation 1. Processing Area showed heating, ventilation, and air conditioning systems in the endoscopy suite should be constructed and designed to meet the parameters shown in Table 1. The Table 1 showed the following:

- For the endoscopy processing room, the temperature is between 60 to 73 °F and the relative humidity is maximum of 60%. A mininum total air changes per hour is 10.

- For the endoscopy procedure room, the temperature is between 68 to 73 °F and the relative humidity is maximum 60%. A minimum of air exchange per hour is 6.

- For the bronchoscopy procedure room, the temperature is between 68 to 73 °F. A minimum of air exchange per hour is 12.

On 5/15/23 at 0926 hours, the endoscopy suites were toured with the Clinical Shift Manager. The Clinical Shift Manager stated there were one bronchoscopy room and two endoscopy procedure rooms (Scope Rooms 1 and 2). The Clinical Shift Manager stated there was a patient in the bronchoscopy room. The Clinical Shift Manager stated GI Room 1 (or Scope Room 1) was mainly used, but GI Room 2 (Scope Room 2) also used for GI procedures.

a. On 5/15/23 at 1008 hours, a patient was observed in the bronchoscopy room. When asked, the Clinical Shift Manager stated the temperature for the bronchoscopy room was 78.3 °F.

Review of the Room Temperature Monitoring Log for Bronchoscopy Room for May 2023 showed the temperature level was 76 °F on 5/15/23. The Room Temperature Monitoring Log for the Bronchoscopy Room showed if temperature is outside of range: notify Engineering at extension 6123; record actions taken and resolution; and if the temperature is not corrected, relocate supplies to an alternate location with appropriate temperature control.

However, further review of the Room Temperature Monitoring Log for the Bronchoscopy Room failed to show any actions were taken and resolved. There was no documentation to show if the temperature was back within the normal range.

The Clinical Shift Manager verified the bronchoscopy procedure was performed when the temperature was out of range.

b. Review of the Room Temperature Monitoring Log for Bronchoscopy Room for May 2023 showed the temperature levels were above 73 °F on 5/9, 5/10, 5/13 and 5/15/23.

Further review of the Temperature Monitoring Logs for Bronchoscopy Room from January to April of 2023 showed the following:

- In February 2023, the temperature levels were out of range for seven days.

- In March 2023, the temperature levels were out of range for three days.

- In April 2023, the temperature levels were out of range for 14 days.

c. Review of the Room Temperature Monitoring Log for Scope Room 1 for May 2023, showed the following:

* On 5/1, 5/2, 5/7, 5/8, 5/9, 5/10, and 5/11/23, the temperature levels were 78 °F.
* On 5/3, 5/5, and 5/12/23, the temperature levels were 77 °F.
* On 5/4/23, the temperature level was 79 °F.
* On 5/13/23, the temperature level was 84 °F.
* On 5/15/23, the temperature level was 82 °F.

Further review of the Temperature Monitoring Logs for Scope Room 1 from January to April of 2023 showed the following:

- In January 2023, the temperature levels were out of range for 21 days.

- In February 2023, the temperature levels were out of range for 23 days.

- In March 2023, the temperature levels were out of range for 20 days.

- In April 2023, the temperature levels were out of range for 24 days.

d. Review of the Room Temperature Monitoring Log for Scope Room 2 for May 2023 showed the temperatures were above 73 °F on 5/1, 5/2, 5/3, 5/4, 5/5, 5/7, 5/8. 5/9, 5/10, 5/11, 5/12, 5/13, and 5/15/23.

Further review of the Temperature Monitoring Logs for Scope Room 2 from January to April of 2023 showed the following:

- In January 2023, the temperature levels were out of range for 10 days.

- In February 2023, the temperature levels were out of range for 19 days.

- In March 2023, the temperature levels were out of range for 22 days.

- In April 2023, the temperature levels were out of range for 22 days.

e. Review of the Room Temperature Monitoring Log for Bronchoscopy Room showed the average temperatures would be 68 to 75 °F and the temperatures in the shaded area would be outside the optimal range. Further review of the form showed the shaded area showing the temperatures would be below 68 and above 75 °F.

Review of the Room Temperature Monitoring Log for Scope Rooms 1 and 2 showed the average temperatures would be 68 to 75 °F and the temperatures in the shaded area would be outside the optimal range. Further review of the form showed the shaded area showing the temperatures would be below 68 and above 75 °F.

The Room Temperature Monitoring Log for Bronchoscopy Room, Scope Rooms 1 and 2 were not created with the temperature acceptable ranges as per the AORN's guidelines.

On 5/17/23 at 1018 hours, the CNO/DSS verified the temperature logs for GI rooms (Scope Rooms 1 and 2) and Bronchoscopy room were not reflected on current AORN's guidelines.

f. There was no documented evidence showing the temperature and humidity levels were monitored for the endoscopy processing room.

On 5/17/23 at 1018 hours, the CNO/DSS verified the above findings.

g. Review of the hospital's Annual Crucial Area Validation dated 9/22/22, showed the air balance for the bronchoscopy room and GI Room 1 (or Scope Room 1). However, further record review failed to show the air balance report for GI Room 2 (or Scope Room 2) and the endoscopy processing room.

On 5/16/23 at 1304 hours, the CNO/DSS and IPD verified the above findings.

2. The AORN's Guidelines for Perioperative Practice, 2022 edition, Guideline for Design and Maintenance, Recommendation 12. Surface and HVAC Maintenance, 12.11 showed do not use free-standing fans, portable humidifiers, air conditioners, and dehumidifiers. The AORN's guidelines also showed 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.

On 5/15/23 at 0926 hours, the endoscopy suites were toured with the Clinical Shift Manager. It was observed a portable air conditioner at the pre procedure area and Scope Room 1.

On 5/15/23 at 1426 hours, Patient 1's endoscopy procedure was observed in Scope Room 1. The portable air conditioner was still observed in Scope Room 1 during the patient's procedure.

On 5/15/23 at 1520 hours, the IPD was interviewed in the presence of the CEO and CNO/DSS. When asked, the IPD stated she was not aware of the portable air conditioner in endoscopy area. The IPD stated the portable air conditioners should not be in the endoscopy area.

On 5/17/23 at 0915 hours, the Director of Quality stated the air conditioning in the hospital's endoscopy area was down since 1/9/23.

3. Review of the manufacturer's IFU for Pure Enzymatic Detergent showed to add 1/2 oz of the concentrate per one gallon of water for manual cleaning.

On 5/15/23 at 0940 hours, the reprocessing room was toured with GI Tech 1 in the presence of the Clinical Shift Manager. The programmed enzymatic dispensing machine on the wall was observed. When asked, GI Tech 1 stated the diluted enzymatic solution was automatically dispensed with water and enzymatic solution through the tubing. GI Tech 1 stated the machine was programmed to dispense of 1/2 oz of enzymatic solution and one gallon of water.

On 5/16/23 at 0958 hours, GI Tech 2 was asked to measure the amount of the diluted enzymatic solution for 1/2 oz of enzymatic detergent with one gallon of water from the machine in the presence of the Clinical Shift Manager and Director of Inpatient Services. It was observed the programed enzymatic dispensing machine dispensed 0.75 gallon of the diluted enzymatic solution. When asked to measure the amount of the 3 oz of enzymatic solution from the machine, it was observed the machine dispensed 50 ml (or 1.69 oz) of enzymatic solution. GI Tech 2 stated she was trained to flush water the enzymatic solution, which might be left in the tubing after the machine dispensed the solution. The Director of Inpatient Services acknowledged the machine did not dispense the diluted enzymatic solution as per the manufacturer's IFU.

4. On 5/15/23 at 1039 hours, during a tour of pre/post operative and endoscopy areas with the Director of Inpatient Services, the following was identified:

* In the pre-op and post-op areas, the counter top's laminate at nursing station and patients' care area (Bays 5, 6, and 7) was chipped, exposing the wood underneath.

* In endoscopy reprocessing room, the water pipe behind the automated endoscope reprocessor was observed to have rust and greenish-substance build-up.

* There were two automated endoscopy reprocessors were observed in the endoscopy processing room. Each automated endoscopy reprocessor had two stations. The vent grill was observed in each basin of each station. The dust accumulation was observed in each vent grill.

5. The AORN's Guidelines for Perioperative Practice, 2022 edition, Guideline for Flexible Endoscopes, Recommendation 1. Processing Area, 1.9 showed a minimum of two decontamination sinks (or one sink with two divisions) should be provided in the endoscopy processing room.

Review of the manufacturer's IFU for Pentax Video Upper G.I Scopes (undated) showed to move endoscope with accessories to a clean basin filled with clean portable water for first rinse after cleaning the endoscope in the enzymatic solution.

On 5/15/23 at 1440 hours, GI Tech 2 was observed performing the leak test and manual cleaning of the used endoscopy in the single sink. GI Tech 2 drained the enzymatic solution after manually cleaned the endoscope with the sponge. GI Tech 2 briefly rinsed the endoscopy in the single sink and leaving the endoscope in this sink, then she filled the water in the sink.

On 5/16/23 at 1304 hours, the IPD and CNO acknowledged the above findings.

6. Review of the manufacturer's IFU for Pentax Video Upper G.I Scopes (undated) showed to rinse detergent from endoscope after cleaning the endoscope in the enzymatic solution. The manufacturer's IFU showed to rinse two times with clean portable water.

On 5/15/23 at 1440 hours, GI Tech 2 was observed performing manual cleaning of the used endoscopy in the sink. It was observed GI Tech 2 drained the enzymatic solution and briefly rinsed the endoscope in the sink. Then, GI Tech 2 filled up the water into the sink and rinsed the endoscopy. GI Tech 2 was observed rinsing the endoscope one time, then transported the manually cleaned endoscope to the automated endoscope reprocessor.

On 5/16/23 at 1335 hours, the Clinical Shift Manager acknowledged the above findings.

7. The AORN's Guidelines for Perioperative Practice, 2022 edition, Guideline for Medication Safety, 5. Administration, 5.12 showed to use alcohol to disinfect the rubber septum on all vials and allow vials to dry before each entry.

On 5/15/23 at 1426 hours, during an observation of Patient 1's endoscopy procedure, Anesthesiologist 1 was observed removing the plastic lid of the medication vial. Anesthesiologist 1 was observed withdrawing medication with the needle and syringe without disinfecting the rubber septum.

8. Review of the hospital's P&P titled Intravenous Therapy Policy; Vascular Access Devices dated 8/8/18, showed injection ports are cleansed with alcohol or chlorohexidine (a disinfectant) prior to accessing.

On 5/15/23 at 1426 hours, during an observation of Patient 1's endoscopy procedure, Anesthesiologist 1 was observed administering the IV medication to the patient using the pre-filled medication syringes after disinfecting the IV port. However, after the medication administration, it was observed the IV port was touching the linen. It was then observed Anesthesiologist 1 administered the IV medication without disinfecting the IV port prior to administering the medications.

On 5/16/23 at 1030 hours, the Clinical Shift Manager acknowledged the above findings.

9. On 5/15/23 at 1426 hours, Patient 1 was observed receiving IV fluid from the 1 L of normal saline bag during the endoscopy procedure. Anesthesiologist 1 was observed withdrawing normal saline from the IV bag through the port of the IV tubing. Anesthesiologist 1 flushed Patient 1's IV line with the normal saline that he withdrew from the IV fluid bag after administering medication to the patient.

On 5/17/23 at 1413 hours, the IPD was interviewed. When shared the above findings, the IPD stated the anesthesiologist should have used the (ready to use) pre-filled normal saline syringe to flush the IV line.


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10. Review of the hospital's P&P titled Intravenous Therapy Policy; Vascular Access Devices dated 8/8/18, showed a procedural technique for an intravenous access is to perform hand hygiene and don gloves.

On 5/15/23 at 1012 hours, an observation of RN 1 providing care to Patient 5 in the Pre-Op area was conducted with the Director of Quality.

RN 1 was observed walking from the nursing station into Patient 5's room. RN 1 was observed not performing hand hygiene prior to walking into Patient 5's room. Patient 5 was observed lying on a gurney. RN 1 stated an IV would be started on Patient 5. RN 1 donned a glove on the left hand. RN 1 did not don glove on the right hand. RN 1 applied a tourniquet to Patient 5's left arm and applied an antiseptic wipe to Patient A's left arm. RN 1 then used the right hand to manipulate the IV catheter into Patient 5's left forearm.

The Director of Quality verified the above findings.

11. Review of the manufacturer's IFU for Super Sani Cloth showed it was a germicidal wipe. The manufacturer's IFU showed to thoroughly wet a surface using the Super Sani Cloth wipe, allow the treated surface to remain wet for two minutes, and let air dry.

a. On 5/15/23 at 0921 hours, the Cath Lab Lead was interviewed regarding Super Sani Cloth in the presence of the Director of Quality. The Cath Lab Lead stated the disinfectant wipes were used by the staff to wipe down medical equipment between cases. When asked how long the medical equipment should stay wet to ensure disinfection, the Cath Lab Lead stated three minutes.

b. On 5/15/23 at 1012 hours, the Lead CT was interviewed regarding Super Sani Cloth in the presence of the Director of Quality. The Lead CT stated the wipes were used on the CT gantry, countertops, and other equipment like the mayo stand. When asked how long the wet time was for the Super Sani Cloth, the Lead CT stated five minutes.

On 5/16/23 at 0900 hours, the above finding was shared and acknowledged by the Director of Quality.

12. Review of the hospital's P&P titled Cleaning and Maintenance of Patient Care Equipment dated 10/20/21, showed all patient care equipment must be clean, in working order, and safe for patient use at all times; and inspect the equipment for cleanliness and safety.

a. On 5/15/23 at 0921 hours, a tour of the Cath Lab was conducted with the Director of Quality and the Cath Lab Lead.

The following medical equipment was observed in the hallway and in the holding area between Cath Lab A, Cath Lab B, and the control room:

- The fractional flow reserve machine had multiple areas of tape remnants and sticky residue.

- The Impella machine had a thick coating of dust on the top and sides of the machine.

- The blood pressure tram had a thick coating of dust, and red-brown residue on the wheel casters. Stuck on one wheel was a tangled piece of string.

- The portable US machine had a transducer holder with a broken surface area exposing a small area of red-brown staining.

- The intra-aortic balloon pump machine had an IV pole with tape fragments and a sticky residue on it.

The Cath Lab Lead stated the Cath Lab staff already cleaned the medical equipment by using Super Sani wipes and the medical equipment was ready for use.

b. On 5/15/23 at 0921 hours, an inspection of Cath Lab B was conducted with the Director of Quality and the Cath Lab Lead. The following medical equipment was observed:

- The shield partition had a thick encrusted black residue on all the wheel casters. The paint was chipped on the sides, exposing the metal underneath. The metal was stained reddish-brown.

- The catheter bed siding had a long strip of sticky residue. The IV pole on the catheter bed was also encrusted with a thick layer of a white powdery residue.

c. A tour of the ORs and OR hallway was conducted with the CNO/DSS. The following medical equipment was
observed:

- In OR 1: an instrument table had the wheel casters with rusty reddish-brown substance. Tape residue was on the arm of the anesthesia cart monitor. The stool had a vinyl covering with rips on it.

- In OR 3: an IV pole had all four-wheel casters with a rusty reddish-brown substance on them.

- In OR 4: a table and IV pole had wheel casters with a rusty reddish-brown substance on them.

The CNO/DSS verified the above findings and stated that excluding OR 3, ORs 1 and 4 were already cleaned and ready to use.

13. The AORN's Guidelines for Perioperative Practice, 2018 edition, Guideline for Sterilization, Storage of Sterile Items showed the following:

* Recommendation 4.1 showed to store sterile items in a controlled environment. Factors that contribute to contamination include handling, air movement, humidity, temperature, location of storage, dust, presence of vermin, whether shelving is open or closed, and properties of the sterile barrier system.

* Recommendation 4.3.6. showed to store sterile items in a manner that protects the integrity of the sterile barrier system.

* Recommendation 4.4 showed to remove supplies and equipment from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use. External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite

On 5/15/23 at 0921 hours, an inspection of Cath Lab B and the Cath Lab Sterile Storage Room was conducted with the Director of Quality and the Cath Lab Lead.

a. Cath Lab B had a small, enclosed room inside. When asked, the Cath Lab Lead stated it was the computer room. The following was observed in the computer room:

- Four pacemaker Micra boxes were leaning on the floor and wall.

- There were multiple electrophysiology catheter boxes leaning on the floor and wall.

- There were to metal racks with shelving with additional electrophysiology catheters piled haphazardly on top of one another.

b. The Cath Lab Sterile Storage was located adjacent to Cath Lab A, the control room, and Cath Lab B. The following was observed in the Cath Lab Sterile Storage:

- One ceiling tile had a dried brown liquid stain.

- Multiple corrugated boxes, including sterile transducers and stents were on the floor.

- Two bins were observed to have dust in them. One bin had a small fragment of cardboard paper.

c. When asked, the Cath Lab Lead stated neither the computer room in Cath Lab B or the Cath Lab Sterile Storage was being monitored for temperature and humidity.

Review of the HVAC Air Balance and ACH report failed to show the ACH and air balance was evaluated in the computer room.

14. The AORN's Guidelines for Perioperative Practice, 2018 edition, Guideline for Design and Maintenance, Design Concepts, Recommendation 2.6.1 showed the following:

* Procedure Rooms will have a temperature range of 70 to 75 °F, humidity of 20% to 60%.

* Sterile Storage Rooms will have a maximum temperature of 75 °F, a maximum humidity of 60%.

a. On 5/15/23 at 0921 hours, an inspection of Cath Lab B was conducted with the Director of Quality and the Cath Lab Lead. Inspection of Cath Lab B showed the humidity level was at 76.1%.

b. On 5/16/23 at 1030 hours, an inspection of the CT room and US 2 was conducted with the Director of Quality and the Director of Imaging Services.

Review of the temperature logs for CT failed to show humidity was tracked daily.

When asking for the US 2 temperature and humidity log, none was provided.

On 5/16/23 at 0940 hours, an interview was conducted with the Director of Imaging Services. The Director of Imaging Services verified the CT room and US 2 was used for minimally invasive biopsy procedures. When asked, the Director of Imaging Services stated temperature and humidity levels were not monitored in US 2, and the humidity level was not monitored in the CT room.

The Director of Imaging Services acknowledged the above findings.


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15. The ORs' temperature and humidity levels were not maintained as per the hospital's P&P and AORN's guidelines Cross reference to A 951, Example #5.

16. A tour of OR 6 was conducted on 5/15/23 at 1055 hours with the CNO/DSS and IPD. A red substance was observed on the surface and dispenser of the HMS. OR 6 had been cleaned and was designated as ready to use for the next surgical patient.

During an observation and interview with the CNO/DSS on 5/15/23 at 1125 hours in OR 6, the CNO/DSS dampened a cloth with water, wiped the surface of the machine, and stated the red substance was "definitely blood." The CNO/DSS confirmed the hospital followed the "Occupational Safety and Health Administration" requirements for bloodborne pathogens. The CNO/DSS stated the cardiovascular perfusionists (CPs) were responsible for maintaining and cleaning the HMS.

During a telephone interview with CP 2 in the presence of the CNO/DSS and the IPD on 5/17/23 at 1413 hours, CP 2 confirmed he provides perfusion treatments at the hospital and CPs were responsible for maintaining and cleaning cardiovascular perfusion equipment. CP 2 stated CPs were responsible for ordering disposable reservoirs (HMS supplies) for the HMS, but he did not routinely use a disposable reservoir to catch the residue blood from the blood sample needle because the disposable reservoirs were not readily available. CP 2 stated he routinely placed an alcohol pad and the packaging on the HMS to catch the residue blood. CP 2 stated "I make do with what I have." CP 2 stated the HMS was cleaned between patients with a purple top cleaner and he did not know the name of the cleaning agent or the contact time (the time required to kill microorganisms). CP 2 stated he was not aware if the hospital oversaw cardiovascular perfusionist infection control/prevention practices because the hospital did not understand cardiovascular perfusion treatments.

During a follow-up interview with the CNO/DSS and IPD on 5/17/23 at 1420 hours in the conference room, the CNO/DSS stated she had reviewed the HMS Operator's Manual and the manufacturer's IFU of the HMS were not followed for using a disposable salvage reservoir to catch potentially infectious material (blood) or for cleaning the HMS between patients. The IPD stated the CPs did not follow OSHA requirements on bloodborne pathogens or follow the hospital's P&P on infection prevention practices related to blood. The CNO/DSS nor the IPD could not explain how the hospital provided oversight and training on infection prevention practices for CPs providing treatments for the hospital's surgical patients.

During an interview with the Governing Board Members (CNO/DSS, IPD, MD 2, Chief Medical Officer, CEO, Director of Quality) on 5/17/23 at 1440 hours, the CEO stated she did not know which cleaning agent CP 2 used to clean and disinfect the HMS because "There is no purple top cleaner used in the operating rooms."

Review of OSHA requirements for bloodborne pathogens dated 8/9/2007, stipulated the following:
"...29 CFR 1910.1030(d)(4)(i)," requires that ...General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the hospital, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area.
29 CFR 1910.1030(d)(4)(ii): All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials.
29 CFR 1910.1030(d)(4)(ii)(A): Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning ..."

Review of the manufacturer's operator's manual titled, "Hemostasis Management System Operator's Manual 2nd edition," dated 12/22/2011, indicated the following: "... Routine Cleaning: The instrument case and exposed surfaces of the actuator and dispenser should be kept clean. Clean the case routinely by wiping off dust and dried blood with a cloth dampened with water or one of the following chemicals: isopropyl alcohol, bleach, Liquid-Nox, hydrogen peroxide, Sani-Cloth, Clorox, Germicidal wipes, or mild detergent. The HMS cleaning kit can be used to clean difficult-to-reach areas in the dispenser ... The salvage reservoir ...located in notched plate under the dispenser, is designed to catch any residue blood from the needle. This disposable reservoir should be changed daily or as required ..."


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17. On 5/15/23 at 1120 hours, a tour of the hospital Operating Room Department was conducted with the CNO/DSS and IPD. During a concurrent interview with the IPD, she stated the hospital followed the Infection Control National Standards from the AORN and AAMI.

On 5/16/23 at 0900 hours, a tour of the hospital's SPD prep and pack area was conducted. An observation and inspection of a clean "stryker precision ideal scope" (a scope used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during laparoscopic procedures) was made. The scope had removable pieces; however, the scope was not disassembled.

During a concurrent interview at 0910 hours with SPDT 1, he stated the scope got disassembled when it was cleaned and disinfected, then it was reassembled lightly and passed through the sterilizer. According to SPDT 1, the surgeons did want to have to assemble the scope in the operating room because they need it "ASAP". SPDT 1 stated instruments with removeable parts got reassembled before sterilizing them, but he was aware the standards were to sterilize them disassembled.

During the same tour, an interview was conducted with SPDT 2 on 5/16/23 at 0920 hours. SPDT 2 stated that he disassembled all parts including the scope's adapter (a screw like device) and coupler during cleaning, then he re-assembled the adapter lightly to the shaft (the long metal part of the scope) which was then reassembled before sterilizing it.

Review of the scope manufacturer's instructions for use which was provided by the SPDS was conducted on 5/16/23 at 0940 hours. The manufacturer's instructions for use stipulated, "Prior to cleaning, disinfection, or sterilization, separate the laparoscope from the camera head, coupler, and adapter, which may come pre-attached to the laparoscope. If any of these components are cleaned, disinfected or sterilized as a single unit, disconnecting the devices during use will compromise the sterility of the products."

Review of the infection control standards the hospital was conducted on 5/16/23 at 1000 hours

Based on observation, interview, and record review, the hospital failed to ensure the IC program included the prevention and control of HAI, including maintaining a clean and sanitary environment as evidenced by:

1. Failure to ensure the corrugated boxes were not stored in the OR as per the AORN's guidelines and AAMI's guideless.

2. Failure to ensure the food storage room was maintained in a sanitary condition.

3. Failure to ensure the SPD was maintained in a sanitary condition or the terminal cleaning was performed in the SPD.

4. Failure to ensure the biohazard sharp containers were closed or had lid covers as her the OSHA requirements.

5. Failure to ensure the used bag of IV fluid containing heparin (medication used to prevent blood clots) was removed from the patient care area after being used.

6. Failure to ensure the HMS was maintained as per the manufacturer's IFU and the OSHA requirements on bloodborne pathogens.

7. Failure to ensure the cartridges were stored as per the manufacturer's IFU.

8. Failure to ensure the terminal cleaning was performed for the ORs to a clean and sanitary OR environment as per the hospital ' s P&P.

9. Failure to ensure the temperature levels, humidity levels, and air exchanges were monitored and maintained in the hospital's endoscopy area as per the AORN's guidelines.

10. Failure to ensure the portable air conditioner was not used in the patient's care area including pre procedure room and procedure room as per the AORN's guidelines.

11. Failure to ensure the EOC rounds were conducted for the OR, endoscopy, and radiology areas as scheduled.

These failures created the increased risk of spreading infections to the patients receiving care in the hospital.

Findings:

Review of the hospital's policy and procedure titled, "Infection Prevention Program," revised 09/09/2016, indicated the following: "...Purpose: The purpose of this policy is to provide surveillance, prevention, and control of communicable disease within the hospital environment for the protection of both the patients and the hospital employee...Policy: All department employees understand the importance of specific infection control practices such as:...11. Surgery suite cleaning procedures ...12. Different disinfecting chemicals...13. Cross-contamination [the transfer of harmful germs from one person, object, or place to another]...15. HIV virus [human immunodeficiency virus-blood borne pathogen] is transmitted: a. Through blood and body fluids, b. Through contaminated needles ..."

On 5/15/23 at 1120 hours, the IPD stated the hospital followed Infection Control National Standards from the AORN and AAMI.

1. a. A tour of OR 6 was conducted on 5/15/23 at 1055 hours, with the CNO/DSS and IPD. OR 6 had been cleaned and was designated as ready for patient use. The following items were observed to be stored on a shelf near the HMS.

* One cardboard box filled with nine "Heparin Assay Cartridges" (supplies used for the HMS to test blood samples), nine needles, and nine syringes.

* One cardboard box filled with 18 "High Range Activated Clotting Time Cartridges," nine syringes, and nine needles.

* One cardboard box filled with nine "Heparin Dose Response Cartridges," nine needles, and nine syringes.

The HMS supplies were available for patient use.

During a concurrent observation and interview with RN 2 on 5/15/23 at 1118 hours in OR 6, RN 2 was preparing OR 6 for a scheduled procedure. RN 2 viewed the supplies on the shelf and stated, the supplies were for cardiovascular perfusion treatments. RN 2 stated she did not know if the perfusion supplies could be potentially contaminated and cause cross-contamination for her scheduled surgical patient.

During a concurrent interview with the EVSD and IPD on 5/15/23 at 1125 hours in OR 6, the EVSD viewed the supplies and stated EVS staff did not clean or disinfect HMS supplies or cardboard boxes during terminal cleaning. The IPD stated cardboard boxes should not be stored in OR 6 or in any patient care area. The IPD stated the disposable HMS supplies should have been properly stored in the storeroom and transported to the OR as needed for patient use.

b. On 5/15/23, multiple observations of the hospital were conducted. The following was identified:

* At 1120 hours, a tour of the hospital Operating Room Department was conducted with the CNO/DSS and IPD.

In the hallway located outside of the hospital ORs, multiple broken-down corrugated boxes were placed on a cart.

* At 1410 hours, 64 corrugated boxes filled with sterile supplies used for surgical and invasive procedures were stored in the hospital's Sterile Storage Room.

During a concurrent interview at 1410 hours with an operating room Registered Nurse 1st Assist (RN 2), she stated the boxes contained surgical supplies that were for daily use.

c. On 5/16/23 at 0950 hours, during a tour of a hospital storage room used to store various patient supplies and used as a room to break down corrugated boxes, the room was filled with many corrugated boxes which contained various patient supplies. According to the CNO/DSS, the room was a semi-restricted area (traffic limited to authorized personal only). The room also contained patient emergency food supplies such as crackers, tube feeding, and other nourishments.

During the same observation of the storage room on 5/16/23, three dead cockroaches were found beneath the food supply and at various areas of the storage room beneath the corrugated boxes.

Review of one of the Infection Control Standards that the hospital followed, AAMI ST79, 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Standard 3.3.6.5 Breakout area/room". The standard stipulated:

"A breakout area/room should be located near or adjacent to a surgical or supply processing department. The purpose of this area/room is to remove items from external shipping cartons, as shipping cartons can harbor and transport dust and debris that should not enter a sterile processing department. Rationale: To eliminate the risk of introducing contaminants that could be present on external shipping cartons, these cartons should not be permitted in clean/sterile storage areas/rooms. External shipping containers and web-edged (corrugated) boxes can collect dust, debris, and insects during shipment and can carry contaminants into the area."

Review of the AORN Guidelines for Perioperative Practice, 2023 that the hospital followed, guideline "5.4 remove reusable surgical instruments from external shipping containers and web-edged or corrugated cardboard boxes before transfer into the sterile processing area. External shipping containers and web-edged cardboard boxes may become contaminated during transport and can carry contaminants into the facility."

During an interview on 5/16/23 at 1300 hours, the IPD stated she was aware of AORN and AAMI standards that corrugated boxes should not be located in semi-restricted areas.

2. During an observation on 5/16/23 at 0950 hours of the storage room, three dead cockroaches were found, one beneath the food supply and at various areas of the storage room beneath corrugated boxes. The floors of the room had grey fuzzy matter, black, brown, and red stains; pieces of torn corrugated boxes; pieces of crumbled paper, debris and partially dried wet spots covered in dark matter. The floors and room were untidy as well as contained grey fuzzy matter on various areas of the room.

During a concurrent interview on 5/16/23 at 0950 hours with the EVS Director who was present during the observations, he stated that the room gets cleaned every other week.

During an interview on 5/16/23 at 0955 hours with the EVSM, she stated that they did not have any documentation to show that the room got cleaned. In addition, EVSM stated, "It doesn't look like it gets cleaned or mopped" (referring to the cleanliness of the room). She also verified the dead cockroach and stated, "It's a dead body."

An interview was conducted with the FN on 5/16/23 at 1000 hours. When asked about the cleaning of the emergency food storage area, she stated they did not clean or mop floors.

3. On 5/16/23 at 1020, a tour of the SPD Decontamination Room (a restricted area where cleaning and disinfection of soiled reusable patient instruments were processed) was conducted. The following observations were made:

* The air-condition grilles (directs the flow of air out of ducts or into the return air vent) of five of five vents and three of three returns located on the ceilings contained thick grey fuzzy matter that was easily wipeable. Upon wiping the grilles, large amounts of thick grey and red substance were removed.

An interview was conducted with the EVSM on 5/16/23 at 1040 hours. The EVSM was asked by surveyor if terminal cleaning was performed in SPD Decontamination Room. The EVSM stated, "It should be done every day including walls, ceiling, floors, grills, vents but it doesn't look like they're done in SPD."

On 5/16/23 at 1110 hours, review of a hospital policy title, "Cleaning and Maintaining the Sterile Processing Department, effective 10/20/21." was conducted. The document stipulated, "Procedure ...C. Walls, air intake and return ducts, must be cleaned on a regularly scheduled basis and more often if needed."

On 5/16/23 at 1130 hours, review of the "AORN Guidelines for Perioperative Practice, 2023" that the hospital followed, was conducted. The document was provided by the hospital IPD, the document stipulated: "6. Sterile Processing Areas 6.2 Terminally clean sterile processing areas each day the areas are used ..."


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4. A tour of the surgical service department was conducted on 5/15/23 at 0840 hours, with the CNO/DSS and IPD. Two red biohazard sharp containers (a regulated container used to store needles, glass, and sharp objects contaminated with blood and/ or body fluid) on medical trolley carts were stored in OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6. The containers were filled with sharp objects, needles, and broken glass. The containers did not have lid covers and were clearly labeled, "Infectious Waste Danger."

During an interview with the IPD on 5/15/23 at 1040 hours in OR 6, the IPD confirmed the following:

* Biohazard waste was regulated waste and the hospital followed "Occupational Safety and Health Administration" requirements for bloodborne pathogens.

* 12 biohazard sharp containers were filled with potentially infectious waste, and the biohazard containers did not have lid covers.

The IPD stated lid covers were not required for biohazard sharp containers stored within the ORs.

During an interview with RN 2 on 5/15/23 at 1050 hours in OR 6, RN 2 confirmed biohazard sharp containers stored in the ORs did not have lid covers and the containers were not closeable. RN 2 stated biohazard containers in the ORs were stored on moveable carts and if the cart was accidentally tipped over, the hazardous waste material within the container would spill onto the floor.

An interview and concurrent review of document was conducted with the IPD on 5/17/23 at 0845 hours in the OR conference room.

Review of OSHA requirements for bloodborne pathogens showed the following: "...29 CFR 1910.1030(d)(4)(iii)(B)(1)(i)," dated 08/09/2007, requires that " ...Regulated waste shall be placed in containers which are: ...Closable."

The IPD stated she was not aware regulated waste containers stored in the ORs required lid covers and the hospital had not provided education to the staff indicating that all biohazard waste containers required lid covers. The IPD stated the ORs' biohazard containers should have had lid covers and the lid cover should have remained closed except when waste was being added to the container. The IPD stated, additional education on storage of potentially hazardous waste and bloodborne pathogens was needed to prevent cross-contamination (the unintentionally transfer of harmful germs from one person, object, or place to another) and/or exposure to potential infectious waste in the operating room setting.

Review of the hospital's P&P titled, "Biohazardous Waste Disposal, Medical," effective date 10/10/18, indicated the following: "Purpose:...Additionally, waste handling methods must comply with the Medical Waste Management ACT as specified in the California Code of Regulations (Title 22, section 65600-65628) and OSHA statues as specified in the Blood-borne Pathogen Standard ..."

5. A tour of OR 6 was conducted on 5/15/23 at 1055 hours, with the CNO/DSS and IPD. An opened bag of IV solution containing 1000 units of heparin in 500 ml of normal saline (a mixture of salt and water) was observed hanging from an IV pole next to the cardiovascular perfusion machine in a pressure infusion device with IV tubing attached. The IV heparin solution bag was dated 5/5/23 and was available for patient use. OR 6 had been cleaned and was designated ready for patent use.

During a concurrent observation and interview with RN 2 on 5/15/23 at 1118 hours in OR 6, RN 2 was observed preparing OR 6 for a scheduled surgical procedure. RN 2 walked over to the other side of the room and reviewed the label attached to the IV heparin solution bag. RN 2 stated she was not responsible for cardiovascular perfusion treatments, and she did not have oversight of the cardiovascular perfusion treatments. RN 2 stated the cardiovascular perfusionist team was responsible for the care and maintenance of the IV heparin solution bag.

During an interview with the CNO/DSS on 5/15/23 at 1121 hours in OR 6, the CNO/DSS confirmed the IV solution bag had been opened and dated 5/5/23. The CNO/DSS stated CP 1 should have ensured the IV heparin solution bag was removed immediately from the OR upon completion of the surgical procedure to prevent cross-contamination. The CNO/DSS discarded the IV heparin solution bag and stated she could not explain how the opened/used IV heparin solution bag remained in OR 6 for 10 days after the surgical procedure. The CNO/DSS stated OR 6 was considered contaminated and required terminal cleaning prior to admitting a patient into the room.

During a concurrent interview with the DOP and IPD on 5/17/23 at 0915 hours in the surgical service office, the DOP stated the opened IV heparin solution bag would not have been safe for patient use on 5/15/23, due to the potential of microbial (germ) growth in the solution and/or cross-contamination. The DOP stated in urgent situations, medication might be prepared at the beside and should be started within 24 hours. The IPD stated the hospital did not have a P&P related to a specific "start time" for urgent medications that were prepared at the bedside. The IPD stated as per the hospital's P&P, the IV solution and tubing should have been changed at least within 96 hours to prevent infection.

On 05/17/2023 at 1400 hours, multiple attempts were made to interview CP 1. However, CP 1 was not available for interview.

Review of the hospital's P&P titled, "Intravascular Therapy Policy; Vascular Access Device," effective 08/08/2018, indicated the following: "...5. Infection Prevention: ...C. IV catheters, solutions, and tubing changes... v. Every 96 hours ..."

6. A red substance was observed on the surface and dispenser of the HMS. The HMS was not maintained as per the manufacturer's IFU and the OSHA requirements on bloodborne pathogens. Cross reference to A 749, Example #16.

7. A tour of OR 6 was conducted on 5/15/23 at 1055 hours, with the CNO/DSS and IPD. OR 6 had been clean and was designated as ready for patient use. The following items were observed stored on a shelf near the HMS.

* One cardboard box filled with nine "Heparin Assay Cartridges" (supplies used for the HMS to test blood samples), nine needles, and nine syringes.

* One cardboard box filled with 18 "High Range Activated Clotting Time Cartridges," nine syringes, and nine needles.

* One cardboard box filled with nine "Heparin Dose Response Cartridges," nine needles, and nine syringes.

The HMS supplies were available for patient use.

During a concurrent observation and interview with RN 2 on 5/15/23 at 1118 hours in OR 6, RN 2 was preparing OR 6 for a scheduled procedure. RN 2 viewed the supplies on the shelf and stated, the supplies were for cardiovascular perfusion treatments. RN 2 stated she did not have oversight of cardiovascular perfusion supplies, and she did not know why perfusion supplies were stored in the OR. RN 2 stated she did not know if the perfusion supplies could be potentially contaminated and cause cross-contamination for her scheduled surgical patient.

During a concurrent interview with the EVSD and IPD on 5/15/23 at 1125 hours in OR 6, the IPD stated the disposable HMS supplies should have been properly stored in the storeroom and transported to the OR as needed for patient use. The IPD could not explain the role of the infection prevention program for the cardiovascular perfusion team related to prevention of healthcare-associated infections and cross-contamination.

During a concurrent observation and interview with the CEO on 5/15/23 at 1255 hours in OR 6, the CEO confirmed the HMS supplies were in cardboard boxes and labeled with a manufacturer's temperature storage limit of 50 to 77°F. The CEO stated due to OR 6's temperature (acceptable temperature range: 68° to 73°F) and humidity (acceptable humidity range: 30% to 60%) being "intermittently" outside of the acceptable range, the hospital could not verify if the cartridges had not been compromised or if the hospital had followed the manufacturer's guidelines for storage. The CEO stated the cartridges were not safe for patient use or critical blood value testing and the cartridges needed to be discarded immediately.

Review of the manufacturer's label titled, "Medtronics: Heparin Assay Cartridges" undated, indicated the following: "...Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (50°F to 77°F)..."

Review of the manufacturer's label titled, "Medtronics: High Range Activated Clotting Time Cartridges" undated, indicated the following: "...Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (36°F to 77°F)..."

Review of the manufacturer's label titled, "Medtronics: Heparin Dose Response Cartridges" undated, indicated the following: ...Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (50°F to 77°F)..."

Review of the hospital's document titled, "Infection Prevention Program Summary," dated 5/25/22, indicated the following: "Overview: The infection prevention program at [Name of Hospital] is part of its overall commitment to quality. The program is designed to perform comprehensive surveillance for healthcare-associated infections and epidemiologically significant organisms and to create, implement, support, and sustain evidenced-based interventions to prevent healthcare associated infections and transmission of organisms ..."

8. A tour of the surgery department was conducted on 5/15/23 at 0848 hours with the CNO/DSS and IPD. OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6 were designated as clean and ready for patient use. The following findings were observed as follows:

* For OR 1, at 0850 hours: there was grey fuzzy matter in the corners of the room; there was grey fuzzy matter behind the emergency cart; and grey fuzzy matter on two air vents located on the wall.

During an interview with the EVSD on 5/15/23 at 0855 hours, the EVSD confirmed the room was designated as clean and was ready for patient use. The EVSD stated OR 1 was terminally cleaned on 5/14/23 and OR 1 should not have been dusty. The EVSD stated EVS staff inspected the room and the EVS supervisor double checked the room and signed the room off indicating the room had been designated as clean and ready for patient use. The EVSD stated "Additional training and coaching is needed on terminal cleaning."

* For OR 2, at 0905 hours: there were cracks in the wall; chipped paint throughout the room; wall base covers missing; brown-orange matter covered the oxygen tank holder; there were stickers and tape attached to the floor that contained grey and black matter; the examination mattress had a large tear (ripped) and six different holes; the mattress was removed from the examination table and the table base contained orange-brown matter that the EVSD removed with excessive scrubbing.

During a concurrent interview with the EVSD and CNO/DSS on 5/15/23 at 0910 hours, the EVSD confirmed OR 2 was designated as clean and ready for patient use. The EVSD stated the walls were difficult to disinfect (kill germs) due to the paint chipping, cracks, and missing wall plates. The EVSD stated he could not confirm that the walls were disinfected properly. The EVSD stated the bed was not cleaned as indicated in the terminal cleaning manual. The EVSD and CNO/DSS confirmed the brown-orange matter was "rust" and should have been removed.

* For OR 3, at 0915 hours: there was paint chipping throughout the room and orange-brown matter that the EVSD easily removed from two areas of the floor with a cloth dampened with water.

* For OR 5, at 0935 hours: there was orange-brown matter on the wall air vents and ceiling air vents; the floor was covered with thick grey fuzzy matter and red spots that the EVSD easily removed from areas of the floor with a cloth dampened with water.

* For OR 6, at 0945 hours: there was orange-brown matter on the intravenous pole; there was orange-brown matter on the anesthesia cart's wheels and cart holder.

During a follow-up interview with the EVSD and CNO/DSS on 5/15/23 at 1011 hours, the EVSD stated EVS staff should have reported abnormal findings to the EVS leadership team and the EVS leadership team would have reported the findings to the surgical service team. The EVSD could not explain why EVS supervisors signed the operating rooms off as "ready for patient use." The CNO/DSS stated the surgical surgery staff should have inspected the rooms prior to a surgical procedure and reported abnormal findings to the surgical service leadership team. There was no documented evidence that showed the EVS leadership team communicated with the surgical service leadership team about the damages of the OR's or the increase potential for cross-contamination. In addition, there was no documented evidence that showed the surgical team reported the damages to the walls, air vents, floors, examination tables, and other furniture to the OR management team. The CNO/DSS confirmed that damaged structural surfaces could harbor dirt and debris that could not be removed during terminal cleaning had the potential for cross-contaminations.

Review of the hospital's document titled, "Main OR Terminal Cleaning Log," dated 5/14/23 was conducted with the EVSD, on 5/17/23 at 1208 hours in the conference room. The document indicated terminal cleaning was completed for OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6. The EVSD confirmed the rooms had not been used for surgical procedures on 5/15/23 and stated that he could not explain the lack of cleanliness that he observed on 5/15/23.

Review of the hospital's manual titled "OR/Invasive Procedure/L&D Room Cleaning Manual," version 6.01.2020 ER JG, showed the following: "Terminal End Of Day Cleaning:...Hospital Clean: Hospital clean is a measure of cleanliness routinely maintained in care areas of the healthcare setting...Floor and baseboards are free of stains, visible dust, spills, and streaks...Items that are broken, torn, cracked, or malfunctioning are replaced...EVS Room Set-up: Inspect the Room: ...Inspect room: Make sure all surfaces are free of blood, dust, and debris. Correct any deficiencies. Report any facilities deficiencies to OR management..."

Review of the hospital's document titled, "Infection Prevention Program Summary," dated 5/25/22, indicated the following: "Overview: The infection prevention program at [Name of Hospital] is part of its overall commitment to quality. The program is designed to perform comprehensive surveillance for healthcare-associated infections and epidemiologically significant organisms and to create, implement, support, and sustain evidenced-based interventions to prevent healthcare associated infections and transmission of organisms ..."


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9. The temperature levels, humidity levels, and air exchanges were not monitored and maintained in the endoscopy area as per the AORN's guidelines. Cross reference to A 749, Example #1.

10. The portable air conditioners were not used in the patient's care area including pre/post procedure room and procedure room as per the AORN's guidelines. Cross reference to A 749, Example #2.

11. a. On 5/15/23 at 1315 hours, the IPD and CNO/DSS were interviewed. When asked if the temperature logs for the endoscopy area were reviewed, the IPD stated no. When asked, the IPD stated the IC department performed the EOC round every month, but at least one department would be touched every quarter. When asked, the IPD stated the EOC was not done for the endoscopy area last quarter.

The IPD and CNO/DSS acknowledged the above findings.

b. The EOC rounds were not conducted in the OR, endoscopy and radiology areas as scheduled. Cross reference to A 951, Example #8.

Based on observation, interview and record review, the hospital failed to ensure the surgical services were provided and organized to ensure the health and safety of patients as evidenced by:

1. The hospital failed to ensure facility and equipment used for patient care were maintained to ensure the safety of patients and staff. Cross reference to A0700.

2. The hospital failed to provide a sanitary environment and an active infection control program. Cross reference to A0747.

3. The hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services. Cross reference to A0951.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide the safe and effective surgical services.

Based on observation, interview, and record review, the hospital failed to provide a safe and effective environment and maintain acceptable standards of care for the patients receiving surgical services as evidenced by:

1. Failure to ensure three of 12 hand scrub sinks were maintained and functioning.

2. Failure to ensure a scope was sterilized as per the manufacturer's IFU.

3. Failure to ensure a heart lung machine was maintained in a sanitary condition.

4. Failure to ensure the temperature and humidity levels were in acceptable ranges prior to performing procedures for seven of 13 sampled patients (Patients 7, 8, 9, 10, 11, 12, and 13).

5. Failure to ensure the ORs' temperature and humidity levels were maintained and the temperature and humidity levels were monitored on the weekends

6. Failure to ensure the temperature level, humidity levels, and air exchanges were monitored and maintained in the hospital's endoscopy area as per the AORN's guidelines.

7. Failure to ensure the ATP testing was performed as per the hospital's P&P.

8. Failure to ensure the EOC rounds were conducted for the OR, endoscopy, and radiology areas as scheduled.

These failures had the potential to result in poor health outcomes to the patients receiving surgical services in the hospital.

Findings:

1. On 5/15/23 at 1030 hours, a tour of the hospital Operating Room Department was conducted with the IPD and the ORT. The IPD stated the hospital followed the Infection Control National Standards from the AORN.

During the tour, the following observations were made:

a. Three of 12 hand scrub sinks were non-functional (no water dispensed).

b. The PM sticker (a sticker used to indicate when preventative maintenance was performed and when the next preventative maintenance was due) indicated, "Next PM 2/19".

During a concurrent interview at 1100 hours, the ORT stated the sinks had not worked for "at least 2 months" and he reported them to the SSS.

On 5/15/23 at 1115 hours, an interview was conducted with the SSS who stated, "I did submit a repair request to engineering and they came to look at it and that's about it." According to the SSS, she reported it to the engineering on 2/22/23.

On 5/16/23 at 1420 hours, an interview was conducted with the ES who stated the work order was assigned to someone in his department but had no evidence to indicate the work was started or completed.

On 5/16/23 and 1500 hours, review of the hospital's P&P provided by the Director of Quality was conducted. The hospital's P&P titled, "Preventative Maintenance Program, effective 8/14/19" stipulated, "Scope: it is the responsibility of the Engineering Department to maintain the life of the facility and its equipment".

2. The Stryker precision ideal scope were not sterilized as per the manufacturer's IFU. Cross reference to A749, Example #17.

3. On 5/15/23 at 1500 hours, a tour of OR 6 was conducted. A raised yellow substance was found inside of a pink vacuum tubing located on a heart lung machine. According to the CEO, the machine was cleaned and ready to use. The CEO stated the hospital did not clean or maintain the heart lung machine because it was the part of their contracted service with the cardiovascular perfusionist.

On 5/15/23 at 1515 hours, during a telephone interview with CP1, CP1 stated that the tubing should have been disposed of.

Review of the hospital's P&P titled, "Cleaning and Maintenance of Patient Care Equipment, effective 10/20/21" was conducted on 5/16/23 at 0800. The hospital's P&P stipulated, "All patient care equipment must be clean, in working order and safe for patient use at all times ..."


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4. Review of surgical procedures performed for Patients 7, 8, 9, 10, 11, 12, and 13 was conducted. The findings were as follows:

a. Patient 7's medical record review was initiated. Patient 7's medical record showed the patient was admitted to the hospital on 4/11/23.

Review of the Intraoperative Record showed Patient 7 entered OR 6 at 0751 hours and would have a coronary artery bypass surgery (heart surgery)

Review of the Log of Daily Temperature and Humidity Checks in Surgery showed on 4/17/23 at 0502 hours, OR 6 had a humidity level of 73%. Further review of the record failed to show the high humidity level was corrected prior to Patient 7 coming into OR 6 for the surgery.

b. Review of Patient 8's "Face Sheet" (contains demographic and medical information) indicated Patient 8 was admitted to the hospital on 05/01/2023, with a diagnosis of shortness of breath (difficulty breathing).

Review of Patient 8's "Intraoperative Record" dated 05/05/2023, indicated Patient 8 was admitted to OR 6 on 5/5/23 at 0700 to 1408 hours, with a preoperative diagnosis of coronary artery disease (heart disease).

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery" dated 5/5/23, indicated the following temperature and humidity levels:

OR 6

Time: 0457 hours

Temperature: 60.4 °F (acceptable temperature range 68 to 73 degrees Fahrenheit [unit of measurement])

Humidity: 76 % (acceptable humidity range 30% to 60%)

Recheck results

Time: 0627 hours

Temperature: 63 °F

Humidity: 68 %

There was no documented evidence showed the hospital ensured the temperature and humidity levels were within an acceptable range prior to performing the surgical procedure.

During an interview with the IPD on 5/17/23 at 0830 hours at the OR nursing station, the IPD stated the hospital did not have a policy and procedure to address acceptable temperature parameters for the ORs and the staff referenced a hospital document titled, "Log of Daily Temperature and Humidity Checks in Surgery," for acceptable temperature and humidity reading parameters. The IPD confirmed OR 6's temperature measurement reading, and humidity measurement reading were not within a safe range. The IPD stated any readings that were found not to be within the acceptable range/parameter should be reported to the Engineering Manager and OR 6 should not have been used for a patient procedure until the room temperature and humidity readings were acceptable. The IPD stated, "To prevent a potential hospital acquired injury and/or infection the patient's procedure should have been postponed, if possible."

c. Review of Patient 9's "Face Sheet," indicated Patient 9 was admitted to the hospital on 4/30/23, with diagnosis of right foot gangrene (a condition where a loss of blood supply causes body tissue to die).

Review of Patient 9's "Intraoperative Record" dated 5/6/23, indicated Patient 9 was admitted to OR 4 on 5/6/23 at 0735 hours, with a preoperative diagnosis of right foot gangrene.

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery," indicated on 5/6/23, the hospital did not measure a temperature level or a humidity level for OR 4 prior to performing Patient 9's surgical procedure.

d. Review of Patient 10's "Face Sheet," indicated Patient 10 was admitted to the hospital on 5/5/23, with diagnosis of right hip fracture (a break in the hip bone).

Review of Patient 10's "Intraoperative Record" dated 5/7/23, indicated Patient 9 was admitted to OR 5 on 5/7/23 at 0710 hours, with a preoperative diagnosis of right hip fracture.

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery," indicated on 5/7/23, the hospital did not obtain a temperature measurement or a humidity measurement of OR 5 prior to performing Patient 10's surgical procedure.

e. Review of Patient 11's "Face Sheet," indicated Patient 11 was admitted to the hospital on 5/7/23, with diagnosis of appendicitis.

Review of Patient 11's "Intraoperative Record" dated 5/7/23, indicated Patient 9 was admitted to OR 3 on 5/7/23 at 1000 hours, with a preoperative diagnosis of acute appendicitis.

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery," indicated on 5/7/23, the hospital did not obtain temperature measurements or humidity measurements of OR 3 prior to performing Patient 11's surgical procedure.

f. Review of Patient 12's "Face Sheet," indicated Patient 12 was admitted to the hospital on 5/6/23, with diagnosis of cholecystitis.

Review of Patient 12's "Intraoperative Record" dated 5/7/23, indicated Patient 12 was admitted to OR 4 on 5/7/23 at 1145 hours, with preoperative diagnoses which included a gangrene gallbladder and cholelithiasis.

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery," showed on 5/7/23, the hospital did not obtain temperature measurements or humidity measurements of OR 4 prior to performing Patient 12's surgical procedure.

g. Review of Patient 13's "Face Sheet" indicated Patient 13 was admitted to the hospital on 5/5/23, with diagnosis of appendicitis.

Review of Patient 13's "Intraoperative Record" dated 05/06/2023, indicated Patient 13 was admitted to OR 4 on 5/6/23 at 1420 hours, with a preoperative diagnosis of left renal stone, hydronephrosis (kidney injury).

Review of the hospital's surgery log titled "Log of Daily Temperature and Humidity Checks in Surgery," indicated on 5/6/23, the hospital did not obtain temperature measurements or humidity measurements of OR 4 prior to performing Patient 13's surgical procedure.

During an interview with the Governing Board Members (CNO/DSS, IPD, MD 2, CMO, CEO, Director of Quality) on 5/17/23 at 1445 hours, MD 2 stated no patient should be admitted to an operating room if the temperature and/or humidity levels were not within an acceptable range. MD 2 stated the surgical procedure should be rescheduled or redirected to areas of the surgical suite where the temperature and humidity levels were functioning within acceptable ranges.

During an interview with the CNO/DSS on 5/17/23 at 1505 hours in the conference room, the CNO/DSS confirmed Patient 9, Patient 10, Patient 11, Patient 12, and Patient 13 had surgical procedures performed on 05/6/2023 and/or 05/07/2023 (weekend) and there was no documented evidenced showed the hospital monitored temperature levels or humidity levels prior to performing the patient's procedures. The CNO/DSS stated she was not aware OR temperature readings and humidity readings were not monitored on weekends until 05/09/23. The CNO/DSS could not explain the oversight process for ensuring staff monitored and documented temperature and humidity levels daily. The CNO/DSS stated the hospital's P&P for daily temperature and humidity documentation was not followed and additional education was needed to ensure temperature and humidity levels were monitored and documented daily.

Review of the hospital's P&P titled, "Humidity Levels: ICU [Intensive Care Unit], NICU [Neonatal Intensive Care Unit], Nursery, Delivery Rooms, and Operating Rooms," revised 01/27/12, indicated the following: Purpose: The purpose of this policy is to outline the proper humidity levels for Operating Rooms ... Procedure: A. Operating Rooms: 1. Humidity level are kept between 30% and 60%...2. Any readings that are found not to be within the acceptable range are reported to the Engineering Manager .... Documentation: Humidity measurement readings are documented daily and maintained in the Engineering Department ..."

5. Review of the hospital's P&P titled Humidity Levels: ICU, NICU, Nursery, Delivery Rooms and Operating Rooms, dated 1/27/12, showed for the Operating Room (OR), the humidity levels are kept between 30% to 60%. Any readings that are found not to be within the acceptable ranges are reported to the Engineering Manager.

a. A tour of the surgery department was conducted on 5/15/23 at 0848 hours with the CNO/DSS and IPD. Temperature and humidity wall monitors were observed in OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6. The following temperature and humidity readings were observed as follows:

* For OR 1, at 0850 hours; the temperature level was 69.3° F (the acceptable temperature range was from 68° to 73° F) and the humidity level was 60%.

* For OR 2, at 0905 hours, the temperature level was 66.4°F and the humidity level was 70 %.

* For OR 3, at 0915 hours, the temperature level was 63.5°F and the humidity level was 80 %.

* For OR 4, at 0925 hours, the temperature level was 68.2°F and the humidity level was 58 %.

* For OR 5, at 0935 hours, the temperature level was 63.1°F and the humidity level was 74 %.

* For OR 6, at 0945 hours, the temperature level was 68.2°F and the humidity level was 58 %.

During an interview with the CNO/DSS on 5/15/23 at 0950 hours in the OR nurse station, the CNO/DSS confirmed four of six sampled ORs (OR 2, OR 3, OR 4, and OR 5) temperature and/or humidity levels were not within an acceptable range. The CNO/DSS stated temperature and humidity levels found outside of the acceptable range should be reported to the Engineering Manager.

During a concurrent interview with MD 1 and the SSS on 5/15/23 at 0955 hours in the OR nurse station, MD 1 stated the surgery schedule was on hold and he did not understand why the hospital's surgery schedule was on hold. The SSS stated the surgery schedule was on hold due to abnormal humidity ranges. MD 1 stated, "I perform surgical procedures daily and I was not aware there was a problem maintaining proper humidity levels."

During an interview with the ES on 5/15/23 at 1003 hours in the OR nurse station, the ES stated the "HVAC" system was not functioning properly and the hospital had to adjust the system manually to achieve the desired temperature and humidity ranges. The ES stated the HVAC could be out of range and exhibit a small variance for a short period of time to a large variance for a long period of time. The ES stated the issue was "worst" on warm days because it was difficult to maintain acceptable temperature and humidity levels. The ES stated the current HVAC system needed to be repaired or be replaced.

During an interview with the CEO on 5/15/23 at 1255 hours in OR 6, the CEO stated the HVAC system had been "intermittently" malfunctioning since June 2022 and the HVAC system had recently worsened due to the warm weather. The CEO stated the engineering department was adjusting the temperature and humidity levels manually and the HVAC's adjusting valves had broken. The CEO stated the hospital did not have a documented HVAC risk assessment and she could not explain how the hospital evaluated the effectiveness of the infection prevention program related to the malfunctioning of the HVAC system.

b. Review of the Log of Daily Temperature and Humidity Checks in Surgery failed to show evidence of temperature and humidity monitoring on 4/15 and 4/16/23 (on the weekends).

Review of the Surgery Log dated 4/15/23, showed there was one surgery in OR 3, three surgeries in OR 4, and one surgery in OR 6.

c. Review of the hospital document titled, "Log of Daily Temperature and Humidity Checks for Surgery," dated 5/1/23 to 5/14/23 was conducted with the IPD on 5/17/23 at 0903 hours in the OR office. The log showed the following humidity and/or temperature levels identified outside of acceptable ranges:

* On 5/1/23 at 0456 hours:

For OR 1, the temperature level was 65.8 °F and the humidity level was 68%.

For OR 2, the temperature level was 63.9 °F and the humidity level was 78%.

For OR 3, the temperature level was 62.2 °F and the humidity level was 81%.

For OR 4, the temperature level was 62.8 °F and the humidity level was 80%.

For OR 5, the temperature level was 60.6 °F and the humidity level was 81%.

For OR 6, the temperature level was 61.9 °F and the humidity level was 77%.

* On 5/2/23 at 0456 hours:

For OR 5, the temperature level was 59.5 °F and the humidity level was 66%.

For OR 6, the temperature level was 60.6 °F and the humidity level was 64%.

* On 5/3/23 at 0556 hours:

For OR 5, the temperature level was 59.6 °F and the humidity level was 62.1%.

* On 5/4/23 at 0455 hours:

For OR 1, the temperature level was 63.9 °F and the humidity level was 68%.

For OR 2, the temperature level was 62.8 °F and the humidity level was 70%.

For OR 3, the temperature level was 61.0 °F and the humidity level was 74%.

For OR 4, the temperature level was 61.7 °F and the humidity level was 72%.

For OR 5, the temperature level was 60.1 °F and the humidity level was 77%.

For OR 6, the temperature level was 61.0 °F and the humidity level was 73%.

* On 5/5/23 at 0457 hours:

For OR 2, the temperature level was 62.8 °F and the humidity level was 71%.

For OR 3, the temperature level was 61.5 °F and the humidity level was 73%.

For OR 4, the temperature level was 61.9 °F and the humidity level was 73%.

For OR 5, the temperature level was 59.9 °F and the humidity level was 79%.

For OR 6, the temperature level was 60.4 °F and the humidity level was 76%.

* On 5/6/23, there was no evidence that showed the temperature and humidity levels were monitored.

* On 5/7/23, there was no evidence that showed the temperature and humidity levels were monitored

* On 5/8/23 at 0510 hours:

For OR 5, the temperature level was 60.4 °F and the humidity level was 72%.

For OR 6, the temperature level was 60.8 °F and the humidity level was 70%.

* On 5/9/23 at 0508 hours:

For OR 2, the temperature level was 63.9 °Fand the humidity level was 72%.

For OR 3, the temperature level was 62.8 °F and the humidity level was 75%.

For OR 4, the temperature level was 63.0 °F and the humidity level was 74%.

For OR 5, the temperature level was 59.2 °F and the humidity level was 78%.

For OR 6, the temperature level was 60.3 °F and the humidity level was 74%.

* On 5/11/23 at 0454 hours:

For OR 1, the temperature level was 61.7 °F and the humidity level was 68%.

For OR 2, the temperature level was 63.7 °F and the humidity level was 65%.

For OR 3, the temperature level was 62.2 °F and the humidity level was 66%.

For OR 4, the temperature level was 62.8 °F and the humidity level was 67%.

For OR 5, the temperature level was 57.0 °F and the humidity level was 76%.

For OR 6, the temperature level was 58.8 °F and the humidity level was 73%.

* On 5/12/23 at 0456 hours:

For OR 1, the temperature level was 65.7 °F and the humidity level was 63%.

For OR 2, the temperature level was 64.7 °F and the humidity level was 68%.

For OR 4, the temperature level was 64.6 °F and the humidity level was 63%.

For OR 5, the temperature level was 59.2 °F and the humidity level was 78%.

For OR 6, the temperature level was 61.5 °F and the humidity level was 69%.

* On 5/13/23 at 1230 hours:

For OR 2, the temperature level was 55.0 °F and the humidity level was 69%.

For OR 3, the temperature level was 54.0 °F and the humidity level was 75%.

For OR 4, the temperature level was 54.0 °F and the humidity level was 75%.

For OR 5, the temperature level was 56.0 °F and the humidity level was 73%.

For OR 6, the temperature level was 55.0 °F and the humidity level was 71%.

* On 05/14/23 at 1315 hours:

For OR 5, the humidity level was 77%.

The IPD confirmed the documented temperature and humidity levels were accurate and were out of the established acceptable ranges. There was no documented evidence showed the temperature and humidity levels were within acceptable ranges prior to performing surgical procedures. The IPD confirmed the hospital's Infection Prevention Program Summary dated 05/25/2022, included the most current infection prevention risk assessments and the HVAC system or ORs were not included. The IPD stated the documented risk assessment of the ORs or HVAC system was not performed when a variance in the temperature and humidity ranges were identified. The IPD stated a malfunction with the HVAC system was considered a significant change and the documented risk assessment should have been initiated for the "ongoing" variance in temperature and humidity ranges identified in June 2022. The IPD stated the hospital followed Infection Control National Standards from the AORN. The IPD confirmed the AORN Guidelines for Perioperative Practice, dated 2023, indicated the following: Guideline "12.6 Designated perioperative team members in collaboration with the interdisciplinary team should perform risk assessments of the surgical suite if a variance in the parameters of the HVAC occurs ..." The IPD stated the purpose of the risk assessment is to reduce the risk of infection transmission and "I have no excuse."

Review of the hospital document titled, "Infection Prevention Program Summary" dated 5/25/22, indicated the following: "Overview: The infection prevention program at [Name of Hospital] is part of its overall commitment to quality. The program is designed to perform comprehensive surveillance for healthcare-associated infections and epidemiologically significant organisms and to create, implement, support, and sustain evidenced-based interventions to prevent healthcare associated infections and transmission of organisms ...Infection Control Risk Assessment: The medical center conducts an annual risk assessment for transmission and acquisition of infectious agents. Additionally, the risk assessment is reviewed whenever there is a significant change in any of the factors listed ...2. Building risk, utility failures ...5. The care, treatment, and service provided ..."


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6. The temperature levels, humidity levels, and air exchanges were not monitored and maintained in the hospital's endoscopy area as per the AORN's guidelines. Cross reference to A 749, example # 1.

7. Review of the hospital's P&P titled Cleaning and Processing Flexible Endoscopes and Endoscope Accessories dated 5/19, showed cultures are obtained after the endoscope has been reprocessed (after drying) and include the instrument channel and the distal end of the endoscope.

On 5/15/23 at 0849 hours, during the entrance conference with the CEO, CNO/DSS, and IPD, the CNO stated the position of the director of GI services had been vacant, and she oversaw GI services as an interim director of endoscopy services.

On 5/15/23 at 1440 hours, GI Tech 2 was observed cleaning the used endoscope in the reprocessing room. It was observed GI Tech 2 performing ATP testing after manual cleaning and before placing the endoscope in the reprocessor.

During an interview with the CNO on 5/17/23 at 1018 hours, the CNO acknowledged the above findings.


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8. Review of the 2022/2023 EOC Rounds Schedule showed the following:

* The OR was scheduled for inspection on 9/21/22 and again on 4/26/23.

* The GI Lab or endoscopy area was scheduled for inspection on 10/5/22 and 5/10/23.

* The Radiology was scheduled for inspection on 10/12/22 and 5/17/23.

However, the IPD confirmed the rounding data was not found and no EOC rounds were done for 2023 as scheduled.

On 5/17/23 at 1423 hours, the IPD verified the above findings.