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Based observations, staff interviews, and review of policies and procedures, it was determined that the facility failed to maintain a safe setting for patient care.

Findings include:

1. The facility failed to ensure a risk assessment was completed prior to the installation of portable air conditioners on the Behavioral Health Unit. (Cross refer to Tag A 0144).

2. The facility failed to ensure a risk assessment was completed prior to the installation of portable air conditioners and portable fans on patient care units. (Cross refer to Tag A 0144).

3. The facility failed to ensure that portable box fans were not used in high-risk areas (Intensive Care Unit). (Cross refer to Tag A 0144).

4. The facility failed to provide maintenance logs and work orders for the portable cooling devices (portable air conditioners and portable fans) to ensure the safety of the devices before use. (Cross refer to Tag A 0144).

Based on staff interviews and review of facility policies, it was determined that the facility failed to provide care in a safe setting by ensuring: 1) a risk assessment is completed prior to the installation of portable air conditioners on the Behavioral Health Unit, in accordance with facility policy; 2) a risk assessment is completed prior to the installation of portable air conditioners and portable fans on patient care units, in accordance with facility policy; 3) portable box fans are not used in high-risk areas (Intensive Care Unit), in accordance with facility policy and; 4) maintenance logs and work orders are provided for the portable cooling devices (portable air conditioners and portable fans) to ensure the safety of the devices before use, in accordance with facility policy.

Findings include:

1. Reference: Facility policy titled "Portable Space Comfort Devices" Revised: May 2022, states, " ... d. Prior to commencing use of a portable space comfort cooling device, confirm: ... iv. A risk assessment has been performed by Infection Control or the Nurse Supervisor (on off-shifts) ..."

On 6/28/22 at 12:24 PM, a tour was conducted of the fourth (4th) floor Involuntary and Voluntary Behavioral Health Units in the presence Staff #2, Staff #3, and Staff #18. There were four (4) portable air conditioners observed in the hallways of the units. Two (2) of the portable air conditioners were located in the corridor on the voluntary unit and two (2) of the portable air conditioners were located in the corridor on the involuntary unit. There was one (1) patient on the voluntary behavioral health unit that expressed suicidal ideation as per his/her medical record.

The portable air conditioners have exposed electrical cords, approximately five (5) feet in length, that present a ligature risk.

Electrical cords on the two (2) portable air conditioners on the involuntary unit are not visible on surveillance cameras or by the security guard.

Hot air output tubing of one (1) portable air conditioner on the involuntary unit was connected to the ceiling with a large zip tie that could present a ligature risk and injury if the tubing was pulled away from the ceiling.

The two (2) portable air conditioners, one (1) on the voluntary unit and one (1) on involuntary unit, have an easily removable filter attached to a metal grid fastener with exposed prongs that could cause injury.

During the tour, a security guard was sitting in a chair in the involuntary corridor outside the locked central nurse's station. The guard was positioned over ten (10) feet away from one (1) portable air conditioner on the side where the electrical cords were not visible. The security guard was down the corridor, approximately 50 feet, from the the second portable air conditioner unit on the involuntary unit.

A review of the monitors in the central nurse's station identified that the second portable air conditioner on the involuntary unit was not easily visible via the video monitoring. The second portable air conditioner was located on two (2) of the video monitors, but was small and covered by the time stamp on each monitor, thus rendering the second portable air conditioning unit unable to be well visualized by the video monitoring.

Upon request to Staff #2 and Staff #3 on 6/28/22 at 12:24 PM, the facility was unable to provide evidence of a documented risk assessment for the portable air conditioners prior to their placement on the behavioral health units.

Staff #2 and Staff #18, a nurse manager, stated that a security guard is placed on the involuntary unit to monitor the portable air conditioners. Staff #2 and Staff #18 also stated that staff were always around to check, and the portable air conditioners were visible on monitors at the central nurse's station.

An interview was conducted with Staff #31, a security guard, it was determined that he/she was able to identify if a person was behind the portable air conditioner because he/she would see a shadow and would go to investigate. Staff #31 stated that he/she did not designate someone on the unit to monitor the other portable air conditioners if he/she got up from his/her chair. Staff #31 stated, "There is always someone around."

On 6/29/22 at 9:30 AM, Staff #5 stated that he/she was unable to find evidence that the facility had conducted a risk assessment prior to the installation of the air conditioners on the behavioral health unit in accordance with facility policy.

The above findings resulted in an Immediate Jeopardy (IJ) related to Patient Rights.

On 6/30/22 at 5:45 PM, the facility Chief Medical Officer (CMO) and the Director of Quality were informed of the IJ.

On 6/30/22 at 5:52 PM, a copy of the IJ template was provided to the CMO and an immediate removal plan was requested at that time.

On 7/5/22 an acceptable removal plan was received. The IJ was removed upon on-site verification that the facility had removed the portable air conditioners and that a risk assessment had been performed with an appropriate plan for monitoring in place to ensure safety of the patients.

2. Reference: Facility policy titled "Portable Space Comfort Devices" Revised: May 2022, states, " ... d. Prior to commencing use of a portable space comfort cooling device, confirm: ... iv. A risk assessment has been performed by Infection Control or the Nurse Supervisor (on off-shifts) ..."

On 6/28/22 at 10:51 AM, a tour was conducted of the following units: Intensive Care Unit (ICU), 5 West, Involuntary and Voluntary Behavioral Health Units, and Detox Unit. Portable air conditioners were observed in the corridors of the units, and portable fans were observed in patient rooms as follows:

ICU: Three (3) portable air conditioners in the following areas: One (1) in the corridor between Rooms 525 and 526; one (1) in the corridor between Rooms 522 and 523; and one (1) unit not in use in a four (4) bed pod area at the end of the corridor in the ICU. Portable box fans were observed in the following patient rooms: Room 523; Room 524; Room 525; and Room 526.

5 West Unit: Four (4) portable air conditioners in the following areas: One (1) in the corridor between Rooms 566 and 567; one (1) in the corridor between Rooms 562 and 563; one (1) in the corridor between Rooms 557 and 558; and one (1) in the corridor between Rooms 582 and 583. Portable box fans were observed in use in the following patient rooms: Room 555; Room 566-1; and Room 569-2.

Upon request, the facility was unable to provide documentation of a risk assessment being performed prior to the installation of the portable air conditioners and the portable box fans on patient care units. On 6/29/22 at 9:30 AM, Staff #5 stated that he/she was unable to find evidence that the facility had conducted a risk assessment prior to the installation of the portable cooling devices on patient care units in accordance with facility policy.

3. Reference: Facility policy titled "Portable Space Comfort Devices" Revised: May 2022, states, "... Cooling Devices ... c. Devices should NOT be used in the following situations: 1. In high-risk areas including operating rooms, critical care units, dialysis units, procedural areas ..."

On 6/28/22 at 10:51 AM, a tour was conducted of the Intensive Care Unit (ICU) and portable fans were observed in patient rooms as follows:

ICU: Three (3) portable air conditioners in the following areas: One (1) in the corridor between Rooms 525 and 526; one (1) in the corridor between Rooms 522 and 523; and one (1) unit not in use in a four (4) bed pod area at the end of the corridor in the ICU. Portable box fans were observed in the following patient rooms: Room 523; Room 524; Room 525; and Room 526.

On 6/28/22 at 1:03 PM, Staff #5 and Staff #6 confirmed the above findings and stated that the fans should not have been used in the critical care areas and would be removed.

4. Reference: Facility policy titled "Portable Space Comfort Devices" Revised: May 2022, states, "... Cooling Devices ... a. Requests for the use of portable space comfort cooling devices shall be made via the department/unit manager. b. Devices will be disinfected between patients and when visibly soiled by Environmental Services via a maintenance care requisition. i. Upon discharge, devices will be moved to the soiled utility room. ii. Staff will submit a maintenance care requisition for device pick-up/disinfection ... iii. Maintenance will retrieve and disassemble the device. Once disassembled, Maintenance will notify environmental services ..."

Reference: Facility policy titled "Utility Management Plan" Reviewed: March 2021, states, "... The Utilities Management Plan supports the organizational environment, which establishes and maintains a facility-wide Utilities Management program which will: -Identify, evaluate, and assess new and existing equipment to determine appropriate use in a patient care environment; -Assure that a comprehensive preventative maintenance and inspection program is maintained ... A current, accurate, unique inventory is kept of all equipment included i the Utilities Management Program, regardless of the equipment's ownership or purpose ..."

Upon request to Staff #3, the facility was unable to provide evidence that preventative maintenance had been completed and/or was scheduled for the portable air conditioners at the facility.

On 6/28/22 at 12:00 PM, Staff #3 stated that the vendor of the portable air conditioners does all the maintenance of the equipment on a monthly basis and that [Staff #3] does not keep a record of the maintenance that was completed, but could get a copy. Upon request, Staff #3 was unable to provide evidence of the monthly preventative maintenance completed for the portable air conditioners at the facility from the vendor.

Upon review of the policy for the Utilities Maintenance Plan on 6/29/22 at 2:50 PM, Staff #3 stated that he/she was now aware that he/she was responsible for the maintenance of a log of the portable air conditioners and performs the preventative maintenance on each unit.

On 6/28/22 at 11:41 AM, a tour was conducted of the 5 West unit. A portable fan was observed in Patient #4's room propped at an angle in between the arms of a chair. The fan was blowing towards the upper body of Patient #4. Upon inspection, the fan's grate and frame had significant indentations. The fan was labeled "Fan #5" and had no other label indicating that it had been checked by the facility as safe to use.

A request was made to Staff #3 for the maintenance care requisition for "Fan #5" for the month of June 2022 and documentation that the fan was deemed safe for use.

On 7/5/22, Staff #5 provided a maintenance care requisition for "Fan #5" dated 6/13/22. When questioned if this requisition was all there was for June, Staff #5 stated that he/she would check with Staff #3. Upon interview, Staff #3 stated "if that was all that was provided, then that is all there is."

Patient #4 was admitted to the facility on 6/27/22. The facility was unable to provide evidence that the fan had been maintained prior to the usage of the fan with Patient #4. The facility was unable to provide evidence that the fan had been checked for safety after the damage had occurred prior to the usage of the fan for Patient #4.

Based on a random observation, staff interview and review of facility policy and procedure, it was determined that the facility failed to ensure that medications are stored in secure and locked areas, in accordance with facility policy.

Findings include:

Reference: Facility policy titled "Storage General" Reviewed: June 2021, states, "I. Policy...Medication Storage Areas...All drugs and biologicals must be secure; ...Generally, all drugs should be kept in a locked room or container. ...Storage of Medications Between Receipt and Administration...All drugs removed from a medication storage area must be removed just prior to administration and only for one patient at a time. Once removed, the drug must remain with the individual at all times and may not be left unattended. ..."

On 6/30/22 at 10:25 AM, during a tour of the Operating Room (OR) Suite, there was a bin on top of the medication refrigerator located directly outside of OR #4. The bin contained one (1) 10 ml (milliliter) vial of 0.25% Bupivicaine 25 mg (milligrams)/10 ml and one (1) 5 ml bottle of Ketorolac Tromethamine Ophthalmic solution. The bin was unlocked and unattended.

The facility policy addressing storage and security of medications was requested and reviewed. The facility failed to ensure that medications were kept locked and secure in accordance with the above referenced policy.

These findings were brought to the attention of Staff #9, who confirmed that the medications should have been in a locked secure area.

Based on observations, document review, and staff interviews, it was determined that the facility failed to ensure a safe environment for the patients.

Findings include:

1. The facility failed to ensure the buildings air handling system was maintained and function sufficiently to ensure the safety and well-being of the patients to maintain facility temperatures in patient care areas. (Cross refer to Tag A 0724).

2. The facility failed to ensure that a hazard vulnerability assessment was completed at the facility. (Cross refer to Tag A 0701).

3. The facility failed to provide maintenance logs and work orders for all the portable cooling devices (portable air conditioners and portable fans) to ensure the safety of the devices before use. (Cross refer to Tag A 0724).

4. The facility failed to ensure proper airflow and ventilation requirements is maintained in the endoscopy reprocessing room in accordance with facility policy, FGI (Facility Guidelines Institute) and SGNA (Society of Gastroenterology Nurses and Associates) guidelines. (Cross refer to Tag A 0726).

5. The facility failed to ensure temperature and humidity is monitored and maintained in Operating Rooms (ORs), Sterile Storage areas, Sterile Processing areas and the Endoscopy Procedure Room, in accordance with facility policy, FGI, and AORN (Association of periOperative Registered Nurses) guidelines. (Cross refer to Tag A 0726).

Based on staff interview and review of facility documentation, it was determined that the facility failed to ensure that a hazard vulnerability assessment is completed at the facility.

Findings include:

Reference: Facility document titled "Emergency Operations Plan" dated April 2019, states, "... Hazard Vulnerability Assessment ... A facility hazard vulnerability analysis is completed on an annual basis to identify events that could affect demand for its services or its ability to provide those services, the likelihood of those events occurring and the consequences of those events ..."

Reference: Facility document titled "2022 Quality and Patient Safety Plan" states, "...The Board of Directors (Board) is the governing body of [Facility Name] and has the ultimate responsibility for the quality of patient care and services in the Hospital ... The Performance Improvement Committee coordinates the various aspects of the Quality and Patient Safety Program ... Patient safety is a responsibility of the Board of the Director, all Employees, and all Medical Staff members. A vital aspect of ensuring a culture of safety is adverse event prevention, management and response ... If Quality, Risk, or Senior Leaders assess an incident as a serious event, or a reportable event, a detailed investigation of the facts, followed by corrective action is implemented ..."

On 6/28/22 at 9:55 AM during an interview, Staff #2 and Staff #5 stated that the facility has a plan to provide for patient comfort and care in times of excessive heat when the building's air conditioning is not working properly. Upon request to Staff #2 and Staff #5, the facility was unable to provide a written plan approved by the governing body for the comfort and care of patients during times of excessive heat.

On 6/28/22 at 12:54 PM, the facility emergency operations plan, dated April 2019, was reviewed. A copy of the hazard vulnerability assessment was requested of Staff #2 at 2:55 PM. The facility was unable to provide documentation of the hazard vulnerability assessment for the facility.

Based on observations, document review, and staff interviews, it was determined that the facility failed to ensure: 1) the buildings air handling system is maintained and functioning sufficiently to ensure the safety and well-being of the patients to maintain facility temperatures in patient care areas; 2) to provide maintenance logs and work orders for all the portable cooling devices to ensure the safety of the devices before use.

Findings include:

1. Reference: Guidelines for Design and Construction of Hospitals The Facility Guidelines Institute (FGI), 2018 edition, Table 7.1 page 9-11 states, "2.1-8.2 Heating, Ventilation, and Air-Conditioning (HVAC) Systems are defined as Part 3 (ANSI/ASHRAE/ASHE Standard 170: Ventilation of Health Care Facilities). ... Table 7.1 Design Parameters-Hospital Spaces,... Critical and Intensive Care ... 70-75 degrees Fahrenheit ... Patient Room ... 70-75 degrees Fahrenheit ... Medication Room ... 70-75 degrees Fahrenheit ..."

On 6/27/22 at 2:35 PM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by three (3) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside the Behavioral Health Unit Day Room.

On 6/27/22 at 2:40 PM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by two (2) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside patient Room 401.

On 6/27/22 at 2:44 PM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by two (2) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside patient Room 418.

On 6/28/22 at 11:00 AM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by two (2) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside ICU patient Room 526.

On 6/28/22 at 11:45 AM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by two (2) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside patient Rooms 558, 562, 567, and 583.

On 6/28/22 at 12:00 PM, in the presence of Staff #2 and Staff #3, a three (3) foot tall by two (2) foot wide by three (3) foot long Movincool Classic Plus portable air conditioner was located in the corridor outside patient Room 400 and 408.

During an interview with Staff #3 on 6/27/22 at 12:00 PM, he/she confirmed that portable air conditioners were installed in the corridors throughout the hospital because the hospital air handlers could not maintain appropriate room temperatures. Staff #3 confirmed that almost every unit in the hospital is utilizing one. Surveyors observed portable air conditioners in the Same Day Surgery Unit, Emergency Department, Fourth Floor Patient Unit, and Fifth Floor.

On 6/27/22 at 2:05 PM, in occupied Intensive Care Unit (ICU) Room M 526, Staff #3 took the room temperature and determined the temperature to be 80 degrees Fahrenheit.

On 6/27/22 at 2:20 PM, on the 5th floor, Staff #3 took the room temperature in occupied patient room 561 and determined the temperature to be 80 degrees Fahrenheit.

On 6/27/22 at 2:25 PM, on the 5th floor, Staff #3 took the room temperature in occupied patient room 560 and determined the temperature to be 80 degrees Fahrenheit.

On 6/27/22 at 2:30 PM, in the 5th floor West Medication Room, Staff #3 took the room temperature and determined the temperature to be 80 degrees Fahrenheit.

Upon request to Staff #3 on 6/28/22 at 10:30 AM, Staff #3 was unable to provide information on how many portable air conditioners were in the facility and where each portable air conditioner was located.

On 6/29/22 at 12:05 PM and on 6/30/22 at 9:55 AM, upon request to Staff #3, the facility was unable to provide documentation of a list of all the portable air conditioners at the facility.


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2. Reference: Facility policy titled "Portable Space Comfort Devices" Revised: May 2022, states, "... Cooling Devices ... a. Requests for the use of portable space comfort cooling devices shall be made via the department/unit manager. b. Devices will be disinfected between patients and when visibly soiled by Environmental Services via a maintenance care requisition. i. Upon discharge, devices will be moved to the soiled utility room. ii. Staff will submit a maintenance care requisition for device pick-up/disinfection ... iii. Maintenance will retrieve and disassemble the device. Once disassembled, Maintenance will notify environmental services ..."

Reference: Facility policy titled "Utility Management Plan" Reviewed: march 2021, states, "... The Utilities Management Plan supports the organizational environment, which establishes and maintains a facility-wide Utilities Management program which will: -Identify, evaluate, and assess new and existing equipment to determine appropriate use in a patient care environment; -Assure that a comprehensive preventative maintenance and inspection program is maintained ... A current, accurate, unique inventory is kept of all equipment included i the Utilities Management Program, regardless of the equipment's ownership or purpose ..."

Reference: The Manufacturer's Instruction Manual titled, "Movincool Spot Cooling Systems" states, "6-1 Daily ... inspection A. Check air filters At least once a week or every two or three days remove the air filters and check them. If they are dirty, wash them."

Upon request to Staff #3, the facility was unable to provide evidence that preventative maintenance had been completed and/or was scheduled for the portable air conditioners at the facility.

On 6/28/22 at 12:00 PM, Staff #3 stated that the vendor of the portable air conditioners does all the maintenance of the equipment on a monthly basis and that [Staff #3] does not keep a record of the maintenance that was completed, but could get a copy. Upon request, Staff #3 was unable to provide evidence of the monthly preventative maintenance completed for the portable air conditioners at the facility from the vendor.

Upon review of the policy for the Utilities Maintenance Plan on 6/29/22 at 2:50 PM, Staff #3 stated that he/she was now aware that he/she was responsible for the maintenance of a log of the portable air conditioners and performs the preventative maintenance on each unit.

On 6/28/22 at 11:41 AM, a tour was conducted of the 5 West unit. A portable fan was observed in patient Room 566-1 propped at an angle in between the arms of a chair. The fan was blowing towards the upper body of Patient #4. Upon inspection, the fan's grate and frame had significant indentations. The fan was labeled "Fan #5" and had no other label indicating that it had been inspected by the facility as safe to use.

A request was made to Staff #3 for the maintenance care requisition for "Fan #5" for the month of June 2022 and documentation that the fan was deemed safe for use.

On 7/5/22, Staff #5 provided a maintenance care requisition for "Fan #5" dated 6/13/22. When asked if this requisition was all there was for June, Staff #5 stated that he/she would check with Staff #3. Upon interview, Staff #3 stated "if that was all that was provided, then that is all there is."

Patient #4 was admitted to the facility on 6/27/22. The facility was unable to provide evidence that the fan had been maintained prior to the usage of the fan with Patient #4. The facility was unable to provide evidence that the fan had been inspected after the damage had occurred and prior to the usage of the fan in Room 566-1.

Upon request to Staff #3 on 6/28/22 at 10:30 AM, Staff #3 was unable to provide information on how many portable air conditioners were in the facility and where each portable air conditioner was located. On 6/29/22 at 12:05 PM and on 6/30/22 at 9:55 AM, upon request to Staff #3, the facility was unable to provide documentation of a list of all the portable air conditioners at the facility.

On 6/30/22 at 9:55 AM, Staff #3 stated that his/her staff were still trying to create a list in order to be able to monitor each piece of equipment for preventative maintenance and repairs. Staff #3 confirmed that the portable air conditioners had not been inspected by the facility biomedical engineering department prior to use in the facility.

Based on observations, staff interviews, review of facility documents and nationally recognized guidelines, it was determined that the facility failed to ensure: 1) proper airflow and ventilation requirements is maintained in the endoscopy reprocessing room in accordance with facility policy, FGI (Facility Guidelines Institute) and SGNA (Society of Gastroenterology Nurses and Associates) guidelines and; 2) temperature and humidity is monitored and maintained in accordance with facility policy, FGI and AORN (Association of periOperative Registered Nurses) guidelines.

Findings include:

1. Reference: Facility policy titled "Temperature, Humidity, and Air flow SPD" Reviewed: January 2018, states, "...VI. Procedure: The data for the temperature, humidity, and air exchanges were selected from the AIA (2001) and Guidelines for Design and Construction of Health Care Facilities (2010). They either meet or exceed recommendations from these 2 references. 1. Decontamination Area...Air flow - 6 air exchanges per hour under negative pressure. ..."

Reference: SGNA Standard of Infection Prevention in the Gastroenterology Setting 2019 states, "... Endoscopy Environment, Cleaning, and Disinfection ... Environment of Care Considerations ... There should be negative air pressure in the reprocessing room and a minimum of 10 exchanges per hour, with at least two being fresh, outside air ..."

Reference: Guidelines For Design And Construction Of Hospitals The Facility Guidelines Institute (FGI) 2018 edition; Table 7.1 page 11 states, "... Design Parameters - Hospital Spaces (continued) Function of Space ... Endoscope cleaning ... Pressure Relationship to Adjacent areas ... Negative ... Minimum Total ach (air exchanges) ... 10 ..."

On 6/30/22 at 11:14 AM, during a tour of the Endoscopy Procedure Room, a door inside the room was observed to be unlatched and ajar. Staff #9 confirmed that the door leads to the Endoscopy Reprocessing Room. Staff #10 explained that the door does not fully close and latch and reported the issue to the facilities department several times since last year. Staff #3, Director of Facilities, indicated that he/she began working for the facility two months ago and was not aware of the issue. Upon interview, Staff #10 stated that he/she monitors the adjoining Endoscopy Reprocessing Room for negative pressure and that the room is not able to maintain negative pressure. Staff #10 confirmed that although he/she monitors negative pressure, he/she does not keep a log.

Staff #2 and Staff #5 confirmed that the facility follows SGNA guidelines for the endoscopy suite.

On 6/30/22 at 11:15 AM, the facility policy regarding air flow in the endoscopy reprocessing room was requested. Staff #2 provided a policy titled "Temperature, Humidity, and Air Flow SPD." The policy indicated that the facility air flow parameters were based on the Guidelines for Design and Construction of Health Care Facilities (2010). On 7/5/22 at 10:15 AM, Staff #3 stated that the facility follows the 2018 FGI guidelines. The facility policy was not in accordance with the above referenced SGNA and FGI guidelines for 2010 or 2018.

2. Reference: Facility policy titled "Temperature, Humidity, and Air flow SPD" Reviewed: January 2018, states, "...VI. Procedure: The data for the temperature, humidity, and air exchanges were selected from the AIA (2001) and Guidelines for Design and Construction of Health Care Facilities (2010). They either meet or exceed recommendations from these 2 references. ...3. Sterile Storage Area: Design Temperature - 68-75F [Fahrenheit] Humidity - Maximum 60% Air exchanges - 4 under positive pressure. 4. Each day the facility is open, the processing staff is required to document the temperature and humidity in the Decontamination, Prep/Packaging/Sterilization and Sterile Storage Areas. The readings will be documented in the logs...5. Any variance from the above norms should be immediately reported to the SPD Supervisor or Perioperative Manager, who will then discuss the variances with Engineering and Infection Control... 6. Any corrective action taken should be documented on the log(s). ..."

Reference: Facility policy titled "Temperature and Humidity Policy" Revised: May 2022, states, "...III. Procedure A. Temperature/Humidity Ranges: Area Operating Room...Temperature 68-75 F...Humidity20-60%..."

Reference: AORN 2022 Edition Guidelines For Perioperative Practice, Guideline For Design and Maintenance Recommendation 12. Surface and HVAC (Heating, Ventilation and Air Conditioning) 12.3 states, "Maintain the operational values for HVAC settings at either the settings described in Recommendation 2.6.1 or the settings that applied at the time of design or the most recent renovation of the HVAC system and as stated in the state or local regulations...12.5 Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedure. ...12.7.1 The HVAC system functionality must be monitored and maintained within acceptable standards of practice. ...12.11 Do not use free-standing fans, portable humidifiers, air conditioners, and dehumidifiers. These devices all contain a fan that when running can disrupt the planned airflow within the room and may transfer unwanted particles from the floor to the surgical site. Humidifiers and dehumidifiers contain standing water that may be a source for Legionella..."

Reference: Guidelines For Design And Construction Of Hospitals The Facility Guidelines Institute (FGI) 2018 edition; Table 7.1 states, "... Design Parameters - Hospital Spaces (continued) Function of Space ...Operating Room [OR]...Pressure Relationship to Adjacent areas ... Positive... Minimum Total ach (air exchanges) ...20...Design Relative Humidity (k), %...20-60...Design Temperature (I), °F/°C...68-75/20-24...Function of Space ...Gastrointestinal endoscopy procedure room...Pressure Relationship to Adjacent areas ... NR [no requirement] ... Minimum Total ach (air exchanges) ...6 ...Design Relative Humidity (k), %...20-60...Design Temperature (I), °F/°C...68-73/20-23...Function of Space ...Sterile Processing Department... Clean workroom...Pressure Relationship to Adjacent areas...Positive...Minimum Total ach (air exchanges) ...4...Design Relative Humidity (k), %...Max 60...Design Temperature (I), °F/°C...68-73/20-23...Function of Space ...Sterile Processing Department... Decontamination room...Pressure Relationship to Adjacent areas...Negative...Minimum Total ach (air exchanges) ...6...Design Relative Humidity (k), %...NR...Design Temperature (I), °F/°C...60-73/16-23...Function of Space ...Sterile Storage room...Pressure Relationship to Adjacent areas ... Positive ... Minimum Total ach ...4...Design Relative Humidity (k), %...Max 60...Design Temperature (I), °F/°C...Max 75/24..."

On 6/29/22 at 12:35 PM, a tour of the OR Suite was conducted in the presence of Staff #9. There was a total of three (3) active ORs. A request was made to review the temperature and humidity log for the month of June. Staff #9 stated that the nurses are responsible to check the analog temperature and humidity gauge in the ORs, however it is not recorded or documented anywhere. At 12:46 PM, an interview was conducted with Staff #27, a Registered Nurse (RN). Staff #27 stated that the nurse looks at the analog temperature and humidity reader on the wall to see if the temperature or humidity falls outside the normal ranges. However, Staff #27 was unaware of what the normal temperature and humidity range was or where to find the reference for the range. At 12:40 PM, in OR #1, the temperature was 72 degrees F and the humidity was 40%, both within the above FGI guideline range for ORs.

Staff #3, from facilities, used a "Hygro-Thermometer Pen" and measured the humidity in OR #1, which was 26.9%. This was a significant difference from the 40% reading on the analog wall gauge. Staff #3 was not sure when the "Hygro-Thermometer Pen" was last calibrated or who is responsible for calibration.

On 6/29/22 at 12:44 PM, a tour of the Sterile Storage Room opposite the RNs (Registered Nurse) desk was conducted in the presence of Staff #9. A request was made to review the temperature and humidity log for the month of June. The log indicated that the humidity range should be < (less than) 60%. The humidity was out of range on the following dates:

June 6 - 63%
June 7 - 63%
June 8 - 73%
June 9 - 72%
June 10 - 71%
June 13 - 74%
June 14 - 71%
June 15 - 63%
June 16 - 66%
June 20 - 61%
June 21 - 62%
June 22 - 63%
June 23 - 63%
June 24 - 65%
June 27 - 71%

The "Out of Range - Action Taken" section of the log was blank. There was no documented evidence on the log that anyone notified the SPD Supervisor, the perioperative manager, engineering, or infection control of the variances and what action was taken, in accordance with the above referenced policy, FGI and AORN guidelines. There was no documented temperature or humidity on 6/28/22.

On 6/29/22 at 1:16 PM, a tour of the Sterile Processing Department was conducted in the presence of Staff #11. A request was made to review the temperature and humidity log for the month of May and June. The "Temperature and Humidity Log," which included both the Sterile Processing and Decontamination areas was received and reviewed. The last entry in the log was on 5/13/22. Upon interview, Staff #11 stated, "we are a bit behind." There were no documented temperatures or humidity for the remainder of May and June.

On 6/30/22 at 10:33 AM, a tour of Operating Room (OR) #4 was conducted. Staff #9 indicated that the the OR was an old cystoscopy room and is now utilized as a Sterile Storage area. There were sterile packs, sterile rigid containers, and sterile blue wrapped sets located on a table in the middle of the room. There were cystoscopy supplies, stents and suture located on a cart along the back wall. A request was made for the temperature and humidity log for this Sterile storage area. Staff #9 stated that temperature and humidity is not monitored in this room and was unable to provide a log. The facility failed to ensure the temperature, humidity and air exchanges were monitored in accordance with the above referenced policy.

On 6/30/22 at 10:51 AM, during a tour of the Sterile Supply Room located next to the anesthesia workroom, in the presence of Staff #2, Staff #3 and Staff #9, there was a "Comfort-Aire" dehumidifier on the floor that was plugged in and contained water in the reservoir. The dehumidifier lacked a biomed inspection. Upon interview, Staff #9 stated "I'm not sure where that came from. I'm not sure who put it in the room." Staff #3 stated, "That's not ours. It's not on so its not being used."

A request was made at that time to review the facility temperature and humidity log for the Sterile Supply Room, for the month of June. The document titled "Temperature and Humidity Log" was provided and reviewed. The log indicated that the humidity range should be < 60%. The humidity was out of range on the following dates:

June 8 - 71%
June 9 - 70%
June 10 - 69%
June 13 - 72%
June 14 - 68%
June 15 - 62%
June 16 - 64%
June 17 - 62%
June 20 - 62%
June 21 - 61%
June 22 - 62%
June 23 - 62%
June 24 - 63%
June 27 - 71%
June 28 - 69%

The "Out of Range - Action Taken" section of the log was blank. There was no documented evidence on the log that anyone notified the SPD Supervisor, the perioperative manager, engineering, or infection control of the variances and what action was taken, in accordance with the above referenced policy.

On 6/30/22 at 11:14 AM, a tour of the Endoscopy Suite was conducted in the presence of Staff #2, Staff #3, Staff #9 and Staff #10. Upon interview, Staff #9 and Staff #10 stated that temperature and humidity is not monitored in the endoscopy procedure rooms, and was unable to provide evidence of temperature and humidity monitoring. On 7/5/22 at 10:15 AM, Staff #3 confirmed that the facility follows the 2018 FGI guidelines. The practice of not monitoring temperature and humidity in the endoscopy procedure rooms is not in accordance with the above referenced FGI guidelines.

Based on observations, staff interviews, facility document review, and review of nationally recognized guidelines, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.

Findings include:

1. The facility failed to ensure implementation of its "High-Level Disinfection of Flexible Endoscopes, Bronchoscopes, Transesophageal Echocardiogram (TEE) Scopes, and Accessories" policy and procedure, and Manufacturer's IFU (Instructions for Use) for Rapicide OPA/28 (ortho-phthalaldehyde) High-Level Disinfectant (HLD). (Cross refer to Tag A 0749).

2. The facility failed to ensure proper airflow and ventilation requirements were maintained in the endoscopy reprocessing room in accordance with facility policy, FGI (Facility Guidelines Institute) and SGNA (Society of Gastroenterology Nurses and Associates) guidelines. (Cross refer to Tag A 0749).

3. The facility failed to ensure temperature and humidity is monitored and maintained in accordance with facility policy, FGI and AORN (Association of periOperative Registered Nurses) guidelines. (Cross refer to Tag A 0749).

4. The facility failed to ensure scopes are reprocessed and stored in accordance with facility policy and SGNA guidelines. (Cross refer to Tag A 0749).

5. The facility failed to ensure development and implementation of policies and procedures to prevent Legionella from contaminating the domestic water supply throughout the hospital. (Cross refer to Tag A 0749).

6. The facility failed to ensure the hospital staff are provided education of the process and protocol to clean and disinfect portable box fans. (Cross refer to Tag A 0749).

7. The facility failed to ensure that all environmental surfaces in the endoscopy reprocessing area are kept clean. (Cross refer to Tag A 0750).

8. The facility failed to ensure that sterile supplies are labeled and stored in accordance with facility policy and AAMI guidelines. (Cross refer to Tag A 0750).

9. The facility failed to ensure that hot and cold-water temperatures were maintained at the proper temperatures in accordance with Centers for Disease Control and Prevention (CDC) guidelines. (Cross refer to Tag A 0749).

Based on observations, staff interviews, review of facility policies and procedures, review of Manufacturer's Instructions for Use (IFU) for Rapicide OPA/28, and review of nationally recognized guidelines, it was determined that the facility failed to ensure: 1) implementation of its "High-Level Disinfection of Flexible Endoscopes, Bronchoscopes, Transesophageal Echocardiogram (TEE) Scopes, and Accessories" policy and procedure, and Manufacturer's IFU for Rapicide OPA/28 (ortho-phthalaldehyde) High-Level Disinfectant (HLD); 2) proper airflow and ventilation requirements are maintained in the endoscopy reprocessing room in accordance with facility policy, FGI (Facility Guidelines Institute) and SGNA (Society of Gastroenterology Nurses and Associates) guidelines; 3) temperature and humidity is monitored and maintained in accordance with facility policy, FGI and AORN (Association of periOperative Registered Nurses) guidelines; 4) scopes are reprocessed and stored in accordance with facility policy and SGNA guidelines; 5) development and implementation of policies and procedures to prevent Legionella from contaminating the domestic water supply throughout the hospital; 6) hospital staff are provided education of the process and protocol to clean and disinfect portable box fans and; 7) hot and cold-water temperatures are maintained at the proper temperatures in accordance with Centers for Disease Control and Prevention (CDC) guidelines.

Findings include:

1. Reference: Rapicide OPA/28 HLD Manufacturer's IFU states, " ...Storage Conditions and Expiration Date: ...3. The expiration date of Rapicide OPA/28 HLD may be found on the bottle label of the immediate container. DO NOT use product from an unopened or opened bottle after the labeled expiration date. 4. The reuse period of Rapicide OPA/28 HLD should never exceed 28 days. ...Directions for Use ...B Preparation and Usage:..Record the date the solution was poured out of the original container into a secondary container. The solution in the secondary container can be used for a period up to 28 days provided that prior to each use the concentration of ortho-phthalaldehyde (OPA) in the solution is verified using Rapicide OPA test strips to be above the MRC [Minimum Required Concentration] of 0.35%. ...this product must be discarded after 28 days, even if the test strips indicate a concentration above the 0.35% OPA."

Reference: Facility policy titled, "High-Level Disinfection of Flexible Endoscopes, Bronchoscopes, Transesophageal Echocardiogram Scopes, and Accessories" Revised: May 2015, states, "...V. Procedure...Manual HLD Rapicide OPA/28...75. Read directions for use on the bottle label and package insert, and then pour Rapicide OPA/28 into container. ... 76. Every day (except for days that the "3 positive controls and 3 negative controls" testing are done), test the Rapicide OPA 28 solution using Rapicide OPA test strips to determine its MEC [Minimum Effective Concentration] (must be above 0.3% ...) This process is critical to ensure the chemical is still effective for high-level disinfection. Document MEC on Rapicide OPA/28 Solution Log Sheet. 77. ... MEC testing is to be performed each time before a scope is inserted into Rapicide throughout the day. 78. ... m) Record test results in Rapicide OPA/28 Log Book. n) retain results with other sterilization records. ... 88. Record device(s) being high level-disinfected along with all other information on the High-Level Disinfection/Rapicide OPA/28 Record Log form. 89. ... soak instruments, scopes, and devices for 10 minutes at a minimum temperature of 20 C (68 F). a) Monitor the temperature of the solution. Verify correct temperature before each use ... b) The solution is NOT to be used unless the solution is at the required temperature. ...100. Enter onto Rapicide OPA/28 log the patient identification and other information as noted below in Documentation section. ...Shelf Life and Use Life for Rapicide OPA/28 ...115 Affix a label with the solution use life (expiration date) on the Rapicide OPA/28 container that will be used to process instruments/scopes. The "use life" is the time the solution is usable once poured out of the bottle and placed into use; the use life is 4 weeks (28 days). ... Documentation of Reprocessing ... 122 Patient account number (...Rapicide OPA/28) 123 Operator ID number, initials or name (...Rapicide OPA/28) 124 Endoscopist name (...Rapicide OPA/28) 125 Serial number of the scope (...Rapicide OPA/28) ..."

On 6/30/22 at 11:15 AM, during a tour of the Endoscopy Reprocessing Room, in the presence of Staff #2, Staff #3, Staff #9 and Staff #10, a blue plastic container (secondary container), labeled Rapicide OPA/28 was sitting on a table. The container was opened by the surveyor and it was observed to contain a solution. Staff #10 confirmed the solution was Rapicide OPA/28 used for the HLD (high level disinfection) of TEE (Transesophageal Echocardiography) probes/scopes. There was no date on the secondary container indicating when the solution was poured out of the original container. Staff #10 stated, "I don't know when it was poured, I was on vacation for two weeks."

The secondary container had a probe resting in the solution that was attached to a digital thermometer device, located on the outside portion of the container. The digital thermometer was observed to have a blank screen. Staff #10 stated that the thermometer was not working and needed to be replaced.

The "Endoscopy Rapicide OPA/28 Solution Log Sheet" was reviewed and revealed that the last entry on the log was documented as the Rapicide OPA/28 solution being opened and tested on 2/7/22, with the last daily solution testing being documented as 2/11/22. The solution discard date was logged as 3/6/22. The last temperature reading of the Rapicide OPA/28 solution was documented on 2/11/22. There were no subsequent entries.

On 6/30/22 at 11:31 AM, during a tour of the Endoscopy Clean Utility Room, there was a scope storage cabinet that contained reprocessed scopes. There were multiple scopes hanging in the cabinet without tags indicating when the probes/scopes were reprocessed. Staff #10 confirmed that one (1) of them was a TEE probe/scope.

On 6/30/22 at 1:25 PM, review of the "Rapicide OPA/28 Patient Log" indicated that the last probe/scope reprocessed was on 2/8/22. There were no subsequent entries. A request was made to Staff #9 for the Operating Room (OR) schedule for TEE procedures performed between 2/7/22 and 6/30/22. Review of the OR Schedule indicated that a total of seven (7) TEE procedures were scheduled and Staff #2 stated that only five (5) were performed; one (1) on each of the following dates: 3/24/22, 4/1/22, 4/8/22, 4/29/22, 6/16/22. There was no documented evidence on the "Rapicide OPA/28 Patient Log" that the five (5) TEE probes/scopes, on the above referenced dates, were reprocessed and logged.

Upon interview at 1:28 PM, in the Endoscopy Clean Utility Room, Staff #10 stated that he/she poured the Rapicide OPA/28 solution on 6/16/22, when he/she reprocessed the TEE probe/scope that was hanging in the storage cabinet. Staff #10 confirmed that the TEE probe/scope hanging in the cabinet was not tagged with the reprocessing date, nor was it logged on the "Rapicide OPA/28 Patient Log."

A request was made to review the Rapicide OPA/28 manufacturer IFU and the facility policies regarding the reprocessing of TEE probes/scopes. The documents were reviewed and the above processes were not in accordance with the above referenced policy and procedure, and manufacturer IFU for Rapicide OPA/28.

Staff #10's personnel file was reviewed in the presence of Staff #28, the Human Resource Director. Staff #10's Job Description Summary indicated that he/she is responsible for following policies and procedures with care of the endoscope immediately after the procedure, which includes decontaminating, cleaning, high-level disinfecting, documenting, and hanging the scopes in a well ventilated storage cabinet. Staff #28 stated that Staff #10 received on the job training and that certification is not a requirement of the Endoscopy Technician job description.

Staff #10's Clinical Competency Validation was reviewed in the presence of Staff #28. Staff #10's competency dated 9/1/16, when Staff #10 was hired, indicated that he/she was competent in the area of HLD of scopes using Rapicide OPA/28. The competency dated 5/24/22 states, "...3 -Job Knowledge consider employee's skill level, knowledge and understanding of all phases of the job and those requiring improved skills and/or experience. Measures employee's demonstrated job relevant knowledge and essential skills, such as work practices, policies, procedures... Reviewer Response 4.0 Outstanding (Exceeds some Expectations)..."

The above findings were confirmed by Staff #2 at the time of the findings.

The above findings resulted in an Immediate Jeopardy (IJ) related to Infection Control.

On 6/30/22 at 5:45 PM, the facility Chief Medical Officer (CMO) and the Director of Quality were informed of the IJ.

On 6/30/22 at 6:07 PM, a copy of the IJ template was provided to the CMO and an immediate removal plan was requested at that time.

On 7/5/22 an acceptable removal plan was received. The IJ was removed upon on-site verification that the facility, replaced the Rapicide OPA/28 solution in the secondary container, labeled the container with the expiration date, replaced the broken thermometer with a new working thermometer, re-educated all responsible staff who utilize Rapicide OPA/28 on the facility policy for HLD, re-educated all responsible staff on following manufacturer's IFUs, and re-educated all responsible staff on completing all required logs.

2. Reference: Facility policy titled, "Temperature, Humidity, and Air flow SPD" Reviewed: January 2018, states, "...VI. Procedure: The data for the temperature, humidity, and air exchanges were selected from the AIA (2001) and Guidelines for Design and Construction of Health Care Facilities (2010). They either meet or exceed recommendations from these 2 references. 1. Decontamination Area...Air flow - 6 air exchanges per hour under negative pressure. ..."

Reference: SGNA Standard of Infection Prevention in the Gastroenterology Setting 2019 states, "... Endoscopy Environment, Cleaning, and Disinfection ... Environment of Care Considerations ... There should be negative air pressure in the reprocessing room and a minimum of 10 exchanges per hour, with at least two being fresh, outside air ..."

Reference: Guidelines For Design And Construction Of Hospitals The Facility Guidelines Institute 2018 edition; Table 7.1 page 11 states, "... Design Parameters - Hospital Spaces (continued) Function of Space ... Endoscope cleaning ... Pressure Relationship to Adjacent areas ... Negative ... Minimum Total ach (air exchanges) ... 10 ..."

On 6/30/22 at 11:14 AM, during a tour of the Endoscopy Procedure Room, a door inside the room was observed to be unlatched and ajar. Staff #9 confirmed that the door leads to the Endoscopy Reprocessing Room. Staff #10 explained that the door does not fully close and latch and reported the issue to the facilities department several times since last year. Staff #3, Director of Facilities, indicated that he/she began working for the facility two months ago and was not aware of the issue. Upon interview, Staff #10 stated that he/she monitors the adjoining Endoscopy Reprocessing Room for negative pressure and that the room is not able to maintain negative pressure. Staff #10 confirmed that although he/she monitors negative pressure, he/she does not keep a log.

Staff #2 and Staff #5 confirmed that the facility follows SGNA guidelines for the Endoscopy Suite.

On 6/30/22 at 11:15 AM, the facility policy regarding air flow in the Endoscopy Reprocessing Room was requested. Staff #2 provided a policy titled "Temperature, Humidity, and Air Flow SPD." The policy indicated that the facility air flow parameters were based on the Guidelines for Design and Construction of Health Care Facilities (2010). On 7/5/22 at 10:15 AM, Staff #3 stated that the facility follows the 2018 FGI guidelines. The facility policy was not in accordance with the above referenced SGNA and FGI guidelines for 2010 or 2018.

The above findings resulted in an IJ related to Infection Control.

On 6/30/22 at 5:45 PM, the facility CMO and the Director of Quality were informed of the IJ.

On 6/30/22 at 6:07 PM, a copy of the IJ template was provided to the CMO and an immediate removal plan was requested at that time.

On 7/5/22 an acceptable removal plan was received. The IJ was removed upon on-site verification that the facility replaced the faulty door handle/lock on the door located between the endoscope procedure room and the endoscope reprocessing room, a new motor and fan were installed in the endoscope reprocessing room creating negative pressure within the room, installation was verified through a smoke test and outside vendor certified air balance testing to ensure negative pressure and sufficient air exchanges.

3. Reference: Facility policy titled "Temperature, Humidity, and Air flow SPD" Reviewed: January 2018, states, "...VI. Procedure: The data for the temperature, humidity, and air exchanges were selected from the AIA (2001) and Guidelines for Design and Construction of Health Care Facilities (2010). They either meet or exceed recommendations from these 2 references. ...3. Sterile Storage Area: Design Temperature - 68-75 F [Fahrenheit] Humidity - Maximum 60% Air exchanges - 4 under positive pressure. 4. Each day the facility is open, the processing staff is required to document the temperature and humidity in the Decontamination, Prep/Packaging/Sterilization and Sterile Storage Areas. The readings will be documented in the logs...5. Any variance from the above norms should be immediately reported to the SPD Supervisor or Perioperative Manager, who will then discuss the variances with Engineering and Infection Control... 6. Any corrective action taken should be documented on the log(s). ..."

Reference: Facility policy titled "Temperature and Humidity Policy" Revised: May 2022, states, "...III. Procedure A. Temperature/Humidity Ranges: Area Operating Room...Temperature 68-75 F...Humidity 20-60%..."

Reference: AORN 2022 Edition Guidelines For Perioperative Practice, Guideline For Design and Maintenance Recommendation 12. Surface and HVAC (Heating, Ventilation and Air Conditioning) 12.3 states, "Maintain the operational values for HVAC settings at either the settings described in Recommendation 2.6.1 or the settings that applied at the time of design or the most recent renovation of the HVAC system and as stated in the state or local regulations...12.5 Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedure. ...12.7.1 The HVAC system functionality must be monitored and maintained within acceptable standards of practice. ...12.11 Do not use free-standing fans, portable humidifiers, air conditioners, and dehumidifiers. These devices all contain a fan that when running can disrupt the planned airflow within the room and may transfer unwanted particles from the floor to the surgical site. Humidifiers and dehumidifiers contain standing water that may be a source for Legionella..."

Reference: Guidelines For Design And Construction Of Hospitals The Facility Guidelines Institute 2018 edition; Table 7.1 states, "... Design Parameters - Hospital Spaces (continued) Function of Space ...Operating Room [OR]...Pressure Relationship to Adjacent areas ... Positive... Minimum Total ach (air exchanges) ...20...Design Relative Humidity (k), %...20-60...Design Temperature (I), °F/°C [Fahrenheit/Celsius]...68-75/20-24...Function of Space ...Gastrointestinal endoscopy procedure room...Pressure Relationship to Adjacent areas ... NR [no requirement] ... Minimum Total ach (air exchanges) ...6 ...Design Relative Humidity (k), %...20-60...Design Temperature (I), °F/°C...68-73/20-23...Function of Space ...Sterile Processing Department... Clean workroom...Pressure Relationship to Adjacent areas...Positive...Minimum Total ach (air exchanges) ...4...Design Relative Humidity (k), %...Max 60...Design Temperature (I), °F/°C...68-73/20-23...Function of Space ...Sterile Processing Department... Decontamination room...Pressure Relationship to Adjacent areas...Negative...Minimum Total ach (air exchanges) ...6...Design Relative Humidity (k), %...NR...Design Temperature (I), °F/°C...60-73/16-23...Function of Space ...Sterile Storage room...Pressure Relationship to Adjacent areas ... Positive ... Minimum Total ach ...4...Design Relative Humidity (k), %...Max 60...Design Temperature (I), °F/°C...Max 75/24..."

On 6/29/22 at 12:35 PM, a tour of the OR Suite was conducted in the presence of Staff #9. There was a total of three (3) active ORs. A request was made to review the temperature and humidity log for the month of June. Staff #9 stated that the nurses are responsible to check the analog temperature and humidity gauge in the ORs, however it is not recorded or documented anywhere. At 12:46 PM, an interview was conducted with Staff #27, a Registered Nurse (RN). Staff #27 stated that the nurse looks at the analog temperature and humidity reader on the wall to see if the temperature or humidity falls outside the normal ranges. However, Staff #27 was unaware of what the normal temperature and humidity range was or where to find the reference for the range. At 12:40 PM, in OR #1, the temperature was 72 degrees F and the humidity was 40%, both within the above FGI guideline range for ORs.

Staff #3, from facilities, used a "Hygro-Thermometer Pen" and measured the humidity in OR #1, which was 26.9%. This was a significant difference from the 40% reading on the analog wall gauge. Staff #3 was not sure when the "Hygro-Thermometer Pen" was last calibrated or who is responsible for calibration.

On 6/29/22 at 12:44 PM, a tour of the Sterile Storage Room opposite the RNs desk was conducted in the presence of Staff #9. A request was made to review the temperature and humidity log for the month of June. The log indicated that the humidity range should be < (less than) 60%. The humidity was out of range on the following dates:

June 6 - 63%
June 7 - 63%
June 8 - 73%
June 9 - 72%
June 10 - 71%
June 13 - 74%
June 14 - 71%
June 15 - 63%
June 16 - 66%
June 20 - 61%
June 21 - 62%
June 22 - 63%
June 23 - 63%
June 24 - 65%
June 27 - 71%

The "Out of Range - Action Taken" section of the log was blank. There was no documented evidence on the log that anyone notified the SPD Supervisor, the periOperative manager, engineering, or infection control of the variances and what action was taken, in accordance with the above referenced policy, FGI and AORN guidelines. There was no documented temperature or humidity on 6/28/22.

On 6/29/22 at 1:16 PM, a tour of the Sterile Processing Department was conducted in the presence of Staff #11. A request was made to review the temperature and humidity log for the month of May and June. The "Temperature and Humidity Log", which included both the Sterile Processing and Decontamination areas was received and reviewed. The last entry in the log was on 5/13/22. Upon interview, Staff #11 stated, "we are a bit behind." There were no documented temperatures or humidity for the remainder of May and June.

On 6/30/22 at 10:33 AM, a tour of OR #4 was conducted. Staff #9 indicated that the the OR was an old cystoscopy room and is now utilized as a Sterile Storage area. There were sterile packs, sterile rigid containers, and sterile blue wrapped sets located on a table in the middle of the room. There were cystoscopy supplies, stents and suture located on a cart along the back wall. A request was made for the temperature and humidity log for this Sterile storage area. Staff #9 stated that temperature and humidity is not monitored in this room and was unable to provide a log. The facility failed to ensure the temperature, humidity and air exchanges were monitored in accordance with the above referenced policy.

On 6/30/22 at 10:51 AM, during a tour of the Sterile Supply Room located next to the anesthesia workroom, in the presence of Staff #2, Staff #3 and Staff #9, there was a "Comfort-Aire" dehumidifier on the floor that was plugged in and contained water in the reservoir. The dehumidifier lacked a biomed inspection. Upon interview, Staff #9 stated "I'm not sure where that came from. I'm not sure who put it in the room." Staff #3 stated, "That's not ours. It's not on so its not being used."

A request was made at that time to review the facility temperature and humidity log for the Sterile Supply Room, for the month of June. The document titled "Temperature and Humidity Log" was provided and reviewed. The log indicated that the humidity range should be < 60%. The humidity was out of range on the following dates:

June 8 - 71%
June 9 - 70%
June 10 - 69%
June 13 - 72%
June 14 - 68%
June 15 - 62%
June 16 - 64%
June 17 - 62%
June 20 - 62%
June 21 - 61%
June 22 - 62%
June 23 - 62%
June 24 - 63%
June 27 - 71%
June 28 - 69%

The "Out of Range - Action Taken" section of the log was blank. There was no documented evidence on the log that anyone notified the SPD Supervisor, the periOperative manager, engineering, or infection control of the variances and what action was taken, in accordance with the above referenced policy.

On 6/30/22 at 11:14 AM, a tour of the Endoscopy Suite was conducted in the presence of Staff #2, Staff #3, Staff #9 and Staff #10. Upon interview, Staff #9 and Staff #10 stated that temperature and humidity is not monitored in the Endoscopy Procedure Rooms, and was unable to provide evidence of temperature and humidity monitoring. On 7/5/22 at 10:15 AM, Staff #3 confirmed that the facility follows the 2018 FGI guidelines. The practice of not monitoring temperature and humidity in the Endoscopy Procedure Rooms is not in accordance with the above referenced FGI guidelines.

4. Reference: SGNA Standard of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes 2018 states, "Endoscope Reprocessing Protocol...8. Drying...f. ensure that a system exists for identifying endoscopes that have been reprocessed and are ready to use, such a a tagging system..."

Reference: Facility policy titled "Storage and Inspection of Flexible Endoscopes, Bronchoscopes, and Transesophageal Echocardiogram Scopes" Reviewed: Feb (February) 2018, states, "...VI. Procedure Storage...6. Every scope must be tagged with the date it was processed and initials of person who performed the task. 7. Scopes that are beyond 5 days post-processing need to be cleaned and reprocessed using Evotech, Steris, or Cidex OPA methodologies before use on a patient. ..."

On 6/30/22 at 11:31 AM, in the Clean Utility room, where the Scope Storage cabinet is located, in the presence of Staff #2 and Staff #10, multiple scopes were observed hanging in the storage cabinet, available for use, without a tag identifying the date the scope was reprocessed and the initials of the person who reprocessed the scope.

Upon interview, Staff #10 stated that five (5) of the scopes were EGD (Esophagogastroduodenoscopy) scopes, two (2) were colonoscopes, and one (1) was a TEE probe/scope. Staff #10 stated that he/she reprocessed the EGD scopes and colonoscopes on 6/29/22 and forgot to apply the tag. Staff #10 stated that the TEE scope was HLD (high level disinfected) on 6/16/22, however he/she could not provide documented evidence of when the scope was HLD.

The Evotech (an endoscope cleaner and reprocessor) mechanical strips were requested and reviewed. One (1) of the colonoscopes was reprocessed on 6/27/22 and the other on 6/29/22. Two (2) of the EGD scopes were reprocessed on 6/27/22 and three (3) were reprocessed on 6/29/22.

The facility policy addressing the storage of scopes was requested. The policy titled "Storage and Inspection of Flexible Endoscopes, Bronchoscopes, and Transesophageal Echocardiogram Scopes" was received and reviewed. The practice of storing scopes without an identification tag is not in accordance with the above referenced facility policy and SGNA guidelines.

Staff #10's personnel file was reviewed in the presence of Staff #28, the Human Resource Director. Staff #10's Job Description Summary indicated that he/she is responsible for following policies and procedures with care of the endoscope immediately after the procedure, which includes decontaminating, cleaning, high-level disinfecting, documenting, and hanging the scopes in a well ventilated storage cabinet. Staff #28 stated that Staff #10 received on the job training and that certification is not a requirement of the Endoscopy Technician job description.

Staff #10's Clinical Competency Validation was reviewed in the presence of Staff #28. Staff #10's competency dated 9/1/16, when Staff #10 was hired, indicated that he/she was competent in the area of Storage of scopes. The competency states, "...Storage Applies tag with date scope processed and tech initials. ..." The competency dated 5/24/22, states, "...3 -Job Knowledge consider employee's skill level, knowledge and understanding of all phases of the job and those requiring improved skills and/or experience. Measures employee's demonstrated job relevant knowledge and essential skills, such as work practices, policies, procedures... Reviewer Response 4.0 Outstanding (Exceeds some Expectations)..."


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5. During a review of the May 6, 2022 Quarterly Surveillance Report for Legionella Water Sampling, conducted on 4/19/22 by Omega Environmental Services, Inc, on 6/30/22, the following areas were positive for Legionella:

"Sample 09, Room 567, Patient Room, Sink, CW (Cold Water), Legionella (b-m) spp. 0.920,

Sample 71, 3rd Floor Restroom, Sink, HW (Hot Water), Legionella (b-m) spp. 66.000,

Sample 92, Room M 503, Sink, Sink, CW (Cold Water), Legionella (b-m) spp. 0.920

Sample 92 was positive for seven (7) consecutive quarterly tests, 12/10/2020: 1.600 CFU/ml (Colony Forming Units/ milliliters), 2/10/2021: 2.000 CFU/ml, 4/26/21: 2.500 CFU/ml, 7/15/2021: 2.400 CFU/ml, 10/5/2021: 10.000 CFU/ml, 1/31/2022: 1.500 CFU/ml, 4/19/2022: 0.920 CFU/ml

Sample 96, Room 256, Sink H/W. Sink, HW (Hot Water), Legionella (b-m) spp. 0.340."

During a tour of the 5th Floor on 6/30/22 at 11:45 AM , patient Room 567 was occupied and the last known test confirmed the presence of Legionella on the cold water side of the handwashing sink during the 5/6/22 test.

During an interview at 11:45 AM, Staff #3 confirmed the sink had not been retested prior to patients being placed in the room.

During a tour of the 5th Floor on 6/30/22 at 11:55 AM , Room M 503, the Respiratory Care Office/ Blood Gas Room was currently being utilized by Respiratory Care Staff and the last known test confirmed the presence of Legionella on the cold water side of the handwashing sink during the 5/6/22 test.

During an interview at 12:00 PM, Staff #31 confirmed respiratory care staff utilize the handwashing sink. Surveyors observed the basin of the sink was wet.

During an interview at 12:00 PM, Staff #3 confirmed the sink had not been retested prior to staff utilizing the sink for handwashing.

During a review of the May 6, 2022 Quarterly Surveillance Report for Legionella Water Sampling, conducted on 4/19/22 by Omega Environmental Services, Inc on 6/30/22, the following immediate recommendations were listed:

"Outlets with positive results should not be utilized by patients or staff until corrective action is completed followed by a retest.

Regularly flush all outlets with positive results. A more aggressive flushing program may be required to keep levels from increasing.

Verify that Chlorine injection treatment systems is being properly maintained and operational.

For outlets that have positive results over several test rounds, consider the following options: 1) Remove, clean, and sanitize any aerators on sink outlets with positive results (Soak 2 hours in 10% bleach solution) 2) Install a Point of Use Filter."

During an interview on 6/30/22 at 12:15 PM, the Surveyor questioned Staff #3, "Have the immediate recommendations listed on the report from Omega been implemented?" Staff #3 stated, "Yes." The Surveyor then questioned if there is any documentation or evidence to show if these recommendations have been implemented?" Staff #3 replied, "No."

During an interview on 6/3/22 at 12:30 PM, Staff #2 and Staff #3 were unable to provide policies and procedure that pertained to how the facility was reducing the risk and the spread of Legionella.


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6. On 6/28/22 at 10:51 AM, a tour was conducted on the Intensive Care Unit (ICU). Portable box fans were observed in use in Rooms 523, 524, 525, and 526. The following interviews were conducted:

Staff #30, a Registered Nurse (RN), at 11:02 AM, stated that education regarding the use and cleaning of the fans was not provided. Staff #30 stated that when a patient is moved from the ICU, a maintenance order can be put in for the fans to be taken to the basement for cleaning, but he/she will sometimes just wipe the outside of the fans with a Sani-wipe.

Staff #29, an RN, at 11:08 AM, stated that staff clean the fans themselves on the ICU. Staff #29 also stated that there were no guidelines given to the staff on the use, placement, and cleaning of the fans.

Staff #22, an Environmental Services (EVS) worker, at 11:21 AM, stated that if a fan needs to be cleaned, someone on the floor will call and the fans will be brought to the basement for cleaning.

Staff #23, a Nurse Educator, at 11:31 AM, stated that he/she was aware that there was a policy regarding the use and cleaning of the fans, but understood that it was in the process of revision. Staff #23 stated that he/she was awaiting the approved policy to educate staff on the 5th floor. Staff #23 stated that he/she had educated the 5th floor staff on the previous policy for the cleaning and use of the fans, but, upon request, was unable to provide evidence of staff inservice education on the fans and the fan policy.

On 6/29/22 at 12:05 PM, upon request to Staff #3 to conducted a tour of the basement where the portable box fans are cleaned, Staff #3 responded that he/she did not know where the fans were cleaned. At 12:13 PM, Staff #21, the EVS Director, conducted a tour of the (EVS) area of the basement. Staff #21 stated that the portable box fans rarely come down to get cleaned and that the cleaning of the fans takes place on the units.

Upon request during the tour, Staff #21 was unable to provide evidence of education or inservices to EVS staff for the cleaning and disinfecting of the portable box fans.

An interview with Staff #3 and Staff #21 at 12:33 PM confirmed that staff were inconsistent in the procedure of how to clean the fans resulting in the portable box fans were not being cleaned and disinfected correctly prior to each patient use.


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7. Reference: CDC Guidelines for Environmental Infection Control in Health-Care Facilities Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Atlanta, GA 30329 2003 Updated: July 2019 states, "To minimize the growth and persistence of gram-negative waterborne bacteria (e.g., thermophilic NTM and Legionella spp.), cold water in health-care facilities should be stored and distributed at temperatures below 68°F [Fahrenheit] (20°C [Celsius]); hot water should be stored above 140°F (60°C) and circulated with a minimum return temperature of 124°F (51°C) or the highest temperature specified in state regulations and building codes."

On 7/1/22 at 10:30 AM, during a tour of the facility, this surveyor and Staff #3 performed a test of the hot and cold water temperatures. The water temperatures were out-of-range as follows:

In the third-floor restroom near the dialysis unit, the cold water was 69 degrees F and the hot water was 90 degrees F.
In the patient restroom in Room #256, the cold water was 76 degrees F and the hot water was 88 degrees F.
In Room M503, the cold water was 70 degrees F and the hot water was 108 degrees F.

Staff #3 confirmed that the hot and cold water temperatures were out of range for the above areas.

Based on observations, staff interviews, a review of facility policy and procedure, and a review of Association for the Advancement of Medical Instrumentation (AAMI) guidelines that the facility follows, it was determined that the facility failed to maintain a clean and sanitary environment by ensuring: 1) all environmental surfaces in the endoscopy reprocessing area are kept clean; 2) sterile supplies are labeled and stored in accordance with facility policy and AAMI guidelines.

Findings include:

1. On 6/30/22 at 11:20 AM, in the Endoscope Reprocessing Room, it was observed that the decontamination sink had a sticker adhered to the inside of the sink. Staff #10 indicated that the sticker is used to measure the water level and temperature. The sticker was peeling on all four edges. The peeling sticker makes it susceptible to debris trapping, making it an uncleanable surface and potential source of cross contamination.


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2. Reference: Facility policy titled, "Storage of Sterile and Clean Supplies SPD" Reviewed: May 2016, states, "... Procedure: ... 3. All sterile supplies, packs, and containers should be stored a) At least 8-10" (inches) off the floor ..."

Reference: AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities section 11.1.1 Storage facilities states, "Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry. Sterile items should be 1) stored far enough away from the floor ... for adequate air circulation, ease of cleaning, ... 2) stored at least 8 to 10 inches above the floor ... 4) positioned so that packaging is not crushed, bent, compressed ... so that so that sterility is not otherwise compromised. ... Sterile items, ... should not be stored next to ... exposed water ... pipes, or in any location where they could become wet. Sterile items should not be stored on floors, ..."

Reference: Facility policy and procedure titled, "Packaging Materials and Methods SPD" Reviewed: February 2015, states, "... Procedure: ... 5. All ... packs should be identified with the specific contents. ... b) All devices prepared must have the preparer's initials/code identified. ..."

Reference: AAMI ST 79 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 9.3 Package labeling states, "Packages should be labeled before sterilization Package labels should ... h) include a description of the contents; i) identify the operator/person responsible for preparation and packaging; ..."

On 6/30/22 at 10:25 AM, Staff #9 indicated that the Cystoscopy Room is being utilized for storage of sterile supplies. During a tour of the room, conducted with Staff #3 and Staff #9, the following was observed:

A large clear plastic bag containing multiple sterile packages labeled "Stryker tubing" was sitting on the floor of the room.

A grey plastic bin, located on a shelf against the wall, contained multiple sterilized instruments. The instruments were stored in a crushed and bent manner that could potentially compromise the package integrity and sterility of the packages.

There was an open door in the room that led to a small processing room that contained a sterilizer. Staff #9 explained that the sterilizer is used for the flashing of instruments. Staff #9 confirmed that the facility does flash instruments routinely but that a flash cycle is ran daily on surgical days with a biological indicator. The side panel of the sterilizer was missing, exposing piping. Next to the exposed piping was an open cabinet that contained sterile supplies. The cabinet contained seven (7) "Bard Polyurethane Urethral Catheters" that had multiple areas of visible staining on the outside of the packaging.

On 6/30/22 at 10:50 AM, a tour of the Sterile Supply Room was conducted with Staff #3 and Staff #9. A large 4-tiered metal shelf in the room contained multiple sterilized peel packaged instruments. The instruments were stored in a crushed and bent manner that could potentially compromise the package integrity and sterility of the packages and were not labeled with a description of the contents and the operator/person responsible for preparation and packaging.

The above findings were confirmed with Staff #9 on 6/30/22 at the time of discovery.

Based on staff interviews and review of facility documents, it was determined that the facility's infection control professional failed to ensure staff are adhering to all elements of infection prevention and control policies and procedures in the Endoscopy Suite.

Findings include:

Reference: Facility policy titled, "High-Level Disinfection of Flexible Endoscopes, Bronchoscopes, Transesophageal Echocardiogram Scopes, and Accessories" Revised May 2015, states, "...V. Procedure...Process Improvement [PI]...143 The Endoscopy staff will be audited for compliance of disinfecting, cleaning, and HLD [High-Level Disinfection] processes once a week. This data will be reported to the Infection Control Committee and the Process Improvement (PI) Committee."

On 6/30/22 during a tour of the facility, it was identified that the facility failed to ensure:

1. Implementation of its "High-Level Disinfection of Flexible Endoscopes, Bronchoscopes, Transesophageal Echocardiogram Scopes, and Accessories" in accordance with policy and procedure.

2. Manufacturer's IFU for Rapicide OPA/28 (ortho-phthalaldehyde) High-Level Disinfectant (HLD) was followed.

3. Proper airflow and ventilation requirements were maintained in the endoscopy reprocessing room in accordance with facility policy, FGI (Facility Guidelines Institute) and SGNA (Society of Gastroenterology Nurses and Associates) guidelines.

4. Temperature and humidity was monitored and maintained in accordance with facility policy, FGI and AORN (Association of periOperative Registered Nurses) guidelines.

5. Scopes are reprocessed and stored in accordance with facility policy and SGNA guidelines.

On 7/5/22 a request was made for the PI data for the Endoscopy suite for February thru June. At 1:25 PM, Staff #5 confirmed there was no PI data and that the weekly audits for compliance were not conducted in accordance with the above referenced policy.