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Based on observation, interview, document and record review, the facility failed to ensure patient privacy was maintained in the Emergency Department (ED) and Cardiac Catheterization Lab (CCL), when:

1. Staff utilized an ED hallway for a lab draw station (blood collection).

2. A shared patient room in the ED lacked privacy.

3. A patient room in the ED had continuous video monitoring.

4. Patients in the CCL were not given consents when vendors were present during surgical procedures.

As a result, this failure had the potential to affect the patients' rights for respect, dignity and comfort.

Findings:

1. During an observation and interview on 1/28/2020 at 10:59 A.M., there were two lab draw stations at the entrance to the ED patient care area, in the hallway. The Emergency Department Director (EDD) stated the lab draw station had been moved to the hallway for efficiency, and the need for patient privacy during the procedure had not been discussed. The EDD stated the lab draw station had been placed in the hallway approximately 4 years prior. The EDD stated the lab draw station had not provided privacy for patients whose blood was being drawn.

During an observation on 1/30/2020 at 10 A.M., Patient 11 was observed wearing a hospital gown and blanket, sitting in a wheelchair in the hallway while a laboratory technician drew Patient 11's blood. Patient 11 was observed moaning, with their eyes closed, as a woman and two children, and an ED Tech walked past.

The facility's policy and procedure, titled Patient Rights and Responsibilities, revised 7/2017, indicated " ...C ...2. Care is provided in a manner that respects and fosters dignity ...Patient Rights ...1. Considerate and respectful care, personal dignity and to be made comfortable ...11. Have personal privacy respected ...examination and treatment are confidential and should be conducted discreetly ...."

2. During an observation and interview on 1/28/2020 at 11:03 A.M., in the ED A-Pod, there was automated supply station next to one bed in a patient room. The ED Director (EDD) stated a patient in that bed would be constantly interrupted by staff coming in and out to retrieve supplies from the automated supply station, and there would not have been privacy.

The facility's policy and procedure, titled Patient Rights and Responsibilities, revised 7/202017, indicated " ...C ...2. Care is provided in a manner that respects and fosters dignity ...Patient Rights ...1. Considerate and respectful care, personal dignity and to be made comfortable ...11. Have personal privacy respected ...examination and treatment are confidential and should be conducted discreetly ...."

3. During an observation on 1/30/2020 at 11:25 A.M., an observation was conducted of the seclusion room in the ED B-Pod. There was a low bed bolted to the floor, two windows with a view of the hallway, and no privacy screen. At the nursing station, there was a video monitor, and on the screen was the bed in the seclusion room.

During an observation on 1/31/2020 at 9:38 A.M., at the nursing station in B-Pod, the video monitor of the seclusion room was on, and the seclusion room bed was visible.

During an observation and interview on 1/31/2020 at 10:20 A.M., RN 12 stated sometimes patients who were not in need of seclusion had been placed in the seclusion room for care. RN 12 stated Patient 12 had been placed in the seclusion room on 1/30/2020 at 7:57 P.M., and received care in the seclusion room until 4:55 A.M. RN 12 stated Patient 12 had not required seclusion. RN 12 stated if a patient had not required seclusion, the door would have been kept open.

During an interview on 2/3/2020 at 8:30 A.M., RN 16 stated the bed in the seclusion room was approximately 8 inches from the floor. RN 16 stated when the room had been used for a patient who had not required seclusion, the door remained open, and there had been no privacy curtain. RN 16 stated patients placed in the room had not been told the room had been used for seclusion. The EDD stated the seclusion room was visible on the video monitor in the nursing station all of the time. RN 16 stated some patients had voiced complaints about the lack of accommodations in the room.

The facility's policy and procedure, titled Patient Rights and Responsibilities, revised 7/2017, indicated, "...C ...2. Care is provided in a manner that respects and fosters dignity ...Conditions of Admission ...1 ....emergency department treatment or services ...may include ... photographic/video ... rendered to the patient under the general and special instructions of the physician ...The attending physician must verbally inform the patient ...and obtain verbal consent from the patient ...The verbal consent must be documented within the patient's medical record by the attending physician ... Patient Rights ...1. Considerate and respectful care, personal dignity and to be made comfortable ...11. Have personal privacy respected ...examination and treatment are confidential and should be conducted discreetly ...."

4. During an observation, interview and record review on 2/3/2020 at 11:50 A.M., RN 11 stated there was no documentation which showed a patient had given consent for a vendor to be present during a surgical procedure. The IRD stated there should have been documentation which showed a patient had given consent when a vendor had been present during a surgical procedure. The IRD stated it was a patient's right to know who would be present in the operating room.

Patient 13 was admitted to the hospital on 1/30/2020, per the hospital's Admission Record. Per the Consent for Operative or Other Procedures, dated 1/30/2020, Patient 13 was to have a pacemaker inserted. No documentation was found which indicated Patient 13 had been informed of, or given consent for, the presence of the pacemaker vendor during the procedure.

Patient 14 was admitted to the hospital on 1/30/2020, per the hospital's Admission Record. Per the Consent for Operative or Other Procedures, dated 1/30/2020, Patient 13 was to have a cardiac defibrillator (a device which shocks the heart to change the rhythm) inserted. No documentation was found which indicated Patient 13 had been informed of, or given consent for, the presence of the cardiac defibrillator vendor during the procedure.

The facility's policy and procedure, titled Business Visitor Visitation Requirements, dated 5/2012, indicated " ...K ...8. Patients should be informed and provide consent of the possibility of business visitors being present during their procedure to support the equipment and/or products used during the case ...."

Based on observation, interview, record and document review, the hospital failed to ensure an effective Quality Assessment and Performance Improvement (QAPI) program was implemented in accordance with their QAPI plan. The QAPI program did not include necessary oversight for all services related to patient care related to the following: (A Tag 0273 1-17).


1. Failed to ensure that monitoring of a blanket warmer in the Interventional Radiology (IR)was maintained at a safe temperature for patient use per hospital protocol.

2. Failed to ensure oversight for the cleaning of patient care equipment in the Interventional Radiology (IR) and Emergency Department (ED).

3. Failed to ensure standard of practice related to point of care glucometers were maintained.

4. Failed to ensure patient room accommodations were assessed prior to patient placement.

5. Failed to ensure staff consumed food and beverage away from patient care areas.

6. Failed to ensure Nursing had knowledge related to safe surrender process in the event of an infant being surrendered in the Emergency Department.

7. Failed to ensure three (3) of 3 scope cabinets used to store clean flexible scopes were located in a clean utility room.

8. Failed to ensure a medivator (a machine used to clean and disinfect flexible scopes) was cleaned and maintained.

9. 3 of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach (Refer to A-0749 #3).

10. There was no evidence to indicate the dirty utility/processing room was terminally cleaned

11. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination

12. Seven (7) of 7 hospital policies were not updated since 2012 and or developed to provide guidance to staff.

13. Staff utilized an ED hallway for a lab draw station (blood collection).

14. A shared patient room in the ED lacked privacy.

15. A patient room in the ED had continuous video monitoring.

16. Patients in the Cardiac Catheterization Lab had not given consent for a vendor to be present during a surgical procedure.

17. The hospital failed to ensure the Biomed Department (BD) performed and documented preventative maintenance (PM) for the following patient care equipment:

The cumulative effect of this systemic practice resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program. The lack of compliance did not ensure an effective, ongoing, hospital-wide, data-driven quality assessment involved all hospital departments and services, and focused on high risk, high volume, problem prone patient populations.

Based on observation, interview, and document review, the hospital's Quality Assessment Performance Improvement (QAPI) plan did not include an ongoing program related to the following:

The operating room suite and sterile processing area had multiple instances of deviation from accepted infection control best practice standards to assure adequate Infection Control and optimal Quality of patient care.

In addition, the QAPI plan did not include all services related to patient care or provide necessary oversight of a hospital wide Infection Control Program.

Findings:

A Quality Assurance Performance Improvement (QAPI) interview were conducted with Chief Medical Officer (CMO), Chief Executive Officer (CEO), Chief Nursing Officer (CNO) and Chief Operating Officer (COO), and Manager Regulatory and Compliance on 2/4/2020 at 10 A.M. During the interview the hospital's QAPI plan dashboard for monitoring quality indicators were reviewed.

The hospital's most current QAPI plan (2019) indicated, it's purpose was to improve the quality of care and services provided by monitoring performance, overseeing action plans and dashboard data, and presenting issues to the hospital's Governing Board.

The dashboard data was not developed to identify high-risk, high-volume, problem prone areas serving the patient population. The hospital was unable to identify their own process, related to the following, in accordance with the hospital QAPI Plan:

1. Failed to ensure that monitoring of a blanket warmer in the Interventional Radiology (IR)was maintained at a safe temperature for patient use per hospital protocol.

During an observation and interview with case management (CM) 11 on 1/29/2020 at 2:20 P.M., in IR, the blanket warmer door was ajar. CM 11 stated the thermometer on the outside of the blanket warmer read 110 degrees Celsius (230 degrees Fahrenheit). CM 11 stated he believed the door was ajar to help cool the blankets down.

During an observation and interview with registered nurse (RN) 11, and RN 15, on 1/29/2020 at 2:20 P.M., in IR, RN 11 stated the blanket warmer was pre-set and she had not known how to change the setting. RN 11 and 15 stated they were not sure what the blanket warmer temperature should have been. RN 11 and 15 stated they had relied on touching the blankets to determine if they were too hot. RN 11 observed the blanket warmer and stated "Oh, there is a thermometer." RN 15 stated the RNs had not been trained on the use of the blanket warmer. RN 15 stated the blanket warmer had been used all day, every day.

During an interview on 1/31/2020 at 10:45 A.M., CM 11 stated the blanket warmer maximum temperature, per hospital policy, had been 130 degrees Fahrenheit. CM 11 stated the blanket warmer needed to be calibrated, and had exceeded 130 degrees Fahrenheit. CM 11 further stated the RNs in IR had not been familiar with the hospital policy and required education on the use of the blanket warmer.

During a review of the hospital policy and procedure, titled Blanket Warmers, revised 8/2012, the policy indicated " ...3. Blanket warmer thermostats shall be set to a maximum temperature of 130*F. a. The temperature should be monitored any time a blanket is removed. Staff should assess the temperature gauge prior to removing blankets from the warmer. B. If blanket warmer gauge is found to be above 131 degrees, the Engineering should be notified. i. Blankets above 130 degrees may pose a risk of skin burns ..."

The facility was unable to provide manufacturer's instructions for the blanket warmer.

2. Failed to ensure oversight for the cleaning of patient care equipment in the Interventional Radiology (IR) and Emergency Department (ED).

2a. An observation, interview and document review was conducted with RN 14 on 1/28/2020 at 10:35 A.M., in the ED. RN 14 stated the portable suction machine in the triage cupboard had received preventative maintenance (PM) in 2017, and had been due for further PM in September 2018. The portable suction machine was observed on a shelf in the cupboard with no covering and no indication of the last time it had been cleaned. RN 14 stated the Emergency department technician (EDT) assigned to the area had been responsible for the portable suction machine, and for ensuring the Biomed department had been notified the equipment needed maintenance.

During an observation and interview with EDT 11 on 1/28/2020 at 10:44 A.M., in the ED, EDT 11 stated he had not known there was a PM date on the portable suction machines. The EDT 11 stated if patient care equipment needed PM or cleaning, the staff should have called the Sterile Processing Department (SPD) for cleaning, or Biomed for service.

Per the manufacturer's instructions, titled Operating and Instruction Manual, revised 11/2018, "Caution notice ...3. Operator should be thoroughly familiar with these operating instructions before this device is used ...Sanitation ...As soon as possible after use, the single use canister, patient tubing and catheter (tube) should be discarded ...Clean using mild detergent ...disinfect with a mild disinfectant ...If the exhaust filter is soiled ...remove the soiled filter and replace ...Preventative Maintenance: Perform ...preventative maintenance procedure at least annually ..."

2b. During an observation and interview on 1/29/2020 at 2:35 P.M., in the IR Department, there was a white, powdery substance under the integrated patient monitor (device that monitored vital signs), on the exam table. On the patient immobilizer straps, the hook and loop fastener had white fibers in the hooks and loops. The clinical manager (CM) 11 stated the patient exam table and the patient immobilizer straps hook and loop fasteners should have been cleaned between patients. The CM 11 stated four patients had procedures performed in the room on 1/29/2020.

During an interview with the Perioperative Aide (POA) 11 and CM 11 on 1/31/2020 at 10:59 A.M., the POA 11 stated she had been responsible to clean the IR room and patient exam table. The POA stated she wiped the patient exam table with sanitizing wipes between each patient, however she was not allowed to lift equipment to clean underneath. The POA 11 stated because she had been unable to move the integrative monitor on the patient exam table, she had cleaned around it, not under it. The CM 11 stated the IR department should have evaluated the position of the integrative monitor in relation to how the POA would have maintained a clean patient exam table. The CM 11 stated the IR department did not evaluate the patient immobilizer straps with the Infection Control Department to determine if they posed an infection control risk.

During a review of the manufacturer's instructions for the patient immobilizer straps, titled Patient Immobilizer" undated, the instructions indicated " ...Cautions ...DO NOT use a damaged or soiled product ...CLEANING INSTRUCTIONS ...1. Prewash to remove any caked on material ...2. Wash the Patient Immobilizer with mild detergent ...by spraying and wiping down ...."

During a review of the Surgical Services Policy and Procedure, titled Sanitation: Perioperative, revised 10/2012, the procedure indicated, "Purpose: to control and reduce the possibility of cross-contamination ....cleaning will ...provide a bacteriologically safe environment ...C. OR Suite Cleaning Procedure: ...6. Moisten a clean, lint-free cleaning cloth with hospital approved disinfecting agent ...7 ...Wipe ...any other flat surfaces that come in direct contact with the patient ...c. Clean all high touch areas after each case, including ...i. OR table ...."

3. Failed to ensure standard of practice related to point of care glucometers were maintained.

During an observation, interview and in the Emergency Department (ED), on 1/30/2020 at 10:26 A.M., RN 13 stated the glucose monitoring machine (GMM-machine that reads the level of sugar in a patient's blood) was to be cleaned before and after each use. RN 13 stated after the GMM was cleaned with sanitizing wipes, it had to air dry for 15-30 minutes before it could be used again. RN 13 demonstrated cleaning the GMM; she wiped the GMM surface once with a sanitizing wipe, set the GMM on a medication cart, removed a second sanitizing wipe, wiped the GMM surface once, then placed it on the charging station. RN 13 reviewed the instructions on the sanitizing wipes and stated the GMM should have been kept wet with sanitizing solution for 3 minutes (dwell time) in order to kill germs, and she had forgotten.

During a review of the manufacturer's instructions, titled [Manufacturer Name], undated, pages 6-3 to 6-6, the cleaning instructions indicated " ...Cleaning and Disinfecting the meter ...should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and health-care professionals ...Cleaning is not the same as disinfecting. Disinfecting means to kill or prevent growth of disease carrying microorganisms ...1. Clean ...wipe the external surfaces of the meter thoroughly with a fresh germicidal bleach wipe ...2. Disinfect ...Using a new, fresh germicidal bleach wipe, thoroughly wipe the surface of the meter ...a minimum of three times horizontally, followed by 3 times vertically ...3 ...Ensure the meter surface stays wet for 1 minute and is allowed to air dry for an additional minute ...."

A review of the hospital policy, titled Glucose Point of Care Testing Using the [brand] Glucose Meter, revised 12/19, was conducted. The policy indicated, " ...F ...2. Cleaning the Meter: ...e. Disinfect the meter after each patient. F. Using a ...disinfectant wipe, remove the wipe, wring out excess liquid, thoroughly clean the outside of the meter ..." The hospital policy did not provide disinfection guidance in accordance with manufacturer's instructions.

4. Failed to ensure patient room accommodations were assessed prior to patient placement.

4a. During an observation and interview in the ED A-Pod, with RN 13 on 1/30/2020 at 11:07 A.M., RN 13 stated there was a used IV bag hanging on the wall in an empty patient room. The used IV bag tubing was observed draped over patient vital sign monitoring equipment. RN 13 stated Environmental Services (EVS) had cleaned the room, and the ED staff should have checked the room after it had been cleaned, and removed the used IV bag.

During an observation and interview in the ED A-Pod, with the Emergency Department Tech (EDT) 12 on 1/30/2020 at 11:15 A.M., there was an empty IV bag hanging from the wall in an empty patient room. The EDT 12 stated the room had been cleaned the night before, and was ready for the next patient. The EDT 12 stated the used IV bag should have been removed when the room had been cleaned. The EDT 12 stated after EVS cleaned a patient room, the EDT's were expected to enter the room and ensure no used patient care items were left, because the EVS staff could not touch or remove used patient items. The EDT 12 further stated checking a patient's room for used items, before the next patient is admitted, was not listed on the EDT assignment sheet, the EDT assigned to that room just knew to do it.

During a review of the facility's job description, titled Emergency Technician, dated 1/10/20, the document indicated " ...Major Position Responsibilities ...1. Maintain a safe, clean working environment, including unit based safety and infection control requirements ...."

4b. During an observation and interview on 1/31/2020 at 9:38 A.M., in the ED B-Pod, RN 12 stated the EVS staff cleaned the ED rooms after each patient. RN 12 stated there was a used electrode stuck to the wall alongside the bed in a patient room. RN 12 stated the previous patient in that room had been discharged at 4:55 A.M., more than four hours ago. RN 12 stated the electrode should have been removed from the wall when the room was cleaned, because the room needed to be ready to receive a patient in need of emergency care immediately.

During a review of the facility's job description, titled Emergency Technician, dated 1/10/20, the document indicated " ...Major Position Responsibilities ...1. Maintain a safe, clean working environment, including unit based safety and infection control requirements ...."

4c. During an observation and interview in the Medical Monitoring Unit on 2/4/2020 at 9:05 A.M., RN 18 stated the patient shower room had been cleaned and was ready for patient use. A pair of grey socks were observed on a shelf in the patient shower room. RN 18 stated the socks had been used, were dirty, and were disposable. RN 18 stated if she had seen the socks after the room had been cleaned, she would have requested Environmental Services come and clean the shower room again. RN 18 removed the socks and placed them in the trash in the patient room across the hall from the shower room. RN 18 stated placing dirty socks in a patient's room did not pose an infection control risk. RN 18 stated she had not wanted to carry the socks down the hall to the dirty utility room trash to dispose of them, because carrying the dirty socks was more of an infection control hazard than disposing of them in a patient's trash.

5. Failed to ensure staff consumed food and beverage away from patient care areas.

On 1/27/2020 at 10:30 A.M., a tour was conducted of the postpartum department and nursery with the Director of Women's Services (DWS). Per the DWS, the nursery area was ready to receive infants for assessment or care as needed.

In the nursery, Postpartum Registered Nurse (PRN) 36 was observed drinking a beverage and closing up a plastic food container. PRN 36 stated, "Sorry, the break room was being used for a meeting." The DWS stated staff were not allowed to eat or bring food into patient care areas.

A review of the hospital Nursing Orientation Education competency was conducted. Which included, "Bloodborne Pathogens ...In work areas including places where specimens are placed, where any exposure is likely, do not: eat, drink, or put objects in your mouth ..."

6. Failed to ensure Nursing had knowledge related to safe surrender process in the event of an infant being surrendered in the Emergency Department.

On 1/29/2020 at 3:15 P.M., the ED Pivot nurse (RN) 35 was interviewed regarding her role if someone presented wishing to surrender a baby. RN 35 stated she would take the baby but was otherwise not sure of the process, and would ask the charge nurse for direction. The charge nurse (CN) 34 stated the baby would be registered in the usual process as a "baby doe", and the surrendering person would not be given or told anything. The ED nurse manager (NM) 33 also stated registration and identification bands were handled like any other patient, and nothing further would be done regarding the person surrendering the baby.

On 1/29/2020 at 3:30 P.M., the ED Educator (EDE) stated in the event of a safe surrender the staff should have obtained the Safe Surrender packet from Triage or the Charge Desk and used the matching ID bands from the packet. The EDE stated the nurse should have instructed the surrendering person about taking the matching band to facilitate reclaiming the infant later. The EDE stated there should have been more staff education regarding the Safe Surrender process.

A review of the hospital policy, titled, Safe Surrender, revised 04/2014, was conducted. This policy indicated, ..."When a newborn is surrendered, the RN will ...access an abandoned newborn packet (stored in the ED Triage, Charge Desk and Radio Room). Contents of the packet must include a coded, confidential identification (ID) ankle bracelet; a matching coded arm ID bracelet ...place the coded ID bracelet on the newborn, make a good faith effort to give the matching coded ID arm bracelet to the person surrendering the newborn. This will facilitate reclaiming the infant later."

7. Failed to ensure three (3) of 3 scope cabinets used to store clean flexible scopes were located in a clean utility room.

On 1/30/20 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room/Scope Storage Room" (a restricted area), The ICP and DOS stated they followed the national infection control standards from AORN (The Association of perioperative Registered Nurses), SGNA (Society of Gastroenterology Nurses and Associates) and manufacture instructions. ET stated the scopes were stored in the "Dirty Utility Room" and placed in the cabinets after they were washed and disinfected in the scope washer (medivator).

On 1/30/2020 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area ..."

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing and GI units. The CNE stated, "at this point it's just a timing issue and we are currently working on other issue."

8. Failed to ensure a medivator (a machine used to clean and disinfect flexible scopes) was cleaned and maintained.

On 1/30/2020 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room/Scope Storage Room", The "Dirty Utility Room" contained a Medivator (washer used to high level disinfect) reusable flexible scopes. The internal chamber (the area where the scopes are placed for cleaning), contained yellow, brown, orange staining, black substance and the surface areas under the lid contained black substance, thick white, orange and yellow staining. The internal basins of the medivator were wet.

During the same observation, the ET was asked what the facility practice was regarding the cleaning of the medivator. ET stated they did not have a practice in place to clean the internal chamber of the medivator and they only wiped the exterior.

A record review was conducted of the manufacture "In-Service Guide" provided by a Registered Nurse Educator (RNED), on 1/30/2020. The guide stipulated the following, "End of Day Shutdown, 1. Close incoming water line. 2. Sanitize upper basins and basin lids with EPA - Registered Sanitizer ...Daily Maintenance ...4. Wipe basins with lint-free cloth. 5. Drain condensation from air tank (pull ring on tank). Weekly Maintenance 1. Lubricate the connector O-ring in the leak test hookup with silicone oil ..." There were no logs provided by the facility to show that the above manufacture guidelines were followed and they were unable to provided policies or procedures to demonstrate they had a process in place for cleaning and maintaining the medivator.

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing and GI units. The CNE stated, "at this point it's just a timing issue and we are currently working on other issue." The hospital did not implement their own QAPI plan.

9. 3 of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach (Refer to A-0749 #3).

On 1/30/2020 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room", During the tour of the hospital GI "Dirty Utility Room", on 1/30/20, the following observations were made at 9:40 A.M., 3 of the 3 cabinets were wiped by the surveyor using a wipe provided by the ET:

· Three (3) flexible scope cabinets contained clean scopes that were ready to be used for patient procedures on that day 1/30/2020.

· 3:3 cabinets contained grey fuzzy matter, dark brown and orange substance on the racks (scope holders) and brown matter with grey fuzzy matter of the bottom areas inside the cabinets and on the vents located inside the cabinets

· 1 of 3 cabinets contained a small dead cockroach beneath a tray located inside the cabinet and the tray contained small dried wet spots directly beneath each scope.

· On 1/30/2020 during the same tour, DOS stated that the scope manufacture of the flexible scopes indicated to "Thoroughly dry scopes before storing them."

During an immediate interview with ET, he stated he did not know that the trays inside the cabinets were removable and they had not been cleaned. The dried water spots beneath the scopes most likely came from the scopes themselves according to DOS, who also stated she considered the scopes to be contaminated and would have them reprocessed.

On 1/30/2020 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Storage cabinets used for flexible endoscopes should be cleaned and disinfected with an EPA-registered hospital-grade disinfectant when visibly soiled and on a regular basis ...Visible soil in the storage cabinet may contaminate endoscopes stored in the cabinet."

On 1/30/2020 at 10:30 A.M., a record review was conducted of a hospital policy titled "High Level Disinfection: To disinfect semi-critical patient care equipment between uses, approval date 6/17." The policy stipulated, "6. Storage a. Store the item in a well-ventilated, dust-free area." The policy did not provide guidance to staff to ensure scopes were thoroughly dried before storing. The policy referenced, "AORN Perioperative Guidelines for Practice, 2016 Edition."

A review of the recent "AORN Perioperative Guidelines for Practice, 2019" was provided by the hospital, stipulated, "If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes. Ventilation promotes continued drying of endoscopes. Using HEPA-filtered air may help prevent bacterial growth in the endoscope. Positive pressure may help prevent contamination of stored endoscopes." The 3 scope cabinets did not have HEPA-filters and were not drying cabinets.

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing and GI units. The CNE stated, "at this point it's just a timing issue and we are currently working on other issue."

10. There was no evidence to indicate the dirty utility/processing room was terminally cleaned

During the tour of the hospital GI "Dirty Utility Room/Scope Storage Room (a restricted area)", on 1/30/2020, the following observations were made at 9:40 A.M.,:

· The floor in the room contained yellow, orange and dark staining, black particulate on the floor

· A drain basin adjacent to the medivator contained large amounts of yellow and orange staining

· The floor in front of the medivator contained white and grey fuzzy matter

· The wall behind a table adjacent to the medivator contained black staini

· Three (3) of 3 flexible scope storage cabinets were not cleaned and maintained

No logs were provided to demonstrate that terminal cleaning was performed in the Dirty Utility Room/Scope Storage room on a regular basis and the facility did not have a policy in place to provide guidance to staff specific to terminally cleaning their Dirty Utility Room and scope storage room (a restricted area).

On 1/30/2020 at 2:30 P.M., during an interview with the DOS, she stated the Dirty Utility Room was supposed to be terminally cleaned daily because the room was used to clean and decontaminate (High Level Disinfect) re-usable patient scopes.

A review of the "AORN Perioperative Guidelines for Practice, 2019" was provided by the hospital on 1/30/2020 at 10 A.M., The guidelines stipulated, "For terminal cleaning in semi-restricted and restricted areas (eg. Operating or procedure rooms, sterile processing areas, corridors, storage areas) a multidisciplinary team should determine the frequency and extent of the cleaning required ...If perioperative team members are present in the area for an extended period or are performing patient care activities, the team may determine that thorough terminal cleaning of the area is necessary. The presence of personnel generates dust from shedding skin squames, which can harbor bacteria ...All floors the perioperative and sterile processing areas should be disinfected ..."

On 1/30/2020 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area ..."

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing and GI units. The CNE stated, "at this point it's just a timing issue and we are currently working on other issue."

11. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination

Patient 22 was admitted to the hospital on 12/30/2019 with diagnoses that included acute bacterial meningitis per the History and Physical, dated 12/30/2019.

Patient 22's medical records were reviewed with the Assistant Nurse Manager (ANM) of the Intensive Care Unit (ICU) on 1/29/2020. A physician order dated 1/2/2020 indicated for Patient 22 to be on Airborne isolation precaution (used for patients known or suspected to be infected with pathogens transmitted by the airborne route) and laboratory testing for AFB (Acid-Fast Bacilli, most commonly used to identify an active tuberculosis (TB) infection).

During an interview on 2/3/2020 at 10:40 A.M., with the Regulatory Compliance and Accreditation Manager (RCAM), the RCAM stated there was only one room with negative pressure in the ICU and it was occupied by another patient, Patient 22 was placed in a room with a HEPA filtration unit used to facilitate AIIR. The RCAM further stated engineering installed and maintained this device.

During an interview on 2/4/2020 at 9:18 A.M., with the Facilities Manager (FM), the FM stated his department installed the HEPA filter device in one of the ICU rooms to make into a negative air pressure room that accommodated Patient 22. However, there was no documented evidence to show the room was monitored for air pressure and that it was always maintained lower than the atmospheric pressure and to show that the HEPA filtration device provided and met its efficiency. The FM added to say there should have been documentation or log for this HEPA filter set up.

During an interview on 2/4/2020 at 9:40 A.M., with the RCAM, the RCAM stated there should have been documentation on maintaining the HEPA filter unit.

The hospital's policy titled Aerosol Transmissible Diseases and Tuberculosis Control Plan, dated 9/2018, indicated, " ...3. Nursing Units ...e. Portable HEPA filtration units can be used to facilitate AIIR. Engineering installs and maintain these devices ...and monitoring..."

During multiple observations, interviews and record reviews during the survey from 1/28/20 to 2/3/2020, the following concerns were identified:

· Three (3) of 3 scope cabinets used to store clean flexible scopes were located in a dirty utility room

· A medivator (a machine used to clean and disinfect flexible scopes) was not cleaned and maintained.

· Three (3) of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach.

· There was no evidence to indicate the dirty utility/processing room was terminally cleaned.

· The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination.


On 2/3/2020 at 8:30 A.M., an interview was conducted with the hospital ICP to discuss the findings identified during the survey. ICP was asked to provide documented hospital surveillance evidence to demonstrate that hospital wide infection control practices are concurrent with the national infection control standards they followed. ICP indicated that she does not conduct surveillance or oversight of staff to ensure they performed their tasks according to standards. ICP also stated that she did not provide "regular routine surveillance in the GI high level disinfecting area".

On 2/3/2020 at 9:30 A.M., a record review was conducted of the ICP job description's "Major Position Responsibilities". The ICPs responsibilities included:

"1. Maintains a safe, clean working environment, including unit based safety and infecton control requirements."
"2. Infection Prevention surveillance, education, monitoring trends that have been identified through surveillance, and maintain all regulatory functions."
"3. Responsible for the coordination and management of a hospital-wide Infection Prevention Program."
"5. Responsible for Prevention surveillance and the organization and coordination of the Infection Prevention Committee agenda, tracking table and minutes."

On 2/3/2020 at 9:45 A.M., a record review was conducted of the hospital "Infection Control Risk Assessment and Surveillance Plan, approved on 1/19. "The plan stipulated, "B. Purpose of Surveillance: 1. The foundation of and most important purpose of this program is to decrease the risk of infectious complications for all patients, healthcare workers, visitors and staff. Ongoing epidemiological information assists with identifying at risk populations and opportunities to interrupt prevent or reduce the occurrence of healthcare associated infections ..."

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing and GI units. The CNE stated, "at this point it's just a timing issue and we are currently working on other issue."

12. Seven (7) of 7 hospital policies were not updated since 2012 and or developed to provide guidance to staff.

The following policies referenced, "AORN, 2011 guidelines" one of the National Infection Control Standards the hospital followed and did not reference the most current 2019 AORN guidelines:

1. "Assembling Surgical Instrument Trays for Sterilization, revised 3/2012"

2. "Packaging Instruments and Trays for Sterilization, revised 3/2012"

3. "Decontamination in Sterile Processing (SPD), revised 4/12"

4. "Cleaning Steam Sterilizers, revised 3/12"

5. "Surgical Services Policy & Procedure Manual, revised 10/12"

6. "Transesophageal Echocardiogram (TEE) Probe Cleaning Protocol, effective date, 4/12"

7. "Sanitation: Perioperative, revised 10/12"

In addition, the hospital did not have a policy to provide guidance to staff specific to terminally cleaning of hospital designated areas. Furthermore, the hospital did not have a procedure or policy in place to provide staff guidance on cleaning the medivator (a washer used to high level disinfect reusable flexible scopes).

On 2/3/2020 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the team and members of the hospital's quality i

Based on observation, interview and record review, the facility failed to ensure nursing had knowledge related to "safe surrender" process in the event an infant was surrendered in the Emergency Department. This failure had the potential to negatively affect the infants surrendered to the facility by individuals.

Finding:

On 1/29/2020 at 3:05 P.M., during a tour of the Emergency Department (ED), the ED Director (EDD) described the flow as patients entered the ED. The EDD stated the first nurse to see the patient in the Triage area was the "Pivot" nurse.

On 1/29/2020 at 3:15 P.M., the ED Pivot nurse (PRN) 35 was interviewed regarding her role if someone presented wishing to surrender a baby. PRN 35 stated she would take the baby but was otherwise not sure of the process, and would ask the charge nurse for direction. The charge nurse (RN) 34 stated the baby would be registered in the usual process as a "baby doe", and the surrendering person would not be given or told anything. The ED nurse manager (RN) 33 also stated registration and identification bands were handled like any other patient, and nothing further would be done regarding the person surrendering the baby.

On 1/29/2020 at 3:30 P.M., the ED Educator (EDE) stated in the event of a safe surrender the staff should have obtained the Safe Surrender packet from Triage or the Charge Desk and used the matching ID bands from the packet. The EDE stated the nurse should have instructed the surrendering person about taking the matching band to facilitate reclaiming the infant later. The EDE stated there should have been more staff education regarding the Safe Surrender process.

Per hospital policy Safe Surrender, revised 04/14, "When a newborn is surrendered, the RN will ...access an abandoned newborn packet (stored in the ED Triage, Charge Desk and Radio Room). Contents of the packet must include a coded, confidential identification (ID) ankle bracelet; a matching coded arm ID bracelet ...place the coded ID bracelet on the newborn, make a good faith effort to give the matching coded ID arm bracelet to the person surrendering the newborn. This will facilitate reclaiming the infant later."

Based on observation, interview and document review, the facility failed to ensure the analysis of accommodation (AOA) in the Emergency Department (ED) reflected a lab draw station and shared patient room.

The inaccuracy of the hospital's AOA did not ensure patient care areas were assessed and provided in a safe location, in accordance with the hospital's original architectural plans.

Findings:

During an observation and interview on 1/28/2020 at 10:59 A.M., there were two lab draw stations at the entrance to the ED patient care area, in the hallway. The Emergency Department Director (EDD) stated the lab draw station had been moved to the hallway for efficiency. The EDD stated the lab draw station had been placed in the hallway approximately 4 years prior.

During an observation and interview on 1/28/2020 at 11:03 A.M., in the ED A-Pod, there was an automated supply station and two beds in A-8/A-9, a patient room. The ED Director (EDD) stated the cast room had been repurposed, and was used to hold patients when the ED was full. The EDD stated the supply station had been used by staff to retrieve supplies for patient care.

During a review of the hospital's Accommodation of Analysis (AOA) for the Emergency Department, the AOA did not include a shared patient room in A-Pod, and did not include a lab draw station in the hallway.

The hospital's AOA did not indicate a lab station in the hallway. In addition, the AOA did not include a shared patient room and cast room in A-8/A-9.

The AOA did not reflect the ED's use of the hallway entrance space for a lab draw station.

The AOA did not stipulate the current practice of a shared room with an automated supply station.

Based on observation, interview and record review, the hospital failed to ensure the Biomed Department (BD) performed and documented preventative maintenance (PM) for the following patient care equipment:

1.Emergency Department (ED) Triage portable suction machine,

2.Interventional Radiology (IR) Blanket Warmer.

This failure had the potential to affect patient safety when the equipment was used.

Findings:

1.During an observation, interview and record review with RN 14 on 1/28/2020 at 10:35 A.M., in the ED, RN 14 stated the portable suction machine in the triage cupboard had received preventative maintenance (PM) in 2017, and per the PM sticker, had been due for PM in September 2018. The portable suction machine was observed on a shelf in the cupboard with no covering, and no indication of the last time it had been cleaned. RN 14 stated the EDT assigned to the area had been responsible for the portable suction machine, and for ensuring the Biomed department had been notified the equipment needed maintenance.

During an observation, interview and record review with EDT 11, on 1/28/2020 at 10:44 A.M., in the ED, EDT 11 stated he had not known there was a PM date on the portable suction machines. The EDT 11 stated if patient care equipment needed PM or cleaning, the staff should have called the Sterile Processing Department (SPD) for cleaning, or the BD for service.

During an interview on 1/31/2020 at 1:37 P.M., with the Biomed Manager (BMM), the BMM stated all equipment should have received PM according to manufacturer's guidelines. The BMM stated portable suction machines should have received PM yearly. The BMM stated a new system had been used to manage the PM of all hospital equipment, and the incorrect PM schedule had been entered for the portable suction machines. The BMM stated he had not reviewed the scheduled PM dates for the portable suction machines after it had been entered into the new system. The BMM stated all portable suction machines in the hospital had been affected.

During a record review of the Biomed Schedule, undated, the schedule indicated there were 59 portable suction machines in use in the hospital, and the PM schedule was every three years. Per the facility document, titled Legacy Workorders Details, dated 1/28/2020, there were 92 portable suction machines in use in the hospital.

Per the manufacturer's instructions, titled Operating and Instruction Manual, revised 11/2018, " ...Preventative Maintenance: Perform ...preventative maintenance procedure at least annually ..."

2. During an observation and interview with CM 11 on 1/29/2020 at 2:20 P.M. in IR, the blanket warmer door was ajar. CM 11 stated and the thermometer on the outside of the blanket warmer read 110 degrees Celsius (230 degrees Fahrenheit). CM 11 stated he believed the door was ajar to help cool the blankets down.

During an observation and interview with RN 11 and RN 15 on 1/29/2020 at 2:20 P.M., in IR, RN 11 stated the blanket warmer was pre-set and she had not known how to change the setting. RN 11 and 15 stated they were not sure what the blanket warmer temperature should have been, and had relied on touching the blankets to determine if they were too hot. RN 11 observed the blanket warmer and stated "Oh, there is a thermometer." RN 15 stated the RNs had not been trained on the use of the blanket warmer. RN 15 stated the blanket warmer had been used all day, every day.

During an interview on 1/31/2020 at 10:45 A.M., CM 11 stated the blanket warmer maximum temperature, per hospital policy, had been 130 degrees Fahrenheit. CM 11 stated the blanket warmer needed to be calibrated, and had exceeded 130 degrees Fahrenheit. CM 11 further stated the RNs in IR had not been familiar with the hospital policy and required education on the use of the blanket warmer.

During an interview on 1/31/2020 at 1:37 P.M., the Biomed Manager (BMM), the BMM stated all equipment should have received PM according to manufacturer's guidelines. The BMM stated the BD was responsible for all equipment in the hospital. The BMM stated the blanket warmer had not been an item that the BD had been responsible for, and Engineering should have maintained it.

During an interview with the Supervisor of Engineering (SOE) on 2/4/2020 at 9:30 A.M., the SOE stated floor staff had been responsible for monitoring the blanket warmer. The SOE stated there had been no maintenance provided to the blanket warmer, no scheduled operational checks, and the blanket warmers had not been tracked by the Engineering Department.

During a review of the hospital policy and procedure, titled PM Schedule Assignment, revised 12/2019, the policy indicated " ...Responsibilities Site Manager- Ensure all devices are set to a compliant PM schedule ...."

During a review of the hospital policy and procedure, titled Blanket Warmers, revised 08/2012, the policy indicated " ...3. Blanket warmer thermostats shall be set to a maximum temperature of 130*F. a. The temperature should be monitored any time a blanket is removed. Staff should assess the temperature gauge prior to removing blankets from the warmer. B. If blanket warmer gauge is found to be above 131 degrees, the Engineering should be notified. i. Blankets above 130 degrees may pose a risk of skin burns ..."

The facility was unable to provide manufacturer's instructions for PM of the blanket warmer.

§482.42 Condition of Participation: Infection Control, condition NOT MET

Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients requiring gastroenterology services (the study, diagnosis and treatment of disorders that deal with the digestive system) and the use of flexible endoscopes (a reusable instrument used to inspect and treat interior portions of the body).

The facility's infection control program failed to:

1. Three (3) of 3 scope cabinets used to store clean flexible scopes were located in a dirty utility room (Refer to A-0749 finding 1).

2. A medivator (a machine used to clean and disinfect flexible scopes) was not cleaned and maintained (Refer to A-0749 finding 2).

3. 3 of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach (Refer to A-0749 finding 3).

4. There was no evidence to indicate the dirty utility/processing room was terminally cleaned (Refer to A-0749 finding 4).

5. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination (Refer to A-0749 finding 5).

6. Seven (7) of 7 hospital policies were not updated since 2012 and or developed to provide guidance to staff (Refer to A-0749 finding 6).

7. Implement its policy and procedure on Aerosol Transmissible Diseases and Tuberculosis Control Plan when there was no documented evidence related to the maintenance of a portable HEPA (High Efficiency Particulate Air) filtration and negative pressure equipment temporarily used in place for an Airborne Infection Isolation Room (AIIR) ( A Tag 749 # 7).

8. Ensure patient care area infection prevention policies, and manufacturer's instructions for disinfection, were followed related to:

Interventional Radiology (IR), Emergency Department (ED) and Cardiac Catheterization (CC) Lab patient care equipment and a patient exam table were not completely cleaned between patient use. ( A Tag 749 # 8a, 8c).

9. In the ED, a used intravenous (administered into a vein) solution bag (IV bag) and electrodes (sticky backed sensors placed on a patient's skin to monitor heart activity) were attached to a wall in two patient rooms. In addition, the ED Registered Nurse (RN) was not aware of dwell times (time an object must remain wet with disinfecting solution in order to effectively kill germs) when cleaning the glucometer (medical device for determining the approximate concentration of glucose in the blood), and the RN did not maintain proper cleaning technique. ( A Tag 749 # 9a, 9b, 9c).

10. In the Medical Monitoring Unit, a patient care shower room had not been completely cleaned prior to patient use. ( A Tag 749 # 10).

11. Failed to ensure staff consumed food and beverage away from patient care areas.
( A tag-749 # 11).

Immediate Jeopardy

On 1/30/20 at 3:20 P.M., the survey team identified significant concerns in the hospitals GI Unit. Due to the seriousness of the situation, an Immediate Jeopardy (IJ) was declared for failing to maintain an environment to prevent the risk of cross contamination. The IJ was called in the presence of the Regulatory Compliance Officer (RCO), Chief Nurse Executive (CNE), Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Medical Officer (CMO).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program with patient care in a safe and effective manner in accordance with the §482.42 Condition of Participation for Infection Control Services.

On 1/30/20 at 4:35 P.M., the hospital CNE, CMO, CEO and the RCO provided the team an acceptable corrective action plan to lift the immediacy of the IJ. On 1/31/20 at 8:45 A.M., the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's corrective action plan. The IJ was abated in the presence of the CNE, the Infection Control Preventionist (ICP) and the Director of Surgical Services (DSS).

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations.

The facility's infection control program failed to:

1. Three (3) of 3 scope cabinets used to store clean flexible scopes were located in a dirty utility room.

2. A medivator (a machine used to clean and disinfect flexible scopes) was not cleaned and maintained.

3. Three (3) of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach.

4. There was no evidence to indicate the dirty utility/processing room was terminally cleaned.

5. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination.

6. Seven (7) of 7 hospital policies were not updated since 2012 and or developed to provide guidance to staff.

7. Implement its policy and procedure on Aerosol Transmissible Diseases and Tuberculosis Control Plan when there was no documented evidence related to the maintenance of a portable HEPA (High Efficiency Particulate Air) filtration and negative pressure equipment temporarily used in place for an Airborne Infection Isolation Room (AIIR) .

8. Ensure patient care area infection prevention policies, and manufacturer's instructions for disinfection, were followed related to:

Interventional Radiology (IR), Emergency Department (ED) and Cardiac Catheterization (CC) Lab patient care equipment and a patient exam table were not completely cleaned between patient use.

9. In the ED, a used intravenous (administered into a vein) solution bag (IV bag) and electrodes (sticky backed sensors placed on a patient's skin to monitor heart activity) were attached to a wall in two patient rooms. In addition, the ED RN was not aware of dwell times (time an object must remain wet with disinfecting solution in order to effectively kill germs) when cleaning the glucometer, and the RN did not maintain proper cleaning technique.

10. In the Medical Monitoring Unit, a patient care shower room had not been completely cleaned prior to patient use.

11. Failed to ensure staff consumed food and beverage away from patient care areas.



Findings:

1. On 1/30/20 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room/Scope Storage Room" (a restricted area), accompanied by an Endoscopy Technician (ET), Infection Control Preventionist (ICP), and Director of Surgery (DOS). The ICP and DOS stated they followed the national infection control standards from AORN (The Association of perioperative Registered Nurses), SGNA (Society of Gastroenterology Nurses and Associates) and manufacture instructions.
In the room were three (3) of 3 flexible endoscopy storage cabinets, which contained clean scopes, according to ET.

During the same observation, ET stated the scopes were stored in the "Dirty Utility Room" and placed in the cabinets after they were washed and disinfected in the scope washer (medivator).

On 1/30/20 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area ..."

On 2/3/20 at 8:30 A.M., an interview was conducted with the hospital ICP who stated that she was aware that the cabinets needed to be in a clean area and well vented but they had a space constraint.

2. On 1/30/20 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room/Scope Storage Room", accompanied by an Endoscopy Technician (ET), Infection Control Preventionist (ICP), and Director of Surgery (DOS). The ICP and DOS stated they followed the national infection control standards from AORN (The Association of perioperative Registered Nurses), SGNA (Society of Gastroenterology Nurses and Associates) and manufacture instructions.
The "Dirty Utility Room" contained a Medivator (washer used to high level disinfect) reusable flexible scopes. The internal chamber (the area where the scopes are placed for cleaning), contained yellow, brown, orange staining, black substance and the surface areas under the lid contained black substance, thick white, orange and yellow staining. The internal basins of the medivator were wet.

During the same observation, the ET was asked what the facility practice was regarding the cleaning of the medivator. ET stated they did not have a practice in place to clean the internal chamber of the medivator and they only wiped the exterior.
A record review was conducted of the manufacture "In-Service Guide" provided by a Registered Nurse Educator (RNED), on 1/30/20. The guide stipulated the following, "End of Day Shutdown, 1. Close incoming water line. 2. Sanitize upper basins and basin lids with EPA - Registered Sanitizer ...Daily Maintenance ...4. Wipe basins with lint-free cloth. 5. Drain condensation from air tank (pull ring on tank). Weekly Maintenance 1. Lubricate the connector O-ring in the leak test hookup with silicone oil ..." There were no logs provided by the facility to show that the above manufacture guidelines were followed and they were unable to provided policies or procedures to demonstrate they had a process in place for cleaning and maintaining the medivator.

3. On 1/30/20 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room", accompanied by an Endoscopy Technician (ET), Infection Control Preventionist (ICP), and Director of Surgery (DOS). The ICP and DOS stated they followed the national infection control standards from AORN (The Association of perioperative Registered Nurses), SGNA (Society of Gastroenterology Nurses and Associates) and manufacture instructions.

During the tour of the hospital GI "Dirty Utility Room", on 1/30/20, the following observations were made at 9:40 AM, 3 of the 3 cabinets were wiped by the surveyor using a wipe provided by the ET:
* Three (3) flexible scope cabinets contained clean scopes that were ready to be used for patient procedures on that day 1/30/20.
* 3:3 cabinets contained grey fuzzy matter, dark brown and orange substance on the racks (scope holders) and brown matter with grey fuzzy matter of the bottom areas inside the cabinets and on the vents located inside the cabinets.
* 1 of 3 cabinets contained a small dead cockroach beneath a tray located inside the cabinet and the tray contained small dried wet spots directly beneath each scope.
On 1/30/20 during the same tour, DOS stated that the scope manufacture of the flexible scopes indicated to "Thoroughly dry scopes before storing them."

During an immediate interview with ET, he stated he did not know that the trays inside the cabinets were removable and they had not been cleaned. The dried water spots beneath the scopes most likely came from the scopes themselves according to DOS, who also stated she considered the scopes to be contaminated and would have them reprocessed.

On 1/30/20 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Storage cabinets used for flexible endoscopes should be cleaned and disinfected with an EPA-registered hospital-grade disinfectant when visibly soiled and on a regular basis ...Visible soil in the storage cabinet may contaminate endoscopes stored in the cabinet."

On 1/30/20 at 10:30 AM, a record review was conducted of a hospital policy titled "High Level Disinfection: To disinfect semi-critical patient care equipment between uses, approval date 6/17." The policy stipulated, "6. Storage a. Store the item in a well-ventilated, dust-free area." The policy did not provide guidance to staff to ensure scopes were thoroughly dried before storing. The policy referenced, "AORN Perioperative Guidelines for Practice, 2016 Edition."

A review of the recent "AORN Perioperative Guidelines for Practice, 2019" provided by the hospital, stipulated, "If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes. Ventilation promotes continued drying of endoscopes. Using HEPA-filtered air may help prevent bacterial growth in the endoscope. Positive pressure may help prevent contamination of stored endoscopes." The 3 scope cabinets did not have HEPA-filters and were not drying cabinets.

After the tour was completed, the significance of the findings was discussed with the hospital staff that were present during the tour on 1/30/20 at 9:30 A.M.

On 1/30/20 at 2:15 P.M., a second tour of the GI Unit was conducted with the DOS, ICP, ET, and the RN Educator. ET stated he had not cleaned the medivator basin yet because he was not provided "clear directives and didn ' t know what to do". ET also stated he was in the process of reprocessing scopes in the medivator, that had not been cleaned prior to re-using it. An immediate interview was conducted with a Gastroentorology Registered Nurse (GIRN), who delivered a scope to the Operating Room (OR) for a patient procedure. The scope which was used for the patient procedure had not been reprocessed and GIRN obtained it from the scope cabinet that had not been re-cleaned. GIRN stated she did not verify to ensure the scope was clean and ready for use.

During an immediate interview with the DOS, she stated the scopes should have been re-processed before using it. According to ET, he had not re-processed the scope that was used for the patient procedure.

A review of the "AORN Perioperative Guidelines for Practice, 2019" was provided by the hospital on 1/30/20 at 10 A.M., The guidelines stipulated, "Flexible endoscopes and storage cabinets should be visually inspected for cleanliness before endoscopes are placed into or removed from storage. If there is any evidence of contamination of the endoscope (eg, soil, moisture), the endoscope should be reprocessed before use. If there is any evidence of contamination of the cabinet (eg., wet spots, soil, ...) all endoscopes in the cabinet should be removed and reprocessed and the cabinet should be cleaned [2, High Evidence].

4. On 1/30/20 at 9:30 A.M., a tour was conducted of the hospital GI Unit "Dirty Utility Room", accompanied by an Endoscopy Technician (ET), Infection Control Preventionist (ICP), and Director of Surgery (DOS). The ICP and DOS stated they followed the national infection control standards from AORN (The Association of perioperative Registered Nurses), SGNA (Society of Gastroenterology Nurses and Associates) and manufacture instructions.

During the tour of the hospital GI "Dirty Utility Room/Scope Storage Room (a restricted area)", on 1/30/20, the following observations were made at 9:40 A.M.:
* The floor in the room contained yellow, orange and dark staining, black particulate on the floor
* A drain basin adjacent to the medivator contained large amounts of yellow and orange staining
* The floor in front of the medivator contained white and grey fuzzy matter
* The wall behind a table adjacent to the medivator contained black staining
* Three (3) of 3 flexible scope storage cabinets were not cleaned and maintained

No logs were provided to demonstrate that terminal cleaning was performed in the Dirty Utility Room/Scope Storage room on a regular basis and the facility did not have a policy in place to provide guidance to staff specific to terminally cleaning their Dirty Utility Room and scope storage room (a restricted area).

On 1/30/20 at 2:30 PM during an interview with the DOS, she stated the Dirty Utility Room was supposed to be terminally cleaned daily because the room was used to clean and decontaminate (High Level Disinfect) re-usable patient scopes.

A review of the "AORN Perioperative Guidelines for Practice, 2019" was provided by the hospital on 1/30/20 at 10 AM. The guidelines stipulated, "For terminal cleaning in semi-restricted and restricted areas (eg. Operating or procedure rooms, sterile processing areas, corridors, storage areas) a multidisciplinary team should determine the frequency and extent of the cleaning required ...If perioperative team members are present in the area for an extended period or are performing patient care activities, the team may determine that thorough terminal cleaning of the area is necessary. The presence of personnel generates dust from shedding skin squames, which can harbor bacteria ...All floors the perioperative and sterile processing areas should be disinfected ..."

On 1/30/20 at 10 A.M., a record review was conducted of the "2019 Guidelines for Perioperative Practice, AORN" provided by the facility. The guidelines stipulated, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area ..."

5. During multiple observations, interviews and record reviews during the survey from 1/28/20 to 2/3/20, the following concerns were identified:
* Three (3) of 3 scope cabinets used to store clean flexible scopes were located in a dirty utility room.

* A medivator (a machine used to clean and disinfect flexible scopes) was not cleaned and maintained.

* Three (3) of 3 scope cabinets contained black, brown, yellow staining, black particles, grey fuzzy matter and one contained a dead cockroach.

* There was no evidence to indicate the dirty utility/processing room was terminally cleaned.

* The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination.

On 2/3/20 at 8:30 AM, an interview was conducted with the hospital ICP to discuss the findings identified during the survey. ICP was asked to provide documented hospital surveillance evidence to demonstrate that hospital wide infection control practices are concurrent with the national infection control standards they followed. ICP indicated that she does not conduct surveillance or oversight of staff to ensure they performed their tasks according to standards. ICP also stated that she did not provide "regular routine surveillance in the Gastrointestinal (GI) high level disinfecting area".

On 2/3/20 at 9:30 AM, a record review was conducted of the ICP job description ' s "Major Position Responsibilities". The ICPs responsibilities included:
* "1. Maintains a safe, clean working environment, including unit based safety and infection control requirements."
* "2. Infection Prevention surveillance, education, monitoring trends that have been identified through surveillance, and maintain all regulatory functions."
* "3. Responsible for the coordination and management of a hospital-wide Infection Prevention Program."
* "5. Responsible for Prevention surveillance and the organization and coordination of the Infection Prevention Committee agenda, tracking table and minutes."

On 2/3/20 at 9:45 AM, a record review was conducted of the hospital "Infection Control Risk Assessment and Surveillance Plan, approved on 1/19. "The plan stipulated, "B. Purpose of Surveillance: 1. The foundation of and most important purpose of this program is to decrease the risk of infectious complications for all patients, healthcare workers, visitors and staff. Ongoing epidemiological information assists with identifying at risk populations and opportunities to interrupt prevent or reduce the occurrence of healthcare associated infections ..."

On 2/3/20 at 12:15 PM a Quality Assurance and Performance Improvement meeting and interviews were conducted with the survey team and members of the hospital ' s quality improvement members. The Chief Nurse Executive (CNE) stated they did not perform "rounding" surveillance in the areas that were identified as having concerns during the survey, specifically in their sterile processing (cleaning and sterilization of devices used in medical procedures) and GI units. The CNE stated, "at this point it ' s just a timing issue and we are currently working on other issue."

6. During multiple observations, interviews and record reviews during the survey from 1/28/20 to 2/3/20, the following concerns specific to hospital policies were identified:
* Seven (7)) of 7 hospital policies specific to cleaning and decontaminating reusable soiled surgical instruments had not been updated since 2012. The policies included,
1. "Assembling Surgical Instrument Trays for Sterilization, revised 3/2012"
2. "Packaging Instruments and Trays for Sterilization, revised 3/2012"
3. "Decontamination in Sterile Processing (SPD), revised 4/12"
4. "Cleaning Steam Sterilizers, revised 3/12"
5. "Surgical Services Policy & Procedure Manual, revised 10/12"
6. "Transesophageal Echocardiogram (TEE- takes pictures of the heart) Probe Cleaning Protocol, effective date, 4/12"
7. "Sanitation: Perioperative, revised 10/12"
The policies referenced, "AORN, 2011 guidelines" one of the National Infection Control Standards the hospital followed and did not reference the most current 2019 AORN guidelines.

* The hospital did not have a policy to provide guidance to staff specific to terminally cleaning of hospital designated areas.
* The hospital did not have a procedure or policy in place to provide staff guidance on cleaning the medivator (a washer used to high level disinfect reusable flexible scopes).

On 2/3/20 at 8:30 A.M,, an interview was conducted with the ICP who stated, she was not aware that the policies needed to be updated because the Sterile Processing Manager (SPM) did not bring it to her attention. ICP stated the policies should have been reviewed every 3 years (in 2015 and in 2018), the policies above according to the ICP were "vague, need to be specific to the processes, need to be more detailed and coincide with the current infection control standards (referring to the 2019 AORN guidelines)." In addition, ICP stated they had no terminal cleaning policy but they would be developing one.

On 2/3/20 at 9:30 A.M,, a record review was conducted of the ICP job description ' s "Major Position Responsibilities". The ICPs responsibilities included: "6. Responsible for coordination and updating infection prevention manual as well as reviewing and updating interdisciplinary and administrative policies and procedures."

On 2/3/20 at 12:15 P.M., a Quality Assurance and Performance Improvement meeting and interviews were conducted with the survey team and members of the hospital ' s quality improvement members. The Chief Nurse Executive (CNE) stated that she was aware the policies needed updating and they may be in a draft format. No evidence was provided during the survey to indicate the policies were in draft format.

Immediate Jeopardy

On 1/30/20 at 3:20 P.M., the survey team identified significant concerns in the hospitals GI Unit. Due to the seriousness of the situation, an Immediate Jeopardy (IJ) was declared for failing to maintain an environment to prevent the risk of cross contamination. The IJ was called in the presence of the Regulatory Compliance Officer (RCO), Chief Nurse Executive (CNE), Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Medical Officer (CMO).

On 1/30/20 at 4:35 P.M., the hospital CNE, CMO, CEO and the RCO provided the team an acceptable corrective action plan to lift the immediacy of the IJ. On 1/31/20 at 8:45 A.M., the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's corrective action plan. The IJ was abated in the presence of the CNE, the Infection Control Preventionist (ICP) and the Director of Surgical Services (DSS).





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7. Patient 22's medical records were reviewed with the Assistant Nurse Manager (ANM) of the Intensive Care Unit (ICU) on 1/29/20. Patient 22 was admitted to the hospital on 12/30/2019 with diagnoses that included acute bacterial meningitis (inflammation of brain and spinal cord membranes caused by an infection) per the History and Physical dated 12/30/2019. A physician order dated 1/2/2020 indicated for Patient 22 to be on Airborne isolation precaution (used for patients known or suspected to be infected with pathogens transmitted by the airborne route) and laboratory testing for AFB (Acid-Fast Bacilli, most commonly used to identify an active tuberculosis (TB) infection).

During an interview on 2/3/2020 at 10:40 A.M., with the Regulatory Compliance and Accreditation Manager (RCAM), the RCAM stated there was only one room with negative pressure (used to contain airborne contaminants within a room) in the ICU and it was occupied by another patient, Patient 22 was placed in a room with a HEPA filtration unit used to facilitate AIIR. The RCAM further stated engineering installed and maintained this device.

During an interview on 2/4/2020 at 9:18 A.M., with the Facilities Manager (FM), the FM stated his department installed the HEPA filter device in one of the ICU rooms to make into a negative air pressure room that accommodated Patient 22. However, there was no documented evidence to show the room was monitored for negative air pressure and to show that the HEPA filtration device provided and had met its efficiency. The FM added to say there should have been documentation or log for this HEPA filter set up.

During an interview on 2/4/2020 at 9:40 A.M., with the RCAM, the RCAM stated there should have been documentation on maintaining the HEPA filter unit.

The hospital's policy titled Aerosol Transmissible Diseases and Tuberculosis Control Plan, dated 9/2018, indicated, " ...3. Nursing Units ...e. Portable HEPA filtration units can be used to facilitate AIIR. Engineering installs and maintain these devices ...and monitoring..."



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8a. During an observation and interview on 1/29/2020 at 2:35 P.M., in the IR Department, there was a white, powdery substance under the integrated patient monitor (device that monitored vital signs), on the exam table. On the patient immobilizer straps, the hook and loop fastener had white fibers in the hooks and loops. RN 11 stated the exam table did not look clean and there was "fuzz and lint" on the hook and loop fasteners. RN 11 stated the patient exam table should have been cleaned with sanitizing wipes between patient use. The Clinical Manager (CM) 11 stated there was lint trapped in the hook and loop fasteners on the patient immobilizer straps. The CM 11 stated the patient exam table and the patient immobilizer straps hook and loop fasteners should have been cleaned between patients. The CM 11 stated 4 patients had procedures performed in the room on 1/29/2020.

During an interview on 1/31/2020 at 10:45 A.M., the CM 11 stated the peri-operative aide had been responsible for cleaning the patient exam table and patient immobilizer straps.

During an interview with the Perioperative Aide (POA) 11 and CM 11 on 1/31/2020 at 10:59 A.M., the POA 11 stated she had been responsible to clean the IR room and patient exam table. The POA stated she wiped the patient exam table with sanitizing wipes between each patient, however she was not allowed to lift equipment to clean underneath. The POA 11 stated because she had been unable to move the integrative monitor on the patient exam table, she had cleaned around it, not under it. The CM 11 stated the IR department should have evaluated the position of the integrative monitor in relation to how the POA would have maintained a clean patient exam table.

The POA 11 further stated the patient immobilizer straps had been wiped with sanitizing wipes between patient use. The CM 11 stated the IR department did not evaluate the patient immobilizer straps with the Infection Control Department to determine if they posed an infection control risk.

During a review of the manufacturer's instructions for the patient immobilizer straps, titled Patient Immobilizer" undated, the instructions indicated " ...Cautions ...DO NOT use a damaged or soiled product ...CLEANING INSTRUCTIONS ...1. Prewash to remove any caked on material ...2. Wash the Patient Immobilizer with mild detergent ...by spraying and wiping down ...."

During a review of the Surgical Services Policy and Procedure, titled Sanitation: Perioperative, revised 10/2012, the procedure indicated "Purpose: to control and reduce the possibility of cross-contamination ....cleaning will ...provide a bacteriologically safe environment ...C. OR Suite Cleaning Procedure: ...6. Moisten a clean, lint-free cleaning cloth with hospital approved disinfecting agent ...7 ...Wipe ...any other flat surfaces that come in direct contact with the patient ...c. Clean all high touch areas after each case, including ...i. OR table ...."

8b. An observation, interview was conducted with RN 14 on 1/28/2020 at 10:35 A.M., in the ED. RN 14 stated the portable suction machine in the triage cupboard had received preventative maintenance (PM) in 2017, and had been due for further PM in September 2018. The portable suction machine was observed on a shelf in the cupboard with no covering and no indication of the last time it had been cleaned. RN 14 stated the Emergency Department Technician (EDT) assigned to the area had been responsible for the portable suction machine, and for ensuring the Biomed department had been notified the equipment needed maintenance.

During an observation, interview and record review with EDT 11 on 1/28/2020 at 10:44 A.M., in the ED, EDT 11 stated he had not known there was a PM date on the portable suction machines. The EDT 11 stated if patient care equipment needed PM or cleaning, the staff should have called the Sterile Processing Department (SPD) for cleaning, or Biomed for service.

Per the manufacturer's instructions, titled Operating and Instruction Manual, revised 11/2018, "Caution notice ...3. Operator should be thoroughly familiar with these operating instructions before this device is used ...Sanitation ...As soon as possible after use, the single use canister, patient tubing and catheter (tube) should be discarded ...Clean using mild detergent ...disinfect with a mild disinfectant ...If the exhaust filter is soiled ...remove the soiled filter and replace ...Preventative Maintenance: Perform ...preventative maintenance procedure at least annually ..."

8c .During an observation and interview with the CM 12, on 1/31/2020 at 2:25 P.M. in the IR department. In Lab 1, the surgical clippers (a wet-dry razor) handle had brown hair on the clipper head. In IR Lab 2, the surgical clippers handle had brown hair on the clipper head. The CM 12 stated the surgical clipper head should have been cleaned with a sanitizing wipe after each patient use, to remove hair.

During an interview with the IR Director (IRD) on 2/3/2020 at 11:50 A.M., the IRD stated the surgical clippers had not been cleaned according to manufacturer's instructions.

During a review of the manufacturer's instructions, titled Using [Brand Name] Surgical Clippers, undated, the instructions indicated " ...4. Clean the clipper handle thoroughly with soap and water, then wipe the device with surface disinfectant or soak the handle in an antimicrobial agent ..."

9a. During an observation, interview and record review in the Emergency Department (ED), on 1/30/2020 at 10:26 A.M., RN 13 stated the glucose monitoring machine (GMM-machine that reads the level of sugar in a patient's blood) was to be cleaned before and after each use. RN 13 stated after the GMM was cleaned with sanitizing wipes, it had to air dry for 15-30 minutes before it could be used again. RN 13 demonstrated cleaning the GMM; she wiped the GMM surface once with a sanitizing wipe, set the GMM on a medication cart, removed a second sanitizing wipe, wiped the GMM surface once, then placed it on the charging station. During the interview, RN 13 reviewed the instructions on the sanitizing wipes and stated the GMM should have been kept wet with sanitizing solution for 3 minutes (dwell time) in order to kill germs, and she had forgotten.

During a review of the manufacturer's instructions, titled [Manufacturer Name], undated, pages 6-3 to 6-6, the cleaning instructions indicated " ...Cleaning and Disinfecting the meter ...should be cleaned and disinfected after each patient use to minimize the risk of transmission of blood-borne pathogens between patients and health-care professionals ...Cleaning is not the same as disinfecting. Disinfecting means to kill or prevent growth of disease carrying microorganisms ...1. Clean ...wipe the external surfaces of the meter thoroughly with a fresh germicidal bleach wipe ...2. Disinfect ...Using a new, fresh germicidal bleach wipe, thoroughly wipe the surface of the meter ...a minimum of three times horizontally, followed by 3 times vertically ...3 ...Ensure the meter surface stays wet for 1 minute and is allowed to air dry for an additional minute ...."

Per the hospital policy, titled Glucose Point of Care Testing Using the [brand] Glucose Meter, revised 12/2019, " ...F ...2. Cleaning the Meter: ...e. Disinfect the meter after each patient. F. Using a ...disinfectant wipe, remove the wipe, wring out excess liquid, thoroughly clean the outside of the meter ..." The hospital policy did not provide disinfection guidance in accordance with manufacturer's instructions.

9b. During an observation and interview in the ED A-Pod, with RN 13 on 1/30/2020 at 11:07 A.M., RN 13 stated there was a used IV bag hanging on the wall in an empty patient room. The used IV bag tubing was observed draped over patient vital sign monitoring equipment. RN 13 stated Environmental Services (EVS) had cleaned the room, and the ED staff should have checked the room after it had been cleaned, and removed the used IV bag.

During an observation and interview in the ED A-Pod, with the Emergency Department Tech (EDT) 12 on 1/30/2020 at 11:15 A.M., there was an empty IV bag hanging from the wall in an empty patient room. The EDT 12 stated the room had been cleaned the night before, and was ready for the next patient. The EDT 12 stated the used IV bag should have been removed when the room had been cleaned. The EDT 12 stated after EVS cleaned a patient room, the EDT's were expected to enter the room and ensure no used patient care items were left, because the EVS staff could not touch or remove used patient items. The EDT 12 further stated checking a patient's room for used items, before the next patient is admitted, was not listed on the EDT assignment sheet, the EDT assigned to that room just knew to do it.

During a review of the facility's job description, titled Emergency Technician, dated 1/10/20, the document indicated " ...Major Position Responsibilities ...1. Maintain a safe, clean working environment, including unit based safety and infection control requirements ...."

9c. During an observation and interview on 1/31/2020 at 9:38 A.M., in the ED B-Pod, RN 12 stated the EVS staff cleaned the ED rooms after each patient. RN 12 stated there was a used electrode stuck to the wall alongside the bed in a patient room. RN 12 stated the previous patient in that room had been discharged at 4:55 A.M., more than four hours ago. RN 12 stated the electrode should have been removed from the wall when the room was cleaned, because the room needed to be ready to receive a patient in need of emergency care immediately.

During a review of the facility's job description, titled Emergency Technician, dated 1/10/2020, the document indicated " ...Major Position Responsibilities ...1. Maintain a safe, clean working environment, including unit based safety and infection control requirements ...."

10. During an observation and interview in the Medical Monitoring Unit on 2/4/2020 at 9:05 A.M., RN 18 stated the patient shower room had been cleaned and was ready for patient use. A pair of grey socks were observed on a shelf in the patient shower room. RN 18 stated the socks had been used, were dirty, and were disposable. RN 18 stated if she had seen the socks after the room had been cleaned, she would have requested Environmental Services come and cle