HospitalInspections.org

Based on observation, document review and interviews, it was determined that the Condition of Participation Governing Body was not met as evidenced by multiple findings in relation to infection control breaches in the Surgical Department which includes the Operating Rooms, Sterile Central Supply, and the Day Surgery Unit; two inpatient units - the Acute Care Unit/Intensive Care and The Birthing Center; clinic areas within the main hospital; the kitchen; the outpatient laboratory collection area; the Emergency Department; and Imaging Department. These failures created an environment which potentially placed patients a risk for infection and serious harm; thus, a determination of immediate jeopardy was made under §482.42(a)(1) Infection Control Program and §482.51 Surgical Services. The governing body failed to effectively ensure a sanitary environment was maintained throughout the hospital.

Findings:

Throughout the survey, surveyors determined the hospital failed to ensure a sanitary environment for patients, observed breaches in infection control practices, and determined that staff were unaware of what manufacturer's recommendations for "wet time" really meant for sanitizing surfaces. Please see §482.42(a)(1) Infection Control Program and §482.51 Surgical Services for details of findings.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on record review and interview, the hospital failed to ensure a physician's order for restraints was renewed or discontinued within the required timeframe for 1 of 3 restraints reviewed (Patient # 22).

Finding:

The hospital's policy "Departmental Directive for Restraint & Seclusion", dated July 11, 2017, indicated restraint orders would not exceed two hours for children and adolescents within the ages of nine (9) to 17.

On April 12, 2018 at 1:15 PM, Patient #22's record was reviewed with a Nurse Manager. Documentation in the record indicated a 17 year old patient was placed in four-point leather restraints, per the physician's order, on March 2, 2017 at 4:22 AM. The restraint was removed at 7:37 AM, three hours and 15 minutes after being applied. There was no evidence in the record to indicate the restraint order had been renewed within the required two hour timeframe.

This finding was confirmed by the Nurse Manager at the time of the record review.

Based on observations, record reviews, and interviews, it was determined that the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI) was not met as evidenced by multiple findings in relation to infection control breaches in the Surgical Department which includes the Operating Rooms, Sterile Central Supply, and the Day Surgery Unit; two inpatient units - the Acute Care Unit/Intensive Care and The Birthing Center; clinic areas within the main hospital; the kitchen; the outpatient laboratory collection area; the Emergency Department; and Imaging Department. These failures created an environment which potentially placed patients a risk for infection and serious harm; thus, a determination of immediate jeopardy was made under §482.42(a)(1) Infection Control Program and §482.51 Surgical Services. The areas identified by the surveyors were not all being monitored as part of an effective quality assessment and performance improvement program.

Finding:

Throughout the survey, surveyors determined the hospital failed to ensure a sanitary environment for patients, observed breaches in infection control practices, and determined that staff were unaware of what manufacturer's recommendations for "wet time" really meant for sanitizing surfaces. Please see §482.42(a)(1) Infection Control Program, also known as A-0749, for details.

A review of the Performance Improvement Plan for Infection Prevention and Control, given to a surveyor, indicated the indicators were hand hygiene compliance within the hospital and physician practices; prevention of health care associated surgical site infections; and prevention of catheter associated urinary tract infections. The plan indicates a fluorescent tracer program was being utilized to monitor and improve environmental disinfection. A review of the checklist of the areas that are monitored by the Infection Control Nurse through the fluorescent tracer program did not include any of the areas identified by the surveyors except for the night stands, bedrails, and bed frames.

No evidence was provided to the surveyors that indicated areas, identified during the survey, were identified and part of an effective quality assessment and performance improvement program.

On April 13, 2018 at approximately 9:00 AM, the Chief Operating Officer stated, "I used to monitor the cleaning and maintenance of hospital, but this was moved to Infection Control several years ago."

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on observation and interviews, the facility failed to ensure a medication was administered in accordance with acceptable standards for 1 of 1 patients observed receiving a nebulizer treatment (Patient #21).

Finding:

One of the acceptable standards of practice for medication administration is to confirm the identity of the patient prior to administration.

On April 12, 2018 at 10:10 AM, a Registered Respiratory Therapist (RRT) administered a nebulizer treatment to Patient #21. Prior to the administration of the nebulizer treatment, the RRT failed to confirm the patient's identity. The RRT was observed scanning the patient's wrist-band part way through the administration

This finding was confirmed with the RRT on April 12, 2018 at 11:27 AM. On April 12, 2018 at 11:42 AM, in an interview with the Director of Cardiopulmonary Care, he/she informed the surveyor that patient identification is standard practice.

Based on observation and interview, the hospital failed to ensure that medications were kept secure (locked) in the crash cart (the cart that contains life saving equipment and medications) in 1 of 1 crash carts observed in the Imaging Department.

Finding:

On April 11, 2018 at 10:24 AM, the crash cart located in the hallway of the Imaging Department was observed to be unlocked. Inside the cart, medications were stored. A staff person, from the Imaging Department, confirmed that patients may be in this hallway alone. He also indicated the cart should be locked.

Based on observations, interviews, and document reviews, it was determined that the Condition of Participation for Infection Control was not met as evidenced by the hospital's failure to have a system in place to ensure the maintenance of a sanitary environment to prevent potential infections in 8 of 10 areas of the main hospital (the Surgical Department which includes the operating rooms, sterile central supply, and the day surgery unit; two inpatient units - the acute care unit/intensive care and the birthing center; outpatient clinic area; the kitchen; outpatient laboratory collection area; emergency department; and imaging department) and 1 of 3 outpatient locations visited (Oakland, ME). This failure to ensure a sanitary environment created a potential for serious harm to a patient; thus, a determination of immediate jeopardy was made.

Findings:

Standard: §482.42(a)(1) Infection Control Program also known as A-0749 - Based on observations, interviews, and document reviews, the hospital failed to have a system to ensure the maintenance of a sanitary environment to prevent potential infections in 8 of 10 areas of the main hospital (the Surgical Department which includes the operating rooms, sterile central supply, and the day surgery unit; two inpatient units - the acute care unit/intensive care and the birthing center; outpatient clinic area; the kitchen; outpatient laboratory collection area; emergency department; and imaging department) and 1 of 3 outpatient locations visited (Oakland, ME). This failure to ensure a sanitary environment, especially in the operating rooms, created a potential for serious harm to a patient; thus, a determination of immediate jeopardy was made. See A-0749 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on observations, interviews, and document reviews, the hospital failed to have a system to ensure the maintenance of a sanitary environment to prevent potential infections in 8 of 10 areas of the main hospital (the Surgical Department which includes the operating rooms, sterile central supply, and the day surgery unit; two inpatient units - the acute care unit/intensive care and the birthing center; outpatient clinic area; the kitchen; outpatient laboratory collection area; emergency department; and imaging department) and 1 of 3 outpatient locations visited (Oakland, ME). This failure to ensure a sanitary environment, especially in the operating rooms, created a potential for serious harm to a patient; thus, a determination of immediate jeopardy was made.

Findings:

The maintenance of a sanitary environment is one of the activities that is implicit in the Infection Control Officer's responsibility for measures to identify, investigate, report, prevent and control infections and communicable diseases. The hospital has failed to ensure that a sanitary environment was maintained as evidence by the following findings:

SURGICAL DEPARTMENT - OPERATING ROOMS/PROCEDURE ROOM:

1. On April 11, 2018 from approximately 10:04 AM to 10:15 AM, two staff were observed cleaning Operating Room (OR) #2 after a surgical procedure had been completed and prior to the next scheduled surgical procedure. The following was noted:

- Staff used disposable disinfectant wipes from a red top container (Sanicloth Plus) to disinfect equipment/items in the OR. The surveyor observed that the staff were wiping surfaces with one or two wipes, discarding the used wipes, and then taking new wipes from the container, and wiping other surfaces without ensuring that the surfaces remained wet for at least three minutes (10:04 AM).

- Registered Nurse (RN) #1 wiped both sides of the transfer board (a device used to slide a patient on when transferring from one bed to another), that was on the operating room table, with a cloth from a container with a red top (Sanicloth Plus) and then hung the board on the wall (10:10 AM). The surveyor observed that the board began to dry within 30 seconds and the RN did not rewipe the board to ensure it remained wet for at least three minutes.

- RN #1 cleaned the OR table with the Sanicloth Plus wipes after cleaning the transfer board. RN #1 removed the cushion, at the foot of the OR table, and a large section of Velcro was seen with many threads within the Velcro hooks. The surveyor asked RN #1 what the threads were and the RN replied, "Oh, those are from blankets that the patient have on. They get hooked in there and we clean them with this." She showed the surveyor a spray bottle of the Hyperfect disinfectant which she indicated would be used for the disinfecting. The surveyor confirmed, with RN #1, that the threads observed were from the blankets that were worn by previous patients that had surgical procedures on the operating room table.

On April 12, 2018, at approximately 8:32 AM, Centralized Sterile Processing (CSP) Employee #1 was observed to wipe the used endoscope and take it into the cleaning room adjacent to the procedure room and place it into the sink. The CSP then returned to the procedure room and was observed to wipe the work table surface with one Sanicloth Plus wipe and then return to the cleaning room. The surveyor continued to observe the work table and noted that the surface dried within 90 seconds.

The manufacturer's label on the container of Sanicloth Plus wipes was observed. The manufacturer's label indicated the "wet time" (i.e.: the time a piece of equipment needs to remain wet for proper disinfection) must be three minutes to provide appropriate sanitizing of the item.

The label on the Hyperfect disinfectant was observed. The label indicated that surfaces must remain wet for ten minutes.

On April 11, 2018, at approximately 10:15 AM, with the Director of Surgical Services present, RN #1 was asked how the long the surface should remain wet for the cleaning agent to be effective. RN #1 replied three minutes. The surveyor asked the RN how she would know if the surfaces remained wet for three minutes and she stated, "We don't time it, we just use the cloths." Another staff that was also cleaning OR #2 stated, "I've wondered about that myself."

On April 12, 2018, at approximately 7:45 AM, CSP #1 was interviewed just prior to a scheduled endoscopy procedure in the procedure room. The CSP was asked about the "wet time" for the Sanicloth Plus wipes. The CSP explained, "That's the time it takes to dry before you can use the surface. Like this is 3 minutes so you wipe it off and you can't use it for 3 minutes. The other stuff (Hyperfect) you spray it on and I think it's five minutes before you can use it." The surveyor then asked, "So, with these red top ones, the Sanicloths, if the surface dries before the three minutes are up, is that OK? Is there anything else you should do?" The CSP #1 replied, "Sure, it's OK. It's clean, isn't it?"

On April 12, 2018 at approximately 12:45 PM, RN #2 was interviewed regarding the use of disinfectants specifically the use of Hyperfect. RN #2 explained, "It's a spray and you spray it on and don't wipe it for 10 minutes." Upon further questioning regarding the "wet time" RN #2 replied, "You spray it on and don't wipe off, it shortens the dry time" and "I guess if it dries before the 10 minutes that's OK."

Immediate Jeopardy is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Based on the observations on two days of incorrect cleaning of items after procedures and interviews with three staff (RN #1, RN #2, and CSP #1), who were not aware of the proper wet times procedures, a determination of immediate jeopardy was made on April 12, 2018.

On April 12, 2018 at 4:15 PM, the surveyors discussed the observations and interviews with Administrative staff. The surveyors requested a plan of action to ensure that patients would receive care in a sanitary environment within the operating rooms.

On April 12, 2108 at 5:35 PM, a plan of action was received from the hospital. The immediate corrective action for the operating rooms was additional staff and management would conduct inspections that evening and would clean rooms.

On April 12, 2018 at 6:10 PM, a surveyor observed several individuals in the operating rooms cleaning. In addition, at this time, the Director of Surgical Services stated, to a surveyor, that there were no specific policies and procedures for cleaning and sanitizing the operating rooms and procedure rooms.

On April 13, 2018 at 8:30 AM, the surveyor observed OR #2 and #3 and found the rooms clean.

On April 13, 2018 between 9:20 AM to 9:55 AM, the surveyor observed four staff cleaning OR #1 after a procedure. The staff cleaned the room using appropriate techniques.

Based on the observations, completed on April 13, 2018 between 9:20 AM and 9:55 AM, it was determined that the immediate jeopardy situation had been abated.

2. On April 10, 2018 between 1:40 PM to 2:50 PM, two surveyors, who were accompanied by the Engineering Manager and the Director of Surgical Services, observed the following:

- In OR #1, dust on the ventilation intake vents.

- In OR #2, dust on the ventilation intake screens; rust on the Zimmer Tourniquet Unit #2 stand; the radiology aprons hung on a hook and touching the floor; chipped paint on the base of an intravenous (IV) pole and on the support arm of the ceiling mounted surgical light; rusty casters on a kick bucket stand; chipped paint and rust on both a linen cart and a trash cart; a damaged area on the door; and the Pyxis machine had a three milliter syringe wrapper on the top of it.

- In OR #3, dust on the ventilation intake screens; tape residue on the top of a stool and on the Drager- Fadious GS machine; rusty casters on a ring stand; and a damaged area on the lower part of the interior of the door.

- In the Suture Room, rusty casters on a stool.

The chipped paint, rusty areas, damaged area on the doors, and tape residue created surfaces which could not easily be cleaned and sanitized.

The above findings were confirmed with the Engineering Manager and the Director of Surgical Services at the time of the observations. At 2:10 PM, the Director of Surgical Services confirmed that OR #2 had already been cleaned prior to the observations made by the surveyors.

3. On April 11, 2018 at approximately 7:44 AM, during the preparation for a surgical procedure, a stirrup, which is designed to hold a patient's legs apart for the procedure, was placed on the floor while the patient was moved. Without cleaning the stirrup, the stirrup was picked up off the floor, put into place on the operating table, and the patient's legs were placed in the stirrups. The cushion on the lower portion of the operating table was removed and placed on the floor leaning against the wall. This cushion had holes in the surface; therefore, could not be cleaned and properly sanitized. This finding was confirmed by the Director of Surgical Services on 4/11/18 at approximately 10:15 AM.

4. On April 11, 2018 at approximately 10:05 AM, two "Toboggan" arm protectors, devices used to rest the patient's arms on while on the operating table, were observed to have cushions that were worn and damaged. These arm protectors could not be cleaned and properly sanitized. This finding was confirmed by the Director of Surgical Services on 4/11/18 at approximately 10:15 AM.

SURGICAL DEPARTMENT - STERILE CENTRAL SUPPLY AND OR STORAGE AREA:

1. On April 10, 2018 between 1:40 PM to 2:50 PM , two surveyors, who were accompanied by the Engineering Manager and the Director of Surgical Services, observed the following:

- In the Orthopedic Supply Room, torn vinyl on the surface of the surgical hand table. This created a surface which could not easily be cleaned and sanitized.

- In the Central Sterilization Sterile Room, on office area with a loose-leaf binder, five pieces of unprotected paper hanging over the desk area, a paper desk blotter, a wall hung paper calendar, three chairs with fabric covering the seats and back, a stool with a fabric covered seat, and other miscellaneous office supplies. These items should not be in the sterile central supply room.

The above findings were confirmed with the Engineering Manager and the Director of Surgical Services at the time of the observations.

2. On April 11, 2018 at 9:57 AM and 9:57 AM, in the OR storage room, multiple tears and glue residue were observed on the vinyl covering of a fracture table and an accumulation of dust on the cart that contained the Arthroscopy pump. This finding was confirmed with the Environmental Services Director at the time of the observation.

SURGICAL DEPARTMENT - DAY SURGERY UNIT:

1. On April 11, 2018, between 9:30 AM and 9:54 AM, two surveyors, who were accompanied by the Engineering Manager and Environmental Services Director, observed the following:

- In the Alcove area, worn vinyl on the seat of a wheelchair.

- In the hallways, dust and or debris on the bases of seven linen hamper carts and two stretchers.

- In the Latex-Free Room, dust on the bases of two stretchers, on one bedside table, and on the upper edges of a wall clock and a dry erase board.

- In Room #1, an accumulation of dust on the base of one bedside table and dried on debris on the base of the other bedside table.

- In Room #4, an accumulation of dust on the bases of a stretcher and an IV pole and on the upper edges of a wall clock and a dry erase board.

- In Room #6, an accumulation of dust on the bases of three stretchers and two intravenous (IV) poles.

- In Room #8, an accumulation of dust on the bases of the stretcher and the bedside table and on the top edge of the dry erase board.

- In Room #9, an accumulation of dust on the bases of the stretcher, the bedside table, and pole of the vital sign machine and on the top edge of the dry erase board.

All of the above findings were confirmed with the Engineering Manager and Environmental Services Director at the time of the observations.

2. On April 11, 2018 at 9:54 AM, in the day surgery pantry, there was no air gap on the ice machine. An air gap is required to ensure that sewer waste does not back up through the drainage pipe, of the ice machine, into the ice machine; thus, contaminating the ice. This finding was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

3. On April 12, 2018 at 5:40 PM, in Day Surgery Patient Room #1, Housekeeper #1 was observed cleaning the surface of the door utilizing Hyperfect. The surveyor observed that the surface began drying within 20 seconds after the Housekeeper applied the Hyperfect. When asked about the Hyperfect, the Housekeeper told the surveyor, "They recommend 10 minutes ..." and "Once you wipe it down you can't touch it for 10 minutes." The surveyor stated "This door surface that I saw you wipe down when I first came in is dry. Do you need to do anything else or wipe it again?" The housekeeper replied, "No, it's alright."

4. On April 12, 2018 at 5:50 PM, in Day Surgery Patient Room #7, Housekeeper #2 was observed wiping the door handle and surfaces, the sink and shelves on and around the sink, and the top and surface of the white board on the wall with the same Sanicloth Plus wipe . The surveyor asked the Housekeeper what wet time was and he replied, "It dries within 3 minutes". The surveyor asked Housekeeper #2, "I see that these surfaces around the sink and door dried within 30 seconds. Is that OK? Do you need to do anything else?" The Housekeeper replied, "That's OK ... it's clean.

INPATIENT UNIT - ACUTE CARE UNIT/INTENSIVE CARE UNIT AREA:

1. On April 11, 2018, from 10:00 AM to 11:20 AM, two surveyors, who were accompanied by the Engineering Manager and Environmental Services Director, entered and observed six patient rooms (#210, #212, #213, #214, #215, and #217) on the Acute Care Unit. All six of these rooms were observed to have an accumulation of dust within the rooms and these rooms had been previously cleaned and were ready for new patients. The room observations and other observations were as following:

- In Patient Room #210, an accumulation of dust on the frame of one bed, on the container used for sharp items, and on the upper edge of the dry erase board.

- In Patient Room #212, an accumulation of dust on the base of one bedside table, on the top of the container of one suction machine, on the top surface of the wall mounted clock, and on the upper edge of the dry erase board.

- In Patient Room #213, an accumulation of dust on the upper edge of one dry erase board and tape residue on the lower left side rail of one bed. The tape residue created a surface which could not easily be cleaned and sanitized.

- In Patient Room #214, an accumulation of dust on the upper edges of two dry erase boards, on the top of the container of two suction machines, on the top of two containers used for sharp items, and both sharps containers; three areas of a dried on substance on one bedside table; and dirt and debris under one of the bed, by the headboard of one of the beds, and along the wall behind one of the nightstand.

- In Patient Room #215, an accumulation of dust on frames of two beds, on the upper edge of the cabinet doors, on the top surfaces of two wall mounted (over the bed) lights, on the top of two containers used for sharp items, on the top of containers for two suction machines, and on the shelf over the sink.

- In Patient Room #217, an accumulation of dust on the frames of two beds, on the upper edges of two dry erase boards, top of two containers used for sharp items, and on the top surface of two wall-mounted (over bed) lights; and dried on debris on the base of two bedside tables.

- In the hallway near Patient Room #201, an accumulation of dust and dried on debris on the base of the vital sign stand.

- In the clean storage room, an accumulation of dust on the bases of eight IV poles and on the base of a vital sign machine.

- In the Intensive Care Unit hallway, an accumulation of dust on the base of a stretcher.

- In the hallway near nurses' station, dried on debris on the base of a linen cart hamper.

All of the above findings were confirmed with the Engineering Manager and/or Environmental Services Director at the time of the observations

2. On April 11, 2018 at 10:45 AM, two surveyors observed one ceiling tile that was stained in the acute care waiting room. Staining on the tile indicates the tiles had become wet, at one point, which then creates a habitat for mold growth. This observation was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

3. On April 11, 2018 at 11:05 AM, in the kitchenette, there was no air gap on the ice machine. An air gap is required to ensure that sewer waste does not back up through the drainage pipe, on the ice machine, into the ice machine thus contaminating the ice. This finding was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

4. On April 12, 2018 between 8:22 AM and 8:24 AM, the surveyor and the Regional Director of Supply Chain observed Room #216. This room had been occupied by a patient on April 11, 2018 and was empty during this observation.

The following was observed by the bed near the door: dried on debris on the base of the nightstand; and an accumulation of dust and debris under the bed, along the wall by the headboard, behind the nightstand, on the top of the container of the suction machine and over the wall mounted light.

The following was observed by the bed near the window: an accumulation of dust under the bed, along the wall by the headboard, behind the nightstand, on the top of the container of the suction machine, and over the wall mounted light.

The following was observed by the bench that is approximately six feet long: an accumulation of dust and dirt along the front of the bench and the laminate click board was lifting in one area in front of the bench. The lifted laminate created a surface which could not be cleaned and sanitized.

These observations were discussed and confirmed by the Regional Director of Supply Chain at the time of the observation.

On April 12, 2018 at 8:28 AM, the housekeeper, that was assigned to the area that Room #216 was located, stated that she had cleaned Room #216 on April 11, 2018 before the patient had been discharged.

On April 12, 2018 at 8:32 AM, a different housekeeper, confirmed that documentation on a form at the nurses' station indicated that Room #216 had been cleaned by housekeeping staff during the evening of April 11, 2018 after the patient was discharged.

5. On April 12, 2108 at 8:34 AM, a surveyor and the Regional Director of Supply Chain observed a form at the nurses' station that indicated the patient in Room #200 had been discharged on April 11, 2018 and the room was cleaned by housekeeping staff.

At 8:38 AM, the surveyor and the Regional Director of Supply Chain observed Room #200. This room was now occupied by a new patient. The following was observed: debris in the corner of the room, behind the chair, along the wall by the closet, and behind the main door to the room and an accumulation of dust on the top of the container of the suction machine and the top of the container used for sharp items

During the observation, the surveyor pointed to the areas and once outside the room discussed and confirmed the observations with the Regional Director of Supply Chain.

6. On April 12, 2018, at approximately 12:40 PM, a surveyor observed a Physician enter Room #201. A sign indicating "Contact Precautions" was posted outside the door of Room #201 and the sign indicated gloves were to be worn. The surveyor observed the Physician enter the room, without washing applying hand sanitizer to his hands, not putting on gloves while in the room, and not washing no applying hand sanitizer to his hands upon exiting the the room. This patient had an infection in the stump of his/her left leg.

7. On April 12, 2018, at approximately 12:50 PM, a surveyor observed Room #212 which had been cleaned and ready for a new admission. The following was observed: dirt and grime in the corners of the room; gouges in the paint down to the sheet rock; dust on the top of the clock; dust and cobwebs on the window sills; and a chair with wooden arms that the protective coating was not present; therefore, it was not sealed. The gouges, and the unsealed wooden arms on the chair created a surface which could not easily be cleaned and sanitized.

8. On April 12, 2018, at approximately 1:00 PM, the surveyor observed heavy dust on the window sills of the large window at the end of the hallway by Room #207.

9. On 4/12/18 at 4:05 PM, visible dust was observed on the bases and on top of three portable computer-on-wheels stations and on one code cart containing medical equipment. These findings were confirmed with the Charge Nurse at the time of the observation.


The hospital's "Patient Room Cleaning" policy and procedure, dated 3/26/2018, was reviewed and it was noted to have a section for "Daily Room Cleaning Procedure" and "Terminal Room Cleaning Procedure". The "Terminal Room Cleaning Procedure" would be utilized when a patient vacates a room and the room is being cleaned for the next patient. The procedures indicated the following:

- "High dust all horizontal ledges wiping down all picture and bulletin board frames" (both daily and terminal procedures)

- "Use same disinfectant solution to clean and damp dust all areas of the patient room...." (both daily and terminal procedures)

- "On over bed table, wipe tray holder and framework of table." (both daily and terminal procedures)

- "Wash exterior of the table post, base and wheels." (both daily and terminal procedures)

- "..... wipe the exterior of the bedside stand." (both daily and terminal procedures)

- "... wipe the bed frame and bedrails." (both daily and terminal procedures)

- "... wipe window ledges ...." (both daily and terminal procedures)

- The floor will be dry mopped and "collect all dust and debris into a pile near the doorway...." (both daily and terminal procedures)

- Wet mop the floor (both daily and terminal procedures)

- Under Wet Mopping: "Move each piece of furniture if possible and mop...." (terminal procedure only)

- "Check overall room appearance - curtains, chairs, floors, garbage, etc." (both daily and terminal procedures)

- "Make sure the room is ready for the next patient" (terminal procedure only)

At the end of the day on April 11, 2018, the team leader made Administrative Staff aware of findings of an accumulation of dust in inpatient rooms.

On April 12, 2018 at 4:15 PM, the surveyors specifically discussed the observations under finding #4 and #5 above with Administrative staff. The surveyors requested a plan of action to ensure that patients would receive care in a sanitary environment.

At 5:35 PM, a plan of action was received from the hospital. The immediate corrective action was additional staff and management would conduct inspections that evening and would clean rooms.

At 5:35 PM, two surveyors observed that staff were in the process of cleaning patient rooms, patient care equipment, and the common areas on the acute care unit.

On April 13, 2018 between 7:20 AM and 8:45 AM, a surveyor observed four inpatient rooms (Rooms #212, #213, #215, and #217), the patient kitchen, and common areas. All rooms and common areas were observed to be clean.

INPATIENT UNIT - THE BIRTHING CENTER:

1. On April 11, 2018, from 12:00 PM to 1:15 PM, two surveyors, who were accompanied by the Engineering Manager and Environmental Services Director, entered and observed five inpatient rooms (Birthing Room #3, #4, #6, and #7 and Room #9) in The Birthing Center. All five of these rooms were observed to have an accumulation of dust within the rooms and these rooms had been previously cleaned and were ready for new patients. The room observations were as follows:

- In Birthing Room #3, an accumulation of dust on the upper edge of the dry erase board and in all corners of the room; and plastic debris around the bed and along the heater.

- In Birthing Room #4, an accumulation of dust on the top of the container of the suction machine and the upper edge of the dry erase board; a glue type adhesive on the right lower bed handrail; and dust and debris on the floor in all corners of the room. The glue type adhesive created a surface which could not easily be cleaned and sanitized.

- In Birthing Room #6, an accumulation of dust on the upper edge of the dry erase board and dust and debris in three corners of the room.

- In Birthing Room #7, an accumulation of dust on the upper edge of the dry erase board and the heater; and debris along the edges of the room and in all the corners of the room.

- In Room #9, an accumulation of dust on the upper edge of the dry erase board and all corners of the room.

All of the above findings were confirmed with the Engineering Manager and/or Environmental Services Director at the time of the observations

2. On April 11, 2018 at 12:11 PM, in the pantry, there was no air gap on the ice machine. An air gap is required to ensure that sewer waste does not back up through the drainage pipe, on the ice machine, into the ice machine thus contaminating the ice. This finding was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

3. On April 11, 2018 at 12:32 PM, a surveyor observed one ceiling that was stained in the bathroom of Birthing Room #7. Staining on the tile indicates the tile had become wet, at one point, which then created a habitat for mold growth. This observation was confirmed with the Engineering Manager and/or Environmental Services Director at the time of the observation.

4. On April 13, 2018 between 7:59 AM and 8:20 AM, a surveyor observed six inpatient rooms (Birthing Rooms #3, #4, #5, #6, #7 and Room #8) and the nursery in The Birthing Center. The following was observed:

- In Birthing Room #5, an accumulation of dust on the base of the soiled linen cart.

- In the nursery, an accumulation of dust on the bottom of a bassinet currently in use.

The above findings were confirmed with the Director of Environmental Services and the Nurse Manager of the Birthing Center at the time of the observations, 8:03 AM and 8:11 AM respectively. The Director of Environmental Services immediately cleaned the linen cart and the bassinet. The Nurse Manager stated that this bassinet had been in use for five days.

CLINIC AREAS:

On April 11, 2018, from 9:10 AM and 9:25 AM, two surveyors, who were accompanied by the Engineering Manager and Environmental Services Director, observed the following:

- In the Infusion Therapy Clinic in Exam Room #2, built up dirt debris on the base of the soiled linen hamper cart and rusty castors and built up dirt debris on the base of an IV pole.

- In the Infusion Therapy Clinic Storage Room, rusty castors on a Concha Therm III unit (heater).

- In the Electroencephalogram (EEG) Room, an accumulation of dust on the base of the soiled linen cart

- In the Pulmonary Function Room, an accumulation of dust on the base of the bed frame.

- In the desk area of the Pulmonary Function Room area, an accumulation of dust on the box fan.

All of the above findings were confirmed with the Engineering Manager and/or Environmental Services Director at the time of the observations.

KITCHEN:

1. On April 10, 2018 at 10:33 AM, the Food Service Director identified which sink in the kitchen the staff utilize for food preparation. No air gap was observed on the identified sink or any sink located in the kitchen area. An air gap is required to ensure that sewer waste does not back up through the drainage pipe into the sink. This finding was confirmed with the Food Service Director at the time of the observation.

2. On April 10, 2018 at 10:31 AM and 10:55 AM respectively, dried on substances were observed on the food slicer and the can opener. These findings were confirmed with the Food Service Director at the time of the observations

OUTPATIENT LABORATORY COLLECTION AREA:

On April 10, 2018 at 9:08 AM, a heavy accumulation of dust on the wall mounted fan was observed. This finding was confirmed with the Engineering Manager and/or Environmental Services Director at the time of the observation.

EMERGENCY DEPARTMENT:

On April 11, 2018, at 1:30 PM, in Bay B of the Emergency Department Trauma Room, chipped/cracked Formica on the top of the counter and a non-intact surface on the mattress of the stretcher was observed. These areas created a surface which could not easily be cleaned and sanitized. These findings were confirmed with the Emergency Department Director at the time of the observation.

IMAGING DEPARTMENT:

On April 11, 2018 at 10:26 AM, three stained ceiling tiles were observed in the hallway outside the processing room. Staining on the tile indicates the tiles had become wet, at one point, which then creates a habitat for mold growth. This observation was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

OFF CAMPUS OUTPATIENT SERVICE (OAKLAND LOCATION):

On 4/12/18, at 9:45 AM, during a tour of the outpatient orthopedic, foot and ankle, and wound clinics, three of three patient rooms used for wound treatment, Rooms #2, #3, and #6, were found with an oscillating fan in the upper corner of each room. Each fan had built up dust on the blades and in the grates. The Practice Manager confirmed that the three rooms were used for wound treatments and the fans needed to be cleaned.

IMPROPER USE OF BIOHAZARD BAGS:

Biohazard Bags are an essential item used in controlling the spread of diseases from human waste, discarded medical supplies and biological contaminants. These high-density red bags are marked with the international symbol to alert others of its hazardous contents.

1. On April 10, 2018, at 2:20 PM in the hall between OR #1 and OR #2, a biohazard zip-lock bag containing, what the Director of Surgical Services explained was, a "formalin mat" that could be used by staff if necessary. An item that is going to be used should not be stored in biohazard bags.

2. On April 11, 2018, at approximately 10:04 AM, an open biohazard zip-lock bag was observed tacked to the back wall of an open metal cabinet in OR #2. This biohazard bag contained blue and red numbered plastic tags. RN #1 explained that the tags in the biohazard bag were used to tag devices which were damaged in some way to track them when they are sent for repairs. The RN confirmed that staff would remove a tag from the bag. On 4/11/18 at approximately 10:15 AM, the Director of Surgical Services confirmed the use of this bag, clearly marked as a biohazard, was used for storage of the tags.

Based on observations, review of manufacturer's labels, and interviews, it was determined that the Condition of Participation for Surgical Services was not met as evidenced by the hospital's failure to ensure the operating rooms were disinfected properly between surgical operations for 2 of 2 observations of cleaning after procedures was completed. These failures created an environment which potentially placed patients a risk for infection and serious harm; thus, a determination of immediate jeopardy was made. In addition, the hospital failed to ensure that equipment was not placed on the floor immediately before use or touching the floor when stored; areas were free from dust; the surfaces of items were able to be cleaned and sanitized properly; there was an air gap on the ice machine to prevent back flow from the sewer waste pipe; and that sanitizing cloths were used per manufacturer's recommendations.

Findings:

SURGICAL DEPARTMENT - OPERATING ROOMS/PROCEDURE ROOM:

1. On April 11, 2018 from approximately 10:04 AM to 10:15 AM, two staff were observed cleaning Operating Room (OR) #2 after a surgical procedure had been completed and prior to the next scheduled surgical procedure. The following was noted:

- Staff used disposable disinfectant wipes from a red top container (Sanicloth Plus) to disinfect equipment/items in the OR. The surveyor observed that the staff were wiping surfaces with one or two wipes, discarding the used wipes, and then taking new wipes from the container, and wiping other surfaces without ensuring that the surfaces remained wet for at least three minutes (10:04 AM).

- Registered Nurse (RN) #1 wiped both sides of the transfer board (a device used to slide a patient on when transferring from one bed to another), that was on the operating room table, with a cloth from a container with a red top (Sanicloth Plus) and then hung the board on the wall (10:10 AM). The surveyor observed that the board began to dry within 30 seconds and the RN did not rewipe the board to ensure it remained wet for at least three minutes.

- RN #1 cleaned the OR table with the Sanicloth Plus wipes after cleaning the transfer board. RN #1 removed the cushion, at the foot of the OR table, and a large section of Velcro was seen with many threads within the Velcro hooks. The surveyor asked RN #1 what the threads were and the RN replied, "Oh, those are from blankets that the patient have on. They get hooked in there and we clean them with this." She showed the surveyor a spray bottle of the Hyperfect disinfectant which she indicated would be used for the disinfecting. The surveyor confirmed, with RN #1, that the threads observed were from the blankets that were worn by previous patients that had surgical procedures on the operating room table.

On April 12, 2018, at approximately 8:32 AM, Centralized Sterile Processing (CSP) Employee #1 was observed to wipe the used endoscope and take it into the cleaning room adjacent to the procedure room and place it into the sink. The CSP then returned to the procedure room and was observed to wipe the work table surface with one Sanicloth Plus wipe and then return to the cleaning room. The surveyor continued to observe the work table and noted that the surface dried within 90 seconds.

The manufacturer's label on the container of Sanicloth Plus wipes was observed. The manufacturer's label indicated the "wet time" (i.e.: the time a piece of equipment needs to remain wet for proper disinfection) must be three minutes to provide appropriate sanitizing of the item.

The label on the Hyperfect disinfectant was observed. The label indicated that surfaces must remain wet for ten minutes.

On April 11, 2018, at approximately 10:15 AM, with the Director of Surgical Services present, RN #1 was asked how the long the surface should remain wet for the cleaning agent to be effective. RN #1 replied three minutes. The surveyor asked the RN how she would know if the surfaces remained wet for three minutes and she stated, "We don't time it, we just use the cloths." Another staff that was also cleaning OR #2 stated, "I've wondered about that myself."

On April 12, 2018, at approximately 7:45 AM, CSP #1 was interviewed just prior to a scheduled endoscopy procedure in the procedure room. The CSP was asked about the "wet time" for the Sanicloth Plus wipes. The CSP explained, "That's the time it takes to dry before you can use the surface. Like this is 3 minutes so you wipe it off and you can't use it for 3 minutes. The other stuff (Hyperfect) you spray it on and I think it's five minutes before you can use it." The surveyor then asked, "So, with these red top ones, the Sanicloths, if the surface dries before the three minutes are up, is that OK? Is there anything else you should do?" The CSP #1 replied, "Sure, it's OK. It's clean, isn't it?"

On April 12, 2018 at approximately 12:45 PM, RN #2 was interviewed regarding the use of disinfectants specifically the use of Hyperfect. RN #2 explained, "It's a spray and you spray it on and don't wipe it for 10 minutes." Upon further questioning regarding the "wet time" RN #2 replied, "You spray it on and don't wipe off, it shortens the dry time" and "I guess if it dries before the 10 minutes that's OK."

Immediate Jeopardy is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Based on the observations on two days of incorrect cleaning of items after procedures and interviews with three staff (RN #1, RN #2, and CSP #1), who were not aware of the proper wet times procedures, a determination of immediate jeopardy was made on April 12, 2018.

On April 12, 2018 at 4:15 PM, the surveyors discussed the observations and interviews with Administrative staff. The surveyors requested a plan of action to ensure that patients would receive care in a sanitary environment within the operating rooms.

On April 12, 2108 at 5:35 PM, a plan of action was received from the hospital. The immediate corrective action for the operating rooms was additional staff and management would conduct inspections that evening and would clean rooms.

On April 12, 2018 at 6:10 PM, a surveyor observed several individuals in the operating rooms cleaning. In addition, at this time, the Director of Surgical Services stated, to a surveyor, that there were no specific policies and procedures for cleaning and sanitizing the operating rooms and procedure rooms.

On April 13, 2018 at 8:30 AM, the surveyor observed OR #2 and #3 and found the rooms clean.

On April 13, 2018 between 9:20 AM to 9:55 AM, the surveyor observed four staff cleaning OR #1 after a procedure. The staff cleaned the room using appropriate techniques.

Based on the observations, completed on April 13, 2018 between 9:20 AM and 9:55 AM, it was determined that the immediate jeopardy situation had been abated.

2. On April 10, 2018 between 1:40 PM to 2:50 PM, two surveyors, who were accompanied by the Engineering Manager and the Director of Surgical Services, observed the following:

- In OR #1, dust on the ventilation intake vents.

- In OR #2, dust on the ventilation intake screens; rust on the Zimmer Tourniquet Unit #2 stand; the radiology aprons hung on a hook and touching the floor; chipped paint on the base of an intravenous (IV) pole and on the support arm of the ceiling mounted surgical light; rusty casters on a kick bucket stand; chipped paint and rust on both a linen cart and a trash cart; a damaged area on the door; and the Pyxis machine had a three milliter syringe wrapper on the top of it.

- In OR #3, dust on the ventilation intake screens; tape residue on the top of a stool and on the Drager- Fadious GS machine; rusty casters on a ring stand; and a damaged area on the lower part of the interior of the door.

- In the Suture Room, rusty casters on a stool.

The chipped paint, rusty areas, damaged area on the doors, and tape residue created surfaces which could not easily be cleaned and sanitized.

The above findings were confirmed with the Engineering Manager and the Director of Surgical Services at the time of the observations. At 2:10 PM, the Director of Surgical Services confirmed that OR #2 had already been cleaned prior to the observations made by the surveyors.

3. On April 11, 2018 at approximately 7:44 AM, during the preparation for a surgical procedure, a stirrup, which is designed to hold a patient's legs apart for the procedure, was placed on the floor while the patient was moved. Without cleaning the stirrup, the stirrup was picked up off the floor, put into place on the operating table, and the patient's legs were placed in the stirrups. The cushion on the lower portion of the operating table was removed and placed on the floor leaning against the wall. This cushion had holes in the surface; therefore, could not be cleaned and properly sanitized. This finding was confirmed by the Director of Surgical Services on 4/11/18 at approximately 10:15 AM.

4. On April 11, 2018 at approximately 10:05 AM, two "Toboggan" arm protectors, devices used to rest the patient's arms on while on the operating table, were observed to have cushions that were worn and damaged. These arm protectors could not be cleaned and properly sanitized. This finding was confirmed by the Director of Surgical Services on 4/11/18 at approximately 10:15 AM.

SURGICAL DEPARTMENT - STERILE CENTRAL SUPPLY AND OR STORAGE AREA:

1. On April 10, 2018 between 1:40 PM to 2:50 PM , two surveyors, who were accompanied by the Engineering Manager and the Director of Surgical Services, observed the following:

- In the Orthopedic Supply Room, torn vinyl on the surface of the surgical hand table. This created a surface which could not easily be cleaned and sanitized.

- In the Central Sterilization Sterile Room, on office area with a loose-leaf binder, five pieces of unprotected paper hanging over the desk area, a paper desk blotter, a wall hung paper calendar, three chairs with fabric covering the seats and back, a stool with a fabric covered seat, and other miscellaneous office supplies. These items should not be in the sterile central supply room.

The above findings were confirmed with the Engineering Manager and the Director of Surgical Services at the time of the observations.

2. On April 11, 2018 at 9:57 AM and 9:57 AM, in the OR storage room, multiple tears and glue residue were observed on the vinyl covering of a fracture table and an accumulation of dust on the cart that contained the Arthroscopy pump. This finding was confirmed with the Environmental Services Director at the time of the observation.

SURGICAL DEPARTMENT - DAY SURGERY UNIT:

1. On April 11, 2018, between 9:30 AM and 9:54 AM, two surveyors, who were accompanied by the Engineering Manager and Environmental Services Director, observed the following:

- In the Alcove area, worn vinyl on the seat of a wheelchair.

- In the hallways, dust and or debris on the bases of seven linen hamper carts and two stretchers.

- In the Latex-Free Room, dust on the bases of two stretchers, on one bedside table, and on the upper edges of a wall clock and a dry erase board.

- In Room #1, an accumulation of dust on the base of one bedside table and dried on debris on the base of the other bedside table.

- In Room #4, an accumulation of dust on the bases of a stretcher and an IV pole and on the upper edges of a wall clock and a dry erase board.

- In Room #6, an accumulation of dust on the bases of three stretchers and two intravenous (IV) poles.

- In Room #8, an accumulation of dust on the bases of the stretcher and the bedside table and on the top edge of the dry erase board.

- In Room #9, an accumulation of dust on the bases of the stretcher, the bedside table, and pole of the vital sign machine and on the top edge of the dry erase board.

All of the above findings were confirmed with the Engineering Manager and Environmental Services Director at the time of the observations.

2. On April 11, 2018 at 9:54 AM, in the day surgery pantry, there was no air gap on the ice machine. An air gap is required to ensure that sewer waste does not back up through the drainage pipe, of the ice machine, into the ice machine; thus, contaminating the ice. This finding was confirmed with the Engineering Manager and Environmental Services Director at the time of the observation.

3. On April 12, 2018 at 5:40 PM, in Day Surgery Patient Room #1, Housekeeper #1 was observed cleaning the surface of the door utilizing Hyperfect. The surveyor observed that the surface began drying within 20 seconds after the Housekeeper applied the Hyperfect. When asked about the Hyperfect, the Housekeeper told the surveyor, "They recommend 10 minutes ..." and "Once you wipe it down you can't touch it for 10 minutes." The surveyor stated "This door surface that I saw you wipe down when I first came in is dry. Do you need to do anything else or wipe it again?" The housekeeper replied, "No, it's alright."

4. On April 12, 2018 at 5:50 PM, in Day Surgery Patient Room #7, Housekeeper #2 was observed wiping the door handle and surfaces, the sink and shelves on and around the sink, and the top and surface of the white board on the wall with the same Sanicloth Plus wipe . The surveyor asked the Housekeeper what wet time was and he replied, "It dries within 3 minutes". The surveyor asked Housekeeper #2, "I see that these surfaces around the sink and door dried within 30 seconds. Is that OK? Do you need to do anything else?" The Housekeeper replied, "That's OK ... it's clean.

The cumulative effect of these deficient practices resulted in noncompliance with this Condition of Participation.

Based on observations and interview, the hospital failed to ensure that policies and procedures were written in relation to the cleaning of operating rooms and procedure rooms.

Findings:

On April 11, 2018 and April 12, 2018, hospital staff were observed cleaning items in an operating room or a procedure room. During these observations, staff failed to ensure the disinfectant wipes were used properly. Please see §482.51 Condition of Participation: Surgical Services (A-940), finding #1, for details of these observations and interviews.

On April 12, 2018 at 6:10 PM, the Director of Surgical Services stated, to a surveyor, that there were no specific policies and procedures for cleaning and sanitizing the operating rooms and procedure rooms.