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Based on observations, record reviews, interview, and review of the hospital's policy and procedures, the hospital failed to ensure all staff met all the applicable minimum qualifications and training/education requirements for for 2 of 2 Registered Nurses(RN) responsible for the care of patients receiving dialysis (RN 1 and 6), 1 of 1 Chief Nursing Officers(CNO), and 1 of 1 Director of Surgical Services responsible for the provision of care for patients in the hospital's Emergency Room or Intensive Care Unit, and failed to show documentation of annual competencies for the processing of scopes used for Endoscopy procedures in the surgical area.

The findings are:

Registered Nurse 3
On 11/30/2018 at 10:00 a.m., review of the personnel file for RN 3 revealed RN 3's date of hire was 8/13/2018. There was no certification or training for RN 3 for Cardiopulmonary Resuscitation or Advanced Cardiac Life Support(ACLS). Review of the job description for RN 3, revealed, "ER(Emergency Room/Critical Care Registered Nurse Qualifications: Graduate from an accredited school of nursing with a current license in the state. To be ACLS certified." On 11/30/2018 at 10:15 a.m., in the conference room, Director 5 verified the finding and stated that RN 3 "is scheduled for a class 1/10/2019." On 11/29/2018, RN 3 was observed in the provision of patient care for two patients in the hospital's Intensive Care Unit.









31672

Chief Nursing Officer and Director of Renal Dialysis
On 11/27/18 at 12:50 p.m., in interview with the Chief Nursing Officer(CNO), the CNO verified that he/she is the current Director of the hospital's Acute Dialysis Unit. On 11/27/2018 at 1:00 p.m., the CNO and Registered Nurse 1 reported they received their dialysis training from for the hospital owned dialysis unit from Hospital B. The CNO stated, "None of the big corporations wanted to work with us, so we just went to Hospital B and got trained. RN 1 stated, "I trained for twelve weeks and our other dialysis nurse has been trained too." On 11/29/18 at 2:30 p.m., Director 1 revealed the CNO who is also the Director of the Dialysis Unit has no documentation of dialysis training or competency and skills checklists related to dialysis on file. A document, titled, "Regional Medical Center Hemodialysis Orientation Checklist and Competency" was provided that was dated 3/15/3017, in the first column on the form, titled, "Equipment Skill" - "Daily heat disinfection of machine" initialed by RN 1.

Registered Nurse 1
On 11/27/18 at 4:15 p.m., review of the hospital's dialysis training records for RN 1 revealed the hospital's "Hemodialysis Competency Dialysis" training record dated 5/9/17 was completed by Hospital B, the hospital that trained the dialysis nurse. On the dialysis competency check list for RN 1, the following assessment code was used:
"1= Yes - I have the knowledge and skills to perform independently", "2= I need to review and practice", and "3 = I do not have the knowledge or skill". On 11/27/2018 at 4:50 p.m., review of RN 1's dialysis competency checklist revealed on page 2 of 2 that RN 1 's competency level for "Demonstrates knowledge and ability to respond to and provide treatment for" was assessed as a 2, which indicated, "I need to review and practice" for Air Emboli, Cardiac or Respiratory Arrest, Dialyze and setup in the ICU (Intensive Care Unit), and Discontinue a Temporary Vas(Vascular) Cath(Catheter). There was no documentation of further education or observance of the above skills assessed as level 2 requiring further review and practice. In an interview with RN 1 on 11/27/2018 at 5:00 p.m., RN 1 stated, "We are supposed to be checked off annually, but I just didn't have time to go to Hospital B for the training and competency check off in 2018."

Registered Nurse 6
On 11/28/18 at 4:00 p.m., review of RN 6's dialysis training record revealed a competency checklist from a corporate dialysis outpatient facility that documented RN 6's dialysis competencies. On 11/28/2018 at 4:35 p.m., RN 6 stated, "I worked for an outpatient corporate dialysis facility when this dialysis competency check list was completed. RN 1 was supposed to check me off for dialysis competency here but it hasn't been done yet. RN 1 trains staff on cleaning the hemodialysis machine, testing the quality water, obtaining the consents, and putting in orders for dialysis. We alternate every other week covering the dialysis unit and we work in other areas in the hospital as well such as the Emergency Room and/or Intensive Care Unit.





39310

Director of Surgical Services
On 11/29/18 from 11:35 a.m. through 11:45 a.m., the Operating Room Director revealed,"Sometimes I circulate in the OR(Operating Room) and in the Endoscopy Room, but I never go in the scope processing room because I don't know how to process scopes. I couldn't if I had to. I have an Associate Degree in Nursing. After graduation, I started out in this hospital and was trained here. For staff education, we do in-services if we get new equipment for the surgical area." On 11/29/2018 at 12:00 p.m., review of hospital's nursing in- service was dated 3/24/2018 related to the Olympus Endoscopy-Bronchoscope taught by an equipment representative.

Based on observations, interviews, record reviews, review of the hospital's policies and procedures review, review of the hospital's infection control program, and review of the hospital's Quality Assurance Performance Improvement (QAPI) program, the hospital failed to ensure that the Surgical Suite and Sleep lab operated in a responsible manner to ensure the safety of the patients receiving procedures in specialty areas in that equipment for patient use is reprocessed in a manner to prevent the potential cross contamination of infectious agents in those hospital settings.

The findings are:

Cross Reference to A 0063: The medical staff failed to ensure accountability for patient care in the hospital's Endoscopy and respiratory services in the monitoring and accountability for processing patient equipment used for Endoscopy procedures and respiratory procedures.

Cross Reference to A 0144: The hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.

Based on observations, interviews, review of the hospital's medical staff bylaws, hospital's policies and procedures, review of the hospital's infection control programs and quality programs, the medical staff failed to ensure accountability for patient care in the hospital's Endoscopy and respiratory services in the monitoring and accountability for processing patient equipment used for Endoscopy procedures and respiratory procedures.


The findings are:


Cross Reference to A 0144: The hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.

In a face to face interview with Medical Doctor 3 in the hospital's board room on 11/29/18 at 1:30 p.m., Medical Doctor 3 stated, "I'm the Chief of surgery. I try to schedule my endoscopies on Mondays and Fridays and schedule surgeries in the middle of the week. I have oversight in Endoscopy. We should have more training in that area. I have no training in that area. I believe we need a scope washer. We also need a dedicated closet for scope storage. I know we need one. I made my requests through the Director of Surgical Services, but it was denied, but there must be money set aside in the budget. My other concern is water pressure. There's not enough hand sanitizer
in the rooms or outside the rooms."

On 11/28/18 at 3:30 p.m., review of the Hospital's Rule and Regulations of the Medical Staff, reads "....C. Physician Responsibility- 1. Each member of the Medical Staff shall provide assurance of immediacy of adequate professional care for his patients in the Medical Center....".

Based on observations, record reviews, interviews, review of the hospital's Quality Program, and review of the hospital's infection control, the hospital failed to ensure the patient's right to receive care in a safe setting for those patients presenting to the hospital for surgical procedures and/or procedures in the hospital's sleep lab.


The findings are:


Cross Reference to A 0144: The hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.

Cross Reference to A 0747: The Hospital failed to ensure acceptable principles of infection control were used in reprocessing of patient equipment used in procedures in the surgical and respiratory settings to avoid sources and potential cross transmission of infections agents in those hospital settings.

Cross Reference to A 0940: The hospital failed to be well organized and provide services in accordance with acceptable standards of practice for reprocessing of patient equipment used in the hospital's Endoscopy suite and Sleep laboratory.

Based on observations, interviews, review of the hospital's policy and procedure, review of the hospital's Quality Assurance Performance Improvement Program (QAPI), and review of the hospital's Infection Control Program, the hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.


The findings are:


Observation 1 Endoscope Processing
On 11/28/18 at 10:00 a.m., observations in the hospital's Endoscopy procedure room showed Surgical Technician 2 received the Colonoscope used during the patient's procedure from the physician. Surgical Technician 2 wiped the Colonoscope with a 4 x(by) 4 gauze soaked in tap water. Observations in the Endoscopy procedure room showed Surgical Technician 2 failed to wipe the insertion tube with a wet cloth or sponge soaked in a freshly prepared detergent solution immediately after the scope was removed from the patient. Surgical Technician 2 suctioned tap water through the Colonoscope, placed the scope in a clear opened container with no cover, and then wrapped a sheet around the container. The container was not labeled as Biohazard. Observations in the Endoscopy procedure room also showed Surgical Technician 2 transported the soiled scope in a plastic container covered with a sheet rather than in a closed container that would prevent potential exposure of infectious agents to staff, patients, or the environment.

In processing room, observations showed Surgical Technician 2 placed the Colonoscope in a clear container to wash and leak test the scope, but the scope was not totally submerged in the water in the plastic container. Surgical Technician 2 stated, "We flip the scope over in the water." Surgical Technician 2 stated, "We don't clean the container we use to handle the scopes until the end of the day. We don't wipe the container out between washing and rinsing the scopes until the end of the day." Observation showed the container used to clean the dirty scope was not large enough for the scope to be fully submerged in the water for cleaning or rinsing the scope. After the dirty water used in the initial cleaning was dumped in a small sink, the plastic container was filled with clean water without cleaning and disinfection of the plastic container used in the initial cleaning process.

Observations on 11/28/18 at 10:10 a.m., Surgical Technician 2 hung the clean Endoscope in the dirty reprocessing/scope cleaning room to dry. Surgical Technician 2 reported the hospital has no separate area in a clean room or a storage cabinet for the clean scopes to hang. On 11/28/2018 at 10:10 a.m., Technician 2 stated, "I wish we had a cabinet to keep the scopes in." On 11/28/18 at 10:04 a.m., Technician 3 removed soiled gloves after loading the Endoscope into the Steris machine, removed his/her soiled gown, and left the processing room without performing hand hygiene. Observations showed the Surgical Technician did not thoroughly dry the scope before placing the scope in the Steris.


Observation 2 Endoscope Processing
On 11/28/18 from 10:20 a.m. to 10:33 a.m., observations in the scope cleaning /reprocessing room with Surgical Technician 2 who was processing a post procedure dirty scope showed Surgical Technician 2 placed the dirty scope in a plastic container with a piece of blue tape labeled "2 gallon line". The water in the plastic container exceeded the marked line for 2 gallons of water. Surgical Technician 2 stated, "Sometimes we put too much water in there when we pour it from the gallon jug. We use two pumps of the Prolistica enzymatic cleaner. We use 1 pump per gallon of water, so if we have 2 gallons of water, we pump two squirts for two gallons of water." Observations showed the dirty scope was not completely submerged in the container of water. When asked about the coiled dirty scope protruding from the water uncovered, Surgical Technician 2 stated, "It(Scope) won't fit in this container all the way so I just flip it and wipe it thoroughly with my sponge." Observations showed Surgical Technician 2 cleaned the channels of the dirty scope using a small bristle single use brush. Surgical Technician 2 dipped the bristle brush in the detergent water after cleaning the channels of the dirty scope. After pre-cleaning the dirty scope for 7 minutes, the dirty scope was placed on the small sink counter and the plastic container of dirty water was dumped into the very small sink. The plastic container was filled with warm to touch water. Observations showed Surgical Technician 2 placed the scope into the water in the plastic container which had not been cleaned after the dirty water had been emptied into the small sink and prior to filling the plastic container with fresh water. Surgical Technician 2 was asked about the cleaning process for the plastic container used for cleaning and rinsing the dirty scopes during the cleaning process. Surgical Technician 2 stated, "Oh no, we only clean the plastic container at the end of the day." Observation showed Surgical Technician 2 rinsed the scope in the plastic container and squirted water into the channels from the water in the container. Surgical Technician failed to clean the plastic container that had been used for the dirty scope prior to filling the plastic container with clean water to continue the cleaning process. Surgical Technician 2 failed to to ensure the scope was fully submerged during the cleaning process and failed to put clean water into the plastic container for the manual rinse step.

After 2 minutes, Surgical Technician 2 removed the scope from the plastic container and placed the scope into the Steris. Surgical Technician 2 stated, "This cycle will run for twenty-four minutes making the complete cycle 34 minutes." Observations revealed no air was purged into the channels and the scope was not dried with a cloth prior to placement in the Steris. Surgical Technician 2 failed to thoroughly dry the clean scope prior to placement of the scope in the Steris.

On 11/28/2018 at 10:36 a.m., observations showed the cleaned scopes were observed hanging behind the door of scope processing room behind the dirty sink. On 11/28/2018 at 10:36 a.m., in an interview with Surgical Technician 2 regarding the scopes observed hanging behind the door, Surgical Technician 2 revealed, "This is all we have. They scopes should not be in this same room where the dirty scopes are cleaned. I know we are supposed to have them in a cabinet, but we don't have room for a cabinet so we never got one."

On 11/28/2018 at 11:00 a.m., observations showed Surgical Technician 2 removed the scope from the Steris, and hung the scope on a hook with the other scopes beside the dirt sink. Surgical Technician 2 did not purge air into the scope channels or use alcohol to flush the scope as part of the drying process. Observations showed Surgical Technician 2 did not wipe the cleaned, reprocessed scope with a soft, lint free cloth before hanging it on the hook. In an interview on 11/28/2018 at 11:00 a.m., Surgical Technician 2 stated, "I never wipe them(scopes). I just remove them(scopes) from the sink to the Steris and then from the Steris to the hanger without wiping it(scope). I'm sure
there is probably some kind of wipe we could probably use, but we just don't have that here."

In an interview on 11/28/2018 at 11:15 a.m., Surgical Technician 2 stated, "We have six scopes here: 2 Colonoscope, 2 endoscopes, and 1 pediatric Colonoscope that is used for difficult cases." When asked how many procedures are completed per day, Surgical Technician 2 stated, "Sometimes seven or eight. Usually on Mondays, Wednesdays, and Fridays. We rotate the scopes. We will just wash them and process them(scopes) fast and use them(scopes) in order of washing." When asked if all three Colonoscope could be used more than one time a day, Surgical Technician 2 stated, "Yes, we rotate them(scopes)." When asked if the scope is wiped down again prior to using the scope again on the same day, Surgical Technician 2 stated, "No, it(scope) should be dry by that time. It's usually like 3 hours or maybe a little longer before we would use it again." When asked about the maintenance and reprocessing of scopes not used for several days between cases, as far as reprocessing them again, or at a minimum, wiping the scope of potential bacteria or contaminants from the room the scopes are hung in, Surgical Technician 2 stated, "No ma'am, we try not to go that long, usually no longer than five days."

On 11/28/18 from 3:32 p.m. to 4:20 p.m., an interview was conducted with the Infection Control Office (ICO) and the Director of Quality. When asked to explain the process of monitoring oversight for surgical and respiratory services, the Infection Control Officer stated, "I have went over the policies with the manager and the policies for disinfection and cleaning are supposed to be being updated. I started reviewing them in June 2018, and all of them just haven't been completed yet. Since June 2018, I have not had any oversight of the surgery area at all including visual audits, and I don't believe any audits were done by the last infection control officer either who left in May 2018." When asked if the OR Manager submitted any data or targets related to infection control audits, the Infection Control Officer stated, "As far as infection control goes, I have been given nothing lately from surgery." When asked what data is monitored in respiratory services related to the sleep lab, the Infection Control Officer stated, "We have been going through policies for the fit test, and we should be reviewing every policy annually. I am not familiar with any policies regarding disinfection of the hoses and EEG leads in the sleep lab. I thought everything they were using was disposable. Unless we realize something needs addressing, we don't monitor or observe areas."

On 11/28/18 at 11:30 a.m., review of the Hospital's Quality meeting minutes revealed no documentation of infection control or quality overview or monitoring related to processing endoscopes and respiratory equipment between patient use.
On 11/29/18 at 2:30 p.m., the Director of Quality revealed, "I do not monitor anything in quality related to effective infection control practices in the scope cleaning area. I recognize now that we obviously have problems there, and I have started working on it and researching some data."

On 11/29/18 from 11:35 a.m. through 11:45 a.m., the Operating Room Director revealed, "Sometimes I circulate in the OR(Operating Room) and in the Endoscopy Room, but I never go in the scope processing room because I don't know how to process scopes. I couldn't if I had to. I have an Associate Degree in Nursing. After graduation, I started out in this hospital and was trained here. For staff education, we do in-services if we get new equipment for the surgical area." On 11/29/2018 at 12:00 p.m., review of hospital's nursing in- service was dated 3/24/2018 related to the Olympus Endoscopy-Bronchoscope taught by an equipment representative.

On 11/30/2018, a review of the hospital's in- service files revealed an in- service for the Steris Machine
dated 10/13/09 by Instructor: Technician 2 and Technician 3 for Program content: Cleaning of endoscopes and proper placement in Steris Machines.


Observations Sleep Lab Equipment Processing
Observations during the physical environment tour with the Physical Plant Supervisor on 11/27/18 at 1:05 p.m. revealed a storage room labeled "soiled respiratory". The soiled respiratory room contained respiratory therapy equipment and supplies identified as clean respiratory supplies and a soiled hose was observed in a sink. A pink patient care basin in the sink contained a dirty respiratory hose submerged in a bluish tinged solution. The basin with the hose was less than 1/2 filled with the bluish solution and the hose was not wholly submerged in the solution. Two Velcro straps used to hold CPAP masks in place were hung on the cabinet handles directly above the sink. Three uncovered respiratory hoses were hung from the plastic glove box holder on the wall opposite the sink with the dirty hose. CPAP masks and attachments were observed on a metal cart under the hoses sitting on a towel and covered by another towel.

On 11/27/18, at approximately 3:15 p.m., observations with the Respiratory Services Director revealed the same observations as above. The Director of Respiratory Services verified clean respiratory equipment and supplies were stored in the same area with dirty or soiled respiratory supplies. The Respiratory Services Director verified the Velcro straps were hanging over the "dirty" sink to dry, and wet "clean" hoses were hanging from the glove box holder right across from the dirty sink, and the cart with the "clean" masks/nozzles/nasal pads was in close proximity to the "dirty" sink.

The Respiratory Director stated that reusable sleep lab equipment such as hoses, masks, nozzles, and nasal pad (inserts) are cleaned in the soiled respiratory room. When asked what was used to clean/disinfect the used respiratory equipment and about the cleaning process, the Respiratory Director pointed to a container of enzymatic cleaner on the sink and to directions posted on a card that stated the cleaning steps. Review of the container of enzymatic cleaner revealed staff used V. Mueller instrument enzymatic single enzyme cleaner. There was no disinfectant listed on the container. The hospital did not provide documentation that any disinfectant was used to clean the re-usable respiratory patient supplies. The Respiratory Director reported the cleaning process included soaking the respiratory equipment for 15-20 minutes in the enzymatic cleaner, rinsing the equipment with tap water really well, and let the respiratory patient supplies/equipment air dry. When asked how long the hose in the sink had soaked, the Respiratory Director reported he/she was unsure of the time, but stated no sleep studies were done the night before. On 11/28/18 at 12:10 p.m., the Respiratory Director revealed the last patient's sleep study was completed on the night of 11/16/18 indicating the hose had soaked since the morning of 11/17/18 which was 10 days ago.

On 11/27/18 at 2:00 p.m., review of the hospital's Sleep/Wake Disorders Center policy with a Subject of "Cleaning and Maintenance of Equipment", reviewed 2/2018, stated the purpose of the policy was "To describe the procedures for cleaning and maintaining equipment used in the sleep center to minimize infection and the spread of germs from patient to patient. These include electrodes, monitors, and CPAP equipment for recording patients in sleep studies. Other items include recorders, computer monitors, and miscellaneous equipment used in the center. Policy: All equipment will be cleaned in accordance with the approved procedures. Cleaning is to be performed by all staff members. Cleaning of Patient Equipment and Positive Airway Pressure Equipment is to be completed during the shift on which the study is completed....Cleaning/Disinfection and Sterilization of Equipment: Disposable equipment: ...disposable CPAP masks and tubing are discarded after patient use. Non Disposable equipment: All CPAP tubing, masks, and headgear will be placed in the designated blue tub and covered with a Biohazard cover and sent down to Central Sterilization for proper washing and sterilizing. EEG wires and thermistor will be wiped down to rid of any residue and tape using alcohol, and then packaged in the appropriate bag to be sent down to Central Sterilization to be sterilized after each patient. All other wires and oximeter probes are to be wiped down with alcohol. Respiratory bands will be washed in hot, soapy water, rinsed, and air dried."

During an interview on 11/28/18 at 11:01 a.m., the Director of Respiratory Services was asked about Infection Control oversight of the Respiratory Therapy/Sleep Lab department, and stated that the Infection Control nurse does not come to monitor the cleaning of the respiratory equipment. When asked about the EEG electrodes and thermistor cleaning/disinfection, the Director of Respiratory Services stated the EEG electrodes are first cleaned with soapy water in the patient's bathroom sink, then wiped down with a Super-Sani-cloth, and air-dried in the closet in the patient room. The thermistors are wiped down with a Super Sani-Cloth and hung in the closet of the patient room. A review of both sleep lab patient rooms revealed a closet in each room that contained "clean" CPAP masks, Velcro straps, thermistors, and EEG electrodes/wires. According to the Director of Respiratory Services, the equipment had not been sent down to Central Sterile for processing, but had been cleaned.

On 11/28/18 at 3:17 p.m., review of the personnel file for the Respiratory Services Director and Respiratory Therapist 1 who is responsible for sleep studies and cleaning of sleep lab equipment revealed the hospital had no training documented related to the proper cleaning/disinfection of sleep lab equipment and supplies. The finding was verified with the Director of Respiratory Services on 11/28/18 at 3:28 p.m. who reported that s/he and Respiratory Therapist 1 cleaned the respiratory equipment/supplies as instructed by the previous Director of the Respiratory Services. The Director of Respiratory Services was unable to provide a hospital policy that directed respiratory staff to clean the respiratory supplies as staff were currently doing with the enzymatic cleaner.

During an interview on 11/28/18 at 3:30 p.m., the Infection Control Officer (ICO) was informed about the concern of the cleaning and disinfection of sleep lab respiratory supplies. According to the ICO, s/he was unaware sleep lab supplies were re-used.

Review of the information provided by the hospital on 11/30/18, of the ResMed sleep lab "Disinfection and sterilization guide" for the Mirage Quattro/Airfit F10/Mirage Softgel masks used in the sleep lab revealed the masks required either high level thermal or chemical disinfection or sterilization. According to the ResMed HumidAire 2i Disinfection and Sterilization Guide, the humidifier water chamber is to be cleaned with high level thermal or chemical disinfection or sterilization. During an interview on 11/29/18 at 2:20 p.m., the Respiratory Director stated the hospital staff cleaned the water chambers in the same way they cleaned the masks and other equipment with just the enzymatic cleaner. According to the Director of Respiratory Services, the hoses used for the CPAP machines were "Slimline", and the hospital provided instructions related to disinfection for this hose that required high level thermal or chemical disinfection, or sterilization. The Respiratory Director verified this was not the process sleep laboratory staff used for disinfection of the re-usable sleep lab equipment.

Hospital policy and procedure, titled, "Cleaning of Endoscopes and High Level Disinfecting", reads, " ....A. Precleaning in the examination room. a. Immediately after the procedure, gently wipe all debris from the insertion tube with a moist gauze pad. b. Place the distal end of the scope in water solution and aspirate through the channel by the depressing the red suction button for 5 - 10 seconds. c. Set the lever to the water bottle to the down or "drain" position. With the air pump of the video processor "ON" and the pressure set on HIGH , depress the green air/water valve on the scope fully until all the water has been discharged from the scope (evident by vigorous bubbling in the solution in which the distal end is submerged). Depressing the valve and releasing it several times helps to forcefully expel debris, which may have entered the air and water channels.
B. Disinfecting a. Before proceeding with any further cleaning steps, the scope should be leak tested.
LEAK TESTING
- Be sure that the PVE soaking cap is placed securely on the electrical contacts on the plug of the umbilical cable of the scope.
- Visually inspect the endoscope for damage after each use.
- Secure the Leakage tester to the air vent on the scope light guide. NEVER CONNECT OR DISCONNECT THE LEAK TESTER UNDER WATER.
- Pressurize the scope by pumping the hand bulb until the indicator gauge is in the green zone. Pressurizing into the RED zone may cause serious damage to the scope.
- Observe the gauge pressure to determine if the indicator remains in the green zone. If the indicator drops in the green zone rapidly, a major leak may be indicated.
- After determining the absence of any major leaks and with the leakage tester securely attached and pressure
PVE cap in place, the entire scope with all valves and inlet seals removed, may be immersed in clean water.
- Observe the instrument carefully while fully angulating the distal tip of the scope. A few bubblers may occur initially. This is normal. If a continuous stream of bubbles is observed from the same spot, a leak is indicated. Immediately remove the scope from the water. DO NOT USE THE SCOPE!
- After removing the scope from the water, release the pressure within the scope by opening the pressure release valve on the handle of the leakage tester. After the gauge indicates zero, disconnect the Leakage tester from the scope.
- If leakage was discovered, the scope will need to be sent for repair.
- If no leakage was discovered, continue with the cleaning process

b. Prepare a basin of warm water and a mild enzymatic detergent.
c. After removing the suction control valve, air/water valve, instrument channel selector and the rubber inlet seals, thoroughly wash the entire surface of the endoscope and its components. At this time, all valve cylinders and the instrument channel selector receptacle may be cleaned with appropriate brushes.
d. Brush clean the entire instruments channels:
i. insert the long cleaning brush into the opening of the suction nipple and gently pass the brush until it appears in the suction control valve receptacle.
ii. Insert the short brush into the opening at the bottom of the suction control valve receptacle on the control head and gently advance until the cylinder of the instrument control channel selector, then gently withdraw. Repeat several times.
iii. Insert the long brush into the inlet channels and gently advance the brush until it exits at the distal end of the scope. Repeat several times, cleaning the brush each time before reintroducing it into the channel.
iv. Insert the cylinder brush into the opening of the instrument channel selector cylinder. Clean the inside of the suction control valve receptacle on the control head.
e. Install the air water channel cleaning adaptors.
f. Attach the luer lock connector.
g. Close rubber inlet seals.
h. Flush all channels with enzymatic detergent using a large (60 cc) syringe
i. Flush all channels with air to remove residual detergent
j. Flush all channels with clean water
k. Flush all channels with air to remove excess water
l. Flush with Isopropyl Alcohol to remove excess water.

Based on observations, interviews, review of the hospital's Quality Assurance Performance Improvement (QAPI) data, the hospital failed to ensure an effective quality program was in place to provide monitoring and oversight of all high risk processes in high risk departments of the hospital in that there was no data or monitoring captured in the hospital's Quality program for the competency and performance of staff responsible for the hospital's processing of patient equipment used in high risk areas such as Endoscopy and respiratory areas to prevent the potential cross contamination of infectious agents in those settings.


The findings are:


Cross Reference to A 0286: The Hospital's governing body failed to ensure the expectations for safety are established for the processing of patient equipment used in high risk problem prone areas such as the surgical department and respiratory department to prevent the potential cross contamination of infectious agents in those hospital settings.

Cross Reference to A 0308: The Hospital's governing body failed to ensure the monitoring and reporting of quality indicators regarding infection control practices in the Surgical Services and Respiratory Therapy areas for processing patient equipment after procedures to prevent the potential cross contamination of infectious agents in the high risk problem prone settings in the hospital.

Based on observations, interviews, review of the hospital's Quality Assurance Performance Improvement (QAPI) data, and review of the hospital's Infection Control Data, the Hospital's governing body failed to ensure the expectations for safety are established for the processing of patient equipment used in high risk problem prone areas such as the surgical department and respiratory department to prevent the potential cross contamination of infectious agents in those hospital settings.


The findings are:


Cross Reference to A 0144: The hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.

On 11/28/2018 at 250 p.m., review of the hospital's quality data and infection control data revealed there was no data demonstrated oversight of the processing of patient equipment used in high risk problem prone areas in the Endoscopy Suite or the hospital's sleep lab by the hospital's quality department or infection control. There was no data to demonstrate that the competencies of the individuals responsible for performance in these areas is monitored on an ongoing basis.

On 11/28/18 from 3:32 to 4:20 p.m., an interview was conducted with the Infection Control Office (ICO) and the Director of Quality. When asked to explain the process for monitoring and oversight of the processing of patient equipment in the surgical areas and respiratory areas, the Infection Control Officer stated, "I have went over the policies with the manager, and the policies for disinfection and cleaning are supposed to be being updated. I started reviewing them in June 2018, and all of them just haven't been completed yet. Since June 2018, I have not had any oversight of the surgery area at all including audits, and I don't believe any audits were done by the last infection control officer either, and she left in May 2018." When asked if the Operating Room Manager submitted anything to related to monthly infection control audits, the Infection Control Officer stated, "As far as infection control goes, I have been given nothing lately." Related to respiratory services, the Infection Control Officer stated, "We have been going through policies for the fit test, and we should be reviewing every policy annually of if things change, like when the Legionella stuff came out last year. I am not familiar with the policies regarding disinfection of the hoses and EEG leads. I thought everything they were using was disposable. Unless we realize something needs addressing, we don't observe areas." The Director of Quality stated, "They need definite education on who ever is doing the sleep studies."

Based on observations, interviews, review of the Quality Assurance Performance Improvement (QAPI) data, and review of the hospital's Infection Control data, the Hospital's governing body failed to ensure the monitoring and reporting of quality indicators regarding infection control practices in the Surgical Services and Respiratory Therapy areas for processing patient equipment after procedures to prevent the potential cross contamination of infectious agents in the high risk problem prone settings in the hospital.


The findings are:


On 11/28/18 at 11:30 a.m., review of the hospital's Quality meeting minutes revealed no documentation addressing the monitoring of the processing of patient equipment in the hospital's surgical and sleep lab's respiratory equipment used for patient procedures. On 11/29/18 at 2:30 p.m., in an interview with the Director of Quality, the Director revealed, "I do not monitor anything in quality related to effective infection control practices in the scope cleaning area. I recognize now that we obviously have problems there, and I have started working on it and researching some data."

Based on record reviews, interviews, and review of the hospital's policy and procedures, the Hospital failed to ensure physician verbal orders were authenticated for 1 of 12 closed patient records. (Closed Patient 8)


The findings are:


On 11/29/18 at 4:00 p.m., review of the closed chart for Patient 8 revealed the patient was admitted on 6/2/18 at 06:14 a.m. with Respiratory Distress. A physician verbal order taken by nursing staff on 6/2/18 at 1:15 p.m. was not authenticated by the physician by the time of the survey.
In an interview with the Chief Nursing Officer (CNO) on 11/30/18 at 11:30 a.m., the CNO verified the finding.

Hospital Policy/Procedure, titled, "No. 2.35 Verbal Orders", reads, "....Verbal orders must be signed, dated and timed within 72 hours....".

Based on patient record reviews, interview, and review of the hospital's policy and procedures, the Hospital failed to ensure nursing staff documented post pain assessments for 1 of 12 closed patient records and 1 of 6 inpatient records. (Closed Patient 9 and Inpatient 2)


The findings are:


On 11/29/18 from 11:10 to 11:20 a.m., record review for Inpatient 2 revealed the patient was admitted on 11/26/18 for Acute Cholecystitis and revealed pain medication was administered to the patient. On 11/26/18 at 7:40 p.m., the patient had a pre-assessment pain score of 7/10 with 10 being the worse pain ever. Oxycodone 5 milligrams (mg) per os (mouth) was administered, but no post medication pain level was documented. On 11/28/18 at 3:45 p.m., the patient had a pre-assessment pain score of 9/10. Oxycodone 5 mgs po was administered, but no post medication pain level was documented.
The finding was verified with Manager 1 at 11:23 a.m. on 11/29/18.

On 11/30/18 at 9:00 a.m., review of the closed record for Patient 9 revealed the patient was admitted on 11/3/18 with Respiratory Distress, and pain medication was administered to the patient. On 11/23/18 at 9:05 p.m., the patient had a pre-assessment pain score of 6/10. Hydrocodone 5/325 Acetaminophen mg po was administered, but no post medication pain level was documented.

Hospital Policy/Procedure No: NUR 4.12, titled, "Pain management", reads, "....Assessment/Reassessment....F. Reassessments should be performed according to type of pain and level of effectiveness regarding medication....Staff Education: B. After receiving education/training the employee should be able to: 1. Perform appropriate pain assessment and reassessments....".

Based on observations, interview, and review of the hospital's policy and procedures, the hospital failed to discard outdated medication from the patient area and failed to label medication when opened in the Endoscopic Suite and Nuclear Medicine department.


The findings are:


On 11/27/18 at 1:00 p.m., random observations in the Endoscopic suite revealed a 20 cubic centimeter (cc) bottle of Xylocaine on a table that was opened but did not have a label with date or initials when the bottle was opened. The findings were verified by Manager 6 at the time of the finding.

On 11/27/18 at 2:50 p.m., random observations in the Nuclear Medicine room revealed 1 Atropine Sulfate 1 milligram (mg)/10 milliliters (ml) Leurjet with an expiration date of 9/18. On 11/27/18 at 2:50 p.m., random observations in the Nuclear Medicine room revealed 1 bottle of Aminophylline 20 mls opened but no label with date and initials when opened. On 11/27/18 at 2:50 p.m., random observations in the Nuclear Medicine room revealed 1 bottle of Nitrostat 0.4 mgs opened but no label with date and initials when opened. The findings were verified by Nuclear Medicine Technician 1 at 2:50 p.m. on 11/27/2018 the time of the findings.

Hospital policy and procedure, titled, "Medication Administration", reads, " ....9. Discard and do not use any medications that are unlabeled, unless the medication is prepared at the patient's bedside and immediately administered ....".

Based on observations, interview, and a review of the hospital's policy, entitled, "Out of Date Supplies", the hospital staff failed to ensure outdated supplies were removed from staff access in the hospital's laboratory (1 of 1 labs). The maintenance staff failed to ensure therapy equipment and sequential compression devices (SCD) was checked at least annually to ensure preventive maintenance needs were carried out. The maintenance staff had documented monthly maintenance checks of the hospital's fire extinguishers for December 2018 when it is still November 2018. The finding of fire extinguishers with a December 2018 date as checked in the Intensive Care Unit, Medical Surgical Unit, and clean supply room, and storage issues in the kitchen area.


The findings included:


Observations in the hospital's laboratory on 11/29/18 at 11:23 AM revealed a counter that held one opened bottle of Crystal Violet that expired 9/30/18, one opened bottle of Gram Iodine (Stabilized) that expired 6/30/18, and one opened bottle of Gram Safranin that expired 9/30/18. These reagents were currently used for lab testing. An opened, expired (4/11/16) bottle of multipurpose sanitizer was observed on top of a chemistry analyzer. According to the Laboratory Manager, the sanitizer was used to disinfect the water system in the chemical analyzer. The above findings were verified with the Laboratory Manager on 11/29/18 at 11:35 AM.

Review of the hospital's policy, provided by the hospital on 11/30/18, reads, "subject: Out of Date Supplies", revealed, "...For medical supplies stocked in other locations in the departments, it will be the responsibility of the department to ensure expiration dates are being monitored and expired items are removed from the unit...".

Observations during the physical environment tour on 11/27/18 at 12:50 PM with the Physical Plant Manager revealed 1 stepper (Physical Therapy equipment) in a West Wing room with an equipment # of 631. The green equipment check sticker indicated a maintenance check had last been completed on 1/25/16, and was due 1/2017. Review of the service history record on 11/29/18 indicated the equipment was last checked on 1/27/15. Observations of storage/utility room 235 on 11/27/18 at 1:41 PM revealed a SCD labeled equipment #636. There was no green maintenance sticker on the equipment to show when it was last checked. Review of the service history record on 11/29/18 revealed it had been added to the hospital's inventory on 11/11/13. There was no documentation to show that it was checked annually. Observations in room 217 at approximately 1:47 PM revealed a SCD with no equipment #, and no maintenance sticker. This was immediately taken out of the room by the Physical Plant Manager. Observations in Emergency Room #4 revealed an Intravenous pump with no equipment number and no green maintenance sticker to show when it had last been checked. The above findings were verified with the Physical Plant Manager at the time of each finding. The Physical Manager reported there is no way to track the maintenance of equipment without an equipment number.



31672

On 11/27/18 from 1:00-1:30 p.m., observations in the Intensive Care Unit (ICU), the Medical-Surgical Unit, and the clean supply rooms revealed five (5) fire extinguishers with the maintenance date written of "12/18". The Chief Nursing Officer (CNO) was present when these findings were discovered and stated, "Those should not have been completed yet." On 11/27/18 at 1:45 p.m., in an interview with the Physical Manager revealed, "One of my technicians came to me yesterday and told me he went ahead and checked them off early to get ahead. I informed him that we couldn't do them before the actual month.



39463

On 11/27/2018 at 1:00 p.m., observations in the kitchen dry storage revealed 5 bins of food product that was not labeled with the date product opened. Additionally, one bin of chicken breading contained a scoop left stored inside dry ingredients. On 11/27/2018 at 1:00 p.m., the finding was verified by the Dietary Director.

On 11/27/2018 at 1:10 p.m., observations of the walk in freezer revealed 20 cardboard boxes of food product stored on the floor, and 2 boxes stored less than 18 inches from the ceiling in the walk in freezer preventing adequate ventilation space and protection from contamination. On 11/27/2018 at !:10 p.m., the findings were verified by the Dietary Director.

On 11/27/2018 at 1:20 p.m., observations in the kitchen of 2 ovens and food warmer revealed the inside of the oven walls, doors, and racks were covered with a brown splatter and grime. On 11/27/2018 at 1:20 p.m., the findings were verified by the Dietary Director.

"Food Code 2017 Recommendations of the United States Public Health Service Food and Drug Administration", reads, "..... Marking the date or day the original container is opened in a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded...FOOD shall be protected from contamination by storing the FOOD at least 15 cm (6 inches) above the floor...Non FOOD-CONTACT SURFACES of EQUIPMENT shall be cleaned at a frequency necessary to preclude accumulation of soil residues."

Based on observations, interviews, record reviews, policy and procedure reviews, and Quality Assurance Performance Improvement (QAPI) review, the Hospital failed to ensure acceptable principles of infection control were used in reprocessing of patient equipment used in procedures in the surgical and respiratory settings to avoid sources and potential cross transmission of infections agents in those hospital settings.

The findings are:


Cross Reference to A 0749: The Hospital failed to ensure an environment whereby the potential cross transmission of infectious agents in the surgical setting and the sleep lab are prevented through proven infection control principles for cleaning and processing of equipment used in patient procedures.

Cross Reference to A 0756: The hospital failed to ensure an active Infection Control Program was in place to monitor the processing of patient equipment used in procedures in the Surgical and Respiratory Therapy areas to prevent the potential cross contamination of infectious agents in those settings.

Cross Reference to A 1160: The respiratory department failed to ensure reprocessing of patient equipment was conducted in accordance with the hospital's policies and procedures for reprocessing patient equipment used in patient procedures for the hospital's sleep lab to prevent the potential cross transmission of infectious agents between patients undergoing procedures in the hospital's sleep lab.

Based on observations, interviews, review of the hospital's policy and procedure reviews, and review of the hospital's Infection Control data, the Hospital failed to ensure an environment whereby the potential cross transmission of infectious agents in the surgical setting and the sleep lab are prevented through proven infection control principles for cleaning and processing of equipment used in patient procedures.


The findings are:


Cross Reference to A 0144: The hospital failed to ensure its processes for cleaning and disinfection of patient use equipment are followed to prevent the potential cross transmission of infectious agents in the surgical department and respiratory department. The hospital failed to ensure monitoring of these high risk problem prone areas by its infection control department and quality department to ensure the safety of the hospital's patients undergoing procedures.

In a face to face interview with Medical Doctor 3 in the hospital's board room on 11/29/18 at 1:30 p.m., medical Doctor 3 stated, "I'm the Chief of surgery. I try to schedule my endoscopies on Mondays and Fridays and schedule surgeries in the middle of the week. I have oversight in Endoscopy. We should have more training in that area. I have no training in that area. I believe we need a scope washer. We also need a dedicated closet for scope storage. I know we need one. I made my requests through the Director of Surgical Services, but it was denied, but there must be money set aside in the budget. My other concern is water pressure. There's not enough hand sanitizer
in the rooms or outside the rooms."

Face to face Interview with Surgical Technician 2 in the Hospital Boardroom
On 11/30/18 at 8:50 a.m., Surgical Technician 2 stated, "After the doctor finishes his procedure, I lay the scope on the cart. Then wipe it down with a 4 x 4 and tap water, all done per our policy. Then, I suck tap water through the scope, flush the biopsy port with water, check the air/water inlet valve, disconnect from the cart and put in the container with a sheet. That's how we've always carried it. Then I put it in the basin, in water, remove all the buttons, hook to leak test with the distal end out of the water, then turn on leak test, submerge the distal end in the water, use the hand controls to move the scope up and down. I check for bubbles, remove the scope from the leak tester, and watch the end deflate to be sure the leak test is doing the job. If there are no bubbles, it's Okay, if there are bubbles, I notify my manager. I dump that water and put more water in the basin, I use 2 gallons of water and 1 pump of the Enzymatic cleaner. I open the scope sponge and wipe the entire scope, then brush through all ports until no debris comes out and it's clear. I don't brush the biopsy port, then flush with a 60 cc(cubic centimeters) syringe through the ports, the suction port, air/water ports 2 times with enzymatic solution, 2 times with water and 2 times with air. Then I pull the scope out of the enzymatic cleaner, dump the basin, and put in clean water and rinse the scope. We usually bleach or Virex the basin at the end of the day. Then I move the scope to the Steris machine and hook it up. I put in the peracetic acid and the chemical indicator. Oh, I put the cap on the scope before leaving the room to clean. I can't leave that off because water will get in the scope and it would have to be repaired, and that's expensive. Then I close the machine and push start. When I open the machine, I wear gloves. I check the indicator and if it turns pink, it's okay. I take out the scope. If it's wet, we wipe it off. We flush 60 cc of alcohol in the scopes at the end of the day. We flush all the scopes. We don't flush with alcohol after drying. When we got the scopes 3 years ago, the rep came and we showed him what we do. That's what we were taught.


28883

Observations during the physical environment tour with the Physical Plant Supervisor on 11/27/18 at 1:05 p.m. revealed a storage room labeled "soiled respiratory". The soiled respiratory room contained respiratory therapy equipment and supplies identified as clean respiratory supplies and a soiled hose in the sink. A pink patient care basin in the sink contained a dirty respiratory hose submerged in a bluish tinged solution. The basin with the hose was less than 1/2 filled with the bluish solution and the hose was not wholly submerged in the solution. Two Velcro straps used to hold CPAP masks in place were hung on the cabinet handles directly above the sink. Three uncovered respiratory hoses were hung from the plastic glove box holder on the wall opposite the sink with the dirty hose. CPAP masks and attachments were observed on a metal cart under the hoses sitting on a towel and covered by another towel.

On 11/27/18, at approximately 3:15 p.m., observations with the Respiratory Services Director revealed the same observations as above. The Director of Respiratory Services verified clean respiratory equipment and supplies were stored in the same area with dirty or soiled respiratory supplies. The Respiratory Services Director verified the Velcro straps were hanging over the "dirty" sink to dry, and wet "clean" hoses were hanging from the glove box holder right across from the dirty sink, and the cart with the "clean" masks/nozzles/nasal pads was in close proximity to the "dirty" sink.

The Respiratory Director stated that reusable sleep lab equipment such as hoses, masks, nozzles, and nasal pad (inserts) are cleaned in the soiled respiratory room. When asked what was used to clean/disinfect the used respiratory equipment and about the cleaning process, the Respiratory Director pointed to a container of enzymatic cleaner on the sink and to directions posted on a card that stated the cleaning steps. Review of the container of enzymatic cleaner revealed staff used V. Mueller instrument enzymatic single enzyme cleaner. There was no disinfectant listed on the container. The hospital did not provide documentation that any disinfectant was used to clean the re-usable respiratory patient supplies. The Respiratory Director reported the cleaning process included soaking the respiratory equipment for 15-20 minutes in the enzymatic cleaner, rinsing the equipment with tap water really well, and let the respiratory patient supplies/equipment air dry. When asked how long the hose in the sink had soaked, the Respiratory Director reported he/she was unsure of the time, but stated no sleep studies were done the night before. On 11/28/18 at 12:10 p.m., the Respiratory Director revealed the last patient's sleep study was completed on the night of 11/16/18 indicating the hose had soaked since the morning of 11/17/18 which was 18 days ago.

On 11/27/18 at 2:00 p.m., review of the hospital's Sleep/Wake Disorders Center policy with a Subject of "Cleaning and Maintenance of Equipment", reviewed 2/2018, stated the purpose of the policy was "To describe the procedures for cleaning and maintaining equipment used in the sleep center to minimize infection and the spread of germs from patient to patient. These include electrodes, monitors, and CPAP equipment for recording patients in sleep studies. Other items include recorders, computer monitors, and miscellaneous equipment used in the center. Policy: All equipment will be cleaned in accordance with the approved procedures. Cleaning is to be preformed by all staff members. Cleaning of Patient Equipment and Positive Airway Pressure Equipment is to be completed during the shift on which the study is completed....Cleaning/Disinfection and Sterilization of Equipment: Disposable equipment: ...disposable CPAP masks and tubing are discarded after patient use. Non Disposable equipment: All CPAP tubing, masks, and headgear will be placed in the designated blue tub and covered with a Biohazard cover and sent down to Central Sterilization for proper washing and sterilizing. EEG wires and thermistor will be wiped down to rid of any residue and tape using alcohol, and then packaged in the appropriate bag to be sent down to Central Sterilization to be sterilized after each patient. All other wires and oximeter probes are to be wiped down with alcohol. Respiratory bands will be washed in hot, soapy water, rinsed, and air dried."

Review of the Cardiopulmonary Services Policy on Standard Precautions, Revised 6/2018, revealed, "...Patient Care Equipment- All patient care equipment that is soiled with blood, body fluids, secretions, and excretions will be handled in a manner that will prevent skin and mucous membrane exposures. Single use, disposable items must be disposed of properly. Make sure that reusable equipment has been cleaned and reprocessed appropriately, prior to
use on another patient...".

During an interview on 11/28/18 at 11:01 a.m., the Director of Respiratory Services was asked about Infection Control oversight of the Respiratory Therapy/Sleep Lab department, and stated that the Infection Control nurse does not come to monitor the cleaning of the respiratory equipment. When asked about the EEG electrodes and thermistor cleaning/disinfection, the Director of Respiratory Services stated the EEG electrodes are first cleaned with soapy water in the patient's bathroom sink, then wiped down with a Super-Sani-cloth, and air-dried in the closet in the patient room. The thermistors are wiped down with a Super Sani-Cloth and hung in the closet of the patient room. A review of both sleep lab patient rooms revealed a closet in each room that contained "clean" CPAP masks, Velcro straps, thermistors, and EEG electrodes/wires. According to the Director of Respiratory Services, the equipment had not been sent down to Central Sterile for processing, but had been cleaned.

On 11/28/18 at 3:17 p.m., review of the personnel file for the Respiratory Services Director and Respiratory Therapist 1 who is responsible for sleep studies and cleaning of sleep lab equipment revealed the hospital had no training documented related to the proper cleaning/disinfection of sleep lab equipment and supplies. The finding was verified with the Director of Respiratory Services on 11/28/18 at 3:28 p.m. who reported that s/he and Respiratory Therapist 1 cleaned the respiratory equipment/supplies as instructed by the previous Director of the Respiratory Services. The Director of Respiratory Services was unable to provide a hospital policy that directed respiratory staff to clean the respiratory supplies as staff were currently doing with the enzymatic cleaner.

During an interview on 11/28/18 at 3:30 p.m., the Infection Control Officer (ICO) was informed about the concern of the cleaning and disinfection of sleep lab respiratory supplies. According to the ICO, s/he was unaware sleep lab supplies were re-used.

Review of the information provided by the hospital on 11/30/18, of the ResMed sleep lab "Disinfection and sterilization guide" for the Mirage Quattro/Airfit F10/Mirage Softgel masks used in the sleep lab revealed the masks required either high level thermal or chemical disinfection or sterilization. According to the ResMed HumidAire 2i Disinfection and Sterilization Guide, the humidifier water chamber is to be cleaned with high level thermal or chemical disinfection or sterilization. During an interview on 11/29/18 at 2:20 p.m., the Respiratory Director stated the hospital staff cleaned the water chambers in the same way they cleaned the masks and other equipment with just the enzymatic cleaner. According to the Director of Respiratory Services, the hoses used for the CPAP machines were "Slimline", and the hospital provided instructions related to disinfection for this hose that required high level thermal or chemical disinfection, or sterilization. The Respiratory Director verified this was not the process sleep laboratory staff used for disinfection of the re-usable sleep lab equipment.

Observations of a Medpass for RN 4 and observations of a respiratory treatment given by the Director Director of Respiratory Services revealed staff removed supplies/medications from their pockets placing the patients at risk for possible cross-contamination of infectious agents. Observations showed RN 4 failed to perform hand hygiene and/or change gloves at an appropriate time before accessing a saline lock, and failed to handle a syringe using aseptic technique while performing a flush.

Observations on 11/29/18 at 9:11 a.m. revealed Registered Nurse (RN) 4 performed a medication pass for Inpatient 6. RN 4 knocked and entered the patient's room, used a hand sanitizer, donned clean gloves, pulled up the computer screen at the patient's bedside, checked/scanned the patient's medications and armband, opened the medications, and administered the medications to the patient with a sip of drink. Without changing the soiled gloves or sanitizing her/his hands, RN 4 reached in his/her scrub pocket, pulled out a Normal Saline flush (single dose ) and an alcohol pad. RN 4 had 4 other separately wrapped Normal Saline flushes in the same pocket. Wearing the same gloves, RN 4 pulled the syringe partially out of the plastic packaging, disconnected the IV(Intravenous) tubing from the patient's saline lock, wiped the port with an alcohol pad, flushed the lock with a couple milliliters of Normal Saline, and set the Normal Saline syringe with the tip uncovered onto the patient's blanket. After administering IV Pepcid, the nurse picked up the syringe from the bed and administered a couple more milliliters of Normal Saline. The findings were verified with RN 4 on 11/29/18 at 9:28 a.m..

Observations on 11/29/18 at 10:21 a.m. in the Intensive Care Unit in Room 3 revealed the Director of Respiratory Services providing a respiratory breathing treatment for Inpatient 1. The Respiratory Director removed 2 packages of medication from his/her scrub pocket, and administered Albuterol Sulfate inhalation solution and Budesonide Inhalation Suspension.





39310

On 11/28/18 at 9:30 a.m., observations revealed Registered Nurse (RN) 7 donned clean gloves without performing hand hygiene, wiped the monitor cords and wires with a wipe, removed the soiled gloves and failed to perform hand hygiene.

Observations in 11/28/18 at 10:15 a.m. revealed RN 5 donned cleaned gloves to initiate an Intravenous Line with an intravenous catheter. RN 5 removed the soiled gloves, picked up the trash from the bed and threw it in the trash can, pulled the patient's bed side rail up, and adjusted and added another piece of tape to the IV site, and exited the bay without performing hand hygiene.

On 11/28/18 at 10:00 a.m., observations showed Technician 2, in the Endoscopy procedure room, was handed the Colonoscope used during the patient's procedure. Technician 2 wiped the Colonoscope with a 4 x(by) 4 gauze soaked in tap water and suctioned tap water through the Colonoscope, placed the scope in a clear open container and then wrapped a sheet around the container that was not labeled as Biohazard. When Technician 2 placed the Colonoscope in the clear container to wash and leak test the scope, observations showed the scope was not totally submerged in water. Technician 2 stated "We flip the scope over in the water." Technician 2 stated, "We don't clean the container we use to handle the scopes until the end of the day. We don't wipe the container out between washing and rinsing the scopes until the end of the day."

Based on observations on 11/28/18 at 10:10 a.m., Technician 2 hung clean Endoscopes in the dirty reprocessing/scope cleaning room to dry. The hospital had no separate area in a clean room or a storage cabinet for the clean scopes to hang. On 11/28/2018 at 10:10 a.m., Technician 2 stated, "I wish we had a container to keep the scopes in."

On 11/28/18 at 10:04 a.m., Technician 3 removed soiled gloves after loading the Endoscope into the Steris machine, removed the soiled gown, and left the room without performing hand hygiene.

Facility policy and procedure, titled, "Hand Hygiene for all Healthcare Workers", reads,
"....3. Decontaminate hands before beginning work, after using the restroom, before eating, and prior to leaving work ....After having contact with patients or their environment, whether or not gloves are worn. After contact with patient's intact skin ....After glove removal ....".

Based on observations, interviews, record reviews, and review of the hospital's infection control program, the hospital failed to ensure an active Infection Control Program was in place to monitor the processing of patient equipment used in procedures in the Surgical and Respiratory Therapy areas to prevent the potential cross contamination of infectious agents in those settings.


The findings are:


On 11/28/2018 at 2:00 p.m., review of the hospital's infection control data revealed there was no data collected for monitoring the activities of the processing of patient equipment used for procedures performed in the hospital's Endoscopy suite and respiratory therapy's sleep lab.

On 11/28/18 from 3:32 to 4:20 p.m., an interview was conducted with the Infection Control Office (ICO)and the Director of Quality. The hospital's Infection Control Officer stated, "I have went over the policies with the managers, and the policies for disinfection and cleaning are supposed to be updated. I started reviewing them in June 2018, and all of them just haven't been completed yet. Since June 2018, I have not had any oversight of the surgery area at all including visual audits, and I don't believe any audits were done by the last infection control officer either who left in May 2018." When asked if the OR Manager submits data related to monthly infection control audits, the ICO stated, "As far as infection control goes, I have been given nothing lately and I have been going through policies for the sleep lab for the fit test and TB, and we should be reviewing every policy annually of if things change, like when the Legionella stuff came out last year. I am not familiar with the policies regarding disinfection of the hoses and EEG leads. I thought everything they were using was disposable. Unless we realize something needs addressing, we don't visually observe areas." On 11/28/2018 at 4:20 p.m., the Director of Quality stated, "They need definite education on who ever is doing the sleep studies."

Based on observations, interviews, record reviews, policy and procedure reviews, and Quality Assurance Performance Improvement (QAPI) review, the hospital failed to be well organized and provide services in accordance with acceptable standards of practice for reprocessing of patient equipment used in the hospital's Endoscopy suite and sleep laboratory.

The findings are:

Cross Reference to A 0951: The hospital failed to ensure the policies governing surgical services related to the cleaning and disinfection of Colonoscope used in Endoscopy procedures were designed to assure the achievement and maintenance of high standards of patient care and ensure practices to prevent the potential cross contamination of infectious agents in the high risk problem prone surgical setting.

Based on observations, interviews, and review of the hospital's policy and procedures, the hospital failed to ensure the policies governing surgical services related to the cleaning and disinfection of Colonoscope used in Endoscopy procedures were designed to assure the achievement and maintenance of high standards of patient care.


The findings are:


Observation 1 Endoscope Processing
On 11/28/18 at 10:00 a.m., observations in the hospital's Endoscopy procedure room showed Surgical Technician 2 received the Colonoscope used during the patient's procedure from the physician. Surgical Technician 2 wiped the Colonoscope with a 4 x(by) 4 gauze soaked in tap water. Observations in the Endoscopy procedure room showed Surgical Technician 2 failed to wipe the insertion tube with a wet cloth or sponge soaked in a freshly prepared detergent solution immediately after the scope was removed from the patient. Surgical Technician 2 suctioned tap water through the Colonoscope, placed the scope in a clear opened container with no cover, and then wrapped a sheet around the container. The container was not labeled as Biohazard. Observations in the Endoscopy procedure room also showed Surgical Technician 2 transported the soiled scope in a plastic container covered with a sheet rather than in a closed container that would prevent potential exposure of infectious agents to staff, patients, or the environment.

In processing room, observations showed Surgical Technician 2 placed the Colonoscope in a clear container to wash and leak test the scope, but the scope was not totally submerged in the water in the plastic container. Surgical Technician 2 stated, "We flip the scope over in the water." Surgical Technician 2 stated, "We don't clean the container we use to handle the scopes until the end of the day. We don't wipe the container out between washing and rinsing the scopes until the end of the day." Observation showed the container used to clean the dirty scope was not large enough for the scope to be fully submerged in the water for cleaning or rinsing the scope. After the dirty water used in the initial cleaning was dumped in a small sink, the plastic container was filled with clean water without cleaning and disinfection of the plastic container used in the initial cleaning process.

Observations on 11/28/18 at 10:10 a.m., Surgical Technician 2 hung the clean Endoscope in the dirty reprocessing/scope cleaning room to dry. Surgical Technician 2 reported the hospital has no separate area in a clean room or a storage cabinet for the clean scopes to hang. On 11/28/2018 at 10:10 a.m., Technician 2 stated, "I wish we had a cabinet to keep the scopes in." On 11/28/18 at 10:04 a.m., Technician 3 removed soiled gloves after loading the Endoscope into the Steris machine, removed his/her soiled gown, and left the processing room without performing hand hygiene. Observations showed the Surgical Technician did not thoroughly dry the scope before placing the scope in the Steris.


Observation 2 Endoscope Processing
On 11/28/18 from 10:20 a.m. to 10:33 a.m., observations in the scope cleaning /reprocessing room with Surgical Technician 2 who was processing a post procedure dirty scope showed Surgical Technician 2 placed the dirty scope in a plastic container with a piece of blue tape labeled "2 gallon line". The water in the plastic container exceeded the marked line for 2 gallons of water. Surgical Technician 2 stated, "Sometimes we put too much water in there when we pour it from the gallon jug. We use two pumps of the Prolistica enzymatic cleaner. We use 1 pump per gallon of water, so if we have 2 gallons of water, we pump two squirts for two gallons of water." Observations showed the dirty scope was not completely submerged in the container of water. When asked about the coiled dirty scope protruding from the water uncovered, Surgical Technician 2 stated, "It(Scope) won't fit in this container all the way so I just flip it and wipe it thoroughly with my sponge." Observations showed Surgical Technician 2 cleaned the channels of the dirty scope using a small bristle single use brush. Surgical Technician 2 dipped the bristle brush in the detergent water after cleaning the channels of the dirty scope. After pre-cleaning the dirty scope for 7 minutes, the dirty scope was placed on the small sink counter and the plastic container of dirty water was dumped into the very small sink. The plastic container was filled with warm to touch water. Observations showed Surgical Technician 2 placed the scope into the water in the plastic container which had not been cleaned after the dirty water had been emptied into the small sink and prior to filling the plastic container with fresh water. Surgical Technician 2 was asked about the cleaning process for the plastic container used for cleaning and rinsing the dirty scopes during the cleaning process. Surgical Technician 2 stated, "Oh no, we only clean the plastic container at the end of the day." Observation showed Surgical Technician 2 rinsed the scope in the plastic container and squirted water into the channels from the water in the container. Surgical Technician failed to clean the plastic container that had been used for the dirty scope prior to filling the plastic container with clean water to continue the cleaning process. Surgical Technician 2 failed to to ensure the scope was fully submerged during the cleaning process and failed to put clean water into the plastic container for the manual rinse step.

After 2 minutes, Surgical Technician 2 removed the scope from the plastic container and placed the scope into the Steris. Surgical Technician 2 stated, "This cycle will run for twenty-four minutes making the complete cycle 34 minutes." Observations revealed no air was purged into the channels and the scope was not dried with a cloth prior to placement in the Steris. Surgical Technician 2 failed to thoroughly dry the clean scope prior to placement of the scope in the Steris.

On 11/28/2018 at 10:36 a.m., observations showed the cleaned scopes were observed hanging behind the door of scope processing room behind the dirty sink. On 11/28/2018 at 10:36 a.m., in an interview with Surgical Technician 2 regarding the scopes observed hanging behind the door, Surgical Technician 2 revealed, "This is all we have. They scopes should not be in this same room where the dirty scopes are cleaned. I know we are supposed to have them in a cabinet, but we don't have room for a cabinet so we never got one."

On 11/28/2018 at 11:00 a.m., observations showed Surgical Technician 2 removed the scope from the Steris, and hung the scope on a hook with the other scopes beside the dirt sink. Surgical Technician 2 did not purge air into the scope channels or use alcohol to flush the scope as part of the drying process. Observations showed Surgical Technician 2 did not wipe the cleaned, reprocessed scope with a soft, lint free cloth before hanging it on the hook. In an interview on 11/28/2018 at 11:00 a.m., Surgical Technician 2 stated, "I never wipe them(scopes). I just remove them(scopes) from the sink to the Steris and then from the Steris to the hanger without wiping it(scope). I'm sure
there is probably some kind of wipe we could probably use, but we just don't have that here."

In an interview on 11/28/2018 at 11:15 a.m., Surgical Technician 2 stated, "We have six scopes here: 2 Colonoscope, 2 endoscopes, and 1 pediatric Colonoscope that is used for difficult cases." When asked how many procedures are completed per day, Surgical Technician 2 stated, "Sometimes seven or eight. Usually on Mondays, Wednesdays, and Fridays. We rotate the scopes. We will just wash them and process them(scopes) fast and use them(scopes) in order of washing." When asked if all three Colonoscope could be used more than one time a day, Surgical Technician 2 stated, "Yes, we rotate them(scopes)." When asked if the scope is wiped down again prior to using the scope again on the same day, Surgical Technician 2 stated, "No, it(scope) should be dry by that time. It's usually like 3 hours or maybe a little longer before we would use it again." When asked about the maintenance and reprocessing of scopes not used for several days between cases, as far as reprocessing them again, or at a minimum, wiping the scope of potential bacteria or contaminants from the room the scopes are hung in, Surgical Technician 2 stated, "No ma'am, we try not to go that long, usually no longer than five days."

On 11/28/18 from 3:32 p.m. to 4:20 p.m., an interview was conducted with the Infection Control Office (ICO) and the Director of Quality. When asked to explain the process of monitoring oversight for surgical and respiratory services, the Infection Control Officer stated, "I have went over the policies with the manager and the policies for disinfection and cleaning are supposed to be being updated. I started reviewing them in June 2018, and all of them just haven't been completed yet. Since June 2018, I have not had any oversight of the surgery area at all including visual audits, and I don't believe any audits were done by the last infection control officer either who left in May 2018." When asked if the OR Manager submitted any data or targets related to infection control audits, the Infection Control Officer stated, "As far as infection control goes, I have been given nothing lately from surgery." When asked what data is monitored in respiratory services related to the sleep lab, the Infection Control Officer stated, "We have been going through policies for the fit test, and we should be reviewing every policy annually. I am not familiar with any policies regarding disinfection of the hoses and EEG leads in the sleep lab. I thought everything they were using was disposable. Unless we realize something needs addressing, we don't monitor or observe areas."

On 11/28/18 at 11:30 a.m., review of the Hospital's Quality meeting minutes revealed no documentation of infection control or quality overview or monitoring related to processing endoscopes and respiratory equipment between patient use.
On 11/29/18 at 2:30 p.m., the Director of Quality revealed, "I do not monitor anything in quality related to effective infection control practices in the scope cleaning area. I recognize now that we obviously have problems there, and I have started working on it and researching some data."

On 11/29/18 from 11:35 a.m. through 11:45 a.m., the Operating Room Director revealed, "Sometimes I circulate in the OR(Operating Room) and in the Endoscopy Room, but I never go in the scope processing room because I don't know how to process scopes. I couldn't if I had to. I have an Associate Degree in Nursing. After graduation, I started out in this hospital and was trained here. For staff education, we do in-services if we get new equipment for the surgical area." On 11/29/2018 at 12:00 p.m., review of hospital's nursing in- service was dated 3/24/2018 related to the Olympus Endoscopy-Bronchoscope taught by an equipment representative.


Observations Sleep Lab Equipment Processing
Observations during the physical environment tour with the Physical Plant Supervisor on 11/27/18 at 1:05 p.m. revealed a storage room labeled "soiled respiratory". The soiled respiratory room contained respiratory therapy equipment and supplies identified as clean respiratory supplies and a soiled hose was observed in a sink. A pink patient care basin in the sink contained a dirty respiratory hose submerged in a bluish tinged solution. The basin with the hose was less than 1/2 filled with the bluish solution and the hose was not wholly submerged in the solution. Two Velcro straps used to hold CPAP masks in place were hung on the cabinet handles directly above the sink. Three uncovered respiratory hoses were hung from the plastic glove box holder on the wall opposite the sink with the dirty hose. CPAP masks and attachments were observed on a metal cart under the hoses sitting on a towel and covered by another towel.

On 11/27/18, at approximately 3:15 p.m., observations with the Respiratory Services Director revealed the same observations as above. The Director of Respiratory Services verified clean respiratory equipment and supplies were stored in the same area with dirty or soiled respiratory supplies. The Respiratory Services Director verified the Velcro straps were hanging over the "dirty" sink to dry, and wet "clean" hoses were hanging from the glove box holder right across from the dirty sink, and the cart with the "clean" masks/nozzles/nasal pads was in close proximity to the "dirty" sink.

The Respiratory Director stated that reusable sleep lab equipment such as hoses, masks, nozzles, and nasal pad (inserts) are cleaned in the soiled respiratory room. When asked what was used to clean/disinfect the used respiratory equipment and about the cleaning process, the Respiratory Director pointed to a container of enzymatic cleaner on the sink and to directions posted on a card that stated the cleaning steps. Review of the container of enzymatic cleaner revealed staff used V. Mueller instrument enzymatic single enzyme cleaner. There was no disinfectant listed on the container. The hospital did not provide documentation that any disinfectant was used to clean the re-usable respiratory patient supplies. The Respiratory Director reported the cleaning process included soaking the respiratory equipment for 15-20 minutes in the enzymatic cleaner, rinsing the equipment with tap water really well, and let the respiratory patient supplies/equipment air dry. When asked how long the hose in the sink had soaked, the Respiratory Director reported he/she was unsure of the time, but stated no sleep studies were done the night before. On 11/28/18 at 12:10 p.m., the Respiratory Director revealed the last patient's sleep study was completed on the night of 11/16/18 indicating the hose had soaked since the morning of 11/17/18 which was 10 days ago.

On 11/27/18 at 2:00 p.m., review of the hospital's Sleep/Wake Disorders Center policy with a Subject of "Cleaning and Maintenance of Equipment", reviewed 2/2018, stated the purpose of the policy was "To describe the procedures for cleaning and maintaining equipment used in the sleep center to minimize infection and the spread of germs from patient to patient. These include electrodes, monitors, and CPAP equipment for recording patients in sleep studies. Other items include recorders, computer monitors, and miscellaneous equipment used in the center. Policy: All equipment will be cleaned in accordance with the approved procedures. Cleaning is to be performed by all staff members. Cleaning of Patient Equipment and Positive Airway Pressure Equipment is to be completed during the shift on which the study is completed....Cleaning/Disinfection and Sterilization of Equipment: Disposable equipment: ...disposable CPAP masks and tubing are discarded after patient use. Non Disposable equipment: All CPAP tubing, masks, and headgear will be placed in the designated blue tub and covered with a Biohazard cover and sent down to Central Sterilization for proper washing and sterilizing. EEG wires and thermistor will be wiped down to rid of any residue and tape using alcohol, and then packaged in the appropriate bag to be sent down to Central Sterilization to be sterilized after each patient. All other wires and oximeter probes are to be wiped down with alcohol. Respiratory bands will be washed in hot, soapy water, rinsed, and air dried."

During an interview on 11/28/18 at 11:01 a.m., the Director of Respiratory Services was asked about Infection Control oversight of the Respiratory Therapy/Sleep Lab department, and stated that the Infection Control nurse does not come to monitor the cleaning of the respiratory equipment. When asked about the EEG electrodes and thermistor cleaning/disinfection, the Director of Respiratory Services stated the EEG electrodes are first cleaned with soapy water in the patient's bathroom sink, then wiped down with a Super-Sani-cloth, and air-dried in the closet in the patient room. The thermistors are wiped down with a Super Sani-Cloth and hung in the closet of the patient room. A review of both sleep lab patient rooms revealed a closet in each room that contained "clean" CPAP masks, Velcro straps, thermistors, and EEG electrodes/wires. According to the Director of Respiratory Services, the equipment had not been sent down to Central Sterile for processing, but had been cleaned.

On 11/28/18 at 3:17 p.m., review of the personnel file for the Respiratory Services Director and Respiratory Therapist 1 who is responsible for sleep studies and cleaning of sleep lab equipment revealed the hospital had no training documented related to the proper cleaning/disinfection of sleep lab equipment and supplies. The finding was verified with the Director of Respiratory Services on 11/28/18 at 3:28 p.m. who reported that s/he and Respiratory Therapist 1 cleaned the respiratory equipment/supplies as instructed by the previous Director of the Respiratory Services. The Director of Respiratory Services was unable to provide a hospital policy that directed respiratory staff to clean the respiratory supplies as staff were currently doing with the enzymatic cleaner.

During an interview on 11/28/18 at 3:30 p.m., the Infection Control Officer (ICO) was informed about the concern of the cleaning and disinfection of sleep lab respiratory supplies. According to the ICO, s/he was unaware sleep lab supplies were re-used.

Review of the information provided by the hospital on 11/30/18, of the ResMed sleep lab "Disinfection and sterilization guide" for the Mirage Quattro/Airfit F10/Mirage Softgel masks used in the sleep lab revealed the masks required either high level thermal or chemical disinfection or sterilization. According to the ResMed HumidAire 2i Disinfection and Sterilization Guide, the humidifier water chamber is to be cleaned with high level thermal or chemical disinfection or sterilization. During an interview on 11/29/18 at 2:20 p.m., the Respiratory Director stated the hospital staff cleaned the water chambers in the same way they cleaned the masks and other equipment with just the enzymatic cleaner. According to the Director of Respiratory Services, the hoses used for the CPAP machines were "Slimline", and the hospital provided instructions related to disinfection for this hose that required high level thermal or chemical disinfection, or sterilization. The Respiratory Director verified this was not the process sleep laboratory staff used for disinfection of the re-usable sleep lab equipment.

Hospital policy and procedure, titled, "Cleaning of Endoscopes and High Level Disinfecting", reads, " ....A. Precleaning in the examination room. a. Immediately after the procedure, gently wipe all debris from the insertion tube with a moist gauze pad. b. Place the distal end of the scope in water solution and aspirate through the channel by the depressing the red suction button for 5 - 10 seconds. c. Set the lever to the water bottle to the down or "drain" position. With the air pump of the video processor "ON" and the pressure set on HIGH , depress the green air/water valve on the scope fully until all the water has been discharged from the scope (evident by vigorous bubbling in the solution in which the distal end is submerged). Depressing the valve and releasing it several times helps to forcefully expel debris, which may have entered the air and water channels.
B. Disinfecting a. Before proceeding with any further cleaning steps, the scope should be leak tested.
LEAK TESTING
- Be sure that the PVE soaking cap is placed securely on the electrical contacts on the plug of the umbilical cable of the scope.
- Visually inspect the endoscope for damage after each use.
- Secure the Leakage tester to the air vent on the scope light guide. NEVER CONNECT OR DISCONNECT THE LEAK TESTER UNDER WATER.
- Pressurize the scope by pumping the hand bulb until the indicator gauge is in the green zone. Pressurizing into the RED zone may cause serious damage to the scope.
- Observe the gauge pressure to determine if the indicator remains in the green zone. If the indicator drops in the green zone rapidly, a major leak may be indicated.
- After determining the absence of any major leaks and with the leakage tester securely attached and pressure
PVE cap in place, the entire scope with all valves and inlet seals removed, may be immersed in clean water.
- Observe the instrument carefully while fully angulating the distal tip of the scope. A few bubblers may occur initially. This is normal. If a continuous stream of bubbles is observed from the same spot, a leak is indicated. Immediately remove the scope from the water. DO NOT USE THE SCOPE!
- After removing the scope from the water, release the pressure within the scope by opening the pressure release valve on the handle of the leakage tester. After the gauge indicates zero, disconnect the Leakage tester from the scope.
- If leakage was discovered, the scope will need to be sent for repair.
- If no leakage was discovered, continue with the cleaning process

b. Prepare a basin of warm water and a mild enzymatic detergent.
c. After removing the suction control valve, air/water valve, instrument channel selector and the rubber inlet seals, thoroughly wash the entire surface of the endoscope and its components. At this time, all valve cylinders and the instrument channel selector receptacle may be cleaned with appropriate brushes.
d. Brush clean the entire instruments channels:
i. insert the long cleaning brush into the opening of the suction nipple and gently pass the brush until it appears in the suction control valve receptacle.
ii. Insert the short brush into the opening at the bottom of the suction control valve receptacle on the control head and gently advance until the cylinder of the instrument control channel selector, then gently withdraw. Repeat several times.
iii. Insert the long brush into the inlet channels and gently advance the brush until it exits at the distal end of the scope. Repeat several times, cleaning the brush each time before reintroducing it into the channel.
iv. Insert the cylinder brush into the opening of the instrument channel selector cylinder. Clean the inside of the suction control valve receptacle on the control head.
e. Install the air water channel cleaning adaptors.
f. Attach the luer lock connector.
g. Close rubber inlet seals.
h. Flush all channels with enzymatic detergent using a large (60 cc) syringe
i. Flush all channels with air to remove residual detergent
j. Flush all channels with clean water
k. Flush all channels with air to remove excess water
l. Flush with Isopropyl Alcohol to remove excess water.

Based on record reviews, interview, and review of the hospital's policies and procedures, the hospital failed to ensure its patient's anesthesia record and the post-anesthesia record were accurately completed for 1 of 4 closed patient records reviewed for care and services. (Patient 4)

The findings are:

On 11/29/17 at 10:50 a.m., review of Patient 4's chart revealed the patient was admitted on 10/29/18 for a excision of right breast cyst, and the anesthesia record was not completed. The findings were verified by the Director of Surgical Services on 11/29/18 at 4:45 p.m. who stated "Yes, these are supposed to be completed."

Hospital policy and procedure, titled, "Post-operative Status", reads, " ....The Anesthetist/Anesthesiologist will give a detailed report to the PACU(Post Anesthesia Care Unit) nurse including:
1. Status of the patient
2. IV fluids and blood or blood products
3. Anesthetic agents, drugs, and dosage
4. Type of surgery and any unusual events
5. Blood loss and urine output
6. Vital signs and level of consciousness
7. Any anticipated problems in the PACU
The anesthetist will record any anesthesia complication. The PACU personnel must report immediately to the anesthesiologist, CRNA(Certified Registered Nurse Anesthetist), or surgeon any unusual changes in the patient's condition. The patient shall be discharged from the post -anesthesia care unit by the anesthesiologist, CRNA or surgeon according to PACU discharge policy.".

Based on record reviews, interview, and review of the hospital's policies and procedures, the hospital failed to ensure the post-anesthesia record was completed for 2 of 4 closed patient records reviewed for care and services. (Closed Patient 1 and 4)

The findings are:

On 11/29/17 at 10:15 a.m., review of Patient 1's chart revealed the patient was admitted on 10/2/18 for a left knee Arthroscopy and the post anesthesia record was not completed. On 11/29/17 at 10:50 a.m., review of Patient 4's chart revealed the patient was admitted on 10/29/18 for a excision of right breast cyst, and the post anesthesia record was not completed. The findings were verified by the Director of Surgical Services on 11/29/18 at 4:45 p.m. who stated, "Yes, these are supposed to be completed."

Hospital policy and procedure, titled, "Post-operative Status", reads, " ....The Anesthetist/Anesthesiologist will give a detailed report to the PACU(Post Anesthesia Care Unit) nurse including:
1. Status of the patient
2. IV fluids and blood or blood products
3. Anesthetic agents, drugs, and dosage
4. Type of surgery and any unusual events
5. Blood loss and urine output
6. Vital signs and level of consciousness
7. Any anticipated problems in the PACU
The anesthetist will record any anesthesia complication. The PACU personnel must report immediately to the anesthesiologist, CRNA (Certified Registered Nurse Anesthetist) or surgeon any unusual changes in the patient's condition. The patient shall be discharged from the post -anesthesia care unit by the anesthesiologist, CRNA or surgeon according to PACU discharge policy.".

Based on observations, interviews, and record reviews, the respiratory department failed to ensure reprocessing of patient equipment was conducted in accordance with the hospital's policies and procedures for reprocessing patient equipment used in patient procedures for the hospital's sleep lab to prevent the potential cross transmission of infectious agents between patients undergoing procedures in the hospital's sleep lab.


The findings are:


Observations during the physical environment tour with the Physical Plant Supervisor on 11/27/18 at 1:05 p.m. revealed a storage room labeled "soiled respiratory". The soiled respiratory room contained respiratory therapy equipment and supplies identified as clean respiratory supplies and a soiled hose in the sink. A pink patient care basin in the sink contained a dirty respiratory hose submerged in a bluish tinged solution. The basin with the hose was less than 1/2 filled with the bluish solution and the hose was not wholly submerged in the solution. Two Velcro straps used to hold CPAP masks in place were hung on the cabinet handles directly above the sink. Three uncovered respiratory hoses were hung from the plastic glove box holder on the wall opposite the sink with the dirty hose. CPAP masks and attachments were observed on a metal cart under the hoses sitting on a towel and covered by another towel.

On 11/27/18, at approximately 3:15 p.m., observations with the Respiratory Services Director revealed the same observations as above. The Director of Respiratory Services verified clean respiratory equipment and supplies were stored in the same area with dirty or soiled respiratory supplies. The Respiratory Services Director verified the Velcro straps were hanging over the "dirty" sink to dry, and wet "clean" hoses were hanging from the glove box holder right across from the dirty sink, and the cart with the "clean" masks/nozzles/nasal pads was in close proximity to the "dirty" sink.

The Respiratory Director stated that reusable sleep lab equipment such as hoses, masks, nozzles, and nasal pad (inserts) are cleaned in the soiled respiratory room. When asked what was used to clean/disinfect the used respiratory equipment and about the cleaning process, the Respiratory Director pointed to a container of enzymatic cleaner on the sink and to directions posted on a card that stated the cleaning steps. Review of the container of enzymatic cleaner revealed staff used V. Mueller instrument enzymatic single enzyme cleaner. There was no disinfectant listed on the container. The hospital did not provide documentation that any disinfectant was used to clean the re-usable respiratory patient supplies. The Respiratory Director reported the cleaning process included soaking the respiratory equipment for 15-20 minutes in the enzymatic cleaner, rinsing the equipment with tap water really well, and let the respiratory patient supplies/equipment air dry. When asked how long the hose in the sink had soaked, the Respiratory Director reported he/she was unsure of the time, but stated no sleep studies were done the night before. On 11/28/18 at 12:10 p.m., the Respiratory Director revealed the last patient's sleep study was completed on the night of 11/16/18 indicating the hose had soaked since the morning of 11/17/18 which was 18 days ago.

On 11/27/18 at 2:00 p.m., review of the hospital's Sleep/Wake Disorders Center policy with a Subject of "Cleaning and Maintenance of Equipment", reviewed 2/2018, stated the purpose of the policy was "To describe the procedures for cleaning and maintaining equipment used in the sleep center to minimize infection and the spread of germs from patient to patient. These include electrodes, monitors, and CPAP equipment for recording patients in sleep studies. Other items include recorders, computer monitors, and miscellaneous equipment used in the center. Policy: All equipment will be cleaned in accordance with the approved procedures. Cleaning is to be preformed by all staff members. Cleaning of Patient Equipment and Positive Airway Pressure Equipment is to be completed during the shift on which the study is completed....Cleaning/Disinfection and Sterilization of Equipment: Disposable equipment: ...disposable CPAP masks and tubing are discarded after patient use. Non Disposable equipment: All CPAP tubing, masks, and headgear will be placed in the designated blue tub and covered with a Biohazard cover and sent down to Central Sterilization for proper washing and sterilizing. EEG wires and thermistor will be wiped down to rid of any residue and tape using alcohol, and then packaged in the appropriate bag to be sent down to Central Sterilization to be sterilized after each patient. All other wires and oximeter probes are to be wiped down with alcohol. Respiratory bands will be washed in hot, soapy water, rinsed, and air dried."

Review of the Cardiopulmonary Services Policy on Standard Precautions, Revised 6/2018, revealed, "...Patient Care Equipment- All patient care equipment that is soiled with blood, body fluids, secretions, and excretions will be handled in a manner that will prevent skin and mucous membrane exposures. Single use, disposable items must be disposed of properly. Make sure that reusable equipment has been cleaned and reprocessed appropriately, prior to
use on another patient...".

During an interview on 11/28/18 at 11:01 a.m., the Director of Respiratory Services was asked about Infection Control oversight of the Respiratory Therapy/Sleep Lab department, and stated that the Infection Control nurse does not come to monitor the cleaning of the respiratory equipment. When asked about the EEG electrodes and thermistor cleaning/disinfection, the Director of Respiratory Services stated the EEG electrodes are first cleaned with soapy water in the patient's bathroom sink, then wiped down with a Super-Sani-cloth, and air-dried in the closet in the patient room. The thermistors are wiped down with a Super Sani-Cloth and hung in the closet of the patient room. A review of both sleep lab patient rooms revealed a closet in each room that contained "clean" CPAP masks, Velcro straps, thermistors, and EEG electrodes/wires. According to the Director of Respiratory Services, the equipment had not been sent down to Central Sterile for processing, but had been cleaned.

On 11/28/18 at 3:17 p.m., review of the personnel file for the Respiratory Services Director and Respiratory Therapist 1 who is responsible for sleep studies and cleaning of sleep lab equipment revealed the hospital had no training documented related to the proper cleaning/disinfection of sleep lab equipment and supplies. The finding was verified with the Director of Respiratory Services on 11/28/18 at 3:28 p.m. who reported that s/he and Respiratory Therapist 1 cleaned the respiratory equipment/supplies as instructed by the previous Director of the Respiratory Services. The Director of Respiratory Services was unable to provide a hospital policy that directed respiratory staff to clean the respiratory supplies as staff were currently doing with the enzymatic cleaner.

During an interview on 11/28/18 at 3:30 p.m., the Infection Control Officer (ICO) was informed about the concern of the cleaning and disinfection of sleep lab respiratory supplies. According to the ICO, s/he was unaware sleep lab supplies were re-used.

Review of the information provided by the hospital on 11/30/18, of the ResMed sleep lab "Disinfection and sterilization guide" for the
Mirage Quattro/Airfit F10/Mirage Softgel masks used in the sleep lab revealed the masks required either high level thermal or chemical
disinfection or sterilization. According to the ResMed HumidAire 2i Disinfection and Sterilization Guide, the humidifier water chamber is
to be cleaned with high level thermal or chemical disinfection or sterilization. During an interview on 11/29/18 at 2:20 p.m., the Respiratory Director stated the hospital staff cleaned the water chambers in the same way they cleaned the masks and other equipment with just the enzymatic cleaner. According to the Director of Respiratory Services, the hoses used for the CPAP machines were "Slimline", and the hospital provided instructions related to disinfection for this hose that required high level thermal or chemical disinfection, or sterilization. The Respiratory Director verified this was not the process sleep laboratory staff used for disinfection of the re-usable sleep lab equipment.

Observations of a Medpass for RN 4 and observations of a respiratory treatment given by the Director Director of Respiratory Services revealed staff removed supplies/medications from their pockets placing the patients at risk for possible cross-contamination of infectious agents. Observations showed RN 4 failed to perform hand hygiene and/or change gloves at an appropriate time before accessing a saline lock, and failed to handle a syringe using aseptic technique while performing a flush.

Observations on 11/29/18 at 9:11 a.m. revealed Registered Nurse (RN) 4 performed a medication pass for Inpatient 6. RN 4 knocked and entered the patient's room, used a hand sanitizer, donned clean gloves, pulled up the computer screen at the patient's bedside, checked/scanned the patient's medications and armband, opened the medications, and administered the medications to the patient with a sip of drink. Without changing the soiled gloves or sanitizing her/his hands, RN 4 reached in his/her scrub pocket, pulled out a Normal Saline flush (single dose ) and an alcohol pad. RN 4 had 4 other separately wrapped Normal Saline flushes in the same pocket. Wearing the same gloves, RN 4 pulled the syringe partially out of the plastic packaging, disconnected the IV(Intravenous) tubing from the patient's saline lock, wiped the port with an alcohol pad, flushed the lock with a couple milliliters of Normal Saline, and set the Normal Saline syringe with the tip uncovered onto the patient's blanket. After administering IV Pepcid, the nurse picked up the syringe from the bed and administered a couple more milliliters of Normal Saline. The findings were verified with RN 4 on 11/29/18 at 9:28 a.m..

Observations on 11/29/18 at 10:21 a.m. in the Intensive Care Unit in Room 3 revealed the Director of Respiratory Services providing a respiratory breathing treatment for Inpatient 1. The Respiratory Director removed 2 packages of medication from his/her scrub pocket, and administered Albuterol Sulfate inhalation solution and Budesonide Inhalation Suspension.