HospitalInspections.org

Based on observation, interview, and record review, the GB failed to oversee the conduct of the hospital. As a result, the COPs for 482.21 (QAPI) and 482.42 (Infection Control) were not met as evidenced by:

1. The GB failed to ensure the hospital's QAPI program reflected the complexity of the hospital's organization and services to involve the staff training regarding environmental and scope cleaning and reprocessing in the outpatient services. Cross reference to A0308.

2. The GB failed to ensure an effective and active hospital-wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving outpatient and surgical services. Cross reference to A0749.

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

Based on observation, interview, and record review, the hospital failed to develop, implement, and maintain an effective QAPI program to ensure a safe and sanitary environment in the outpatient and surgical areas as evidenced by:

The GB failed to ensure the hospital's QAPI program reflected the complexity of the hospital's organization and services to involve the staff training regarding environmental and scope cleaning and reprocessing in the outpatient services. Cross reference to A0308.

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

Based on observation, interview, and record review, the hospital's GB failed to ensure the program reflected the complexity of the hospital's organization and services to involve the staff training regarding environmental and scope cleaning and reprocessing in the outpatient services. This increased the risk of the spread of infections and could result in an unsafe patient care.

Findings:

On 5/15/19 at 1030 hours, Director 2, Infection Prevention and Control Director was interviewed. The Director acknowledged the infection control committee overlooked the significance of joining the purchasing committee and attending inservice education when buying new products to be updated with the manufacturer's guidelines and standards of current practice.

On 5/15/19 at 1330 hours, observation of RN 1 demonstrating how to reprocess the ENT scopes was conducted with Manager 2, Infection Control 1, and RN 2. There was no unidirectional workflow pattern and no distinct separation between the dirty and clean work areas. The scope storage area was not equipped with proper ventilation. Cross reference to A0749, examples #10 and 11.

On 5/16/19 at 0930 hours, review of the QAPI data failed to show the data analysis in the outpatient clinics.

On 5/16/19, the training documents for five staff from the outpatient service areas were reviewed. Review of the annual infection control training for the last three years showed no documented evidence the five staff were trained on the scope processing specific to each unit particularly, the type of scopes used in the urology and ENT clinics, until 5/10/19, when the urology staff were trained by the vendor from the scope manufacturer. This training was provided as the hospital's corrective action for previously cited noncompliance with the HLD process identified during a survey conducted by the accrediting organization.

On 5/16/19 at 1100 hours, the CNO acknowledged the job descriptions for county employees were generalized, but specific competencies respective of each specific unit should also be evident.

In an interview with Manager 1 on 5/16/19 at 1100 hours, she stated the flexible scope services in the outpatient service area was high risk but low in volume, thus the committee did not consider as problem-prone areas. As a result, oversight of the scope cleaning and reprocessing were not prioritized, including the staff's training for specific unit.

Based on observation, interview, and record review, the hospital failed to ensure an effective and active hospital-wide infection control program was maintained for the prevention, control, and investigation of infections and communicable diseases as evidenced by:

The hospital's infection control program did not meet the needs of all patients receiving outpatient and surgical services. Cross reference to A0749.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide a safe and effective infection control program.

Based on observation, interview, and record review, the hospital failed to ensure an effective hospital-wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The hospital's infection control program did not meet the needs of all the patients receiving outpatient and surgical services as evidenced by:

1. Failure to ensure the SPD staff sterilized and dried a dental equipment according to the manufacturer's instructions.

2. Failure to ensure the SPD staff monitored the temperature of the water used to dilute the enzymatic solutions, failed to ensure the correct amount of water and enzymatic solutions during dilution, and failed to ensure the instruments were fully submerged in the enzymatic solutions in accordance with the manufacturer's guidelines and AORN (one of the nationally recognized infection control guidelines the hospital followed) guidelines.

3. Failure to ensure a hand washing sink was available, the floor and floor drain mats were maintained in a sanitary condition, and the sink pipe was not leaking in the SPD decontamination area.

4. Failure to ensure a clock or timer was available for use when monitoring the wet time when disinfecting the surgical equipment in the SPD.

5. Failure to ensure the GI scopes were rinsed three times during the disinfection process as per the manufacturer's instructions.

6. Failure to ensure the temperature and humidity levels were monitored in the storage room and storage cabinets for the GI scopes. In addition, the heating, ventilation, and air conditioning of the GI scope processing room were not monitored as per the AORN's guidelines.

7. The scopes used in the ENT clinic were not cleaned and disinfected as per the hospital's P&P and manufacturer's instructions.

8. The wet time (the length of time a disinfectant must remain wet on a surface in order to achieve efficacy) for the floor cleaning agent used in the ORs was not followed as per the manufacturer's instructions.

9. Two scrub sinks in the OR suite had yellow brown discolorations on the external surface.

10. The hospital's P&P did not include guidelines for the clinical staff in cleaning the examination/treatment rooms in-between patients to determine which surface areas and instruments needed to be disinfected to prevent cross contamination.

11. Failure to ensure a unidirectional work flow pattern during the ENT scope reprocessing was monitored.

These failures created an unsafe environment for the patients receiving care in the hospital and increased the risk for poor health outcomes to these patients.

Findings:

1. On 5/15/19 at 1203 hours, the SPD was toured with Manager 4.

The sterilization log was reviewed. The log showed a Cavitron (dental instrument) was processed on 5/10/19. The printed Pre-Vacuum Sterilization strip showed the instrument was sterilized on a sterilization cycle of four minutes sterilizing and eight minutes drying time. However, review of the manufacturer's instructions showed to sterilize the instrument for 10 minutes and dry for 20-30 minutes.

During a concurrent interview, Manager 4 confirmed the findings.

2. According to the AORN's Guidelines for Perioperative Practice: Instrument Cleaning, 2019 edition, the instrument should be submerged for cleaning in a solution of water and detergent intended for cleaning surgical instruments. The detergent should be compatible with the device to be cleaned and used at the concentration and temperature specified in the detergent manufacturer's IFU. Full submersion of the instrument in the cleaning solution reduces the risk of splashing potentially contaminated cleaning solution onto personnel and into the environment. The concentration and temperature of the cleaning solution specified in the detergent IFU have been validated by the detergent manufacturer as necessary for the detergent to be effective.

Review of the manufacturer's instructions for Prolystica showed to fill a sink with warm water that does not exceed 130 °F to dilute 1/8 to 1/2 ounce of Prolystica in a gallon of water.

On 5/16/19 at 1451 hours, SPD 2 was observed cleaning multiple dirty surgical instruments that were transported into the decontamination area after a surgical case. The dirty instruments in the sink were not fully submerged in the cleaning solution. The water was half full to the marked line. The temperature probe was observed on top of the Prolystica dispensing machine (located on top of the sink) and not in the water.

In a concurrent interview, SPD 2 stated filling the sink with water up to the marked line would total to four gallons. The dispensing machine was programmed for one push and that would deliver two ounces of Prolystica, the enzymatic solution. SPD 2 stated he already did it. However, the water inside the sink was observed only half way to the marked line (about two gallons). In addition, the water temperature was not being monitored when the instruments were submerged in the cleaning solution. Manager 4 stated the dispensing machine was not functioning.

3a. Review of the AORN's Guidelines for Perioperative Practice: Instrument Cleaning, 2019 edition, in the SPD Decontamination area, the sinks should be separate for washing instruments and for hand hygiene.

On 5/16/19 at 1451 hours, a tour of the SPD decontamination room was conducted. There was no hand washing sink found in the SPD decontamination room.

During a concurrent interview, SPD 3 stated there was a hand washing sink in the SPD decontamination room that currently was used for cleaning dirty instruments. During the interview, water was observed dripping from the sink's drain pipe. The floor under the sink was observed with brown-greenish residues.

In a concurrent interview with Manager 4, she stated she was not aware of the above findings. The EVS staff was responsible for cleaning daily.

b. On 5/15/19 at 1203 hours, the floor mats under the instrument cleaning sinks were observed with heavy accumulation of dust and debris on the top and bottom sides. The floor underneath was dusty.

4. Review of the manufacturer's instructions for Coverage Spray (a quaternary ammonium chloride based disinfectant) showed the treated surface must remain wet for 10 minutes.

On 5/16/19 at 1451 hours, during the tour in the SPD decontamination room, SPD 3 was observed spraying Coverage Spray on a surgical camera cord, then SPD 3 walked away and worked on other tasks. Sometime after the first spray, SPD 3 returned to the camera cord and sprayed it again with the Coverage Spray. SPD 3 stated the wet time for the Coverage Spray was 10 minutes. SPD 3 stated he used the wall clock to monitor the 10 minutes; however, that clock was not working properly. SPD 3 stated he could not tell if the 10 minutes was up so he sprayed the camera cord again to make sure it was disinfected properly. There was no other clock or time device observed in the decontamination room other than the wall clock SPD 3 pointed to.

5. According to the AORN's Guideline for Processing Flexible Endoscopes, 2019 edition, after the manual cleaning and inspection, the flexible endoscopes and endoscope accessories should be high-level disinfected or sterilized. Following disinfection, the endoscope and endoscope channels should be mechanically rinsed and flushed with critical or sterile water.

Review of the manufacturer's instructions for rinsing instrument after the manual processing for OPA Plus solution showed after removing the instrument from the Metricide OPA Plus solution, the staff should thoroughly rinse the device by immersing it completely in a large volume of fresh water. Keep the instrument totally immersed for a minimum of one minute unless a longer time is specified by the instrument manufacturer. Manually flush all lumens with large volumes of water (not less than 100 ml) unless otherwise noted by the device manufacturer. Repeat the procedure two additional times for a total of three rinses.

On 5/16/19 at 1330 hours, the GI scope processing area was toured with Manager 4. RNs 4 and 5 were interviewed for the GI scope cleaning and HLD. The RNs stated they followed the manufacturer's instructions by rinsing the instruments two times after the OPA Plus soaking, but they did not rinse the instruments the third time.

6a. According to the AORN's Guideline for Processing Flexible Endoscopes, 2019 edition, the flexible endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturer's IFU. Flexible endoscopes should be stored in a drying cabinet. If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes.

On 5/16/19 at 1330 hours, the GI Scope Storage room was toured with the Nurse Manager Surgical Services. Two scope storage cabinets were observed with closed doors. Inside the cabinets were five scopes and a clear plastic tube with clear color inside. The bottom level of the cabinet was covered with a white towel.

A concurrent interview with RN 4 was conducted. When asked about the clear plastic tube inside the scope storage cabinet, RN 4 stated the plastic tubes were part of the GI scope cleaning attachment. RN 4 stated the plastic tubes should be hanged vertically to dry with no water in the GI scope storage.

b. According to the AORN's Guidelines for Design and Maintenance of the Surgical Suite, 2019 edition, the interdisciplinary team should use evidence-based design concepts in the planning and design of the surgical suite support areas. Heating, ventilation, and air conditioning (HVAC) systems for the endoscopy suite should be designed in compliance with state and local building codes and other guidelines as set forth by the FGI and American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE). Flexible endoscopes should be processed in an area designed and constructed to support processing activities. The guidelines showed for a one-room Endoscopy processing room, the minimum total air changes per hour should be 10, the maximum humidity should be 60%, and the temperature should be 60°F to 73°F (16°C to 23°C); and for the clean/sterile storage room, the minimum total air changes per hour settings for airflow patterns should be 4, pressure should be positive, maximum humidity should be 60%, and the temperature should be < 75°F (<24°C).

On 5/16/19 at 1330 hours, during the tour in the GI scope processing room, Manager 4 was interviewed regarding the HVAC in the endoscopy processing room and storage room. Manager 4 stated the HVAC should be monitored by the Facility. The Facility's monitoring data was requested for review. However, as of the survey exit date of 5/20/18, the requested document was not provided to the surveyors for review.


21177


7. On 5/15/19 at 1315 hours, a tour of the ENT clinic was conducted with the CNO. When asked who cleaned and disinfected the scopes after patient use, RN 1 stated the clinic staff would did the prewash at the bedside, then the disinfection was performed in the scope processing room. When the surveyors asked if they could observe how the staff disinfected the scopes used in the clinic, RN 1 was introduced to demonstrate the processing of the scopes.

In the scope processing room, RN 1 used a clean flexible scope (to insert into a patient's throat) to demonstrate the steps used in the scope processing room. However, during RN 1's demonstration, the following steps were not observed to be done in comparison with the manufacturer's checklist:

- Under the Leakage Test section:
* Inspect the vent port to confirm that the area is clean. If debris is present carefully remove the debris with a 70% alcohol wipe
* Submerge the entire scope into a basin or sink containing room temperature water during the leakage test

- Under Manual Cleaning Detergent Cleaning section:
* While immersed, use a soft, lint-free cloth to clean the exterior of the entire scope. A minimum of one complete wipe of the entire exterior of the scope should be performed.
* Use of the soft, flat cleaning brush to brush the exterior surfaces of the scope handle, including the interface areas between the deflection lever and handle. Brush the entire handle surface for a minimum of three times.

- Under Water Rinsing section:
* Thoroughly wipe the exterior of the entire scope with a fresh, soft, lint-free cloth
* Discard the water and repeat with fresh water for a total of two immersion/rinses.

During RN 1's demonstration, the RN was asked to explain the water rinsing steps. The RN stated she would completely immerse the scope in the water two times while the manufacturer's guidelines/checklists showed to discard the water and repeat with fresh water with a total of two more immersion/rinses.

- Under Inspection section:
* Visually inspect the scope for cleanliness.
* Prior to sterilization/high level disinfection, inspect the scope for signs of damage that may trap residual debris.
* Clean the distal lens using 70% alcohol wipe after a visual inspection

On 5/16/19 at 1530 hours, the above findings were shared with the CNO.

8. Review of the manufacturer's directions for the floor cleaner showed the treated surface must remain wet for 10 minutes.

On 5/16/19 at 1350 hours, observation of EVS 1 cleaning OR 1 was conducted with the CNO and Manager 3.

When asked, EVS 1 stated he used a cleaning solution with a 10 minute wet time.

At 1402 hours, EVS 1 started to mop the floor with a wet mop beginning from the middle of the room then moved to the two sides of the room, and the area in front of the door. In the middle of cleaning at 1405 hours, the floor on the middle section of the room was not observed to be wet after three minutes. After mopping the floor, EVS 1 set the timer for 10 minutes, closed the door, and stood outside. The Manager explained the door should be closed and the EVS stayed outside for 10 minutes to ensure nobody entered the room.

While waiting outside the door, the hospital staff was asked to open the door to determine if the floor remained wet, the door was opened, and the timer showed there were five minute plus left. When asked to check for the wetness of the floor, it was observed the floor was already dry when the timer showed there were still four minutes left. Manager 3 and EVS 1 were informed the floor was not retained wet for 10 minutes. EVS 1 stated he would re-mop the floor and ensure it would stay wet for 10 minutes.

9. On 5/16/19 at 1120 hours, the OR was toured with the CNO and Manager 3. The two scrub sinks between ORs 3 and 4 were observed with yellowish brown discolorations that were scattered on the entire external surface of the sinks. When the surface was wiped with a white paper towel, the yellow stain was observed on the white paper towel.

The above finding was shared with the CNO and Manager 3 at the same time of observation.


21262


10. Review of the hospital's P&P on Cleaning Examination and Treatment Rooms showed the EVS department personnel would clean all examination and treatment rooms on a daily basis. Floors would be mopped, counters and furniture would be damp dusted with approved disinfectant solution, walls would be spot clean and waste containers would be emptied. Caution: do not clean equipment unless instructed to do so. However, the P&P did not include guidelines for the clinical staff in cleaning the examination/treatment rooms in-between patients, and which surface areas and instruments were designated clean and/or contaminated for disinfection to prevent cross contamination.

On 5/15/19 at 1015 hours, during the tour of one procedure room in the urology outpatient clinic, the examination gurney was observed to have multiple cuts on the upholstery making it difficult to disinfect. The blue cushion was noted to have a cracking line exposing the white underneath layer. In addition, a hair with dried fluid stain was observed on the left extremity stirrup.

RN 2 and LVN 1 were asked about cleaning in-between patients in the Urology outpatient clinic. LVN 1 demonstrated how the examination gurney and stirrups were cleaned and prepared for the next patient. The blue gurney cushion with cut upholstery and bed rails were wiped with disinfectant solution. LVN 1 waited for the effective dwell time of the disinfectant solution before covering the cushion with a new linen. However, the surrounding counter surface areas and other instruments surrounding the gurney were not wiped off with the disinfectant solution.

In a concurrent interview with RN 2, she acknowledged the specimens and instrument accessories were being laid out on the counter, thus contaminating its surfaces and the staff only wiped of any visible contaminants such as spills on the surface area. RN 2 acknowledged it was not part of their routine to disinfect the surrounding area for the next patient.

In a concurrent interview, Manager 2 acknowledged the findings.

11. Review of the AORN's Guidelines for Perioperative Practice: Flexible Endoscopes showed the flexible endoscopes should be processed in an area designed and constructed to support processing activities. Endoscope processing may occur in a single endoscopy processing room or in two separate rooms (decontamination room and clean workroom). The endoscopy processing room should be designed to facilitate a unidirectional workflow from the decontamination area to the clean area then to the clean storage in a separate location. Cross contamination can result when soiled items are placed in close proximity to the clean items or are placed on surfaces upon which clean items are later placed. Proper airflow and ventilation requirements, including water filtering requirements should be adequate.

On 5/15/19 at 1330 hours, RN 1 demonstrated how the ENT scopes were being processed in the ENT outpatient clinic. The area had adequate lighting and separated from the examination/treatment room. During RN 1's demonstration of the scope processing, the unidirectional workflow process was broken when RN 1 placed the scope on the counter for leak test then stepped back to the entry side for low-level disinfectant, then back to the center counter next to the leak test site for higher level of disinfectant. There was no distinct separation between the dirty and clean work area.

In a concurrent interview with Manager 2, she stated the work surfaces were limited, staff tried to have a unidirectional flow process where processed scopes were taken out the back door through an examination room and to the clean utility room where the storage cabinet was located. Inspection of the storage cabinet failed to show any ventilation capacity.

On 5/16/19, three clinical staff form the Urology outpatient clinic and two staff from the ENT clinic were randomly selected for staff competency review. Review of the personnel files showed all of the staff went through the annual infection control training during the last three years; however, there was no documented proof of training on the scope processing specific to each unit and particularly, the type of scopes used for urology and ENT. The latest training on scope processing was on 5/10/19, when the scope company representative started training the staff as part of the hospital's plan of correction to the deficiency cited by an accrediting company that started on 5/7/19.

On 5/16/19 at 1100 hours, the CNO acknowledged the job description for the county employees was generalized and specific competencies respective of each specific unit should be evident.