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Based on observation, staff interviews, clinical record and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. An effective infection prevention program was not implemented and maintained to provide a safe and sanitary environment for surgical services. The processing and sterilization of surgical instruments did not follow nationally recognized standards of practice. The cleaning, sterilization, processing and transport of endoscopes did not follow nationally recognized standards. The physical environment of the sterile processing area was visibly dirty. The hospital infection control preventionist was ineffective in ensuring a quality infection control program that followed hospital procedures and nationally recognized standards. (refer to A273, A286, A749, A951)

Because of the serious issues identified in the sterile processing area, an Immediate Jeopardy situation was called under tag A 749 with hospital administrators on 8/24/15 at 5:30 p.m. The hospital implemented corrective actions to adequately address the immediate jeopardy findings and the IJ was removed on 8/25/15 at 1:30 p.m.

2. The Quality Assessment and Performance Improvement (QAPI) program did not collect accurate and complete data in order to ensure the quality of services provided in the hospital. No quality assurance program was in place to ensure the cleanliness of the physical environment in the sterile processing area. No data was collected and no plan was developed and implemented to ensure the quality of the processing and sterilization of surgical instruments. No oversight was provided and no monitoring system was in place to ensure staff followed hospital policies and procedures and nationally recognized standards of practice when performing duties in the sterile processing area and the endoscopy center. (refer to A273, A286, A749, A951)

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

Based on observation, interview and record review, the hospital failed to ensure that a hospital-wide quality assurance program was implemented when:

1. Data gathered regarding the environment of care was inaccurate and incomplete, and did not form the basis for quality improvement activities. (Cross reference A-0273.)

2. The quality management program did not ensure a comprehensive investigation was undertaken to determine possible sources of infection after a cluster of infections in patients who had undergone Endoscopic retrograde cholagiopancreatography (ERCP-a diagnostic procedure used to examine diseases of the liver, bile ducts, and pancreas) was detected and failed to ensure that analysis of hospital processes related to the incident occurred. (refer to A-0286.)

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

Based on interview and record review, the hospital failed to ensure data collected regarding the quality and safety of the environment in the endoscopy and sterile processing areas was complete and accurate.

This failure had the potential to provide invalid data regarding hospital processes and the potential for substandard patient care.

Findings:

On 8/24/15 at 9:45 a.m., during a tour of the endoscopy center, a brown residue was seen crusted on the interior chambers of the endoscope processors, and the humidity of the endoscope storage room (62%) was higher than upper limit of 60% (Cross reference A-0749, #3). Neither finding was documented on the Environment of Care (EOC) rounding sheets for the area.

On 8/26/15 at 2:00 p.m., during an interview, the Director of Endoscopy (Dir END) stated she thought the EOC rounds for the endoscopy center were being performed by an infection control nurse.

On 8/24/15 at 12:25 p.m. and on 8/26/15 at 4:00 p.m., during interviews, the Director of Quality Management (Dir QM) stated she reviewed the EOC rounds minutes and was unable to find documentation about the endoscope processing and storage areas. The Dir QM stated EOC rounds were part of patient safety data, and the data was forwarded to the Quality committee.

The EOC Round documentation of the endoscopy area during a 2/18/15 tour was reviewed and showed that there was no department manager identified, and no specific reference to endoscope storage or processing areas, and it was uncertain if those areas were reviewed. The same generic questions were present on the form as were present on the EOC rounds for Central Sterile Processing. There was no documentation that processes of care or infection control issues specific to that area were considered, or that issues specific to environmental controls of the areas, such as temperature and humidity in endoscope processing or storage areas, were considered during the EOC rounds in the endoscopy center.

The hospital policy, titled, "Environment of Care Program" (effective date 10/15/2012), read, "The mission of the Environment of Care program is to ensure a functional and safe environment for patients and other individuals served by or providing services within [Hospital name] in a collaborative and systematic approach." The policy showed the Environment of Care Committee included an infection control practitioner, and was charged with supporting an interdisciplinary approach to management of the environment of care, and with performing environmental rounds to perform hazard surveillance. The policy showed that the responsibility of the department manager included directing the investigation of all accidents, injuries and hazards occurring in the department and reporting corrective action.

On 8/24/15 at 2:15 p.m., during a tour of the Sterile Processing Department (SPD), 45 out of 75 carts used to transport and store sterile instruments for the operating rooms (OR) were observed to have layers of tape and tape residue covering the top rails. The storage bins that held the instruments were covered with dust. The machine used to sterilize respiratory equipment was seen with a layer of thick dust behind the machine and dirt was noted under the table that the machine was placed on. The sink next to that machine was noted to have a layer of dust on the surface around the caulking and a black substance embedded in the grout.

On 8/25/15 at 8:30 a.m., during a tour of the central sterile processing department, the surgical instrument sterilization process was found to be inadequate because surgical instruments were seen being processed in a dirty and unsanitary environment, and the surgical instruments were not being arranged in an open configuration, with all surfaces exposed to the steam sterilant, creating the risk of inadequate sterilization. Also, during the tour, a 6 by 7 centimeter puddle of water was seen on the floor by the bottom of instrument washer 2.

On 8/25/15 at 9:30 a.m., during an interview, the Director of Sterile Processing Department (Dir SPD) stated she had not been receiving the EOC rounds reports for the past two months. She reviewed the EOC rounds from sterile processing and stated some responses did not appear correct, such as the "N/A" response to storage under sinks. She stated the EOC rounds documentation represented an opportunity for improvement.

On 8/27/15 at 10:00 a.m., during a record review with the Dir SPD, the SPD EOC Rounds documentation from 7/15/15 was reviewed. The document included a list of questions on the left, and an answer on the right. The question, "Rooms clean and orderly?" with the answer, "No, restroom floors", and "Sinks are clean?", with the answer, "Yes", and the question, "Nothing under sinks and locked?", with the answer, "N/A".

On 8/26/15 at 4:00 p.m., during an interview, the Director of Quality Management (Dir QM) stated she knew the EOC rounds did not present information specific for infection control, but she had not had time to change them yet.

Based on interview and record review, the Quality Management (QM) program did not ensure a thorough investigation of a cluster of infections in patients who had undergone Endoscopic retrograde cholagiopancreatography (ERCP-a diagnostic procedure used to examine and visualize diseases of the liver, bile ducts, and pancreas) was conducted and did not ensure preventative actions were put into place as a result of an investigation.

These failures had the potential to result in cross contamination and additional infections for patients receiving ERCPs.

Findings:

The hospital's 2015 Infection Control Plan read, "When surveillance and other reporting methods indicate a possible outbreak of unusual infections the ICPs will initiate an outbreak investigation to confirm the outbreak, identify the possible causes, institute measures to contain the outbreak, and develop and implement methods to prevent future occurrences."

According to the infection control department's documentation of the investigation of a cluster of infections that occurred in patients who had an ERCP procedure in July 2015, the quality management program undertook its own investigation of the incident. During interviews with hospital staff (Director of Quality Management, Risk Manager, Infection Control Preventionist, Pharmacist, Surgical Technician, Director of Clinical Education, Director of Endoscopy), gaps in the investigation of the incident and in the implementation of remediation were identified, leaving possible sources of infection that were not investigated, identified or corrected, and thus potentially continued to form a threat to patients, including:

Endoscope storage room temperature and humidity were not controlled (Cross reference A747, #3)

Endoscopes were not protected from contamination during transport (Cross reference A747, #2);

Environmental cultures were not performed in endoscope processing and storage units as part of the investigation;

Sterilization of instruments used during endoscopic procedures was not reviewed ;

Endoscope processor cleanliness was not ensured (Cross reference A747, #2);

Endoscope processors were used incorrectly because instruments were placed underneath the endoscopes during processing (Cross reference A747, #2);

Gaps in staff training;

Contrast agent sterility was not verified;

On 8/24/15 at 11:00 a.m., during an interview, the Director of Quality Management (Dir QM) stated retraining of staff in endoscope processing had been performed in May and June, 2015. In July a cluster of three infections was seen in patients who had ERCP procedures. The Dir QM stated a multidisciplinary team was gathered to investigate the cluster of infections. Documentation of the meeting minutes of the ad hoc committee were requested, but were not provided. The Dir QM, stated that subsequently, there had been positive cultures of endoscopes in August 2015. She stated that at that time, there had been no cultures of the environment done, and the endoscope storage area temperature and humidity had not been reviewed.

On 8/25/15 at 11:15 a.m., during an interview, the Risk Manager (RM) stated a Root cause analysis (RCA-a method of problem solving used for identifying the root causes of faults or problems) for the cluster of infections was initiated on 7/27/15. After a second meeting on 8/3/15, she was informed that QM would take over the investigation. She stated that after they identified the need to investigate the endoscope storage and processing environments, the RCA was stopped prior to those issues being addressed, and there were no preliminary conclusions formed based on the RCA.

On 8/25/15 at 1:40 p.m., during an interview, the Infection Control Preventionist (ICP) 1 stated she had not reviewed the processing of the endoscopic instruments used in the procedures, as she had believed they were single use and the instruments had not been cultured to see if they were a source of infection.

On 8/25/15 at 3:30 p.m., during an interview, Pharmacist (Pharm) 1 and Pharm 2 stated that there had been no review of the use of contrast as a risk factor in the infection cases.

On 8/24/15 at 4:30 p.m., during an interview, Surgical Technician (ST) 1 on 8/24/15 stated reusable surgical instruments used with the endoscopes were washed by hand and placed in the scope processor. During a second interview, on 8/26/15 at 2:50 p.m., ST 1 stated the small instruments used with endoscopes were placed underneath the scope in the scope processor, and there was no separate documentation showing the instruments were processed. ST 1 stated there was no way to track which instruments were used with which patients. When asked where he received his training, ST 1 stated he learned the process of instrument reprocessing from previous department personnel.

Review of manufacturer's instructions for the endoscope processor and for an endoscopic instrument showed that ST 1 did not follow manufacturer instructions to sterilize the instrument prior to reuse.

On 8/27/15 at 9:50 a.m., during an interview, the Director of Clinical Education (Dir CL Edu) stated several areas of the hospital had education specialists, but this did not include the endoscopy center. The Dir CL Edu stated the manager of each area was to determine the education needed, and the managers were to self-identify if they or their staff had a training need. The Dir CL Edu stated scrub techs were trained by nurse educators in some departments, but not in the endoscopy center. She stated the infection control nurses participated in general orientation and role specific training for staff working with patients. In a concurrent interview with Clinical Nurse Specialist 1, she stated there was role-specific training in infection control for staff who had patient contact but some staff, such as scrub techs in the endoscopy center and radiology technicians, were not included in the infection control role-specific training.

On 8/27/15 at 2:00 p.m., during an interview, the Director of Endoscopy (Dir END) stated she did not have formal infection control training. Dir END stated she believed the infection control department was to guide instrument processing in the department but that no formal infection control training occurred in the endoscopy center.

Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and did not have an active program for the prevention, control and investigation of infections and communicable diseases when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions; rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent; and the work environment in the Sterile Processing Department (SPD) was visibly dirty and not sanitary. (refer to A 749, finding 1)

Because of the hospital's failure to have a system in place to reduce the risk of the spread of infection from inadequate instrument sterilization, Immediate Jeopardy was called on 8/24/15 at 5:30 p.m. with the Chief Nursing Officer, the Chief Information Officer, and an Administrative Staff. The hospital implemented corrective actions that adequately addressed the immediate jeopardy situation and the IJ was removed on 8/25/15 at 1:30 p.m.

2. Endoscopes (device with light attached inserted through the mouth or anus to look inside the body) and instruments used during endoscopic procedures were not cleaned and/or sterilized properly in accordance with manufacturer's guidelines and the Association of periOperative Registered Nurses guidelines. (refer to A 749, finding 2)

3. The humidity in the endoscope storage room did not measure within acceptable standards range. (refer to A 749, finding 3)

4. Disinfection practices were not in accordance with the hospital's policies and procedures and Association of periOperative Registered Nurses guidelines in the Cardiac Catheterization (Cardiac Cath) and Endoscopy procedure areas. (refer to A 749, finding 4)

5. Nationally recognized standards for restricted and semi-restricted traffic patterns were not followed. (refer to A 749, finding 5)

6. Staff were not following hospital procedures for hand hygiene in patient care areas. (refer to A 749, finding 6)

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

Based on observation, staff interview, and clinical and administrative document review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards, hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and the work environment in the Sterile Processing Department (SPD) was not sanitary.

Because of the hospital's failure to have a system in place to reduce the risk of the spread of infection from inadequate instrument sterilization, Immediate Jeopardy was called on 8/24/15 at 5:30 p.m. with the Chief Nursing Officer, the Chief Information Officer, and an Administrative Staff. The hospital implemented corrective actions that adequately addressed the immediate jeopardy situation and the IJ was removed on 8/25/15 at 1:30 p.m.

2. Endoscopes (device with light attached inserted through the mouth or anus to look inside the body) and instruments used during endoscopic procedures were not cleaned, sterilized, and stored according to nationally recognized standards.

3. The humidity in the endoscope storage room did not measure within acceptable standards range.

4. Disinfection practices were not in accordance with the hospital's policies and procedures and Association of periOperative Registered Nurses guidelines in the Cardiac Catheterization (Cardiac Cath) and Endoscopy procedure areas.

5. Nationally recognized standards for restricted and semi-restricted traffic patterns were not followed.

6. Staff were not following hospital procedures for hand hygiene in patient care areas.

These failures resulted in an unsanitary environment and increased the risk for spread of infection.

Findings:

1. On 8/24/2015 at approximately 1:00 p.m.., during a concurrent observation, interview, and document review, with the Director of Sterile Processing Department (Dir SPD) and the Infection Control Preventionist (ICP), both acknowledged widespread deficient practices in the environment of care. The tour included the sterile and sub sterile area, decontamination area and Gastroenterology/ Radiology procedure units.

During the tour the following practices were observed:

A. The sub-sterile area contained approximately 35-45 service carts [carts used to transport sterile supplies to the operating room (OR)] were observed stored behind and in front of the red line. The carts were covered with adhesive substance and tape. The carts were covered with an undated plastic drape that covered the top 1/3 of the cart without indication of readiness for service. Ten out of the 35-45 carts located behind the red line were found to be covered with visible dust and debris, in addition to the adhesive substance and tape.

B. 1. A sample storage bin, measuring approximately 2 feet (ft) by 1 ft. with twenty-four (24) packages were viewed and pushed into the bin space placing pressure on the packages. ICP and the Dir SPD acknowledged peel packs viewed were creased and crumpled. The packages were stored horizontally allowing compression on the packages. ICP and Dir SPD agreed sterility could not be ensured.
2. Wrapping stations to prepare surgical instruments for sterilization were found with debris and dust covered.
3. Two random instruments were located underneath two separate stations.
4. The washers were found leaking with substance build up in front of washer #1 and #2 in a 2 ft. oblong surface area. The Gastroenterolgy Supervisor (GI Sup), Dir SPD, and ICP all acknowledged the substance build up and leak. Each confirmed the leak and amount of substance build up had been an issue for some time. No timeline was provided as to knowledge of the issue and lack of action.

On 8/24/2015 at 1:45 p.m., during a concurrent observation and interview with the Dir SPD and ICP, surgical trays were observed to be packed in a manner that was inconsistent with the Association of periOperative Registered Nurses (AORN) standards. Both Dir SPD and ICP acknowledged the facility followed AORN standards in the sterilization of surgical instruments.

The following items were opened and inspected:

C. A laminectomy or spine tray (instruments used for surgery on the back) also known as a Major Tray ready for transport to the operating room .

Assembled in the tray:
1. On the stringer (a device used to position instruments for sterilizing) were twenty-three (23) hinged instruments observed packed in a tight group. Ten (10) out of Twenty (20) hinged instruments blades were closed and tips were touching.
2. A large handle instrument (approximately 12 inches with each handle approx. ½ inch wide) stacked on top of surgical instruments layered on the bottom of the tray. Additionally, 10 instruments were observed stacked on top of each other.

On 8/24/15 at 2:00 p.m., during an observation, one smaller tray identified as a minor tray was opened in sterile processing room. This tray contained hinged instruments in the closed position with blades touching. Wrapped instruments were noted to be placed over the tips of the hinged instruments.

Assembled in tray:
One Large long blade scoop type instrument was packed touching the side of the rigid tray with other instruments stacked on top. Stacked on top of those instruments were 12 smaller instruments with 6 of 10 hinged instruments in the closed position with blades touching.

On 8/24/15 at 2:00 p.m. during a concurrent interview, Dir SPD stated this was the typical process for loading all rigid trays . ICP stated staff were not following the hospital's adopted AORN standards for loading rigid trays of surgical instruments.

(AORN) Recommendation IV (2012)
"Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

· IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces...
Sterilant contact is necessary for sterilization to be achieved.
· IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written and validated IFU [Instructions For Use] specifies that disassembly is not required...
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.
· IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position..."

On 8/25/15 at 11:00 a.m., during an interview, ICP, GI Sup, Dir SPD, and a Sterile Processing Technician were unable to verbalize the hospital's Quality Control Program to ensure the sterility of surgical instruments.

On 8/24/15 at 3:45 p.m., during a tour of the Sterile Processing Department (SPD), the department environment was found to be unclean and unsanitary related to accumulations of dust and loose debris and adherent substances found on numerous surfaces.

On 8/25/15 at 8:30 a.m., during a tour of the sterile processing area, there was a 6 x 7 cm puddle of water on the floor near the base of instrument washer 2.

On 8/25/15 at 9:10 a.m., during an interview, the Environmental Services Supervisor (EVS Sup) 1 stated there was an Environmental Services (EVS) staff member who performed terminal cleaning in SPD daily. He stated terminal cleaning included cleaning the vents, ceiling tiles, wall, and floors per a schedule, and the work was inspected by the supervisor daily. He provided an Area Assignment Checklist that he stated was presented to the EVS staff member assigned to the Central Sterile Processing department when he was initially assigned. The document read, "complete area to be terminally cleaned daily," and listed areas within the SPD department, such as the sterile room, and the decontamination area. However, he stated the form was not used as a checklist to confirm the work was actually completed.

The documentation of supervisory review of the sterile processing area was requested, but was not provided. The requested policy for terminal cleaning was provided, but the policy described terminal cleaning of patient rooms after departure, and did not describe terminal cleaning of the central sterile processing department.

On 8/27/15 at 9:30 a.m., during an interview, the Director of Environmental Services stated her understanding was that the housekeeper was to dust, and to sweep and disinfect flooring and baseboards. She stated she understood the Central Sterile staff was to clean the work tables. She stated there was a gray area of uncertain responsibility for cleaning some parts of the Central Sterile Processing department.

Because of the hospital's failure to have a system in place to reduce the risk of the spread of infection from inadequate instrument sterilization, Immediate Jeopardy was called on 8/24/15 at 5:30 p.m. with the Chief Nursing Officer, the Chief Information Officer, and an Administrative Staff. The hospital immediately cancelled all Operating room procedures that used any hinged instruments and implemented corrective actions which included: terminal cleaning of the Sterile Processing Department, education of staff regarding proper cleaning of sterile and sub sterile areas, education of staff regarding infection control standards, and re-sterilaztion of all hinged instruments in a maximum exposure position. These corrective actions adequately addressed the immediate jeopardy situation and the IJ was removed on 8/25/15 at 1:30 p.m.

2. a. On 8/24/15 at 9:00 a.m., during a tour of the procedure room where Endoscopic retrograde cholagiopancreatography (ERCP-a diagnostic procedure used to examine and visualize diseases of the liver, bile ducts, and pancreas) procedures were carried out, reprocessed instruments in sterile processing peel packs were seen, including surgical scissors and forceps (An instrument resembling a pair of pincers, used for grasping, manipulating, or extracting, especially in surgery). The manufacturer's processing instructions for the surgical scissors were reviewed and showed the warning, "Failure to properly clean and sterilize the instrument after each examination can compromise patient safety." The instructions outlined the need to immediately immerse, then ultrasonically clean, then sterilize the instrument. The instructions advised against the use of glutaraldehyde as a sterilant for the processing the instrument. The forceps manufacturer instructions showed that they could be sterilized in an autoclave (steam sterilizer machine).

On 8/24/15 at 4:30 p.m., during an interview, Surgical Technician (ST) 1 stated reusable surgical instruments used with the endoscopes were washed by hand and placed in the scope processor.

On 8/25/15 at 1:50 p.m., during an interview, the Infection Control Preventionist (ICP) stated she had not looked at the endoscopic instrument cleaning and processing because she assumed the instruments were a onetime use. She stated she was not aware of endoscopic processor being approved for processing surgical instruments.

On 8/26/15 at 2:50 p.m., during a second interview, ST 1 stated small instruments used with endoscopes were placed under an endoscope in the endoscope processor for cleaning.

The endoscope processor user manual was reviewed, and did not contain instructions to place other instruments under the endoscopes being processed.

On 8/24/15 at 10:00 a.m, during an observation of the scope washers in the endoscopy center, the chambers where endoscopes were to be placed for disinfection, for each of the three processors, had 1 to 2 cm wide bands of brown crusty residue at the edges of the chamber and surrounding a projection in the chamber.

On 8/24/15 at 2:40 p.m., during an interview, the ICP stated the interior of the endoscope processors had a less than smooth surface, and she was trying to obtain the cleaning recommendations for them.

On 8/24/15 at 2:00 p.m., during an interview, the Dir GI stated she spoke with the endoscope processor manufacturer's representative and was told that the residue on the interior of the processors was a common problem caused by interaction between water and the chemical disinfectant. She obtained instructions for cleaning the residue from the processors. The Dir GI stated she was advised by the manufacturer to purchase a cleaning sponge to remove the residue.

On 8/24/15 at 3:30 p.m., during an interview, the Dir GI stated the brown residue had been removed from the interior of the scope processors.

On 8/25/15 at 8:40 a.m., during an observation of the [brand name] 1E sterilizer in the sterile processing department, inside the processing chamber of the machine was visibly wet, and there was a small amount of brown discoloration in the liquid.

In a concurrent interview with the Director of the Sterile Processing Department (Dir SPD), she stated she was not aware of the daily maintenance instructions for the machine.

On 8/25/15 at 8:50 a.m., during an interview, Sterile Processing Technician (SPD Tech) 1 stated she performed testing on the [brand name] 1E sterilizer daily, and believed the daily care involved wiping the surfaces with a towel.

The hospital policy, "[Brand Name] System Sterilization," effective date January, 2014, showed that the 1E sterilizer was to undergo daily cleaning using a hospital approved cleaning agent, including, "A. Clean external surfaces, B. open lid, C. clean processing tray/container, d. wipe aspirator assembly and sterilant compartment, checking aspirator assembly, E. check drain screen, ensure screen is clean. Remove any debris from screen. F. Remove processing tray from chamber and clean chamber. G. Replace processing tray. H. Check printer paper and replace with new roll if needed.

On 8/25/15 at 8:15 a.m., during an observation of the endoscope (device with a light attached inserted through the mouth or anus to look inside the body) processing room and storage room and concurrent interview, Surgical Technician (ST) 1 stated the endoscopes should be carried to and from the procedure rooms in a disposable transport bag. In the endoscope storage room, 28 scopes approximately 6 feet in length were noted to be hanging from racks.

On 8/25/15 at 8:35 a.m., during an observation, Gastroenterology Technician (GI tech) 1 entered the endoscope storage room and selected an endoscope (for a procedure) hanging from a rack. GI tech 1 was observed wrapping the scope around her arm; she then left the scope room.

On 8/25/15 at 8:45 a.m., during an interview, GI tech 1 stated, "Yes, I didn't put the scope in a bag, I suppose I need to now."

On 8/26/15 at 2:55 p.m., during an interview, the Gastroenterology Supervisor (GI Sup) stated the training for the staff is peer to peer, "We train each other and oversight of job performance is also peer to peer."

2. b. On 8/24/15 at approximately 1:00 p.m., during a concurrent observation and interview in the Endoscopy procedure area, with the Gastroenterology Supervisor (GI Sup) and ICP, observed in the unrestricted area of the procedure unit was an endoscope storage room containing endoscopes. A concurrent interview with the unit ST 1 indicated the facility follows the Association of periOperative Registered Nurses (AORN) standards in processing and storing scopes. GI Sup, ICP and ST 1 acknowledged the endoscope room was not maintained in accordance with nationally recognized standards and facility policies. It was noted that the scopes were air dried with compressed air from a local home improvement retailer. In a concurrent interview, the GI Sup stated the compressed air was used for a long time. The compressed air was used before she was hired and she did not question the use. The ICP acknowledged she was not aware of the use of the compressed air.

Review of previous interview on at 8/20/15 1:00 p.m., ICP and GI Sup, acknowledged the scope storage closet was not maintained according to national standards and she did not know if a facility policy existed. ICP stated, "We do not have much space, however, we have put in a request to purchase two scope cabinets and the cabinets will be moved to a space to allow them to be maintained in accordance with nationally recognized standards."

AORN Standard Ix 2012 indicated: "...Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination. Ix.a. Flexible endoscopes should be stored: in a closed cabinet with: venting that allows air circulation around the flexible endoscopes, internal surfaces composed of cleanable materials, adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching...

When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential develop.m.ent of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. Opening all valves and removing all accessories facilitates drying. The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight."

3. On 8/24/15 at 10:05 a.m., during an observation of the endoscope storage room, the humidity gauge mounted on the wall indicated the humidity (moisture in the air) registered at 62%. Review of the endoscope storage room log for August 2015 indicated relative humidity levels should be maintained between 30%-60% and any discrepancies were to be reported to the facilities manager and director. On 8/23/15 the humidity was documented on the log at 61%. The log contained a column to document "comments/actions taken". There was no documentation of action taken on 8/23/15. On 8/24/15, there was documentation of an adjustment being made, but no time was recorded.

On 8/25/15 at 8:30 a.m., during an observation, concurrent interview and record review in the scope processing and storage area, documentation on the log began on 8/20/15, and Surgical Technician (ST) 1 stated it was a newly created form and daily log, implemented on 8/20/15.

On 8/25/15 at 1:40 p.m., during an interview, the Infection Control Preventionist (ICP) stated she had reviewed data collected regarding a cluster of infections related to endoscopic retrograde cholangiopancreatography (ERCP- a diagnostic procedure used to examine and visualize diseases of the liver, bile ducts, and pancreas) procedures. The ICP stated she reviewed the staff practices regarding cleaning, handling and storage of endoscopes. The ICP stated one part of her recommendations to prevent infection included monitoring the humidity in the storage room, and keeping the level between 20%-60% humidity to prevent excess moisture in the room

AORN Standards and Recommended Practices, published in 2012, was reviewed. Under "Guideline For a Safe Environment of Care, Part 2 IV.e.1 Relative humidity should be maintained between 20 per cent and 60 per cent." Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed ... V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system..."

4. On 8/25/15 at 1:10 p.m., an observation of the cleaning process was made in the Cardiac Catheterization (Cath lab) Procedure room after completion of a surgical case. All surface areas and equipment were noted to be wiped with disinfectant wipes by Registered Nurse (RN) 4 and Radiology Technician (RT) 1.

On 8/25/15 at 1:15 p.m., during an interview, RN 4 was asked if the floor was going to be mopped after the procedure. She stated, "No, we don't mop, a cleaning crew comes in during the evening hours and does the terminal cleaning and mopping of the procedure rooms."

On 8/25/15 at 1:17 p.m., during an interview, Radiology Technician (Rad Tech) 1 stated, the procedure room was cleaned with sanitizing wipes after each procedure. Rad Tech 1 was asked if he mopped the floor between cases. Rad Tech 1 stated, "They don't give us a mop. If the floor is dirty we get down on our hands and knees and wipe the floors down with wipes if it is soiled."

On 8/25/15 at 1:19 p.m., RN 4 told Rad Tech 1 the next patient was being transported to the room for a surgical procedure. The floor was not mopped or cleaned before that patient arrived.

On 8/25/15 at 3 p.m., during an interview, the Dir End stated the Cath Lab followed AORN (Association of periOperative Registered Nurses) standards for cleaning of Cath lab procedure rooms. She stated the Cath lab staff was responsible for the cleaning of the procedure rooms during the day between cases. She stated she didn't know if the staff was mopping between procedures, but they should be following the standards.

The Environmental Tool Kit published by AORN in 2012 indicated cleaning rooms between procedures must include, "Equipment and Supplies: Gather the correct equipment and supplies needed to clean and disinfect the room detergents and disinfectants, low-linting cloths, mop, and single-use disposable wipes. Floor Cleaning: Clean and disinfect the floor surfaces at the edge of the room first moving toward the center of the room. The center of the room is where most patient care happens the center is likely to be dirtier."

Review of the facility policy and procedure, NO. 7570.702, titled "Infection Control of Restricted Areas" dated 9/2012 indicated, "...Procedure: 2. Patients shall be provided with a safe and clean environment ....4. I. Procedure room floors shall be cleaned with a hospital-grade disinfectant/detergent."

On 8/26/15 at 11:25 a.m., during an observation in Endoscopy Procedure Room 3, the floor was not cleaned after one procedure was finished and before the next patient was brought into the room for the next procedure.

On 8/26/15 at 11:30 a.m., during an interview, when asked if the floor was cleaned between patients, the ST 1 stated, "No never, am I supposed to?"

Administrative Policy and Procedure titled, "Sanitation, O.R., Environmental" , dated January 2014, indicated, " ...F. Cleaning between cases shall be done immediately after the patient is transported out of the room ... I. 4. Mop floors after each use using a fresh mop ..."

5. On 8/24/15 at 1 p.m., during an observation in the Endoscopy Department, no designation of semi-restricted or restricted access could be found. The Endoscopy Department was configured in an oval shape that was divided into a pre/post procedural area on one side, and a procedural area on the other side. Unrestricted access was allowed from the entrance of the department to the procedural area. There was no signage for restricted passage from one area to the other. Also located on the procedural side of the department were the decontamination and scope storage rooms.

On 8/26/15 at 2:08 p.m., during a concurrent observation and interview, the Director of Endoscopy, (Dir End) stated the hospital had no policy to indicate restricted areas in the Endoscopy Department as it was not considered to be the same as an operating room. The Dir End stated there is a secretary that sits in the middle of the two areas and it would be her job to stop unauthorized individuals from entering the procedure area of the department. When asked what would happen if the secretary was not sitting there or got called away, the Dir End stated, " You're right, we need to mark it (restricted area) better, I will put red lines or stop signs up right away." When asked what standards of practice are followed in the endoscopy department, the Dir End stated, "We follow AORN (Association of periOperative Registered Nurses) standards."

Review of surgical cases performed in the endoscopy unit indicated the following types of procedures are done here: Endoscopy with biopsy (direct visualization of the throat, esophagus, stomach and/or small intestines with a device and removal of tissue to examine for diseases), and colonoscopy with biopsy (direct visualization of the colon with a device and removal of tissue to examine for diseases).

The American College of Surgeons Bulletin dated May 1, 2012, defines surgery as: "Surgery is performed for the purpose of structurally altering the human body by incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transportation of live human tissue, which include lasers, ultrasound, ionizing, radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reduction for major dislocations, and fractures, or otherwise altered by any mechanical, thermal, light-based, electromagnetic or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system is also considered to be surgery (this does not include administration by nursing personnel of some injections, such as subcutaneous, intramuscular, and intravenous when ordered by a physician). All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel... " According to this definition, endoscopic procedures, regardless of where in hospital performed, would be considered surgery.

"Recommended Practices for Traffic Patterns in the periOperative Practice Setting" , published in the AORN Journal, dated 2012 indicated, Traffic patterns should be designed to facilitate movement of patients, personnel, equipment, and supplies into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and a patient ...The restricted area includes operating rooms, procedure rooms and the clean core area.

6. On 8/26/15 at 10:33 a.m., during an observation, Registered Nurse (RN) 5 did not wear gloves while cleaning Endoscopy Procedure Room 3 after a procedure. RN 5 then exited procedure room, and returned to the nurse's station without washing hands.

On 8/26/15 at 10:35 a.m., during an interview, when asked why she did not wear gloves while cleaning procedure room, RN 5 stated, "I am supposed to wear gloves ...I just didn't think." When asked why she did not wash her hands when she was done cleaning, RN 5 stated, "Again, I just didn't think."

On 8/26/15 at 11:30 a.m., during an interview, when asked if it was the hospital's policy to wear gloves while cleaning a room, the Surgical Technician (ST 1) stated, "Yes, always."

On 8/26/15 at 2:08 p.m., during an interview, the Dir End stated, "They (staff) know they are supposed to wear gloves and wash their hands when they clean ..."

Administrative Policy and Procedure titled, "Cleaning of Blood and Body Fluid Spills" , dated 11/13, indicated "... Procedure: I. A. At a minimum, gloves are worn while cleaning and disinfecting the area ..."
Administrative Policy and Procedure titled, "Hand Hygiene" , dated 11/13, indicated ... "XV. Gloves: D. Hand hygiene must be practiced both before and after glove use ..."

Based on observation, interview, clinical and administrative document review, the hospital failed to provide surgical services in accordance with nationally recognized standards when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards, hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and the work environment in the Sterile Processing Department (SPD) was not sanitary. (Refer to A951, finding 1)

2. Endoscopes (device with light attached inserted through the mouth or anus to look inside the body) and instruments used during endoscopic procedures were not cleaned and/or sterilized properly in accordance with manufacturer's guidelines and the Association of periOperative Registered Nurses guidelines. (Refer to A951, finding 2)

3. The humidity in the endoscope storage room measured outside of acceptable standards range. (Refer to A951, finding 3)

4. Disinfection practices were not in accordance with the hospital's policies and procedures and Association of periOperative Registered Nurses guidelines in the Cardiac Catheterization (Cardiac Cath) and Endoscopy procedure areas. (Refer to A951, finding 4)

5. Nationally recognized standards for restricted and semi-restricted traffic patterns were not followed. (Refer to A951, finding 5)

6. Staff were not following hospital procedures for hand hygiene in patient care areas. (Refer to A951, finding 6)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe manner.

Based on observations, staff interview, and clinical and administrative document review, the hospital failed to ensure surgical services policies, procedures, and protocols were developed, implemented, and enforced in accordance with acceptable standards of care and practice when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards, hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and the work environment in the Sterile Processing Department (SPD) was not sanitary.

2. Endoscopes (device with light attached inserted through the mouth or anus to look inside the body) and instruments used during endoscopic procedures were not cleaned, sterilized and stored according to nationally recognized standards.

3. The humidity in the endoscope storage room did not measure within acceptable standards range.

4. Proper disinfection practices were not followed in the Cardiac Catheterization (Cardiac Cath) and Endoscopy procedure areas.

5. Nationally recognized standards for restricted and semi-restricted traffic patterns were not followed.

6. Staff were not following hospital procedures for hand hygiene in patient care areas.

These failures resulted in an unsanitary environment and increased the risk for spread of infection.

Findings:

1. On 8/24/2015 at approximately 1:00 p.m.., during a concurrent observation, interview, and document review, with the Director of Sterile Processing Department (Dir SPD) and the Infection Control Preventionist (ICP), both acknowledged widespread deficient practices in the environment of care. The tour included the sterile and sub sterile area, decontamination area and Gastroenterology/ Radiology procedure units.

During the tour the following practices were observed:

A. The sub-sterile area contained approximately 35-45 service carts [carts used to transport sterile supplies to the operating room (OR)] were observed stored behind and in front of the red line. The carts were covered with adhesive substance and tape. The carts were covered with an undated plastic drape that covered the top 1/3 of the cart without indication of readiness for service. Ten out of the 35-45 carts located behind the red line were found to be covered with visible dust and debris, in addition to the adhesive substance and tape.

B. 1. A sample storage bin, measuring approximately 2 feet (ft) by 1 ft. was viewed with twenty-four (24) packages inside, pushed into the bin space placing pressure on the packages. ICP and the Dir SPD acknowledged peel packs viewed were creased and crumpled. The packages were stored horizontally allowing compression on the packages. ICP and Dir SPD agreed sterility could not be ensured.

2. Wrapping stations to prepare surgical instruments for sterilization were found with debris and dust covered.

3. Two random instruments were located underneath two separate stations.

4. The washers were found leaking with substance build up in front of washer #1 and #2 in a 2 ft. oblong surface area. The Gastroenterolgy Supervisor (GI Sup), Dir SPD, and ICP all acknowledged the substance build up and leak. Each confirmed the leak and amount of substance build up had been an issue for some time. No timeline was provided as to knowledge of the issue and lack of action.

On 8/24/2015 at 1:45 p.m., during a concurrent observation and interview with the Dir SPD and ICP, surgical trays were observed to be packed in a manner that was inconsistent with the Association of periOperative Registered Nurses (AORN) standards. Both Dir SPD and ICP acknowledged the facility followed AORN standards in the sterilization of surgical instruments.

The following items were opened and inspected:

C. A laminectomy or spine tray (instruments used for surgery on the back) also known as a Major Tray ready for transport to the operating room .

Assembled in the tray:
1. On the stringer (a device used to position instruments for sterilizing) were twenty-three (23) hinged instruments observed packed in a tight group. Ten (10) out of Twenty (20) hinged instruments blades were closed and tips were touching.

2. A large handle instrument (approximately 12 inches with each handle approx. ½ inch wide) stacked on top of surgical instruments layered on the bottom of the tray. Additionally, 10 instruments were observed stacked on top of each other.

On 8/24/15 at 2:00 p.m., during an observation, one smaller tray identified as a minor tray was opened in sterile processing room. This tray contained hinged instruments in the closed position with blades touching. Wrapped instruments were noted to be placed over the tips of the hinged instruments.

Assembled in tray:
One Large long blade scoop type instrument was packed touching the side of the rigid tray with other instruments stacked on top. Stacked on top of those instruments were 12 smaller instruments with 6 of 10 hinged instruments in the closed position with blades touching.

On 8/24/15 at 2:00 p.m. during a concurrent interview, Dir SPD stated this was the typical process for loading all rigid trays . ICP stated staff were not following the hospital's adopted AORN standards for loading rigid trays of surgical instruments.

(AORN) Recommendation IV (2012)
"Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

· IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces...
Sterilant contact is necessary for sterilization to be achieved.
· IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU [Instructions For Use] specifies that disassembly is not required...
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.
· IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position..."

On 8/25/15 at 11:00 a.m., during an interview, ICP, GI Sup, Dir SPD, and a Sterile Processing Technician were unable to verbalize the hospital's Quality Control Program to ensure the sterility of surgical instruments.

On 8/24/15 at 3:45 p.m., during a tour of the Sterile Processing Department (SPD), the department environment was found to be unclean and unsanitary related to accumulations of dust and loose debris and adherent substances found on numerous surfaces.

On 8/25/15 at 8:30 a.m., during a tour of the sterile processing area, there was a 6 x 7 cm puddle of water on the floor near the base of instrument washer 2.

On 8/25/15 at 9:10 a.m., during an interview, the Environmental Services Supervisor (EVS Sup) 1 stated there was an Environmental Services (EVS) staff member who performed terminal cleaning in SPD daily. He stated terminal cleaning included cleaning the vents, ceiling tiles, wall, and floors per a schedule, and the work was inspected by the supervisor daily. He provided an Area Assignment Checklist that he stated was presented to the EVS staff member assigned to the Central Sterile Processing department when he was initially assigned. The document read, "complete area to be terminally cleaned daily," and listed areas within the SPD department, such as the sterile room, and the decontamination area. However, he stated the form was not used as a checklist to confirm the work was actually completed.

The documentation of supervisory review of the sterile processing area was requested, but was not provided. The requested policy for terminal cleaning was provided, but the policy described terminal cleaning of patient rooms after departure, and did not describe terminal cleaning of the central sterile processing department.

On 8/27/15 at 9:30 a.m., during an interview, the Director of Environmental Services stated her understanding was that the housekeeper was to dust, and to sweep and disinfect flooring and baseboards. She stated she understood the Central Sterile staff was to clean the work tables. She stated there was a gray area of uncertain responsibility for cleaning some parts of the Central Sterile Processing department.

2. a. On 8/24/15 at 9:00 a.m., during a tour of the procedure room where Endoscopic retrograde cholagiopancreatography (ERCP-a diagnostic procedure used to examine and visualize diseases of the liver, bile ducts, and pancreas) procedures were carried out, reprocessed instruments in sterile processing peel packs were seen, including surgical scissors and forceps (An instrument resembling a pair of pincers, used for grasping, manipulating, or extracting, especially in surgery). The manufacturer's processing instructions for the surgical scissors were reviewed and showed the warning, "Failure to properly clean and sterilize the instrument after each examination can compromise patient safety." The instructions outlined the need to immediately immerse, then ultrasonically clean, then sterilize the instrument. The instructions advised against the use of glutaraldehyde as a sterilant for the processing the instrument. The forceps manufacturer instructions showed that they could be sterilized in an autoclave (steam sterilizer machine).

On 8/24/15 at 4:30 p.m., during an interview, Surgical Technician (ST) 1 stated reusable surgical instruments used with the endoscopes were washed by hand and placed in the scope processor.

On 8/25/15 at 1:50 p.m., during an interview, the Infection Control Preventionist (ICP) stated she had not looked at the endoscopic instrument cleaning and processing because she assumed the instruments were a onetime use. She stated she was not aware of an endoscopic processor being approved for processing surgical instruments.

On 8/26/15 at 2:50 p.m., during a second interview, ST 1 stated small instruments used with endoscopes were placed under the endoscope in the endoscope processor for cleaning.

The endoscope processor user manual was reviewed, and did not contain instructions to place other instruments under the endoscopes being processed.

On 8/24/15 at 10:00 a.m, during an observation of the scope washers in the endoscopy center, the chambers where endoscopes were to be placed for disinfection, for each of the three processors, had 1 to 2 cm wide bands of brown crusty residue at the edges of the chamber and surrounding a projection in the chamber.

On 8/24/15 at 2:40 p.m., during an interview, the ICP stated the interior of the endoscope processors had a less than smooth surface, and she was trying to obtain the cleaning recommendations for them.

On 8/24/15 at 2:00 p.m., during an interview, the Dir GI stated she spoke with the endoscope processor manufacturer's representative and was told that the residue on the interior of the processors was a common problem caused by interaction between water and the chemical disinfectant. She obtained instructions for cleaning the residue from the processors. The Dir GI stated she was advised by manufacturer to purchase a cleaning sponge to remove the residue.

On 8/24/15 at 3:30 p.m., during an interview, the Dir GI stated the brown residue had been removed from the interior of the scope processors.

On 8/25/15 at 8:40 a.m., during an observation of the [brand name] 1E sterilizer in the sterile processing department, inside the processing chamber of the machine was visibly wet, and there was a small amount of brown discoloration in the liquid.

In a concurrent interview with the Director of the Sterile Processing Department (Dir SPD), she stated she was not aware of the daily maintenance instructions for the machine.

On 8/25/15 at 8:50 a.m., during an interview, Sterile Processing Technician (SPD Tech) 1 stated she performed testing on the [brand name] 1e daily, and believed the daily care involved wiping the surfaces with a towel.

The hospital policy, "[Brand Name] System Sterilization," effective date January, 2014, showed that the 1E sterilizer was to undergo daily cleaning using a hospital approved cleaning agent, including, "A. Clean external surfaces, B. open lid, C. clean processing tray/container, d. wipe aspirator assembly and sterilant compartment, checking aspirator assembly, E. check drain screen, ensure screen is clean. Remove any debris from screen. F. Remove processing tray from chamber and lean hamber. G. Replace processing tray. H. Check printer paper and replace with new roll if needed.

On 8/25/15 at 8:15 a.m., during an observation of the endoscope (device with a light attached inserted through the mouth or anus to look inside the body) processing room and storage room and concurrent interview, Surgical Technician (ST) 1 stated the endoscopes should be carried to and from the procedure rooms in a disposable transport bag. In the endoscope storage room, 28 scopes approximately 6 feet in length were noted to be hanging from racks.

On 8/25/15 at 8:35 a.m., during an observation, Gastroenterology Technician (GI tech) 1 entered the endoscope storage room and selected an endoscope (for a procedure) hanging from a rack. GI tech 1 was observed wrapping the scope around her arm; she then left the scope room.

On 8/25/15 at 8:45 a.m., during an interview, GI tech 1 stated, "Yes, I didn't put the scope in a bag, I suppose I need to now."

On 8/26/15 at 2:55 p.m., during an interview, the Gastroenterology Supervisor (GI Sup) stated the training for the staff is peer to peer, "We train each other and oversight of job performance is also peer to peer."

2. b. On 8/24/15 at approximately 1:00 p.m., during a concurrent observation and interview in the Endoscopy procedure area, with the Gastroenterology Supervisor (GI Sup) and ICP. Observed in the unrestricted area of the procedure unit was an endoscope storage room containing endoscopes. A concurrent interview with the unit ST 1 indicated the facility follows the Association of periOperative Registered Nurses (AORN) standards in processing and storing scopes. GI Sup, ICP and ST 1 acknowledged the endoscope room was not maintained in accordance with nationally recognized standards and facility policies. It was noted that the scopes were air dried with compressed air from a local home improvement retailer. In a concurrent interview, the GI Sup stated the compressed air was used for a long time. The compressed air was used before she was hired and she did not question the use. The ICP acknowledged she was not aware of the use of the compressed air.

Review of previous interview on at 8/20/15 1:00 p.m., ICP and GI Sup, acknowledged the scope storage closet was not maintained according to national standards and she did not know if a facility policy existed. ICP stated, "We do not have much space, however, we have put in a request to purchase two scope cabinets and the cabinets will be moved to a space to allow them to be maintained in accordance with national recognized standards."
AORN Standard Ix 2012 indicated: "...Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination. Ix.a. Flexible endoscopes should be stored: in a closed cabinet with: venting that allows air circulation around the flexible endoscopes, internal surfaces composed of cleanable materials, adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching...

When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential develop.m.ent of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. Opening all valves and removing all accessories facilitates drying. The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight."

3. On 8/24/15 at 10:05 a.m., during an observation of the endoscope storage room, the humidity gauge mounted on the wall indicated the humidity (moisture in the air) registered at 62%. Review of the endoscope storage room log for August 2015 indicated relative humidity levels should be maintained between 30%-60% and any discrepancies were to be reported to the facilities manager and director. On 8/23/15 the humidity was documented on the log at 61%. The log contained a column to document "comments/actions taken". There was no documentation of action taken on 8/23/15. On 8/24/15, there was documentation of an adjustment being made, but no time was recorded.

On 8/25/15 at 8:30 a.m., during an observation, concurrent interview and record review in the scope processing and storage area, documentation on the log began on 8/20/15, and Surgical Technician (ST) 1 stated it was a newly created form and daily log, implemented on 8/20/15.

On 8/25/15 at 1:40 p.m., during an interview, the Infection Control Preventionist (ICP) stated she had reviewed data collected regarding a cluster of infections related to endoscopic retrograde cholangiopancreatography (ERCP- a diagnostic procedure used to examine and visualize diseases of the liver, bile ducts, and pancreas) procedures. The ICP stated she reviewed the staff practices regarding cleaning, handling and storage of endoscopes. The ICP stated one part of her recommendations to prevent infection included monitoring the humidity in the storage room, and keeping the level between 20%-60% humidity to prevent excess moisture in the room

AORN Standards and Recommended Practices, published in 2012, was reviewed. Under "Guideline For a Safe Environment of Care, Part 2 IV.e.1 Relative humidity should be maintained between 20 per cent and 60 per cent." Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed ... V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system..."

4. On 8/25/15 at 1:10 p.m., an observation of the cleaning process was made in the Cardiac Catheterization (Cath lab) Procedure room after completion of a surgical case. All surface areas and equipment were noted to be wiped with disinfectant wipes by Registered Nurse (RN) 4 and Radiology Technician (RT) 1.

On 8/25/15 at 1:15 p.m., during an interview, RN 4 was asked if the floor was going to be mopped after the procedure. She stated, "No, we don't mop, a cleaning crew comes in during the evening hours and does the terminal cleaning and mopping of the procedure rooms."

On 8/25/15 at 1:17 p.m., during an interview, Radiology Technician (Rad Tech) 1 stated, the procedure room was cleaned with sanitizing wipes after each procedure. Rad Tech 1 was asked if he mopped the floor between cases. Rad Tech 1 stated, "They don't give us a mop. If the floor is dirty we get down on our hands and knees and wipe the floors down with wipes if it is soiled."

On 8/25/15 at 1:19 p.m., RN 4 told Rad Tech 1 the next patient was being transported to the room for a surgical procedure. The floor was not mopped or cleaned before that patient arrived.

On 8/25/15 at 3 p.m., during an interview, the Dir End stated the Cath Lab followed AORN (Association of periOperative Registered Nurses) standards for cleaning of Cath lab procedure rooms. She stated the Cath lab staff was responsible for the cleaning of the procedure rooms during the day between cases. She stated she didn't know if the staff was mopping between procedures, but they should be following the standards.

The Environmental Tool Kit published by AORN in 2012 indicated cleaning rooms between procedures must include, "Equipment and Supplies: Gather the correct equipment and supplies needed to clean and disinfect the room detergents and disinfectants, low-linting cloths, mop, and single-use disposable wipes. Floor Cleaning: Clean and disinfect the floor surfaces at the edge of the room first moving toward the center of the room. The center of the room is where most patient care happens the center is likely to be dirtier."

Review of the facility policy and procedure, NO. 7570.702, titled "Infection Control of Restricted Areas" dated 9/2012 indicated, "...Procedure: 2. Patients shall be provided with a safe and clean environment ....4. I. Procedure room floors shall be cleaned with a hospital-grade disinfectant/detergent."

On 8/26/15 at 11:25 a.m., during an observation in Endoscopy Procedure Room 3, the floor was not cleaned after one procedure was finished and before the next patient was brought into the room for the next procedure.

On 8/26/15 at 11:30 a.m., during an interview, when asked if the floor was cleaned between patients, the ST 1 stated, "No never, am I supposed to?"

Administrative Policy and Procedure titled, "Sanitation, O.R., Environmental" , dated January 2014, indicated, " ...F. Cleaning between cases shall be done immediately after the patient is transported out of the room ... I. 4. Mop floors after each use using a fresh mop ..."

5. On 8/24/15 at 1 p.m., during an observation in the Endoscopy Department, no designation of semi-restricted or restricted access could be found. The Endoscopy Department was configured in an oval shape that was divided into a pre/post procedural area on one side, and a procedural area on the other side. Unrestricted access was allowed from the entrance of the department to the procedural area. There was no signage for restricted passage from one area to the other. Also located on the procedural side of the department were the decontamination and scope storage rooms.

On 8/26/15 at 2:08 p.m., during a concurrent observation and interview, the Director of Endoscopy, (Dir End) stated the hospital had no policy to indicate restricted areas in the Endoscopy Department as it was not considered to be the same as an operating room. The Dir End stated there is a secretary that sits in the middle of the two areas and it would be her job to stop unauthorized individuals from entering the procedure area of the department. When asked what would happen if the secretary was not sitting there or got called away, the Dir End stated, " You're right, we need to mark it (restricted area) better, I will put red lines or stop signs up right away." When asked what standards of practice are followed in the endoscopy department, the Dir End stated, "We follow AORN (Association of periOperative Registered Nurses) standards."

Review of surgical cases performed in the endoscopy unit indicated the following types of procedures are done here: Endoscopy with biopsy (direct visualization of the throat, esophagus, stomach and/or small intestines with a device and removal of tissue to examine for diseases), and colonoscopy with biopsy (direct visualization of the colon with a device and removal of tissue to examine for diseases).

The American College of Surgeons Bulletin dated May 1, 2012, defines surgery as: "Surgery is performed for the purpose of structurally altering the human body by incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transportation of live human tissue, which include lasers, ultrasound, ionizing, radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reduction for major dislocations, and fractures, or otherwise altered by any mechanical, thermal, light-based, electromagnetic or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system is also considered to be surgery (this does not include administration by nursing personnel of some injections, such as subcutaneous, intramuscular, and intravenous when ordered by a physician). All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel... " According to this definition, endoscopic procedures, regardless of where in hospital performed, would be considered surgery.

"Recommended Practices for Traffic Patterns in the periOperative Practice Setting" , published in the AORN Journal, dated 2012 indicated, Traffic patterns should be designed to facilitate movement of patients, personnel, equipment, and supplies into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and a patient ...The restricted area includes operating rooms, procedure rooms and the clean core area.

6. On 8/26/15 at 10:33 a.m., during an observation, Registered Nurse (RN) 5 did not wear gloves while cleaning Endoscopy Procedure Room 3 after a procedure. RN 5 then exited procedure room, and returned to the nurse's station without washing hands.

On 8/26/15 at 10:35 a.m., during an interview, when asked why she did not wear gloves while cleaning procedure room, RN 5 stated, "I am supposed to wear gloves ...I just didn't think." When asked why she did not wash her hands when she was done cleaning, RN 5 stated, "Again, I just didn't think."

On 8/26/15 at 11:30 a.m., during an interview, when asked if it was the hospital's policy to wear gloves while cleaning a room, the Surgical Technician (ST 1) stated, "Yes, always."

On 8/26/15 at 2:08 p.m., during an interview, the Dir End stated, "They (staff) know they are supposed to wear gloves and wash their hands when they clean ..."

Administrative Policy and Procedure titled, "Cleaning of Blood and Body Fluid Spills" , dated 11/13, indicated "...Procedure: I. A. At a minimum, gloves are worn while cleaning and disinfecting the area ..."
Administrative Policy and Procedure titled, "Hand Hygiene" , dated 11/13, indicated ... "XV. Gloves: D. Hand hygiene must be practiced both before and after glove use ..."