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Based on observation, document review and staff interview, it was determined the hospital's governing body failed to effectively oversee the hospital's facilities, infection control program, surgery department and QAPI program to ensure services were provided to patients in a safe manner.

See tags A-0263, A-0700, A-0747 and A-0940.

Based on observation, document review and staff interview, it was determined the hospital's QAPI program failed to ensure the hospital's facilities services, infection control program and surgical services were provided in a manner consistent with accepted standards of practice.

See tags A-0700, A-0747 and A-0940.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. ensure the surgery department was designed and maintained to designate appropriate unrestricted, semi-restricted and restricted areas and traffic patterns;

b. build, equip and maintain adequate sterile supply storage areas and failed to provide adequate housekeeping facilities within the surgery department;

c. ensure proper ventilation, air exchanges, temperature and humidity controls were maintained in the various areas of the surgery department;

d. perform high-level disinfection in locations designed and constructed for this purpose; and

e. the hospital failed to incorporate facility maintenance, buildings and equipment into the hospital's quality assessment and performance improvement (QAPI) program.

Findings:

1. On 09/11/15 and 09/14/15 tours were conducted of the hospital's surgical suite. Two sets of double doors on two separate corridors allowed unrestricted traffic to enter the department. (Doors, signage or a line of demarcation should identify the separation between the unrestricted and the semi-restricted area. Doors should separate the semi-restricted areas from the restricted areas of the department. Doors also provide a physical barrier to assist in maintaining control of the HVAC system. AORN, 2015)

The surgery control station was located too far from the two sets of entry doors to ensure visual observation and control of all traffic entering and leaving the department.

Because there was no semi-restricted area of designation, the surgical suite design incorrectly allowed traffic to transition from the unrestricted corridor immediately into the restricted corridor.(The HVAC, surgical attire, and traffic pattern requirements of the surgical suite are designed to be more stringent as one moves from unrestricted to restricted areas. The progression of restrictions is intended to provide the cleanest environment within the restricted area. AORN, 2015)

Upon entering the department, both surgery staff and non-surgery staff travelled through corridors that opened to the endoscopy procedure rooms, endoscopy supply room, surgical instrument decontamination room, and surgery sterile processing room. This traffic pattern demonstrated the hospital had incorrectly identified these corridors as "unrestricted" rather than "semi-restricted." (The semi-restricted zone includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for processing of instruments, scrub sink areas and corridors leading to the restricted areas of the surgical suite. Traffic is limited to authorized personnel in surgical attire and those patients accompanied by authorized personnel. AORN, 2015)

During the tour, non-surgery staff wearing street clothes (administrative staff, security, housekeeping, etc.) entered the surgery department unobserved as they travelled through the semi-restricted corridors. (Personnel are required to wear surgical attire and cover all head and facial hair in the semi-restricted areas. AORN, 2015)

Non-surgery staff in street clothes travelled past the endoscopy procedure rooms where procedures were actively taking place. Unauthorized persons traveling through this corridor could see into the procedure rooms when the doors were opened and could hear personal conversations between the surgery staff and the patients. (The nurse safeguards the patient's right to privacy. The nurse advocates for an environment that provides for sufficient physical privacy, including auditory privacy. AORN, 2015)

Non-surgery staff in street clothes also walked past surgery staff in surgical attire who were transporting contaminated surgical instruments to the decontamination room.

Surgery staff arriving or leaving the department in street clothes also traveled through the procedure room corridor because this was the only access to and from the surgery changing rooms. (Movement of personnel from unrestricted areas to either semi-restricted or restricted areas should be through a transition zone. A transition zone exists where one can enter the area in street clothing and exit into the semi-restricted or restricted zones in surgical attire. Locker rooms serve as transition zones between the outside and inside of a surgical suite and may serve as a security point to monitor people admitted to the suite. AORN, 2015)

Housekeeping staff brought large trash collection bins from the public corridors into the surgery semi-restricted corridor and then through another set of double doors into the pre-op and recovery areas. The surgery manager stated the housekeeping staff used this route through the surgery suite in order to collect trash from the pre-op and recovery areas. The manager stated they did this because the other route was through a visitor waiting room. (Unrelated traffic should not travel through the surgical suite. AORN, 2015)

Housekeeping staff transported a housekeeping cart between the surgery department and areas outside of the surgery suite (pre-op and recovery). The housekeeping staff used this cart to clean unrestricted areas outside the surgery department and then used the same cart to clean restricted areas within the surgery suite. The surgery suite housekeeping room and equipment should not be shared with areas outside the suite. (Cleaning activities in the surgery suite should move from cleanest areas to the dirtiest areas. AORN, 2015 and ANSI/AAMI ST79, 2012)

2. A staff toilet was located in the restricted corridor across from the operating rooms. Toilet facilities should be located in staff changing rooms and/or break areas. The staff could not verify this toilet room maintained negative airflow relative to the restricted corridor.

3. Shipping containers were delivered to the surgery department and placed inside the surgery semi-restricted corridor on the floor immediately outside of an endoscopy procedure room. The surgery manager stated the staff would unpack the shipping containers and place the sterile surgical supplies on an open rack next to the shipping containers. The hospital had not designated an appropriate break-out area for de-casing and transporting supplies to the surgery department. (To eliminate the risk of introducing contaminants that may be present on external shipping cartons, these cartons should not be permitted in the clean/sterile areas. ANSI/AAMI ST79, 2012)

This corridor where sterile supplies were stored was unrestricted to non surgery-related traffic. Therefore, the hospital could not guarantee the integrity of the surgical items stored in this corridor. (Supplies and equipment should be protected from tampering and theft. AORN, 2015)

4. The surgery department did not have identified sterile supply storage rooms that were designed and constructed to maintain proper ventilation, temperature and humidity controls. Sterile supplies were stored on open wire carts and on shelves in various corridors within the department, as well as in equipment rooms and other areas that were not designed and dedicated to this purpose. (Closed or covered cabinets are preferable for high traffic areas. Open or wire shelving is suitable for confined storage areas provided that proper attention is given to traffic control, area ventilation and housekeeping. ANSI/AAMI ST79, 2012)

Large amounts of sterile supplies were stored in the sterile processing room where the pass-through instrument washers and steam sterilizers were located. This room did not maintain proper temperature and humidity for sterile supply storage. (Sterile storage should be located in a separate, enclosed, limited-access area, the only function of which is to store sterile and clean supplies. ANSI/AAMI ST79, 2012)

5. The hospital did not provide adequate housekeeping equipment and supply storage facilities. The surgery department had one very small housekeeping closet. The closet was not large enough to store all the supplies and equipment necessary to clean the department. To compensate for this, the staff placed mops and containers of water and cleansers in various locations in the corridors. Housekeeping carts were also stored in the surgery corridors.

Because the surgery department housekeeping closet did not have storage facilities, additional housekeeping supplies were stored on racks in the surgery corridors. Some housekeeping supplies were stored on open racks in a contaminated soiled workroom where trash, soiled linens and biohazardous materials were held. (Clean and dirty processes and activities should be separated. Clean supplies should not be stored where there is the potential for contamination. AORN, 2015 and ANSI/AAMI ST79, 2012)

6. The hospital was asked to provided monitoring records for temperature and humidity for various areas within the surgery department. The director of facilities stated that temperatures were not recorded in all the required areas in the surgery department.

The hospital did not monitor temperature controls in all required areas of the surgery department to include the operating rooms, endoscopy rooms, sterile processing, instrument decontamination, recovery, anesthesia gas storage, and the endoscopy instrument processing room. (Bacteria thrive at high temperatures. The HVAC system is intended to reduce the amount of environmental contaminants. AORN, 2015. Work areas should be comfortable for properly attired personnel. ANSI/AAMI ST79, 2012)

The hospital did not monitor humidity levels in the surgical instrument decontamination room, the endoscopy instrument processing room and in all areas where sterile supplies were stored.

Humidity records for the endoscopy procedures rooms for July and August 2015 documented humidity above 60%, and readings as high as 79% (acceptable range 30-60%). The records provided did not have documentation of actions taken for these high readings.

Humidity records for the sterile processing room documented that humidity levels were below 30% on 16 days in February 2015. Two days in February 2015 were not recorded. There was no documentation of actions taken to correct the low humidity in February 2015.

(Relative humidity higher than those recommended can promote microbial growth and thus increase bioburden. Relative humidity lower than 30% will permit absorbent materials to become excessively dry, which can adversely affect certain sterilization parameters, such as steam penetration and the performance of some biological and chemical indicator products. ANSI/AAMI ST79, 2012)

7. The hospital did not monitor ventilation and air exchanges in the sterilizer equipment room, the instrument decontamination rooms, the sterile processing room, where sterile supplies were stored, in anesthesia gas storage, in endoscopy and bronchoscopy, in the sterilizer equipment room, and in the soiled workroom and in the janitor's closet. (The ventilation system should be designed so that airflow patterns will not allow air contaminants to enter clean areas. Air flow should be from areas of positive pressure to areas of negative pressure. Air from rooms or areas under negative pressure should be exhausted to the outside via a non-recirculating system. Each functional area has its own requirements for air flow, number of air exchanges and exhaust. ANSI/AAMI ST79, 2012)

8. The hospital performed high-level disinfection in a room too small and inadequately designed for this purpose. The room was designed for manual processing but the hospital installed two automated high-level disinfection machines on the working counter space between two sinks. This configuration did not allow for adequate separation between the dirty and clean processes. (Separating "clean" and "dirty" areas limits environmental contamination and, therefore, the potential for bioburden on devices to be sterilized or disinfected. Adherence to functional design recommendations helps contain potential contaminants within a particular portion of the decontamination area and thus helps prevent cross-contamination or recontamination. ANSI/AAMI ST79, 2012)

The single instrument processing sinks in this room were not large enough, or designed or equipped to safely and correctly process the endoscopes. There was insufficient counter space to accommodate the endoscope decontamination and disinfection processes. (Sinks should be constructed with three sections - for soaking, washing, and rinsing- and they should have water ports to facilitate the flushing of instruments with lumens. Sinks should be large enough to contain large instruments. Sinks should be deep enough to allow items to be cleaned beneath the surface of the water. Forced air should be provided at the sink, as well as faucets or manifold systems for flushing lumened devices. Sinks should have attached solid counters or adjacent work surfaces on which to place soiled and clean instruments separately. ANSI/AAMI ST79, 2012 and Olympus Endoscope Reprocessing Manual)

Because the majority of the room's counter space was taken up with the automated processors, the room had no space for drying endoscopes prior to introduction into the automated processors. (The flexible endoscope should be dried using low-pressure forced air through the internal channels and the exterior surfaces wiped with a soft cloth before placing the endoscope in an automatic endoscope processor. Moisture remaining on the surface and in the flexible endoscope's lumens may dilute the high-level disinfecting solution, potentially reducing its effectiveness. AORN, 2015)

9. The endoscopes were stored in unventilated cabinets. (Flexible endoscopes should be stored in a closed cabinet with venting that allows for circulation around the flexible endoscopes. AORN, 2015)

10. The hospital allowed high-level disinfection to be performed in sub-sterile rooms between operating rooms where clean items were assembled and stored and where immediate use steam sterilization was performed, rather than in appropriately designed and equipped decontamination and processing rooms. (Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled. This area should be physically separated and should contain the automated equipment. Physical separation minimizes cross-contamination. AORN, 2015)

11. The hospital had no documentation the facility maintenance staff submitted reports to the QAPI program. The hospital QAPI program had not identified deficient practices related to the physical environment in the surgery department.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. perform endoscope processing and endoscope storage in a manner to minimize the risk of infection;

b. evaluate and approve appropriate disinfectant agents to be used within the surgery department;

c. ensure housekeeping practices including terminal cleaning, were carried out effectively within the surgery department to maintain a safe patient environment;

d. enforce the use of surgical attire in the semi-restricted and restricted corridors of the surgery department and prohibit the inappropriate use of cover garments; and

e. the hospital failed to ensure the approved infection control program was applied effectively to the surgical services department and failed to include high-level disinfection and sterilization practices as a part of the program.

Findings:

1. The hospital did not ensure endoscopic instruments and accessories were disinfected according to the manufacturer's instructions. On 09/14/15, an observation was made in the endoscope decontamination room. One automated processor was running. The processor contained an endoscope and other endoscopic accessories that were being disinfected. A water bottle being disinfected in the machine was not completely submerged in the high-level disinfectant solution. The consultant stated the bottle did not need to be completely submerged because it did not need to be sterile. She said only the endoscope needed to be completely submerged. (Endoscopic accessories should be completely immersed in the disinfecting solution. AORN, 2015)

The hospital was asked to provide the manufacturer's instructions for endoscope processing. The hospital provided only the manufacturer's instructions for the Olympus endoscope and not the attachments and accessories. The Olympus instructions did not list the water bottle as a reusable part that is normally reprocessed with the endoscope.

The hospital did not provide the manufacturer's instructions for the automated processors to show what other accessories could be processed in the machine. (Endoscopic accessories have been found to be a source of contamination. All manufacturer's written instructions for flexible endoscopes and all their accessories should be followed regarding cleaning processes and compatibility with automatic endoscope processors. All endoscope accessories cannot be processed successfully in all automated endoscopic processors. AORN, 2015)

2. The hospital did not verify the effectiveness of the high level disinfectant solution used to process endoscopy equipment. The hospital was asked to provide information regarding the high-level disinfectant agent used in the automated processors. The hospital provided a policy titled, "High Level Disinfection." The policy documented the automatic endoscopic reprocessor manufacturer's recommendations should be strictly followed. The manufacturer's information was not provided to the surveyor.

The hospital's policy required the high level disinfectant solution to be tested for efficacy. The hospital had no documentation this testing was performed for the solution used in the automatic processors.

3. The hospital had no process to verify the efficacy of endoscope processing. (Policies and procedures should establish authority, responsibility, and accountability for flexible endoscope care, cleaning and processing; to include the frequency and method of evaluating mechanical washers. Testing automatic endoscope processors on a regular basis verifies that the equipment is functioning properly or identifies an opportunity for correction. AORN, 2015)

4. The hospital did not process endoscopes in a room designed and equipped to minimize cross-contamination (See Tag A-0700) and did not store endoscopes in a manner to reduce the growth of microbes. Endoscopes were stored in an unventilated cabinet and some endoscopes in the cabinet were stored with plastic accordion tubing covering them. These practices interfered with the drying conditions needed to inhibit microorganisms.

5. The hospital did not ensure the surgery staff responsible for endoscope processing were trained and competent to perform these duties. On 09/15/15, the hospital was asked to provide documentation of staff training and competence. The hospital provided documentation for three staff persons who were identified for endoscope processing. One of the three staff had documentation of evaluation on 09/10/15 but the form was not signed by the evaluator.

Another file documented evaluation on 09/15/15, but this form was not signed by the evaluator. The third file had no documentation the staff was trained and verified for endoscope processing.

6. The hospital infection control committee had not evaluated and approved the disinfectant agents used within the surgery department prior to the survey. After this information was requested by the surveyor on the afternoon of 09/14/15, the hospital held an evening meeting to approve the chemicals that were observed on the housekeeping carts during a tour in the surgery department. The next day, on 09/15/15, the hospital provided documentation of the official approval by the infection control committee. The approved disinfectant list documented the following:

"HDQL 10 Neutral - A highly concentrated germicidal cleaner based on a blend of quaternaries." The product information for this product indicated it was not effective against clostridium difficile. The hospital provided this chemical in a spray bottle. The product information warned that the mist or spray should not be inhaled. The hospital had no documentation to instruct staff on where and how this product should be applied.

"Spar Cling - Acid bathroom cleaner for heavy buildup." The hospital provided this chemical in a spray bottle. The product information warned that the mist or spray should not be inhaled. The hospital had no documentation to instruct staff on where and how this product should be applied.

"Fast and Easy - Hard surface and glass cleaner." This product was not EPA registered. The product information did not indicate it was developed for use in health care settings. The hospital provided this chemical in a spray bottle. The product information warned that the mist or spray should not be inhaled. The hospital had no documentation to instruct staff on where and how this product should be applied.

"hdqC 2 - neutral disinfectant for high gloss floors." The hospital had no documentation to instruct staff on where and how this product should be applied. The product information warned that the mist or spray should not be inhaled. This product had no documentation it was effective against clostridium difficile.

"Comet - disinfectant with chlorinol." This product was not EPA registered. The product information did not indicate it was developed for use in health care settings. There was no documentation it was effective against any microorganisms. The product information indicated it was applied as a powder or a spray. The hospital had no documentation to instruct staff on where and how this product should be applied.

The only disinfectant product on the list that was effective against clostridium difficile was PDI Sani Cloth Bleach Germicidal Disposable Wipes. This product was to be applied by wiping a surface. The staff stated it was only used when the staff knew the patient was infected with clostridium difficile.

The approved list did not include the high-level disinfectant agents used within the surgery department. The hospital did not have a policy that required hospital disinfectants to be EPA registered. (The CDC recommends that EPA-registered disinfectants be used in health care settings. AORN, 2015)

The files for the housekeeping and surgery staff had no documentation of education and training for the use of these products to include the application of the disinfectants and the exposure time needed to ensure effectiveness.

7. The hospital did not ensure disinfectant agents were applied to the surgical environment according to recommended standards of practice for proper infection control and in a manner to protect patient and worker safety. The housekeeping cart held spray bottles and aerosol cans that were used for environmental cleaning within the surgery department. (Spray and misting methods eg, spray bottles, should not be used to apply cleaning chemicals in the perioperative practice setting. Chemicals that are sprayed produce aerosols. Chemical aerosols may cause respiratory symptoms, acute or chronic, in personnel and patients. AORN, 2015)

8. Housekeeping equipment was not dedicated solely to the surgery department. The staff was observed using the same cart inside and outside of the surgery department. Housekeeping rooms and equipment should be dedicated to the surgery department. (OAC 310:667)

9. The surgery department housekeeping carts were not equipped with the correct implements to provide appropriate and effective environmental cleaning within the surgery department. A housekeeping cart was observed in a corridor outside the endoscopy procedure rooms. A housekeeping staff person was cleaning in that area. The housekeeping cart contained a bristle broom the staff stated was used to sweep the floors in the surgery department. (Dry methods of environmental cleaning ie, dusting and sweeping, should not be used in the semi-restricted and restricted areas. AORN, 2015)

The housekeeping cart held a used, wet disposable string mop head and a mop bucket with gray water in it. This cart was later observed in use in other areas within the surgery department. The cart had the same dirty items on it. (Reusable cleaning materials should be changed after each use. Disposable cleaning materials should be discarded after each use. Using a dirty mop or cloth on a clean area or to clean for multiple patients may increase the possibility of cross-contamination. Used cleaning materials eg, mop heads, cloths, should not be returned to the cleaning solution container. Used cleaning materials are considered contaminated and returning them to the cleaning solution container contaminates the solution. AORN, 2015)

The OR manager was asked who supervised and evaluated the work performed by the housekeeper in the endoscopy area. She stated the housekeeping supervisor was responsible for that person and that she, as the OR manager, did not evaluate this person's work.

10. The hospital did not ensure operating rooms and procedure rooms were correctly terminally cleaned at the end of the day. During the tour of the surgery department, the staff stated operating room #1 had no other cases scheduled for that day and the room had been terminally cleaned and was ready for use. The hospital staff verified the room could be used for emergency surgery at any time.

At the time of the observation however, iodine stains remained on the floor around the operating room table. The OR manager stated the stains were always on the floor and were difficult to remove.

The operating table itself did not appear to be terminally cleaned. There were no clean linens on the table and the safety strap was hanging off of the table and touching the floor. (Floors in the perioperative setting should be considered contaminated at all times. Non-critical items such as safety straps, should be disinfected after contact with the floor before patient use. AORN, 2015)

Trash remained in a receptacle in the room. Some receptacles used to collect surgical sponges had no plastic liners. Equipment was not set up in the proper locations that would normally indicate the room was ready to receive a patient.

Despite the fact the room had the appearance it was only partially cleaned, the anesthesia machine had been set up with a new circuit and had other new components that indicated it was prepared for the next patient. The anesthesia machine itself did not appear to have been terminally cleaned because of the amount of clutter and supplies and other items that were found stored on this machine. (Clean and sterile items should not be brought into or opened in an operating room that has not been disinfected and prepared for use. AORN, 2015)

When these observations were pointed out to the OR manager, she stated she was no longer sure the room had been terminally cleaned. (The responsibility for verifying a clean surgical environment before the start of an operative procedures rests with the perioperative nurse. AORN, 2015)

The hospital's operating room terminal cleaning policy did not reflect national standards of practice. The policy documented, "Equipment and furniture should be inspected and cleaned as needed..." (Terminal cleaning of operating rooms and procedure rooms should include cleaning and disinfecting of all exposed surfaces, including wheels and casters, of all items. AORN, 2015)

None of the hospital's surgical environmental cleaning policies had documentation they were based on national standards of practice.

The OR manager was asked who verified the housekeeping and surgery staff were trained and verified as competent for environmental cleaning tasks in the surgery department. She stated she and the housekeeping supervisor did that.

11. The hospital did not ensure the housekeeping and surgery staff were trained and verified to be competent to perform environmental cleaning in the surgery department. The hospital was asked to provide a list of policies and procedures for the housekeeping department. The list the hospital provided had no policies related to housekeeping procedures specific to the surgery department.

On 09/15/15, the hospital provided a list of three housekeeping staff who provided service to the surgery department. The personnel files for two housekeepers had no documentation of training for surgery department environmental cleaning. The file for the person identified as the surgery housekeeper documented the person had training during orientation in 2008. There was no documentation of any other training after this time.

All three files documented that either the OR manager or the housekeeping manager had verified competency for surgery department environmental cleaning tasks the day before, on 09/14/15.

On 09/15/15, the hospital was asked to provide the training and education files for three scrub techs who performed environmental cleaning in the surgery department. All three had competency evaluations performed and dated on 09/15/15.

12. The hospital did not enforce its policy to require staff to wear surgical attire or other cover garments while in the semi-restricted and restricted areas of the surgery department. On 09/14/15, multiple hospital staff in street clothes were observed in the semi-restricted corridors.

Also on this date, a pharmacy staff member was observed wearing a disposable cover garment (bunny suit) while working in the anesthesia workroom. The workroom is considered a restricted room within the restricted surgery corridor. This staff person left the restricted workroom, exited the surgery department still wearing the cover garment, hair cover and shoe covers, and then traveled through the public corridors. She later returned back to the restricted workroom inside the surgery department still wearing the same cover garment.

13. The hospital's infection control and prevention plan was not applied effectively to the surgical services department.

The plan's scope did not include the infection control complexities related to include special environmental controls, cleaning and maintenance of the surgery department.

The hospital's infection control and prevention plan did not include the standards, resources and recommendations from professional practice organizations such as AORN, AAMI and others.

The hospital's plan for surveillance did not include all the high risk infection control processes within the surgery department such as high-level disinfection and sterile processing.

Based on observation, document review and staff interview, the hospital failed to provide surgical services in a manner consistent with accepted standards of practice.

Findings:

1. Observations were made of the surgical environment and the traffic patterns within the department. The hospital failed to design, build and maintain the surgery department to provide safe conditions for patients. See tag A-0700 Physical Environment.

2. Aseptic and sterile practices were not followed. See tags A-0700 and A-0747.

3. Appropriate routine and terminal cleaning was not provided. See tag A-0747.

4. Staff were not required to wear surgical attire or appropriate cover garments in the semi-restricted areas of the surgery department. See tags A-0700 and A-0747.

5. Sterilized materials were not stored appropriately. See tags A-0700 and A-0747.

6. Temperatures and humidity were not monitored and maintained within acceptable parameters. See tag A-0700.

7. During the course of the survey, the hospital provided various policies and procedures related to the provision of surgical services. The policies had no documentation they were based on nationally recognized standards of practice.