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Based on observation, policy review, and staff interview the infection control (IC) officer failed to develop an active infection control system to identify, report, investigate, monitor and implement infection control practices for two of two observed endoscopy procedure rooms, one of one observed cleaning of a discharged patient room, one of one observed cleaning of an operating room between cases, one of one observed Cardiac Catheter Laboratory area, one of one observed area in the central sterile processing decontamination area, one of one observed post anesthesia care unit (PACU), and one of one observed breech in handling the patient's linen. The failure to follow the hospitals policies and procedures manufactures guidelines for control of infections placed patients at risk for healthcare acquired infections.

The cumulative effective of failure to develop and implement an effective IC program, failure to conduct hospital wide surveillance for both patients and personnel working in the hospital placed all patients at risk for healthcare acquired infections.

Findings include:

- The hospital's designated infection control officer failed to ensure the policies and procedures followed manufacture guidelines, monitored all areas of the hospital for compliance related to basic infection control practices to maintain safe, sanitary practices for patients in the Outpatient Endoscopy Department, Patient Care Units, Surgical Department, Cardiac Catheter Laboratory, Sterile Processing Department, and PACU (Post Anesthesia Care Unit). See further evidence at 42 CFR 482.42,(a)(1), A-0749.

The Hospital reported a census of 101 patients with 34 medical records reviewed. Based on observation, policy review, and staff interview the infection control officer failed to develop an active infection control system to identify, report, investigate, monitor and implement infection control practices for two of two observed endoscope procedure rooms, one of one observed cleaning of a discharged patient room, one of one observed cleaning of an operating room between cases, one of one observed Cardiac Catheter Laboratory area, one of one observed area in the central sterile processing decontamination area, one of one observed post anesthesia care unit (PACU), and one of one observed breech in handling the patient's linen.

Findings include:

- The Association of Operating Room Nurses (AORN) recommendation chapter XI for "Endoscope Cleaning and Processing" reviewed on 8/22/12 at 12:10pm directed, "Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed."

- The AORN recommendation chapter XII for "Personal Protective Equipment (PPE) for Endoscope Reprocessing" reviewed on 8/22/12 at 12:10pm directed, "Personnel handling contaminated endoscopic equipment must wear appropriate PPE."

- The Hospital's Infection Prevention policy titled, "Standard Precautions" reviewed on 8/22/12 at 2:30pm directed, "Appropriate PPE will be worn when handling patient-care equipment and instruments/devices that are visibly soiled or may have been in contact with blood or body fluids."

- Observation in the endoscopy area located in the emergency department on 8/22/12 at 9:50am revealed two rooms were used to perform endoscopy procedures (Esophagogastroduodenoscopy ' s (EGD) (looking into the esophagus and stomach with a scope), Colonoscopy (looking into the colon with a scope), Bronchoscopy (looking into the bronchial tubes with a scope), and placement of peg tubes (a tube placed in the small bowel through the abdomen used to feed patients liquid food.). The two rooms contained a patient cart, equipment used to perform an endoscopy procedure, cabinets, a large sink, and counter space. Staff C explained, after a scope procedure the staff use one of the two patient rooms to clean the scope in the sink in the room, take the scope across the hall to the "closet" and place the scope in the "Medivator" (a machine used to disinfect the scope).

Staff C and D interviewed on 8/22/12 at 9:00am acknowledged the staff clean the scopes in the same rooms they perform the scope procedures. The patients are not in the room when they clean the scopes. Staff C and D confirmed they use a gown and gloves when cleaning the scopes, but do not use a mask or face protection when cleaning the scopes.

Staff E interviewed on 8/22/12 at 9:10am acknowledged the staff clean the scopes in the same rooms they perform endoscopy procedures. The Hospital does not have a separate area to clean the scopes.

- Observation in the PACU of the six bays (an area where they care for the patients immediately after surgery) on 8/21/12 at 10:35am revealed two open Yankauer suction tips (a rigid hollow tube made of disposable plastic with a curve at the distal end used to remove thick secretions during oral pharyngeal suctioning) at each of the six bays for a total of twelve open Yankauer suction tips. The Yankauer package label states " sterile unless opened or damaged " .

Staff F interviewed on 8/21/12 at 10:35am acknowledged the open Yankauer suction tips in the PACU.

- The manufacturer's guidelines for "Virex II 256" reviewed on 8/22/12 at 9:00am directed, "To disinfect, all surfaces must remain wet for 10 minutes."

- The Hospital's policy titled "Surgery, Environmental Cleaning" reviewed on 8/22/12 at 11:30am directed, "...Hospital approved disinfectant must remain on cleaned surfaces for the appropriate contact time."

- Observation in surgery room five on 8/21/12 at 11:45am revealed staff cleaning the room between cases. The OR staff and one housekeeper, using a solution of "Virex II 256" wiped the OR table, lights, Mayo stands, back table, IV (intravenous) poles, kick buckets, and equipment in the room. The surfaces remained wet for a contact time of two to five minutes. The cleaned surfaces did not remain wet for the required ten minutes or disinfection.

Staff F interviewed on 8/21/12 at 11:45am acknowledged the surfaces failed to remain wet for the required ten minutes as directed by the manufacturer.

- Observation in the Cardiac Cath Lab on 8/21/12 at 3:00pm revealed staff preparing to clean one of the Cardiac Cath rooms after dismissal of the patient. Staff G explained they clean the room using a solution of "Virex II 256". Staff G explained the surfaces have to dry for ten minutes before they can prepare them for the next patient. Staff G and Staff H confirmed they lacked knowledge that the surfaces must remain wet for ten minutes for disinfection.

Staff I interviewed on 8/21/12 at 3:00pm acknowledged they lacked knowledge of the manufacturer's directions that the surfaces must remain wet for ten minutes to disinfect.

- Observation on 8/22/12 at 10:15am of a terminal cleaning of a discharged patient room in the Intensive Care Unit revealed staff J, using "Virex II 256" cleaning solution wet wiped the bed frame, bedside stand, over bed table and fixtures in the room. The surfaces remained wet for a contact time of four to six minutes. The cleaned surfaces did not remain wet for the required ten minutes for disinfection.

Staff J interviewed on 8/22/12 at 11:35am acknowledged the surfaces cleaned with the "Virex II 256" solution must remain wet for ten minutes. Staff J confirmed they were unaware that the surfaces did not remain wet for the required ten minutes per the manufacturer's guidelines.

- The manufacturer's guidelines for "Cidex OPA" reviewed on 8/22/12 at 8:30am directed, "Record the date the solution was poured out of the original container into a secondary container in a log book... The solution in the secondary container can be used for a period up to 14 days. During reuse, it is recommended that the "Cidex OPA" Solution be tested with a "Cidex OPA Test Strips prior to each usage."

- The manufacturer's guidelines for reprocessing instructions for "...endoscopes used with da Vinci system" directed, "Disinfection for Endoscopes...Endoscopes may be disinfected after cleaning to ensure proper infection control and handling by hospital personnel. The following methods are compatible with endoscope disinfection. ...Cidex OPA" ...Follow the manufacturer's instructions for proper use of the disinfecting agents."

- The Hospital's policy titled "Sterile Processing Decontamination" reviewed on 8/22/12 at 11:30am directed, "If a device is unable to be mechanically cleaned, after manually cleaning it should be disinfected accordingly by both the manufacturer's instructions of the device and the chemical disinfectant.

_ Observation in Central Sterile Processing decontamination area on 8/21/12 at 11:20am revealed a plastic unlabeled container with a green liquid in the container on a metal table. Staff K explained the container held the "Cidex OPA" solution used to disinfect the daVinci endoscope according to the manufacturer before they wrap the endoscope and sterilize it. Review of the "Cidex Record Sheet " revealed staff failed to change the Cidex OPA solution every 14 days. Review of the record sheet revealed staff changed the solution on the following dates:
1) 3/27/12 and 4/13/12 or three days past the manufactures 14 day recommendation.
2) 4/13/12 and 5/1/12 or four days past the manufactures 14 day recommendation.
3) 5/1/12 and 5/22/12or seven days past the manufactures 14 day
recommendation.
4) 6/6/12 and 6/26/12 or six days past the manufactures 14 day recommendation.
5) 6/26/12 and 7/18/12 or eight days past the manufactures 14 day
recommendation.

Review on 8/21/12 at 11:00am of the "Cidex Record Sheet" revealed staff tested the Cidex solution eight times between 3/27/12 to 8/16/12 on the following days; 4/2/12, 4/4/12, 4/13/12, 4/17/12, 5/1/12, 5/22/12, 8/2/12 and 8/16/12.

Staff F interviewed on 8/21/12 at 11:20am explained the Hospital performs procedures with the da Vinci endoscopes at least one to two times per week. Staff F acknowledged the Hospital failed to change the "Cidex OPA" solution and test the "Cidex OPA" solutions as recommended by the manufacturer.

- The Hospital Policy titled, " Standard Precautions " , reviewed on 8/23/12 at 10:10am, revealed under tab " H. Textiles and Laundry, 1.) All laundry is potentially contaminated, and should be handled with minimum agitation to avoid contamination of air, surfaces, and person, and 3.) instructed staff to never drag or set linen bags on the floor. "

- Observation made on the Medical/surgical unit on 8/22/12 at 11:15am revealed housekeeping staff B performing a terminal clean in a discharged patient ' s room. Staff B gathered the soiled linen from the room and placed it in two separate laundry bags, then walked down the hallway dragging the two bags of soiled linen on the floor.

Staff A, housekeeping supervisor, interviewed on 8/22/12 at 11:16am, acknowledged staff B failed to follow hospital policy to keep linen bags off the floor to reduce the potential for cross contamination.