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Based on staff interview, review of policies and procedures, observation of decontamination/ sterilization processes, and infection control documentation, the hospital failed to develop, implement, and maintain a system and infection control program to prevent the potential transmission of diseases from one patient to another. See the regulation at C0278.

The cumulative effect of these systemic problems resulted in the hospital's inability to provide an effective infection control program. This failure placed patients who had a surgical or certain radiological procedures at risk to their health and safety for healthcare acquired infections and was identified on 7/19/13. Hospital staff implemented procedures which abated the risk on 7/20/13.

Patients were identified to be at risk for their health and safety (also known as immediate jeopardy - IJ) when the hospital failed to identify and implement procedures to ensure surgical instruments and equipment used during surgical and radiological procedures were disinfected or sterilized as directed by manufacturer instructions or hospital procedures. The hospital abated the Immediate Jeopardy on 7/20/13 by:

1) replacing the undated Cidex (a solution used for high level disinfection/sterilization of multiple types of equipment) test strips with strips dated with the correct expiration date that ensure effective concentration;
2) removing all gas sterilized equipment from the Central Sterile (CS) area to prevent patient use until this equipment could be sterilized per manufacturer's directions;
3) removing equipment previously sterilized in Cidex in the CS department for Radiology from service until it could be sterilized per manufacturer's directions;
4) placing all personal protective equipment in the Operating Room (OR) soiled utility room which contained the flushing rim sink;
5) removing the Olympus 180AL colonoscopes from service until staff adequately trained on the cleaning and use of the colonoscope;
6) placing measurement equipment for both the enzymatic solution and water by the CS sink;
7) writing new policies based on manufacturer's directions and professional practice guides for:

- " BIOLOGICAL MONITORING" for CS which directed staff where to place the biological indicator (a device used to detect the presence of bacteria),
- use of "CIDEX OPA" which directed staff on replacement time frames for the Cidex OPA test strips,
- "STERILIZATION PROCESS (STEAM) which provided written direction of placement of the biological indicator,
- "MEDLINE ENZYMATIC DETERGENT AND PRESOAK" (an enzyme concentrate mixed with water to a directed concentration to clean and begin the breakdown of organic materials) which directed staff on the proper mixing ratio of product and water and how to use,
- "STERILIZATION PROCESS (CHEMICAL) which addressed their gas sterilizers and the proper placement of the biological indicator,
- "DECONTAMINATION-RECEIVING AND HANDLING" which instructed staff on general information for following manufacturer's recommendations and following infection control guidelines, and
- "PROPER PACKAGING OF ARTICLES FOR STERILIZATION " which instructed staff on thickness of wrapping trays in CS as well as folding techniques and weight per package.

8) completing training to all OR/CS staff on the following:

- Olympus Steris 1E (system for the liquid chemical sterilization of equipment unable to be sterilized by other methods)
- disposal of regulated medical waste
- Cidex OPA
- decontamination-receiving and handling
- biological monitoring

9) and having the OR/CS staff complete demonstrate their understanding of training after each inservice listed above.

The Hospital reported a census of 20 patients.

Based on observations, review of documents and manufacturer's guidelines, and staff interview, the Infection Control Officer failed to:

1) develop and maintain a system to ensure hospital policies remained current with manufacturer's guidelines for use,
2) ensure hospital staff followed established guidelines for cleaning and sanitizing of scopes and other equipment processed in the Central Sterile (CS) department,
3) mix an enzymatic soak solution (used to remove debris from an instrument or surgical equipment) - both for the Operating Room (OR) and the CS department - following manufacturer guidelines,
4) ensure Cidex (a solution used for high level disinfection/sterilization of multiple types of equipment) test strips were within the manufacturer ' s 90 day end-use-date that verified the proper concentration of the solution,
5) failed to ensure all hospital personnel wore protective equipment required when disposing of intestinal gastric juices, and
6) failed to place the Attest Biological indicator (a device used to detect the presence of bacteria) in the proper position during gas sterilization.

Hospital staff identified 278 patients received an endoscopic procedure between 1/3/13 and 7/3/13.

The breakdown in infection control systems placed patients who had a surgical or certain radiological procedures at risk to their health and safety for healthcare acquired infections and was identified on 7/19/13. Hospital staff implemented procedures which abated the risk on 7/20/13.

Findings include:

- A colonoscope is an instrument used by a physician when examining a person's lower gastointestinal (GI) tract--the colon. The Olympus 180 AL colonoscope is comprised of a long tube with openings (ports) on the end: one for a camera for the physician to see inside the colon, one for instruments to pass through for taking samples of tissue, one to suction, one to emit water to clean the camera lens, and a water auxiliary port for cleaning debris from the field.

The Hospital purchased three new Olympus 180AL colonoscopes and placed the first one into service on 1/4/13 and put the other two in service on 3/5/13. Review of the procedure for reprocessing of the Olympus endoscopes, sizes 140,160 and 180, contained directions for both manual and automated precleaning and cleaning of the scopes. Directions included the procedures to preclean and clean the water auxiliary channel.

Licensed OR nurse H interviewed on 7/19/13 at 8:15pm stated they remember a 180AL scope that had half of the camera lens covered when they hooked it up to check the picture prior to using the scope on a patient. Staff H stated the staff did not use that scope and obtained another clean scope to use. Staff H stated the scope end contained a "flake" of brown substance, more like a piece of the Wyp-All (cotton towels OR staff use to handle the scopes with during procedures and to initially wipe off the colonoscope after the end of the procedure). Staff H stated this happened on 6/20/13 or 6/21/13.

OR/CS Administrative Staff A purchased a new light source, new magnifying glass and new cleaning brush for the Olympus 180AL Colonoscope in June 2013.

Licensed OR nurse G interviewed on 7/19/13 at 8:02pm verified seeing debris on the end of a 180AL colonoscope which looked like water deposit, but when plugged in to look through the camera realized it was brown in color. Nurse G did not use this scope and returned it to CS for recleaning and could not remember the date when this occurred.

Current Licensed OR/CS Nurse Supervisor F, interviewed on 7/18/13 at 6:20pm, verified they sent back a 180AL Colonoscope that was not clean and had a light color brown color on the camera. Nurse F stated lack of knowledge when this happened.

OR/CS Administrative Staff A performed circulating RN duties on 6/28/2013 which included pre-procedure checks on the 180AL scope. They found an Olympus 180AL colonoscope with debris or residue present. As a result, Hospital staff removed these three new scopes from service on 6/28/13 due to the continuing issue with debris/residue after reprocessing (cleaning and disinfecting). CAH staff were aggressive in reviewing documents and identifying patients potentially at risk for an infection acquired from any instrument which may not have been cleaned and disinfected as required. They determined that 269 patients may have had a colonoscopy or other endoscopic procedure from the time the new Olympus 180AL scopes had been placed into use until they were removed from use on 6/28/13.

However, when CS technician B returned to work after time off, they believed the other technicians were taught how to clean the scopes correctly and returned the three Olympus180AL scopes into service to again use them during patient procedures. This occurred on 7/1/13. When Hospital staff found out the scopes were back in use, on 7/3/13, the Licensed Administrative Nurse C removed the 180AL scopes from service, placed them in their cases, and secured them away from the Surgical Area. Hospital staff determined that 9 patients received a procedure using a scope which may have been disinfected from 7/1/13 through 7/3/13.

- Review of the Hospital policy titled "DECONTAMINATION-RECEIVING AND HANDLING" last revised on 6/2006 found it stated, "...The person assigned to this area will render all items returned to central Sterile free of disease-causing bacteria thereby making it safe for handling by hospital personnel and safe for patient contact..."

- During observation in the CS cleaning room, CAH staff first placed scopes in MEDLINE Enzymatic solution (an enzyme concentrate mixed with water to a directed concentration to clean and begin the breakdown of organic materials) for brush cleaning of all ports and gross decontamination. Then, Hospital staff placed scopes in either the Cidex OPA or the Olympus Steris 1E system for final cleaning/disinfecting/sterilization.

CAH staff placed the scopes in MEDLINE Enzymatic solution. The manufacturer's directions on the side of the gallon bottle with a pump apparatus directed staff to mix 1-2 ounces of the pre-soak with one gallon of warm water and soak 2-3 minutes (15-20 minutes for heavily soiled material). Observation found Staff member B mixing the enzymatic cleaning solution in Central Sterile, on 7/18/13 at 3:35pm. Staff B placed 3 squirts of the pump into the sink. The staff member then turned on the water and filled the sink to approximately 4.5 inches up the sides. CS staff member B, on 7/18/13 at 3:40pm, stated they utilized 2-3 squirts of the enzymatic solution for the 1/2 sink of water. When brought to their attention the directions on the bottle the CS staff obtained a measuring container for both the enzymatic cleaner and the water. The 3 squirts of the enzymatic cleaner measures less than 2 ounces, and the water previously utilized by the hospital for mixture was approximately 3 gallons. This enzymatic mixture was inadequate to disinfect equipment or scopes. CS staff B verified they utilized this mixture for both CS and the Operation Room (they provide a bowl of enzymatic to use in the Operating Room after the procedure and prior to equipment and instruments arriving in CS. Staff B verified the solution was too dilute in both OR and CS.

- The manufacturer ' s directions for use of Cidex OPA, reviewed on 7/19/13 at 8:00am, instructed staff that the solution may be reused for up to a maximum of 14 days and concentration of the product must be verified by the Cidex test strip prior to each use. The test strip determines the concentration is above the Minimum Effective Concentration (MEC) of 0.3%. The manufacturer ' s product information for the Cidex OPA test strips directs staff to, "Precautions: Do not use any remaining strips 90 days after opening the bottle...."

Observation of the Cidex OPA solution present in CS on 7/18/13 at 4:08 pm revealed a container labeled Cidex which contained a tape label documenting the solution expired on 7/24/13. Beside this container was a bottle of concentration test strips. This second bottle contained a line on the bottle for staff to document the expiration date of the test strips. Although the bottle had been opened, no date was written on the label. Staff B, interviewed on 7/18/13 at 4:08pm, verified CS staff failed to document the date when the MEC test strips expired.

CS staff member I, interviewed on 7/19/13 stated they were the staff member who placed the bottle of test strips by the Cidex mixture and stated they put the new bottle of strips there on 7/10/13 and had changed the Cidex mixture at that time. CS staff member I stated that she had not followed the hospital policy to date the Cidex test strips when she opened them.

The Hospital utilized the CS cleaning room for reprocessing instruments from the Radiology department. These included ureteroscopes and vaginal speculums. Hospital staff failed to identify that these instruments may be potentially contaminated due to improper disinfection/sterilization using the Cidex OPA undated test strips. Further review by the Hospital on 07/19/13 identified 5 other patients (#1, #2, #3, #4, #5) who were potentially affected when these instruments were used during a procedure between 07/10/13 and 07/18/13.

- Observation of a Colonoscope procedure on 7/19/13 at 3:30pm revealed after completion of the procedure and cleaning performed in the OR by Licensed Nurse H, this nurse covered the scope and other equipment and placed them on a metal cart for transport to CS. On the way to the CS department Licensed Nurse H stopped at the dirty utility room, took the suction container which contained approximately 500 cubic centimeters (cc) of gastric bile and feces (fluids suctioned from a patient during a procedure), and wearing only goggles and gloves, poured this liquid material into the water of a flushing rimmed sink. Observation revealed a full face mask on the wall directly beside this sink, but the room contained no gowns staff could use to cover themselves (to protect themselves from splashes of potentially contaminated material when performing this task). Licensed Nurse H, interviewed on 7/19/13 at 3:32pm and 3:35pm, verified the room lacked cover gowns and also stated staff were to wear mask, gloves, and gown prior to dumping material down this sink.

Review of the hospital policy titled-"REGULATED MEDICAL WASTE" found it stated, "3 All persons required to handle regulated medical wastes (any biological product such as blood, bodily fluids, tissues) or materials will be provided with appropriate orientation, equipment...it will be the responsibility of the employee to wear their Personal Protective Equipment (PPE) and dispose of regulated medical wastes appropriately...."

Infection Control Licensed Nurse K, interviewed on 7/10/13 at 5:05pm, verified staff were to wear full face shield, gloves, and gown when disposing of regulated medical waste.

- On 7/19/13 at 1:48pm, observation revealed CS staff member B placing the Attest Biological Indicator for gas sterilization in the back corner of the tray which was placed to the back of the sterilizer.

The Hospital policy titled "Biological Monitoring", last revised 1/2008, and reviewed 7/19/13 at 6:00pm failed to direct staff to place the biological indicator in the center of the load for ethylene oxide sterilization. Licensed Administrative Nurse C, interviewed on 7//19/13 at 6:10pm, verified the manufacturer ' s information directed staff to place the Biological Indicator in the center of the load and the hospital policy failed to direct staff in the proper place of the biological indicator.