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Based on observation, interview, and record review, the hospital failed to provide an environment to avoid sources and transmission of infections as evidenced by the hospital's failure to have effective infection prevention program in place to ensure:

1. A functional and sanitary environment for the provision of services in the cardiac catheterization laboratory (a specialized department of the hospital that performs tests and procedures on the heart). (Refer to A-749 item 1)

2. A functional and sanitary environment for the provision of sterilization of surgical instruments and that surgical instruments were sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position. (Refer to A-749 item 2)

3. A functional and sanitary environment for the provision of decontamination of surgical instruments in the central processing department. (Refer to A-749 item 3)

4. A functional and sanitary environment in the wound care clinic. (Refer to A-749 item 4)

Due to the hospital's failure to have an effective method to sterilize hinged instruments and provide a sanitary environment in the catheterization laboratory a situation of Immediate Jeopardy (IJ) was called on 8/13/13 at 4:58 PM. On 8/15/13 at 4:52 PM, with an acceptable plan of correction the IJ was abated.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, interview, and record review, the hospital failed to provide an environment to avoid sources and transmission of infection as evidenced by the hospital's failure to have an effective infection prevention program in place to ensure:

1. A sanitary environment in the cardiac catheterization laboratory (catheterization laboratory, is a specialized department of the facility that performs tests and procedures on the heart) where hinged instruments were sterilized in closed position, supplies/equipment were not in good repair, and improper use of sharp container (a container that is filled with used medical needles).

2. Surgical instruments were sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position in the hospital's Central Processing Department (CPD) (a department to clean and sterilize instruments, devices, and patient care items) when hinged instruments were sterilized in closed position.

3. The staff in the decontamination area of the Central Processing Department followed the manufacturer's recommendations and the hospital's policy and procedure to prevent spread of infectious germs.

4. A sanitary environment when clean and dirty patient care items as well as supplies were stored together in the wound care clinic.

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment which had placed its patients' at risk to infectious and communicable diseases.

Findings:

1. During an observation and concurrent interview in Catheterization Laboratory (Cath Lab 3), on 8/13/13, at 10:25 AM, with the Director of Cardiac Services (DCS), the Central Processing Department Manager (DM) 1 and Manager of Environmental Services (MES), the following was observed:

1.(A) There was a three-drawer fabric file cabinet inside the catheterization room. There were some brown stains noted on the front cover of the fabric cabinet. Inside the top drawer, it contained a portable intravenous pole (a pole without stand that is used to attach to a bed or gurney) and 16 sealed peel packages (a sealable envelope with paper on one side and plastic on the other used during the sterilization process). The intravenous pole, lying flat on top of these sealed peel packages, had dried brown spots on it. During further inspection of these sealed peel packages, each one contained a hinged clamp, in a closed position, and a chemical indicator. The chemical indicator indicated each clamp had undergone a sterilization process and then sealed in a peel package. It was noted three of these sealed packages had brown round spots on the paper side. When a sealed peel package has stains on it, the sterility of the clamp is compromised and should not be used. Clamps in closed positions for sterilization can prohibit exposure of all surfaces to the sterilization process. The DCS stated, "I didn't know we kept supplies in that file cabinet (the fabric file cabinet), and it shouldn't even be in here (Cath Lab 3)." For the peel packages with stains, the DCS stated, "All compromised packages, such as those in water-stained (round brown spots) packages, should be re-processed."

At this time, there were three trays of sterilized instruments, wrapped in blue fabric, noted in a cupboard. On request, these trays were opened by DM 1. Each tray contained 16 to 20 instruments, some of them were hinged instruments still in closed positions. All instruments were piled randomly on top of each other. There was no stringer (a metal device used to help to organize and secure instruments in any size container or instrument pan) used to organize these instruments to allow them to be properly sterilized.

During a further observation of the Central Processing Department with DM 1, on 8/13/13, at 2 PM, she stated, "We literally have hundreds, no maybe thousands of hinged instruments, sterilized in the closed position. Will we have to redo all of them?"

The 2013 Perioperative Standards and Recommended Practices published by Association of Operating Room Nurses (AORN, a national recognized organization that establishes the standards of excellence in the delivery of perioperative nursing care) was reviewed. It recommended: "All surfaces in a procedure room should be cleaned and disinfected," and indicated fabric surfaces harbor contaminated particles including fungus and mold. In regards to organizing surgical instruments, the AORN standards of practice indicated moisture could compromise the integrity of barrier material (such as the paper of a peel packages) and the sterility of the contents. The recommendation read, "Cleaned surgical instruments should be organized for packaging in a single layer to allow a sterilizing agent to contact all exposed surfaces and instruments with hinges should be opened..."

1.(B) The floor and two mats on each side of the cardiac catheterization procedure table in Cath Lab 3 were stained with red and brown spots. The corners of these mats had multiple torn edges. The MES stated, "It looked like they forgot to clean the floors and staff usually clean right after the case is done." He further stated the mats needed to be replaced. The DCS explained there was a case that ended at 11 PM last night, 8/12/13, and the next case was scheduled to proceed in the next hour. The floor of Cath Room 3 had not been cleaned from the previous case that ended at 11 PM the previous night until now, more than 12 hours and was ready to start another procedure.

1.(C) The cabinet in Cath Lab 3 contained four outdated supplies: two percutaneous lead introducers (used to thread catheters into the heart), outdated on 7/13, and two packages of surgical equipment, outdated on 6/13.

1.(D) In Cath Lab 3, a 3-gallon sharps container was observed. This sharps container, without a lid, had three syringes with needles attached and fluid inside, a needle, a scalpel without a cover, and three instruments (metal surgical hammer, large metal clamp, and a metal instrument stringer). During a concurrent interview with the DCS, he stated he had not expected to see re-usable instruments such as the surgical hammer, metal clamp, and the stringer in the container and that those instruments were expensive, re-usable, and should have been sent back for re-processing. The DCS further stated it was a dangerous practice to mix non-disposable items with uncapped used syringes in a container meant for disposable items only.

Association for Professionals in Infection Control and Epidemiology (APIC, a professional organization for healthcare practitioners dedicated to the principles of infection control) position paper titled: "Safe Injection, Infusion, and Medication Vial Practices in Health Care," published in 2010, recommended used needles and syringes should be disposed of at the point of use in an approved sharps container. Sharp waste should be disposed of promptly after use into a sharps container that is a rigid, puncture resistant container that when sealed is leak resistant and cannot be opened without great difficulty. Failure to properly dispose of used needles and syringes in an approved manner placed hospital personnel at risk for exposure and infection from pathogens left on these items..."

Due to the hospital's failure to have an effective method to sterilize hinged instruments and provide a sanitary environment in the Cardiac Catheterization Laboratory, a situation of Immediate Jeopardy (IJ) was called on 8/13/13, at 4:58 PM with the survey team and DM 1, Chief Operating Officer, DCS, and Director of Quality Management (DQM) in attendance. On 8/15/13, at 4:52 PM, with the survey team and Chief Executive Officer, DQM, and Nurse Manager 1 present, with an acceptable plan of correction, the IJ was abated.



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2.(A) During an interview with DM 1 on 8/13/13, at 2:20 PM, in the Central Processing Department, she stated she was training staff not to sterilize instruments in the closed position. At that time, a tray of instruments was observed. There were 25 various hinged instruments on a stringer (a tool used to ensure hinged instruments are held in the opened position). Many of the scissors and clamps on the stringer were not in the opened position, and others were only partially opened. At the time of the observation, DM 1 stated the stringer was not the correct size and the hospital had ordered more in other sizes. Also in the container, were several other instruments touching as they laid side by side and stacked upon each other which would prohibit the exposure of all surfaces to the sterilization process. DM 1 acknowledged the observation and stated they will need to break the surgical pack up into smaller packages.

According to The Association for Advancement of Medical Instrumentation (AAMI) standards 2013, under section titled Packaging, Preparation and Sterilization, sterilization depends on contact of the sterilizing agent with the instruments.

The hospital policy and procedure titled "Sterilization of Reusable Surgical Instrumentation," undated, under the sub heading titled "Wrapping Reusable Instruments for Sterilization" indicated in part that instruments must be in the open position....

2.(B) During an observation and interview with Central Processing Technician (CPT) 4 on 8/13/13, at 2:30 PM, CPT 4 was observed in the sterile processing area removing the sterile packaging from the instruments and placing them in new packaging. CPT 4 stated the instruments did not go through the decontamination area. She stated she had received the instruments directly from the operating room and the various floors in the hospital.

According to AAMI standards 2013, under section 2.122 sterile storage area is used to protect items from contamination and is used to store clean and sterile items.

The hospital policy #DP-CS 112 titled "Decontamination-Receiving, Handling and Dress Code Requirements", last revision 6/22/11, indicated all items returned are considered contaminated and received in the decontamination area only.

2.(C) During observations in the sterile processing area on 8/14/13, at 2:50 PM, three CPD staff, a supervisor (S) 1, CPT 2 and CPT 3, were noted with uncovered beards and mustaches. At the time of the observation S 1 indicated he did not know what type of covering should be used to cover his facial hair. On 8/15/13, at 10:15 AM, S 1 was observed wearing an isolation mask to cover his beard and mustache. While giving instructions to staff, regarding packaging instruments, S 1 was observed lifting the mask off of his face while he spoke thus exposing his beard and mustache.

According to AAMI standards under section "4.5 Attire 4.5.1 General considerations," it read in part, "All head and facial hair (except eyebrows and eyelashes) should be completely covered with a surgical-type hair covering..."

2.(D) During observations of the sterile processing area on 8/15/13, at 10:20 AM, CPT 3 was asked to open a tray of instruments that had already been packaged and was waiting to be sterilized. Once opened the tray was noted to contain clamps and scissors in the closed position. CPT 3 indicated he would reprocess the instruments. At 10:25 AM, Staff 5 was observed in the sterile processing area packaging instruments for sterilization. During her packaging, she stopped to pick paper up off of the floor. She put the paper in the trash can, and using her hands pressed the trash down into the can. Without washing her hands, Staff 5 returned to packaging instruments.

2.(E) During an interview with the MES on 8/15/13, at 3:52 PM, he was asked to describe the cleaning process of the central processing area. He stated staff go into the decontamination side of the area first. He stated while cleaning the decontamination side they do not change their clothing. After the decontamination side is cleaned they then clean the staff bathrooms and lounge. After that area is cleaned they put on protective covering and clean the sterile processing area. After cleaning that area staff remove the protective clothing and go to other areas of the hospital to clean the rooms of discharged patients. When questioned about staff cleaning the decontamination area in their regular work clothing and then wearing the same clothing to go out to various parts of the hospital to clean, he stated "there is always a minute chance of cross contamination."

According to AAMI standards 2013, under section "3.2.4 Traffic control" it read in part traffic should be controlled to protect staff and visitors from environmental contaminates.



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3.(A) During an observation in the decontamination area of the CPD, on 8/15/13, which started at 9:25 AM, the CPT 1 was noted performing the decontamination process (the physical and chemical process of removing organic material, soil and debris, and microorganisms from inanimate objects, such as instruments) for the surgical instruments received in the area. The following was observed during this cleaning process: a) there was an unmeasured amount of detergent used to clean the surgical instruments; b) there was no soaking of the instruments, the instruments were randomly placed in the second and third sink and the water was left running; c) there was inconsistency with rinsing, whereby some of the instruments were thoroughly rinsed and others were rinsed in less than a few seconds with no regard to whether the detergent was thoroughly rinsed off before transferring those instruments to the ultrasonic machine (cleaning equipment that uses ultrasonic vibration to remove soil from joints, crevices, lumens, and other areas that are difficult to clean by other methods); d) there was inconsistency with scrubbing the instruments, some of the instruments were scrubbed with a brush, while other instruments were not scrubbed at all; e) there were multiple large tubs with several surgical instruments in each tub. Each of the tubs had varying amounts of the solution and the surgical instruments were randomly placed on top of each other. Some of the tubs had surgical instruments that were fully immersed and others had surgical instruments that were not fully immersed in the water solution.

During an interview with CPT 1, on 8/15/13, at 9:50 AM, he acknowledged he did not scrub all the instruments. CPT 1 stated, "I eyeball it" in regards to whether he scrubbed the instruments or not. It depended if he visibly saw blood on the instruments or not.

During a subsequent interview with CPT 1, on 8/15/13, at 10:20 AM, the manufacturer's recommendations for the detergent was reviewed with CPT 1. The manufacturer's recommendations on the detergent indicated to use "0.2 - 1 oz./gal depending on water quality." He acknowledged he was aware of the need to measure, but he stated he did not have a measuring cup from the manufacturer of the detergent. He also stated, the large tubs that contained liquid were actually tubs with a mixture of water and detergent. The tubs were from the operating rooms (ORs), Cardiac Catheterization laboratories and Labor and Delivery (L and D) areas. The large portable tubs were transported in a dumbwaiter (a small elevator for carrying things between the floors of a building) or the staff from the designated area brought them down individually. An empty package of the detergent was noted in one of the large tubs. The package indicated it was a "presoak and detergent" and the instructions, read in part, "to mix the contents with one gallon of water and soak for 2-3 minutes or 15-20 minutes."

During an interview with S 1 of the CPD, on 8/15/13, at 10:50 AM, he was informed of the inconsistent practices observed above. He acknowledged CPT 1 should have followed the manufacturer's recommendations when using the detergent and the manufacturer's recommendations for the surgical instruments. S 1 stated he does not have all the manufacturer's recommendations for the surgical instruments.

During an interview with Surgical Technician (ST) 1 on the OR floor, on 8/15/13, at 2:35 PM, he explained the process after the surgical instruments were used. The instruments were placed in a large plastic tub, an unmeasured amount of water was added just enough to immerse all the surgical instruments and he typically used two of the prepackaged presoak and cleaners and then he sent the instruments on the dumbwaiter to the CPD.

The hospital policy and procedure titled, "Sterilization of Reusable Surgical Instrumentation" read in part, "The process and products used for cleaning, disinfection and/or sterilization of surgical instruments and equipment must be compatible with the equipment. All...instruments that will be reprocessed must have written device-specific manufacturer's cleaning, decontamination, disinfection, wrapping and sterilization instructions..."

The hospital policy and procedure title, "Decontamination - Receiving, Handling and Dress Code Requirements" indicated under the Guidelines/Policy Statement subheading, "...The OR (Operating Room) personal (sic) is to ensure that all of the instrumentation are placed open and laying flat in the Plastic container with enzymatic cleaners and full submerged in water..."

3.(B) During an interview with the Department Manager (DM) 1 of the CPD, on 8/14/13, at 2:35 PM, she stated the staff just recently began monitoring the temperature and humidity in the Decontamination area, although they do not monitor the air exchange (air changes per hour is a measure of how many times the air within a defined space is replaced). The thermostat was observed in the Decontamination area and it read, "71" degrees Fahrenheit (F) and the humidity level was 53%. DM 1 stated the Director of Facilities (DF) monitored other areas for temperature, humidity and air exchange but not this area. The CPTs have recently started logging the temperature and humidity in the Decontamination area and follow the standards set by AAMI (a professional organizations that sets standards for the reprocessing of instruments) and AORN. According to 2013 AAMI's Recommended Practices for Sterilization and the parameters for controlled environments during sterilization it indicated in part, for the decontamination area the temperature should be 60-65 degrees F, humidity should be 20-60%, and the air exchange should be negative air flow (negative pressure is generated and maintained by a ventilation system that removes more exhaust air from the room than air is allowed into the room) with a minimum number of air exchanges per hour at 10.

The temperature and humidity logs for the Decontamination area were reviewed, with S 1, on 8/14/13. He acknowledged the temperature and humidity should be monitored daily and the staff have recently began monitoring the temperature and humidity and documenting the results on a log. The instructions on the bottom of the log read as follows, "TEMPERATURE RANGE: 60 Fahrenheit - 65 Fahrenheit. IF TEMP GOES OUT OF THIS PARAMETERS PLEASE CONTACT THE LEAD TECH AND SUPERVISOR.." For the day starting June 12, 2013 - June 30, 2013 the temperature ranged from 70.5 - 72.0 F, which was above the recommended temperature range. Under the column titled, "COMPLIANT (Y/N) IF NO, ACTION TAKEN" there were 15 days where the staff documented the temperature was not compliant. Under the action taken there were several entries which indicated there was no action taken or "Nothing was done". For July 1, 2013 - July 31, 2013 the temperatures ranged from 70 - 74.5 degrees F. There were entries which indicated the lead staff was notified. No other documentation of the action taken. For August 1, 2013 - August 14, 2013 the temperature ranged from 70 - 72 degrees F. No action was documented.

During an interview with the DF, on 8/15/13, at 8:57 AM, he stated his department was not monitoring the temperature, humidity or air exchange in the Decontamination area of the CPD.

3.(C) During an observation in the Decontamination area, on 8/15/13, at 9:36 AM, S 1 was noted with Personal Protective Equipment (PPE) which consisted of a head covering, mask, scrub uniform, overcoat, shoe covers. At 10:27 AM, S 1 walked into the clean utility area with the same PPE applied and then back into the Decontamination area. At 10:35 AM, S 1 was observed with the same PPE exiting the Decontamination area into the main hall way, into the staff lounge and then into the sterile processing department.

During an observation in the Decontamination area, on 8/15/13, at 9:36 AM, CPT 6 was noted wearing head covering, scrub uniform, overcoat and shoe covers. At 10:35 AM, she was noted walking out of the Decontamination area and into the lounge with the same PPE.

During an observation in the Decontamination area, on 8/15/13, at 9:50 AM, DM 1 was noted entering the area. DM 1 was wearing a head covering, scrub uniform, and regular shoes. At 9:55 AM, DM 1 left the Decontamination area wearing the same head covering, scrub uniform and shoes.

During an interview with S 1, on 8/15/13, at 10:35 AM, he was asked what PPE should be worn in the CPD? He was unable to indicate if PPE should be changed when going from one area of the CPD to another, such as when moving from the Decontamination area to the sterile processing area.

The hospital policy and procedure titled, Decontamination - Receiving, Handling, and Dress Code Requirements" was reviewed on 8/15/13. Under the "Dress Code Decontamination area", "Head covering...Shoe covers. Removed when leaving the decontamination area...Cover gown...to prevent clothing becoming wet..."

4. During a tour of the hospital wound care clinic on 8/14/13, at 4 PM, with Registered Nurse (RN) 1 and the Infection Control Nurse (ICN), the following was observed:

4.(A) The clean utility room contained staff lockers as well as assorted clean patient supplies. The top supply shelf cart had office supplies, multiple single use saline vials for patient use, lotions, disinfectants, and dressing supplies. The second shelf contained more office supplies and patient care supplies such as wound dressings. The ICN indicated the room would be re-organized and patient care equipment would be stored properly and staff property would be placed in another area.

4.(B) The wound center clean utility room sink had a dirty paint scraper in it, next to it was placed a stack of seven patient records and six patient x-ray's. The soap dispenser was nonoperational.

4.(C) A skin graft container was found in a patient treatment room, RN 1 indicated the container was for multiple patient use and Certified Nursing Assistant (CNA) 1 further indicated she cleaned the container by rinsing it off with tap water. RN 1 stated he did not have a policy for cleaning the container found in a supply cupboard next to sterile supplies, but that it should be cleaned with bleach wipes after each use. The counter also had an unlabeled container with a blue liquid with particles floating in it and contained numerous used instruments. RN 1 indicated they were removed at the end of the day and transferred to central processing in a large plastic container. He stated the instruments probably should be removed from the treatment room after each patient use.

4.(D) The wound center clean utility room sink had a dirty paint scraper in it, next to it was placed a stack of seven patient records and six patient x-ray's. The soap dispenser was in-operational. RN 1 stated staff used the sink in the central office area for handwashing.

4.(E) The central office area had several cupboards, these cupboards held a combination of patient supplies including wound dressings, undated and expired supplies and office supplies. RN 1 stated, "We need to re-organize this area and put the patient supplies in the clean utility room, they shouldn't be stored together."