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Based on observation, record review and interview, the facility failed to ensure that patient care was provided following the facility's infection control policies, potentially leading to the spread of communicable diseases.

Findings were:

Tour and observation in the facility on 7/6/15-7/8/15 revealed the following:

· The ICU had 6 patients with 2 patients on isolation. A physician was gowning to go into a room of a patient on contact isolation. The physician did not take his white lab coat off and had his stethoscope was hanging around his neck. He did not tie the isolation gown in the back and did not wash or use hand sanitizer prior to gloving and entering the room. He used the stethoscope to listen to the patient and then placed it back around his neck. He removed the gown and touched his white lab coat with his gloves when he was removing the gown. He then went back into the room and talked with the patient and his wife with no PPE on. He did not wash his hands or use hand sanitizer after coming out of the isolation room. The nurse handed him a sanitizer wipe to clean his stethoscope and he walked out of the ICU with the wipe in his hand and I never observed him cleaning the stethoscope or sanitizing his hands prior to leaving the ICU.

· A physical therapy assistant was observed walking in the hallway and stuffing a handful of gloves into the pocket of his scrub pants. He then proceeded to put on an isolation gown and gloves and went into the room of a patient on contact isolation. He did not wash his hands or use hand sanitizer when he entered the room. He proceeded to perform care on the patient in the room using the gloves he had stuffed into his scrub pants pocket.

· A patient family member was observed in the room of a patient on contact isolation for C-Diff. The family member was not wearing a gown or gloves in the room. A nurse went into the room and told the patient's family member that he needed to wear PPE while he was in the room. She asked him to wash his hands as he left the room. A sign on the door said that all visitors need to wear PPE while in the room and wash hands upon entering and leaving the room.

· A central bathing room was located on the first floor nursing unit. There were used washcloths hanging on the handrails by the shower chairs in the room. There were 3 shower chairs in the room that were not identified as being clean or dirty.

· A clean supply room was located on the first and second floor nursing units. In both rooms there were supplies that were stored on the wire shelves in cardboard shipping boxes that were stored on the shelf above clean supplies that would allow debris from the containers to drop onto clean and sterile supplies.

· In a storage area on the first floor by the nursing station there were patient bed scales and a hoyer lift stored. There were yellowish brown spots on the top of the hoyer lift base. It was able to be wiped off with a sanitizing wipe which verified it was not properly cleaned before storing in the area.

· In the dirty supply room there were trash cans that contained dirty linen and trash that were not covered.

· On the outside loading dock of the facility there were containers with bags of trash and containers with bags of linen that were not covered to keep vermin out of them. Birds were flying around the containers and landing on the sides of the containers. There was also an unlocked gate to the fenced area that contained biohazard waste containers.

Wound care observation #1 performed by staff #8 (Wound Care Nurse) at 2:05 pm on 7/7/15. The patient had ulcerated areas to buttocks. Staff #8 used hand sanitizer when she went in the patient's room. She assembled her items and opened an abdominal pad and placed it on the patient's bedside table. (Of note the bedside table was not wiped with a disinfectant wipe prior to placing the abdominal pad on the table) She opened a 4X4 gauze and placed it on top of the abdominal pad. She put on gloves. She used the gauze pad and a wound cleaning solution to clean the wound. She disposed of the gauze pad in the regular trash can in the patient's room, not in the biohazard bin. She then placed clean dry 4X4 gauze pads on the ulcerated areas and took the abdominal pad off the table and taped it on the patients buttocks and handed the patient a pair of disposable undergarments to put on. She then disposed of her gloves in the patient trash can in the room.

In an interview with the staff #8 after the procedure was completed I asked her what the policy was for disposing of used contaminated gauze. She said "There is no policy I am aware of. Should it go in the biohazard." When I said you are wiping off a contaminated wound she said "Oh I see. I guess it should go in biohazard. I see what you are getting at."

During an interview with staff #5 (ICU Nurse) on 7/7/15 she acknowledged that doctors did not always appropriately use PPE and follow infection control procedures. She said she tried to remind them when they come in but they do not always follow the policy. She said the physicians wear their lab coats in from outside the facility and wear it under their isolation gown and at times they contaminate the fabric lab coat when removing the disposable PPE. She said the physician use their personal stethoscopes and do not always cleanse it after use on the patient and do not always follow hand hygiene practices. She said on the date of the observation she did not say anything to the physician regarding his breaks in the facility infection control and isolation policies.

Wound care observation #2 performed by staff #11 (Wound Care Nurse) at 8:35 a.m. on 7/8/15. The patient had wound-vac on a wound on the left upper leg. Staff #11 used hand sanitizer when she entered room and put gloves on. She went to the cabinet in the room and took out a pink plastic basin and set it on the end of the patient's bed mattress. She then cleared off the patient's overbed table and took a clean pad and opened it on the overbed table. She removed her supplies from the plastic basin and put it on the open pad on the overbed table. She then picked up the wound-vac and outer bag from the floor and laid it on the patient's bed and removed the used wound-vac canister, tubing and dressing from the patient's wound. She removed her gloves and threw them, the wound-vac canister, and the dressing in the trash can and put on new gloves. She opened wound care supplies and placed them on the clean pad. She took a spray bottle with wound cleanser and saturated the gauze and performed wound care on the area around the open wound. Obvious blood was on the gauze from a skin tear near the wound. She threw the bloody gauze in the regular trash can in the room. She changed her gloves. She then touched the wound-vac with her clean gloves that she had previously touched with dirty gloves. She then placed a new canister on the wound-vac. Staff member #11 removed scissors from her scrub pocket and cut pieces of the clear wound-vac bandage and also cut the sponge like material that is packed in the wound under the suction of the wound-vac. She put on clean gloves and placed the wound cleanser bottle back in the pink plastic container and returned it to the cabinet. She then placed the scissors inside a clean glove and took it out of the room. She set the glove and the scissors on the top of her wound care cart that was sitting in the hallway. She placed the trash can liner from the patient trash can in the hallway on the floor outside the room. She changed gloves and took a Super Sani Wipe and cleaned the scissors off and laid them back on the top of the wound care cart. A patient care tech picked up the trash bag and placed it in another trash can that was sitting in the hallway then carried down the hallway to the soiled utility room.
While in the room observing the dressing change it was noted there was a box of gloves, a bottle of baby powder, and 2 soft sided packages of wet wipes on the top of the red biohazard container.

In an interview with the staff #11 she acknowledged she removed the scissors from her scrub pocket that she used to cut the tape and the sponge for the wound-vac. She acknowledged she set the scissors on the wound care cart and never cleaned/sanitized the top of the wound care cart before or after cleaning the scissors and the dirty scissors had contaminated the top of the wound care cart and she laid the scissors back on the same area after cleaning the scissors. She acknowledged she set the plastic container on the bed and that she touched the wound-vac with the same gloves that she had picked the outer bag off the floor. She also acknowledged she did not disinfect the wound-vac prior to touching it with clean gloves and putting a new canister and suction tubing on it prior to the dressing change. She said she always puts the wound-vac tubing in the regular trash can and then takes it to the soiled utility room and puts it in the larger trash container. She said she did not know the policy was to put the soiled dressing and used wound-vac canister in the biohazard container. She acknowledged that she never used hand gel on her hands between glove changes when she went from dirty to clean tasks during the dressing change. In an interview with the wound care nurse and the Director of Quality Management at the time of the dressing change both acknowledged clean supplies were sitting on top of the red biohazard container.

Policy "Infection Control Plan Vibra Hospital" states, in part "The goals of the program are: Identify and evaluate healthcare associated infections by: 1. Identifying expected and unexpected infections early and implement appropriate interventions when they occur. 2. Analyze practices that have the potential to affect the rate of hospital-acquired infections. 3. Institute changes as needed to reduce the health care acquired infections, including but not limited to: Enhancing hand hygiene; minimizing the risk of transmitting infections associated with the use of procedures, medical equipment, and devices; provide education to staff, employees, patients, and visitors."

Policy "Infectious Waste Management Program" states, in part "Infectious waste is waste capable of producing an infectious disease. The following types of infectious wastes are relevant within Vibra Hospital of Amarillo. All isolation waste materials, dressings, or anything containing evidence of visible blood, all dressings, all gloves, all suction and urinary tubing are to be placed in red isolation bags. Bags will be placed in impervious red plastic containers marked hazardous waste where it will await the bimonthly medical waste disposal company. All department managers are responsible for monitoring compliance with the Infectious Waste Management Program as it applies to their department."

Policy "Initiation of Transmission based Precautions" states, in part "Purpose: To reduce the risk of transmission of epidemiologically important pathogens for which additional precautions beyond Standard Precautions are needed. To successfully interrupt spread from patients who are known or suspected to be infected or colonized by such microorganisms to other patients and healthcare workers."

Policy "OSHA Bloodborne Pathogens Exposure Control Plan" states, in part "Standard Precautions: All human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens. Methods of Compliance: General: Standard Precautions are observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluids is difficult or impossible, all body fluids should be considered potentially infectious materials."

Policy "Storage Collection and Transportation of Linen" states, in part "All linens will be stored, handled, transported, and processed in a manner that prevents the transmission of microorganisms to other patients and areas."

The facility failed to ensure that equipment used for wound care was cleaned and disinfected adequately to prevent the spread of communicable diseases. Cross refer Tag-749, CFR 482.42(a)(1).

Based on observation, staff interview, and policy review the facility staff failed to follow their infection control policies to ensure the patients received care in a safe and sanitary environment. Failure to follow their policies and procedures in infection control can lead to cross contamination between patients.

Findings were:

Wound care observation #2 performed by staff #11 (Wound Care Nurse) at 8:35 a.m. on 7/8/15. The patient had wound-vac on a wound on the left upper leg. Staff #11 used hand sanitizer when she entered room and put gloves on. She went to the cabinet in the room and took out a pink plastic basin and set it on the end of the patient's bed mattress. She then cleared off the patient's overbed table and took a clean pad and opened it on the overbed table. She removed her supplies from the plastic basin and put it on the open pad on the overbed table. She then picked up the wound-vac and outer bag from the floor and laid it on the patient's bed and removed the used wound-vac canister, tubing and dressing from the patient's wound. She removed her gloves and threw them, the wound-vac canister, and the dressing in the trash can and put on new gloves. She opened wound care supplies and placed them on the clean pad. She took a spray bottle with wound cleanser and saturated the gauze and performed wound care on the area around the open wound. Obvious blood was on the gauze from a skin tear near the wound. She threw the bloody gauze in the regular trash can in the room. She changed her gloves. She then touched the wound-vac with her clean gloves that she had previously touched with dirty gloves. She then placed a new canister on the wound-vac. Staff member #11 removed siscors from her scrub pocket and cut pieces of the clear wound-vac bandage and also cut the sponge like material that is packed in the wound under the suction of the wound-vac. She put on clean gloves and placed the wound cleanser bottle back in the pink plastic container and returned it to the cabinet. She then placed the scissors inside a clean glove and took it out of the room. She set the glove and the scissors on the top of her wound care cart that was sitting in the hallway. She placed the trash can liner from the patient trash can in the hallway on the floor outside the room. She changed gloves and took a Super Sani Wipe and cleaned the scissors off and laid them back on the top of the wound care cart. A patient care tech picked up the trash bag and placed it in another trash can that was sitting in the hallway then carried down the hallway to the soiled utility room.
While in the room observing the dressing change it was noted there was a box of gloves, a bottle of baby powder, and 2 soft sided packages of wet wipes on the top of the red biohazard container.

In an interview with the staff #11 she acknowledged she removed the scissors from her scrub pocket that she used to cut the tape and the sponge for the wound vac. She acknowledged she set the scissors on the wound care cart and never cleaned/sanitized the top of the wound care cart before or after cleaning the scissors and the dirty scissors had contaminated the top of the wound care cart and she laid the scissors back on the same area after cleaning the scissors. She acknowledged she set the plastic container on the bed and that she touched the wound vac with the same gloves that she had picked the outer bag off the floor. She also acknowledged she did not disinfect the wound vac prior to touching it with clean gloves and putting a new canister and suction tubing on it prior to the dressing change. She said she always puts the wound vac tubing in the regular trash can and then takes it to the soiled utility room and puts it in the larger trash container. She said she did not know the policy was to put the soiled dressing and used wound vac canister in the biohazard container. She acknowledged that she never used hand gel on her hands between glove changes when she went from dirty to clean tasks during the dressing change. In an interview with the wound care nurse and the Director of Quality Management at the time of the dressing change both acknowledged clean supplies were sitting on top of the red biohazard container.

Policy "Infection Control Plan Vibra Hospital" states, in part "The goals of the program are: Identify and evaluate healthcare associated infections by: 1. Identifying expected and unexpected infections early and implement appropriate interventions when they occur. 2. Analyze practices that have the potential to affect the rate of hospital-acquired infections. 3. Institute changes as needed to reduce the health care acquired infections, including but not limited to: Enhancing hand hygiene; minimizing the risk of transmitting infections associated with the use of procedures, medical equipment, and devices; provide education to staff, employees, patients, and visitors."

Policy "Infectious Waste Management Program" states, in part "Infectious waste is waste capable of producing an infectious disease. The following types of infectious wastes are relevant within Vibra Hospital of Amarillo. All isolation waste materials, dressings, or anything containing evidence of visible blood, all dressings, all gloves, all suction and urinary tubing are to be placed in red isolation bags. Bags will be placed in impervious red plastic containers marked hazardous waste where it will await the bimonthly medical waste disposal company. All department managers are responsible for monitoring compliance with the Infectious Waste Management Program as it applies to their department.

Policy "Initiation of Transmission based Precautions" states, in part "Purpose: To reduce the risk of transmission of epidemiologically important pathogens for which additional precautions beyond Standard Precautions are needed. To successfully interrupt spread from patients who are known or suspected to be infected or colonized by such microorganisms to other patients and healthcare workers."

In an interview with the Director of Quality Improvement at the time of occurrence she verified the facility staff did not follow their own policies in providing a safe environment for the care of the patients in the facility.

Based on record review, and interviews it was determined that the facility failed to ensure that equipment used for wound care was adequately disinfected between patient use to reduce and control the spread of communicable diseases.

Findings were:

The Infection Preventionist stated in an interview on 7/8/15 that the facility had an outbreak of the Acinetobacter organism after they admitted a patient from a Dallas hospital. She stated the infections were hospital acquired and also seen in patients that were transferred from other hospitals; a commonality amongst the affected patients was wound-vac therapy. KCI (contracted company that provides the hospital with wound-vacs, and cleans the wound-vacs) was then asked to review their equipment cleaning procedures. She said KCI staff wiped the wound-vacs with a disinfectant wipe after it has been removed from the patient's wound, then it is put in a bag and tagged as dirty. KCI staff then pick up the wound-vacs and they clean and process the wound-vacs in a van. She stated the wound-vac company did not use wipes that were effective in killing the Acinetobacter organism.

A letter to KCI from Materials Management Manager of Vibra Hospital dated 2/5/15, stated the following "We are tightening up our infection control practices in the facility. In this community we have an infection called Acinebacter baumanii which is a multi drug resistant bacteria. It can only be killed by using bleach/bleach wipes or a germicidal wipe that specifically states that it kills acinebacter. Upon looking at the cleaning process that KCI used it was found that the wipes used to wipe down the wound vac was not appropriate in killing this infection. We would like to request what the cleaning protocol is and explanation if something is done during this process that we have missed to curtail the spread of the infection. It was noted the wound vac is wiped down in your van and does not go through any other cleaning process."

A letter from Director of Operations with KCI dated 3/25/15, stated in part "In response to your request we have outlined the cleaning process for our wound vacs. Upon pick up of the wound vac we follow these steps; Proper Infection Prevention and Control Guidelines to include PPE and hand hygiene. Removal of unit from packaging and disposing of all single use items. Inspection of unit. Using approved cleaning product, the unit is wiped down. The unit must remain wet for a minimum of 1 minute. After the unit is dry, the unit is inspected for chemical residue. All products are moved from the process area to a "Clean" area before continuing the Quality Control process to minimize any cross-contamination. We currently use PDI Sani-Cloth Plus Germicidal disposable cloths for cleaning of all of our devices. This product purports to be effective against Gram-negative bacteria."

A facility document titled "TDSHS (Texas Department of State Health Services) Site Visit KCI VAC van" stated in part "Note the PDI red top wipes state a minimum of 3 minute contact time but the KCI procedure book stated a minimum of 1 minute contact time; they also have Ecolab TB disinfectant and Lysol but it is not clear when the employees are to use that. New cases that KCI is now delivering the VACs in; note the black inside, it is foam; it was noted that these are just sprayed down with Lysol."

The technical Data Bulletin for Sani-Cloth Plus Germicidal Disposable Cloths states, in part:
"Product Description: Use on hard non-porous surfaces and equipment made of stainless steel, plastic, Formica, and glass.
Bacterial Organism Efficacy:
Organisms:
· Methicillin Resistant Staphylococcus aureus (MRSA)
· Staphylococcus aureus
· Salmonella enterica
· Psuedomonas aeruginosa
· Escherichia coli
· Campylobacter jejuni
Exposure Time: 3 minutes
Organism:
· Vancomycin Resistant Enterococcus Faecalis (VRE)
Exposure Time: 3 minute"

The Director of Materials Management stated in an interview on 7/7/15 that KCI brings in the Ulta Instill wound-vacs in a plastic bag that is labeled "clean". They just started using a company called Recover Care that supplies the facility with other wound-vacs. These wound vacs come in a hard black plastic case that has a black porous foam insert to cushion the wound-vac. When the wound-vac is removed from a patient it is wiped down by the wound care nurses and placed in a plastic bag and then placed back in the case with the foam insert. KCI then picks up the black hard plastic cases and takes the wound-vac to their van for processing. He said he sent a letter to KCI requesting their
process for cleaning the wound-vacs. He said KCI sent him a letter back stating they use the appropriate disinfectant wipes to kill gram negative bacteria.

Policy "Negative Pressure Wound Therapy" states, in part "Discontinuation of Equipment: When NPWT has been ordered to be discontinued: Wound vac unit is removed from the patient. The unit is wiped down with appropriate germicidal. The unit is allowed to dry according to germicidal recommendations. Unit is placed in a plastic bag upon leaving patient room. Wound vac unit is transported to designated equipment area for vendor pick up and cleaning."