Fmc Prichard

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to provide a safe and sanitary environment for 59 of 59 patients for the provision of services in the dialysis facility. Failure to provide a sanitary environment placed all patients at risk for transmission of infectious agents. Findings include: Observation in the dialysis facility on 06/30/25 from 8:00 AM to 4:45 PM revealed the following: 1. The wall paper on two walls in the waiting room were non-adherent to the wall creating a space for bugs and vermin to hide. 2. Fluid was observed behind and under the hemodialysis machines at Station 10, Station 11, and Station 14. This created a slip hazard for patients and staff in the treatment room. 3. Countertops by three sink areas were noted to be made of wooden material that was scarred and had a porous surface. Inability to effectively clean surfaces in the treatment room can provide a mode of transmission of infectious agents. 4. Supply storeroom had drums of acid that had residue spilled on the floor that had been tracked all around the room. Bicarbonate mixing area had white powder residue all over the floor from the bicarbonate mixing tank and around the acid storage tanks. White powder residue was also noted on the cushions of two stools and all over the outside of the bicarbonate mixing tank. 5. White wire baskets attached to 24 of 24 hemodialysis machines were rusted. Bottles of hand sanitizer and blood pressure cuffs were noted in the baskets. Rust on surfaces cannot be effectively cleaned and sanitized and will lead to cross contamination between patients. Interview with Certified Clinical Hemodialysis Technician (CCHT) 3 on 06/30/25 at 4:15 PM, he/she verified the acid/bicarbonate residue on the floor in the storage room. CCHT 3 also verified the baskets on the machines had rust on them and could not be cleaned effectively. Interview with Clinical Manager on 06/30/25 at 4:45 PM verified the storeroom floor was dirty and had acid and bicarb residue on it. The Clinical Manager stated facility staff are responsible for keeping the bicarbonate mixing area and the storeroom clean. The Clinical Manager stated he/she was trying to get the housekeeping people to start mopping the storeroom floor. Facility policy titled “General Cleanliness and Infection Control Guidelines” published 05/05/25, indicated, “Policy: All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms. Walkways must be kept clear of debris and free of clutter...Facility staff are accountable for cleaning rooms/areas not assigned to contracted staff. Such cleaning should be done regularly using a schedule developed by the facility.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure equipment used in patient care was disinfected as per facility policy and stored appropriately. The facility failed to ensure staff appropriately disinfected equipment that was used on patients before returning to a clean area. Failure to disinfect appropriately has the potential to cause harm to all 59 patients dialyzed in the facility. Findings include: During observation in the patient treatment area on 06/30/25 at 9:28 AM, five of 20 blue hemostats in the container designated as “clean” were observed to be in the closed position. In a separate container with fistula clamps two of 15 fistula clamps were noted to have paper tape wrapped on the clamps. In an interview with Registered Nurse (RN) 7 on 06/30/25 at 9:45 AM, he/she acknowledged the blue hemostats were in a closed position and he/she could not verify if they had been open when disinfected. RN 7 also verified the fistula clamps were in the clean container with paper tape still on the clamp and they were supposed to have been disinfected. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” published 09/05/23, indicated, “Cleaning Clamps: Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution...Make sure the items are completely submerged, unclamped, and in open position when placed in the solution.””

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure the cart with bleach solution containers and wipes were kept a sufficient distance from the splash/spatter zone to prevent contamination. Two of two carts were pushed between machines in the splash/spatter zone. This practice can lead to contamination of the clean wipes used for cleaning of the patient machines and stations. Findings include: During observation in the patient treatment room on 06/30/25 from 9:15 AM-12:05 PM it was observed that two of two carts that contained bleach solution containers and bundles of disposable wipes that were being used to surface disinfect the machines, patient chairs, and other equipment in the patient stations were pushed up against the eyewash sink in an area beside the hemodialysis machines that could be contaminated by splash/spatter of blood and fluids. Interview with Clinical Manager on 06/30/25 at 11:15 AM confirmed the carts were not supposed to be in the area beside and behind the patient hemodialysis machines as this was considered a splash/spatter zone. Facility policy titled “General Cleanliness and Infection Control Guidelines” published 05/05/25 indicated, “Policy...Supplies...should not be kept or stored behind the machine at the station.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure infectious waste in the isolation room was contained in red biohazard bags. One of one observations the waste container had a clear plastic bag. Failure to ensure infectious waste from hepatitis positive patients is clearly identified in red biohazard bag has the potential for cross contamination to all personnel who touch the container. Findings include: Observation of the care of the hepatitis B antigen positive patient on 07/01/25 between 6:45 AM to 9:34 AM revealed all gloves, gowns, paper towels, and saline bags were discarded by Patient Care Technician(PCT) 5 in a waste container that had a clear plastic liner. Interview with PCT 5 on 07/01/25 at 9:35 AM, he/she acknowledged the trash in the isolation room, other than the bloodlines and dialyzer, was placed in a waste container that had a clear plastic liner. Interview with the Clinical Manager on 07/01/25 at 10:02 AM he/she stated a red biohazard bag is to be used in the trash can in the room and the bag is to be discarded in the red biohazard container that is also in the room. The Clinical Manager further stated the clinical staff is responsible for all cleaning performed in the room at the end of the treatment day. Review of the facility’s policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen” indicates, “Equipment and Supplies...All disposable items, including the patient’s dialyzer, shall be considered infectious, and shall be red-bagged, labeled as “Infectious Waste,” and removed from the HBsAg (Hepatitis B surface Antigen) positive patient care room/area each day using Standard Precautions.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 52064 Based on observation, staff interviews, and policy review, the facility staff failed to ensure all surfaces and equipment were maintained to ensure complete cleaning and disinfection of the surfaces between patient use. Failure to ensure complete and effective cleaning and disinfection of surfaces and equipment places all 59 patients at risk for cross contamination. Findings include: 1. During observation in the patient treatment area on 06/30/25 at 11:34 AM Certified Clinical Hemodialysis Technician (CCHT) 6 used the mechanical lift with a patient and was unable to completely clean the equipment prior to storing as it had rust on the bottom rails and the wheels of the equipment. In an interview with CCHT6 on 06/30/25 at 11:37 AM, he/she acknowledged the mechanical lift had rust on the equipment and was unable to clean effectively due to the rust buildup. 2. During observation in the patient treatment area on 06/30/25 between 9:20 AM-9:46 AM, it was noted 24 of 24 machines being used for dialysis treatments had wire baskets attached to the side of the machine that had rusted areas that did not allow for effective cleaning of the equipment. In an interview with CCHT3 on 06/30/25 at 10:15 AM, he/she stated the baskets on the machine were rusty and could not be effectively cleaned/disinfected between patients. 3. During observation in the patient treatment area on 07/01/25 at 7:05 AM, it was noted 14 of 14 wall boxes had debris and residue in them. This debris and residue was noted also during observation in the patient treatment area on 06/30/25 between 9:20 AM and 4:30 PM. In an interview with CCHT4 on 06/30/25 at 4:00 PM stated the wall boxes are cleaned weekly. Interview with the Clinical Manager on 07/01/25 at 9:52 AM he/she stated the wall boxes are to be cleaned daily and that some of them have stains on them they are trying to clean with Magic Eraser. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” published 09/05/23, indicated, “Definitions: Dialysis Station:.. Equipment in the dialysis station may include the following: Dialysis machine/cycler and attachments such as IV pole, B/P cuff and hand sanitizer/holder, organizer...General Cleaning: After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach...before being removed from the dialysis station. Cleaning of the Dialysis Machine: Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. Cleaning of the Dialysis Wall Boxes: Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution. General Cleaning:..After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach...before being removed from the dialysis station.””

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 52064 Based on observations, staff interview, and policy review, the facility staff failed to ensure they followed their policy in regard to the care of the patient in Isolation Room. One of one staff members, (Patient Care Technician 5) did not remove non-disposable hair covering when entering and exiting the Isolation Room. This deficient practice can lead to cross contamination to susceptible patients dialyzing in the facility. Findings include: During observation of the care of the hepatitis B positive patient in the facility treatment area on 07/01/25, between 6:45 AM and 7:30 AM, PCT5 was observed entering and exiting the isolation room wearing a cloth hair covering. In an interview on 07/01/25 at 7:30 AM with PCT5, he/she confirmed the hair covering was not disposable and was worn to protect hair braids from contamination. He/she stated there were no disposable hair coverings in the facility to wear over the cloth hair covering. PCT5 further stated, “Not sure what the policy is about the cloth hair covering.” Review of the facility’s policy titled “Dialyzing Patients with Positive Hepatitis B Antigen”, published 06/04/25, indicated, “Hand Hygiene and PPE ...Personal protective equipment (PPE) must be removed and discarded or left in the Isolation Room/area if not soiled.””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 52064 Based on personnel file review and staff interview, the facility failed to ensure one of three staff members (Certified Clinical Hemodialysis Technician (CCHT) 4) who failed the color blindness test was tested on an alternate method of testing and documented on the annual skills checklist to ensure accuracy in the testing procedure. Failure to ensure annual competency in the use of the colorimeter as an alternate method of testing for staff with color blindness places all 59 patients at risk for inaccurate testing results. Findings include: Review of personnel file on 07/02/25 at 12:01 PM for Certified Clinical Hemodialysis Technician (CCHT) 4 revealed when the annual competency validation test was performed on 03/21/25 CCHT 4 was not validated for the use of the colorimeter. Documentation revealed CCHT 4 had received remedial education and validation testing on the use of the colorimeter on 02/01/24. Interview with the Biomedical Technician on 07/02/25 at 12:35 PM, he/she stated the validation had not been performed with the annual skills checklist performed on 03/21/25 and had not been validated since 02/01/24.”