Davita Florissant Dialysis

“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: 18018 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff provided and maintained a clean environment when staff failed to: - Maintain a clean floor in the Bio-Hazard Room; - Maintain clean surfaces in the Storage Room; - Maintain clean surfaces of various equipment, drains, pipes and floor in the Water Treatment Room; and - Maintain clean surfaces of the Treatment Floor’s drains and the supply/wall boxes located behind the dialysis machines. These failed practices had the potential for increased risk of cross-contamination and transmission of pathogens to all patients and staff. The In-Center-Hemodialysis (hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 75 and the Home Peritoneal Dialysis (a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was 13 for a total census of 88. Findings included: 1. Observation and concurrent interview during the Flash Tour on 12/02/24 from 3:00 PM to 4:00 PM showed: BIO-HAZARD ROOM The following items were located on the floor in the corner to the right after entry into the Bio-Hazard Room: - Three brown colored pieces of paper; - Two dead bug carcasses; - One black rubber cap; and - One black oxygen tank key. STORAGE ROOM Five wire metal storage units contained various amounts of dirt and a rust-like substance on the metal of the frame’s surfaces. WATER TREATMENT ROOM - The dry acid mixing system’s top contained a large amount of a dried white substance on the surface. - The dry acid mixing system’s black top was missing from the opening at the top of the system and was placed on a portable black cart located next to the dry acid mixing system. Without the black top placed in the opening of the dry mixing system increased the risk of unwanted items to enter the system and contaminate the contents inside the system. - The dry acid mixing system’s black top contained a dried white substance on the top’s surface. - The wall behind the dry acid mixing system contained several dark brownish tan streaks on the wall surface. - The floor under the dry acid mixing system contained several areas of broken concrete and the top surface of the floor was worn off. Staff A, Facility Administrator (FA), stated a work order had been placed to replace the Water Treatment Floor. - The blue motor located under the dry acid mixing system contained a large amount of dried white substance on the surface of the motor and a large amount of dried white substance was on the metal under the motor. - Three black hoses with 3K (potassium) - 2.5 Ca (calcium) and 2K - 2.5 Ca contained a dried whitish brown colored substance on the surface of the hoses. - The electric box located under the black hoses contained a moderate amount of rust-like substance on the surface. - The green filters contained a dried whitish brown colored substance on the surface of the filters. - The Reverse Osmosis (RO) system contained various amounts and size of a dried white substance on the system’s surface. - The metal above the blue filter contained a large amount of rust-like substance on the surface. - A bluish green colored substance was on the surface of the back flow preventer pipe. - A dried white substance was on the floor surface throughout the water treatment room that varied in amount and size. - The boost pump/expansion tank contained dust, a brownish tan colored substance and a rust-like substance on the surface. - The floor drain located behind the RO system contained a dark blackish orange colored substance on the inside surface of the drain. - The floor under the black pallets contained dust and dirt. TREATMENT FLOOR Observations and concurrent interview conducted on 12/02/24 at 4:00 PM, 12/03/24 at 5:45 AM and 12/03/24 at 11:47 AM showed: - 20 out of 20 supply/wall boxes located behind the dialysis machines at each patient Station contained various amounts and size of a thick yellowish orange colored substance on the inside surfaces. - Nine out of nine floor drains between patient Stations #1 and #2, #5 and #6, #7 and #8, #9 and #10, #11 and #12, #13 and #14, #15 and #16, #17 and #18, and #19 and #20 contained various amounts and size of a yellowish orange colored substance on the inside surface of the drain and various amounts and size of a dark colored or light gray colored substance on the outside surface of the drain. - The floor drain located at patient Station #3 contained a large amount of a yellowish orange colored substance on the inside surface of the drain. - The floor drain located at patient Station #4 (Isolation Room) contained a yellowish orange colored substance on the inside surface of the drain. - Several ceiling tiles in POD 1, POD 3, POD 5, and the oxygen/equipment storage area contained various amounts and size of a light brownish tan-colored substance on the tile’s surfaces. Staff A, FA, stated the discolored ceiling tiles was caused by a roof leak due to heavy rains and a work order had been placed to replace the discolored 14 ceiling tiles on the Treatment Floor. 2. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” dated April 2023, showed staff directives: At the end of each treatment, the dialysis station will be cleaned and disinfected. The wall box, drain and water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area. Teammates will monitor and address wall box residue/build up and patency issues. 3. During an interview on 12/05/24 at 1:15 PM, Staff A, FA, stated the expectation was for teammates and bio-medical staff to work as a team to keep surfaces throughout the dialysis facility clean and staff expectation was to follow the facility’s policy and procedures.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 18018 Based on observation, policy review, and interview the facility failed to ensure staff: - Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff provided care and treatments to patients. - Wore gloves when indicated and performed hand hygiene after glove removal and before re-gloving after removal. - Repeated the cleansing process of patients’ access sites before cannulation (insertion of a needle into the blood vessels to enable blood to be circulated between the patient and dialysis machine during dialysis treatment) when staff touched the area after the area was cleansed for five (#7, #15, #16, #17 and #18) patients out of seven observations conducted of staff cannulating patients’ access sites. - Removed gloves, performed hand hygiene, and re-gloved after staff removed and discarded the old dressing on patients’ Central Venous Catheter (CVC, a line placed in a large vein used to deliver dialysis treatments) exit site prior to cleansing the CVC exit site and applying a sterile dressing for three (#3, #4 and #13) out of five observations made of staff providing CVC exit site care. These failures to ensure staff practiced appropriate infection control prevention had the potential for cross contamination and the spread of infections to both patients and staff. The In-Center Hemodialysis census was 75 and the Home Peritoneal Dialysis census was 13 for a total census of 88. Findings included: HAND HYGIENE - GLOVE USE 1. Observation on 12/03/24 at 6:28 AM, showed Staff E, Certified Clinical Hemodialysis Technician (CCHT), connected Patient #2’s bloodlines and dialyzer to initiate the dialysis treatment. After Staff E finished with the connection process, Staff E removed gloves and re-gloved without performing hand hygiene before re-gloving. Observation on 12/03/24 at 6:41 AM, showed Staff D, CCHT, removed gloves and re-gloved without performing hand hygiene before re-gloving. Staff D then removed the glove from the right hand and re-gloved without performing hand hygiene before re-gloving. Observation on 12/03/24 at 6:45 AM, showed Staff B, CCHT, prepared Patient #18 for cannulation of the patient’s Arteriovenous Fistula (AVF - a permanent access that is surgically created by sewing an artery to a vein, usually located in the arm) access sites. After Staff B palpated the patient’s assess sites, Staff B failed to remove gloves, perform hand hygiene and re-glove before Staff B applied antiseptic to the patient’s skin for cannulation. Observation on 12/03/24 at 7:00 AM, showed Staff D, CCHT, prepared Patient #16 for cannulation of the patient’s AVF access sites. After Staff D palpated the patient’s assess sites, Staff D failed to remove gloves, perform hand hygiene and re-glove before Staff D applied antiseptic to the patient’s skin for cannulation. Observation on 12/03/24 at 3:15 PM, 3:21 PM, and 3:27 PM, showed Staff E, CCHT, removed gloves four times and re-gloved without performing hand hygiene before re-gloving each time gloves were removed and before re-gloving. Observation on 12/05/24 at 6:50 AM, showed Staff C, Patient Care Technician (PCT), prepared Patient #16 for cannulation of the patient’s AVF. After Staff C palpated the patient’s access sites, Staff C failed to remove gloves, perform hand hygiene and re-glove before Staff C applied antiseptic to the patient’s skin for cannulation. Observation on 12/05/24 at 9:20 AM and 9:23 AM, showed Staff B, CCHT, disinfecting patient Station #13. During the disinfection process, Staff B removed gloves four times and re-gloved without performing hand hygiene before re-gloving each time gloves were removed and before re-gloving. Observations on 12/05/24 showed Staff E, CCHT: - At 9:57 AM, Staff E touched the dialysis machine’s screen without wearing gloves. - At 10:00 AM, Staff E disconnected and removed the bloodlines from Patient #2, removed gloves but failed to perform hand hygiene after glove removal and before re-gloving. - Between 10:00 AM and 10:06 AM, Staff E removed gloves three times and re-gloved without performing hand hygiene before re-gloving each time gloves were removed and before re-gloving. - At 10:10 AM, Staff E removed gloves and placed a glove against the dialysis machine’s screen to turn off an alarm. - At 10:15 AM, Staff E wrapped a glove around a finger on the right hand to turn off the dialysis machine’s alarm at patient Station #20. - At 10:35 AM, Staff E touched the dialysis machine screen without wearing gloves. Observation on 12/05/24 at 10:13 AM, showed Staff B, CCHT, removed gloves and re-gloved without performing hand hygiene before re-gloving. Observation on 12/05/24 at 10:44 AM, showed Staff C, PCT, removed the glove from the right hand and re-gloved without performing hand hygiene before re-gloving. Observation on 12/05/24 at 11:16 AM, showed Staff E, CCHT, removed gloves twice and re-gloved without performing hand hygiene before re-gloving each time gloves were removed and before re-gloving. Observation on 12/05/24 at 11:25 AM, showed Staff B, CCHT, removed gloves twice and re-gloved without performing hand hygiene before re-gloving each time gloves were removed and before re-gloving. 2. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” dated April 2023, showed staff directives: - All Teammates, Physicians and Non-Physician (NP) will perform hand hygiene: - Prior to gloving and immediately after removal of gloves. - After patient and dialysis delivery system contact. - Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station. 3. Review of the facility’s policy titled, “AV Fistula or Graft Cannulation with JMS Sysloc ® Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” dated October 2024, showed staff directives: - Perform hand hygiene and put on PPE (Personal Protective Equipment - coat/gown, gloves, face shield or goggles). Hand hygiene protects patient and teammate from cross-contamination. PPE is worn to protect teammate. - Perform inspection, auscultation, and palpation on entire length of access. Determine presence of bruit and thrill. The presence of a bruit and thrill indicates flow through the access. - Locate and palpate the needle cannulation sites prior to skin preparation. - Remove gloves, perform hand hygiene, and put on clean gloves prior to cannulation. 4. During an interview on 12/05/24 at 1:15 PM, Staff A, Facility Administrator (FA), stated the expectation for staff was to perform hand hygiene before gloving, after removal of gloves and before re-gloving. Staff A stated staff should wear gloves anytime they touch the dialysis machine to program it or to shut off alarms. Staff A stated staff was expected to remove gloves, perform hand hygiene and re-glove after assessing and palpating patients’ access sites and before applying antisepsis to patients’ access sites before cannulation. Staff A stated staff expectations was to follow the facility’s policy and procedures related to hand hygiene and gloving. REPEAT THE CLEANSING PROCESS 5. Observation on 12/03/24 at 6:21 AM, showed Staff F, Registered Nurse (RN), cannulated Patient #15’s access sites for dialysis treatment. Staff F touched both bottom and top access sites, however, Staff F failed to repeat the skin antisepsis process before Staff F cannulated the patient’s access sites. Observation on 12/03/24 at 6:45 AM, showed Staff B, CCHT, cannulated Patient #18’s access sites for dialysis treatment. Staff B touched both bottom and top access sites, however, Staff B failed to repeat the skin antisepsis process before Staff B cannulated the patient’s access sites. Observation on 12/04/24 at 10:18 AM, showed Staff F, RN, cannulated Patient #7’s access sites for dialysis treatment. Staff F touched the top access site, however, Staff F failed to repeat the skin antisepsis process before Staff F cannulated the patient’s access site. Observation on 12/05/24 at 6:50 AM, showed Staff C, PCT, cannulated Patient #16’s access sites for dialysis treatment. Staff C touched the top access site, however, Staff C failed to repeat the skin antisepsis process before Staff C cannulated the patient’s access site. Observation on 12/05/24 at 11:00 AM, showed Staff C, PCT, cannulated Patient #17’s access sites for dialysis treatment. Staff C touched the bottom access site, however, Staff C failed to repeat the skin antisepsis process before Staff C cannulated the patient’s access sites. 6. Review of the facility’s policy titled, “AV Fistula or Graft Cannulation with JMS Sysloc ® Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” dated October 2024, showed staff directives: - Perform hand hygiene. - Perform inspection, auscultation, and palpation on entire length of access. Determine presence of bruit and thrill. - Locate and palpate the needle cannulation sites prior to skin preparation. - While maintaining aseptic technique (process that is maintained free of germs or bacteria), cleanse the sites by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. - Do not palpate insertion site once area has been prepped. Once the access sites has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 7. During an interview on 12/05/24 at 1:15 PM, Staff A, FA, stated the expectation of staff was to repeat the cleansing process before staff cannulate a patient’s access sites if staff touched the patient’s access sites after the cleaning process and to follow the facility’s policy and procedure related to cannulating patients’ access sites. CVC Exit Site Care 8. Observation on 12/05/24 at 10:12 AM, showed Staff B, CCHT, prepared Patient #13 for a CVC exit site dressing change. Staff B removed and discarded the old CVC dressing, however, Staff B failed to remove gloves, perform hand hygiene and re-glove after removal and discarding the old dressing. Wearing the same gloves, Staff B cleansed the CVC exit site and applied a sterile dressing. Observation on 12/05/24 at 11:15 AM, showed Staff E, CCHT, prepared Patient #3 for a CVC exit site dressing change. Staff E removed and discarded the old CVC dressing, however, Staff E failed to remove gloves, perform hand hygiene and re-glove after removal and discarding the old dressing. Wearing the same gloves, Staff E cleansed the CVC exit site and applied a sterile dressing. Observation on 12/05/24 at 11:25 AM, showed Staff B, CCHT, prepared Patient #4 for a CVC exit site dressing change. Staff B removed and discarded the old CVC dressing, however, Staff B failed to remove gloves, perform hand hygiene and re-glove after removal and discarding the old dressing. Wearing the same gloves, Staff B cleansed the CVC exit site and applied a sterile dressing. 9. Review of the facility’s policy titled, “Central Venous Catheter (CVC) With TEGO Connections or CVC End Caps Procedure,” dated October 2024, showed in part staff directives: - Use Dialysis Precautions and aseptic technique throughout procedure. - Perform hand hygiene per procedure. Hand hygiene protects patient and teammate from cross-contamination. - Remove old dressing and discard. - Remove gloves and discard, perform hand hygiene per procedure and re-glove. - Using aseptic technique clean exit site and each CVC limb/cap. - Remove gloves and discard, perform hand hygiene per procedure and re-glove. - Place sterile 2 X 2 gauze over the catheter exit site. - Remove gloves and discard, perform hand hygiene per procedure and re-glove. 10. During an interview on 12/05/24 at 1:15 PM, Staff A, FA, stated staff was expected to remove gloves, perform hand hygiene and re-glove after staff removed the old CVC exit site dressing and to follow the facility’s CVC Exit Site dressing change policy and procedure.”

“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: 18018 Based on observation, policy review, and interview, the facility failed to ensure staff appropriately disposed of bio-hazardous waste (blood and/or body fluids) for 11 out of 11 observations made of staff disposing bio-hazardous waste materials/items (used bloodlines and dialyzer) after patients’ dialysis treatments. This failed practice had the potential for increased exposure to blood and/or body fluids to both patients and staff. The In-Center-Hemodialysis census was 75 and the Home Peritoneal Dialysis census was 13 for a total census of 78. Findings included: 1. Observation on 12/02/24 at 4:18 PM showed Staff D, Patient Care Technician (PCT), carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #18 to the large red bio-hazardous cart located across from the clean sink in. Observation on 12/02/24 at 4:35 PM, showed Staff F, Registered Nurse (RN), carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #16 to the large red bio-hazardous cart located across from the clean sink. Observation on 12/03/24 at 1:55 PM, showed Staff B, Certified Clinical Hemodialysis Technician (CCHT), carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #16 to the large red bio-hazardous cart located across from the clean sink. Observation on 12/03/24 at 2:28 PM, showed Staff F, RN, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located at the end of the dirty sink. Observation on 12/04/24 at 9:42 AM, showed Staff F, RN, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located at the end of the clean sink. Observation on 12/04/24 at 10:24 AM, showed Staff D, CCHT, removed used bloodlines/dialyzer from patient Station #9 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located at the end of the dirty sink. Staff D carried the uncontained bio-hazardous items in front of Patient #11 at patient Station #6 and Patient #20 at patient Station #8 as the patients sat in the dialysis chairs receiving their dialysis treatments. Observation on 12/05/24 at 9:20 AM, showed Staff B, CCHT, removed used bloodlines/dialyzer from patient Station #13 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located across from the clean sink. Staff B carried the uncontained bio-hazardous items in front of Patient #21 at patient Station #12 as the patient sat in the dialysis chair receiving their dialysis treatment. Observation on 12/05/24 at 9:30 AM, showed Staff E, CCHT, removed used bloodlines/dialyzer from patient Station #15 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located across from the clean sink. Staff E carried the uncontained bio-hazardous items in front of Patient #9 at patient Station #13 and Patient #21 at patient Station #12 as the patients sat in the dialysis chairs receiving their dialysis treatments. Observation on 12/05/24 at 10:01 AM, showed Staff E, CCHT, removed used bloodlines/dialyzer from patient Station #19 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located across from the clean sink. Staff E carried the uncontained bio-hazardous items in from of the patient at patient Station #20 as the patient sat in the dialysis chair receiving their dialysis treatment. Observation on 12/05/24 at 10:24 AM, showed Staff E, CCHT, removed used bloodlines/dialyzer from patient Station #17 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located across from the clean sink. Staff E carried the uncontained bio-hazardous items in front of Patient #2 at patient Station #19 as the patient sat in the dialysis chair after removal of needles from the patient’s access sites. Observation on 12/05/24 at 11:04 AM, showed Staff B, CCHT, removed used bloodlines/dialyzer from patient Station $14 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located across from the clean sink. 2. Review of the facility’s policy titled, “Termination of Dialysis Utilizing B Braun Dialog + Dialysis Delivery Systems With All Single Use Dialyzer Types and Streamline Blood Lines,” dated October 2023, showed staff directives: Remove bloodlines and dialyzer per manufacturer’s recommendations and discard in bio-hazardous waste container. 3. During an interview on 12/05/24 at 1:15 PM, Staff A, Facility Administrator, stated the expectation of staff was to bring the large red bio-hazardous cart to the patient Station, remove the used bloodlines/dialyzer and dispose of the used bio-hazardous items in the large red bio-hazardous cart at the patient Station.”

“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: 18018 Based on observation, policy review, and interview the facility failed to ensure staff: - Consistently, thoroughly, and properly cleaned/disinfected patient Stations at the end of a patient’s dialysis treatment and prior to the initiation of the next patient’s dialysis treatment for four out of four observations made of staff performing Station disinfection. - Consistently only cleaned/disinfected the patient Stations after patients vacated the patient Station with the patient’s belongings at the completion of their dialysis treatment for two out of two observation conducted of staff cleaning/disinfecting the patient Stations while patients sat in the dialysis chair. - Consistently cleaned/disinfected the facility lift after being used to transfer patients for three out of four observations made of staff utilizing the facility lift to transfer patients from a wheelchair to the dialysis chair and from the dialysis chair to the wheelchair. These failures to properly clean external surfaces that are frequently touched by patients and staff, to ensure the patient vacated the patient Station prior to the cleaning/disinfection process, and to clean/disinfect the facility lift after being used on patients increased the potential for cross-contamination that could cause infection risks to all patients and staff. The In-Center-Hemodialysis census was 75 and the Home Peritoneal Dialysis census was 13 for a total census of 88. Findings included: PATIENT STATION CLEANING/DISINFECTION & VACATED PATIENT STATION 1. Observation on 12/05/24 at 9:31 AM, showed Staff E, Certified Clinical Hemodialysis Technician (CCHT), started to clean/disinfect patient Station #15 at the end of Patient #22’s dialysis treatment. As Patient #22 sat in the dialysis chair holding gauze to the access sites, Staff E cleaned/disinfected the front and base of the dialysis machine. Observation on 12/05/24 at 9:32 AM, showed Staff B, CCHT, failed to clean/disinfect the following items at patient Station #13: - The dialysis machine’s supply lines/cords; - The back of the dialysis machine; - The supply/wall box and the chase wall; - The emergency kit located on the Intravenous (IV - in a vein) pole hook; - Drop the dialysis chair’s side trays and clean all areas and surfaces of the side trays; - The blood pressure cords; - The television (TV), TV remote control and TV arm; - The IV pole hooks; and - The outside surface of the red sharps container and trash can. Observation on 12/05/24 at 9:41 AM, showed Staff C, Patient Care Technician (PCT), failed to clean/disinfect the following items at patient Station #11: - The prime bucket’s internal and external surfaces; - The emergency kit located on the IV pole hook; - Drop the dialysis chair’s side trays and clean all areas and surfaces of the side trays; - The blood pressure cuff and cords; - The TV, TV remote control and TV arm; and - The outside surface of the red sharps container and trash can. Observation on 12/05/24 showed Staff E, CCHT: - At 10:02 AM, Staff E failed to wait until Patient #2 had left patient Station #19 with their belongings before Staff E initiated the cleansing/disinfection process. Patient #2 sat in the dialysis chair while Staff E cleansed/disinfected the dialysis machine’s top, front, sides, base and back. - At 10:35 AM, Staff E failed to clean/disinfect the following items at patient Station #19: - The dialysis machine’s supply lines/cords; - The supply/wall box and chase wall; - The emergency kit located on the IV pole hook; - Drop the dialysis chair’s side trays and clean all areas and surfaces of the side trays; - The blood pressure cuff and cords; - The TV, TV remote control and TV arm; - The IV pole and hooks; and - The outside surface of the red sharps container and trash can. Observation on 12/05/24 showed Staff E, CCHT, failed to clean/disinfect the following items at a patient Station: - The dialysis machine’s supply lines/cords; - The back of the dialysis machine’s back; - The prime bucket’s interior and exterior surfaces; - The supply/wall box and chase wall; - The emergency kit located on the IV pole hook; - Dop the dialysis chair’s side trays and clean all areas and surfaces of the side trays; - The TV, TV remote control and TV arm; and - The outside surface of the red sharps container and trash can. FACILITY LIFT 2. Observation on 12/03/24 at 3:23 PM, showed Staff E, CCHT, and Staff F, Registered Nurse (RN), used the facility lift to transfer the patient at patient Station #19 from the dialysis chair to the patient’s wheelchair. At 3:30 PM, Staff E returned the facility lift to the equipment storage area without cleaning/disinfecting the lift after being used to transfer the patient. Observation on 12/04/24 at 10:30 AM, showed Staff M, CCHT, used the facility lift on Patient #11. After Staff M finished using the facility lift to transfer Patient #11, Staff M returned the facility lift to the equipment storage area without cleaning/disinfecting the lift after being used to transfer the patient. Observation on 12/05/24 at 10:51 AM, showed Staff E, CCHT, and Staff G, RN, used the facility lift on Patient #23 to transfer the patient from their wheelchair to the dialysis chair at patient Station #19. After Staff E and Staff G transferred the patient with the facility lift, Staff G returned the lift to the equipment storage area. Neither Staff E nor Staff G cleansed/disinfected the lift after being used to transfer the patient. 3. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” dated April 2023, showed staff directives: - Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. - At the end of each treatment, dialysis (patient) Station will be cleaned and disinfected. - Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). - Priming containers are to be emptied prior to disinfection. - Dialysis (patient) Station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the Station, clean or disinfect the station and set up for the next patient. 4. During an interview on 12/05/24 at 1:15 PM, Staff A, Facility Administrator, stated the expectation for staff was to: - Drop the dialysis chair’s side trays and clean/disinfect all surfaces/areas of the dropped side trays. - Clean/disinfect all surfaces and equipment in the patient Station. - Wait until the patient has vacated the patient Station with their belongings before staff started the process of cleansing/disinfection patient Stations. - Clean/disinfect the facility’s lift after each time the lift was utilized to transfer patients and before the lift was returned to the equipment storage area. Staff A stated the expectation of staff was to follow the facility’s infection control policy related to cleaning/disinfection of all surfaces and equipment in the patient Station and all surfaces of supplies, and equipment used on patients when teammates provided services, care, and treatments.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 18018 Based on observation, policy review, and interview, the facility failed to ensure medications and supplies were not expired and easily accessible for staff use. This failure had the potential to affect the quality of the medications and supplies and potentially cause an increase of complication due to the expired items. The facility In-Center-Hemodialysis Census was 75 and the Home Peritoneal Dialysis census was 13 for a total census of 88. Findings included: 1. Observation on 12/03/24 at 11:16 and 11:26 AM and 12/05/24 at 7:25 AM showed the following expired items: - Six red-topped blood specimen collection tubes with expiration date: 04/30/24 and Lot#: 2341162. - Five Zemplar (medication used to treat secondary hyperparathyroidism [increased parathyroid hormone levels]) 5 micrograms (mcg - unit of measurement) with expiration date: 09/23/24 and Lot#: A00004277. - Two HLA Antibody (Human Leukocyte Antigens - proteins found on the surface of cells in the body that help the immune system to identify foreign substances) Donor Specific Antibody Screen Kits with expiration date: 09/30/24. - Four Bactec Lytic/10 Anaerobic/F Culture Vials (used to identify rapid detection of bacteria and fungi in a person’s blood) 40 milliliters (mL - a measurement of liquid) with expiration date: 10/23/24 and Lot#: 4017860. - Two un-opened tubes of E-Z Check Blood Leak Test Strips with expiration date: 11/30/24 and Lot#: 101070. - One bottle of Cefepime (medication used to treat bacterial infections in the body) 1 gram with expiration date: 07/2024 with Lot#: 0015E11. - Two Fisherbrand Transport Swabs (used to collect and transport specimens to be tested for viruses) with expiration date: 09/17/23 and Lot#: 1J17A. 2. Review of the facility’s policy titled, “Obtaining Patient Lab Specimens,” dated April 2024, showed staff directives: Teammates are to verify the expiration date on all laboratory specimen tubes prior to collection. Expired laboratory specimen tubes are not to be used and are to be discarded in the sharps container. 3. Review of the facility’s policy titled, “Medication Policy,” dated November 2023, showed staff directives: - All open or unopened medication packages (i.e. vials, ampules etc..) are stored according to the manufacturer’s directions. Do not use any medications that has been stored improperly or has expired. - All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates. - Disposal of expired medications, including all over the counter and nutritional product samples are removed from treatment and inventory areas and disposed of per state/local regulations. 4. During an interview on 12/05/24 at 1:15 PM, Staff A, Facility Administrator, stated staff expectation was for staff to remove all outdated/expired supplies and medications, so the outdated/expired items are not easily accessible to staff for patient use. Staff A stated staff are expected to follow the facility’s policy and procedures related to outdate/expired supplies and medications.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 18018 Based on review of patients’ Treatment Details Report, policy review, and interview, the facility failed to ensure staff followed physician orders for: - Perform and document a pre-nursing treatment assessments within one hour of the start of the dialysis treatment for two patients (#7, and #8) out of five patients’ Treatment Details Report reviewed for pre-nursing treatment assessments. - Heparin (medication used to thin blood and/or prevent blood clot formation) administration for three patients (#6, #8, and #25) out of five patients’ Treatment Details Report reviewed for heparin loading bolus administration, 60-minute heparin stop time before the end of the dialysis treatment or no heparin stop time before the end of the dialysis treatment. The failure to follow the heparin order had the potential for dialysis complications including excessive bleeding or clotting for all patients that received heparin. - Duration of dialysis treatment for two patients (#6 and #25) out of five patients’ Treatment Details Report reviewed for duration of dialysis treatment. The failure to follow the prescription time had the potential for dialysis complications due to inadequate treatment time. - Blood flow rate (BFR - how fast blood is pumped through the dialyzer - artificial kidney and then pumped back into the patient during their hemodialysis treatment) for two patients (#7 and #8) out of five patients’ Treatment Details Report reviewed for BFR. - Dialysate flow rate (DFR - how fast toxins are removed from blood into the dialysate) for one patient (#8) out of five patients’ Treatment Flowsheets reviewed for DFR . The failure to follow the BFR and DFR order had the potential to affect the adequacy of patients’ dialysis treatments. These failures had the potential to affect all patients that received dialysis treatments at the facility. The In-Center Hemodialysis census was 75 and the Home Peritoneal census was 13 for a total census of 88. Findings included: 1. Review of Patient #6’s Treatment Details Report showed: - The hourly heparin infusion was ordered to be stopped 60 minutes before the end of the dialysis treatment. - The ordered duration of the dialysis treatment was 210 minutes (three hours and 30 minutes). - On 12/02/24 staff documented: - The hourly heparin infusion was stopped at 9:02 AM and the dialysis treatment ended at 11:02 AM. The hourly heparin infusion was not and stopped 60 minutes before the end of the dialysis treatment as ordered. - On 11/29/24 staff documented: - The hourly heparin infusion was stopped at 9:31 AM and the dialysis treatment ended at 10:01 AM. The hourly heparin infusion was not and stopped 60 minutes before the end of the dialysis treatment as ordered. - On 11/26/24 staff documented: - The hourly heparin infusion was stopped at 8:31 AM and the dialysis treatment ended at 10:07 AM. The hourly heparin infusion was not and stopped 60 minutes before the end of the dialysis treatment as ordered. - The dialysis treatment start time was 6:50 AM and the dialysis treatment was ended at 10:07 AM, which was approximately 17 minutes short of the ordered 210 minutes. Staff failed to document the reason the patient’s duration was short of the ordered duration time. Review of Patient #7’s Treatment Details Report showed: - The ordered BFR was ordered to run at 400 milliliters (mL)/per minute (min). - On 12/02/24 staff documented: - Staff failed to document a pre-nursing treatment assessment within one hour of the start of the patient’s dialysis treatment. The patient’s dialysis treatment was initiated at 10:55 AM and staff documented the pre-nursing Treatment Nurse Assessment at 1:34 PM, which was not within one hour of the start of the patient’s dialysis treatment. - The documented BFR was ran at 350 mL/min from 12:02 PM to 2:14 PM without documentation to explain the reason the BFR was not ran at the ordered rate. - On 12/26/24 staff documented: - Staff failed to document a pre-nursing treatment assessment within one hour of the start of the patient’s dialysis treatment. The patient’s dialysis treatment was initiated at 10:03 AM and staff documented the pre-nursing Treatment Nurse Assessment at 11:17 AM, which was not within one hour of the start of the patient’s dialysis treatment. Review of Patient #8’s Treatment Details Report showed: - The ordered BFR was ordered to run at 350 milliliters (mL)/per minute (min). - The DRF was ordered at 600 mL/min. - The hourly heparin infusion was ordered to run to the end of the dialysis treatment. - On 12/02/24 staff documented: - Staff failed to document a blood pressure every 30 minutes throughout the patient’s dialysis treatment. - The documented BFR was ran at 395 mL/min from 11:39 AM to 1:05 PM and ran at 400 mL/min from 1:41 PM to 3:08 PM without documentation to explain the reason the BFR was not ran at the ordered rate. - On 11/29/24 staff documented: - Staff failed to document a pre-nursing treatment assessment within one hour of the start of the patient’s dialysis treatment. The patient’s dialysis treatment was initiated at 11:44 AM and staff documented the pre-nursing Treatment Nurse Assessment at 1:28 PM, which was not within one hour of the start of the patient’s dialysis treatment. - Staff failed to document a blood pressure every 30 minutes throughout the patient’s dialysis treatment. - The hourly heparin infusion was stopped at 2:32 PM and the dialysis treatment ended at 3:27 PM. The hourly heparin infusion was not ran to the end of the dialysis treatment as ordered. - The documented BFR was ran at 400 mL/min throughout the patient’s dialysis treatment without documentation to explain the reason the BFR was not ran at the ordered rate. - The documented DFR was ran at 800 mL/min throughout the patient’s dialysis treatment without documentation to explain the reason the BFR was not ran at the ordered rate. - On 11/26/24 staff documented: - The hourly heparin infusion was stopped at 2:33 PM and the dialysis treatment ended at 3:25 PM. The hourly heparin infusion was not ran to the end of the dialysis treatment as ordered. - The documented DFR was ran at 500 mL/min throughout the patient’s dialysis treatment without documentation to explain the reason the BFR was not ran at the ordered rate. - On 11/24/24 staff documented: - The hourly heparin infusion was stopped at 2:02 PM and the dialysis treatment ended at 3:16 PM. The hourly heparin infusion was not ran to the end of the dialysis treatment as ordered. Review of Patient #25’s Treatment Details Report showed: - Heparin loading bolus ordered with every dialysis treatment. - The ordered duration of the dialysis treatment was 210 minutes (three hours and 30 minutes). - On 12/02/24 staff failed to document a blood pressure every 30 minutes throughout the patient’s dialysis treatment. - On 11/25/24 staff documented: - The loading heparin bolus was administered at 8:44 AM and the dialysis treatment was started at 8:41 AM. The loading heparin bolus was administered three minutes after the start of the dialysis treatment and not within three to five minutes before the start of the dialysis treatment. - The dialysis treatment start time was 8:41 AM and the dialysis treatment ended at 11:49 AM, which was approximately 22 minutes short of the ordered 210 minutes. Staff failed to document the reason the patient’s duration was short of the ordered duration time. 2. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated April 2024, showed staff directives: - The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. - Vital signs and treatment monitoring: Non-nocturnal treatments are completed at least every thirty (30) minutes (to include monitoring blood pressure every 30 minutes). - If the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain blood flow rate) the reason will be documented and the licensed nurse informed. 3. Review of the facility’s policy titled, “Anticoagulation,” dated September 2024, showed staff directives: - Heparin is administered per physician/Non-Physician Practitioner (NPP) order. Order is to include date, time, patient name, route, frequency and as applicable; heparin loading does, hourly infusion or bolus does, CVC (Central Venous Catheter - a line placed in a large vein used to deliver dialysis treatments) locking solution and stop/discontinuation time. - To anticoagulated the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the central venous catheter (CVC) as least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment. 3. During an interview on 12/05/24 at 1:15 PM, Staff A, Facility Administrator, stated expectations of staff was to follow physician’s prescription orders and if the orders were not followed, staff was expected to document the reason the orders were not followed in the patient’s Electronic Medical Health Record. Staff A stated staff was expected to follow the facility’s policy and procedures.”