Davita Niagara Falls Kidney Center

“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: 40430 Based on policy review, observation, and interview, the facility does not ensure that staff follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff do not change gloves and/or perform hand hygiene when entering/exiting the dialysis station, when performing safety checks/touching the machine, and/or when using the chairside computer keyboard while monitoring patients during their hemodialysis treatment. Findings include: Review of the policy “Infection Control for Dialysis Facilities,” last revised 04/2023 indicated all teammates will perform hand hygiene prior to gloving and immediately after the removal of gloves, after patient and dialysis delivery system contact, and before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station. The chairside cart, monitor and keyboard are considered clean areas. Observation on 06/02/25 at 10:40 AM at Station #3 for Patient #18 revealed Staff (J), Patient Care Technician, touched the sharps container (puncture/leak resistant container that holds contaminated needles and sharps) to pull it closer to the station. Without changing gloves or performing hand hygiene, Staff (J) cannulated (inserted needles) Patient #18’s fistula (surgically created access to perform dialysis) then flushed the needles with normal saline (NS-intravenous solution used during dialysis). At 10:50 AM Staff (J) removed their gloves, performed hand hygiene then touched the dialysis machine display screen without wearing gloves, then typed on the computer keyboard on the chairside computer stand. At 10:55 AM at Station #3 for Patient #18, Staff (H), Licensed Practical Nurse, entered the station without performing hand hygiene before applying gloves and administering heparin (medication used to prevent clotting during dialysis) through Patient #18 fistula needle. Observation on 06/02/25 at 11:10 AM at Station #1 for Patient #16 revealed Staff (J), Patient Care Technician, perform hand hygiene, then put a glove onto their left hand but not their right hand. Staff (J) touched the dialysis machine screen with their gloved left hand while typing on the computer keyboard on the chairside computer stand with their right hand. After touching the dialysis machine screen, Staff (J) removed the glove from their left hand, did not perform hand hygiene, and used both hands to type on the computer keyboard. At 11:25 AM at Station #4 for Patient #22, Staff (J) did not wear a glove while touching the dialysis machine screen with their right hand and typing on the keyboard on the chairside computer stand with left hand. Without performing hand hygiene, Staff (J) began to type on the computer keyboard on the chairside computer stand with both hands. Observation on 06/03/25 at 09:50 AM at Station #9 for Patient # 24, Staff (M), Registered Nurse, had a glove on their right hand but not on their left hand. Staff (M) touched the sharps container with their ungloved left hand to pull it closer to the station. Without performing hand hygiene, Staff (M) put a glove on their left hand to administer medication through the dialysis tubing. Staff (M) removed their gloves, did not perform hand hygiene, and put on a new pair of clean gloves to check/aspirate/flush Patient #24 central venous catheter (CVC- tube inserted into a large vein in the body to provide access for dialysis) ports. At 10:55 AM at Station #9 for Patient # 24, Staff (M), Registered Nurse discontinued treatment. Staff (M) discarded used syringes into the sharp’s container. Without removing gloves and performing hand hygiene Staff (M), exited the station to retrieve a roll of tape from the common clean supply cart. Staff (M) re-entered Station #9 removed a syringe from a port of Patient #24’s CVC and placed a cap on the port. Staff (M) removed their gloves, but did not perform hand hygiene before putting on a new clean pair of gloves. Interview on 06/04/25 at 01:00 PM with Staff (B), Facility Administrator, and Staff (G), Regional Coordinator, verified these findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, the facility does not ensure staff wear personal protective equipment (PPE-equipment worn for protection from workplace hazards such as blood). Specifically, staff do not wear protective face/eyewear appropriately when performing procedures during which spurting or splattering of blood may occur. Findings include: Review of policy “Infection Control For Dialysis Facilities,” revised April 2023, revealed appropriate PPE will be worn whenever there is the potential for contact with body fluids. Observation on 06/02/25 revealed Staff (J), Patient Care Technician, wore their face shield pushed up high on their forehead, above their eyeglasses, without side shields, that did not cover and/or protect their eyes or mouth during the following activities: -At 10:55 AM at Station #2, Staff (J), cannulated (inserted needles) the fistula (surgically created access to perform dialysis) for Patient #16, flushed the needles with a syringe, then connected the bloodlines to the needles to initiate the treatment. -At 11:00 AM at Station #3, Staff (J), connected the bloodlines to the needles for Patient #18 to initiate treatment. -At 11:10 AM at Station #4, Staff (J), cannulated the fistula for Patient #22, flushed the needles with a syringe, then connected the bloodlines to the needles to initiate the treatment. -At 02:35 PM at Station #3, Staff (J), terminated treatment for Patient #18. Staff (J) disconnected the bloodlines from the fistula needles, removed the needles from the fistula, and stripped the dirty bloodlines from the hemodialysis machine. -At 02:45 PM at Station #1, Staff (J), terminated treatment for Patient # 5. Staff (J) disconnected the bloodlines from the fistula needles, removed the needles from the fistula, and manually held pressure to the needle sites until the bleeding stopped. Observation on 06/03/25 at 10:00 AM at Station #15 revealed Staff (J), Patient Care Technician, terminated treatment for Patient #15. Staff (J) disconnected the bloodlines, then removed both needles from the fistula wearing their face shield up high on their forehead not covering their mouth. Interview on 06/04/25 at 01:00 PM with Staff (B), Facility Administrator, and Staff (G), Regional Coordinator, verified these findings.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, staff do not utilize aseptic technique (practices to prevent spread of infection) when distributing and administering intravenous (IV-administration of fluids and/or medications into a vein) medication. Findings include: Review of policy “Preparation and Administration of Parenteral Medications,” revised April 2024, indicated to distribute the medication to the patient station in an aseptic manner and when medication administration is complete remove gloves and perform hand hygiene. Review of the policy “Infection Control for Dialysis Facilities,” revised April 2023, indicated measures will be taken to prevent cross contamination between patients. Gloves will be worn when touching one patient or their dialysis delivery system (tubing and/or machine used to deliver hemodialysis treatment) and before arriving to touch another patient’s dialysis delivery system. Observation on 06/03/25 at 11:45 AM in the medication room revealed Staff (M), Registered Nurse, drew up medication into syringes for four different patients and placed the syringes in a small plastic basket. At 12:00 PM, Staff (M) walked over and placed the small basket of medication on the chairside computer stand between Station #2 and Station #4. Staff (M) performed hand hygiene, put on clean gloves, removed a medication syringe from the basket and administered the medication through Patient #23 dialysis tubing. Without removing gloves or performing hand hygiene, Staff (M) retrieved a second medication syringe from the small basket and administered it to Patient #23 through their dialysis tubing. Without removing gloves or performing hand hygiene Staff (M) picked up the small basket and exited Station #2. At 12:05 PM, Staff (M) walked over and placed the small basket on the chairside computer stand between Station #1 and Station #3. Staff (M) removed their gloves, performed hand hygiene, and applied a clean pair of gloves. Staff (M) retrieved a syringe of IV medication from the small basket and administered it to Patient #13 through their dialysis tubing. Interview on 06/04/25 at 01:00 PM with Staff (B), Facility Administrator, and Staff (G), Regional Coordinator, verified these findings.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, in three of three months reviewed, the facility does not ensure that corrective actions were performed when the daily water readings are not within facility established parameters (March, April, and May of 2025). Findings include: Review of the policy “Daily Water Treatment System Monitoring,” revised April 2025, indicated if observations or test results are found outside the specified limits, staff are to follow the instructions given on the log for the parameters in question. The staff member completing the log will notify the facility administrator/designee and biomed of any observations or test results outside the limits. A licensed nurse will review the log for completeness and verify all parameters are within the specified limits. Upon satisfactory completion of this review, the licensed nurse will initial and sign the log. Review of the “CWP (Continuous Water Purification-a system to purify the water used for hemodialysis) Daily Water Log,” from March 2025 to May 2025, revealed the following daily readings that were not within the facility established parameters: -The “Pure Water Flow Rate (product water),” readings were not greater than15 liters/minute on 03/03/25, 04/01/25, 04/02/25, 04/17/25, 05/19/25 through 05/31/25. -The “Ultrafilter Outlet Pressure (the pressure that separates solid particles form liquid using a membrane),” readings were not greater than 60 psi (pound per square) and less than 100 psi on 03/22/25, 03/26/25, 03/31/25, 04/21/25, 04/22/25, 04/28/25, 04/29/25, and 04/30/25. -The “Ultrafilter Delta Pressure (pressure that separates solid particles from liquid but retains minerals using a pore sized membrane)” readings were not less than 30 psi on 03/03/25, 03/04/25, 03/31/25, 04/01/25, 04/02/25, 04/15/25, 04/16/25, 04/17/25, 04/18/25, and 04/30/25. -Staff notified Biomed of the readings that were not within established parameters on 03/03/25, 03/04/05, 03/05/25, 03/19/25, 03/26/25, 03/29/25, 04/02/25, 04/18/25, 04/28/25, 05/19/25 through 05/31/25. No corrective actions were found addressing the out-of-range readings. No evidence was found to indicate a licensed nurse reviewed the logs and verified parameters were within the specific limits. Interview on 06/03/25 at10:20 AM with Staff (F), Biomedical Technician, verified these findings.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 16136 Based on document review, and interview, in three of three months reviewed, the facility does not ensure the hot water return temperature of the CWP (Continuous Water Purification- a system to purify the water used for hemodialysis) is 85 degrees Celsius when utilized to disinfect the water system (March, April, and May of 2025). Findings include: Review of the manufacturer recommendations “The 2012 Mar Cor Purification CWP 100, Model H/S, Revision B,” indicated the return hot water from the distribution loop from the farthest point should be 85 degrees Celsius when using hot water to disinfect the water loop. Review of the “CWP Daily Water Log,” from March 2025 to May 2025 did not document the hot water temperature during the nightly disinfection of the CWP water loop. Interview on 06/02/25 at 02:25 PM with Staff (F), Biomedical Technician, and Staff (L), Biomedical Operations Manager, verified this finding.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 16136 Based on document review and interview, in five of five months reviewed, the facility does not ensure that the one-micron filter (to remove micron size particles) on the acid mixing tank is replaced after six batches of acid has been mixed. Findings include: Review of the manufacturer recommendations “GranuFlo Concentrate Dissolution Unit Operator’s Manual, Revision E, Acid Concentrate Mixing and Handling,” indicated the one-micron filter should be changed after mixing six batches of acid concentrate.” Review of the “Granuflo (132 Gallon) Batch Production Record (for acid mixing),” from 01/23/25 to 05/30/25, revealed that the one-micron filter was changed on 01/08/25. The next filter change did not occur until 05/16/25, after 12 batches of acid concentrate had been prepared. Interview on 06/04/25 at 12:25 PM with Staff (F), Biomedical Technician, verified this finding.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that the sprinkler system was maintained. Findings include: Observation on 06/02/25 at 10:45 AM, in the water room revealed the sprinkler head (discharges water when a fire has been detected by the fire prevention system) had dropped down approximately two inches from the ceiling tile requiring repair. Sprinkler systems must be maintained per National Fire Protection Association (NFPA) 25-2011 edition to ensure proper operation in the event of an actual fire. Interview on 06/02/25 at 10:55 AM with Staff (F), Biomedical Technician, verified this finding.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that the hemodialysis machines were cleaned, and heat disinfected daily; the hemodialysis machines were chemically disinfected weekly; the hemodialysis machines were tested for residual disinfectant prior to use after being chemically disinfected (March, April, May of 2025); and that weekly maintenance was performed for four of five oxygen (O2) concentrators (January, February, March, April, and May 2025). Findings include: Review of the policy “Nipro Surdial DX Dialysis Delivery System Cleaning and Disinfection Policy,” reviewed April 2024, indicated 50% Citric Acid/ Thermal Disinfection (disinfection method used to reduce bacteria and biofilm (layer of bacteria that attaches to a surface) in the water system) is to be performed daily and chemical disinfection is to be performed weekly with the verification of a negative chemical residual test prior to the hemodialysis machine’s next use. Review of the “Nipro Surdial DX Dialysis Delivery System Clean and Disinfect Log,” from March 2025 to May 2025, revealed the following: -Hemodialysis machines were not acid cleaned and heat disinfected daily on 03/12/25, 03/19/25, 04/02/2504/05/25, 04/12/25, 04/19/25, 05/15/25 and 05/23/25. -Hemodialysis machines were not chemically disinfected during the weeks of 04/13/25, 05/11/25 and 05/19/25. -Staff did not obtain a test to verify negative chemical residual after chemical disinfection on 04/04/25, 04/10/25 and 05/09/25. Review of the “Oxygen Concentrator Filter Cleaning Log,” from January 2025 to May 2025, indicated cleaning will be performed weekly per specified manufacturer instructions. The log revealed weekly cleaning was not performed for the following weeks revealed the following: -O2 concentrator “N253864DS” did not have the filter cleaned the week of 01/26/25, 02/09/25, 02/23/24, 03/09/25 and 04/13/25. -O2 concentrator “N227019DS” did not have the filter cleaned the week of 02/09/25, 03/09/25 and 04/13/25. -O2 concentrator “B21C16061405” did not have the filter cleaned the week of 01/26/25, 02/09/25, 02/23/25, 03/09/25 and 04/13/25. -O2 concentrator “N238795DS” did not have the filter cleaned the week of 01/27/25, 02/09/25, 02/24/25, 03/09/25, 04/13/25 and 05/11/25. Interview on 06/04/25 at 01:15 PM with Staff (F), Biomedical Technician, verified these findings.”

“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: 40430 Based on policy review, medical record review, and interview, in five of seven medical records reviewed, nursing staff did not ensure blood flow rates (BFR-speed at which blood is pumped through the dialyzer or artificial kidney during dialysis) and dialysate flow rates (DFR-the rate fluid passes through the dialyzer to remove toxins from a patient’s bloodstream) are implemented and/or maintained per physician order (Patient #2, Patient #7, Patient #9, Patient #10, and Patient #17). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, indicated if the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate), the reason will be documented, and the licensed nurse will be informed. Review of the medical record treatment flowsheets for Patient #2 dated 05/19/25 to 05/30/25 revealed an ordered/prescribed BFR of 350 milliliters/minute (ml/min) and a DFR of 700ml/min. The BFR and DFR were not implemented as ordered on 05/19/25 and 05/22/25. There was no documentation in the medical record to indicate why the BFR and DFR were not implemented as ordered. Review of the medical record treatment flowsheets for Patient #7 dated 05/08/25 to 05/29/25 revealed an ordered BFR of 350 ml/min and DFR of 800ml/min. The BFR was not implemented as ordered on 05/22/25, 05/27/25, and 05/29/25. The DFR was not implemented on 05/15/25, and 05/27/25. There was no documentation in the medical record to indicate why the BFR and DFR were not implemented as ordered. Review of the medical record treatment flowsheets for Patient #9 dated 05/09/25 to 06/02/25 revealed an ordered DFR of 800ml/min. The DFR was not implemented as ordered on 05/12/25. There was no documentation in the medical record to indicate why the DFR was not implemented as ordered. Review of the medical record treatment flowsheets for Patient #10 dated 05/08/25 to 05/31/25 revealed an ordered BFR of 400ml/min and DFR of 600ml/min. The BFR and DFR were not implemented and/or maintained as ordered on 05/17/25, 05/22/25, and 05/24/25. The DFR was not implemented as ordered on 05/10/25. There was no documentation in the medical record to indicate why the BFR and DFR were not implemented and/or maintained as ordered. Review of the medical record treatment flowsheets for Patient #17 dated 05/09/25 to 05/30/25 revealed an ordered BFR of 400 ml/min and DFR of 700ml/min. The BFR was not implemented and/or maintained on 05/12/25, 05/14/25, 05/23/25, and 05/30/25. The DFR was not implemented as ordered on 05/19/25. There was no documentation in the medical record to indicate why the BFR and DFR were not implemented and/or maintained as ordered. Interview on 06/04/25 at 01:00 PM with Staff (B), Facility Administrator, and Staff (G), Regional Coordinator, verified these findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, in three of seven medical records reviewed, the patient care technician did not notify the registered nurse regarding changes in a patient’s condition and/or prescription (Patient #2, Patient #17 and Patient #20). Findings include: Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024 indicated abnormal intradialytic (during dialysis) data collection findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. All findings, interventions, and patient response will be documented in the record. Review of medical record treatment flowsheets revealed the patient care technician did not notify the registered nurse of changes in condition and/or physician ordered parameters for the following patients: -On 05/26/25 at 12:54 PM, the patient care technician reduced blood flow rate (BFR) for Patient #2 from the prescribed rate, but did not notify the registered nurse. -On 05/30/25 at 01:34 PM, 01:35 PM, and 01:38 PM, Patient #17 experienced elevated blood pressures. The patient care technician documented rechecking the elevated blood pressures but did not notify the registered nurse. -On 05/14/25 at 08:52 AM, treatment was initiated for Patient #20 by a patient care technician. The prescribed BFR was not implemented as ordered and continued at a reduced rate until the end of treatment at 12:02 PM with no registered nurse notification. On 05/16/25 at 09:53 AM, the patient care technician reduced the BFR from the prescribed rate but did not notify the registered nurse. On 05/21/25 at 10:53 AM, Patient #20 experienced a decrease in blood pressure. The patient care technician rechecked the blood pressure, turned the ultrafiltration rate (UFR-removal of fluid) off, and reduced the BFR from the prescribed rate. At 11:15 AM, the patient care technician turned the UFR back on at a reduced rate, and did not return the BFR to the prescribed rate. The patient care technician did not notify the registered nurse of any of these events and/or interventions. Interview on 06/04/25 at 01:00 PM with Staff (B), Facility Administrator, and Staff (G), Regional Coordinator, verified these findings.”