Fkc Montgomery

“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: 49894 Based on observations, review of facility policies, and staff interview it was determined the facility failed to ensure staff followed policies related to infection prevention and control which could result in transmission of bacteria and poor patient outcomes. This did affect Patient Identifier (PI) # 20 in one of three observations of discontinuation of dialysis with an Arteriovenous Fistula/Graft (AVF/AVG), PI # 19 in one of three observations of discontinuation of dialysis with a Central Venous Catheter (CVC), PI # 13, PI # 8, PI # 11, in three of four observations of initiation of dialysis with a Arteriovenous Fistula/Graft (AVF/AVG), and one of four observations of cleaning of the dialysis station, and had the potential to negatively affect all 89 patients dialyzing at this facility. Findings include: Facility Policy: Hand Hygiene Policy Number: Not listed Date Published: Not listed Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol bases antiseptic hand rub ... Hands will be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water when ... Before and after direct contact with patients, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain, or water lines, after contact with other objects within the patient station or treatment space. Caution Regarding Fingernails: Do not wear artificial fingernails, extenders, or nail wraps when having direct contact with patients. Natural fingernail length shall be kept to ¼ inch or less. Facility Policy: Access Assessment and Cannulation Reference Number: 45178 Published: 5/6/24 ...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin...when performed properly, increases the longevity of the access...minimizes...complications... Policy: Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. Assessment of Vascular Access: ...6. Listen: Bruit high pitch/whistle... 7. Feel: Pulse not soft/not easily compressible Thrill not strong...not present 9...After assessing the access, staff must perform hand hygiene and don new gloves. With the new gloves, staff may perform the full cannulation procedure including skin disinfection... 1. An observation was conducted on 1/29/25 at 10:15 AM with Employee Identifier (EI) # 9, Certified Clinical Hemodialysis Technician (CCHT) discontinuing treatment and performing post dialysis access care for PI # 20 at station 14. EI # 9 had very long, artificial nails. This surveyor asked EI # 9 if the nails were artificial and he/she replied, “They are gel nails.” An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area Registered Nurse (RN), who confirmed artificial nails and/or nails longer than ¼ inch in length were not per facility policy. 2. An observation was conducted on 1/29/25 at 11:00 AM with EI # 9 performing cleaning and disinfection of the dialysis station at station 14. After emptying the prime waste container, EI # 9 failed to remove his/her gloves, perform hand hygiene, and don clean gloves before continuing disinfection of the dialysis station. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, who confirmed staff failed to perform hand hygiene after emptying the prime waste container per facility policy. 3. An observation of access of AVF/AVG for initiation of dialysis for PI # 8 was conducted on 1/29/25 at 11:35 AM with EI # 3, CCHT at station 1. With gloves on, EI # 3 cleaned the stethoscope with an alcohol pad, evaluated the access using auscultation, cleaned the access sites with alcohol pads, and cannulated the access. EI # 3 failed to perform hand hygiene and don clean gloves after cleaning the stethoscope and after access site evaluation. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, Facility Administrator, and EI # 12, Director of Operations. who confirmed staff failed to follow the facility policy hand hygiene policy during AVF/AVG cannulation. 4. An observation of access of AVF/AVG for initiation of dialysis for PI # 11 was conducted on 1/29/25 at 11:44 AM with EI # 5, CCHT, at station 21. With gloves on, EI # 5, evaluated the access using auscultation, cleaned the access sites with alcohol pads, and cannulated the access. EI # 5 failed to perform hand hygiene and don clean gloves after access site evaluation. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, and EI # 12, who confirmed staff failed to follow the facility policy hand hygiene policy during AVF/AVG cannulation. 5. An observation was conducted on 1/29/25 at 12:00 PM at station 2 with EI # 3, CCHT, initiating dialysis with an AVF for PI # 13. After EI # 3 evaluated the access he/she failed to change gloves and perform hand hygiene. An interview was conducted on 1/31/25 at 10:29 AM with EI # 2, who confirmed the staff failed to perform a glove change and hand hygiene per facility policy. 6. An observation was conducted on 1/30/25 at 10:20 AM with EI # 8, RN, performing discontinuation of dialysis with a CVC for PI # 19 at station 32. EI # 8 entered the patient station with gloves on. EI # 8 failed to remove the gloves, perform hand hygiene, and don new gloves before discontinuing treatment for PI # 19. After completing the CVC discontinuation, EI # 8 removed his/her gloves and exited the station without performing hand hygiene. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, who confirmed staff failed to perform hand hygiene per facility policy. 30952 49797”

“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: 49894 Based on observations, review of facility policies, and staff interview, it was determined the facility failed to ensure staff and patients wore masks appropriately during discontinuation of dialysis with a Central Venous Catheter (CVC) and initiation of dialysis with a CVC. This affected Patient Identifier (PI) # 19 in one of three observations of discontinuation of dialysis with a CVC and PI # 18 in one of three observations of initiation of dialysis with a CVC and had the potential to negatively affect all patients with a CVC dialyzing at this facility. Findings include: Facility Policy: Termination of Treatment Using a CVC and Optiflux Single Use Ebeam Dialyzer Reference Number: 45640 Version: 8 Published: 11/4/24 ...Prior to Termination: Preparation ...3. Don gown and full face shield with mask...Place mask on patient. Facility Policy: Central Venous Catheter Dressing Change Reference Number: 47516 Version: 5 Published: 5/6/24 ...Removal of Dressing and Inspection of Site ...2. Apply a mask to the patient and Inpatient Services Staff 1. An observation was conducted on 1/30/25 at 10:20 AM with Employee Identifier (EI) # 8, Registered Nurse (RN) discontinuing dialysis with a CVC for PI # 19. During the entire procedure, the mask worn by PI # 19 was below his/her nose and was never corrected by EI # 8. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area RN, who confirmed staff failed to ensure the mask was properly worn by the patient per facility policy. 2. An observation was conducted on 1/30/25 at 11:40 AM with EI # 8 initiating dialysis with a CVC for PI # 18 at station 5. Before starting the procedure, EI # 8 did not place a mask on PI # 18 and the patient did not have on a mask during the entire procedure. EI # 8 did not ensure his mask was properly worn and covering his nose during the procedure. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area RN, who confirmed staff failed to ensure the mask was properly worn by the patient and his/herself per facility policy.”

“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: 49797 Based on observations, facility policy and procedure, and interviews it was determined the facility failed to ensure the staff cleaned and disinfected the dialysis station per the policy. This did affect one of four observations of cleaning of the dialysis station and had the potential to negatively affect all 89 patients served by this facility. Findings Include: Facility Policy: Cleaning and Disinfecting the Dialysis Station Published: 9/5/2023 Reference Number: 47806 Purpose: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with the appropriate regulations, and to maintain a clean safe, and aesthetically pleasant environment for patients, staff, and visitors... General Cleaning: The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station (ex. stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station... Work Surface Cleaning and Disinfection without Visible Blood using Bleach Solutions: All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make sure the surface is glisteningly wet and let air dry unless otherwise specified by the manufacturer... 1. An Observation was conducted on 1/29/25 at 10:46 AM with Employee Identfier (EI) # 7, Certified Clinical Hemodialysis Technician (CCHT) during cleaning and disinfection at dialysis station 9. The CCHT failed to clean the shelf behind the dialysis station. An interview was conducted on 1/31/25 at 10:29 AM with EI # 2, Area Registered Nurse (RN), who confirmed the staff failed to follow facility policy and disinfect all dialysis station surfaces. 30952 2. An observation of cleaning and disinfection of the dialysis station was conducted on 1/29/25 at 12:10 PM at station 24 with EI # 5. EI # 5 failed to disinfect the top of the intravenous (IV) pole, the hooks, laminate, and stethoscope. EI # 5 failed to disinfect the blood pressure (BP) cuff tubing, the wire basket and basket inside, the hand sanitizer/holder, and surrounding counter. EI # 5 placed the cleaned BP cuff on the counter which was not disinfected. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, Facility Administrator and EI # 12, Director of Operations, who confirmed staff failed to follow the policy for disinfection of the dialysis station.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 49894 Based on review of the facilities Hepatitis B Summary Report and staff interview, it was determined the facility failed to obtain Hepatitis B Vaccination Declinations for patients declining the Hepatitis B Vaccination. This did affect one of five patients who were candidates for the vaccine and refused the Hepatitis B Vaccination and had the potential to negatively affect all susceptible patients dialyzing at the facility. Findings Include: Facility Policy: Patient Vaccination for Hepatitis B Reference Number: 47676 Version: 5 Published: 2/7/22 ...Declination Patients who are candidates for the Hepatitis B vaccine and decline, should be offered the Hepatitis B vaccine on an annual basis, at minimum. Provide education as needed. A vaccine declination must be signed by the patient each year the vaccine is offered and refused. Each offering of the vaccine should be documented in the patient’s medical record. After reviewing the facility’s Hepatits B Summary Report, five patients who were candidates for the Hepatitis B Vaccine and had declined the vaccine were selected and a Hepatitis B vaccine declination for each patient was requested. The facility was unable to provide a declination for one of the five patients selected. An interview was conducted on 1/31/25 at 12:45 PM with Employee Identifier # 2, Area Registered Nurse, who confirmed the facility failed to obtain a Hepatitis B vaccination declination for the selected patient per the facility policy.”

“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: 49894 Based on observation, review of facility policy, and staff interview, it was determined the facility failed to ensure staff kept pre-drawn heparin under the preparer’s control or in a locked, dedicated storage area until delivery to the patient. This affected Patient Identifier (PI) # 17 in one of four observations of access of the Arteriofistula/Graft (AVF/AVG) for initiation of dialysis and PI # 19 in one of three observations of discontinuation of dialysis with a Central Venous Catheter (CVC) and had the potential to affect all patients who receive heparin at the facility. Findings include: Facility Policy: Medication Preparation Reference Number: 47488 Version: 9 Published: 2/6/23 ...Pre-drawing Medications ...These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated area...until the delivery to the appropriate patient for administration. ...Securement All medications will be kept in a locked cabinet except when in use. 1. An observation was conducted on 1/29/25 at 11:30 AM with Employee Identifier (EI) # 9, Certified Clinical Hemodialysis Technician (CCHT) performing access of the AVF/AVG for initiation of dialysis for PI # 17 at station 13. The heparin syringe for PI # 17 was laying on the chairside table with other supplies. After EI # 9 accessed the AVF/AVG, the Registered Nurse (RN) came to the station and administered the heparin to the patient. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area Registered Nurse (RN), who confirmed the heparin was not kept under the prepare’s control or in a locked designated area until delivery to the patient per facility policy. 2. An observation was conducted on 1/30/25 at 10:20 AM with EI # 8, RN, discontinuing dialysis with a CVC for PI # 19 at station 32. This surveyor accompanied the RN into the patient station and observed two three milliliter syringes containing heparin for heplock (heparin instilled in the CVC limbs to prevent clotting) previously placed on the chairside table. After completing the discontinuation, EI # 8 instilled the heparin into PI # 19’s CVC limbs. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area RN, who confirmed the heparin was not kept under the preparer’s control or in a locked designated area until delivery to the patient per facility policy.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 49797 Based on observation, review of facility policy, and interviews it was determined the facility failed to ensure the staff followed the policy when terminating treatment using a Central Venous Catheter (CVC). This affected one of three observations of CVC exit site care, including Patient Identifier (PI) # 10 and PI # 14 in one of three observations of discontinuation of dialysis with a CVC and had the potential to affect all patients with a CVC served by this facility. Findings include: Facility Policy: Termination of Treatment Using Central Venous Catheter and Optiflux Single use Ebeam Dialyzer. Published: 11/4/2024 Reference Number: 45640 Purpose: The purpose of this procedure is to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment using a CVC and an Optiflux Single Use electron beam (ebeam) Dialyzer. Supplies: The following supplies are needed for this procedure: ...Under pad- if exiting pad is soiled... Prior to Termination Preparation: Follow these steps below to prepare for the termination of dialysis. Step: ...5. Ensure that a clean underpad is below the catheter limbs to protect the work area and the clothing... Termination: Disinfection of the Catheter and Disconnecting the Patient. Follow the steps below to disinfect the catheter and to disconnect the patient from the extracorporeal system... Step: 1. Obtain the patient’s sitting blood pressure (with legs down) and standing blood pressure ( if patient is able to stand) prior to disconnecting the patient... 6. ...Do not place uncapped catheter limbs on under pad to prevent contamination... 1. An observation of care was conducted on 1/29/25 at 10:50 AM at station 2 with Employee Identifier (EI) # 8, Registered Nurse (RN), during discontinuation of dialysis with a CVC for PI # 10. The surveyor observed 3 blood/fluid stains on PI # 10’s barrier pad while EI # 8 prepared to discontinue dialysis with a CVC. EI # 8 failed to place a clean barrier under the CVC ports before reinfusing the extracorporeal circuit, disinfection of the hubs, and blood line disconnection. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, Clinical Manager, and EI # 12, Director of Operations, who confirmed staff must change the under pad if the existing barrier pad was soiled. 2. An observation was conducted on 1/29/25 at 11:22 AM with EI # 6, RN, during discontinuation of dialysis with a CVC for PI # 14 at station 12. PI # 14 stood up for post-treatment blood pressure check, and the under pad fell from the chest area onto the floor. The patient sat back down before the cleaning of the CVC limbs, and EI # 6 continued with the care of the CVC and did not replace the under pad. An interview was conducted on 1/31/25 at 10:29 AM with EI # 2, Area Registered Nurse (RN), who confirmed staff did not follow facility policy for discontinuation of dialysis with a CVC. 30952”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 30952 Based on the review of the Manufacturer Directions for Use, facility Clinical Log Readings Report, and interviews, it was determined the facility failed to ensure staff conducted and documented the disinfection for all Reverse Osmosis (RO-water purification method) units every week. This had the potential to affect the 89 patients served by this facility. Findings include: Manufacturer Directions for Use: Mar Cor Purification CWP (circulating water pump) 100 Operators Guide: 3. Regular Maintenance 3.2 Chemical Disinfection: Chemical Disinfection ensures a high microbiological water quality... 3.2.1 Frequency: Disinfection must be performed on a regular basis to ensure consistent microbiological quality of the product water. The required frequency depends on factors such as inlet water quality and operation schedule and should be determined by regular microbiological testing. Disinfection once a week is a minimum. Review of the Clinical Log Readings Report CWP Disinfect documentation provided revealed no weekly disinfect start for RO Asset Number (#) 134664 from 12/3/24 to 1/15/25. An interview was conducted on 1/29/25 at 3:37 PM with Employee Identifier (EI) # 11, Area Technical Manager (ATOM) after review of facility water quality documents provided. EI # 11 reported staff must perform weekly disinfects on the facility two RO units. EI # 11 confirmed the missing disinfect documentation and reported the facility had a meeting recently about December 2024 missing RO disinfect documentation. The surveyor requested the meeting documentation. Review of the Governing Body Meeting Minutes dated 1/15/25 included a recent facility audit revealed noncompliance with CWP disinfection on 12/3/24, and 12/11/24. The meeting actions included the Facility Administrator will work with the ATOM and conduct staff re-education to bring the clinic back in compliance immediately. Review of the Clinical Log Readings Report revealed no disinfect for RO unit # 134664 the week of 1/28/25, including disinfect initiation, the type or brand name of the disinfectant, the disinfectant log number identification, and the disinfectant expiration date. A phone interview was conducted on 2/3/25 at 1:26 PM with # EI # 2, Area Registered Nurse, who confirmed following the 1/15/25 education, staff had failed to document RO disinfect initiation.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 30952 Based on two of two observations, facility policy, and interviews, it was determined the facility failed to ensure staff followed the policy and labeled the Granuflo mixing tank with the solution contents. This had the potential to affect all 89 patients served by this facility. Findings include: Facility Policy: Concentrate Labeling Requirements Version 5 Published: 05/27/2021 Policy: Temporary Labeling When a mix tank contains a solution, a label identifying the solution must be conspicuously displayed on the tank and must remain until the mix tank is emptied. Mix tank labeling must include: Date and time of mixing... 1. A tour of the water treatment room was conducted on 1/29/25 at 8:40 AM with Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician (CCHT)/Preceptor. An observation was conducted of the Granuflo system mixing area which revealed the Dry Acid Dissolution Unit (DADU) tank was full, the approximate amount was 132 gallons. The sign displayed on the DADU tank revealed the following: Mixer contains purified water only, prepared on 1/28/25, test with transfer. The surveyor asked EI # 4 what the display sign meant? EI # 4 reported the DADU mixing tank was full of acid, and staff were to test the specific gravity when transferred to the Granuflo concentrate tank. The DADU mixing tank was not labeled to reveal the correct contents of the tank, the Granuflo, and not purified water as displayed on the tank. 2. A tour of the water treatment room was conducted with EI # 11, Area Technical Manager, on 1/30/25 at 10:40 AM. An observation was conducted of the Granuflo system mixing area which revealed the DADU tank was full, the approximate amount 132 gallons. The sign displayed on the DADU tank revealed the following: Mixer contains purified water only, prepared 1/28/25, test with transfer. The surveyor asked EI # 11 what solution was in the DADU mixing tank. EI # 11 reported the mixing tank contained Granuflo acid. EI # 11 stated the tank contents were not transferred to the Granuflo concentrate tank when mixed. EI # 11 confirmed the DADU mixing tank was not correctly labeled.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 30952 Based on observations, staff interviews, review of facility policy, and Granuflo (an acid concentrate) Mixing Log documentation, it was determined the facility failed to ensure staff documentation of acid concentrate preparation was accurate. The deficient practice had the potential to jeopardize the health and safety of all 89 patients receiving dialysis treatments at this facility. Findings include: Facility Policy Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit (DADU) Reference Number: 25910 Version: 7 ...The DADU...a device used to prepare acid concentrate solution (Granuflo...) from a dry powder and RO (reverse osmosis) water...Prior to being allowed to operate the DADU, the staff MUST complete training necessary to perform their assigned operational responsibilities...include...Preparing of Granuflo...concentrate batches. Performing specific gravity (ratio of the density of a liquid to the density of water) tests...Completing batch records...The batch record will contain...Case catalog # (number), Each box #, Potassium Value...Operator, date, and time...Solution temperature...Low and high specific gravity, Pass/fail checked, Operator’s signature, Verifier’s signature, time of transfer to holding tank... A tour of the water treatment room was conducted on 1/29/25 at 9:00 AM with Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician (CCHT)/Preceptor. An observation was conducted of the Granuflo system mixing area which revealed the Dry Acid Dissolution Unit (DADU) tank was full, the approximate amount was 132 gallons. The sign displayed on the DADU tank revealed the following: “Mixer contains purified water only, prepared on 1/28/25, test with transfer. The surveyor asked EI # 4 what the display sign meant? EI # 4 reported the DADU Mix tank was full of acid, and staff were to test the specific gravity when transferred to the Granuflo Concentrate Holding tank. Review of the facility Granuflo Mixing Log documentation revealed on 1/28/25 Granuflo Dry Acid Concentrate was mixed, tested, immediately transferred to the Holding tank on 1/28/25 at 9:24 AM. Observations and interview was conducted on 1/31/25 at 9:20 AM in the water treatment area with EI # 4, Certified Clinical Hemodialysis Technician, who verified Granuflo observed in DADU mixing tank Wednesday morning was not transferred as documented on the 1/28/25 log and was transferred to the Granuflo Concentrate Holding tank on 1/30/25. EI # 4 reviewed the facility 1/28/25 Granuflo mixing log documentation and confirmed the 1/28/25 Granuflo Concentrate log documentation was not accurate. An interview was conducted on 1/31/25 at 10:40 AM with EI # 12, Director of Operations, who confirmed staff failed to complete accurate Granuflo Acid mixing and handling per policy.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, facility policy, the Digital Dialysate Meter Operation Manual instructions for use (IFU), and staff interviews, the facility failed to ensure: 1. Staff performing dialysate pH (potential of hydrogen) testing with a Myron L D-6 meter immediately re-tested dialysate pH when results were not within the acceptable pH range. 2. Staff performing dialysate pH testing with a Myron L D-6 meter knew the acceptable pH range for dialysate pH. This affected one of three observations of dialysis machine preparation, including Patient Identifier (PI) # 8, and had the potential to negatively affect the 89 patients dialyzing at the facility. Findings include: Facility Policy: Checking Conductivity and pH of Final Dialysate Reference Number: 25912 Published: 5/6/24 Version: 11 ...purpose...provide guidelines to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments... ...Dialysate pH Range....at which the test method can display values...within the Association for the Advancement of Medical Instrumentation... recommendation for dialysate pH of 6.9-7.6 Policy ...Treatments may not be initiated...if...The dialysate pH is not within or equal to 6.9-7.6... Acceptable Test Devices...Myron L D6 meter... Interpreting Test Results...pH is outside of the allowable 6.9-7.6 range...Retest...pH... Digital Dialysate Meter Operation Manual Myron L Company Water Quality Instrumentation 18 February 16 ...V. Rules of Operation ...pH measurements require temperature compensation, always fill both pH sensor well and conductivity cell with sample... 1. An observation was conducted on 1/29/25 at 10:39 AM with Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician, to observe the preparation of the hemodialysis (HD) machine for PI # 8 at station 1. During the observation, EI # 3 obtained a dialysis sample from the HD machine at the station, entered the Tri Station test counter, poured the samples into the Myron L D 6-meter, pressed the measurement key for conductivity, then for pH, and exited the Tri Station. The pH test result was 4.38, not within acceptable pH range. An interview was conducted on 1/29/25 at 10:55 AM on the way back to station 1. The surveyor asked EI # 3 what the dialysate pH results were. EI # 3 reported “7 point something.” The surveyor asked EI # 3 what the acceptable range for dialysate pH was. EI # 3 stated, “I can’t remember off the top of my head, I will have to get back with you.” The surveyor asked EI # 3 if pH 4.83 was within the acceptable range. EI # 3 returned to the Tri Station, obtained a second sample, and re-tested the dialysate pH within acceptable range. EI # 3’s intent was to proceed with HD preparation without re-testing the pH. EI # was unable to verbalized to the surveyor the acceptable pH range for safe dialysis treatments. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, Facility Administrator, and EI # 12, Director of Operations, who confirmed staff failed to follow the policy for dialysate pH testing.”

“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: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), facility policy, and staff interview, the facility failed to ensure staff followed the bloodline manufacturer’s DFU during dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level during one of two survey observation days. The failure to follow the manufacturer’s DFU affected 8 unsampled patients and had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 89 patients receiving incenter hemodialysis treatments at this facility. Findings include: Fresenius Medical Care Combiset True Flow Series Comibset Blood Tubing with Access Flow Reversing Connector twister) Instructions for Use ...Dialysis Treatment Precautions ...2. During Treatment ...b. Maintain fluid level in pre-pump arterial chamber at 85 to 95 % full...Readjust levels as needed... Facility Policy: Patient Assessment and Monitoring Published: 5/1/23 Reference Number: 45284 Version: 4 ...During Treatment ...Follow the steps...for monitoring patient and machine...during treatment: ...3. Machine Parameters and Extracorporeal Circuit Check the machine settings and measurements: ...Observe and ensure that: ...Venous and arterial chambers are filled to the fill level... 1. Observations of the hemodialysis treatment area were conducted on 1/29/25 revealed from 9:22 AM to 12:30 PM the arterial drip chamber for 8 incenter patients was less than 85% full. An interview was conducted on 1/31/25 at 10:30 AM, Employee Identifier (EI) # 1, Facility Administrator, and EI # 12, Director of Operations confirmed staff failed to ensure the arterial fluid levels were maintained at the correct levels.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility policies, and staff interviews, it was determined the facility failed to ensure: 1. Staff followed the physician orders and notified the physician when the post weight was greater than 2 kilogram (kg) below the Estimated Dry Weight (EDW). 2. Staff followed facility policies and notified the patient’s physician/physician extender for abnormal findings. This affected three of seven records reviewed, and included Patient Identifier (PI) # 4, PI # 6, PI # 1, and had the potential to affect the 89 patients who dialyze at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Reference Number: 45284 Version: 4 Published: 5/1/23 Data Collection The Registered Nurse (RN) will notify the patient’s physician for abnormal findings... Facility Policy: Patient Safety Event Reporting and Documentation Reference Number: 61085 Version: 2 Published: 2/6/23 Procedure Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient’s physician. Safety Event ...Requires additional monitoring, intervention, and/or medical care. Reporting Clinical Staff to notify: Physician Categories, Event Description, and Definitions Below is a table that includes a list of categories, modality, event descriptions, and definitions for Near Miss, Safety Events, and Serious Safety Events. Category Treatment Orders Not Met Event Description Dialysis Weight/UF Goal Variance Definitions Dialysis weight variance above or below the expected post weight... 1. PI # 4 was admitted to the facility 6/23/15 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Order Summary Report (OSR) dated 12/11/24 revealed orders which included EDW 62.5 kg, and a Special Attentions order dated 1/31/24 to notify physician or physician extender if post treatment weight variance is plus/minus 2 kg from EDW. Review of Treatment Sheets (TS) dated 12/31/24, 1/10/25, 1/13/25, and 1/15/25, 1/17/25, revealed post treatment weights greater than 2.0 kg below the 62.4 kg EDW. There was no documentation staff notified the physician or physician extender the post treatment weight variance was greater than 2 kg below the ordered EDW. An interview was conducted on 1/31/25 at 9:58 AM with Employee Identifier (EI) # 2, Area RN, who confirmed staff failed to notify the physician for post treatment weight variance as ordered. 49797 2. PI # 6 was admitted to the facility on 9/1/11 with a diagnosis of ESRD. Review of the OSR revealed an order dated 1/18/25 for an EDW of 52 kg. Review of TS dated 1/23/25, 1/25/25 and 1/28/25 revealed post treatment weights greater than the 52 kg EDW. There was no documentation staff notified the physician or physician extender the post treatment weight variance above the ordered EDW. An interview was conducted on 1/31/25 at 10:19 AM with EI # 2, who confirmed staff failed to notify the physician for post treatment weight variance. 49894 3. PI # 1 was admitted to the facility on 7/29/22 with a diagnosis of ESRD. Review of the OSR revealed a hemodialysis order dated 11/13/24 with an EDW of 152.5 kg. Review of the TS dated 1/27/25 revealed a post treatment weight of 158.1. There was no documentation the physician was contacted for a post treatment weight greater than 152.5. An interview was conducted on 1/31/25 at 12:35 PM with EI # 2, Area RN, who confirmed the physician was not contacted for a post weight greater than 152.5.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 49894 Based on observations, medical record (MR) review, facility policies, and staff interview, it was determined the facility failed to ensure: 1. Staff administered the heparin bolus three to five minutes before the start of treatment to allow systemic anticoagulation to occur. 2. Staff followed the physician’s order for Blood Flow Rate (BFR). 3. Staff followed the physician’s order for Dialysate Flow Rate (DFR). 4. Staff obtained an Early Termination or Arriving Late (AMA) form signed by the patient. This affected Patient Identifier (PI) # 21 in one of six observations of medication preparation and administration, PI # 1, PI # 2, PI # 3, PI # 5, PI # 4, in five of seven MR reviews, and one of seven dialysis prescription verifications, and included PI # 12. This had the potential to affect all 89 patients dialyzing at the facility. Findings include: Facility Policy: Heparinizarion Reference Number: Not listed Version: 4 Published: 8/3/20 ...Heparin Administration Heparin must be given at least 3-5 minutes prior to dialysis. This allows time for full anticoagulation at the start of treatment. Facility Policy: Patient Assessment and Monitoring Reference Number: 45284 Version: 4 Published 5/1/23 ...During Treatment ...Machine Parameter and Extracorporeal Circuit Check machine settings and measurements: Check prescribed blood flow is being achieved or reason documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. Facility Policy: Early Termination or Arriving Late for Treatment Reference Number: 45263 Version: 3 Published: 11/7/22 Background Treatment duration and frequency is prescribed by a patient’s physician and the facility expects that all patients will adhere to their prescribed treatment time and schedule. Serious health related consequences may result from missed treatments or terminating treatments earlier than prescribed. Documentation Document in Chairside the specific unexpected end reason that the treatment was shortened. All discussion with the patient including information or instructions given, and any notification with the physician, must be documented in the patient’s medical record. Complete documentation “Early Termination of Treatment Against Medical Advice” form. 1. An observation was conducted on 1/30/235at 12:03 PM with Employee Identifier (EI) # 8, Registered Nurse (RN), preparing and administering medication for PI # 21 at station 2. EI # 8 administered the heparin bolus for PI # 21 at 12:03 PM. At 12:05 PM, EI # 7, Certified Clinical Hemodialysis Technician (CCHT), connected the blood lines and started the treatment. EI # 7 failed to wait three to five minutes before starting treatment to allow for systemic anticoagulation per facility policy. An interview was conducted on 1/31/25 at 10:30 AM with EI # 2, Area RN, who confirmed staff failed to wait three to five minutes after heparin bolus administration to allow for systemic anticoagulation per facility policy. 2. PI # 1 was admitted to the facility on 7/29/22 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Sheet (OSR) revealed a hemodialysis order dated 11/13/24 that included a DFR of Autoflow 2.0 (two times the BFR or maximum 800) and BFR of 500. Review of the MR revealed on 1/3/25, 1/8/25, 1/17/25, and 1/27/25 the DFR was not as prescribed and there was no documentation of why it was not per the physician’s order. Further review of the MR revealed on 1/3/25, 1/8/25, 1/13/25, and 1/22/25 the BFR was not as prescribed and there was no documentation of why the prescribed BFR was unable to be achieved. Further review of the MR revealed on 1/3/25 there was no AMA form obtained for the patient for ending the treatment early. An interview was conducted on 1/31/25 at 12:35 PM with EI # 2, Area RN, who confirmed staff failed to follow the physician’s order for DFR and BFR per facility policy and obtain AMA forms per facility policy. 3. PI # 2 was admitted to the facility on 11/21/24 with a diagnosis of ESRD. Review of the OSR revealed a hemodialysis order dated 12/24/24 that included a BFR of 350. Review of the MR revealed on 11/27/24 and 12/10/24 the BFR was not as prescribed and there was no documentation of why the prescribed BFR was unable to be achieved. An interview was conducted on 1/31/25 at 10:25 AM with EI # 2, Area RN, who confirmed staff failed to follow the physician’s order for DFR and BFR. 49797 4. PI # 3 was admitted to the facility on 7/22/21 with a diagnosis of ESRD. Review of the OSR revealed a HD order dated 1/16/25 for dialysis treatments 3 times a week, with a treatment time of 3 hours 15 minutes, BFR 400, and DFR Autoflow 2.0(800). Review of TS dated 1/16/25 and 1/18/25 revealed the BFR and DFR was not at 400/800 as ordered. There was no documentation of a new order or reason. An interview was conducted on 1/31/25 at 10:14 AM with EI # 2, who confirmed staff failed to follow physician BFR/DFR orders. 30952 5. PI # 5 was admitted to the facility on 10/8/24 with a diagnosis of ESRD. Review of the OSR revealed a hemodialysis (HD) order dated 12/17/24 for dialysis treatments 3 times a week 3 hours 45 minutes, and BFR 400. Review of TSs dated 1/4/25, 1/14/25, and 1/28/25 revealed the treatment time was less than 3 hours 45 minutes. There was no documentation staff followed the facility policy for early termination of treatment, obtained and completed the Early Termination of Treatment Against Medical Advice form. Review of TS dated 1/9/25 revealed the BFR was not 400 as ordered. An interview conducted on 1/31/25 at 12:15 PM with EI # 13, Clinical Manager, Sister Facility, confirmed staff failed follow the BFR order and obtain a signed AMA forms for treatment times not completed as ordered per policy. 6. PI # 4 was admitted to the facility 6/23/15 with a diagnosis of ESRD. Review of the OSR revealed orders dated 12/11/24 for BFR 400, DFR Autoflow 2.0 (800). Review of TS dated 1/10/25 revealed BFR and DFR was 350 and 700 from 10:01 AM to treatment end at 10:48 AM. There was no documentation why the BFR and DFR was not 400 and 800 as ordered. An interview was conducted on 1/31/25 at 9:58 AM with EI # 2, who confirmed staff failed to follow physician BFR/DFR orders. 7. The flash tour of the patient treatment room was conducted on 1/29/25 at 8:55 AM. At station 17, the BFR was 400 for PI # 12. Review of PI # 12’s TS dated 1/29/25 revealed HD Orders for the BFR 450. Further review of the 1/29/25 TS revealed the BFR was not 450 from 8:00 AM to treatment end at 9:32 AM. There was no reason documented why the BFR was not as ordered. An interview was conducted on 1/31/25 at 10:30 with EI # 2, who confirmed staff failed to follow orders for BFR.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 30952 Based on the review of medical records (MR) and interviews, it was determined the facility failed to provide anemia management in three of five records reviewed with patients receiving Venofer and/or Mircera. This affected Patient Identifier (PI) # 4, PI # 5, PI # 7, and had the potential to negatively affect all patients requiring anemia management served by this facility. Findings include: 1. PI # 4 was admitted to the facility on 6/23/15 with a diagnosis of End Stage Renal Disease (ESRD). Record review revealed Treatment Medications order dated 12/20/24 for Venofer 100 milligram (mg) three times a week (MWF-Monday/Wednesday/Friday) x (for) 10 doses, no discontinue date was documented. Review of facility documentation revealed four doses of Venofer 100 mg was administered on 12/22/24, 12/24/24, 12/27/24, and 12/29/24. Review of the Treatment Sheets (TS) dated 12/31/24, 1/3/25, 1/8/25, and 1/10/25 revealed Venofer was administered, which was four additional Venofer doses for a total of eight Venofer doses. Review of subsequent TSs dated 1/13/25, 1/15/25 and 1/17/25 revealed no Venofer was administered. Staff failed to administer ten doses of Venofer as ordered. An interview was conducted on 1/31/25 at 2:31 PM with Employee Identifier (EI) # 12, Director of Operations, who confirmed staff failed to administer 10 Venofer doses per order. 2. PI # 5 was admitted to the facility on 10/8/24 with a diagnosis of ESRD. Review of the Plan of Care Meeting documentation dated 12/26/24 revealed the hemoglobin (hgb) was below goal, actions were to follow the algorithm for ESA (Erythropoiesis-Stimulating Agent, medication that treats anemia by stimulating the bone marrow to produce red blood cells) and ensure missed ESA does are given in a timely manner. Review of the Orders Summary Report (OSR) revealed orders dated 12/5/24 for Mircera 200 micrograms (mcg) IVP (intravenous push) during dialysis every 2 weeks. Review of the TS dated 12/19/24 revealed Mircera 200 mcg was administered. Record review revealed PI # 5 was hospitalized 12/30/24 to 1/1/25. Review of the next TS dated 1/4/25, revealed lab was obtained, and no Mircera was administered. Review of the TSs dated 1/7/25, 1/9/25, 1/11/25, 1/14/25, and 1/28/25, revealed the hgb was less than goal. There was no documentation Mircera was given during the 5 treatments. An interview was conducted on 1/31/25 at 12:19 PM with EI # 13, Clinical Manager, Sister Clinic, who confirmed Mircera was not administered as ordered. 49894 3. PI # 7 was admitted to the facility on 12/1/11 with a diagnosis of ESRD. Review of the MR revealed an order on the OSR for Mircera 225 mcg to be given every two weeks dated 11/23/24. Review of the TS dated 12/20/24, 12/22/24, 1/3/25, 1/6/25, 1/8/25, 1/10/25, and 1/15/25 revealed the under “ESA Details” the last date the Mircera was given was 11/11/24. An interview was conducted on 1/31/25 at 10:15 AM with EI # 2, Area Registered Nurse, confirmed the Mircera was not administered per physician’s order.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interviews, it was determined the facility failed to ensure staff followed the facility policy for Arteriovenous Fistula/Graft (AVF/AVG) access site skin disinfectant. This affected two of three observations of initiation of treatment with an AVF/AVG, including Patient Identifier (PI) # 11 and PI # 15, and had the potential to negatively affect all patients with an AVF/AVG who dialyze at this facility. Findings include: Facility Policy: Access Assessment and Cannulation Reference Number: 45178 Version: 4 Published: 5/6/24 Background: ...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin...Cannulation is a skill...when performed properly, increases the longevity of the access...minimizes...complications... Policy: Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. Assessment of Vascular Access: Follow the steps below to assess the vascular access: ...Skin Disinfection: Step 1: Disinfect cannulation sites as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward two inches in a concentric circle for 30 seconds and allow to dry before cannulating. Step 2: Perform skin asepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... 1. An observation was conducted on 1/29/25 at 11:44 AM at station 21 with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), to access an AVF/AVG for initiation of dialysis for PI # 11. With gloves on, EI # 5 evaluated the access site using palpation and auscultation, and cleaned each site with one alcohol pad for 20 seconds, and not for 30 seconds per policy. An interview was conducted on 1/31/25 at 10:30 AM with EI # 1, Facility Administrator, and EI # 12, Director of Operations, who confirmed staff failed to follow the facility policy for AVF/AVG access site preparation. 2. An observation was conducted on 1/29/25 at 10:55 AM with EI # 7 initiating dialysis and performing AVF/AVG access site preparation for PI # 15 at station 7. EI # 7 cleansed each AVF site with alcohol for 10 seconds each and not 30 seconds prior to cannulation. An interview was conducted on 1/31/25 at 10:29 AM with EI # 2, Area Registered Nurse (RN) who confirmed the staff failed to cleanse the AVF site per facility policy for AVF/AVG access site preparation. 49797 49894”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 30952 Based on review of the facility technical indicator data presented to the QA (quality assurance) Committee at the monthly quality meeting, the facility Quality Assessment and Performance Program (QAPI) policy and staff interview, it was determined the facility failed to implement a plan to ensure improvement for water system and concentrate preparation was achieved and sustained. This had the potential to negatively affect the 89 patients who dialyzed at the facility. Findings include: Facility Policy: QAPI Published: 5/2/22 Reference Number: 25799 Version: 5 Purpose: This policy outlines the purpose, structure, and required activities of the facility QAPI Program. Policy: ...QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. ...QAPI Meeting Objectives: The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement...action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: ...Technical Operations, including water and dialysate quality and safety... An effective and successful review of the QAPI meeting and program activities will include: ...Prioritizing identified opportunities for improvement. Performing a Root Cause Analysis on the identified opportunities... Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority... The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety... Review of the facility technical dashboard Clinical Logs documentation during the facility QA review on 1/31/25 at 1:00 PM revealed Water Systems logs compliance for 2024, June 33.3 %, July 66.7 %, August 50 %, September 66.7 %, October 66.7 %, November 66.7%, and December 66.7% Further review of the facility technical dashboard Clinical Logs documentation revealed 2024 Concentrate Preparation compliance, June 100 % July 75 %, August 100 %, September 66.7%, October 100 %, November 33.3 %, and December 25 %. The surveyor asked what actions the facility had taken to address the declining performance with water system and concentrate preparation compliance. Employee Identifier (EI) # 1, Facility Administrator, reported the facility has an ongoing action plan, initiated 7/24/24 that had been updated 3 times. EI # 1 stated the action plan is never closed out as the 90 % compliance goals for 3 months have not been met. EI # 1 reported a new action plan will be initiated this month. The surveyor asked EI # 1 what actions the facility had taken to address the declining scores. EI # 1 stated staff re-education, follow up, and disciplinary action had been taken. EI # 1 reported the water system log documentation was inconsistent. The facility failed to implement performance improvement actions, sustain improvement to ensure safe water and concentrate was delivered during patient treatments. In an interview conducted on 1/31/25 at 1:30 PM, EI # 1 confirmed past facility action plans had not been successful in meeting and sustaining the facility compliance goals for a safe water system.”