Dialyze Direct Il - Glen Ellyn

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 39802 Based on document review, observation, and interview, the Facility failed to comply with the Condition for Coverage 42 CFR 494.40, Water and Dialysate Quality. Finding Include: 1. The Facility failed to ensure that the Myron-L TDS Meter (equipment used for daily testing of the RO/reverse osmosis total dissolved solids/TDS), was done in accordance with the manufacturer’s instructions and policy. (V-200) 2. The Facility failed to ensure that pH (measure of acidity/alkalinity) testing was completed prior to each patient treatment and that the test strips were not expired. (V-250) An immediate jeopardy (IJ) was identified on 09/16/2025 due to the Facility’s failure to ensure that dialysate pH/conductivity monitoring was performed as required by policy at Locations L#1 and L#2, and was identified at 42 CFR 494.40, Water and Dialysate Quality. The IJ was announced on 09/16/2025 at 5:20 PM, with the Regional Operations Director (E#1). The IJ was removed by the survey exit date of 09/18/2025; however, the Condition for Coverage, 42 CFR 494.40, Water and Dialysate Quality, remains out of compliance.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 34411 Based on document review and interview, for 1 of 4 dialysis facilities (Location 2/L #2), the facility failed to ensure that emergency equipment (AED -automated external defibrillator and suction machine) was available. Findings include: 1. The Facility’s policy titled, “Cardiac Arrest during Dialysis: Code Blue Procedure in the Long-Term Care Setting” (dated 5/5/2020) was reviewed and indicated, “...The [Facility] dialysis staff to coordinate resuscitation (CPR) with long-term care emergency response team and/or EMS (emergency medical system)...” 2. The Facility’s “Mock Code Evaluation Form”, included steps for staff to follow during resuscitative measures...AED applied - CPR resumed after rhythm evaluated...” 3. Location #2’s “Crash Cart Supply check sheet” (attached on top of crash cart), included, “...Suction machine, AED, IV bags .9NS and D5/.45 NS [intravenous solutions]...” 4. On 9/15/2025 between 12:45 PM-4:00 PM, an observational tour of the dialysis treatment area was conducted at L#2. The crash cart located inside the dialysis treatment area, lacked an AED, and a suction machine. The 0.9 NS IV bag was dated 6/2019. 5. On 9/15/2025 at 2:45 PM, an interview was conducted with the Registered Nurse (E #6). E #6 stated that the nursing home staff are responsible for checking the crash cart. 6. On 9/15/2025 at approximately 3:15 PM, an interview was conducted with the Nursing Home Supervisor (Z #1). Z #1 stated that the crash carts (in the dialysis treatment area and on the floor in the nursing unit), should have the required emergency equipment available. Z #1 confirmed that there was no AED on the dialysis room’s crash cart or on the unit’s crash cart.”

“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: 50411 A. Based on document review, observation, and interview, for 1 of 4 dialysis treatment locations (L#1-Conventional) observed, the Facility failed to ensure that staff were wearing appropriate PPE (personal protective equipment). Findings include: 1. On 9/17/2025, the Facility’s policy titled, “Infection Prevention and Control Policy and Practices (Effective 12/1/2014) was reviewed and included, “Staff shall 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 ...” 2. On 9/15/2025 at approximately 10:20 AM through 2:00 PM, an observational tour of the dialysis treatment floor at L#1 was conducted. At approximately 10:34 AM, The Patient Care Technician (PCT-E#2) was observed discontinuing dialysis for a patient at Station #2 with an AVF (Arteriovenous Fistula). E #2 was not wearing any face shield or eye protection. 3. On 9/15/2025 at approximately 12:50 PM, findings were discussed with E #10 (Charge Nurse). E #10 stated that a face shield or eye protection should be worn when discontinuing a dialysis treatment. B. Based on document review, observation, and interview, for 1 of 4 dialysis treatment locations (L#1-Conventional) observed, the Facility failed to ensure that staff did not eat or drink in the dialysis treatment area. Findings include: 1. On 9/17/2025, the Facility’s policy titled, “Infection Prevention and Control Policy and Practices (Effective 12/1/2014) was reviewed and included, “ ... Staff members shall not eat, drink or smoke in the dialysis treatment area ...” 2. On 9/15/2025 at approximately 10:20 AM through 2:00 PM, an observational tour of the dialysis treatment floor was conducted at L#1. An orange water bottle was observed at the Nurse’s Station and E#2 was observed drinking from the water bottle while in the treatment area on two instances. 3. On 9/15/2025 at approximately 12:50 PM, an interview was conducted with the Charge Nurse (E#10). E#10 stated that no food or drink should be placed at the nurse’s station and staff should not be eating or drinking in the treatment area.”

“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: 34411 Based on document review, observation, and interview, for 3 of 4 conventional dialysis locations (L #1, L #2, L #4), the Facility failed to ensure that supplies were not placed on the dialysis stations without using a clean barrier, in order to maintain a sanitary environment. Findings include: 1. The Facility’s policy titled, “Infection Prevention and Control Policy and Practices” (dated 12/1/2014), was reviewed and required, “The ESRD [end stage renal disease] Facility shall provide and monitor a sanitary environment to minimize the transmission of infectious agents...Supplies should not be placed on top of the dialysis machine without a barrier between the supplies...” 2. On 9/15/2025 between 12:45 PM and 4:00 PM, an observational tour of L #2’s dialysis treatment area was conducted. The following was observed: - At Station #1, Station #2, Station #4, there were 2 saline syringes placed directly on top of the dialysis machine (the syringes at Station #2 were unwrapped). There was no barrier in between the syringes and the machine. - At Station #1, tape was applied to the dialysis chair’s table. - At Station #3, tape was applied directly on the dialysis machine. 3. On 9/17/2025 between 9:25 AM and 10:30 AM, an additional tour of L #2, was conducted. - At Station #2 and #3, 2 saline syringes were placed directly on top of the machines without a barrier. 4. During an observational tour of the dialysis treatment area at L#1(Conventional) on 9/15/2025, at approximately 10:34 AM, the patient care technician (PCT-E#2) was observed discontinuing a patient’s dialysis treatment at Station #2. Pieces of tape were observed hanging on the side table of the patient’s dialysis chair with no barrier. 5. During an observational tour of the dialysis treatment area at L#4 (Conventional) on 9/17/2025, at approximately 9:53 AM, the Registered Nurse (RN-E#7) was observed discontinuing a patient’s dialysis treatment at Station #5 and E#7 was observed preparing pieces of tape and sticking them on to the back rest of the dialysis chair with no barrier. 6. On 9/15/2025 at 1:30 PM, an interview was conducted with the Registered Nurse (E #6). E #6 stated that is the unit’s normal practice to have tape on the chair’s tables, since the stations are considered clean. 7. On 9/17/2025 at 10:20 AM, an interview was conducted with the Clinical Educator (E #4). E #4 stated that supplies should not be placed directly on top of the machines unless a barrier is used. E #4 stated that tape should not be directly applied to the sides of the chairs. E #4 stated that although the machines are cleaned in between patient use, there still may be some uncertainty of all the areas being cleaned.”

“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: 39802 Based on document review and interview, for 6 of 20 patients (Pts. #11-16) reviewed for susceptibility to Hepatitis B (liver infection), the Facility failed to ensure that Hepatitis B vaccine was administered or offered. Findings include: 1. The Facility’s policy titled, “Vaccination Protocol Policy” (revised 06/01/2024) was reviewed and required, “...Hepatitis B vaccine is to be offered to all ESKD [end-stage kidney disease] patients whose HBsAb [antibody] is < [less than] 10 mIU/mL [milli-international units per milliliter]... Document start date and due dates... A declination form must be signed and placed in the patient medical record for all patients who refuses any vaccination... Patients will be reassessed on an annual basis...” 2. The Hepatitis B vaccination reports were reviewed on 09/18/2025 which indicated the following: - Pt. #11 was admitted on 07/25/2025 with ESKD. As of, 07/25/2025, the HBsAb was less than 10. Pt. #11 signed a consent form on 07/25/2025 indicating that Pt. #11 consented to receiving the vaccine series. The record lacked documentation that Pt. #11 received the vaccine or a reason why the vaccine was not administered. - Pt. #12 was admitted on 07/14/2025 with ESKD. As of, 07/14/2025, the HBsAb was less than 10. Pt. #12 signed a consent form on 07/14/2025 indicating that Pt. #12 consented to receiving the vaccine series. The record lacked documentation that Pt. #12 received the vaccine or a reason why the vaccine was not administered. - Pt. #13 was admitted on 10/16/2023 with ESKD. As of 01/06/2025, the HBsAb was less than 10. The record lacked documentation that Pt. #13 was offered the vaccination series. - Pt. #14 was admitted on 01/14/2025 with ESKD. As of 01/14/2025, the HBsAb was less than 10. The record lacked documentation that Pt. #14 was offered the vaccination series. - Pt. #15 was admitted on 12/01/2023 with ESKD. As of 01/06/2025, the HBsAb was less than 10. The record lacked documentation that Pt. #15 was offered the vaccination series. - Pt. #16 was admitted on 10/17/2017 with ESKD. As of, 01/06/2025, the HBsAb was less than 10. Pt. #16 signed a consent form on 01/30/2025 indicating that Pt. #16 consented to receiving the vaccine series. The record lacked documentation that Pt. #16 received the vaccine or a reason why the vaccine was not administered. 3. An interview was conducted with the Area Manager (E#14) on 09/18/2025, at approximately 11:30 AM. E#14 stated that the hepatitis B vaccine should be offered to each susceptible patient, and if they consent, the vaccination should be administered.”

“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: 50411 Based on document review, observation, and interview, for 1 of 4 dialysis treatment locations (L#3 - NxStage) observed, the Facility failed to ensure that CVC (Central Venous Catheter) ports were properly disinfected, in order to prevent catheter related infections. Findings include: 1. The facility’s policy entitled “Central Venous Catheter Care Policy” dated 8/16/2021 was reviewed on 9/17/2025. The policy required, “ ... Pre-treatment/Initiation of Treatment ...Procedure ... 5. Soak two 4x4 gauze pads in Alcavis (Antiseptic). Scrub each catheter connection cap separately for 1 minute. Pads are then wrapped around the connection ports and allowed to soak for 3-5 minutes ...” 2. On 9/16/2025 between 8:40 AM to 10:45 AM, an observational tour of the dialysis treatment area at L#3 was conducted, and the following were observed: - At approximately 9:29 AM, the Patient Care Technician (PCT-E#12) was observed disinfecting the two CVC ports with Alcavis soaked gauze during initiation of dialysis for a patient in Station #3. E #12 was observed scrubbing the CVC ports together for approximately 10 seconds. - At approximately 9:37 AM, E#13 (PCT) was observed disinfecting the two CVC ports with Alcavis soaked gauze during initiation of dialysis for a patient in Station #5. E#13 was observed scrubbing the CVC ports together for approximately 4 seconds. - At approximately 9:44 AM, E#12 (PCT) was observed disinfecting the two CVC ports with Alcavis soaked gauze during initiation of dialysis for a patient in Station #9. E#12 was observed scrubbing both CVC ports together for approximately 10 seconds. - At approximately 9:50 AM, E#13 (PCT) was observed disinfecting the two CVC ports with Alcavis soaked gauze during initiation of dialysis treatment for a patient in Station #8. E#13 was observed scrubbing the CVC ports together for approximately 4 seconds. 3. On 9/16/2025 at approximately 10:14 AM, an interview was conducted with E#12 (PCT). E#12 stated that CVC ports should be soaked with Alcavis (Antiseptic) for 1-2 minutes and the ports be scrubbed for 60 seconds and allowed to air dry for 2 minutes.”

“RO-MONITOR/ALARM/PREVENT UNSAFE H20 USE CFR(s): 494.40(a) 5.2.7 Reverse osmosis: alarm/prevent use of unsafe water Refer to RD62:2001, 4.3.7 Reverse osmosis: Reverse osmosis devices shall be equipped with on-line monitors that allow determination of rejection rates and product water conductivity. The product water conductivity monitor should activate audible and visual alarms when the product water conductivity exceeds the preset alarm limit. The audible alarm must be audible in the patient care area when reverse osmosis is the last chemical purification process in the water treatment system. Monitors that measure resistivity or TDS may be used in place of conductivity monitors. 6.2.7 Reverse osmosis: Reverse osmosis systems should be monitored daily using continuous-reading monitors that measure product water conductivity (or total dissolved solids (TDS)). 5.2.7 Reverse osmosis: Refer to RD62:2001, 4.3.7 Reverse osmosis: When a reverse osmosis system is the last chemical purification process in the water treatment system, it [should] include a means to prevent patient exposure to unsafe product water, such as diversion of the product water to drain, in the event of a product water conductivity or rejection alarm. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, for 2 of 4 (L#2 and L#4) conventional dialysis locations observed, the Facility failed to ensure that the Myron-L TDS Meter (equipment used for daily testing of the RO/reverse osmosis total dissolved solids/TDS), was used and calibrated in accordance with the manufacturer’s instructions and policy. This failure has the potential to expose the patients on census, to unsafe water. 1. The Facility’s policy titled, “Utilization and Calibration of the Myron L TDS Meter” (effective 10/2019) was reviewed and required, “ ... Policy: ... product water are to be tested daily to determine effective operation of the reverse osmosis system ... to ensure the final concentration of TDS (total dissolved solids) in product industry standards ...” 2. The Facility’s instructions on how to use the TDS meter was posted on the wall in the water treatment room and required, “STEP 1: Set meter to “S”, press black button for reading (standard value is on the bottom of the meter). This test is checking the overall function of the meter, if the value does not match the standard, recalibrate the internal standard as directed in the policy. STEP 2: [Calibration procedure] ...STEP 3: Set meter to “100”, test the feed water from SP1 (feed water port). Multiply the number at the pointer x 100. STEP 4: Set meter to “10”, test the RO water from each RO (rinse the cell cup 3 times with RO water before performing the test to ensure a more accurate result. Multiply the number at the pointer x 10. The acceptable range is <15 (1-14). Contact Biomed if results are out of range. Log ALL results.” 3. The Facility’s “Daily Water Treatment” log (dated 8/1/2025-9/15/2025), was reviewed on 9/15/2025. The log included “TDS Feed Tap Water” [untreated/unpurified water] and “TDS RO Product Water Sample” [post RO machine/purified water] readings. The log included entries every treatment day as required per policy. However, the “TDS Feed Tap Water” readings were all less than the “TDS RO Product Water” samples. 4. On 09/15/2025 between 12:45 PM-4:00 PM, an observational tour of L#2 was conducted. During the tour, the Patient Care Technician (E #5) was observed performing RO TDS testing using the Myron meter. The following was observed during the testing: - E #5 set the Myron meter to the “S” dial setting on the meter in order to obtain the “standard value” (meter’s number located on the bottom of the machine/4.3). After the dial was set to the “S” dial, E #5 pressed the gauge button. The reading was 4.4. - E #5 then proceeded to obtain a “feed water” sample from the tap water sink. E #5 then placed the sample water in the Myron meter. E #5 kept the dial on the “S” setting on the meter. E #5 pressed the gauge button and obtained a reading of 4.4. - After E #5 obtained the “feed water” reading, E #5 the proceeded to test the “RO product water” (purified water post RO machine). E #5 obtained the sample and then placed the sample water in the Myron meter. The Myron meter’s dial remained on the “S” setting. E #5 stated that the result was 4.4 as well. - The RO had an on-line monitor that would display/scroll through different readings from the RO including percent rejection and conductivity. However, when asked the staff at L #2 including the Nurse (E#6) and the PCT (E#5) were not aware that the RO displayed the percent rejection. There was an audible alarm box in the water room near the doorway adjacent to the treatment floor, and was audible/visible from treatment floor. 5. During a tour of L#4 on 9/17/2025, at approximately 10:30 AM, the PCT (E#8) demonstrated the process to measure the feed water for total dissolved solids using the Myron L meter; however, did not know how to calibrate the meter if the readings were off. 6. On 9/15/2025 at 3:35 PM, an interview was conducted with the Patient Care Technician (E #5). E #5 stated that the TDS is tested every morning by E #5. E #5 stated that after the “feed water” and “product water” samples are collected and read, there is a formula that the staff use to obtain the percent rejection reading. E #5 stated that after the formula is calculated (product water divided by the feed water -1 x100), this will result in the RO’s percent rejection. E #5 stated that the percent rejection should be greater than 95 percent. E #5 stated that when obtaining the TDS water samples, the “feed water” sample should be a higher reading then the “product water” sample. 7. An interview was conducted with the Biomedical Technician (E#3), 09/16/2025, at approximately 10:20 AM. E#3 stated explained the procedure for obtaining samples for testing of the TDS in order to calculate the % rejection. E#3 stated that the RO at L#2 is old and does not have a continuous display of the percent of water rejected so the staff have to test water samples and calculate it manually. E#3 stated that if the % rejection is below 90% they will stop treatments. E#3 stated that depending on the location, the TDS for feed water can vary but E#3 has seen it typically between 150-200 ppm. E#3 stated that the TDS for the product water should be less than the feed water since the RO is supposed to purify the water (removing contaminants) thereby reducing the parts per millions (ppm). E#3 stated that the product water TDS is typically in the single digits and if it exceeds 15 ppm, the staff should notify Biomed so that they can order parts if necessary to replace the membrane. E#3 stated that the staff member should set the range dial to the correct setting depending on the expected result. E#3 stated that for example the range dial should be set to 100 if trying to measure feed TDS with a typical range in the hundreds. E#3 stated that the dial is set to 10 when measuring the product TDS. E#3 stated that the “S” dial should only be used to ensure the meter is matching the standard value noted on the bottom of the meter and should not be used to measure feed or product water samples. E#3 stated that E#3 had no record of any issues with the readings at L#2. E#3 stated that TDS measurements should be accurate for patient safety, as a higher TDS could indicate that minerals such as magnesium or calcium are passing through the membranes which could affect the patients blood levels (labs) and make them sick. 8. An interview was conducted with the Clinical Educator (E#4) on 09/16/2025, at approximately 11:00 AM. E#4 stated that the educators are responsible to teaching new hires how to complete the tests with the Myron TDS meters and conduct audits of the staff doing the tests every couple months. E#4 stated that the staff use the TDS meter in order to calculate the % rejection to ensure that it is over 95%. E#4 stated that a lower percent rejection indicates that solutes are not being purified (filtered) from the water that is being used to make the dialysate. E#4 stated that depending on the contaminants in the standard (source) water, if not removed, it could be detrimental to the patients. E#4 stated that the feed TDS should be higher than the product TDS and stated that the manager of the location reviews the logs. E#4 stated that if any numbers are out of range, the staff are expected to notify Biomed and the Manager, so that the system can be checked out.”

“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: 39802 Based on observation, document review and interview, for 2 of 3 (L#1 and L#2) conventional dialysis locations observed, the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was completed prior to each patient treatment and that the test strips were not expired, which could lead to the patients receiving unsafe dialysate that may lead to serious health complications such as hemolysis (breakdown of red blood cells) or death. Findings include: 1. During a tour of the dialysis treatment area at L#1 on 09/15/2025, between approximately 10:54 AM and 11:10 AM, a Patient Care Technician (E#2) began setting up 3 dialysis machines at stations #1-#3 during a break in between the first and second shift of patients. At approximately 11:30 AM, E#2 tested the machine at station #3 for pH following the manufacturer’s instructions. At approximately 12:08 PM, the first patient of the shift arrived for treatment and E#2 had them sit at station #1. E#2 prepared the patient for treatment and was about to start the patient’s treatment without first performing a pH test on the dialysis machine at station #1. 2. During a tour of the dialysis treatment area at L#2 on 09/15/2025, at approximately 1:20 PM, there were 5 patients already on dialysis treatment for the last shift of the day, therefore, unable to observe machine setup prior to treatment. There was one opened bottle of pH tests strips on the treatment floor that had an expiration date of 05/31/2025, with an opened date 08/31/2025. The Registered Nurse (E#6) went to check the storage room for another bottle and found 3 unopened bottles; however, one had an expiration date of 05/31/2025 and the other two had an expiration date of 08/31/2025. There were no other non-expired bottles of pH test strips available at this location. The PCT (E#5) provided a demonstration of the pH testing procedure on a machine which not in use [using the expired strips], and the pH strip’s color did not match any of the color blocks on the bottle, which are used to determine the results of testing. 3. The Facility’s policy titled, “Dialysate pH Testing” (revised 11/01/2024), was reviewed and required, “ ...Dialysate pH is tested prior to the initiation of each dialysis treatment to confirm the pH is within the acceptable range ... Obtain pH test strips indicated for use in testing the pH of acid/bicarbonate dialysate checking the expiration date on the container to ensure quality of test result ... Do not use test strips for an opened or unopened bottle after expiration date printed on the bottle label ...” 4. An interview was conducted with the PCT (E#5) on 09/15/2025, at approximately 12:08 PM. E#5 stated that E#5 thought E#5 had done test on the machine at station #1 already. E#5 stated that E#5 should test for pH prior to starting each patient treatment. 5. Interviews were conducted with the PCT (E#5) and the Registered Nurse (E#6) at L#2 on 09/15/2025, at approximately 1:25 PM. Both E#5 and E#6 stated that using expired strips could affect the accuracy of the results and should have been discarded. E#5 stated that E#5 already tested all the machines for pH prior to each treatment using the opened bottle on the floor. E#5 stated that E#5 should have checked the expiration date prior to testing. E#6 stated that the strip color (bright orange) did not match the color block on the bottle (light orange) likely because they were expired. E#6 stated that they check for expired supplies twice a month and if they need to order more supplies, they will send an email to their logistics department to order more. E#6 stated that they will order more pH test strips from logistics. 6. An interview was conducted with the Clinical Educator (E#4) on 09/16/2025, at approximately 11:00 AM. E#4 stated that the pH test should be completed prior to each patient being put on the dialysis machine for treatment. E#4 stated that each morning they should check the expiration dates of the strips prior to the first shift of patients. E#4 stated that if expired, they should dispose of the strips right away. E#4 stated that if the strips are expired, they may throw of the readings, leading to an inaccurate result. E#4 stated that if the pH is off that means that the constitution of the dialysate may be off and should be retested with a new sample and the machine pulled if still out of range. E#4 stated that if a patient receives dialysate with the pH out of acceptable range, it could lead to hemolysis.”

“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: 34411 A. Based on document review and interview, for 1 of 3 conventional dialysis locations (Location #2/L #2), the Facility failed to ensure that the Biomed Technician was notified when the RO (reverse osmosis/used to purify water) machine’s pump pressures were not within the required parameters. Findings include: 1. The Facility’s policy titled, “Daily Operation of the Ameriwater MR03/MR04 Manual Reverse Osmosis Unit Policy, Procedure” (3/30/2020), was reviewed and required, “To provide guidelines for the safe operation of the manual reverse osmosis system...[Facility] trained and qualified staff will document all required temperature, pressure, and sample port readings on the following forms: Daily Water Treatment Log.” 2. The Daily Water Treatment Log (dated 8/1/2025-9/15/2025), was reviewed on 9/15/2025. The log included an entry column for the “RO Pump Discharge Pressure”, with the parameters of 105-230 PSI. The daily logs from 8/1/2025-9/15/2025, included documented readings of 90 PSI (not the required 105-230 PSI), each treatment day. The log included notation, “If operating parameters are not within range, call Biomed ASAP and record problem in the box. The logs lacked any documentation that the Biomed Technician was notified of the pressure readings that were out of range.” 3. On 9/16/2025 at 1:05 PM, an interview was conducted with the Biomed Technician (E #3). E #3 stated that when any equipment or machine related issues arise, the PCT or the nurse should let E #3 know right away. E #3 stated that E#3 was not aware of the RO pump pressure being low. E #3 stated that, regarding the RO pump pressure, if it is low, it could be a sign that the machine could be going bad or in need of maintenance. 50411 B. Based on document review, observation, and interview, for 1 of 4 dialysis treatment locations (L#3 NxStage) observed, the Facility failed to ensure that chairs were maintained to allow effective cleaning/disinfection or remove torn chairs from use to prevent cross contamination. Findings include: 1. On 9/18/2025, the facility’s policy titled, “ Skilled Nursing Facility Dialysis Treatment Area and Equipment Maintenance Policy (Effective 10/1/2022)” was reviewed and included, “ ...Policy: ...3. Equipment purchased by the Skilled nursing facility ... will be maintained by the nursing facility. Such equipment may include but not limited to scales, chairs ...Procedure ... 1. [Facility] clinical leadership will document observations of the treatment area and furnishings/equipment on the SNF [Skilled Nursing Facility] Encounter Form during monthly visits. 3. The designated Business Development representative or Regional Director will communicate with the SNF administration to address the required maintenance or repairs ...” 2. On 9/16/2025, between 8:45 AM and 10:30 AM, an observational tour of the dialysis treatment area was conducted at L#3. Five of the nine dialysis chairs were torn on the arms, footrests, and back rests, not allowing for proper disinfection. 3. On 9/18/2025 at 11:24 AM, an interview was conducted with the Area Manager (E #14). E #14 stated that dialysis chairs at their locations will be maintained by who purchased the chairs. E#14 stated that for chairs purchased by their Facility, they would be responsible for maintaining or replacing the chairs. E#14 stated that their staff will notify them regarding chairs that need repair or replacement. E#14 stated that for chairs purchased by the nursing homes, the nursing homes would be responsible. E#14 stated that their Facility will communicate with the nursing home regarding any chairs that needs repair or replacement.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 50411 Based on document review, observation, and interview, for 1 of 4 dialysis treatment locations (L#3-NxStage) observed, the Facility failed to ensure that sufficient space in between patient stations was provided to prevent cross-contamination. Findings include: 1. The Facility’s policy titled, “Patient Care Environment Policy (Effective 12/1/2014) was reviewed on 9/18/2025 and included, “ ...The space for treating each patient at the [Facility] is sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff ...” 2. On 9/15/2025 from approximately 8:45 AM to 10:45 AM, a tour of the dialysis treatment area at L#3 was conducted. The Facility had a total of nine dialysis stations. There were eight second shift patients receiving dialysis treatment at approximately 10:00 AM and the following was observed: - The dialysis machine at station #1 was touching the chair of the patient in station #2. - The dialysis machine at station #2 was touching the chair of the patient in station #3. - The dialysis machine at station #6 was touching the chair of the patient in station #5. 3. On 9/18/2025 at 11:24 AM, an interview was conducted with the Area Manager (E #14). E #14 stated that the determination of appropriate space was determined by clinical services in collaboration with business development. E#14 stated that patients should not be touching each other or that one patient should not be able to reach the other patient.”

“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: 34411 Based on document review, observation, and interview, for 3 of 5 patients (Pt #3, Pt #4, Pt #17) observed for order verification at L #2 (Location #2/conventional dialysis center), it was determined that the Facility to ensure that prescriptions that were set on the dialysis machines, were in accordance with the orders. Findings include: 1. The Facility’s policy titled, “Initiation/Monitoring/Termination of HD Treatment using the Fresenius 2008 Series or Baxter Phoenix Dialysis Machines” (dated 10/1/2019), was reviewed and required, “...Initiate Treatment: Verify dialysis prescription order and machine set up...” 2. The clinical record for Pt #3 was reviewed on 9/15/2025. Pt #3 was admitted on 2/17/2023, with a diagnosis of ESRD (end stage renal disease). The hemodialysis treatment order (6/27/2025), did not include a set sodium level. 3. The clinical record for Pt #4 was reviewed on 9/15/2025. Pt #4 was admitted on 9/3/2025, with a diagnosis of ESRD. The hemodialysis treatment order (dated 9/3/2025), included a prescribed sodium level at 138. 4. The clinical record for Pt #17 was reviewed on 9/15/2025. Pt #17 was admitted on 8/22/2025, with a diagnosis of ESRD. The hemodialysis treatment order (8/22/2025), included a dialysis bath of 2K 2.5 Ca. 5. On 9/15/2025, between 12:45 PM and 4:00 PM, an observational tour of the dialysis treatment area was conducted and the following was observed: - At Station #6, Pt #4’s prescription/order was verified on the dialysis machine, with the Registered Nurse (E #6). Pt #4’s machine was set with the sodium level at 140 (not the prescribed 138). - At Station #5, Pt #3’s prescription was verified on the dialysis machine with E #6. Pt #3’s machine was set with the sodium level at 137. There was no sodium order. However, E #6 stated that the machine should have been set at the standard sodium level of 138, not 137. - At Station #3, Pt #17’s prescription was verified on the dialysis machine with E #6. Pt #17’s dialysate bath was set at 2K 2Ca (not the prescribed 2K 2.5 Ca). 6. On 9/15/2025 at 1:50 PM, an interview was conducted with the Registered Nurse (E #6). E #6 stated that the patient care technicians should verify the patient’s prescription when putting the patients on the machines. E #6 stated that the nurse then verifies the correct prescription.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 50411 Based on document review, observation and interview, for 3 of 4 dialysis treatment locations (L#1 - Conventional, L#3 - NxStage, and L#4 - Conventional) observed, the Facility failed to ensure that one fistula clamp is used at a time and the AVF (Arteriovenous Fistula) were assessed every 3-5 minutes as required by the Facility’s policy. Findings include: 1. On 9/17/2025, the Facility’s policy titled, “Use of Fistula Clamps Policy, Procedure” (Effective 7/1/2021) was reviewed and included, “ ...Policy: 2. Use only one clamp at a time ...Procedure ... 4. Palpate the access for a thrill every 3-5 minutes on both sides of the clamp and document findings in dedicated nursing progress note. 2. During the observational tour of L#1, on 9/15/2025 at approximately 10:20 AM through 2:00 PM, an observational tour of the dialysis treatment floor was conducted at L#1. At approximately 10:34 AM, Patient Care Technician (PCT-E#2) was observed discontinuing a dialysis treatment for a patient at Station #2. A clamp was used after removing each fistula needles. No assessment of the fistula was observed. 3. During the observational tour of L#3 on 9/16/2025 at approximately 8:45 AM, a patient was observed in Station #8 with 2 clamps placed over the AVF site. No assessment of the fistula was observed. 4. During the observational tour of L#4 on 9/17/2025 at approximately 9:37 AM, PCT (E#8) was observed removing fistula needles for a patient in Station #4. A clamp was used after removing the fistula needle. No assessment of the fistula was observed. 5. During the observational tour of L#4 on 9/17/2025 at approximately 9:54 AM, RN (E#7) was observed removing the fistula needles of a patient in Station #5. A clamp was used after removing the fistula needle. No assessment of the fistula was observed. 6. On 9/16/2025 at approximately 10:21 AM, an interview was conducted with the PCT at L#3 (E#13). E#13 stated that 2 clamps may be used at the same time when removing fistula needles. E#13 stated that the thrill and bruit should be checked when using clamps after removing the needles.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 39802 Based on document review and interview, for 3 of 6 months (April-June 2025) of Quality Assessment and Performance Improvement (QAPI) meetings data/minutes reviewed, the Facility failed to ensure that the QAPI Committee reviewed adverse occurrences including but not limited to intradialytic morbidities (i.e. chest pain or cramping during dialysis), blood loss, and non-adherence to procedures (i.e. shortened treatments) to track, trend, and identify the prevalence of occurrences and causes. Findings include: 1. The Facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) Policy” (revised 07/01/2020), was reviewed and required, “...Members of the QAPI Committee will be responsible for the implementation of comprehensive data collection , as well as monitoring and improvement activities including, but not limited to, measurement, evaluation, and analysis of the data related to the following items; and the development of improvement plans for the following measures when indicated: ...Medical injuries and errors identification...” 2. The Facility’s adverse occurrence reporting from January 2025-June 2025 was reviewed electronically with the Area Manager (E#14) on 09/18/2025, at approximately 1:00 PM, and included the following information: - April = 5 occurrences (1 hypotension, 1 cramping, and 4 shortened treatments) - May = 2 occurrences (1 chest pain and 1 shortened treatment) - June = 6 occurrences ( 1 blood loss and 5 shortened treatments) 3. The Monthly QAPI Meeting Data and Minutes from Jan 2025-June 2025 were reviewed and included that there was 1 adverse event in April 2025 (minutes did not identify what event occurred) and had 0 in May and June. 4. An interview was conducted with the Area Manager (E#14) on 09/18/2025, at approximately 1:30 PM. E#14 stated that the manager for each location is responsible for reviewing all adverse events. E#14 stated that before the QAPI meeting, the managers are supposed to tally up the adverse events and enter them into the QAPI data form so they can discuss what adverse events occurred. E#14 stated that they don’t count shortened treatments as adverse events.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 34411 A. Based on document review, observation, and interview, for 1 of 4 (Location #2/conventional dialysis location), observed for the supplies’ expiration dates, the Medical Director failed to ensure that staff adhered to patient care policies. Findings include: 1. The Facility’s “Conventional Dialysis Den Products Management Guide”, was reviewed, and required, “...Remember to check all supplies and medication monthly for expiration dates!...” 2. On 9/17/2025, a policy on expired lab supplies was requested. The Facility did not provide a policy. 3. On 9/15/2025 between 12:45 PM and 4:00 PM, an observational tour of Location #2’s dialysis treatment area was conducted. The area where laboratory supplies are kept, was observed. The following expired lab tubes and blood culture bottles were noted: 10 mint green (expired 5/31/2025); 2 purple tops (expired 8/31/2025); and 2 sets of blood culture bottles (expired 6/19/2024). - In the storage room, there were 2 sets of blood culture bottles (expired 9/25/2024 and 8/7/2025). L#2 did not have any usable (non-expired) blood culture bottles. 4. On 9/15/2025 at 2:15 PM, an interview was conducted with the Registered Nurse (E #6). E #6 stated that supplies are checked at least twice a month and should be checked before use. E #6 stated that expired supplies should be discarded. E #6 stated that the logistics department should be contacted to order new supplies. 5. On 9/18/2025 at 12:05 PM, a phone interview was conducted with the Medical Director (MD #1). MD #1 stated that staff are required to adhere to policies. MD #1 stated that staff are expected to check supplies for expiration dates. 50411 B. Based on document review, observation, and interview, for 2 of 4 dialysis treatment locations (L#1 - Conventional and L#3 - NxStage) observed, the Facility failed to ensure the medications were kept secure when left unattended, as required by the Facility’s policy. Findings include: 1. On 9/17/2025, the Facility’s Policy entitled, “Medication Preparation and Administration Policy, Procedure” (Effective 12/1/2014) included, “ ...All medication, when pre-drawn or not in use, must be secured in preparer’s control, and/or locked in a designated medication storage area or medication refrigerator ...” 2. During an observation in the facility treatment area at L#1 on 9/15/2025 at approximately 10:27 AM, a medication labeled “Heparin 30,000 units per 30 ml” was observed on the counter at the nurses station left unattended and unsecured. 3. An interview was conducted with the Charge Nurse (E#10). E#10 stated that medications can be left on the counter unattended as long as they are labeled and dated. 4. During an observation in the facility treatment area at L#3 on 9/16/2025 at approximately 8:50 AM, a medication labeled “Heparin 30,0000 units per 30 ml” was observed on the counter at the nurse’s station left unattended and unsecured. 5. On 9/16/2025 at approximately 10:36 AM, an interview was conducted with the Charge Nurse (E#11) at L#3. E#11 stated that all medications should be placed in a locked cabinet when left unattended. 6. On 9/18/2025 at approximately 12:05 PM, an interview was conducted with the Medical Director (MD#1). MD#1 stated that all staff should follow all company policies 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: 27125 A. Based on document review, observation and interview, it was determined that for 1 of 3 (E#7 - at L#3) staff observed, the facility failed to ensure gloves were removed and hand hygiene performed between tasks. Findings include: 1. The facility’s policy titled, Hand Hygiene Handwashing Policy, Procedure (10/6/2020)” was reviewed on 9/25/2024 and required, “All staff will use the hand-hygiene techniques ... Before each patient encounter ... after contact with medical equipment/supplies in patient areas ... after removing gloves.” 2. During a tour of the dialysis den on 9/24/2024 from 9:00 AM to 12:00 PM at L#3, the following was observed: - 9:50 AM - E#7 (technician) adjusted the dialysis machine at station #6, took off gloves and went to the clean supply cart without performing hand hygiene. - 10:00 AM - E#7 adjusted the dialysis machine at station #10, went to station #6 to adjust dialysis machine alarm. E#7 did not remove gloves or perform hand hygiene between stations. - 11:30 AM, E#7 removed the used dialysis cartridge from the dialysis machine at station #10, discarded the cartridge, removed gloves and took supplies from clean cart. E#7 did not perform hand hygiene. 3. During an interview on 9/24/2024 at 11:30 AM, the nurse (E#5) stated that hand hygiene is to be performed between patient activity and after removing gloves. 36774 B. Based on observation, document review and interview, it was determined that for 1 of 1 patient (Pt. #5) observed for hand hygiene, the facility (L #4) failed to ensure that the patient performed hand hygiene following self-hold of dialysis cannulation site, potentially causing cross contamination to staff or other patients. Findings include: 1. On 9/24/2024 between approximately 9:00 AM through 11:45 AM, an observational tour of the facility’s treatment area was conducted. At approximately 9:10 AM, Pt. #1 was observed holding cannulation site with gloved right hand. E #13 (Patient Care Technician) assisted in removing Pt. #5’s gloves and helped Pt. #5 transferred to the wheelchair. Pt. #5 then opened the dialysis treatment door and wheeled self out of the treatment area. E #13 did not instruct Pt. #5 to perform hand hygiene after glove removal. 2. On 9/24/2024, the facility’s policy titled, “Vascular Access” (3/2017) was reviewed and included, “... 10. If patient will be encouraged to hold their (dialysis cannulation) site, the patient should be offered a glove to hold their site and encouraged to perform hand hygiene after glove removal... Gloves and hand hygiene protects patient and others from cross contamination...” 3. On 9/24/2024 at approximately 9:30 AM, an interview was conducted with E #13 (PCT). E #13 stated that E #13 forgot to instruct Pt #5 to perform hand hygiene after glove removal. E #13 stated that Pt. #5 should have been instructed to perform hand hygiene after glove removal to prevent cross contamination.”

“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: 27125 Based on document review, observation, and interview, it was determined that for 4 of 5 Nursing Home facility staff observed transporting patients from the dialysis treatment area at L#1, the facility failed to ensure that staff wore personal protective equipment (PPE) when entering the treatment area, where patients were being disconnected from dialysis. Findings include: 1. The facility’s policy titled, “Personal Protective Equipment [PPE] (dated 12/01/2014)” was reviewed on 9/25/2024, and required, “Staff shall wear personal protective equipment appropriate to the anticipated potential exposure. Staff shall wear PPE during the initiation and termination of dialysis treatment... for times when the spurting or spattering of blood, and body fluid might occur. At those times, staff must wear cover garment that provides an impervious barrier to fluids...” 2. During an observational tour of the dialysis den on 9/23/2024 from 9:30 AM to 12:00 PM at L#1 the following was observed: - 10:30 AM - One nursing home staff entered the treatment area to transport the patient at stations #7 out of the treatment area. The staff did not wear protective PPE while patients close by were being removed from dialysis treatment. - 11:05 AM - Two nursing home staff entered the treatment area to transport patients from stations #1 and #3 out of the treatment area. The staff did not wear protective PPE while patients close by were being removed from dialysis treatment. - 11:10 AM - One nursing home staff entered the treatment area to transport the patient from station #4 out of the treatment area. The staff did not wear protective PPE while patients close by were being removed from dialysis treatment. 3. During an interview on 9/23/2024 at 11:10 AM, the nurse (E#3) stated that the nursing home staff have been instructed to wear cover gowns when entering the treatment area for protection from potential blood splattering. E#3 stated, “We try to catch them before they walk up to the patient but have a real problem with the nursing home agency staff not wanting to wear cover gowns””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 36774 Based on observation, document review and interview, it was determined that for 1 of 2 PCTs/patient care technicians (E #13) observed for cleaning and disinfection of dialysis/medical equipment, the facility (L #4) failed to ensure that the PCT cleaned the thermometer, as required. Findings include: 1. On 9/24/2024 between approximately 9:00 AM through 11:45 AM, an observational tour of the facility’s treatment area was conducted. At approximately 9:15 AM, E #13 took Pt. #6’s temperature using a reusable patient thermometer. E #13 did not disinfect the thermometer before putting the thermometer on the clean table to be used by staff for the next patient. 2. On 9/24/2024, the facility’s policy titled, “Cleaning and Disinfection of Medical Devices and Equipment” (9/2020) was reviewed and included, “... Policy... staff shall clean and disinfect... medical devices and equipment... using a facility-approved... disinfectant or 1:100 bleach solution...” 3. On 9/24/2024 at approximately 9:30 AM, an interview was conducted with E #13. E #13 stated that E #13 forgot to clean and disinfect the thermometer before placing the thermometer on the clean table.”

“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: 39802 A. Based on document review, observation, and interview, it was determined that for 1 of 2 locations (L#2) observed for bicarbonate handling, the facility failed to ensure that preparation and storage of bicarbonate was done in a clean area. This had the potential to affect the 20 patients on census at L#2. Findings include: 1. The facility’s policy titled, “Infection Prevention and Control Practices” (revised 06/01/2023), was reviewed and required, “...Clean areas shall be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas shall be clearly separated from contaminated areas where used supplies and equipment are handled...” 2. During a tour of the dialysis treatment area at L#2 on 09/24/2024, the following was observed: - At approximately 11:00 AM, staff were cleaning stations after dialysis treatment and were emptying the used acid and bicarbonate jugs in the sink in the water room. There was only one sink in the water room and it was labeled as “dirty sink.” As staff were emptying the used jugs, three containers of bicarbonate were sitting inside the dirty sink. The Patient Care Technician (E#11) then moved the 3 bicarbonate jugs to a cart; the jugs were later used for dialysis treatment for the next shift of patients. - At approximately 11:46 AM, E#11 went to the water room to mix a jug of bicarbonate. E#11 set the jug inside the dirty sink and filled the jug with water from a dispenser on the sink labeled “RO [reverse osmosis] water.” E#11 added the concentrate powder to the jug and shook the jug to mix the contents while the jug remained in the dirty sink. 3. An interview was conducted with E#11 on 09/24/2024, at approximately 12:40 PM. E#11 stated that preparation of bicarbonate is not a sterile procedure but is considered a clean procedure. E#11 stated that ideally they should do the mixing and storage in a clean area, but there is limited space in the water room. E#11 stated that the purified (RO) water could be taken directly from the RO product water port instead of from the dirty sink. B. Based on document review, observation and interview it was determined that for 1 of 1 storage rooms at L#2, the Facility failed to ensure that supplies were secure and stored off the floor to prevent contamination. Findings included: 1. The facility’s policy titled, “Equipment Storage in Long Term Care Facilities Policy, Procedure” (revised 4/2/2020) was reviewed and required, “...Dialysis equipment when not in use must be stored in a safe and secure location...” 2. The facility’s policy titled, “Infection Prevention and Control Practices” (revised 06/01/2023), was reviewed and required, “...Clean areas shall be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas shall be clearly separated from contaminated areas...” 3. An observational tour of the dialysis storage area at L#2 was conducted on 09/23/2024, at approximately 10:40 AM. The storage room included a stock of boxes (saline bags and lab tubes) that were located directly on the floor. 4. An interview was conducted with the Registered Nurse (E#8) on 09/23/2024, at approximately 10:42 AM. E#8 stated that the supplies are not suppose to be on the floor.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 27125 Based on document review, observation and interview it was determined that for 1 of 2 (E#4 - at L#1) staff observed in the dialysis den, the facility failed to ensure infection control procedures were followed by staff not keeping supplies in their pockets. Findings include: 1. The facility’s policy titled, “Infection Prevention and Control Program (6/1/2020)” was reviewed on 9/25/2024 and included, “Ensures appropriate use of personal protective equipment, including gowns, gloves. ...” 2. An observation of the dialysis den at L#1 was conducted on 9/23/2024 from 9:30 AM to 12:00 PM. During the observation E#4 (technician) was noted to have gloves in E#4’s cover gown pockets and personal scrubs that E#4 used for patient care. 3. During an interview on 9/23/2024 at 12:00 PM, the nurse (E#3) stated that no supplies are to be kept in staff pockets. E#3 stated, “Administration even ordered cover gowns that didn’t have pockets for awhile to prevent that practice. Recently, we started getting gowns with pockets.””

“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: 39802 Based on document review and interview, it was determined that for 3 of 3 patients (Pts. #11-#13) reviewed for susceptibility to Hepatitis B (liver infection) at L#3, the facility failed to ensure that Hepatitis B vaccine was administered or offered. Findings include: 1. The facility’s policy titled, “Vaccination Protocol Policy” (revised 06/01/2024) was reviewed and required, “...Hepatitis B vaccine is to be offered to all ESKD [end-stage kidney disease] patients whose HBsAb [antibody] is < [less than] 10 mIU/mL [milli-international units per milliliter]... Document start date and due dates... A declination form must be signed and placed in the patient medical record for all patients who refuses any vaccination... Patients will be reassessed on an annual basis...” 2. The Hepatitis B vaccination reports for L#3 were reviewed on 09/25/2024 which indicated there were 3 patients who were susceptible to Hepatitis B infection as follows: - Pt. #11 was admitted on 07/18/2023 with ESKD. As of, 07/18/2023, the HBsAb was less than 10. Pt. #11 signed a consent form on 07/18/2023 indicating that Pt. #11 consented to receiving the vaccine series. The record lacked documentation that Pt. #11 received the vaccine or a reason why the vaccine was not administered. - Pt. #12 was admitted on 08/17/2023 with ESKD. As of 08/17/2023, the HBsAb was less than 10. The record lacked documentation that Pt. #12 was offered the vaccination upon admission and annually. - Pt. #13 was admitted on 08/07/2023 with ESKD. As of 08/07/2023, the HBsAb was less than 10. Pt. #13 signed a consent form on 08/07/2023 indicating that Pt. #13 consented to receiving the vaccine series. The record lacked documentation that Pt. #13 received the vaccine or a reason why the vaccine was not administered. 3. An interview was conducted with the Area Manager (E#2) on 09/25/2024, at approximately 2:40 PM. E#2 stated that there is no record that any of the susceptible patients from L#3 received the Hepatitis vaccine series. On 09/26/2024, at approximately 9:00 AM, E#2 stated that vaccination series should be offered to susceptible patients at least annually.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 27125 Based on documentation review, observation and interview, it was determined that for 1 of 2 (E#6 - at L#3) staff observed cannulating (introduce a tube into a vein) an arteriovenous fistula (connection between an artery and vein), the facility failed to ensure that staff demonstrated knowledge of infection control practices by not touching the site after prepping the site, potentially causing contamination. Findings included: 1. The facility’s policy titled, “Cannulation of an Arteriovenous Fistula [AVF] Policy, Procedure (3/2/2020)” was reviewed on 9/25/2024 and required, “Trained dialysis staff is responsible to prepare the access area and to use proper technique in cannulating the AV fistula. ... Once area is prepared, do not palpate access unless a repeat prep is done.” 2. During an observation on 9/24/2024 at 11:00 AM at L#3, E#6 (technician) was observed prepping the dialysis site at station #5. E#6 cleaned the site, placed E#6’s hand over the site to palpate and then cannulated the site. E#6 did not prep the area again after touching the site. 3. During an interview on 9/24/2024 at 11:45 AM, the nurse (E#5) stated that the site should have been cleaned again before cannulating after it was touched. 39802 B. Based on document review, observation, and interview, it was determined that for 2 of 2 staff (E#9 and E#11) at L#2 observed cannulating (inserting dialysis needle) arteriovenous access sites, the Facility failed to ensure that staff disinfected the sites for the appropriate contact time. Findings include: 1. The facility’s policy titled, “Cannulation of an Arteriovenous Fistula Policy, Procedure” (effective 03/02/2020), was reviewed and required, “...Scrub access... Alcohol has short bacteriostatic action time and should be applied in a rubbing motion for 1 minute immediately prior to cannulation...” 2. During a tour of the dialysis treatment area at L#2 on 09/23/2024, at approximately 11:56 AM, the Patient Care Technician/PCT (E#9) was preparing to initiate dialysis treatment for a patient with an arteriovenous access site. E#9 wiped the access for a total of approximately 10 seconds with an alcohol wipe before inserting the dialysis needle. 3. During a tour of the dialysis treatment area at L#2 on 09/24/2024, at approximately 12:50 PM, the PCT (E#11) was preparing to initiate dialysis treatment for a patient with an arterviovenous access site. E#11 wiped the first site with alcohol for approximately 6 seconds and then inserted the dialysis needle. E#11 then wiped the second access site with alcohol for approximately 10 seconds before inserting the dialysis needle. 4. An interview was conducted with the PCT E#9 on 09/23/2024, at approximately 1:00 PM. E#9 stated that arteriovenous access sites should be wiped with alcohol for 60 seconds.”

“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: 50702 A. Based on document review, observation, and interview, it was determined that for 1 of 3 PCT’s/patient care technicians (E #6) observed initiating dialysis on a patient with CVC (Central Venous Catheter/dialysis access), the facility failed to ensure that the staff clean/scrub the catheter caps for 60 seconds before initiation of the dialysis treatment, per policy. Findings included: 1. On 9/25/2024, the facility’s policy titled, “Central Venous Catheter Care” (7/2019) was reviewed and included, “ ... Pre-treatment/Initiation of Treatment ...Soak two 4 x 4 gauze pads in Alcavis [disinfectant]. Scrub each catheter connection cap separately for 1 minute.” 2. On 9/24/2024 between approximately 10:15 AM and 11:30 PM, an observational tour of the dialysis treatment area was conducted. At approximately 11:15 AM, E #6 was observed initiating dialysis on patient at station #1 with a CVC access. E#6 cleansed each CVC access cap for 14-seconds (per wall clock) instead of 60-seconds. 3. On 9/24/2024 approximately 11:35 AM, findings were discussed with E#5 (Registered Nurse). E#5 stated that the CVC access for dialysis is supposed to be scrubbed for 60 seconds before the start of treatment. 39802 B. Based on document review, observation, and interview, it was determined that for 2 of 2 staff (E#9 and E#11) observed initiating or terminating dialysis treatment with central venous catheters (CVCs), the facility failed to ensure that the staff wore a face shield and the patient wore a mask that covered both nose and mouth. Findings include: 1. The facility’s policy titled, “Central Venous Catheter” (revised 08/16/2021), was reviewed and required, “...PPE [personal protective equipment] required for both initiation and termination of treatment: Masks for the patient and staff, Gloves, Gown, Goggles or face shield... Don PPE. Patient must wear a mask... secure patient’s mask and ask patient to turn head when opening catheter...” 2. During a tour of the dialysis treatment area at L#2 on 09/23/2024, at approximately 9:30 AM, Patient Care Technician/PCT (E#9) was discontinuing dialysis treatment for a patient with a CVC. E#9 was not wearing a face shield and the patient’s mask was below the patient’s nose when the catheters were opened. 3. During a tour of the dialysis treatment area at L#2 on 09/24/2024, at approximately 9:20 AM, PCT (E#11) was discontinuing dialysis treatment for a patient with a CVC. E#11 was not wearing a face shield and the patient’s mask was below the patient’s nose when the catheters were opened. 4. An interview with PCT (E#11) was conducted on 09/24/2024, at approximately 12:40 PM. E#11 stated that a face shield is only required when inserting a needle as there is a potential for blood to splatter. E#11 stated that when accessing a CVC, the staff and patient should be wearing a mask that covers the nose and mouth to prevent possible contamination of the catheter.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 1 of 2 locations (L#2) observed for bicarbonate handling, the facility failed to ensure that prepared/mixed batches of bicarbonate were labeled with the date /time the concentrate was mixed. This had the potential to affect the 20 patients on census at L#2. Findings include: 1. The facility’s policy titled, “Preparation of Bicarbonate Concentrate Solution for Dialysis” (effective 10/01/2019), was reviewed and required, “...Ensure the container is appropriately labeled with all of the following: “Bicarbonate Concentrate”; Date and time the concentrate was mixed; Initials of the person who mixed the concentrate...” 2. During a tour of the dialysis treatment area at L#2 on 09/23/2024 and 09/24/2024, prepared (mixed) bicarbonate jugs were used for dialysis treatments; however, none of the jugs were labeled with the date/time prepared and initials of the staff who prepared the solutions. 3. An interview was conducted with the Patient Care Technician (E#9) on 09/23/2024, at approximately 1:00 PM. E#9 stated that E#9 prepares all the bicarbonate for the day each morning. E#9 stated that they discard any unused portions of the bicarbonate at the end of the day. E#9 stated that E#9 prepared the bicarbonate this morning but didn’t label them.”

“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: 50702 Based on the document review, observation, and interview, it was determined that for 4 of 4 staff (E#3 - registered nurse, E#4, E#9 and E#11- technicians) observed initiating dialysis treatment at L#1, the facility failed to ensure that the pH/ conductivity was performed prior to initiation of the dialysis treatment and that the test was performed correctly. Findings include: 1. On 9/25/2024, the facility’s policy titled, “Dialysate pH Testing” (10/01/2019)” was reviewed and included, “Dialysate pH is tested prior to initiation of each dialysis treatment to conform pH is in acceptable range (6.9 to 7.6) ...To ensure the conductivity of conventional Dialysate meets the required standards for safe, effective dialysis treatments.” 2. The pH Test Strip Manufacturer’s Application Note (undated), included “...Failure to follow instructions for use... may result in inaccurate test results... For every test, use a stop watch or second hand of a clock/watch to make sure the dip/swish time and wait time called for in the IFUs [instructions for use] is correct. Proper test sample exposure time and wait time are critical for test strip accuracy...” 3. On 9/23/2024, between 9:00 AM and 12:50 PM, an observational tour of the dialysis treatment den at location number one (L #1) was conducted. At approximately 12:30 PM and 12:35 PM, E#3 and E#4 were observed initiating dialysis on Pt. on station #1 and station #3. E#3 and E#4 did test the pH conductivity for acceptable range before starting dialysis treatment. 4. During a tour of the dialysis treatment area at L#2 on 09/23/2024, at approximately 11:05 AM, a Patient Care Technician/PCT (E#9) was preparing dialysis machines for treatment. E#9 obtained dialysate samples from 4 machines and placed a pH test strip in each cup. E#9 then took out the strips and read the results immediately. The pH strip bottle had instructions to read the results between 5 to 10 seconds. 5 During a tour of the dialysis treatment area at L#2 on 09/24/2024, at approximately 12:19 PM, PCT (E#11) was preparing a dialysis machine for treatment at station #5. E#11 obtained a dialysate sample, dipped a pH test strip in the solution, then compared it to bottle without using a timer or clock. At approximately 12:55 PM, E#11 cannulated the patient’s access site at station #5 and was ready to begin treatment. E#11 had not performed a conductivity test of the machine at station #5 yet. 6. On 9/23/2024 at approximately 12:40 PM, an interview was conducted with E#3 (Charge Nurse). E#3 stated that E#3 and E#4 forgot to test the pH level. E#3 stated that they should have checked the pH conductivity before starting the dialysis treatment. E#3 and E#4 were able to demonstrate the process for conducting the teat and able to discuss the acceptable range of results. 39802 7. An interview was conducted with E#9 on 09/23/2024, at approximately 11:06 AM. E#9 stated that E#9 dips the strip in the sample, takes it out, shakes it off, then reads the result right away. E#9 stated that you have to read the result within a few seconds. E#9 stated that the acceptable pH range is between 6.8-7.8. 8. An interview was conducted with E#11 on 09/24/2024, at approximately 12:40 PM. E#11 stated that after dipping the test strip in the sample, E#11 shakes the excess solution off then waits 30 seconds to read the result. 9. A second interview was conducted with E#11 on 09/24/2024, at approximatley 12:57 PM. E#11 stated that E#11 only tests the conductivity of the machines in the morning before the first shift using the white Myron-L meter. E#11 stated that the conductivity must be between 14.0 and 14.9 and that it does not have to be within a certain range of the dialysis machine’s conductivity.”

“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: 27125 A. Based on document review, and interview it was determined that for 5 of 9 (Machine#s 41898, 10682, 32774, 11798 and 10177) active use NxStage cyclers (portable dialysis machine) and for 7 of 9 (Machine #s 3954, 42887, 43647, 3978, 51643, 40937, and 36115) active use Pure Flow (water purification system) at L#3, the facility failed to ensure the required preventative maintenance was performed. Findings include: 1. The facility’s policy titled, “Cleaning and Maintenance: NxStage System one and PureFlow SL Policy, Procedure (9/29/2020)” was reviewed on 9/25/2024 and required, “Periodic Maintenance is to be performed on all equipment in active use. a) The PureFlow SL drain is to be flushed weekly. b) The NxStage System One blood leak detector is to be cleaned monthly 2. The maintenance log of NxStage machines for L#3 was reviewed on 9/25/2024. the log included: - 7 of 9 (Machine #s 3954, 42887, 43647, 3978, 51643, 40937, and 36115) Pure Flow did not have weekly drain line bleaching performed from 8/25/2024 to 9/21/2024 (4 weeks). - 5 of 9 (Machine#s 41898, 10682, 32774, 11798 and 10177) cyclers did not have a monthly blood leak detector cleaning performed in August and September 2024. 3. During an interview on 9/25/2024 at approximately 10:45 AM, the area manager (E#2) stated that there is no documentation of those tasks being performed. 50702 B. Based on the document review, observation, and interview, it was determined that for 6 of 9 dialysis chairs found in the dialysis treatment area at L#3, the facility failed to ensure that chairs were maintained to allow effective cleaning/disinfection or remove torn chairs from use to prevent cross contamination. Findings include: 1. On 9/25/2024, the facility’s policy titled, “ Cleaning and Disinfection of Medical Devices and Treatment Policy” (dated-9/29/2020)” was reviewed and included, “Environmental surfaces shall be cleaned and disinfected after each patient use and at the end of the day ...Environmental surfaces to be clean and disinfected included: Patient chair.” 2. On 9/24/2024, between 9:00 AM and 11:35 AM, an observational tour of the dialysis treatment den was conducted at L#3. Six of nine dialysis chairs were torn on the arms and foot rests, not allowing for proper disinfection. 3. On 9/24/2024 around 10:50 AM, findings were discussed with E#6 (Patient Care Technician). E# 6 stated, “The condition of the chairs being torn and ripped has been a problem for a long time.” E#6 stated that nothing has been done about the torn and ripped of chairs, and they try to maintain disinfecting and cleaning of the chairs the best they can.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 39802 A. Based on document review, observation, and interview, it was determined that for 3 of 3 (Pt. #7, Pt. #14 and Pt. #15) patients observed with clamps, the facility failed to ensure that only one clamp was used at a time on a vascular access site after dialysis treatment, and that the access site was assessed while the clamp was in use as required. Findings include: 1. The facility’s policy titled, “Use of Fistula Clamps Policy, Procedure” (effective 7/1/2021), was reviewed and required, “...Use only one clamp at a time... Leave the clamp on the site for 10 minutes to stop bleeding. Palpate the access for a thrill [vibration felt over the access to indicate blood flow] every 3-5 minutes on both sides of the clamp and document findings...” 2. During a tour of the dialysis treatment area at L#2 on 9/24/2024, at approximately 9:40 AM. a patient (Pt. #7) was at station #6 after dialysis treatment and had 2 clamps applied to the AV (arteriovenous) fistula on the left arm. The clamps remained on for approximately 10 minutes; however, staff did not assess the access for a thrill every 3-5 minutes as required. 3. During an observation of the dialysis den on 9/24/2024 from 9:00 AM to 12:00 AM at L#3, the following was observed at L#3: - 9:30 AM - E#7 (technician) removed both lines from the dialysis fistula sites and placed a clamp over both sites at the same time to apply pressure for the patient at station #8 (Pt. #14). E#7 did not monitor the sites until the clamps were removed approximately 8 minutes after application. - 10:35 AM - E#6 (technician) removed both lines from the dialysis fistula sites and placed a clamp over both sites at the same time to apply pressure for the patient at station #4 (Pt. #15). E#6 did not monitor the sites until the clamps were removed approximately 10 minutes after application. 4. An interview was conducted with the Patient Care Technician (E#11) on 09/24/2024, at approximately 12:40 PM. E#11 stated that E#11 did not know they were not supposed to use 2 clamps at a time. 5. An interview was conducted with Registered Nurse (E#10) on 09/24/2024, at approximately 1:30 PM. E#10 stated that only one clamp should be used at a time in case there are any issues; it would be easier to manage one access instead of two at the same time. B. Based on document review, observation, and interview, it was determined that for 2 of 3 staff (E#8 and E#9) observed initiating dialysis treatments on patients with arteriovenous access sites, the facility failed to ensure that staff assessed the access for patency (unobstructed blood flow) prior to initiating treatment. Findings include: 1. The facility’s policy titled, “Assessing Patency of Arteriovenous AV Fistula/Graft Policy, Procedure” (revised 03/31/2017), was reviewed and required, “The [Facility] Staff RN [Registered Nurse] will assess the patient’s AV fistula/graft and affected extremity before the initiation of dialysis... Palpate the area over the shunt to assess for a thrill or vibration... Auscultate, with a stethoscope, the fistula to assess for a swishing noise or bruit...” 2. During a tour of the dialysis treatment area on 09/23/2024, at approximately 11:55 AM, a Patient Care Technician/PCT (E#9) was initiating dialysis treatment for a patient with an arteriovenous access site. The Registered Nurse (E#8) assessed the patient’s lungs using a stethoscope and checked for the presence of edema; however, E#8 did not assess the access site for thrill or bruit. At approximately 11:57 AM, E#9 inserted the dialysis access needles without assessing the access site for thrill or bruit. 3. An interview was conducted with the Registered Nurse (E#8) on 09/23/2024, at approximately 12:05 PM. E#8 stated that the PCT is the one who assesses the access site and documents it in the treatment record. E#8 stated that E#8 will only assess for the thrill and bruit if the PCT is having trouble hearing the bruit or felling the thrill. 4. An interview was conducted with the PCT (E#9) on 09/23/2024, at approximately 1:00 PM. E#9 stated that they should assess for the thrill and bruit before cannulating (inserting dialysis needles); however, E#9 forgot.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 2 of 2 patients’ (Pt. #9 and Pt. #10) care plans reviewed for unstable patients, the facility failed to ensure that the required monthly modification of care plan was completed. Findings include: 1. On 9/25/2024, the facility’s policy titled, “Comprehensive Interdisciplinary Assessment Policy” (revised 3/31/2017) was reviewed and included, “...The frequency of the assessment and plan of care depends on the stability of the patient as determined by the physician with input from the other members of the IDT [interdisciplinary team]... The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his/her needs. The comprehensive assessment shall be used to develop the patient’s treatment plan and expectations for care... “Unstable patients” include but are not limited to patients with the following: Extended or frequent hospitalization... Change in psychosocial needs...” 2. On 9/25/2024, the clinical record for Pt. #9 was reviewed. On 10/17/2023, Pt. #9 was admitted to the facility with a diagnosis of End Stage Renal Disease (ESRD). On 5/15/2024, the IDT conducted a comprehensive assessment and developed a plan of care for Pt. #9, identifying Pt. #9 as unstable due to attitude/behavior affecting adherence to dialysis treatments. Pt. #9 received dialysis treatments in June, July, and August 2024. There was no monthly care plan for June, July, and August 2024. 3. On 9/25/2024, the clinical record for Pt. #10 was reviewed. On 6/25/2022, Pt. #10 was admitted to the facility with a diagnosis of ESRD. On 6/5/2024, the IDT conducted a comprehensive assessment and developed a plan of care for Pt. #10, identifying Pt. #10 as unstable due to frequent hospitalization. Pt. #10 received dialysis treatments in July and August 2024. There was no monthly care plan for July and August 2024. 4. On 9/25/2024 at approximately 11:30 AM, findings were discussed with E #2 (Area Manager). E #2 stated that a monthly comprehensive assessment and care plan should be completed for unstable patients. E #2 was not able to show that the required care plans were completed for Pt. #9 and Pt. #10.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 36774 A. Based on document review and interview, it was determined that the facility failed to ensure that the QAPI (Quality Assessment and Performance Improvement) team analyzed and evaluate the contributing factors related to patient mortalities. Findings include: 1. On 9/26/2024, the facility’s policy titled, “Quality Assessment and Performance Improvement” (7/2020) was reviewed and included, “... Policy... 6. Members of the QAPI Committee will be responsible for the implementation of comprehensive data collection, as well as monitoring and improvement activities including, but not limited to... evaluation and analysis of the data related to... c. Health Outcomes: Patient Survival...” 2. On 9/26/2024, the facility’s monthly QAPI Meeting Minutes were reviewed and indicated the following: 3/27/2024, 6 patient mortalities; 4/24/2024, 6 patient mortalities; 5/21/2024, 12 patient mortalities; 6/26/2024, 2 patient mortalities; 7/31/2024, 5 patient mortalities; and 8/28/2024, 2 patient mortalities. The meeting minutes lacked documentation that the QAPI team analyzed and evaluate contributing factors related to patient mortalities. 3. On 9/26/2024 at approximately 9:30 AM, findings were discussed with E #2 (Area Manager). E #2 stated that the facility only looks at the number of deaths and do not discuss contributing factors, e.g., patient’s dialysis prescription, adherence to dialysis treatments, or infection control issues. B. Based on document review and interview, it was determined that the facility failed to ensure that the QAPI team developed action plans regarding high KDQOL (Kidney Disease Quality of Life/physical and mental functioning survye tool) refusal rate. Findings include: 1. On 9/26/2024, the facility’s policy titled, “ Quality Assessment and Performance Improvement” (7/2020) was reviewed and included, “... Policy... 6. Members of the QAPI Committee will be responsible for the implementation of comprehensive data collection, as well as monitoring and improvement activities including, but not limited to... development of improvement plans for the following measures when indicated: a. Health Outcomes: Physical and Mental Functioning...” 2. On 9/26/2024, the facility’s monthly QAPI Meeting Minutes were reviewed and indicated the following: 3/27/2024, KDQOL refusal rate 7/11 (63%); 4/24/2024, 4/7 (57%) 5/21/2024, 6/8 (75%); 6/26/2024, 2/6 (33%); 7/31/2024, 9/16 (56%); and 8/28/2024, 3/11 (27%). The meeting minutes lacked documentation that the QAPI team developed an action plan to address KDQOL high refusal rate. 3. On 9/26/2024 at approximately 9:30 AM, an interview was conducted with E #15 (Lead Social Worker). E #15 acknowledged that the facility has high KDQOL refusal rate. E #15 stated that there should be action plan developed to address the issue and make improvements.”