Davita Sweetwater Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 1/15/24 at 1:15 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the potential to cause harm to 16 hemodialysis patients (P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25, P#26, P#27, and P#28), who were to undergo hemodialysis treatment shortly after the time of this observation, when one of one Patient Care Technician (PCT AA) who was assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P & P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Facility Administrator, Regional Operations Manager, and the Manager of Clinical Services were informed of the IJ finding on 1/15/25 at 1:15 p.m. The noncompliance related to the IJ was identified to have existed on 1/15/25 when PCT AA performed the Total Chlorine Testing two times (at 5:01 a.m. and 5:30 a.m.) and did not perform the procedure according to the manufacturer’s DFU. The IJ was abated on 1/15/25 at 2:54 p.m., when the facility implemented a Credible Allegation of Compliance related to the IJ that included staff training, return demonstration, and successful completion of skills competency checklists, and monitoring plan. The facility census was 70. Findings include: Cross-reference: V196 - Failure of PCT AA to correctly test the dialysis water for Total Chlorine according to the manufacturer’s DFU and facility P&P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on observation, facility record review, staff interviews, a review of manufacturer’s Directions for Use (DFU) and a review of facility policy and procedures (P&P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 70 dialysis patients who were under the care of this facility. Findings were: Cross-Reference: V196 - Failure of PCT AA to correctly test the dialysis water for Total Chlorine according to the manufacturer’s DFU and facility P&P.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 03383 Based on observation, staff interviews, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure the sink used for handwashing in the Isolation Room was repaired and functional to encourage patients and staff to wash their hands. Failure to provide a handwashing sink in the Isolation Room for Hepatitis B virus positive (a viral infection that primarily affects the liver) patients and staff, increased the risk for cross contamination and spread of infection. Findings were: During observation in the patient treatment area on 1/15/25 between 5:00 a.m. and 6:30 a.m., the following was revealed: - The sink in the Isolation Room had a sign posted above the sink that informed staff and patients that the sink was out-of-order. PCT AA was present during discovery and confirmed this finding. PCT AA stated that the sink in the Isolation Room has been down for a couple weeks. The Manager of Clinical Services (MCS) was informed about this finding on 1/15/25 at 5:23 a.m. MCS confirmed the sink was out of service. MCS provided surveyor with a work order that showed a request for repair for the sink was made on 11/15/24; however, the sink was not repaired prior to exit on 1/16/25 at 4:30 p.m. A review of Policy: 8-04-01 titled, “Physical Environment” dated April 2018 showed the following: The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.”

“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: 03383 Based on observation, staff interview, and a review of facility Policy and Procedures (P&P), it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented P&P for the prevention and control of hepatitis and other infections at the facility. A soiled dialysis chair with a piece of tape and brown substance splattered on the arm of chair was observed in Station (S) 14 at 5:15 a.m., prior to the initiation of the first shift patient’s treatment. This deficient practice increased the risk for cross contamination and could affect the health and safety of one of one patient who was assigned to dialyze at S14 on 1/15/24 first shift.. Findings include: During a tour with PCT AA in the Patient Treatment Room on 1/15/25 between 5:15 a.m. and 5:50 a.m., the following was observed: - The chair at S14 was observed to have a piece of tape and brown substance splattered on the arm of chair. PCT AA agreed that the chair did not look like it had been cleaned and disinfected on 1/14/25 after it was used by another patient. PCT AA removed the piece of tape and wiped down the chair with bleach water and the brown splatter wiped off. A review of Policy: 1-05-01 titled, “Infection Control for Dialysis Facilities” dated April 2023 revealed the following: At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops).”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 03383 Based on observation, staff interview, and a review of facility policy and procedures (P&P), it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented P&P for the prevention of the spread of Hepatitis B virus (HBV: a viral infection that primarily affects the liver) when one of one visiting Facility Administrator did not remove his gown prior to leaving the Isolation Room, where an HBV + (positive) patient was dialyzing at. This deficient practice increased the risk of cross contamination with the potential to expose all Hepatitis B surface Antigen susceptible patients who were dialyzing at this facility. The facility’s in-center hemodialysis census was 70. Findings include: During observation in the Patient Treatment Room on 1/14/24 at 1:18 p.m., the following was observed: - A visiting Facility Administrator from another facility was present to support the Facility Administrator of this facility. This surveyor and the Facility Administrator observed the visiting Facility Administrator entered the Isolation Room while he wore a gown used in the main Patient Treatment Room. There was a HBV + patient (P#15) who was dialyzing in the Isolation Room at the time. The Facility Administrator of this facility stated “I hope he leaves his gown in the Isolation Room”. However, the visiting Facility Administrator did not remove his gown before exiting the room. The Facility Administrator informed the visiting Facility Administrator that he was supposed to leave his gown in the Isolation Room. The visiting Facility Administrator stated “I don’t have an Isolation Room (at his home facility)” (Reason given for not removing his gown). A review of Policy: 1-05-02 titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance dated April 2024 revealed the following: PPE (Personal Protedtive Equipment) a. When entering the isolation room/area or station for any reason, physicians, NPPs, social workers, dietitians, and all other teammates will wear long-sleeved fluid resistant/fluid impervious gowns in addition to gloves, face shield, or mask and eye protection. b. The long sleeved gown will be tied in the back and gloves will be pulled over the cuffs of the sleeves. c. PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 1/15/24 at 1:15 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the potential to cause harm to 16 hemodialysis patients (P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25, P#26, P#27, and P#28), who were to undergo hemodialysis treatment shortly after the time of this observation, when one of one Patient Care Technician (PCT AA) who was assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P & P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Facility Administrator, Regional Operations Manager, and the Manager of Clinical Services were informed of the IJ finding on 1/15/25 at 1:15 p.m. The noncompliance related to the IJ was identified to have existed on 1/15/25 when PCT AA performed the Total Chlorine Testing two times (at 5:01 a.m. and 5:30 a.m.) and did not perform the procedure according to the manufacturer’s DFU. The IJ was abated on 1/15/25 at 2:54 p.m., when the facility implemented a Credible Allegation of Compliance related to the IJ that included staff training, return demonstration, and successful completion of skills competency checklists, and monitoring plan. The facility census was 70. Findings were: - PCT AA was observed during the performance of Total Chlorine Testing on 1/15/25 at 5:01 a.m., using RPC Ultra-Low Total Chlorine Test Strip K100- 0118 and did not perform chlorine test according to manufacturer’s DFU. PCT AA swished the strip in the sample dialysis water for 60 seconds, waited an additional 15 seconds, and then walked over to area where color chart was kept and compared the strip to the color chart. When PCT AA was asked how long she counted for swishing and waiting to compare the strip, PCT AA stated 60 seconds for swishing and 15 seconds before comparing to color chart. According to the manufacturer’s DFU, it takes 20 seconds for the color to develop. - PCT AA performed the chlorine test again using RPC Ultra Low Chlorine Test Strip at 5:30 a.m. PCT AA waited only 15 seconds before she compared the strip to color chart. At this time, this surveyor informed PCT AA that she did not perform the procedure according to the manufacturer’s DFU and facility P&P. A review of the manufacturer’s DFU and facility Policy: 1-18-05 titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip” dated October 2023, stated: Procedure: 1. Fill the sample cup to the line marked 100 ml with the sample. 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds... 3. Remove the strip and shake once, briskly... 4. Wait 20 seconds for the test strip color to develop... 5. After 20 second wait period, immediately compare the strip color to K100-0118 color chart to determine the Total Chlorine level in the sample... - PCT AA retested the dialysis water for chlorine on 1/15/25 at 5:35 a.m. in the presence of the Manager of Clinical Services (MCS) and demonstrated the correct way to test Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118 according to the manufacturer’s DFU, specifically, waiting 20 seconds for the color to develop before comparing the test strip to the color chart and the result was < 0.1. The Total Chlorine level in the water was confirmed to be safe. The Facility Administrator, Regional Operations Manager, and the Manager of Clinical Services were informed of the IJ finding on 1/15/25 at 1:15 p.m. The noncompliance related to the IJ was identified to have existed on 1/15/25 when PCT AA performed the Total Chlorine Testing two times (at 5:01 a.m. and 5:30 a.m.) using RPC Ultra-Low Total Chlorine Test Strip K100- 0118 and did not perform chlorine test according to manufacturer’s DFU. The IJ was abated on 1/15/25 at 2:54 p.m. upon completion of the following: - The Manager of Clinical Services on 1/15/25, immediately began conducting re-education/staff in-service with all Direct Patient care Staff with return demonstration, and skills competency checklists. - PCT AA demonstrated the correct way to test Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118 according to the manufacturer’s DFU, specifically, waiting 20 seconds for the color to develop before comparing the test strip to the color chart. - Governing Body meeting was conducted and approved by the Facility Administrator, Regional Operations Director, and Medical Director. - Audits of staff performing chlorine testing was conducted and will be ongoing. Based on the above corrective actions, the IJ was removed; however, the Condition remained out of compliance.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 03383 Based on observation and staff interviews, it was determined that the facility failed to maintain a clean, orderly, and safe environment. These environmental concerns were observed in one of one Patient Treatment Room. Unsanitary surfaces increased the risk for microbial growth on a porous surface. Findings include: During a tour with Patient Care Technician (PCT) AA in the Patient Treatment Room on 1/15/25 between 5:15 a.m. and 5:50 a.m., the following was observed: - The face of a drawer was completely missing, and a buildup of white powder (bicarbonate) was observed on the inside of the drawer, on the counter and on the front of remaining drawers in this area. - All 17 dialysis machines had a layer of white residue/substance that covered the screen. PCT AA tried rubbing it off and the white residue came off. PCT AA stated that it was probably from wiping the machine down with bleach. The Clinical Nurse Manager confirmed the above findings on 1/15/25 at 5:30 a.m.”

“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: 03383 Based on observation, staff interviews, and a review of policy, it was determined that the facility failed to maintain a safe environment as evidenced by torn leather upholstery and/or broken mechanisms on 10 of 17 patient treatment chairs (at Station [S] 1, S2, S3, S4, S7, S9, S10, S11, S15, and S17) in the patient treatment area. This deficient practice could hinder effective cleaning/disinfection and could have a negative effect on the health and safety of 70 in-center hemodialysis patients who were receiving dialysis treatment at this facility. Findings include: During observation in the patient treatment area on 1/15/25 between 5:00 a.m. and 6:30 a.m., the following was revealed: - The dialysis chairs at S15 and S17 had multiple torn leather upholstery on the seat and armrest approximately one to three inches long. PCT AA was present at the time of discovery and confirmed these findings. - The dialysis chairs at S1, S2, S3, S4, S7, S9, S10, and S11 had broken metal mechanisms. PCT AA tried to recline the chairs and confirmed the broken mechanisms. PCT AA stated that the chairs had been broken for quite some time. The Manager of Clinical Services (MCS) was informed and confirmed the above findings on 1/15/25 at 5:23 a.m. MSC provided a work order dated 11/21/24 for the repair of chairs in the treatment area. The mechanisms for the chairs arrived on 12/27/24 however, the chairs were not repaired prior to exit on 1/16/25. A review of Policy: 8-04-01 titled; “Physical Environment” dated April 2018 showed the following: The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 03383 Based on medical record review, employee interview, and policy review, it was determined that the interdisciplinary team (IDT) failed to ensure that patient’s plan of care is reviewed and signed by the IDT, patient, or the patient’s representative in three of eight patient’s (P#2, P#3, and #7’s) plans of care reviewed. Findings include: A review of patient care plans on 1/15/25 and 1/16/25 revealed the following: - P#2’s plan of care dated 12/17/24 was not signed by P#2. A note entered on form showed “Patient unable to sign at time (sic).”. However, surveyor interviewed P#2 on 1/14/25 and found the patient to be alert, oriented, and capable of signing the care plan form. The Facility Administrator was informed about the lack of signature on the care plan on 1/16/24 at 1:47 p.m. The Facility Administrator acknowledged the lack of signature and was not sure why the patient had not signed the form past 12/17/24 to ensure that the plan of care was reviewed with the patient. - P#3 had a care plan dated 12/5/24 but was not signed by the nurse, provider/physician, or the patient. The Facility Administrator confirmed this finding on 1/16/25 at 1:55 p.m. and offered no explanation for why the signature page was not signed. - P#7’s care plan dated 8/12/24 was not signed by the IDT that included the nurse, provider/physician, social worker, dietician or the patient. The signature page was blank. The Facility Administrator confirmed this finding on 1/16/25 at 2:09 p.m. and offered no explanation for why the signature page was not signed by the IDT or patient. A review of Policy: 1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” dated October 2024 showed the following: The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.”

“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: 03383 Based on a review of the facility’s Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to make changes to plans of action to improve and sustain the facility’s fluid management, mineral metabolism/bone disorder, vascular access, adequacy, anemia, and nutrition outcomes for in-center hemodialysis (ICHD) patients and/or home program patients, in six of six months (July 2024 - December 2024) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 70 ICHD patients and 21 home patients who were receiving dialysis services at this facility. Findings were: A review of the FY2025 QDFR, revealed that the facility was above the United States (US) threshold in: ICHD patients: 1. Fluid Management: (Avg UFR > 13 ml/kg/hr) - facility was 10.8 %, whereas US was 9.4%. 3. Mineral Metabolism and Bone Disorder: (Phosphorus greater than [>] 7.0) - facility was 29.5%, whereas US was 15.6%. 4. Vascular Access: (Long-Term Catheter Rate) - facility was 22.9%, whereas US was 10.7 %. Home patients: 5. Adequacy: (Kt/V < 1.7) - facility was 5.9 %, whereas US was 5.2 %. In Comparison, a review of the facility’s third and fourth quarter 2024’s QAPI meeting minutes from July 2024 to December 2024 revealed that the facility was above the United States (US) threshold in: Vascular Access: (CVCs only > 90 days/3 months) - for ICHD patients at this facility was 29% in July 2024, 28.6% in August 2024, 25.4% in September 2024, 23.4% in October 2024, 25 % in November 2024 and 2024, 24.6% in December 2024 when compared to US at 10.7% nationally. Anemia: (Hemoglobin < 10.0 g/dL) - for home patients at this facility was 37% in September 2024, 37% in November 2024 and 37% in December 2024 when compared to US at 26.2% nationally. Nutrition: (Albumin <4.0 g/dL) - for home patients at this facility was 94% in July 2024, 94% in August 2024, 82% in September 2024, 71% in October 2024, 82% in November 2024 and 81% in December 2024 when compared to US at 67% nationally. Additionally, the facility’s QAPI meeting minutes from July 2024 - November 2024 revealed documentary evidence that the interdisciplinary team (IDT) conducted a review of anemia, nutrition, and vascular access. However, there were no changes made to the action plans to attain and sustain improvement. The Facility Administrator and Clinical Nurse Manager were present during the review on 1/16/25 and stated that the IDT will work toward improvement of these outcomes. The FA confirmed there were no changes made to the plans for anemia, nutrition, or vascular access in June 2024 through November 2024. A review of Policy: 1-14-06 titled, “Continuous Quality Improvement Program” dated April 2021 revealed the following: The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: o Adequacy of Dialysis (Kt/V) o Nutritional Status (Albumin) o Mineral Metabolism and Renal Bone Disease o Anemia Management o Vascular Access Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.”