Davita Cottonwood Dialysis

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 52534 Based on document review, and interview, it was determined that the facility failed to follow state and local rules for securing biohazard storage, which poses a safety risk to patients and staff if local laws are not followed. Findings include: The Arizona Administrative Code (A.A.C.) requires “...R18-13-1408. Storage ...B.1 Secure the storage area in a manner that restricts access to, or contact with the biohazardous medical waste to authorized persons ....” Facility policy titled “On-Site Storage of Medical Waste” requires “...To provide guidelines on the storage of on-site medical waste ....Indoor storage areas will have restricted access and be designated as such....” Observation on 06/16/2025 revealed the door to the room labeled “Soiled Waste” was unlocked. On the door was a sign stating “Biohazardous waste storage authorized personnel only”. The door handle had a keyhole but did not contain a locking mechanism. Employee #1 confirmed on 06/16/2025 that the door to the room containing biohazardous waste did not have a lock, and was not secured according to facility policy.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 52534 Based on document review, observation and interview, it was determined that the facility failed to ensure: 1. Staff did not touch the disinfected access of (1) of (8) patients (Patient #16) prior to cannulation; and 2. Staff appropriately disinfected (1) of (8) patient’s (Patient #17) vascular access prior to cannulation. These deficient practices pose the potential risk of blood stream infection and vascular access infection if the site is not disinfected properly. Findings include: 1. And 2. Facility Policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” requires “... Skin Antiseptic ...ExSept Plus ...Effective Contact Time ...60 seconds ...Air Drying Time ...2 minutes ...While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allowing to dry. (For contact and dry time refer to the table above)....Do not palpate insertion site once area has been prepped ....Once the access has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation ....” 1. Observation on 06/17/2025 revealed Employee #8 disinfecting Patient #16 ’ s vascular access. Employee #8 disinfected the site and allowed time to dry. While Employee #8 was inserting the venous cannulation needle, Employee #8 ’ s hand was resting on the arterial cannulation site. Employee #8 then proceeded to cannulate the arterial site. Employee #8 did not re-disinfect the arterial site prior to cannulation. Employee #1 confirmed on 06/17/2025 that Employee #8 touched the disinfected site and did not re-disinfect it according to facility policy. 2. Observation on 06/17/2025 revealed Employee #9 disinfection Patient #17 ’ s vascular access. Employee #9 disinfected the arterial site using ExSept for 50 seconds, and then disinfected the venous site for 90 seconds. Employee #1 confirmed on 06/18/2025 that Employee #9 did not disinfect Patient #17 ’ s vascular access according to facility policy.”

“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: 52534 Based on document review, observation, and interview it was determined that the facility failed to ensure staff appropriately performed hand hygiene. This deficient practice poses the potential risk of cross contamination between patients; and patients and staff. Findings include: Facility policy titled “Infection Control for Dialysis facilities” requires “... All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ...Prior to gloving and immediately after removing gloves ...after patient and dialysis delivery system contact ...between patients even if the contact is casual ...before touching clean areas such as supplies, supply care and chairside keyboard/mouse ...” Observation on 06/18/2025 revealed Employee #2 assessing the patient at Station 5. Employee #2 removed their dirty gloves and placed them under the arm to hold them. Employee #2 then performed hand hygiene and grabbed a new pair of gloves. Employee #2 then left Station 5 with their dirty gloves under their arm and the clean pair of gloves in their hand. Employee #2 then grabbed the dirty gloves and discarded them and immediately after donned the new pair of gloves. Employee #2 did not perform hand hygiene between discarding the dirty gloves and donning the clean gloves. Observation on 06/18/2025 revealed Employee #9 at Station 10. Employee #9 removed their gloves, left the station and went to the nurses station to grab a medication. Employee #9 came back to Station 10 and placed the medication syringe on the chair. Employee #9 then donned clean gloves. Employee #9 did not perform hand hygiene after removing their gloves, before and after handling the medication, or prior to donning clean gloves. Observation on 06/18/2025 revealed Employee #12 assessing the patient at Station 10. Employee #12 performed their assessment and started charting at the chairside computer. Employee #12 then removed their gloves and donned new gloves. Employee #12 then continued their assessment of the patient. Employee #12 did not perform hand hygiene between glove changes. Employee #1 confirmed on 06/18/2025 that Employees #2, 9, and 12 did not perform hand hygiene according to facility policy.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 52534 Based on document review and interview it was determined that the facility failed to ensure (2) of (5) patients (Patients #1 and 3) and (2) of (7) employees (Employees #2 and 19) had tuberculosis (TB) tests read within the correct time frame. This deficient practice poses the potential risk of falsely negative or altered test results which can lead to the spread of tuberculosis. Findings include: Facility policy titled “Tuberculosis Infection Control Policy” requires “...Tuberculin skin test (TST)...TST results are to be read within 48-72 hours of placing the test by a licensed nurse ...” Patient #1 ’ s medical record review on 06/16/2025 revealed a TB Skin Test administered on 04/24/2025 at 1130. The test was read on 04/25/20025 at 1200. Patient #3 ’ s medical record review on 06/16/2025 revealed a TB Skin Test administered on 11/24/2025 (Sic) at 1515 and read on 04/26/2025 at 1515. Employee #1 confirmed on 06/16/2025 that Patients #1 and 3 ’ s TB Skin Tests were not read correctly according to facility policy. Employee #2 ’ s file review on 06/17/2025 revealed a TB Skin Test administered on 08/07/2024 at 0800. The test was read on 08/10/2024 at 1030. Employee #19 ’ s file review on 06/17/2025 revealed a TB Skin Test administered on 08/06/2024 at 1600. The test was read on 08/08/2024 at 1530. Employee #1 confirmed on 06/17/2025 that Employees #2 and 19 ’ s TB Skin Tests were not read correctly according to facility policy.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 52534 Based on document review, observation and interview, it was determined that the facility failed to ensure: 1. Staff appropriately disinfected (2) of (8) patients ’ (Patients #18 and 19) Central Venous Catheter (CVC); and 2. Staff ensure (1) of (4) patients ( Patient #19) wore a mask during CVC dressing change and access. These deficient practices pose the potential for increased CVC and/or bloodstream infections and adverse outcomes for dialysis patients. Findings include: 1. And 2. Facility policy titled “Central Venous catheter (CVC) with Cleargard HD Antimicrobial End Caps Procedure” requires “...Device Disinfect and and Skin Antiseptic ...70% Alcohol pad ... Effective Contact Time ...15 second scrub ...Procedure ...Put on PPE and provide a mask to the patient. Teammate and patient will wear masks covering the nose and mouth during this procedure ....” 1. Observation on 06/17/2025 revealed Employee #10 disinfecting Patient #18 ’ s CVC. Employee #10 disinfected the arterial hub with an alcohol pad for 19 seconds and then disinfected the venous hub with an alcohol pad for 14 seconds. Observation on 06/18/2025 revealed Employee #12 disinfecting Patient #19 ’ s CVC. Employee #12 disinfected the arterial hub with an alcohol pad for 7 seconds and then disinfected the venous hub with an alcohol pad for 13 seconds. Employee #1 confirmed on 06/17/2025 and 06/18/2025, respectively, that Employee #10 and Employee #12 did not disinfect the patient ’ s CVC according to facility policy. 2. Observation on 06/18/2025 revealed Employee #12 performing a CVC dressing change on Patient #19 and then accessing the CVC to initiate treatment. The patient was not given a mask or asked to wear a mask for the entirety of the dressing change and initiation of treatment. Employee #1 confirmed on 06/18/2025 that Employee #12 did not ensure Patient #19 was wearing a mask according to facility policy.”

“BACT OF H20-MAXIMUM & ACTION LEVELS CFR(s): 494.40(a) 4.1.2 Bacteriology of water: max & action levels Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. This Standard is not met as evidenced by: 52534 Based on document review and interview it was determined that the facility failed to notify the Facility Administrator and Medical Director within 48 hours of elevated bacterial test results from dialysate cultures. This deficient practice poses the potential risk of adverse outcomes in dialysis patients if bacteria is found in the dialysis machine and dialysate. Findings include: Facility policy titled “Water Culture Policy” requires “...Interpreting culture results:...Unacceptable level: 100 cfu/ml or greater ...Required responses to action or unacceptable culture results:...More than one site at or above the action level or any site at or above unacceptable level: Notify the Facility Administrator/designee, Biomedical Services and Medical Director within 48 hours of receiving the results ....” Document titled “Lab Results” revealed “...Dialysate Culture 380 CFU/mL Unacceptable 05/14/2025 ...” Documentation of the notification of the Facility Administrator and Medical Director was requested but unable to be provided. Employees #1 and #20 confirmed on 06/18/2025 that the Facility Administrator and Medical Director were not notified of the culture results.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure: 1. Staff followed the hemodialysis treatment orders for prescribed Blood Flow Rate (BFR) for (4) of (5) patients (Patients #1, 2, 3, and 5); and 2. Staff followed the hemodialysis treatment orders for changing patients dialysate during treatment for (5) of (6) patients (Patients #20, 21, 23, 24, and 25). Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings include: 1. And 2. Facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” requires “...The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) prior o the start of the dialysis treatment and prior to the patient being discharged from the facility post dialysis. The assessment includes the following components:...Verification of prescription including machine parameters ...Patient identity, prescription and machine settings are verified by a teammate prior to initiation of treatment ...Intradialytic Data Collection/Assessment ...At a minimum, obtain and document the following:...Blood and dialysate flows ...If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ....All findings, interventions and patient response will be documented in the patient’s medical record ....” 1. Patient #1 Patient #1 ’ s medical record review on 06/16/2025 revealed the prescribed BFR of 450 mL/min. The following dialysis treatment was not delivered as prescribed: 06/05/2025 - BFR was 400mL/min for the entirety of the treatment. No documentation or the changes or rationale were found in the treatment record. Patient #2 Patient #2 ’ s medical record review on 06/16/2025 revealed the prescribed BFR of 400 mL/min. The following dialysis treatments were not delivered as prescribed: 06/11/2025 - BFR changed from 400 to 350 mL/min at 1105. 06/06/2025 - BFR changed from 400 to 300 mL/min at 1213. No documentation or the changes or rationale were found in the treatment record. Patient #3 Patient #3 ’ s medical record review on 06/16/2025 revealed the prescribed BFR of 350 mL/min. The following dialysis treatment was not delivered as prescribed: 06/03/2025 BFR changed from 330 to 350 mL/min at 1526. BFR changed from 350 to 330 mL/min at 1550. BFR changed from 330 to 310 mL/min at 1624. No documentation or the changes or rationale were found in the treatment record. Patient #5 Patient #5 ’ s medical record review on 06/16/2025 revealed the prescribed BFR of 450 mL/min. The following dialysis treatments were not delivered as prescribed: 06/11/2025 - BFR was set to 400 for the entirety of the treatment. 06/06/2025 - BFR was set to 400 for the entirety of the treatment. 06/02/2025 - BFR was set to 400 for the entirety of the treatment. 05/30/2025 - BFR was set to 400 for the entirety of the treatment. No documentation or the changes or rationale were found in the treatment record. Employee #1 confirmed on 06/16/2025 that Patients #1, 2, 3, and 5 did not receive their hemodialysis treatment as prescribed. 2. Patient #20 Patient #20 ’ s medical record review on 06/17/2025 revealed “In-Center Hemodialysis Treatment ... Dialysate (Start of TX) - 2K, 2.5Ca ... Dialysate Bath TX time (Start of TX) - 2h 15m (135 min)... Dialysate (End of Tx) - 1K, 2.5Ca ... Dialysate Bath Tx Time (End of TX) - 1h 0m (60 min)... Start date - 04/23/2025...” The following treatments did not contain documentation regarding the change of the dialysate at the end of treatment: 06/06/2025 06/04/2025 Patient #21 Patient #21 ’ s medical record review on 06/17/2025 revealed “In-Center Hemodialysis Treatment ... Dialysate (Start of TX) - 2K, 3Ca ... Dialysate Bath TX time (Start of TX) - 2h 30m (150 min)... Dialysate (End of Tx) - 1K, 2.5Ca ... Dialysate Bath Tx Time (End of TX) - 1h 0m (60 min)... Start date - 05/24/2025...” The following treatments did not contain documentation regarding the change of the dialysate at the end of treatment: 06/13/2025 06/09/2025 06/06/2025 06/04/2025 06/02/2025 Patient #23 Patient #23 ’ s medical record review on 06/17/2025 revealed “In-Center Hemodialysis Treatment ... Dialysate (Start of TX) - 2K, 2.5Ca ... Dialysate Bath TX time (Start of TX) - 2h 0m (120 min)... Dialysate (End of Tx) - 1K, 2.5Ca ... Dialysate Bath Tx Time (End of TX) - 2h 0m (120 min)... Start date - 06/10/2025...” The following treatments did not contain documentation regarding the change of the dialysate at the end of treatment: 06/14/2025 06/12/2025 06/10/2025 06/07/2025 06/05/2025 06/03/2025 Document titled “File Summary Report” revealed “...General Event Type: medication/Treatment ... Specific Event Type: Treatment - Wrong Bath ... Person Affected: (Patient #23)...Event Date: 03-27-2025 ... ’ I didn ’ t realize that the patient was supposed to be on 1k jug for half of his tx. I put him on the last hour and half when I noticed the order. (Employee #4) aware ’ (Sic)...” Patient #24 Patient #23 ’ s medical record review on 06/17/2025 revealed “In-Center Hemodialysis Treatment ... Dialysate (Start of TX) - 2K, 2.5Ca ... Dialysate Bath TX time (Start of TX) - 2h 30m (150 min)... Dialysate (End of Tx) - 1K, 2.5Ca ... Dialysate Bath Tx Time (End of TX) - 1h 0m (60 min)... Start date - 06/11/2025...” The following treatments did not contain documentation regarding the change of the dialysate at the end of treatment: 06/12/2025 06/10/2025 06/07/2025 06/05/2025 Patient #25 Patient #25 ’ s medical record review on 06/17/2025 revealed “In-Center Hemodialysis Treatment ... Dialysate (Start of TX) - 2K, 2.5Ca ... Dialysate Bath TX time (Start of TX) - 3h 0m (180 min)... Dialysate (End of Tx) - 1K, 2.5Ca ... Dialysate Bath Tx Time (End of TX) - 1h 0m (60 min)... Start date - 06/17/2025...” The following treatments did not contain documentation regarding the change of the dialysate at the end of treatment: 06/07/2025 06/05/2025 05/31/2025 Employee #1 confirmed on 06/17/2025 that Patients #20, 21, 23, 24, and 25 did not receive their hemodialysis treatment as prescribed by their nephrologist.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure hemodialysis treatment orders for patients with hyperkalemia were reviewed and updated monthly based on patient outcomes. This deficient practice poses the potential risk of decreased clearances and hospitalizations if treatment orders are not adapted to achieve patient outcomes. Findings include: Facility policy titled “Use of Low Potassium Dialysate” requires “...Initiation of low potassium dialysate less than 2K+ (<2K+) is restricted to patients with a pre-dialysis potassium greater than 6mEq/L (>6) and management and follow up consistent with this policy ....No order for <2K+ dialysate will exceed one (1) month duration ....” Patient #20 ’ s medical record review on 06/17/2025 revealed an active Hemodialysis Treatment order from 04/23/2025 utilizing 1K, 2.5Ca dialysate. There was not a more recent physician order for a 1K dialysate. Employee #1 confirmed on 06/17/2025 that Patient #20 ’ s hemodialysis treatment order for a 1K, 2.5Ca dialysate lasted longer than one month, and was not reordered according to facility policy.”