Davita Edgewood Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conducted fire drills quarterly per the facility’s policy. This failure placed the patients and visitors at potential risk of harm in the event of a fire. Review on 09/24/2025 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed “Fire safety drills: Required on a Quarterly basis.” During review of the emergency preparedness binder on 09/24/2025, the surveyor noted that the facility conducted a fire drill on 05/24/2024. There was no fire drills documented before or after 05/24/2024. The Facility Administrator was given the opportunity to provide additional dire drills; However, no additional documentation was provided. The Facility Administrator corroborated that the facility did not conduct fire drills quarterly as required per policy. The Facility Administrator was informed of the finding on 09/24/2025.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by Staff #1, who come in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #1 Findings included: Review on 09/23/2025 of the facility’s policy 1-05-01 entitled, “Infection Control for Dialysis Facilities” states that, “Gloves shall be changed when: After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” 1. Observation of the clinical treatment area on 09/23/2025 at 09:45 a.m., Staff #1 responded to the machine alarm at occupied Station #4 and then removed the gloves. Staff #1 did not perform hand hygiene. 2. Observation of the clinical treatment area on 09/23/2025 at 09:49 a.m., Staff #1 checked the pH of the machine at Station #5 and then removed the gloves. Staff #1 did not perform hand hygiene. The Facility Administrator was informed of the findings on 09/23/2025.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that all expired medications are removed and not available for use and all open multidose vials are labeled. This failure placed the patients at potential risk of cross contamination. Findings include: Review on 09/24/2025 of the facility’s policy 1-06-01 entitled, “Medication Policy” revealed, “Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations... Medication containing a preservative must be discarded 28 days after opening or accessed...Each vial is labeled with the initial of the persons opening the vial and the expiration date.” Observation of the clinical treatment area on 09/24/2025 at 10:00 a.m. revealed the following: · Twenty-five (25) vials of Ceftazidime 1gram/vial, lot number 14NE4918, expired 08/2025. · An open multidose vial of Heparin that was not labeled with a person’s initials or an expiration date. The Charge Nurse and the Facility Administrator were informed of the findings on 09/24/2025.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that staff #2 and #3 complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #2 and #3 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review on 09/22/2025 of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” The policy also states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly... “Clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds , apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery ...Then wait 60 seconds for air dry time.” According to the facility’s policy 1-04-02B entitled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” page 3 number 1 states, “Perform hand hygiene per procedure: Rationale: Hand hygiene protects patient and teammate from cross contamination; number 2 states, set up clean field ...number 4 states ‘Remove old dressing and discard ...Page 4 number 7 states, Re-perform hand hygiene per procedure and put on clean gloves; Page 4 number 7 states, “Remove gloves and discard. Perform hand hygiene per procedure and re-glove; number 9 states, Clean each CVC limb/cap with a large alcohol prep ...Page 5 number 10 states, Remove gloves and discard, perform hand hygiene per procedure and re-glove; number 12 states, Place a sterile 2x2 gauze over the catheter exit site ... number 14 states, Remove gloves and discard, perform hand hygiene per procedure and re-glove ...” 1. During observation of the clinical treatment area on 09/22/2025 at 10:41 a.m., the surveyor noted that during initiation of treatment of a CVC patient at station #4, Staff #1 cleaned the exit site for only 12 seconds and allowed the site to dry for only 20 seconds before placing a clean dressing. Staff #1 cleaned the venous hub for seven (7) seconds and cleaned the arterial hub for 10 seconds. Staff #1 did not change gloves as required during the process. 2. During observation of the clinical treatment area on 09/24/2025 at 09:45 a.m., during initiation of treatment of a CVC patient at station #7, Staff #2 removed gloves after initiating the patient’s treatment and did not perform hand hygiene before gathering supplies from the clean supply cart. Staff #2 did not remove dirty gloves, perform hand hygiene and re-glove during the treatment initiation process as required when manipulating a CVC. The Facility Administrator was informed of the findings on 09/22/2025 and 09/24/2025.”

“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: 44367 Based on observations, the Facility’s Administration and the Medical Director failed to ensure that Staff #2 checked the pH of each dialysis machine according to the facility’s policy and procedures. This failure placed the patient affected at potential risk of harm. Staff: #2 Findings Included: It is necessary for the operator of the hemodialysis machine 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. Each machine must be tested for pH using a handheld meter or other appropriate testing device before every dialysis treatment and whenever a different composition of acid concentrate is used. According to the facility’s policy 2-08-01B “Operation of Portable Myron L Conductivity Meter”, “Manual pH testing must be performed prior to each patient treatment.” Step 36. If all tests are completed successfully, press “Reset” ...Step 41. Check Independent pH with approved test method for final dialysate. Acceptable range for final dialysate pH is 6.9-7.6.” During an interview with the Biomedical technician on 09/23/2025 the surveyor was informed that the pH is to be performed after testing has been completed. 1. On 09/23/2025 at 09:45 a.m., Staff #2 did check the manual pH for the machine at station 5; However, Staff #2 checked the pH while the machine was still in test mode. 2. On 09/24/2025 at 11:25 a.m., Staff #2 did not check the manual pH for the machine at station 11, prior to initiating the patient’s treatment. The Facility Administrator was informed of the findings on 09/23/2025 and 09/24/2025.”

“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: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility was free of expired supplies. This failure placed the patients at potential risk of harm. When supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. Inspection of the facility’s lab area on 09/24/2025 revealed the following expired supplies: · Nine (9) Red Top blood tubes, lot number 4107822, expired on 08/31/2025 · Two (2) sets of Blood Culture Kits, lot number 4348260, expired 09/15/2025. · Two (2) sets of Blood Culture Kits, lot number 4346213, expired 09/12/2025. · Four (4) sets of Blood Culture Kits, lot number 4319766, expired 08/21/2025. · One (1) set of Blood Culture Kit, lot number 4305051, expired 08/07/2025. · Six (6) Wound Culture Kit, lot number 3F22A, expired 06/22/2025. The Facility Administrator was informed of the findings on 09/24/2025.”

“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: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were followed as prescribed by the Nephrologist. This failure placed the patients at potential risk of harm and denied the patients their rights. Patients: #5, #7 and #8 Findings included: The hemodialysis prescription includes the number of treatments per week, the length of treatment time, the dialyzer, the primary access being used for the patient; specific parameters of the dialysis delivery system, such as the blood flow rate (BFR), dialysate flow rate (DFR), and electrolyte composition of the dialysate; anticoagulation, and the patient’s target weight. Review on 09/23/2025 of the facility’s policy 1-03-08 entitled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” page 4 number 10, “If the dialysis prescription is not being met (including the inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” A review of the eight (8) selected patients’ treatment flowsheets on 09/23/2025 revealed that three (3) or 37% of the patients did not receive the correct dialysis prescription as ordered by the Nephrologist. 1. On treatment date 09/20/2025, Patient #5’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min for the entire treatment. There was no documentation from the clinical staff explaining why Patient #5’s BFR was not set on the dialysis machine as prescribed. 2. On treatment date 09/20/2025, Patient #7’s BFR was prescribed for 450 ml/min. However, the BFR was set at 400 ml/min from 08:36 a.m. to 11:01 a.m. and then 360 ml/min from 11:32 a.m. to 11:52 a.m. There was no documentation from the clinical staff explaining why Patient #7’s BFR was not set on the dialysis machine as prescribed. 3. On treatment date 09/17/2025, Patient #8’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min from 11:36 a.m. to 02:00 p.m. There was no documentation from the clinical staff explaining why Patient #8’s BFR was not set on the dialysis machine as prescribed. The Facility Administrator was informed of the findings on 09/23/2025.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration failed to ensure that Staff #3 complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access. Staff: #3 Findings included: Review on 09/23/2025 of the facility’s policy entitled “Cannulation of Fistula or Graft”, Procedure 01-04-01E page 3 #13 states: “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” 1. During observation of the clinical treatment area on 09/23/2025 at 10:14 a.m. at station 14, the surveyor noted that during treatment initiation, Staff #3 palpated patient’s access after cleaning, prior to cannulation. Staff #3 did not re-clean the patients access. The Facility Administrator was informed of the findings on 09/23/2025.”