Davita Cedarburg Dialysis

“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: 29963 Based on record review, observation and interview the facility staff failed to perform glove changes and/or hand hygiene when moving from “dirty” to “clean” tasks while providing cares for 2 of 10 patients (Patients #9, 10); failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 1 of 2 patients (Patient #4) observed holding access sites; and failed to wear gloves when touching the dialysis machine for 3 of 10 patients (Patients #8, 7, 15) in a total of 16 observations of patient care. Findings include: A review of the facility’s policy 1-05-01 titled, “Infection Control for Dialysis Facilities,” last revised April 2023 revealed, “All teammates ... will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, ... after patient and dialysis delivery system contact ... before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse ...7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station... a. Gloves should be changed when: ii. When going from a ‘dirty’ area or task to a ‘clean’ area or task... iv. 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.” A review of the facility’s policy #1-04-01B titled, “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles” last revised April 2023 revealed, “... When the patient holds their cannulation sites, the patient will be offered gloves and performs hand hygiene when completed...” Examples of staff failing to complete hand hygiene: During an observation on 01/12/2026 at 9:01 AM, Registered Nurse C was discontinuing dialysis on Patient #9’s Central Venous Catheter (CVC). Registered Nurse C administered heparin to Patient #9’s CVC, removed gloves and put on new gloves without completing hand hygiene. At 9:05 AM Registered Nurse C disconnected the syringes from Patient #9’s CVC, removed gloves walked over to the clean supplies and grabbed gauze returned to the dialysis station and put on clean gloves and did not complete hand hygiene. During an observation on 01/12/2026 at 4:55 PM, Registered Nurse C did not do hand hygiene prior to drawing up medication for Patient #10. Registered Nurse C did not do hand hygiene prior to putting on gloves to administer the medication to Patient #10. Examples of staff failing to ensure patients completed hand hygiene after glove removal after holding dialysis access sites: During an observation on 01/12/2026 at 8:30 AM, Patient #4 was observed holding dialysis access site with a gloved hand. Patient #4 removed the glove, transferred into wheelchair and used the scale prior to leaving the facility. Patient #4 did not perform hand hygiene prior to exiting the treatment area. Examples of staff touching the dialysis machines with a glove wrapped around the finger: During an observation on 01/12/2026 at 8:52 AM, Patient Care Technician E touched Patient #8’s dialysis machine using a glove wrapped around the finger. During an observation on 01/12/2026 at 10:42 AM, Patient Care Technician E touched Patient #7’s dialysis machine using a glove wrapped around the finger. During an observation on 01/12/2026 at 1:02 PM, Patient Care Technician E touched Patient #15’s dialysis machine using a glove wrapped around the finger. During an interview on 01/13/2026 at 11:34 AM, the observation findings were discussed with Manager of Clinical Services L who stated the expectation is that staff perform hand hygiene with glove removal and that staff should be offering hand gel to every patient at the completion of dialysis. Manager of Clinical Services L stated gloves should be fully worn on the hand when touching the dialysis machine.”

“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: 29963 Based on record review, observation and interview the facility staff failed to ensure that supplies were not past expiration dates in 1 of 1 patient treatment areas observed in a total of 1 patient treatment areas observed. Findings include: A review of the facility’s policy #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, “... Expiration date and package integrity will be verified prior to use... the package and its contents must be disposed of and not used.” Examples of expired supplies observed in the treatment area on 01/12/2026 at 12:34 PM: -4 boxes each containing (50) fifty vacutainer (a device used to draw blood) with an expiration date of 10/31/2025. -1 box containing (50) fifty vacutainers with an expiration date of 07/31/2025. -1 yellow lab tube dated 08/31/2025 -2 purple lab tubes dates 11/30/2025 During an interview on 01/13/2026 at 11:31 AM, Manager of Clinical Services L stated the staff should have disposed the expired supplies.”

“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: 29963 Based on record review, observation and interview, the facility staff failed to complete disinfection of all equipment in the dialysis station for 1 of 2 dialysis stations (Stations #9) observed being cleaned in a total of 16 observations of patient care. Findings Include: A review of the facility’s policy #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, “At the end of each treatment, the dialysis station will be cleaned and disinfected... Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings... and frequently contacted by healthcare personnel...” During an observation on 01/12/2026 at 8:45 AM, Registered Nurse F was observed cleaning Station #9 and did not wipe down the IV pole, hooks and did not open and recline the dialysis chair while wiping down the surface. During an interview on 01/12/2026 at 11:34 AM with Manager of Clinical Services L, she stated that all surfaces of the dialysis machine need to be cleaned and dialysis chairs should be fully opened when disinfecting.”

“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: 29963 Based on record review, observation and interview, the facility staff failed to dispose of expired emergency medication from 1 of 1 medication storage area and failed to follow facility policy when drawing up medication for 10 of 10 patient’s (#1, 3, 6, 7, 11, 13, 14, 16, 17, 18) medications in a total universe of 24 patients. Findings include: A review of facility policy #1-02-08 titled, “Emergency Equipment Checks,” last revised October 2025 revealed, “The following equipment checks will be performed by the licensed nurse teammate to verify the designated equipment is available and functional: Weekly: Emergency... medications have not expired...” A review of facility policy #1-06-01 titled, “Medication Policy,” last revised October 2023 revealed, “Medications preparation should be performed only for the current shift of patients, i.e. do not prepare medication for more than one shift of patients.” During an observation on 01/12/2026 at 1:00 PM, a box containing 2 syringes of Epinephrine dated 09/30/2025 was found in the emergency medication box. During an observation on 01/12/2026 at 8:30 AM, the medications for the entire second shift of patients (#1, 3, 6, 7, 11, 13, 14, 16, 17, 18) were drawn up into syringes. The syringes were dated and timed as being prepared on 01/12/2026 at 8:00 AM. The first shift of patients were being treated for dialysis until 9:30 AM. During an interview on 01/13/2026 at 11:31 AM, the observation findings were discussed with Manager of Clinical Services L who stated expired medication should be replaced. During an interview on 01/13/2026 at 11:32 AM, Assistant Facility Administrator K stated the medications for the second shift should not have been drawn up that early.”

“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: 29963 Based on record review, observation and interview, the facility staff failed to cleanse central venous catheter (CVC) hubs per facility policy for 1 of 2 patients with a CVC observed (Patients #9) and failed to perform central venous catheter exit site care using aseptic technique for 1 of 2 patients observed (Patients #7) in a total sample of 16 observations of patient care. Findings include: A review of the facility’s policy #1-04-02B titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” last revised April 2025 revealed, “ ...Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines ...Remove old dressing and discard ...Remove gloves and discard. Perform hand hygiene per procedure and re-glove ...” During an observation on 01/12/2026 at 9:00 AM, Registered Nurse C was observed discontinuing Patient #9’s dialysis utilizing her CVC. RN C disinfected each of Patient #9’s CVC hubs with alcohol for 6 seconds each, 9 seconds less than per policy. During an observation on 01/12/2026 at 10:25 AM, Patient Care Technician (PCT) E was observed performing CVC exit site care for Patient #7. PCT E was observed removing the old dressing and proceeded to cleanse Patient #7’s exit site without changing gloves or performing hand hygiene. During an interview on 01/12/2026 at 11:34 AM, the observation findings were discussed with Manager of Clinical Services L who stated gloves should be taken off and hand hygiene should be completed before new gloves are put on.”

“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: 29963 Based on record review and interview, the facility staff failed to monitor chlorine and chloramine levels every 4 hours in 2 of 2 months of water testing logs reviewed (November 2025 and December 2025), in a total sample of 2 months of water logs reviewed. Findings Include: A review of facility policy #1-17-02 titled, “Daily Water Treatments System Monitoring” last revised October 2025 revealed, “If the CM 130 (on-line monitoring system that monitors Chlorine and Chloramines continuously) is not functioning properly... manual Total Chlorine testing must be done... Begin manual total chlorine testing post primary carbon tank with every four (4) hours.” Review of the patient schedule for Monday, Wednesday, and Friday revealed the first patient treatment begins at 5:00 AM and the last patient’s treatment ends at 7:00 PM. On patient schedule for Tuesday, Thursday, and Saturday revealed the first patient begins at 5:00 AM and the last patient’s treatment ends at 2:45 PM. A review of facility documentation on log titled, “Routine Total Chlorine Testing Logs” dated 12/13/2025 (Saturday) revealed the only chlorine check was completed at 3:45 AM. The chlorine should have been checked prior to 7:45 AM and again prior to 11:45 AM. On 12/01/2025 (Monday) the chorine was last checked at 11:20 AM, another check should have been completed prior to 3:20 PM. On 11/13/2025 (Thursday) the chlorine was last checked at 4:50 AM, another check should have been completed prior to 8:50 AM and again prior to 12:50 PM. During an interview on 01/12/2026 at 3:00 PM Biomed M stated the CM 130 continuous chlorine monitor was not working from 11/03/2025 through 12/13/2023. During an interview on 01/13/2026 at 11:31 AM, the findings were discussed with Manager of Clinical Services L who stated the staff are expected to complete manual chlorine checks at least every 4 hours while patients are receiving dialysis treatments when the CM 130 is not working.”

“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: 29963 Based on observation and interview, staff failed to maintain a sanitary environment free from potential infection risk in 2 of 10 dialysis treatment stations (#7, 8) in a total of 10 stations observed. Findings Include: During an observation on 01/12/2026 at 1:00 PM revealed the dialysis chairs at station #7 and #8 has tears in the vinyl material of the seats exposing a porous surface making it difficult to disinfect. During an interview on 01/13/2026 at 4:30 PM, Manager of Clinical Services L stated the staff should be notifying the administrator when tears in the vinyl are noticed so they can be fixed.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to complete documentation of why physician orders were not followed for prescribed blood flow rates and/or dialysate flow rates for 2 of 5 in-center medical records reviewed (Patients #1, 3, 4) in a total universe of 5 medical records reviewed. Findings include: A review of the facility’s policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised April 2024 revealed, “ ...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 ...” A review of Patient #1’s medical record revealed a physician order for the blood flow rate (BFR) of 500 mL/min (milliliters per minute). The treatment sheet dated 12/01/2025, 12/05/2025, and 12/15/2025 revealed the BFR was set at 450 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR was lower than the ordered rate. A review of Patient #3’s medical record revealed a physician order for the blood flow rate BFR of 450 mL/min and a dialysate flow rate (DFR) of 600 mL/min. The treatment sheet dated 01/02/2026 revealed the BFR was set at 400 mL/min and the DFR was set at 500 mL/min for the entire treatment. There was no documentation in the medical record for the reason the BFR/DFR was lower than the ordered rate. A review of Patient #4’s medical record revealed a physician order for the DFR of 800 mL/min. The treatment sheet dated 12/30/2025 revealed the DFR was set at 500 mL/min for the entire treatment. There was no documentation in the medical record for the reason the DFR was lower than the ordered rate. During an interview on 01/13/2026 at 11:02 AM, the medical record findings were discussed with and confirmed by Manager of Clinical Services L who stated facility staff were expected to document a reason for not meeting prescribed blood and dialysate flow rates.”

“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: 29963 Based on record review and interview the facility staff failed to ensure that a comprehensive Registered Nurse assessment was completed prior to initiation of the first treatment at the facility in 1 of 1 newly admitted patients (Patient #3) reviewed in a total sample of 5 medical records reviewed. Findings include: A review of the facility’s policy #1-03-07 titled, “Initial Patient Nursing Assessment for New Patients” last revised April 2024 revealed, “... A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility...” A review of Patient #3’s medical record revealed Patient #3 was admitted for their first dialysis treatment on 12/01/2025. The first dialysis treatment was started on 12/01/2025 at 10:39 AM. Patient #3’s “Initial Assessment” was completed on 12/01/2025 at 11:02 AM (23 minutes after initiation of first dialysis treatment). During an interview on 01/13/2026 at 11:20 AM, the medical record review findings were reviewed with and confirmed by with Clinical Service Manager L who stated, the initial assessment should be done before the start of the first dialysis treatment.”