Davita Sheboygan 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 hand hygiene prior to preparing medications for 1 of 2 patients (Patient #14); failed to perform glove changes and/or hand hygiene when moving from “dirty” to “clean” tasks while providing cares for 4 of 14 patients (Patients #10- 2 observations, #8, #15, #16); failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 2 of 2 patients (Patients #10, 12) observed holding access sites; and failed to wear gloves when touching the dialysis machine for 4 of 14 patients (Patients #10, #15 #16, #17) in a total of 16 observations of patient care. Findings include: A review of facility’s policy 1-06-01 titled, “Medication Policy,” last revised February 2021 revealed, “An aseptic environment and aseptic technique is used when preparing medications. Careful attention to proper hand washing is performed at this time.” 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 04/2023 revealed, “... When the patient holds their cannulation sites, the patient will be offered gloves and performs hand hygiene when completed...” Example of staff failing to complete hand hygiene before medication preparation: During an observation on 06/17/2025 at 12:54 PM, Registered Nurse H was preparing medications for Patient #14. Registered Nurse H did not do hand hygiene prior to preparing the medications. Examples of staff failing to complete hand hygiene: During an observation on 06/17/2025 at 9:32 AM, Patient Care Technician G was discontinuing dialysis on Patient #10’s fistula. Patient Care Technician G disconnected the blood lines from Patient #10, picked up the garbage on the floor, removed gloves and did not complete hand hygiene. During an observation on 06/17/2025 at 10:12 AM, Patient Care Technician G was disinfecting Patient #10’s chair after completion of dialysis. Patient Care Technician G removed the blood lines from the dialysis machine and disposed the lines in the biohazard bin. Patient Care Technician G then took off gloves and put on new gloves and grabbed bleach wipes to disinfect the dialysis station without completing hand hygiene. During an observation on 06/17/2025 at 1:10 PM, Patient Care Technician B was initiating dialysis on Patient #8’s central venous catheter. Patient Care Technician B removed gloves and put on new gloves without completing hand hygiene. During an observation on 06/18/2025 at 9:40 AM, Patient Care Technician B was discontinuing dialysis on Patient #16. Patient Care Technician B placed a clean field under Patient #16’s central venous catheter ports, removed gloves and put on new gloves without completing hand hygiene. During an observation on 06/18/2025 at 9:50 AM, Patient Care Technician C was setting up a dialysis machine at station #5 with gloved hands. Patient Care Technician C then walked over to Patient #15’s dialysis machine with the same gloves and touched the dialysis machine to turn off an alarm. Patient Care Technician C then walked back to station #5 and continued to set up dialysis machine for the next patient with the same gloves. Examples of staff touching the dialysis machines with a glove wrapped around the finger: During an observation on 06/17/2025 at 9:25 AM, Patient Care Technician G touched Patient #10’s dialysis machine at station #12 using a glove wrapped around the finger. During an observation on 06/17/2025 at 9:59 AM, Patient Care Technician L touched Patient #5’s dialysis machine at station #14 without gloves. During an observation on 06/18/2025 at 9:45 AM, Patient Care Technician C touched Patient #16’s dialysis machine at station #9 using a glove wrapped around the finger to silence an alarm. During an observation on 06/18/2025 at 9:46 AM Registered Nurse H touched Patient #17’s dialysis machine at station #14 using a glove wrapped around the finger. During an observation on 06/18/2025 at 10:00 AM, Patient Care Technician B touched Patient #16’s dialysis machine at station #9 using a glove wrapped around the finger to discontinue dialysis. Examples of staff failing to ensure patients completed hand hygiene after glove removal after holding dialysis access sites: During an observation on 06/17/2025 at 9:21 AM, Patient #12 was observed holding dialysis access site with a glove, removed the glove, and did not perform hand hygiene prior to exiting the treatment area. During an observation on 06/17/2025 at 9:25 AM, Patient #10 was observed holding dialysis access site with a glove, removed the glove, and did not perform hand hygiene prior to exiting the treatment area. During an interview on 06/18/2025 at 12:14 PM, 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 before drawing up the medications. Manager of Clinical Services L stated the staff should be offering hand gel to every patient at the completion of dialysis and staff are expected to put the glove on the hand prior to touching the dialysis machine. 47413”

“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: 29963 Based on record review, observation and interview, the facility staff failed to follow facility policy and only have natural fingernails for 1 of 8 staff (Registered Nurse H) observed in a total universe of 8 staff observed. Findings include: A review of the facility policy #1-05-01 titled, “Infection Control for Dialysis Facilities,” last revised April 2023 revealed, “...It is a requirement for all DaVita teammates whose primary location is working in the facility to have only natural nails and fingernail length should not extend more than 1/4 inch...” During an observation on 06/17/2025 at 12:54 PM, Registered Nurse H was observed to have artificial fingernails longer than 1/4 of an inch. During an interview on 06/17/2025 at 12:13 PM, the observation findings were discussed with Facility Administrator A who stated the staff should not have artificial nails.”

“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: 29963 Based on record review, observation and interview, facility staff failed to ensure that non-disposable items taken into the patient station (stethoscope and thermometer) were cleaned and disinfected following use for 2 of 2 patients observed (Patients #7, 9) 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, “... Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area... Non-disposable items are to be disinfected after each patient use... Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution...” A review of the facility’s policy #1-05-01 titled, “Infection Control for Dialysis Facilities,” last revised October 2023 revealed, “... If electronic thermometers and/or blood glucose meters are used, measures will be taken to prevent cross contamination between patients. For example, the thermometer should not be placed on potentially contaminated equipment such as the dialysis delivery system. If the potential for contamination exists, the device outer casing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient...” During an observation on 06/17/2025 at 9:35 AM, Patient Care Technician B was observed evaluating Patient #9’s fistula using a stethoscope. After access was evaluated, Patient Care Technician B returned the stethoscope to the common area on the center countertop without disinfecting the stethoscope. During an observation on 06/17/2025 at 10:56 AM, Registered Nurse A completed an assessment on Patient #9 using a stethoscope. After the assessment Registered Nurse A returned the stethoscope to the common area on the countertop without disinfecting the stethoscope. During an observation on 06/17/2025 at 2:39 PM, Patient Care Technician I was observed using the thermometer on Patient #7 at the completion of dialysis. Patient Care Technician I then returned the thermometer to a common area without disinfecting the thermometer. During an interview on 06/18/2025 at 12:12 PM, the observation findings were discussed with Manager of Clinical Services L who stated stethoscopes and thermometers should be bleached between patients.”

“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 2 of 2 dialysis stations (Stations #12, 14) 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 06/17/2025 at 9:59 AM, Patient Care Technician L was observed cleaning Station #14 and did not wipe down the IV pole and hooks or the TV. During an observation on 06/17/2025 at 10:12 AM, Patient Care Technician G was observed cleaning Station #12 and did not wipe down the IV pole hooks or blood pressure basket attached to the side of the dialysis machine. During an interview on 06/18/2025 at 12:12 PM, the observation findings were discussed with Manager of Clinical Services L who stated that staff should be wiping down everything in the dialysis station. 47413”

“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 ensure aseptic technique was maintained when working with central venous catheters (CVC), per facility policy for 2 of 4 patients with a CVC observed (Patients #8, 16), and failed to cleanse central venous catheter hubs per facility policy for 2 of 4 patients with a CVC observed (Patients #8, 16) in a total sample of 4 observations of care of patients with a CVC. 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 May 2025 revealed, “... Teammate and patient will wear masks covering the nose and mouth during this procedure...” A review of the facility’s policy #1-04-02B titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” last revised May 2025 revealed, “...Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines ...” During an observation on 06/17/2025 starting at 1:10 PM, Patient Care Technician B was observed performing exit site care and initiation of dialysis for Patient #8 who had a CVC. Patient Care Technician B’s mask was under the tip of her nose throughout the initiation and cleansing process. Patient Care Technician B disinfected each of the CVC hubs with alcohol for 10 seconds each, 5 seconds less than per policy. During an observation on 06/18/2025 at 9:40 AM, Patient Care Technician B was observed discontinuing dialysis on Patient #16 who had a CVC. Patient Care Technician B was wearing a mask under the tip of her nose throughout the discontinuation and cleansing process. Patient Care Technician B disinfected each of Patient #16’s CVC hubs with alcohol for 5 seconds each, 10 seconds less than per policy. During an interview on 06/18/2025 at 12:01 PM, the observation findings were discussed with Manager of Clinical Services L who stated that it is the expectation that the teammate wear a mask above the nose when working with a CVC and the staff needs to complete a 15 second scrub every time the CVC is accessed.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to ensure blood pressure readings outside of ordered parameters were reported to the nurse for further assessment or the nephrologist, per policy, in 1 of 5 (Patients #7) in-center medical records reviewed in a total universe of 7 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, “ ...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary... 12. All findings, interventions and patient responses will be documented in the patient’s medical record...” A review of Patient #7’s physician orders revealed, “Notify Nurse for Post Assessment if Systolic blood pressure (BP) is above 180 mmHg.” A review of Patient #7’s treatment sheet dated 06/03/2025 revealed Patient Care Technician N documented at 5:56 PM a blood pressure of 198/105. There was no documentation of blood pressure being noted as outside of ordered parameters, notification of the Registered Nurse, or that the Registered Nurse assessed Patient #7 as a result. A review of Patient #7’s treatment sheet dated 06/10/2025 revealed Patient Care Technician N documented at 5:40 PM a blood pressure of 210/126. There was no documentation of blood pressure being noted as outside of ordered parameters, notification of the Registered Nurse, or that the Registered Nurse assessed Patient #7 as a result. A review of Patient #7’s treatment sheet dated 06/14/2025 revealed Patient Care Technician M documented at 5:41 PM a blood pressure of 217/169. There was no documentation of blood pressure being noted as outside of ordered parameters, notification of the Registered Nurse, or that the Registered Nurse assessed Patient #7 as a result. During an interview on 06/18/2025 at 11:44 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services L who stated the Patient Care Technician should be notifying the nurse if the blood pressure is out of ordered parameters and the nurse should be completing and documenting an assessment.”

“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 #5, 6) in a total universe of 7 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 #5’s medical record revealed a physician order for the blood flow rate (BFR) of 450 mL/min (milliliters per minute). The treatment sheet dated 06/12/2025 revealed the BFR was set at 430 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 #5’s medical record revealed a physician order for the dialysis flow rate (DFR) of 800 mL/min. The treatment sheet dated 06/10/2025, 06/07/2025, 06/05/2025 and 06/03/2025 revealed the DFR was set from 810 mL/min-820 mL/min for part of the treatment. There was no documentation in the medical record for the reason the DFR was higher than the ordered rate. A review of Patient #6’s medical record revealed a physician order for the BFR of 350 mL/min. The treatment sheet dated 06/03/2025 and 06/06/2025 revealed the BFR was set at 300 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. During an interview on 06/18/2025 at 1:19 PM, the medical record findings were discussed with and confirmed by Manager of Clinical Services K who stated facility staff were expected to document a reason for not meeting prescribed blood and dialysate flow rates.”

“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: 47413 Based on record review, observation and interview, the facility staff failed to perform skin antisepsis prior to cannulation per policy for 1 of 2 patients (Patient #5) observed for initiation of dialysis with an AV Fistula/Graft in a total of 16 observations of care. Findings Include: A review of the facility’s policy #1-04-01D titled, “AV Fistula or Graft Cannulation..., “ last revised 04/2025 revealed, “... Do not palpate insertion site once area has been prepped...” During an observation on 06/17/2025 at 10:14 AM, Patient Care Technician I was observed cleansing Patient #5’s insertion site and palpated the site again before cannulation. During an interview on 06/18/2025 at 12:06 PM, Manager of Clinical Services L stated that once a site is cleaned it cannot be touched again without recleaning.”

“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: 47413 Based on record review and interview, the facility staff failed to ensure data is being collected, analyzed, and trended to identify potential problems with patient infections for 1 of 1 monthly Infection Trackers and failed to ensure mortality review is conducted for 3 of 3 patient deaths in 1 of 1 quality program reviewed. Findings Include: A review of the facility’s policy #1-14-06 titled, “Continuous Quality Improvement Program” last revised 04/2021 revealed, “... The facility will measure, analyze, and track quality indicators... The program must include, ... Infection Control, including Incidence of infections... Mortality- review of deaths...” A review of the facility’s “Infection Tracker” data from February 2025, April 2025, and May 2025 revealed missing documentation related to the type of infection, name of antibiotic, and if blood cultures were drawn. A review of the facility’s “Morality Review Summary” from February 2025 revealed 3 patient deaths and no documentation that a mortality review was initiated or completed for any of the 3 patients. During an interview on 06/18/2025 at 9:15 AM, the above findings were discussed with Manager of Clinical Services L who stated there are pieces missing from the infection log and morality review summary.”

“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 2 newly admitted patients (Patient #6) reviewed in a total sample of 7 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 #6’s medical record revealed Patient #6 was admitted for their first dialysis treatment on 04/15/2025. The first dialysis treatment was started on 04/15/2025 at 10:18 AM. Patient #6’s “Initial Assessment” was completed on 04/15/2025 at 10:28 AM (10 minutes after initiation of first dialysis treatment). During an interview on 06/18/2025 at 11:05 AM, the medical record review findings were reviewed with and confirmed by with Clinical Service Manager K who stated, “The initial assessment should be done before the start of the first treatment.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to ensure nursing staff were documenting their pre-dialysis treatment assessment within 1 hour of dialysis treatment initiation per facility policy for 3 of 5 patients (Patients #5, 6, 7) in a total universe of 7 medical records reviewed. Findings Include: A review of the facility policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated April 2024 revealed, “... The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law.” A review of Patient #5’s medical record revealed a treatment sheet dated 06/05/2025, treatment was documented as initiated at 9:59 AM and the pre-nursing assessment was documented at 11:54 AM. Treatment sheet dated 06/07/2025 revealed treatment was initiated at 10:00 AM and the pre-nursing assessment was documented at 1:29 PM. Treatment sheet dated 06/10/2025 revealed treatment was initiated at 10:09 AM and the pre-nursing assessment was documented at 1:20 PM. A review of Patient #6’s medical record revealed a treatment sheet dated 06/05/2025, treatment was documented as initiated at 11:35 AM and the pre-nursing assessment was documented at 1:01 PM. Treatment sheet dated 06/06/2025 revealed treatment was initiated at 4:16 PM and the pre-nursing assessment was documented at 9:35 PM. Treatment sheet dated 06/09/2025 revealed treatment was initiated at 9:43 AM and the pre-nursing assessment was documented at 1:05 PM. A review of Patient #7’s medical record revealed a treatment sheet dated 06/05/2025, treatment was documented as initiated at 2:33 PM and the pre-nursing assessment was documented at 10:54 PM. Treatment sheet dated 06/10/2025, revealed treatment was initiated at 2:14 PM and the pre-nursing assessment was documented at 3:47 PM. Treatment sheet dated 06/12/2025 revealed Patient #7’s treatment was initiated at 2:19 PM and the pre-nursing assessment was documented at 4:00 PM. During an interview on 06/18/2025 at 11:24 AM, the medical record review findings were discussed with and confirmed by Manager of Clinical Services K who stated the pre-dialysis assessments should be completed and documented within 1 hour of the start of dialysis treatment. 47413”