Davita Elkhart 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: 51199 Based on observation, record review, and observation, the dialysis facility failed to ensure PCT 10 performed hand hygiene and changed gloves while alternating between setting up the clean hemodialysis [HD] (a process to filter the blood in a patient whose kidneys do not work normally) machine and assisting a patient in 1 of 3 observations of cleaning and disinfection of the dialysis station. Findings include: 1. A revised policy, dated April 2023, titled “Infection Control For Dialysis Facililties,” indicated that the dialysis station must be completely vacated by the previous patient before disinfection or setting up for the next patient can begin. The policy indicated that if a patient is not sufficiently stable to be moved from the dialysis station, cleaning and disinfection of the equipment at the station and preparation for the next patient must be delayed until the patient is able to be safely moved outside the station. 2. During an observation on 03/12/2025, beginning at 2:53 PM, PCT 10, at station #6, was performing cleaning and disinfection of the HD station. PCT 10 cleaned and disinfected the HD machine and began to set up the HD machine for the next patient while the previous patient remained seated in the HD chair. PCT 10 alternated between assisting the patient and setting up the HD machine. PCT 10 failed to change gloves or perform hand hygiene in between assisting a patient and continuing to set up hemodialysis machine, contaminating previously disinfected area. 3. During an interview on 03/12/2025, beginning at 4:15 PM, PCT 10 indicated that it is not facility policy to set up the HD machine for the next patient prior to the previous patient vacating the station. PCT 10 indicated that she does not always follow policy when it is busy to accommodate patient start times.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure RN 4 and PCT 10 completed cleaning and disinfection of the all items within the dialysis station in 3 of 3 station cleaning and disinfections observed (RN 4 and PCT 10). Findings include: 1. A revised policy, dated April 2023, titled, “Infection Control For Dialysis Facilities,” indicated at the end of each HD treatment, the dialysis station will be cleaned and disinfected and surfaces to disinfect would include but were not limited to all surfaces in contact with patient or their belongings [examples: dialysis chair, tray tables, blood pressure cuffs]. 2. During an observation on 03/12/2025, beginning at 2:53 PM, PCT 10 was observed to clean and disinfect the dialysis chair in station #6, using a bleach solution; PCT 10 failed to recline the chair and open the sides of the chair and left the inner chair folds and chair sides not disinfected nor cleaned. 3. During an interview on 03/12/2025, beginning at 4:15 PM, PCT 10 indicated that she should fully recline chair when performing cleaning and disinfection of the dialysis station. PCT 10 indicated that she will not follow policy at times when it is busy in order to ensure patient treatment start times are on schedule. 47022 4. During an observation on 03/13/2025, beginning at 3:15 PM, RN 4 was cleaning the dialysis chair at station #6. During the observation, RN 4 cleaned the chair with a bleach solution and failed to open the sides of the chair to clean. 5. During an observation on 03/13/2025, beginning at 3:30 PM, RN 4 was cleaning the dialysis chair at station #2. During the observation, RN 4 cleaned the chair with a bleach solution and failed to open the sides of the chair to clean. 6. During an interview on 03/13/2025, beginning at 4:00 PM, RN 4 indicated during the cleaning of the dialysis chairs the sides of the chairs should be opened to clean but could not remember if she opened and cleaned station #2’s or station #6’s sides of the chairs.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure Hepatitis B (liver infection) surveillance was conducted in 17, or 24%, of their 71 in center hemodialysis (a process to filter the blood of a patient whose kidneys do not work normally) patients, who were identified as Hepatitis B susceptible (with a Hepatitis B antibody less than 10) and did not have documentation they declined a Hepatitis B vaccine, was in the series of receiving the Hepatitis B vaccine, or was considered a non-responder (Patient #6, Patient #13, Patient #16, Patient #19, Patient #21, Patient #22, Patient #25, Patient #31, Patient #32, Patient #33, Patient #34, Patient #35, Patient #36, Patient #37, Patient #38, Patient #39, Patient #40). Findings include: 1. A revised policy, dated April 2024, titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” indicated all vaccinated patients would be tested for Hepatitis B surface antibodies 1 to 2 months after the last dose of the full vaccine series and if the Hepatitis B surface antibody was less than 10 mIU/mL (milli-international units per milliliter) the patient would be considered susceptible to Hepatitis B and should be revaccinated with an additional full series. The policy indicated annual testing of the Hepatitis B surface antibody with a results less than 10 mIU/mL the patient would receive a booster dose of the Hepatitis B vaccine. The policy indicated a Hepatitis B antibody less than 10 mIU/mL with a negative Hepatitis B total core and a negative Hepatitis B antigen would indicate the patient was susceptible to Hepatitis B and the Hepatitis B vaccine series would be offered. 2. Administrative staff #1, provided Vaccination and Surveillance Reports on 03/13/2025 at 4:30 PM, for Patient #6, Patient #13, Patient #16, Patient #19, Patient #21, Patient #22, Patient #25, Patient #31, Patient #32, Patient #33, Patient #34, Patient #35, Patient #36, Patient #37, Patient #38, Patient #39, and Patient #40. A. A Vaccination and Surveillance Report, for Patient #6, indicated Patient’s Hepatitis B surface antibody, dated 07/15/2024, was 9. The Report indicated Patient required a Hepatitis B series or a documented refusal and failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. B. A Vaccination and Surveillance Report, for Patient #13, indicated Patient’s Hepatitis B surface antibody, dated 08/05/2024, was 5, and received a Hepatitis B vaccine on 04/05/2017, 10/25/2017, 11/27/2017, 06/22/2018, and 09/26/2022. The Report indicated Patient required a Hepatitis B booster; the report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. C. A Vaccination and Surveillance Report, for Patient #16, indicated Patient’s Hepatitis B surface antibody, dated 07/17/2024, was less than 3. The Report indicated Patient received 3 doses of the Hepatitis B vaccine at the patient’s primary care physician in 11/2023, 12/2023, and 05/2024 and indicated Patient required another Hepatitis B series. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccine/booster. D. A Vaccination and Surveillance Report, for Patient #19, indicated Patient’s Hepatitis B antibody, dated 10/15/2024, was 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccine/booster. E. A Vaccination and Surveillance Report, for Patient #21, indicated Patient’s Hepatitis B antibody, dated 09/10/2024, was 5 and had received the Hepatitis B vaccine 05/14/2024. The Report indicated Patient required a 2nd Hepatitis B series. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccine/booster. D. A Vaccination and Surveillance Report, for Patient #22, indicated Patient’s Hepatitis B antibody, dated 04/16/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. E. A Vaccination and Surveillance Report, for Patient #25, indicated Patient’s Hepatitis B antibody, dated 07/11/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. F. A Vaccination and Surveillance Report, for Patient #31, indicated Patient’s Hepatitis B antibody, dated 10/15/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. G. A Vaccination and Surveillance Report, for Patient #32, indicated Patient’s Hepatitis B antibody, dated 01/07/2025, was less than 3. The Report, indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. H. A Vaccination and Surveillance Report, for Patient #33, indicated Patient’s Hepatitis B antibody, dated 08/13/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. I. A Vaccination and Surveillance Report, for Patient #34, indicated Patient’s Hepatitis B antibody, dated 04/23/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. J. A Vaccination and Surveillance Report, for Patient #35, indicated Patient’s Hepatitis B antibody, dated 01/25/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. K. A Vaccination and Surveillance Report, for Patient #36, indicated Patient’s Hepatitis B antibody, dated 03/20/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received or refused the Hepatitis B vaccine/booster. L. A Vaccination and Surveillance Report, for Patient #37, indicated Patient’s Hepatitis B antibody, dated 08/06/2024, was less than 3 and had received a Hepatitis B vaccine on 06/15/2015 and 10/03/2016. The Report indicated Patient required a Hepatitis B series. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccine/booster. M. A Vaccination and Surveillance Report, for Patient #38, indicated Patient’s Hepatitis B antibody, dated 12/10/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccine/booster. N. A Vaccination and Surveillance Report, for Patient #39, indicated Patient’s Hepatitis B antibody was less than 3 on 08/06/2024. The Report indicated Patient required a Hepatitis B series or a documented refusal. O. A Vaccination and Surveillance Report, for Patient #40, indicated Patient’s Hepatitis B antibody, dated 04/17/2024, was less than 3. The Report indicated Patient required a Hepatitis B series or a documented refusal. 3. During an interview on 03/13/2025, beginning at 4:30 PM, the Administrator, Administrative Staff 1, indicated the facility had to catch up on the surveillance of Hepatitis B, refusals should be documented and signed by the patient, and further documented refusals would have to be located. 4. During a follow up interview on 03/14/2025, beginning at 1:00 PM, Corporate Staff 1, indicated there was no further Hepatitis B documentation these patients were offered or declined the vaccine.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 27183 Based on observation and interview, the facility failed to ensure a copy of the Patient’s Rights was prominently displayed in 1 of 1 facility including displayed in a format which patients with poor vision can read and in a language all patients can understand, including their Patient Right to participate in their plan of care, refuse treatment, discontinue treatment, declination to participate in experimental research, advance directives, the facility policy regarding isolation of patients with infectious diseases, informed of the facility charges not covered by medicare, and placed in an area where the Patient Rights can be easily seen and read by all 90 of their current in-center and home program patients. The findings include 1. On 03/12/2025 at 11:30 AM, observed Patients Rights were not posted in the Providers lobby, the patient designated restroom, neither of the two home training rooms, nor were the Patient Rights easily found within the walls of the In-Center. The patients rights were observed on card stock measuring 10 inches by 17 inches, posted in a corner, to the right of the in-center scales. The font of the title of the posted Patient Rights, was not large enough to be clearly distinguishable and identified as Patient Rights and the individual patient rights listed beneath the title was not large enough to be read from the closest point to which an individual could gain access. The document was posted above eye level of a 5 foot 2 inch individual and all patients whose mobility was via a wheelchair. 2. On 3/14/2025 at 2:30 PM, Corporate Staff 1 indicated the Patient Rights were not posted in an area where all patients and their family members and / or designated decision makers, may easily find, read, and understand.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure continuous monitoring of Hepatitis B (Liver infection) immunizations for incenter hemodialysis (a process to filter the blood of a patient whose kidneys do not work properly) patients to take action that resulted in performance improvements, and failed to ensure performance improvements were tracked and sustained in 1 of 1 dialysis facility. Findings include: 1. A revised policy, dated April 2021, titled, “Continuous Quality Improvement Program,” indicated the dialysis facility would measure, analyze, and track quality indicators. The policy indicated the program would include vaccination rates for Hepatitis B. The policy indicated areas identified as underperforming would be reviewed to identify root causes, have an action plan identified that would result in performance improvement and would track the change in performance to verify improvements were sustained. 2. A February 2025 Facility Health Meeting, for Infection Prevention and Management, evidenced the following percentage of patients were vaccinated with the full Hepatitis B series: A. February 2024 37% B. March 2024 37% C. April 2024 38% D. May 2024 56% E. June 2024 59% F. July 2024 56% G. August 2024 59% H. September 2024 46% I. October 2024 44% J. November 2024 47% K. December 2024 66% L. January 2024 49% The February 2025 Facility Health Meeting Report failed to evidence actions were taken that resulted in performance improvement or performance improvement were sustained. The report indicated there were no outcomes or concerns, no root cause events, nor interventions, nor education of patients refusing vaccines. 3. The dialysis facility failed to ensure Hepatitis B vaccination surveillance were completed for 17, or 24% ,of the current in center hemodialysis patient census, who have less than 10 (susceptible to Hepatitis B) Hepatitis B antibodies, and their records failed to evidence documentation of a refusal, considered a non-responder, nor was currently in the Hepatitis B vaccine series. 4. During an interview on 03/14/2025, beginning at 1:00 PM, Administrative Staff 4 indicated there was no Hepatitis B trending results and no interventions to ensure performance improvement was maintained.”

“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: 51199 Based on record review and interview, the dialysis failed to ensure patient records were accurate in 3 of 3 patients with a 30 minute or more early termination of their treatment (Patient #28, Patient #29, and Patient #30) on January 06, 2025 and failed to ensure PCT 9 completed accurate documentation when she documented an Against Medical Advice (AMA) form for each patient. Findings include: 1. A revised policy, dated April 2024, titled, “Prescribed Treatment Time Not Met,” indicated that the RN would verify a patient signed an AMA form when the patient requested to terminate the prescribed treatment time, the patient’s nephrologist would be notified when the early termination time exceeded 30 minutes or more. The policy indicated a patient’s treatment time could be terminated by the facility early included medical reasons, behavioral issues, power outages, weather-related emergencies, facility wide equipment failure, and patient transportation problems. 2. A complaint, dated 01/08/2025, indicated that on 01/06/2025, Patient #28 arrived to the dialysis facility on time; their HD treatment was started 56 minutes late due to PCT 9 who arrived to the facility late. The complaint indicated that an AMA form was signed by PCT 9; the form was not signed by Patient due to Patient did not agree to their shortened HD treatment time. 3. A complaint, dated 01/08/2025, indicated that on 01/06/2025, Patient #29 arrived to the dialysis facility on time and HD treatment was started 46 minutes late. The complaint indicated that an AMA form was signed by PCT 9; the form was not signed by Patient due to Patient did not agree to a shortened HD treatment time. 4. Treatment Run Sheets, dated 01/06/2025, indicated early termination of HD treatment by 30 minutes or more for the following patients: A. Patient #28 HD treatment was terminated 57 minutes early. Start time 6:41AM, End time 9:14AM. Prescribed time 210 minutes. B. Patient #29 HD treatment was terminated 43 minutes early. Start time 6:16AM, End time 9:33AM. Prescribed time 240 minutes. C. Patient #30 HD treatment was terminated 31 minutes early. Start time 6:03AM, End time 9:02AM. Prescribed time 210 minutes. 5. The Clinical records of the three patients with AMA forms dated 01/06/2025, were reviewed and evidenced the following A. Patient #28 an AMA form, dated 01/06/2025, indicated PCT 9 arrived late to the dialysis facility and Patient requested to terminate HD treatment early. The AMA form was signed by RN 1 and PCT 9. AMA form failed to evidence patient signature. B. Patient #29 AMA form, dated 01/06/2025, indicated PCT 9 arrived late to the dialysis facility and Patient requested to terminate treatment early. The AMA form was signed by RN 1 and PCT 9. AMA form failed to evidence patient signature. C. Patient #30 failed to evidence an AMA form was completed by staff, and failed to evidence Patient’s nephrologist was notified of early termination of treatment on 01/06/2025. 6. During an interview on 03/13/2025, beginning at 10:00 AM, the Facility Administrator [FA], Administrative Staff 1, indicated if a HD treatment was started late and was not the patient’s fault, the facility staff should ask the patient if they want their full HD treatment time or if they want their HD treatment time to end as scheduled. The FA indicated if a patient started HD treatment late and requested to end HD treatment as scheduled an AMA forms should be completed.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed perform the required steps for involuntary discharge in 1 of 1 involuntary discharge records [Patient 27]. Findings include: 1. A revised policy, dated October 2023, titled “Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge or Involuntary Transfer,” indicates that a patient with non-threatening behavior will have a comprehensive patient assessment completed by the interdisciplinary team to identify any potential action or plan of correction required and then a Patient Care Conference that includes the patient is required. Both the comprehensive assessment and Patient Care Conference should be documented in the patient electronic health record. If the behavior continues, the patient shall receive a First Letter of Concern that provides specific details of the patient’s behavior and the concerns the facility has regarding the behavior. If a patient has threatening behavior, The ESRD Network, Risk Manager, and facility will decide if the patient should be immediately discharged from the facility. If a behavior agreement is appropriate, the behavior agreement will be discussed in a Patient Care Conference with the patient. The agreement will also be mailed to the patient via Certified Mail. If the Patient acts in violation of the behavior agreement, the Risk Manager will consult the ESRD Network regarding 30 day discharge. Good faith efforts should be made to place the patient at the patient’s preferred facility or find the closest facility to the patient’s residence that will accept the patient. The patient electronic health record must include evidence of placement efforts. 2. The clinicial record for Patient #27 indicated an admission to the ESRD dated 02/15/2024. Review of the clinical record failed to evidence a comprehensive assessment was conducted by the Interdisciplinary Team [IDT] in regards to Patient behavioral problems or prior to a possible involuntary discharge, nor was documentation of the IDT efforts to resolve problems, nor if or of contact made to another facility in attempt to transfer Patient. 3. A letter from the Medical Director, dated 06/04/2024, indicated that she will no longer be able to treat Patient #27 and that termination of physician/patient relationship will be effective in 30 days. The letter failed to inform the patient of the reason for involuntary discharge. The letter states that the patient should contact insurance plan for names of other physicians. 4. A letter from Elkhart Dialysis, dated 06/12/2024, indicated that Patient #27 will be discharged from the facility 07/13/2024 unless patient obtains a new nephrologist who agrees to take over care. A list of nephrologists, area dialysis facilities, and area hospitals was provided with letter. 5. During an interview on 03/14/2025, beginning at 11:50AM, the Medical Social Worker [MSW] indicated that Patient #27 had multiple medical and psychosocial problems and began to have behavioral problems/outbursts approximately 4-6 weeks after admission to facility. MSW indicated that to assist patient with problems, he called Patient’s family to discuss psychosocial issues. After this call, Patient #27 made verbal threats to staff in reference to MSW. MSW indicated that Patient #27 missed many treatments and was eventually given a 30 day discharge notice by hospital staff, as that was where Patient wad arriving to receive hemodialysis [HD] (a process to filter blood in a patient whose kidneys do not work normally) treatments. MSW indicated that no dialysis facilities were contacted for patient transfer, nor were any nephologists contacted for patient transfer of care, nor was there any patient care conference or meeting with interdisciplinary team, nor was there any behavioral plan or interventions initiated prior to 30 day discharge notice, nor was the patient notified of reason for 30 day discharge. 6. During an interview on 03/14/2025, beginning at 7:30AM, The Medical Director [MD] indicated that she attempted to communicate with Patient #27 as an intervention prior to her issue of a 30 day discharge notice. She relayed the reason she was discharging from her care, was due to Patients’ violence and threats made towards staff. MD indicated she acted as Patients’ nephrologist for 60 days from the discharge notice letter dated 06/04/2024.”