Davita Merrillville 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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure staff removed gloves, performed hand hygiene (hand sanitizing with an alcohol-based antiseptic or hand washing) between patients and stations, after glove removal, and during central venous catheter care [CVC] (large catheter into vein) in 4 of 7 observations of PCT 3 (with Patient #16, Patient #22, Patient #24, and in Station #13), in 2 of 3 observations of PCT 1 (with Patient #6 and Patient #24) and in 2 of 5 observations of CVC access care of intiation and discontinuation (PCT 3). Findings include: 1. A revised policy, dated April 2023, titled, “Infection Control For Dialysis Facilities,” indicated staff would perform hand hygiene upon entering and exiting the patient treatment area, prior to gloving and immediately after glove removal, after patient and dialysis delivery system contact, between patients, before touching clean areas and during station cleaning for 2. During an observation, on 04/21/2025, beginning at 10:15 AM, PCT 3 was at Station #15, with Patient #22, PCT 3 had gloves on, touched Patient #22’s hemodialysis [HD](a process to filter the blood of a patients whose kidneys do not work normally) machine, exited Station #15, without performing hand hygiene or glove change entered Station #14, with Patient #9, and touched Patient #9’s HD machine. During an observation, on 04/21/2025, beginning at 10:15 AM, PCT 3 was at Station #13, with Patient #23, PCT 3 had gloves on and touched Patient #23’s HD machine, exited Station #13, without performing hand hygiene or glove change entered Station #12, with Patient #8, and PCT 3 touched Patient #8’s PCT machine. During an observation, on 04/21/2025, beginning at 10:45 AM, PCT 3 was cleaning Station #14, removed her gloves, without performing hand hygiene applied new gloves and emptied the drain bucket. During an observation, on 04/22/2025, beginning at 11:00 AM, PCT 3 was at Station #7, with Patient #16, for CVC initiation. During the observation, PCT 3 removed the dressing to the CVC site, removed her gloves and without performing hand hygiene applied new gloves and touched the HD machine, PCT 3 then exited Station #7, entered Station #5 and removed gloves. During an observation, on 04/22/2025, beginning at 2:05 PM, PCT 3 discontinued the CVC, for Patient #16, at Station #7. During the observation, PCT 3 discontinued 1 line, removed gloves and without performing hand hygiene applied new gloves and flushed the 2nd line. During the observation, PCT 3 used a glove that was not applied to her hand to touch the HD machine. During an observation, on 04/22/2025, beginning at 2:05 PM, PCT 3 was wearing gloves, removed the blood lines for the Station #7’s HD machine, placed the lines in the biohazard bag and without performing hand hygiene or changing gloves entered Station #10 with Patient #19, touched the HD machine, then PCT 3 removed her gloves and without performing hand hygiene applied new gloves. 3. During an observation, on 04/21/2025, beginning at 10:30 AM, PCT 1 was at Station #10, with Patient #24, PCT 1 had gloves on, touched Patient #24’s HD machine, exited Station #10, PCT 1 removed her gloves and without performing hand hygiene, went to the center supply station, PCT 1 returned to Station #10 applied new gloves and typed on the computer, PCT 1 removed her gloves and without performing hand hygiene applied new gloves and entered Station #14. During an observation, on 04/21/2025, beginning at 11:05 AM, PCT 1 was at Station #14, with Patient #6, PCT 1 had gloves on and removed her gloves, without performing hand hygiene she applied new gloves and adjusted the arteriovenous fistula (access for HD) needles. 4. During an interview, on 04/21/2025, beginning at 11:40 AM, PCT 3 indicated gloves should be changed and hand hygiene should be done before and after patient care and between patients’ stations.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure non-disposable items taken into the dialysis station were disinfected before being taken to a common clean area or used on another patient in 1 of 2 observations of a station set up (PCT 4). Findings include: 1. A revised policy, dated April 2023, titled, “Infection Control For Dialysis Facilities,” indicated non-disposable items were to be disinfected after each patient use, and prior to removal from treatment station. 2. During an observation, on 04/22/2025, beginning at 11:15 AM, PCT 4 brought the phoenix meter to Station #6 with Patient #15, they touched the hemodialysis machine to obtain a water sample; PCT 4 returned the phoenix meter to the clean sink counter and failed to clean the phoenix meter. 3. During an interview, on 04/22/2025, beginning at 2:20 PM, PCT 3 indicated the phoenix meter should be cleaned after each use at a hemodialysis station.”

“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) vaccination surveillance and monitoring and failed to ensure susceptible (with a Hepatitis B antibody less than 10) patients were offered a Hepatitis B vaccination in 40% of in center hemodialysis [HD] (a process to filter the blood of a patients whose kidneys do not work normally) patients without a documented refusal (Patient #1, Patient #15, Patient #17, Patient #22, Patient #24, Patient #25, Patient #27, Patient #28, Patient #29, Patient #30, Patient #31, Patient #32, Patient #33, Patient #34, Patient #35, Patient #36, Patient #37, Patient #38, Patient #39, Patient #40, Patient #41, and Patient #42). Findings include: 1. A revised policy, dated April 2024, titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” indicated all permanent patients would have a Hepatitis B surface antigen and Hepatitis B surface antibody upon admission and if the Hepatitis B antibody was less than 10 and the Hepatitis B antigen was negative the patient would be offered a vaccination series. The policy indicated an annual Hepatitis B antibody would be obtained. The policy indicated if a Hepatitis B surface antibody was less than 10 after a full vaccine series the patient would be revaccinated with an additional full series, and no additional doses of vaccine were warranted for patients who do not respond to a full second series. The policy indicated if the Hepatitis B surface antibody was greater than 10 consider the patient immune and retest annually and if the Hepatitis B surface antibody was less than 10 on an immune patient due to vaccination a booster dose of the Hepatitis B vaccine would be administered with a physician order. 2. A Vaccinations and Surveillance Report, for Patient #25, indicated a Hepatitis B surface antibody, dated 03/15/2024 of 8 and a Hepatitis B surface antibody, dated 03/03/2025 of 6. The Report indicated a Hepatitis B vaccine was given 01/13/2020, 02/17/2020, 03/20/2020, and 07/17/2020. The Report failed to evidence Patient was offered, received, or refused a repeat the Hepatitis B vaccine/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #25 should have been offered a Hepatitis B vaccine booster. 3. A Vaccinations and Surveillance Report, for Patient #1, indicated a Hepatitis B surface antibody, dated 04/03/2024, of less than 3 and a Hepatitis B surface antibody, dated 02/20/2025 of less than 3. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccine/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #1 should have been and was not offered a Hepatitis B vaccination series. 4. A Vaccination and Surveillance Report, for Patient #27, indicated a Hepatitis B surface antibody, dated 02/20/2025, of 8. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccine/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #27 needed to be offered a Hepatitis B booster vaccine. 5. A Vaccination and Surveillance Report, for Patient #28, indicated a Hepatitis B surface antibody, dated 10/31/2023 of 3, a Hepatitis B surface antibody, dated 04/18/2024, of less than 3, and a Hepatitis B surface antibody, dated 02/21/2025 of 3. The Report indicated one Hepatitis B vaccine was given 04/12/2022. The Report failed to evidence Patient was offered, received, or refused a repeat Hepatitis B vaccine/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #28 should have been offered a Hepatitis B booster vaccine. 6. A Vaccination and Surveillance Report, for Patient #29, indicated a Hepatitis B surface antibody, dated 11/09/2023 of less than 3, a Hepatitis B surface antibody, dated 04/17/2024, of less than 3, and a Hepatitis B surface antibody dated 02/26/2025 of less than 4. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccine/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #29 should have been offered a Hepatitis B booster. 7. A Vaccination and Surveillance Report, for Patient #30, indicated a Hepatitis B surface antibody, dated 02/26/2025, of 9. The Report indicated Patient received Hepatitis B vaccinations 04/07/2023, 05/10/2023, 07/26/2023 and 04/12/2024. The Report failed to evidence Patient was offered, received, or refused a repeat Hepatitis B vaccine/booster after the 02/26/2025 Hepatitis B surface antibody result. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #30 would need to be offered a Hepatitis B booster vaccine. 8. A Vaccination and Surveillance Report, for Patient #31, indicated a Hepatitis B surface antibody, dated 11/02/2023 of less than 3, a Hepatitis B surface antibody, dated 04/18/2024 of less than 3, and a Hepatitis B surface antibody, dated 02/20/2025, less than 3. The Report indicated Hepatitis B vaccinations were given 07/10/2023, 08/21/2023, and 09/18/2023. The Report failed to evidence a repeat Hepatitis B vaccine/booster was offered, refused, or received. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #31 needed to be offered a Hepatitis B vaccination series. 9. A Vaccination and Surveillance Report, for Patient #17, indicated a Hepatitis B surface antibody, dated 02/27/2025, of 3. The Report failed to evidence a Hepatitis B vaccine/booster was offered, refused, or received. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #17 needed to be offered a Hepatitis B vaccination booster. 10. A Vaccination and Surveillance Report, for Patient #24, indicated a Hepatitis B surface antibody, dated 08/08/2022, of less than 3, a Hepatitis B surface antibody, dated 10/30/2023, of less than 3, and a Hepatitis B surface antibody, dated 02/21/2025, of less than 3. The Report indicated Patient received Hepatitis B vaccines on 11/22/2022, 12/26/2022, 01/23/2023, and 07/17/2023. The Report failed to evidence a repeat Hepatitis B vaccine/booster was offered, refused, or received. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #24 needed to be offered a Hepatitis B vaccination series. 11. A Vaccination and Surveillance Report, for Patient #15, indicated a Hepatitis B surface antibody, dated 09/05/2024, of less than 3 and a Hepatitis B surface antibody, dated 02/21/2025, of less than 3. The Report failed to evidence a Hepatitis B vaccine/booster was offered, refused or received. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #15 needed to be offered a Hepatitis B vaccination series. 12. A Vaccination and Surveillance Report, for Patient #22, indicated a Hepatitis B surface antibody, dated 10/22/2024, of less than 3, a Hepatitis B surface antibody, dated 05/09/2024 of less than 3, and a Hepatitis B surface antibody, dated 02/21/2025, of 4. The Report indicated Patient received a Hepatitis B vaccination on 08/10/2024 and 09/10/2024. The Report failed to evidence the Hepatitis B series was completed. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #22 missed the 3rd dose of the Hepatitis B vaccine and the Hepatitis B vaccination series needed to be restarted. 13. A Vaccination and Surveillance Report, for Patient #32, indicated a Hepatitis B surface antibody, dated 04/17/2024, of less than 3, a Hepatitis B surface antibody, dated 08/21/2024 of 3, and a Hepatitis B surface antibody, dated 02/20/2025 of less than 3. The Report indicated Hepatitis B vaccination series was given 05/10/2023, 07/17/2023, 08/18/2023, and 04/12/2024. The Report failed to evidence Patient was offered, received or refused a repeat Hepatitis B vaccination series. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #32 should have had a repeat Hepatitis B surface antibody test one month after the Hepatitis B vaccination series was completed and Patient required a repeat Hepatitis B vaccination series to be offered. 14. A Vaccination and Surveillance Report, for Patient #33, indicated a Hepatitis B surface antibody, dated 11/07/2023, of less than 3, a Hepatitis B surface antibody, dated 04/23/2024, of less than 3, and a Hepatitis B surface antibody, dated 04/01/2025 of 3. The Report indicated Patient received a Hepatitis B vaccine on 11/29/2022, 01/03/2023, and 07/22/2023. The Report failed to evidence Patient was offered, received, or refused a repeat Hepatitis B vaccination series. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #33 should have been offered a repeat Hepatitis B vaccination series. 15. A Vaccination and Surveillance Report, for Patient #34, indicated a Hepatitis B surface antibody, dated 02/07/2025, of less than 3. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccination. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #34 needed to be offered a Hepatitis B vaccination. 16. A Vaccination and Surveillance Report, for Patient #35, indicated a Hepatitis B surface antibody, dated 05/24/2024, of less than 3, and a Hepatitis B surface antibody, dated 02/21/2025, of less than 3. The Report failed to evidence a Hepatitis B vaccine was offered, received, or refused. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #35 should of had a Hepatitis B vaccination series offered. 17. A Vaccination and Surveillance Report, for Patient #36, indicated a Hepatitis B surface antibody, dated 12/01/2023, of less than 3, a Hepatitis B surface antibody, dated 04/17/2024, of less than 3, and a Hepatitis B surface antibody, dated 02/21/2025, of less than 3. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccination. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #36 should have had a Hepatitis B vaccination series offered. 18. A Vaccination and Surveillance Report, for Patient #37, indicated a Hepatitis B surface antibody, dated 10/30/2023, of less than 3, a Hepatitis B surface antibody, dated 04/17/2024, of less than 3 and a Hepatitis B surface antibody, dated 02/21/2025, of less than 3. The Report indicated one Hepatitis B vaccination was given on 10/02/2023. The Report failed to evidence the full Hepatitis B vaccination series was offered, received, or refused. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #37 should be offered a Hepatitis B vaccination series. 19. A Vaccination and Surveillance Report, for Patient #38, indicated a Hepatitis B surface antibody, dated 12/05/2024, of less than 3, and a Hepatitis B surface antibody, dated 02/20/2025, of less than 3. The Report failed to evidence Patient was offered, received, or refused the Hepatitis B vaccination. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #38 should be offered a Hepatitis B vaccination series. 20. A Vaccination and Surveillance Report, for Patient #39, indicated a Hepatitis B surface antibody, dated 03/03/2023, of less than 3, a Hepatitis B surface antibody, dated 10/19/2024, of 11, and a Hepatitis B surface antibody, dated 02/20/2025, of 4. The Report failed to evidence Patient received, was offered, or refused the Hepatitis B vaccination. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #39 should be offered a Hepatitis B vaccination series. 21. A Vaccination and Surveillance Report, for Patient #40, indicated a Hepatitis B surface antibody, dated 08/29/2024, of less than 3, and a Hepatitis B surface antibody, dated 02/20/2025, of less than 3. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccination. During an interview, on 04/23/2025, beginning at 1:30 PM, RN 1 indicated Patient #30 should be offered a Hepatitis B vaccination series. 22. A Vaccination and Surveillance Report, for Patient #41, indicated a Hepatitis B surface antibody, dated 04/18/2024, of 10, and a Hepatitis B surface antibody, dated 02/20/2025, of 8. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccination. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #41 needed to be offered a Hepatitis B booster vaccination. 23. A Vaccination and Surveillance Report, for Patient #42, indicated a Hepatitis B surface antibody, dated 02/22/2024, of 8, and a Hepatitis B surface antibody, dated 04/18/2024, of 5. The Report failed to evidence Patient was offered, received, or refused a Hepatitis B vaccination/booster. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated Patient #42 needed to be offered a Hepatitis B vaccination series.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 47022 Based on observation and interview, the dialysis facility failed to ensure an isolation room waiver was obtained, in 1 of 1 ESRD provider which existed before October 14, 2008 and is without an isolation room or area. Findings include: During observation of the providers’ facility, beginning with the flash tour on April 20, 2025, no isolation room or area was identified in which to provide hemodialysis in a patient with Hepatitis B. During an interview, on 04/22/2025, beginning at 8:45 AM, Corporate Staff 2 indicated the facility did not have an isolation room waiver and was unaware one was required.”

“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: 47022 Based on observation, and interview, the dialysis facility failed to ensure the staff demonstrated aseptic techniques when dispensing and administering intravenous medications from vials in 1 of 1 observations of heparin multi-dose vial dispensing (PCT 3). Findings include: 1. During an observation, on 04/22/2025, beginning at 11:00 AM, PCT 3 did not clean the top of a heparin (blood thinner) multi-dose vial, for Patient #15, and inserted a syringe to draw up the heparin, PCT 3 then inserted another syringe to draw up a 2nd syringe of heparin and did not clean the top of the heparin multi-dose vial prior to insertion of the syringe. 2. During an interview, on 04/22/2025, beginning at 2:20 PM, PCT 3 indicated heparin vials should be cleaned prior to drawing up medication in a syringe.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure staff followed standard infection control precautions to prevent catheter related infections when providing central venous catheter [CVC] (catheter into vein) access care for hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) in 1 of 2 CVC exit site care observed (Patient #16). Findings include: 1. A revised policy, dated October 2024, titled, “Central Venous Catheter [CVC] With Clearguard HD Antimicrobial End Caps Procedure,” indicated the exit site would be cleaned with chlorhexidine swab in a back-and-forth pattern from the insertion site to the periphery using both sides of the swab. 2. During an observation, on 04/22/2025, beginning at 11:15 AM, PCT 3 was performing CVC exit site care at Station #7 with Patient #16. During the observation, PCT 3 cleaned the CVC exit site with an antiseptic swab from the exit site to the outside and then cleaned the outside and completed the cleaning at the exit site. 3. During an interview, on 04/22/2025, beginning at 2:20 PM, PCT 3 indicated CVC site care should include cleaning the exit site with a chloraprep (antiseptic) swab from the inside to the outside.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure staff were able to correctly perform chlorine testing (PCT 3). Findings include: 1. A revised policy, dated October 2024, titled, “Daily Water System Total Chlorine Monitoring,” indicated total chlorine testing was done daily prior to the use of the dialysis quality water for dialysis treatments. The policy indicated samples for total chlorine testing were to be drawn from the sample port located downstream of the first (primary) carbon tank or set of tanks in facilities having series connected banks of carbon filters. 2. During an observation, on 04/21/2025, beginning at 3:20 PM, PCT 3 conducted a chlorine water test by drawing a sample from sample port 2 prior to the primary carbon tank and failed to draw a sample from sample port 3 in between the primary and secondary carbon tank. 3. A Multi-Station Basic Components and Monitoring of Dialysis Quality Water Treatment Systems Skills Verification for Teammates who perform water monitoring and testing for PCT 3, dated 06/02/2024, indicated PCT 3 verbalized reason for total chlorine testing and satisfactorily located the appropriate sample collection valves for total chlorine water samples on the facility’s water system. 4. During an interview, on 04/22/205,beginning at 10:15 AM, biomedical technician 1 indicated manual chlorine testing was to be completed every AM, and the sample should be taken from sample port 3 between the primary and secondary carbon tank.”

“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: 47022 Based on observation, and interview, the dialysis facility failed to ensure Patients’ Rights were posted where it could be easily seen and read by patients in 1 of 1 facility. Findings include: 1. During an observation upon entrance to the dialysis facility, on 04/21/2025, beginning at 9:45 AM, the lobby failed to evidence posting of Patient’s Rights. 2. During an interview, on 04/21/2025, beginning at 1:50 PM, the Facility Administrator, Administrative Staff 1, indicated the Patient’s Rights should have been posted in the lobby of the facility and were not posted.”

“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: 47022 Based on record review, and interview, the dialysis facility failed to ensure staff administered Patients’ prescribed hemodialysis prescription in order to manage Patients’ volume status in 4 of 6 in-center hemodialysis [HD](a process to filter the blood of a patient whose kidneys do not work normally) clinical records reviewed (Patient #1, Patient #3, Patient #4, Patient #5). Findings include: 1. A revised policy, dated April 2024, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” indicated patient data would be obtained and documented by the PCT or a nurse. The policy indicated patient prescription and machine settings are verified by staff prior to initiation of treatment and the blood flow rate [BFR] which would be verified and documented when the ordered rate was obtained after onset of treatment. The policy indicated the prescription components were to be confirmed by a nurse within one hour of treatment initiation and would include but not limited to ultrafiltration rate [UFR] (amount of fluid being removed), and BFR. The policy indicated any abnormal findings outside of physician ordered parameters would be documented and reported to the nurse, and if abnormal findings were reported to the nurse pre-treatment, the nurse would assess the patient prior to initiation of dialysis. The policy indicated intradialytic treatment monitoring and data collection would include but not limited to blood pressure, BFR, fluid removal and or replacement, and if the dialysis prescription was not being met including DFR or change to or inability to obtain BFR the reason would be documented and the nurse informed. The policy indicated abnormal findings that would be reported to the nurse included but not limited to predialysis systolic blood pressure greater than 180 or less than 90, or diastolic blood pressure greater than 100 or less than 50, and intradialytic systolic blood pressure greater than 180 or less than 90, and signs and symptoms of hypotension (low blood pressure) to include nausea and vomiting. 2. An undated PCT Job Description indicated technician duties would include but not limited to monitoring patients, before, during and after dialysis treatment including measuring and record stats, patient observations, and HD machine set up. 3. A Dialysis Order, dated 03/19/2025, for Patient #3, indicated the BFR was 450 milliliters/minute (ml/min) and the DFR was 800 ml/min. A Treatment Details Report, dated 03/20/2025, indicated during HD treatment from 6:30 AM until 8:34 AM the DFR was documented as 0. A Treatment Details Report, dated 03/21/2025, indicated from start of HD treatment at 5:57 AM until end of treatment at 8:21 AM the BFR was at 400 ml/min and failed to evidence documentation of the reason the BFR was not as prescribed. During an interview, on 04/24/2025, beginning at 1:30 PM, RN 1 indicated the PCT should have documented the reason the BFR was not administered as prescribed. 4. A Dialysis Order, dated 03/22/2025, for Patient #4, indicated the BFR was prescribed at 400 ml/min and the DFR was prescribed at 800 ml/min. A Treatment Details Report, dated 03/28/2025, indicated Patient started treatment at 10:48 AM with a DFR at 800 ml/min and at 11:00 AM until end of treatment at 2:37 PM the DFR was at 600 ml/min and failed to evidence documentation the reason the DFR was not as prescribed. During an interview, on 04/24/2025, beginning at 2:00 PM, RN 1 indicated the PCT should have documented the reason for the change in the DFR. A Treatment Details Report, dated 04/14/2025, indicated treatment parameter orders were to not initiate HD treatment and notify the nurse for pre-assessment diastolic blood pressure above 120. The Treatment Report indicated at 10:50 AM HD treatment was initiated with a blood pressure of 158/121 and failed to evidence documentation the nurse was notified of the blood pressure. During an interview, on 04/24/2025, beginning at 2:00 PM, RN 1 indicated PCTs are to follow the blood pressure parameters to notify the nurse and the PCT should document that the nurse was notified of the blood pressure was out of parameters. A Treatment Details Report, dated 04/16/2025, indicated treatment parameter orders were to not initiate HD treatment and notify the nurse for pre-assessment diastolic blood pressure above 120. The Treatment Report indicated at 10:36 AM HD treatment was initiated with a blood pressure of 200/126 and failed to evidence documentation the nurse was notified of the blood pressure, and at 11:00 AM the blood pressure was 210/130 and failed to evidence documentation the nurse was notified of the blood pressure. The Treatment Report indicated at 2:00 PM Patient complained of nausea and the ultrafiltration profile was ended and failed to evidence the nurse was notified of Patient’s complaints or the change in the ultrafiltration profile. The Treatment Report indicated at 12:00 PM the DFR was at 700 until end of HD treatment at 2:45 PM and failed to evidence documentation of the reason the DFR was not as prescribed. During an interview, on 04/24/2025, beginning at 2:00 PM, RN 1 indicated the PCT should notify the nurse and document when the patient’s blood pressure were outside of the parameters, the PCT should notify the nurse and document and patient complaints, and the DFR change from the prescribed dialysis order should be documented and reported to the nurse due to a possible TMP problem for the machine to be addressed by biomed. 5. A Dialysis Order, dated 02/05/2025, for Patient #5, indicated a DFR of 800 ml/min. A Treatment Details Report, dated 02/24/2025, indicated the DFR was at 800 at start of HD treatment at 10:46 AM and at 11:30 AM until 2:00 PM the DFR was at 600 and failed to evidence documentation of the reason the prescribed DFR was not given. During an interview on 04/24/2025, beginning at 2:00 PM, RN 1 indicated the DFR was decreased due to a TMP and the PCT should have documented the reason the DFR was decreased. A Treatment Details Report, dated 02/28/2025, indicated at 1:30 PM Patient’s blood pressure was 88/57 and at 1:35 PM Patient’s blood pressure was at 64/33, and Patient was symptomatic, ultrafiltration was turned off and 200 ml of fluid was given and failed to evidence documentation the nurse was notified. During an interview on 04/24/2025, beginning at 2:00 PM, RN 1 indicated the PCT should notify the nurse and document the notification when a patient was symptomatic or required interventions. A Treatment Details Reports, dated 03/13/2025, indicated at 12:59 PM Patient’s blood pressure was 83/50 and at 1:10 PM Patient complained of cramping and trouble breathing and failed to evidence documentation the nurse was notified of the Patient’s symptoms, at 1:25 PM the HD treatment was terminated with a blood pressure of 142/135 and a note by RN 1 was documented at 2:25 PM blood pressure at 142/72 and Patient came off HD treatment early due to stomach pain. During an interview, on 04/24/2025, beginning at 2:00 PM, RN 1 indicated the PCT should notify the nurse and document the notification when a patient was symptomatic. 6. A Dialysis Order, dated 03/27/2025, for Patient #1, indicated the BFR was prescribed at 400 ml/min. A Treatment Details Report, dated 04/02/2025, indicated BFR at 300 from 7:05 AM to 8:03 AM and the BFR was at 350 from 8:04 AM until end of HD treatment at 9:56 AM. The Report failed to evidence documentation of the reason why Patient did not have the prescribed BFR. A Treatment Details Report, dated 04/04/2025, indicated BFR at 300 from 8:55 AM to 8:59 AM and the BFR was at 250 from 9:59 AM to end of HD treatment at 12:59 PM. The Report failed to evidence documentation of the reason why Patient did not have the prescribed BFR. A Treatment Details Report, dated 04/05/2025, indicated BFR at 400 from 7:57 AM to 7:59 AM and the BFR was at 350 from 8:30 AM until end of HD treatment at 10:37 AM. The Report failed to evidence documentation of the reason why Patient did not have the prescribed BFR. During an interview on 04/24/2025, beginning at 2:00 PM, RN 1 indicated PCTs should document if the BFR was changed due to central venous catheter (catheter into a large vein).”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure staff assessed patients’ hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) access to prevent access failure in 3 of 3 initiations of HD with an arteriovenous fistula [AVF] or arteriovenous graft [AVG] (HD access) (PCT 2 and PCT 4). Findings include: 1. A revised policy, dated April 2025, titled, “Arteriovenous Fistula and Arteriovenous Graft Vascular Access Care,” indicated inspection of the access and access extremity should be performed each dialysis, pre, during and post treatment. The policy indicated inspection of the AVF or AVG would include presence/absence of thrill [felt vibration sensation] and or bruit [swishing sound] heard through a stethoscope. 2. During an observation, on 04/21/2025, beginning at 10:15 AM, PCT 2 was initiating HD using an AVF/AVG site at Station #7 for Patient #14. During the observation, PCT 2 cannulated (inserted needles) without auscultating (listening with a stethoscope) the access site for a bruit. 3. During an observation, on 04/21/2025 beginning at 10:45 AM, PCT 2 initiated HD using an AVF/AVG site at Station #6 for Patient #4. During the observation, PCT 2 cannulated the AVF/AVG without auscultating the access site for a bruit. 4. During an observation, on 04/21/2025 beginning at 10:40 AM, PCT 4 was initiating HD using an AVF/AVG site at Station #4 with Patient #13. During the observation, PCT 4 cannulated the AVF/AVG without auscultating the access site for a bruit. 5. During an interview, on 04/21/2025 beginning at 11:35 AM, PCT 2 indicated AVF site assessment should include palpating (touching) the site and auscultating the site with a stethoscope.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure medical records were accurate and complete in 3 of 3 arteriovenous fistula [AVF]/arteriovenous graft [AVG] (dialysis access) initiations observed (Patient #4, Patient #13, Patient #14) and in 1 of 1 AVF/AVG adverse event observed (Patient #6). Findings include: 1. A revised policy, dated April 2025, titled, “Arteriovenous Fistula [AVF] and Arteriovenous Graft [AVG] Vascular Access Care,” indicated inspection of the AVF and AVG included assessment of the presence/absence of thrill (felt vibration sensation) and/or bruit (swishing sound heard through stethoscope), and presence of swelling. The policy indicated findings and interventions would be documented in the patient’s electronic health record. 2. An undated PCT Job Description indicated PCT duties would include monitoring patients including measuring and recording stats, and patient observations. 3. During an observation, on 04/21/2025, beginning at 10:45 AM, PCT 2 initiated HD using an AVF/AVG site at Station #6 for Patient #4. During the observation, PCT 2 cannulated the AVF/AVG without auscultating the access site for a bruit. A Treatment Details Report, dated 04/21/2025, indicated PCT 2 assessed that the AVF had a continuous bruit and thrill. 4. During an observation, on 04/21/2025, beginning at 10:40 AM, PCT 4 was initiating HD using an AVF/AVG site at Station #4 with Patient #13. During the observation, PCT 4 cannulated the AVF/AVG without auscultating the access site for a bruit. A Treatment Details Report, dated 04/21/2025, indicated PCT 4 assessed that the AVF had a continuous bruit and thrill. 5. During an observation, on 04/21/2025, beginning at 10:15 AM, PCT 2 was initiating HD using an AVF/AVG site at Station #7 for Patient #14. During the observation, PCT 2 cannulated (inserted needles) without auscultating (listening with a stethoscope) the access site for a bruit. A Treatment Detail Report, dated 04/21/2025, indicated PCT 2 assessed that the AVF had a continuous bruit and thrill. 6. During an observation, on 04/21/2025, beginning at 11:05 AM, PCT 3 was at Station #14 with Patient #6. During the observation, Patient’s left arm was observed to be swollen from the left upper arm to wrist area, and PCT 3 cannulated (inserted needles) for 2 lines to the AVF site. During the observation, Patient complained of pain to the left arm insertion sites and RN 1 assessed Patient. During an interview, on 4/24/2025, beginning at 2:40 PM, the Facility Administrator, Administrative Staff 1, indicated there was not documentation of Patient #6’s 04/21/2025 treatment record in Patient’s electronic medical record because dialysis treatment was not started. During an interview, on 04/24/2025, beginning at 2:00 PM, RN 1 indicated he should have documented Patient #6’s short treatment and complaints of pain and swelling at the AVF site.”