Davita Mishawaka Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure bleach solution was stored according to facility policy (see V111), failed to ensure staff and patients followed facility infection control policies and procedures (see V113), failed to ensure all staff disinfected the dialysis station according to infection control policies and best practice (see V122), failed to ensure all staff followed facility policy and best practice when drawing up and storing medication from a multi-dose vial (see V143), and failed to ensure staff performed infection control measures according to policy when caring for a CVC (see V147). Due to the cumulative effects of these systemic issues, Mishawaka Dialysis failed to provide adequate infection control measures and was found out of compliance with Condition of Coverage 42 CFR 494.30 Infection control.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 42617 Based on EP plan review and interview, the dialysis facility failed to maintain and update its communication plan to include federal emergency preparedness staff, which had the potential to affect 74 active patients and all staff. Findings include: 1. The review of the facility’s EP communication plan failed to evidence contact information for federal EP staff. 2. During an interview on 11/21/2025 beginning at 3:31 PM, FA and Corporate Employee 2 reported they could not find where the contact information for federal EP staff was located in the facility’s EP communication plan.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 42617 Based on personnel file review and interview, the dialysis facility failed to develop and maintain an EP training program for new staff for 3 of 3 personnel files reviewed of staff hired in 2024 and 2025 (RN 3, PCT 1, PCT 7). Findings include: 1. A document titled “Contents,” identified by Alternate Administrator as the topics discussed during a “safety” training online course done on hire, failed to evidence the training included all elements of the facility’s EP plan, including the agency’s emergency preparedness policies and procedures. 2. RN 3’s personnel file evidenced a hire date of 1/24/2024. The file failed to evidence training on all elements of the facility’s EP plan was conducted upon hire. 3. PCT 1’s personnel file evidenced a hire date of 12/16/2024. The file failed to evidence training on all elements of the facility’s EP plan was conducted upon hire. During an interview on 11/18/2025 beginning at 3:28 PM, PCT 1 reported she had only received online training upon hire and had not received any additional training on the facility’s EP policies and procedures. 4. PCT 7’s personnel file evidenced a hire date of 3/17/2025. The file failed to evidence training on all elements of the facility’s EP plan was conducted upon hire. 5. During an interview on 11/21/2025 beginning at 3:31 PM, FA and Corporate Employee 2 reported the facility considered the “safety” online training as its EP training done on hire for all new staff, and did not provide further education on its EP policies and procedures to RN 3, PCT 1, or PCT 7 upon hire.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure bleach solution was stored according to facility policy for 2 of 2 days of ICHD treatment observations, which had the potential to affect 50 active ICHD patients. Findings include: 1. The facility policy “Bleach Policy,” revised 10/2023, indicated staff were to cover bleach solution “with a secure lid ... Without a secure lid, the bleach solution is open to air causing the solution to degrade over time and become less effective.” 2. During an ICHD treatment floor observation on 11/18/2025 beginning at 11:49 AM, one container of 1:100 bleach solution was observed at a clean sink station across from Stations 1 and 2. The container’s lid was not secure. The container remained open throughout treatment floor observations, which ended at 12:49 PM. 3. During an ICHD treatment floor observation on 11/18/2025 beginning at 2:00 PM, one container of 1:100 bleach solution was observed at a clean sink station across from Stations 3 and 4. The container’s lid was not secure. At 2:45 PM, PCT 1 placed gauze pads into the container, soaked them in the bleach solution, then took them to a station to clean. PCT 1 failed to secure the lid on the bleach solution container. 4. During an ICHD treatment floor observation on 11/19/2025 beginning at 10:05 AM, one container of 1:100 bleach solution was observed at a supply station across from Station 5. The container’s lid was not secure. The lid was not secured by staff until 11:02 AM. 5. During an ICHD treatment floor observation on 11/19/2025 beginning at 10:16 AM, one container of 1:100 bleach solution was observed at a clean sink station across from Stations 1 and 2. The container did not have a lid on it. The lid remained off through treatment floor observations, which ended at 11:05 AM. 6. During an interview on 11/18/2025 beginning at 3:28 PM, PCT 1 reported the bleach solution should be stored with the container lid secured. 7. During an interview on 11/19/2025 beginning at 12:52 PM, PCT 5 reported the bleach solution should be stored with the container lid secured. 8. During an interview on 11/19/2025 beginning at 1:05 PM, PCT 4 reported the bleach solution should be stored with the container lid secured.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff and patients followed facility infection control policies and procedures for 5 of 6 PCTs observed providing care on the ICHD treatment floor (PCT 1, PCT 2, PCT 3, PCT 4, PCT 5) and 1 of 1 observations of an arteriovenous (AV) fistula disconnection where the patient held pressure to the access site (Patient #12). Findings include: 1. The facility policy “Handwashing,” last revised 10/2020, indicated when staff washed their hands, they should apply soap, “cover hands ... and wrists with lather and wash vigorously for a minimum of 20 seconds,” then “rinse well using running water ....” 2. The facility policy “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles,” revised 4/2023, indicated when a patient held pressure to their own fistula or graft access sites after decannulation, the patient “will be offered gloves and perform hand hygiene when completed.” 3. The facility policy “Infection Control for Dialysis Facilities,” revised 4/2023, indicated staff were to perform hand hygiene “prior to gloving and immediately after removal of gloves ... after patient and dialysis delivery system contact ... between patients ... before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” Patients would be “encouraged to ... perform hand hygiene after treatment before leaving treatment area ....” 4. During an ICHD treatment floor observations on 11/18/2025 between 11:10 AM - 12:50 PM, the following was observed: a. At 11:53 AM, PCT 2 entered Station 4 where PCT 1 was assisting Patient #11 with a bleeding access site. PCT 1 failed to perform hand hygiene prior to donning gloves and entering the station. After leaving the station, PCT 2 washed her hands for 10 seconds under running water. No soap was visible while the technician scrubbed her hands. b. At 11:58 AM, PCT 3 left Station 12 where Patient #3 was dialyzing and removed her gloves. The technician washed her hands for five seconds, then scrubbed for the remainder of time under running water. No soap was visible while the technician scrubbed her hands under water. c. At 12:38 PM, PCT 2 washed her hands for 14 seconds. d. At 12:42 PM, PCT 2 left Station 4 after cleaning the station. The technician removed her gloves and washed her hands for seven seconds. 5. During ICHD treatment floor observations on 11/19/2025 between 4:06 AM - 7:10 AM and 8:50 AM - 11:05 AM, the following was observed: a. At 5:05 AM, PCT 3 washed her hands for 12 seconds under running water. No soap was visible while the technician scrubbed her hands. b. At 5:59 AM, PCT 5 washed her hands for 10 seconds under running water. No soap was visible while the technician scrubbed her hands. c. At 9:21 AM, PCT 4 was in Station 2 preparing Patient #15 for dialysis. PCT 4 removed his gloves and donned new gloves, failing to perform hand hygiene in between the glove change. d. At 9:29 AM, PCT 5 left Station 6, removed her gloves, entered Station 8, and donned new gloves. The technician failed to perform hand hygiene in between glove changes. e. At 9:48 AM, PCT 5 was in Station 6 preparing the station for the next dialysis treatment. PCT 5 removed the glove from her left hand, charted on a nearby computer station, then donned a new glove to her left hand. The technician failed to perform hand hygiene after removing a glove and prior to donning the new glove. f. At Station 10 beginning at 9:32 AM, PCT 1 discontinued Patient #12’s dialysis and decannulated Patient’s fistula access sites. Patient held pressure to the two access sites until the sites stopped bleeding, removed his/her glove, walked to the patient scale to obtain his/her weight, then re-entered Station 10. Patient returned a bedside table to a supply cubby then left the treatment area. PCT 1 failed to offer or advise Patient to perform hand hygiene after removing their gloves. 6. During an interview on 11/18/2025 beginning at 3:28 PM, PCT 1 reported hand hygiene should be done after every contact with a patient or the dialysis machine. When washing hands, PCT 1 reported she should scrub for 60 seconds outside of running water. 7. During an interview on 11/19/2025 beginning at 12:28 PM, PCT 3 reported hand hygiene should be performed in between glove changes. When washing hands, PCT 3 reported she should scrub her hands for 45 seconds outside of running water. 8. During an interview on 11/19/2025 beginning at 12:52 PM, PCT 5 reported hand hygiene should be performed in between glove changes and after removing gloves. When washing hands, PCT 5 reported she should scrub for 30 seconds outside of running water. 9. During an interview on 11/19/2025 beginning at 1:05 PM, PCT 4 reported hand hygiene should be performed in between glove changes. 10. During an interview on 11/19/2025 beginning at 1:39 PM, FA, Alternate Administrator, and Corporate Employee 1 reported staff should perform hand hygiene prior to donning gloves and in between changing gloves. The administrative staff reported when washing their hands, staff should scrub their hands for 20 seconds outside of running water. The administrative staff also reported after a patient held pressure to a fistula or graft cannulation site, staff should offer hand sanitizer to the patient.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff disinfected the dialysis station according to infection control policies and best practice for 2 of 2 observations of staff disinfecting a dialysis station (PCT 1, PCT 2). Findings include: 1. The facility policy “Infection Control for Dialysis Facilities,” revised 4/2023, indicated staff were to clean and disinfect each dialysis station at the end of each treatment. The policy indicated “surfaces to disinfect include ... all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) ....” 2. During an observation at Station 4 on 11/18/2025 beginning at 12:42 PM, PCT 2 cleaned the treatment station, including the blood pressure (BP) cuff and arm cushion. The technician rolled the BP cuff and placed it in a basket immediately after wiping it with bleach, failing to allow the cuff to dry. PCT 2 also wiped the arm cushion with bleach then placed it on a dirty shelf behind the treatment station. 3. During an observation at Station 6 on 11/18/2025 beginning at 2:45 PM, PCT 1 cleaned the treatment station, including the treatment chair. The technician wiped the sides of the chair with bleach, then closed the sides immediately, failing to allow them to dry. During an interview on 11/18/2025 beginning at 3:28 PM, PCT 1 reported when cleaning the treatment chair, staff were to close the sides of the chair after wiping if another patient was due to receive treatment at that station. If there were no further patients scheduled, staff were to leave the chair sides open to dry. 4. During an interview on 11/19/2025 beginning at 1:39 PM, FA, Alternate Administrator, and Corporate Employee 1 reported staff should allow all equipment wiped with bleach to dry prior to returning to a clean area. The administrative staff also reported the treatment chair sides should be left open to dry after wiping with bleach.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff followed facility policy and best practice when drawing up and storing medication from a multi-dose vial for 2 of 2 observations of medication preparation from a multi-dose vial (PCT 5, PCT 6). Findings include: 1. The facility policy “Medication Policy,” revised 10/2023, indicated staff were to use “aseptic technique” (procedures used to prevent the spread of germs) when preparing medications. Medication vials were to be “labeled with the initials of the person opening the vial and the expiration date.” 2. “WHO [World Health Organization] Best Practices for Injections and Related Procedures Toolkit,” obtained from www.who.int, indicated when administering an injection, staff should “wipe the top of the [medication] vial [diaphragm] with 60-70% alcohol using a swab ...” prior to drawing up the medication. 3. During an observation at the ICHD medication station on 11/19/2025 beginning at 5:01 AM, PCT 5 was observed drawing up Heparin (a blood thinner administered intravenously) for four patients from a multi-dose vial. PCT 5 failed to wipe the diaphragm of the vial prior to drawing up the medication for each patient. During an interview on 11/19/2025 beginning at 12:52 PM, PCT 5 reported the diaphragm of a multi-dose medication vial should be scrubbed with an alcohol wipe prior to drawing up medication. 4. During an observation at the ICHD medication station on 11/19/2025 beginning at 5:47 AM, PCT 6 was observed drawing up Heparin for Patient #12 from a multi-dose vial. PCT 5 failed to wipe the diaphragm of the vial prior to drawing up the medication. The opened vial of Heparin failed to evidence the date and time the vial was opened nor the initials of the staff who opened the vial. During an interview on 11/19/2025 beginning at 6:58 AM, PCT 6 reported staff should have labeled the opened vial of Heparin with the date and time it was opened. During an interview on 11/20/2025 beginning at 3:11 PM, PCT 6 reported she would wipe the diaphragm of a multi-dose medication vial with alcohol prior to drawing up the medication.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff performed infection control measures according to policy when caring for a CVC for 2 of 2 observations of CVC site care and dialysis initiation (Patient #1, #8). Findings include: 1. The facility policy “Central Venous Catheter (CVC) with Tego Connectors or CVC End Caps Procedure,” revised 4/2025, indicated when staff performed site care to a CVC, the staff and patient would wear a mask “covering the nose and mouth.” When cleaning the CVC site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (Chloraprep), staff should clean the site for 30 seconds in a “back and forth motion.” The policy also indicated staff should scrub the CVC hub for 15 seconds prior to connecting dialysis blood lines. 2. During an observation at Station 13 on 11/19/2025 beginning at 10:33 AM, PCT 4 was observed performing site care to Patient #8’s CVC then initiating dialysis through the CVC. Prior to beginning site care, PCT 4’s mask fell on the floor. The technician picked the mask up and then donned it. While performing CVC site care, PCT 4 scrubbed the CVC site for 20 seconds with Chloraprep. During initiating procedures, the technician scrubbed one CVC hub for two seconds and the second CVC hub for three seconds with an alcohol wipe prior to connecting the blood lines. During the observation, PCT 4 failed to perform hand hygiene in between glove changes on three occasions and failed to perform hand hygiene after removing his gloves upon completion of dialysis initiation. During an interview on 11/19/2025 beginning at 1:05 PM, PCT 4 reported if Personal Protective Equipment (PPE) falls on the floor prior to donning, staff should get new PPE. PCT stated when performing site care to a CVC, the site should be scrubbed for 20 seconds with Chloraprep, and the CVC hubs should be scrubbed for 20 seconds each with an alcohol pad prior to connecting the hubs to the blood lines. PCT 4 also reported hand hygiene should be performed in between glove changes. 3. During an observation at Station 11 on 11/19/2025 beginning at 10:56 AM, PCT 1 was observed performing site care to Patient #1’s CVC. PCT 1 scrubbed the CVC site for 14 seconds with Chloraprep. During an interview on 11/19/2025 beginning at 1:08 PM, PCT 1 first reported when performing site care to a CVC, the site should be scrubbed for 60 seconds with Chloraprep. PCT 1 then stated she was unsure on the facility’s policy for the timeframe to scrub a CVC site with Chloraprep.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff followed facility procedure when completing a total chlorine test for 1 of 1 observation of a total chlorine test being performed (PCT 6), which had the potential to affect 50 ICHD patients. Findings include: 1. The facility policy “CM 130 Total Chlorine Online Monitor Daily Start-Up and End of Day Procedures,” revised 10/2024, indicated prior to use of ICHD quality water, staff were to conduct a manual total chlorine test and compare the results to the facility’s CM130 Total Chorine Online Monitor (system which automatically checked the chlorine level of product water every five minutes). 2. The facility policy “E-Z Chek TM Sensitive Total Chlorine Testing,” revised 10/2025, indicated after staff removed the test strip from the water sample, they were to “wait a full 30 seconds” prior to reading the test results. 3. During an observation of water room opening procedures on 11/19/2025 beginning at 4:41 AM, PCT 6 performed a total chlorine test using an E-Z Chek TM Sensitive Total Chlorine and Chloramine test strip. After removing the test strip from the water sample, PCT 6 waited 13 seconds then read the test result. 4. During an interview on 11/19/2025 beginning at 4:45 AM, PCT 6 reported when conducting a total chlorine test using E-Z Chek TM Sensitive Total Chlorine and Chloramine strips, staff did not need to wait to read the test results after removing the strip from the water sample.”

“BACT CONTROL-SUPPLY LINE DISINFECTED CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: machine supply line disinfected Users should establish a procedure for regular disinfection of [the line between the outlet from the water distribution system and the back of the dialysis machine]. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff performed residual bleach testing according to facility policy for 1 of 2 observations of staff performing residual bleach testing (PCT 6), which had the potential to affect patients who dialyzed at 8 of 16 ICHD treatment stations (Stations 3, 4, 5, 6, 7, 8, 9, 10). Findings include: 1. The facility policy “Residual Bleach Testing,” revised 4/2025, indicated staff were to test for the presence of residual bleach in “distribution loops or equipment fluid pathways after bleach disinfection [of dialysis machines] and prior to use.” Staff were to perform the test by using Reprocessing Products Corporation (RPC) Residual Chlorine test strips. 2. The facility policy “Residual Bleach Testing Using RPC E-Z Chek TM Residual Chlorine (Bleach) Test Strips,” revised 9/2013, indicated when staff performed the test, they were to hold the test strip “in a gentle stream of test water for five (5) seconds ....” 3. During an observation of ICHD treatment floor opening procedures on 11/19/2025 beginning at 4:19 AM, PCT 6 performed residual chlorine testing using RPC E-Z Chek Residual Chlorine test strips at ICHD treatment stations 3, 4, 5, 6, 7, 8, 9, and 10. The technician held the strip under the water sample for 2-3 seconds at each station prior to reading the test result. 4. During an interview on 11/19/2025 beginning at 4:31 AM, PCT 6 reported all the ICHD dialysis machines had been bleached after dialysis treatments had ended on 11/18/2025, so staff needed to verify there was no residual bleach prior to initiating dialysis treatment. PCT 6 reported there was no required time she needed to hold the E-Z Chek TM Residual Chlorine test strips under the water sample.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 42617 Based on observation and interview, the dialysis facility failed to ensure all oxygen tanks were safely secured for 1 of 1 ICHD flash tour, which had the potential to affect 50 ICHD patients. Findings include: 1. During an ICHD treatment floor flash tour on 11/18/2025 beginning at 11:10 AM, five oxygen tanks were observed unsecured in a supply cubby. 2. During an interview on 11/18/2025 beginning at 12:51 PM, FA reported all oxygen tanks should be stored in a holder.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all patients’ access sites were visible throughout the duration of treatment for 1 of 2 days of ICHD treatment floor observations (Patients #8, #11, #16, #17, #18, #19). Findings include: 1. The facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 4/2024, indicated the vascular access site and blood line connections should be visible “throughout the dialysis treatment.” 2. During ICHD treatment floor observations on 11/18/2025 between 11:10 AM - 12:50 PM and 2:00 PM - 2:47 PM, the following was observed: a. At 11:19 AM, Patient #16 was receiving dialysis treatment in Station 16. Patient’s access site was not visible. b. At 11:37 AM, Patient #11 was receiving dialysis treatment in Station 4. Patient’s access site was not visible. c. At 11:40 AM, Patient #17 was receiving dialysis treatment in Station 6. Patient’s access site was not visible. d. At 11:45 AM, Patient #8 was receiving dialysis treatment in Station 10. Patient’s access site was not visible. e. At 11:53 AM, Patient #11 was receiving dialysis treatment in Station 4. Patient’s access site was not visible. Patient reported to PCT 1 that his/her access site was bleeding. PCT 1 and PCT 2 entered the station. After repositioning and retaping Patient’s cannulation needle, Patient recovered his/her access site and the technicians left the station. The technicians failed to instruct Patient to keep his/her access visible. f. At 11:59 AM, Patient #8 was receiving dialysis treatment in Station 10. Patient’s access site was not visible. PCT 2 entered the station and provided care. The technician failed to instruct Patient to keep his/her access visible while in the station. g. At 12:00 PM, Patient #17 was receiving dialysis treatment in Station 6. Patient’s access site was not visible. PCT 1 entered the station and provided care. The technician failed to instruct Patient to keep his/her access visible while in the station. h. At 12:15 PM, four of nine patients receiving dialysis treatment’s access sites were covered, including Patient #11 in Station 4, Patient #17 in Station 6, Patient #8 in Station 10, and Patient #16 in Station 16. i. At 12:33 PM, Patient #18 was receiving dialysis treatment in Station 8. PCT 2 entered the station and provided care. The technician failed to instruct Patient to keep his/her access visible while in the station. j. At 12:39 PM, Patient #8 was receiving dialysis treatment in Station 10. Patient’s access site was not visible. k. At 2:04 PM, Patient #19 was receiving dialysis treatment in Station 16. Patient’s access site was not visible. 3. During an interview on 11/18/2025 beginning at 2:07 PM, RN 1 reported during ICHD treatment, staff would monitor patients’ access site for visibility every 30 minutes. If the patient’s access site was covered, staff were to uncover the access site to ensure it was visible. 4. During an interview on 11/18/2025 beginning at 3:28 PM, PCT 1 reported during ICHD treatment, staff would monitor patients’ access site for visibility every 30 minutes. 5. During an interview on 11/19/2025 beginning at 12:28 PM, PCT 3 reported during ICHD treatment, staff would monitor patients’ access site for visibility every 30 minutes. If the patient’s access site was covered, staff were to ask the patient to uncover the site to ensure it was visible.”

“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: 42617 Based on observation, record review, policy review, and interview, the medical director failed to ensure staff followed policies specific to fistula access site cleaning and disinfection for 2 of 2 observations of ICHD fistula cannulation (Patient #9, #10), monitoring and reporting of abnormal vital signs for 3 of 4 ICHD records reviewed (Patient #2, #3, #4), verification of correct dialysis prescription for 3 of 4 ICHD records reviewed (Patient #1, #2, #3), and obtaining standing blood pressure (BP) pre-dialysis readings for 1 of 1 ICHD records reviewed of an ambulatory patient (Patient #4). Findings include: 1. The facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 4/2024, indicated staff were to obtain a standing blood pressure (BP) measurement “pre and post treatment.” The patient’s dialysis prescription and machine settings were to be verified by a PCT prior to treatment and by a nurse within one hour of treatment initiation. This included verification of the correct Dialysate Flow Rate (DFR). Staff were to perform and document “vital signs and treatment monitoring ... at least every thirty (30) minutes.” PCTs were to report “abnormal findings or findings outside of any patient specific physician ordered parameters” to the nurse “immediately.” These “abnormal findings” included but were not limited to: a. Systolic BP (SBP, top number of the BP reading) greater than 180 millimeters of mercury (mmHg) or less than 90 mmHg during dialysis b. Diastolic BP (DBP, bottom number of the BP reading) greater than or equal to 100 mmHg during dialysis c. Heart rate “less than 60 beats per minute or greater than 100 beats per minute” during and post dialysis 2. During an observation at Station 15 on 11/19/2025 beginning at 5:12 AM, PCT 3 was observed initiating Patient #9’s dialysis with a fistula. Patient ambulated independently from the waiting room to the dialysis station but failed to wash his/her fistula access sites prior to entering the station. PCT 3 failed to clean the access sites prior to disinfection. PCT 3 scrubbed the first access site for 25 seconds and the second access site for 27 seconds with a 70% alcohol wipe. During an interview on 11/19/2025 beginning at 12:28 PM, PCT 3 stated Patient #9 did not wash their access site prior to entering the station. The technician reported if a patient did not wash their access site prior to disinfection, staff could use an extra 70% alcohol wipe on each site, however PCT 3 stated she did not perform this additional cleaning with Patient #9. PCT 3 reported each fistula access site should be scrubbed with a 70% alcohol wipe for 1 minute prior to cannulation. 3. During an observation at Station 7 on 11/19/2025 beginning at 5:30 AM, PCT 5 was observed initiating Patient #10’s dialysis with a fistula. When disinfecting the access sites, PCT 5 scrubbed each site with a 70% alcohol swab for 14 seconds each. During an interview on 11/19/2025 beginning at 12:52 PM, PCT 5 reported when disinfecting a fistula or graft access site with 70% alcohol, each site should be scrubbed for 30 seconds. 4. Patient #1’s clinical record evidenced an ordered DFR of 800 milliliters per minute (ml/min). A dialysis flowsheet dated 11/10/2025 evidenced Patient’s DFR was 500 ml/min for the last 57 minutes of treatment. During an interview on 11/21/2025 beginning at 4:08 PM, RN 2 reported she had noticed the dialysis machines would automatically adjust the DFR to 500 ml/min if staff changed the bicarbonate concentrate bag during treatment. RN 2 stated staff must have forgotten to change the DFR back to the ordered rate on 11/10/2025. 5. Patient #2’s clinical record evidenced an ordered DFR of 800 ml/min. The record included five treatment flowsheets between 11/05/2025 - 11/13/2025. The flowsheets evidenced the following: a. On 11/06/2025, Patient’s DFR was changed to 500 ml/min for the last 57 minutes of treatment. During treatment, Patient had one DBP of 121 mmHg. The record failed to evidence the reason Patient’s DFR was not run at the ordered rate and failed to evidence the PCTs notified the nurse of the elevated DBP. b. On 11/08/2025, Patient had one DBP of 111 during treatment. The record failed to evidence the PCTs notified the nurse of the elevated DBP. c. On 11/11/2025, Patient had one DBP of 119 during treatment. The record failed to evidence the PCTs notified the nurse of the elevated DBP. During an interview on 11/20/2025 beginning at 3:13 PM, PCT 5 stated she would report a DBP greater than “80-90” mmHg to a nurse. The technician stated she would document this in the clinical record. The technician was unsure the reason Patient’s DFR was not run at the ordered rate during the 11/06/2025 treatment. During an interview on 11/21/2025 beginning at 1:57 PM, PCT 4 stated he would report a DBP greater than 100 mmHg to a nurse. The technician was unsure the reason Patient’s DFR was not run at the ordered rate during the 11/06/2025 treatment. 6. Patient #3’s clinical record evidenced an ordered DFR of 800 mL/min. The record included six treatment flowsheets between 11/04/2025 - 11/15/2025. The flowsheets evidenced the following: a. On 11/04/2025, Patient’s DFR was changed to 500 ml/min for the last 27 minutes of treatment. The record failed to evidence the reason Patient’s DFR was not run at the ordered rate for the entire treatment. b. On 11/08/2025, Patient had three SBPs between 79 - 88 mmHg during treatment. The record failed to evidence the PCTs notified the nurse of the low SBPs. c. On 11/11/2025, Patient’s DFR was set at 500 ml/min for the entire treatment. During the treatment, Patient had two DBPs between 105-111 mmHg. The record failed to evidence the reason Patient’s DFR was not run at the ordered rate and failed to evidence the PCTs notified the nurse of the elevated DBPs. d. On 11/13/2025, Patient had three DBPs between 103-112 mmHg and two heart rates between 53-56 during treatment. The record failed to evidence the PCTs notified the nurse of the high DBPs or low heart rates. During an interview on 11/20/2025 beginning at 3:05 PM, PCT 6 stated she would report a SBP less than 100 mmHg and DBP above 90 mmHg to the nurse. The technician stated she would document this in the clinical record. During an interview on 11/21/2025 beginning at 1:52 PM, PCT 4 was unsure the reason Patient’s DFR was not set at the ordered rate during the 11/04/2025 or 11/11/2025 treatments. 7. Patient #4’s clinical record included seven treatment flowsheets between 11/03/2025 - 11/17/2025. The flowsheets evidenced the following: a. On 11/03/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. During their treatment, Patient had four DBPs between 102-117 mmHg. The record failed to evidence the PCTs notified the RN of the elevated DBPs. b. On 11/05/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. c. On 11/08/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. During their treatment, Patient had two DBPs between 105-106 mmHg. The record failed to evidence the PCTs notified the RN of the elevated DBPs. d. On 11/11/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. During their treatment, Patient had six DBPs between 102-118 mmHg. The record failed to evidence the PCTs notified the RN of the elevated DBPs during treatment. e. On 11/12/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. f. On 11/14/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. During their treatment, Patient had a DBP of 106 mmHg. The record failed to evidence the PCT notified the RN of the elevated DBP. g. On 11/17/2025, Patient was noted to be ambulatory. The record failed to evidence a standing BP was performed prior to dialysis treatment. During their treatment, Patient had four DBPs between 103-107 mmHg. The record failed to evidence the PCTs notified the RN of the elevated DBPs. During an interview on 11/21/2025 beginning at 2:20 PM, PCT 5 reported standing BPs should be performed prior to dialysis treatment. The technician was unsure why Patient did not have standing BPs perform prior to treatment. PCT 5 also stated staff should report a DBP above 90 mmHg to the nurse and document this in the clinical record. During an interview on 11/21/2025 beginning at 4:12 PM, RN 2 reported standing BPs should be performed prior to dialysis treatment.”