Davita North Evansville Dialysis

“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: 38262 Based on observation, record review, and interview, the facility failed to ensure the treatment floor was free of debris and spills for 1 of 3 observation days (treatment floor); and failed to ensure staff prepared bleach solutions daily for 1 of 3 observation days. Findings include: 1. A 2018 “Physical Environment” policy indicated the facility would be clean and maintained to provide the dialysis patients, teammates, and the public with a safe treatment environment. 2. A 10/2023 “Bleach Policy” indicated bleach solutions degrade over time and become less effective. 48387 3. During the Flash Tour on 01/28/2025 at 9:10 AM, a large white stain appeared on the floor between station 21 and 22 at the emergency exit door of the treatment room, a clear container lying under the cabinet between stations 20 and 21, and multiple small pieces of white paper pieces on the floor under the back station cabinets between stations 18 to 20. During an interview on 01/28/2025 at 9:10 AM, PCT 2 indicated the large stain on the floor was from a chair getting knocked into BiCarb (maintain the acid-base balance) hook-up yesterday or this morning; no patients would be in that area of the treatment floor until 2nd shift. During an interview with the FA and Manager of Clinical Services on 01/29/2025 at 2:05 PM, the Manager of Clinical Services indicated a cleaning crew comes in every night and uses cleaner for floors but does not use vinegar, which was needed to clean up bicarb spill; FA indicated she has been in contact with cleaning services several times regarding not cleaning under cabinets at the back of the station and not cleaning under equipment. 4. During a treatment floor observation on 01/28/2025 at 9:25 AM, the surveyor found one container of 1:10 bleach solution and one container of 1:100 bleach solution with an expiration date of 01/28/2025 at pod #1. During an interview on 01/28/2025 at 9:30 AM, PCT 2 stated she should have discarded the old bleach solutions and had no chance to change them. She stated that the staff should change the bleach solutions daily. During an interview on 01/29/2025 at 2:30 PM, the FA stated it was unusual for the bleach solution not to be discarded when it expired. The FA was unsure why staff were using expired bleach solutions.”

“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: 38262 Based on observation, record review, and interview, the facility failed to ensure the staff adheres to infection control standards of hand hygiene and changing gloves during dialysis for 1 of 3 discontinuation of a CVC observations (PCT 1) and for 3 of 12 patient care observations. (RN 1, PCT 3), with the potential of cross-contamination to all patients. Findings include: A 04/2023 policy titled “Infection Control for Dialysis Facilities” indicated staff should perform hand hygiene “prior to gloving and immediately after removal of gloves, after contamination with blood products ... between patients ... before touching clean areas”. 48387 During an observation on 01/28/2025 at 10:40 AM, PCT 1 failed to hand hygiene before gloving to provide care to Patient #7. PCT 1 failed to perform hand hygiene after removing gloves and before donning new gloves to provide CVC (a thin, flexible tube inserted into a large vein near the heart) hub disinfection on Patient #7. During an observation on 01/28/2025 at 12:00 PM, RN 1 touched the computer at Station #15, gloved, and administered IV medication. RN 1 failed to perform hand hygiene before gloving. During an observation on 01/28/2025 at 10:49 AM, PCT 1 reinfused Patient #2’s bloodlines, removed her gloves, and placed them next to clean items onto the chair side arm tray. She then retrieved an alcohol pad from a drawer from a designated clean area. PCT 1 failed to perform hand hygiene after removing her gloves and failed to dispose of gloves properly. During an interview on 01/29/2025 at 1:45 PM, PCT 1 stated she performs hand hygiene after removing gloves and before touching clean items. During an observation on 01/28/2025 at 2:40 PM, PCT 3 failed to perform hand hygiene before providing care to Patient # 19. PCT 3 removed bloodlines from dialysis machines at Station 14, changed gloves, and applied a new gauze to Patient #19’s access site; PCT failed to perform hand hygiene between gloves changes. PCT 3 used her gloved pinkie on her right hand to pull the sharps container to Station #14. PCT 3 used the left gloved hand to remove the glove on the right hand and placed a new glove on the right hand; PCT failed to hand hygiene after removing the glove and before donning the new glove. During an observation on 01/28/2025 at 2:50 PM, PCT 3 removed gloves, went to clean area for clamp, returned to Patient #8, donned gloves, and removed 1st needle on Patient #8’s AV fistula. PCT 3 failed to hand hygiene after removing gloves and before donning new gloves. During an observation on 01/28/2025 at 3:15 PM, PCT 3 used a gloved pinkie on the right hand to pull the sharps container to station 17; PCT removed needles from the AV site of Patient # 22. PCT failed to change gloves and hand hygiene after touching the sharps container and removing needles. During an interview on 01/28/2025 at 2:45 PM, PCT 1 indicated the staff should change gloves after cleaning CVC and AV sites; “after touching anything.” PCT 1 indicated hand hygiene should be done before and after gloving. During an interview on 01/29/2025 at 11:00 AM, RN 2 indicated that staff should make glove changes with “everything.” During an interview with the FA and MCS on 01/29/2025 at 2:05 PM, MCS indicated hand hygiene after patient care, before and after removing gloves.”

“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: 51751 Based on observation, record review, and interview the facility staff failed to clean and disinfect the mechanical lift between patients and before returning to the common clean area on 2 of 2 patient transfer observations. (Patients #23 ,#24) Findings include: 1. A revised policy dated 04/2023, titled “Infection Control for Dialysis Facilities” states “Cleaning and/or disinfection of equipment will be performed as soon as possible after exposure and prior to returning to clean/designated area.” 2. During an observation on 01/29/2025 at 11:42 AM, PCT2 and PCT4 transferred Patient #23 with the mechanical lift. PCT2 returned mechanical lift to clean area after use. The facility failed to clean/ disinfect mechanical lift after transferring a patient and before returning the lift to clean area. 3. During an observation on 01/29/2025 at 11:55 AM, RN 2 and PCT 2 transferred Patient #24 with the mechanical lift prior to cleaning from use on Patient #23 and before placing back in clean area. The facility staff failed to clean/disinfect the mechanical lift after transferring a patient and before returning the lift to clean area. 4. During an interview on 01/29/2025 at 2:30 PM, the Manager of Clinical Services stated staff should clean the mechanical lift after each patient use and before placing it in a clean area.”

“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: 48387 Based on observation, record review, and interview, the agency failed to disinfect contaminated surfaces for 3 of 3 PCTs (PCT 1, PCT 3, PCT 4), and for 1 of 1 RN observed disinfecting dialysis stations. (RN 1) Findings include: 1. A 04/2023 revised policy titled “Infection control for Dialysis Facilities” indicates that after the end of treatment, the staff will clean the dialysis station surface areas will be disinfected to including wall box, water lines, dialysis delivery systems, all surfaces that patients come in contact with and Non-disposable items will be disinfected after each patient use. 2. A 10/2022 policy titled “Termination of Dialysis Utilizing Fresenius 2008 series Dialysis Delivery System and Streamline Blood Lines” indicated staff are to empty, rinse, and disinfect the interior and exterior of the prime rinse container. 3. During an observation on 01/28/2025 at 10:47 AM, PCT 1 disinfected the outside of the prime waste but failed to disinfect the inside of the prime waste container. During an interview on 01/29/2025 at 9:30 AM, PCT 1 stated she should have disinfected the inside of the prime waste container. 38262 4. During a cleaning and disinfection station observation on 01/28/2025 at 3:05 PM, PCT 3 removed fluid from the prime waste container and returned it to the dialysis machine without disinfecting the internal surface of a prime waste container. PCT 3 failed to disinfect tubes from the wall to the dialysis machine and the countertop at the back of station 16. PCT 3 failed to disinfect contaminated surfaces while cleaning the dialysis station. During an interview on 01/29/2025 at 1:45 PM, PCT 3 indicated team members should clean the prime waste container with 1:100 bleach solution. PCT 3 indicated that team members should clean the dialysis machine, hoses, and the top of the cabinet behind the station between patients. 5. During a cleaning and disinfection station observation on 01/28/2025 at 3:45 PM, RN 1 removed fluid from the prime waste container and returned it to the dialysis machine. RN 1 did not clean the countertop at the back of station 24. RN 1 failed to disinfect contaminated surfaces while cleaning the dialysis station. 6. During an observation on 01/29/2025 at 9:17 AM, PCT 4 disinfected the blood pressure cuff and cords and then placed it back in the wired basket attached to the station 11 dialysis machine before disinfecting it. PCT 4 disinfected station 11’s dialysis machine but failed to lift the metal box to disinfect the Hansen connectors (connects dialyzer to a dialysate-delivery line of a dialysis machine). PCT 4 failed to disinfect the countertop located directly behind the dialysis station. During an interview on 01/29/2025 at 9:25 AM, PCT 4 stated she completed cleaning station 11. PCT 4 stated she should clean the Hansen connectors and would go back and disinfect the countertop. During an interview on 01/29/2025 at 2:30 PM, the FA and Manager of Clinical Services stated staff should start disinfecting the dialysis machine first, then disinfect the blood pressure cuff and cords. The FA stated staff are to clean the countertops and Hansen connectors after each treatment. 7. During an interview with the FA and Manager of Clinical Services on 01/29/2025 at 2:05 PM, the Manager of Clinical Services indicated staff should clean reusable items between each patient. She indicated that between each patient, team members should disinfect the inside and outside of the prime waste container, the countertop behind each station, and the tubing from the wall to the machine.”

“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: 51751 Based on record review and interview the facility failed to ensure that assigned staff are capable of distinguishing between shades of pink and other colors by circling the correct response on the color vision test on 1 of 4 PCT records reviewed. (PCT 1) Findings include: A policy dated 10/2017 titled “Color Vision Evaluation” states” Teammates who will be utilizing test kits or strips that rely on color differentiation for test results will be evaluated for ability to see color.” An employee file for PCT 1, hire date 03/11/2024, included an ungraded document titled “ Color Vision Test Results”. The facility failed to ensure the color vision test was completed by circling either “Normal” or “Color Vision Defect” response for each plate tested. During an interview on 01/29/2025 at 2:20 PM, the Manager of Clinical Services indicated that the FA should write the teammate’s answers on the left and circle normal or defect on the right.”

“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: 38262 Based on observation, record review, and interview, the facility failed to ensure that patient access sites and faces were fully visible to the staff during hemodialysis for 5 of 12 patient access site observations. (Patients #2, #7, #14, #25, #26) Findings include: 1. An 04/2018 “Physical Environment” policy indicated that staff should always visualize patients during hemodialysis treatments. 2. A 04/2024 policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” indicated staff are to complete an assessment every 30 minutes. The policy indicated that the patient’s access site, bloodline connections, and face should be visible throughout the treatment. 3. During Flash Tour on 01/28/2025 at 9:10 AM, the following patients had access sites not visible: Patient #7 at Station 3, Patient #25 at Station 6, Patient #26 at Station 11, and Patient #2 at Station 12. During an interview on 01/28/2025 at 1:45 AM, PCT 1 stated her role in keeping patients safe was ensuring she uncovered access sites. 4. During an observation on 01/29/2025 from 9:45 AM to 11:00 AM, Patient #14’s cap covered their eyes, and they left the arteriovenous (AV) site partially covered with a blanket for 1 hour 15 minutes. Patient #14 covered their jaw and lower lip with a mask. Staff failed to check for alertness and uncover the access site and face. During an interview on 01/29/2025 at 10:55 AM, PCT 2 stated Patient #14 works the night shift and likes to sleep during dialysis. At that time, PCT 2 did not remove the patient’s cap or visualize the access site. During an interview on 01/29/2025 at 11:05 AM, RN 2 stated staff are to check Patient #14’s access site every 30 minutes. 48387 5. During an interview on 01/29/2025 at 2:30 PM, the FA and Manager of Clinical Services stated staff provided education to Patient #14 about keeping access lines and face visible during dialysis treatment. They stated they didn’t want to rock the boat with the patient due to past behaviors and non-compliance. Both stated patients’ access lines and faces should be visible during dialysis treatment. 6. During an interview on 01/30/2025 at 11:20 AM, the Medical Director stated staff are to follow the facility protocol regarding checking the patient’s access site, bloodline connections, and face should be visible throughout the treatment regardless of whether they are non-compliant. He stated if the patient’s bloodlines or needles disconnect, they could bleed out within a minute.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 51751 Based on observation, record review, and interview the agency failed to maintain confidentiality by locking computer screen when left unattended for 1 of 3 observation days. Findings include: 1. A policy dated 06/2022 titled “ Administrative, Technical, and Physical Safeguards for Protected Health Information” states “ Teammates are required to log off terminals or use the lock workstation function prior to leaving the work area.” 2. An observation on 01/29/2025 at 11:52 AM, PCT 1 failed to logout of the computer prior to walking away from station 17. The facility failed to maintain confidentiality of patient health information (PHI). 3. An interview on 01/29/2025 at 2:30 PM with the Manager of Clinical Services indicated that all staff are expected to log off computers before leaving the work area.”

“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: 51751 Based on record review and interview the facility failed to ensure that all policies and procedures were adhered to by all individuals who treat patients in the facility for 3 of 4 PCT personnel files reviewed. (PCT 1, PCT 2, and PCT 4) Findings include: 1. A policy dated 10/2024 titled “Tuberculosis Monitoring and Follow-Up” states “If exemption criteria for TST is not met, the following testing options are available: ... Baseline TST using a two-step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated One to three weeks after the first, U the initial test is negative). Test results will be recorded on the Teammate Health Monitoring Record (attached).” 2. An employee file of PCT 1, date of hire 03/11/2024, indicates that the facility administered a negative one-step tuberculin (TB) skin test at the time of hire; however, they failed to administer the required second-step TB test. 3. An employee file of PCT 2, date of hire 09/11/2017, indicates that the facility administered a negative one-step tuberculin (TB) skin test at the time of hire; however, they failed to administer the required second-step TB test. 4. An employee file of PCT 4, date of hire 04/10/2023, indicates that the facility administered a negative one-step tuberculin (TB) skin test at the time of hire; however, they failed to administer the required second-step TB test. 5. An interview with the Manager of Clinical Services, on 01/29/2025 at 02:30 PM, indicated that they follow policy by giving a second-step TB skin test upon hire and doing a yearly risk assessment. 6. During an interview on 01/20/2025 at 11:20 AM, the Medical Director stated he expects staff to follow all written policies.”

“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: 48387 Based on record review and interview, the facility failed to obtain the patient’s early termination of treatment documentation for 2 of 7 records reviewed (Patient #1, #5) Findings include: 1. A 04/2024 revised policy titled “Prescribed Treatment Time Not Met” indicated a patient will sign an Early Termination of Treatment Against Medical Advice for any time the patient requests to terminate their treatment earlier than the prescribed run time. If the shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s physician. 2. The clinical record for Patient #1 was reviewed and evidenced with the following: A Treatment Detail report dated 12/06/2024 indicated a prescribed treatment time of 4 hours 0 minutes and a treatment duration of 2 hours 31 minutes. The facility failed to complete 1 hour 29 minutes of the prescribed treatment time. A Treatment Detail report dated 12/10/2024 indicated a prescribed treatment time of 4 hours 0 minutes and a treatment duration of 2 hours 30 minutes. The facility failed to complete 1 hour 30 minutes of the prescribed treatment time. A Treatment Detail report dated 01/02/2025 indicated a prescribed treatment time of 4 hours 0 minutes and a treatment duration of 3 hours 29 minutes. The facility failed to complete 31 minutes of the prescribed treatment time. The record failed to evidence a signed Against Medical Advice (AMA) document for the following treatment days: 12/06/2024, 12/10/82024, and 01/02/2025. During an interview with the FA on 01/30/2025 at 10:16 AM, the FA reviewed the medical record of Patient #1 and could not locate the AMA document for the following days: 12/06/2024, 12/10/2024, 01/02/2025. The FA indicated that an AMA document should be completed on the day the patient leaves treatment early; the physician should be notified that the patient ended treatment early, and the AMA should be included in the patient’s medical record. 3. During an interview on 01/29/2025 at 1:45 PM, PCT 3 indicated that if a patient leaves early, the patient signs an AMA (Against Medical Advice) form. PCT 3 indicated that the patient’s medical record contains this form. 51751 4. The clinical record review for Patient #5 evidenced the following: A review of the Post Treatment Record dated 01/18/25 indicated Patient #5’s duration of treatment was 120 minutes of the prescribed 210 minutes. No records of a completed Early Termination of Treatment form were available for the patient on this date. The staff shortened Patient #5’s treatment duration by 90 minutes. No records were available on interventions offered to the patient or plan to address early termination or nephrologist notification. A review of the Post Treatment Record dated 01/23/2025 indicated Patient #5’s duration of treatment was 90 minutes of the prescribed 210 minutes. No records of a completed Early Termination of Treatment form were available for the patient on this date. The staff shortened Patient #5’s treatment duration by 120 minutes. No records of a completed Early Termination of Treatment form were available for the patient on this date. 5. During an interview on 01/29/2025 at 1:06 PM, PCT 3 stated that staff educate patients on the implications of leaving treatment early. If a patient refuses to sign the AMA form, then two staff members must sign it.”