Davita Indy East 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: 44232 Based on observation, record review, and interview, the facility failed to ensure hand hygiene and glove changes were performed by direct care staff (Employees: RN 1 (1 time) , RN 2 (twice), PCT 1 (1 time), PCT 2 (6 times), while on the treatment floor, and failed to ensure patients were offered or were instructed to perform hand hygiene after holding their access in 4 of 4 post dialysis treatment observations. (Patients: #1, 16, 21, and 22) Findings include: 1. A review of a DaVita Incorporated policy revision dated April 2023, titled “Infection Control for Dialysis Facilities,” indicated but was not limited to, “... Hand hygiene ... 1. All teammates ... prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... 2. Patients and caregivers will be encouraged to ... b. Perform hand hygiene after treatment before leaving treatment area ... PPE ... a. Gloves should be changed when ... ii. When going from a “dirty” area or task to a “clean” area or task ... Patients ... will be encouraged to ... b. Perform hand hygiene after treatment before leaving the treatment area ... “ 2. During a flash tour of the treatment floor on 06/02/2025 at 7:30 AM, noted a sign above the clean sink of the treatment floor entrance that stated, “Why Hand Hygiene Is Important. 1. When entering and leaving the treatment floor. 2 Before and after contact with patients. 3. Before and after performing a procedure. 4. Before and after contact with patient treatment area. 5. After potential contact with blood and body fluids ....”. 3. During an observation on 06/02/2025 8:05 AM, PCT 4 was observed at Station 5 discontinuing the dialysis treatment for Patient #16. Patient #16 held pressure to their access site of their right lower vascular access site with their left hand, refusing to wear a glove. Following a post treatment assessment, Patient #16 weighed themselves at the scale and left the treatment floor without performing hand hygiene. During an interview on 06/05/2025 at 10 :00 AM, PCT 4 confirmed the patients are to be offered hand hygiene after holding their access post dialysis treatment. PCT 4 further indicated Patient #16 refuses to wear gloves when holding their access dressing. 4. During an observation on 06/02/2025 at 8:45 AM, PCT 2, was observed at Station 3, initiating dialysis for Patient #7. PCT 2 moved from the dialysis machine to the computer keyboard after discarding their gloves in the trash receptacle without performing hand hygiene after removing their gloves. 5. During an observation on 06/02/2025 at 9:03 AM, RN 1 was observed at Station 8 administrating parenteral medication. RN 1 donned gloves without performing hand hygiene wiped the injection port with an alcohol swab and injected Venofer (a medication used to treat iron deficiency anemia) 100 micrograms (mcg). During an interview on 06/02/2025 at 12:40 AM, when queried regarding hand hygiene, RN 1 indicated every time gloves are removed, prior to procedures and applying gloves, and when you touch a patient. When questioned whether they performed hand hygiene prior to donning gloves during medication administration confirmed they didn’t and should had. 6. During an observation on 06/02/2025 at 9:34 AM, PCT 1 was observed discontinuing dialysis treatment at Station 13. PCT 1 performed hand hygiene, donned clean gloves, touched the dialysis machine, and continued to close the CVC clamps. PCT 1 failed to discard their gloves after touching the dialysis machine and perform hand hygiene prior to touching the CVC clamps. 7. During an observation on 06/02/2025 9:40 AM, PCT 2 was observed at Station 1 discontinuing the dialysis treatment for Patient #1. Patient #1 held pressure to their access site of their left upper vascular access site with their right gloved hand. Following a post treatment assessment, Patient #1 weighed themselves at the scale and left the treatment floor without performing hand hygiene. 8. During an observation on 06/02/2025 9:46 AM, PCT 4 was observed at Station 4 discontinuing the dialysis treatment for Patient #22. Patient #22 held pressure to their access site of their left lower vascular access site with their right gloved hand. Following a post treatment assessment, Patient #22 weighed themselves at the scale and left the treatment floor without performing hand hygiene. 9. During an observation on 06/02/2025 at 9:48 AM, PCT 2 was observed at Station 1adjusting settings on the dialysis machine with gloved hands. PCT 2 removed their gloves and discarded the gloves in the trash receptacle. PCT 2 was observed obtaining a dressing from the drawer at the nurse’s station without performing hand hygiene. 10. During an observation on 06/02/2025 at 9:49 AM, PCT 2 was observed performing CVC, (a venous access located below the collar bone) exit site care at Station 3. PCT 2 removed Patient 7’s old dressing and discarded the dressing in the trash receptacle. PCT cleansed the area around the CVC exit site with antiseptic swab. PCT 2 failed to discard their gloves and perform hand hygiene after removing the old dressing. During an interview on 06/02/2025 at 10:12 AM, when queried regarding glove changes and hand hygiene, PCT 1 and PCT 2 indicated hand hygiene is to be performed prior to applying gloves and after gloves are removed, after touching patient, doing a procedure, and after touching the dialysis machine. 11. During an observation on 06/02/2025 2:30 PM, PCT 3 was observed at Station 8 discontinuing the dialysis treatment for Patient #21. Patient #21 held pressure to their access site of their left lower vascular access site with their right gloved hand. Following a post treatment assessment, Patient #21 weighed themselves at the scale and left the treatment floor without performing hand hygiene. 12. During an observation on 06/02/2025 at 2:35 PM, RN 2 was observed at Station 16 answering the dialysis machine alarm with gloved hands, then went to the nurse’s station and obtained a vial of heparin, cleansed the bottle with an alcohol prep, obtained syringes, filled the syringes with heparin, discarded their gloves in the trash receptacle, and donned clean gloves. RN 2 failed to discard their gloves after touching the dialysis machine and perform hand hygiene and don new gloves prior to obtaining medication. RN 2 obtained their stethoscope from the nurse’s station, obtained the med cup, and went to Station 11 administered the med cup to the patient and touched the back of their hair that was pulled back. RN 2 was observed cleaning the stethascope bell, listened to the posterior and anterior chest of the patient, and removed and discarded their gloves in the trash receptacle. RN 2 failed to perform hand hygiene and don new gloves prior to med administration and touching their hair. During an interview on 06/02/2025 at 4:07 PM, RN 2 indicated hand hygiene is to be completed prior to donning gloves, after gloves are removed, patient contact, and after touching the dialysis machines. 13. During an observation on 06/02/2025 at 3:50 PM, PCT 2, was observed at Station 1, initiating dialysis for Patient #8. PCT 2 moved from the dialysis machine to the computer keyboard after discarding their gloves in the trash receptacle without performing hand hygiene after removing their gloves. PCT 2 donned new gloves without performing hand hygiene and applied a blood pressure cuff to Patient #8. PCT 2 removed their gloves and discarded then in the trash receptacle entered data into the chairside computer utilizing the keyboard without performing hand hygiene. PCT 2 donned new gloves without performing hand hygiene and answered the dialysis machine alarm removed their gloves without performing hand hygiene. 14. During an observation on 06/05/2025 at 3:47 PM, observed RN 2 at the nurse’s station donning gloves without performing hand hygiene, withdrew heparin into two sterile syringes, applied labels to the syringes, removed their gloves, and donned new gloves without performing hand hygiene. 15. During an observation on 06/02/2025 at 3:49 PM, PCT 2, was observed at Station 1, initiating dialysis for Patient #8. PCT 2 moved from the dialysis machine to the computer keyboard after discarding their gloves in the trash receptacle without performing hand hygiene after removing their gloves. PCT 2 donned new gloves without performing hand hygiene and applied a blood pressure cuff to Patient #8. PCT 2 removed their gloves and discarded then in the trash receptacle entered data into the chairside computer utilizing the keyboard without performing hand hygiene. PCT 2 donned new gloves without performing hand hygiene and answered the dialysis machine alarm removed their gloves without performing hand hygiene. 16. During an observation on 06/02/2025 at 3:50 PM, PCT 2 was observed performing CVC exit site care at Station 3. PCT 2 removed Patient 8’s old dressing and discarded the dressing in the trash receptacle. PCT cleansed the area around the CVC exit site with antiseptic swab. PCT 2 failed to discard their gloves and perform hand hygiene after removing the old dressing.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure Personal Protective Equipment (PPE) was worn appropriately to mitigate any exposure risk in 1 of 1 stand-alone dialysis treatment centers. (Employees: PCT) 1(twice)) Findings Include: 1. A review of a DaVita Incorporated policy revision date April 2023, titled “Infection Control for Dialysis Facilities.” The policy indicated but was not limited to, “ ... Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces, for example, patient care areas .... “ 2. On 06/02/2025 at 6:35 AM, entering the facility, observed PCT 1 without a mask or gown opened the door to the treatment area. 3. On 06/02/2025 at 6:45 AM, observed PCT 1 in the isolation room without a gown or mask with a patient setting up the dialysis machine. 4. On 06/05/2025 at 7:00 AM, observed RN 1instructing PCT 1 to don a gown and mask, in the isolation room. During an interview on 06/02/2025 at 12:40 PM, RN 1 confirmed gown and gloves were to be worn while on the treatment floor. 5. During an interview on 06/02/2025 at 1:04 PM, the Medical Director indicated all the staff had just had a meeting and reviewed wearing proper personal protective equipment (PPE) while on the treatment floor.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the agency failed to ensure all items were stored without risk of exposure to contaminants in 3 of 3 treatment floor observations. Findings Include: 1. A review of a DaVita Incorporated policy revision dated April 2018, titled “Physical Environment” indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public ... provide needed care and services, prevent cross contamination ... “ 2. On 06/02/2025 at 7:15 AM, observed during the flash tour a blood pressure cuff, a tv remote, and papers towels behind Station 2, and a tan arm cushion behind Station 4, on the wall unit shelf 3. On 06/02/2025 at 7:35 AM, observed a roll of paper towels behind Station 9, and a blood pressure cuff, neck pillow, clamp, and water connection line behind Station 10, on the wall unit shelf. 4. On 06/02/2025 at 3:30 PM, observed a roll of paper towels behind Station 9, and a blood pressure cuff, neck pillow, clamp, and water connection line behind Station 10, on the wall unit shelf. When questioned PCT 3 regarding items on the wall unit shelf, PCT 3 indicated nothing was to be on the wall unit shelf as they removed the items from behind Station 9 and 10.”

“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: 44232 Based on observation, record review, and interview, the facility failed to initial, and date 6 opened multidose containers of medications, and 2 open vials of medications, and failed to initial and date an open container of grape sugar free protein liquid for 2 of 2 observations. Findings Include 1. A review of a DaVita Incorporated policy revision date October 2023, titled, “Medication Policy,” indicated but was not limited to, “ ...All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates ....” 2. During the flash tour observation on 05/02/2025 at 9:00 AM, observed on the counter of the first nurse’s station two half open 30 milliliter (ml) vials of Heparin 1,000 units/ml. Both opened vials of Heparin failed to evidence a date opened and the staff’s initials on the label. During an interview on 05/02/2025 at 9:10 AM, when queried about when the heparin vials were opened processes, PCT 1 and PCT 2 indicated the heparin bottles should be labeled date opened and staff initials. 3. During an observation on 05/02/2025 at 9:20 AM, observed on the counter of the first nurse’s station of the medication area, contained a half-full open container of grape sugar free protein drink, titled, “LiquaCel,” half full bottles of Calcitriol 0.5 micrograms (mcg) tablets, Cinacalcet 90 milligrams (mg), Cinacalcet 60 mg, Cinacalcet 30 mg, Calcitriol 0.25 mcg, and Acetaminophen 325 mg opened without a label with date opened and the staff’s initials. Both the protein drink container and the medications containers failed to evidence a date opened and the staff’s initials on the label. During an interview on 05/03/2025 at 12:40 PM, RN 1, confirmed the protein drink, and all opened containers of medications were to have been labeled with the date opened and staff initials.”

“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: 44232 Based on observation and interview the agency failed to maintain the proper care and treatment of the CVC for patients 6 of 7 observations of initattian and diconitnuation of treatments . (Employees: PCT 1 (twice), and PCT 2 (3 times) ). Findings include: 1. A review of a DaVita Incorporated policy revision dated April 2025, titled “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure” indicated but was not limited to, “ Verify patient’s clothing is secured away from the exit site/work area...7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove... 8... using aseptic technique...swab for a minimum of 30 seconds ... Using aseptic technique, remove each cap...disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides...”. 2. During an observation on 06/02/2025 at 9:49 AM, PCT 2 was observed providing CVC (a vessel inserted into a vein below the collar bone) exit site care and initiation of dialysis treatment for Patient #7 at Station 3. PCT 2 removed the old CVC dressing, discarded the dressing in the trash receptacle, cleansed the area around the exit site with antiseptic, and immediately applied the dressings. PCT #2 failed to remove their old gloves after removing the old dressing, perform hand hygiene and don new gloves. PCT 2 failed to scrub the insertion site for 30 seconds and allow it to dry prior to placing a new dressing over the insertion site. PCT 2 scrubbed the CVC venous hub for 6 seconds and the arterial hub for 7 seconds and failed to scrub the hubs for 15 seconds. 3. During an observation on 06/02/2025 at 3:50 PM, PCT 2 was observed providing CVC exit site care for Patient #8 at Station 1. PCT 2 removed the old CVC dressing, discarded the dressing in the trash receptacle, cleansed the area around the exit site with antiseptic, and immediately applied the dressings. PCT #2 failed to remove their old gloves after removing the old dressing, perform hand hygiene and don new gloves. PCT 2 failed to scrub the insertion site for 30 seconds and allow it to dry prior to placing a new dressing over the insertion site. PCT #2 removed the old dressing from the CVC and discarded the dressing into the trash receptacle. PCT 2 failed to scrub the insertion site area for 30 seconds and immediately applied a new dressing, failing to let the site dry completely. PCT #2 connected two syringes to the CVC lines and aspirated blood into the syringes. PCT 2 flushed the CVC lines and disposed of the syringes. PCT 2 removed their gloves, entered data into the chairside computer keyboard, donned new gloves without hand hygiene and applied the blood pressure cuff on Patient #8. PCT 2 entered the dialysis prescription into the dialysis machine, discarded their gloves, entered data in the chairside computer keyboard, donned new gloves without hand hygiene and answered the dialysis machine alarm. PCT 2 did not perform hand hygiene after removing old gloves or prior to applying new gloves. 4. During an observation on 06/02/2025 at 9:35 AM, PCT 1 was observed discontinuing the dialysis treatment for Patient #9. Patient #9 had a CVC. PCT 1 failed to disinfect the hubs for 15 seconds following treatment. 5. During an observation on 06/02/2025 at 9:51 AM, PCT 1 was observed discontinuing the dialysis treatment for Patient #10. Patient #10 had a CVC. PCT 1 failed to disinfect the hubs for 15 seconds following treatment. 6. During an observation on 06/02/2025 at 9:56 AM, PCT 2 initiated CVC exit site care for Patient #11. PCT #2 failed to disinfect the hubs for 15 seconds following treatment. On 06/02/2025 at 9:36 AM, when questioned PCT 1 and PCT 2 regarding infection prevention for patients during treatment and hub scrubs, PCT 2 indicated the CVC hub was to be scrubbed for 30 seconds, hand hygiene is to be performed when removing gloves, before donning gloves, after touching a patient, machine, keyboard or blood contamination.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to provide a safe and conformable environment for 1 of 1 stand alone in-center dialysis facilities. Findings include: 1. A review of a DaVita Incorporated policy revision dated April 2018, titled “Physical Environment,” indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public ... “ 2. On 06/02/2025 at 7:30 AM, observed a white dried substance covering the tile floor under the wall unit shelf to the walkway of Station 10 to Station 11. Further observed at Station 10 a blue water line from the wall box to the dialysis machine dripping water at the connection site. During an interview on 06/02/2025 at 8:35 AM, the Biomed Technician confirmed the white substance on the floor had been there and it had been an ongoing issue with the cleaning crew not cleaning the floors. The Biomed Technician further indicated the line connector of the blue tubing was missing the Teflon tape causing the dripping. 3. During an interview on 06/02/2025 at 2:00 PM Patient #20, when asked about the physical environment being clean, pointed to Station 10’s floor and indicated the floor with the white substance on the floors had been an ongoing problem. 4. On 06/02/2025 at 10:15 AM, observed in the water room a white substance with salt pellets covering approximately 3 inches up the base surround of the brine tank. During an interview on 06/02/2025 at 11:30 AM, when asked regarding the white substance built up around the bottom of the brine tank, the Biomed Technician indicated it had been that way for a year since they had been there but was worse today. 5. On 06/02/2025 at 3:16 PM, observed a blue glove, two clear plastic saline flush wrappers, and an alcohol pad surrounding the trash receptacle by the refrigerator at the first nurse’s station. During an interview on 06/02/2025 at 11:44 AM, the MSW indicated there had been an issue with trash being on the floors of the treatment areas and staff not picking up after themselves. 6. On 06/02/2025 at 3:20 PM, observed two 2x2 dressing wrappers, 4 weight slips by the trash receptacle by the scale. 7. On 06/02/2025 at 3:42 PM, observed a blue glove, two syringe wrappers, one plastic saline wrapper, and 4 alcohol pads surrounding the trash receptacle by the clean sink at the first nurse’s station. During an interview on 06/02/2025 at 2:15 PM, Patient #3 stated, “The clinic is barely cleaned. The lobby and treatment area have trash on the floors.” 8. During an interview on 06/02/2025 at 3:30 PM PCT 3 indicated the cleaning company is horrible and the staff need to pick up their trash.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure patient’s access sites remained uncovered during dialysis treatments as noted over 2 of 2 observations. (Patients: #9, 16, and 19) Findings include: 1. A review of a DaVita Incorporated policy revision date April 2018, titled “ Physical Environment” indicated but was not limited to, “...8. Teammates will be able to visualize patients at all times during hemodialysis treatments for patient safety...”. 2. On 05/02/2025 at 6:45 AM, Patient #4 was observed at Station #5. Patient 16’s fistula/graft was fully covered with a grey blanket. Their access was not visible to the staff. At 8:20 AM, Patient #16 remained fully covered. At 8:45 AM, Patient #16 dialysis machine alarmed Patient #16 removed their grey blanket covering their access. 3. On 05/02/2025 at 6:45 AM, Patient #9 was observed at Station #14. Patient #9’s Central Venous Catheter (CVC) was fully covered with a blue colt’s blanket. Their access was not visible to the staff. At 8:20 AM, Patient #9 remained fully covered. At 9:30 AM, Patient #9’s dialysis machine alarmed, PCT 1 answered the alarm and removed Patient 9’s blue blanket covering their access. 4. On 05/02/2025 at 6:45 AM, Patient #4 was observed at Station #12. Patient #19’s fistula/graft was fully covered with a blue flowered blanket. Their access was not visible to the staff. At 8:20 AM, Patient #19 remained fully covered. At 10:12 AM, PCT 1 removed Patient 9’s blue flowered blanket covering their access. During an interview on 05/02/2025 at 10:12 AM, PCT 1 and PCT 2 confirmed all accesses are to be visible during dialysis treatment for safety.”

“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: 44232 Based on record review, and interview, the agency failed to ensure the initial nursing comprehensive assessment was completed, prior to the initiation of the first dialysis treatment for 1 of 1 admission records reviewed. (Registered Nurse (RN): 2) (Patient: #37) Findings Include: 1. A review of a revised October 2021, agency policy titled, “CWOW-Initial Patient Nursing Assessment For New Patients,” indicated but was not limited to, “ ...1. A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility ... “ 2. A review of the clinical record of Patient #37, with an admit date of 01-04-2024, was reviewed on 01-09-2024. The record contained a facility document titled, “Initial Patient Nursing Assessment,” dated 01-04-2024, at 11:34 AM, and completed by RN 2. The record evidenced a facility document dated 01-04-2024, titled, “Treatment Details Report” which indicated Patient #37’s initial dialysis treatment started at 10:50 AM, and the Pre-Treatment nursing assessment was completed at 11:36 AM, by RN 2. 3. On 01-09-2024 at 11:55 AM, when queried as to the time RN 2 performed the initial assessment for Patient #37, who was a new admission to the hemodialysis in-center facility, and the initiation of treatment, the Regional Operation Director/Interim Facility Administrator, Admin 3, confirmed that RN 2 completed the initial assessment on 01-04-2024 at 11:36 AM, after Patient #37’s dialysis treatment was initiated.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44232 Based on observation, record review, and interview, the ESRD provider failed to ensure proper hand hygiene was performed (see V113); failed to ensure Personal Protective Equipment was utilized appropriately (see V115), failed to ensure accepted disinfection practices were completed regarding the disinfection of equipment and reusable supplies (see V116); failed to ensure all staff performed proper cleaning and disinfection of a arteriovenous (AV) fistula (see V550); and failed to ensure all staff performed proper cleaning and disinfection of a central venous catheter (CVC) (see V147). The cumulative effect of these systemic problems resulted in the dialysis provider being out of compliance with 42 CFR 494.30 Infection Control with the potential to impact all staff and patients.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44232 Based on observation, record review, and interview, the ESRD provider failed to ensure the facility was maintained to ensure the safety of patients and staff, (see V401); failed to ensure that systems were in place to maintain the integrity of the facility structure of the floors, and walls to allow for effective cleaning (see V402); and failed to ensure the patient’s access was visible at all times (see V407); and failed to ensure the equipment utilized in the facility was maintained to ensure the safety of patients and staff (see V403). The cumulative effect of these systemic problems resulted in the dialysis provider being out of compliance with 42 CFR 494.60 Physical Environment with the potential to impact all staff and patients.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to maintain emergency supplies according to manufacturer instructions for 1 of 1 Emergency Carts observed. Findings include: 1. A policy titled, “Emergency Equipment Checks” was provided by the Facility Administrator (FA). The policy indicated but was not limited to, “ ... Emergency cart (crash cart) is clean, operational and supplies/medications have not expired ...” 2. During the flash tour observation, a Yankauer suction instrument (a disposable suction catheter designed to clear patient airways preventing aspiration) with the expiration date 09-30-2023 was found in the Emergency Cart on the treatment floor. 3. A facility document dated 11-01-2023 to 11-29-2023, titled, “Daily Phillips Heart Start FR2+ AED and Emergency Medication Lock Log” was proved by the Registered Nurse (RN) 1. The document indicated a review of the contents daily was completed and discard or replace any expired items. The checklist was checked as completed 11-29-2023 and signed by RN 1. 4. On 11-29-2023 at 9:50 AM, RN 1, confirmed the Yankauer suction instrument was expired, and they checked the Emergency Cart daily.”

“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: 47343 Based on observation, record review, and interview the facility failed to ensure staff used Personal Protective Equipment (PPE) and hand hygiene appropriately while on the treatment floor by 6 of 7 Patient Care Technician and 2 of 2 Nursing Staff. (Patients: #10, 14, 15, 16, 17, 18, 19, 21, 23, 25, 26, 29 and 35) (Registered Nurse (RN) 3(twice), Licensed Practical Nurse (LPN) 1) and Patient Care Technicians (PCT) 1, 2 (3 times), 3 (twice), 6, 7, and 8( 8 times)) Findings Include: 1. A revised policy titled “Infection Control For Dialysis Facilities” Policy No. 1-05-01 indicated but was not limited to, “ ... Hand Hygiene ... 1. All teammates ... a. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... 2. Patients and caregivers will be encouraged to ... b. Perform hand hygiene after treatment before leaving treatment area ... PPE ... a. Gloves should be changed when ... ii. When going from a “dirty” area or task to a “clean” area or task ...” 2. PCT 1 was observed at Station 1 cleaning and disinfecting the station. PCT 1 failed to perform hand hygiene after doffing the gloves they used to clean the dialysis station. 3. RN 3 was observed at Station 12, touching Patient #21’s central venous catheter (CVC, a line inserted into a large, central vein for dialysis) with gloves on, then proceeded to grab new alcohol swabs from the tech’s station. With the same gloves, touched the screen on the Dialysis machine, scrubbed the hubs of the patient’s lines, and attached the lines. With the same gloves, touched the Dialysis machine went back to the patient to adjust the lines, and then back to the dialysis machine. RN 3 failed to ensure proper hand hygiene and gloving procedures were followed according to the agency’s policy. 4. PCT 8 was observed at Station 5 accessing Patient #23 left upper arm arteriovenous (AV, a surgically placed connection between an artery and a vein) for dialysis. PCT 8 failed to perform hand hygiene before donning new gloves and after doffing gloves. PCT 8 failed to don gloves to touch the dialysis machine. PCT 8 used the same gloves to touch the dialysis machine and touch the patient. 5.PCT 8 failed to perform hand hygiene prior to doffing dirty gloves and typing on the computer keyboard. 6.PCT 8 failed to perform hand hygiene before donning gloves, touched the dialysis machine, and failed to perform hand hygiene after doffing the gloves. 7.PCT 8 failed to fully don gloves to touch the dialysis machine twice. PCT 8 had a glove bundled in their right hand and when the dialysis machine alarmed, they used it to press the button. 8.PCT 8 was observed accessing Patient #26’s left lower arm AV for dialysis at Station 7. PCT 8 failed to perform hand hygiene after doffing gloves, then proceeded to clip the tubing to the patient, moved the machine, and typed on the computer. PCT 8 failed to perform hand hygiene prior to donning a glove to turn off the alarm on the dialysis machine. PCT 8 failed to perform hand hygiene after they doffed the glove. 9.PCT 8 was observed in the isolation room, initiating Patient #22’s treatment through the patient’s CVC. PCT 8 failed to perform hand hygiene before donning clean gloves. 10.PCT 6 failed to perform hand hygiene after doffing used gloves. During an interview with PCT 8, they indicated they were to perform hand hygiene before and after care, touching the keyboard, after taking off the gloves, and they were to wear gloves when caring for the patient. 11. RN 2 was observed discontinuing Patient #25’s access on their left lower arm AV at Station 1. RN 2 failed to perform hand hygiene after doffing dirty gloves. RN 2 failed to offer the patient hand sanitizer after assisting the patient in doffing the dirty glove Patient #25 used to hold gauze over the used access site. 12.PCT 7 was observed at Station 9, discontinuing Patient #29 from dialysis through their CVC. PCT 7 was observed touching the patient, then touching the dialysis machine, and going back to the patient with the same gloves. PCT 7 failed to change gloves and perform hand hygiene before switching from the dialysis machine to the patient. During an interview with PCT 1, they indicated hand hygiene was to be performed before and after care, between patients, before touching the machine, before touching the patient, between patients, before gloving, and after doffing gloves. They indicated they were to change gloves in between touching the machine and touching the patient. 13. During an interview with RN 3, they indicated they were to perform hand hygiene before and after the procedure, before donning gloves, after donning gloves, and change gloves after the procedure. 44232 14. During a flash tour observation, a sign posted on the wall above the clean sink at the entrance to the treatment area was reviewed, The sign stated, “Why Is Hand Hygiene Important?” 15. RN 3, was observed to assisting Patient #15 in the Isolation Room. Patient #15 held pressure on their left upper vascular access site with a with a left gloved hand. Patient #15 obtained their weight at the scale, handed the weight reading to RN #3, discarded their glove in the trash receptacle, and left the treatment area. Patient #13 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 16. The Licensed Practical Nurse (LPN) 1, was observed assisting Patient #16 at Station #4. Patient #16 held pressure to their left lower vascular access with a right gloved hand. The patient removed their glove, discarded it in the trash receptacle, and was assisted with their walker by the LPN to the scale. Patient #16 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor 17. RN 3, was observed discontinuing treatment at Station #14 for Patient #14 who had a Central Venous Catheter (CVC) (a catheter inserted into a major vein). The RN was observed scrubbing the hub after disconnecting the blood lines, obtained supplies from the supply drawer at the nurse’s station and applied Patient #14’s dressing. RN 3 failed to discard their gloves in the trash receptacle, failed to perform hand hygiene prior to getting supplies, failed to perform hand hygiene and don new gloves after obtaining supplies and applying the CVC dressing. 18.PCT 2, was observed assisting Patient #10 at Station #8, after the patient held pressure on their left lower vascular access with a gloved right hand. Patient #10 removed their glove and discarded in the trash receptacle beside their chair. Patient #10 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 19. PCT 2, was observed assisting Patient #19 at Station #10 after the patient held pressure on their right lower vascular access with a gloved left hand. PCT 2 applied tape to the new dressing and Patient #19 removed their glove and discarded in the trash receptacle beside their chair. Patient #19 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 20. Patient #17 at Station #4 was observed removing their glove form their left hand after the patient held pressure on their right lower vascular access. Patient #17 removed their glove and discarded in the trash receptacle beside their chair. Patient #17 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 21.PCT 8, was observed assisting Patient #18 at Station #9 after the patient held pressure on their right upper thigh vascular access with a gloved right hand. Patient #18 removed their glove and discarded in the trash receptacle beside their chair. Patient #18 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 22. Patient #35 at Station #15, was observed removing their glove after the patient held pressure on their right vascular access with a left gloved hand. Patient #35 discarded the glove in the trash receptacle by their chair and left the treatment floor. Patient #35 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. RN 1, confirmed the staff should offer hand sanitizer or encouraging hand hygiene to the patients after they held their access with a gloved hand. 23. Requested the facility Infection control audits on 11-29-2023 at 4:55 PM, and 11-30-2023 at 2:25 PM. The Facility Administrator failed to provide the Infection Control audits for the facility.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure Personal Protective Equipment (PPE) was worn appropriately to mitigate any exposure risk in 1 of 1 stand alone dialysis treatment centers. (Employees: Patient Care Technician (PCT) 1(twice)) Findings Include: 1. A revised April 2023 policy titled, “Infection Control for Dialysis Facilities.” indicated but was not limited to, “ ... Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces, for example, patient care areas .... “ 2. A revised October 2023, policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure.” indicated but was not limited to, “ ... Teammate and patient will wear masks covering the nose and mouth during this procedure ...” 3. A review of a sign on the treatment floor above the entrance clean sink on 11-29-2023 at 9:15 AM, stated, “Keep mask over your nose and mouth the entire time you are in the building.” 4. PCT 1 was observed discontinuing the dialysis treatment for Patient #15 in the isolation room. PCT 1 had their mask hanging off the clasp of their surgical cap around their right ear. The PCT did not wear a mask or face shield during the procedure. 5. PCT 1 was observed initiating the dialysis treatment for Patient #11. PCT 1 cannulated (inserted the needles) into the patient’s access and secured the needles with tape. PCT 1 failed to wear a mask or face shield during the procedure. When queried PCT 1 regarding infection control and use of PPE, indicated they had been instructed they did not have to wear masks anymore by the facility manager. The PCT further indicated they now understood of possible risk for exposure. 6. The Regional Operations Director (ROD), Admin 3, confirmed that face shields or goggles, and masks are to be worn by staff when providing patient care.”

“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: 47343 Based on observation and interview, the agency failed to ensure all items taken to the dialysis station were disposed of after use, cleaned and disinfected, and stored without risk of exposure to containments in 1 of 1 stand alone in-center dialysis treatment treatment centers. Findings Include: 1. A revised April 2023, policy titled “Infection Control For Dialysis Facilities” Policy No. 1-05-01 indicated but was not limited to, “ ... 10. Unused supplies ( ... tape ...) ... taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients ...” 2. During the flash tour at Station 16 had 4 tubing baskets, 4 sodium chloride solutions, and 4 dialyzers on the chase wall box behind the station. 3. RN 3 brought a roll of tape from Station 15, where a patient was receiving treatment, and placed the tape on top of clean, new rolls of tape. 4. Patient Care Technician (PCT) 1 obtained the used tape placed in the box by RN 3 and brought it to Station 14 for an initiation. 5. During an observation 2 blood pressure cuffs behind station 14 and a blood pressure cuff behind station 15 on the chase wall box. There were 2 tubing sets, 2 sodium chloride solution bags, and 2 dialyzers in between stations 15 and 16 on the chase wall box. There was a blood pressure cuff and monitor on the chase wall box behind station 16 as well. RN 3 indicated patient supplies were to be single-use only and were to be thrown away after being at a station. 44232 6. During the flash tour, observed 4 unopened packages of dialyzers(the filter used the clean the blood often referred to as the artificial kidney) , blood connection tubing kits (the tubing used to transport the blood from the needles through the machine and back to the patient) , 0.9% Sodium Chloride Intravenous (IV) bags 1,000 milliliters (ml) (an intravenous solution given to replenish water and salt), on top of the wall box unit shelf behind Station #16. 7. Observed 4 unopened packages of dialyzers, blood connection tubing kits, and 0.9 % Sodium Chloride IV bags 1,000 ml, on top of the wall box unit shelf between Station #1 and #2. 8. Observed 2 unopened packages of dialyzers, blood connection tubing kits, and 0.9 % Sodium Chloride IV bags 1,000 ml, on top of the wall box unit shelf between Station #1 and #2. 9. Observed 2 unopened packages of dialyzers, blood connection tubing kits, and 0.9 % Sodium Chloride IV bags 1,000 ml, on top of the wall box unit shelf between Station #16. Between Station #1 and Station #2 observed, observed 4 unopened packages of dialyzers, blood connection tubing kits, and 0.9 % Sodium Chloride IV bags 1,000 ml, on top of the wall box unit shelf. During an interview, the Facility Administrator (FA), confirmed no items are to be on the wall unit box unit shelf.”

“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: 44232 Based on observation, record review, and interview, the facility failed to properly manage the handling of expired supplies in 2 of 2 observations. Findings Include: 1. A revised October 2023 policy titled, “Obtaining Patient Lab Specimens.” indicated but was not limited to, “ ... Expired laboratory specimen tubes are not to be used and are to be discarded ... “ 2. During a flash tour, observed in the Home Peritoneal Dialysis Room 2. The cabinet above the clean sink noted the following: 4 Spectrum DNA specimen swabs and vial samples (to obtain human salvia for testing) expired 09-30-2023; 1 specimen swab and vial kits for COVID testing expired 09-01-2023; 4 classic swabs expired on 10-31-2023; and 1 specimen tube expired 02-28-2023. 3. During a flash tour, observed in the Home Peritoneal Dialysis storage room, 2 boxes of APD drain manifold kits that expired 06-15-2023. 4. During a flash tour, observed 2 BD Aerobic Culture vials expired 07-30-2023, in the lab area of the in-center treatment area. During an interview, Registered Nurse (RN) 1, indicated the nurses check supplies and medications for expiration dates.”

“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: 44232 Based on observation, record review, and interview, the facility failed to maintain the proper care and treatment of the Central Venous Catheter (CVC) for patients in 1 of 3 discontuation of dialysis, 1 of 3 initiation of dialysis. and 1 of 3 exit site care observations. (Patients: #12, 14, and 22) (Employees: Registered Nurse (RN) 3), Patient Care Technician (PCT) 7, and 8) Findings Include: 1. A revised October 2023 policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure.” indicated but was not limited to, “ ... Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines ...” 2. RN 3 was observed discontinuing the dialysis treatment for Patient #14. Patient #14 had a CVC (a a flexible tube placed in the large vein above the heart to give medicine, nutrients, or blood products). RN 3 failed to scrub the hubs for 15 seconds following treatment. 3. PCT 7 was observed providing CVC exit site care for Patient #12 at Station #5. The PCT removed the old dressing from the CVC and discarded the dressing in the trash receptacle. PCT 7 cleansed the area around the CVC exit site. The PCT removed their gloves applied a glove to their right hand, silenced the dialysis machine alarm at Station #4, discarded their glove and donned new gloves without performing hand hygiene. PCT 7 then applied the CVC dressing to Patient #12’s CVC site and ports. RN 1, was queried on the care and treatment of a patient with CVC. RN 1 indicated the process involved multiple glove changes, hand hygiene, exit site care cleaned and allowed to dry, new dressing applied, and scrubbing the hubs for 15 seconds. 47343 4. During an observation on 11-30-2023 at 11: 00 AM, PCT 8 was observed initiating Patient #22 on dialysis. PCT 8 scrubbed the hub for 3 seconds. PCT 8 failed to scrub the hub for 15 seconds. During an interview with the Regional Operations Director on 11-30-2023 at 3:30 PM, they indicated the Registered Nurses and PCTs were to scrub the hubs for 15 seconds.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to accurately monitor and maintain the water softener equipment and allowed the brine tank to lack salt pellets to the manufacturer’s required levels. This failure had the potential to negatively affect the health and well being of al 65 in-center hemodialysis patients. Findings Include: 1.A revised October 2021, policy titled, “Water Treatment Systems Minimum Component Requirement.” indicated but was not limited to, “ ... When water softeners are required, the maximum hardness of softened water produced will meet the Reverse Osmosis (RO) manufacturer’s specifications ... “ 2. Facility documents titled, “CWP Daily Water Log” dated 11-01-23 through 11-29-2023. indicated but were not limited to, “ ... Salt Level in Brine Tank? Tank at least half full. Above the water Yes/No/ or Not Applicable. Brine Tank ... “ The dates of 11-01-2023 through 11-29-2023, were documented as “Yes.” 3. A review of manufacturer label on the brine tank on 11-29-2023 at 10:00 AM, stated, “Brine Tank. Contains salt used for softener regeneration. Verify salt level is above water level in the brine tank.” 4. During a flash tour, observed the 2 brine tanks lids both opened, the tanks were a fourth full, and the water was a foot above the salt pellets. During an interview, the Biomed Technician, confirmed the brine tank lids were to be closed, the salt level should be above the water level, and fill the tanks halfway.”

“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: 44232 Based on observation, record review, and interview, the facility failed to provide a safe and comfortable environment for 1 of 1 stand alone in-center dialysis facilities. Findings Include: 1. A revised April 2018, policy titled, “Physical Environment” indicated but was not limited to, “ ... The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment ... Supplies will not be stored directly on the floor but stored on shelves or pallets ... “ 2. Observed Patient #5 in the lobby pacing upon entering the facility. When queried Patient #5, regarding the safety and cleanliness of the facility, indicated the lobby and treatment area was full of bedbugs. 3. RN 1, when queried regarding the bedbugs, confirmed the facility had an issue with the bedbugs. RN 1 further indicated the exterminator had treated the facility 1 time a week, since February or March. The RN indicated the patient who brought them in had received their treatments in the isolation room. 4. During the Entrance Conference, the Facility Administrator (FA), confirmed the facility had an issue with bedbugs and the exterminator treated the facility 1 time a week. The FA further indicated the patient who carried the bedbugs received their dialysis treatments in the isolation room. 5. During a flash tour, observed a large box on the floor of the employee break room labeled J-cups, and 3 large boxes in the housekeeping closet. During an interview, the Facility Administrator (FA) confirmed boxes were not to be stored on the floor. 6. During a flash tour, noted a white plastic broken tray under the clean sink at the nurses station on the floor. Observation of the floor tiles contained a white substance and debris from the wall unit to in front of the dialysate machine at the 16 Stations, and the isolation room. During interview, Patient Care Technician (PCT) 3, indicated the floors were a mess and the patients need new chairs. 7. Observed square black boxes bed bug traps on the wall unit surround shelves behind Stations #3, 4, 9, and 12. During an interview, RN 1 indicated the black boxes on the wall unit surround shelves was bed bug traps. 8. During an interview, Patient #6, indicated they had seen a mouse run across the treatment floor during their treatment. Patient #6 further indicated the facility had bedbugs, the floors were always dirty, and the chairs were worn. 9. Documents titled, “Invoice” from Entity 2, the pest control company, dated start date 05-05-2023 through 06-05-2023 and 07-31-2023 through 09-30-2023. The documents indicated inspections completed, applied chemical bed bug treatments, and rodent trap placements. 10. A document titled, “Work Order” from Entity 3, the flooring company dated 09-28-2023. The document indicated that tiles in multiple rooms are damaged, and the facility wants the floors redone. The scheduled start date was documents at 10-30-2023. The facility failed to evidence floor replacement that had been completed. During an interview, the Director Lead of Registered Dieticians (RLRD) Admin 6, confirmed the facility had mouse traps set out around the building. 11. During an interview, a facility Nephologist (kidney doctor) 1, confirmed the facility had an issue with bedbugs, but it had been a while. 47343 12. During an observation of the back door, in front of the back door there were leaves and trash on the interior side of the door. The room marked “Housekeeping” evidenced 3 boxes on the floor. 13. During the flash tour of the treatment room, a puddle of water was observed to the right of station 14. A small puddle of water was next to station 15. Station 3 had a wrapper on the floor to the right of the station and a cap under the dialysis machine. Between Stations 15 and 16 there was a puddle of water. The isolation room had a small trash can under the sink closest to the windows. The dirty sink in front of Station 9 had a trash can under the sink. Behind Stations 1 and 2, the chase wall box had a long, white counter side on top of the wall box. The agency failed to ensure all puddles were investigated and cleaned, chase wall boxes had nothing on them, and sinks had nothing under them. 14. During an observation, between stations 11 and 12, there was a glove on the floor next to the trash can. On the chase wall box behind Station 11, there was a clear container on it. The trash can next to the Medication fridge #1 was overflowing and 2 gloves were on the floor next to it. 15. During an observation, behind stations 1 and 2, the chase wall box had the long, white counter side from the previous day. There was a glove on the ground between stations 2 and 3. The sink in the isolation room had a trash can under the smaller sink. A puddle of water was seen next to Station 1’s dialysis machine. The dirty sink in front of stations 8 and 9 had a trashcan and a clear wrapper under it. There was a glove on the ground at stations 10 and 12. There was a clear container on the chase wall box behind stations 11 and 12.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure systems were in place to maintain the integrity of the facility structure of the floors, and walls to allow for effective cleaning for 1 of 1 stand alone dialysis facilities. Findings Include: 1. A revised April 2018 policy titled, “Physical Environment” indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public .... “ 2. Upon entry to the facility, noted gloves, masks, trash, and debris was located outside the main entrance of the facility. Between the double glass entry doors observed an electrical wall plate broken and the floor tiles broken and missing, 7 chairs in the front lobby with ripped and torn seat cushions. Registered Nurse (RN) 1, led the survey team to the conference room. Observed 2 more chairs as the front lobby’s chairs, with ripped and torn seat cushions. 3. On a flash tour, observed entering the treatment area, the base boards broken and not attached to the base of the wall on both sides of the exit door, observed on the treatment floor, the lab area sink’s hot water faucet nonfunctional. 4. On a flash tour of the water room, observed a wet floor sign behind standing water on the floor that drained into the floor drain separating the supply room to the water room. Observed further the standing water on the floor in front of the Reverse Osmosis (RO) machine. The water surrounded the water heater, the multimedia tank, the water softener, and organic scavenger tank. Upon further investigation noted the booster pump connector ring and pipe connection was leaking water to the floor. Observed both brine tanks lids open. The booster pump continued leaking at the connector ring and pipe connection. Observed water on the floor covering the back of the water room surrounding all the tanks to the front of the water room leading to the floor drain separating the water room and supply room. During an interview, the Biomed Technician, confirmed the brine tank lids are to be closed, and the water is from the booster pump that needs replaced. The Biomed Technician further indicated they had a work order in since October. 5.The Biomed Technician provided a document titled, “Confirmation Email.” The email dated 11-29-2023 at 11:34 AM, indicated a processed order with a reference number from Entity 1, a water technology service company. 6. Observed in the treatment area, the aisle walkway in front of Station #10, floor tiles chipped, broken, and cement showing with debris. At Station #5, observed torn upholstery of seat and arms of the patient’s treatment chair. The white anterior trim from the wall unit shelf missing and laying in the wall unit shelves behind Stations #2, 4 and 14.The lab refrigerator had two containers that held vacutainers (blood collection tubes used for lab testing). The refrigerator failed to evidence a thermometer. 7. During an observation on 11-29-2023 at 9:39 AM, at Station #8, observed torn upholstery of the left corner footrest of the patient’s treatment chair. 8. On 11-30-2023 at 7:45 AM, observed the gloves, masks, and debris remain in the entry of the facility. 9. During an interview, Patient #2 stated, “The trash outside is bad.” 10. During an interview, Registered Nurse (RN) 2, when queried regarding the hot water faucet not working indicated it had not worked for a long time. 11. During an interview, the Facility Administrator (FA), when queried regarding the hot water faucet not working at the sink in lab area of the treatment floor, indicated they were not aware and confirmed the upholstery of the chairs in the lobby and conference room were ripped and torn and had not put in a work order for repair or replacements. The FA further indicated bed bugs would have been able to burrow in the open, torn chairs. 12. A facility document titled, “Work Order” from Entity 3, the flooring company dated 09-28-2023. The document indicated that tiles in multiple rooms are damaged, and the facility wants the floors redone. The scheduled start date was documents at 10-30-2023. The FA failed to evidence floor replacement that had been completed. 13. RN 1, when queried about the temperature in the lab refrigerator, confirmed they used the lab refrigerator for lab specimens. RN 1 further indicated the refrigerator was new and the thermometer from the old refrigerator was not put in the new one.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to provide temperature monitoring of the lab refrigerator, failed to provide the patients chairs in the waiting area and treatment chairs free of torn upholstery to allow proper effective cleaning and disinfection for 1 of 1 stand alone dialysis in-center facilities. Findings Include: 1. On 12-01-2023 at 1:09 PM, the Facility Administrator for Marion County (FA), Admin 1, provided revised April 2018, DaVita Incorporated policy titled, “Physical Environment” The policy indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public .... “ 2. On 11-29-2023 at 8:25 AM, upon entry of the facility observed the 7 chairs in the front lobby with ripped and torn seat cushions. 3. On 11-29-2023 at 8:35 AM, the Registered Nurse (RN) 1, led the survey team to the conference room. Observed 2 more chairs as the front lobby’s chairs, with ripped and torn seat cushions. 4. During an observation on 11-29-2023 at 9:35 AM, at Station #5, observed torn upholstery of seat and arms of the patient’s treatment chair. 5. During an observation on 11-29-2023 at 9:39 AM, at Station #8, observed torn upholstery of the left corner footrest of the patient’s treatment chair. During an interview on 11-30-2023 at 11:15 AM, Patient #2, indicated the patient chairs were bad in the lobby. 6. During an interview on 11-30-2023 at 3:30 PM, the Facility Administrator (FA), confirmed the upholstery of the chairs in the lobby and conference room were ripped and torn. The FA further indicated they had not put in a company workorder for repair or replacement of the chairs. 7. On 12-01-2023 at 9:15 AM, observed the lab refrigerator had two containers that held vacutainers (blood collection tubes used for lab testing). The refrigerator failed to evidence a thermometer. During an interview on 12-01-2023 at 9:35 AM, RN 1, when queried about the temperature in the lab refrigerator, confirmed they used the lab refrigerator for lab specimens. RN 1 further indicated the refrigerator was new and the thermometer from the old refrigerator was not put in the new one. 8. During an observation on 11-30-2023 at 9:52 AM, the Fresenius 2008K dialysate machines #5, 11, 12, 13, 14, 15, 16, 17, 18, and 19 had discolored tape applied to the top far right of the machines, the paint was worn and missing around the monitors, the bottom ledges were discolored yellow and brown. During an interview on 11-29-2023 at 9:39 AM, PCT 1, indicated the Fresenius 2008 K machines were older dialysis machines. The PCT had to pull 3 machines this morning related to machine alarms due to the Transmembrane Pressure (TMP) (the pressure exerted on the filter which effects the the dialysate and blood pressure on the filter ) going to 600-800. The normal range of TMP is 100-150 mmHg. 9. During an interview on 11-29-2023 at 11:40 AM, the Biomed Technician confirmed the machines were older and are being replaced in 2024. 47343 10. During an observation on 11-29-2023 at 4:19 PM, a chair at the center computer of the technician station was worn down and peeling. The 4 metal bars at the base of the chair were not loosely resting on the legs of the chair. 11. During an observation on 12-01-2023 at 10:25 AM, the chair with the blue cushion at the technician’s station was shedding and worn down. During an interview with the FA on 11-30-2023 at 3:30 PM, they indicated bed bugs would have been able to burrow in the open, torn chairs.”

“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: 44232 Based on observation, record review, and interview, to ensure patient’s access sites remained uncovered during dialysis treatments for 1 of 1 stand alone in-center dialysis facilities. (Patients: #10 and 17) Findings Include: 1. A revised April 2018 policy titled, “Physical Environment” indicated but was not limited to, “ ... 8. Teammates will be able to visualize patients at all times during hemodialysis treatments for patient safety ... “ 2. Patient #10 was observed at Station #8. Patient #10’s fistula/graft access was fully covered with a pink and white blanket. Their access was not visible to the staff. 3. Patient #17 was observed fully covered at Station #4 with a gray blanket. Patient #17’s fistula/graft access was not visible to the staff. 4.Registered Nurse (RN) 1, was queried about monitoring the patient’s access site during treatment. RN 1 indicated a patients access site should always be visible to the staff during their treatment.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 44232 Based on record review and interview, the interdisciplinary team (IDT) failed to ensure they developed a plan of care (POC) for 1 of 7 clinical records reviewed. (Patient #2) Findings Include: 1. A revised July 2023 policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care.” indicated but was not limited to, “ ... The facility’s interdisciplinary team (IDT) consists of, at minimum, the patient or patient’s personal representative, a registered nurse, a physician, ... a social worker, and a dietician ... A comprehensive-assessment of each patient and a revision in the plan of care will be conducted: At least annually for stable patients ... “ 2. The clinical record of Patient #2 with an admission date of 05-07-2020, evidenced a Plan of Care (POC) and IDT Meeting for 10-18-2022. The record failed to evidence a current POC had been established for 10-18-2023. During an interview, the Facility Administrator (FA, when queried regarding the plan of care for Patient #2, confirmed no Plan of Care could be provided. The FA further indicated the POC was late and had not been completed.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 47343 Based on observation and interview, the agency failed to ensure antiseptic was applied to the patient’s skin effectively to prevent infection for 1 of 3 observation days. (Patient Care Technicians (PCT) 8) Findings Include: An agency policy with a revised date of October 2022 and titled “AV (sic Arteriovenous, a surgically placed connection between the artery and the vein) Fistula or Graft Cannulation with JMS Sysloc mini safety fistula needles (SFN) and Administration of Heparin Loading Dose” Policy No. 1-04-01D indicated but was not limited to, “ ... Skin Antiseptic ... Isopropyl Alcohol 70% ... Effective Contact Time ... 60 seconds ... 11. While maintaining aseptic technique, prep planned needle sites by applying a 70% alcohol prep pad to each site using a circular motion, center out ...” During an observation on 11-30-2023 at 10:47 AM, PCT 8 was observed initiating Patient #26 on dialysis using their left lower arm access. During the initiation, PCT 8 lightly wiped the patient’s site 3 times with an alcohol pad and proceeded to insert the needle. PCT 8 failed to follow the agency’s policy to ensure the patient’s arm was properly disinfected before inserting the needle for dialysis treatment. During an interview with the Facility Administrator (FA) on 11-30-2023 at 3:30 PM, they indicated when a technician or nurse was prepping a site for dialysis, a few swipes with the alcohol pads were not acceptable practice. During an interview with PCT 3 on 12-01-2023 at 10:30 AM, they indicated they would scrub the access site for 30 to 60 seconds with alcohol before starting the treatment.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 47343 Based on record review and interview, the agency failed to ensure all employees had tuberculosis tests or chest x-ray completed prior to first patient contact for 1 of 3 employee records reviewed. (Patient Care Technician (PCT) 1) Findings Include: 1. A revised April 2018 policy titled “Tuberculosis Infection Control Policy” Policy No. 1-05-03 indicated but was not limited to, “ ... 2. Patients with chronic kidney disease (CKD) are considered high risk for progression from latent TB infection (LTBI) to active TB disease ... 3. ... tuberculin skin test (TST) ... TST results are to be read within 48-72 hours of placing the test 5. A chest X-ray (CXR) obtained for any purpose that has been interpreted by a radiologist as clear, negative, normal or unremarkable, is acceptable ...” 2. During a review of the employee records, the agency failed to evidence a TB skin test or chest x-ray for PCT 1. During an interview with the Facility Administrator of Marion on 12-01-2023 at 1:55 PM, they indicated they were unable to find PCT 1’s TB test. 3. During an interview with the Manager of Clinical Services, they indicated they were unable to find PCT 1’s chest x-ray.”

“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: 44232 Based on record review, and interview the facility failed to ensure maintained complete and accurate clinical records by obtaining a patient signed AMA (Against Medical Advice) form for 1 of 7 patient records reviewed. (Patient: #3) Findings Include: 1. A revised October 2022, policy titled, “Refusal of Care/Treatment Against Medical Advice.” indicated but was not limited to, “ ... The RN (Registered Nurse) will verify that a patient signs the Refusal of Care/Treatment Against Medical Advice form if a patient: Refuses their entire dialysis treatment ... “ 2. A review of the clinical record for Patient #3, evidenced a total of 12 dialysis treatment record for the period of 10-31-2023 through 11-28-2023. The treatment records indicated the patient’s prescibed treatment duration was for 4 hours. The treatment records for 8 of 12 treatments where the patient actual treatment time was less than the 4-hour prescribed treatment time documented as: 2:52 hours on 11-09-2023 (1 hour and 8 minutes less than prescribed treatment time) 2:00 hours on 11-11-2023 (2 hours less than prescribed treatment time) 2:55 hours on 11-14-2023 (1 hour and 5 minutes less than prescribed treatment time) 2:38 hours on 11-16-2023 (1 hour and 22 minutes less than prescribed treatment time) 2:53 hours on 11-18-2023 (1 hour and 7 minutes less than prescribed treatment time) A Missed Treatment on 11-20-2023 2:48 hours on 11-22-2023 (1 hour and 12 minutes less than prescribed treatment time) 2:54 hours on 11-25-2023 (1 hour and 6 minutes less than prescribed treatment time) 3:00 hours on 11-28-2023 (1 hours less than prescribed treatment time) During an interview on 12-01-2023 at 1:44 PM, Admin 3, when requested Patient #3’s signed AMA forms, indicated they were unable to provide the signed AMA forms for the dates of 11-11, 11-14, 11-16, 11-18, 11-22, 11-25, and 11-28-2023. Admin 3 further confirmed there should be patient signed AMA forms documented for patients that requested termination of treatment earlier than prescribed time.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the Facility Administrator (FA) failed to have a plan in place for insufficient staffing at 1 of 1 stand alone in-center dialysis facilities. Findings Include: 1. On 11-29-2023 at 8:25 AM, Patient #5 was observed in the lobby pacing upon entering the facility. When queried Patient #5 regarding the safety and staff of the facility indicated, they had concerns with management and staff shortages. 2. During the Entrance Conference on 11-29-2023 at 10:30 AM, when queried regarding adverse events regarding the facility being closed due to staffing, the FA indicated November 24, 2023, the third shift had to be canceled due to staffing. The FA further indicated all the patients were scheduled for the next day except for Patient #21 who refused. There were no plans documented to address the staffing shortages. 3. During an interview on 11-29-2023 at 12:15 PM, the Registered Nurse (RN) 1, confirmed the facility had staffing issues. The RN indicated on November 24, 2023; third shift treatments had to be canceled as no nurse was scheduled for the third shift. 4. During an interview with Patient #7 on 11-29-2023 at 12:35 PM, indicated the agency had informed them not to come in and would offer for them to come in the next day for their treatment. 5. During an interview on 11-29-2023 at 1:05 PM, Patient #6, confirmed the FA called them on 11-24-2023 to cancel their treatment due to staffing. Patient #6 indicated the drive to the other facility they offered to schedule their treatment was too far. The patient stated, “I did not have treatment from Tuesday until Saturday when they rescheduled my treatment due to the holiday schedule.” 6. On 11-29-2023 at 1:10 PM, the clinical record review for Patient #5 evidenced a facility document titled, “Patient Rights.” The Patient Rights indicated but was not limited to, “ ... 6. To receive adequate, safe, sanitary, and efficient dialysis treatment ... “ 7. On 11-29-2023 at 1:49 PM, the FA provided facility documents dated 11-29-2023, titled “Monthly Facility Events by Location.” The facility adverse events dated 05-04-2023 through 11-29-2023 failed to evidence the facility canceling treatments due to staffing on 11-24-2023. No plans were documented to address the staffing shortages. 8. On 11-30-2023 at 11:42 AM, the FA provided the Governing Body Meeting Minutes, dated 11-01, 11-24, and 11-27-2023. The minutes evidenced the following: A. On 11-01-2023 at 3:30 PM, the meeting minutes stated the FA, Nurse Manager, RN 1, attended in person, Regional Operations Director (ROD) and Medical Director attended by phone. The meeting minutes staffing levels being inadequate to run patients after 4:15 PM. The patients were contacted and offered chair times at another facility, rescheduled, and 3 refused to be rescheduled. B. On 11-24-2023 at 1:30 PM, the meeting minutes stated the FA, Nurse Manager, RN 1, attended in person, Regional Operations Director (ROD) and Medical Director attended by phone. The meeting minutes indicated staffing levels being inadequate to run patients for third shift due to RN being unavailable. Patients were contacted and offered to rescheduled treatment and Indy East Saturday during third shift to accommodate early closure. All patients accepted. C. On 11-27-2023 at 9:30 AM, the meeting minutes stated the FA, Nurse Manager, RN 1, attended in person, Regional Operations Director (ROD) and Medical Director attended by phone. The meeting minutes indicated seven patients attended rescheduled appointments. One patient did not show for rescheduled appointment. During an interview on 11-30-2023 at 12:35 PM, the Medical Director, Admin 5, when queried regarding staffing and the FA canceling patient treatments, confirmed the facility had staffing issues. Admin 5 further indicated they were notified of the schedule changes and the patients were offered another spot. 9. During an interview on 11-30-2023 at 11:05 AM, Patient #2 confirmed they filed a grievance with the facility regarding staffing. Patient #2 indicated their only complaint now with staffing was about the lack of patient and staff support from the facility manager. 10. During an interview on 11-30-2023 at 12:44 PM, the Medical Social Worker (MSW), indicated the patients’ voiced concerns regarding staffing. The MSW further indicated the patients had complained when their treatments had to be rescheduled to either the next day or at Entity 4, another dialysis location. 11. During an interview on 12-01-2023 at 7:45 AM, the FA of Entity 4, Admin 1, indicated there needed to be education regarding the episode of canceling patient’s treatments. 12. During an interview on 12-01-2023 at 9:05 AM, Physician 1, a facility Nephrologist (a kidney doctor), confirmed they were made aware of the facility’s staffing issue. Physician 1 further indicated their patients had no adverse outcomes and were accommodated the next day or offered treatment at another dialysis facility.”