Davita Summit City Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44714 Based on observation, record review, and interview, the dialysis facility failed to ensure staff completed hand hygiene according to hand hygiene policies and procedures (See V113), failed to ensure each handwashing sink had antibacterial liquid (V114), failed to ensure staff completed disinfection of dialysis stations according to facility policies and procedures (See V122), failed to ensure PCTs prepared, labeled open multidose vials, and immediately labeled patient specific heparin syringes (V143), and failed to ensure staff performed central venous catheter (CVC) site care according to facility policies and procedures (See V147). The cumulative effect of these systemic issues resulted in the facility being unable to provide adequate infection control measures. Therefore, Summit City Dilaysis was found out of compliance with Conditions of Coverage 494.30 Infection control.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure clinical staff completed hand hygiene according to accepted standards of practice on 2 of 3 observation days. Findings include: 1. A review of the facility policy on infection control, last revised April 2023, indicated staff were to complete hand hygiene “ ... prior to gloving and immediately after removal of gloves ... after patient and dialysis delivery system contact ... before touching clean areas such as supplies, supply cart and chairside keyboard/ mouse.” The policy indicated gloves were to be worn when caring for the patient or touching the patient’s equipment at the dialysis station. Gloves were to be changed when going from a dirty area or task to a clean area or task and when moving from a contaminated body site to a clean body site of the same patient. 2. A review of the facility policy on CVC procedures, last revised April 2025, indicated hand hygiene was required before setting up the clean barrier and supplies, before cleaning the CVC exit site, prior to applying a clean dressing to the CVC exit site, prior to disinfecting the CVC hubs, before disconnecting each blood line, and after the completion of all CVC care. 3. A review of the facility policy on fistula or graft procedures, last revised April 2025, indicated hand hygiene was required before setting up the clean barrier and supplies, and prior to inserting the canula into the dialysis access. 4. A review of the facility medication policy, last revised October 2023, indicated hand hygiene was required prior to the preparation of medications. 5. During an observation of the discontinuation of a dialysis with a fistula on 6/3/2025 at 8:23 AM, PCT 3 failed to complete hand hygiene after moving a sharps container. 6. During an observation on 6/3/2025 at 9:12 AM, PCT 2 failed to complete hand hygiene prior to putting on clean gloves while performing fistula care. 7. During an observation on 6/4/2025 at 5:38 AM, LPN 1 failed to complete hand hygiene prior to putting on clean gloves two times while performing CVC care. 8. During an observation on 6/4/2025 at 5:28 AM, PCT 2 failed to complete hand hygiene after touching a patient’s dialysis access site. 9. During an interview on 6/4/2025 beginning at 2 PM, the primary FA indicated they are working on hand hygiene and infection control issues.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 44714 Based on observation, record review, and interview, the facility failed to ensure each handwashing sink had antibacterial liquid soap for 1 of 6 treatment sections. Findings include: 1. A review of the facility policy on handwashing, last revised October 2020, required the use of antibacterial liquid soap for handwashing. 2. A review of the facility infection control policy, last revised April 2023, indicated soap must be available at each clean sink. 3. During an observation period on 6/4/2025 at 6:22 AM, no antibacterial soap was available at the handwashing sink across from treatment station 14. 4. During an interview at the time of the observation, LPN 1 indicated there should be soap at each handwashing sink.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure accepted disinfection practices were completed regarding the disinfection of dialysis chairs for 2 of 2 cleaning and disinfection observations. Findings include: 1. A review of the facility policy on infection control, last revised April 2023, indicated the dialysis chair should be disinfected after each dialysis treatment. Surfaces should be visibly we with the disinfectant and should be allowed to air dry to provide sufficient disinfectant contact time. 2. Observation 1 occurred on 6/3/2025 at 8:35 AM. When disinfecting the dialysis chair at station 4, PCT 3 opened the side panels, wiped them with a bleach wipe, then immediately closed the panels. PCT 3 failed to allow the bleach solution to dry on all parts of the dialysis chair. 3. Observation 2 occurred on 6/4/25 at 9:45 AM. When disinfecting the dialysis chair, PCT 4 opened the side panels, wiped them with a bleach wipe, then immediately closed the panels. PCT 4 failed to allow the bleach solution to dry on all parts of the dialysis chair. During an interview on 6/4/2025 at 1:30 PM, PCT 4 indicated they opened the chair side panels and cleaned the inside and outside. When asked if the panels were left open or closed immediately, PCT 4 indicated they were closed. 4. During an interview on 6/4/2025 beginning at 2 PM, Corporate Person 1 indicated the chair panels should be left open to air dry.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure PCTs prepared, labeled open multidose vials, and immediately labeled patient specific heparin syringes for 1 of 2 medication preparation observations (Observation 2). Findings include: 1. A review of the facility medication policy, last revised October 2023, indicated medication not immediately administered must be labeled with the patient’s name, medication name, date, time prepared, dose, and initials of the employee who prepared the medication. 2. A review of the facility PCT annual procedural skills verification checklist indicated the following: “A multidose vial must be labeled with initials and date opened. The vial stopper [septum] must be cleaned with an alcohol pad after removing the cap and with a new alcohol pad prior to accessing the multidose vial each time. The medication syringes must be properly labeled.” 3. A review of the article “Labeling of Syringes” in the Institute for Excellence, retrieved from chrome-extension:// efaidnbmnnni bpcajpcglclefindmkaj/https:// www.ccianesthesia.com/wp-content /uploads/2020/12/ cci_labeling_syringes.pdf, identified best practices for the labeling of syringes that were not administered immediately. The article indicated the filled syringe must not leave the provider’s hand unless labeled. “Once it is, in any way, out of the provider’s hand, then you have interrupted the continuous process and it must be labeled.” The article further stated, “There can be no ‘batching’ (filling multiples [sic] syringes) then labeling afterward.” 4. During an observation on 6/4/2025 at 6 AM, PCT 6 was observed filling syringes with heparin (used to prevent clotting of the dialysis access sites). PCT 6 did not clean the septum of the multidose vial. PCT 6 filled three syringes with heparin. They retrieved a new vial, cleaned the septum and filled one additional syringe. They had 5 syringes for 2 patients on the counter. PCT 6 then applied labels to all the syringes. PCT 6 did not indicate the date opened on the newly opened vial of heparin. During an interview on 6/4/2025 at 6 AM, PCT indicated they could fill syringes for multiple patients and then label them. PCT 6 indicated they knew which patients got which dose, so it was not a problem to label them at one time. 5. During an interview on 6/4/2025, Corporate Person 1 indicated multiple syringes for multiple patients had to be labeled before staff left the work area. They indicated if the staff still had control over the syringes, it was acceptable to label them at the same time. Corporate Person 1 indicated their policy did not specifically address filling multiple syringes at the same time. When asked about cleaning the vial septum, the primary FA indicated the septum needed to be cleaned before each puncture. Corporate Person 1 indicated it only needed cleaned once if filling multiple syringes, as it did not have time to get contaminated. When asked, Corporate Person 1 indicated a newly opened multidose vial needed to be labeled with the name of who opened it and the date.”

“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: 44714 Based on observation, record review and interview, the facility failed to ensure CVCs were cleaned appropriately to reduce the risk of bloodstream infections in 2 of 2 CVC disinfection observations. Findings include: 1. A review of the facility policy on CVC procedures, last revised April 2025, identified procedures for the disinfection of the CVC exit site. 2. During an observation of the disinfection of the CVC exit site on 6/4/2025 at 5:38 AM, LPN 1 held Patient #11’s shirt open to clean the exit site. While cleaning, the disinfecting swab went under the shirt and touched the inside of the shirt. LPN 1 continued to use the swab. While placing the dressing on the exit site, LPN 1 held the shirt open with the left hand and held the dressing in the right hand, which was the clean hand. While attempting to place the dressing, LPN 1 moved Patient #11’s necklace out of the way of the dressing, with their clean hand. LPN 1 failed to maintain the disinfection of the CVC exit site. During an interview on 5/4/2025 beginning at 2 PM, Corporate Person 1 said the swab touching the shirt or the nurse moving the necklace were an issue as they were not near the insertion site of the CVC. 3. During an observation of the CVC “hub scrub” prior to the replacement of end caps on 6/4/2025 at 10:40 AM, PCT 1 completed an 8 second hub scrub. During an interview at the time of the observation, PCT 1 indicated the hub scrub should have been 15 seconds.”

“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: 44714 Based on observation and interview, the facility failed to provide a sanitary treatment environment for 1 of 1 facility surveyed. Findings include: During the flash tour (initial observation of the facility, done immediately on survey entrance) on 6/3/2025 at 8:10 AM, observed numerous small papers, syringe caps, and CVC end caps on the floor, as well as stains on the walls. The treatment floor was dingy. The counters were cluttered with supplies and boxes. During an interview at the time of the flash tour, the primary FA indicated the papers came out of a supply package each time the package was opened. The FA indicated the cleaning people were expected to mop the floor each night but were not doing a satisfactory job. The primary FA indicated they purposely left a sticky stain on the floor and the cleaning crew failed to clean it. The primary FA indicated they were addressing the poor performance of the cleaning crew.”

“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: 44714 Based on observation, record review, and interview, the facility failed to ensure patients faces and access sites were always visible on 3 of 3 observation days. Findings include: 1. A review of the facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised April 2024, indicated the nursing assessment included verification that the “ ... patient [dialysis] access is visible and face is not covered.” The documentation of monitoring during the dialysis treatment included “The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment.” 2. During an observation on 6/3/2025 at 9:16 AM, observed Patient #19 with a blanket covering their dialysis access. During an interview at the time of the observation, PCT 5 indicated they check patients every 30 minutes to ensure their access is not covered. 3. During an observation on 6/4/2025 at 10:20 AM, observed Patient #21 with a blanket covering their face. During an interview on 6/4/25 at 11:39 AM, RN 1 indicated Patient #21 covered their face and head because the lights bothered him/her when they nap. 4. During an observation on 6/5/2025 at 10:09 AM, observed Patient #19 with a blanket covering their dialysis access. During an interview on 6/5/25 starting at 1 PM, the primary FA indicated Patient #19 always covers their access with a blanket.”

“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: 44714 Based on observation, record review and interview, the Medical Director failed to ensure PCTs followed the policy to report abnormal blood pressures to the nurse for 6 of 10 patient record reviews (Patients #2, 4, 5, 6, 7, and 9). Findings include: 1. A review of the agency policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised April 2024, indicated abnormal findings must be reported to the nurse immediately. The policy identified abnormal blood pressure readings for pre, during, and post dialysis as follows: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg During Dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mg/Hg or less than 50 mm/Hg Post- Dialysis: Systolic greater than 140 mm/Hg or less than 90 mm/Hg Diastolic greater than 90 mm/Hg or less than 50 mm/Hg 2. A review of the facility PCT annual procedural skills verification checklist indicated the PCT “Verbalizes findings that require informing the nurse and nurse intervention pre, during, or post dialysis.” 3. A review of the treatment flowsheets evidenced abnormal blood pressure readings as follows: Patient #2 5/20/25 193/99, 184/95, and 93/48 5/22/25 61/39, 82/58, 134/47, and 92/44 5/24/25 206/111, 152/88, 188/106, and 196/103 5/28/25 195/107 and 183/107 Patient #4 5/17/25 189/113, 181/83, 184/127, 189/106, 184/113, 183/118, 157/129, 186/110, and 185/106 5/27/25 196/114, 174/102, 178/114, 153/113, 180/113, and 169/112 5/31/25 202/98, 164/115, 158/101, 177/110, 180/112, and 182/101 Patient #5 5/20/25 192/102 5/27/25 197/109, 177/102, 174/100, 172/101, 184/99, 177/100, 192/108, 179/107, and 195/101 Patient #6 5/20/25 179/155 5/24/25 216/174 5/27/25 184/83 Patient #7 5/26/25 183/111, 172/109, 182/113, 181/111, 180/117, 182/111, 181/121, 170/114, and 182/116 Patient #9 5/23/25 213/123, 200/112, 211/111, and 188/102 5/26/25 235/134, 221/126, 200/99, 209/103, 214/113, 220/108, 198/95, 201/96, 194/89, and 210/98 5/31/25 222/134, 210/118, 217/134, 200/139, 181/95, 193/100, 196/97, and 200/93 6/2/25 229/138, 216/135, 204/121, 225/134, 211/107, 204/98, 220/100, 224/135, 205/105, and 215/109 There was no evidence the PCTs notified the RN of the abnormal blood pressures for Patients #2, 4, 5, 6, 7, and 9. 4. During an interview on 6/3/2025 at 3:42 PM, the Medical Director indicated they were responsible for all staff actions and compliance with policies and guidelines. 5. During an interview on 6/5/2025 at10:45 AM, RN 2 indicated they believed the PCTs forget to notify the RNs of abnormal blood pressure readings. “They just enter it in the computer and think we see it. They have to tell us.” 6. During an interview on 6/5/2025 beginning at 9 AM, the primary FA indicated the PCTs must notify the RN when a patient’s blood pressure is abnormal according to the facility parameters. PCTs must document they notified the RN on the treatment flowsheets.”

“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: 44599 Based on observation, record review, and interview, the dialysis facility failed to ensure expired medical supplies and nutrition were removed and failed to ensure the in-center and supply room were cleaned of debris on 1 of 1 observation day. Findings include: 1. Review of an agency policy titled “Physical Environment” indicated the dialysis facility stores supplies to minimize contamination, and boxes are undamaged. 2. Review of an agency policy titled “Infection Control for Dialysis Facilities” indicated supplies would be stored in a manner that maintains their integrity and anytime the integrity of a package with or without an expiration date was in question, such as torn, the package and its contents would be disposed of and not used, and soap would be available at each clean sink. 3. During an observation of the supply room on 06/28/24 beginning at 12:05 PM, 2 bottles of LiquaCel liquid protein with expiration date 12/2023, open box (full box contains 50 sets) intravascular administration sets (used to administer medications or fluids through intravenous access) with expiration date 3/14/2022, open box (full box contains 100 count) safety glide syringes with needles with expiration date 0/31/2023, 2 damaged boxes containing protein yogurt bars, and debris on the floor, which included pieces of paper, packing pieces, and areas of thick dust on the floor were observed. During an observation of the dialysis treatment floor on 6/28/2024 beginning at 12:05 PM, expired medical supplies and nutrition, and debris on floor and inside nutrition drawer were observed. The items included antimicrobial liquid hand soap at 2 cleans sinks with expiration dates 01/2024 and 09/2022, 1 opened bottle of LiquaCel liquid protein with expiration date 12/2023, unknown sticky substance to bottom of nutrition drawer, and debris on floor between the medication refrigerator and drawers. During an observation of the lab area 6/28/2024 beginning at 12:05 PM, the following expired medical supplies were observed: 9 green top vacutainers (blood collection tube) with expiration date 05/31/2024 and antimicrobial hand soap with expiration date 08/2023. During an observation of the employee women’s restroom on6/28/2024 beginning at 12:05 PM, 2 bottles of antimicrobial hand soap with expiration date 08/2023 were observed. 4. During an interview on 06/28/2024 at 12:45 PM, when asked why the supply room had expired items, the administrator indicated the staff does not use expired items and will remove expired items. When asked why debris was on the floor of the supply room, the administrator indicated must have received a shipment for stocking. 5. During an interview on 06/28/2024 at 1:42 PM, when asked who was responsible for management of the supply room, the administrator indicated he/she is and the inventory tech. When asked what the process was for managing the supply room, the administrator indicated they would rotate stock and should be disposing of expired items. When asked who is responsible for the cleanliness of the supply room, the administrator indicated everyone. When asked who is responsible for management of the supplies in the lab area, the administrator indicated the lab technician would rotate the supplies and inform him/her when expired items are found.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 44599 Based on record review and interview, the agency failed to document the date, description, and resolution of a grievance for 1 of 5 patient grievances documented in the previous 6 months (Patient #2). Findings include: 1. Review of an agency policy titled “Patient Grievance” indicated if a patient’s grievance cannot be resolved by the administrator, the regional operations director (ROD) and medical director will be notified, and a formal grievance conference will be coordinated, and this grievance conference should occur within 10 days of receipt of the grievance. 2. Review of an agency document titled “Patient Grievance Log” indicated a column titled “Date ROD and medical director discussion with patient if needed, within 10 days of complaint”. Agency documentation indicated “ongoing” in this column. 3. Review of an agency document titled “Grievance/Investigation Document” entered by the administrator included a grievance made by Patient #2 with the date of incident entered as May. Documentation for the description of the complaint indicated to see the attached emails from Patient #2. The attached emails sent to the administrator from Patient #2 were dated 05/18/2024, 05/19/2024, 05/21/2024, 05/22/2024, and 05/23/2024. The undated documentation under investigation indicated the administrator and another facility administrator had met with Patient #2 to discuss complaints. Documentation under the plan of resolution indicated the resolution was still in progress and continuing to escalate. Documentation of grievance failed to evidence the date, including day and year, of the grievance, failed to evidence a description of the grievance, failed to evidence the identity of the other facility administrator who met with the patient and the date of the meeting, and failed to evidence resolution to the grievance within 10 days of the complaint. 4. During an interview on 06/27/2024 at 3:45 PM, when asked what the date of the grievance was from Patient #2, the administrator indicated the emails were from May 18 through May 23. When asked what May and ongoing meant under the date on the grievance, the administrator indicated the grievance was still under investigation. When asked to explain where the facility was with the investigation, the administrator indicated Patient #2 wanted to meet with the ROD and was not returning calls from the facility. When asked who documented the handwritten notes on page 2 of the grievance, the administrator indicated he/she entered the documentation. When asked to explain what escalate means with a grievance, the administrator indicated means to move the grievance to the next level. When asked how often Patient #2 was in the facility for treatment, the administrator indicated three times a week. When asked what other attempts had been made to set-up a meeting between the patient and the ROD, the administrator indicated had made attempts and spoken with Patient #2 and when asked to see the documentation of the attempts, the administrator indicated every attempt had not been documented. Documentation failed to evidence the date of the grievance included the date and year, failed to evidence identification of the individual who entered handwritten notes, and failed to evidence attempts made to contact the patient to set up a meeting with ROD 5. During an interview on 06/28/2024 at 9:25 AM, when asked who suggested a conversation with the ROD and medical director, Patient #2 indicated he/she had and indicated he/she had called the facility corporate number and asked to speak with someone higher up with no response from corporate. When asked what date had contacted the facility corporate number, Patient #2 indicated he/she contacted the facility corporate number shortly after the incident in May. When asked what the facility was doing in making arrangements for Patient #2 to speak with the ROD and medical director, Patient #2 indicated nothing.”