Davita Waterbury Dialysis Center

“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: 47491 Based on review of clinical records, observations, interviews, and policies, for one (1) of three (3) patients (Patient #18) reviewed for hand hygiene, the facility failed to perform hand hygiene following glove removal during treatment initiation, and for one (1) of three (3) patients (Patient #17), the facility failed to ensure a patient was offered hand hygiene after applying pressure to their access sites following treatment. The findings included: 1. Patient #18 had diagnoses which included end stage renal disease. Physician’s orders directed hemodialysis treatments three (3) times weekly using a left upper arm Arteriovenous Fistula (AVF). Observation on 7/14/25 at 10:24 AM identified Staff Person #1 initiating Patient #18’s treatment. After handling the dialysis treatment lines and placing them back onto the intravenous pole, Staff Person #1 removed his/her gloves and failed to perform hand hygiene prior to retrieving a new box of gloves and clamps from the clean supply area. Staff Person #1 then returned to Patient #18, applied new gloves without performing hand hygiene, and connected the dialysis lines to the patient and initiated dialysis treatment. 2. Patient #17 had diagnoses which included end stage renal disease. Physician’s orders directed hemodialysis treatments three (3) times weekly using a left upper arm arteriovenous fistula. On 7/16/25 at 10:18 AM, Patient #17 was observed holding his/her hemodialysis access site with his/her gloved right hand. Patient #17 had his/her glove removed at 10:34 AM, was not provided with hand sanitizer after removing the glove, proceeded to walk to the scale to obtain his/her weight, returned back to the dialysis station to gather his/her belongings, and exited the clinic without performing hand hygiene. Interview with the Group Facility Administrator on 7/16/25 at 3:19 PM identified patients were to be offered hand sanitizer after holding their access sites following treatment and before being discharged from the clinic floor. Review of the Infection Control for Dialysis Facilities policy directed all teammates, physicians, and non-physician will perform hand hygiene prior to and immediately after glove removal and that patients would be encouraged to perform hand hygiene after treatment, before leaving the treatment area.”

“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: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to ensure patient visitors were provided with and donned Personal Protective Equipment (PPE) while on the treatment floor in accordance with facility policy. The findings include: 1. Patient #15 was admitted to the facility with diagnoses that included End Stage Renal Disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and fifteen (15) minutes with a left upper arteriovenous fistula (AVF). Observation on 7/14/25 at 9:30 AM of Station #21 identified Patient #15 with a clamp on his/her upper access, one needle still remaining, and a visitor sitting in the station next to the patient without PPE. Patient #15’s visitor remained without PPE on the treatment floor until discharge from the facility. 2. Patient #16 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty-five (45) minutes with a right upper AVF. Observation on 7/16/25 at 9:17 AM of Station #7 identified Patient #16 during his/her hemodialysis treatment with a visitor sitting in the station in front of Patient # 7 without PPE. At 10:13 AM Patient #16 treatment was terminated and Patient #16’s visitor left the station and proceeded to the middle of the treatment floor. Once the first needle was removed, the visitor returned to the station in front of Patient #16. At 10:25 AM Patient #16 second needle was removed with Patient #16’s visitor still in the station without PPE. Interview with the Clinical Specialist on 7/15/25 at 1:00 PM identified visitors are to have PPE on at all times when on the treatment floor. Review of the infection control for dialysis facilities policy directed that appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, physicians and visitors when in the treatment area.”

“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: 47491 Based on observations made during station disinfection, the facility failed to properly disinfect a treatment station between patient treatments. The findings included: 1. Observation of Station #9 disinfection on 7/14/25 at 10:03 AM identified Staff Person #2 failed to disinfect the lines in front of the dialysis machine, television monitor, television arm, and back counter. 2. Observation of Station #5 disinfection on 7/16/25 at 10:22 AM identified Staff Person #3 failed to disinfect the Hansen tubing, lines in front of the dialysis machine, intravenous pole, back counter, wall box, television and television arm. Review of the Infection Control for Dialysis Facilities policy directed the dialysis station to be cleaned and disinfected at the end of each treatment, including all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs), frequently contacted by healthcare personnel (e.g., control panel, top, front, and sides of dialysis machine, touchscreens, and countertops.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) out of six (6) hemodialysis patients reviewed for vaccinations (Patient #2), the facility failed to offer a second series of the hepatitis B vaccination for a patient who did not respond to the first series in accordance with facility policy. The finding includes: Patient #2 was admitted to the facility with diagnoses that included End Stage Renal Disease (ESRD). Review of the physician’s orders directed hemodialysis two (2) times weekly for four (4) hours with a right central venous catheter (CVC). Review of Patient #2’s hepatitis B antibodies dated 5/21/24 identified Patient #2’s hepatitis B antibodies were less than 3 (less than 10 indicates susceptibility of the hepatitis B virus). Review of Patient #2’s energix (hepatitis B vaccination) administration report identified Patient #2 started the first vaccination series on 8/7/24 and completed the first series on 2/7/25. Review of Patient #2’s hepatitis B antibodies dated 6/16/25 identified Patient #2’s hepatitis B antibodies were seven (7). Review of Patient #2’s medical record failed to identify if the second series of the vaccination was offered and/or administered. Interview with the Clinical Coordinator on 7/16/25 at 2:30 PM identified Patient #2 had an extreme needle phobia. She identified with the practitioner; the second series was not offered due to that reason. The medical record failed to identify documentation as to why the second series was not offered and/or administered. Review of the hepatitis B surveillance, vaccination, infection control measures and isolation guidance directed for a hepatitis B antibody less than ten (10) the patient is susceptible and to offer vaccination series. Test all vaccinated patients for hepatitis antibodies one (1) to two (2) months after the last dose of the full vaccine series. If the hepatitis b antibody is less than ten (10), consider the patient susceptible and revaccinate with an additional full series.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 44675 Based on observations, facility documentation, facility policy, and interviews, the facility failed to ensure the isolation room doors remained closed for hemodialysis treatments in accordance facility policy. The findings include: Patient #14 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and ten (10) minutes with a left upper arteriovenous fistula (AVF). Review of Patient #14’s hepatitis labs identified on 9/15/23 Patient #14’s surface confirmed antigen was positive (actively infected with hepatitis B). Subsequent monthly hepatitis antigen labs were negative (previously infected, currently inactive). Observations conducted during the flash tour on 7/14/25 at 9:20 AM of the isolation room identified Patient #14 during treatment termination, The ante-room door (a small room leading to another room) was held open by a door stop and the treatment room door was open. Interview with the Clinical Coordinator on 7/14/25 at 9:30 AM identified she was not aware the isolation door had to be closed when hepatitis B patients were treating. Subsequent to surveyor inquiry, she closed the treatment and ante doors. Interview with the Clinical Specialist on 7/14/25 at 10:00 AM identified upon admission to the clinic, Patient #14 was hepatitis B core positive and antigen negative. She identified the company Infection Prevention Manager was contacted and identified to treat Patient #14 in isolation as a hepatitis patient because he/she has a higher risk of the antigen becoming positive again (reactivation). Review of the hepatitis B surveillance, vaccination, infection control measures and isolation guidance policy directed for patients with negative antigen and core body they can treat in general population if no reactivation risk factors and if there are reactivation risk factors consult with the Infection Prevention Manager. It directed confirmed patients are dialyzed in an isolation room or area designated for use by only surface antigen positive patients. A door is required to the isolation room and must be closed during times when blood spurting or spattering is possible, for example at initiation and termination of treatment.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47491 Based on observations and review of facility policy for one (1) of three (3) patients, (Patient #19), observed fro Central Venous Catheter (CVC) care, the facility failed to clean the patient’s exit site in accordance with facility policy, and for one (1) of three (3) patients (Patient #20), the facility failed to ensure a patient’s access was prepared for treatment in accordance with facility policy. The findings included: 1. Patient #20 had diagnoses that included End Stage Renal Disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours utilizing a central venous catheter (CVC). Observation conducted on 7/14/25 at 10:44 AM identified Staff Person #2 preparing Patient #20’s central venous catheter for treatment. Staff Person #2 was observed removing the caps from each hub (end of the catheter limb) and connecting a syringe to each limb to withdraw the heparin instilled (to prevent blood clots formation) from the previous treatment. However, Staff Person #2 failed to scrub the open end of the catheter limb prior to attaching the syringe(s) and removing the previous heparin instillation. 2. Patient #19 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes utilizing a central venous catheter (CVC). Observation conducted on 7/14/25 at 10:58 AM identified Staff Person #4 preparing to clean Patient #20’s CVC exit site. Upon removing his/her gloves after discarding the bandage that covered Patient #20’s CVC, Staff Person #4 failed to perform hand hygiene prior to applying new gloves and proceeded to clean Patient #20’s exit site. Review of the Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure directed to remove and discard the old dressing, to remove, discard, perform hand hygiene per procedure, and re-glove prior to cleaning a CVC exit site, to use aseptic technique when removing each cap and to disinfect the hub (end of each catheter limb), one at a time, with a new alcohol prep pad, and to scrub each hub for fifteen (15) seconds including the sides, threads, and end of hub thoroughly with friction making sure to remove any residue.”

“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: 38422 Based on review of facility documentation and interviews, the facility failed to ensure that sprinkler inspections were completed, a load test, and inspection of the generator was conducted. The findings include: a. On 07/15/25, the surveyor was not provided documentation that indicated the sprinkler system was tested and inspected as required by NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”; i.e. there was no documentation provided to indicate that a 2nd quarter sprinkler inspection was completed. b. On 07/15/25, the surveyor was not provided documentation that indicated the major service of the facilities generator was conducted as required by NFPA 110 “Standard for Emergency and Standby Power Systems”. i.e. the last major service was completed 07/2024 and there was no service scheduled at the time of survey. c. On 07/15/25, the surveyor was not provided documentation that indicated the load bank test of the facilities generator was conducted as required by NFPA 110 “Standard for Emergency and Standby Power Systems”. i.e. the last load bank test was completed 07/2024 and there was no service scheduled at the time of survey.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44675 Based on clinical records, facility policy and interviews for four (4) of six (6) patients (Patient #1, #7, #10 and Patient #12), reviewed for assessments, the facility failed to obtain vital signs and ensure abnormal vital signs were addressed with the physician per facility The findings included: 1. Patient #1 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis treatments three (3) times a week, for three (3) hours per treatment, using 2.0 potassium/2.5 calcium dialysate, at a blood flow rate (BFR) of 450, a dialysate flow rate (DFR) of 600, while using a central venous catheter (CVC). Review of Patient #1’s treatment records identified the following: a. On 6/23/25, treatment was initiated at 10:53 AM. Intradialytic pressures of 184/120 at 10:53 AM, 188/123 at 11:32 AM, and 189/123 at 12:02 PM were recorded, however, the record failed to identify the patient’s blood pressure was rechecked or that the patient was further assessed by a registered nurse. b. On 7/4/25, treatment was initiated at 10:26 AM. Intradialytic blood pressures of 181/115 at 10:26 AM 196/122 at 10:31 AM, 200/123 at 11:01 AM, 197/117 at 11:02 AM, and were recorded, however, the record failed to identify the nurse was notified of the abnormal findings. c. On 7/9/25, treatment was initiated at 10:44 AM. Intradialytic blood pressures of 194/122 at 10:44 AM, 204/128 at 11:01 AM, and 207/137 at 11:31 AM were recorded, however, the record failed to identify the patient’s blood pressure was rechecked or that the patient was further assessed by a registered nurse. 2. Patient #7 had diagnoses that included ESRD. Physician’s orders directed to hemodialysis treatments three (3) times a week for three (3) hours and thirty (30) minutes per treatment, using 2.0 potassium/2.5 calcium dialysate, at a blood flow rate (BFR) of 350, a dialysate flow rate (DFR) of 600, while using a left upper arm arteriovenous fistula. Review of Patient #7’s treatment records identified the following: a. On 7/5/25, treatment was initiated at 6:34 AM. Intradialytic blood pressures of 241/148 at 6:34 AM, 242/125 at 6:38 AM, 215/121 at 7:11 AM, 207/108 at 8:01 AM, 199/108 at 8:23 AM, 224/128 at 8:40 AM, 204/110 at 9:03 AM, and 201/104 at 9:12 AM were recorded. The treatment record further identified a pre-treatment sitting blood pressure of 208/166 and post-treatment sitting blood pressure of 204/104, however, the record failed to identify the patient was further assessed by a registered nurse or that the physician was notified. b. On 7/8/25, treatment was initiated at 6:27 AM. Intradialytic blood pressures of 253/124 at 6:31 AM, 244/130 at 7:01 AM, 206/108 at 8:01 AM, 194/103 at 8:31 AM, 227/115 at 9:01 AM, and 207/109 at 9:31 AM were recorded. The treatment record further identified a pre-treatment sitting blood pressure of 249/171 and post-treatment sitting blood pressure of 207/109, however, the record failed to identify the blood pressures were rechecked, that the patient was further assessed by a registered nurse, or that the physician was notified. 3. Patient #10 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left forearm arteriovenous fistula (AVF). The annual stable care plan dated 12/18/24 identified for the care area of fluid and blood pressure, Patient #10’s blood pressure was within range. Review of Patient #10’s hemodialysis flowsheets identified the following: a. On 6/28/25 Patient #10 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. b. On 7/1/25 Patient #10 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. Patient #10’s post treatment sitting blood pressure was 187/106. The medical record failed to identify if Patient #10’s hypertension was addressed and/or if the physician was notified. c. On 7/3/25 Patient #10 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. Patient #10’s post treatment sitting blood pressure was 184/116. The medical record failed to identify if Patient #10’s hypertension was addressed and/or if the physician was notified. d. On 7/5/25 Patient #10’s post treatment standing blood pressure was 187/117. The medical record failed to identify if Patient #10’s hypertension was addressed and/or if the physician was notified. e. On 7/10/25 Patient #10 ambulated independently and did not have a post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. f. On 7/12/25 Patient #10’s post treatment standing blood pressure was 181/114. The medical record failed to identify if Patient #10’s hypertension was addressed and/or if the physician was notified. 4. Patient #12 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left upper arteriovenous fistula (AVF). Review of the annual stable care plan dated 1/29/25 identified for the care area of fluid and blood pressure, Patient #10’s blood pressure was within range. Review of Patient #12’s hemodialysis flowsheets identified the following: a. On 6/27/25 Patient #12’s pre-treatment standing blood pressure was 217/129. Treatment was initiated at 6:56 AM and the nursing assessment was at 7:01 AM. The medical record failed to identify if the registered nurse was notified of Patient #12’s hypertension pre-treatment and if the patient was assessed pre-treatment. b. On 7/7/25 Patient #12’s post treatment standing blood pressure was 214/129. The medical record failed to identify if Patient #12’s hypertension was addressed and/or if the physician was notified. Interview with the Group Facility Administrator on 7/16/25 at 3:14 PM identified abnormal blood pressures (pre-treatment and intradialytic readings of greater than 180 systolic or less than 90 systolic, greater than 100 diastolic or less than 50 diastolic, and post-treatment sitting blood pressures greater than 140 or less than 90 systolic) require nursing notification and assessment and that the physician should be notified of the abnormal blood pressure readings even when the patient admits to not taking their blood pressure medication(s). Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed during pre-treatment data collection any abnormal findings or findings outside of patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse. If any abnormal finding id reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to initiation of dialysis. The policy further directed post treatment if an abnormal finding(s) or concern is identified post treatment, it needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. The licensed nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions or notifications of the physician are necessary prior to discharge from the facility. The abnormal findings are identified as pre-treatment blood pressure systolic greater than 180 and/or diastolic greater than or equal to 100 and post treatment standing systolic greater than 180 and/or diastolic greater than or equal to 100. 47491”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 44675 Based on clinical records, facility policy and interviews for two (2) of six (6) patients (Patient #2 and Patient #12), reviewed for anemia, for Patient #2, the facility failed to obtain hemoglobin levels as prescribed and document that an abnormal hemoglobin level was addressed, and for Patient #12 the facility failed to monitor iron levels per protocol. 1. Patient #2 had diagnoses that included End Stage Renal Disease. Review of the physician’s orders directed hemodialysis two times weekly for four (4) hours with a right central venous catheter (CVC). a) A physician’s order dated 11/11/24 directed hemoglobin two (2) times a month. Review of Patient #2’s January 2025 hemoglobin levels identified on 1/5/25 Patient #2’s hemoglobin was 8.0 (goal is greater than or equal to 10). There was only one Hemoglobin level drawn that resulted in the month of January although the patient attended dialysis four (4) times in January 2025. Review of the care plan dated 1/29/25 identified Patient #2’s current goal for anemia was to use the lowest dose of ESA (stimulate red blood cell production) to reduce the risk of a blood transfusion. A physician order dated 1/6/25 - 6/30/25 directed Epogen 15,000 units once a week for anemia (stimulates red blood cell production). Review of Patient #2’s lab results identified on 2/2/25 Patient #2’s hemoglobin was 7.9. There was only one Hemoglobin level drawn and resulted in the month of February although the patient attended dialysis four (4) times in February 2025. Review of Patient #2’s lab results identified on 4/6/25 Patient #2’s hemoglobin was 10.1. There was only one Hemoglobin level drawn and resulted in the month of April although there the patient attended dialysis seven (7) times in April 2025. b. Review of Patient #2’s hemoglobin levels identified on 5/11/25 Patient #2’s hemoglobin was 9.4. Review of Patient #2’s hemoglobin levels identified on 6/15/25 Patient #2’s hemoglobin was 7.5. Central Anemia Manager note dated 6/20/25 at 8:45 AM identified she communicated to the team for review the following: hemoglobin of 7.5. However, the medical record failed to identify the clinic followed up on Patient #2’s hemoglobin of 7.5. Review of Patient #2’s lab results identified on 6/27/25 Patient #2’s hemoglobin was 6.0. A Registered Nurse (RN) note dated 6/30/25 at 4:43 PM identified Patient #2 missed treatment. The practitioner was notified of Patient #2’s hemoglobin of 6. The patient was called and instructed to go to the hospital. A physician order dated 6/30/25 - current directed Epogen 20,000 units two times a week for anemia. A RN note dated 7/2/25 at 4:05 PM identified Patient #2 went to the emergency department yesterday (7/1/25) for a transfusion. Interview and record review with the Charge Nurse on 7/16/25 at 10:00 AM identified there was communication documented with the practitioner on 6/30/25 about Patient #2 going to get a blood transfusion but no documentation in regard to Patient #2’s hemoglobin of 7.5 on 6/18/25. Interview with the Physician Assist (PA) on 7/16/25 at 11:00 AM identified Patient #2’s hemoglobin was drawn on Wednesday 6/18/25 and resulted on Friday 6/20/25 of 7.5. She identified Patient #2 missed Friday 6/20/25 and Monday 6/23/25. She identified on 6/25/25 a transfusion was suggested for Patient #2 but Patient #2 refused due to the patient not feeling sick. She identified two treatments later on 6/30/25 Patient #2’s resulted hemoglobin was 6.0 and Patient #2 went to the emergency department for a transfusion. 2. Patient #6 was admitted to the facility on 5/5/25 with diagnoses that included AKI (Acute Kidney Injury). Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a right central venous catheter (CVC). A physician’s order dated 5/5/25 directed the “iron works protocol”. Review of Patient #6’s admission bloodwork results dated 5/5/25 identified Patient #6’s iron (carries oxygen throughout the body) was 41 (range 50-170), tstat (protein that carries iron in the blood) was 14 (range 16-46) and the ferritin (stores iron in the body) was cancelled. Patient #6 had no subsequent iron, tstat and/or ferritin labs in his/her medical record. A nurses note dated 5/27/25 identified the physician wanted Patient #6 to be on a loading dose of venofer (iron). A physician’s order dated 5/28/25 - 6/24/25 directed venofer (iron) 100 mg every treatment. Review of the medical record failed to identify that ferritin and tstat was drawn after completion of the loading venofer dose. Interview with the Charge Nurse on 7/16/25 at 9:28 AM identified Patient #6 should have monthly lab draws for iron, ferritin and tstat. Interview with the Physician on 7/16/25 at 1:56 PM identified Patient #6’s iron, ferritin and tstat should be drawn monthly. He identified Patient #6 received a loading dose of iron but the iron protocol would order maintenance venofer based on the lab results. Review of the iron works protocol identified the protocol monitors the specified labs and dosing of iron sucrose as part of the treatment of anemia related to ESRD or AKI. The policy directed that iron status will be monitored by testing the serum ferritin and tsat monthly. Serum ferritin and tstat will be repeated after completed of the loading dose.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 44675 Based on clinical records, facility policy and interviews for two (2) of six (6) patients (Patient #2 and Patient #12), reviewed for plan of care, the facility failed to adjust the patient’s plan of care for an outcome not achieved and update the care plan for an outcome not met per facility policy. 1. Patient #2 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis two (2) times weekly for four (4) hours with a right central venous catheter (CVC). Review of the monthly unstable care plan dated 1/29/25 identified Patient #2 missed seven (7) treatments and terminated treatment early on six (6) occasions in the month of January 2025 (out of 15 total treatments). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. Review of the monthly unstable care plan dated 2/24/25 identified Patient #2 missed six (6) treatments and terminated treatment early on seven (7) occasions in the month of February 2025 (out of 12 total treatments). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. Review of the monthly unstable care plan dated 3/17/25 identified Patient #2 missed one (1) treatments and terminated treatment early on thirteen (13) occasions in the month of March 2025 (out of 14 total treatments). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. Review of the monthly unstable care plan dated 4/17/25, identified Patient #2 missed two (2) treatments and terminated treatment early on eight (8) occasions in the month of April 2025 (out of 16 total treatments). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. Review of the monthly unstable care plan dated 5/19/25, identified Patient #2 missed ten (10) treatments and terminated treatment early on three (3) occasions in the month of May 2025 (out of 13 total treatments). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. Review of the monthly unstable care plan dated 6/19/25, identified Patient #2 missed one (1) treatment and terminated treatment early on two (2) occasions in the month of April 2025 (out of 8 total treatments at the time of data collection). Patient #2’s psychosocial goal was to attend dialysis treatment as prescribed. The timeframe was set for three (3) months with the intervention to provide psychosocial counseling as indicated. The interdisciplinary team failed to updated the care plan with new goals and/or interventions after Patient #2’s psychosocial goal was not achieved. Interview with the Social Worker on 7/16/25 at 2:00 PM identified Patient #2 was due for a new care plan goal and intervention and would update on the next monthly unstable care plan in July 2025. 2. Patient #12 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) weekly for four (4) hours with a left upper arteriovenous fistula (AVF). Review of the annual stable care plan dated 1/29/25 identified Patient #2 was to maintain adequacy goal. Review of Patient #12’s kt/v labs (adequacy of dialysis with the goal of 1.2 or greater) identified the following: i. On 4/10/25 the kt/v was .99 ii. On 5/16/25 the kt/v was .83 iii. On 5/19/25 the kt/v was 1.03 iiii. On 5/26/25 the kt/v was .72 iv. On 6/4/25 the kt/v was .88 v. On 6/13/25 the kt/v was .77 vi. On 6/23/25 the kt/v was .76 vii. On 7/9/25 the kt/v was .92 Interview with the Group Facility Administrator on 7/26/25 at 3:14 PM identified two (2) months of a patient not meeting the goal, the recommendation would be to implement a care plan goal and intervention(s). She identified Patient #12 should have an adequacy care plan. Review of the interdisciplinary team patient assessment and plan of care policy identified that the comprehensive assessment and plan of care will be used to develop the patient’s treatment plan and expectations for care. The policy directed that plan of care will address, but not be limited to an in-center hemodialysis kt/v (adequacy of dialysis) of at least 1.2 and psychosocial status which addresses necessary monitoring and social work interventions. The policy further directed if the expected outcome is not achieved, the interdisciplinary team (or IDT team member) will adjust the patient’s plan of care to achieve the specified goal. When a patient is unable to achieve the desired outcomes, the team will adjust the plan of care to reflect the patient’s current condition, document in the patient’s medical record the reasons why the patient was unable to achieve the goals and implement the plan of care changes.”

“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: 32738 Based on observations, clinical records, facility policy and interviews for one (1) of six (6) hemodialysis patients (Patient #11), reviewed for treatment prescriptions, the facility failed to ensure the patient’s hemodialysis treatment was in accordance with the physician orders, for two (2) of twelve (12) patients (Patient #1 and Patient #10) reviewed for treatment compliance, the facility failed to ensure that Against Medical Advice (AMA) forms were completed in accordance with facility policy, for one (1) of six (6) patients (Patient #9), reviewed for blood pressures, the facility failed to ensure an ambulatory patient had their post treatment standing blood pressure completed prior to leaving the clinic, and during flash tour of the facility, the facility failed to ensure the emergency evacuation box contained updated patient information and unexpired supplies. The findings included: 1. Patient #11 had a diagnoses that included End Stage Renal Disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left upper arteriovenous fistula (AVF) bloodflow rate (BFR) of 450 and dialysate flow rate (DFR) of 800. Review of Patient #11’s treatment flowsheet dated 7/5/25 identified Patient #11’s treatment was set at 600 DFR for the entirety of the treatment with no rationale as to why the prescribed DFR of 800 was not met. Observation conducted on 7/15/25 at 10:29 AM identified Patient #11 treating at Station #13, Machine #15 with the DFR set at 600 DFR. Review of the interdialytic treatment notes failed to identify was Patient #11’s DFR was 600 and not 800 as prescribed. Interview with Staff Person #5 at 10:35 AM identified Patient #11’s DFR should be 800 and subsequent to surveyor inquiry, Staff Person #5 changed Patient #11’s DFR to 800. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that during treatment if the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse notified. 2. Patient #1 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis treatments, for three (3) hours per treatment, using 2.0 potassium/2.5 calcium dialysate, at a blood flow rate (BFR) of 450, a dialysate flow rate (DFR) of 600, while using a central venous catheter (CVC). Review of Patient #1’s treatment records identified the following: i. On 6/23/25, Patient #1 was administered two (2) hours and twenty-five (25) minutes of treatment (terminated treatment thirty-five (35) minutes early). Review of Patient #1’s medical record failed to identify an AMA form was reviewed and completed. ii. On 7/2/25, Patient #1 was administered two (2) hours and thirty-three (33) minutes of treatment (terminated treatment twenty-seven (27) minutes early). Review of Patient #1’s medical record failed to identify an AMA form was reviewed and completed. 3. Patient #10 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left forearm arteriovenous fistula (AVF). A sample review of Patient #10’s dialysis treatment sheets identified the following: i. On 7/1/25 Patient #10 received three (3) hours and thirty-one (31) minutes of treatment (terminated 29 minutes early). The flowsheet and nursing notes failed to identified why Patient #10’s treatment was terminated early. Review of Patient #10’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. ii. On 7/3/25 Patient #10 received three (3) hours and twenty-nine (29) minutes of treatment (terminated 31 minutes early). The flowsheet and nursing notes failed to identified why Patient #10’s treatment was terminated early. Review of Patient #10’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. iii. On 7/5/25 Patient #10 received three (3) hours and thirty-three (33) minutes of treatment (27 minutes early). The flowsheet and nursing notes failed to identified why Patient #10’s treatment was terminated early. Review of Patient #10’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. iiii. On 7/8 /25 Patient #10 received three (3) hours and thirty (230) minutes of treatment (30 minutes early). The flowsheet and nursing notes failed to identified why Patient #10’s treatment was terminated early. Review of Patient #10’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. iv. On 7/10/25 Patient #10 received three (3) hours and twenty-six (26) minutes of treatment (34 minutes early). The flowsheet and nursing notes failed to identified why Patient #10’s treatment was terminated early. Review of Patient #10’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. Interview with the Group Facility Administrator on 7/16/25 at 3:17 PM identified patients were to complete an AMA form for early treatment terminations of five (5) minutes or greater. Review of the Early Termination or Arriving Late for Treatment policy directed Against Medical Advice (AMA) forms were to be signed with each early termination event and filed in the patient’s medical record. 4. Patient #9 had diagnoses that included ESRD. Review of physician’s orders directed to hemodialysis treatments, for three (3) hours per treatment, using 2.0 potassium/2.5 calcium dialysate, at a blood flow rate (BFR) of 450, a dialysate flow rate (DFR) of 600, while using a central venous catheter (CVC). Review of Patient #1’s treatment records on 7/1/25 and 7/8/25 failed to identify the patient was administered a post-treatment standing blood pressure, although ambulatory. Interview with the Group Facility Administrator on 7/16/25 at 3:19 PM identified ambulatory patients were to have a post-treatment standing blood pressure prior to exiting the facility. Review of the Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment policy directed pre and post treatment blood pressure measurements were required and for staff to document if the patient was unable to stand. 4. Observation on 7/14/25 at 9:45 AM of the Emergency Evacuation Kit identified the following: i. Patient Information Summary documentation with a print date of 5/3/25. ii. Fifteen (15) 3 milliliter safety lock syringes with an expiration date of 2/28/22. iii. Ten (10) 10 milliliter saline flushes with an expiration date of 4/30/25. iiii. Eight (8) intravenous administration sets with an expiration date of 12/6/24. Interview with the Group Facility Administrator on 7/16/25 at 3:20 PM identified expired supplies should be discarded of no later than the expiration date on the package and that patient information summaries were to be updated monthly. Review of the Facility Emergency Management Plan directed an updated copy of each patient’s treatment orders and medication list was to be placed in the Emergency Evacuation Kit at least monthly.”