Davita Gwu Southeast Dialysis

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 27689 Based on record review and interview, the facility failed to provide emergency preparedness training to its staff, based on the facility specific emergency plan. The findings include: There was no documentation to show that dialysis staff were provided an annual facility specific emergency preparedness training as required. The Facility Administrator confirmed the findings during a face-to-face interview on July 25, 2025, at approximately 4:00 PM.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 27689 Based on record review, interview, and staff interview, facility staff failed to provide orientation and training to patients based on its emergency plan. The findings include: There was no documentation to show that dialysis patients were made aware of the facility’s emergency plan and educated on proper procedures to safely disconnect from the machine in an emergency. The Facility Administrator confirmed the findings during a face-to-face interview on July 25, 2025, at approximately 4:00 PM.”

“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: 27513 Based on observations made on the Dialysis clinic treatment floor and interview with the Nurse Manager, facility staff failed to wear disposable gown to cover up street clothes when caring for patients in the dialysis unit clinic area as evidenced by a physician seen not wearing a disposable gown while caring for patients on the clinic treatment floor area. The findings include: On 07/22/2025 at approximately 10:25 PM, Employee#4 was observed wearing his regular clothing without PPE [disposable gown] covering his clothing in the dialysis clinic treatment area while interacting with his patients. During a face-to-face contact with Employee #4 on the dialysis unit clinical area, this surveyor reminded him he needed a disposable gown to be worn during visit to the dialysis treatment area. The Employee##, [Registered Nurse Manager] provided employee#4 a disposable gown to wear over his clothing while working with the dialysis patients in the clinical treatment area. The nurse response “all physicians are aware that disposable gowns are to be worn when they are interacting with the patients in the clinical treatment area”. The evidence showed the Employee#4, [Physician] failed to adhere to dialysis center protocol to wear proper PPE gown provided by the facility to cover up clothing while caring for patients on the clinical floor. These observations were acknowledged by Employee 3, [Registered Nurse Manager].”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 27513 Based on two (2) of 10 sampled patients and seventeen (17) supplemental patients reviewed on the Hepatitis Immunization Report and interview with the Nurse Manager, facility staff failed to ensure that the Hepatitis B virus (HBV) serologic status for two (2) supplemental patients were known upon admission to the dialysis unit, and to ensure that once the Hepatitis B virus (HBV) serologic status for two (2) sampled patients and fifteen (15) supplemental patients were known to the dialysis unit the patients were appropriately manage based on the results (Patients #7#, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, and #27). The findings include: The Centers for Disease Control (CDC) stipulates, “Chronic Hemodialysis Patients. Routinely test all chronic hemodialysis patients for HBV and HCV infection ..., promptly review results, and ensure that patients are managed appropriately based on their testing results ... Communicate test results (positive and negative) to other units or hospitals when patients are transferred for care. ... The HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs) of all patients should be known before admission to the hemodialysis unit. For patients transferred from another unit, test results should be obtained before the patients ’ transfer. If a patient ’ s s HBV serologic status is not known at the time of admission, testing should be completed within 7 days. The hemodialysis unit should ensure that the laboratory performing the testing for anti-HBs can define a 10 -mIU/mL concentration to determine protective levels of antibodies. Persons who test negative for HBsAg should be considered susceptible to HBV infection. Hepatitis B vaccination is recommended for all susceptible chronic hemodialysis patients on admission ... Susceptible patients should begin receipt of hepatitis B vaccine immediately upon admission” www.cdc.gov/mmwr/pdf/rr/rr5005.pdf A. Facility staff failed to ensure that the Hepatitis B virus (HBV) serologic status for two (2) supplemental patients be known before admission or the testing completed within seven days after admission. (Patient #19, and #20). 1. Patient #19 admission date was 07/08/2025. The documentation in the space allotted for the result stated “Hepatitis B surface antigens (HBsAg) test not available/ treat as unknown. The patient has no current HepB vaccination documented”, indicating not done. 2. Patient #20 admission date was 05/20/2025. The documentation in the space allotted for the result stated “Hepatitis B surface antigens (HBsAg) test not available/ treat as unknown. The patient has no current HepB vaccination documented”, indicating not done. The Immunization Summary Report record showed evidence that before and within seven (7) days of admission to the facility, facility staff failed to complete patients #19, and #20 Hepatitis B surface antigens (HBsAg) tests, and their HBV serological status were unknown. A face-to-face interview was conducted with the Nurse Manager on 07/25/2025, at approximately 2:45 PM. She acknowledged the findings. B. Facility staff failed to ensure that once the Hepatitis B virus (HBV) serologic status for two (2) sampled patients and fifteen (15) supplemental patients were known to the dialysis unit the patient’s vaccination would be appropriately managed based on the results. (Patients #7, #10, #11, #12, #13, #14, #15, #16, #17, #18, #21, #22, #23, #24, #25, #26, and #27). 1. Patient #7 admission date was 06/27/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 01/24/2025 <10 [6]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 2. Patient #10 admission date was 09/08/2023. Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 03/05/2025 <3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 3. Patient #11 admission date was 03/31/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 04/01/2025 <10 [6]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 4. Patient #12 admission date was 05/05/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 05/14/2025 was <10 [7]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 5. Patient #13 admission date was 04/01/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 02/13/2025 was <10[7]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 6. Patient #14 admission date was 03/21/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 03/25/2025 was <3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 7. Patient #15 admission date was 03/18/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 03/24/2025 was <10 [3]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 8. Patient #16 admission date was 07/09/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 07/14/2025 was <10 [4]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 9. Patient #17 admission date was 11/01/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 11/04/2024 and 02/12/2025 was <10 [5]. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 10. Patient #18 admission date was 09/11/2024. Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 09/14/2024 was 5 and on 02/13 2025 was 4. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 11. Patient #21 admission date was 05/12/2021. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 2/15/2024 was <3, on 02/12/2025 was <3, and on 03/28/2025 3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 12. Patient #22 admission date was 11/01/2022. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 02/16/2023 was <3, on 02/15/2024 was <3, and on 02/13/2025 was 3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 13. Patient #23 admission date was on 06/04/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 07/23/2024 were <3, on 08/15/2024<3 and 02/13/2025 was 3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 14. Patient #24 admission date was 08/01/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 08/06/2024 was <3, and 02/18/2025 was 3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 15. Patient #25, admission date was 04/12/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 04/23/2024 was <3 , and on 02/13/2025 <3. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 16. Patient #26, admission date was 05/29/2024. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 08/15/2024 was 9, on 12/10/2024 was 3, and 02/13/2025 was 5. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. 17. Patient #27, admission date was 07/21/2025. The Hepatitis B surface antigens (HBsAg) test was negative with HBV serological status results on 07/21/2025 was <10. The space allotted for HepB vaccine administration read, “the patient has no current Hepatitis B vaccinations documented” indicating not done. The Immunization Summary Report record showed evidence that since admission staff failed to promptly review patients #7, #10, #11, #12, #13, #14, #15, #16, #17, #18, #21, #22, #23, #24, #25, #26, and #27 Hepatitis B surface antigens (HBsAg) test result and vaccinate based on their HBV serological status results. A face-to-face interview was conducted with the Nurse Manager on 07/25/2025 at approximately 2:45PM. She acknowledged the findings.”

“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: 27689 Based on observations and interview, it was determined that facility staff failed to provide dialysis patients with a safe, functional, and comfortable treatment environment. The findings include: During a walkthrough of the storage room on July 21, 2025, at approximately 12:30 PM, 69 of 95 17g x 1” Nipro Safetouch Tulip Safety fistula needles were expired as of June 30, 2025. The Facility Administrator confirmed the findings during a face-to-face interview on July 21, 2025, at approximately 1:00 PM.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 27689 Based on observations and interview, it was determined that facility staff failed to comply with the 2012 edition of the Life Safety Code of the National Fire protection Association (NFPA) 101, as evidenced by a ‘trouble’ alarm that continuously flashed on the fire alarm panel and a lack of documented fire drills during the year of 2024 and 2025. The findings include: 1. The facility’s fire alarm control communicator box continuously beeped and flashed a ‘trouble’ message on the screen. The message read “System Trouble Phone line”. The 2012 Edition of NFPA 101 section 9.6.1.3 states “A fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code, unless it’s an approved existing installation, which shall be permitted to be continued in use.” The 2010 edition of NFPA 72 section 14.2.1.2.2 states “System defects and malfunctions shall be corrected”. 2. Fire drills documentation for the year 2024 through 2025, were not available for review. Evidence that fire drills were conducted quarterly once per quarter per shift as required was not presented during the survey. The 2012 Edition of NFPA 101section 21.7.1.6 states “...Drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions”. During a face-to-face interview on July 25, 2025, at approximately 4:00 PM, the facility administrator acknowledged the findings.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 27513 Based on the record review of two (2) of 10 sampled clinical records and interview with the Nurse Manager, the facility staff failed to ensure that a current Annual History and Physical (H&P) was completed and were part of the patient’s clinical records. (Patients’ 6, and #9). Findings included ... 1. A review of Patient#2’s clinical record showed an admission date of 08/07/2023. The annual H and P on the chart was dated 08/01/2023. The annual H and P for the year 2024 was not on clinical record. 2. A review of Patient#6’s clinical record showed an admission date of 06/13/2022. The annual H and P on the chart was dated 05/04/2022. The annual H and P for the year 2023 and 2024 was not on the clinical record. A face-to-face interview was conducted on 07/25/2021, at approximately 11:45 AM with the Nurse Manager. She acknowledged the findings and stated, “Will get the patient current H&P on the patient’s chart.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 27513 Based on a review of the Vaccination/ Report record for five (5) of 10 sampled patients and 12 supplemental patients and interview with the Nurse Manager, facility staff failed to track and trend the 17 patient’s immunization history for Influenza and Pneumococcal, to document the patient’s immune status. (Patients #1, #3, #5, #7, #9, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, and #22 ). Findings include: According to the Center for Disease Control and Prevention (CDC) recommends that all dialysis patients: “ ... Be offered the Influenza and Pneumococcal vaccine and have immunization histories for these vaccines to be tracked. Both are universally recommended for this population and relate directly to infection control issues.” On 07/23/2025, a review of the Vaccination/Test Result Report record showed the following: 1. Patients’ #1, #3, #11, #12, #13, #16, #18, #19, #20, #21, and #22 immunization history for Influenza was not found on their record. 2. Patients’ #5, #7, #9, #11, #13, #14, #15, #16, #17, #18, #19, and #20 immunization history for Pneumococcal vaccine status was not found on their record. There was no documented evidence in the clinical record that the patients were offered the Influenza and Pneummocal vaccine in accordance with the CDC guidelines. A face-to-face interview was conducted with the Nurse Manager on 07/25/2025, at approximately 2:45PM. She acknowledged the findings.”

“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: 27513 Based on a review of four (4) of the ten (10) sampled clinical records and interview with the Nurse Manager, the facility staff failed to ensure that four 4 sampled patient achieved their prescribed dialysis dry weight per the post dialysis treatment record. (Patient #1, # 3, #7, and #10). The findings include: 1.A review of the Patient #1 treatment flow sheet records dated from 07/01/2025 to 07/19/2025 showed a prescribed dry weight rate of 74.5kg, this dry weight prescription was dated 06/21/2025. A review of the treatment sheets for dates mentioned above showed the following post dialysis dry weights: 07/01/2025, Post dry weight 75.3 kg 07/05/2025, Post dry weight 75.7kg 07/08/2025, Post dry weight 76.5kg, 07/10/2025, Post dry weight 74.9kg 2 A review of the Patient #3 treatment flow sheet records dated from 07/02/2025, to 07/21/2025 showed a prescribed dry weight rate of 72kg, this dry weight prescription was dated 03/21/2025. A review of the treatment sheets for dates mentioned above showed the following post dry weights: 07/02/2025, Post dry weight 73.0kg 07/04/2025, Post dry weight 74.4kg 07/07/2025, Post dry weight 74.5kg 07/09/2025, Post dry weight 74.5kg 07/11/2025, Post dry weight 73.6kg 07/21/2025, Post dry weight 73.2kg 3 A review of the Patient #7 treatment flow sheets dated from 07/01/2025 to 07/19/2025 showed a prescribed dry weight rate of 55kg, this dry weight prescription was dated 05/31/2025. A review of the treatment sheets for dates mentioned above showed the following post dry weights: 07/01/2025, Post dry weight 66kg 07/05/2025, Post dry weight 57.5kg 07/08/2025, Post dry weight 69.5kg 07/10/2025, Post dry weight 68.6kg 07/12/2025, Post dry weight 61.4kg 07/15/2025, Post dry weight 67.4kg 07/17/2025, Post dry weight 65.2kg 07/19/2025, Post dry weight64.5 kg 4.A review of the Patient #10 treatment flow sheets dated from 07/02/2025 to 07/21/2025 showed a prescribed dry weight rate of 90.5kg, this dry weight prescription was dated 05/19/2025. A review of the treatment sheets for dates mentioned above showed the following post dry weights: 06/30/2025 Post dry weight 91.8kg 07/07/2025, Post dry weight 110kg 07/09/2025, Post dry weight 110.5kg It should be noted dry weight rate was changed to 88 07/16/2025 Post dry weight 108.7kg 07/18/2025, Post dry weight 108.6kg 07/21/2025, Post dry weight 107.9kg The evidence revealed that facility staff failed to achieve Patient #1, # 3, #7, and #10#’s prescribed estimated dry weight on the four (4) patients treatment flow sheets records that were reviewed by the surveyor. A face-to-face interview was conducted on 07/25, 2025, at approximately 2:45PM with the Nurse Manager. She acknowledged the findings.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 27513 Based on six (6) of 10 sampled patients clinical record review and interview with the Nurse Manager, facility staff failed to ensure that the sampled patients’ (TT) Treatment Time, BFR (blood flow rate) and DFR (dialysis flow rate) were achieved and sustained according to the rate prescribed by the physician. (Patients #3, #4, #6, #9, and #10) The findings include ... 1.Patient #3 Physician order on the Dialysis Treatment Sheet directed “Treatment time 3h 30m and BFR 350 “. Review of the Treatment sheet showed that on 07/02/2025 dialysis treatment time 3h 1m, on 07/04/2025 dialysis treatment time 2h 19m, on 07/07/2025 dialysis treatment time 2h 42m and the dialysis BFR “300/200” and on 07/09/2025 dialysis treatment time 2h 54m for dialysis treatment performed on the date mentioned. 2. Patient #4 Physician order on the Dialysis Treatment Sheet directed “DFR 600”. Review of the Dialysis treatment sheet showed that on 07/18/2025 “DFR 500’ for dialysis treatment performed on the date mentioned. 3. Patient #6 Physician order on Dialysis Treatment Sheet directed “Treatment Time 3h [hour], 30m [minutes], BFR 400 and DFR 500”. Review of the Treatment Sheet showed that on 07/04/2025 the treatment time was 3h, and the “DFR 600”, on 07/09/2025 the treatment time was 2h 45m, and on 07/21/2025 “BFR 350” for dialysis treatment performed on the dates mentioned. 4. Patient #9 Physician order on Dialysis Treatment Sheet directed “BFR 350 and DFR 600”. Review of the Treatment Sheet showed that on 07/09/2025 showed the “DFR 500”, on 07/11/2025 “BFR 300”, on 07/16/2025 “DFR 500” and on 07/21/2025 “BFR 300” for dialysis treatment on the dates mentioned 5. Patient #10 Physician order on Dialysis Treatment Sheet directed “BFR 450 and DFR 600”. Review of the Treatment Sheet showed that on 06/30/2025 “BFR 400/DFR 300”, on 07/04/2025 “BFR 400”, on 07/07/2025 “BFR400/DFR500”, on 07/09/2025 “BFR 400”, on 07/16/2025 “BFR 400” and on 07/18/2025 “BFR 400” for dialysis treatment on the dates mentioned. The evidence showed that the facility staff failed to ensure that the five (5) sampled patients’ TT (treatment time), BFR (blood flow rate), and DFR (dialysis flow rate) were achieved and sustained according to the rate prescribed by the physician on the dates mentioned above. A face-to-face interview was conducted with Employee#3 [Nurse Manager] on 07/25/2025, at approximately 2:45PM. She acknowledged the findings.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 27513 Based on the clinical record review of two (2) supplemental patients and an interview with the Clinical Manager, facility staff failed to ensure that the patient’s Albumin levels were achieved and sustained according to their established target goals of greater than 4.0. (Patients #11, and #14). The findings include ... 1.Review of the Albumin levels for Patient#11 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #11 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 04/01/2025 Albumin level was 2.9, 05/01/2025 Albumin level was 3.4, and 06/12/2025 Albumin level was 3.2. The patient was admitted on 03/31/2025. 2. Review of the Albumin levels for Patient #14 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #14 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 05/22/2025 Albumin level was 2.2, 05/17/2025 Albumin level was 2.2, and 06/21/2025 Albumin level was 2.0. The patient was admitted on 03/21/2025. The evidence showed that facility staff failed to ensure that Patient#11, and #14 Albumin levels were achieved and sustained according to the established target goals mentioned above. A face-to-face interview was conducted on 07/25/2025 at approximately 2:45 PM the Nurse Manager. He acknowledged the findings.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 27513 Based on reviews of two (2) of 10 sampled patient and 11 supplemental patients clinical records and interview with the Clinical Nurse, facility staff failed to ensure that the patients received adequate dosage of Erythropoietin Stimulating Agent medication (ESA) to maintain their anemia management needs between the clinical target level (10 -12 g/dl). (Patient #3, #7, #11, #18, #23, #29, #38, #39, #40, #41, #42, #43, and #44). The findings include: A review of the Lab Results/Medication Administration Summary record showed that facility staff failed to ensure that the 13 patients had adequate dosage of Erythropoietin Stimulating Agent medication (ESA) to maintain their anemia management needs between clinical target levels (10 -12 g/dl). 1. A review of Patient #3’s clinical record showed the Hemoglobin [Hgb] lab values on 05/05/2025 was 5.9, 05/282025 was 7.9, and 06/25/2025 was 7.7. 2. A review of Patient #7’s medical record showed the Hemoglobin lab values on 05/01/2025 was 8.7, 05/29/2025 was 8.7, and 06/26/2025 was 9.9. 3. A review of Patient #11’s clinical record showed the Hemoglobin [Hgb] lab values on 04/01/2025, was 8.2, 05/01/2025, was 8.7, and 06/26/2025 was 9.1. 4. A review of Patient #18’s clinical record showed the Hemoglobin [Hgb] lab values on 04/03/2025 was 12.9, 05/01/2025 was 7.5, and 06/26/2025 was .9.3. 5. A review of Patient #23’s clinical record showed the Hemoglobin [Hgb] lab values on 05/01/2025 was 9.0, 06/10/2025 was 7.1, and 06/25/2025 was 7.2. 6. A review of Patient #29’s clinical record showed the Hemoglobin [Hgb] lab values on was 04/03/2025 8.2, 05/01/2025 was 7.2, and 06/02/2025 was 6.5. 7. A review of Patient #38’s clinical record showed the Hemoglobin [Hgb] lab values on 05/05/2025 was 12.5, 05/28/2025 was 12.8, and 06/25/2025 was 13.8. 8. A review of Patient #39’s clinical record showed the Hemoglobin [Hgb] lab values on 05/01/2025 was 9.6, 05/29/2025 was 9.3, and 06/26/2025, was 9.0. 9. A review of Patient #40’s clinical record showed the Hemoglobin [Hgb] lab values on 05/05/2025, were 14.0, 05/28/2025, was 14.5, and 06/25/2025, was 13.5. 10. A review of Patient #41’s clinical record showed the Hemoglobin [Hgb] lab values on 05/01/ 2025 were 9.2, 05/29/2025, was 8.2, and on 06/26/2025, was 8.2. 11. A review of Patient #42’s clinical record showed the Hemoglobin [Hgb] lab values on 05/06/2025, was 7.5, 05/29/2025 was 7.0, and on 06/26/2025, was 7.8. 12. A review of Patient #43’s clinical record showed the Hemoglobin [Hgb] lab values on 05/05/2025, were 8.6, 05/28/2025, was 8.0, and on 06/25/2025, was 8.9. 13. A review of Patient #44’s clinical record showed the Hemoglobin [Hgb] lab values on 04/02/2025, was 12.6, 05/05/2025, was 13.0, and on 06/04/2025, was 13.7. It should be noted that the Lab Results / Medication Administration Summary Record of Hb [hemoglobin] values were not found within the range of 10-12 g/dL for the patients mentioned above anemia management. The evidence of Hb values show that over 2/3 months facility staff failed to ensured Patients received the adequate dosage of Erythropoietin Stimulating Agent medication (ESA) to maintain the anemia management clinical range. According to CMS National Coverage Analysis Erythropoietin Stimulating Agents (ESA) for Treatment of Anemia in Adults with Chronic Kidney Disease (CKD) Including Patients on Dialysis and Patients not on Dialysis: “... With the use of ESAs in the anemic CKD patients, Hb [hemoglobin] values are well maintained and blood transfusions, with their associated risks, are reduced. When patients with anemia of CKD are treated to HB levels greater than 12 g/dL, there appears to be a greater risk for adverse outcomes compared to patients treated to Hb targets less than 12 g/dL. The current labels for ESAs marketed in the United States provide guidance on the appropriate Hb range for patients with chronic renal failure and dosage and administration guidance to initiate and maintain the HB within the range of 10-12 g/dL for all these patients.” www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/0715PhillipsComment.pdf A face-to-face interview was conducted on 02/25/2025 at approximately 2:45PM with the Nurse Manager. She acknowledged the findings.”

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 27513 Based on review of four (4) of ten (10) sampled patient clinical records and interview with the Nurse Manager, facility staff failed to maintain availability of the medication Micera for the use of the 4 patients to address anemia management. (Patient #1, #2, #7 and #9). The findings include ... Review of the four (4) patients dialysis treatment record showed Physician Order that direct, “Micera intravenous, push ESA dosing every two weeks”. Review of Patient #1,#2,#7 and #9 Dialysis treatment flow sheets dated from 06/30/2025 to 07/21/2025 documentation under medication administered during dialysis showed that for the 4 patients mentioned “Micera (dosage) not given, reason: not in stock”. It should note that “the patients were not given medication Micera because it was not available in stock” during the dates mentioned. A face-to-face interview was conducted on 02/25/2025 approximately 2:45 PM with the Nurse Manager. She acknowledged the findings”

“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: 27513 Based on the review of ten (10) sampled patient Treatment Detail Records and interview with the Nurse Manager, facility staff failed to maintain a complete, and accurate record of the ten patients’ replacement fluid as it pertains to the dialysis treatment record. (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9, and #10) The findings include ... 1.A review of Patient #1’s Treatment Details Report sheets dated from 07/01/2025, to 07/19/2025, showed that the patient had nine (9) treatments completed. The treatment flow sheet of the dates mentioned showed that the 9 treatment flow sheet showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicating that the amount of normal saline fluid given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given, indicating “not done”. 2. A review of Patient #2’s Treatment Details Report flow sheets dated from 06/30/2025 to 07/21/2025, showed that the patient had 10 treatments completed. The treatment flow sheet of the dates mentioned showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicating that the amount of normal saline fluid given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was not documented as given, indicating “not done”. 3. A review of Patient #3 Treatment Details Report sheets dated from 06/30/2025, to 07/21/2025, showed that the patient had eight (8) treatments completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 4. A review of Patient#4’s Treatment Details Report sheets dated from 07/18/2025, to 07/21/2025, showed that the patient had two (2) treatments completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 5. A review of Patient#5’s Treatment Details Report sheets dated from 07/08/2025 to 07/21/2025, showed that the patient had three (3) treatments completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 6. A review of Patient#6’s Treatment Details Report sheets dated from 06/30/2025, to 07/21/2025, showed that 10 treatments were completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 7. A review of Patient#7 Treatment Details Report sheets dated from 07/01/2025, to 07/02/2025, showed that nine (9) treatments were completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 8. A review of Patient#8 Treatment Details Report sheets dated from 07/01/2025 to 07/19/2025, 2024, showed that nine (9) treatments were completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 9. A review of Patient#9 Treatment Details Report sheets dated from 06/30/2025, to 07/19/2025, showed that nine (9) treatments were completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. 10. A review of Patient#10 Treatment Details Report sheets dated from 07/02/2025, to 07/21/2025, showed that nine (9) treatments were completed. The treatment flow sheet of the dates mentioned above showed the space allotted for documentation of fluid given on the Treatment Detail Reports was left “blank” indicting that the amount of normal saline given during the process of priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment was left “blank” indicating “not done”. It should be noted that the saline fluid needs to be documented in Realtime [has it happens] because it is for treatment, the administration date, the amount and time the saline were administered. The Treatment Details Report sheets mentioned above for Patients #1, #2, #3, #4, #5, #6, #7, #8. #9, and #10 showed evidence that facility staff failed to maintain a complete, and accurate record of the patients’ replacement fluid as it pertains to the dialysis treatment record during the priming at the initiation of dialysis, throughout dialysis, and for rinse back at the termination of dialysis treatment. The area under “Saline” allotted to document the amount of saline fluid administer during treatment was left Blank indicating “not done”. A face-to-face interview was conducted on 07/25/2025 at approximately 2:45 PM with the Nurse Manager. She acknowledged the findings and stated “All patients receive 250ml of saline fluid during initiation of dialysis, and at termination of dialysis another 250ml of saline fluids, equaling 500ml of normal saline unless otherwise throughout treatment (cramping or blood pressure drop, patient unresponsive) extra fluids are given.”