Rai Potomac Dialysis

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 27689 Based on record review and interview, facility staff failed to maintain an updated emergency preparedness plan every two years. The findings include: On June 5, and June 9, 2025, a review of the facility’s Emergency Preparedness plan lacked documentation to confirm the plan was updated within the required timeframe of a minimum of two (2) years. During a face-to-face interview on June 9, 2025, at approximately 1:00 PM, the Facility Administrator confirmed the findings.”

“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 observation, record review, and interview with the Clinical Manager, facility staff failed to ensure staff donned the appropriate PPE [Personal protective equipment] for covering their face while attending to patients in the dialysis clinical treatment area. The findings include ... “Staff members must wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing, must wear a cover garment which provides an impervious barrier to fluids if they are providing service to any patient in the treatment area during a time of high risk for spurting and splattering of blood, for example, during initiation or termination of dialysis. Staff PPE must be a gown, face shields, eyewear or masks to protect themselves.” swww.cms.gov/Medicare/Provider-Enrollment-andCertification/GuidanceforLawsAndRegulations/Downloads/esrdpgmguidance.pdf During observation in the clinical treatment area on 6/4/2024 at 10:00 am, Employee#5, CCHT [Certified Clinical Hemodialysis Technician] was observed without the appropriate PPE covering on her face while discontinuation [termination] of a patient dialysis treatment. It should be noted that at the time of observation Employee was not wearing appropriate type of PPE [face shield] while termination of patient’s dialysis where she was removing the patient’s needles from the access site and stopping the bleeding at the access site. 0n 6/4/2024 at approximately 10:05AM when Employee#6 [CCHT] was query concerning “wearing of inappropriate PPE eye covering in the clinical area”. She acknowledged the findings and stated, “It was given to me by a previous facility staff who told us the glasses were safe to wear during care”. A face-to-face interview was conducted on 06/09/2025 at approximately 2:45PM with Employee#2 [Clinical Manager] who acknowledge the finding, He stated “Staff will be educated”.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 27513 Based on observation and interview with the Clinical Manager, facility staff failed to maintain functional biohazard waste containers with intact covers for the handling, storage, and disposal of potentially infectious waste. The findings include... “Potentially infectious waste and soiled will be placed in sealable, leak-proof biohazard waste bags that are clearly marked or colored. All extracorporeal disposable supplies such as dialyzers and bloodlines will be placed in the red biohazard waste bags immediately after use.” “Biohazardous waste containers should be clearly labeled and sealed prior to being full” www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/esrdpgmguidance.pdf During the survey “Environmental Flash Tour” on 6/4/205, the following observations were made: At 10:00 AM four (4) of four (4) Biohazard waste container large red boxes were observed to have no covers and this caused them to be left open exposing the contents in the containers [soiled supplies containers and covers, soiled used dialyzers and tubing with visible blood,]. All four (4) containers had the content mentioned above in them or were placed in them by the CCHT [Certified Clinical Hemodialysis Technician]. At 10:15 AM face-to-face interview was conducted with Employee#2 [Clinical Manager] concerning the biohazard waste containers having no covers, he stated the covers were around here somewhere and will have staff to replaced them. It should be noted upon evaluation of biohazard box cover showed that the lids were completely broken off the containers and were not able to open place item in and return to a lock position. The broken lids were taken off and laid around in cornered areas on the dialysis unit. A face-to-face interview was conducted on 06/09/2025, at approximately 2:45pm with Employee#2 [Clinical Manager]. He acknowledged the findings and stated, “we will replace the covers for the biohazard waste containers”.”

“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 record review and interview with the Clinical Manager, facility staff failed to ensure that four (4) sampled patient and nine (9) Supplemental patients’ hepatitis B levels were managed based on the results of their Hepatitis B Surface Antibody [HBsAb] test. Patient #1, #4, #6, #8, #13, #14, #15, #16, #17, #18, #19, #20 and, #30. The Findings include ... According to the CDC [Center for Disease Control]: “The CDC defines an adequate response to vaccination as a laboratory result of greater or equal 10mIU/mL anti-HBs. All susceptible patients are offered an appropriate Hepatitis B vaccination schedule in an appropriate timeframe. “Appropriate timeframe” means that vaccinations should be offered upon admission or earlier for patients and the course completed according to the timeline suggested by the manufacturer of the vaccine. The HBV serological status of all patients should be known before admission to the hemodialysis unit and treatment. If the results of this testing are not known at admission because of an emergency situation, the patient should be tested immediately upon intake, and results known within 7 days of admission. Promptly review results and ensure that patients are managed appropriately based on their testing results.” Review of the Hepatitis Summary Report showed the management of 15 patients’ hepatitis levels based on their test HBsAb results. 1.Patient #1 HBsAb lab results showed that on 02/19/2025 (<10) and 05/21/2025 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 02/19/2025. 2.Patient #4 HBsAb lab results showed that on 10/25/2019 (<10), and 11/27/2025 (<10). The space allotted for vaccine status is documented as “given” on 06/12/2024 and 07/29/2024. No lab results were posted at the admission time frame. The patient was admitted on 02/16/2024. 3.Patient #6 HBsAb lab results showed that on 03/01/2024 (<10), and 05/21/2025 (<10). The space allotted for vaccine status is documented as “given” on 08/24/2024. No lab results were posted at the admission time frame. The patient was admitted on 02/28/2024. 4.Patient #8 HBsAb lab results showed that on 05/07/2024 (<10), and 05/22/2025 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 02/19/2024. 5.Patient #13 HBsAb lab results showed that on 11/29/2023 (<10) and 11/11/2024 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 11/29/2023 6.Patient#14 HBsAb lab results showed that on 01/31/2025 (<10), and 01/31/2025 (<10). The space allotted for vaccine status is documented as “not given indicating no action was taken regarding the lab results posted. The patient was admitted on 06/19/2023. 7.Patient #15 HBsAb lab results showed that on 10/03/2014(<10), and 08/07/2024 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding lab results posted. The patient was admitted on 08/08/2024. 8.Patient #16 HBsAb lab results showed that on 10/14/2024 (<10), and 02/20/2025 (<10). The space allotted for vaccine status is documented as “given” on 06/12/2024. No lab results were posted at the admission time frame. The patient was admitted on 07/17/2023. 9.Patient#17 HBsAb lab results showed that on 10/27/2022(<10), and 05/21/2025 (<10). The space allotted for vaccine status is documented as “given” on 11/20/2022 and 08/08/2023. There was no lab results posted for 2023, and no action was taken regarding lab results posted for 2024. The patient was admitted on 04/24/2016. 10.Patient #18 HBsAb lab results showed that on 05/05/2025 (<10). The space allotted for vaccine status is documented as “given” on 06/12/2024. No lab results were posted at the admission time frame. The patient was admitted on 08/15/2023. 11.Patient #19 HBsAb lab results showed that on 09/12/2022 (<10), and 01/31/2025 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 09/23/2022. 12.Patient #20 HBsAb lab results showed that on 06/01/2024 (<10), and 08/07/2024 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 04/09/2024. 13. Patient #30 HBsAb lab results showed that on 06/01/2024 (<10), and 10/07/2024 (<10). The space allotted for vaccine status is documented as “not given” indicating no action was taken regarding the lab results posted. The patient was admitted on 04/09/2024. A face-to-face interview was conducted on 06/09/2025, at approximately 2:45pm, with Employee #2 [Clinical Manager]. He acknowledged the findings.”

“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: 27513 Based on observations made during a tour of the dialysis clinical area, showed that the facility staff failed to ensure that infection control practices were maintained for one (1) patient while the catheter dressing change was being performed. Patient #16 The findings include: On 06/03/2025 at approximately 10:15am Employee#7 [CCHT] was observed performing catheter dressing site care on Patient#16’s chest area. The employee had her appropriate PPE on, but the staff failed to ensure the patient was wearing a face mask during the patient ’ s catheter site care. “Airbourne contaminants from both patients and staff are prevented best by the use of surgical mask when the catheter lumen and access site are exposed. Patients who undergo dialysis treatment have an increased risk of getting a healthcare-associated infection (HAI). Hemodialysis patients are at a high risk for infection because the process of hemodialysis requires frequent use of catheters or insertion of needles to access the bloodstream. Also, hemodialysis patients have weakened their immune systems, which increase their risk for infection, and they require frequent hospitalization and surgery where they might acquire an infection.” http://www.cdc.gov/dialysis/ The dialysis technician at the time of observation did not ensure infection control was maintained during catheter care dressing change by making sure the patient was wearing a surgical mask to prevent infection via the patient’s dialysis access site. A face-to- face interview was conducted on 06/09/2025 at approximately 2:45pm with the Clinical Manager. He acknowledged the finding and stated, “Each dialysis technicians received an annual in-service on infection control.”

“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 made from June 4, 2025, through June 9, 2025, it was determined that facility staff failed to provide dialysis patients with a safe, functional, and comfortable treatment environment. The findings include: 1. Eight (8) of eight (8) oxygen tanks were stored upright and unsecured, on the floor at the entrance of the storage room. 2. Six (6) of 21 television (TV) sets, assigned to patient stations #3, #9, #11, #16, #17, and #21, were not functioning as expected. The TV’s either had sound problems, or connection problems, and could not be used as intended by patients. 3. A crawling insect that appeared to be a cockroach was observed on the floor of the patient treatment area on June 4, 20225, at approximately 10:30 AM, and another was seen on a wall in the staff breakroom on June 9, 2025, at 10:19 AM. 4. The digital hour meter to seven (7) of 23 dialysis machines were blank, indicating they were broken, and needed to be replaced. During a face-to-face interview on June 9, 2025, at approximately 1:00 PM, the Facility Administrator confirmed the findings.”

“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 eight (8) of eight (8) E size oxygen tanks that were unsafely stored, one (1) of one (1) fire sprinkler in the hallway of the storage room that was partially detached from the ceiling tile, and a lack of documented fire drills for the Tuesdays, Thursdays, and Saturdays (TTS) shifts for the year 2024, and the year 2025. The findings include: 1. Eight (8) of eight free standing oxygen cylinders (E size) were unsafely stored on the floor at the entrance of the storage room. This deficient practice did not meet the requirements of NFPA 99, Section 11.6.2.3. The 2012 edition of NFPA 99, section 11.6.2.3 states: 11.6.2.3 Cylinders shall be protected from damage by means of the following specific procedures: (11) freestanding cylinders shall be properly chained or supported in a proper Cylinder stand or cart. 2. One (1) of one (1) fire sprinkler located in the hallway of the storage room was partially detached from the ceiling tile. Section 9.7.5 of NFPA 101 Life Safety Code 2012 edition states: “All automatic sprinkler and standpipe systems required by this Code shall be inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, testing, and maintenance of water-based Fire Protection systems.” Section 5 of NFPA 25 states: 5.2.1.1.1* Sprinklers shall not show signs of leakage; shall be free of corrosion, foreign materials, paint, and physical damage; and shall be installed in the correct orientation (e.g., upright, pendent, or sidewall).” 5.2.1.1.1* Any sprinkler that show signs of any of the following shall be replaced: (1) Leakage (2) Corrosion detrimental to sprinkler performance (3) Physical damage (4) Loss of fluid in the glass bulb heat-responsive element (5) Loading detrimental to sprinkler performance (6) Paint other than that applied by the sprinkler manufacturer 3. Fire drills documentation for the third quarter of the year 2024, (TTS) shifts, and the first quarter of the year 2025, (TTS) shifts were not available for review, and fire drills were not conducted once per quarter per shift as required. The facility provides dialysis treatments for two (2) shifts on Mondays, Wednesdays, and Fridays (MWF), and two (2) shifts on Tuesdays, Thursdays, and Saturdays (TTS). 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 June 9, 2025, at approximately 1:00 PM, the Facility Administrator confirmed the findings.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 27513 Based on observation, patients and staff interviews, it was determined that facility staff failed to display the State Agency’s (current address and telephone complaint numbers), the dialysis network 5 contact information in an area of their facility lobby where it will be visible to patients, patient significant others and visitors. Findings included... During a tour of the facility’s waiting area on 06/04/2025, at approximately 2:19pm, the surveyor observed that there was no posting of the State Agency and/or Dialysis Network 5 contact information. An inquiry was made with Employee #2, [Clinical Manager], regarding State Agency and the Network 5 contact information not being posted along with the patient’s right information in an area where it will be visible to patients, patients significant others and visitors. The information that was pointed out to the surveyor confirmed there was no state agency or Network 5 contact information posted on the board in the patient waiting area. This observation was made and acknowledged by Employee #2, [Clinical Manager] on 06/04/2025, at approximately 2:30pm, when he observed with the surveyor that the contact information for the agencies mentioned above was not found to be posted in a visible area of the facility waiting room area. A face-to-face interview conducted on 06/09/2025 at approximately 2:45pm with Employee#2 [Clinical Manager] and he acknowledged the findings. The state agencies contact information was corrected and both the state agency and Network 5 information were updated using a larger font along with patient’s right information was placed in a visible area of the patients waiting room.”

“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 and Surveillance Report record for four (4) of 12 sampled patients and 27 supplemental patients and an interview with the Clinical Manager showed facility staff failed to track and include four (4) sampled patients and 19 supplemental patient’s immunization history for Influenza, Pneumococcal, and Tuberculosis to document the patient’s status. (Patients #1, #5, #8, #10,#14,#15, #16, #23,# 21, #22, #29, #31, #32, #33, #34, #35,#36, #37,#38, #39, #40, #41, #42, #43, #44, #45, #46, #47, #48, and #49,) The findings include ... According to the Center for Disease Control and Prevention (CDC) recommends that all dialysis patients: “Immunization history” should include whether the patient has received standard immunizations (pneumococcal, hepatitis, and influenza for tuberculosis), and has been screened for tuberculosis. The immunization record is expected to include at least the patient’s immunization histories for these vaccines be tracked. Be tested at least once for baseline tuberculin skin test results (TST) and rescreened if TB exposure is detected. Chest X-rays may be used for individuals for whom the TST is not an option. Be offered the Influenza and Pneumococcal vaccines 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 06/05/2025, a review of the Pneumonia and Influenza Vaccination and Surveillance Report record showed the following: 1. Patients #1, #5, #8, #10,#14,#15, #16, #23,#29, #31, #32,#33, #34,#35,#36, #37,#38,#39, #40, #41, #42, #43, #44, #45, #46, #47, #48, and #49, immunization history for Influenza vaccine status found on their record did not report information pertaining to the administration of the flu vaccine. The record just stated, “Vaccination administered elsewhere” 2. Patients #14, #21, #22 and #23, immunization history for Pneumococcal vaccine status showed there was none found on their record. 3. Patients’ #1 immunization history for TB (Tuberculosis) vaccine status was not found on his record. It should be noted that Patients #1, #5, #8, #10,#14,#15, #16,#21, #22, #23,#29, #31, #32,#33, #34,#35,#36, #37,#38,#39, #40, #41, #42, #43, #44, #45, #46, #47, #48, and #49, were not being tracked in accordance with the CDC guidelines. A face-to-face interview was conducted with Employee#2 [Clinical Manager] on 06/09/2025, at approximately 2:45pm. He acknowledged the findings.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 27513 Based on the review of five (5) of 12 sampled clinical records and interviews with the Clinical Manager, the facility staff failed to develop for five (5) patients’ plans of care. (Patient#1, #2,#3, #6 and #9) The findings included ... 1. Review of Patient #1’s clinical record showed no initial and no 90-day plans of care developed for year 2023 indicating “Not done.” Patient #1 was admitted 02/19/2025. 2. Review of Patient #2’s clinical record showed no annual plans of developed for the year 2023 indicating “Not done.” Patient #2 was admitted 02/16/2019. 3.Review of Patient #3’s clinical record showed no annual plan of care developed for the year 2023 indicating “Not done.” Patient #3 was admitted February 05/28/2022. 4.Review of Patient #6’s clinical record showed no annual plan of care develop for the year 2023 indicating “Not done.” Patient #6 was admitted February 10/05/2021. 5.Review of Patient #9’s clinical record showed no annual plan of care develop for the year 2023 indicating “Not done.” Patient #9 was admitted February 12/16/2020. A face-to- face interview was conducted on 06/09/2025 at approximately 2:45pm with the Clinical Manager. He 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 reviews of nine (9) of 12 sample clinical records and interview with the Clinical Manager, facility staff failed to ensure pre and post standing Blood pressures were completed for nine (9) patients who ambulates with or without assistive devices, and to ensure the eight (8) patients achieved their prescribed estimated dry weight according to the post treatment flow sheets reviewed. (Patient #1, #2, #3, #4, #5, #6, #7, #8 and #9) The findings include ... A. Facility staff failed to monitor standing Blood pressure for nine (9) patients who ambulate with or without assistance devices. (Patient #1, #2, #3, #4, #5, #6, #7, #8 and #9). “Hypertension is a risk factor for cardiovascular disease which is the main cause of morbidity and mortality in the dialysis population. Pre and post-dialysis blood pressure values of < 140/90 mmHg are recommended as the optimal blood pressure. The extra-cellular volume (ECV) expansion is the main pathophysiological determinant of hypertension in dialysis patients. The efforts should be made to correctly estimate and achieve the patient ’ s dry body weight and to limit dietary sodium intake. Angiotensin II receptor antagonists, beta blockers and calcium channel blockers are recommended as first choice drugs. Beta blockers and calcium channel blockers have been associated with reduced cardiovascular mortality and give their protective effects in patients at high risk. Antihypertensive drug therapies can effectively reduce blood pressure and are needed by the vast majority of hemodialysis patients” <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2552978/> 1. A review of patient #1’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were not done per the following dialysis treatment sheet dates mentioned below: 5/7/2025 5/9/2025 5/12/2025 5/16/2025 5/19/2025 5/21/2025 5/23/2025 5/26/2025 5/28/2025 5/30/2025 6/2/2025 2. A review of patient #2’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were not done per the following dialysis treatment sheet dates mentioned below: 5/6/2025 5/8/2025 5/10/2025 5/13/2025 5/15/2025 5/17/2025 5/19/2025 5/20/2025 5/22/2025 5/24/2025 5/27/2025 5/29/2025 5/31/2025 6/3/2025 3. A review of patient #3’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were not done per the following dialysis treatment sheet dates mentioned below: 5/5/2025 5/7/2025 5/9/2025 5/12/2025 5/14/2025 5/16/2025 5/19/2025 5/21/2025 5/23/2025 5/26/2025 5/28/2025 5/29/2025 6/2/2025 4. A review of patient #4’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were “not done” per the following dialysis treatment sheet dates mentioned below: . 5/5/2025 5/7/2025 5/9/2025 5/12/2025 5/14/2025 5/16/2025 5/19/2025 5/21/2025 5/23/2025 5/26/2025 5/28/2025 5/30/2025 6/2/2025 5. A review of patient #5’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were “not done” per the following dialysis treatment sheet dates mentioned below: 5/13/2025 5/15/2025 5/17/2025 5/20/2025 5/27/2025 5/29/2025 5/31/2025 5/21/2025 5/23/2025 5/26/2025 5/28/2025 5/29/2025 6/2/2025 6. A review of patient #6’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were “not done” per the following dialysis treatment sheet dates mentioned below: 5/7/2025 5/9/2025 5/12/2025 5/16/2025 5/19/2025 5/21/2025 5/23/2025 5/26/2025 5/28/2025 5/30/2025 6/2/2025 7. A review of patient #7’s treatment records dated between 05/05/2025 through 06/07/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were “not done” per the following dialysis treatment sheet dates mentioned below: 5/6/2025 5/8/2025 5/10/2025 5/13/2025 5/15/2025 5/17/2025 5/20/2025 5/22/2025 5/24/2025 5/27/2025 5/29/2025 5/31/2025 6/3/2025 8. A review of patient #8’s treatment records dated between 05/05/2025 through 06/03/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were “not done” per the following dialysis treatment sheet dates mentioned below: 5/6/2025 5/8/2025 5/10/2025 5/13/2025 5/15/2025 5/17/2025 5/20/2025 5/22/2025 5/23/2025 5/24/2025 5/27/2025 5/31/2025 6/3/2025 9. A review of patient #9’s treatment records dated between 05/07/2025 through 06/02/2025 showed that the space allotted for documenting post standing blood pressure as “Cannot Assess” indicating the measurements were not done per the following dialysis treatment sheet dates mentioned below: 5/23/2025 The evidence showed that facility staff failed to monitor Patients #1, # 2, 3, #4, #5, #6, #7, #8, and #9 who ambulate with or without assistance Pre and Post standing Blood Pressure. A-face- to-face interview was conducted on 06/09/2025 at approximately 2:45pm with the Clinical Manager. He acknowledged the findings and stated he has purchased manual blood pressures to measure and monitor the patients’ blood pressure. B. Facility staff failed to ensure that eight (8) sampled patient achieved their prescribed estimated dry weight. (Patient #1, #2, #3, #4, #5, #6, #8 and #9). 1.A review of Patient #1’s treatment flow sheet records dated 03/13/2025, to 04/01/2025 with a prescribed dry weight of 63.2kg showed the following dry weights: 05/07/2025, Post dry weight 64.6kg 05/12/2025, Post dry weight 64.8kg 05/23/2025, Post dry weight 64.7kg 05/25/2025, Post dry weight 65.7kg 05/28/2025, Post dry weight 64.9kg 05/30/2025, Post dry weight 64.7kg It is to be noted that change in dry weight to 64.5kg 03/18/ 2025, Post dry weight 65.9kg 03/20/2025, Post dry weight 65.5kg 03/22/2025, Post dry weight 63.7kg 2.A review of Patient #2’s treatment flow sheet records dated 03/14/2025, to 04/02/2025 with a prescribed dry weight of 90.7kg showed the following dry weights: 05/06/2025, Post dry weight 94.7kg 05/20/2025, Post dry weight 91.4kg 05/22/2025, Post dry weight 91.6kg, 05/24/2025, Post dry weight, 92.9kg 05/27/2025, Post dry weight 92.6kg 05/29/2025, Post dry weight 92.6kg 05/31/2025, Post dry weight 91.2 kg A review of Patient #3’s treatment flow sheet records dated 03/14/2025, to 04/02/2025 with a prescribed dry weight of 57.5kg showed the following dry weights: 05/5/2025, Post dry weight 59.1kg 05/19/2025, Post dry weight 58.4kg 05/26/2025, Post dry weight 60.2kg 05/28/2025, Post dry weight 59.4kg 05/30/2025, Post dry weight 59.7kg 06/02/2025, Post dry weight 62.4kg A review of Patient #4’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 66kg showed the following dry weights: 05/5/2025, Post dry weight 67.5kg 05/07/2025, Post dry weight 67.4kg 05/12/2025, Post dry weight 67.9kg 05/19/2025, Post dry weight 67kg 05/28/2025, Post dry weight 67.6kg 05/30/2025, Post dry weight 67.2kg 06/2/2025, Post dry weight 67.9kg A review of Patient #5’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 49kg showed the following dry weights: 05/6/2025, Post dry weight 50.4kg 05/8/2025, Post dry weight 50.3kg 05/10/2025, Post dry weight 51.0kg 05/13/2025, Post dry weight 50.5kg 05/15/2025, Post dry weight 50.0kg 05/17/2025, Post dry weight 50.0kg 05/20/2025, Post dry weight 50.3kg It is to be noted that the change in dry weight to 50kg 05/29/2025, Post dry weight 53kg A review of Patient #6’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 78kg showed the following dry weights: 05/6/2025, Post dry weight 79kg 05/7/2025, Post dry weight 79.2kg It is to be noted that the change in dry weight to 77.50kg 05/9/2025, Post dry weight 78.7kg 05/12/2025, Post dry weight 79.7kg 05/16/2025, Post dry weight 80.1kg 05/19/2025, Post dry weight 78.8kg 05/21/2025, Post dry weight 78.2kg 05/23/2025, Post dry weight 79kg 05/26/2025, Post dry weight 78.2kg 05/28/2025, Post dry weight 77.9kg 05/30/2025, Post dry weight 78kg A review of Patient #8’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 120.5kg showed the following dry weights: 05/6/2025, Post dry weight 122.4kg 05/8/2025, Post dry weight 121.4kg It is to be noted that the change in dry weight to 120kg 05/31/2025, Post dry weight 123.5kg A review of Patient #9’s treatment flow sheet records dated 03/12/2025, to 04/02/2025 with a prescribed dry weight of 73kg showed the following dry weights: 05/12/2025, Post dry weight 74kg 05/21/2025, Post dry weight 74kg The evidence showed that facility staff failed to achieve Patient #1, #2, #3, #4, #5, #6, #8 and #9 prescribed estimated dry weight according to the post treatment flow sheets reviewed. A face-to-face interview was conducted on 06/09/2025, at approximately 2:45pm with Employee #2 [Clinical Manager]. He 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 eight (8) of 12 sampled patients clinical record review and interview with the Clinical Manager, facility staff failed to ensure that the eight (8) sampled patients’ BFR (blood flow rate), (dialysis flow rate) and the dialysis treatment time are achieved and sustained during dialysis is according to the rate prescribed by the physician. (Patients #1, #2, #3, #4, #5, #8, and #9.) The findings include ... 1.Patient #1 Physician order dated 7/29/24 directed “BFR 400/DFR 800”, and Treatment time 3:45 hours. Review of the Treatment Detail Report dates between the dates of 5/9/2025 and 6/6/2025 showed the following: “BFR/DFR” rates for dialysis treatment performed between the dates mentioned above were in ranges of 350/700, 350/500, 300/500, and 300/600 The treatment time for dialysis treatment on 05/14/2025 was 2:47hours, 05/26/2025 was 2:51 hours, and 05/02/2025 was 2: 49 hours. 2.Patient #2 Physician order dated 4/10/24 directed Treatment Time 4.0 hours The Treatment Detail Report dates between 5/8/25 and 6/3/25 showed the following: The treatment time for dialysis treatment on 05/15/2025 was 2:49 hours 3. Patient #3 Physician order dated 7/29/24 directed “BFR 350” and Treatment Time 4.0 hours. Review of the Treatment Detail Report dates between 5/7/25 and 6/4/25 showed the following: On 8/14/24 a “BFR 300” for dialysis treatment. The treatment time for dialysis treatment on 5/23/2025 3:20 hours, and 05/26/2025 3:02 hours. 4. Patient #4 Physician order dated 4/10/24 directed “BFR 450/DFR”800 and Treatment Time 4.0 hours. Review of the Treatment Detail Report dates between 5/7/25 and 6/4/25 showed the following: “BFR 400, BFR 350, and DFR 500 for dialysis treatment performed between the dates mentioned. The treatment time for dialysis treatment on 05/05/2025 3.58 hours 5. Patient #5 Physician order dated 2/14/24 directed “BFR 400” and Treatment Time 3.0 hours Review of the Treatment Detail Report dates between 5/7/25and 6/3/25 showed “BFR 350”, BFR 300, for dialysis treatment performed between the dates mentioned. The treatment time for dialysis treatment on 05/06/2025 2:17 hours, 05/10/2025 2:35 hours, 05/20/2025 2:19 hours, and 05/29/2025 2:21 hours 6. Patient #7 Physician order dated 2/14/24 directed “BFR 400/DFR 800”and Treatment Time 3:30 hours. Review of the Treatment Detail Report dated between 5/8/25and 6/4/25 showed BFR 200, BFR 350, BFR 325, DFR 500, DFR 600, and DFR700 for dialysis treatment performed between the dates mentioned. The treatment time for dialysis treatment on 05/08/2025 3:10 hours, and 05/27/2025 3:00 hours 7. Patient #8 Physician order dated 2/14/24 directed “BFR 400/DFR 800” and 5:00 hours. Review of the Treatment Detail Report dated between 5/10/25and 6/3/25 showed BFR 200, BFR 255, BFR 200, BFR 350, DFR500 and DFR 600 for dialysis treatment performed on the dates mentioned above. The treatment time for dialysis treatment on 05/13/2025 4:55 hours, 05/22/2025 4:52 hours, 05/24/2025 4:55 hours, and 05/31/2025 3:13 hours 8. Patient #9 Physician order dated 2/14/24 directed “BFR 350 /DFR 800”and 3:15 hours Review of the Treatment Detail Report dated between 5/9/25and 6/4/25 showed BFR 255, and BFR 200 for dialysis treatment performed between the dates mentioned above. The treatment time hours between the dates mentioned above were 2:47 hours, 2:51 hours, and 2:49 hours. The evidence showed that the facility staff failed to ensure that the eight (8) sampled patients’ BFR , DFR and dialysis treatment time 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 the Clinical Manager on 06/09/2025, at approximately 2:45pm. He 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 review of two (2) of 12 sampled patients and six (6) supplemental patients clinical records 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 #8, #10, #26, #40, #42, #46, #50, and #51). The findings include ... 1.Review of the Albumin levels for Patient #8 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #8 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 03/20/2025 Albumin level was 3.1, 04/17/2025 Albumin level was 2.9, and 05/22/2025 Albumin level was 3.0. The patient was admitted on 05/07/2024. 2. Review of the Albumin levels for Patient #10 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #10 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 3.2, 05/01/2025 Albumin level was 3.2, and 06/02/2025 Albumin level was 2.9. The patient was admitted on 03/17/2025. 3. Review of the Albumin levels for Patient #26 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #26 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/04/25 Albumin level was 3.3, 03/20/2025 Albumin level was 3.3, and 04/17/2025 Albumin level was 3.4. The patient was admitted on 02/04/2025. 4. Review of the Albumin levels for Patient #40 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #40 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/10/2025 Albumin level was 3.3, 03/11/2025 Albumin level was 3.7, and 04/01/2025 Albumin level was 3.3. The patient was admitted on 08/07/2023. 5. Review of the albumin levels for Patient #42 showed “Albumin” level were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #42 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/04/2025 Albumin level was 3.2, 03/11/2025 Albumin level was 3.5, 04/03/2025 Albumin level was 3.2, and 05/01/2025 Albumin level was 3.4. The patient was admitted on 07/22/2019. 6. Review of the albumin levels for Patient #46 showed “Albumin” levels were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #46 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/19/2025 Albumin level was 3.3, 03/05/2025 Albumin level was 3.5, 04/02/25 Albumin level was 3.2, and 05/07/2025 Albumin level was 2.8. The patient was admitted on 12/28/2024. 7. Review of the albumin levels for Patient #50 showed “Albumin” level were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #50 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/19/2025 Albumin level was 2.6, 03/19/2025 Albumin level was 2.7, 04/16/2025 Albumin level was 2.8, and 05/21/2025 Albumin level was 3.0. The patient was admitted on 02/01/2021. 8. Review of the Albumin levels for Patient #51 showed “Albumin” level were not achieved and sustained according to their established target goals as follows: Review of the Dialysis lab values for Patient #51 showed that the Albumin level established target goals of greater than 4.0 were not met for the following dates: 02/04/2025 Albumin level was 3.3, 03/05/2025 Albumin level was 3.5, 04/02/25 Albumin level was 3.4, and 05/06/2025 Albumin level was 3.3. The patient was admitted on 06/17/2024. The evidence showed that facility staff failed to ensure that Patient#8, #10,#26, #40, #42, #46, #50, and #51 Albumin levels were achieved and sustained according to the established target goals mentioned above. A face-to-face interview was conducted on 06/09/2025 at approximately 2:45 PM with Employee #2 [Clinical 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 one (1) of 12 sampled patient and six (6) supplemental patients clinical records and interview with the Clinical Manager, facility staff failed to ensure that the 8 patients received adequate dosage of Erythropoietin Stimulating Agent (ESA) to maintain their anemia management needs. (Patient #8, #25, #26, #27, #28, #29, and #31) The findings include ... A review of the Lab Results/Medication Administration Summary record showed that facility staff failed to ensure that the 11 patients Erythropoietin Stimulating Agent Medication (ESA) maintained their anemia management needs by maintaining clinical target level (10 -12 g/dl). 1. A review of Patient #8’s clinical record showed the Hemoglobin [Hgb] lab values on 01/30/2025 was 9.0g/dl, 02/27/2025 was 8.0g/dl, 03/27/2025 9.4g/dl, 04/24/2025 was 8.2g/dl and 05/22/2025 was 9.0g/dl . 2. A review of Patient #25’s medical record showed the Hemoglobin lab values on 04/01/2025 were 13.4g/dl, 05/02/2025 was 13.5g/dl, and 06/02/2025 was 13.9g/dl. 3. A review of Patient 26’s clinical record showed the Hemoglobin [Hgb] lab values on 02/20/2025 was 9.4g/dl, 03/20/2025 was 9.1g/dl, 04/24/2025 was 8.7g/dl and 05/22/2025 was 8.7g/dl. 4. A review of Patient #27’s clinical record showed the Hemoglobin [Hgb] lab values on 01/23/2025 was 9.6g/dl, 02/27/2025 was 8.8g/dl, 03/27/2025 was 7.2g/dl, 04/24/2025 was 7.1g/dl and 05/24/2025 was 8.4g/dl 5. A review of Patient #28’s clinical record showed the Hemoglobin [Hgb] lab values on 01/22/2025 was 13.5g/dl, 02/19/2025 was 14.4g/dl, 03/19/2025 was 12.7g/dl 04/23/2025 was 12.3g/dl and 05/21/2025 was 14.3g/dl. 6. A review of Patient #29’s clinical record showed the Hemoglobin [Hgb] lab values on 01/02/2025 was 13.8g/dl, 02/06/2025 was 14.6g/dl, 03/05/2025 was 13.7g/dl, 04/03/2025 was12,6g/dl, 05/01/2025 was 13.2g/dl and 06/03/2025 was 15.0g/dl 7. A review of Patient #31’s clinical record showed the Hemoglobin [Hgb] lab values on 01/13/2025 was 9.8g/dl, 02/13/2025 was 8.0g/dl, 03/13/2025 was 7.8g/dl, 04/22/2025 was 6.9g/dl, 05/12/2025 was 8.2g/dl and 06/21/2025 was 8.8g/dl. 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 3/6 months facility staff failed to ensure that the administration of the Patients mentioned above Erythropoietin Stimulating Agent medication (ESA) maintained the anemia level management within the clinical range of 10-12g/dL. 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 06/09/2025 at approximately 2:45PM with Employee #2 [Clinical Manager]. He acknowledged the findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 27513 Based on a review of five (5) of 12 sampled patient’s clinical record and an interview with the Clinical Manager, facility staff failed to ensure that the Plans of Care (POC) were completed and signed by the interdisciplinary Team and the patient and if patient refused the reason why. (Patients #2,#4, #5, #7, and #8). The findings include: 1.Review of Patient #2’s clinical record showed that the patient was admitted to the dialysis center on 02/16/2019. The annual POC dated 10/29/2024 on the clinical record showed that at the space allotted for both the dietitian and social worker to sign and date was left blank indicating not done. 2. A review of Patient#4’s clinical record showed that the patient was admitted to the dialysis center on 10/28/2019. The annual POC dated 06/26/2023 and 07/30/2024 on the clinical record showed that at the space allotted for the patient or patient Designee to sign and date was left blank indicating not done and there was no reason documented for patient/patient designee not to sign the POC 3. A review of Patient#5’s clinical record showed that the patient was admitted to the dialysis center on 10/28/2023. The annual POC dated 10/30/2024 on the clinical record showed that at the space allotted for the patient or patient Designee to sign and date was left blank indicating not done and there was no reason documented for patient/patient designee not to sign the POC. 4. A review of Patient#7’s clinical record showed that the patient was admitted to the dialysis center on 10/05/2021. The annual POC dated 10/28/2024 on the clinical record showed that at the space allotted for the patient or patient Designee to sign and date was left blank indicating not done and there was no reason documented for patient/patient designee not sign the POC. 5. A review of Patient #8’s clinical record showed that the patient was admitted to the dialysis center on 01/19/2023. The annual POC dated 09/11/2023 on the clinical record showed that at the space allotted for both the dietitian and social worker to sign and date was left blank, indicating not done. A face-to-face interview was conducted on 06/09/2025, at approximately 2:45pm with Employee#2 [Clinical Manager]. He acknowledged the findings and stated, “I will have them to sign the POCs.””