Alexandria Kidney Center

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 42929 Based on review of documents and interviews with staff (EMP), it was determined the facility failed to maintain evidence that the facility conducted or participated in exercises to test the emergency plan annually. Findings: Review of facility document “Guidelines for Emergency Preparedness” published September 2, 2025, reads in part: “... Community Based Drill: Annually, each facility MUST participate in a community-based disaster drill. If unable to participate, document who was contacted in the community and why the clinic was unable to participate, on the Facility Specific Disaster Safety Plan form. If the EOC [Emergency Operations Center] or similar agency has not performed a community-based drill, or it was missed for a particular year, the DO [Director of Operations] should coordinate a dialysis facility area-based drill.... Mock Table Top Drill: In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill. It is recommended a different drill be completed annually. A list of table-top exercises are located on the Disaster Preparedness page under National Accounts.... Actual Emergency: If facility is involved in an actual disaster, it can take the place of community-based drill or tabletop drill. The facility must have pictures and local news to document the event. The DO must complete an after-action review and make any revision to the emergency plan as needed....” Review of the facility’s emergency preparedness documentation on September 10, 2025, at 12:30 PM with EMP1 and EMP2 revealed no documentation of a community based drill, mock table drill, or actual emergency documented for 2023 and 2024. Interview on September 10, 2025, at 12:30 PM, EMP1 confirmed that there was no documentation and after action report of any drills or actual emergencies for 2023 and 2024.”

“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: 49355 Based on observation, staff (EMP) interview and facility document review, it was determined the facility failed to ensure Personal Protective Equipment (PPE) was worn, per policy, for all visitors on the patient treatment floor. The findings: Review of facility document, “Visitor Policy,” published February 6, 2023, reference number 25806, version 5, reads in part: ... “PPE will be provided along with instructions for proper use....” At 3:43 PM on September 9, 2025, a visitor entered the treatment floor and proceeded to station #19, where patient (MR)10 had finished treatment. The visitor did not have a gown on and was not offered one for five (5) minutes. At 3:48 PM, EMP7 approached the visitor with a gown and instructed the visitor to don the gown. During an interview on September 9, 2025, at 3:50 PM, EMP7 indicated that all visitors should don appropriate PPE when entering the treatment floor. In this situation, EMP7 indicated that a gown was the appropriate PPE.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 42725 Based on observations, interview, and document review, it was determined that the facility failed to ensure the bleach solution used for disinfection was maintained according to facility policy. Findings: Review of facility document, Cleaning and Disinfecting the Dialysis Station, under the heading “Bleach-Solutions”, it partly reads: “... Bleach solutions will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air...”. The document was published September 2, 2025. While conducting treatment floor observations on September 10, 2025, the state agency (SA) identified three separate areas where labeled containers with bleach solution was sitting. Each area had two containers of bleach solution. In two of the areas, the lid to one of the containers was laying on top of the container next to it. The third area, one of the containers had a lid that was partially covering the container. On September 10, 2025 at approximately 4:50 PM, employee (EMP) 1 and EMP2 confirmed that bleach solution containers should remain covered when not in use.”

“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: 42725 Based on observations, interview, and document review, it was determined that the facility staff failed to appropriately dispose of needles during four (4) of five (5) decannulations and during one (1) of two (2) medication administration observations. Findings: Review of facility document, Post Treatment Fistula Needle Removal, under the heading “Procedure”, it partly reads: “... 3. It is recommended that the arterial needle be removed first... 6. Carefully remove the needle... Engage the safe needle device per manufacturer’s instructions for use. Discarded needle in sharps container as soon as feasible... 9. Remove the second needle following steps 4-8...”. The document was published on July 7, 2025. Review of facility document, General Cleanliness and Infection Control Guidelines, under the heading “Contaminated Needles and Sharps Container, it partly reads: “... Contaminated sharps will be discarded immediately or as soon as feasible in containers...”. The document was published on September 2, 2025. On September 9, 2025 at 2:45 PM, EMP12 was observed at station #4 decannulating MR12’s access site. EMP12 placed the needle on the chair side table, covered the site, and then carried the contaminated needle across the treatment floor for disposal. On September 9, 2025 at 3:07 PM, EMP11 was observed at station #23 decannulating MR11’s access site. EMP11 placed the contaminated needle on the chair side table, covered the site, and then carried the contaminated needle across the treatment floor to a sharps container. EMP11 then repeated the process with the second needle. On September 10, 2025 at 10:58 AM, EMP15 was observed administering a medication using a needled syringe. After administering the medication through the tubing port, EMP15 laid the needled syringe on top of the machine and continued with patient care. Afterward, EMP15 picked up the needled syringe and walked a few steps across the floor to dispose in the sharps container. On September 10, 2025 at 12:13 PM, EMP12 was observed decannulating a patient. After removing the needles, EMP12 laid both needles down on the tray and continued with patient care. Afterward, EMP12 disposed of the needles in the sharps container. On September 11, 2025 at 10:20 AM, EMP18 was observed decannulating a patient. After removing the needles, EMP18 laid both needles down on the tray and continued providing patient care. Afterward, EMP18 picked up the needles and walked around the chair to the other side for discarding. Interview on September 9, 2025 at 3:50 PM, EMP7 indicated that contaminated fistula needles should be disposed of in a sharps container immediately after removal. The SA noted that many stations do not have sharps containers immediately adjacent to them. EMP7 agreed having sharps containers at each station would avoid this issue.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 42725 Based on observations, interview, and document review, it was determined that the facility staff failed to follow procedure for cleaning and disinfection of the dialysis station during five (5) of six (6) observations. Findings: Review of facility document, Cleaning and Disinfecting the Dialysis Station, under the heading “Procedure”, it partly reads: “... 3. Use a cloth wet with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis stations (chair/bed, tables, machine, television, IV pole, B/P cuff, ... chaise {sp} wall behind chair) ... 4. Clean all surfaces... 5. ... While wiping, remember to wipe all surfaces of the machine...”. The document was published on September 2, 2025. On September 9, 2025 at 3:15 PM, EMP11 was observed cleaning station #23. EMP11 folded the contaminated blood pressure cuff that had been used on the previous patient and stuffed it into the holder on the side of the machine. EMP11 did not perform disinfection of the blood pressure cuff. On September 10, 2025, the following observations were made: At 12:00 PM, while cleaning station #24, EMP12 did not remove the prime waste container for disinfection and did not wipe the counter on the chase wall behind the chair. At 12:09 PM, while cleaning station #2, EMP4 did not wipe under the trays on both sides of the chair and did not wipe the counter behind the chair. At 12:50 PM, while cleaning station #1, EMP14 did not remove the prime waste container for disinfection, did not wipe under the trays of the chair, and did not wipe the counter behind the chair. On September 11, 2025 at 9:50 AM while cleaning station #30, EMP18 did not wipe under the trays of the chair and did not wipe the counter behind the chair. Interview on September 9, 2025 at 3:50 PM, EMP7 indicated that all parts of the dialysis station, including non-disposable items such as a blood pressure cuff, should be disinfected after each treatment.”

“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: 42725 Based on observations, interview, and document review, it was determined that the facility staff failed to follow procedure when providing exit site care for a central venous catheter site and initiating treatment during two (2) of two (2) observations. Findings: Review of facility document, Changing the Catheter Dressing Procedure, under the heading “Cleaning the Site”, it partly reads: “... 2% Chlorahexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds...”. The document was published on May 2, 2025. Review of facility document, Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer, under the heading “Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heparin Administration”, it partly reads: “... Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad ... for 10-15 seconds ...”. The document was published on May 5, 2025. On September 10, 2025, the following observations were made” At 12:40 PM, EMP4 provided exit site care for a CVC and initiated a CVC treatment. EMP4 cleansed the exit site for less than thirty seconds. After cleaning, the patient’s clothing fell slightly over the clean site. The site was not recleansed before applying a new dressing. During the hub cleansing, each hub was scrubbed for less than ten seconds. At 12:50 PM, EMP12 provided CVC exit site care and initiated CVC treatment. EMP12 did not clean the exit site for thirty seconds. After cleansing, the patient’s clothing slipped down and touched the clean site. The site was not recleansed prior to the application of a new dressing. During the hub cleansing, each hub was scrubbed for less than ten seconds. Interview on September 10, 2025 at approximately 4:55 PM, EMP1 indicated that that a patient’s clothing should be secured and out of the way to avoid the risk of it touching a cleansed CVC exit site. EMP1 also confirmed the cleansing time of a CVC exit site and the hubs.”

“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: 49355 Based on medical record reviews, facility staff (EMP) interviews and document review, it was determined the facility failed to document reportable events and document the notification to the charge nurse of: 1) unmet dry/target weights (TW) compared to post treatment weights (PTW) in five (5) out of five (5) medical records reviewed; 2) blood pressure (BP) measurements outside of facility guidelines in three (3) out of five (5) medical records reviewed; 4) heart rate (HR) measurements outside of facility guidelines in three (3) out of five (5) medical records reviewed; 3) and documentation of timely pre-treatment nursing assessment, per policy, in one (1) out of five (5) medical records reviewed. The findings: A review of the facility document, “Nursing Supervision and Delegation,” published May 1, 2023, reference number 45265, version 6, reads in part: ... “The registered nurse must evaluate each patient preferably within an hour... ... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. ... The staff member who collects information pre, post and during treatment will document their findings. ... The following criteria can be used as a guideline.... ... Fluid Status ... Any post treatment weight with a variance from the estimated dry weight of .5 kg. ... Blood Pressure A Systolic blood pressure greater than 180 mm/Hg and/or diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the treatment. ... Heart Rate/Cardiac ... below 60 beats per minute or greater than 100 beats per minute....” A review of the facility document, “Patient Assessment and Monitoring,” reference number 45284, version 4, reads in part: ... “During Treatment... ... Step 1 Blood Pressure ... Report to the nurse: ... Blood Pressure less than or equal to 100 mm/hg systolic. ... Document any findings and interventions in the medical record.” A review of the following medical records revealed: Patient (MR)3: Flowsheet dated August 21, 2025: diastolic BP 102 mm/Hg at 11:51 AM. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 57 to 50 beats per minute (bpm) throughout the entire three hour fifteen minute (3:15) treatment. No documentation noted on the flowsheet. Flowsheet dated August 26, 2025: PTW was documented as 58.6 kg, TW was 57.4 kg, a deviation of 1.2 kg. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 56 to 49 bpm throughout the entire 3:15 treatment. No documentation noted on the flowsheet. Flowsheet dated August 28, 2025: PTW was documented as 58.0 kg, TW was 57.4 kg, a deviation of 0.6 kg. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 55 to 49 bpm throughout the majority of the 3:15 treatment. No documentation noted on the flowsheet. Flowsheet dated September 2, 2025: PTW was documented as 58.9 kg, TW was 57.4 kg, a deviation of 1.5 kg. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 57 to 49 bpm throughout the entire 3:15 treatment. No documentation noted on the flowsheet. Flowsheet dated September 4, 2025: PTW was documented as 58.5 kg, TW was 57.4 kg, a deviation of 1.1 kg. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 58 to 53 bpm throughout the majority of the 3:15 treatment. No documentation noted on the flowsheet. Flowsheet dated September 9, 2025: PTW was documented as 58.1 kg, TW was 57.4 kg, a deviation of 0.7 kg. No documentation was noted on the flowsheet. : heart rate (HR) ranged from 56 to 47 bpm throughout the entire 3:15 treatment. No documentation noted on the flowsheet. : pre-treatment nursing assessment was completed at 1:05 P.M., treatment started at 11:30 AM, a 1:35 minute span. MR4: Flowsheet dated September 1, 2025: PTW was documented as 85.0 kg, TW was 87.0 kg, a deviation of -2.0 kg. No documentation was noted on the flowsheet. : HR was recorded at 59 and 58 bpm during two (2) thirty (30) minute sessions of the 3:30 treatment. No documentation noted on the flowsheet. Flowsheet dated September 3, 2025: PTW was documented as 85.0 kg, TW was 87.0 kg, a deviation of -2.0 kg. No documentation was noted on the flowsheet. Flowsheet dated September 5, 2025: PTW was documented as 86.4 kg, TW was 87.0 kg, a deviation of 0.6 kg. No documentation was noted on the flowsheet. : HR was recorded at 59 bpm during two (2) thirty (30) minute sessions of the 3:30 treatment. No documentation noted on the flowsheet. MR5: Flowsheet dated August 26, 2025: PTW was documented as 86.5 kg, TW was 84.9 kg, a deviation of 1.6 kg. No documentation was noted on the flowsheet. Flowsheet dated August 28, 2025: PTW was documented as 85.7 kg, TW was 84.9 kg, a deviation of 0.8 kg. No documentation was noted on the flowsheet. Flowsheet dated September 2, 2025: PTW was documented as 85.8 kg, TW was 84.9 kg, a deviation of 0.9 kg. No documentation was noted on the flowsheet. MR6: Flowsheet dated August 27, 2025: PTW was documented as 74.8 kg, TW was 74.0 kg, a deviation of 0.8 kg. No documentation was noted on the flowsheet. Flowsheet dated August 29, 2025: HR ranged from 59 to 49 bpm during the majority of the 3:30 treatment. No documentation noted on the flowsheet. Flowsheet dated September 1, 2025: PTW was documented as 75.1 kg, TW was 74.0 kg, a deviation of 1.1 kg. No documentation was noted on the flowsheet. : HR was recorded at 59 and 49 bpm during two (2) thirty (30) minute sessions of the 3:30 treatment. No documentation noted on the flowsheet. Flowsheet dated September 3, 2025: PTW was documented as 73.0 kg, TW was 74.0 kg, a deviation of -1.0 kg. No documentation was noted on the flowsheet. : HR ranged from 59 to 54 bpm during the majority of the 3:30 treatment. No documentation noted on the flowsheet. Flowsheet dated September 5, 2025: HR ranged from 57 to 55 bpm during the majority of the 3:30 treatment. No documentation noted on the flowsheet. Flowsheet dated September 8, 2025: PTW was documented as 73.2 kg, TW was 74.0 kg, a deviation of -0.8 kg. No documentation was noted on the flowsheet. : BP 95/71 mm/Hg at 3:00 P.M. No documentation was noted on the flowsheet. : HR ranged from 57 to 54 during half of the 3:30 treatment. No documentation was noted on the flowsheet. MR7: Flowsheet dated August 28, 2025: PTW was documented as 94.9 kg, TW was 92.0 kg, a deviation of 2.9 kg. No documentation was noted on the flowsheet. Flowsheet dated August 29, 2025: PTW was documented as 95.1 kg, TW was 92.0 kg, a deviation of 3.1 kg. No documentation was noted on the flowsheet. : BP 90/53 mm/Hg at 7:35 P.M., 90/52 mm/Hg at 7:49, 94/56 mm/Hg at 8:02 P.M., 97/59 mm/Hg at 8:22 P.M. No documentation was noted on the flowsheet. Flowsheet dated August 30, 2025: PTW was documented as 93.0 kg, TW was 92.0 kg, a deviation of 1.0 kg. No documentation was noted on the flowsheet. Flowsheet dated September 3, 2025: PTW was documented as 96.5 kg, TW was 92.0 kg, a deviation of 4.5 kg. No documentation was noted on the flowsheet. : BP 85/48 mm/Hg at 7:05 P.M. No documentation was noted on the flowsheet. Flowsheet dated September 5, 2025: PTW was documented as 98.2 kg, TW was 92.0 kg, a deviation of 6.2 kg. No documentation was noted on the flowsheet. Flowsheet dated September 6, 2025: BP 92/64 mm/Hg at 12:31 P.M., 97/63 mm/Hg at 1:06 P.M. No documentation was noted on the flowsheet. During an interview on September 9, 2025, at 3:50 PM, EMP7 indicated patient care technicians (PCTs) should notify the nurse of vitals that fall outside of the acceptable range and those findings should be entered on the flowsheet. EMP7 also indicated the nursing pre-treatment assessment should be completed within one (1) hour of treatment initiation. EMP7 continued If it is the patient’s first treatment, the pre-treatment assessment should be completed before treatment starts. During an interview on September 11, 2025, at 11:17 AM, EMP3 indicated their expectation that any deviation from the dialysis prescription, including the dry/target weight, must be documented on the flowsheet and the nurse notified. EMP3 indicated dry weights are re-evaluated for each patient once monthly during the treatment team meeting. EMP3 also reported highlighted topics rotate every month for the treatment team and other providers that may follow patients in the facility. Evaluation of dry/target weight is one of those rotating topics.”

“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: 49355 Based on medical record reviews, facility staff (EMP) interviews and document review, it was determined the facility failed to follow dialysis orders and failed to document the reason for deviations in prescribed blood flow rate (BFR) and/or dialysate flow rate (DFR) for four (4) of five (5) medical records reviewed, patient (MR)3, MR4, MR6 and MR7. The findings: Review of the facility document, “Patient Assessment and Monitoring,” published May 1, 2023, reference number 45284, version 4, reads in part: ... “3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: * Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. * Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” A review of the following medical records revealed: MR3: Flowsheet dated August 21, 2025: prescribed BFR of 350 ml/min and DFR of 700 ml/min. were not run from 1:52 PM until 2:32 PM. No documentation noted in the flowsheet. Flowsheet dated August 26, 2025: prescribed DFR of 700 ml/min. was not run from 12:21 PM until 1:29 PM. No documentation noted in the flowsheet. Flowsheet dated September 2, 2025: prescribed DFR of 700 ml/min. was not run the entire 3:15 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated September 4, 2025: prescribed DFR of 700 ml/min. was not run the entire 3:15 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated September 9, 2025: prescribed BFR of 350 ml/min and DFR of 700 ml/min. were not run from 2:10 PM until 3:03 PM. No documentation noted in the flowsheet. MR4: Flowsheet dated September 3, 2025: prescribed BFR of 350 ml/min was not run from 7:03 AM until 9:50 A.M. No documentation noted in the flowsheet. Flowsheet dated September 8, 2025: prescribed BFR of 350 ml/min and DFR of 600 ml/min. were not run during the entire 3:30 treatment cycle. No documentation noted in the flowsheet. MR6: Flowsheet dated August 27, 2025: prescribed BFR of 400 ml/min was not run during the entire 3:30 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated August 29, 2025: prescribed BFR of 400 ml/min was not run from 3:06 PM through 3:56 PM. Prescribed DFR of 600 ml/min. were not run during the entire 3:30 treatment cycle. No documentation noted in the flowsheet. MR7: Flowsheet dated August 28, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated August 29, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated August 30, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated September 3, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated September 5, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. Flowsheet dated September 6, 2025: prescribed BFR of 450 ml/min and DFR of 700 ml/min. were not run during the entire 3:00 treatment cycle. No documentation noted in the flowsheet. During an interview on September 9, 2025, at 3:50 PM, EMP7 indicated patient care technicians (PCTs) should document on the flowsheet the reason prescribed BFR and/or DFR is not being run and notify the nurse. During an interview on September 11, 2025, at 11:17 AM, EMP3 indicated their expectation that any deviation from the dialysis prescription must be documented on the flowsheet and the nurse notified.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 42725 Based on observation, interview, and document review, it was determined that the facility staff failed to follow procedure when initiating an arteriovenous (AV) fistula/graft treatment during three (3) of five (5) observations. Findings: Review of facility document, Access Assessment and Cannulation, under the heading “Assessment of Vascular Access”, it partly reads: “... 1. Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water. Note: If unable to wash with soap and water, staff may use hand sanitizer with 60-70% alcohol to clean access arm ... in place of soap and water...”. Under the heading “Skin Disinfection”, it partly reads: “... 1. Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating...”. The document was published on May 5, 2025. On September 10, 2025, the following observations were made: At 10:41 AM, EMP14 was initiating treatment for an AVF/AVG. EMP5 performed skin disinfection for less than ten seconds at both of the access sites. At 11:20 AM, EMP16 was initiating treatment for an AVF/AVG. The patient did not wash their access site prior to going to their assigned station. EMP16 did not wash the patient’s access site with soap and water or hand sanitizer before initiating treatment. EMP16 performed skin disinfection for less than ten seconds at both of the access sites. At 12:28 PM, EMP12 was initiating treatment for an AVF/AVG. The patient did not wash their access site prior to going to their assigned station. EMP12 did not wash the patient’s access site with soap and water or hand sanitizer before initiating treatment. EMP12 performed skin disinfection for less than ten seconds at both of the access sites. Interview on September 10, 2025 at approximately 4:55 PM, EMP1 confirmed that if the patient does not and/or cannot wash their access site, the staff should wash the site with soap and water or hand sanitizer.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 49355 Based on facility document review and staff (EMP) interviews, it was determined the facility failed to complete the initial plan of care (POC) within thirty (30) calendar days or thirteen (13) treatments, per policy, for one (1) of five (5) medical records reviewed, patient (MR)6. The findings: A review of facility document, “Comprehensive Interdisciplinary Assessment and Plan of Care,” published July 3, 2023, reference number 45283, version 6, reads in part: ... “CIA and POC for Patients New to Dialysis An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. A review of the medical record of MR6, an in-center hemodialysis (ICHD) patient, was reviewed on September 11, 2025, at 9:47 AM with the assistance of EMP1 and EMP2. MR6 had transitioned from home hemodialysis to ICHD, receiving their first in-center treatment on July 30, 2025. A POC located in the record was dated September 9, 2025. The surveyor also confirmed MR6 had received over thirteen (13) treatments at that date. EMP1 and EMP2 agreed the POC for MR6 was completed in over thirty (30) days from the initiation of treatment and MR6 had received greater than thirteen (13) treatments. EMP1 and EMP2 acknowledged the completion date was not per facility policy.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 49355 Based on observations, facility document review and staff (EMP) interviews, it was determined that the facility failed to follow policies and procedures related to: 1- ensuring expired sterile medical supplies are not available on the treatment floor; and 2- facility safety events are reported accurately and completely for patients (MR)3, MR4, MR6 and MR7. The findings: Review of facility document “Expiration Dates Sterile Supplies” published July 4, 2012, reads in part: “... Purpose: This policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date.... Policy: ... Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date.” A review of facility document, “Patient Safety Event Reporting and Documentation,” reference 61085, version 3, reads in part: ... “The purpose of this policy is to provide guidelines for all clinical staff on identifying, reporting and documenting patient related Near Misses, Safety Events and Serious Safety Events in the In-Center and Home Therapy setting.... ... Staff are encouraged to report patient events without blame or shame, and with an understanding that event review is focused on opportunities for learning and improving the quality and safety of patient care. ... When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in this policy. Staff are responsible for timely completion of these policy requirements. ... Documentation of all patients events shall be: * Factual, complete, timely and concise. * Include patient assessment and represent an accurate recording of the events, times, interventions, and result of interventions. *... Documentation should include that the physician was notified. ... Category ... Cardiac Cardiac-Arrhythmia-Bradyarrhythmia During Dialysis <50 ... Occurrence of an arrhythmia during dialysis with heart rate below 50 beats per minute that is new or sustained. ... Treatment Orders Not Met ... Incorrect Blood Flow Rate (BFR) and/or Dialysate Flow Rate (DFR) ... Prescribed BFR/DFR not utilized for dialysis treatment.” A review of facility document, “Nursing Supervision and Delegation,” published May 1, 2023, reference number 45265, version 6, reads in part:... “Prior to discharge, the RN must review the treatment record to: ... Identify any process that could have resulted in the patient experiencing a safety event or near miss The record must be reviewed for: ... * Heart rate <50 or >120 addressed by the registered nurse with documentation present ... * Blood pressures <100 systolic or greater than 180 systolic addressed by the registered nurse with or [sic] documentation present.” Observations with EMP2 on September 9, 2025, at approximately 2:00 PM, revealed: a drawer full of tuberculosis syringes with expiration dates of September 30, 2022, February 28, 2023, and January 31, 2025; about fifty (50) safety glide needles with expiration dates of May 31, 2024, and August 31, 2024; half a box of sure seal pressure bandages with expiration date of December 30, 2024; two (2) 3 ml syringes with expiration dates of December 31, 2022, and September 30, 2024; and a bag of green and yellow topped blood collection tubes with expiration dates of May 31, 2025, and August 31, 2025. Review of treatment flowsheets in the evening of September 9, 2025, for MR3, MR4 and MR6 and MR7 revealed heart rate readings of below 50 beats per minute (bpm) for MR3 and MR6. BFR and/or DFR that were not as prescribed were present for MR3, MR4, MR6 and MR7. Systolic blood pressures of less than 100 mm/Hg for MR6 and MR7. These findings have been cited in V-0543 and V-0544. No documentation was noted on the flowsheets and no entries were present on the Adverse Events Report requested and provided. Interview on September 9, 2025, at approximately 2:00 PM, EMP2 indicated that expired supplies should be discarded and not available for use as per the facility’s policy. During an interview on September 11, 2025, at 9:47 AM, EMP1 and EMP2 indicated they were both aware of the policy concerning Patient Safety Event reporting. EMP1 indicated they encourage the staff to report events and educate staff on how to report events, but have not had much success. EMP1 and EMP2 indicated they see the benefit of tracking these parameters to look for trends.”