East Henrico Dialysis Center

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 49355 Based on facility staff (EMP) interview and document review, it was determined the facility failed to provide documentation that local agencies were contacted to inform of the existence and needs of the facility. Specifically, local agencies were not contacted, at least annually, to insure cooperation and collaboration with emergency preparedness processes during disaster or emergency situations. The findings: A review of the facility’s document entitled, “EM01 Facility Emergency Management Plan,” revision date January 13, 2025, reads, in part: ... “Emergency Management Plan Objectives: ... Communication with utility providers, local public health, and emergency preparedness agency for our in-center dialysis and Home patients. ... Comply with federal, state, and local laws and regulations. ... Communication with our community partners is essential during a disaster event. The dialysis facility must contact the local public health and emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency.” A review of the facility’s document entitled, “Emergency Preparedness Plan IRC/ARA - East Henrico Dialysis,” policy EPM--04C, Appendix III, revised 052022, reads, in part: ... “Annual contact with utility providers and emergency management agency: IRC/ARA - East Henrico Dialysis will contact the local emergency management agency to make them aware of the acute needs of the dialysis center to expedite the restoration of services following an emergency including transportation assistance for patients. Emergency Management Agency: Name of Emergency Agency: Virginia Dept. of Emergency Management ... IRC/ARA - East Henrico Dialysis will establish contact with the appropriate utility providers to ensure the center is considered a priority in the restoration of services following an emergency situation. Power/Electric Provider: Name of Provider: Dominion Energy Water Provider: Name of Provider: Henrico Dept of Public Utilities” During review of the Emergency Preparedness binder with EMP3 on July 29, 2025, a copy of a letter to Henrico County Emergency Services dated March 10, 2025, was reviewed. There was no documentation in the binder that any other agencies were notified for 2025. No documentation was identified that local, regional, State or Federal agencies were notified in 2024 or 2023.”

“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: 49355 Based on facility staff (EMP) interview and document review, it was determined the facility failed to provide documentation of annual exercises to test the emergency preparedness plan. The findings: A review of the facilities policy entitled, “EM01 Facility Emergency Management Plan,” revision date January 13, 2025, reads, in part: ... “Emergency Preparedness Response Plan: ... The facility will perform quarterly drills/testing and will complete a full-scale exercise to [sic] every two years, and the alternate year will conduct an additional exercise such as a second full-scale exercise that is community-based or individual, facility-based functional exercise; or a mock disaster drill; or a tabletop exercise or workshop.” During review of the Emergency Preparedness binder with EMP3 on July 29, 2025, there was documentation of an actual natural disaster that occurred in March 2025. A tabletop exercise was noted for February 2024, but no details or documentation was included. A tabletop exercise noted for January 2023 did not include any details or documentation. EMP3 indicated that no further information was available.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 49355 Based on three (3) infection control observations, facility staff (EMP) interview and document review, it was determined the facility failed to follow infection control and prevention practices related to hand hygiene (HH). Specifically, HH was not performed, per policy, prior to donning new gloves or when moving from a dirty area to a clean area. The findings: The facility’s policy entitled, “G40 Infection Control,” revision date November 29, 2022, reads, in part:... “General Infection Control Measures ... 8. Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items. 9. Antiseptic hand cleaners must be alcohol-based and may be used in place of soap and water.... ... 16. Each center will maintain and clearly label separate ‘clean’ and ‘dirty’ work areas.” During observations on July 28 ,2025, EMP3 was observed, multiple times, not performing HH after removing gloves and prior to donning clean gloves. At 8:57 A.M., EMP3 touched the dialysis machine without gloves, donned new gloves without performing HH and then touch the patient at station #4. At 9:00 A.M., 9:02 A.M., 9:03 A.M. and 9:10 A.M., this surveyor witnessed EMP3 remove soiled gloves and don new gloves, never performing HH in between. On July 28, 2025, at 12:55 P.M., EMP3 used a stethoscope on patient (MR) 10 at station #20. EMP3 removed soiled gloves and carried the “dirty” stethoscope to an area where bleach wipes were available. EMP3 cleaned the stethoscope and then donned new gloves, without performing HH. On July 29, 2025, at 9:57 A.M., EMP12 touched the “clean” keyboard and then touched the dialysis machine at station #11 and then returned back to the “clean” keyboard, never changing gloves or performing HH and donning new gloves. During an interview on July 28, 2025, at 4:04 P.M., EMP4 indicated that HH should always be performed once soiled gloves are removed and prior to donning new gloves. EMP4 also confirmed the keyboard not attached to the dialysis machine is considered “clean” versus the keyboard attached to the dialysis machine, which is “dirty.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49355 Based on observations, facility staff (EMP) interview and document review, it was determined that staff failed to clean and disinfect non-disposable equipment, per policy, prior to use on a new patient or prior to returning the equipment to a clean area. The findings: In the facility’s policy entitled, “G40 Infection Control,” revision date November 29, 2022, reads, in part: ... “16. Each center will maintain and clearly label separate ‘clean’ and ‘dirty’ work areas.” In the facility’s policy entitled, “G45 Cleaning and Disinfection of Equipment, Supplies and Treatment Area,” revision date June 20, 2024, reads, in part: ... “12. Some reusable supplies must be disinfected after each patient use by soaking for a minimum of 10 minutes in the bleach/water solution defined by this policy. Care must be taken to ensure all surfaces of all items are fully covered by the bleach. This includes, but is not limited to: Fistula clamps....” In the facility’s policy entitled, “IC24 Checking Conductivity & pH of Dialysate,” revision date June 20, 2024, reads, in part: ... “Policy: ... 11. The external portion of the conductivity meter must be cleaned with a cloth soaked in 1:100 bleach solution after each use, prior to using at another station , or if storing in a clean designated area.” During an observation on July 28, 2025, at 12:34 P.M., EMP5 did not clean the PHoenix XL conductivity meter prior to returning it to the clean area where it is stored. EMP5 removed the meter from the dialysis station where the conductivity was tested and placed the dirty meter on the countertop of the clean area where disinfected meters are stored. EMP5 retrieved cleaning clothes wetted with disinfectant from another area of the treatment room, returning to the counter where the contaminated meter lay. EMP5 disinfected the meter and placed in a rack with the other cleaned meters. On July 29, 2025, at 10:04 A.M., this surveyor observed a container containing bleach and used clamps. Most of the clamps were not fully submerged in the disinfectant. During an interview on July 28, 2025, at 4:04 P.M., EMP4 indicated there are defined “clean” and “dirty” areas on the treatment floor and a dirty piece of equipment should not be placed on the countertop of a clean area without first being disinfected.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 49355 Based on observations, facility staff (EMP) interview and document review, it was determined the facility failed to: 1) ensure all expired medications are not available for patient use in the dialysis facility 2) and/or ensure that all predrawn medications are labeled appropriately and per policy. The findings: The facility’s policy entitled, “G40 Infection Control,” revision date November 29, 2022, reads, in part: ... “22. Medications...should be drawn up just prior to administration. However...medications may be drawn up no more than 4 hours before the anticipated time of administration. 23. Medications...drawn up and stored prior to administration....must be clearly labeled with the following information: Patient’s name Medication name and dose Date and time medication was drawn up Initials of the nurse who drew up the medication.” The facility’s policy entitled, “G48 Medications: Handling, Administration, Storage & Disposal,” revision date June 11, 2025, reads, in part:... “40. Expired medications...are immediately removed from the treatment and inventory areas and disposed of per state/local regulations.” On July 28, 2025, at 9:39 A.M., two (2) pre-filled syringes of heparin were found in a cabinet in the medication area with a preparation date of July 21, 2025, 7 days prior to this date. Employee (EMP) 4 disposed of the syringes at the time of discovery. On July 28, 2025, at 12:30 P.M., EMP4 prefilled two (2) syringes with heparin in the medication area and did not label the syringes. EMP4 walked into the patient area and handed both unlabeled syringes to EMP3, who then placed the syringes on the chairside table at unoccupied station #20. EMP4 agreed, when the heparin syringes prepared on July 21, 2025, were discovered, that the syringes should have been disposed of four (4) hours after the labeled preparation time. EMP4 also indicated that any prefilled syringes not used immediately on the intended patient, should be labeled, per policy.”

“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: 49355 Based on observations, facility staff (EMP) interviews and document review, it was determined the facility failed to follow appropriate infection control measures, per policy, when providing care to a central venous catheter (CVC) in one (1) out of two (2) observations. The findings: In the facility’s policy entitled, “IC05A CVC: Initiation and Discontinuation of Treatment,” revision date June 11, 2025, reads, in part: ... “Discontinuation of Treatment ...15. Place a new clean field under the catheter limbs/caps.” On July 29, 2025, at 10:32 A.M., while discontinuing dialysis on patient (MR) 7 at station #6, EMP5 did not place a clean field under MR7’s CVC limbs, per policy, but left the field in place that had been there throughout the entire treatment. During an interview on July 29, 2025, EMP10 indicated that a new clean field should be placed under the CVC limbs.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49355 Based on observations and facility document review, it was determined the facility failed to perform dialysate conductivity testing using the PHoenix XL meter accurately and according to the facility’s policy and the manufacturer’s instructions for use in three (3) out of three (3) observations. The findings: The facility’s policy entitled, “IC24 Checking Conductivity & pH of Dialysate,” revision date June 20, 2024, reads, in part: ... “Policy: ... 12. Refer to machine manufacturer guidelines (machine manual), found using the link provided, to verify the requirements for machine testing of conductivity and pH testing.” A review of the on-line manufacturer’s “PHoenix XL User’s Guide,” reads, in part: ... “A. Sample directly from the Hemodialysis delivery system: 1. Connect to Dialysis Machine a. If using a slip Luer, place a slip Luer on the meter ’ s port and push the slip connection into the dialysate port. b. If using a sample tube, connect a sampling tube to the port of the instrument, and the other side to the delivery system (add Luer fitting to the sample tube as needed). 2. Pull the syringe out about halfway to create a vacuum. 3. While holding the syringe in place with one hand, open the dialysate port valve (or push button) to deliver solution into the meter. You will feel the pull of the vacuum cease as the syringe fills. 4. Close the valve, disconnect from the dialysis system, and expel the solution into a waste container. 5. Repeat the above process, and once the syringe has filled, press the (Hold) button to freeze the readings on the display. 6. Close the valve, disconnect from the dialysis system and record the readings.” On July 28, 2025, the following process was used at each of the observations made of the usage of the PHoenix XL meter to check the conductivity: the user would directly attach the sample tubing of the meter to the dialysate port and take a single sample to indicate the conductivity reading. An initial sample was not obtained and discarded, prior to obtaining the sample used to measure the value, per manufacturer’s directions for use. The observations noted include: at 12:29 P.M. at station #19 with employee (EMP) 3; at 12:32 P.M. at station #12 with EMP11; and at 12:33 P.M. at station #6 with EMP5. During an interview with EMP3 on July 29, 2025, the observations were discussed and proper technique was emphasized.”

“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: 49355 Based on observations, facility staff (EMP) interview and document review, it was determined the facility failed to maintain a safe environment by not disposing of contaminated sharps at the point of use in one (1) out of two (2) observations when deaccessing a patient (MR) with a fistula or graft. The findings: A review of the facility’s policy entitled, “IC04A AVF-AVG Cannulation, Treatment Initiation and Termination,” revision date June 20, 2024, reads, in part: ... “Actions ... 39. Carefully withdraw the needle, keeping the angle of the needle almost parallel with the skin. Engage the needle safety device as described in the safety fistula needle manufacturer instructions. Discard the needle in a sharp container with the safety device enable [sic].” On July 28, 2025, at 12:33 P.M., EMP4 deaccessed patient (MR) 8’s fistula at station #10, placing each contaminated needle on the chair side table before disposing of it in the sharps container. During an interview on July 28, 2025, at 4:04 P.M., EMP4 indicated fistula/graft needles should be immediately placed in a sharps container after pulling.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 49355 Based on observations, facility staff (EMP) interview and document review, it was determined the facility failed to ensure access sites were visible during the dialysis treatment for two (2) dialysis patients. The findings: The facility’s policy entitled, “IC08 Monitoring and Documentation of Patient Care During Treatment,” revision date November 29, 2022, reads, in part: ... “Policy: ... 10. Data that must be documented...at least every 30 minutes and PRN depending on the paitent’s condition includes, but is not limited to: ... Visibility of the vascular access and interventions taken to address non-visibility of the access. ... 12. The patient’s vascular access should remain uncovered and readily visible throughout the course of the patient’s treatment.” During observations on July 29, 2025, at 9:53 A.M. and at 10:10 A.M., the access sites of patients at station #9 and station #2, respectively, were covered. During an interview on July 29,2025, EMP10 indicated the access sites of patients receiving dialysis should be in clear view throughout the entire treatment.”

“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) interview and document review, it was determined the facility failed to document abnormal findings and document the notification to the charge nurse of: 1) unmet target weights (TW) compared to post treatment weights (PTW) in three (3) out of five (5) medical records reviewed; 2) blood pressure (BP) measurements outside of facility guidelines in one (1) out of five (5) medical records reviewed; 4) heart rate/pulse (HPR) measurements outside of facility guidelines in two (2) out of five (5) medical records reviewed; 3) and documentation of completed pre-treatment nursing assessments by the policy-specified time in one (1) out of five (5) medical records reviewed. The findings: The facility’s policy entitled, “IC08 Monitoring & Documentation of Patient Care During Treatment,” revision date November 29, 2022, reads, in part: ... “Policy: ... 6. Patient pre-assessment must be performed by the nurse prior to initiation or at the beginning of treatment and documented within one hour of treatment initiation. ... 10. Data that must be documented...at least every 30 minutes and PRN depending on the patient’s condition includes, but is not limited to: ... Patient status - some notes must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints or observations about the patient’s status must be documented. In addition, any interventions provided to the patient and the patient’s response must be documented. ...15. Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations, such as slowing blood flow for access problem, target weight change.... ... if the patient’s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” The facility protocol entitled, “IC07A Charge Nurse Notification Protocol,” revision date January 13, 2025, reads, in part: “Events Reportable to the Nurse by Direct Patient Care Staff ... Intradialytic Blood Pressure: systolic >180 OR <90 or any significant change in pressure Cardiac: Pulse >110 OR <55, any significant change in rate or rhythm. Any c/o chest pain or discomfort. ... Post-Treatment Weight: 1.0 kg < or > EDW post treatment ... ALWAYS REPORT ANY COMPLAINTS OR UNUSUAL SIGNS AND SYMPTOMS TO THE NURSE AND DOCUMENT THAT THE NURSE WAS NOTIFIED.” A review of the following medical records revealed: Patient (MR) 1: Flowsheet dated July 9, 2025: PTW was documented as 99.4 kg, TW was 100.5 kg, a deviation of 1.1 kg. No documentation was noted on the flowsheet. Flowsheet dated July 25, 2025: PTW was documented as 87.3 kg, TW was 99.5 kg, a deviation of 12.2 kg. No documentation was noted on the flowsheet. MR 2: Flowsheet dated July 14, 2025: systolic BP: 185 mm/Hg at 1:41 P.M. No documentation was noted on the flowsheet. heart/pulse rate (HPR) 52 beats per minute (bpm) at 12:24 P.M.; 53 bpm at 12:26 P.M.; 54 bpm at 12:31 P.M.; and 50 bpm at 1:01 P.M. No documentation noted on the flowsheet. Flowsheet dated July 16, 2025: systolic BP: 183 mm/Hg at 3:00 and 189 mm/Hg at 3:23 P.M. No documentation was noted on the flowsheet. heart/pulse rate (HPR) 54 bpm at 12:31 P.M.; and 51 bpm at 1:00 P.M. No documentation noted on the flowsheet. Flowsheet dated July 21, 2025: systolic BP: 182 mm/Hg at 2:01 and 184 mm/Hg at 2:31 P.M. No documentation was noted on the flowsheet. heart/pulse rate (HPR) 52 bpm at 12:22 P.M.; 53 bpm at 1:01 P.M. and 54 bpm at 1:31 P.M. No documentation noted on the flowsheet. Flowsheet dated July 23, 2025: heart/pulse rate (HPR) 52 bpm at 12:19 P.M.; and 50 bpm at 12:40 P.M. No documentation noted on the flowsheet. Flowsheet dated July 25, 2025: systolic BP: 186 mm/Hg at 2:01; 191 mm/Hg at 2:31 P.M.; and 184 mm/Hg at 3:35 P.M. No documentation was noted on the flowsheet. heart/pulse rate (HPR) 51 bpm at 12:17 P.M.; 51 bpm at 12:31 P.M.; and 54 bpm at 1:01, 1:31 and 2:01 P.M. No documentation noted on the flowsheet. MR 3: Flowsheet dated July 22, 2025: PTW was documented as 70.3 kg, TW was 69 kg, a deviation of 1.3 kg. No documentation was noted on the flowsheet. MR 4: Flowsheet dated July 16, 2025: heart/pulse rate (HPR) 120 bpm at 7:55 and 7:59 A.M. No documentation noted on the flowsheet. Flowsheet dated July 18, 2025: heart/pulse rate (HPR) 128 bpm at 10:52 A.M.; and 130 bpm at 11:01 A.M. No documentation noted on the flowsheet. MR 5: Flowsheet dated July 16, 2025: PTW was documented as 73.8 kg, TW was 62 kg, a deviation of 11.8 kg. No documentation was noted on the flowsheet. Flowsheet dated July 21, 2025: PTW was documented as 74.1 kg, TW was 62 kg, a deviation of 12.1 kg. No documentation was noted on the flowsheet. Flowsheet dated July 23, 2025: PTW was documented as 75.6 kg, TW was 62 kg, a deviation of 13.6 kg. No documentation was noted on the flowsheet. Flowsheet dated July 25, 2025: PTW was documented as 73.2 kg, TW was 62 kg, a deviation of 11.2 kg. No documentation was noted on the flowsheet. pre-treatment nursing assessment documented at 2:21 P.M., treatment started at 12:47 P.M. No documentation was noted on the flowsheet. Flowsheet dated July 28, 2025: PTW was documented as 72.2 kg, TW was 62 kg, a deviation of 10.2 kg. No documentation was noted on the flowsheet. During an interview on July 28, 2025, at 2:50 P.M., EMP6 indicated that any measurement outside of “normal” should be documented on the flowsheet and reported to the charge nurse. EMP6 continued that there may be reasons why the target weight is not being attained, but those readings should be monitored and tracked. During an interview on July 28, 2025, at 4:04 P.M., EMP4 indicated that pre-assessment nursing notes should be completed within one (1) hour from the start of treatment and any unmet target weights or abnormal BP readings or HPR should be documented in the flowsheet and the charge nurse notified. EMP4 continued they prefer to complete the pre-assessment note prior to the patient beginning treatment.”

“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 physician’s orders and failed to document the reason for deviations in prescribed blood flow rate (BFR) and/or dialysate flow rate (DFR) for three (3) out of five (5) records reviewed The findings: The facility’s policy entitled, “IC08 Monitoring & Documentation of Patient Care During Treatment,” revision date November 29, 2022, reads, in part: ... “Policy: ... 4. The following must be documented before ‘starting’ the patient’s treatment in the electronic documentation system: ... Treatment RX - indicating caregiver review and verification of all patient treatment data and machine set-up information Orders ... 7. Two signatures are required before ‘starting’ the patient’s treatment in the electronic documentation system: ... second signature - nurse who verifies the patient’s set-up matches the order, or a non-nurse can verify that the patient’s set-up matches the order IF a nurse rounding note is documented within 1 hour of treatment initiation. ... 10. ... Patient status - some notes must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints or observations about the patient’s status must be documented. In addition, any interventions provided to the patient and the patient’s response must be documented. ... 15. Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations, such as slowing blood flow for access problem, target weight change... ... if the patient’s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” A review of the following medical records revealed: Patient (MR) 3: Flowsheet dated July 23, 2025: prescribed BFR 400 ml/min, actual BFR was 0 ml/min at 9:00 A.M. and 350 ml/min at 9:30 A.M. No documentation noted in the flowsheet. MR4: Flowsheet dated July 18, 2025: prescribed BFR 450 ml/min, actual BFR was 200 ml/min at 10:52 A.M. No documentation noted in the flowsheet. Flowsheet dated July 23, 2025: prescribed BFR 450 ml/min, actual BFR was 0 ml/min at 9:01 A.M. No documentation noted in the flowsheet. MR5: Flowsheet dated July 23, 2025: prescribed BFR 550 ml/min, actual BFR was 400 ml/min at 3:31 P.M. No documentation noted in the flowsheet. Flowsheet dated July 25, 2025: prescribed DFR 600 ml/min, actual DFR was 500 ml/min throughout the entire 210 minute treatment. No documentation noted in the flowsheet. During an interview on July 28, 2025, at 2:50 P.M., EMP6 indicated that the reasons for deviations from the prescribed values should be documented in the flowsheet and the charge nurse notified. EMP6 indicated the expectation is prescription parameters should be followed. During an interview on July 28, 2025, at 4:04 P.M., EMP4 indicated any changes to the prescribed values should be documented and the charge nurse notified.”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 49355 Based on medical record reviews, facility staff (EMP) interview and facility document review, it was determined the facility failed to complete a thirty (30) day Plan of Care (PoC) review for one (1) of four (4) unstable patients (MR), MR1. The findings: A review of the facility’s document entitled, “G35 Comprehensive Assessment, Plan of Care CAPOC,” revision date June 11, 2025, reads, in part: ... “POLICY for Comprehensive Assessment: ... 5. Ongoing comprehensive reassessments will be completed at the following times: ... monthly for patients deemed unstable by the IDT Unstable Patient Criteria ... 19. After a patient has been deemed unstable, there must be documentation that the patient has been re-assessed monthly (for at least 1 month) with the plan of care revised to address the issues related to the unstable status.” A review of the medical record on July 29, 2025, with the assistance of EMP3, revealed MR1 was deemed unstable on June 12, 2025 by the IDT. There was no documentation in the medical record of a thirty (30) day reassessment for MR1 on or after July 12, 2025. EMP3 agreed a thirty (30) day reassessment for MR1, due to the unstable assessment on June 12, 2025, was not present in the medical record. EMP3 indicated that there should have been a reassessment documented, due to MR1’s unstable status.”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 49355 Based on facility staff (EMP) interviews and document review, it was determined that the facility failed to employ a nurse manager for the facility. The findings: Based on CMS regulations: “(1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis.” During an interview on July 28, 2025, EMP4 indicated this facility did not currently have a nurse manager. The prior employee left the position in April 2025. During an interview on April 29, 2025, EMP3 indicated this facility does not currently have a nurse manager. The position has been recently vacated and has been posted in hopes of filling it soon. EMP3 indicated that a job description for the nurse manager position was not available.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 42042 Based on interview and document review, it was determined the facility failed to ensure that all clinical variances and adverse events were appropriately documented and reviewed in an ongoing effort to improve care. Specifically, the facility’s Quality Assurance of Performance Improvement (QAPI) program failed to document and address issues related to reoccurring leaks and water room equipment issues. The findings include: On 04/10/24 at 11:04 am, the surveyor conducted an interview with Patient #2 who stated that they could recall observing several instances of water leaks occurring while being dialyzed. The patient stated the last one having occurred “about two to three weeks ago”. On 04/10/24 at 11:10 am, the surveyor interviewed Patient #3 on the treatment floor. Patient #3 informed the surveyor they could recall a significant water leak occurring on the treatment floor “a couple months ago” while receiving dialysis treatment. The patient indicated during the interview that they could recall seeing Staff Member #7 addressing the leak prior to their treatment termination. On 04/10/24 at 11:19 am, the surveyor met with Staff Member #6 for interview. The staff member advised they could recall a “significant water leak” involving the HVAC unit occurring sometime late last year. Staff Member #6 advised the event may have occurred during the previous Fall season but verbalized they were not entirely sure. The staff member added during interview that the leak in the HVAC System located on the roof of the building resulted in leakage in the tile roof above the treatment floor while patients were being dialyzed. Staff Member #6 stated that although patient care was not delayed or otherwise affected, patients had to be temporarily relocated to another area of the treatment floor until the leak was addressed. On 04/10/24 at 1:27 pm, the surveyor conducted an interview with Staff Member #7 who stated this past Saturday (04/06/24), the facility had a delayed opening due to a technical issue involving the Reverse Osmosis (RO) machine. Staff Member #7 stated they were made aware of the delayed opening after a phone call by the opening PCT, Staff Member #12. Staff Member #7 stated that the event was related to the routine pre-rinse cleaning cycle of the RO not being completed upon start of day. Staff Member #7 added that dialysis care for the Saturday shift was administered in full despite an approximate hour delay of opening. Staff Member #7 also stated that various drain areas adjacent to the wall boxes of each treatment station have been known to cause leaks from time to time. Staff Member #7 was unable to provide the surveyor with specific occurrence date and times but added that when they occur patient treatment is not compromised. Staff Member #7 stated they could recall around “last fall” of the HVAC/AC unit malfunctioning causing a leak in the roof tiles of the treatment floor. Staff Member #7 stated the leak had occurred during patient treatments but that it was resolved that day without any interference with patient care except for having to relocate several patients who were stationed nearby to the affected area. On 04/10/24 at 1:59 pm, the surveyor conducted an interview with Staff Member #12 who was able to provide the following details regarding the reported RO issue on 04/06/24: Staff Member #12 stated that while opening the facility this past Saturday, they had become aware that the RO had not finished performing the routine pre-rinsing cleaning cycle. Staff Member #12 added that they had contacted Staff Member #7 regarding the issue and was informed to wait until the RO was finished before initiating dialysis care. Staff Member #12 added that the water room issue resulted in the facility having a delayed opening beyond typical opening hours due to not being ready for patient care. The staff member added that the delayed opening only involved patients who were scheduled to receive treatment by 6:00 am. Staff Member #12 approximated the delay to be “around one hour” in duration. Staff Member #12 stated similar issues surrounding the water room equipment not being ready for patient treatment had occurred with last occurrence happening while the full-time biomed tech (Staff Member #7) being out on leave “on a Friday, a couple of months ago”. Staff Member #12 added the delayed opening on the Friday was exacerbated by the fact that the covering biomed counterpart did not live in the immediate area, and by the time they had presented on-site to resolve the problem, patient care was delayed for “about 2 hours” with morning patients not starting treatment until 8:30 am. On 04/10/24 at 3:06 pm, the surveyor reviewed the facility’s Total Quality Meeting (TQM) minutes for the past six (6) months provided by Staff Member #1. During review, the surveyor was unable to locate any information from the TQM minutes that the issues surrounding the reoccurring leaks in the treatment floor or delayed openings for patient care due to issues of the water room equipment were discussed. On 04/10/24 at 3:49 pm, the surveyor met with Staff Member #1 for interview. The surveyor informed the staff member that they could not find any documentation of the aforementioned events being discussed in the TQM minutes, nor was there any documentation of the events within the Adverse Events Tracking documentation. The staff member denied being aware of the water room equipment issue. The staff member denied any patient being dialyzed later than scheduled and advised that the water leak occurring the past fall was discussed in the TQM but could not provide the surveyor with corresponding documentation. In the afternoon of 04/10/24, the surveyor was provided both the “RM300 Incident/Event Reporting” (with last revision date of 05/2022) and “G09 Quality Assessment & Performance Improvement (QAPI)” (with effective date of 01/2021) policies by Staff Member #1. On page three (3) and four (4) of the GM300 Policy, the document stated in part, “15. The following incidents at a minimum must ALWAYS be reported as an incident/event: significant water treatment issues resulting in interruption of treatments, malfunction of dialysis machine, cycler, or equipment during dialysis treatment, malfunction of any component of the water treatment system ...This list is not intended to be an all-inclusive list” [sic]. Under “Purpose” section of the G09 QAPI Policy, the document stated, in part, “Regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes”. The same policy continued to state the following: “The interdisciplinary team (IDT) must demonstrate effective communications and must devote sufficient time and attention to produce effective QAPI activities that positively influence outcomes. Communication between the Medical Director and Governing Body related to QAPI activities may be documented in the minutes of the QAPI meeting minutes [sic]. The QAPI program must: Continually look at indicators for patients and associates as they are available, trend outcomes, develop an improvement plan ...[sic]. At a minimum, the QAPI program must include equipment maintenance, review of documentation on forms required by policies and procedures for timeliness, accuracy, and appropriate interventions when indicated [sic]. QAPI indicators must be monitored routinely and not just quarterly. Continuous monitoring means that outcome data, adverse events ...are monitored as this data is available or as these events occur. This process is facilitated by documenting and reviewing the indicators on a monthly basis [sic]. At each QAPI meeting ...must set priorities for performance improvement, considering the prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes” [sic]. On 04/11/24 at 4:30 pm, the surveyor met with Staff Member #1, Staff Member #15, and Staff Member #16 to disseminate the aforementioned findings. Opportunity given for questions and concerns by the surveyor without response.”

“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: 49355 Based on observations, interview and document review, it was determined the facility staff failed to ensure that dialysis stations were appropriately disinfected between patients in three (3) out of three (3) observations. The findings include: On 01/29/2024, the surveyor observed Staff Member (SM) 6 cleaning and disinfecting a vacated chair at station #6 and a short time later, at station #8. SM6 did not wipe down the counter behind the chair, where the patient’s belongings had been stored, at either station that SM6 cleaned. On 01/29/2024, SM7 was observed cleaning station #7. SM7 did not wipe down the counter behind the chair. A review of the facility’s policy titled, G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area,” with a last revision date of 11/15/2023, states, in part: ... “7. All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. ... This includes, but is not limited to the: ... counters and wall boxes. The observation was discussed with SM1. The above concerns were discussed with SM #1, 4, 9, and 10 at the exit conference on 01/29/2024 at 3:15 p.m.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 49355 Based on observation and document review, it was determined the facility staff failed to follow the facility’s policy ensuring that access sites are visible on patients during the dialysis treatment. The findings include: On 01/29/2024 at 2 p.m., the surveyor observed that the access site on Patient (P) 5 at station #9 was completely covered up by a blanket. When the surveyor left the treatment floor at 2:35 p.m., the site was still covered by the blanket. A review of the facility’s policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment,” last revision date 11/29/2022, reads, in part: “Purpose: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment. ... Policy: ... 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every 30 minutes and PRN depending on the patient’s condition includes, but is not limited to: ... Visibility of the vascular access and interventions taken to address non-visibility of the access.” The above finding was discussed at the exit interview on 01/29/2024 at 3:15 p.m. with SM 1, 4, 9, and 10.”

“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 review and policy review, it was determined the facility staff failed to follow the dialysis treatment orders, specifically blood flow rate (BFR), for three (3) out of five (5) sampled patients. Findings: The six (6) most recent flowsheets for five (5) in-center hemodialysis patients were reviewed on 01/29/2024. Dialysis orders were not followed in three (3) of the five (5) patients reviewed. There was no documentation to notify the charge nurse of the reason for the discrepancy. Patient # 1 01/24/2024 - BFR was documented at 300 ML/min, a decrease from the prescribed rate of 400 ML/min, for 2.5 hours during the treatment cycle. No documentation was noted on flowsheet. Patient # 3 01/20/2024 - BFR was documented at 400 ML/min for the entire 3.5 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on the flowsheet. Patient # 7 01/17/2024 - documented at 400 ML/min for the entire 4.0 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on the flowsheet. 01/19/2024 - BFR was documented at 400 ML/min for the entire 4.0 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on the flowsheet. 01/22/2024 - BFR was documented at 400 ML/min for the entire 4.0 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on the flowsheet. 01/26/2024 - BFR was documented at 400 ML/min for the entire 4.0 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on the flowsheet. A review of the facility’s policy titled “IC08 Monitoring & Documentation Of Patient Care During Treatment,” last revision date 11/29/2022, states, in part: ... 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every 30 minutes and PRN depending on the patient’s condition includes, but is not limited to: ... Blood flow rate (BFR) ... 15. Information that must be entered manually includes, but is not limited to: ... if the patient’s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” The above findings were discussed at the exit conference on 01/29/2024 at 3:15 p.m. with SM 1, 4, 9, and 10.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 40084 Based on interview and record review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues related to the patients’ treatment BFR matching the patients’ dialysis prescription. The findings include: Tag V-0544 This complaint survey Based on medical record review and policy review, it was determined the facility staff failed to follow the dialysis treatment orders, specifically blood flow rate (BFR), for three (3) out of five (5) sampled patients. The recertification survey ending August 17, 2022. Based on interview, medical record and policy review, it was determined that the facility staff failed to: document the reason and notification to the registered nurse of the change in blood flow rate (BFR) for two (2) of seven (7) patients sampled; and administer the prescribed order for the dialysate flow rate (DFR) for one (1) of seven (7) patients sampled.”