Beechnut Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48020 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: rodent/pest droppings in clean supply drawers in the hemodialysis treatment area B) dead insects in the light covers of the lobby, hemodialysis treatment area, business office, and conference room Cross Reference V111 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to wash/sanitize hands after removal of contaminated gloves in 1 of 3 staff observed: Patient Care Technician (G) and Patient #s 6, 7 Cross Reference V113 Based on observation, interview and record review, the facility failed to prevent potential contamination risks as evidenced by storing a roll of paper towels on the counter above the clean sink. Cross Reference V114 Based on observation, interview and record review, the facility’s direct care staff failed to prevent cross contamination by cleaning and disinfecting the hemodialysis chair with contaminated gloves after cleaning the waste receptacle in 1 of 3 staff observed: Patient Care Technician (G) Cross Reference V117 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect the blood pressure cuff holders, hand sanitizers, back of hemodialysis machines, dialysate lines, and chase countertops in 1 of 3 staff observed: Patient Care Technician (G) Cross Reference V122”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 48020 Based on observation, record review, and interview the facility failed to ensure a sanitary environment and avoid sources and transmissions of infection by failing to follow the manufacturers direction for use as evidenced by: blood glucose meters identified as single patient use were shared between multiple patients. This failure has a potential for exposure to the facility’s current population of diabetic patients and future diabetic patient exposure to blood born viruses and infection through contaminated equipment. The facility has a current census of 6 diabetic patient. It was determined that the deficient practices posed an Immediate Jeopardy to the health and safety of the patients, and placed all the patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. B) multi-dose vials of medication were not properly labeled when opened. Based on observation, interview, the facility’s governing body failed to ensure: conductivity and pH solutions are not available for use past the discard date. B) expired supplies are not stored, and in use in the facility for care and services of patients beyond the manufacturer’s directions for use. Cross Reference V403 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: white crystallized build up on the left side of the brine tank, and on the bottom of the water softener and secondary carbon tank in the water treatment room B) white crystallized residue, debris, and dust on the floor of the water treatment room C) black buildup on the floor underneath the acid tank and utility sink of the water treatment room D) rust on the stands that hold the reverse osmosis and acid tank in the water treatment room E) dust collection and residue on the Heating, Ventilation, and Air Conditioning (HVAC) intake vents. Cross Reference V402”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s staff failed to evaluate hazard/risk of its facility and develop and implement a plan to address identified hazard/risk based on the assessment. Findings: Observation on 07/21/2025 and 07/23/2025 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on two shifts Monday and Wednesday. Interview with Facility Administrator (F) on 07/21/2025 revealed the facility has 24 patients who receive hemodialysis treatment in the facility on two shifts from 5:00 AM - 2:00 PM on Monday, Wednesday, and Friday. Review of the facility’s emergency plan provided by the Facility Administrator (F) revealed no evidence that the facility’s staff evaluate hazard/risk to facility or develop and implement plans to address identified hazard/risk. Surveyor requested evidence that the facility’s staff evaluate hazard/risk to facility, develop and implement plans to address identified hazard/risk from the Facility Administrator (F). No hazards risk assessment was provided.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 48020 Based on observation, record review interview and, the facility failed to notify its area office of emergency management annually of its existence, the type of patients served and the need base of the patients in an emergency. Findings: Review of the facility’s Pt (Patient) Roster Report printed 07/21/205 at 7:17 AM and revealed the facility has 25 patients who receive hemodialysis treatment in the facility on two shifts on Monday, Wednesday, and Friday. Observation on 07/21/2025 and 07/23/2025 during the survey of the facility revealed, patients were observed receiving hemodialysis treatment on two shifts. Review of the facility’s emergency management record provided by Facility Administrator (F), revealed the most current documentation that the facility notified its area office of emergency management of its existence, the type of patients served and the need base of the patients in an emergency was dated 03/08/2019. On 07/23/2025 at 12:33 PM the Surveyor requested evidence that the facility notified its area emergency management annually as required. No evidence was provided.”

“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: 48020 Based on record review and interview, the facility’s staff failed to perform an evaluation process on the emergency preparedness drills. Findings: Review of facility’s current policy and procedure on emergency preparedness directs staff as follows: “Employee and Patient Emergency Preparedness Drills and Evaluations Perform timed disaster drills quarterly, be sure every shift has a drill ... All drills require planning to ensure the most benefit. The three essential requirements for conducting a successful drill include: Pre-drill education for all staff and patients. This should be an on-going effort. Step-by-step plan for executing the drill. Post-drill critique and recommendations. Post-Drill Critique and Recommendations - The Nurse-in-Charge completes a verbal and written evaluation following each drill. Group discussion with employees/occupants will also be held. - Points which should be covered are: not hearing the alarm, fire equipment blocked or unusable, exits and/or hallways blocked, operation hindered, duties not understood or carried out, etc. - The Nurse-in-Charge or designee completes a Drill Report. - Note the following: o Circulate the sign-in-sheet to record staff attendance. o File critique form and attendance record in quality assurance/improvement report log and staff training log. o Ensure all facility staff attend drill or demonstrate essential skills to ERT personnel if absent. o Provide deadline for performance skills/drill make up for absentee staff.” Review of the facility’s emergency preparedness records revealed that emergency preparedness drills were held in the facility on 01/20/2025, 05/19/2025, and 06/18/2025 as evidenced by a sign-in sheet signed by employees who participated. There were no post-drill critiques and recommendations documented on the emergency preparedness drills. Interview with Facility Manager (F) on 07/23/2025 at 3:00 PM confirmed the above findings.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48020 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: rodent/pest droppings in clean supply drawers in the hemodialysis treatment area. B) dead insects in the light covers of the lobby, hemodialysis treatment area, business office, and conference room. Findings: HEMODIALYSIS TREATMENT AREA Observation of the hemodialysis treatment area on 07/21/2025 at 9:35 AM revealed the following: Rodent/Pest Droppings Near Station #23 Isolation Room - Clean supply drawer (top left)- 8 black cylindrical bits, approximately 0.25-inch, with both ends tapered to a point, like rodent excrement in the drawer with one opened and one closed sleeve of medication cups. - Clean supply drawer (middle left)- 2 black cylindrical bits, approximately 0.25-inch, with both ends tapered to a point, like rodent excrement in the drawer with JMS WingEater Safety A.V. Fistula Needle Sets Interview during observation with Medical Director (E) confirmed that there were rodent/pests droppings in the clean supply drawers. FACILITY Observation of the facility on 07/22/2025 at 9:33 AM revealed the following: Dead insects in light covers - Lobby- near the door - Hemodialysis Treatment Area- lights near the isolation rooms - Business office- near entrance of hemodialysis treatment area - Conference Room- over the table Interview conducted with Facility Administrator (F) and Medical Director (E) at 1:45 PM confirmed the infection control findings with the light covers.”

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to encourage patients to wash/sanitize hands after removal of contaminated gloves in 1 of 3 staff observed: Patient Care Technician (G) and Patient #s 6, 7 Findings: Review of facility’s current policy and procedure: Standard Precautions in the Dialysis Unit #4.01 directs staff as follows: “ II. Standard Precautions will be utilized for the care of all patients ... B. Gloves Wear gloves (clean, nonsterile gloves are adequate) when touching blood, body fluids, secretions, excretions, and contaminated items. Put on clean gloves just before touching mucous membranes and nonintact skin. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of micro-organisms. Remove gloves promptly after use, before touching noncontaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganism to other patients or environments.” Patient Care Technician (G) Patient #6 Observation on 07/21/2025 at 2:02 PM, revealed Patient #6 holding his vascular access with a gloved hand at station #5. After the bleeding ceased, Patient Care Technician (G) taped the patient’s vascular access site. The patient removed his glove, picked up his personal items, was weighed, and left the treatment floor without washing/sanitizing his hands. Patient #7 Observation on 07/21/2025 at 2:45 PM, revealed Patient #7 holding his vascular access with a gloved hand at station #5. After the bleeding ceased, Patient Care Technician (G) taped the patient’s vascular access site. The patient removed his glove, picked up his personal items, was weighed, and left the treatment floor without washing/sanitizing his hands. The Surveyor notified Patient Care Technician (G) at 3:03 PM that Patient #s 6 and 7 failed to wash/sanitize their hands after removal of the contaminated glove used to hold their vascular accesses. Patient Care Technician (G) said, “Okay.””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 48020 Based on observation and interview, the facility failed to prevent potential contamination risks as evidenced by storing a roll of paper towels on the counter above the clean sink. Findings: Observation of the hemodialysis treatment area on 07/21/2025 at 8:42 AM revealed a roll of paper towels sitting on the counter above the clean sink used for handwashing near station #12. Subsequent observation at 8:53 AM revealed Registered Nurse (C) removed her gloves after providing care to a patient, walked to the clean sink, washed her hands, grabbed the paper towel roll, tore a section of the paper towel roll, wiped her hands, and returned to the patient care area to document. Interview during observation with Medical Director (E) confirmed that paper towels protected from contamination were not available at the clean sink.”

“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: 48020 Based on observation and interview, the facility’s direct care staff failed to prevent cross contamination by cleaning and disinfecting the hemodialysis chair with contaminated gloves after cleaning the waste receptacle in 1 of 3 staff observed: Patient Care Technician (G) Findings: Patient Care Technician (G) Station #5 Observation on 07/21/2025 at 2:25 PM revealed Patient Care Technician (G) terminally cleaning station #5 post hemodialysis treatment of a patient. Patient Care Technician (G) wiped the waste receptacle, dropped the bleach towel on the floor, pick it up and put it in his left gloved hand, picked up the clean bleach towel sitting on the hemodialysis chair, and wiped the hemodialysis chair with his contaminated right gloved hand. Patient Care Technician (G) did not remove his gloves and wash/sanitize his hands before grabbing the clean bleach towel to disinfect the hemodialysis chair. The Surveyor notified Patient Care Technician (G) at 3:03 PM that he failed to prevent cross contamination by not removing his contaminated gloves and washing/sanitizing his hands before wiping the hemodialysis chair. Patient Care Technician (G) said, “Okay.””

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect the blood pressure cuff holders, hand sanitizers, back of hemodialysis machines, dialysate lines, and chase countertops in 1 of 3 staff observed: Patient Care Technician (G) Findings: Review of facility’s current policy and procedure: Standard Precautions in the Dialysis Unit #4.01 directs staff as follows: “ II. Standard Precautions will be utilized for the care of all patients ... E. Equipment All patient care/dialysis equipment will be wiped down with a bleach towel between patients to prevent skin and mucous membrane exposures, contamination of clothing and transfer of micro-organisms to other patients.” Patient Care Technician (G) Station #5 Observation on 07/21/2025 at 2:25 PM revealed Patient Care Technician (G) terminally cleaning station #5 post hemodialysis treatment of a patient. Patient Care Technician (G) failed to clean and disinfect the blood pressure cuff holder and hand sanitizer bottle in it, back of the hemodialysis machine, dialysate lines, and chase countertop. Station #8 Observation on 02/25/2025 at 2:45 PM revealed Patient Care Technician (G) terminally cleaning station #8 post hemodialysis treatment of a patient. Patient Care Technician (G) failed to clean and disinfect the blood pressure cuff holder and hand sanitizer bottle in it, back of the hemodialysis machine, and dialysate lines. The Surveyor notified Patient Care Technician (G) at 3:03 PM that he failed to clean and disinfect the dialysis station as required at station #s 5 and 8. Patient Care Technician (G) said, “Okay.””

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility failed to document the total chlorine test every four hours while the dialysis water was in use. Findings: Observation on 07/21/2025 of the facility’s water treatment room revealed two carbon tanks in place used for absorption of free chlorine, chloramine, or total chlorine in water utilized for hemodialysis of patients. Review of the facility’s total chlorine testing log on 07/23/2025 revealed the following: 06/04/2025: Total chlorine test results 4:15 AM- <0.1 ppm (parts per minute) 5:20 AM- <0.1 ppm 8:20 AM- <0.1 ppm There were no other total chlorine tests documented for the day. The “Nurse’s Signature Verifying Log is completed and Accurate” was signed and dated for 06/04/2025. Interview during record review with Registered Nurse (C) at 1:50 PM confirmed that patients received hemodialysis treatments on the second shift the ends at 2 PM. Review of the Patient #6’s hemodialysis treatment sheet dated 06/04/2025 revealed that the patient received the treatment between 8:40 AM - 12:40 PM. There was no total chlorine test at 12:20 PM to meet every four hour testing requirement while the dialysis water is in use per regulation. 06/06/2025: Total chlorine test results 4:30 AM- <0.1 ppm 4:58 AM- <0.1 ppm There were no other total chlorine tests documented for the day. The “Nurse’s Signature Verifying Log is completed and Accurate” was signed and dated for 06/06/2025. Interview during record review with Registered Nurse (C) confirmed that patients received hemodialysis treatments on the first and second shifts. Review of the Patient #6’s hemodialysis treatment sheet dated 06/06/2025 revealed that the patient received the treatment between 8:48 AM - 12:48 PM. There was no total chlorine test at 8:58 AM to meet every four hour testing requirement while the dialysis water is in use per regulation. 06/09/2025: Total chlorine test results 4:38 AM- <0.1 ppm 5:03 AM- <0.1 ppm 8:45 AM- <0.1 ppm There were no other total chlorine tests documented for the day. The “Nurse’s Signature Verifying Log is completed and Accurate” was signed and dated for 06/09/2025. Interview during record review with Registered Nurse (C) confirmed that patients received hemodialysis treatments on the second shift. Review of the Patient #6’s hemodialysis treatment sheet dated 06/09/2025 revealed that the patient received the treatment between 9:02 AM - 13:03 PM. There was no total chlorine test documented at 12:45 PM to meet every four hour testing requirement while the dialysis water is in use per regulation. Interview during record review with Registered Nurse (C) confirmed the missing total chlorine tests on 06/04/2025, 06/06/2025 and 06/09/2025.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the staff assigned water room duties, failed to review and identify irregularity in documentation on the facility’s water treatment log and document action taken to address out of range documentation. Findings: Observation on 07/21/2025 of the facility’s water treatment room revealed a reverse osmosis system in place used for purification of water utilized for hemodialysis of patients. Review on 07/23/2025 of the facility’s water quality log revealed the following documentation: 07/04/2025: RO Percentage Rejection (%SR- set range), acceptable limit(s) = greater than or equal to 90%, facility’s documented result = 5.8. 07/07/2025: RO Percentage Rejection (%SR- set range), acceptable limit(s) = greater than or equal to 90%, facility’s documented result = 6.4. Review of the facility’s water treatment log revealed no documentation that facility’s staff identified the irregularity with documentation on the log and addressed the irregularity with facility’s staff. On 07/23/2025, the Surveyor reviewed the facility’s water treatment log with Biomedical Technician (H) who confirmed the findings.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48020 Based on observation and interview, the facility failed to maintain a sanitary environment as evidenced by: white crystallized build up on white crystallized build up on the left side of the brine tank, and on the bottom of the water softener and secondary carbon tank in the water treatment room. B) rust on the stands that hold the reverse osmosis and acid tank in the water treatment room. C) white crystallized residue, debris, and dust on the floor of the water treatment room. D) black buildup on the floor underneath the acid tank and utility sink of the water treatment room. E) dust collection and residue on the Heating, Ventilation, and Air Conditioning (HVAC) intake vents. Findings: WATER TREATMENT AREA Observation of the water treatment room on 07/21/2025 at 8:26 AM revealed the following: - White crystallized build up on the brine well opening and the down the left side of the brine tank, and on the bottom of the water softener and secondary carbon tank near the floor - Rust on the stands that hold the reverse osmosis and acid tank in the water treatment room - White crystallized residue on the floor near the carbon tanks, water softener, and reverse osmosis - Debris and dust on the floor by the water heater and carbon tanks - Black buildup on the floor underneath the acid tank and utility sink Interview during observation with Medical Director (E) confirmed the findings. FACILITY Observation of the facility on 07/22/2025 at 9:33 AM revealed the following: Dust collection and residue on the HVAC intake/output vents: - In the lobby - In the treatment area Interview conducted with Facility Administrator (F) and Medical Director (E) vents at 1:45 PM confirmed the findings with the HVAC vents.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30124 Based on observation, record review, and interview the facility failed to ensure a sanitary environment and avoid sources and transmissions of infection by failing to follow the manufacturers direction for use as evidenced by: blood glucose meters identified as single patient use were shared between multiple patients. This failure has a potential for exposure to the facility’s current population of diabetic patients and future diabetic patient exposure to blood born viruses and infection through contaminated equipment. The facility has a current census of 6 diabetic patient. It was determined that the deficient practices posed an Immediate Jeopardy to the health and safety of the patients, and placed all the patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death. B) multi-dose vials of medication were not properly labeled when opened. Based on observation, interview, the facility’s governing body failed to ensure: conductivity and pH solutions are not available for use past the discard date. B) expired supplies are not stored, and in use in the facility for care and services of patients beyond the manufacturer’s directions for use. Findings: Review on 07/21/2025 of the manufacturer’s operations directions for use for the CVS Health Advanced Blood Glucose Meter document the glucometer is intended for single patient use only. The facility has a current population of 6 diabetic patients requiring glucose monitoring. Per CDC blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies if devices used for testing and/or insulin administration (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared. Review on 07/23/2025 of the facility’s current policy titled, “Multi-Dose Vial Protocol; Number: 9.03; Date 5/05 reads: Multi-dose vials are acceptable for usage under the following guidelines: ....4. The person beginning the usage will date and initial the started vial. 5. The vial will be discarded after 30 days if not utilized. Package directions from the manufacturer’s directions for use states “Discard opened product after 30 days”. Medication Area: During a tour of the facility medication area on 07/21/2025 at 10:55 a.m. along with the Facility Medical Director (E) the following was identified: 2 - CVS Health Advanced Blood Glucose Meter with manufacture’s directions for use documented the glucometer is intended for single patient use only. One glucose meter remained in the original manufacture box unopened. The second glucometer was identified as in use. Review of the CVS Health Advanced Blood Glucose Meter history of use documented the second meter had been used for glucose reading on 05/09/2025, 06/18/2025 and 06/27/2025. No documentation of the names of patient’s blood glucose tested on the above dates was provided. Interview on 07/21/2025 with the Medical Director (E) stated that he was unaware the glucometers were designated by the manufacturer as single patient use only and not to be shared between patients. Medication Storage: During a tour of the facility medication storage area on 07/22/2025 at 10: 20 a.m. along with the Facility Administrator (F) the following was identified in the medication refrigerator: 1 - opened vial of Tuberculin Purified Protein Derivative (PPD) Mantoux multi-dose vial, 10 test. Lot #2CA93C1, Expiration 10/26. Medications was not labeled with the required initials of the person who opened the vial and no open dated was found. In an interview on 07/22/2025 at 10:25 a.m. with the Facility Administrator (F) confirmed the opened multi-dose vial had not been labeled with an open date and initials of the person who opened the vial resulting in the inability to determine the date of discard which was noted as 30 days after opening on the tubersol packaging. 48020 Treatment Area: Observation of the hemodialysis treatment area on 07/21/2025 at 08:45 AM revealed the following: Conductivity/pH Solutions: 1- Conductivity/pH station with two pHoenix meters with residual fluid inside of them. The station also had the following solutions stored in the bottle holder: 1- MesaLabs Standard Buffer Solution 7.00 pH bottle, Date Opened 04/02/2025, Discard Date 07/02/2025, Lot #ML-P7-1863, expiry 2025-09-18 The manufacturer’s label on the front of the bottle states, “DISCARD 90 DAYS AFTER OPENING.” 1- MesaLabs Conductivity Standard Solution 14.0 mS/cm bottle, Date Opened 05/29/2025, Discard Date 06/28/2025, Lot #ML-C14-1906, expiry 2026-06-02 The manufacturer’s label on the front of the bottle states, “Discard 30 days after opening.” Both solutions were available for use past the discard date written on the bottles by the facility’s staff. Interview during observation with Medical Director (E) verified the above conductivity and pH solutions were beyond the discard date recommended by the manufacturer. Supplies: Clean supply drawers: 3- HACH Sterichek Residual Chlorine Reagent Strips bottles Lot #2125 Use by date 2025-05 Clean supply countertops: 20- Molded Products Incorporated Sterile Recirculation Sets Lot # 300888 expiration 2024-04-28 2- Molded Products Incorporated Sterile Recirculation Sets Lot # 30064B expiration 2021-08-22 Interview during observation with Medical Director (E) verified the above supplies were expired.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 48020 Based on observation, record review, and interview, the facility failed to obtain a CLIA (Clinical Laboratory Improvement Amendments) waiver for point of care testing (POCT) of patient blood glucose levels with a glucometer. Findings: During a tour of the facility medication area on 07/21/2025 at 10:55 a.m. along with the Facility Medical Director (E) the following was identified: 2 - CVS Health Advanced Blood Glucose Meter with manufactures directions for use documented the glucometer is intended for single patient use only. One glucose meter remained in the original manufacture box unopened. The second glucometer was identified as in use. Review of the CVS Health Advanced Blood Glucose Meter history of use documented the second meter had been used for glucose reading on 05/09/2025, 06/18/2025 and 06/27/2025. No documentation of the names of patient’s blood glucose tested on the above dates was provided. The Surveyor requested documentation of the CLIA waiver for point of care testing (POCT) of patient blood glucose levels with glucometer from Medical Director (E) and Facility Administrator (F). None was provided.”

“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: 48020 Based on observation, record review and interview, per the Texas Administrative Code (TAC), Title 26 §117.45(d)(3)(B), the facility’s registered nurses failed to conduct Predialysis Assessments when patients were admitted to the facility for hemodialysis treatments in 2 of 7 sampled patients: Patient #s 1, 4 B) Based on observation, record review and interview, per the Texas Administrative Code (TAC), Title 26 §117.45(d)(3)(C), the facility’s registered nurses failed to conduct assessments before, during or after the hemodialysis treatment per the facility’s policy in 5 of 7 sampled patients: Patient #s 4, 3, 5, 1, 2 Findings: Review of facility’s current policy and procedure: Patient Assessment Protocols for Hemodialysis Therapy # 1.07 directs staff as follows: “POLICY: A comprehensive nursing assessment will be completed prior to initiation of each hemodialysis treatment and a follow-up assessment will be performed at the end of each hemodialysis treatment. GENERAL INFORMATION: The degree and complexity of problems arising during hemodialysis will vary from patient to patient and will depend on many factors. Important variables are the patient’s diagnosis, stage of illness, age, medical problems, fluid and electrolyte balance, and emotional status. An essential first step in the hemodialysis procedure is a review of the patient’s history, the clinical records, laboratory reports, and finally, the nurse’s observation of the patient.” INITIAL NURSING ASSESSMENT: Patient #4 Observation on 07/21/2025 at 10:15 a.m. revealed Patient #4 was seated at station #1 machine #46 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and a dialysate flow rate of autoflow 800 mL/min via left arteriovenous graft. Review of the patient’s clinical record on 07/22/2025 revealed the patient was admitted to the facility on 12/18/2024 with the diagnoses of end-stage renal disease, anemia of chronic kidney disease, diabetes, hypertension, on in-center hemodialysis three times a week. Review of the patient’s clinical record revealed an Initial Nursing Assessment Update was completed on Patient #4 on the date of admission to the facility. The Initial Nursing Assessment Update was dated 12/18/2024 and signed by the Registered Nurse (B) but there was no evidence of the time the initial assessment was completed. There was no evidence that the assessment was completed before the patient started the hemodialysis treatment. Interview during record review with Registered Nurse (B) confirmed the findings above. REPORTABLE PARAMETERS: Treatment sheet dated 07/14/2025: Patient #4 Observation on 07/21/2025 at 10:15 a.m. revealed Patient #4 was seated at station #1 machine #46 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and a dialysate flow rate of autoflow 800 mL/min via left arteriovenous graft. Review of the patient clinical record on 07/22/2025 revealed the following documentation: Treatment sheet dated 07/11/2025: 08:48 a.m.: documented blood pressure of 126/68 mmHg, heart rate of 74 bpm, ultrafiltration (UF) removed of 0 mL - PCT documented “Tx started” 09:00 a.m.: documented blood pressure of 118/76 mmHg, heart rate of 76 bpm, UF removed of 77 mL - PCT documented “BFR increased to 450” 09:30 a.m.: documented blood pressure of 123/74 mmHg, heart rate of 82 bpm, UF removed of 291 mL - PCT documented “Pt alert” 10:00 a.m.: documented blood pressure of 97/52 mmHg, heart rate of 81 bpm, UF removed of 489 mL - PCT documented “Pt alert” 10:30 a.m.: documented blood pressure of 91/54 mmHg, heart rate of 93 bpm, UF removed of 701 mL - PCT documented “Pt alert” 11:00 a.m.: documented blood pressure of 101/81 mmHg, heart rate of 82 bpm, UF removed of 1364 mL - PCT documented “ 11:30 a.m.: documented blood pressure of 85/50 mmHg, heart rate of 88 bpm, UF removed of 1224 mL - PCT documented “Pt alert” 12:00 p.m.: documented blood pressure of 89/47 mmHg, heart rate of 88 bpm, UF removed of 1393 mL - PCT documented “Pt alert” 12:18 p.m.: documented blood pressure of 102/47 mmHg and heart rate of 81 bpm, UF removed of 1500 mL - PCT documented “Tx completed” 12:26 p.m.: registered nurse documented the post treatment assessment as follows: Breath Sounds- Clear Heart Sounds- RRR (regular, rate and rhythm) Abdomen/GI- Soft and non-distended Edema- none Additional Notes: left blank There was no mention of the decrease in systolic blood pressure below the parameter of 90 mmHg Facility parameters for blood pressure on the treatment sheet were as follows: “If SBP ABOVE 180 OR BELOW 90 HAS RN/MD EVALUATED THE PATIENT YES NO” The question was not answered and space to document a note on the patient’s blood pressure were left blank. There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse. PRE and POST NURSING ASSESSMENTS: Treatment sheet dated 07/14/2025: 09:17 a.m.: documented blood pressure of 124/67 mmHg, and heart rate of 70 beats per minute (bpm) - Patient Care Technician (PCT) documented “Tx started” 09:20 a.m.: registered nurse documented the PRE Assessment Breath Sounds- Clear Heart Sounds- RRR Abdomen/GI- Soft and non-distended Edema- none 12:43 p.m.: registered nurse documented the POST Assessment Breath Sounds- Clear Heart Sounds- RRR Abdomen/GI- Soft and non-distended Edema- none 12:47 p.m.: documented blood pressure of 122/102 mmHg, and heart rate of 76 bpm - PCT documented “Tx ended” The PRE Assessment was documented after the initiation of the hemodialysis treatment and the POST Assessment was documented before the termination of the hemodialysis treatment. The registered nurse did not complete the pre and post assessments according to the facility’s policy. Treatment sheet dated 07/09/2025: 12:40 p.m.: registered nurse documented the POST Assessment Breath Sounds- Clear Heart Sounds- RRR Abdomen/GI- Soft and non-distended Edema- none 12:45 p.m.: documented blood pressure of 108/64 mmHg, and heart rate of 82 bpm - PCT documented “Tx complete” The POST Assessment was documented before the termination of the hemodialysis treatment. The registered nurse did not complete the post assessment according to the facility’s policy. Patient #3 Observation on 07/21/2025 at 7:37 a.m. revealed Patient #3 was seated at station #1 machine #46 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of autoflow 700 mL/min via right central venous catheter. Review of the patient clinical record on 07/23/2025 revealed the following documentation: Treatment sheet dated 07/07/2025: 09:00 a.m.: registered nurse documented the POST Assessment Breath Sounds- Clear, Tracheostomy Heart Sounds- RRR Abdomen/GI- Soft and non-distended Edema- none 09:06 a.m.: documented blood pressure of 103/64 mmHg, and heart rate of 90 bpm - PCT documented “Tx ended” The POST Assessment was documented before the termination of the hemodialysis treatment. The registered nurse did not complete the post assessment according to the facility’s policy. Patient #5 Review of the patient’s clinical record on 07/21/2025 revealed the patient was admitted to the facility on 08/29/2022 with the diagnoses of end-stage renal disease, anemia of chronic kidney disease, congestive heart failure, hyperlipidemia, renal osteodystrophy, on in-center hemodialysis three times a week. Review of the patient’s treatment sheet dated 07/18/2025 revealed the following documentation: Registered nurse documented the PRE Assessment: Breath Sounds- Clear Heart Sounds- RRR Abdomen/GI- Soft and non-distended Edema- none The time of the PRE Assessment was left blank. The registered nurse did not complete the pre-treatment assessment according to the facility’s policy. Interview with Registered Nurse (B) and (C) on 07/23/2025 at 12:10 p.m. confirmed that the nursing assessments were not being completed according to the facility’s policy. 30124 INITIAL HEMODIALYSIS TREATMENT NURSING ASSESSMENT: Patient #1 Review of the patient’s clinical record on 07/21/2025 revealed the patient was admitted to the facility on 03/31/2025 with diagnosis of end-stage renal disease, on in-center hendiadys three times a week. Initial treatment was initiated at 6:10 a.m. Review of the patient’s Initial Nursing Assessment was documented it was completed and signed by Registered Nurse (C) on 03/31/2025, but there was no evidence of the time the initial assessment was completed. There was no evidence that the assessment was completed before the patient started the hemodialysis treatment. Interview during record review with Registered Nurse (C) confirmed the findings above. NURSING ASSESSMENT PRE AND POST DIALYSIS PATIENT #1 Review of the patient’s hemodialysis treatment records revealed the following: 07/21/2025 treatment initiated at 6:16 a.m. Predialysis nursing assessment has no time documented as to when the assessment was completed. Post dialysis nursing assessment has no time documentation as to when the assessment was completed. 07/18/2025 treatment initiated at 5:45 a.m. Predialysis nursing assessment completed at 6:00 a.m. 07/07/2025 treatment initiated at 6:07 a.m. Predialysis nursing assessment completed at 6:10 a.m. PATIENT ID #2 07/21/2025 treatment initiated at 5:59 a.m. Predialysis nursing assessment completed at 6:00 a.m. Post dialysis assessment has no time documented as to when the assessment was completed. 07/18/2025 treatment initiated at 6:00 a.m. Predialysis nursing assessment completed at 6:41 a.m. PARAMATERS OUT OF RANGE NOT REPORTED TO NURSE: Patient ID #1 Parameters “Hypotension Notify MD if SPB < 85” documented on the Plan of Care/Kardex Review of the patient clinical record dated 07/21/2025 revealed the following documentation: 8:00 a.m.: documented blood pressure 84/46 mmHg, heart rate 96, UF removed 2760 mL - PCT documented “Pt watching TV” 9:00 a.m.: documented blood pressure 83/53, heart rate 68, UF 3852 ml - PCT documented “UF off” 9:29 a.m.: documented blood pressure 92/46, heart rate 92, UF 3852 - PCT documented “Treatment complete” Comment section of treatment sheet for blood pressure that reads the following: “If SBP ABOVE 180 OR BELOW 90 HAS RN/MD EVALUATED THE PATIENT YES NO” The question was not answered and space to document a note on the patient’s blood pressure were left blank. There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse. No post assessment treatment time was documented by the nurse. Review of the patient clinical record dated 07/14/2025 revealed the following documentation: 8:55 a.m.: documented blood pressure of 65/46 mmHg, heart rate of 91 bpm, UF removed of 4045 mL - RN documented “UF off, blood flow rate to 300, dizzy” 9:20 a.m.: Documented blood pressure 83/57, heart rate 90, UF removed 4045 ml - PCT documented “Treatment Complete” Comment section of treatment sheet for blood pressure that reads the following: “If SBP ABOVE 180 OR BELOW 90 HAS RN/MD EVALUATED THE PATIENT YES NO” The question was not answered and space to document a note on the patient’s blood pressure were left blank. There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse. The POST Assessment was documented at 9:15 a.m. before the termination of the hemodialysis treatment. The registered nurse did not complete the post assessment according to the facility’s policy. Review of the patient clinical record dated 07/4/2025 revealed the following documentation: 8:30 a.m.: documented blood pressure of 92/67 mmHg, heart rate of 60 bpm, UF removed of 1601 mL - PCT documented “UF off patient cramping” 9:00 a.m.: documented blood pressure 83/54, heart rate 76, UF removed 1601 mL - PCT documented “Patient still cramping” 9:15 a.m.: documented blood pressure 83/45, heart rate 86, UF removed 1601mL - PCT documented “Patient treatment ended” Comment section of treatment sheet for blood pressure that reads the following: “If SBP ABOVE 180 OR BELOW 90 HAS RN/MD EVALUATED THE PATIENT YES NO” The question was not answered and space to document a note on the patient’s blood pressure were left blank. There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse. The POST Assessment was documented at 9:10 a.m.before the termination of the hemodialysis treatment. The registered nurse did not complete the post assessment according to the facility’s policy. PATIENT #2 Parameters “Hypotension Notify MD if SPB < 85” documented on the Plan of Care/Kardex. Review of the patient clinical record dated 07/14/2025 revealed the following documentation: 8:30 a.m.: documented blood pressure 88/50, pulse 78, UF removed 2666 mL - RN documented “UF off low BP” 9:00 a.m.: documented blood pressure 86/57, heart rate 75, UF removed 2666 mL - PCT documented “Patient UF remains off” 9:30 a.m.: BP 87/54, heart rate 74, UF removed 2666 mL - PCt documented “Patient listing to TV” 10:00 a.m.: documented blood pressure 90/41, heart rate 78, UF removed 2665 mL - PCT document “Patient alert” 10:02 a.m.: documented blood pressure 89/39, heart rate 72, UF removed 2666 - PCT documented “Treatment completed” “If SBP ABOVE 180 OR BELOW 90 HAS RN/MD EVALUATED THE PATIENT YES NO” The question was not answered and space to document a note on the patient’s blood pressure were left blank. There was no documentation that the PCT reported the patient’s below parameter blood pressures to the registered nurse. There was no documented assessment of the patient’s below parameter blood pressures by the registered nurse. The POST Assessment was documented at 10:00 a.m. before the termination of the hemodialysis treatment. The registered nurse did not complete the post assessment according to the facility’s policy.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility’s governing body failed to ensure adverse occurrence documentation involving patient care was accurate and complete. Findings: Review of the facility’s Adverse Patient Outcome log on 07/23/2025 revealed the following: 8- Adverse patient outcome reports in which patients had post weight variances above the dry weight. The reports had a signature by the registered nurse and the education provided to the patients but had no documented dates that the adverse patient outcomes occurred. 6- Adverse patient outcome reports in which patients had post weight variances above the dry weight. The reports had no documented signature by the registered nurses. 1- Adverse patient outcome report in which a patient had a post weight variance above the dry weight. The report had a signature by the registered nurse and the education provided to the patient but had no patient name and no documented date that the adverse outcome occurred. Interview during record review with Registered Nurse (B) and (C) confirmed the documentation irregularities for the adverse patient outcomes.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review facility failed to ensure supplies stored in it’s emergency cart are not expired. Findings: Observation on 07/01/2024 at 9:00 a.m. of the facility’s emergency (crash ) cart revealed the following expired supplies: Emergency crash cart: I Shiley catheter ( tracheostomy), lot # 19C0489JZX expired 3/23/2024. 2 Nipro Priming set Lot 050919 A KS expired 5/4/2024.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, facility’s governing body failed to ensure direct care staff providing care and treatment to hemodialysis treatment maintain cardiopulmonary resuscitation certificate from an organization which provides theoretical and practical aspects of procedure in 2 of 4 staff personnel records reviewed. Patient Care Technicians D and J Findings Patient Care Technician (D) On 07/01/2024 during the survey Patient Care Technician (D) was observed on the treatment unit of the facility. The patient Care technician was providing direct care and service to facility’s patients who were receiving hemodialysis treatment. Review of Patient Care Technician’s (D) personnel and training record revealed documentation which indicated the patient care technician was hired to the facility on 5/12/2023 as a patient care technician. Review of the record revealed a cardiopulmonary resuscitation certificate issued on 07/01/2024 by an on line organization. The training does not include the practical aspect of providing cardiopulmonary resuscitation to a patient. Patient Care Technician (J) On 07/01/2024 during the survey Patient Care Technician (J) was observed on the treatment unit of the facility. The patient Care technician was providing direct care and service to facility’s patients who were receiving hemodialysis treatment. Review of Patient Care Technician’s (J) personnel and training record revealed documentation which indicated the patient care technician was hired to the facility on 3/9/2023 as a patient care technician. Review of the record revealed a cardiopulmonary resuscitation certificate issued on 011/16/2022 by an online organization. The training does not include the practical aspect of providing cardiopulmonary resuscitation to a patient. On 07/02/2024, the Surveyor reviewed the staffs’ personnel record with the Facility’s Medical Director who confirmed that the training of direct staff D and J were done online and did not include hands on practical training.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, facility’s staff failed to review and identify irregularity in documentation on the facility’s water treatment log and document action taken to address out of range documentations. Findings: Observation on 07/01/2024 of the facility’s water treatment room revealed a reverse osmosis system in place use for purification of water utilized for hemodialysis of patients. Review on 07/02/2024 of the facility’s water quality log revealed the following findings: 05/24/2024: Reverse osmosis water quality set range< 40 Us/CM, facility’s documented result 98.6. Reverse osmosis rejection rate set range greater than or equal to 90%, facility’s documented result 4.7. 05/27/2024: Reverse osmosis water quality set range< 40 Us/CM, facility’s documented result 98.6. Reverse osmosis rejection range set range greater than or equal to 90 %, facility’s documented result 4.6. Review of the facility’s water treatment log revealed no documentation that facility’s staff identified the irregularity with documentation on the log and addressed the irregularity with facility’s staff. On 07/02/2024, the Surveyor reviewed the facility’s water treatment log with the Facility’s Medical Director who concurred with the findings.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 10802 Based on observation, and interview, the facility’s staff failed to conduct electrical safety test/ preventative maintenance on ancillary equipment. Findings: Observation on 07/01/2024 at 9:00 a.m. and 11:30 a.m. of facility’s ancillary equipment revealed the following equipment electrical safety test/ preventative maintenance were last performed on 7/2022. Review of the sticker on the suction machine stored on the crash cart revealed documentation that electrical safety test/ preventative maintenance was last performed on 7/2022. Review of the sticker on an Ascend laboratory centrifuge revealed documentation which indicated electrical safety test/ preventative maintenance was last performed on 7/2022. The Facility’s Medical Director who was present during the observation was notified of the expired stickers on the ancillary equipment.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility’s direct care staff failed to administer patient’s hemodialysis treatment based on the physician’s order in 1 of 6 sampled patients. Patient #3 Findings: Patient #3 On 07/01/2024 at 8:08 a.m. Patient #3 was observed on the treatment unit of the facility at station #21. The patient was receiving hemodialysis treatment, at a blood flow rate of 450 mls/ minute and dialysate flow rate of 800 mls/ minute via a left upper arm vascular access (arteriovenous fistula). Review of the patient’s clinical record revealed a physician’s order dated 6/2024 for blood flow rate of 450 mls/ minute and dialysate flow rate two times the blood flow rate. Review of the patient’s treatment sheets revealed documentation that on the following dates the patient’s blood flow was maintained at 350 mls/ minute without documented justification: 06/10/2024: Patient’s hemodialysis treatment initiated at 06.08 a.m by the patient care technician assigned to the patient, at a blood flow rate of 200 mls/ per minute. 06:15 a.m. Patient’s blood blow rate increased to 350 mls/ minute and remained at 350 mls/ minute until 09:00 a.m.. Review of the record ( treatment sheet) revealed no justification documented why the patient’s blood flow rate was not maintained at the prescribed rate of 450 mls/ minute. 06/21/2024: Patient’s hemodialysis treatment initiated at 06:21 a.m by the patient care technician assigned to the patient, at a blood flow rate of 200 mls/ per minute . 06:25 a.m. Patient’s blood blow rate increased to 350 mls/ minute and remained at 350 mls/ minute until 09:00 a.m. Review of the record ( treatment sheet) revealed no justification documented why the patient’s blood flow rate was not maintained at the prescribed rate of 450 mls/ minute. Interview on 07/01/2024 at 3:00 P.M with the Facility’s Charge Nurse revealed the arterial pressure may have been high but the reason was not documented.”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s quality assessment performance committee failed to conduct root cause analysis to address the incidence of central venous catheters in use by patients over 90 days . Findings: Review of the facility’s quality assessment performance improvement data and meeting minutes revealed documentation which indicated the facility has a census of 24 hemodialysis patients. The record revealed 40% of patients utilize central venous catheter during hemodialysis treatment. Review of the Core Survey Data Worksheet revealed documentation which indicated that 40% of the patients have central venous catheters in place and in use for hemodialysis treatment over 90 days. Review of the facility’s quality assessment performance improvement data and meeting minutes revealed no root cause assessment done to determine the reason for 40@ the patients having a central venous catheter in place. On 07/02/2024, The surveyor reviewed the quality assessment performance improvement data and meeting minutes with the Facility’s Medical Director, CEO and Clinical Manager who confirmed that deep dive ( root cause ) and a plan was not developed and implemented to address the numbers of patients with central venous catheter over 90 days.”