Davita Magnolia Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48749 Based on observation, record review, and staff interview, the facility’s staff failed to: A. monitor and provide a sanitary environment to minimize the transmission of infectious agents within 5 areas (Medication Preparation Area, Laboratory, In-Center Treatment Area, Storage Room, and Home Therapy Department) of 5 areas in the dialysis center. Also, the facility staff failed to follow the facility’s “Infection Control for Dialysis Facilities” policy. (Cross Refer to Tag V 0111) B. allow the disinfectant on the access site to dry in the allotted timeframe on 1 (#8) of 1 patient. The facility staff failed to follow the facility’s “AV Fistula or Graft Cannulation With Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose” policy. (Cross Refer to Tag V 0113) C. ensure that 2 (#8 and #12) of 2 patients had washed their vascular access site prior to dialysis treatment. The facility staff failed to follow the facility’s “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Care” policy (Cross Refer to Tag V 0114) D. ensure that staff did not have personal food items while in the patient treatment area. The facility staff failed to follow the facility’s “ Infection Control for Dialysis Facilities” policy. (Cross Refer to Tag V 0115) E. ensure that medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. In addition, the facility failed to store vaccines according to the CDC (Centers for Disease Control) guidelines. The facility staff failed to follow the facility’s “Medication Requiring Refrigeration” and “Medication Policy” policies (Cross Refer to Tag V 0117) F. “Chemical (bleach) disinfect” one of the 14 dialysis machines (machine #7 #3TOS-272390) before placing the machine back in service. (Cross Refer to Tag V 0122) G. ensure the Hepatitis B vaccine was made available and administered per the facility’s Hepatitis B policy to 3 (Patient #13, #14, and #15) of 3 susceptible patients at the facility. The facility staff failed to follow the facility’s “Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance” policy. (Cross Refer to Tag V 0126)”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 29191 Based on observation, record review, and interviews, A. the facility staff failed to ensure that chlorine/chloramines tests were performed in accordance with the facility’s policy and followed the manufacturer’s guidelines. Cross Refer to Tag V 196 B. the facility staff failed to verify that all disinfectant had been removed from the (CWP) central water plant before patients were connected to the dialysis machines. Cross Refer to Tag V 219 C. the facility’s biomedical staff failed to identify and promptly correct an acid leak present in the facility’s water treatment room. Also, the facility staff failed to follow the policy, “Responsibilities of the Biomed Department”. Cross Refer to Tag V 222 D. the facility staff failed to ensure 4 of 4 acid 1-gallon jugs were in a secure area. Also, the facility failed to follow the policy on “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS.” Cross Refer to Tag V 228 E. the facility staff failed to ensure the 5-micron “Hytrex” filter on the “Dri-Sate” acid mixer was changed monthly or after the transfer of 1500 gallons for April, May, and June 2025 logs reviewed. Cross Refer to Tag V 229 F. the facility staff failed to ensure that 3 of 3 Reverse Osmosis (RO) water bottles located in the treatment area had a secure cap to prevent contamination of the RO water. Cross Refer to Tag V 250”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48749 Based on observation, record review, and staff interview, the facility’s staff failed to: A. complete the pre-treatment and post-treatment nursing assessments within one hour of treatment initiation on 3 (#8, #9, and #10) of 5 patient medical records reviewed. The facility staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. (Cross Refer to Tag V 0502) B. follow the physician’s prescribed orders for the blood flow rate (BFR) and the dialysis flow rate (DFR) for 4 (Patient #4, #8, #9, and #10) of 5 medical records reviewed. Also, the facility staff failed to verify the patient’s prescriptions within an hour of initiation of treatment for 4 (Patient #4, #8, #9, and #10) of 5 medical records reviewed. The facility staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” policy. (Cross Refer to Tag V 0503) C. ensure that direct care staff were notifying the physician/non-physician practitioner of abnormal findings in 2 (#4 and #10) of 5 patient charts reviewed. In addition, the facility’s direct care staff removed more than the prescribed 13 ml/kg/hr (milliliters per kilogram per hour) in 2 (#9 and #10) of 5 patient charts reviewed. The facility’s direct care staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. (Cross Refer to Tag V 0504)”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] 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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to provide documented evidence that fire drills were conducted with both facility staff and patients quarterly. The staff failed to follow the facility’s “Emergency Management Plan” policy. This deficient practice has the likelihood to cause harm to the health and safety of the 38 in-center and 7 home Peritoneal Dialysis (PD) patients receiving dialysis treatments by not providing the education and training needed to safely evacuate the facility during a fire. The facility treats patients on Monday, Wednesday, and Friday, with 3 shifts on every treatment day. A review of the facility’s fire drills revealed that a fire drill with staff and patients was not conducted for the last quarter of 2024 and the third quarter of 2025. A review of facility policy titled “Emergency Management Plan “ dated October 2024, revealed the following; “3. Fire safety drills: a. Refer to policies: Fire Safety Preparedness, Facility Evacuation Plan, and Emergency Evacuation Device (as applicable) b. Required on a QUARTERLY basis. c. One drill to be conducted for each shift of patients. d. Utilize Emergency Exercise Template “FIRE WITHIN FACILITY.” i. Emergency event drill template ii. Drill evaluation iii. Teammate attendance sheet e. Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency. f. Document training for both teammates and patients. i. Patients use Reggie form Emergency Evacuation Acknowledgement Form ii. Teammates use policy: Training/In-service Documentation Form iii. Identify patients requiring assistance in an evacuation 1. Document exercises and drills by completing: Exercise Scenario Template for an appropriate scenario. Exercise Evaluation i. Evaluates effectiveness of EMP ii. Determines if revisions to EMP are required i. Teammate Attendance Sheet j. Update and revise facility EMP, as needed k. Attach appropriate policy(s) l|. Document in Governing Body meeting m. Maintain with facility EMP” An interview with Staff #2 was conducted on 07/08/2025 at 3:00 PM. Staff #2 confirmed that the facility was unable to provide documented evidence that fire drills and patient education had been conducted every quarter.”

“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: 48749 Based on observation, policy review, and staff interview, the facility’s administrative staff failed to ensure that the patient information was updated in the evacuation kit in case of a disaster. The facility staff failed to follow the facility’s “Evacuation Kit” policy. This deficient practice was likely to harm a dialysis patient in an emergency disaster situation if the patient’s information and prescriptions were not updated for treatment. Findings included: During a tour of the facility on 07/07/2025 at 12:30 PM, a review of the patient roster in the evacuation kit revealed that the roster was printed on 06/02/2025. There was not a current roster in the evacuation kit for the month of 07/2025. A review of the facility policy titled “Evacuation Kit” dated 04/2019, revealed the following: “6. Each evacuation kit(s) should contain: a) Copy of each patient’s treatment orders and medication list. The Facility Administrator (FA) or designee will verify patient information is updated and replaced at least monthly. b) A copy of the Facility Emergency Disaster Plan. Replace with updated plan as needed. c) A roster of all facility teammate’s emergency contact information. Update information needed. d) A copy of the physician contact.” An interview was conducted with Staff #2 on 07/08/2025 at 4:30 PM. Staff #2 acknowledged the surveyor’s findings that the patient roster in the evacuation kit was not current for the month of 07/2025.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within 5 areas (Medication Preparation Area, Laboratory, In-Center Treatment Area, Storage Room, and Home Therapy Department) of 5 areas in the dialysis center. Also, the facility staff failed to follow the facility’s “Infection Control for Dialysis Facilities” policy. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. Findings include: During a tour of the facility on 07/07/2025 at 12:30 PM, the surveyor observed the following infection control issues; Medication Preparation Area: * There was an accumulation of dust, debris, and cleaning wipes under the sink. * There was an accumulation of dust on the cabinet shelves. *There was an accumulation of dust and debris on the bottom of the nutrition refrigerator. *There was an accumulation of dust and debris on the bottom of the medication refrigerator. Laboratory: * There was an accumulation of dust and debris in the drawers next to the laboratory refrigerator. *There was a clutter of Bicarbonate Wands, baskets, cleaning wipes, and tubing in a drawer next to the refrigerator. Also, the lid of the cleaning wipes was missing, leaving the wipes and solution exposed to the other items stored in the drawer. * There was an accumulation of dust and debris on the bottom of the laboratory refrigerator. *There was an open cardboard box on the shelf above the laboratory tubes in the cabinet. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material, serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). *The spray head of the emergency wash station was lying at the bottom of the sink designated as a “dirty sink” in the laboratory. *The bottom of the cabinet under the sink was missing the laminate. The wood was peeling and chipped. There was a garbage can under the sink pipe for a water leak. In-Center Treatment Area: * There was an accumulation of lint and debris on the blood pressure cuffs of all 12 stations in the in-center treatment area. * There was an accumulation of dust on top of the emergency crash cart (code cart). * There was an accumulation of dust on top of the plastic bin and inside the drawers of the plastic bins next to the sink. *There was a used, wet paper towel sitting on top of a blood pressure cuff in an open drawer of a plastic bin. *There was a blue pad with an accumulation of an unknown white dried substance on the bottom of the plastic bin designated for “white wands.” *There was an accumulation of an unknown dried white substance inside the plastic bins designated for “clean clamps and vascular clamps.” *There was an accumulation of an unknown dried white substance on the supply carts at the nurse’s station. *There was an accumulation of dust and debris inside the drawers storing sterile supplies at the nurses’ stations. *There was a missing plastic cover for the lid on the biohazard trash can. The metal frame had an accumulation of rust on the lid. *There was a build-up of dust and debris on the base and wheels of the biohazard trash cans. *The cabinet drawers storing sterile supplies were broken and would not stay closed. This allowed for sterile supplies to be exposed to contaminants. Also, the broken drawers had a likelihood to cause injury to staff and patients by not securely closing. A review of the facility’s “Infection Control for Dialysis Facilities” dated April 2023 revealed the following; “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. SUPPLIES 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet, or contaminated, the package and its contents must be disposed of and not used. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to the clean/designated area or removal from the treatment area. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain, and Water supply lines are considered part of the dialysis delivery system. 15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas. a. Wipe-able keyboard covers or medical grade keyboards are to be utilized. b. The chair side cart components will be cleaned at the end of each treatment day. c. Sharps containers are not stored on the chair side cart. d. Disposable gloves and alcohol based hand rub containers may be stored on the chair side cart shelves but not stored on counters where terminals are mounted. e. The monitor screen is cleaned as needed and daily at end of each treatment day using a disposable wipe moistened with 65 - 70% isopropyl alcohol solution. FACILITY HYGIENE 16. 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.” An interview was conducted with Staff #2 and Staff #15 on 07/08/2025 at 4:30 PM. Staff #2 and Staff #15 acknowledged the infection control and safety issues found by the surveyor during the tour of the facility. 29191 Storage Area During a tour of the patient supply storage area on 07/07/2025 at 3:00 PM with Staff #1 and #11, the surveyor observed dust, dirt, millipedes, and trash underneath the supply shelves. The plastic covering on the bottom shelves was covered in dust and dirt. Home Therapy Department During a tour of the home training department on 07/07/2025 at 1:20 PM with Staff #3, the following infection control issues were observed: * Two ceiling tiles in the home training room had large brown stains, which appeared to be water stains. * The electric outlet was hanging out of the wall and positioned directly on the floor. The wall insulation was exposed. * The wall behind the patient’s dialysis chair had missing paint and plaster. * A gallon of bleach labeled to expire 7/20/2025 actually expired on January 30, 2025. Staff #3 had opened the gallon of bleach on 01/20/2025, after the expiration date, and was using the solution for disinfecting patient equipment. * The Formica edging along the top of the cabinet was peeling off. * The cabinets on the clean and dirty sides were very cluttered. Patient supplies were in the splash zone. * An exam room next to the training room contained an exam table with three plastic containers on top. These containers were used for patient peritoneal supplies. The counter in the exam room was cluttered with peritoneal supplies and nutritional supplements, both in the splash zone of the handwashing sink. Additionally, cardboard boxes mixed with the supplies were present. Cardboard boxes harbor parasites, insects, and microorganisms. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST 46-Section 5.2 Receiving items). An interview with Staff #3 on 07/07/2025 at 2:00 PM confirmed the infection control issues observed in the peritoneal training room and the exam room.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to allow the disinfectant on the access site to dry in the allotted timeframe on 1 (#8) of 1 patient. The facility staff failed to follow the facility’s “AV Fistula or Graft Cannulation With Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose” policy. Findings include: During a tour of the in-treatment center on 07/07/2025, the following was observed; At 2:15 PM, the surveyor observed Patient #8 dialyzing at station #1. Staff #4 was observed with gloved hands after cleaning the access site, fanning the site to speed up the drying time. Staff #4 preceded in accessing the graft with the hemodialysis needles. A review of the facility’s “AV Fistula or Graft Cannulation With Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose” policy dated April 2025 revealed the following; “1. Have patient wash the access site with appropriate antibacterial soap, if able. If the patient is unable to wash the access site, the patient care teammate will clean the access extremity with skin cleansing agent and pat dry ... 10. While maintaining aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site using a circular rubbing motion, center out. 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out, and allow to dry. (For contact and dry time, refer to the table above.) 12. For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular rubbing motion, center out for 60 seconds, and allow to dry for 15 seconds.” An interview was conducted with Staff #2 on the afternoon of 07/07/2025. Staff #2 acknowledged the surveyor’s findings of the staff fanning the access site.”

“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: 48749 Based on observation and staff interview, the facility’s direct care staff failed to ensure that 2 (#8 and #12) of 2 patients had washed their vascular access site prior to dialysis treatment. The facility staff failed to follow the facility’s “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Care” policy. This deficient practice had the likelihood to increase infections at the patient’s vascular access site. Findings include: On 07/07/2025 between 2:00 PM and 3:00 PM, the Surveyor observed Patient #8 and Patient #12 entering the treatment area. The patients weighed themselves and then went straight to their treatment chair without washing their vascular access site. Also, staff did not ensure that Patient #8 and Patient #12 had washed their vascular access site prior to treatment. A review of the facility’s “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Care” policy dated April 2025 revealed the following; “PURPOSE: To reduce the risk of infection in the patient, to reduce trauma to the fistula or graft while minimizing blood loss, and to maximize the lifetime of each access. 1. Patients are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry.” An interview was conducted with Staff #2 on the afternoon of 07/08/2025. Staff #2 acknowledged the surveyor’s findings that patients had not washed their vascular access site prior to starting their treatment.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 48749 Based on observation, policy review, and staff interview, the facility failed to ensure that staff did not have personal food items while in the patient treatment area. The facility staff failed to follow the facility’s “ Infection Control for Dialysis Facilities” policy. Findings include: During the observation tour of the patient treatment area on 07/07/2025 at 12:30 PM, the Surveyor observed candy, gum, and a package of cookies inside a black medication lock box designated to secure patient medications. Also, there were pens, markers, sticky note pads, and a pair of scissors mixed in with food items. A review of the facility’s “Infection Control for Dialysis Facilities” policy dated April 2023 revealed the following; “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. FACILITY HYGIENE 16. 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. 17. Food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area is not allowed.” An interview was conducted with Staff #2 on the afternoon of 07/08/2025. Staff #2 acknowledged the Surveyor’s findings of food items inside the medication boxes on the treatment floor.”

“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: 48749 Based on observation, record review, and staff interview, the facility’s direct care staff failed to ensure that medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility’s direct care staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. In addition, the facility failed to store vaccines according to the CDC (Centers for Disease Control) guidelines. The facility staff failed to follow the facility’s “Medication Requiring Refrigeration” and “Medication Policy” policies. These deficient practices had the likelihood to cause harm to all patients who receive care at the facility by using vaccines that were not stored according to CDC guidelines. Findings include: During a tour of the facility on 07/07/2025 at 12:30 PM, the surveyor observed the following: *The lock for the cabinet door in the medication preparation area was broken, preventing the facility’s medication from being secured and making it accessible to unauthorized persons. * Inside the medication refrigerator, the Hepatitis B and Tuberculin vaccines were stored in a bin on the top shelf, next to the wall of the refrigerator. The Influenza vaccines were lying on the top shelf at the back, next to the wall of the refrigerator. *There was an open multi-dose vial of Tuberculin in the box. There was no date of opening or staff initials written on the label or box. *There were two boxes of 10 0.5 milliliter(ml) syringes of Flucelvax Influenza vaccine with an expiration date of 06/30/2025. *There were two 0.5 ml syringes in a box of Fluzone Influenza vaccine with an expiration date of 06/2025. *There were 7 boxes of Mircera designated for Home Therapy stored in the refrigerator with patient nutrition. *There were 7 prefilled syringes of Heparin stored in a medication lock box on the counter at the nurse’s station. A review of the medication revealed there were no staff initials or time written on the label. Further review revealed the medication was drawn up for all of the patients scheduled in that pod for the day. In addition, the medication lock box was not locked. There were paper sticky notes, pens, and markers stored in a bin with the medication. An interview was conducted with Staff #5 on the afternoon of 07/07/2025. Staff #5 was asked about the Heparin labels. Staff #5 confirmed that the Heparin was not timed or initialed, and that the medications were for the patients scheduled for treatment in Staff #5’s pod for the day. A review of the facility’s policy “Medication Requiring Refrigeration” dated April 2025, revealed the following: “PURPOSE: To provide guidance for the storage and management of medications requiring refrigeration. POLICY: 1. Medications that require refrigeration are stored in the facility refrigerator designated for medications only ... ... i. Avoid storing vaccines and diluents in any part of the unit that may not provide stable temperatures or sufficient air flow, such as directly under cooling vents, in deli, fruit, or vegetable drawers, or on refrigerator door shelves. Place water bottles on the top shelf, and floor, and in the door racks to assist with maintaining stable temperatures caused by frequently opening and closing unit doors or a power failure ... ..... b. Daily checks will include: * Medication placed near center of refrigerator. *No expired medication *General refrigerator cleanliness *DDL buffered probe placed near center of refrigerator *Water bottles are in place, if required *Lock on door or refrigerator door, or in a room that locks 5. Per Centers for Disease Control (CDC), place vaccines in center refrigerator space, contained in original packaging, inside designated storage trays positioned 2 - 3 inches from refrigerator walls.” According to CDC guidelines for the storage of immunizations: www.cdc.gov/vaccines “Store between 35 and 46 degrees. Place the vaccine in bins with open airflow or leave the top off. Make sure the door is shut. Remove crisper bins and place water bottles labeled ‘Do Not Drink in the bottom.’ Leave 2-3 inches between all vaccine containers and refrigerator walls. Post do not unplug on the refrigerator. Don’t use a dormitory-style refrigerator. Don’t store vaccines on top shelf Don’t put food and beverages in the refrigerator. Don’t put vaccines or diluents in the door or floor of the refrigerator. Don’t drink or remove water bottles.” A review of the facility’s “Medication Policy” policy dated October 2023 revealed the following: “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. 11. All refrigerated medications, for example, erythropoietin-stimulating agents (ESA) and vaccines, are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 13. All open or unopened medication packages (i.e., vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. 17. Medication preparation should be performed only for the current shift of patients, i.e., do not prepare medications for more than one shift of patients. 18. All syringes prepared from single-use vials/ampules (without preservatives) or multidose vials should be prepared and administered within a four (4) hour period [within one (1) hour for States of New Jersey and South Carolina] period, unless there is specific testing and documents on file, which extends dating.” An interview was conducted with Staff #1 and Staff #2 on the afternoon of 07/08/2025. Staff #1 and Staff #2 acknowledged the Surveyor’s findings that medication was left unsecured, vaccines were stored against the wall of the refrigerator, and Heparin was drawn up for more than one shift of patients.”

“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: 29191 Based on observation, record review, and staff interview: A. The facility staff failed to “Chemical (bleach) disinfect” one of the 14 dialysis machines (machine #7 #3TOS-272390) before placing the machine back in service. This deficient practice had the likelihood to place all patients being dialyzed on this machine at risk for potential harm, due to the use of bicarbonate during the dialysis process. Bicarbonate has a high potential for bacterial growth. Findings Include: A. The facility staff failed to “bleach disinfect” one of the 14 dialysis machines (machine #7 #3TOS-272390) before placing the machine back in service. A review of the “Machine Disinfect Log” on June 25, 2025, indicated that the machine was out of service. The machine was placed back in service on July 7, 2025, as per the work order, and had only been heat-disinfected by the Biomedical technician. Dialysis Machine #7 missed bleach days on June 25, 2025, and July 2, 2025. The dialysis machine was placed back into service after maintenance and was not bleached within the seven-day timeframe. Also, the staff did not follow the facility’s policy, “Fresenius Dialysis Delivery System Cleaning and Disinfection.” A review of the facility’s policy titled “FRESENIUS DIALYSIS DELIVERY SYSTEM CLEANING AND DISINFECTION POLICY” dated April 2019 revealed the following: “PURPOSE: To promote patient safety by cleaning and disinfection of Fresenius dialysis delivery systems. NOTES: All dialysis delivery systems, including backup dialysis delivery systems intended for patient use, are required to be disinfected at no more than a 72-hour interval. A dialysis delivery system that has not been disinfected within the 72-hour interval must be disinfected prior to patient use. Cleaning/disinfection intervals depend on the facility’s operations: Bleach or Peracetic Acid Disinfection Weekly” A review of the Fresenius hemodialysis machine manual guidelines for the dialysis machine was to be chemically disinfected weekly. An interview with Staff #13 (Bio-Medical Technician) was conducted on 07/08/2025 at 10:00 AM. Staff #13 acknowledged the findings that one of the dialysis machines had not received chemical disinfection before being put back into service for patient use. B. The facility’s direct care staff failed to properly clean and disinfect the dialysis station and equipment before the next patient’s treatment. Additionally, the staff did not follow the facility’s policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES.” During a tour of the facility’s in-center treatment area on 07/07/2025 at 2:00 PM with Staff #2, the surveyor observed the following; Direct Care Staff were cleaning and disinfecting Dialysis Stations #6 and #9 after a patient’s hemodialysis treatment. The surveyor observed the Staff members #5 and #16 open the wings of the dialysis chairs, clean them, and then promptly close the wings. They did not allow enough time for the disinfectant to dry before closing the wings. C. The Direct Care Staff failed to disinfect the weight scale handrail between patients, touching the handrail for 3 of 3 patients observed. During turnover between the second hemodialysis session and the third hemodialysis session, the surveyor observed 3 patients hold the handrail on the scale when obtaining their weight for treatment. The facility staff did not clean and disinfect the scale handrail between each patient. There were no disinfectant cleaning supplies available at the scale for the staff to clean the handrail. A review of the facility’s policy titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES,” dated 09/05/2023, revealed the following; “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. a. Prior to routine disinfection, remove all visible blood i. For visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. ii. After all visible blood is cleaned with the 1:10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time iii. Cleaning of visible blood should be performed when first observed b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time iv. Items disinfected via submersion will be fully submerged c. Spray bottles containing cleaning solutions are single use and cannot be reused or refilled. This practice does not include contracted housekeeping services.” During an interview with Staff #2 on 07/07/2025 at 2:00 PM, Staff #2 acknowledged that Direct Care Staff did not allow the chair to air dry before closing the wing and that the Direct Care Staff were not cleaning and disinfecting the handrail on the scale. D. The Home Therapy staff failed to label the bleach solution container that was sitting on the side of the dirty sink counter with the time, date, and initials. During a tour of the home therapy room at 1:25 PM, the surveyor observed a bleach solution container that was not labeled with date, time, and initials for the 1:10 bleach solution. A review of the facility’s policy titled, “PREPARATION OF 1:100 BLEACH SOLUTION”, dated April 2017, revealed the following; “With an indelible marking pen label, expiration date, time, and initials, the container with a maximum allowable time. The solution is good for 24 hours only. 12. The solution must be changed when the maximum allowable time is not to exceed 24 hours, or when the solution becomes cloudy and turbid. 13. When the solution is not being used, place a lid on the bleach solution. Bleach solution open to the air causes the solution to degrade over time and become less effective.” An interview with Staff #3 on 07/07/2025 at 1:25 PM confirmed that the bleach container was not labeled with date, time, and initials.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to ensure the Hepatitis B vaccine was made available and administered per the facility’s Hepatitis B policy to 3 (Patient #13, #14, and #15) of 3 susceptible patients at the facility. The facility staff failed to follow the facility’s “Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance” policy. Hepatitis B Virus is an infection that causes both short-term and long-term liver disease. It is a virus spread through contact with body fluids such as blood. Hemodialysis patients are at an increased risk of contracting the virus due to compromised immune systems and frequent exposure to blood. A review of the facility’s “Vaccinations and Surveillance Report” dated 07/08/2025 revealed the following, The facility had an in-center hemodialysis patient census of 38. There were 15 of 38 patients considered susceptible to the Hepatitis B virus. Patient #13 Patient #13 was admitted to the facility on 08/02/2024. Patient #13 had a Hepatitis B Surface Antibody (HBsAb) result of “<3” on 05/12/2025, indicating the patient was susceptible to the Hepatitis B virus. The patient received the first dose of the Engerix-B Hepatitis B vaccine series on 01/08/2025. There was no documentation found to support that the patient received any further doses, and the patient remained susceptible to the Hepatitis B virus while receiving in-center hemodialysis treatment. Patient #14 Patient #14 was admitted to the facility on 09/23/2024. Patient #14 had a Hepatitis B Surface Antibody (HBsAb) result of “<3” on 05/12/2025, indicating the patient was susceptible to the Hepatitis B virus. The patient’s vaccine administration dates are as follows: Dose 1: 01/08/2025 Dose 2: 03/10/2025 There was no documentation found to support that the patient received any further doses, and the patient remained susceptible to the Hepatitis B virus while receiving in-center hemodialysis treatment. Patient #15 Patient #15 was admitted to the facility on 01/31/2025. Patient #15 had a Hepatitis B Surface Antibody (HBsAb) result of “<3” on 02/03/2025, indicating the patient was susceptible to the Hepatitis B virus. As of 07/08/2025, the patient had not received the first dose of the vaccine series and remained susceptible to the Hepatitis B virus while receiving in-center hemodialysis treatment. A review of the facility’s “Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance” policy dated April 2024 revealed the following; “PURPOSE: To prevent the spread of hepatitis B infections in the dialysis setting .... New to DaVita (permanent or guest) 7. Results from Hepatitis B surface antigen drawn within 30 days are required prior to the first treatment date. All permanent patients, including AKI patients, will have HBV serologic testing drawn immediately upon admission to the facility, and results known within seven (7) days of admission (i.e., Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody total anti-HBc or HBsAb, and Hepatitis B Surface Antibody [anti-HBs or HBsAb] a. Review results and determine status and next steps (refer to Admission Screening table) b. Obtain orders for routine surveillance testing (refer to Routine Surveillance Testing) ... HEPATITIS B VACCINATION 10. An order will be obtained for hepatitis B vaccination. The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in the Patient Registration Packet found in Reggie). The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record. 11. Patients who start hemodialysis may have a history of vaccination against hepatitis B. These persons should have responded to the vaccine when their immune status was normal, but if their hepatitis B surface antibody (HBsAb or anti-HBs) levels are less than (<<) 10 mIU/mL when they begin dialysis, they should be revaccinated with a complete primary series. 12. Vaccinate per manufacturer’s guidelines. (Note: Hepatitis B vaccine is to be administered by the intramuscular route in the deltoid muscle for adult patients).” A review of the Engerix-B manufacturer’s guidelines reveals that “adult patients on hemodialysis are scheduled to receive injections in 4 doses. An initial dose, a 1-month dose, a 2-month dose, and a 6-month dose”. An interview was conducted with Staff # 2 on 07/08/2025 at 10:15 AM. Staff # 2 confirmed that the facility staff were not following the facility’s policy for the administration of the hepatitis-B vaccine. Staff #2 stated, “We ran out of the vaccine. It has been an ongoing issue to get the medication.””

“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: 29191 Based on observation and interviews, the facility failed to ensure that chlorine/chloramines tests were performed in accordance with the facility’s policy and followed the manufacturer’s guidelines. Findings included: During the observation of the chlorine test on 07/07/2025 at 4:00 PM, Staff #5 conducted the test; the surveyor observed Staff #5 rinse the collection cup once. The surveyor asked how many times the collection cup was rinsed, and Staff #5 answered, “Once.” The surveyor asked how much solution should be placed in the collection cup, and Staff #5 said, “100 cc.” The surveyor corrected Staff #5, and the procedure was repeated with the correct rinse following the facility’s policy and manufacturer guidelines. Interview with Staff #13 on 07/07/2025 at 4:00 PM confirmed that Staff #5 did not follow the chlorine/chloramines testing procedure. The manufacturer’s guidelines stipulate that the collection cup should be rinsed three times and contain 100 cc for testing purposes. A review of the “Routine Total Chlorine Testing Log” revealed that the facility member (signature not readable) on 5/23/2025 documented 0908 (9:08 AM) on the chlorine check. The time frame was past the 4-hour window for checking chlorine. A review of the facility’s policy titled “ DAILY WATER SYSTEM TOTAL CHLORINE MONITORING” dated October 2024, revealed the following: “PURPOSE: To establish that total chlorine testing is regularly performed and within limits specified by International Organization of Standardization (ISO)/Association for the Advancement of Medical Instrumentation (AAMI) and DaVita standards. POLICY: 1. Only trained teammates may perform daily water system total chlorine testing. 2. To verify that Chlorine and Chloramine levels are within the limits specified by ISO/AAMI and DaVita standards. DaVita facilities measure Total Chlorine, the sum of Free Chlorine and Chloramine, to verify that Total Chlorine levels are less than or equal to 0.1 ppm (< 0.1 ppm). 3. Total Chlorine testing is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment(s) and within every four (4) hours until all activities that require use of dialysis quality water are completed. All samples are to be drawn only after the water system has been operating for at least 15 minutes. Document results on either the Routine Total Chlorine Testing Log or Daily Water Treatment Log (with CM130) and in IT Clinical System. 6. The following test kits/strips are approved for Total Chlorine testing of water used for dialysis in DaVita facilities: * RPC Ultra Low Total Chlorine Test Strip 7. Using one of the approved methods listed above, samples for Total Chlorine are tested immediately to avoid errors due to the instability of chlorine/chloramines in water. 8. Verify that all supplies used for total chlorine testing have not expired. Discard any expired supplies. Verify cap is in place and tightly secured both pre and post use of test strips. 9. Each facility will maintain an approved secondary test method to be utilized if there is a questionable Total Chlorine test result of the primary test method. The secondary test method should be a different approved test method. 10. Samples for Total Chlorine testing are drawn from the sample port located downstream of the first (primary) carbon tank or set of tanks in facilities having series-connected banks of carbon filters. 11. If the results of Total Chlorine testing from the primary carbon filter or set of tanks indicate a level of less than or equal to 0.1 ppm (< 0.1 ppm), Record results on the “Routine Total Chlorine Testing” log which contains entries for day, date, test number, test time, signature of person performing the test, test results, and signature of licensed nurse verifying that each test on the daily log is complete and results appropriate. If the licensed nurse performs the Total Chlorine test, they may also sign results as verified. a. If the results of Total Chlorine testing from the primary carbon filter indicate a level of greater than 0.1ppm (> 0.1 ppm), the test should be immediately repeated on a freshly drawn sample to verify the results are not a “false positive.” b. If the results of the repeat Total Chlorine testing is less than or equal to 0.1 ppm (< 0.1 ppm), no additional testing is needed. Results should be recorded as described above. Resume routine total chlorine testing every 4 hours. c. If the result of the repeat Total Chlorine testing is greater than 0.1 ppm (> 0.1 ppm) proceed immediately with the steps below.” A review of the RPC Ultra Low Total Chlorine Test Strip manufacture guideline instructions was rinse the cup 3 times and fill to 100 cc of dialysis quality water for chlorine testing. Interview with Staff #13 on 07/08/2025 at 11:00 AM confirmed that Staff #5 did not follow the chlorine/chloramines testing procedure and that the chlorine check was not completed within the 4-hour timeframe.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility staff failed to verify that all disinfectant had been removed from the (CWP) central water plant before patients were connected to the dialysis machines. This deficient practice had the likelihood to expose patients to chemical disinfectants and cause harm to all patients receiving dialysis at the facility. Findings include: The staff should be performing the disinfectant tests weekly. A review of the CWP disinfectant log for 4/28/2025 through 6/30/2025 revealed that the disinfection was performed, but on the following days, the facility staff failed to check for disinfectant clearance. 04/29/2025 no time documented for when the disinfection was checked for clearance, and the facility was closed on 4/29/2025, on the day that staff documented the clearance was checked. 05/06/2025, there was no time, date, or initial of a staff member checking the CWP for disinfectant clearance. 05/20/2025, there was no time, date, or initial of a staff member checking the CWP for disinfectant clearance. 05/27/2025, there was no time, date, or initial of a staff member checking the CWP for disinfectant clearance. 06/03/2025 no time documented for when the disinfection was checked for clearance, and the facility was closed on 06/03/2025, on the day that staff documented the clearance was checked. 06/11/2025, there was no time or initial of the staff member checking the CWP for disinfectant clearance. 06/17/2025, staff documented that the disinfection clearance was checked, but the facility was closed on 06/17/2025. A review of the CWP water purification system instruction manual 3.2.1 stated, “Disinfection must be performed on a regular basis to ensure consistent microbiological quality of the product water. Required frequency depends on factors such as inlet water quality and operation schedule and should therefore be determined by regular microbiological testing. Once a week should, however, be the minimum.” An interview with Staff #13 on 07/08/2025 at 10:00 AM confirmed that the disinfection clearance for the CWP was not being completed and that the facility staff were recording the clearance as done on days when the facility was closed.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation, record review, and staff interviews, the facility’s biomedical staff failed to identify and promptly correct an acid leak present in the facility’s water treatment room. Also, the facility staff failed to follow the policy, “Responsibilities of the Biomed Department”. During a tour of the facility’s water treatment room on 07/07/2025 at 2:43 PM, the surveyor observed a large build-up of dried white crystals on the outlet piping located on the acid storage tank . A review of the facility policy titled “Responsibilities of the Biomed Department” with a revision date of October 2021 revealed the following: “PURPOSE: To provide guidance for the responsibilities of the DaVita Biomed department. POLICY: 1. The responsibilities of the Biomed Department include: Repair and maintain, with support documentation, all dialysis delivery machines, RO water treatment systems, ancillary equipment, and related equipment used in the provision of care to patients as recommended by the equipment manufacturer’s specifications and DaVita policies and procedures ....” An interview with Staff #13 on 07/07/2025 at 2:43 PM acknowledged the acid leak on the outlet piping located on the acid storage tank.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility staff failed to ensure 4 of 4 acid 1-gallon jugs were in a secure area. Also, the facility failed to follow the policy on “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS.” Findings include: During the tour of the in-center treatment area on 07/07/2025 at 3:00 PM the following issues were observed: * Observed four 1-gallon “CitraPure” dialysate containers with a concentration of 3 K (potassium) and 2.5 Ca (calcium) in a room off the in-center treatment floor. The containers were partially used, each with some solution remaining. One container was dated 06/27/2025, another 06/30/2025, and two were dated 07/04/2025. All four containers were used for different patients being dialyzed at the facility. There was no way to verify if the containers had been disinfected after removal from the chairside. The room was accessible to housekeeping, which allowed unauthorized staff to tamper with the unsealed “CitraPure” dialysate of 3 K and 2.5 Ca left in the unsecured room. The room appeared unclean, with a blue pad under the citric acid bottles showing a dried dark brown stain. The blue pads are white when new. Also, this room was used to store oxygen “E” cylinders, both full and empty. A review of the facility’s policy titled, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS” dated April 2019 revealed the following: “PURPOSE: To provide guidance for acid concentrate distribution and documenting receipt and pump off, where applicable, of acid concentrates. To provide guidance for the use and disposal of acid concentrate containers. ACID GALLON CONCENTRATE CONTAINERS 17. Acid concentrate is to be stored at room temperature in a secure designated area. 18. Upon opening an acid gallon concentrate container, label container with date opened, and initials of teammate. 19. The entire solution volume in the acid gallon concentrate containers should be used prior to opening another acid gallon container of the same concentrate. NOTE: Open, unused acid concentrate solutions remain in the original container, are not to be combined, and should be capped when not in use. 20. Unopened and opened standardized acid concentrate containers must be used prior to the manufacturer’s expiration date on the label, if applicable.” An interview with Staff #15 on 09/17/2025 at 3:00 PM confirmed that the 1-gallon containers were stored in an unsecured room accessible to unauthorized staff, allowing them to tamper with the solution, and that the room had an unclean appearance.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 29191 Based on the record review and interview, the facility staff failed to ensure the 5-micron “Hytrex” filter on the “Dri-Sate” acid mixer was changed monthly or after the transfer of 1500 gallons for April, May, and June 2025 logs reviewed. This deficient practice had the likelihood of causing harm by mixing the wrong mixture of acid for the dialysis patient due to a dirty acid filter. Findings include: During a tour of the water room on 07/07/20 at 2:43 PM observed that the acid filter housing on the acid mixer was broken. The surveyor asked the biomedical technician to show the surveyor the acid mixer filter. The filter housing was broken, and the biomedical technician was unable to remove the filter housing. A review of the “CitrPure Batch Production Record” for April, May, and June 2025 revealed that the acid filter had not been changed monthly. A review of the facility policy titled “PREPARATION OF CITRAPURE® CONCENTRATE” dated October 2024 revealed the following; “Procedure: Open filter housing and inspect filter for cleanliness. Filter may be rinsed in dialysis quality water to remove surface debris. If filter appears dirty or if flow from filter outlet is diminished, the filter should be replaced.” The frequency of filter replacement in a dialysis acid mixing unit, such as those used with dry acid concentrates, is crucial for maintaining proper function and preventing complications. An interview with the Bio-Medical Director (BOM) #13 on 07/07/2025 at 2:45 PM indicated that “Citrapure Concentrate” requires the filter to be replaced on the acid mixer monthly. An interview with Bio-Medical Manger (BOM) #13 on 07/08/2025 at 11:00 AM confirmed that the acid filter was not being changed monthly as per manufacturer guidelines.”

“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: 48749 Based on observation and staff interview, the facility staff failed to ensure that 3 of 3 Reverse Osmosis (RO) water bottles located in the treatment area had a secure cap to prevent contamination of the RO water. These findings had the likelihood to cause harm to all patients. An unsecured RO bottle would allow airborne contaminants and microorganisms present in the environment to enter the water. Findings include: During a tour of the treatment floor on 07/07/2025 at 12:30 AM revealed the following; *An RO bottle on the counter at the nurse’s station had a plastic medication cup sitting over the opening of the bottle. There was no cap found for the bottle. *Two RO bottles on the counter next to the clean sink had caps hanging from the side of the bottle by a thin rubber tube for flushing. An interview was conducted with Staff #15 on 07/7/2025 at 12:50 PM. Staff #15 confirmed the Surveyor’s findings that the RO bottles did not have secure lids.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to ensure quality control solutions and test strips for the glucometers were dated when opened. The facility staff failed to follow the “EmbracePro Blood Glucose Monitor: Quality Control (QC)” policy. Findings include: During a tour of the facility treatment floor on 07/07/2025 at 12:30 PM, the surveyor observed an open bottle of glucose test strips and a box of quality control solutions. The bottles were not labeled with a date of opening or the staff member’s initials who opened the test strips and quality control solutions. A review of the facility’s “EmbracePro Blood Glucose Monitor: Quality Control (QC)” policy dated 09/2020 revealed the following: “3. Do not use control solutions past expiration date. Discard control solutions 90 days after opening or on the expiration date printed on the bottle, whichever comes first. When opening a new control solution, write the open and discard dates on the side of the bottle along with teammate initials. 4. Do not use test strips past expiration date. Discard test strips four (4) months after opening or on the expiration date printed on the bottle, whichever comes first. When opening new test strips, write the open and discard dates on the side of the bottle along with teammate’s initials.” An interview was conducted with Staff #1 and Staff #2 on the afternoon of 07/08/2025. Staff #1 and Staff #2 acknowledged the Surveyor’s findings that the glucose test strips and the quality control solutions were not labeled with a date of opening or with the staff member’s initials.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 29191 Based on record review and staff interview, the facility failed to ensure a properly executed informed consent for hemodialysis treatment was completed for 1 (#4) of 6 patient medical records reviewed. Also, the facility staff failed to follow the policy, “INFORMED CONSENT FOR DIALYSIS TREATMENT”. Findings included: Patient # 4 During a review of Patient # 4’s medical record, the surveyor observed that the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 03/14/2025. There was no Registered Nurse who witnessed the informed consent. The consent was signed by the patient, with date and time, but there was no registered nurse to witness the signature. There was no way to know if the risks and benefits had been explained to the patient before the initial hemodialysis treatment was started. The medical record lacked documentation from the physician confirming that the risks and benefits had been explained to the patient before starting hemodialysis, as required by the facility’s informed consent policy. During an interview with Staff # 7 (Administrative Assistant) on 07/08/2025 at 2:30 PM, Staff # 7 stated, “I obtain the consent forms for all of the patients except the hemodialysis consent. I read the consent for hemodialysis form to the patient, and the patient signs the form. If the patient has any questions, I send the patient to the Registered Nurse for questions related to the informed consent.” A review of the facility policy, “INFORMED CONSENT FOR DIALYSIS TREATMENT,” with a revision date of April 2023 revealed the following; “PURPOSE: To provide guidance for the informed consent for dialysis treatment. POLICY: 1. This policy applies to all patients receiving dialysis treatment within a DaVita Inc. facility (including visiting patients). This does not pertain to any home training programs or other procedures that require separate consent. 2. A statement signed by the patient will be placed in the patient’s chart. 3. To guarantee that every patient is fully informed regarding dialysis treatment, prior to the first dialysis treatment in the facility he/she must have the following: a. Explanation of ESRD diagnosis, risks, benefits, complications, and alternatives to treatment explained to them by the patient’s physician. b. An opportunity to ask questions of the dialysis facility teammates relating to the facility operation. c. An informed consent (Authorization for the Verification of Consent to Hemodialysis Procedure or Authorization for and Verification of Consent to Peritoneal Dialysis Procedure) signed by the patient or personal representative and witnessed by the Registered Nurse. 4. If a patient or the patient’s personal representative is unable to sign the informed consent in person, the registered nurse will send an encrypted email with the informed consent to the patient or the Davita approved video platform for web conferencing to fully inform the patient or the patient’s representative of the patient’s dialysis treatment including 3(a)-(b) above. a. Using the DaVita-approved platform for web conferencing, the Registered Nurse must then verbally obtain the patient or the patient’s personal representative’s informed consent. The RN must then document that verbal consent was obtained from the patient or the patient’s personal representative via a DaVita-approved platform for web conferencing and provide the reason for obtaining verbal consent (e.g., out of town, unavailable, etc). 5. The consent, original signed consent form must be filed in the patient’s current medical record at all times. 6. A new consent form must be signed: a. When a patient transfers to another Davita facility. b. When the patient is readmitted to DaVita after discharge/transfer c. When the patient changes modalities. 7. If a patient is officially discharged or transferred to another facility, the patient must review and sign a new consent form prior to returning for treatment in the original DaVita facility.” During an interview with Staff #1 on 07/08/2025 at 3:00 PM, Staff #1 acknowledged there was no documentation from the physician stating risks and benefits had been explained to the patient before obtaining consent, and that the Registered Nurse’s witness signature was missing.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48749 Based on observation, record review, and staff interview, the Registered Nurse failed to complete the pre-treatment and post-treatment nursing assessments within one hour of treatment initiation on 3 (#8, #9, and #10) of 5 patient medical records reviewed. The facility staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. Findings Include: Patient #8 A review of 4 of 6 treatment sheets for Patient #8 revealed that a pre-treatment nursing assessment was not completed within 1 hour of initiating the patient’s treatment. Also, post-treatment nursing assessments were not timely completed A review of the treatment sheet dated 06/27/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 06/27/2025 at 3:14 PM) within 1 hour of the initiation of treatment. Treatment started on 06/27/2025 at 1:59 PM. Patient #8 completed treatment at 5:03 PM. The post-treatment nursing assessment was not documented until 06/27/2025 at 6:54 PM. A review of the treatment sheet dated 06/30/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 06/30/2025 at 4:24 PM) within 1 hour of the initiation of treatment. Treatment started on 06/30/2025 at 2:42 PM. Patient #8 completed treatment at 5:51 PM. The post-treatment nursing assessment was not documented until 06/30/2025 at 7:31 PM. A review of the treatment sheet dated 07/04/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 07/04/2025 at 3:50 PM) within 1 hour of the initiation of treatment. Treatment started on 07/04/2025 at 2:26 PM. A review of the treatment sheet dated 07/07/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 07/07/2025 at 4:46 PM) within 1 hour of the initiation of treatment. Treatment started on 07/07/2025 at 3:15 PM. Patient #9 A review of 3 of 6 treatment sheets for Patient #9 revealed that a pre-treatment assessment was not completed within 1 hour of initiating the patient’s treatment. Also, post-treatment nursing assessments were not timely completed. A review of the treatment sheet dated 07/02/2025 revealed that Patient #9 completed treatment at 9:36 AM. The post-treatment nursing assessment was not documented until 07/02/2025 at 11:48 AM. A review of the treatment sheet dated 07/04/2025 revealed that Patient #9 completed treatment at 9:57 AM. The post-treatment nursing assessment was not documented until 07/02/2025 at 12:08 PM. A review of the treatment sheet dated 07/07/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 07/07/2025 at 7:03 AM) within 1 hour of the initiation of treatment. Treatment started on 07/07/2025 at 6:01 AM. Patient #10 A review of 4 of 6 treatment sheets for Patient #10 revealed that a pre-treatment nursing assessment was not completed within 1 hour of initiating the patient’s treatment. A review of the treatment sheet dated 06/27/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 06/27/2025 at 6:30 AM) within 1 hour of the initiation of treatment. Treatment started on 06/27/2025 at 5:31 AM. A review of the treatment sheet dated 06/30/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 06/30/2025 at 6:47 AM) within 1 hour of the initiation of treatment. Treatment started on 06/30/2025 at 5:43 AM. A review of the treatment sheet dated 07/02/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 07/02/2025 at 7:01 AM) within 1 hour of the initiation of treatment. Treatment started on 07/02/2025 at 5:46 AM. A review of the treatment sheet dated 07/04/2025 revealed Staff #2 did not complete the pre-treatment nursing assessment (documented on 07/04/2025 at 7:14 AM) within 1 hour of the initiation of treatment. Treatment started on 07/04/2025 at 5:35 AM. Patient #10 completed treatment at 9:02 AM. The post-treatment nursing assessment was not documented until 07/04/2025 at 12:10 PM. A review of the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy dated 04/2024, revealed the following; “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge .... 3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment, with the exception of blood flow rate, which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation, along with the nursing assessment or as allowable by state law .... 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law.” An interview was conducted with Staff #2 on 07/08/2025 at 3:00 PM. Staff #2 confirmed that the patient assessments were not completed within an hour of initiation or treatment. Staff #2 stated, “I’m the only registered nurse hear and sometimes I can’t get the assessments done.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for the blood flow rate (BFR) and the dialysis flow rate (DFR) for 4 (Patient #4, #8, #9, and #10) of 5 medical records reviewed. Also, the facility staff failed to verify the patient’s prescriptions within an hour of initiation of treatment for 4 (Patient #4, #8, #9, and #10) of 5 medical records reviewed. The facility staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” policy. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders, which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 38 in-center hemodialysis patients receiving care at the facility. Findings include: Patient #4 *A review of the treatment sheet dated 06/16/2025 revealed the following, “Dialysis Prescription: BFR (blood flow rate): 400 ml/min DFR (dialysis flow rate): 800 ml/min (milliliters per minute)” The patient’s set BFR was set for “400 ml/min” during initiation of treatment at 3:41 PM. At 4:32 PM and throughout the remaining treatment, the BFR was “220 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR for this treatment date. *A review of the treatment sheet dated 06/20/2025 revealed the following, “Dialysis Prescription: BFR (blood flow rate): 400 ml/min DFR (dialysis flow rate): 800 ml/min (milliliters per minute)” The patient’s set BFR throughout treatment was “350 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR for this treatment date. *A review of the treatment sheet dated 07/02/2025 revealed the following, “Dialysis Prescription: BFR (blood flow rate): 400 ml/min DFR (dialysis flow rate): 800 ml/min (milliliters per minute)” The patient’s set BFR throughout treatment was “350 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate. There was no documented order from the physician to adjust the BFR for this treatment date. Further review of the treatment sheet dated 07/02/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/02/2025 at 4:09 PM) within 1 hour of the initiation of treatment. Treatment started on 07/02/2025 at 3:02 PM. Patient #8 *A review of the treatment sheet dated 06/27/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 06/27/2025 at 3:12 PM) within 1 hour of the initiation of treatment. Treatment started on 06/27/2025 at 1:59 PM. *A review of the treatment sheet dated 06/30/2025 revealed the following, “Dialysis Prescription: BFR: 400 ml/min DFR: 800 ml/min “ The patient’s set DFR at “500 ml/min” from 2:42 PM through 3:30 PM. There was no documentation found on why the patient was unable to meet the prescribed dialysate flow rate. There was no documented order from the physician to adjust the DFR for this treatment date. Further review of the treatment sheet dated 06/30/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 06/30/2025 at 4:23 PM) within 1 hour of the initiation of treatment. Treatment started on 06/30/2025 at 2:42 PM. *A review of the treatment sheet dated 07/04/2025 revealed the following, “Dialysis Prescription: BFR: 400 ml/min DFR: 800 ml/min “ The patient’s set BFR throughout treatment was “350 ml/min”. The patient’s set DFR throughout treatment was “500 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed blood flow rate and dialysate flow rate. There was no documented order from the physician to adjust the BFR and DFR for this treatment date. Further review of the treatment sheet dated 07/04/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/04/2025 at 3:49 PM) within 1 hour of the initiation of treatment. Treatment started on 07/04/2025 at 2:24 PM. *A review of the treatment sheet dated 07/07/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/07/2025 at 4:46 PM) within 1 hour of the initiation of treatment. Treatment started on 07/07/2025 at 3:15 PM. Patient #9 *A review of the treatment sheet dated 07/04/2025 revealed the following, “Dialysis Prescription: BFR: 350 ml/min DFR: 800 ml/min “ The patient’s set DFR throughout treatment was “500 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed dialysate flow rate. There was no documented order from the physician to adjust the DFR for this treatment date. *A review of the treatment sheet dated 07/07/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/07/2025 at 7:03 AM) within 1 hour of the initiation of treatment. Treatment started on 07/07/2025 at 6:01 AM. Patient #10 *A review of the treatment sheet dated 06/30/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 06/30/2025 at 6:46 AM) within 1 hour of the initiation of treatment. Treatment started on 06/30/2025 at 5:43 AM. *A review of the treatment sheet dated 07/02/2025 revealed the following, “Dialysis Prescription: BFR: 350 ml/min DFR: 800 ml/min “ The patient’s set DFR throughout treatment was “500 ml/min”. There was no documentation found on why the patient was unable to meet the prescribed dialysate flow rate. There was no documented order from the physician to adjust the DFR for this treatment date. Also, further review of the treatment sheet dated 07/02/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/02/2025 at 6:48 AM) within 1 hour of the initiation of treatment. Treatment started on 07/02/2025 at 5:46 AM. *A review of the treatment sheet dated 07/04/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/04/2025 at 7:13 AM) within 1 hour of the initiation of treatment. Treatment started on 07/04/2025 at 5:35 AM. *A review of the treatment sheet dated 07/06/2025 revealed Staff #2 did not complete the nursing prescription verification (documented on 07/06/2025 at 7:06 AM) within 1 hour of the initiation of treatment. Treatment started on 07/06/2025 at 5:41 AM. A review of the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” policy dated April 2024 revealed the following; “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. 3. Patient identity, prescription, and machine settings are verified by a teammate prior to initiation of treatment, with the exception of blood flow rate, which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation, along with the nursing assessment or as allowable by state law. Prescription components include, but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb) and settings j. Heparinization (intradialytic infusion setting)” An interview was conducted with Staff #2 on 07/08/2025 at 3:06 PM. Staff #2 confirmed that the facility staff were not following the Physician’s prescription orders and that the nursing prescriptions were not verified within one hour of initiating treatment.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility failed to ensure that direct care staff were notifying the physician/non-physician practitioner of abnormal findings in 2 (#4 and #10) of 5 patient charts reviewed. In addition, the facility’s direct care staff removed more than the prescribed 13 ml/kg/hr (milliliters per kilogram per hour) in 2 (#9 and #10) of 5 patient charts reviewed. The facility’s direct care staff failed to follow the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. This deficient practice had the likelihood to cause harm and delay in care to all 38 in-center hemodialysis patients receiving care at the facility. Findings Include: Patient #4 A review of 1 of 6 treatment sheets revealed that the direct care staff did not report out-of-parameter vital signs to the physician prior to initiating dialysis treatment, during treatment, and post-treatment. A review of the treatment sheet dated 06/30/2024 revealed Staff #2 initiated dialysis treatment with the patient’s pre-treatment blood pressure “203/101 mmHg” Staff #2 documented the following vital signs: “2:41 PM (treatment initiation): BP (blood pressure)- 192/109 3:04 PM: BP- 202/101 3:34 PM: BP- 189/110 4:04 PM: BP- 186/98 There was no documentation found from Staff #2 to support that the Physician was made aware of the abnormal blood pressure findings. The patient was discharged home with a blood pressure of “155/88” by Staff #2. Patient #9 A review of 1 of 6 treatment sheets revealed that the direct care staff removed more than the patient’s prescribed 13.0 ml/kg/hr of fluid. The facility’s direct care staff removed 14.6 ml/kg/hr (milliliters per kilogram per hour) of fluid from Patient #9 for the treatment date 07/07/2025. There was no documentation found to support that an order was obtained from the physician to remove more than 13.0 ml/kg/hr on this treatment date. Patient #10 A review of 3 of 6 treatment sheets revealed the facility’s direct care staff did not report the out-of-parameter vital signs to the physician prior to initiating dialysis treatment and post-treatment. Also, the direct care staff removed more than the patient’s prescribed 13.0 ml/kg/hr of fluid. A review of the treatment sheet dated 06/30/2025 revealed that the facility’s direct care staff removed 15.7 ml/kg/hr (milliliters per kilogram per hour) of fluid on Patient #10 for the treatment date 06/30/2025. There was no order from the physician to remove more than 13.0 ml/kg/hr on this treatment date. A review of the treatment sheet dated 07/04/2025 revealed that the facility’s direct care staff removed 17.1 ml/kg/hr (milliliters per kilogram per hour) of fluid on Patient #10 for the treatment date 07/04/2025. There was no order from the physician to remove more than 13.0 ml/kg/hr on this treatment date. A review of the treatment sheet dated 07/07/2025 revealed Staff #2 initiated dialysis treatment with the patient’s pre-treatment blood pressure “188/82 mmHg” Staff #2 documented the following post-treatment vital signs: “9:41 AM: BP - 165/61” Further review of the treatment sheet dated 07/07/2025 revealed that the facility’s direct care staff removed 18.8 ml/kg/hr (milliliters per kilogram per hour) of fluid on Patient #10 for the treatment date 07/07/2025. There was no order from the physician to remove more than 13.0 ml/kg/hr on this treatment date. A review of the facility’s “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy dated April 2024, revealed the following; “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge ... PRE-TREATMENT DATA COLLECTION/ASSESSMENT 3. Patient identity, prescription, and machine settings are verified by a teammate prior to initiation of treatment, with the exception of blood flow rate, which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation, along with the nursing assessment or as allowable by state law. Prescription components include, but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb) and settings j. Heparinization (intradialytic infusion setting) 4. Any abnormal findings or findings outside of any patient-specific physician-ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to the “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pretreatment as warranted by the patient’s condition. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis ... b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access visible and line connections intact vi. Patient subjective statement(s), i.e., patient report on overall health, any complaints. 11. Abnormal findings or findings outside of any patient-specific physician-ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions, and patient responses will be documented in the patient’s medical record ... 16. If an abnormal finding(s) or concern is identified post-treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. Blood pressure: Pre-dialysis: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations *Excessive yawning * Diaphoretic Blood Pressure Post Treatment: * If the patient can stand: *Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg *If the patient is not able to stand, document the reason and the sitting BP * Sitting BP for patients who cannot stand: * Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg *Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin *Restlessness *Rapid, shallow respirations *Excessive yawning *Diaphoretic *Dizziness *Feeling faint” An interview was conducted with Staff #2 on 07/08/2024 at 3:06 PM. Staff #2 confirmed the facility staff did not consistently report out-of-parameter vital signs to the Charge Nurse, and the Charge Nurse did not notify the Physician of abnormal findings. Also, Staff #2 confirmed the facility’s direct care staff removed more than 13.0 ml/kg/hr during patient treatments.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 48749 Based on observation, policy review, and staff interview, the facility’s direct care staff failed to assess the vascular access to determine the access patency for 2 (#8 and #12) of 2 patients observed. Also, the facility staff failed to follow the facility’s “Vascular Access Monitoring and Surveillance” policy. This deficient practice of not assessing the patient’s access had the likelihood of not detecting potential problems, such as infection, clotting, stenosis, and access failure. Findings include: During a tour of the in-center treatment area on 07/07/2025 at 12:30 PM, the surveyor observed the following; *Staff #4 accessed Patient #8’s arteriovenous (AV) graft without completing a full assessment of the access. Staff #4 failed to auscultate the AV graft to determine patency and check for a bruit (the sound of blood flowing through the graft, and it should sound like a continuous hum or whooshing). *Staff #5 accessed Patient #12’s AV graft without completing a full assessment of the access. Staff #5 failed to auscultate the AV graft to determine patency and check for a bruit. A review of the facility’s “Vascular Access Monitoring and Surveillance” policy dated October 2020 revealed the following; “PURPOSE: To promote routine monitoring and surveillance of arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular accesses for early recognition of signs and symptoms of stenosis, infection, or other access dysfunctions... 4. Vascular access monitoring includes physical examination of the patient’s AVF or AVG. The vascular access is examined every treatment prior to cannulation. The examination includes: * Inspection, auscultation, and palpation for pulse, thrill, and bruit * Inspection for signs and symptoms of infection or other dysfunction *Swelling or bruising of the access extremity” An interview was conducted with Staff #2 on the afternoon of 07/07/2025. Staff #2 confirmed the Surveyor’s findings of direct care staff not auscultating the AV graft sites prior to cannulation. Staff #2 stated, “They are supposed to be auscultating the sites.””

“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: 29191 Based on the record review and interview, the facility staff and governing body failed to review the “Dialysis Facility Report for Fiscal Year 2025” for hospitalizations and readmissions, hospitalizations for septicemia, anemia, and catheters greater than 90 days for patients being treated at the facility. These deficient practices had the likelihood to harm all patients receiving care in the facility due to there was no action plan to correct the outcomes of the data presented in the “Dialysis Facility Report.” Findings included: Review of the “Dialysis Facility Report for Fiscal Year 2025” revealed that the facility’s Hospitalization Ratio (SHR-Admissions) at this facility is 1.46, which is 46% more admissions than expected. Review of the “Dialysis Facility Report for Fiscal Year 2025” revealed that the facility’s Hospitalizations with septicemia are 19%, compared to 14% in your State, 14% in your Network, and 12% nationally. Review of the “Dialysis Facility Report for Fiscal Year 2025” revealed that the facility’s anemia management had 29% of eligible hemodialysis patient-months had a hemoglobin value below 10 g/dL, compared to 21% in your State, 21% in your Network, and 23% nationally. Review of the “Dialysis Facility Report for Fiscal Year 2025” revealed that the patients with a catheter in place for greater than 90 days were 20%, compared to 16% in your State, 16% in your Network, and 18% nationally. Review of the Facility Health Report (FHR) meeting minutes from September 2024 until present revealed the facility had failed to acknowledge the findings reported in the “Dialysis Facility Report for Fiscal Year 2025”. The facility had not been able to determine hospitalizations and readmissions, and the high number of patients admitted to hospitals with Septicemia. The meeting minutes revealed that the facility failed to review the report, and there was no drill-down to determine the cause and develop a corrective action plan. There was no report or discussion of the catheters being in place for greater than 90 days, being treated in the facility. Interview with Staff #1 on July 8, 2025, at 4:30 PM acknowledged that, as the Facility Administrator, she did not know what the “Dialysis Facility Report’ (DFR) meant. Interview with Staff #11 on July 8, 2025, at 4:30 PM acknowledged that, as the Regional Operation Director, she did not know what the “Dialysis Facility Report” (DFR) meant. Interview with Staff #14 (Director of Clinical Specialists) on July 8, 2025, at 4:30 PM acknowledged that he did know what the “Dialysis Facility Report” was, but that the facility had failed to discuss the data provided in the “Dialysis Facility Report” in the monthly “FHR” per the Facility Health Meetings (FHM) minutes to develop action plans.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 48749 Based on observation, record review, and staff interviews, the Governing Body failed to ensure that Staff #2 (Clinical Coordinator) was not assigned to direct patient care. Also, the facility failed to ensure the patient/staff ratio was appropriate to the level of dialysis care provided and met the needs of patient care. Findings include: The facility’s patient schedule revealed that the facility has a current census of 38 patients, has 12 dialysis stations, and operates 3 shifts on Monday, Wednesday, and Friday. The facility opens at 4:15 AM, and the first patient shift starts at 5:15 AM. The staff and patient daily assignments for 07/07/2025 showed that Staff #2 (RN) was the charge nurse responsible for all nursing duties for all patients, including initiating and terminating all cardiovascular venous catheters (CVC) during all three shifts. Staff #2 was in charge of all patient assessments before the Patient Care Technician (PCT) could began dialysis treatments. A review of the facility’s daily assignment sheets revealed there were 2 CVCs on first shift, 1 CVC on second shift, and 7 CVCs on third shift. There was no consideration given to the acuity and care needs of the patients by only having one licensed nurse in the facility. If Staff #2 was performing CVC care, there was no other licensed nurse in the facility to render care for a patient medical emergency. If Staff #2 had a medical emergency, there was no other licensed nurse in the facility to oversee the patients. During an observation tour of the facility’s in-center treatment floor, the surveyor observed Staff #2 answering phones, conducting patient assessments, administering patient medications, performing CVC care, and initiating dialysis treatments. There was no other licensed nurse observed in the facility to oversee staff and patient care during Staff #2’s lunch breaks or personal breaks. The Governing Body failed to ensure that a sufficient number of staff were present in the treatment area to observe every patient during treatment, including lunch breaks and shift changes, and to quickly respond to and address patient needs (such as changes in physical or mental condition). An interview was conducted with Staff #2 on 07/08/2025 at 3:06 PM. Staff #2 reported being the only nurse working at the facility. Staff #2 reported that the assigned duties included overseeing the PCT, answering the phones, conducting all patient assessments, administering medications to patients, and performing all cardiovascular venous catheter (CVC) procedures and difficult cannulations. Additionally, Staff #2 reported being responsible for monitoring patient anemia reports and Hepatitis B surveillance. An interview was conducted with Staff #1, Staff #11, and Staff #15 on 07/08/2025 at 3:45 PM. Staff #1, Staff #11, and Staff #15 confirmed that Staff #2 was the only licensed nursing staff working at the facility.”