Fmcna - East Arkansas

“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: 51070 Based on review of policy, observation and interview it was determined the facility failed to keep an emergency evacuation kit in case an emergency evacuation was required. The failed practice did not ensure that patients could be safely and quickly moved during emergencies. The failed practice had the likelihood of affecting all patients receiving dialysis. A. Review of policy “Emergency Medications, Equipment, and Supplies” dated 02/03/25, showed “an emergency cart must be available in the facility”, it further defines “Emergency Evacuation Box: ...contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location.” Additionally, the emergency box should be “maintained in close proximity and is easily and quickly accessible” to patient areas. B. During a tour of the Dialysis Den, located in a long term care facility, on 06/24/25 between 9:00 AM and 10:00 AM, one patient was receiving dialysis. No emergency evacuation box was available in the Dialysis Den to quickly and safely care for patients in the event of an emergency disaster. C. During an interview with the Director of the Home Dialysis Program on 06/24/25 at 1:30 PM, she confirmed the findings in A-B.”

“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: 52740 Based upon review of policy and procedure, observation, and interview, it was determined Registered Nurse (RN) #1 of six (RN#1 and #2, Patient Care Technician (PCT) #1- #4) direct patient care staff members observed failed to perform hand hygiene after removing gloves and prior to donning clean gloves. The failed practice placed patients at risk for complications related to infections due to cross contamination. The failed practice had the likelihood of affecting all 73 in-center hemodialysis (ICHD) patients. The findings follow: A. Review of the Fresenius Kidney Care Clinical Services policy “Hand Hygiene” Version 8 published 11/06/2023 showed: 1. Apply alcohol-based hand rub to the palm of one hand using the amount recommended by the product manufacturer. 2. Rub hands together covering all surfaces of the hands and fingers, until hands are dry. 3. Duration of the entire procedure: 20-30 seconds. B. During observation of initiation of treatment using central venous catheter (CVC) on 6/24/25 at 10:55 AM, showed the following: 1. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with finger tips. RN #1 removed patient #14s dirty CVC dressing then palpated exit site without performing hand hygiene or changing gloves. 2. RN #1 removed soiled gloves and placed them on blue drape in patient’s lap. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers. RN #1 stated to PCT #4 that the gloves would not completely fit hands due to being too small. PCT #4 recommended that RN #1 allow time for hand gel to dry. RN #1 cleaned CVC exit site wearing gloves with tips hanging approximately one inch from end of fingers then applied clean dressing. 3. RN #1 removed soiled gloves and placed them on blue drape in patient’s lap. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers tips. RN #1 performed CVC care, gave pre-treatment medications, removed blue drape from patient’s lap which containing trash from procedure, and then removed gloves. 4. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers tips. RN #1 then connected blood lines to CVC. 5. At 11:45 AM on 06/24/2025, PCT #2 called for a nurse to give Heparin to patient #6. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers tips. RN #1 gave medication, assessed patient, removed gloves and did not perform hand hygiene. C. Interview with In-center Hemodialysis Clinic Manager on 06/25/25 at 9:30 AM confirmed findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 52740 Based upon review of policy and procedure, observation, and interview, it was determined one Registered Nurse (RN) #1 of six (RN#1 and RN#2, Patient Care Technician (PCT) #1 - #4) direct patient care staff members observed failed to wear personal protective equipment (PPE)/ gowns properly to protect them and prevent soiling of clothing when performing patient care. The failed practice placed patients at risk for complications related to infections due to cross contamination. The failed practice had the likelihood of affecting all 73 in-center hemodialysis (ICHD) patients. The findings follow: A. The Fresenius Medical Care Human Resources Policy: Employee Dress Code, effective 06/18/2021, states, “Employees working in environments with potential exposure to hazardous chemicals, blood or other potentially infectious material are required to adhere to all Company policies or external regulatory guidelines related to personal protective equipment.” Conditions for Coverage for End-stage renal disease facilities §494.30 (a)(1)(i) interpretive guidance states, “The protective garment should fully cover the arms and torso from the neck area to the thigh/knee area.” C. Observation on 06/24/2025 at 10:55 AM revealed that Registered Nurse (RN)#1 performed central venous catheter (CVC) care of the patient at station 22 with her gown unsecured behind her neck which allowed the gown to drape below her shoulders and exposed her clothing to potential contact with bodily fluids of the patient. D. Observation on 06/24/2025 at 11:45 AM revealed RN #1 administering medication and assessing the patient at Station 15 with her gown unsecured behind her neck which allowed the gown to drape below her shoulders and left her clothing exposed to potential contact with body fluids of the patient. F. Interview with ICHD Clinic Manager on 6/25/25 at 9:30 AM confirmed findings.”

“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: 51070 Based on review of policy, observation, and interview, it was determined the facility failed to clearly designate clean storage supply from dirty areas in the Dialysis Den, located at the Long-Term Care facility. The failed practice did not prevent contamination of clean supplies used during dialysis treatments or the spread of infection. The failed practice had the likelihood of affecting all patients receiving dialysis treatments. Findings follow: A.Review of policy titled “General Cleanliness and Infection Control Guidelines” published 05/05/25, showed infection control measures included “preventing the spread of infectious disease and maintaining a clean, safe aesthetically pleasant environment for patients, staff, and visitors.” B. During a tour of the Dialysis Den on 06/25/25 at 9:30 AM, the door from the treatment room to the clean supply room was propped open. Supplies used for dialysis were stored on open shelving next to a food prep area which employees use during breaks. Also the door to the bathroom which opens directly into the supply room was propped open. C. During an interview with the Director of the Home Dialysis Program on 06/25/25 at 10:00 AM, she confirmed the findings in A-B.”

“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: 52740 Based upon review of policy and procedure, observation, and interview, it was determined that facility failed to ensure direct patient in-center hemodialysis (ICHD) care staff adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment in the dialysis treatment area. The failed practice did not prevent the spread of infection. The failed practice had the likelihood of affecting all 73 ICHD patients. The findings follow: A. A review of Fresenius Kidney Care General Cleanliness and Infection Control Guidelines policy (published 05/05/2025) showed: 1.Facility staff are accountable for cleaning rooms/ areas not assigned to contracted cleaning staff. 2.Noncritical medical equipment must be disinfected with 1:100 bleach or an Environmental Protection Agency (EPA) registered disinfectant. B. A review of Fresenius Kidney Care Cleaning and Disinfecting the Dialysis Station policy (published 09/05/2023) showed: 1. Definition: Dialysis Station - “area including the dialysis machine, chair/bed and other reusable equipment or supplies ... Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/ cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer; chair/bed, individual television and remote.” 2. “ ...a dialysis station must be cleaned and disinfected between dialysis patients.” 3. “Any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.” C. During facility tour on 06/23/2025 at 12:05 PM, Surveyor #2 observed: 1. Build up of splatter/spray of concentrated solution on hoses of machine at station 14. 2. Build up of dust on the television swing arms and bolt attachments at all dialysis stations. 3. Red/brown dried spots on television swing arm at station 11. 4. Red/ brown dried spots on oxygen concentrator #5 located in clean equipment area by medication preparation area. 5. Build up of dust on lower shelf and casters of shared supply carts in treatment area. D. Findings were confirmed with ICHD Clinic Manager during interview on 06/25/2025 at 9:30 AM.”

“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: 52740 Based upon patient record review and interview, it was determined that all susceptible patients were not offered an appropriate Hepatitis B vaccination schedule in an appropriate timeframe. Nine ICHD patients (#5 through #13) were reviewed for immunization and medication records. Three patient records (#9, #11, and #12) did not contain evidence of patient being offered Hepatitis B vaccination at any point since admission. This failed practice placed the 17 in-center hemodialysis (ICHD) patients who are susceptible to infection with Hepatitis B at risk for contracting Hepatitis B. The findings follow: A. Policy for Hepatitis B vaccination was requested on 06/23/2025, 06/24/2025, and again on 06/30/2025. Policy for Hepatitis B testing was provided, but no policy for vaccination was provided. B. Electronic medical records for patients #5-13 were reviewed. The records for patients #9, #11, and #12 did not contain evidence of vaccine declination by the patient. C. Findings werewere confirmed with ICHD Clinic Manager during interview on 06/25/2025 at 9:30 AM.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 52740 Based upon observation, review of policy and procedure, and interview, it was determined that in-center hemodialysis (ICHD) nursing staff had failed to ensure expired medications are not available for use. The failed practice did not ensure that expired medications were not available for use. Because all treatment modalities share common medication supply, the failed practice had the likelihood of affecting all 73 in-center hemodialysis (ICHD) patients, seven peritoneal dialysis (PD) patients, and two home hemodialysis (HHD) patients. The findings follow: A. A review of Fresenius Kidney Care Medication Preparation and Administration policy (published 02/06/2023) showed: 1. Expiration dates for all stored medications are to be monitored on a monthly basis. 2. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law. B. During facility tour on 06/23/2025 at 12:05 PM, an expired multi-vial box of Gentamicin 80mg/2ml IV or IM single dose vials, which contained 19 vials, was observed in the medication cabinet at the medication preparation station. C. Finding in B was visually and verbally confirmed with ICHD Clinic Manager during interview on 06/23/2025 at 12:10 PM.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 52740 Based upon observation, review of policy and procedure, and interview, it was determined one (Registered Nurse (RN) #1 of two (RN#1, RN#2) In-center Hemodialysis (ICHD) direct patient care nursing staff members and one patient care technician (PCT#2) of four (#1through #4) PCTs observed failed to maintain aseptic technique for the care of all vascular accesses, including intravascular catheters. These failured practices placed all 73 ICHD patients at risk for bacteremia due to access infection. The findings follow: A. A review of Fresenius Kidney Care Changing the Catheter Dressing Procedure showed: 1.Only solutions recommended by the Association for Professionals in Infection Control and Epidemiology (APIC), NKF K/DOQI, and/or Centers for Disease Control and Prevention (CDC) as listed below will be used for catheter exit site cleaning and disinfection unless otherwise prescribed by the provider ... 2. Removal of Dressing and Inspection of Site: Place an under-pad under catheter limbs to protect work area and clothing; perform hand hygiene; don clean gloves; inspect and remove the old dressing; visually inspect the exit site and surrounding area; discard dressing and remove gloves; perform hand hygiene. 3. Cleaning the Site: 2% Chlorhexidine and 70% alcohol a. using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. b. Reminder: Chlorhexadine swab contains alcohol. The alcohol must vaporize to dry. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. If dressing is applied prior to drying, the alcohol vapors will be trapped resulting in blistering of the skin. B. A review of Fresenius Kidney Care Access Assessment and Cannulation showed: Skin disinfection- Disinfect cannulation site as follows: a. 70% isopropyl alcohol pad: using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. b. perform skin antisepsis on one site at a time, allow to dry and then cannulate ...This method minimizes the risk of contaminating the second site while cannulation the first site. C. Observation of initiation of treatment using CVC on 6/25/25 at 10:55 AM by RN #1 1. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers. RN #1 did not place a blue under-pad under CVC limbs. RN #1 removed patient #14s old CVC dressing then palpated exit site without performing hand hygiene or changing gloves. 2. RN #1 removed soiled gloves and placed them on blue drape in patient’s lap. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers. RN #1 stated to PCT #4 that the gloves would not completely fit hands due to being too small. PCT #4 recommended that RN #1 allow time for hand gel to dry. RN #1 cleaned CVC exit site wearing gloves with tips hanging approximately one inch from end of fingers using a Chloraprep swab stick. 3. RN #1 wiped the Chloraprep swab in a counterclockwise motion twice with no evidence of back-and-forth friction observed. 4. RN #1 immediately followed by wiping skin around exit site with an Alcohol swab in a counterclockwise motion. She then applied clean dressing without allowing 30 second minimum dry time. 5. RN #1 removed soiled gloves and placed them on blue drape in patient’s lap. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers tips. RN #1 performed CVC care, gave pre-treatment medications, removed blue drape from patient’s lap which containing trash from procedure, and then removed gloves. 6. RN#1 applied alcohol gel to left palm, rubbed hands together 4-5 times then donned gloves. Hands remained wet with alcohol gel preventing RN #1 from fully applying gloves. Approximately one inch of each glove finger was not in contact with fingers tips. RN #1 then connected blood lines to CVC. D. Observation of initiation of treatment using an Arteriovenous Fistula (AVF) on 06/24/2025 at 11:40 AM by PCT #2. After completing her assessment of the AVF, completing hand hygiene, and donning gloves, PCT #2 opened Alcohol 70% prep pad. PCT #2 then wiped the alcohol pad in an upward motion from the center/bottom of the AVF to the center/top of the AVF. She proceeded to make counterclockwise circles covering both the arterial and venous needle insertion sites for 5-7 seconds. Without allowing dry time, PCT cannulated the arterial needle site and secured the needle. PCT then cannulated the venous needle site and secured the needle. Sites were not allowed to dry for the required 30 seconds. E. Findings of A-D were confirmed with ICHD Clinic Manager during interview on 06/25/2025 at 9:30 AM”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 51070 Based on review of policy, observation, and interview it was determined the facility failed to prevent unauthorized access to medications, dialysis supplies, cleaning chemicals, and the water room. The failed practice did not ensure that patients and visitors remained free from harm. The failed practice had the likelihood of affecting all patients and visitors in the facility. Finding follow: A. Review of policy “Sodium Bicarbonate 8.4%, 50 milliliters (mL)” dated 05/23/23, showed that sodium bicarbonate is a medication used to correct metabolic acidosis associated with cardiac arrest and that adverse reactions included cerebral hemorrhage, congestive heart failure, tetany, and pulmonary edema. B. Review of policy “Calcium Gluconate Injection, United States Pharmacopoeias (USP) 10% (100 milligrams (mg)/mL” dated 05/24/23, showed the indication for use “hypocalcemic tetany and hypocalcemia related to hypoparathyroidism or Hungry Bone Syndrome”. Adverse effects if “given by rapid intravenous injection included vasodilation, hypotension, bradycardia, cardiac arrythymias, syncope, and cardiac arrest”. C. During a tour of the facility on 06/23/25 between 12:00 PM and 1:30 PM, the following was observed: 1. A crash cart in the dialysis treatment area was unlocked allowing unauthorized access to Sodium Bicarbonate and Calcium Gluconate medications. 2. The door to the janitors closet, containing cleaning chemicals, located in the hallway where Home Dialysis patients and patients from a contracted Nephrology Clinic receive treatment was unlocked allowing for unauthorized entry and access to chemicals. 3. The door leading to the supply room and water treatment area had no locking mechanism to prevent unauthorized entry of patients and visitors. D. During a tour of the Home Dialysis Program on 06/23/25 between 1:30 PM and 2:45 PM, showed three treatment rooms containing unsecured supplies in clear plastic bins/drawers used during treatment of Home Hemodialysis (HHD) and Peritoneal Dialysis (PD). During the tour the Director of Home Dialysis confirmed that each treatment room is shared by a separately owned and operated Nephrology Clinic to see and treat their patients which allowed for unauthorized access and tampering of HHD and PD patient supplies. Additionally, there was no delineation of equipment or supplies making it unclear what belonged to the Home Dialysis Program or the Nephrology Clinic. The HHD treatment room #3 had a full face shield and disposable stethoscope hanging on an pole, it was not clear if these items were clean or dirty and which program they belonged to. E. During an interview on 06/25/25 at 11:00 AM with the Director of the Home Dialysis Program and the Clinic Manager, the findings in A-D were confirmed. Based on observation and interview it was determined the facility failed to provide a safe clutter free environment in that the Dialysis Den, located in a long term care facility, was designed for 6 dialysis treatment stations but contained equipment for eight stations which was stacked against each other creating barriers and hazards to performing patient care. The failed practice did not ensure dialysis was performed in a safe functional environment. The failed practice had the likelihood of affecting all patients receiving dialysis in the Den. A. During a tour of the Dialysis Den on 06/24/25 between 9:00 AM and 10:00 AM, one patient was receiving dialysis in the six station treatment room. Equipment was observed for eight stations in which dialysis chairs, pumps, and machines were pushed very close or touching. The additional equipment left an inadequate amount of space on either side of the patient to ensure privacy and safe care. During the tour the Charge Nurse stated (named) was supposed to remove the extra equipment, however this had not been done. B. During an interview on 06/25/25 at 11:00 AM with the Director of the Home Dialysis Program, she confirmed the additional equipment should have been removed to create a safe adequate space for dialysis.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined the facility failed to maintain a safe functional environment free from defects in five areas (waiting area, in-center treatment room, home dialysis treatment area, supply room, and water room) observed. The failed practice did not prevent the spread of infection or ensure patients were free from harm. The failed practice had the likelihood of affecting all patients receiving dialysis. A. During a tour of the facility on 06/23/25 between 12:00 PM and 2:00 PM, the following findings were observed: 1. Waiting Area a. A poster was taped to the front entry window which showed a heavy build up of dead insects between the glass and poster. b. The carpet in the front entryway was heavily stained with dirt and grime. c. There was paper signs taped to the wall that had small rips, tears, and discolored edges throughout the waiting area. d. There was an approximately 3.5 inch hole in the laminate floor adjacent to the vending machines. e. Several unfolded wheelchairs were stored in front of the patient bathrooms, creating hazards that patients had to walk around to use the bathroom. 2. In-Center Dialysis Treatment Room: a. The drywall near the scale had been cut open and not repaired leaving two cuts to the wall that could not be disinfected. b. The wall throughout the treatment area showed scrapes and gouges that went into the drywall and could not be disinfected. c. The floor by the scale showed a heavy build-up of dirt and grime. d. The floor in front of the scale had been broken out to repair the scale. The floor had not been repaired leaving a section of concrete open that could not be disinfected 3. Home Dialysis Treatment Rooms: a. All three treatment room showed small areas of chipped and/or scratched paint. b. Treatment room one (#1) of three (#1-#3), showed a wall box with dust, dirt, and rust like patina. Also the sink showed dirt and stains around the drain and had cobwebs and pest. c. Treatment room three (#3) showed heavily soiled walls with black scuff marks and an oil like stain. d. All three treatment rooms had paper signs with peeling, dirty edges that were taped to the walls. 4. Supply Room: a. The floor throughout the supply room had cracks, chipped paint, stains, dirt, and grime. b. The back door showed a gap that allowed for pest to enter. c. Laminate walls throughout the supply room showed dirt, grime, and areas of peeling laminate. d. The back supply near the double side doors showed unfinished wooden shelves that could not be disinfected. e. Supply carts had dirt and dust on the lower shelf and casters. f. A box of ceiling tiles was stored on the floor. 5. Water Room: a. The floor throughout the water room showed cracks and chipped paint. b. The walls showed peeling laminate. B. The findings were confirmed in A with the Area Technical Operations Manager and Clinic Manager during the tour on 06/23/25 between 12:00 PM and 2:00 PM.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined the facility failed to maintain a comfortable temperature for patients and staff in the Dialysis Den, located in a long term care facility. The failed practice did not allow for a comfortable environment in which to receive and/or perform dialysis. The failed practice had the likelihood affecting all patients receiving dialysis. Findings follow: A. During a tour of the Dialysis Den, located at a long term care facility, on 06/24/25 between 9:00 AM and 10:00 AM, showed the treatment room to be uncomfortably hot. One dialysis patient complained while receiving hemodialysis, asking for the blanket to be moved for comfort. During the tour three staff members were visably uncomfortable. During the tour, the Charge Nurse stated the thermostat was not inside the Dialysis Den and that it was frequently hot and that policy did not allow for fans. B. During an interview with the Director of Home Dialysis on 06/24/25 at 2:00 PM, she confirmed the findings.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined the facility failed to maintain patient privacy and confidentiality of patient records in that the shared Physician office which was unlocked and in a hallway used by patients and staff, contained patients medical records. The failed practice allowed unauthorized access to sensitive patient information. The failed practice had the likelihood of affecting all patients whose files were stored in the office. A. During a tour of the facility on 06/23/25 between 12:00 PM and 2:00 PM and again on 06/25/25 at 10:00 AM, both Surveyor #1 and #2 of two, observed a bookshelf in the shared Physician office that contained a full shelf of patient files. The door to the office remained open throughout the survey and is located in a hallway adjacent to the Home Dialysis program and a separately owned and operated Nephrology clinic that utilizes the space one day per week. Patients and staff were observed using the hallway. B. During an interview with the Clinic Manager on 06/25/25 at 9:00 AM and the Director of Operations on 06/25/25 at 11:15 AM, both confirmed the findings in A, and stated they did not know which patient files were being stored in that location.”

“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: 51070 Based on review of policy, clinical record review, and interview it was determined the facility failed to notify the physician or update the plan of care for two (#5 and #13) of 11 (#1-#11) patients reviewed in that the patient had terminated their treatments early on one or more occasions and showed no evidence that they had signed an “Against Medical Advice” (AMA) form that indicated the patient and/or their legal representative understood the risk of terminating treatment before completing the prescribed treatment time. The failed practice did not allow the patients to achieve their treatment goals and had the potential of experiencing complications. The failed practice had the likelihood of affecting all in-center hemodialysis (ICHD) patients. Finding follow: A. Review of “Early Termination or Arriving Late for Treatment” dated 06/18/25, showed if a patient request to terminate treatment early then “the patient must take full responsibility for consequences of the missed or shortened treatment.” Also, the registered nurse (RN) must document the rationale for early termination and is responsible for notifying the provider, and documenting on the Against Medical Advice (AMA) form. AMA forms should “signed by the patient and witnessed by the supervising nurse”, which include the risk of missing a dialysis treatment or terminating treatment early. B. Review of treatment flowsheet dated 06/20/25, showed Patient #5 had a physician order for a four hour treatment. Patient #5 requested to terminate treatment two hours early due to “gastric (GI) upset”. Evidence was requested on 06/25/25 at 8:45 AM, which showed the Physician had been notified, treatment for GI upset had been ordered and/or provided, and that an AMA form had been signed indicating Patient #5 understood the risk of terminating treatment early. None was provided. C. Review of treatment flowsheets dated 06/12/25, 06/16/25, and 06/20/25, showed Patient #13 had an orders for each date for a four hour dialysis treatment. Patient #13 requested to terminate treatment early on each date with no reason provided for request on flowsheet. Evidence was requested on 06/25/25 at 9:00 AM, which showed the Physician had been notified and/or that an AMA form had been signed indicating Patient #5 understood the risk of terminating treatment early. None was provided. D. The findings in A-C were confirmed during an interview with the Clinic Manager on 06/25/25 at 9:15 AM.”

“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: 52740 Based upon review of policy and procedure, patient record review, and interviews, it was determined that the in-center hemodialysis (ICHD) registered nurses (RN)s failed to assess the blood pressure and fluid management needs of eight (pt #5, 6, 7, 8, 10, 11, 12, 13) of nine (pt #5-13) in-center hemodialysis (ICHD) patients reviewed. The failed practice placed all 73 ICHD patients at risk for complications of hypertension and fluid overload. The findings follow: A. A review of Fresenius Kidney Care Hypertension policy shows, “Staff will recognize, report, and immediately address systolic blood pressures (SBP) greater (>) than 180 millimeters of Mercury (mm/Hg) and/or diastolic blood pressures (DBP) > 100 mm/Hg. 1. Prevention of Hypertension: Consider initiating the Corporate Medical Advisory Board (CMAB) algorithm per physician order. 2. Reevaluate patient’s dry weight at least monthly. Monitor and make timely changes to estimated dry weights. 3. Signs and Symptoms of Hypervolemia: Shortness of breath, dyspnea on exertion, peripheral edema, hypertension, neck vein distention, and jugular venous pressure. 4. Treating hypertension: Notify the nurse in charge if a patient has a SBP >180 mm/Hg and/or DBP >100 mm/ Hg. The RN will assess the patient and determine if further nursing interventions are needed. If hypertension is related to hypervolemia, decrease EDW: Follow CMAB Fluid Management algorithm or notify physician for possible estimated dry weight adjustment outside of algorithm parameters. If hypertension is not related to hypervolemia, notify the physician for additional orders/ interventions. Document in patient’s treatment record. B. A review of Fresenius Kidney Care Comprehensive Interdisciplinary Assessment and Plan of Care policy (published 07/03/2023) shows, “If the patient specific expected outcome as determined by the attending physician, IDT and patient for the Plan of Care is not achieved within the identified timeframe: The Interdisciplinary team must adjust the patient’s Plan of Care and document changes made to the POC. Implement the Plan of Care changes to address the identified issues.” C. A review of the Fresenius Kidney Care (FKC) Patient Monitoring and Safety Checks During Hemodialysis Treatment Policy (published 09/05/2023) shows: 1. Patient Monitoring: monitor and document every 30 minutes or more frequently, but not to exceed 45 minutes ... 2. Patient monitoring includes: changes in the patient’s status and blood pressure, pulse, respirations 3. Document monitoring and safety checks in the FKC treatment record ... D. A review of the Fresenius Kidney Care Intradialytic Hypotension policy (published 07/01/20241) shows: 1. Definition: patient’s pre-treatment sitting systolic blood pressure (SBP) is greater than (>) or equal to (=) 110 millimeters (mm) of Mercury (Hg) and then drops to less than (<) 90 mmHg during the treatment, or patient’s pre-treatment sitting SBP >/= 101 and </= 109 mmHG and has a 20 mmHg drop during the treatment. 2. Staff, patient and/or care partner will monitor for the occurrence of intradialytic hypotension and immediately perform interventions to mitigate progression of symptoms and prevent serious consequences and recurrence. Staff, patient and/or care partner will report intradialytic hypotensive episodes to the nurse in charge. The nurse in charge will report to the physician severe or frequent intradialytic hypotensive episodes. 3. Prevention of Intradialytic Hypotension: a. Assess the patient’s fluid status before each treatment. b. Consider using the Corporate Medical Advisory Board (CMAB) Fluid Management algorithm (per physician order). c. Obtain accurate weights and reevaluate patient’s dry weight at least monthly. Monitor and make timely changes to estimated dry weights. d. Monitor blood pressure (BP) at least every 30 minutes during treatment- recheck potentially aberrant readings. 4. Treating Hypotension on Hemodialysis: a. If BP is low or patient is symptomatic, administer 100-200 milliliters (ML) fluid bolus as ordered by the provider. b. If patient is symptomatic, place patient in modified Trendelenburg position. c. Notify the nurse in charge. d. If symptoms continue or worsen, ultrafiltration can be reduced to a minimum or turned OFF. e. Monitor and record the BP at least every five minutes until any symptoms related to hypotension have resolved. Administer additional fluid bolus(es) as needed based on patient’s symptoms as ordered by the provider. f. The nurse may administer IV medications or oxygen as prescribed by patient’s provider/ standing orders. g. When BP is stable: review UF goal and revise to prevent further intradialytic hypotension. h. Notify the provider of the event if indicated and follow orders. i. Document in patient’s medical record. E. Review of Medical Advisory Board (MAB) Recommended Volume and Hypertension Evaluation and Management Algorithm Decision Support 1.0 (rev 03/01/2024) shows: 1. Goals: patient’s post treatment weight will be within 1 kilogram (kg) of Estimated Dry Weight (EDW) without signs or symptoms of hypervolemia or hypovolemia. Systolic Blood Pressure (SBP) targets: pre dialysis sitting- >/= to 100mmHg and </= 160mmHg and post dialysis sitting SBP >/= to 100mmHg and </= 140mmHg. 2. General Orders: a. Ultrafiltration Rate (UFR) >/= to 10 mL/kg/hour (hr) are associated with increased mortality b. CMS QIP reporting measure includes patient UFR >13 mL/kg/hr. The measure is intended to guard against risks associated with high UFR rates for adult dialysis patients. c. If pre-weight is less than or equal to EDW, or sitting SBP is >160mmHg pre-dialysis, set target weight removal (TWR) to 1kg below pre-dialysis. d. If pre-weight is less than or equal to EDW, or sitting SBP is <160mmHg pre-dialysis, set target weight removal (TWR) to 0.5kg below pre-dialysis. e. If pre-weight is > EDW and UFR is </= 13 mL/kg/hr, adjust TWR to 0.5kg below EDW not to exceed UFR of 13mL/kg/hr. f. If UFR is > 13 mL/kg/hr increase today’s dialysis duration by 15 minutes. g. If patient is symptomatic with symptoms of hypervolemia post treatment (shortness of breath (SOB), difficulty breathing) or post sitting SBO is >180mmHg or <100 mmHg, call physician/ NP/ PA prior to patient discharge. F. Review of patient records revealed: 1. Patient #5: a. On 06/20/2025, SBP dropped by >20 mmHg. No evidence of RN notification was found. Post treatment sitting BP was 198/100. No evidence of provider notification prior to discharge was found. b. On 06/18/2025, Post treatment sitting BP was 236/114. No evidence of provider notification prior to discharge was found. c. On 06/16/2025, Post treatment sitting BP was 210/106. No evidence of provider notification prior to discharge was found. 2. Patient #6 a. On 06/17/2025, Post treatment weight was 3kg>EDW. Pre and post treatment assessments did not document edema or SOB. BP was within provider ordered parameters. No evidence of provider notification of elevated post weight on treatment record. b. On 06/10/2025, Post treatment weight was 4.3kg>EDW. Pre and post treatment assessments did not document edema or SOB. BP was within provider ordered parameters. No evidence of provider notification of elevated post weight on treatment record. c. Review of patient care plan shows no evidence of goal adjustment, plan change, or plan implementation since 02/19/2025. 3. Patient #7 a. On 06/21/2025, post treatment weight was 2.8kg>EDW. On 6/19/2025, post treatment weight was 2.3kg > EDW. On 06/17/2025, post treatment weight was 3kg>EDW. On 06/14/2025, post treatment weight was 2.1kg> EDW. On 06/12/2025, post treatment weight was 3kg>EDW. On 06/10/2025, post treatment weight was 2.7kg> EDW. No evidence of EDW evaluation or order change in record since 05/01/2025. No evidence of provider notification of elevated post weights on treatment record. No evidence in record of care plan goal review, update, or implementation since 02/19/2025. b. On 06/14/2025, SBP decreased from 219/34 to 160/82 in 30 minutes. No evidence of RN or provider notification in treatment sheet. On 06/12/2025, SBP decreased from 210/108 to 154/82 in 30 minutes. No evidence of RN or provider notification in treatment sheet. On 06/110/2025, SBP decreased from 219/95 to 154/75 in 30 minutes. No evidence of RN or provider notification in treatment sheet. 4. Patient #8 a. On 06/23/2025, There is no evidence of BP and intradialytic monitoring recorded from 5:30 AM to 6:30 AM. On 06/16/2025, there is no evidence of BP and intradialytic monitoring recorded from 5:10 AM to 6:40 AM. b. On 06/16/2025, SBP decreased from 194 to 159 with no evidence of RN notification recorded on treatment sheet. 5. Patient #10 a. Patient has current physician’s order to follow MAB Recommended Volume and Hypertension Decision Support Algorithm daily. On 06/21/2025, maximum mL/hr allowed UFR was 753mL/hr. Patient’s dialysis machine was set to remove 1,210 mL/hr. On 06/19/2025, maximum mL/hr allowed UFR was 760mL/hr. Patient’s dialysis machine was set to remove 1,090 mL/hr. On 06/12/2025, maximum mL/hr allowed UFR was 673mL/hr. Patient’s dialysis machine was set to remove 860 mL/hr. On 06/10/2025, maximum mL/hr allowed UFR was 638mL/hr. Patient’s dialysis machine was set to remove 1,000 mL/hr. No evidence was found in chart of a physician order for > 13mL/kg/hr fluid removal. b. Patient’s EDW recorded on 04/17/2025 physician note was 44.9kg. On 06/10/2025, post treatment weight was 2.3kg>EDW. On 06/12/2025, post treatment weight was 4.4kg>EDW. On 06/19/2025, post treatment weight was 9.7kg>EDW. On 06/21/2025, post treatment weight was 9.1kg> EDW. No evidence of physician notification was found on treatment sheets. Care plan does not contain evidence of goal adjustment, plan change, or plan implementation since 03/29/2025. c. On 06/19/2025, patient’s post treatment blood pressure was 168/100 sitting. There is no evidence that provider was notified of elevated blood pressure or patient’s refusal to stay for observation. 6. Patient #11 a. On 6/21/2025, SBP decreased from 196 to 160 at 7:55 AM and 154 to 125 at 11:25 AM. No evidence of RN notification was recorded on treatment sheet. On 6/14/2025, SBP decreased from 177 to 147 at 8:02 AM. No evidence of RN notification was recorded on treatment sheet. b. On 06/10/2025, There is no evidence of BP and intradialytic monitoring recorded from 9:30 AM to 10:45 AM. On 06/07/2025, there is no evidence of BP and intradialytic monitoring recorded from 10:00 AM to 10:56 AM. 7. Patient #12 a. Patient has current physician’s order to follow MAB Recommended Volume and Hypertension Decision Support Algorithm daily. On 06/21/2025, maximum mL/hr allowed UFR was 1,174mL/hr. Patient’s dialysis machine was set to remove 1,250 mL/hr. On 06/10/2025, maximum mL/hr allowed UFR was 1,164mL/hr. Patient’s dialysis machine was set to remove 1,230 mL/hr. No evidence was found in chart of a physician order for > 13mL/kg/hr fluid removal. b. On 06/17/2025, patient presented for treatment with a sitting BP of 193/99. There is no evidence of physician/NP/PA notification prior to initiating treatment. On 06/14/2025, patient presented for treatment with a sitting BP of 229/122. Patient’s post treatment sitting BP was 230/142. There is no evidence of physician/NP/PA notification prior to initiating treatment or discharging patient to home. On 06/10/2025, patient’s pre-treatment sitting blood pressure was 241/132 and post treatment sitting BP was 198/119. There is no evidence of physician/NP/PA notification prior to initiating treatment or discharging patient to home. c. On 06/10/2025, There is no evidence of BP and intradialytic monitoring recorded from 11:03 AM to 12:05 PM. 8. Patient #13: On 06/20/2025, patient presented for treatment with a sitting BP of 228/53. Patient discharged home with a sitting blood pressure of 200/98. There is no evidence of physician/NP/PA notification prior to initiating treatment or discharging patient to home. On 06/16/2025, patient presented for treatment with a sitting BP of 211/102. There is no evidence of physician/NP/PA notification prior to initiating treatment. G. Findings were confirmed with ICHD Clinic Manager during interview on 06/25/2025 at 9:30 AM.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 52740 Based upon patient record review, policy review, and interview, it was determined that not all In-Center Hemodialysis (patients) were offered the influenza and pneumococcal vaccines as recommended by the Centers for Disease Control and Prevention (CDC) for all dialysis patients. This failed practice increased the risk for contracting influenza and pneumonia. The failed practice had the likelihood to affect all 73 ICHD patients at increased risk for contracting influenza and pneumonia. The findings follow: A. Review of the Fresenius Kidney Care Pneumococcal Vaccine for Adults policy (published 02/05/2024) showed: 1.Pneumococcal vaccination is recommended for adults with chronic renal failure. 2.A physician’s order must be entered into the electronic medical record to administer a pneumococcal vaccine. 3. Obtain a declination statement for any patient who declines the pneumococcal vaccine. Patients should be offered pneumococcal vaccination on an annual basis, at minimum. The vaccine declination must be signed by the patient for each refusal and documented in the patient’s medical record. B. Review of Fresenius Kidney Care Patient Influenza Vaccination and Care of Patient with Influenza or Influenza-like Illness policy (published: 09/05/2023): 1. Each facility will offer influenza vaccination to all patients with a valid physician order on an annual basis. 2. For patients that refuse the vaccine, obtain a declination statement with the patient’s signature. 3. Enter the vaccine administration or reason for refusal in the patient medical record. C. Nine ICHD patients (#5 through #13) were reviewed for immunization and medication records. Five patient records (#5, #9, #11, #12, and #13) did not contain proof of patient being offered pneumococcal vaccination at any point since admission. Electronic medical records did not contain proof of vaccine declination by the patient. D. Nine ICHD patients (#5 through #13) were reviewed for immunization and medication records. One patient record (#12) did not contain evidence of patient being offered influenza vaccination at any point since admission. Electronic medical records did not contain evidence of vaccine declination by the patient. E. Findings were confirmed with ICHD Clinic Manager during interview on 06/25/2025 at 9:30 AM.”