Dci Montgomery

“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: 49894 Based on review of the facility’s Crash Cart Inspection Record, the facility’s Emergency Box Checklist, facility policy and procedure, and staff interview, it was determined the facility failed to perform defibrillator (AED), Oxygen, and suction checks daily and the Emergency Box Checklist monthly per facility policy. This deficient practice had the potential to negatively affect all 39 patients dialyzed at the facility. Findings include: Facility Procedure: Crash Cart and Emergency Equipment Checks Procedure Number: 910.0 Date Issued: 10/28/13 ...Policy: Defibrillator (AED), Oxygen, and Suction Checks: 1. The defibrillator or AED will be checked for proper function on a daily basis... 2. Emergency oxygen tanks will be checked for oxygen levels and the presence of necessary supplies...on a daily basis. 3. The suction apparatus will be checked on a daily basis for proper function and availability of necessary supplies... 4. The daily checks of emergency equipment will be documented on the Crash Cart Checklist. Crash Cart Contents Check/Inventory: 1. ...Inventory the contents of the crash cart monthly... 2. Check expiration date of supplies during monthly inventory... 1. A tour of the treatment floor was conducted on 11/18/25 at 11:30 AM. The following was revealed: The facility’s Crash Cart Inspection Log, located on the crash cart, revealed checks for suction, AED, and Oxygen Level for September 19, 2025 and October 10, 2025 were not performed. The facility’s Emergency Box Checklist revealed monthly checks of contents in the emergency box had not been performed in January, February, March, April, May, July, August, September, and October of 2025. An interview was conducted on 11/20/25 at 2:00 PM with Employee Identifier # 1, Nurse Manager, who confirmed staff failed to perform daily crash cart equipment checks and monthly emergency box checks per the facility policy.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 49603 Based on review of the facility Emergency Preparedness (EP) Plan documentation, and staff interview, it was determined the facility failed to conduct and document a full-scale community/facility-based exercise, actual event, or tabletop exercise for the past two years. This had the potential to negatively affect all patients served by the facility and staff. Findings include: Dialysis Clinic Inc./ Montgomery, Emergency Preparedness Plan ...VI. Testing A. The facility will participate in one exercise annually. a. A community based full scale exercise, or an individual facility based functional exercise is required every 2 years. b. In the opposite years, the facility will choose one of the following exercises to conduct: i. A second full-scale exercise .... ii. A mock disaster drill or iii. A tabletop exercise or workshop .... B. In the event that the facility experiences an actual natural or manmade emergency that requires activation of the EPP, the facility is exempt from engaging in their next required full-scale community based or individual facility based exercise following the onset of the actual event. C. After full scale exercises, tabletops or actual events, the facility should analyze the response ... Review of the EP Plan revealed no documentation the facility conducted or participated in a full-scale community-based, facility-based exercise, or an actual emergency event within the past two years. An interview was conducted on 11/20/25 at 2:45 PM with Employee Identifier # 9, Area Operations Director, who confirmed the facility had failed to conduct or document a full-scale community/facility-based exercise, or actual event, within the past two years and was unable to provide the last completed exercise or actual event.”

“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: 49603 Based on observations and interviews, it was determined the facility failed to maintain and ensure a safe and sanitary environment for patients. This had the potential to affect all 39 patients currently dialyzed at the facility. Findings include: A tour of the facility and observations were conducted on 11/18/25 at 11:00 AM. Eight of twenty-four in center hemodialysis treatment chairs had tears in the vinyl covering at the armrests, the top middle headrests and bottom seat cushions. Some chairs had multiple tears in different locations of the treatment chair. This failure prevented the patient treatment chairs from being properly disinfected between patient dialysis treatments, and increased the potential for contamination with blood and pathogenic microorganisms, including hepatitis B. An interview was conducted on 11/20/25 at 1:45 PM with Employee Identifier (EI) # 2, Technical Manager and EI # 9, Area Operations Director, who confirmed the facility failed to maintain and ensure a safe and sanitary environment for patients, staff, and visitors.”

“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: 49894 Based on observations, review of facility policy and procedure, and staff interviews, it was determined the facility failed to ensure staff followed facility policy for hand hygiene. This affected Patient Identifier (PI) # 7 and PI # 3 in two of two observations of discontinuation of dialysis with a Central Venous Catheter (CVC) and had the potential to affect all thirty-nine incenter dialysis patients dialyzed at the facility. Findings include: Facility Procedure: General Facility Infection Control Procedure Number: 310 Revision Date: 4/2/24 ...Policy 1. Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. 1. An observation of care was conducted on 11/19/25 at 9:55 AM with Employee Identifier (EI) # 3, Registered Nurse, at station 18 to discontinue dialysis with a CVC for PI # 7. EI # 3 disconnected one of the two blood lines, and PI # 7 held the blood line with an ungloved hand while EI # 3 flushed the CVC ports and applied sterile port caps. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, Nurse Manager, who confirmed PI # 7 must wear gloves when touching dialysis supplies/equipment. 2. An observation was conducted on 11/19/25 at 10:03 AM with EI # 4, RN, discontinuing dialysis with a CVC for PI # 3 at station 6. After disconnecting the Venous bloodline from the CVC, PI # 3 held the bloodline with an ungloved hand while EI # 4 flushed and capped the CVC ports. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the facility policy for hand hygiene. 30952”

“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: 30952 Based on observation, review of the facility policies and procedures, and interview, the facility failed to ensure the patient and staff wore a mask covering the nose during one of two observations of Central Venous Catheter (CVC) exit site care and dialysis treatment initiation, which affected Patient Identifier (PI) # 6. The failure to have a mask covering the nose and mouth during exit site care and dialysis treatment initiation via the CVC had the potential for exposure of the CVC to infectious material and this deficient practice could negatively affect all patients with CVC’s. Findings include: Facility Procedure: CVC Exit Site Disinfection and Dressing Change Procedure Number: 103 Revision Date: 10/8/21 ...Policy: ...3. Catheter care and dressing changes should be done prior to treatment initiation. ...Procedure 1. Wash hands. Put on personal protective equipment (PPE). Don facemask... 5. Assist patient in donning face mask...Instruct patient to turn their head away from insertion site during procedure... Facility Procedure: Treatment Initiation with a CVC Procedure Number: 115 Date Revised: 1/21/25 ...Supplies: PPE ...Procedure 1. Don PPE... 1. An observation was conducted on 11/19/25 at 9:25 AM with Employee Identifier (EI) # 3, Registered Nurse at station 14 with Patient Identifier (PI) # 6 for CVC exit site care and dialysis initiation via CVC. EI # 3’s mask and PI # 6’s mask did not cover the nose as required to prevent contamination of the CVC. During dialysis treatment initiation with a CVC, EI # 3’s mask did not cover the nose. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, Nurse Manager, who confirmed the mask should cover the nose during CVC exit site care and dialysis initiation via a CVC. 49894”

“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: 49894 Based on observations, review of facility policy and procedure, and staff interview, it was determined the facility failed to store clean supplies in a clean area and dirty supplies in a dirty area per the facility policy. This deficient practice had the potential to negatively affect all 39 patients dialyzed at the facility. Findings include: Facility Procedure: General Facility Infection Control Procedure Number: 310 Revision Date: 4/2/24 ...Policy ...6. Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. 7. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. 8. Do not handle or store medications or clean supplies in the same are or adjacent to where used equipment or blood samples are handled. A tour of the facility conducted on 11/18/25 at 11:30 AM revealed the following: Two boxes of Optiflux F180NRe dialyzers, Three boxes of F160NRe dialyzers, one box of F200NRe dialyzers, one box of CombiSet hemodialysis blood tubing sets, and two boxes of 1000 milliliter (ml) bags normal saline were stored directly on the floor in the patient treatment area. Two opened, used jugs of Naturalyte acid bath dated 11/17/25 were on the clean countertop. One box of 10 ml syringes, opened, on the countertop directly next to the handwashing sink. There were splash marks on the box and on the individual syringe packages inside the box. An interview was conducted on 11/20/25 at 4:30 PM with Employee Identifier # 1, Nurse Manager, who confirmed the facility failed to follow the facility policy for supply storage in clean and dirty areas.”

“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: 30952 Based on observations, review of the facility policy and procedure, and staff interviews, it was determined the facility failed to ensure staff cleaned and disinfected all surfaces and equipment in the dialysis station between patient use, which had the potential to expose patients and staff to infectious organisms. This affected two of two observations of dialysis station cleaning and disinfection and had the potential to affect all patients who dialyze at the facility. Findings include: Facility Procedure: Routine Disinfection in the Hemodialysis Unit Procedure Number: 300 Revision Date: 4/2/24 ...Procedure ...3. To clean the dialysis machine start at the top of the machine. Ensure that all items from top to bottom are cleaned, including but not limited to: IV Pole (used to hang intraveneous solutions), stethoscope if left on machine, prime bucket/container, all components of machine (i.e. air detector, heparin pump, blood pump doors, hansen connector and tubing), blood pressure cuff and tubing, any concentrate containers, bottom, sides, shelf and back of machine... 1. An observation of cleaning and disinfection of the dialysis station was conducted 11/19/25 at 9:55 AM at station 21 with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician. During cleaning of the dialysis machine intravenous (IV) pole, EI # 5 failed to disinfect the stethoscope hanging on the IV pole hook. During cleaning of the dialysis machine, EI # 5 failed to remove the prime waste container from the dialysis machine and disinfect all surfaces of the container and dialysis machine. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, Nurse Manager, who confirmed staff failed to clean all dirty equipment and surfaces in the dialysis station. 49894 2. An observation was conducted on 11/19/25 at 10:26 AM with EI # 4, Registered Nurse, cleaning and disinfecting dialysis station 6. EI # 4 failed to remove the prime bucket from the machine and wipe all surfaces of the prime bucket, inside and out. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the facility policy for station disinfection.”

“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: 46293 Based on observation, facility policy and procedure, and staff interview, it was determined the facility failed to ensure: 1. Staff dated and labeled multi-dose vials (MDV) with the correct date and time the vial was opened. 2. An opened, unlabeled syringe with needle attached in a box of Prevnar 20 Pneumococcal vaccine was available for patient use. These deficient practices had the potential to negatively affect all 39 patients served by the facility. Findings include: Facility Policy: Use of Multi-dose Vials Policy Number: 500 Date: Not listed Purpose: To provide the hemodialysis clinic with guidance and recommendations for the safe and proper use of MDV. Policy: ...2. When a MDV has been opened, the vial should be dated, initialed and discarded within 28 days... 1. A tour of the patient treatment floor was conducted on 11/18/25 at 11:33 AM. An observation of the medication refrigerator revealed the following: a. One Tuberculin Purified Protein Derivative five tuberculin units per 0.1 milliliter (ml) MDV labeled on the box as opened 12/17/25 and expired 1/16/26, and labeled as opened on the vial 11/17/25. b. One Retacrit 20,000 units per 2 ml MDV not dated or labeled when opened. c. One opened, unlabeled syringe with needle attached in the Pneumococcal 20-Valent Conjugate Vaccine box available for patient use. d. One Gentamycin Sulfate 0.1 percent cream not dated when opened. Employee Identifier (EI) # 6, Registered Nurse, confirmed during the tour the MDVs were not dated and labeled correctly and the unlabeled syringe with needle attached was available for patient use.”

“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: 30952 Based on review of the facility procedure, and medical records (MR), it was determined the facility failed to ensure staff followed the facility procedure for central venous catheter (CVC) exit site care. This affected two of three incenter hemodialysis patient records reviewed, including Patient Identifier (PI) # 1, and PI # 4, and had the potential to negatively affect all patients who dialyze with a CVC. Findings include: Facility Procedure: Central Venous Catheter Exit Site Disinfection and Dressing Change Procedure Number: 103 Revision Date: 10/8/21 ...Due to increasing microbial resistance to mainstream antibiotics, infection prevention must be considered the first rule of vascular access maintenance. Supplies: ...PPE Face mask for patient... Disinfection Solution... 6...Option # (number) 1 (preferred) 2% Chlorhexidine with 70 % alcohol... Option # 2: Povidone-iodine... Option # 3: ExSept Plus... 8. Document procedure... 1. PI # 1 was admitted to the facility on 5/25/25 with a diagnosis of End Stage Renal Disease and dialyzed with a CVC. Review of the Hemodialysis Treatment Flowsheets (HDTFs) dated on 9/15/25, 9/22/25, 10/1/25, 10/6/25, and 11/3/25 revealed no documentation of the CVC exit site care performed. An interview was conducted on 11/20/25 at 4:13 PM with Employee Identifier (EI) # 1, Nurse Manager, and EI # 6, Registered Nurse, who confirmed staff failed to document the CVC exit site care provided on five of six treatments reviewed. 2. PI # 4 was admitted to the facility on 8/1/25 with a diagnosis of Acute Kidney Injury and dialyzes with a CVC. Review of the HDTFs dated on 11/7/25, 11/10/25, 11/12/25, 11/14/25, 11/17/25 revealed no documentation of the CVC exit site care performed and/or no documentation of the type of disinfectant solution used during exit site care. An interview was conducted on 11/20/25 at 3:54 PM with EI # 1, who confirmed the staff failed to document the care performed to CVC exit site on four of six treatments reviewed.”

“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: 30952 Based on observations, review of the facility procedure, and interviews, it was determined the facility failed to ensure staff followed the facility procedure for chlorine and chloramine tests. This deficient practice had the potential to negatively affect all thirty-nine incenter hemodialysis patients who dialyze at the facility. Findings include: Facility Procedure: Total Chlorine Testing with RPC (brand) Ultra-Low Total Chlorine Test Strip Procedure Number: 151.6 Date Issued: No date documented. Purpose: To define the steps involved for testing the presence of Chlorine and Chloramine using the RPC Ultra-Low Total Chlorine Test Strip. ...Procedure ...4. Set timer for 60 seconds. Remove one test strip...dip it in sample... 5...move it back and forth... 6. Remove strip...shake once, briskly, to remove excess water. 7. Wait 20 seconds for test strip color to develop... 8. After the 20 second wait period immediately compare the strip color to the...color chart. 1. An observation of Total Chlorine testing was conducted on 11/19/25 at 10:40 AM with Employee Identifier (EI) # 4, Registered Nurse, Incenter Hemodialysis (ICHD). EI # 4 tested the water temperature, dipped the test strip into the solution, swished the strip back and forth for 32 seconds, removed the strip from the solution, shook off the excess sample, waited 32 seconds, and compared the test strip to the color chart. EI # 4 failed to follow the facility procedure, wait 20 seconds, and compare the test strip to the color chart. After the procedure was complete, the surveyor reviewed the directions on the RPC instructions with EI # 4, who confirmed he/she waited 32 seconds and not 20 seconds, as directed An interview was conducted on 11/19/25 at 1:55 PM with EI # 2, Technical Manager, who verified the staff failed to perform the Total Chlorine test per the facility procedure.”

“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: 30952 Based on review of facility policy and procedure, the facility Rockwell Acid Concentrate Batch Mix and Transfer Log documentation, Bicarbonate (Bicarb) Batch Mixing and Checking Log instructions and staff interviews, it was determined the facility failed to ensure: 1. A second trained staff verified the acid concentrate batch mix and transfer and documented the acid concentrate batch mix/transfer verification on the log. 2. Staff tested the bicarbonate loop after bleaching and documented chlorine test results on the bicarbonate (bicarb) batch mix log. These deficient practices had the potential to jeopardize the health and safety of the thirty-nine in-center hemodialysis patients who dialyze at this facility. Findings include: Facility Procedure: Acid Concentrate Mix, Transfer, and Rinsing of the Rockwell DMAX45 Mixer Procedure Number. 409.2 Date Issued: No date documented. Purpose: Ensure the dry powder acid concentrate is correctly mixed into solution at the proper proportioning ration and formulation(s). ...Policy: ...2. Any staff member who operates or maintains the Rockwell dry acid mix system must complete a training program... 7. The following documentation requirements for mixing acid concentrate will be recorded on the Rockwell Acid Concentrate Batch Mix and Transfer Log as the steps are completed: ...Initials of person verifying the mixed batch information... 1. Review of the Rockwell Acid Concentrate Batch Mix and Transfer Log documentation revealed on 6/6/25 and 6/11/25, there was no documentation of the name of the technician who mixed the acid concentrate. Further review of the Rockwell Acid Concentrate Batch Mix and Transfer Log revealed on 6/13/25, 6/23/25, 6/25/25, 7/2/25, 7/11/25, 7/28/25, 8/15/25, 9/3/25, 9/3/25, 9/19/25, 9/24/25, 9/29/25, 10/1/25, 10/13/25, 10/15/25, 11/3/25, 11/5/25, and 11/7/25 the technician who mixed the acid concentrate was the same technician who verified accuracy of mixing and transfer of the acid concentrate. There was no documentation a staff member, trained and competent in acid contentrate mixing and testing, verified the mixed acid concentrate batch. Review of the 8/7/25 Rockwell Acid Concentrate Batch Mix and Transfer Log documentation revealed no documentation the mixed acid concentrate batch was verified by a second trained staff member. Interviews were conducted on 11/19/25 at 2:35 PM with Employee Identifier (EI) # 1, Nurse Manager, and EI # 2, Technical Manager, who confirmed the acid concentrate batch mix documentation included only intials of staff who mixed the acid concentrate. EI # 1 confirmed staff failed to follow the facility policy and procedure for acid batch concentrate mixing verification for accuracy and safety by a second trained staff. An interview was conducted on 11/19/25 at 2:45 PM with EI # 5, Certified Clinical Hemodialysis Technician, who confirmed he/she failed to have a second trained staff verify the acid concentrate batch mixing and transfer. 2. Review of the facility instructions printed on the bottom of Bicarb Batch Mixing and Checking Log dated 7/2/25 to 11/17/25, revealed “...Test and document that the bicarb loop water was negative for bleach...” Review of the July 2025 Bicarb Batch Mix Log dated 7/30/25 revealed no documentation the bicarb loop was negative for bleach. Review of the September 2025 Bicarb Batch Mix Log documentation dated 9/12/25 and 9/17/25 revealed no documentation the bicarb loop was negative for bleach. Interviews were conducted on 11/19/25 at 2:35 PM with EI # 1, who confirmed staff failed to ensure the Bicarb Batch Mix Log contained results of chlorine tests after bleaching the bicarb loop water.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy and procedure, and interview, it was determined the facility failed to ensure the dialysis station bicarbonate outlets were labeled accurately and identified the bicarbonate proportion ratio delivery. This had the potential to negatively affect the thirty-nine incenter patients who dialyze at this facility. Findings include: Facility Procedure: Tank, Container, and Outlets Labeling Requirements Procedure Number: 401.3 Date Issued: No date documented. Purpose: Identify the contents, proportioning ratios, chemical composition or formulation and hazards in mixing and holding containers to prevent confusion and incorrect delivery of dialysate solutions. ...Policy: 1. All acid and bicarbonate concentrate outlets at the dialysis machine connection boxes will be labeled to indicate the contents of each connection in a manner to prevent possible delivery of incorrect dialysis solutions... 1. Observations of care were conducted on the incenter treatment floor on 11/19/25 at 8:25 AM with Employee Identifier (EI) # 1, Nurse Manager, to verify dialysis prescriptions. At station one, station six, and station fifteen, the surveyor observed the dialysis station concentrate outlets labeled 2 K (Potassium (acid concentrate) 2 Ca (Calcium-bicarbonate concentrate) and 3 K 2 Ca. The ordered dialysis solutions for the three unsampled patients was 2.5 Ca and not 2 Ca. An interview was conducted on 11/19/25 at 8:45 AM with EI # 1 who reported the twenty-four dialysis station concentrate outlets were labeled incorrectly for the central delivery of the 2.5 Ca bath.”

“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: 30952 46293 49603 49894 Based on a tour of the facility, observations, review of the facility’s Machine Disinfection Logs, facility policy and procedure, Myron L Digital Dialysate Meter Operation Manual, Combiset (bloodlines) instructions for use, and staff interview, it was determined the facility failed to ensure: 1. Staff completed and documented daily acid cleaning per facility policy and procedure. 2. Staff completed and documented heat disinfection per facility policy and procedure. 3. Staff completed and documented post bleach residual verification by the Registered Nurse (RN) per facility policy and procedure. 4. Staff completed and documented disafe testing per facility policy and procedure. 5. Staff completing the machine log documented their initials per facility policy and procedure. 6. Staff completed and documented charge nurse verification of disinfectant log completion. 7. Staff rinsed the cell of the Myron L D6 meter (used for verification of conductivity and potential of Hydrogen (pH) of dialysate) after use per the manufacturer’s directions for use (MDFU). 8. Expired supplies were not available for patient use. 9. Staff maintained the Arterial drip chamber to 90% full and Venous drip chamber to 70% full per the MDFU. These deficient practices affected four of four observations of conductivity and pH testing of dialysate using the MyronL D6 meter, three of three months of Machine Disinfection Logs reviewed, and had the potential to negatively affect all 39 patients dialyzed at the facility. Findings include: Facility Procedure: Disinfecting the Hemodialysis Machine Procedure Number: 326 Date Issued: 4/2/24 Purpose: To provide a standard for the daily and weekly rinsing and disinfection of the dialysis machine. Policy: Each hemodialysis machine, if used, will be acid cleaned daily with vinegar at the end of the day and then followed with either a heat or Chemical/Rinse disinfectant. The machine must be rinsed after performing a chemical disinfection. The Heat Disinfectant program will be used daily, except for the day a Chemical/Rinse program is used. Chemical/Rinse program will be used at least once a week using bleach. The disinfectant log will be completed by the staff member performing the procedure. Before staff are allowed to leave for the day, the charge nurse will ensure all disinfectant logs have been completed... Procedure Steps ...Chemical/Rinse ...26. Using the appropriate test strip, check for the presence of chemical disinfectant (bleach) from the drain line. 27. Document on the Disinfectant Log the time and presence of disinfectant was obtained and write initials... 29. At the two minute mark or less, check the machine for the presence of residual chemical disinfectant from the drain line. 30. Document the Disinfectant Log the time a negative result chemical disinfectant was obtained... 32. At start-up the next treatment day, check for the presence of chemical disinfectant. 33. Document results obtained on the Disinfectant Log. Digital Dialysate Meter Operation Manual Page 11 Myron L Company Date Issued: 2/18/16 ...IV. After Using the Dialysate Meter A. Maintenance of the Conductivity Cell Rinse out the conductivity cell with clean water. Fresenius Medical Care Combiset True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors Instructions for Use ...Dialysis Treatment Precautions ...2. During Treatment ...b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full... Failure to follow the manufacturer’s instructions for use (mifu) had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the thirsty-nine patients who received incenter hemodialysis treatments at the facility. 1. Review of the Machine Disinfection Logs for September, October, and November 2025 revealed the following: September: a. Nine machines were missing documentation of daily acid cleaning. b. Two machines were missing documentation of daily heat disinfection. c. Three machines were missing documentation of weekly post bleach residual verification by the RN following bleach disinfection. d. Twenty-two machines were missing daily documentation of the initials of the person completing the machine log. October: a. Ten machines were missing documentation of daily acid cleaning. b. Five machines were missing daily documentation of the initials of the person completing the machine log. November: a. Seven machines were missing documentation of daily acid cleaning. b. Four machines were missing documentation of daily heat disinfection. c. Four machines were missing documentation of weekly post bleach residual verification by the RN following bleach disinfection. d. Three machines were missing documentation of weekly diasafe (polysulfone filter used in hemodialysis to remove bacteria and endotoxins in fluid) testing following bleach disinfection. e. Eight machines were missing daily documentation of the initials of the person completing the log. f. Nine machines were missing daily documentation of charge nurse verification the logs had been completed. An interview was conducted on 11/20/25 at 4:30 PM with Employee Identifier (EI) # 1, Nurse Manager, who confirmed staff failed to complete and document daily acid cleaning, heat disinfection, bleach residual verification by the RN following bleach disinfection, diasafe testing, initials of the person completing the log, and charge nurse verification of daily machine log per the facility policy and MDFU. 2. A tour was conducted on 11/18/25 at 11:55 AM of the Peritoneal Dialysis (PD) Room. The following supplies were expired and available for patient use. a. 22 Baxter MiniCap with Povidone-Iodine Solutions with an expiration date of 10/28/25. b. Two Baxter UltraClamp Tubing Clamps with an expiration date of 1/1/25. c. 10 Baxter Short Nose Clamp for Outlet Port of Plastic Containers with an expiration date of 11/28/24. EI # 6, Registered Nurse (RN), confirmed at the time of the tour the items were expired and available for patient use. 3. A tour of the lab area was conducted on 11/18/25 at 12:24 PM. Sixty-five Becton Dickinson Vacutainer Tubes with an expiration date of 10/31/25 were in a basket on the countertop and available for patient use. EI # 6, RN, confirmed at the time of the tour the tubes were expired and available for patient use. 4. An observation of the hemodialysis treatment area was conducted on 11/19/25 at 8:25 AM with EI # 1 which revealed the arterial drip chamber fluid level was less than 50 % (percent) full at station 6. EI # 1 adjusted the arterial fluid level to the required fill line during the observation. At 10:45 AM, the arterial drip chamber fluid levels were approximately 40-50 % full in stations 15, and 14, and not 85-95 % full per mifu. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to ensure arterial drip chambers were at the required level. 5. An observation was conducted on 11/19/25 at 9:02 AM with EI # 8, Certified Clinical Dialysis Technician, preparing the dialysis machine for patient treatment at station 11. After testing the pH and conductivity of the dialysate at station 11, EI # 8 failed to rinse the conductivity cell of the Myron L D6 meter. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the MDFU for the Myron L D6 meter. 6. An observation was conducted on 11/19/25 at 9:58 AM with EI # 6, RN, preparing the dialysis machine for patient treatment at station 9. After testing the pH and conductivity of the dialysate at station 9, EI # 6 failed to rinse the conductivity cell of the Myron L D6 meter. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the MDFU for the Myron L D6 meter. 7. An observation was conducted on 11/19/25 at 10:05 AM with EI # 7, Patient Care Technician, who performed final dialysate conductivity and pH testing at station 15. EI # 7 failed to rinse the Myron L D6 meter conductivity cell. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the MDFU of the Myron L D6 meter. 8. An observation was conducted on 11/19/25 at 11:02 AM with EI # 6 preparing the dialysis machine for patient treatment at station 8. After testing the pH and conductivity of the dialysate at station 8, EI # 6 failed to rinse the conductivity cell of the Myron L D6 meter. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the MFDU for the Myron L D6 meter. 9. An observation was conducted on 11/19/25 at 11:20 AM with EI # 6 initiating dialysis for PI # 11 at station 3. After testing the pH and conductivity of the dialysate at station 3, EI # 6 failed to rinse the conductivity cell of the Myron L D6 meter. An interview was conducted on 11/20/25 at 4:30 PM with EI # 1, who confirmed staff failed to follow the MDFU for the Myron L D6 meter.”

“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: 30952 Based on review facility policy and procedure, medical records (MR), facility initial standing orders and interview with staff, it was determined the facility failed to ensure Tuberculin (test by hypodermic injection for infection with or immunity to tuberculosis) skin testing was performed at time of admission. This deficient practice affected Patient Identifier (PI) # 3, one of five MR’s reviewed, and had the potential to affect the thirty-nine patients who dialyze at this facility. Findings include: Facility Procedure Number: 309 Date Issued: 12/20/19 Purpose: To provide guidelines...for testing hemodialysis patients for tuberculosis. ...Policy: ...2. All patients will be tested on admission for baseline tuberculin skin test results (TST)... Acute Kidney Injury (AKI) Initial Standing Orders Revised 9/1/22 ...Immunizations... 4. TB skin test on day admission and annually. 1. PI # 3 was admitted to the facility on 8/1/25 with a diagnosis of AKI. Review of the MR revealed AKI Initial Standing Orders dated 8/1/25. Further review of the MR revealed no documentation a TST was completed and no documentation the test was performed at time of admission as ordered. An interview was conducted on 11/20/25 at 3:54 PM with Employee Identifier # 1, Nurse Manager, who confirmed there was no documentation of a TST was completed at time of admission.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 30952 Based on observation, review of medical records (MR) and staff interviews, it was determined the facility failed to ensure staff administered the Blood Flow Rate (BFR) and Dialysiate Flow Rate (DFR) according to physician’s orders. This affected one unsampled patient in one of three flash tour dialysis prescription verifications, and Patient Identifier (PI) # 1 and PI # 4, in two of four incenter hemodialysis records reviewed. This had the potential to negatively affect all thirty-nine incenter hemodialysis patients who dialyzed at the facility. Findings include: 1. A flash tour of the patient treatment floor was conducted on 11/19/25 at 8:25 AM with Employee Identifier (EI) # 1, Nurse Manager, at station 15, with an unsampled patient. The BFR was 400, and the ordered BFR was 500. EI # 1 confirmed the electronic record contained no documentation of why the BFR was not 400 as ordered. EI # 1 confirmed staff failed to follow physician’s order for BFR delivery. 2. PI # 1 was admitted to the facility on 5/25/25 with a diagnosis of End Stage Renal Disease. Review of the dialysis prescription dated 8/20/25 revealed the ordered BFR was 400. Review of the Hemodialysis Treatment Flowsheets dated 9/22/25 and 11/3/25 revealed the BFR was not 400 as ordered. An interview was conducted on 11/20/25 at 4:13 PM with EI # 1, and EI # 6, Registered Nurse, who confirmed staff failed to deliver the BFR as ordered in two of six treatments reviewed. 49603 3. PI # 4 was admitted to the facility on 1/11/23 with a diagnosis of Hypertensive Chronic Kidney Disease with Stage 1-4 Unspecified. Review of the dialysis treatment plan dated 10/24/25 revealed the ordered DFR was 600. Review of the Hemodialysis Treatment Flowsheets dated 10/24/25 revealed the DFR was not 600 as ordered. Review of the dialysis treatment plan dated 11/3/25 revealed the ordered BFR was 500. Review of the Hemodialysis Treatment Flowsheet dated 11/3/25 revealed the BFR was not 500. An interview was conducted on 11/20/25 at 1:37 PM with EI # 1, who confirmed staff failed to deliver the BFR and DFR as ordered in two of six treatments reviewed. 49894”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 30952 Based on medical record (MR) review and interview, it was determined all Interdisciplinary Care Plans were not reviewed/approved by all interdisciplinary team members. This affected Patient Identifier (PI) # 1, in one of five MR reviews, and had the potential to negatively affect all patients who dialyze at the facility. Findings include: 1. PI # 1 was admitted to the facility on 5/25/25 for incenter hemodialysis treatments with a diagnosis of End Stage Renal Disease. Review of the Interdisciplinary Care Plan, Stable, completion date of 11/4/25, revealed no Social Worker (SW) date and signature. An interview was conducted on 11/20/25 at 4:13 PM with Employee Identifier (EI) # 1, Nurse Manager, and EI # 6, Registered Nurse, who confirmed the 11/4/25 POC failed to include a SW signature and date.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 30952 Based on review of facility policy and procedure, medical record (MR), and interview with facility staff, it was determined the facility failed to ensure the initial Plan of Care (POC) was completed within 30 days or 13 treatments for one of four incenter hemodialysis record reviews. This affected Patient Identifier (PI) # 1 and has the potential to negatively affect all patients admitted to this facility. Findings include: Facility Procedure NO (number): 801 Date Issued: 9/29/21 Policy: ...Timeline and Frequency 1. All initial assessments and care plan must be completed within 30 days of admission... 1. PI # 1 was admitted to the facility on 5/25/25 with a diagnosis of End Stage Renal Disease. Medical record review revealed an Interdisciplinary (IDT) Care Plan; Stable, completion date was 8/19/25. The IDT failed to develop PI # 1’s POC within 13 treatments or 30 calendar days. An interview was conducted on 11/20/25 at 4:13 PM with Employee Identifier (EI) # 1, Nurse Manager, and EI # 6, Registered Nurse, who confirmed the initial 30-day POC dated 8/19/25 was completed more than 30 days from PI # 3’s admission date of 5/25/25.”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 30952 Based on review of facility policy and procedure, medical record (MR), and interview with staff, it was determined the facility failed to ensure all interdisciplinary (IDT) comprehensive assessments were completed within fifteen days of the 3-month plan of care (POC) implementation date. This affected Patient Identifier (PI) # 1, in one of one record reviews requiring 90-day (3 month) reassessment POC updates and had the potential to negatively affect all patients who dialyze/receive home therapy support at the facility. Findings Include: Facility Procedure NO (number): 801 Date Issued: 9/29/21 Policy: ...Timeline and Frequency ...2 All assessments and a new plan of care must be completed within 90 days of completion of the initial care plan... 1. PI # 1 was admitted to the facility on 5/25/25 with a primary diagnosis of End Stage Renal Disease. Review of the MR revealed the three-month psychosocial assessment was completed by the Social Worker on 10/9/25. Further record review revealed documentation of an IDT Care Plan: Stable, completion date 11/4/25. The SW re-assessment was completed twenty-seven days before the IDT Care Plan completion/implementation date. An interview was conducted on 11/20/25 at 4:15 PM with Employee Identifier (EI) # 1, Nurse Manager, and EI # 6, Registered Nurse, who confirmed the SW re-assessment dated 10/9/25 was completed more than 15 days prior to the 11/4/25 POC implementation date.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 49894 Based on review of the facility Hospitalization log, Quality Assurance Performance Improvement (QAPI) data, policy, and staff interview, it was determined the facility QAPI failed to assess gathered data to prioritize and develop a performance improvement plan for hospitalizations. This deficient practice had the potential to negatively affect all 39 patients dialyzed at the facility. Findings include: Facility Policy: Quality Assurance Performance Improvement (QAPI) Policy Number: 800 Date Issued: 10/1/21 ...Policy ...3. 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. 4. The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time (CMS V638). To identify opportunities for improvement and track progress for all QAPI indicators, the IDT must: Review aggregate patient data; Identify any commonalities among patients who do not reach the minimum expected targets; Develop a plan to address those causes; Implement the plan; Monitor the effectiveness of the plan; and Adjust portions of the plan that are not successful. 5. The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. 6. The facility must immediately correct any identified problems that threaten the health and safety of patients. Documentation of action steps taken, results, and follow-up must be documented in the QAPI meeting minutes. Review of the facilities QAPI documentation for the month of September 2025 revealed documentation of nine hospitalizations (2.18 %) and six readmissions. There was no documentation the facility had developed a performance improvement plan for the identified issue. An interview was conducted on 11/20/25 at 2:30 PM with EI # 1, Nurse Manager, who confirmed the facility’s QAPI Committee failed to develop an improvement plan for hospitalizations.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility procedure, and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policy and performed and documented a nurse assessment evaluation prior to the first dialysis treatment in one of one new patient records reviewed. This affected Patient Identifier (PI) # 3 and had the potential to affect all new patients admitted to this facility. Findings include: Facility Procedure: Pretreatment & Initial Assessment Facility Procedure Number: 610 Revision Date: 9/29/21 Purpose: To provide guidance on the pretreatment assessment of a hemodialysis patient. Supportive Data: An initial assessment must be conducted on all new patients. Prior to the first dialysis treatment, an “initial assessment” must be completed... In order for dialysis treatment to be initiated, each patient must have...baseline physical and nursing assessments before treatment is begun at the facility. ...the minimal nursing evaluation prior to initiating treatment for a patient new to the facility should include... Neurologic: level of alertness/mental status., orientation, identification of sensory deficits. Subjective Complaints Rest and comfort: pain status Activity: ambulation status, support needs, fall risk Access: assessment Respiratory: respirations description, lung sounds Cardiovascular: heart rate and rhythm: presence and location of edema Fluid gains, blood pressure and temperature pre-treatment Integumentary; skin color. temperature and as needed, type/location of wounds... 1. PI # 3 was admitted to the facility on 8/1/25 with a diagnosis of Acute Kidney Injury and the patient’s first hemodialysis treatment was on 8/1/25. Review of the MR revealed no documentation the licensed nurse completed an initial nursing evaluation prior to dialysis treatment initiation. An interview was conducted on 11/20/25 at 3:54 PM with Employee Identifier # 1, Nurse Manager, who verified there was no documentation of an initial nursing evaluation.”