Davita Franconia Dialysis Center

“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: 42929 Based on review of documents and interviews with staff (EMP) it was determined the facility failed to maintain evidence that the facility completed after-action review of exercises or actual emergencies, or made revisions to the emergency plan as needed, as per the facility’s policy. Findings: Review of facility document “Guidelines for Emergency Preparedness” published September 2, 2025, reads in part: “... Community Based Drill: Annually, each facility MUST participate in a community-based disaster drill. If unable to participate, document who was contacted in the community and why the clinic was unable to participate, on the Facility Specific Disaster Safety Plan form. If the EOC [Emergency Operations Center] or similar agency has not performed a community-based drill, or it was missed for a particular year, the DO [Director of Operations] should coordinate a dialysis facility area-based drill.... Mock Table Top Drill: In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill. It is recommended a different drill be completed annually. A list of table-top exercises are located on the Disaster Preparedness page under National Accounts.... Actual Emergency: If facility is involved in an actual disaster, it can take the place of community-based drill or tabletop drill. The facility must have pictures and local news to document the event. The DO must complete an after-action review and make any revision to the emergency plan as needed....” Review of the facility’s emergency preparedness documentation on September 29, 2025, revealed no evidence that the facility completed an after-action review of any emergency drills or actual emergencies completed in 2023, 2024, and 2025. Interview on September 30, 2025, in the morning, EMP1 confirmed that there was no after-action report completed for any drills or actual emergencies for 2023, 2024, and 2025.”

“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: 42725 Based on five (5) infection control observations, document review, and interview, it was determined that staff failed to follow infection control practices related to glove use and hand hygiene. Findings: Review of facility document, Infection Control for Dialysis Facilities, under the heading “Hand Hygiene”, it partly reads: “1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... b. prior to gloving and immediately after removal of gloves,... d. after patient and dialysis delivery system contact...”. Under the heading “PPE” reads, in part: “... 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station... a. Gloves should be changed when: ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system...”. The document was last revised April 2023. On September 30, 2025, the state agency (SA) was present on the treatment floor from 9:35 AM to 1:15 PM. The following was observed: At 10:02 AM, while wearing gloves, employee (EMP) 13 moved from station #9 to #8, touched the machine, and then went back to station #9 and continued working while still wearing the same pair of gloves. At 10:05 AM, EMP14 removed gloves and donned a new pair without performing hand hygiene. At 10:06 AM, while working at station #2, EMP14 left the station wearing gloves, went to the clean supply area and retrieved a new bicarbonate bag, and returned to station #2 to replace the bag. Wore the same pair of gloves throughout the task. At 11:55 AM, while working at station #8, EMP12 touched the machine with gloves and then resumed providing patient care. There was no glove change performed. Between 12:20 PM and 12:39 PM, EMP14 removed gloves and donned a new pair without performing hand hygiene three separate times. On September 30, 2025, while reviewing the observations, EMP1 indicated that staff are expected to follow the facility’s infection control policy regarding gloves and hand hygiene.”

“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: 42725 Based on observation, document review, and interview, it was determined that staff failed to follow infection control practices related to the use of personal protective equipment (PPE) while on the treatment floor. Findings: Review of facility document, Infection Control for Dialysis Facilities, under the section titled “PPE”, it partly reads: “... 6. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area...”. The document was last revised April 2023. On September 29, 2025 at 11:35 AM, the SA observed a visitor accompany a patient onto the treatment floor. The visitor was not wearing a gown. The visitor assisted the patient into the chair at station #9. EMP5 informed the visitor that the patient needed to be at station #10. EMP7 and the visitor moved the patient, who remained sitting in the chair, to the correct station. At 11:49 AM, a visitor entered the treatment floor to accompany a patient to station #9. The visitor did not don a gown prior to entering the treatment floor. On September 30, 2025 between 11:20 AM and 12:05 PM, four different visitors were observed entering the treatment floor to accompany a patient to their assigned station. None of the four visitors donned a gown before entering the treatment floor. On September 30, 2025, while reviewing the observations, EMP1 indicated that visitors should be wearing gowns while they are on the treatment floor.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 42725 Based on observations, interview, and document review, it was determined that staff failed to ensure the bleach solution, used for disinfection, was maintained according to facility policy. Findings: Review of facility document, Bleach Policy, under the heading “Policy”, partly reads: “... 5. Bleach solution needs to be covered with a secure lid and the solution should not be placed in the splash zone. NOTE: Without a secure lid, the bleach solution is open to air causing the solution to degrade over time and become less effective...”. The document was last revised October 2023. While conducting observations on September 29, 2025, a labeled container of bleach solution remained uncovered from 11:15 AM until 12:00 PM. On September 30, 2025, while reviewing observations, EMP1 acknowledged that bleach solution containers should remain covered when not in use.”

“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: 42725 Based on observations, document review, and interview, it was determined that staff failed to follow procedure for cleaning and disinfection of the dialysis station during eight of nine observations. Findings: Review facility document, Infection Control for Dialysis Facilities, under the heading “DISINFECTION”, it partly reads: “... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system... ii. Priming containers are to be emptied prior to disinfection... b. Dialysis station must be completely vacated by the previous patient before teammates can bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient...”. The document was last revised April 2023. On September 29, 2025, the following observations were made: At 10:40 AM, EMP11 cleaned station #9. After cleaning, a tape residue remained on both side tables of the chair. At 11:02 AM, EMP7 had difficulty opening the right side of the chair at station #12. After a few attempts, EMP7 moved on to wiping other areas of the chair while leaving the inside of the chair (on the right side) dirty. On September 30, 2025, the following observations were made: At 10:40 AM, while cleaning station #8, EMP12 did not open the sides of the chair for cleaning, did not clean the wall box, or the counter behind the chair. At 10:42 AM, while cleaning station #11, EMP13 did not clean the wall box or the counter behind the chair. At 10:55 AM, EMP14 hung a new fluid bag and new tubing before cleaning station #3. When the station was cleaned, EMP14 did not clean under the side trays of the chair, the wall box, or the counter behind the chair. At 11:10 AM, EMP14 repeated the same process above at station #1. At 11:30 AM, while cleaning station #2, EMP14 did not open the chair to clean the inside of the arms, did not clean the area under the side trays, the wall box, or the counter behind the chair. At 12:50 PM, while cleaning station #7, EMP12 did not clean the top of the machine and did not wipe the prime waste container after emptying. On September 30, 2025, while reviewing observations, EMP1 confirmed that staff are expected to clean all parts and areas of the dialysis station and occurs prior to hanging any new supplies.”

“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: 42725 Based on observations, interview, and document review, it was determined that staff failed to follow procedure when providing exit site care for a central venous catheter site and initiating treatment during two of three observations. Findings: Review of facility document, Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure, under the heading “Procedure”, it partly reads: “... 4. Remove old dressing and discard... 8. Holding catheter with non-dominant hand and using aseptic technique, clean exit site... 9. Clean each CVC limb/cap... 12. Place sterile 2x2 gauze over the catheter exit site... 16. Verify both catheter clamps are closed. Using aseptic technique, remove each cap. One at a time, disinfect... Connection and Treatment Initiation. 17. Attach sterile 10 ml syringes to the arterial and venous limbs...”. The document was last revised April 2025. On September 29, 2025, at 11:15 AM, EMP3 provided exit site care for a CVC and initiated a CVC treatment. EMP3 did not place a new dressing over the exit site before initiating treatment. On September 30, 2025, at 12:12 PM, EMP12 removed the exit site dressing, cleaned the site, and applied a new dressing. EMP12 then proceeded to removed the dressing from the limbs for cleaning and treatment initiation. On September 30, 2025, while reviewing observations, EMP1 confirmed that staff are expected to remove all the dressings for cleaning prior to treatment initiation and a new exit site dressing applied before initiating treatment.”

“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: 42929 Based on observations, review of documents, and interviews with staff (EMP) it was determined that the facility failed to ensure it maintained a safe environment related to sharps disposal. Findings: Review of facility document “Physical Environment” last revised April 2018 reads in part: “... 1. The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment....” Observations on September 29, 2025 at 10:00 AM, four (4) full sharps containers on the treatment floor near station 1. Three (3) of the sharps containers had openings about 6 x 6 inches wide. Two (2) of those sharps containers had opening covers that were not latched and would allow the contents to fall out of the container if the containers were knocked over, and also allow someone to easily reach into the container. One (1) full container with a smaller round opening that was not capped was set on top of another container. Contents of this container could fall out of the opening if the container was knocked over. Interview on September 29, 2025, at 10:30 AM, EMP3 indicated that the full sharps containers are set by station 1 until the staff are able to package them in a box for removal by Stericycle. Interview on September 30, 2025, in the AM, EMP1 indicated that Stericycle drops off the new sharps containers and the facility staff do not know which sharps containers they receive until the boxes are opened. EMP1 indicated that Stericycle has recently started providing the sharps containers with the large openings and closure that does not lock shut. EMP1 indicated that they would reach out to Stericycle to ensure they receive safe sharps containers moving forward.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42725 Based on observations, document review, and interview, it was determined the staff failed to ensure that a patient’s access site was uncovered and visible during the dialysis treatment. Findings: Review of facility document, Central Venous Catheter (CVC) Care, under the heading “POLICY”, it partly reads: “... 12. CVC lumen and blood tubing connections will be verified for accurate, patent and secure connections, and remain visible throughout the treatment...”. The document was last revised April 2025. Review of facility document, AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose”, under the heading “Procedure”, it partly reads: “... 32. When securing blood lines with tape: ... Access sites are to remain visible at all times during treatment...”. The document was last revised April 2025. Upon entering the treatment floor on September 30, 2025 for observations, the patients at station #2 and #11 were receiving treatment; however, the access sites were not visible. At 10:29 AM, EMP13 uncovered the site at station #11 to discontinue treatment. At 12:56 PM, the patient at station #10 was receiving treatment, but their site was covered. On September 30, 2025, while reviewing observations, EMP1 confirmed that access sites should remain uncovered and visible throughout treatment.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42929 Based on review of medical records (MR), document review, and interviews with staff (EMP) it was determined the facility staff failed to document the reason for and notification to the registered nurse of the change in blood flow rate (BFR) for two (2) of five (5) patients’ (MR) medical records, MR4 and MR5; failed to document the reason for and notification to the registered nurse of the change in dialysate flow rate (DFR) for two (2) of five (5) patients’ medical records, MR2 and MR5; and failed to have the patient sign an Against Medical Advice (AMA) form for shortened dialysis treatments and notify the attending physician of the shortened treatment for three (3) of five (5) patients’ medical records reviewed, MR1, MR2, and MR3. Findings: Review of facility document “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised April 2024 reads in part: “... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy).... 13. All findings, interventions, and patient response will be documented in the patient’s medical record.” Review of facility document “Prescribed Treatment Time Not Met” revised April 2024 reads in part: “... A. Completion of the Early Termination of Treatment Against Medical Advice Form 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time.... 3. The RN will obtain the patient’s signature on the Early Termination of Treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. If unable to obtain the patient’s signature prior to rinse-back, the RN will obtain the patient’s signature on the form prior to the patient’s departure from the facility. 4. A RN must countersign all Early Termination of Treatment Against Medical Advice forms. A witness signature is required only if the patient refuses to sign the form. 5. If a patient refuses to sign the Early Termination of Treatment Against Medical Advice form, the RN will document the patient’s refusal with the words “patient refused” in the patient signature box along with the date. Under such circumstances, the RN will sign the form and will also obtain a witness’ signature on the form. 6. This applies only to shortened treatments.... B. Prescribed Treatment Time Not Met. 1. If the shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs. NOTE: Shortened/Early Termination of dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes.... 3. If a patient’s treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: * The amount of time by which the treatment was shortened * A description of why the treatment was shortened * Whether the patient’s nephrologist was notified * A description of the follow-up medical orders provided by the patient’s attending nephrologist (if any) * A description of all other interventions planned to address the shortened treatment, including recommendation to the patient.... 5. Additionally, if the patient’s dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment times.... 6. The Facility Administrator (FA)/Designee will verify that all shortened treatments are recorded and trended, and the FA/Designee shall verify that such records are reviewed and discussed at the Facility Health Meetings (FHM), as appropriate.” BFR Review of flow sheet for MR4 dated September 16, 2025, revealed the BFR was run at 0 mL/min and 300 mL/min during the dialysis treatment when the prescribed BFR was 350 mL/min. There was documented reason why the BFR was not run as prescribed and no documentation that the nurse was notified. Review of flow sheet for MR5 dated September 15, 2025, revealed the BFR was run at 300 mL/min and 320 mL/min during the dialysis treatment when the prescribed BFR was 350 mL/min. There was documented reason why the BFR was not run as prescribed and no documentation that the nurse was notified. Review of flow sheet for MR5 dated September 17, 2025, revealed the BFR was run at 300 mL/min during the dialysis treatment when the prescribed BFR was 350 mL/min. There was documented reason why the BFR was not run as prescribed and no documentation that the nurse was notified. Review of flow sheet for MR5 dated September 26, 2025, revealed the BFR was run at 200 mL/min and 300 mL/min during the dialysis treatment when the prescribed BFR was 350 mL/min. There was documented reason why the BFR was not run as prescribed and no documentation that the nurse was notified. DFR Review of flow sheet for MR2 dated September 18, 2025, revealed the DFR was run at 500 mL/min, 800 mL/min, and 0 mL/min during the dialysis treatment when the prescribed DFR was 700 mL/min. There was documented reason why the DFR was not run as prescribed and no documentation that the nurse was notified. Review of flow sheet for MR5 dated September 19, 2025, revealed the DFR was run at 500 mL/min during the dialysis treatment when the prescribed DFR was 600 mL/min. There was documented reason why the DFR was not run as prescribed and no documentation that the nurse was notified. Interview on September 29, 2025, at 4:20 PM, EMP7 indicated that if the patient care technician (PCT) needs to change the BFR or DFR from the prescribed rate during dialysis treatment then the PCT needs to notify the nurse first and document in the flow sheet the reason for the change and that the nurse was notified. Interview on September 29, 2025, at 4:30 PM, EMP5 indicated that the PCTs are not allowed to change the BFR or DFR, but will lower it if the access is not working correctly. The PCT will reposition the needle and notify the nurse and documented in the flow sheet. Interview on September 30, 2025, in the morning, EMP1 confirmed that if the BFR and DFR are changed from the prescription during dialysis treatment the reason for the change and notification to the nurse should be documented. Shortened Treatments and AMA Forms Review of the flow sheets for MR1 dated September 17, 2025, revealed the patient’s dialysis treatment was shortened by 12 minutes of the prescribed treatment time. There was no documentation of a signed AMA form for the shortened treatment. Review of the flow sheets for MR2 dated September 16, 2025, revealed the patient’s dialysis treatment was shortened by 30 minutes of the prescribed treatment time. There was no documentation of a signed AMA form for the shortened treatment or that the attending nephrologist was notified. Review of the flow sheets for MR2 dated September 18, 2025, revealed the patient’s dialysis treatment was shortened by 57 minutes of the prescribed treatment time. There was no documentation of a signed AMA form for the shortened treatment or that the attending nephrologist was notified. Review of the flow sheets for MR3 dated September 25, 2025, revealed the patient’s dialysis treatment was shortened by 12 minutes of the prescribed treatment time. There was no documentation of a signed AMA form for the shortened treatment. Interview on September 29, 2025, at 3:50 PM, EMP7 indicated that if a treatment is shortened the staff will documented the reason and will have the patient sign an AMA form if it is shortened by more than 10 minutes.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 42929 Based on review of medical records (MR), review of documents, and interviews with staff (EMP) it was determined the physicians failed to document a progress note monthly for five (5) of five (5) patients’ (MR) records reviewed, MR1, MR2, MR3, MR4, and MR5. Findings: Review of facility document “Progress Note Policy” last revised October 2024 reads in part: “... Purpose: ... Documentation needs to include treatment given or planned, patient encounters and the condition of the patient. Policy: 1. Progress notes are completed to verify documentation of patient’s problems/needs, intervention, and response to intervention and are expressed in a narrative format.... 2. Progress notes are used to communicate information among various disciplines, or to expand upon information or problems noted in other parts of the medical records, or obtained from other sources (consults, treatment records, etc.) ... Physician: The attending Nephrologist is required to record a progress notes [sic] at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times....” Review of medical records for MR1 revealed no attending nephrologist progress note for July 2025 and September 2025. The attending nephrologist’s progress notes dated August 13, 2025, revealed the physician documented “Reviewed, no comment entered” for all indicators in the progress note. Review of medical records for MR2 revealed no attending nephrologist progress note for July 2025 and September 2025. The attending nephrologist’s progress notes dated August 26, 2025, revealed the physician documented “Reviewed, no comment entered” for all indicators in the progress note. Review of medical records for MR3 revealed no attending nephrologist progress note for July 2025, August 2025, and September 2025. Review of medical records for MR4 revealed no attending nephrologist progress note for August 2025 and September 2025. The attending nephrologist’s progress notes dated July 29, 2025, revealed the physician documented “Reviewed, no comment entered” for all indicators in the progress note. Review of medical records for MR5 revealed no attending nephrologist progress note for September 2025. The attending nephrologist’s progress notes dated July 30, 2025, and August 27, 2025, revealed the physician documented “Reviewed, no comment entered” for all indicators in the progress note. There was no documentation in the attending nephrologists’ progress notes for MR1, MR2, MR3, MR4, and MR5 demonstrating implementation of the plan of care, complete and pertinent information about the condition of the patient, that clearly portrayed the patient and the care provided. The progress notes only contained the patients’ dialysis prescription and lab results. Interview on September 30, 2025, in the morning, EMP1 confirmed that there were no attending nephrologist progress note for the patients’ medical records as above. EMP1 indicated that there were progress notes by the nurse practitioner or physician’s assistant monthly. EMP1 confirmed that the policy indicates that the attending nephrologist must document a progress note monthly.”

“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: 42929 Based on review of medical records (MR), review of documents, and interviews with staff (EMP) it was determined the facility staff failed to report risk events as per the facility’s policy for medication errors, blood stream infections (BSI), incorrect blood flow rates (BFR) and dialysate flow rates (DFR); and failed to complete Against Medical Advice form for early termination of treatment for three (3) of five (5) patients’ (MR) medical records reviewed, MR1, MR2, and MR3. Findings: Review of facility document “Risk Event Reporting Policy (Non-Teammate Related)” last revised October 2024 reads in part: “... 1. Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event. Such risk events include, but are not limited to, personal injury or potential personal injury to a patient or third party, property damage, theft, equipment failure, flood or ‘near miss’ events. Please refer to the REM [Risk Event Management] Event Category list found on the Villageweb.... 2. All risk events will be promptly reported to the facility Administrator/Manager or designee. The teammate involved in the risk event will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.... REM Categories ... Clinical Care, Against Medical Advice (NOT shortened or missed treatments) ... Near Miss ... Potential Medication Issue ... Infection ... Bloodstream Infection ... Medication/Treatment ... Lack of Availability of Medication ... Medication Not Given ... Rate Incorrect ...” Review of facility document “Medication Policy” last revised October 2023 reads in part: “... 36. All medication errors are reported to the Facility Administrator/designee. She/he will then notify the patient’s physician of the event and of any adverse changes in the patient’s condition. Physician will be notified of any medication errors prior to patient leaving the facility. Examples of medication errors include: ... A prescribed medication not administered to the patient....” Review of facility document “Prescribed Treatment Time Not Met” last revised April 2024 reads in part: “... A. Completion of the Early Termination of Treatment Against Medical Advise Form. 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time.... B. Prescribed Treatment Time Not Met. 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs. NOTE: Shortened/Early Termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during the treatment i.e. machine or access problems or use of the bathroom by the patient.... 3. If a patients’ treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: The about of time by which the treatment was shortened. A description of why the treatment was shortened. Whether the patient’s nephrologist was notified. A description of the follow-up medical orders provided by the patient’s attending nephrologist (if any). A description of all other interventions planned to address the shortened treatment, including recommendations to the patient. 4. A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient’s health record. 5. Additionally, if the patient’s dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment times. A. All available reasons must be reviewed and the most accurate reason must be selected....” Review of flow sheets for MR1 dated September 15, 2025, revealed that Mircera 30 Micrograms was not given because it was “Not in Stock”. There was no documentation that the patient’s physician was notified, and the event was not documented in the facility’s risk event management system as per the facility’s policy. Review of the infection logs and Nurse Practitioner Progress Note for MR5 dated August 22, 2025, revealed the patient had a recent hospital admission for an access site blood stream infection (BSI), had a new central venous catheter (CVC) placed, and was taking Ancef (antibiotic). Review of the flow sheets for MR2 and MR5 revealed documentation that the patient’s BFR was not run at the prescribed rate. Review of the flow sheets for MR4 and MR5 revealed documentation that the patient’s DFR was not run at the prescribed rate. Review of the facility’s Risk Event Management report dated January 1, 2025, through September 29, 2025, revealed no documentation of the Lack of Availability of Medication ... Medication Not Given for MR1 dated September 15, 2025. There was no documentation of the access related blood stream infection for MR5 dated August 15, 2025. There was no documentation of the “Incorrect Rate” for the BFR and DFR documented in the facility’s REM system. Interview on September 29, 2025, at 3:50 PM, EMP7 indicated that the nurse will document medication errors in the Risk Event Management (REM) system. EMP7 indicated that EMP7 did not document that Mircera was out of stock and not administered to MR1 on September 15, 2025, because EMP7 did not realize it needed to be documented in the REM system. EMP7 indicated that the facility is frequently out of stock of anemia medications to include Mircera. EMP7 was not sure who orders that medication. Interview on September 30, 2025, in the morning, EMP1 reviewed the REM Event list with the surveyor and confirmed the medication error, blood stream infections, and incorrect rates should be reported in the REM system as per facility policy. Review of the flow sheets for MR1, MR2, and MR3 revealed the patients’ dialysis treatments were shortened but there was no documentation of a signed AMA form for the shortened treatment or that the attending nephrologist was notified. Interview on September 29, 2025, at 3:50 PM, EMP7 indicated that if a treatment is shortened, the staff will documented the reason and will have the patient sign an AMA form if it is shortened by more than 10 minutes. Interview on September 30, 2025, in the morning, EMP1 indicated that the AMA form should be completed as per facility policy and the attending nephrologist notified.”