Davita State Fair Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47415 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment and follow standard infection control practices to minimize the transmission of infectious agents which could result in an increased potential for infection for all 62 in-center patients currently being treated by the facility. Findings include: The facility failed to ensure treatment floor was debris free and patient belongings were stored properly. (See Tag V-0111) The facility failed to ensure all staff members performed hand hygiene between the change of gloves. (See Tag V-0113) The facility failed to ensure all staff members wear the required Personal Protective Equipment (PPE). (See Tag V-0115)”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 27408 Based on interview and record review, the facility failed to ensure that the interdisciplinary comprehensive assessments of patients were completed within the timelines required for 10 (P-1, P-3, P-12, P-14, P-16, P-18, P-19, and P-20) of 20 hemodialysis patients Findings include: See Tags: V-503 - Failure to provide dialysis as prescribed V-516 - Failure to provide initial assessments within 30 days of admission V-517 - Failure to perform assessments within 90 days of admission V-519 - Failure to complete assessments annually V-520 - Failure to complete monthly assessments for unstable patients On 08/27/25 and 08/28/25, it was noted during medical record review of patients (P-1, P-3, P-12, P-14, P-15, P-16, P-18, P-19, and P-20) that the comprehensive assessments were not completed by any Registered Nurse, or Physicians practicing at the facility. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.””

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 27408 Based on interview and record review, the facility failed to ensure the completion of individualized plans of care for 12 (P-1, P-3, P-11, P-12, P-13, P-14, P-15, P-16, P-18, P-19, and P-20) of 20 hemodialysis patients, was completed according to the facility policy, resulting in the potential for poor patient outcomes. Findings include: On 08/27/25 and 08/28/25, it was noted during medical record review of patients (P-1, P-3, P-11, P-12, P-13, P-14, P-15, P-16, P-18, P-19, and P-20) that the comprehensive assessments were not completed by any Registered Nurse, or Physicians practicing at the facility. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” See Tags: V-541, Care Plan initiated within 90 days of admission and annually V-557, Initial Care Plan /30 days after admission”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 50585 Based on interview and record review, the facility’s Medical Director failed to communicate quality assurance and performance improvement data with other medical staff providing care at the facility resulting in the increased likelihood of negative outcomes for all 62 patients served by the facility. Findings include: See Tag V-763 - The facility’s Medical Director failed to ensure that all medical staff who provide care in the facility are informed of the facility’s quality assessment and performance improvement program.”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 22960 Based on interview and record review, the facility failed to have an updated Hazard Vulnerability Assessment. This has the potential to decrease the effectiveness of the Emergency Preparedness Plan by not having up to date information to mitigate risks and prepare all patients and staff for an emergency. Findings Include: On 8/26/25 at 11:00 AM, the facility’s Emergency Management Plan was reviewed. In the binder provided, there was a section for a Hazard Vulnerability Assessment (HVA). There was a blank HVA form located inside the binder. On 8/26/25 at 12:35 PM, the Facility Administrator “B” was queried about an HVA, and confirmed that the facility did not have a completed Hazard Vulnerability Assessment.”

“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: 22960 Based on interview and record review, the facility failed to conduct and document exercises to test the emergency plan. This has the potential to decrease the effectiveness of the facility’s emergency preparedness which could affect all patients and staff in the event of an emergency. Findings Include: A review of the Emergency Preparedness Binder, provided by Facility Administrator (FA) “B”, starting on 8/26/25 at 11:00 AM, found the following staff inservices: 1/25/25 Active shooter inservice attended by 8 staff members, 3/18/25 Shelter-in-place inservice attended by 4 staff members. There was no documentation that showed any emergency scenarios were carried out by the facility in the form of a table top, work shop, or community based exercise. Further review found no documentation of any other area agencies being involved, or any after action reports on what the facility may be able to learn from the exercises. An interview with FA “B”, on 8/26/25, at 12:35 AM, confirmed there was no additional documentation for table top exercises, work shops, or community-based exercises that the facility had performed.”

“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: 27408 Based on observation and interview, the facility failed to monitor and maintain a sanitary environment to minimize the transmission of infectious agents, resulting in an increased risk of infection to all 14 patients receiving dialysis treatment at time of observation. Findings include: On 08/26/25, an observational tour was conducted between the hours of 0930 and 1200. While touring, the treatment room floor was observed to have discarded plastic supply wrappers, dialysis fluid & tubing caps, paper clips, 4 x 4’ s’ and accumulated dust and debris scattered in and around patient treatment stations (stations #1, 3, 4, 5, 7 and 15). Discarded paper hand towels and gloves were observed on the floor around one of two designated clean hand washing sinks. On 08/26/25, between 0930 and 1200, at the middle nurse’s station, it was observed that there was a tan purse and a pink & blue tote bag. Findings were reviewed with and acknowledged by the Clinical Nurse Coordinator, Staff A, at the time of observations. During an interview Staff A stated that “they should be picking up after themselves” and that personal belongings do not belong out on the floor and that staff “should use their lockers”. On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” 50585 On 8/27/2025 at 0945, during a tour of the facility’s dialysis treatment area, debris was observed in the overhead lights above five dialysis stations (#1, 5, 8, 10, and 12) and in the overhead light above the patient care desk. On 8/27/2025 at 1340, Patient Care Technician Staff L confirmed the findings of debris in the lights and referred to the debris as “you mean the flies.” According to the facility management services agreement between the facility and an outside vendor, dated 1/1/2025, the facility and the outside vendor will “Provide and monitor a sanitary environment” and “Among the services that (Outside Vendor) will provide or arrange are the following: Interior and Exterior Lighting.””

“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: 47415 Based on observation and interview, it was determined the facility failed to ensure that staff changed gloves and practiced handwashing after removing gloves between tasks. Findings include: On 8/26/25 at 1015, at station #3, PCT Staff H was observed removing a central line dressing and disposing of it, then removing gloves and donning new gloves without performing hand hygiene, then returning to station #3 to clean a central line site. On 8/26/25 at 1036, at station #8, PCT Staff H was observed touching the top of a sharps container with gloved hands while disposing of biohazard waste, then removing gloves and donning new gloves without performing hand hygiene. On 8/26/25 at 1040, PCT Staff H was asked if hand washing should be performed after removing gloves and before donning new gloves, and she replied “yes”. On 8/26/25 at 1100, PCT Staff I was observed discontinuing dialysis, at station #19, for a patient with a central line catheter. After discarding unused supplies and waste, Staff I removed the gloves and donned new gloves without performing hand hygiene, then proceeded directly to the supply cart to obtain items. On 8/26/25 at 1102, Staff I was asked if hand hygiene was required after removing gloves and he stated “yes”. On 8/26/25 at approximately 1130, Charge RN Staff J was notified that the PCTs are not always performing hand hygiene after removing gloves and donning new ones. Staff J stated hand washing is required every time you remove gloves, and she would follow up with the staff on handwashing requirements. Record review of policy (1-05-01) titled, “Infection Control for Dialysis Facilities”, revealed: “All teammates...will perform hand hygiene...a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid/bicarb lines form dialysis machine, changing acid types, when exchanging a dialysis machine)f. between patients even if the contact is casual, g. before touching”.”

“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: 27408 Based on observation and interview, the facility failed to ensure that all staff wear personal protective equipment (PPE) properly in the treatment area, resulting in the potential to spread infectious agents among the 14 patients receiving dialysis treatment at the time of observation. Findings include: On 08/26/25 at 0930, Patient Care Technician (PCT), Staff H, was observed touching the machines at stations #6 and #8 with no gown, nor gloves on. This was observed through the window in the waiting room, before the announcement of the survey. Announcement was made then Staff H, went and put on a gown. On 08/26/25 at 0945, an interview with Staff H revealed that she was “just silencing the alarm” and that she should’ve had a gown/glove on. On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/26/25 at 1445, review of policy “Infection Control for Dialysis Facilities”, policy: 1-05-01 dated/revised 4/2023 on page 2 stated under “PPE (i.e. gown, gloves, eye protection, face shield), 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas”.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47415 Based on interview and record review, the facility failed to ensure that staff followed the prescribed treatment plan for dialysis for 2 (P-3, P-6) of 7 patients reviewed, resulting in the potential for negative patient outcomes for these patients. Findings include: On 8/26/2025 at 1400, P-3’s dialysis flow treatment sheets were reviewed. P-3 had an order for a Blood Flow Rate (BFR) of 400 milliliter (mL) per minute (min), and a Dialysate Flow Rate (DFR) of 700 mL/min. The following times of treatment and corresponding BFR/DFR rates were documented in P-3’s medical record: Date/time DFR BFR 8/20/25 - 1403-1521 800 400 8/22/25 - 1359-1500 700 350 1520-1641 500 350 8/25/25 - 1438-1640 700 275 There was no documentation in P-3’s notes for why the BFR/DFR was administered at a higher/lower rate than prescribed or that the licensed nurse was informed. A nurse documented that “the patient’s prescription matches what is currently being delivered” during the dialysis treatment on all 3 dates (8/20/25, 8/22/25, & 8/8/25). On 8/26/2025 at 1430, P-6’s dialysis flow treatment sheets were reviewed. P-6 had an order for a Dialysate Flow Rate (DFR) of 600 milliliter (mL) per minute (min). The following times of treatment and corresponding DFR rates were documented in P-6’s medical record: Date/time DFR 8/6/25 - 1235 500 8/6/25 - 1306 500 8/6/25 - 1335 500 8/8/25 - full treatment time (1224-1451) DFR at 500 No documentation found in P-6’s notes revealing why the DFR was administered at a lower rate than prescribed or that the licensed nurse informed. A nurse documented that “the patient’s prescription matches what is currently being delivered” during the dialysis treatment on both dates (8/6/25 & 8/8/25). Review of the facility’s policy (1-02-04) titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing assessment” dated April 24, revealed under heading “INTERDIALYTIC DATA COLLECTION/ASSESSMENT ...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”. On 8/27/25 at 1100, an interview with the Medical Director Staff C revealed that it is her expectation that staff follow the prescribed orders and policies of the facility.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 27408 Based on interview and record review, the facility failed to ensure that the interdisciplinary comprehensive assessments of 2 (P-11, P-12) of 4 new hemodialysis patients, were completed within the timelines required (30 days or 13 treatments), resulting in the potential for un-recognized and un-met patient needs. Findings include: On 08/26/25 at 1430, during record review, it was revealed that P-11 was newly admitted to the facility on 05/13/25. He had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-11’s care plan was due on 06/13/25, but scheduled for 06/18/25. He did not have a completed interdisciplinary comprehensive assessment completed by the Registered Nurse or the Physician. On 08/26/25 at 1430, during record review, it was revealed that P-12 was newly admitted to the facility on 04/11/25. She had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-12’s care plan was due on 05/11/25, but scheduled for 06/18/25. She did not have a completed interdisciplinary comprehensive assessment completed by the Registered Nurse, Physician, or the Registered Dietician. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” She also noted that the “care plan meeting is not scheduled with the doctor until the nurse has completed their portion.” On 08/27/25at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/28/25 at 1500, during review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, 1-14-01, revised 10/2024” documented, “An initial Plan of Care based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or within 13 treatments) beginning with the first outpatient dialysis treatment or per state guidelines.””

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 27408 Based on interview and record review, the facility failed to ensure that the interdisciplinary comprehensive assessments of 2 (P-11 and P-12) of 2 hemodialysis patients, were completed within the timelines required (90 days), resulting in the potential for un-recognized and un-met patient needs. Findings include: On 08/26/25 at 1430, during record review, it was revealed that P-11 was newly admitted to the facility on 05/13/25. He had been dialyzing at the facility over 90 days. According to the facility’s care plan scheduling calendar, P-11’s care plan was due on 08/13/25, but scheduled for 09/02/25. He did not have any completed 90-day comprehensive assessments, documented at the time of survey entrance on 08/26/25. On 08/26/25 at 1430, during record review, it was revealed that P-12 was newly admitted to the facility on 04/11/25. She had been dialyzing at the facility over 90 days. According to the facility’s care plan scheduling calendar, P-12’s care plan was due on 07/11/25, but scheduled for 10/03/25. She did not have any completed 90-day comprehensive assessments, documented at the time of survey entrance on 08/26/25. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/27/25 at 1500, during review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, 1-14-01, revised 10/2024” documented, “5. A follow up 90-day re-assessment will be completed to evaluate patient’s status and provide information to adjust the patient’s plan of care.””

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 27408 Based on interview and record review, the facility failed to ensure that the interdisciplinary comprehensive assessments of patients were completed within the timelines required (annually) for 5 (P-15, P-16, P-17, P-18, and P-19) of 5 hemodialysis patients Findings include: On 08/26/25 at 1530, record review revealed that assessments were not completed annually for the following stable patients: *P-15’s last comprehensive assessments were dated 07/21/24, and the annual care plan was not held until 08/26/25. The assessments were not within the 15-day window. (See tag 558) *P-16’s annual comprehensive assessments were due on 07/31/25. *P-17’s annual comprehensive assessments were due on 07/11/25. *P-18’s annual comprehensive assessments were due on 07/13/25. *P-19’s annual comprehensive assessments were due on 08/05/25. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/27/25 at 1500, during review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, 1-14-01, revised 10/2024” documented, “5. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: *At least annually for stable patients or semiannually when required by State regulations.””

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 47415 Based on record review and interview the facility failed to identify and reassess unstable patients in a timely manner in 2 (P-1, P-3) of 3 patients reviewed for care plans, resulting in the increased potential for unrecognized needs and less than optimal outcomes for all patients serviced by the facility. Findings include: On 8/27/25 at 1000, a review of the hospitalization log revealed P-3 was hospitalized 4 times in the month of June. (6/1/25 - 3 days, reason listed as other, 6/18/25 - 3 days, fall with fracture, 6/21/25 - 3 days, access/other, 6/29/25 - 3 days, fluid overload). Medical record review for P-3 revealed the last care plan meeting conducted for P-3 was held on 3/19/2025. (P-3 was assessed as stable at this meeting). An unstable care plan was not initiated nor conducted in a timely manner following P-3’s return to the dialysis center after being frequently hospitalized in June. The provider notes of 7/16/2025 reveal that adequacy was unsatisfactory (inadequate treatment time), hemoglobin 8.8, Phosphorus 6.4 (high). On 8/27/35 at approximately 1400, an interview with Social Worker Staff D revealed that P-3 was identified as unstable on 8/20/25. ___ On 8/27/25 at approximately 1430, a review of P-1’s medical record was conducted. According to P-1’s plan of care dated 7/8/25, she was identified as unstable, and is listed on the facility data log as “Unstable-Concurrent Conditions”. A 30-day care planning reassessment for P-1 (an unstable patient) was not found (due 8/8/25). During an interview with the Clinical Coordinator Staff A on 8/27/25 at 1500, the care plan meeting for an unstable patient is due in 30 days, and he was aware that P-1’s was overdue. Record review of policy (1-14-01), titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, revealed, “. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least monthly for unstable patients including, but not limited to, patients with the following ...Extended or frequent hospitalizations ...Marked deterioration in health status ...Significant changes in psychosocial needs ...Concurrent poor nutritional status ...unmanaged anemia and inadequate dialysis ...”.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 27408 Based on interview and record review, the facility failed to create a plan of care for 2 (P-11, 12) of 4 new patients admitted, resulting in the potential for un-recognized and un-met patient needs. Findings include: On 08/26/25 at 1430, during record review, it was revealed that P-11 was newly admitted to the facility on 05/13/25. He had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-11’s care plan was due on 06/13/25, but scheduled for 06/18/25. He did not have a completed interdisciplinary team plan of care (IDT-POC) documented at the time of survey entrance on 08/26/25. On 08/26/25 at 1430, during record review, it was revealed that P-12 was newly admitted to the facility on 04/11/25. She had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-12’s care plan was due on 05/11/25, but scheduled for 06/18/25. She did not have a completed interdisciplinary team plan of care (IDT-POC) documented at the time of survey entrance on 08/26/25. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/27/25 at 1500, during review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, 1-14-01, revised 10/2024” documented, “A comprehensive assessment will be conducted on all new patients within 30 calendar days (or within 13 treatments) for new patients...””

“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: 27408 Based on interview and record review, the facility failed to implement a plan of care for 2 (P-11 and 12) of 4 new patients admitted, resulting in the potential for un-recognized and un-met patient needs. Findings include: On 08/26/25 at 1430, during record review, it was revealed that P-11 was newly admitted to the facility on 05/13/25. He had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-11’s care plan was due on 06/13/25, but scheduled for 06/18/25. He did not have a completed interdisciplinary team plan of care (IDT-POC) documented at the time of survey entrance on 08/26/25. On 08/26/25 at 1430, during record review, it was revealed that P-12 was newly admitted to the facility on 04/11/25. She had been dialyzing at the facility over 30 days, and for more than thirteen treatments. According to the facility’s care plan scheduling calendar, P-12’s care plan was due on 05/11/25, but scheduled for 06/18/25. She did not have a completed interdisciplinary team plan of care (IDT-POC) documented at the time of survey entrance on 08/26/25. On 08/27/25 at 0930, during an interview with the Social Worker (Care-plan Scheduler), Staff D, she stated that they were “behind because that nurse is really busy working out on the floor.” On 08/27/25 at 1100, the Medical Director, Staff C, was made aware of the findings and stated that the “staff need to follow the policies.” On 08/27/25 at 1500, during review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, 1-14-01, revised 10/2024” documented, “A comprehensive assessment will be conducted on all new patients within 30 calendar days (or within 13 treatments) for new patients...””

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 50585 Based on interview and record review, the facility’s Medical Director failed to communicate quality assurance and performance improvement data with other medical staff providing care at the facility resulting in the increased likelihood of negative outcomes for all 62 patients treated at the facility. Findings include: On 8/27/2025 at 1100, Medical Director Staff C was queried whether they shared QAPI (Quality Assurance and Performance Improvement) data with the other Nephrologist’s covering the facility, and they said “No,” we “probably should do that.” According to the facility’s policy Quality Assurance and Performance Improvement (QAPI), dated 1/13/2025, “The Medical Director is the chair of the QAPI committee in the (facility)” and “The interdisciplinary team (IDT) must demonstrate effective communications and must devote sufficient time and attention to produce effective QAPI activities that positively influence outcomes.””

“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: 38269 Based on observation and interview, the facility failed to keep a sanitary environment in the dialysis treatment area resulting in the potential spread of infectious agents amongst all 68-patients receiving dialysis treatments at the facility. Findings include: On 07/31/2024 at 0930, during initial tour of the dialysis treatment area it was observed that the treatment floor was filthy, causing footwear to stick to the floor. The floor was wiped with an alcohol pad confirming the floor was both filthy and stained in multiple areas. On 07/31/2024 at 0937, a designated clean sink located outside of the isolation room was observed to have a broom, dustpan and a dirty appearing shop vac leaning on the rim of the sink with the hose up and over the sink. On 07/31/2024 between the hours of 0915 and 1200, while surveying the dialysis treatment area, several black flies were observed throughout the clinic and in the treatment area. On 07/31/2024 at 1100, an interview was conducted with the Regional Operations Director, Staff A. Staff A was queried about the concerns of an unsanitary environment within the dialysis unit, specifically the dialysis treatment area. Staff A stated that they “have had several cleaning companies and finding a good one is an ongoing battle.” 50585 On 7/31/2024 at 1014, during a tour of the facility’s dialysis treatment area dust was observed on the ceiling ventilation grid. On 7/31/2024 at 1030, during a tour of the facility’s medication preparation area, tape residue was observed on the windowsill (glass partition edge) located above the counter where medications were prepared. .According to record review of the facility’s policy “Infection Control for Dialysis Facilities,” dated April 2023, the policy indicated “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.” and “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” According to record review of the facility’s cleaning contract with an outside vendor, dated 12/5/2021, the vendor would provide the following work: “Daily: Dust mop and then damp mop hard surface floors with approved disinfectant cleaner. Clean and disinfect and polish lobby furniture, clean doors, walls, all baseboard areas, horizontal surfaces including windowsills, counter tops, tables, and television sets if applicable” and “Weekly: Dust and damp wipe light fixtures and ceiling vents.””

“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: 38269 Based on observation, interview, and record review, the facility failed to ensure all staff don personal protective equipment (PPE), resulting in the potential to spread infectious agents to the 17 patients actively dialyzing at the time of observation. Findings include: On 07/31/2024 at 1050, during observations on the hemodialysis treatment floor, Nephrologist (Staff L) was observed entering the dialysis treatment room while 17 patients were actively dialyzing. Staff L was further observed walking in and out of multiple patient treatment areas without donning any PPE over his personal clothing. On 07/31/2024 at 1100, Staff L was queried as to where his PPE was. Staff L stated, “oh they didn’t give me any at the front, but mine is right there.” Staff L pointed to the isolation (St 21) PPE cart adjacent to station 9 where he was interacting with one of his patient. On 07/31/2024 at 1105, during an interview, Staff A (Facility Manager), confirmed the above findings. Staff A further confirmed the findings were not congruent with facility policy. On 07/31/2024 at 1416, during an interview with Staff B (Medical Director), it was confirmed that all staff (including physicians) must follow facility policies. A policy regarding use of PPE while on the treatment room floor and in a station where a patient was actively receiving hemodialysis was requested at the time of interview. The following was received: Policy: 1-05-01, Revision Date: April 2023...PPE (i.e., gown, gloves, eye protection, face shield) 1., 2., 3., 4., 5., 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.”

“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: 50585 Based on observation, interview, and record review the facility failed to separate clean items and areas from dirty items and areas and appropriately store medications, resulting in the potential of spreading infectious agents to all patients. Findings include: On 7/31/2024 at 1015, Technician Staff J was observed tearing 8 strips of medical adhesive tape (clean) and applying the tape strips to the edge of a dialysis monitor (dirty) at station 7. Staff J was observed applying two of the tape strips from the dirty dialysis monitor to a cotton gauze and to a patient’s arm so that part of the tape was on the skin and the other part fo the tape was on the cotton gauze. On 7/31/2024 at 1025, during a tour of the facility’s medication preparation area, five plastic bottles of a nutritional oral supplement beverage with each bottle containing 237 milliliters of fluid were observed in the medication refrigerator. Two bottles were located on the top shelf (1st shelf) next to a box of hepatitis B vaccine and three bottles were stored on the base of the refrigerator unit. Other vaccines were stored on the 2nd, 3rd, and 4th shelves within the medication refrigerator. On 8/1/2024 at 1410, interviewed Facility Administrator Staff B. When asked if she approved the storage of the nutritional supplements in the medication refrigerator, she said “yes.” When queried whether she understood medication vaccines were present, she said “yes.” According to review of the facility’s policy “Oral Nutrition Supplement (ONS) Provision - Used Only for Patients with Sub-Optimal Nutritional Status,” dated October 2023, the policy indicated “FA (Facility Administrator) to determine where supplement will be stored. Supplement to be stored in secure location and inventory monitored.” Additional review of the document “Vaccine Storage and Handling Toolkit” developed by the U.S Centers for Disease Control and Prevention, dated March 29th, 2024, revealed “Food and beverages should never be stored in the unit with vaccines. If other biologics (medications which may include vaccines, growth factors, immune modulators, monoclonal antibodies) are stored in the unit, vaccines should be stored on the shelf above them.” Additional review of the document developed by the American Society of Health-system Pharmacists titled “Technical Assistance Bulletin on Hospital Drug Distribution and Control,” dated November 1981, the bulletin indicated “Medications stored in a refrigerator containing items other than drugs should be kept in a secured, separate compartment.” According to review of the facility’s policy “Infection Control for Dialysis Facilities,” dated April 2023, the policy indicated that “Dialysis delivery systems with computers/keyboards mounted on top, the computer and keyboard are considered ‘dirty’ equipment.” 47415 On 7/31/24 at approximately 1145 during a tour of the treatment floor. Technician Staff J was observed carrying a labeled heparin flush syringe to station #2 and placing it directly on the keyboard to the computer for future use. Tech (preceptor) Staff I asked about the practice of placing a medication syringe on the keyboard, and she stated, it was OK to set the machine syringe there. On 7/31/24 at approximately 1230 Charge Nurse Staff G stated during an interview that all medication syringes must be stored on a clean surface dedicated for medications. On 8/1/24 at 1130 record review of policy (1-05-01) titled, “Infection Control for Dialysis Facilities”, dated April 2023, revealed, “clean areas should be designated for the preparation, handling and storage of medications ...clean areas should be clearly separated for contaminated areas ...””

“IC-SINGLE USE VIALS CFR(s): 494.30(a)(1)(i) Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. This Standard is not met as evidenced by: 47415 Based on observation, interview, and record review, the facility failed to ensure that expired intravenous medications/fluids were discarded, and that medications drawn up into syringes from vials were labeled appropriately, resulting in the potential for medication errors and less-than-optimal outcomes to the 15 patients receiving treatment at the time of observations. Findings include: On 7/31/24 observational tour of the treatment floor between 0910 and 1230 revealed the following: 0915: In the medication preparation area (located just prior to the treatment floor), two (2) syringes of pre-drawn medication found unattended and without a label (unable to identify correct patient, drug, dose, time of preparation, or who prepared syringe). Charge Registered Nurse (RN) Staff G interviewed at time of observation stated, the syringes should have been labeled when they were drawn up. 1000: Eight (8) pre-drawn Heparin syringes (2000 units/1:1000) were noted on top of clean supply cart in POD 1, labeled with time of preparation as 0800. At approximately 1015, Tech Staff I was asked about the syringes and stated that she drew them up this morning for second shift and they are good for four (4) hours. At 1225 the heparin syringes drawn up at 0800 were unused and still available for use, (past expiration time). 1230: Charge RN Staff G stated during interview that medications for second shift should not be drawn up in the morning. Medication should be drawn up just before use, and confirmed the syringes drawn up at 0800 expired at 12 noon (4 hours). On 8/1/31 at approximately 1300 review of policy (1-06-1) titled, “Medication policy” dated October 2023 revealed, “All open or unopened medication packages (i.e. vials, ampules etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired ...All syringes prepared from single dose vials ... should be prepared and administered ...in 4 hours ... If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. 50585 On 7/31/2024 at 1000, during a tour of the facility’s medication preparation area, the crash cart was observed. In the top drawer, three one-liter intravenous bags of 0.9% Sodium Chloride were found to be expired. Two bags had an expiration date of June 2024, and one bag had an expiration date of April 2024. When queried, Charge Nurse Staff G confirmed the findings. According to review of the facility’s policy “Emergency Equipment Checks,” dated April 2024, the policy indicated “The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Weekly: Emergency cart (crash cart) is clean, operational and supplies/medications have not expired.””

“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: 50585 Based on observation, interview, and record review the facility failed to ensure that cleaning and disinfection of contaminated surfaces, medical devices, and equipment was completed in between patient treatments and when providing patient care resulting in the potential for negative outcomes for all patients. Findings include: On 8/1/2024 at 1050, it was observed that Technician Staff I failed to disinfect the priming container (waste water container) after emptying the contents following a patient’s treatment on dialysis machine number 18. On 8/1/2024 at 1100, it was observed that Charge Nurse Staff G failed to disinfect the priming container (waste water container) and the back shelf behind the dialysis machine following a patient’s treatment on dialysis station number 14. On 8/1/2024 at 1430, when queried whether the priming container and back shelf were parts of the disinfecting process following a patient’s treatment, Staff G said “yes.” Based on review of the facility’s policy “Infection Control for Dialysis Facilities, dated April 2023, the policy indicated “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. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area Teammates will monitor and address wall box residue/build up and patency issues. ii. Priming containers are to be emptied prior to disinfection. Drain line and water supply line should not be placed with ends in prime containers or in a position where they can drip into or contaminate the prime bucket.” 38269 On 08/01/2024, at 1010 Staff G was observed completing a patient assessment at station #13. Once the assessment was complete, Staff G proceeded to use one alcohol pad to wipe the bell of his stethoscope. After wiping the stethoscope bell, Staff G was observed to sling the stethoscope on to his neck while in full (personal protective equipment) PPE. On 08/01/2024, at 1012 Staff G walked from station #13 to the middle of the treatment room floor, where he was observed assisting a patient in a lift device to a chair. While Staff G stood behind the treatment chair, Staff G leaned into the chair allowing his stethoscope to press against the chair and the lift device. Staff G was was not observed to clean the stethoscope after contact was made with the chair and the lift device. On 08/01/2024, at 1018 Staff G was observed to walk to the front of the treatment room, take the stethoscope and PPE off and hang them on a hook. At the time of observation Staff G was queried regarding the policy for cleaning stethoscopes, if the used stethoscope would be considered clean after being draped over a cover gown. Staff G stated, “I did clean my scope after I did a patient assessment, but didn’t realize it was touching the back of the chair or the Hoyer. No, the stethoscope would not be considered clean if it was hanging on PPE. Makes sense to clean the whole scope after it has been on the dirty gown, then hang it.” On 08/01/2024, at 1130 Staff M was observed to place a stethoscope on the left upper arm of a patient at station #9. Staff M was observed to leave station #9 and enter into station #11 without cleaning the stethoscope. Facility Policy title Infection Control for Dialysis Facilities, Policy: 1-5-01, originated September 2007, latest revision/review April 2023... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient. a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 39083 Based on observation, interview, record review, the facility failed to ensure the water purification system was secured resulting in the potential for unauthorized access to the water room and the potential for harm for all 17 patients receiving treatment at the time of observation. Findings include: On 7/31/24 at 10:53 AM, during an observation of the water treatment room, the rear door frame, exiting to the loading/storage area, was observed to have a portion of metal cut out near the door latch, allowing for the door to be pushed open from either direction, without turning the door handle. At this time, Biomed “F” stated the door has been an issue in the past and that the property management company has attempted repairs instead of replacing the door frame to resolve the issue. Biomed “F” was queried on supervision of vendors in the facility and stated that delivery services are supervised but the cleaning company has off-hour access to the building without staff supervision. According to the “Janitorial Statement of Work,” effective 12/5/21, it notes the cleaning vendor is scheduled to clean Monday through Saturday after 6:00PM, when facility staff are not present in the building.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 39083 Based on observation, interview, and record review, the facility failed to maintain the plumbing system, and properly store oxygen tanks, resulting in pest harborage conditions, and an increased risk of hazardous conditions, affecting all patients receiving treatment in the facility. Findings include: On 7/31/24 at 9:24 AM, standing water was observed covering approximately fifty percent of the biomedical office, where a floor drain was observed to be submerged, allowing for conditions favorable to pests and risk of clogging further down the sewer line. During an interview at 10:34 AM, Biomed “F” stated that when the water treatment room gets sprayed down, the water travels across the door thresholds and into the biomedical office, where the drain is clogged. According to the facility’s policy “PHYSICAL ENVIRONMENT,” revision date April 2018, it notes, “... POLICY: 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. 2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public...” On 7/31/24 at 9:27 AM, five oxygen canisters, located in the lab area, were observed to not be secured from tipping over. The oxygen canisters were considered empty, but some still had a measurable amount of oxygen (psi). Additionally, the oxygen canisters were not labeled whether they were full or empty. At approximately 10:40 AM, Biomed “F” confirmed the finding. A policy for storage of oxygen canisters was requested, and on 8/1/24 at 2:00 PM, Facility Administrator “B” stated there was no policy available.”

“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: 45246 Based on observation, interview and record review, the facility failed to ensure staff adhered to policy and procedure regarding following dialysate flow rates as prescribed by the physician for 3 patients (P-1, 2, and 6), ensuring pre/ post-treatment nursing assessments are performed and documented timely for 2 patients (P-1 and 2) of 10 in-center patients reviewed, and that emergency medical equipment checks are performed as indicated, resulting in the potential for adverse patient outcomes. Findings include: On 8/1/24 at 1210 during interview with facility’s Medical Director, Staff K, she stated that expectations are for all clinical and nursing staff to follows facility’s policies and procedure. When asked if staff must follow physician’s orders for BFR (blood flow rate) and DFR (dialysate flow rate), she stated yes and staff are to call the physician with notification of any changes. Staff K was asked if her expectation for nurses was to complete pre/post-treatment assessments accurately and timely with proper documentation. She stated yes. On 7/31/24 at 1330 review of P-1 treatment sheets revealed the following documentation. Treatment flowsheet dated 11/06/23 had dialysis treatment documented as started at 1339 and completed at 1642. P-1’s treatment orders indicated: duration- 180 min, BFR (blood flow rate)- 450, DFR (dialysate flow rate)- 800. At 1340 BFR was recorded 450 (as ordered) and DFR was 500. DFR remained 500 until the end of the patient’s treatment at 1642. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. Treatment flowsheet dated 11/10/23 had dialysis treatment documented as started at 1303 and completed at 1601. P-1’s treatment orders indicated: duration- 180 min, BFR- 450, DFR- 800. At 1305 BFR was recorded 450 (as ordered) and DFR was 500. DFR remained 500 until the end of the patient’s treatment at 1601. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. Treatment flowsheet dated 11/13/23 had dialysis treatment documented as started at 1329 and completed at 1636. P-1’s treatment orders indicated: duration- 180 min, BFR- 450, DFR- 800. At 1330 BFR was recorded 375 and DFR was 500. At 1402 BFR was changed to 450 (as ordered) and DFR remained 500 until the end of the patient’s treatment at 1636. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. During interview with Registered nurse, Staff G, on 7/31/23 at 1512, he was asked how staff checks BFR and DFR rates for patient treatments. He stated that technicians usually initiate treatments and set up machines according to physician’s orders. Nurse would check each machine within an hour of treatment initiation for accuracy of the set up. He added that facility’s old machines would default DFR settings to 500 and would not go higher. When asked if facility’s leadership was aware of that fact, Staff G stated yes. Further review of P-1’s record revealed that patient was discharged from the facility on 3/20/23 due to prolonged (over 30 days) hospitalization. P-1 was re-admitted to facility, as per policy, on 4/24/23. Upon review there was no record of nursing pre-treatment initial assessment on 4/24/23. Review of P-2 treatment flowsheets revealed the following documentation. Treatment flowsheet dated 07/19/24 had dialysis treatment documented as started at 1056 and completed at 1507. P-2’s treatment orders indicated: duration- 240 min (4 hours), BFR- 400, DFR- 700. At 1057 DFR was recorded as 700. At 1401 DFR was changed to 500 remained 500 until the end of the patient’s treatment at 1507. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. Treatment flowsheet dated 07/24/24 had dialysis treatment documented as started at 1244 and completed at 1628. P-2’s treatment orders indicated: duration- 240 min (4 hours), BFR- 400, DFR- 700. At 1245 DFR was recorded as 700. At 1537 DFR was changed to 500 remained 500 until the end of the patient’s treatment at 1628. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. P’2 treatment sheet dated 07/22/24 had dialysis treatment documented as started at 1122 and completed at 1441.Discharge status was recorded “discharge to home (routine discharge)”. Under close treatment reason there was a note: “patient symptomatic (sent to ER (emergency room), feels unwell)”. Nursing pre-treatment assessment was documented as completed on 07/22/24 at 1632 (after patient was transported to hospital). Nursing post-treatment assessment was documented at 1646. Medical Director Qualifications and Responsibilities Policy, dated 12/9/2016, was reviewed on 8/1/24. Policy indicated: Medical Director responsibilities. Delivery of patient care and clinical outcomes in the facility. Oversight of staff education, training, and performance. Oversight of 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 non-physician providers. Pre-Intra-Post Treatment Data Collection, Monitoring and nursing assessment policy, dated 09/2007 and revised 04/2024, was reviewed and indicated. Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. 2. The Nursing assessment will be performed and documented by a licensed nurse. a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters iv. Verification that the patient access is visible and face is not covered v. Review of documentation for accuracy, completion and patient data 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) Pre-treatment data collection. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. Intradialytic data collection/assessment. 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. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. 47415 On 7/31/24 at approximately 1400 during record review (treatment sheets) for 1 (P-6) of 2 patients revealed: Treatment orders for P-6 dated 7/5/24, contained an order for a dialysate flow rate (DFR) of 700. P-6’s treatment dated 7/24/24 started at 0603 and terminated at 0936 revealed the DFR was recorded at a rate of 500 during the entire treatment. On 8/1/24 record review of policy (1-03-06), “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, revealed: “Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ...The prescription components are confirmed by a licensed nurse within one (1) hour ...”. On 8/1/24 at 1230, a phone interview was conducted with Medical Director Staff K, who stated it is her expectations that all staff follow the policies and procedures of the facility. 50585 On 7/31/2024 at 0940, it was observed that the crash cart log did not have documentation of staff performing the safety checks of emergency medical equipment on three days: 7/19/2024, 7/21/2024, and 7/27/2024 when the dialysis center was open in July 2024. According to record review of the facility’s policy “Emergency Equipment Checks,” dated April 2024, the policy indicated “The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Daily: defibrillator including pads are present on cart.””

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 38269 Based on observation, interview, and record review, the governing body failed to ensure adequate staffing to patient ratio resulting in failure to meet the needs of all patients. Findings include: On 07/31/2024 at 0915, while observing patient care in the isolation room station #21, Staff H (Registered Nurse), was queried regarding how many patients she was caring for. Staff H stated, “well I have the pod from the clock back, eleven I guess. My tech went home sick.” When queried if this was normal staffing, Staff H stated “no I usually have a technician.” As Staff H was queried, the patient receiving treatment was shaking his head, rolling his eyes and finally stated, “it is way more often than it should be.” to which Staff H replied by explaining that there is a high turn over rate in the facility. On 07/31/2024 between 0915 and 0936, during observation of Staff H in the (isolation room station #21) an alarming dialysis machine was heard (at station #9.) Staff H was unable to leave the isolation room, due to being the only staff working the “back pod.” On 07/31/2024 at 0936, this surveyor left the area of observation to inform the Staff G (Charge Nurse), of the alarm at treatment station #9. On 07/31/2024 at 0940, Staff G entered station #9. Staff G confirmed that the access was clotted, treatment was stopped early and the patient was unable to receive all of the blood back from the clotted lines. On 07/31/2024 at 1005, Staff A (Facility Manager) was queried regarding staffing at the facility. Staff A stated, “I have someone coming in, one of the technicians went home sick.” Staff A confirmed that staffing can be difficult, and was later observed cleaning treatment stations. 45246 During initial tour of the facility, on 7/31/24 from 0915 until 1100 staff was observed providing care to patients during dialysis treatments. There were 19 patients receiving dialysis in the facility. Registered nurse, Staff H, was assisting patient in an isolation room, another nurse, Staff G, was covering the rest of the floor, along with 2 dialysis technicians. At 0930 P-14 was observed sleeping in her treatment chair. Patient ‘s blood was noted dripping form the dialysis filter connection to the base of the machine. The puddle of blood was about 4 inches in diameter. No staff was around to note this. Staff J, dialysis technician, was asked for assistance immediately. She tightened the connection and stopped the line from dripping patient’s blood. When asked about the reason for connection not being tight, Staff J stated that she did not set up this machine, some other staff did not check if connection was tight. At 0945 P-4 was interviewed while she was receiving her dialysis treatment. When she was asked about any concerns to share, patient stated that waiting to “get on” and “get off” (to begin and end treatment) the machines some days is very long. P-4 shared that one day she had to wait 3 hours before she was able to leave the facility after her treatment was already finished. She said, “I have a life, you know, I can’t wait all day”. Patient added that staff is very kind, she just feels there are not enough of them to take care of all the patients. At approximately 1100 front lobby was noted to have a full room of patients waiting for their treatments. Review of the schedule for 7/31/24 revealed that many second shift treatments were scheduled for a range from 0930 to 1130 start time. Observation of the treatment floor at 1100 confirmed many empty treatment chairs that were not cleaned yet or set up for patients. Staff was busy assisting with ongoing treatments. P-1 medical record was reviewed and revealed that on 10/27/23 his dialysis treatment started at 1624 and was done at 1829. The reason for “close treatment” was indicated as “setup issue, delayed getting patient on, machine set up incorrectly”. There was a physician’s order which indicated treatment time 180 min (3 hours). Further review of the patient’s record indicated no dialysis treatment was provided to P-1 on his scheduled day on 10/31/23. Next treatment patient received was on 11/1/23 (4 days after his shortened treatment on 10/27/23). On 8/1/24 at 0940 during interview with registered nurse, Staff G, she recalled the events on 10/27/23. He stated that one staff nurse called in sick that day and P-1 treatment was rescheduled for a later time due to lack of nursing staffing for isolation room. Staff G volunteered to stay late (after most patient treatments were finished) and provide treatment for P-1. Staff G experienced trouble with dialysis machine in isolation room before initiation of the treatment and had to bring a different machine, set it up and prime it. All above actions delayed P-1’s treatment and Staff G said it had to be stopped an hour earlier. When asked about the treatment not being provided on 10/30/23, Staff G recalled that a staff nurse called in again and P-1’s treatment had to be cancelled due to lack of staffing for the isolation room. Staff G could not cover late shift that day due to being off. Staffing sheets were requested for the above dates and revealed the following: 2 staff nurses worked on Friday 10/27/23 (including Staff G), one staff nurse on Monday 10/30/23 (Staff G was off), and 2 nurses on Tuesday 10/31/23. On 7/31/23 at 1512 Staff G was interviewed regarding the staffing in the facility. He stated that is had been challenging with many staff leaving and calling in. He said facility has only 2 long-term technicians. It is difficult to retain new technicians due to nature of the job combined with reimbursement rates. Medical Director Qualifications and Responsibilities Policy, dated 12/9/2016, was reviewed on 8/1/24. Policy indicated: Governing Body. The operating body of the facility that has overall responsibility for the operations of the facility, consisting of the Medical Director the facility, administrator, and the regional operations director. Medical Director responsibilities. Delivery of patient care and clinical outcomes in the facility. Oversight of staff education, training, and performance. Oversight of 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 non-physician providers.”