Davita Janesville Dialysis

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 29972 Based on observation, record review and interview, the facility staff failed to develop and implement an effective comprehensive plan of care with measurable goals and individualized interventions for Peritoneal Dialysis (PD) home patients in 1 of 1 PD medical record revealed (Patient (Pt) #2); failed to ensure that facility staff perform nursing assessments when blood pressure (BP) and/or heart rate are out of parameters in 3 of 4 In-Center Hemodialysis medical records reviewed (Patient (Pt) #1, #3, #5); failed to address abnormal findings of Fluid management post treatment in 1 of 4 In-Center Hemodialysis medical records reviewed (Pt #3); failed to monitor and assess BP and Fluid management needs in Peritoneal Dialysis (PD) home patients in 1 of 1 PD medical records reviewed (Pt #2); failed to develop and implement and accurate and effective Plan of Care for BP and Fluid Management in 1 of 1 PD medical records reviewed (Pt #2); failed to follow prescribed blood flow rates (BFR) for 2 of 4 In-center Hemodialysis medical records reviewed (Patient (Pt) #1, #5); failed to assess, evaluate and develop an individualized plan of care for patients with a Central Venous Catheter (CVC) in 1 of 1 record reviewed of patients with a CVC greater than 90 days (Pt #4); failed to develop and implement an individualized and comprehensive Plan of Care to address Psychosocial needs in 1 of 5 medical records reviewed (Patient (Pt) #2), in a total sample of 5 medical records reviewed; and failed to perform skin antisepsis as per policy when when using a Arteriovenous Fistula/Graft (AVF/G) in 3 of 3 observations of dialysis treatment initiation using an AVF/G (Patient (Pt) #3, #8, #9), in a total sample of 14 observations of patient care. Findings Include: Facility staff failed to develop and implement an effective comprehensive plan of care with measurable goals and individualized interventions for Peritoneal Dialysis (PD) home patients. See Tag V-0541. Facility staff failed to ensure that nursing staff perform nursing assessments when blood pressure (BP) and/or heart rate are out of parameters for In-Center Hemodialysis, failed to address abnormal findings of Fluid management post for In-Center Hemodialysis patients, failed to monitor and assess BP and Fluid management needs in Peritoneal Dialysis (PD) home patients, and failed to develop and implement and accurate and effective Plan of Care for BP and Fluid Management for PD home patients. See Tag V-0543. Facility staff failed to follow prescribed blood flow rates (BFR) for In-Center Hemodialysis patients. See Tag V-0544. Facility staff failed to perform skin antisepsis as per policy when when using a Arteriovenous Fistula/Graft (AVF/G), and failed to assess, evaluate and develop an individualized plan of care for patients with a Central Venous Catheter (CVC). See Tag V-0550. Facility staff failed to develop and implement an individualized and comprehensive Plan of Care to address Psychosocial needs. See Tag V-0552.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 29972 Based on interview and record reviews, the facility staff failed to contact the Water utility provider to ensure a coordinated emergency response in case of water interruption as per policy in 1 of 1 emergency preparedness (EP) plans reviewed (In-center hemodialysis). Findings Include: Review of the “Facility Emergency Management Plan” last reviewed April 2024 revealed, “The FA (Facility Administrator) or designee, shall have communication at least on an annual basis with the following local agencies regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility, and reviewing agency’s emergency plan... f. Water utility provider...” Review of the facility’s EP plan revealed there was no documentation of contact with the Water utility provider. Per interview with Facility Administrator (FA) A on 03/06/2025 at 12:40 PM, FA A stated that she was unable to find documentation of contact with the Water utility provider. FA A stated that a certified letter should have been sent to the Water utility provider but has not been done yet.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 29972 Based on interview and record review, the facility staff failed to ensure all staff were trained in Emergency Preparedness (EP) in 1 of 4 personnel files reviewed (Medical Director (MD) H), in a total sample of 4 personnel files reviewed. Findings Include: Review of the “Facility Emergency Management Plan” last reviewed April 2024, revealed the “Training and Education” for physicians should be completed on an “Annual basis” and should include the following, “1. Policy Facility Emergency Management Plan...2. Appropriate hazard policies...3. Clinical emergency policies...4. Facility specific emergency response procedures...iv. Document training in physician file.” Per interview with Facility Administrator (FA) A and FA C, while reviewing personnel files on 03/06/2025 at 2:30 PM, FA A stated there was no documentation of facility specific EP training and education for MD H.”

“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: 29972 Based on record review and interview, the facility staff failed to conduct a full-scale community based exercise to test their response to emergency events, as per policy in 1 of 1 Emergency Preparedness (EP) program reviewed (In-center Hemodialysis), in a total sample of 1 EP program reviewed. Findings Include, Review of the “Facility Emergency Management Plan” last reviewed April 2024 revealed, “The facility will conduct and/or participate in one exercise to test the facility EMP (Emergency Preparedness Plan) at least annually, conducted on opposite years...1. Full-scale exercise that is community-based...” Per review of the EP binder, there was no documentation of the facility conducting and/or participating in a full-scale community based exercise. Per interview with Facility Administrator (FA) A on 03/06/2025 at 12:40 PM, FA A stated that she is unable to find documentation that the facility conducted and/or participated in a full-scale community based exercise as per policy.”

“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: 29972 Based on observations, record review and interview, the facility staff failed to maintain a sanitary environment free from potential infection control risk in 1 of 4 areas observed (Water room), in a total sample of 4 areas observed. Findings Include: Review of policy and procedure #8-04-01 titled, “Physical Environment” last revised 2018 revealed, “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.” On 03/05/2025 beginning at 1:30 PM, during tour of Water room with Patient Care Technician (PCT) F, observed a large amount of white powder/residue, dust, and debris on the floor around the acid machine, 2 large acid tanks, and the bicarbonate equipment. Per interview with PCT F on 03/05/2025 at 1:45 PM, PCT F confirmed the findings and stated that the Water room should be cleaned by the closing staff on a daily basis.”

“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: 29972 Based on observation, record review and interview, the facility staff failed to perform hand hygiene immediately after removing gloves as per policy in 2 of 14 observations of patient care (Patient (Pt) #7, #11), in a total sample of 14 observations of patient care. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed 2023 revealed, - “All teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...g. before touching clean areas such as supplies...” On 03/05/2025 at 10:45 AM observed Patient Care Technician (PCT) E discontinuing Pt #11’s dialysis treatment using a Arteriovenous Fistula/Graft (AVF/G). PCT E reinfused Pt #11’s blood and disconnected the blood lines; PCT E then removed gloves and donned a new pair of gloves without performing hand hygiene between glove changes. On 03/05/2025 at 11:30 AM observed PCT E initiating Pt #7’s dialysis treatment using a Central Venous Catheter (CVC). PCT E removed Pt #7’s CVC (old) dressing, then removed gloves and proceeded to obtain clean supplies from a supply drawer; PCT E did not perform hand hygiene immediately after removing gloves and before obtaining clean supplies. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that staff should be performing hand hygiene after glove removal as per policy.”

“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: 29972 Based on record review, observation and interview, the facility staff failed to wear personal protective equipment (PPE) appropriately to protect from potential blood splatter and contaminants in 1 of 4 observations of staff (Patient Care Technician (PCT) E), in a total of 4 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: - “Appropriate PPE will be worn whenever there is potential for contact with body fluids...contaminated equipment and environmental surfaces...” - “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates...when in the treatment area.” On 03/05/2025 from 10:30 AM to 12:00 PM, observed PCT E providing patient care with his lab coat sleeves pushed up on his forearms, exposing PCT E’s arms and 2 wrist bracelets to potential blood splatter and contaminants. Observed PCT E’s sleeves pushed up on forearms while discontinuing dialysis treatment for Pt #11, Pt #10 and initiating dialysis treatment for Pt #7 and Pt #9. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that lab coat sleeves should cover the arms and any bracelets around the wrist when there is potential exposure to blood and other contaminates.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 29972 Based on observation, record review and interview, the facility staff failed to ensure that equipment brought into the dialysis station is cleaned and disinfected before returning to a common “clean” area in 1 of 14 patient observations (Patient (Pt) #10), in a total sample of 14 patients observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, “Non disposable items are to be disinfected after each patient use, prior to removal from treatment area/station...” On 03/05/2025 at 10:45 AM, observed Patient Care Technician (PCT) E discontinuing Pt #10’s dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G). Observed Pt #10 using an oxygen concentrator for oxygen administration via a nasal cannula during dialysis treatment. Per observations, PCT E held Pt #10’s AVF/G to achieve hemostasis (bleeding stopped) then proceeded to remove Pt #10’s nasal cannula and turn off the oxygen concentrator wearing the same gloves used to hold Pt #10’s vascular access site. At 11:30 AM, observed Registered Nurse (RN) D move that same oxygen concentrator to a “clean” storage area before the oxygen concentrator was cleaned and disinfected. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that the oxygen concentrators should be cleaned after use and before returning to the common storage 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: 29972 Based on observation, record review and interview, the facility staff failed to ensure that “clean” equipment and supplies are stored away from “dirty” areas in 1 of 4 areas observed (In-center hemodialysis treatment area); and failed to ensure the medication preparation (prep) area is clearly designated as a “clean” medication prep area in 1 of 4 areas observed (In-center hemodialysis treatment area), in a total sample of 4 areas observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, - “Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean area should be clearly separated from contaminated areas where used supplies and equipment are handled.” - “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” - “The chair side cart...monitor and keyboard are considered clean areas...b. the chair side cart components will be cleaned at the end of each treatment day.” On 03/05/2025 at 10:45 AM, observed the computer cart within the dialysis station between the dialysis machines at Station (St) 5 and St 6. The computer cart was observed to be touching the prime waste container attached to the dialysis machine at St 6 during Pt #17’s dialysis treatments, allowing for potential cross contamination. The computer cart was not cleaned and disinfected after Pt #17’s dialysis treatment. On 03/05/2025 at 11:10 AM, observed 4 oxygen concentrators, uncovered, being stored under and in front of the “dirty” sink. On 03/05/2025 at 11:20 AM, observed a container filled with unused packaged syringes on the counter next to the “dirty” sink. On 03/05/2025 at 12:10 PM, observed binders, papers, and pen in the medication prep area, the area was not clearly designated as a “clean” medication prep area. Per interview with Registered Nurse (RN) D on 03/05/2025 at 12:00 PM, RN D stated that the “clean” oxygen concentrators are usually stored next to the “dirty” sink. When asked if the oxygen concentrators should be stored in a “dirty” or “clean” area, RN D stated that the oxygen concentrators should be stored in a “clean” area. RN D confirmed that the unused syringes should not be on the counter next to the “dirty” sink. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A confirmed that the medication prep area was not clearly labeled and the space used to draw up medications was not clearly defined to ensure this area stayed “clean” and free from potential cross contamination. FA A stated that the computer carts are considered “clean” and are not considered part of the patient station. Per FA A the computer carts are cleaned at the end of the treatment day, and not between patients.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 29972 Based on observation, record review and interview, the facility staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent potential cross contamination in 2 of 2 observations of dialysis station cleaning (Station (St) #2, 6), in a total sample of 2 observations of station cleaning; and failed to ensure the PD (Peritoneal dialysis) home training equipment was clean and free from contamination in 1 of 2 PD training rooms observed (PD training room 1), in a total sample of 2 PD training rooms observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“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)...the Wall box, drain, and water supply lines are considered part of the dialysis delivery system.” - “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.” Station Cleaning: On 03/05/2025 at 11:05 AM, observed Patient Care Technician (PCT) E cleaning and disinfecting St 2. PCT E did not clean the following: -Dialysate hoses and lines attached to the dialysis machine -Outside of red biohazard sharps container at the station -Outside of garbage can at the station -Crevices between the arm rest and tray table (fold down the tray table) -Counter tops at the station -TV arm and plastic evacuation bag hanging from the TV -Laminated sign hanging from the IV (intravenous) pole -IV pole and hooks On 03/05/2025 at 11:40 AM, observed PCT F cleaning and disinfecting St 6. PCT F did not clean the following: -Basket attached to the dialysis machine -Dialysate hoses and lines attached to the dialysis machine -Outside of red biohazard sharps container at the station -Outside of garbage can at the station -Crevices between the arm rest and tray table (fold down the tray table) -Counter tops at the station -TV arm and plastic evacuation bag hanging from the TV -Laminated sign hanging from the IV (intravenous) pole -IV pole and hooks During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that staff should be cleaning and disinfecting all areas of the dialysis station identified during the observations. PD home training room: On 03/06/2025 at 1:00 PM, observed blood splatter on the lid of the biohazard container in the PD training room (no patients were seen on 03/05/25 and 03/06/25). During interview with FA A on 03/06/2025 at 1:00 PM, while observing the biohazard container in the PD training room 1, FA A confirmed the findings and stated that the biohazard container should have been cleaned and disinfected after the patient visit.”

“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: 29972 Based on record review, observation and interview, the facility staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 2 of 4 patients observed with a CVC (Patient (Pt) #6, #7) in a total sample of 4 patients observed with a CVC. Findings include: Review of policy and procedure #1-04-02B titled, “Central Venous Catheter....” last reviewed October 2024 revealed the following: - “Clean each CVC limb/cap with new large alcohol prep pad, starting close to the exit site and finishing with the cap - “Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” - “2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (ChloraPrep)...Effective for CVC access exit site...Effective Contact Time 30 seconds back and forth motion...Air Drying Time 60 seconds.” - “Verify patient’s clothing is secured away from the exit site/work area...” On 03/05/2025 beginning at 11:30 AM, observed Patient Care Technician (PCT) G performing Pt #6’s CVC exit site care. After PCT G cleaned the CVC exit site, Pt #6’s shirt touched the CVC exit site allowing for potential contamination; PCT G did not perform repeat skin antisepsis. On 03/05/2025 beginning at 11:45 AM, observed PCT E initiating Pt #7’s dialysis using a CVC. PCT E did not clean the CVC limbs starting close to the exit site down to the caps/hubs as per policy. PCT E applied ChloraPrep (antiseptic) to clean CVC exit site and let dry for 10 seconds before applying the dressing; not 60 seconds as per policy. PCT E scrubbed the CVC hubs with an alcohol wipe for 7 seconds (hub #1) and 9 seconds (hub #2), not 15 seconds per hub as per policy. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that staff should ensure clothing is secure when doing exit site care. FA A stated that staff should be cleaning the catheter limbs from the exit site down to the hub and then scrub the hubs for 15 seconds each. FA A stated that ChloraPrep should be allowed to dry for 60 seconds before applying the dressing to the CVC exit site.”

“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: 29972 Based on observation, record review and interview, the facility staff failed to ensure that all vascular access sites are visible during dialysis treatment in 2 of 14 patients observed (Patient (Pt) #12, #13), in a total sample of 14 patients observed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” last revised April 2024 revealed, “The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment.” On 03/05/2025 beginnning at 12:35 PM observed Pt #12’s vascular access site covered with a blanket during dialysis treatment. Observed Registered Nurse (RN) D ask Pt #12 how they were doing and then fixed Pt #12’s blanket; RN D did not uncover Pt #12’s vascular access site. On 03/05/2025 beginning at 2:55 PM, observed Pt #13’s vascular access site covered during dialysis treatment. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that patient’s vascular access sites should be uncovered at all times during dialysis treatment as per policy.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to assess and evaluate blood pressure (BP) and fluid management needs in the Comprehensive Assessment for Peritoneal Dialysis (PD) patients in 1 of 1 PD patient medical record reviewed (Patient (Pt) #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #5-15-02 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 revealed; - “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectation for care.” - “Assessment criteria will include, but not be limited to, evaluation of: ...blood pressure and fluid management needs...” Review of Pt #2’s Annual Comprehensive Assessment Report finalized by Registered Nurse (RN) I on 01/22/2025 at 8:22 AM revealed, “No Data Available” was documented for the categories of “Weight,” “Pre-Treatment Blood Pressure,” and “Post-Treatment Blood Pressure.” There was no documentation on the RN Comprehensive Assessment evaluating Pt #2’s BP and weights pre and post PD treatments to assess Pt #2’s BP and fluid management needs. Review of Pt #2’s Dialysis Prescription for PD treatment dated 12/13/2024 at 11:50 AM revealed a target weight (TW) order of 63.0 kg (kilograms). Per Pt #2’s Dialysis Prescription, pre treatment BP parameters are ordered which determine the solution strength to be used during the PD treatment. Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed, “Skipped” is documented in the categories of “Pre-Weight,” “Pre-Systolic BP,” and “Pre-diastolic BP.” There was no documentation of Pt #2’s BP and weight on the PD flowsheets reviewed. A review of Pt #2’s PD flowsheets revealed “Not Surveyed” is documented in the categories of “Night Concentration” (PD solution strength used during the PD treatment); there is no documentation in the flowsheets of the solution strength being used for treatment, so staff can effectively monitor and assess BP and Fluid management needs. Per interview with PD RN I on 03/07/2025 beginning at 10:00 AM, RN I stated that she prints out Pt #2’s PD flowsheets directly from Baxter (PD Cycler supplier). Per RN I the patient has the option to enter in the BP and weight but Pt #2 does not do this, so “skipped” appears in these categories on the PD flowsheet. RN I stated that she does not routinely complete an evaluation of PD patient’s pre and post treatment BP and weights in the RN Comprehensive Assessment. RN I stated that Pt #2 has not brought in additional PD flowsheets for the months reviewed.”

“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: 29972 Based on record review and interview, the facility staff failed to develop and implement an effective comprehensive plan of care with measurable goals and individualized interventions for Peritoneal Dialysis (PD) home patients in 1 of 1 PD medical record revealed (Patient (Pt) #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #5-01-29 titled, “Daily Home Treatment Record (Flowsheet) revealed; - “Each peritoneal dialysis patient has agreed and been trained to complete documentation of each treatment procedure on the Daily Home Treatment Record also referred to as a flowsheet.” - “All Daily Home Treatment Records will be reviewed, attested to, and maintained as a part of the patient’s medical record...” - “...the patient’s plan of care should address any problems with adherence to this requirement.” - “...all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient’s progress and self-care decision-making process.” - “If the patient...indicates a treatment was not completed or fails to confirm a treatment occurred, the licensed nurse is responsible for...documenting why the patient did not treat within the medical record.” - “When a patient submits their treatment information electronically, or via paper, the licensed nurse teammate will be responsible for reviewing this data every seven days from receipt of treatment level data. The Registered Nurse is responsible for marking treatments as reviewed in the applicable data platform or paper flowsheet...Based on treatment records provided by the patient, follow up may be necessary and the patient’s electronic medical record must be updated to reflect any new information obtained.” Review of policy and procedure #5-15-02 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 revealed: - “The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations of care.” - “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least monthly for unstable patient’s including, but not limited to, patient with the following: ...Marked deterioration in health status, significant changes in psychosocial needs...” - “...if the expected outcome is not achieved, the interdisciplinary team will adjust the patient’s plan of care to achieve the specified goal. When a patient is unable to achieve the desired outcomes, the team will: Adjust the patient’s plan of care to reflect the patient’s current condition...Document in the patient’s medical record the reasons why the patient was unable to achieve the goals...Implement plan of care changes to address the issues identified.” Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed, “Skipped” is documented in the categories of “Pre-Weight,” “Pre-Systolic BP,” and “Pre-diastolic BP.” There was no documentation of Pt #2’s BP and weight on the PD flowsheets reviewed. A review of Pt #2’s PD flowsheets revealed “Not Surveyed” is documented in the categories of “Night Concentration” (PD solution strength used during the PD treatment); there is no documentation in the flowsheets of the solution strength being used for treatment, so staff can effectively monitor and assess BP and Fluid management needs. Review of Pt #2’s PD dialysis prescription dated 10/31/2024 and 02/13/2025 revealed the ordered “Fill Volume” was 1900 ml (milliliters) and the “Target Dwell Time” was 1 hour and 21 minutes. Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed that out of the 87 PD treatments documented, none of the treatments used a 1900 ml Fill Volume; the Fill volumes ranged from 1614 ml to 1728 ml. Review of Pt #2’s PD treatments flowsheet revealed 72 of the 87 PD treatments did not meet the Target Dwell time as per physician orders. Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed the following missed PD treatments: November 2024--12 treatments December 2024-- 10 treatments January 2025--5 missed treatments February 2025--10 missed treatments March 1st, 2025 to March 5th, 2025--2 missed treatments Review of Pt #2’s PD RN (Registered Nurse) I progress note dated 11/07/2024 at 3:39 PM revealed, “RN explained that when pt was checked for adequacy in October, she came back not adequate and that we needed to recheck adequacy but that we had to change PD prescription so that pt would come back adequate and to make sure dialysis was working. Pt did not like that...Pt not agreeable to (change in prescription)...Pt labs are poor, pt fluid overloaded, not compliant with home dialysis, this RN recommends pt transition to HD if not willing to change PD prescription and complete dialysis daily as prescribed.” Review of Pt #2’s PD RN (Registered Nurse) I progress note dated 12/13/2024 at 3:30 PM revealed, “Pt does not complete home treatment records. RN educated pt regarding the importance of keeping records and bringing to the clinic for review.” Review of Pt #2’s Social Worker (SW) J progress note dated 12/27/2024 at 4:47 PM revealed, “The pt missed her appointment today in the PD clinic and the pt. was called to do a tele-health call...The PD RN has verified that the pt. is not doing her prescription of dialysis 7 days/week. She is missing 50% of her treatments from the data provided by the PD RN. The physician...had proposed to the pt. to go back to hemodialysis for 1 month to re-set herself and her approach....The pt. is not interested in going back to ICHD (in-center hemodialysis) treatment. Pt. reports she has ‘skipped treatments there for 1 month when her belly was hurting.’ She acknowledges she has not been doing treatment consistently...The goal is for the pt to complete PD treatment more consistently and if not, will reconsider having the pt. go to ICHD...” Review of Pt #2’s PD RN I progress notes documented on 01/22/2025 at 12:00 AM (no actual time) revealed, “...Pt did not bring in home treatment records. RN educated pt on importance of completing home treatment records and bringing them to clinic for review.” Review of Pt #2’s PD RN I progress notes dated 02/19/2025 at 12:19 PM revealed, “The pt was scheduled to come to the PD clinic on 02/18/2025 and she was not feeling well. There is a concern that the pt. is not adequate and has not been doing her dialysis treatment for 12 days. There is a concern related to the patient’s lab work per dietician. Pt has rescheduled her lab work 3x’s (times)...There was some discussion from the IDT about her needing to go back to ICHD if she is not completing her PD treatments...PD RN has attempted to call the patient 2x’s yesterday and she did not pick up the phone...” Review of Pt #2’s PD RN I progress notes dated 02/21/2025 at 3:14 PM revealed, “...Pt did not bring in home treatment records. RN educated pt on importance of bringing records to every visit for review...” Review of Pt #2’s IDT Comprehensive Plan of Care (POC) dated 01/22/2025 revealed that there was no documentation of the IDT identifying the reasons why Pt #2 was not completing the PD flowsheets, not following the dialysis prescription, and missing PD treatments. Per review of Pt #2’s POC, there was no documentation of the IDT developing measurable goals and individualized interventions to address Pt #2’s non-compliance. Per review of the PD RN I and SW J’s progress notes from November 2024 through February 2025 and the IDT POC completed on 01/22/2025, Pt #2 continued to be non-compliant with the treatment plan in November, December, January, and February and there was no documented evidence of the IDT adjusting/changing Pt #2’s plan of care to reflect the patient’s continued non-compliance, documenting in the patient’s medical record the reasons why Pt #2 was unable to achieve the goals, and implementing plan of care changes to address the issues of non-compliance as per policy. Per interview with PD RN I on 03/07/2025 beginning at 10:00 AM, RN I stated that she took over as the PD RN in November 2024. RN I stated that she has not received PD Flowsheets from Pt #2 since RN I started working at the facility (4 months ago). RN I stated that she prints out Pt #2’s PD flowsheets from Baxter (PD Cycler company) but due to Pt #2’s non-compliance, the required information to monitor Pt #2’s blood pressure, fluid, and prescription adherence is not documented on the electronic flowsheet. When asked how RN I is able to monitor Pt #2’s PD treatments including blood pressure and fluid management, RN I stated, “I have not.” RN I stated that the IDT should have conducted an Unstable POC after the first month of Pt #2 not completing PD treatments, but this did not happen. RN I stated that the IDT was supposed to make Pt #2 Unstable in January 2025 but Pt #2’s missed treatments improved so the IDT did not follow through with an Unstable POC. RN I stated that the IDT did not consider that Pt #2 was not providing PD flowsheets when this decision was made. PD RN I stated that the IDT has an Unstable POC scheduled for March 25, 2025.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that nursing staff perform nursing assessments when blood pressure (BP) and/or heart rate are out of parameters in 3 of 4 In-Center Hemodialysis medical records reviewed (Patient (Pt) #1, #3, #5); failed to address abnormal findings of Fluid management post treatment in 1 of 4 In-Center Hemodialysis medical records reviewed (Pt #3); failed to monitor and assess BP and Fluid management needs in Peritoneal Dialysis (PD) home patients in 1 of 1 PD medical records reviewed (Pt #2); and failed to develop and implement and accurate and effective Plan of Care for BP and Fluid Management in 1 of 1 PD medical records reviewed (Pt #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed April 2024 revealed; - “If abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis.” - “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” - “If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” - “All findings, interventions and patient response will be documented in the patient’s medical record.” - Abnormal findings include: Fluid Status Pre-Treatment...”Removal goal not to exceed maximum ordered by physician...Post-treatment: If patient is above or below 1 kilogram from the target weight (TW);” - Abnormal Findings include: Blood Pressure-Intradialytic (during treatment)...”Systolic (blood pressure) greater than 180...or less than 90...Diastolic (blood pressure) greater than or equal to 100 or less than 50...” - Abnormal Findings include: Blood Pressure Post Treatment... “Standing systolic BP greater than 140...Standing diastolic BP greater than 90...If patient is not able to stand, document the reason...” -Abnormal findings include: Heart or pulse rate of “Less than 60 beats per minute or greater that 100 beats per minute...” Review of policy and procedure #5-01-29 titled, “Daily Home Treatment Record (Flowsheet) revealed; - “Each peritoneal dialysis patient has agreed and been trained to complete documentation of each treatment procedure on the Daily Home Treatment Record also referred to as a flowsheet.” - “All Daily Home Treatment Records will be reviewed, attested to, and maintained as a part of the patient’s medical record...” - “...the patient’s plan of care should address any problems with adherence to this requirement.” In-Center Hemodialysis BP assessments and monitoring: Review of Pt #1’s Treatment Sheets revealed the following: -On 03/03/2025 at 1:46 PM Pt #1’s BP was 136/107 (normal diastolic 50-100); at 12:15 PM and 12:45 PM Pt #1’s heart rate was 106 and 107 respectively (normal 60-100); there was no documentation of the RN assessing and addressing Pt #1’s abnormal BP and heart rate as per policy. -On 02/28/2025 at 2:50 PM Pt #1’s BP was 136/108; there was no documentation of the Registered Nurse (RN) assessing and addressing Pt #1’s abnormal BP as per policy. Review of Pt #3’s Treatment Sheets revealed the following: -On 03/03/2025 Pt #3’s BP was 202/99 at 2:39 PM and 195/122 at 3:09 PM (normal systolic 90-180)(normal diastolic 50-100); there was no documentation of the RN addressing Pt #3’s abnormal BP as per policy. -On 02/28/2025 Pt #3’s BP was 175/101 at 1:34 PM, 177/106 at 2:17 PM, and 181/106 at 2:32 PM; there was no documentation of the RN assessing and addressing Pt #3’s abnormal BP as per policy. Pt #3’s sitting BP post treatment was 178/115, RN post assessment documented at 9:33 PM (9 hours after treatment ended) revealed, “Ended HD (hemodialysis) tx (treatment) early r/t (related to) anxiety and cramping” RN post assessment did not address Pt #3’s abnormal BP post treatment and interventions to address Pt #3’s cramping. -On 02/19/2025 Pt #3’s BP was 208/128 at 12:29 PM, the RN did not assess Pt #3 until 1:18 PM (49 minutes later). Pt #3’s BP was 168/118 at 1:56 PM; there was no documentation of the RN assessing and addressing Pt #3’s abnormal BP as per policy. Pt #3’s standing BP post treatment was 160/117, RN post assessment documented at 8:34 PM (more than 6 hours after treatment ended) did not address Pt #3’s abnormal BP. Review of Pt #5’s Treatment Sheets revealed the following: -On 02/26/2025 Pt #5’s BP was 207/119 at 6:56 AM and 211/130 at 7:26 AM; there was no documentation of the RN addressing Pt #5’s abnormal BP as per policy. In-Center Hemodialysis Fluid assessment and monitoring: Review of Pt #3’s Treatment Sheets revealed the following: -On 02/19/2025 Pt #3’s Target Weight (TW) ordered was 44.5 kg (kilograms); Pt #3’s post treatment weight was 46.1 kg (1.6 kg more than TW). Pt #3’s RN post assessment documented at 8:34 PM (more than 6 hours after treatment ended) did not address Pt #3’s abnormal findings of the post weight being more than 1.0 kg above TW as per policy; including interventions and physician notification. During interview with Facility Administrator (FA) A on 03/07/2025 at 2:25 PM, while discussing medical record findings, FA A confirmed the findings and stated that the RN should be assessing patients when there are abnormal findings and documenting these assessments and interventions as per policy. FA A stated that if a patient’s post weight is more than 1 kg above the TW, the nurse should document interventions and notify the physician. PD home treatment BP and Fluid assessments and monitoring: Review of Pt #2’s Dialysis Prescription for PD treatment dated 12/13/2024 at 11:50 AM revealed a target weight (TW) order of 63.0 kg (kilograms). Per Pt #2’s Dialysis Prescription, pre treatment BP parameters are ordered which determine the solution strength to be used during the PD treatment. Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed, “Skipped” is documented in the categories of “Pre-Weight,” “Pre-Systolic BP,” and “Pre-diastolic BP.” There was no documentation of Pt #2’s BP and weight on the PD flowsheets reviewed. A review of Pt #2’s PD flowsheets revealed “Not Surveyed” is documented in the categories of “Night Concentration” (PD solution strength used during the PD treatment); there is no documentation in the flowsheets of the solution strength being used for treatment, so staff can effectively monitor and assess BP and Fluid management needs. PD BP and Fluid management Plan of Care: Review of Pt #2’s PD treatment flowsheets (printed from Baxter) from November 2024 through January 2025 showed no documentation of “Pre-Weight,” “Pre-Systolic BP,” “Pre-diastolic BP,” and “Night Concentration (solution strength).” Review of Pt #2’s “Fluid/BP” Comprehensive Plan of Care dated 01/22/2025 revealed to “Maintain post weight compared to target weight. Blood pressure within range.” Pt #2’s Fluid/BP Plan of Care goal did not reflect the incomplete treatment records; the Fluid/BP Plan of Care did not include measurable goals and interventions indicating how staff will effectively and accurately assess, monitor, and evaluate Pt #2’s BP and fluid management needs. Per interview with PD RN I on 03/07/2025 beginning at 10:00 AM, RN I stated that she prints out Pt #2’s PD flowsheets directly from Baxter (PD Cycler supplier). RN I stated that the patient has the option to enter in the BP, weight, and fluid concentration, but Pt #2 does not do this so “skipped” appears in these categories on the PD flowsheet. RN I stated that Pt #2 has not brought in PD flowsheets for the months reviewed. When asked how RN I is able to monitor Pt #2’s PD treatment BP and fluid without this information on the flowsheets, and RN I stated, “I have not.” Per RN I, she monitors Pt #2’s BP and weight at the monthly lab visit.”

“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: 29972 Based on record review and interview, the facility staff failed to follow prescribed blood flow rates (BFR) for 2 of 4 In-center Hemodialysis medical records reviewed (Patient (Pt) #1, #5), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed April 2024 revealed the following: -“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.” A review of Pt #1’s Treatment Sheets revealed orders for a BFR of 450. Review of Pt #1’s Treatment Sheets revealed the following: -On 03/03/2025 the BFR was set between 390 and 400 for the entire dialysis treatment; there were no documentation recognizing and addressing Pt #1 not dialyzing at the ordered BFR. -On 02/26/2025 the BFR was set at 400 for the entire dialysis treatment; there were no documentation recognizing and addressing Pt #1 not dialyzing as per physician ordered BFR. A review of Pt #5’s Treatment Sheets revealed orders for a BFR of 350. Review of Pt #5’s Treatment Sheets revealed the following: -On 02/26/2025 the BFR was set at 300 for the entire dialysis treatment; there were no documentation recognizing and addressing Pt #5 not dialyzing as per physician ordered BFR. During interview with Facility Administrator (FA) A on 03/07/2025 at 2:25 PM, while discussing medical record findings, FA A confirmed the findings and stated that the BFR should be set as per physician orders. FA A stated that if staff are not able to maintain the ordered BFR, they should document the interventions and inform the nurse. Per FA A the physician should be notified if the staff are unable to achieve the BFR and this should be documented.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29972 Based on record review, observation and interview, the facility staff failed to perform skin antisepsis as per policy when when using a Arteriovenous Fistula/Graft (AVF/G) in 3 of 3 observations of dialysis treatment initiation using an AVF/G (Patient (Pt) #3, #8, #9), in a total sample of 14 observations of patient care; and failed to assess, evaluate and develop an individualized plan of care for patients with a Central Venous Catheter (CVC) in 1 of 1 record reviewed of patients with a CVC greater than 90 days (Pt #4), in a total of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-06-01C titled, “Intradermal Administration of Lidocaine (numbing medication)” last revised October 2022 revealed, “Expose injection site and clean area with alcohol 70% prep pad” prior to injection of Lidocaine into the AVF/G cannulation site. Review of policy and procedure #1-04-01D titled, “AV Fistula or Graft Cannulation...” last revised October 2024 revealed the following: -Povidone Iodine “Effective Contact Time” is 30 seconds and “Air Drying Time” is 2 minutes. - “While maintaining aseptic technique, cleanse the sites by applying skin antiseptic using a circular motion...and allow to dry.” - “Do not palpate insertion site once area has been prepped...Once the access site has been prepped touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” Review of policy and procedure #1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 revealed, “The facility interdisciplinary team will 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 will include measurable and expected outcomes and estimated timetables to achieve these outcomes...The plan of care will address, but not limited to, the following:...When indicated, vascular access which addresses vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. All hemodialysis patients are evaluated for vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a candidate for arteriovenous fistula placement” AVF/G observations: On 03/05/2025 beginning at 10:55 AM, observed Patient Care Technician (PCT) G initiating Pt #8’s dialysis treatment using a AVF/G. PCT G cleansed the skin over the cannulation sites with alcohol and then applied povidone iodine (betadine) antiseptic. PCT G then injected Lidocaine into the cannulation sites touching the previously cleaned vascular access site allowing for potential contamination; PCT G did not perform repeat skin antisepsis prior to cannulation. On 03/05/2025 beginning at 11:20 AM, observed PCT F initiating Pt #3’s dialysis treatment using a AVF/G. PCT F cleansed the skin over the cannulation sites with alcohol and then applied povidone iodine (betadine) antiseptic. PCT F then injected Lidocaine into the cannulation sites touching the previously cleaned vascular access site allowing for potential contamination; PCT F did not perform repeat skin antisepsis prior to cannulation. On 03/05/2025 beginning at 11:35 AM, observed PCT E initiating Pt #9’s dialysis treatment using a AVF/G. PCT E performed skin antisepsis as per policy, then palpated the access sites immediately prior to cannulation allowing for potential contamination. During interview with Facility Administrator (FA) B on 03/06/2025 at 9:45 AM, while discussing observations, FA B stated that staff should be cleansing the vascular access site with alcohol, injecting lidocaine into the cannulation sites, then performing the skin antisepsis with the betadine after the lidocaine is injected. FA B stated that staff should not retouch the vascular access site after performing skin antisepsis. CVC greater than 90 days: Review of Pt #4’s Patient Plan of Care revealed Pt #4 currently had a CVC that was placed on 11/27/2024. Review of the Comprehensive Assessment Report completed by the nursing staff on 12/18/2024, revealed in the “Access” column there was, “No documentation Provided.” There was no documentation of staff assessing and evaluating the function of Pt #4’s CVC access in the nursing Comprehensive Assessment. Per review of Pt #4’s Patient Plan of Care document completed by the IDT on 12/27/2024, the “Access” section revealed to “Support maintenance and functioning of permanent dialysis access.” Review of Pt #4’s Patient Plan of Care revealed there was no documentation of an individualized care plan to address Pt #4 having a CVC, including measurable goals and individualized interventions and addressing any barriers that are preventing placement of a permanent vascular access. During interview with Facility Administrator (FA) A on 03/07/2025 at 2:25 PM, while discussing medical record findings, FA A confirmed the findings and stated that staff should be assessing the CVC access site and developing an individualized plan of care to address interventions and goals for a more permanent vascular access site as per policy.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to develop and implement an individualized and comprehensive Plan of Care to address Psychosocial needs in 1 of 5 medical records reviewed (Patient (Pt) #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 revealed, “The facility interdisciplinary team will 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 will include measurable and expected outcomes and estimated timetables to achieve these outcomes...The plan of care will address, but not limited to, the following:..Psychosocial status which addresses necessary monitoring and social work interventions. Included are counseling services and referrals for other socials services to assist patients in achieving and sustaining an appropriate psychosocial status...” Review of Pt #2’s Social Worker (SW) J progress note dated 12/27/2024 at 4:47 PM revealed, “...The PD RN has verified that the pt is not doing her prescription of dialysis 7 days/week. She is missing 50% of her treatments from the data provided by the PD RN. The physician...had proposed to the pt. to go back to hemodialysis for 1 month to re-set herself and her approach...The pt. is not interested in going back to ICHD (In-center hemodialysis) treatment...” Review of Pt #2’s Comprehensive Assessment Report finalized by SW J on 01/21/2025 at 5:11 PM revealed, “Pt continues to struggle on home therapy with completing all dialysis treatments as prescribed. Pt was educated that if she does not complete all treatments and labs do not improve, that she would have to go to backup HD (hemodialysis) and then after a month could return to home therapy.” Per review of Pt #2’s IDT Plan of Care (POC) completed on 01/22/2025 (no time), the Psychosocial POC Goals revealed to, “Meet and maintain optimal mental and/or functional status;” Interventions documented in the POC are to “Provide psychosocial counseling as indicated.” Pt #2’s Psychosocial POC goal is not measurable and individualized and does not reflect Pt #2’s issues with missed treatment and non-compliance as discussed in the comprehensive assessment. Pt #2’s Psychosocial POC does not include addressing barriers and potential reasons for missing treatments and non-compliance and developing a comprehensive individualized POC to address Pt #2’s Psychosocial needs. During interview with Facility Administrator (FA) A on 03/07/2025 at 2:25 PM, while discussing medical record findings, FA A confirmed the findings and stated that Pt #2’s POC does not reflect the concerns identified in the comprehensive assessment. Per FA A the IDT should develop a individualized comprehensive POC as per policy.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to accurately review and maintain records from Peritoneal Dialysis (PD) home patients at least every 2 months in 1 of 1 PD medical record reviewed (Patient (Pt) #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #5-01-29 titled, “Daily Home Treatment Record (Flowsheet) revealed; - “Each peritoneal dialysis patient has agreed and been trained to complete documentation of each treatment procedure on the Daily Home Treatment Record also referred to as a flowsheet.” - “All Daily Home Treatment Records will be reviewed, attested to, and maintained as a part of the patient’s medical record...” - “...the patient’s plan of care should address any problems with adherence to this requirement.” Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed, “Skipped” is documented in the categories of “Pre-Weight,” “Pre-Systolic BP,” and “Pre-diastolic BP.” There was no documentation of Pt #1’s BP and weight on the PD flowsheets reviewed. A review of Pt #2’s PD flowsheets revealed “Not Surveyed” is documented in the categories of “Night Concentration” (PD solution strength used during the PD treatment); there is no documentation in the flowsheets of the solution strength being used for treatment, so staff can effectively monitor and assess BP and Fluid management needs. Review of Pt #2’s PD dialysis prescription dated 10/31/2024 and 02/13/2025 revealed the ordered “Fill Volume” was 1900 ml (milliliters) and the “Target Dwell Time” was 1 hour and 21 minutes. Review of Pt #2’s PD flowsheets from 11/01/2024 to 03/05/2025 revealed that out of the 87 PD treatments documented, none of the treatments used a 1900 ml Fill Volume; the Fill volumes ranged from 1614 ml to 1728 ml. Review of Pt #2’s PD treatments flowsheet revealed 72 of the 87 PD treatments did not meet the Target Dwell time as per physician orders. Review of Pt #2’s PD Registered Nurse (RN) I’s progress notes dated 12/13/2024 at 3:24 PM, revealed RN I’s attestation stating, “I (RN I), RN, Home...attest that the above treatments and medications have been completed as expected and that the patient (Pt #2), has provided the necessary documented confirmation.” RN I attested that Pt #2 completed PD treatments on 11/26/2024, 11/28/2024, and 11/30/2024; however, per review of the PD flowsheets there is no record of PD treatment on these days. Review of RN I progress notes dated 01/31/2025 at 2:06 PM, revealed RN I’s attestation stating, “I (RN I), RN, Home...attest that the above treatments and medications have been completed as expected and that the patient (Pt #2), has provided the necessary documented confirmation.” RN I attested that Pt #2 completed PD treatments on 12/03/2024, 12/05/2024, 12/7/2024, 12/11/2024, 12/14/2024, 12/17/2024, 12/19/2024, 12/21/2024, 12/24/2024, 12/27/2024, 01/08/2025, 01/16/2025, 01/21/2025, 01/24/2025, and 02/26/2025; however, per review of the PD flowsheets there is no record of PD treatment on these days. RN I attested that Pt #2’s flowsheets were completed as expected for PD treatments from 11/20/2024 through 01/30/2025; however, review of Pt #2’s PD treatment flowsheets (printed from Baxter) from November 2024 through January 2025 revealed the flowsheets did not have documentation of “Pre-Weight,” “Pre-Systolic BP,” “Pre-diastolic BP,” and “Night Concentration (solution strength).” Per interview with PD RN I on 03/07/2025 beginning at 10:00 AM, RN I stated that she took over as the PD RN in November 2024. RN I stated that she has not received PD Flowsheets from Pt #2 since RN I started working at the facility (4 months ago). RN I stated that she prints out Pt #2’s PD flowsheets from Baxter (PD Cycler company) but due to Pt #2’s non-compliance, the required information to monitor Pt #2’s blood pressure, fluid, and prescription adherence is not documented on the electronic flowsheet. When asked how RN I is able to monitor Pt #2’s PD treatments including blood pressure and fluid management, RN I stated, “I have not.””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that quality data is tracked and analyzed to address issues with Fluid management, Modality choice, Mortality, Hospitalizations, and Readmissions < 30 days in 2 of 2 Quality Assessment and Performance Improvement (QAPI) programs reviewed (In-Center Hemodialysis, Peritoneal Dialysis), in a total of 2 QAPI programs reviewed. Findings include: Review of policy #5-15-06 titled, “Continuous Quality Improvement Program” last revised April 2024 revealed the following: - “Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid).” - “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following:...Mortality-review of deaths, Hospitalizations...Other indicators as reflected in the Quality Improvement and Facility Management Meeting minutes form.” - “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement...” Fluid Management: Review of the FHR Fluid management dashboard for In-center Hemodialysis (HD), revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing quality indicators for Fluid management including; “Freq (frequent) Post Wt (weight) Below TW (Target Weight)” and “Average UFR (Ultrafiltration) >= 13.” Modality Choice: Review of the FHR dashboard for HD and Peritoneal Dialysis (PD), revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing of Modality choice/referrals (HD & PD). Mortality Review: Review of the FHR Mortality dashboard for HD and Peritoneal Dialysis (PD), revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing of Mortality reviews (HD & PD). Hospitalizations and Readmissions < 30 days: Review of the FHR Hospitalizations dashboard for HD and PD, revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing of Hospitalizations and Readmissions < 30 days (HD & PD). Per interview with Social Worker (SW) J on 03/07/2025 beginning at 1:00 PM, while reviewing FHR, SW J stated that she does not review Modality choice/referrals with the IDT in FHM. During interview with Facility Administrator (FA) A, while discussing QAPI on 03/07/2025 beginning at 12:20 PM, FA A confirmed the findings and stated that there was no documentation of IDT QI meeting minutes addressing Fluid management, Modality choice, Mortality, Hospitalizations, and Readmissions < 30 days in the FHR for October, November, and December 2024.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure the interdisciplinary team (IDT) address Anemia management quality indicators, including tracking blood transfusions, Transferrin Saturations (Tsat %), and Ferritin in 2 of 2 Quality Assessment and Performance Improvement (QAPI) programs reviewed (In-Center Hemodialysis, Peritoneal Dialysis), in a total of 2 QAPI programs reviewed. Findings Include: Review of policy #5-15-06 titled, “Continuous Quality Improvement Program” last revised April 2024 revealed the following: - “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following:...Anemia Management...” - “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement...” Review of the FHR dashboard for HD and Peritoneal Dialysis (PD), revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing quality indicators for Anemia management including; blood transfusions, Tsat %, and Ferritin. During interview with Facility Administrator (FA) A, while discussing QAPI on 03/07/2025 beginning at 12:20 PM, FA A confirmed the findings and stated that there was no documentation of meeting minutes addressing the Anemia management indicators in FHR for October, November, and December 2024.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that quality data is tracked and analyzed to address issues with Infection Control in 2 of 2 Quality Assessment and Performance Improvement (QAPI) programs reviewed (In-Center Hemodialysis, Peritoneal Dialysis), in a total of 2 QAPI programs reviewed. Findings include: Review of policy #5-15-06 titled, “Continuous Quality Improvement Program” last revised April 2024 revealed the following: - “Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid).” - “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following:...Infection Control, including; Incidence of infections, Vaccination rates for Hepatitis B, Influenza, and Pneumococcal...Other indicators as reflected in the Quality Improvement and Facility Management Meeting minutes form.” - “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement...” Review of the Communicable Disease FHR dashboard for In-center Hemodialysis (HD) and Peritoneal Dialysis (PD), revealed in the December 2024, November 2024, and October 2024 FHM, the interdisciplinary team (IDT) did not document QI meeting minutes showing evidence of continuous monitoring, tracking, and analyzing quality indicators for Infection Control including; Hepatitis B vaccinations and susceptible patients, Hepatitis C surveillance, Tuberculosis surveillance, and Pneumococcal vaccinations (PD & HD). During interview with Facility Administrator (FA) A, while discussing QAPI on 03/07/2025 beginning at 12:20 PM, FA A confirmed the findings and stated that there was no documentation of IDT QI meeting minutes addressing the Infection Control indicators in FHR for October, November, and December 2024.”

“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: 29972 Based on record review and interview, the facility staff failed to ensure nursing staff verify medication orders prior to medication administration as per policy in 1 of 1 medication administration observations (Patient (Pt) #4), in a total of 1 medication administrations observed. Findings Include: Review of policy and procedure #1-06-01 titled, “Medication Policy” last revised October 2023 revealed, “Prior to administration of medication, verify physician...order. Check for patient allergies when receiving or entering a medication order and prior to administering any medications.” On 03/05/2025 at 16:00 PM, observed Registered Nurse (RN) D administering an intravenous (IV) medication to Pt #4. RN D did not check the medication to verify the order in the electronic medical record prior to administering the IV medication. During interview with Facility Administrator (FA) A on 03/06/2025 at 9:45 AM, while discussing observations, FA A stated that the nurse should verify the medication order in the patients electronic medical record prior to administration.”