Davita Carmel Dialysis

“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: 51279 Based on observation, record review, and interview, the agency failed to ensure the proper storage of supplies in 4 of 5 observations. Findings Include: 1. A review of a policy revised on April 2023, titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES,” indicated but was not limited to, “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment ... Supplies will be stored in a manner that maintains their integrity ... should not be placed on potentially contaminated equipment such as the dialysis delivery system ... The Wall box ... are considered part of the dialysis delivery system ...” 2. On 01/14/2025 at 11:00 AM the following treatment floor observations were made: An observation of patient labs on the wall box of Station #3. During an interview on 01/14/2025 at 12:30 PM, RN 2 indicated nothing should be on the wall box. 47343 3. On 01/14/2025 at 9:16 AM, during the Flash Tour, the following observations were made: An observation of a hand sanitizer bottle and a clear bin on the wall unit shelf between Stations #4 and #5. An observation of two blood pressure cuffs were on the wall unit shelf behind Station 8. An observation of a hand sanitizer bottle on the wall unit shelf between Stations #8 and #9. 4. On 01/14/2025 at 10:09 AM, the following treatment floor observations were made: An observation of a patient’s bag on the wall unit shelf behind Station #3. 5. On 01/14/2025 at 1:00 PM, the following treatment floor observations were made: An observation of hand sanitizer bottle and a patient’s coat were on the wall unit shelf behind Station #4. An observation of a glove box and hand sanitizer bottle on the wall unit shelf behind Station #6. An observation of two blood pressure cuffs were on the wall unit shelf behind Station 8. During an interview with PCT 4 on 01/14/2025 at 11:10 AM, they indicated nothing was supposed to be on the wall unit shelves. 6. On 01/15/2025 at 10:45 AM, the following treatment floor observation was made: An observation of a clear bin on the wall unit shelf behind Station #2. 7. During an interview with RN 4 on 01/15/2025 at 12:30 PM, they indicated the wall unit shelves were to be kept clean and nothing was supposed to be on them. They explained patients liked to put their bags up on the wall unit shelves and had to be reminded they had to keep the wall unit shelves clear and clean. 8. During an interview with the Facility Administrator on 01/15/2025 at 5:22 PM, they indicated the wall unit shelves were not supposed to have anything on them and supplies stored there should be removed.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51279 Based on record review and interview the facility failed to maintain a complete and accurate medical record by not obtaining and retaining a completed Against Medical Advice (AMA) Form for 2 of 2 clinical records reviewed (Patient #2 and Patient #6) with patients ending treatment early. Findings Include: 1. A review of a policy revised on October 2022 titled, “REFUSAL OF CARE / TREATMENT AGAINST MEDICAL ADVICE,” indicated but was not limited to, “Purpose: To provide requirements for teammates to follow when a patient refused care or treatment against medical advice ... If a patient refuses care/treatment, the RN will document the event in the patient’s medical record. Documentation will include ... A copy of the Refusal of Care / Treatment Against Medical Advice form signed by the patient ... The RN will verify that a patient signs ... if a patient ... Refuses their entire dialysis treatment ...” 47343 2. A review of the clinical record for Patient #2 contained a dialysis (a treatment that removes excess fluid in the body when the kidneys are unable to function appropriately) order dated 01/02/2025 for a treatment duration of 3:30 hours. A review of Patient #2 ’ s treatment sheet dated 01/04/2025, indicated treatment was initiated at 10:56 AM and ended at 12:09 AM. Patient #2 ’ s treatment ran for 64 minutes. The treatment record evidenced the patient ’ s venous line infiltrated (when fluid leaks into the surrounding tissue) and the patient refused to allow the staff to place a new line in their left upper arm access site. The treatment record failed to evidence documentation of a signed AMA. During an interview with the Facility Administrator on 01/15/2025 at 4:30 PM, the Administrator confirmed they were unable to find Patient #2 ’ s signed AMA document for the treatment run on 01/04/2025. 3. A review of the clinical record for Patient #6 contained a dialysis order dated 01/14/2025 for a treatment duration of 4:15 hours. A review of Patient #6 ’ s treatment sheet dated 12/19/2025, indicated treatment was initiated at 10:14 AM and ended at 1:03 PM. Patient #6 ’ s treatment ran for 2:52 hours. The treatment sheet evidenced the patient had an incontinence episode and complained of bedsores. The sheet revealed the facility was unable to perform incontinence care, and the Medical Director and the patient ’ s nephrologist, Person 12, agreed that the patient was unable to be changed safely due to the patient’s size and injuries. The treatment record failed to evidence documentation of a signed AMA. During an interview with the Facility Administrator on 01/15/2025 at 2:26 PM, they concluded they were unable to find Patient #6 ’ s signed AMA documents for the treatment runs on 12/19/2024. 4. During an interview with RN 4 on 01/15/2025 at 12:30 PM, they explained when a patient chooses to leave their treatment early for any reason, they must sign an AMA document.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 51279 Based on record review and interview the facility failed to document an internal grievance for 1 of 1 patient complaints (Patient #6). Findings Include: 1. A review of a policy revised on October 2024 titled, “ADDRESSING PATIENT GRIEVANCES: DAVITA TEAMMATES,” indicated but was not limited to, “Purpose: To provide guidance to DaVita teammates for receiving and addressing Patient Grievances ... All complaints/grievances should be documented on the facility Patient Grievance Log ...” 47343 2. A review of the complaint logs dated 08/01/2024 to 01/02/2025 failed to evidence the complaint made by Person 13, a Care Coordinator at an insurance company, Entity 19, on 12-19-2024 regarding the incontinence care for Patient #6. The facility failed to ensure all complaints were investigated and discussed with all team members, and a resolution was determined. 3. During an interview with Patient #6, the person affected by the complaint, on 01/14/2025 at 10:25 AM, they indicated they were able to express themselves if they had a concern and had no current complaints with the agency. They evidenced the staff checked on them when they had problems during dialysis. When queried regarding whether the staff assisted the patient with their incontinence needs, Patient #6 explained they were unable to go to the restroom because they required a Hoyer lift (a device used to assist with transferring people with limited mobility). They said they usually tried to use the restroom before they arrived to attempt to prevent any incontinence. They expressed the staff assisted them when they needed help and provided privacy. They indicated if they had an incontinence episode, the facility staff turned them in the chair to clean them. 4. During an interview on 01/14/2025 at 12:54 PM, Person 1, Licensed Practical Nurse, indicated they work at Entity 1, an assisted living facility, and cared for Patient #6 several times. Person 1 indicated Patient #6 has stopped treatments short at least twice a week. They indicated Patient #6 normally has an accident when there is thirty minutes to an hour left in their treatment. When queried if the facility offered to clean up the patient instead of send them back to Entity 1, Person 1 indicated Patient #6 has been instructed the facility would not provide incontinent care due to the patient’s body size. When queried about the type of accidents Patient #6 has, Person 1 indicated Patient #6 usually has stool accidents. 5. During an interview with Person 14 (the complainant), a Care Coordinator Manager for an insurance company, on 01/14/2025 at 1:27 PM, they indicated on 12/19/2024, Person 15 (Patient #6 ’ s spouse) called the patient ’ s Care Coordinator, Person 13, and informed them Patient #6 had called the spouse crying and upset because there were sores on the patient ’ s buttocks and it was burning. They explained the dialysis facility was called by Person 13, and the staff indicated the patient was unable to be changed during dialysis because the patient had bed sores and was too heavy to lift. Person 14 indicated they felt the dialysis facility should have enough staff to change the patient. Person 14 evidenced Person 13 spoke with RN 4 regarding their concerns and informed RN 4 that the Nephrologist, Person 12 would need to be notified of them stopping treatment early for Patient #6. Person 13 had called Person #12 ’ s office and they had indicated the patient would need to go to rehab for dialysis. They indicated the patient had not complained about anything since 12/19/2025. Person 14 explained they wish they would have known the facility was not able to move the patient with their injuries. Person 14 indicated they were working on admitting the patient into an assisted living facility. 6. During an interview with Person 13, Patient #6 ’ s insurance Care Coordinator, on 01/14/2025 at 3:15 PM, they evidenced that the patient ’ s spouse, Person 15, had called them and said, “You are my last hope”. They indicated the spouse had called Person 13, and informed them, Patient #6 had called the spouse crying after dialysis because their buttocks were burning. The Care Coordinator confirmed the patient had sustained an injury to their leg and arm and was unable to stand. They called Entity 2, Patient #6 ’ s assisted living facility, and spoke with the nurse, Person 16. They confirmed with Person 16 that the patient was incontinent regularly and they sent incontinent supplies with the patient to dialysis on Tuesdays, Thursdays, and Saturdays. Person 13 evidenced they called the dialysis facility and spoke with RN 4. They explained RN 4 informed them they were unable to change Patient #6 at the facility because the patient had bed sores and it was an infection risk to the treatment room. They evidenced RN 4 planned to send the patient back to their facility, and Person 13 informed RN 4 they had to notify the physician of them taking the patient off of their treatment early. Person 13 called the Nephrologist ’ s office and was told the Medical Director was aware the patient needed to be transferred. They explained the Medical Director confirmed they could normally change the patient, and with the patient ’ s injuries, they were unable to change the patient. Person 13 attempted to reach out to MSW 1 with no return call back. Person 13 followed up with the patient ’ s spouse, and they indicated they had no complaints about the treatment from 12/23/2024 to 01/14/2025. On 01/09/2025, Person 13 indicated they followed up with Person 12 ’ s office and were informed the physician was out of the office and they had not received any notification. They indicated they had not received a call back from the dialysis facility. They evidenced they were working to find the patient a long-term care facility due to their health concerns. 7. During an interview on 01/15/2025 at 8:56 AM, Person 11, a new RN, indicated they work at Entity 1 and have cared for Patient #6. Person 11 indicated Patient #6 is the type of person who likes for their requests to be completed right away. Person 11 indicated there have been times staff have not responded fast enough and Patient #6 yelled “emergency”, and they would need to change their shirt. When queried if Patient #6 had any complaint regarding the facility, Person 11 indicated the only complaint Patient #6 has had is regarding staff body size. When queried if Patient #6 had ever returned from the facility visibly upset and crying, Person 11 indicated not as far as they were aware. 8. Attempted to contact Patient #6 ’ s spouse, Person 15, on 01/15/2025 at 9:25 AM, 1:43 PM, and 4:54 PM. Voicemails were left, no return call by exit. 9. During an interview with RN 4 on 01/15/2025 at 12:30 PM, they explained they reported any complaints and documented accordingly and reviewed it in their Quality Assessment Improvement meetings. They evidenced they recently had a “toileting” issue. When asked to elaborate, RN 4 explained a nurse manager, Person 13, from an insurance company had called and informed RN 4 they were supposed to take Patient #6 to the restroom when needed and inform the Nephrologist, Person 12, they took the patient off of dialysis early on 12/19/2024. RN 4 indicated they explained to Person 13 they were unable to transfer the patient to the restroom because Patient #6 was non-weight bearing because of their broken arm and knee from a fall. They indicated the patient required a Hoyer lift to transfer and was difficult to turn in the bariatric chair due to their size. They evidenced they expressed the safety concerns to Person 13. RN 4 explained the Medical Director and Person 12 were notified of the incontinence on 12/19/2025 and agreed the patient was unable to be changed during dialysis treatments because of safety concerns for the patient and the staff. RN 4 evidenced the patient had wanted to end their treatment early on 12/19/2025 to return to their Assisted living facility, Entity 2. 10. During an interview with MSW 1 on 01/15/2025 at 1:45 PM, when queried regarding Person 13 calling with a concern about Patient #6 ’ s care, indicated they were made aware of it yesterday, 01/14/2025. They indicated the nephrologist was aware of the concern and MSW 1 had reached out to Person 13 on 01/15/2025. They evidenced Patient #6 required a higher level of care. MSW 1 further indicated that when a nurse informs them of a complaint, they inform the administrator. 11. During an interview with the Facility Administrator on 01/15/2025 at 1:53 PM, they explained RN 4had informed the Facility Administrator of the call from Person 13 regarding Patient #6 ’ s incontinence care. They indicated RN 4 had informed them, RN 4 made Person 13 aware it was unsafe to turn the patient in the dialysis chair and perform incontinence care. The Facility Administrator evidenced they had not included the concern from Person 13 in the complaint binder because the patient had not complained about it. They explained since the patient or relative had not complained, and Person 13 had not requested a follow-up regarding the concern, they thought it was resolved between RN 4 and Person 13. 12. During an interview with the Medical Director on 01/15/2025 at 2:26 PM, they reviewed complaints monthly. They indicated they were informed about a patient who had an incontinence episode, and the facility the patient was at had called and asked the nurse at the dialysis facility to change the patient. The Medical Director explained the task was out of the scope of what the nurses were able to reasonably do on the treatment floor. They explained they felt it was a safety risk to change the patient.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, policy review and interview, the dialysis facility failed to maintain a sanitary environment within the In-Center Hemodialysis (ICHD) treatment area (see Tag V111), failed to ensure all staff and patients followed hand hygiene procedures (see Tag V113), failed to ensure staff wore the required personal protective equipment (PPE) when spurting or spattering of blood might occur (see Tag V115), failed to store potentially infectious waste properly to maintain a sanitary environment within the ICHD treatment area (see Tag V121), failed to ensure staff effectively disinfected a multi-use medication vial prior to drawing up a medication (see Tag V143), and failed to ensure staff followed procedures and best practices related to Central Venous Cather (CVC) care (see Tag V147). The scope and severity of these systemic issues evidenced Carmel Dialysis failed to provide adequate infection control measures, which resulted in the facility being found out of compliance with Condition of Coverage 494.30 Infection control.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure all components of the water purification system were present and staff were educated on how to access (see Tag V185), failed to ensure staff performed a total chlorine test according to facility procedure and manufacturer’s instructions (see Tag V196), failed to ensure the conductivity of a bicarbonate mixture was tested using 2-person verification (see Tag V229), and failed to ensure staff performed an independent verification of dialysate pH at each station prior to initiating in-center hemodialysis patient treatment (see Tag V250). The scope and severity of these systemic issues evidenced Carmel Dialysis failed to ensure adequate monitoring of the facility’s water and dialysate system, which resulted in the facility being found out of compliance with Condition for Coverage 42 CFR 494.40 Water and dialysate quality.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 42617 Based on observation, record review and interview, the dialysis facility failed to ensure the Registered Nurse and/or physician were notified of blood pressures (BP) outside of parameters during In-Center Hemodialysis (ICHD) treatment, failed to ensure pre-treatment and/or post-treatment standing BP checks were performed, failed to ensure the Estimated Ultrafiltration Rate (UFR) adhered to the physician order and best practice, and failed to ensure the patient received the correct dialysate bath concentration as ordered (See Tag V543); failed to ensure the blood flow rate (BFR) and/or dialysate flow rate (DFR) were set according to physician orders and failed to ensure the patient received their entire treatment time (see Tag V544); and failed to update the plan of care (POC) based on the patient’s condition (see Tag V559). The scope and severity of these systemic issues evidenced Carmel Dialysis failed to implement and maintain the patient’s plan of care, which resulted in the facility being found out of compliance with Condition for Coverage 42 CFR 494.90 Patient plan of care.”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to secure and maintain the availability of patient records in case of facility evacuation for 1 of 4 Monday, Wednesday, and Friday in-center hemodialysis (ICHD) shifts (Shift 3). Findings include: 1. The facility emergency plan policy, revised April 2024, indicated the facility should be able to communicate with and account for all patients and be able to confirm dialysis treatment location and schedule. 2. Review of the facility’s emergency plan failed to include patient transfer sheets for the third shift of Monday, Wednesday, and Friday patients. 3. During an interview on 9/18/24 at 3:09 PM, the Administrator indicated she didn’t see the third shift Monday, Wednesday, and Friday patients in the Emergency Evacuation binder and indicated they should have been in there.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to ensure the emergency preparedness (EP) communication plan contained updated contact information for the State Department of Health for 1 of 1 EP communication plan. Findings include: 1. Review of the Emergency Preparedness Communication Plan included a phone number for the State Health Department of (317) 509-4336, which when tested on 9/18/24 at 1:36 pm was no longer in service. 2. During an interview on 9/18/24 at 3:09 PM, the Administrator indicated she did not check the phone numbers in the communication plan for accuracy.”

“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: 48224 Based on observation, policy review and interview, the dialysis facility failed to maintain a sanitary environment within the In-Center Hemodialysis (ICHD) treatment area during 2 of 2 days of ICHD treatment area observations, which had the potential to affect 66 active ICHD patients. Findings include: 1. The facility policy “Bleach Policy” indicated bleach solution needed to be covered with a secure lid. Without a secure lid, the bleach solution was open to air, which caused the solution to degrade over time and become less effective. 2. During the flash tour observation on 9/16/24 beginning at 9:22 AM, 3 bleach containers sitting on a counter with the ICHD treatment floor did not have the lids secured. 3. During an observation on 9/16/24 beginning at 1:38 PM, Patient Care Technician (PCT) 2 cleaned dialysis Station #5. She walked over to the counter and dipped the prime bucket in the open bleach container containing used clamps. PCT 2 then rinsed the prime bucket in the sink and returned the prime bucket to Station #5. 4. During an observation on 9/16/24 beginning at 2:50 PM, PCT 3 emptied the small trash can from Station #3 into the large trash can. PCT 3 smashed the waste down into the larger trash can by pushing the small trash can from Station #3 down into the large trash can. PCT 3 failed to clean the small trash can before placing back into the clean Station #3. 5. During an observation on 9/16/24 beginning at 3:04 PM, the trash can next to the medication prep counter was overflowing; gauze dressing wrappers and paper towels were on the floor next to the trash can. 6. During an observation on 9/17/24 beginning at 8:38 AM, 3 bleach containers sitting on a counter within the ICHD treatment floor did not have the lids secured. 7. During an interview on 9/17/24 beginning at 1:45 PM, the Alternate Nurse Director relayed the bleach container lids should “typically” remain on, however staff could have the bleach container lid tilted off during shift change in order for easy acccess in and out of the container, and station trash bins should be emptied in between patients. Alternate Nurse Director reported the prime bucket should not have been dipped in the bleach container and should have been cleaned with bleach wipes in the station. 42617 8. During an interview on 9/17/24 beginning at 11:38 AM, PCT 5 reported the lids to the bleach containers should remain on except when staff were getting bleach out.”

“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: 48224 Based on observation and interview, the dialysis facility failed to ensure all staff and patients followed hand hygiene procedures for 1 of 2 Patient Care Technicians (PCTs) observed assisting a performing discontinuation of AV fistula/graft dialysis (PCT 1) and 1 of 1 Home therapy clinic visit observation (Registered Nurse (RN) 3). Findings include: 1. The agency policy “Infection Control for Dialysis Facilities” indicated hand hygiene will be performed prior to gloving and immediately after removal of gloves. 2. During an observation on 9/16/24 beginning at 9:44 AM, PCT 1 was observed handing Patient #1 a glove to don to hold pressure on their right arm post treatment to achieve homeostasis. PCT 1 failed to instruct Patient #1 to perform hand hygiene prior to donning the glove and failed to provide hand sanitizer to the patient prior to handing the patient the glove. During an interview on 9/16/24 beginning at 9:53 AM, PCT 1 relayed the patient should use hand sanitizer when they enter and leave the treatment area. During an interview on 9/18/24 beginning at 1:44 PM, Nurse Director relayed hand hygiene should have been performed prior to donning gloves and the PCT should have given the patient hand sanitizer to apply to hands prior to donning the glove. 45607 3. During a clinic visit observation of RN 3 providing care for Patient #9 on 9/17/24 beginning at 1:17 PM, the nurse used gloved hands to put on a face shield prior to accessing Patient #9’s peritoneal dialysis (PD) catheter. RN 3 failed to change gloves and perform hand hygiene after putting on the face shield and prior to accessing the catheter. After peeling back the dressing with gloved hands to assess Patient #9’s PD catheter exit site, RN 3 doffed the gloves, performed hand hygiene, and removed the packaging from a Mircera pre-filled syringe (a medication used to treat anemia related to chronic kidney disease). RN 3 then donned gloves without again performing hand hygiene. During an interview on 9/17/24 at 1:58 PM, RN 3 hand hygiene should be done before a treatment or procedure, after putting on a face shield, immediately before putting on gloves, and immediately after glove removal.”

“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: 48224 Based on observation, policy review and interview, the dialysis center failed to ensure staff wore the required personal protective equipment (PPE) when spurting or spattering of blood might occur for 1 of 3 Patient Care Technicians (PCTs) observed on the treatment floor during the flash tour observation (PCT 2). Findings include: 1. The agency policy “Personal Appearance” indicated teammates must wear slip-resistant, closed toe shoes. 2. During the flash tour observation on 9/16/24 beginning at 9:22 AM, PCT 2 was observed providing care on the in-center treatment floor (ICHD) wearing rubber shoes with holes throughout them. PCT 2 failed to wear the required footwear while in the patient care area. 3. During an interview on 9/18/24 beginning at 1:14 PM, Nurse Director relayed all staff should wear closed shoes while on the treatment floor. 42617 4. During an interview on 9/16/24 beginning at 3:41 PM, PCT 2 reported shoes worn on the ICHD treatment floor should have a covered toe and be slip-resistant. When queried if the employee’s current shoes adhered to the facility’s dress code since there were ventilation holes on the top of the shoes, PCT 2 reported the shoes were appropriate “as long as I don’t get fluid on” them. The technician reported she had not been advised by administrative staff these shoes violated the dress code policy.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 48224 Based on observation and interview, the dialysis facility failed to store potentially infectious waste properly to maintain a sanitary environment within the In-Center Hemodialysis (ICHD) treatment area during 2 of 2 days of ICHD treatment area observations. Findings include: 1. During the flash tour observation on 9/16/24 beginning at 9:22 AM, two red waste bins labeled “Biohazard” were observed hinged open during the entire flash tour observation. The Biohazard bins evidenced a label on the lid which stated the lid should remain closed. Staff were observed placing potentially infectious waste from the stations into open biohazard bins. 2. During an observation on 9/16/24 beginning at 1:38 PM, two red waste bins labeled “Biohazard” were observed hinged open during the entire observation. The Biohazard bins evidenced a label on the lid which stated the lid should remain closed. Staff were observed placing potentially infectious waste from the stations into open biohazard bins. 3. During an observation on 9/17/24 beginning at 8:38 AM, two red waste bins labeled “Biohazard” were observed hinged open during the entire observation. The Biohazard bins evidenced a label on the lid which stated the lid should remain closed. Staff were observed placing potentially infectious waste from the stations into open biohazard bins. 42617 4. During an interview on 9/17/24 beginning at 11:38 AM, Patient Care Technician (PCT) 5 reported potentially infectious waste was stored in the red biohazard bins, which were “always” kept open. PCT 5 was unsure of the reason there was a label on the bin which stated to keep the lid closed. 5. During an interview on 9/17/24 beginning at 1:45 PM, when quieried if the biohazard bin lids should remain open or closed, Alternate Nurse Director reported she was unsure. Corporate Employee 1 reported the biohazard bin lids should remain closed.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42617 Based on observation, record review and interview, the dialysis facility failed to ensure staff disinfected a multi-use medication vial prior to drawing up a medication for 1 of 4 intravenous medication preparation observations (Patient Care Technician (PCT) 4). 48224 1. During an observation on 9/18/24 beginning at 1:42 PM, PCT 4 was observed at the medication prep counter. PCT 4 drew up Heparin in a syringe from the multi-use bottle. PCT 4 failed to disinfect the top of the multi-use Heparin bottle prior to inserting the needle to draw up the medication. During an interview on 9/18/24 beginning at 1:54 PM, the Nurse Director relayed PCT 4 should have cleansed the top of the Heparin bottle and let it air dry for at least 5 seconds before drawing up the medication in the syringe.”

“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: 48224 Based on observation, policy review and interview, the dialysis facility failed to ensure staff followed procedures and best practices related to Central Venous Cather (CVC) care for 1 of 1 CVC discontinuation of dialysis performed by the Registered Nurse (Patient #16) and 1 of 2 CVC site care observations (Patients #28) Findings include: 1. The agency policy “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” indicated a 15 second hub scrub of the CVC should be performed 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. When performing site care to a patient’s CVC, staff should remove the old dressing, change gloves and perform hand hygiene, then clean the CVC exit site with a disinfectant. The disinfectant should be applied “progressing from the insertion site to the periphery ....” After cleaning the site, staff should change their gloves and perform hand hygiene. With new gloves on, staff should place a “sterile 2x2 gauze over the catheter exit site ... Minimize contact with the 2x2 gauze by holding only a corner. Seal edges of gauze with tape ....” The procedure’s “rationale” for holding the gauze by only the corner was to minimize “cross-contamination.” 2. During an observation at Station #12 on 9/16/24 beginning at 3:04 PM, Registered Nurse (RN) 2 was observed disconnecting Patient #16’s blood lines during the discontinuation of dialysis. PCT 2 cleansed the red hub for 8 seconds and the blue hub for 10 seconds. RN 2 failed to cleanse the CVC hubs for at least 15 seconds. During an interview on 9/16/24 beginning at 3:26 PM, RN 2 relayed the hubs should have been cleansed for 60 seconds each. 42617 3. During an observation at Station #12 on 9/17/24 beginning at 6:54 AM, PCT 1 was observed performing site care to Patient #28’s CVC. The technician removed the old dressing then immediately performed external disinfection of the catheter hubs, failing to change gloves and perform hand hygiene after removing the old dressing. PCT 1 cleaned the catheter site with a disinfectant from the outer part of Patient’s chest (a “dirty” area) to the insertion site (a “clean” area). During an interview on 9/17/24 beginning at 12:07 PM, PCT 1 reported when performing CVC site care, he disinfected the area in a “clockwise” manner, starting at the insertion site and going outward. PCT 1 reported staff should not use the same wipe when going from a “dirty” area to a “clean” area. During an interview on 9/17/24 beginning at 1:45 PM, Alternate Nurse Director relayed the CVC hubs should be scrubbed for at least 15 seconds. When performing CVC site care, staff should change gloves and perform hand hygiene after removing the old dressing, and should “never cross back” from a dirty area to a clean area with a disinfectant.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure all components of the water purification system were present and staff were educated on how to access for 1 of 1 observation of water room opening procedures, which had the potential to affect 66 active in-center hemodialysis patients. Findings include: 1. The review of facility policy “Daily Water Treatment System Monitoring” indicated “observations and test results listed on the Daily Water Treatment Log ... are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments ....” 2. During an observation of water room opening procedures on 9/17/24 beginning at 4:00 AM, Patient Care Technician (PCT) 5 completed the “CWP Daily Water Log,” which included tracking of the “Feed Water Temperature.” PCT 5 failed to log this temperature during opening procedures. During an interview with PCT 5 on 9/17/24 at 4:26 AM, she reported the temperature gauge for feed water temperature had been gone approximately 1 week. PCT 5 reported staff had no other way to obtain this temperature. 3. The review of the “CWP Daily Water Log” evidenced staff failed to log a feed water temperature while opening the water room from 9/11/24 - 9/18/24. 4. During an interview with Biomed Technician 1 on 9/17/24 beginning at 11:16 AM, he reported the temperature gauge used to obtain the feed water temperature had been removed approximately 1 week prior to the survey and had not yet been replaced. Biomed Technician 1 reported the feed water temperature could be monitored through the Reverse Osmosis (RO) system, however floor staff were “probably” not trained on how to obtain the temperature this way as the clinic did not want staff “pushing too many buttons.” 5. During an interview on 9/17/24 beginning at 1:45 PM, Alternate Nurse Director reported the thermometer gauge for the feed water temperature had been “missing” for approximately 1 week. Alternate Nurse Director stated staff could obtain this temperature from a temporary booster pump currently in use, however she did not think this method of obtianing the temperature reading was shown to staff.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff performed a total chlorine test according to facility procedure and manufacturer’s instructions for 1 of 1 observation of a total chlorine test performed by a Patient Care Technician (PCT 5). Findings include: The review of facility procedure “Total Chlorine Test using PRC Ultra Low Total Chlorine Test Strip” indicated staff were to dip the chlorine testing strip into the water sample for “60 seconds,” shake the strip to remove excess water, then wait “20 seconds for the test strip color to develop” prior to reading the test. During an observation of water room opening procedures on 9/17/24 beginning at 4:00 AM, PCT 5 performed a total chlorine test. The technician failed to dip the testing strip in the water sample for 60 seconds and failed to wait 20 seconds after removing the strip to read the test results. During an interview with PCT 5 on 9/17/24 beginning at 4:10 AM, she reported the total chlorine testing strip should be dipped in the water sample for “10 seconds” and the results could be read immediately after removing the strip from the sample. During an interview with Alternate Nurse Director on 9/17/24 beginning at 1:45 PM, she reported the total chlorine testing strip should be dipped in the water sample for “1 minute.” When queried how long staff should wait to read the test after removing the strip from the sample, Alternate Nurse Director reported she would read the test strip results immediately after shaking the strip once to remove excess water. During a follow-up interview with Alternate Nurse Director on 9/17/24 at 2:48 PM, she reported staff should wait 20 seconds to read a total chlorine test strip after removing it from the water sample.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure the conductivity of a bicarbonate mixture was tested using 2-person verification for 1 of 1 observations of bicarbonate concentrations mixed on-site, which had the potential to affect 66 active in-center hemodialysis (ICHD) patients. Findings include: The review of facility policy “Better Water-Central Bicarb Mixing and Delivery” indicated after one employee prepared and tested the bicarbonate mixture, a second employee was to perform “secondary verification.” During an observation of opening water room procedures on 9/17/24 beginning at 4:00 AM, Patient Care Technician (PCT) 5 was observed preparing 2 batches of a bicarbonate mixture. The technician performed a test of the bicarbonate mixture’s conductivity and logged the result in the “Bicarb Mix Log.” During an interview with PCT 5 on 9/17/24 beginning at 4:37 AM, she reported Registered Nurse (RN) 4 would perform an independent test to verify the bicarbonate mixture’s conductivity. During an interview with RN 4 on 9/17/24 beginning at 7:49 AM, she reported she verified the conductivity of the bicarbonate mixture by reviewing PCT 5’s logged conductivity value. RN 4 reported she did not perform an independent check to verify the bicarbonate mixture’s conductivity. During an interview with Alternate Nurse Director on 9/17/24 beginning at 1:45 PM, she reported both the technician preparing the bicarbonate mixture and a nurse should perform conductivity testing of all bicarbonate mixtures prepared.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 42617 Based on observation, procedure review, and interview, the dialysis facility failed to ensure staff performed an independent verification of dialysate pH prior to initiating patient treatment for 12 of 12 in-center hemodialysis (ICDH) patients observed initiating treatment on 9/17/24 (Patients #6, 11, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28). Findings include: 1. The review of facility procedure “Machine Start Up and Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Streamline Blood Lines for First Shift of the Day,” indicated staff should perform an independent verification of the dialysis stations’ dialysate pH prior to initiating a patient’s treatment. 2. During an ICHD treatment observation on 9/17/24 beginning at 4:00 AM, Patient Care Technicians (PCT) 1, 5, and 6 were observed performing opening procedures and initiating dialysis treatments on Patients #6, 11, 18, 19, 20, 21, 22, 24, 25, 26, 27, and 28 at Stations #1-12. The employees failed to perform independent verification of the dialysate pH at each station prior to initiating the patients’ dialysis treatments. During an interview with PCT 6 on 9/17/24 beginning at 7:20 AM, he reported independent testing of each machine’s dialysate pH was to be performed prior to initiating treatment using pH testing strips, however the technician was unable to locate the testing strips on the treatment floor. PCT 6 stated he did not perform pH testing of the machines that morning prior to initiating the patients’ dialysis treatments. During an interview with PCT 5 on 9/17/24 beginning at 7:40 AM, she reported independent testing of each machine’s dialysate pH was to be performed using pH testing strips, however the testing strips were not on the treatment floor that morning. PCT 5 was unsure if the pH testing had been performed prior to initiating patient treatments. During an interview with RN 4 on 9/17/24 beginning at 7:49 AM, she reported independent testing of each machine’s dialysate pH was normally included in opening and treatment initiation procedures. RN 4 reported she did not perform independent pH verification of the machines’ dialysate prior to the first shift patients’ treatment being initiated. During an interview with PCT 1 on 9/17/24 beginning at 7:59 AM, he reported an independent verification test of the dialysate pH was no longer required prior to initiating treatment. During an interview with Alternate Nurse Director on 9/17/24 beginning at 1:45 PM, she reported each machine’s dialysate pH should be independently tested prior to the initiation of each patient treatment.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to ensure medications were not expired and supplies were stored off the floor for 1 of 1 flash tour and failed to ensure the floor was dry in the treatment area for 1 of 1 in-center hemodialysis ICHD treatment station observed with fluid on the floor (Station 1). Findings include: 1. Review of the Medication Policy, revised October 2023 indicated “The Facility Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory ... All medications are checked monthly for expiration dates ... Disposal of expired medications ... are removed from the treatment and inventory areas and disposed of per state/local regulations ...” 2. A review of the Medications Requiring Refrigeration policy, revised December 2022, indicated “The refrigerator is checked ... by a licensed nurse teammate or designee ... Daily checks will include ... No expired medication ...” 3. Review of the Patient Fall Prevention policy, revised April 2021, indicated “Some examples of basic safety interventions are ... Keep spills wiped up ...” 4. During a flash tour on 9/16/24 beginning at 9:17 AM, observed 2 boxes of face shields and 2 jugs of 2K Granuflo dialysate on the floor of the water treatment room and observed 2 unopened boxes of Parsabiv injector 10 x 0.5 milliliters single dose vials (a medication used to treat secondary hyperparathyroidism in adult hemodialysis patients). One box expired in July 2024, and the other box expired in August of 2024. Two boxes of supplies were observed to be directly on the floor outside the water treatment room door next to a pallet with other boxes, and 15 boxes of supplies were observed stacked directly on the floor outside the storage room next to pallets with other boxes on them. 5. During an interview on 9/16/24 at 9:25 AM, BioMed 1 indicated the facility does not usually use jugs of dialysate and a permanent storage area needed to be found for them. BioMed 1 further indicated the boxes of face shields should not be on the floor. 6. During an interview on 9/16/24 at 9:35 AM, RN 3 indicated the 2 boxes of Parsabiv were expired, and as far as she knew shouldn’t be in the refrigerator. 7. During an interview on 9/16/24 at 9:37 AM, RN 1 indicated the 2 boxes of Parsabiv were expired and shouldn’t be in the refrigerator. 8. During an interview on 9/16/24 at 9:46 AM, the Administrative Assistant indicated the boxes on the floor were stuff that needed to be put away. 9. During an interview on 9/16/24 at 10:00 AM, the Administrator indicated the boxes on the floor in the hallway were from a new shipment that had been delivered that staff was in the process of putting away. The Administrator further indicated anything inside the storage or water treatment areas should be off the floor and on pallets and indicated a nurse should check medications monthly for expiration dates. 42617 10. During an observation on 9/17/24 beginning at 7:03 AM, Registered Nurse (RN) 4 took Patient 18 to Station #1 for their dialysis treatment. A clear liquid was observed in the station extending out from under the dialysis machine approximately 2 feet. After Patient was seated in the treatment chair, PCT 5 covered the fluid with absorbent pads, a “Caution” sign, and a portable oxygen machine. During an interview with PCT 5 on 9/17/24 beginning at 7:04 AM, she reported the machine at Station 1 “leaks” intermittently and staff generally clean up the leak with absorbent pads. During an interview with Alternate Nurse Director on 9/17/24 beginning at 1:45 PM, she reported staff should clean up any fluid on a treatment station’s floor prior to the patient entering the station in order to reduce fall risk.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to store and monitor glucometer testing and quality control supplies according to facility procedure and manufacturer’s instructions for 1 of 1 flash tour observations, which had the potential to affect 66 active in-center hemodialysis patients. Findings include: 1. The facility policy “EmbracePro Blood Glucose Monitor: Quality Control (QC)” indicated when opening a new container of glucometer test strips and control solutions, staff should write the “open and discard dates” on the side of the containers. 2. During a facility flash tour on 9/16/24 beginning at 9:21 AM, one opened container of glucometer test strips and 2 opened containers of glucometer control solutions were observed. The containers failed to evidence open nor discard dates. 3. During an interview with Nurse Director on 9/16/24 beginning at 11:30 AM, she reported staff should write the date a container of glucometer test strips and control solutions was opened on the side of the container.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 45607 Based on observation, record review, and interview, the dialysis facility failed to ensure mailing addresses and telephone complaint numbers for the renal network and State Agency (SA) were posted where it could easily be seen and read by patients for 1 of 1 flash tour. Findings include: 1. Review of the Patient Rights policy, revised October 2021, indicated “The facility will prominently display a copy of the patient rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers.” 2. During a flash tour on 9/16/24 beginning at 9:17 AM, observed contact information for the renal network and SA were not posted in the patient waiting area.’ 3. During an interview on 9/16/24 at 9:51 AM, when queried regarding where the renal network and State agency contact information was posted, the Administrative Assistant produced a flyer with that information from her workstation and indicated she needed to find something to hang it with. 4. During an interview on 9/16/24 at 5:05 PM, the Administrator indicated the renal network and SA hotline numbers were not posted in the patient lobby area.”

“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: 45607 Based on record review and interview, the dialysis facility failed to identify the patient as unstable, conduct monthly reassessments, and revise the plan of care (POC) for 1 of 2 home therapy patient records reviewed (Patient #9). Findings include: 1. A review of the Interdisciplinary Team (IDT) Patient Assessment and Plan of Care policy, revised July 2023, indicated “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 ... marked deterioration in health status ...” 2. A review of Patient #9’s clinical record included a POC dated 1/24/24. The POC included but not limited to a goal to prevent peritonitis. The clinical record also included a nurse noted signed by RN 3 on 5/13/24 indicated Patient #9 was positive for Staphylococcus peritonitis, a life-threatening condition that involves inflammation of the tissue that lines the abdominal wall and covers most of the abdominal organs. A Peritonitis Worksheet included but not limited to “Change patient status to ‘Unstable’ in EMR [electronic medical record] and plan for Assessment and Plan of Care ...” with the date 5/14/24 next to it. A Peritonitis Worksheet started on 8/13/24 Patient #9 had Staphylococcus peritonitis again. The clinical record failed to evidence Patient #9 was marked as unstable or that the patient was reassessed monthly with POC revisions. During an interview on 9/18/24 at 11:27 AM, RN 3 indicated a peritonitis worksheet was filled out each time the patient had peritonitis. RN 3 further indicated she wasn’t sure if the patient’s status had been updated to unstable or whether the POC had been updated. During an interview on 9/18/24 at 2:46 PM, RN 3 relayed Patient #9 had not been designated as unstable and had not had an update to his POC from 1/24/24. During an interview on 9/18/24 at 5:37 PM, Corporate Person 2, the Regional Home Therapy Manager, indicated the facility’s policies did not expressly say peritonitis was a cause for an update to the POC or for the patient to be designated as unstable.”

“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: 48224 Based on observation, record review and interview, the dialysis facility failed to ensure the Registered Nurse (RN) and/or physician were notified of blood pressures (BP) outside of parameters during In Center Hemodialysis (ICHD) treatment for 3 of 6 ICHD clinical records reviewed (Patient #1, 4 and 7); failed to ensure pre-treatment and/or post-treatment standing BP checks were performed for 4 of 5 ambulatory ICHD clinical records reviewed (Patient #1, 5, 6 and 7); failed to ensure the Estimated Ultrafiltration Rate (UFR) adhered to the physcian order and best practice for 2 of 6 ICHD clinical records reviewed (Patient #4 and 6), and failed to ensure the patient’s dialysate bath concentration adhered to their orders for 1 of 12 ICHD dialysis prescription verifications performed on 9/17/24 (Patient #28). Findings include: 1. The facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” indicated standing blood pressure measurements were “required” pre-and post- treatment. If a patient was unable to stand, staff were to document the reason in the record. The patient’s prescription and machine settings were to be verified by an employee prior to the initiation of treatment, and the nurse was to confirm the settings within one hour of treatment initiation, including “UFR [ultrafiltration rate, the rate fluid is removed from the body] and Max UFR ... Correct dialysate composition ....” The policy indicated “abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately,” which included: a. A pre-dialysis systolic (top number of the BP reading) above 180 or below 90 b. A pre-dialysis diastolic (bottom number of the BP reading) above 100 or below 50 c. An intra-dialysis systolic reading above 180 or less than 90 d. An intra-dialysis diastolic reading above 100 or less than 50 e. A post-dialysis systolic reading above 140 or less than 90 f. A post-dialysis diastolic reading above 90 or less than 50 The policy indicated the nurse would notify the physician or nurse practitioner “as needed for changes in patient status.” 2. Patient #1’s ICHD treatment sheets, dated 8/28/24 to 9/16/24, were reviewed and evidenced the following: a. On 8/28/24, the ICHD treatment began at 5:53 AM. The BP check at 5:54 AM indicated BP of 191/78.The BP check at 6:02 AM indicated BP of 199/100. The BP check at 6:32 AM indicated BP of 189/91. The clinical record failed to evidence the PCT notified the RN of the high BP. b. On 8/30/24, the ICHD treatment began at 6:03 AM. The BP check at 6:04 AM indicated BP of 186/87. The clinical record failed to evidence the PCT notified the RN of the high BP. The clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. c. On 9/02/24, the ICHD treatment began at 6:20 AM. The BP check at 7:03 AM indicated BP of 184/87. The clinical record failed to evidence the PCT notified the RN of the high BP. The BP check at 8:03 AM indicated BP of 181/79. The clinical record failed to evidence the PCT notified the RN of the high BP. d. On 9/09/24, the ICHD treatment began at 6:51 AM. The BP check at 7:00 AM indicated BP of 187/88. The clinical record failed to evidence the PCT notified the RN of the high BP. The BP check at 7:30 AM indicated BP of 185/79. The clinical record failed to evidence the PCT notified the RN of the high BP. e. On 9/11/24, the ICHD treatment began at 5:47 AM. The BP check at 6:02 AM indicated BP of 193/97. The clinical record failed to evidence the PCT notified the RN of the high BP. During an interview on 9/17/24 beginning at 2:20 PM, the Alternate Nurse Director relayed the clinical record for Patient #1 failed to include documentation of the RN being notified of the above elevated BPs. During an interview on 9/18/24 beginning at 1:14 PM, the Nurse Director relayed standing BP checks should be performed on all ambulatory patients pre and post dialysis treatment. 3. Patient #5’s ICHD treatment sheets, dated 8/28/24 to 9/13/24, were reviewed and evidenced the following: a. On 8/28/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. b. On 8/30/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. c. On 9/02/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. d. On 9/04/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. e. On 9/06/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. f. On 9/09/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. g. On 9/11/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. h. On 9/13/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. During an interview on 9/18/24 beginning at 2:03 PM, the Nurse Director relayed the clinical record for Patient #5 did not include standing BP checks during any of the above treatment dates. 4. Patient #6’s ICHD treatment sheets, dated 8/31/24 to 9/17/24, were reviewed and evidenced the following: a. On 8/31/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre and post dialysis standing BP checks were performed. b. On 9/03/24, the ICHD treatment began at 6:45 AM. The Pre-treatment fluid calculation evidenced an Estimated Ultrafiltration Rate (UFR) of 14.18 ml/kg/hr. RN 1 verified the machine settings at 6:53 AM. RN 1 failed to adjust the UFR to the maximum prescribed dose of 13.0 ml/kg/hr. The post-treatment total evidenced an actual UFR of 16.6 ml/kg/hr. The clinical record failed to evidence the physician was notified of the increased UFR. The clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. c. On 9/05/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. d. On 9/07/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. e. On 9/10/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. f. On 9/12/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. g. On 9/14/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. h. On 9/17/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. During an interview on 9/18/24 beginning at 1:55 PM, the Nurse Director relayed Patient #5 often refused to stand for BP checks. She verified the clinical record for Patient #5 did not include standing BP checks during any of the above treatment dates and did not include documentation of Patient #5 refusing standing BP checks. She also relayed the clinical record did not include documentation of physician notification regarding the UFR on 9/03/24. 5. Patient #7’s ICHD treatment sheets, dated 9/03/24 to 9/14/24, were reviewed and evidenced the following: a. On 9/03/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. b. On 9/05/24, the BP check at 2:35 PM indicated BP of 187/83. The clinical record failed to evidence the PCT notified the RN of the high BP. The clinical record evidenced that the patient was ambulatory and failed to evidence the pre and post dialysis standing BP checks were performed. c. On 9/07/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. d. On 9/10/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. e. On 9/12/24, the clinical record evidenced that the patient was ambulatory and failed to evidence the pre dialysis standing BP check was performed. f. On 9/14/24, the BP check at 2:31 PM indicated BP of 192/103. The clinical record failed to evidence the PCT notified the RN of the high BP. The BP check at 5:01 PM indicated BP of 80/46, recheck at 5:03 PM indicated BP of 83/42 and recheck at 5:04 indicated BP of 79/35 at the end of dialysis treatment. The clinical record evidenced Patient #7 was discharged to home and failed to evidence the PCT notified the RN of the low BP’s. The clinical record evidenced that the patient was ambulatory and failed to evidence the pre and post dialysis standing BP checks were performed. During an interview on 9/18/24 beginning at 1:44 PM, the Clinical Manager verified the clinical record for Patient #7 did not include standing BP checks during any of the above treatment dates and the clinical record failed to include documentation of the RN being notified of low or high BP checks. 42617 6. Patient #4’s ICHD treatment sheets, dated 9/03/24 - 9/14/24, were reviewed and evidenced the following: a. On 9/03/24, Patient’s pre-treatment blood pressure was 191/100. Treatment began at 4:01 PM. Patient’s vital sign readings intra-dialysis, record by PCT 5, evidenced the following: i. At 4:02 PM, Patient’s BP was 189/100 ii. At 4:04 PM, Patient’s BP was 185/102 Patient’s treatment ended at 7:24 PM. His/her post-treatment standing BP was 207/105 and sitting BP was 191/99. The record failed to evidence PCT 5 notified Nurse Director of Patient’s elevated blood pressure pre-treatment and during treatment, nor did Nurse Director notify the physician of Patient’s elevated blood pressures. b. On 9/07/24, Patient’s pre-treatment blood pressure was 196/105. Treatment began at 3:10 PM. The pre-treatment fluid calculation evidenced an Estimated UFR of 18.83 ml/kg/hr. RN 2 verified the machine settings at 3:12 PM but failed to adjust the UFR to the maximum prescribed rate of 13.0 ml/kg/hr. Patient’s vital sign readings intra-dialysis, recorded by PCTs 3 and 4, evidenced the following: i. At 3:31 PM, Patient’s BP was 206/107 ii. At 3:33 PM, Patient’s BP was 186/101 iii. At 4:01 PM, Patient’s BP was 193/97 iv. At 4:31 PM, Patient’s BP was 190/98 v. At 5:01 PM, Patient’s BP was 191/98 vi. At 5:31 PM, Patient’s BP was 189/102 vii. At 6:01 PM, Patient’s BP was 195/101 viii. At 6:11 PM, Patient’s BP was 193/97 Patient’s treatment ended at 6:15 PM, and his/her post-treatment sitting blood pressure was 204/95. Patient’s Actual UFR during treatment was 21.7 ml/kg/hr. The record failed to evidence PCT 3 and PCT 4 notified RN 2 of Patient’s elevated blood pressure pre-treatment and during treatment, nor did RN 2 notify the physician of Patient’s elevated blood pressure and UFR greater than 13.0 ml/kg/hr. c. On 9/10/24, Patient’s pre-treatment blood pressure was 188/103. Treatment began at 4:09 PM. The pre-treatment fluid calculation evidenced an Estimated UFR of 22.93 ml/kg/hr. Nurse Director verified the machine settings at 4:47 PM but failed to adjust the UFR to the maximum prescribed rate of 13.0 ml/kg/hr. Patient’s vital sign readings intra-dialysis, recorded by PCT 4, evidenced the following: i. At 4:09 PM, Patient’s BP was 206/115 ii. At 7:01 PM, Patient’s BP was 191/101 iii. At 7:11 PM, Patient’s BP was 220/116 Patient’s treatment ended at 7:11 PM. His/her post-treatment sitting BP was 216/116, standing BP was 205/117, and Actual UFR during treatment was 22.7 ml/kg/hr. The record failed to evidence PCT 3 notified Nurse Director of Patient’s elevated blood pressures pre-treatment and during treatment, nor did Nurse Director notify the physician of Patient’s elevated blood pressures and UFR greater than 13.0 ml/kg/hr. d. On 9/14/24, Patient’s treatment began at 4:14 PM. The pre-treatment fluid calculation evidenced an Estimated UFR of 14.32 ml/kg/hr. RN 5 verified the machine settings at 4:16 PM but failed to adjust the UFR to the maximum prescribed rate of 13.0 ml/kg/hr. Patient’s vital sign readings intra-dialysis, recorded by PCTs 3 and 7, evidenced the following: i. At 4:15 PM, Patient’s BP was 172/118 ii. At 4:34 PM, Patient’s BP was 228/120 iii. At 5:02 PM, Patient’s BP was 199/108 iv. At 5:32 PM, Patient’s BP was 199/109 Patient’s treatment ended at 7:14 PM. His/her Actual UFR was 16.7 ml/kg/hr. The record failed to evidence PCT 3 and PCT 7 notified RN 5 of Patient’s elevated BPs during treatment, nor did RN 5 notify the physician of Patient’s UFR greater than 13.0 ml/kg/hr. During an interview with Nurse Director on 9/18/24 beginning at 3:38 PM, she reported Patient was non-compliant with his/her medication which resulted in their blood pressure readings being elevated. When queried if nursing staff notified Patient’s physician of the elevated blood pressures, Nurse Director reported Nurse Practitioner (NP) 1 was “usually” on the treatment floor and the nursing staff would inform her of Patient’s BP readings. Nurse Director reported Patient’s record included a written physician order for Patient to receive treatment with an elevated BP, however the facility was unable to produce this order. Nurse Director stated the dialysis machines “usually” could not be set to a UFR greater than 13 ml/kg/hr, however Patient was “tiny,” and if the machine removed fluid “quicker,” Patient’s UFR would be higher than the maximum ordered rate. 7. Patient #28’s ICHD treatment sheet dated 9/17/24 evidenced a current prescription for a dialysate bath composition of 3.0 Potassium (K). During an observation at Station #12 on 9/17/24 beginning at 6:35 AM, PCT 1 set up Patient #28’s machine for treatment. RN went to the station at 6:38 AM, performed Patient’s pre-treatment nursing assessment, and reviewed Patient’s dialysis settings with PCT 1. Patient’s dialysis treatment began at 7:11 AM. At 7:55 AM, Patient’s dialysis settings were reviewed with PCT 1. Patient’s dialysate bath was 2.0 K and the DFR was 500 ml/min. During an interview with PCT 1 on 9/17/24 at 7:59 AM, he confirmed Patient had not been receiving the correct dialysate bath concentration. PCT 1 reported the nurse was to verify all machine settings, including dialysate bath concentration. During a follow-up interview with PCT 1 on 9/18/24 at 11:50 AM, PCT 1 stated he reported the incorrect dialysate bath to RN 4 after it was discovered. During an interview with Medical Director on 9/18/24 beginning at 8:32 AM, she reported she was not notified Patient received the incorrect dialysate bath concentration during the first 44 minutes of treatment on 9/17/24. During an interview with RN 4 on 9/18/24 beginning at 2:20 PM, she reported she was unaware Patient #28 had received the incorrect dialysate bath concentration during the first 44 minutes of treatment. RN 4 reported she had verified Patient’s dialysis settings prior to treatment initiation.”

“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: 48224 Based on observation, record review, and interview, the dialysis facility failed to ensure the blood flow rate (BFR) and/or dialysate flow rate (DFR) were set according to physician orders for 3 of 6 in-center hemodialysis (ICHD) patient records reviewed (Patient #5, 6 and 7) and 1 of 12 ICHD prescription verification observations (Patient #28); and failed to ensure the patient received their entire treatment time as ordered for 4 of 6 ICHD patient records reviewed (Patient #1, 3, 6 and 7). Findings include: 1. The agency policy “Prescribed Treatment Time Not Met” indicated the Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice (AMA) form any time the patient requests to terminate their treatment earlier than the prescribed run time and if shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention and the RN will document the event in the patient’s health record including the amount of time shortened, description of why the treatment was shortened, whether the nephrologist was notified. 2. The agency policy “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” indicated the nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) and will include verification that machine safety checks have been completed and documented and verification of prescription including machine parameters. The policy also indicated machine settings are verified by a teammate prior to initiation of treatment and the prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. 3. Patient #1’s ICHD treatment sheets, dated 8/28/24 to 9/16/24, were reviewed and evidenced a physician ordered total run time of 3 hours and 30 minutes during the dialysis treatments. On 8/30/24, the ICHD treatment began at 6:03 AM. The total run time was 2 hours and 59 minutes. PCT 5 documented the shortened run time reason as facility emergency. The clinical record for Patient #1 failed to include documentation of the facility emergency and failed to include documentation that the physician was notified regarding the shortened run time. During an interview on 9/17/24 beginning at 2:20 PM, RN 1 relayed they were unsure of the reason for the shortened treatment and the clinical record for Patient #1 failed to evidence documentation of the facility emergency and failed to evidence documentation of the physician being notified. During an interview on 9/18/24 beginning at 11:49 AM, the Administrator relayed the dialysis facility does not have any record of a facility emergency on 8/30/24 and they were unsure why Patient #1’s treatment was shortened on 8/30/24. 4. Patient #3’s ICHD treatment sheets, dated 9/02/24 to 9/16/24, were reviewed and evidenced a physician ordered total run time of 3 hours and 30 minutes during the dialysis treatments. On 9/16/24, the ICHD treatment began at 4:51 PM. The total run time was 2 hours and 1 minute. PCT 3 documented the shortened run time reason as patient choice. The clinical record for Patient #3 failed to include a signed AMA form and failed to include documentation that the physician was notified regarding the shortened run time. During an interview on 9/18/24 beginning at 1:35 PM, the Nurse Director relayed the clinical record for Patient #3 did not include a signed AMA form and failed to include documentation that the physician was notified regarding the shortened treatment. 5. Patient #5’s ICHD treatment sheets, dated 8/28/24 to 9/13/24, were reviewed and evidenced the following: On 9/02/24, the ICHD treatment began at 4:13 PM with a DFR setting of 500 ml/hour for the entire treatment. The clinical record evidenced RN 2 verified the machine settings at 5:15 PM. RN 2 failed to adjust the DFR to the prescribed dose of 600 ml/hour and the clinical record failed to evidence the physician was notified of the incorrect DFR rate. During an interview on 9/18/24 beginning at 2:03 PM, the Nurse Director relayed Patient #5 probably had CVC issues and she verified the clinical record for Patient #5 failed to include documentation of the physician being notified of the incorrect DFR setting. 6. Patient #6’s ICHD treatment sheets, dated 8/31/24 to 9/17/24, were reviewed and evidenced a physician ordered BFR of 350 and DFR of 500ml/hour, with a total run time of 3 hours and 30 minutes during the dialysis treatments. On 9/05/24, the ICHD treatment began at 6:42 AM with a BFR setting of 200 ml/hour. At 8:02 AM, the BFR setting was increased to 250 ml/hour for the remainder of treatment. The clinical record evidenced RN 4 verified the machine settings at 6:51 AM. RN 4 failed to adjust the BFR to the prescribed dose of 350 ml/hour. The clinical record failed to evidence the physician was notified of the incorrect BFR rate. On 9/10/24, the ICHD treatment began at 7:00 AM with a BFR setting of 200 ml/hour. At 9:32 AM, the BFR setting was increased to 300 ml/hour for the remainder of treatment. The clinical record evidenced RN 4 verified the machine settings at 7:00 AM. RN 4 failed to adjust the BFR to the prescribed dose of 350 ml/hour and the clinical record failed to evidence the physician was notified of the incorrect BFR rate. On 9/14/24, the ICHD treatment began at 6:49 AM. The total run time was 2 hours and 35 minutes. RN 1 documented the shortened run time reason as patient choice. The clinical record for Patient #6 failed to include a signed AMA form and failed to include documentation that the physician was notified regarding the shortened run time. During an interview on 9/18/24 beginning at 11:10 AM, the Administrator relayed the clinical record for Patient #6 did not include a signed AMA form for the 9/14/24 shortened treatment. During an interview on 9/18/24 beginning at 1:55 PM, the Nurse Director relayed she was unsure the reason for the shortened treatment on 9/14/24 and verified the clinical record did not include a signed AMA form and did not evidence documentation that the physician was notified regarding the shortened treatment time or incorrect machine settings. 7. Patient #7’s ICHD treatment sheets, dated 9/03/24 to 9/14/24, were reviewed and evidenced a physician ordered BFR of 400 and DFR of 500ml/hour, with a total run time of 4 hours during the dialysis treatments. On 9/03/24, the ICHD treatment began at 2:58 PM with a BFR setting of 350 ml/hour for the entire treatment. The clinical record evidenced the Clinical Manager verified the machine settings at 3:58 PM. The Clinical Manager failed to adjust the BFR to the prescribed dose of 400 ml/hour and the clinical record failed to evidence the physician was notified of the incorrect BFR rate. On 9/12/24, the ICHD treatment began at 2:51 PM with a BFR setting of 350 ml/hour for the entire treatment. The clinical record evidenced RN 4 verified the machine settings at 2:58 PM. RN 4 failed to adjust the BFR to the prescribed dose of 350 ml/hour and the clinical record failed to evidence the physician was notified of the incorrect BFR rate. The total run time was 2 hours and 46 minutes. The PCT documented the shortened run time reason as patient choice. The clinical record for Patient #7 failed to include a signed AMA form and failed to include documentation that the physician was notified regarding the shortened run time. During an interview on 9/18/24 beginning at 11:10 AM, the Administrator relayed the clinical record for Patient #7 did not include a signed AMA form for the 9/14/24 treatment. During an interview on 9/18/24 beginning at 1:44 PM, the Nurse Director relayed the BFR settings were probably set low due to a sluggish Central Venous Catheter (CVC) and verified the clinical record failed to evidence documentation regarding this. During an interview on 9/18/24 beginning at 1:54 PM, RN 2 relayed they were unsure if Patient #7 signed an AMA form after treatment ended early on 9/14/24. 42617 8. Patient #28’s ICHD treatment sheet dated 9/17/24 evidenced a current prescription for a DFR of 700 ml/min. During an observation at Station #12 on 9/17/24 beginning at 6:35 AM, PCT 1 set up Patient #28’s machine for treatment. RN went to the station at 6:38 AM, performed Patient’s pre-treatment nursing assessment, and reviewed Patient’s dialysis settings with PCT 1. Patient’s dialysis treatment began at 7:11 AM. At 7:55 AM, Patient’s current dialysis settings were reviewed with PCT 1. Patient’s DFR was 500 ml/min. During an interview with PCT 1 on 9/17/24 at 7:59 AM, he confirmed the machine’s DFR was incorrect. PCT 1 reported the nurse was to verify all machine settings, including DFR. The technician reported the dialysis machine would intermittently change the DFR to a rate of 500 ml/min without staff knowledge. During a follow-up interview with PCT 1 on 9/18/24 at 11:50 AM, PCT 1 stated he reported the incorrect DFR to RN 4 after it was discovered. During an interview with RN 4 on 9/18/24 beginning at 2:20 PM, she reported she was unaware Patient #28 had received the incorrect DFR during the first 44 minutes of treatment. RN 4 reported she had verified Patient’s dialysis settings prior to treatment initiation.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to update the plan of care (POC) based on the patient’s condition for 1 of 2 home therapy patient records reviewed (Patient #9). Findings include: 1. A review of the Interdisciplinary Team (IDT) Patient Assessment and Plan of Care policy, revised July 2023, indicated “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted ... At least annually for stable patients ... At least monthly for unstable patients including, but not limited to, patients with ... marked deterioration in health status ... In addition, if the expected outcome is not achieved, the interdisciplinary team (or individual IDT member) will ... Adjust the patient’s plan of care to achieve the specified goal ... When the patient is unable to achieve the desired outcomes, the team will ... Adjust the 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 ...” 2. A review of Patient #9’s clinical record included a POC dated 1/24/24. The POC included but not limited to a goal to prevent peritonitis. A nurse noted signed by RN 3 on 5/13/24 indicated Patient #9 had tested positive for peritonitis due to Staphylococcus, a life-threatening condition that involves inflammation of the tissue that lines the abdominal wall and covers most of the abdominal organs. The clinical record failed to evidence the POC was updated to reflect the patient’s condition. 3. During an interview on 9/18/24 at 11:27 AM, RN 3 indicated a peritonitis worksheet was filled out each time the patient had peritonitis. RN 3 further indicated she wasn’t sure whether the POC had been updated. 4. During an interview on 9/18/24 at 2:46 PM, RN 3 relayed Patient #9 had not had an update to his POC. 5. During an interview on 9/18/24 at 5:37 PM, Corporate Person 2, the Regional Home Therapy Manager, indicated the facility’s policies did not expressly say peritonitis was a cause for an update to the POC.”

“H-PT/CAREGIVER DEMO COMPREHEND TRAINING CFR(s): 494.100(b)(1) The dialysis facility must - (1) Document in the medical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training; This Standard is not met as evidenced by: 45607 Based on record review and interview, the dialysis facility failed to ensure the medical record included documentation the patient was educated specific to their needs for 1 of 1 home therapy patient records reviewed with recurrent peritonitis (Patient #9). Findings include: 1. Review of Patient #9’s clinical record included a nurse note dated 5/10/24 and signed by RN 3 indicated Patient #9 had brought in an effluent sample for adequacy testing which RN 3 felt to have questionable clarity. The note further indicated RN 3 contacted Patient #9 who denied any other symptoms of infection and contacted Other Physician 1 for a culture and sensitivity order. Patient #9’s culture and sensitivity results were positive for Staphylococcus, indicating peritonitis. A nurse noted signed by RN 3 on 5/13/24 indicated Patient #9 continued to deny signs or symptoms of peritonitis, a life-threatening condition that involves inflammation of the tissue that lines the abdominal wall and covers most of the abdominal organs, despite testing positive for Staphylococcus. A Peritonitis Worksheet was started by RN 3 for Patient #9 on 5/14/24. The worksheet indicated the effluent was slightly cloudy on 5/13/24, was clearer on 5/14/24, and was clear on 5/19/24. A nurse note dated 8/06/24 and signed by RN 3 indicated Patient #9 called to say they thought they had peritonitis again, complaining of chills and abdominal pain. Patient #9 was instructed to go to the emergency room as their systolic blood pressure was also low. A nurse note dated 8/07/24 and signed by RN 3 indicated Patient #9 had contacted her the previous night to say the emergency department had done labs and a belly scan and had found no issues. A nurse note dated 8/13/24 indicated RN 3 observed Patient #9’s effluent was cloudy, and RN 3 found out the emergency department had not checked Patient #9’s peritoneal dialysis (PD) fluid. RN 3 obtained orders from Other Physician 1 for culture sensitive gram stain and antibiotics. A Peritonitis Worksheet started on 8/13/24 indicated Patient #9’s effluent was cloudy on 8/14/24 and 8/15/24 and was clear on 8/16/24 and Patient #9 had Staphylococcus peritonitis again. Patient #9’s treatment sheets dated 4/23/24 through 9/17/24 failed to evidence Patient #9 had recorded their effluent appearance. The clinical record failed to evidence Patient #9 was educated to observe their effluent regularly, despite cloudy effluent being the only sign or symptom leading to the diagnosis of peritonitis in May 2024 and a sign leading to the diagnosis of peritonitis in August 2024. 2. During an interview on 9/18/24 at 11:27 AM, RN 3 indicated education was performed for Patient #9 to document their effluent status, but they usually don’t because it’s draining into the shower or toilet. The clinical record failed to include documentation of Patient #9 being educated to record their effluent status.”

“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: 42617 Based on observation, policy review, and interview, the Medical Director failed to ensure staff adhered to all policies, procedures, and best practices specific to medication storage and fistula cannulation for 1 of 1 flash tour of the facility and 2 of 2 fistula cannulation observations (Patients #11, 26). Findings include: 1. The facility policy “Medication Policy” indicated non-refrigerated medications were to be “stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate ....” All opened and unopened medication packages were to be “stored according to the manufacturer’s directions ....” 2. The facility policy “AV Fistula or Graft Cannulation ...” indicated when staff were preparing to cannulate a fistula or graft, staff should cleanse the cannulation sites with 70% alcohol prep pads for “60 seconds,” change gloves and perform hand hygiene, then cannulate. 3. During a flash tour of the in-center hemodialysis (ICHD( treatment floor on 9/16/24 beginning at 9:21 AM, the following was observed: a. 1 opened multi-dose bottle of Tylenol (used to treat pain and/or fever) which failed to evidence a date the bottle was opened b. 1 opened multi-dose bottle of Calcium Carbonate (used to treat heartburn and/or indigestion) which failed to evidence a date the bottle was opened c. 1 opened multi-dose bottle of Heparin (used to thin the blood) which failed to evidence a date the bottle was opened d. Medicine cups filled with medications and patient labels on a counter where patients and staff had access. No staff were present monitoring access to the medications e. Medication cabinets unlocked with no staff present monitoring access to the medications During an interview with Nurse Director on 9/16/24 beginning at 11:30 AM, she reported opened bottles of medication should be labeled with the date the bottle was opened. During an interview with Alternate Nurse Director on 9/16/24 beginning at 2:47 PM, she reported she prepared the patients’ medications at the beginning of the shift. The medications would stay on the prep counter until Alternate Nurse Director took the medicine cup to the appropriate patient. When queried how the staff ensured the medications on the counter and in the unlocked medication cabinets were kept secured, Alternate Nurse Director reported she would “monitor” the medication area while on the ICHD treatment floor and the medication cabinets were locked at night. 4. During an observation at Station 7 on 9/17/24 beginning at 5:33 AM, Patient Care Technician (PCT) 6 was observed cannulating Patient #11’s fistula prior to initiating dialysis. After assessing the site, PCT 6 failed to change gloves and perform hand hygiene prior to cleaning the sites with 70% alcohol pads. The technician cleaned the first cannulation site for 10 seconds and the second site for 8 seconds. PCT 6 failed to change gloves and perform hand hygiene prior to cannulating the sites. During an interview with PCT 6 on 9/17/24 beginning at 7:24 AM, he reported each fistula cannulation site should be cleaned for “20 seconds” with betadine or 70% alcohol prep pads. When queried when he performed glove changes and hand hygiene during the procedure, PCT 6 stated he did this after cannulation. When queried if gloves should be changed and hand hygiene performed in between cleaning the site and cannulating, PCT 6 answered yes. 5. During an observation at Station 10 on 9/17/24 beginning at 6:22 AM, PCT 1 was observed cannulating Patient #26’s fistula prior to initiating dialysis. After assessing the site, PCT 1 failed to change gloves and perform hand hygiene prior to cleaning the sites with 70% alcohol pads. The technician cleaned the cannulation sites with alcohol pads for 4 seconds each. During an interview with PCT 1 on 9/17/24 beginning at 7:59 AM, he reported each fistula cannulation site should be cleaned for “3-5 seconds” with 70% alcohol prep pads. When queried when he performed glove changes and hand hygiene during the procedure, PCT 1 stated he did this after cannulation. When queried if gloves should be changed and hand hygiene performed in between cleaning the site and cannulating, PCT 1 answered yes. During an interview with Alternate Nurse Director on 9/17/24 beginning at 1:45 PM, she reported staff should change gloves and perform hand hygiene between cleaning the fistula sites and cannulation. Alternate Nurse Director was unsure how long staff were to clean each site with 70% alcohol prep pads. During a follow-up interview with Alternate Nurse Director on 9/17/24 beginning at 2:58 PM, she reported staff should clean each fistula site for “30 seconds” with 70% alcohol.”