Pure Life Renal of Sanford, LLC

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 13640 Based on interview and a review of facility documentation, the facility failed to ensure the performance of exercises to test the emergency plan annually, including either a full-scale community based exercise or a facility-based functional exercise, Findings: A review of the facility’s Emergency Plan revealed that a tabletop exercise for a hurricane was performed on 6/28/24. However, it did not include a post-drill evaluation. There was no evidence of any disaster drills having taken place from 2020 to present. On 8/07/25 at approximately 3:00 PM, the Administrator confirmed the preceding.”

“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: 37965 Based on observations, interviews and policy review the End Stage Renal Disease center (ESRD) failed to ensure that nursing staff utilized personal protective equipment appropriately during care of the dialysis patients for 1 of 2 charge Registered Nurses (RN) observed (RN A) and 1 of 4 Patient Care Technicians (PCT) observed (PCT B). The findings include: On 8/6/2025 at approximately 10:10 AM, an observation was made of staff member, B, a PCT initiating dialysis treatment for the patient at station #8. The PCT donned a pair of clean gloves, typed information into the station’s computer, obtained clamps from the supply cart in the center of the treatment floor, returned to the station, tore strips of tape and secured them to the side of the tray table attached to the dialysis chair, moved the patient’s shirt up and out of the way of the dialysis access site, cleaned the access site with alcohol, checked the site with two fingers, inserted the bottom needle then the top needle and secured the needles with the tape noted on the tray table. He was not observed to change his gloves or perform hand hygiene during the entire observation. On 8/6/25 at approximately 10:19 AM, an observation was made of staff member A, RN, approaching dialysis station 8 wearing a pair of blue gloves and carrying a syringe. She was observed to check the patient’s wrist and pedal pulses and listen to the patient’s lung sounds. She was then observed to attach the syringe to the patient’s upper port and flush the contents of the syringe stating at this time that it was “heparin”. She was not observed to change her gloves or perform hand hygiene during this observation. On 8/6/25 at approximately 10:22 AM, an observation was made of staff member B, PCT at station 8. He was observed to donn a clean pair of gloves, obtain a blanket from the patient’s bag, cover the patient, secure her dialysis lines to her shoulders using tape, type into the computer, adjust the blood pressure cuff, flush the dialysis lines with normal saline and connect the patient’s dialysis tubing to the dialysis machine. At no point was he observed to change his gloves or perform hand hygiene. On 8/7/25 at approximately 4:54 PM, an interview was conducted with the facility administrator who stated that it is never appropriate to wear one pair of gloves during the initiation of dialysis treatment. The gloves are to be changed after touching a contaminated surface such as the computer or the patient’s clothing/personal belongings. She stated that hands are to be sanitized before and after gloving. Review of policy 5.0 Handwashing, states the purpose as “To prevent the spread of infection among patients and staff.” The policy states “All dialysis practitioners (MD, ARNP, RN, RD, etc) must practice hand hygiene as outlined in the policy.” Examples of when hand washing should be performed: “After touching blood, body fluid, secretions, excretions and potentially contaminated items.” “Before and after direct contact with patients;” “Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications;” “Immediately after gloves are removed;” After contact with inanimate objects, including medical equipment or environmental surfaces at the patient station.” “When moving from a contaminated body site to a clean body site.””

“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: 37965 Based on observation and interview, the facility failed to ensure the separation of clean supplies and equipment from dirty supplies and equipment in 1 of 1 patient treatment areas observed. The findings include: On 8/6/25 at approximately 10:10 AM, an observation was made of dialysis station number 8 during which a patient was receiving dialysis treatment. Next to and touching the dialysis chair was a large sharps container that was visibly full to about an inch of the opening of used/contaminated dialysis treatment supplies to include blood filled syringes, tubing, and other medical waste. Bright red spots, that appeared to be blood, were noted on several areas on the outside of the lid of the container which was resting against the dialysis chair. On 8/6/25 at approximately 10:38 AM, an observation was made of a sink with a sign that stated “clean sink”. Next to the sink approximately 2 feet away was a large biohazard trash receptacle with the lid hanging open, that housed used dialysis tubing and blood lines. On 8/7/25 at 11:31 AM, a follow up observation was made of the sharps container adjacent to station 8. There was a blood full intravenous line sticking out of the opening in the top of the container, the container was observed to be full to about an inch from the top with discarded dialysis treatment supplies. At this time a follow up observation was made of the clean sink at the center island which revealed the large biohazard trash container pressed up against the sink. (Photographic evidence obtained) On 8/7/25 at 11:34 AM, the Facility Administrator who was working as the charge nurse on the floor was shown the overflowing sharps container at station 8 to which she stated that the sharps container should be replaced when it is ¾ of the way full. She verified this sharps container should have been changed out and that it was too full. She stated she was not sure why staff had not changed it out. She then verified the biohazard trash container up against the clean sink and stated this was not acceptable and should not be so close to the clean area. Review of the policy 7.0 a Medication Administration states under item 4, “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 where used equipment or blood samples are handled.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 13640 Based on interview and a review of facility documentation, the facility failed to ensure the implementation of a training program that includes quality water and dialysate testing, the risks and hazards of improperly prepared concentrate and bacterial issues for one of three sampled personnel files. Findings: A review of the personnel file Registered Nurse (RN) D revealed that she was hired on 9/09/24. There was no documentation which indicated that she had received training in quality testing, the risks and hazards of improperly prepared concentrate and bacterial issues. On 8/7/25 at 4:15 PM, the Administrator confirmed the preceding and stated the RN should have received the training..”

“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: 13640 Based on observation, interview and a review of facility documentation, the facility failed to ensure the provision of a safe environment with regards to opened vials of medication. Findings: On 8/06/25 at approximately 10:09 AM, an observation of the nurse’s station revealed nine opened vials of multi-dose Doxercalciferol injection 4 MG (milligrams) per 2 ML (Milliliters). None of the vials had any notation on their respective labels indicating when they had been opened. They had November of 2026 expiration dates. During an interview of staff member A, an RN at the above stated time, she confirmed that the vials had not been labeled and that they should have been labeled. She stated that she “just opened them a while ago and forgot to label them.” A review of facility policy Medication Administration revealed the following: “Multi-dose vials will be labeled with the first date opened and person’s initials who opened vial. Multi-dose vials will be discarded after 28 days (per CDC recommendation) unless the manufacturer guidelines or package inserts specify a different time period.” A review of facility policy Medication Policy revealed the following: “Multi-dose vials are to be dated, initialed when opened and kept after opening for the period of time as recommended by the manufacturer.” Per manufacturer instructions, vials of Doxercalciferol injection which had been opened must be discarded after three days of opening. The use of unlabeled vials has the potential to result in administration of a medication to a patient beyond the defined safety time limits. In addition, the facility was not in compliance with policies that address multi-dose vials.”

“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: 37965 Based on record reviews, interviews and a review of the facility’s policy and procedure, the facility failed to ensure patients with more than 3 hospitalizations in a 30 day period were identified as unstable for 1 of 4 patient medical record reviews (Patient #4 ) The findings include: A review of policy 1.20 Interdisciplinary Assessment and Plan of Care revealed the criteria that defines “unstable status” include - extended or frequent hospitalizations (i.e. hospitalization longer than 15 days and more than 3 hospitalizations within 30 days). The policy states that the comprehensive assessment and care plan are updated annually for stable patients and monthly for patients determined to be unstable. A record review was conducted for patient #4 which revealed he was admitted to the facility on 6/12/24 and was receiving dialysis treatment 3 times a week. A review of the dialysis prescription orders dated 2/13/25 revealed that he was to receive dialysis treatments three times a week for 255 minutes (4 hours and 25 minutes). A review of the dialysis center’s Hospital Admission and Readmission report for the calendar year of 2025 revealed that patient #4 had been in the hospital 14 times since January 2025. Between June 3, 2025 and July 30, 2025 he was admitted to the hospital on 5 occasions; June 3 for 8 days for high potassium, and June 27 for 3 days with the reason being noted as “patient admitted Friday night after dialysis”. For the month of July he was admitted on 4 occasions, on July 4 for 4 days for abdominal pain; July 12 for 3 days for constant vomiting and July 30 for 3 days the reason noted as “Wife states she is brining him to the hospital this morning at 6:11 AM States they got back in town late Monday.” No further information was provided. A review of the treatment count report for the month of May 2025 revealed the patient had received dialysis treatment 7 times, was noted to be in the hospital 4 times (May 12, 14, 16, and 19) and was absent twice (May 7 and 28th) A review of the treatment count report for the month of June 2025 revealed the patient had received dialysis treatment 7 times, was noted to be in the hospital 5 times (June 4, 6, 9, 11 and 30) and absent 1 time (June 2). Review of the physician note dated June 10, 2025, revealed the comment “Pt (patient) no shows and currently in the hospital.” No other information was documented or provided. Review of the last Hemodialysis Interdisciplinary Assessment and Plan of Care dated 9/17/24 does not identify concerns with missed dialysis treatments or hospitalization. On 8/6/26 at approximately 1:30 PM an interview was conducted with the Social Worker who stated the dialysis center did not have any patients identified as unstable at this time. She offered a book titled Patient Assessment and Care Plan Tracking. The book had charts for each month on which she documented the patients name, start of care date, whether the assessment was an Initial, 90 day, annual, unstable, or monthly assessment. For the Months of May and July 2025 there were no patients identified as “unstable”. June was not available for review. She offered that if a patient was determined to be unstable they would review them monthly but they had not been required to do this in a while. She further stated that it was the Charge Nurse or the Facility Administrator who put unstable patients in her book for tracking. She was asked at this time about patient #4 to which she stated that he had been hospitalized a lot but for a patient to be unstable they had to have more than one issue, with more challenging concerns. On 8/6/25 at 2:27 PM, an interview was conducted with the Facility Administrator during which she stated that the facility has no unstable patients. When asked how a patient was determined to be unstable, she stated if there were concerns with low hemoglobin, issues with kt/v or a hospitalization longer than one month continuously or lots of hospitalizations in a few months, the facility would assess unstable patients monthly and update the care plan. The Social Worker, the nurse and the dietitian would meet monthly. When asked about patient #4 she stated that he will miss 3 to 4 treatments then come back, is very non-compliant and comes in late a lot. She stated the social worker should be talking with him but she was not sure if this was documented in the record. She clarified that there should be documentation in the record of the meeting with the patient and education on missing treatments. She asked how often he had been in the hospital over the last few months she stated she would have to look and pulled up the treatment count records for May and June and verified that he had been in the hospital several times but stated that none of the stays had been longer than 30 days.”

“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: 37965 Based on record reviews, and interviews, the dialysis facility failed to follow hemodialysis treatment orders for post dialysis weight/estimated dry weight (EDW), and/or implement a corrective plan when the EDW was not achieved for 1 of 5 patients reviewed for dialysis prescription, (#4). The findings include: A record review was conducted for patient #4 which revealed he was admitted to the facility on 6/12/24 and was receiving dialysis treatment 3 times a week. A review of the dialysis prescription orders dated 2/13/25 revealed that he was to receive dialysis treatments three times a week for 255 minutes (4 hours and 25 minutes). He had a physician ordered EDW of 100.5 kg (kilograms). A review of the treatment records for the period of 7/2/25 to 8/4/25 revealed the patient was well below the ordered EDW; on 7/2/25 his post dialysis dry weight was documented as 95.8 kg; on 7/9/25 his post dialysis dry weight was documented as 92.20 kg; on 7/16/25 his post dialysis dry weight was documented as 94 kg; 7/21/25 his post dialysis dry weight was documented as 104.10 kg; 7/24/25 his post dialysis dry weight was documented as 113.30 kg; and on 8/4/25 his post dialysis dry weight was documented as 94 kg. On 8/7/25 at 2:27 PM, an interview was conducted with the Facility Administrator during which she was shown the treatment records for patient #4 and the EDW documented in the record. She stated these were wrong and proceeded to use her computer to verify the weights documented in the dialysis treatment record. She stated they are varying widely and that the patient should have been re-weighted due to him being so far below the ordered EWD. She stated the physician should have been notified but she did not see evidence of this in the record.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 37965 Based on interviews and record reviews the facility failed to ensure that 1 of 5 sampled patients who had been referred to a transplant center had the appropriate follow up and requested information was provided to the center (patient #3). The findings include: During a review of the medical record for patient #3, several letters were noted from two transplant centers requesting additional information from patient #3, with the dialysis center carbon copied (cc) on the letters. A letter dated 12/23/24 from the Transplant Institute addressed to patient #3 with a cc to the dialysis center, states, “This letter will serve as follow-up to your New Patient Clinic visit here at the (name of hospital) July 10, 2024. At that time you were given a list of tests that were required to assess your candidacy for transplantation. As of today, I am still in need of the following test/results: “Documentation of Health Weight Loss (goal weight 225 pounds or less). Letter dated 1/20/25 from the Transplant Institute addressed to patient #3 with a cc to the dialysis center. The letter states, “This letter will serve as follow-up to your New Patient Clinic visit here at the (name of hospital) July 10, 2024. At that time you were given a list of tests that were required to assess your candidacy for transplantation. As of today, I am still in need of the following test/results: “Documentation of Health Weight Loss (goal weight 225 pounds or less). Echocardiogram (due January 2025). Letter dated 2/19/25 from the Transplant Institute addressed to patient #3 with a cc to the dialysis center. The letter states, “This letter will serve as follow-up to your New Patient Clinic visit here at the (name of hospital) July 10, 2024. At that time you were given a list of test that were required to assess your candidacy for transplantation. As of today, I am still in need of the following test/results: “Documentation of Health Weight Loss (goal weight 225 pounds or less). A letter dated 1/16/25 from (name of another hospital) transplant surgery center addressed to patient #3 with a cc to the dialysis center, states “We regret to inform you that your kidney transplant evaluation referral is closed due to multiple unanswered communications.” Review of the transplant waitlist update for the 2025 QAPI (Quality Assurance Performance Improvement) Meeting Minutes - May (June 25-QAPI) stated, “Data are obtained from the Dashboard include all active patients in the facility; In-center Hemodialysis, Peritoneal, and Home hemodialysis.” The report has a chart that includes, “#of patients active on waitlist”; “# (number) of potential transplant”% of Transplant waitlist”; “# transplanted” and “% of Transplant waitlist”. Each calendar month is represented on the chart. Under the chart is “Discuss intervention this month: 7 workup” and lists seven patient names none of which were patient #3. On 8/6/25 at 1:27 PM an interview was conducted with the Social Worker during which she stated that she works with the patients to ensure they have all the information they need to make appointments with the transplant centers. She shows them what website to access for the applications and will help them if needed. She states that she is responsible for ensuring the transplant receives requested records, such as labs (blood work) or incenter issues however any medical records or physician orders that are outside the dialysis center are the responsibility of the patient. She sends records she has on site with the application however it is the patient’s responsibility to follow up with the transplant center with anything records outside the dialysis center. When shown the letters that were in patient #3’s records she stated she had never seen them before. She said they usually put these letters on her desk but they do not always give them to her. After she assists with the referral she will follow annually with the patient. On 8/7/25 at 2:27 PM, an interview was conducted with the Facility Administrator during which she stated that communications from the transplant centers are put on the Social Worker’s desk. She stated that the social worker should follow up on the letters and the requested tests/documentation. The social worker should be communicating with the patients about transplant referral status. A review of policy 1.21 Kidney Transplant Evaluation states, “The dialysis facility will supply medical summary of the candidate to the Transplant Center. The facility will keep a list of all active patients on a transplant list. If any change occurs, the patient will be informed. A change in status refers to a medical or psychosocial event that could either temporarily or permanently change a transplant patient status. The change could either enhance or limit the patient’s opportunities to receive a transplant. Such events may include cardiac events, weight loss, smoking cessations, or identification of a new potential living organ donor. A review of the Social Worker job description offers under “on-going psychosocial support of ESRD (End Stage Renal Disease) patients including, but not limited to:” item c. “Assisting the patient in changing the treatment modality (e.g. transplant), or permanent transfers to other units.””

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 37965 Based on record reviews and interviews the facility failed to develop, implement, maintain and evaluate an effective, data-driven, quality assessment and performance improvement program related to infection control as evidenced by failing to analyze infection data to identify trends and failing to develop recommendations and action plans to minimize infection transmission. The findings include: A review of the Infection Control data report for the months of January, February, March, April, May and June revealed the facility reported ‘zero’ infections. The report included under “other Infection Data” tracking of such infections as fistula access, graft access, catheter infections, wounds, cellulitis, pneumonia, bronchitis, urinary tract, septicemia, vancomycin resistant organism, Methicillin Resistant Organism, and TB conversions. A review of the Hospital Admit and Readmit 2025 report revealed that a patient had been admitted to the hospital on 3 occasions related to leg infections. On 3/08/25 the patient was admitted to the hospital for 10 days the reason for the admission was noted to be “infection in the leg”; On 3/25/25 the patient was admitted to the hospital for 4 days for “infected leg”; and on 5/27/25 the patient was admitted to the hospital for 26 days for “due to smell from his legs after Dr (doctor) removed bandage from his legs.” Other than this report there was no other means to identify infections in the facility. On 8/7/25 at approximately 4:54 PM, an interview was conducted with the Facility Administrator who was asked if she tracks infections in the facility she stated they do not have any and haven’t in a very long time. When asked about the leg infection noted on the hospitalization report she stated she is only required to track infections in dialysis ports/catheters. She was asked if she monitored for antibiotic use, wounds, hospitalizations she stated “no” and offered that is not required. When shown the Infection Control data report she stated she did not know why the other fields were on there because they were not required to track those. A review of policy 5.21 Quality Management of Infection Control Practices states the purpose, “To monitor staff and patients on an ongoing basis to ensure policies and procedures pertaining to infection control practices are followed.” Under Policy, “The Infection Control Committee will meet to develop and implement policies and procedures for preventing, monitoring and controlling infections within the facility. Reports of infections such as bacteremia are monitored on a continual basis. The committee shall consist of at least the Facility Administrator, the Medical Director and a registered nurse. Infections such as bacteremia, septicemia, hepatitis, suspected pyrogenic reactions, communicable disease, in addition to any wound that may allow for cross contamination of patients are documented by the infection control committee through established mechanism, and noted in patient records. Infections will be tracked and trended. Specific action plans will be developed to address infection control issues. The facility must demonstrate that it follows standard infection control precautions by: Monthly tracking of patient infections and antibiotic usage; Proper handling, storage and disposal of infection waste; completion of patient infection tracking and antibiotic usage, maintaining a safe and clean physical environment. It is the responsibility of the Medical Director, Facility Administrator, and the RN designee to analyze statistics, data and identify trends. Specific areas that necessitate improvement are identified; tools and in-services are developed and education is provided to the dialysis staff. Outcomes are reviewed on an ongoing basis.” The policy states under Methodology “Tracking of patient infection and antibiotic usage is completed monthly. Trends are identified and action plan formulated.””