Davita Renal Care of Buffalo

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 40430 Based on policy review, document review, and interview, for two of two patient medical records reviewed, the facility failed to ensure all staff are available to meet the scope of practice and licensure requirements to meet patient needs. Specifically, there was not a registered nurse (RN) responsible for the nursing care provided, available to meet the needs of in-center patients being treated at all times; RN pre-treatment assessment, including machine/prescription verification are completed; RN post-treatment assessments are completed; and medications are not left unattended and are administered/signed out by administering nurse. (Patient #1 and Patient #2). Findings include: Review of the policy “Teammate Qualifications, Licensure, and Adequate Teammate Staffing,” revised May 2018, indicated all dialysis facility teammates will meet applicable scope of practice, and board/licensure requirements in effect in the state in which they are employed. An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the care given meets the needs of the patients. A registered nurse, who is responsible for the nursing care provided, is present in the facility at all times that patients are being treated. Review of the policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024, indicated a nursing assessment that includes, but is not limited to, verification of prescription including machine parameters, a physical assessment (listen to lungs and heart rate, evaluation of volume status including edema (fluid accumulation in the body) and patient statement of well-being, will be documented by the registered nurse. The prescription and machine setting are verified by a teammate prior to initiation of treatment and the prescription components are confirmed by the registered nurse. Additional documentation includes all medications, the time administered, and initials of person administering the medication. The nurse will assess the patient prior to discharge. Review of the policy “Medication Policy,” revised October 2023, indicated non-refrigerated medications are to be stored in a cabinet and locked at the close of each business day if not under supervision by the licensed teammate. Medications are administered as prescribed and documented in the patient’s medical record. Document the time and signature of the teammate administering the medication. Review of the policy “Preparation and Administration of Parenteral (IV) Medications,” revised April 2024, indicated when medication administration is completed, document the administration of the medication and the signature of the person administering the medication. Review of the medical record and treatment flowsheet for Patient #1, dated 10/21/25, revealed: -Treatment orders indicated a 03:30 hour hemodialysis treatment, three times per week. Ordered medications for the treatment included: Heparin (blood thinner) 500 units intravenously (IV-in vein); Cinacalcet (used to normalize calcium/phosphorus levels in the blood) 60 milligrams (mg) orally; Venofer (used to treat iron deficiency) 50mg IV; and Calcitriol (medication used to treat vitamin D deficiency and normalize calcium/phosphorus levels in the blood) 25 micrograms (mcg) orally. -At 06:25 AM, the dialysis prescription/machine check was signed off as verified by Staff (E), Patient Care Technician (PCT). (No RN machine/prescription verification or RN pre-treatment assessment were documented). -At 06:40 AM, the Heparin 500 units IV was signed off as administered by Staff (C), RN (who was not onsite while Patient #1 received hemodialysis treatment). -At 06:45 AM, Patient #1 was cannulated (insert needles into access) and the treatment was initiated by Staff (E), PCT. -At 07:00 AM, Cinacalcet 60 mg orally, Venofer 50 mg IV, and Calcitriol 25 mcg orally was signed off as administered by Staff (C), RN (who was not onsite while Patient #1 received hemodialysis treatment). -At 07:43 AM, Staff (E), PCT, terminated the hemodialysis treatment due to a “facility emergency.” -At 08:09 AM, Staff (A), Facility Administrator (FA), documented Staff (B), RN unexpectedly fell ill and could not continue working. No RN coverage was able to be found. The nurse practitioner was notified. -At 08:22 AM, Staff (A), FA, documented Patient #1 received heparin and pills. (No RN post treatment assessment was documented). Review of the medical record and treatment flowsheet for Patient #2, dated 10/21/25, revealed: -Treatment orders indicated a 02:30 hour hemodialysis treatment, two times per week. Ordered medications for the treatment included: Heparin 1000 units IV; Cinacalcet 150 mg orally; and Calcitriol 1.25 mcg orally. -At 06:54 AM, the dialysis prescription/machine check was signed off as verified by Staff (E), PCT. (No RN machine/prescription verification or RN pre-treatment assessment were documented). -At 07:08 AM, the Heparin 1000 units IV was signed off as administered by Staff (C), RN (who was not onsite while Patient #1 received hemodialysis treatment). -At 07:13 AM, Patient #2 cannulated and treatment initiated by Staff (E), PCT. -At 07:30 AM, Cinacalcet 150 mg and Calcitriol 1.25mcg, taken orally, were signed off as administered by Staff (C), RN (who was not onsite while Patient #1 received hemodialysis treatment). The treatment was terminated by Staff (E), PCT due to a “facility emergency.” -At 08:33 AM, Staff (K), Dietitian, documented the nurse practitioner was notified of the sudden clinic closure due to staff illness, and Patient #2 was rescheduled for treatment on 10/22/25. (No RN post treatment assessment was documented). Review of the patient schedule “TTS (Tuesday, Thursday, Saturday),” revealed on 10/21/25, eight patients were scheduled for dialysis treatments with start times between 07:00 AM and 08:15 AM, including Patient #1 and Patient #2. Review of the staff schedule for 10/21/25 revealed Staff (B), RN, was scheduled as the “Charge Nurse” from 06:00 AM to 12:00 PM and Staff (E), PCT, was scheduled from 06:00 AM to 12:00 PM. (Staff (C), RN was not scheduled to work.) Review of time clock “punches,”dated 10/12/25 to 10/25/25, revealed on 10/21/25, Staff (B), RN, punched in at 05:56 AM and out at 08:20 AM; Staff (E), PCT, punched in at 05:39 AM and out at 09:14 AM; and Staff (C), RN, punched in at 10:50 AM and out at 02:00 PM. Interview on 10/27/25 at 10:30 AM Staff (A), Facility Administrator, revealed they arrived at the facility at 07:25 AM. Staff (B), RN did not look well, went between Staff (A)’s office and the bathroom, and was unable to return to the treatment floor. Staff (B), RN remained in Staff (A)’s office until they left the facility once the patients left. All the providers were notified. Interview on 10/27/25 at 11:40 AM with Staff (B), RN, revealed they started feeling sick and went to the bathroom. Staff (B) came back out to say “hi” to Patient #1 quickly and administered their Heparin. Staff (B) had to go back to the bathroom. Staff (B) called Staff (A), FA, and went to Staff (A), FA’s office. Staff (B) stated tall they could do was go back and forth from the office to the bathroom. No RN pre/post assessments or prescription verifications/machine checks were done for Patient #1 or Patient #2. Staff (B) said they normally would have done those assessments but was sick and had to go home. Staff (B) went home after all the patients left the clinic. Staff (B) stated their normal process is to prepare the Heparin boluses and patient medications by labeling them with preprinted medication labels. Staff (B) would distribute the medications leaving them at each patient’s dialysis station. Interview on 10/27/25 at 12:00 PM with Staff (E), PCT, revealed they came into the unit in the morning and started setting up the hemodialysis machines. Staff (B), RN, started getting medications and Heparins ready. Staff (E) prepared to initiate Patient #1’s treatment. Staff (B) had to leave the unit for the bathroom. When Staff (B) returned, they were not looking too good. Staff (B) gave Patient #1 their Heparin. After that Staff (B) stated they were going to the office for a few minutes because they were not feeling well. Patient #2 came in and Staff (E) started their treatment. It was determined not to put on any more patients. Staff (E) discontinued the treatments for Patient #1 and Patient #2. Staff (E) stated Patient #1 and Patient #2 medications were at their station ready for them. Staff (E) did not pay much attention because “I don’t give medications to patients.” Staff (E) could not remember if Patient #2 received their Heparin or not. Interview on 10/27/25 at 01:50 PM with Staff (C), RN, revealed they were called by Staff (A), FA to see if they could relieve Staff (B) when they were sick. Staff (C) was not able to come in until 11:00 AM. Staff (C) was told by Staff (A) to sign off the treatment sheets that both patients had received their medications from Staff (B), RN. Staff (C) was told by IT the only way to generate another treatment flow sheet for Patient #1 and Patient #2’s next treatment was to sign off the medications and close out the flow sheet. Staff (C) did not administer medications for Patient #1 or Patient #2 on 10/21/25. Staff (C) did not sign off any of the assessments or prescription verification/machine checks because they were not at the facility and did not do them. Follow up interview on 10/27/25 at 3:30 PM Staff (B), RN revealed the RN pre-treatment prescription verification/machine checks, and RN pre and/or post assessments of Patient #1 and Patient #2 were not completed. The patient medications were prepped, placed in a medication cup, labeled, and placed at the dialysis station and/or tray table attached to the dialysis chair with their protein drinks. The patients “know to take them.” Staff (B) could not verify if Patient #1 or Patient #2 take their oral medications. Staff (B) stated they gave Patient #1 their Heparin and never went back to the treatment floor. Staff (B) never even saw Patient #2 on 10/21/25. Staff (B) did not give Patient #1 their Venofer. Interview on 10/21/25 at 04:20 PM with Staff (A), FA, verified the RN pre-treatment prescription verification/machine checks, and pre and/or post treatment assessments had not been done. Staff (A) verified the medications were signed out by Staff (C), RN in order to close out the flow sheets for Patient #1 and Patient #2. Staff (A) was told by Staff (B), RN, Patient #1 and Patient #2 received their medications. Staff (A) stated they did not want Patient #1 and Patient #2 “getting double dosed.””

“GOV-RN PRESENT AT ALL TIMES CFR(s): 494.180(b)(2) The governing body or designated person responsible must ensure that- (2) A registered nurse, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated; This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, document review, and interview, in two of two patient medical records reviewed, the facility failed to ensure a registered nurse (RN) was responsible for the nursing care provided. Specifically, the RN was not available to meet the needs of patients at all times when in-center patients are being treated. (Patient #1 and Patient #2). Findings include: Review of the policy “Teammate Qualifications, Licensure, and Adequate Teammate Staffing,” revised May 2018, indicated all dialysis facility teammates will meet applicable scope of practice, and board/licensure requirements in effect in the state in which they are employed. An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the care given meets the needs of the patients. A RN, who is responsible for the nursing care provided, is present in the facility at all times that patients are being treated. Review of the medical records/treatment flowsheets for Patient #1 and Patient #2, dated 10/21/25, revealed no evidence a registered nurse participated and/or supervised the care of either patient. All treatment documentation was by Staff (E), Patient Care Technician (PCT). No documentation was found by Staff (B), RN. Interview on 10/27/25 at 10:30 AM Staff (A), Facility Administrator (FA), revealed they received a call on 10/21/25 at about 06:58 AM from Staff (B), RN, who had suddenly become ill with stomach upset, dizziness, feeling like they were going to pass out, could not stay at the facility, and want to go home. Staff (A) attempted to find alternative RN coverage but was unsuccessful. Staff (A) called the medical director who directed them to keep trying to find coverage, but the attempt was unsuccessful. Staff (A) arrived at the facility at 07:25 AM. Staff (B), RN, did not look well and went between my office and the bathroom. Staff (B) was unable to return to the treatment floor and the decision was made to terminate the treatments for Patient #1 and Patient #2. Staff (B) remained in Staff (A)’s office and left the facility once the patients left. Interview on 10/27/25 at 11:40 AM with Staff (B), RN (with Staff (A), FA present), revealed Staff (B) stated some of the patients were already in the unit getting their things ready at their chairs when they started feeling sick and went to the bathroom. Staff (B) came back out to say “hi” to Patient #1 quickly and administered their Heparin. Staff (B) had to go back to the bathroom. Staff (B) called Staff (A) and went to Staff (A)’s office. When Staff (A) arrived, Staff (B) stated all they could do was go back and forth from the office to the bathroom. Patient #2 was put on (hemodialysis treatment started) while Staff (B) was in the bathroom. It was determined to stop patient treatments, and Staff (E), PCT, took the patients off treatment. No RN pre/post assessments or prescription verifications/machine checks were done for Patient #1 and Patient #2. Staff (B) stated they normally would have done those assessments but was sick and had to go home. Staff (B) went home after all the patients left the clinic. Interview on 10/27/25 at 12:00 PM with Staff (E), PCT, revealed they came into the unit in the morning and started setting up the hemodialysis machines. Staff (B), RN, started getting medications and Heparins ready. When we were ready, Staff (E) prepared to initiate Patient #1’s treatment. Staff (B) had to leave the unit for the bathroom. When Staff (B) returned, they were not looking too good. Staff (B) gave Patient #1 their Heparin. After that Staff (B) stated they were going to the office for a few minutes because they were not feeling well. Patient #2 came in and Staff (E) started their treatment. Follow-up interview on 10/27/25 at 3:30 PM Staff (B), RN, revealed the RN pre-treatment prescription verification/machine checks, and RN pre and/or post assessments of Patient #1 and Patient #2 were not completed. The patient medications were prepped, placed in a medication cup, labeled, and placed at the dialysis station and/or tray table attached to the dialysis chair with their protein drinks. Staff (B) stated they gave Patient #1 their Heparin and never went back to the treatment floor. Staff (B) never even saw Patient #2 on 10/21/25. Interview on 10/21/25 at 04:20 PM with Staff (A), FA, verified the RN pre-treatment prescription verification/machine checks, and pre and/or post treatment assessments had not been done.”

“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: 34528 Based on observation, policy review, and interview, nursing staff did not ensure that patients wear gloves when holding access sites post hemodialysis. Findings Include: Observation on 02/07/24 at 11:40 AM at Station #2 revealed Patient # 25 held needle insertion sites after the removal of both needles without wearing gloves. Review on 02/08/24 of policy “Post Dialysis Vascular Access care: Fistula/Graft Using Safety Fistula Needles”, last revision April 2023, revealed when the patient holds their own cannulation sites, the patient will be offered gloves. Interview on 02/09/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (G), Facility Administrator-Orchard Park, confirmed these findings.”

“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: 32261 Based on observation, policy review, and interview, staff did not wear personal protective equipment, as required. Specifically, impervious gowns were not fastened/protective from the neck to the thigh when worn performing procedures during which spurting or spattering of blood might occur. Findings Include: Observations on the treatment floor revealed the following staff did not fasten their gowns neck to thigh area while initiating and discontinuing dialysis, stripping the dialysis machines of bloodlines and dialyzers, while cleaning the machines and stations following patient treatments, and stringing/setting up the machines for patient treatments as follows: - On 02/07/24 from 10:00 AM to 12:30 PM: Staff (H), Patient Care Tech, Staff (I), Patient Care Tech, Staff (J), Patient Care Tech, Staff (L), Patient Care Tech, Staff (M), Licensed Practical Nurse, Staff (N), Registered Nurse, and Staff (O), Registered Nurse. - On 02/09/24 from 09:30 AM to 11:00 AM: Staff (H), Patient Care Tech, Staff (J), Patient Care Tech, Staff (L), Patient Care Tech, Staff (M), Licensed Practical Nurse Staff (N), Registered Nurse, Staff (O), Registered Nurse, and Staff (P), Registered Nurse. Review on 02/09/24 of policy “Infection Control for Dialysis Facilities” last revised 04/2023 indicates that Personal Protective Equipment will be worn whenever there is the potential for contact with body fluids. Interview on 02/09/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (G), Facility Administrator-Orchard Park, confirmed these findings.”

“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: 32261 Based on observation, policy review, and interview, nursing staff do not ensure medications are secure and drawn up per facility policy. This can potentially lead to unauthorized access/tampering of patient medications and/or affect medication stability. Findings Include: Observation on 02/07/24 at 10:10 AM on the treatment floor revealed the following medications were left unsecured and unattended on the counter in the medication preparation area as follows: - Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5: two pre-filled Heparin syringes and four capsules of Calcitroil. - Patient #6: two pre-filled Heparin syringes, four capsules of Calcitroil, and one pre-filled Venofer syringe. - Patient #7, Patient #8, Patient #9, and Patient #19: four capsules of Calcitroil. - Patient #11 and Patient #12: two pre-filled heparin syringes. Review of policy “Medication Policy,” last revised October 2023 indicates non-refrigerated medications are to be stored in cabinets and locked at the close of each business day or if not under supervision by the licensed teammate. Interview on 02/09/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (G), Facility Administrator-Orchard Park, confirmed these findings.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 34528 Based on observation, policy review, and interview, staff did not clean and disinfect all items at the dialysis station post treatment. This lapse in disinfecting equipment places staff and patients at risk for facility acquired infections. Findings Include: Observation on 02/07/24 on the treatment floor revealed at 11:55 AM at Station #2, Staff (H), Patient Care Technician, did not disinfect the treatment chair, television, and television arm after Patient # 25’s treatment. At 12:20 PM at Station #19, Staff (M), Licensed Practical Nurse, did not disinfect the hooks on the IV pole after Patient # 26’s treatment. Review on 02/08/24 of policy “Infection Control For Dialysis Facilities”, last revised April 2023 revealed at the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient. Interview on 02/09/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (G), Facility Administrator-Orchard Park, confirmed these findings. THIS IS A REPEAT DEFICIENCY FROM THE 11/03/17 RECERTIFICATION SURVEY.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 42572 Based on observation and interview, the building is not maintained, free from defects, and/or hazards to ensure safety and functionality for patients, staff, and visitors. Findings Include: Observations on 02/07/24 at 10:30 AM on the treatment floor revealed an approximately one square foot area of drywalled ceiling that was stained yellow and cracked above Station #12. An adjacent ceiling tile was also stained yellow and the metal frame supporting the tile was rusting. This is evidence of a leak above the ceiling. Observations on 02/07/24 from 11:00 AM to 11:45 AM in the patient treatment area, revealed self-closing doors to clean utility room, soiled utility room, and the housekeeping room did not fully close and latch. The top edge of the clean utility room door hits the door frame, the upper corner of the latch side of the soiled utility room door hits the door frame, and the latch side of the housekeeping room door binds on the door frame. Observations on 02/08/24 at 10:45 AM on the treatment floor at the wall chase of Station #4 revealed white crystals formed around and below the dialysate plumbing connections on the back of the dialysis wall box. This is evidence of a leak. Interview on 02/08/23 at 03:00 PM with Staff (A), Facility Administrator, and Staff (E), Bio Med, verified these findings. THIS IS A REPEAT DEFICIENCY FROM THE 11/03/17 RECERTIFICATION SURVEY”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 34528 Based on policy review, document review and interview, the facility does not ensure all quality indicators are analyzed for trends to ensure the quality of the patient care provided. This has the potential for missed opportunities to improve care and services. Findings Include: Review on 02/08/24 of policy “Continuous Quality Improvement Program”, last revised April 2021, revealed the facility will measure, analyze and track quality indicators. The program must include Mortality- review of deaths. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review on 02/08/24 of the Davita Mortality Review documents from July 2023 to December 2023 revealed the following: - For July 2023: one patient death dated 07/07/23. - For August 2023: two patient deaths dated 08/03/23 and 08/05/23. - For September 2023: one patient death dated 09/29/23. - For November 2023: two patient deaths dated 11/16/23 and 11/24/23. - For December 2023: one patient death dated 12/23/23. Review on 02/08/24 of the Quality Meeting minutes from August 2023 to December 2023 revealed no monthly ongoing review for trends in data from the Mortality Review documents starting in July 2023. Interview on 02/08/24 at 02:00 PM with Staff (R) Manager of Clinical Services verified findings and stated there should have been some discussion of mortality in the meeting minutes. THIS IS A REPEAT DEFICIENCY FROM THE 11/03/17 RECERTIFICATION SURVEY”