Pure Life Renal of Buffalo Inc.

“GOV-ADM RESP FOR RELATIONSHIP W/ESRD NW CFR(s): 494.180(a)(3) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (3) The relationship with the ESRD networks; This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, document review, and interview, in two of five medical records reviewed, the governing body and/or designee failed to maintain a relationship with the End Stage Renal Disease (ESRD) Network including timely notification of patient behavioral issues, patient involuntary discharges (IVD), and the submission of documentation as requested by the ESRD Network (Patient #1 and Patient #2). Findings include: Review of the policy “Bylaws Of The Governing Body,” revised 04/01/18, indicated the governing body will receive and act upon recommendations and communications from the ESRD Network. The medical director is responsible for ensuring continuing supervision of all patients, will take appropriate steps, and document actions to resolve patient conflict prior to any involuntary discharge. Review of the policy “Relationship With Network,” revised 04/01/18, indicated the facility agrees to maintain an open relationship with the ESRD Network. All required reports will be submitted in a timely manner and completed accurately. If any report is inadvertently late, all efforts will be made to submit the report without further delay and the network will be contacted with a verbal explanation regarding the delay. Sample reasons for contacting the ESRD Network include, but not limited to, patient behavioral issues. Clinics should be contacting the Network for collaborative support in addressing patient behavioral issues up to and including involuntary discharge. The ESRD facility must respond promptly to requests for information, data, or corrective action plans from its ESRD Network. There is a potential for condition level non-compliance for actions such as failure to follow the requirements for IVD and failure to respond to the ESRD Network requests for corrective action plans for problems identified by the ESRD Network. Review of the medical record and documentation for Patient #1 revealed no evidence that a 30-day notice was provided to Patient #1, New York State Department of Health (NYS DOH) or the ESRD Network related to the IVD that occurred on 09/09/25. Review of an email between the ESRD Network and NYS DOH, dated 12/09/25, revealed the following timeline demonstrating contact with the hemodialysis unit related to the IVD of Patient #1: - On 09/09/25, the ESRD Network received outreach from Staff (D), Facility Administrator (FA-has since resigned) indicating they were notified by Staff (B), Nephrologist, Patient #1 would be discharged immediately from their services. Patient #1 was rude, disrespectful, and wanted to dictate their own care. Patient #1 did not respond well to Staff (B), Nephrologist, and stated they do not want to receive services from them. Staff (D), FA, was unsure if Staff (B), Nephrologist, provided a discharge notice. - On 09/11/25, Staff (D), FA, called the ESRD Network and reported Staff (A), Staff (B), Nephrologist(s), and/or the clinic did not provide Patient #1 with a discharge notice. Patient #1, Staff (A), and Staff (B), Nephrologist, mutually decided on a voluntary transfer as Patient #1 no longer wanted to receive services under Staff (A) or Staff (B), Nephrologist(s). Staff (B), Nephrologist spoke to one of their partners, Staff (H), Nephrologist, who agreed to accept Patient #1. Patient #1 was hospitalized. A voluntary transfer will take place once Patient #1 was discharged from the hospital. Staff (D), FA will have the social worker provide the ESRD Network with hospital discharge date, the new facility information, and the start date. The ESRD Network did not receive information about a new accepting facility. Follow-up attempts with the facility were made on 09/18/25, 09/23/25, 09/24/25, and 09/26/25 with no success. - On 09/30/25, the ESRD Network received a call from Staff (F), Social Worker, who reported Patient #1 was accepted by a nephrologist but does not know the facility information or start date. The ESRD Network informed Staff (F), Patient #1 was still registered under their facility and should not be discharged until they are admitted to another facility. Staff (F) verbalized understanding and will follow-up and provide an update. No update was received. - On 10/07/25, a follow-up call, and email were sent to the facility. Other follow-up calls were made on 10/08/25 and 10/09/25. - On 10/09/25, Staff (F), Social Worker, called the ESRD Network. The regulations and the involuntary discharge process were reviewed. The ESRD Network informed Staff (F) that a physician refusing to treat a patient is categorized as a physician discharge. Staff (F) reported there was no available nephrologist to treat Patient #1, and no discharge notice was given. - On 10/09/25, a follow-up call was made by the ESRD Network to Patient #1 who indicated on 09/09/25, they contacted the FA to discuss their Medicaid cab services for treatment. Patient #1 was told they could not get treatment (there) because Staff (B), Nephrologist, released them as a patient. - On 10/14/25, Staff (C), Chief Operating Officer, provided an overview of the case to the ESRD Network. Patient #1 refused Staff (B), Nephrologist’s care. Staff (B), Nephrologist, was no longer willing to oversee Patient #1’s care. The facility was unable to secure another physician. The ESRD Network requested facility records. - The ESRD Network received and reviewed facility records. No discharge notice was included from Staff (B), Nephrologist or from the facility. - On 10/31/25, a follow-up email was sent by the ESRD Network to the facility requesting a copy of the discharge notice from Staff (B), Nephrologist and the facility. If notices were not provided, a notice to Patient #1 would still need to be provided with the present date; provide proof the NYS DOH was informed of discharge; and leadership needed to complete staff in-service training on communication and discharge procedures (the social worker, facility administrator, and nephrologists). - On 10/31/25, the ESRD Network received an email from Staff (C), Chief Operating Officer, indicating “the FA has resigned. They were the only staff member involved to be in-serviced other than the social worker, and I see absolutely nothing that the social worker did incorrectly. There is no discharge notification available from the doctor as the patient fired the doctor.” The facility had no choice but to discharge immediately because there was not a physician to provide orders. The facility will not be able to provide an additional discharge notice with current date as the patient is no longer in our facility.” The ESRD Network provided recommendations including staff in-service training be done on communication and the discharge procedure to prevent re-occurrence of similar situation; and Patient #1 should still be provided with a discharge notice by the nephrologist and the clinic (even if the “patient fired the nephrologist.”) Interview on 11/20/26 at 09:43 AM with a NYS DOH surveyor onsite during the recertification survey on 10/02/25, revealed Staff (D), FA, was asked if there had been any involuntary discharges since the last recertification survey. Staff (D) stated “no” they did not have an involuntary discharge, only Patient #1 who requested a voluntary transfer. Review of the medical record and documentation for Patient #2 revealed no evidence that the ESRD Network or NYS DOH were notified timely of the event occurring on 12/05/25 resulting in an IVD. On 12/15/25, the ESRD Network contacted the facility after receiving a grievance related to Patient #2.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview in two of five medical records reviewed, the Medical Director failed to ensure involuntary discharge (IVD) policies were followed. Specifically, there was no medical director/attending physician written order and note related to the reasons for an IVD for both Patient #1 and Patient #2. A 30-day notice was not provided to Patient #1/End Stage Renal Disease (ESRD) Network, no immediate notification of the IVD to the ESRD Network for Patient #2, and no timely notification of the IVD to the New York State (NYS) Department of Health (DOH) for both Patient #1 and Patient #2. Findings include: Review of the policy “Medical Director Responsibilities,” revised 04/01/18, indicated the medical director will assume responsibilities and tasks related to the oversight of dialysis care at the facility, monitor the appropriate treatment settings for facility patients in conjunction with the patient’s attending physician, if necessary, ensure that all policies and procedures are adhered to by all individuals treating patients in the facility, and that the interdisciplinary team adheres to the discharge and transfer policies and procedures specified in 494.180 of the ESRD regulations. The medical director is expected to be actively involved in the oversight of the facility patient care delivery and outcomes. Review of the policy “Involuntary Discharge,” revised 04/01/18, indicated the medical director must be informed and approve any involuntary discharges of patients. The medical director must ensure the intradisciplinary team (IDT) documents the re-assessment, ongoing problems, and efforts made to resolve the problem and enter the documentation in the patient’s medical record. Provide the patient and ESRD Network with a 30-day notice of planned discharge and notify the state survey agency. Obtain a written physician order signed by the medical director and the patients attending physician concurring with the patients discharge or transfer from the facility. A 30-day notice is not required in the care of imminent severe threat to safety of patients and staff. The state agency and Network must be notified immediately of the use of the abbreviated discharge procedure. Review of the medical record and documentation for Patient #1 revealed no evidence of a written physician IVD order for the first (07/21/25) or second IVD (09/09/25), no progress notes by Staff (A), Medical Director, or Staff (B), Nephrologist related to the 2nd IVD events that occurred on 09/09/25, no 30-day notice was provided to Patient #1 for the second IVD on 09/09/25, and no immediate notification to the NYS DOH for either of the IVD’s. Notification was given to NYS DOH on 11/20/25. Interview on 01/09/26 at 11:00 AM with Staff (B), Nephrologist, revealed they were not Patient #1’s nephrologist, but agreed to see Patient #1, and had not reviewed Patient #1’s medical record. Patient #1 became upset stating they did not want Staff (B) to be their doctor. If Staff (B) knew who this patient was beforehand, they would have never agreed to see them. Staff (B) told the facility they could not take Patient #1 as a patient. Staff (B) did not issue an IVD notice because Patient #1 was not their patient. Staff (B) did not document the meeting/discussions with Patient #1 at the facility. When Patient #1 went to the hospital to receive dialysis, another nephrologist Staff (H) agreed to accept/follow Patient #1. To date, no outpatient dialysis units have accepted Patient #1, who continues to dialyze at the hospital. Telephone interview on 01/09/26 at 12:00 PM with Staff (A), Nephrologist/Medical Director, revealed they accepted Patient #1, in July 2025, without knowing who it was. Staff (A) consulted with the office lawyer and issued the IVD indicating they would not be providing further care. Staff (A) was told Staff (B), Nephrologist, would then take care of Patient #1. Staff (A) had already issued an IVD (07/21/25 event) and Patient #1 did not want Staff (B), Nephrologist, as a doctor. Patient #1 had already gone to the hospital. Staff (D), Facility Administrator, was up to date on all the notifications and Staff (A) felt all the notifications were appropriate. Telephone interview on 01/09/29 at 02:15 PM with Staff (F), Social Worker, revealed Staff (B), Nephrologist, asked why Patient #1 was so difficult and then discharged them. There are no notes in the medical record from Staff (B), Nephrologist. There was no reassessment of Patient #1 or behavioral plan because Patient #1 kept rescheduling or missed the meetings, then they were at the hospital at that point. Review of the medical record and documentation for Patient #2 revealed no evidence of a written physician IVD order or progress note by Staff (A), Medical Director, or Staff (K), Nephrologist, related to the events that occurred on 12/05/25. There was no evidence to indicate the ESRD Network and NYS DOH were immediately notified of the IVD. The ESRD Network was made aware of the IVD after receiving a grievance about Patient #2 on 12/15/25 and NYS DOH was notified by Staff (C), Chief Operating Officer, by phone on 12/17/25. Interview on 01/08/26 at 03:00 PM with Staff (G), Facility Administrator, stated they called Staff (K), Nephrologist, who gave an order to tell Patient #2 to go to the emergency department when next treatment is needed. Staff (G) only called Staff (K), not the ESRD Network, NYS DOH, or Medical Director. Staff (G) stated they did not really know proper process as they had just taken over in the facility administrator role and had not really been trained. Staff (G) stated they knew the medical director signed the incident report. Telephone interview on 01/09/26 at 10:30 AM with Staff (K), Nephrologist, stated they were called and notified by the facility. Patient #2 was reported as being belligerent, verbally and physically abusive. The police were called. Patient #2 did not want to come back to the facility. Staff (K) stated they had no way to get a new unit over the weekend, so they directed Patient #2 to report to the ED for their next hemodialysis. Staff (K) spoke with Patient #2 after the incident and told them to report to the hospital ED when their next hemodialysis was due. Patient #2 was admitted to the hospital until placement was found. Staff (K) said they wrote a hospital consultation note. Staff (A), Nephrologist/Medical Director, was aware because they cover for Staff (K). Telephone interview on 01/09/26 at 12:10 PM with Staff (A), Nephrologist/Medical Director, stated Patient #2 had been their patient first then switched to Staff (K), Nephrologist. Patient #2 had a history of noncompliance and fights with staff. Staff (A) was aware of the incident and viewed it as a mutual transfer. Interview on 01/09/26 at 04:10 PM with Staff (L), Registered Nurse, revealed Staff (B), Nephrologist, came to see Patient #1 in the clinic. Patient #1 told Staff (B), Nephrologist, to “take a hike,” and that Staff (A), Nephrologist/Medical Director, was their doctor, and they did not need a new one. Patient #1 has no documentation from Staff (A) or Staff (B), Nephrologists, in the medical record. Telephone interview on 01/12/26 at 02:10 PM with Staff (C), Chief Operating Officer, verified this finding and stated they were not aware of requirement for attending physician and medical director order concurring with a patient’s discharge or transfer from the facility.”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 25545 Based on document review and interview, the facility does not ensure the emergency disaster preparedness plan contains all core elements that would guide facilities to effectively prepare, respond, and recover from emergencies; no facility and/or staff disaster drills annually; and the plan was not updated every two years as required. Findings include: Review of the documents “Disaster Plan,” “Disaster Reports,” and “Blizzard Plan,” revealed that the facility did not develop an all-hazards approach to address a wide range of potential emergencies, including natural disasters, human-made events, and facility specific incidents. The “Disaster Plan” did not include a hazardous vulneribility assesment for events such as a bomb threat, active shooter, water outage, natural gas outage, ice storm, wind storm, or civil unrest. There was no evidence of staff training or testing in 2024 or in 2025. There was no evidence that the emergency disaster plan was updated in 2023 or 2024. Interview on 10/01/25 at 10:45 AM with Staff (B), Facility Administrator, verified these findings.”

“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 policy review, observation, and interview, nursing staff do not follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff do not ensure patients holding their cannulation/needle access sites perform hand hygiene after treatment and staff do not change gloves and/or perform hand hygiene when performing access (natural or man-made source to access a patient’s blood for treatment) care and/or initiating and/or terminating hemodialysis treatment. Findings include: Review of the policy “Termination of Treatment with an Arterial Venous Fistula or Arterial Venous Graft,” revised 02/06/17, indicated if the patient is holding their own site (access), the patient must wear clean gloves. Review of the policy “Initiation of Treatment via Central Venous Catheter/Heparin Administration and Catheter Care,” revised 02/06/17, indicated staff are to use aseptic technique (method to prevent contamination by organisms) to clean the catheter exit site (insertion site into the body for a central venous catheter used as a treatment access); remove gloves, and discard; perform hand hygiene; and re-glove. Verify the catheter lines are clamped. Using a fresh antiseptic/disinfectant, scrub the hub (end point of the catheter port) thread (ridged surface to seal the connection for another ridged surface) of the catheter. Review of policy “Blood Borne Pathogens Exposure Control Plan,” revised 04/01/18, indicated employees shall wash their hands immediately or as soon as feasible after removal of gloves. Observation on 09/29/25 at 10:01 AM at Station #3 revealed Patient #8 held their needle insertion sites after the removal of both needles to stop the bleeding without wearing gloves. Patient #8 did not perform hand hygiene before leaving the unit. Observation on 09/29/25 at 10:15 AM at Station #21 revealed Patient #9 held their needle insertion sites after the removal of both needles to stop the bleeding without wearing gloves. Patient #9 did not perform hand hygiene before leaving the unit. Observation on 09/29/25 at 11:20 AM at Station #16 for Patient #21 revealed Staff (G), Patient Care Technician, terminated treatment for Patient #21 via fistula (man-made natural access used for treatment). Staff (G) removed their gloves but did not perform hand hygiene before applying a new clean pair of gloves. Staff (G) removed Patient #21’s needles one at time and held pressure to the sites. When the needle sites were no longer bleeding, Staff (G) removed their gloves but did not perform hand hygiene before applying a new clean pair of gloves to apply a clean gauze and tape up the previous needle sites. At 11:35 AM at Station #5 for Patient #22, Staff (J), Licensed Practical Nurse, exited the station to walk to the sink across from Station #7 and #8 to grab a wet/soap a cloth to wash Patient #22 fistula, without removing their gloves. Without removing gloves and performing hand hygiene, Staff (J) disinfected the fistula with alcohol pads, cannulated (inserted needles) the fistula, and initiated the hemodialysis treatment. Observation on 09/29/25 at 11:30 AM at Station #10 revealed Staff (H), Registered Nurse (RN), disinfected the central venous catheter (CVC- tube inserted into a large vein used as an access for treatment) exit site, but did not change gloves and/or perform hand hygiene before disinfecting the hub thread for Patient #1. Observation on 09/29/25 at 12:25 PM at Station #13 revealed Staff (H), RN disinfected the CVC exit site but did not change gloves and/or perform hand hygiene before disinfecting the hub thread for Patient #2. Interview on 10/02/25 at 01:00 PM with Staff (B), Facility Administrator, verified 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 policy review, observation, and interview, staff do not clean and disinfect all items at the hemodialysis station after use and between patient treatments. Findings Include: Review of policy “Blood Borne Pathogens Exposure Control Plan,” revised 04/01/18, revealed all equipment and environmental/working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. Dialysis machines and chairs will be wiped down with a diluted bleach solution after each use. Observation on 09/29/25 at 10:45 AM at Station #21 revealed Staff (K), Licensed Practical Nurse, did not clean the IV pole and hooks at the top of the IV pole, when disinfecting the hemodialysis machine post treatment for Patient #9. Observation on 09/29/25 at 11:45 AM at Station #23 revealed Staff (I), Registered Nurse, did not clean the IV pole and hooks on top of the IV pole, and did not open the sides of the chair to clean inside the armrest and side of the chair post treatment for Patient #23. Interview on 10/02/25 at 01:00 PM with Staff (B), Facility Administrator, verified findings.”

“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: 40430 Based on policy review, observation, and interview, staff do not ensure expired medication and supplies are not available for use. Findings include: Review of the policy “Multidose Intravenous (IV) Medication Vial,” revised 04/01/18, indicated if more than one professional is preparing Epogen (medication used to stimulate red blood cell production) from a multidose vial, there should only be one opened vial at a time. A second vial must not be opened until all the Epogen (multidose vial) is withdrawn from the previously punctured vial and the vial is discarded. (The policy did not include guidance on expiration and/or labeling the vial with the date opened and/or when expires). Review of the instructions for use/package insert for “Epogen,” indicated unused portions of Epogen in multiple dose vials are to be discarded 21 days after the initial entry (with a needle). Review of the policy “Tuberculosis Skin Test,” revised 04/01/18, indicated after opening the Tuberculin (Tubersol-used to test for exposure to tuberculosis-bacterial disease that affects the lungs) vial, staff are to document the date, time, and staff initials to ensure that the medication vial is discarded once expired Review of the instructions for use/package insert for “Tubersol,” indicated a vial which has been opened and in use for 30 days should be discarded. Do not use after expiration date. Review of the instructions for use/package insert for “RPC Blood Leak Test Strips (used to test for the presence of blood),” indicated not to use a test strip (from an opened or unopened bottle) after the expiration date. Observation on 09/29/25 at 10:45 AM of the medication refrigerator located in the medication room in the center of the unit between the front and back nursing stations revealed two multidose vials of Epogen 20,000 units/two milliliters (ml) that were not labeled with date opened and staff initials on the vial or the date the multidose vial was opened and/or when the vial expires. There was one vial of Tubersol labeled with an opened date of 05/28/25 and expiration date of 06/28/25. At 12:15 PM at the nursing station on the window ledge, there was a container of RPC Blood Leak Test Strips bottle with an expiration date of 08/31/24. Interview on 10/02/25 at 10:30 AM with Staff (B), Facility Administrator, verified these findings.”

“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: 25545 Based on observation and interview the facility did not ensure that all oxygen tanks were stored in cylinder stands or carts to prevent damage to the tanks based on NFPA (National Fire Protection Association) 99- 11.6.2.3 (11). Findings Include: Observation on 09/28/25 at 10:40 AM revealed that two oxygen tanks, approximately 25.5 inches in height and four inches in diameter, were laying on the treatment floor, on their sides, adjacent to the code cart. The two oxygen tanks were on their side, unsecured, and subject to rolling which is liable to damage the cylinder. Interview on 10/01/25 at 11:00 AM with Staff (B), Facility Administrator, verified these findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in three of five medical records reviewed, nursing staff did not ensure blood flow rates (BFR-the rate blood is being processed through the artificial kidney) were maintained per physician order (Patient # 15, Patient #17, Patient#16). Findings include: Review of the policy “Patient Assessment During Treatment,” revised 04/01/18, indicated blood flow rates will be monitored during dialysis treatment. Review of the medical record treatment flowsheets for Patient #15, dated 08/07/25 to 09/27/25, revealed an ordered/prescribed BFR of 500 milliliters/minutes (ml/min) was not maintained on 08/09/25, 08/12/25, 08/14/25, 08/16/25, 08/19/25, 08/21/25, 08/23/25, and 08/26/25. There was no documentation in the medical record indicating why the blood flow rate was not maintained. Review of the medical record treatment flowsheets for Patient #17, dated 08/23/25 to 09/27/25, revealed an ordered/prescribed BFR of 500 ml/min was not maintained on 08/23/25, 08/30/25, 09/04/25, 09/23/25, 09/25/25, and 09/27/25. There was no documentation in the medical record indicating why the blood flow rate was not maintained. Review of the medical record treatment flowsheets for Patient #16, dated 08/23/25 to 09/30/25, revealed an ordered/prescribed BFR of 500 ml/min was not maintained on 08/23/25, 08/28/25, 08/30/25, 09/02/25, and 09/09/25. There was no documentation in the medical record indicating why the blood flow rate was not maintained. Interview on 10/02/25 at 01:00 PM with Staff (B), Facility Administrator, verified these findings.”

“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: 34528 Based on policy review, medical record review, and interview, in one of five medical records reviewed, nursing staff did not notify the physician of adverse treatment events. (Patient # 17). Findings include: Review of the policy “Hypertension,” reviewed 04/01/18, indicated staff are to notify the nephrologist if the diastolic blood pressure (lower number blood pressure measurement of the heart at rest) is greater than 100mm/Hg or if systolic (top number blood pressure measurement of the force blood is pumped from the heart) is greater than 200 mm/Hg. (normal blood pressure is 120/80). Review of the medical record treatment flow sheets for Patient # 17, from 08/23/25 to 09/27/25, revealed elevated blood pressure documentation for the following treatments: -On 09/04/25 at 12:40 PM, a blood pressure of 179/139; at 01:02 PM, 187/123; at 03:01 PM, 173/101; at 03:31 PM, 163/105; at 04:01 PM, 164/108; and at 04:30 PM, 171/109. -On 09/25/25 at 12:21 PM, a blood pressure of 157/112; at 12:31 PM, 157/102; at 01:01 PM, 157/107; at 01:31 PM, 166/114; at 02:01 PM, 174/120; at 02:31 PM,153/105; at 03:01 PM, 179/123; at 4:01 PM, 194/135; and at 04:12 PM, 183/133. There is no medical record documentation that nursing notified a physician of elevated blood pressures. Interview on 10/02/25 at 01:00 PM with Staff (B), Facility Administrator, verified these findings.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in one of five medical records reviewed, the facility does not ensure the provider documents a monthly note (Patient # 17). Findings include: Review of the policy “Medical Record General Policies,” last revised 04/01/18, indicated medical records need to include a monthly progress note showing that the patient has been seen by a physician, nurse practitioner, clinical nurse specialist or physician assistant. Review of the medical record for Patient #17 revealed no monthly provider notes from January 2025 to August 2025. Interview on 10/02/25 at 01:00 PM with Staff (B), Facility Administrator, verified these findings.”

“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: 40430 Based on policy review, document review, and interview, the facility did not ensure the Quality Assurance and Performance Improvement (QAPI) program tracked, trended, and analyzed pneumococcal (pneumonia-bacterial infection causing respiratory illness) immunization (vaccine) surveillance/vaccination rates and/or offered the pneumonia vaccination on admission. Findings include: Review of policy “Quality Management of Infection Control Practices,” revised 04/01/18, indicated infections such as communicable (can be transmitted from one person to another) diseases are documented by the infection control committee through established mechanisms and will be tracked and trended. It is the responsibility of the medical director, facility administrator, and registered nurse 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. Review of the policy “Pneumococcal Vaccine Administration,” revised 04/01/18, indicated the purpose was to provide pneumococcal vaccine to patients at risk for pneumococcal infections. Recommendations for vaccine included immunocompromised (immune system not working as it should) adults at increased risk of pneumococcal disease or its complications (e.g. chronic renal failure or conditions such as organ transplantation associated with immunosuppression). According to clinical studies, after vaccination the protective efficacy was 60% for patients with renal (kidney) disease. Review of policy “Admission of New Patient,” revised 02/08/19, indicated new patient admission process includes licensed personnel review and obtain patient signature/date consent for pneumonia vaccine and provide vaccine information sheet (VIS). Review of the facility’s QAPI meeting minutes template, dated January 2025 to August 2025, revealed the data related to the “percent of patients who have received pneumonia vaccine” was documented as “to be determined.” Review on 10/01/25 at 02:30 PM of the “Consent,” binder located at the charge nurse desk and interview Staff (I), Registered Nurse, revealed no evidence of pneumonia vaccine consents and/or vaccine information. Staff (I) stated “we don’t carry or offer that vaccine. That is usually done with the primary physician.” Review of the “New Patient Admission Packet,” with Staff (I), revealed it did not include consent or VIS for pneumococcal vaccination. Interview on 10/02/25 at 10:30 AM with Staff (B), Facility Administrator verified these findings and stated they identified pneumonia vaccine data tracked in QAPI was inaccurate in December 2024 and pneumococcal immunization had not been tracked, trended, or analyzed. Staff (B) stated the pneumonia vaccine had not been carried nor offered at the facility since they started working there in April 2024.”

“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, in one of eight personal files reviewed, the facility did not ensure all staff meet the applicable scope of practice board and licensure requirements in the state in which they practice (Staff (D), Dietitian); and in three of eight health files reviewed, there was no proof of immunity for measles (Rubeola), mumps, and rubella (Staff (B), Staff (D), and Staff (E). Findings include: Review of the New York State Education Department (NYSED-agency responsible for ensuring individuals meet requirements to be licensed or certified; issues professional licenses/certifications and oversees the regulations for dietetics and nutrition) Office of the Professions website revealed a professional certification is the authorization to practice and use a professional title in New York State (NYS). To practice in NYS under the authority of a certification, individuals must reregister every three years. Dietitians and Nutritionists must be certified to practice in NYS. Review of the “Bylaws of the Governing Body,” revised 04/01/18, indicated the governing body is responsible for ensuring that all staff are qualified to perform the duties and responsibilities assigned to them and meet all Federal, State, and local professional requirements of the conditions for coverage under Medicare. Review of the policy “Medical Director Responsibilities,” revised 04/01/18, indicated the medical director will identify policies that shall meet requirements of Medicare and Medicaid or applicable state and federal laws, rules and regulations. Review of the facility job description (no date) “Dietitian,” indicated qualifications for a dietitian include the “Registered Dietitian with the Commission on Dietetic Registration (CDR-the credentialing agency for the Academy of Nutrition and Dietetics),” and licensure in states where it is available. Review of the credential/personnel file for Staff (D), Dietitian, revealed an “Offer of Employment,” letter dated 06/12/24, signed by Staff (D), Dietitian, that indicated employment is contingent upon maintaining and complying with all licensure and certification requirements associated with the position. The document “Commission on Dietetic Registration (CDR),” certified Staff (D) had successfully completed requirements for dietetic registration for the period of 09/01/25 through 08/31/26. The personnel file did not include a New York State Education Department (NYSED) Office of the Professions “Registration Certificate.” Interview on 10/01/25 at 03:30 PM with Staff (B), Facility Administrator, and Staff (D), Dietitian verified Staff (D) does not have a current NYS registration certificate (NYS certification) but has been credentialed through the Commission on Dietetic Registration. Review of personnel health files revealed no evidence of measles (Rubeola), mumps, and rubella screening and/or testing for Staff (B), Staff (D), and Staff (E). Interview on 10/01/25 at 03:15 PM Staff (B), Facility Administrator, verified these findings and stated the facility does not have NYS specific regulatory guidance and/or policy regarding requirement for proof of immunity to measles (Rubeola), mumps, and rubella.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 40430 Based on policy review, medical record review, and interview, in one of three medical records reviewed, the facility does not ensure patients are seen by a provider monthly (Patient #1). Findings include: Review of the policy “Progress Notes,” last revised 04/01/18, indicated at a minimum, monthly medical progress notes should document that a physician or advanced practice provider has seen each patient. Each discipline must enter their notes in the facility’s electronic medical record and may use a hard copy of the form as backup when the electronic medical record is inaccessible. The hard copy is filed in the medical record and is considered part of the patient’s chart. Review on 12/04/24 of the medical record for Patient #1 revealed no monthly provider notes from 12/2023 through 09/2024. Interview on 12/05/24 at 11:35 AM with Staff (K), Administrative Assistant, and at 03:30 PM with Staff (B), Facility Administrator, verified this finding.”

“PQ-PCT CERTIFIED CFR(s): 494.140(e)(4) Patient care dialysis technicians must- (4) Be certified under a State certification program or a national commercially available certification program, as follows- (i) For newly employed patient care technicians, within 18 months of being hired as a dialysis patient care technician; or (ii) For patient care technicians employed on October 14, 2008, within 18 months after such date. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview, in one of three personal files reviewed, the facility did not ensure all patient care technicians were certified (Staff J). Findings: Review of the policy “Administrative Structure,” last 04/01/18, indicated 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 patient care technician must become certified under a state certification program or a national commercially available certification program within 18 months of being hired as a dialysis patient care technician. Review on 12/04/24 of the personnel files for Staff (J), Patient Care Technician, revealed the “Employment and Acceptance of Employment Letter,” dated 04/18/24, indicated Pure Life Renal of Buffalo offered Staff (J) a full time Patient Care Technician position contingent upon maintaining and complying with all licensure and certification requirements associated with “your” position. Staff (J) started at the facility on 05/06/24. The “Board of Nephrology Examiners Nursing and Technology (BONET),” patient care technician certificate expired on 11/30/24. Review on 12/05/24 of the “Thursday Assignment Sheet,” dated 12/05/24, confirmed Staff (J), Patient Care Technician, was currently working at the facility. Interview on 12/05/24 at 03:30 PM with Staff (B), Facility Administrator, verified these findings.”

“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: 40430 Based on policy review, medical record review, and interview, in one of three medical records reviewed, the facility does not ensure staff and/or patients sign the “Early Termination of Treatment, Against Medical Advice (AMA),” form when a patient requests to discontinue their treatment before the prescribed treatment duration has been completed and staff do not notify the family/responsible party of the early termination of treatment/AMA, when a patient has cognitive impairment (Patient #1). Finding include: Review of the policy “Early Termination of Treatment,” revised 04/01/18, indicated if a patient requests to discontinue their treatment before the prescribed time they may do so. Facility staff must inform the patient of the risks and ask the patient to sign the “Early Termination of Treatment” (AMA-against medical advice form) if requesting to terminate their treatment 10 minutes or more than the prescribed time. If a patient refuses to sign the form, the staff member will sign the form and should write “patient refused to sign” in the patient signature area. Review on 12/04/24 of the medical record for Patient #1 revealed “Hemodialysis Flowsheets,” dated 10/23/24 through 12/04/24, indicated the hemodialysis treatment duration ordered by the physician of 210 minutes (3.5 hours) was not met for the following treatment dates: -On 10/25/24, treatment was terminated early due to Patient #1 yelling, screaming, and refusing to sit in chair during treatment. The treatment duration was 161 minutes (2.683 hours). -On 11/01/24, treatment was terminated early due to confusion and “patient tolerance,” The treatment duration was 163 minutes (2.717 hours) -On 11/04/24, treatment was terminated early due to Patient #1 continuously screaming to be taken off the machine, climbing out of the chair, and being combative with staff. staff attempted multiple times to de-escalate Patient #1 with no success. The treatment duration was 187 minutes (3.117 hours). -On 11/08/24, treatment was terminated early due to Patient #1 being confused at times, restless, and would not keep their access arm still despite health teaching. The treatment duration was 168 minutes (2.8 hours). -On 11/18/22, treatment was terminated early due to Patient #1 being non-cooperative. The treatment duration was 189 minutes (3.15 hours). A physician note, dated 10/15/24, indicated Patient #1 had cognitive deficit and agitation. No “Early Termination of Treatment,” forms were found for 11/04/24 or 11/18/24. No documentation was found to indicate Patient #1’s family/responsible party were informed of early termination of treatment on 10/25/24, 11/01/24, 11/04/24, 11/08/24 or 11/18/24. Interview on 12/04/24 at 09:40 AM, Staff (F), Registered Nurse, revealed Patient #1’s confusion has progressed over the last year. The physician is notified if a treatment ends early 60 minutes or more. The family and/or provider are not notified if a treatment is cut short by less than 30 minutes unless it becomes habit. Interview on 12/04/24 at 11:20 AM, Staff (C), Social Worker, revealed Patient #1 has had a cognitive decline, has become very restless, and overall status has declined. Staff (C) would call the family if directed by a nurse due to shortened treatments but was not directed to prior to the incident. Interview on 12/05/24 at 12:52 PM Staff (A), Nephrologist, indicated Patient #1 has had cognitive impairment that has declined over time. Patient #1 has been agitated during treatment. Social work and/or nursing staff would call families regarding shortened treatments. Interview on 12/05/2024 at 12:00 PM with Staff (F), Registered Nurse, and at 03:30 PM with Staff (B), Facility Administrator, verified these findings.”