Fresenius Medical Care of Albany

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 52051 Based on staff interviews and a review of facility records, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 41 in-center hemodialysis (ICHD) patients who were dialyzing at this facility. Findings include: Cross References: V 402 - Failure of the Governing Body to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of the patients and staff. V 757 - Failure of the Governing Body to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 10 patients who were receiving dialysis care per shift.”

“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: 52051 Based on observation, staff interview, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA) observed, performed hand hygiene (handwashing with soap and water or use of an alcohol-based hand sanitizer), after removing potentially contaminated gloves during a Central Venous Catheter (CVC - a soft plastic tube inserted into a large vein in the neck or groin, used to provide hemodialysis [HD] for patients), dressing change. This breach in infection control techniques, such as hand hygiene, had the potential to increase the risk for cross contamination and access site infection for Patient (P)#10 and eight other patients who had CVCs as their primary dialysis access. The facility had 41 in-center hemodialysis patients under their care. Findings Include: During observation in the Patient Treatment Room on 6/11/25, between 10:50 a.m. and 12:20 p.m., the following was revealed: - RN AA was observed preparing to initiate hemodialysis treatment for P#10. RN AA donned gloves and placed an underpad beneath the catheter limbs of P#10’s CVC access site. He then removed the old dressing (dirty). After completing this step, RN AA removed his gloves but did not perform hand hygiene before putting on a new pair of gloves. He then proceeded to clean the exit site using a swab stick and applied a new dressing. - During an interview with RN AA on 6/11/25, at 12:11 p.m., he admitted that he forgot to perform hand hygiene after removing his gloves before cleaning P#10’s CVC exit site. RN AA also acknowledged the importance of performing hand hygiene between glove changes. - According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ... A review of the facility’s Policy, titled, “Central Venous Catheter (CVC) Dressing Change, published on May 6, 2024, stated: Removal of Dressing and Inspection of Site 7. Discard dressing and remove gloves. Perform hand hygiene Cleaning the Catheter Site 1. Perform hand hygiene and don clean gloves. - On 6/13/24, at 11:00 a.m., the covering Director of Operations (DO BB) was notified of this observation, but offered no comments.”

“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: 52051 Based on observation and staff interviews, it was determined that the facility failed to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of the patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Dialysate Preparation Room and one of one Supply Room/Biomedical Technician (BMT) Work Area. The facility had 41 in-center hemodialysis (ICHD) patients. Findings include: During a tour of the facility on 6/11/25, between 9:40 a.m. and 10:45 a.m., the following was observed: In the Dialysate Preparation Room: - Two of the discharge ports on the Backflow Preventer (diverts the treated water to drain insuring the integrity of the potable water feed), were partially covered with a moderate amount of a rust-colored substance. Two of four levers were completely coated with the same rust-colored substance. The top part of one of two gauge-meters (located directly above the discharge port), had white and brownish colored substance surrounding its base. - The floor drain located beneath the Backflow Preventer was partially covered with brownish to rust colored substance. - The gray pipe, which houses the Sediment Filter #2 Cartridge, along with four black wires located just below the sampling station, was covered with a moderate amount of flaky white substance. - There was a moderate amount of rust-colored buildup around the base of the Booster Pump. - In the Sampling Station, the valve of the sample port for post-water carbon (where total chlorine samples were collected every three to four hours for testing) was broken. This caused the fluid to flow continuously from the port. - The floor in front of the Sampling Station was wet. The wet area measured about 4.5 feet in length and 2.5 feet in width. - On the floor, adjacent to the right side of the Granuflo Acid Concentrate Tank, was a Granuflo recirculation pump, which was surrounded by thick, crystallized residues that exhibited a mixture of brownish-black, and rust-colored build-ups. In the Supply Room/BMT Work Area: - The bottoms of the four legs of the sink were coated with a noticeable amount of rust-colored substance. - The floor, in front of the sink, was wet and marked by distinct blackish smudges that resembled shoe tracks. - The exit door leading to the outside had three holes/openings: one was at the bottom of the door frame, one on the right side just below the grab bar, and another hole was on the right side just above the grab bar. Each opening was approximately one inch long and half an inch wide, allowing light to pass through. These gaps could potentially permit insects and rodents to enter the building. - During an interview with the BMT (who was present at the time of this observation) on 6/11/25, at 10:35 a.m., he stated that the Backflow Preventer was very old and needed to be replaced, and the management was aware of the issue. The BMT also confirmed that he could see the openings/holes in the exit door that this surveyor pointed out. The BMT also acknowledged all of the other observations mentioned above. - A review of facility policy #47685, published 7/1/24, version 7, titled, “General Cleanliness and Infection Control Guidelines”, stated: All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. - Neither the Clinic Manager nor the Director of Operations were available for an interview or to be notified of this observation. - On 6/12/25, at 11:10 a.m., this surveyor showed all the observations mentioned above to the Director of Technical Operations. He stated that the facility was planning to change the entire water system, as it was no longer supported by the manufacturer. He also expressed concern about the openings in the exit door and assured that all the buildup around the acid recirculation pump would be cleaned up.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 49321 Based on observation, a review of facility records, staff interviews, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that one of one Registered Nurse (RN AA) observed, administered intravenous medications in accordance with facility procedures. Additionally, the Medical Director failed to ensure that all Direct Patient Care (DPC) Staff (Registered Nurses - RNs and Patient Care Technicians - PCTs), adhered to dialysis orders by maintaining the prescribed ultrafiltration (an amount of fluid drawn by the hemodialysis machine during hemodialysis treatment), rate at or below 13 mL/kg/hr (milliLiter per kilogram per hour - the maximum safe rate for fluid removal during treatment), and by ensuring that blood flow rates (BFRs) were maintained at prescribed levels. This failure had the potential to cause harm to patients, including risks of hypotension (low blood pressure - BP), cramping, increased likelihood of cardiovascular complications, inadequate dialysis clearance, and an increased risk of clotting. Excessive ultrafiltration may lead to sympathetic activation that causes BP increase during hemodialysis. The facility census was 41 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 6/11/25 between 10:00 a.m. and 12:00 p.m., the following was revealed: - At Station 9 (S9), the hemodialysis treatment for Patient (P) #10 had been completed. All of P#10’s blood had been returned, and the dialysis bloodlines had been disconnected from P#10’s dialysis needles (arteriovenous fistula - AVF needles). RN AA then administered Hectorol injection (a treatment for secondary hyperparathyroidism [SHPT] in adult patients on dialysis), 1 mcg (microgram) by intravenous (IV) push through the dialysis needle, followed by a flush of the line with normal saline. Subsequently, RN AA administered Venofer (iron sucrose) injection, (used to treat iron deficiency anemia), 50 mg by IV push for one minute and again flushed the line with normal saline. The dialysis needle was then removed. During an interview conducted on 6/11/25 at 2:20 p.m., RN AA stated that he believed he had administered the Venofer over a period of two minutes. When asked why the medication was not given during the dialysis treatment as per protocol, RN AA explained that he became busy and forgot to administer it at the appropriate time. A review of facility records revealed an elevated ultrafiltration rate (UFR) in one of one patient (P#11), who was sampled for fluid management. Further investigation identified additional patients with UFRs exceeding 13 mL/kg/hr with no documented evidence to support why. P#11 - Ultrafiltration and Blood Pressure Summary: - On 5/17/25: o Estimated Dry Weight (EDW): 39 kg (kilogram) o Pre-treatment weight: 44.1 kg o Post-treatment weight: 42.7 kg o UFR: 19.3 mL/kg/hr o Blood Pressure (BP): Pre-treatment: 227/97 mmHg (millimeters of mercury) | Post-treatment: 216/110 mmHg - On 5/31/25: o EDW: Increased to 41 kg o Pre-treatment weight: 44.6 kg o Post-treatment weight: 43.6 kg o UFR: 13.5 mL/kg/hr o BP: Pre-treatment: 227/98 mmHg | Post-treatment: 198/93 mmHg - On 6/3/25: o EDW: 41 kg o Pre-treatment weight: 43.5 kg o Post-treatment weight: 42.1 kg o Treatment time: 1 hour 40 minutes o UFR: 20 mL/kg/hr P#12 - Ultrafiltration and Blood Pressure Summary: - On 5/19/25: o EDW: 63.3 kg o Pre-treatment weight: 67.6 kg o Post-treatment weight: 63.9 kg o UFR: 15.8 mL/kg/hr o BP: Pre-treatment: 174/114 mmHg | Post-treatment: 179/106 mmHg - On 5/28/25: o EDW: 63.3 kg o Pre-treatment weight: 67.6 kg o Post-treatment weight: 63.9 kg o Treatment time: 3 hours 30 minutes o UFR: 16.2 mL/kg/hr - On 5/30/25: o EDW: 63.3 kg o Pre-treatment weight: 66.1 kg o Post-treatment weight: 63.1 kg o Treatment time: 3 hours 1 minute o UFR: 15.8 mL/kg/hr o BP: Pre-treatment: 187/119 mmHg | Post-treatment: 187/120 mmHg P#3: - The prescribed blood flow rate (BFR) for P#3 was 450 mL/minute (min.). However, on 5/29/25, 5/31/25, and 6/3/25, the patient’s BFR ranged between 300 and 350 mL/min. There was no documented reason for the reduced BFR, nor any documentation indicating that the nurse was notified. - During an interview with PCT AA on 6/11/25 at approximately 12:15 p.m., she stated that something was wrong with the dialysis machine. When this surveyor asked what did it have to do with the BFR, PCT AA stated that she didn’t know. P#5: - The prescribed BFR for P#5 was 500 mL/min. On 4/23/25, 4/25/25, and 4/30/25, P#5’s BFR ranged from 400 to 475 mL/min. There was no documented reason for the reduced BFR, nor any documentation indicating that the nurse was notified. - During an interview conducted on 6/12/25 at 11:54 a.m., RN CC stated that she was not consistently notified by the PCTs about patients’ EDWs when the patients first arrived for dialysis treatment, nor if there were any cannulation issues. She also reported that on the Tuesdays-Thursdays-Saturdays (TTS) schedule, she was assigned to work in a dual role as both a nurse and PCT. Due to this dual responsibility, she found it challenging to manage her assigned patients while also monitoring other patients’ EDWs, BFRs, and BPs. RN CC added that she provided education to patients who were significantly over their EDW; however, she did not always document these educational interactions. - During an interview conducted on 6/13/25 at 11:30 a.m., the Medical Director stated that there were standing orders to perform pure ultrafiltration on patients who presented with significantly higher weight than their EDW. When informed that no documented evidence could be found on the patients’ treatment sheets, he stated that he was not aware that documentation was not being completed. A review of Policy #47534, Version 3, published 7/1/2024, titled, “Special Consideration: Venofer”, stated: Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 ml of 0.9% normal saline over a period of at least 15 minutes. Venofer should be administered early during the dialysis session generally within the first hour. A review of Policy #47582, version 2, published 2/6/2023, titled, “Special Consideration: Doxercalciferol”, stated: IV bolus anytime DURING hemodialysis treatment. A review of Policy #45284, version 4, published 5/1/2023, titled, “Patient Assessment and Monitoring”, stated: Monitor UF rate (Ultrafiltration). NOTE: Ultrafiltration rates greater than 13 ml/kg/hr should be avoided if possible, by providing adequate prescribed dialysis duration, and scheduling of additional treatments if medically necessary. Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate. 52051 Based on observation, a review of Food and Drug Administration (FDA) Guidelines, staff interview, a review of Centers for Disease Control and Prevention (CDC) Recommendations, a review of the manufacturer’s Direction for Use (DFU), and a review of facility Policies and Procedures (P&P), it was determined that the facility failed to ensure that the opened vial of Tuberculin Purified Protein Derivative (PPD Mantoux - a diagnostic antigen used to detect infection with Mycobacterium tuberculosis), was properly dated, in order to track the medication’s shelf life after it was opened and for preventing the administration of expired products. This failure had the potential to negatively affect the health and safety of 41 in-center hemodialysis (ICHD) patients, six home peritoneal dialysis patients, and two home hemodialysis patients who were under the care of this facility. Findings include: During the facility tour, with Registered Nurse (RN BB) on 6/11/25, between 9:40 a.m. to 10:45 a.m., the following was revealed: In the Medication Refrigerator: - There was an opened and accessed vial of Tuberculin PPD Mantoux, which did not have a date and time indicating when it was opened. - During an interview with RN BB, who was present at the time of the observation, on 6/11/25, at 10:15 a.m., she acknowledged that the medication was not dated properly. RN BB was also unaware of who had opened the vial or how long the medication could be used. According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. - A review of the facility’s Policy: 47488, Version 9, titled, “Medication Preparation and Administration”, with latest revision date of February 6, 2023, stated: Labeling Vials When preparing medications if the vial is not used immediately in its entirety, the nurse must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all opened vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Monitoring Expired Medications Any open multi-dose vials must be discarded 28 days after opening or per manufacturer’s expiration date. - A review of the Manufacturer’s DFU stated: - A vial of Tuberculin PPD solutions which has been entered and in use for 30 days should be discarded. A review of FDA guidelines stated: - A vial of Tuberculin PPD (Mantoux) Tubersol, which has been entered and in use for 30 days should be discarded. - Neither the Clinic Manager nor the Director of Operations (DO AA) was available for an interview or to be notified of this observation. - On 6/13/24, at 11:00 a.m., the covering Director of Operations (DO BB) was notified of this observation, but no comments were made.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 52051 Based on staff interviews and a review of facility records, it was determined that the Facility Administrator failed to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility had 41 in-center hemodialysis (ICHD) patients under their care. Findings include: - During an interview with Registered Nurse (RN CC) on 6/12/25, at 11:53 a.m., she stated that the facility was open from Monday to Saturday. On the Mondays, Wednesdays, and Fridays (MWF) schedule, the facility ran three shifts for ICHD patients, while on Tuesdays, Thursdays, and Saturdays (TTS) schedule, there were two shifts. RN CC also stated that even though TTS only had two shifts, there was only one nurse and two Patient Care Technicians (PCTs) caring for 10 patients on the first shift and eight or nine patients on the second shift. - During an interview with PCT AA on 6/12/25, at 1:43 p.m, she stated that the RN was assigned as the dialysis care giver to two patients at Station (S)1 and S2 during the first shift. She added that on Tuesdays and Saturdays, there were nine patients during the second shift that included Patient (P#9), who was a Hepatitis B (a highly contagious infection of the liver caused by Hepatitis B Virus, that is transmitted via infected blood and other body fluids), positive patient who was receiving hemodialysis treatment in the isolation room. PCT AA added that the RN was responsible for P#9’s dialysis care, in addition to her nursing duties. PCT AA also stated, “If I was a nurse, I would feel overwhelmed. It’s only today that we got four people (two PCTs and two RNs) on the floor”. - During an interview on 6/12/25, at 2:10 p.m., the Director of Operations (DO BB), who was filling in for DO AA and the facility’s Nurse Manager, stated that the Governing Body was fully aware of the staffing issues. - A review of the facility’s “Patient and Teammate Schedule,” (schedule of the number of ICHD patients dialyzing each shift and the number of Patient Care Technicians and licensed nurses providing patient care services), specifically the TTS schedule from April 2025 to June 2025, revealed the following: The Patient Treatment Room was divided into three Pods (sections): - Pod #1 (which included S1, S2, and the Isolation Room), was typically assigned to the RN on duty. - Pod #2 (which included S3, S4, S5, and S6), was assigned to a PCT. - Pod #3 (which included S7, S8, S9, and S10), was also assigned to a PCT. -The TTS schedule had two shifts. During the first shift, there were a total of 10 ICHD patients. For the second shift, there were eight ICHD patients on Thursdays and nine ICHD patients on Tuesdays and Saturdays. -The TTS schedule for the specified dates indicated that the RN functioned as a dialysis caregiver, providing total care to two patients in a Pod during the first shift and one patient (P#9) in an isolation room during the second shift. P#9 was scheduled for treatment twice a week, on Tuesdays and Saturdays. The RN was responsible not only to oversee and deliver nursing care to all the patients in the Patient Treatment Room that included, but not limited to: pre- and post-dialysis assessments, preparing and administering medications, communicating with doctors as necessary, responding to complications and other medical issues and emergencies related to hemodialysis that may arise, and supervising the care provided by the two PCTs assigned to other patients on the schedule, but the RN was also responsible as a dialysis caregiver. - A review of the “Patient and Teammate Schedule”, specifically, TTS schedule between 4/5/25 through 6/10/25, showed there were only two PCTs and one RN that was on the schedule during these dates. - A review of the Governing Body meeting minutes dated April 7, 2025, which included the participation of the Medical Director, the Director of Operations (DO AA), and the Nurse Manager, revealed that the DO AA informed the Governing Body that the State’s staffing regulations had been misinterpreted, and as a result, the clinic was not in compliance. - During an interview with RN CC on 6/13/25, at 8:05 a.m., she confirmed that on the TTS schedule, she was responsible for the total care of patients on S1 and S2 during the first shift and for patient #9 in the isolation room during the second shift on Tuesdays and Saturdays. RN CC expressed that she felt rushed and found it overwhelming to serve both as a caregiver and as a charge nurse simultaneously. - On 6/13/25, at 11:05 a.m., this surveyor notified the Medical Director of this observation, but the Medical Director made no comments.”

“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: 49321 Based on a review of medical records, staff interviews, and a review of facility Policy and Procedures (P&P), it was determined that the facility failed to obtain a written physician’s order that was signed by the patient’s attending Physician before involuntarily discharging one of one patient (P) #1, from the dialysis facility. This deficient practice had the potential to negatively affect the heath and safety of P#1. Findings include: During a review of P#1’s chart, the following was revealed: - A discharge letter addressed to P#1, dated 2/6/25, written and signed by the associate Nephrologist, (Dr. BB), one of the Nephrologists in the attending/primary Nephrologist’s (Dr. AA’s) Group, stated: ... Because of your non-compliance with your dialysis treatment, we are dismissing you from our practice. We will continue to be available to you for the next 30 days for emergent care only... - A discharge letter addressed to P#1, with no date, written and signed by the Medical Director, stated: ... It is reported to myself and staff and his previous nephrology team that he averages only 1-2 dialysis treatments per month. His actual treatment is 3 days per week. Other issues include, not adhering to his medications, treatment plans, refusing to go to the hospital for blood transfusions when his hemoglobin was under 7. He also refuses to answer calls when the dialysis facility is reaching out to communicate care. He was given a 2 weeks’ notice by his current provider to be more compliant and still failed to do so... As of 03/06/2025, (patient’s name - P#1) will no longer have dialysis orders at (name of current facility). He was advised to find another provider at another facility that can accept him for dialysis. He was told that he would have the hospital for dialysis if unable to be assigned to another provider group. (sic) - Another discharge letter, addressed to P#1, dated 2/11/25, written and signed by Dr. BB, stated: To whom it may concern patient has history of end-stage renal disease and was not compliant to his dialysis treatment at (name of current facility). (sic) Patient (referring to P#1) was missing his appointments and only comes to the clinic once or twice a month. Patient was not adherent to his medications. Despite counseling and recurrent education, patient (P#1) was not compliant to his treatments... I advised the patient (P#1) to be adherent to his medication treatment and he refused to comply upon which he will be dismissed from the dialysis clinic and will be discharged. As of 03/06/2025 will no longer have dialysis orders. Advised to find another provider in another facility that can accept him for dialysis. If he wants to come back on dialysis at another facility, needs to go to the hospital first to be assigned for another provider group and dialysis unit. (sic) Patient (P#1) was advised to go to the hospital for further assessment if needed. Name and address of P#1, and signed by Dr. BB. - During a telephonic interview with the Medical Director on 4/3/25 at 12:56 p.m. The Medical Director told the State’s Program Manager and this surveyor, that P#1 was not discharged because of noncompliance; the patient was discharged from the facility because he did not have a doctor to oversee his care at the facility. He also stated that he was not willing to take him on as a patient because of his noncompliance. The Medical Director went on to say, doctors have the right to refuse patients just like patients have the right to refuse doctors. - During an interview with the Clinical Manager on 4/3/25 at 1:05 p.m., the Clinical Manager stated that the patient was noncompliant. The patient was only here to remove fluid and would only allow the staff to set him up for two hours of dialysis treatment. The patient stated that he took laxatives to make his potassium drop and he would just not show up for his dialysis treatments. We had plenty of discussions with him. His attending Physician discharged him, and the Medical Director was not willing to take him on as a patient. The facility had to discharge him. When asked if the letters were sent via certified mail and if there were certified mail receipts (proof) when the letters were sent to P#1, the Clinical Manager stated that they were all in P#1’s chart. This surveyor did not find any certified mail receipts in P#1’s chart. - During a telephonic interview with P#1’s grandson (P#1’s emergency contact), on 4/3/25 at approximately 1:40 p.m., he stated that he did not know what was going on and P#1 was at his home. - During a telephonic interview with P#1 on 4/3/25 at 1:45 p.m., P#1 was asked by this surveyor if he was undergoing hemodialysis treatment somewhere. P#1 stated, “Dr. Al, Friday, Monday, Davita”. P#1 repeated this same sentence twice then hanged up. - During a telephonic interview with P#1’s attending Nephrologist (Dr. AA), on 4/3/25 at 2:11 p.m., Dr. AA stated that he did not discharge P#1, but he was discharged by one of the other doctors in the practice (Dr. BB), because of P#1’s noncompliance. Dr. AA also added that P#1 was currently at the hospital, but when Dr. AA verified P#1’s status at the hospital he found out that P#1 had been discharged. Dr. AA was asked if he was willing to take P#1 back under a contract, Dr. AA stated, yes if the patient agreed to run three hours and thirty minutes and come to dialysis three times a week. - During a telephonic interview with the Social Worker on 4/3/25 at 3:42 p.m., she stated that P#1 did not come for dialysis treatment for over a month. The practice discharged him because of his non-compliance with his dialysis treatments. The SW was asked if the facility tried to put P#1 on a contract. The SW stated, there was no behavioral contract for non-compliance. - A review of facility Policy# 45111, titled, “Immediate and Non- Immediate Involuntary Patient Discharge”, Version 5, last revised, 11/4/24, stated: Page 7 If there is no other attending physician at the facility willing to accept the patient, obtain a written order for discharge from the attending physician.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 03383 Based on interviews, observation, and a review of medical records and facility policies, it was determined that the facility failed to ensure that all direct patient care staff adhered to the facility policy to ensure that each patient at this facility received medical care and supervision appropriate to the patient’s dialysis needs. This deficient practice was observed on three of three patients (P#1, P#2, and P#5) observed, during shift change.. Findings were: During an interview on 3/20/24 at 9:12 a.m., P#1 stated, “I’ve been on dialysis for 10 years. I’ve had a catheter three times; they removed the catheter last year and started using the graft. It hurts so bad when they put the needles in. I’ve told them not to stick me in the same place, I have knots in my arm from sticking me in the same place. I have an appointment with the doctor who put the graft in. I’ve seen staff spray stuff on arm, but they don’t use it on me”. During observation in the Patient Treatment Room between 9:39 a.m. and 11:00 a.m., the following was revealed: - P#1 experienced excessive bleeding from AVG after needle was removed at 10:26 a.m., P#1’s access started bleeding at 10:35 a.m. while the patient held pressure to one needle site. Blood saturated the patient’s arm, left shirt sleeve to underarm of shirt, and blue pad. The Charge Nurse (CN) applied pressure to access site with gloved finger, applied gauze pad on access needle site and continued to hold the site; the second needle was removed and P#1 began holding pressure to the access site while Patient Care Technician (PCT) CC removed the bloody pad from underneath patient’s arm, along with gauze pads that were saturated with blood; placed bloody items in the biohazard container, removed gloves, performed hand hygiene, placed a clean blue pad under the patient’s left arm, and cleansed P#1’s arm of remaining blood. Once second needle site stopped bleeding, PCT CC secured access site with tape. A review of P#1’s Comprehensive Interdisciplinary Assessment (CIA) dated 7/31/23 and Plan of Care (POC) dated 8/31/23, addressed catheter access and was not updated to AVG, that has been active since 10/31/23. - P#2, who was seated at Station (S) 4 was observed during initiation of dialysis treatment at 10:34 a.m. P#4 had an AVG that bled from one needle site after the needle was inserted; PCT DD removed the needle and held pressure to the site; and inserted another needle. When asked by this surveyor what happened, PCT DD stated, “He has a graft; blood leaked from around the needle site and I had to insert another needle in a different spot”. A review of the treatment records dated 3/20/24 did not show issues encountered with P#1 and P#2. P#1’s excessive bleeding from the AVG access site after needle removal; and P#2’s bleeding from AVG access site after needle insertion, which were witnessed by this surveyor on 3/20/24, were not documented. - During the insertion of dialysis needle, P#5 who was seated at S5, flinched/winced and exhibited facial grimacing indicating possible pain. During an interview with the CN on 3/20/24 at 10:55 a.m., surveyor asked about using a numbing agent on access sites before inserting the needles. CN stated, “Some patients get Lidocaine 0.5% for numbing; patients do this before they get here; we have to have an order for it”. During an interview on 3/20/24 at 11:00 a.m., the Clinical Manager (CM) stated “Staff know where to insert needles based on the last stick; a scab has usually formed so they know not to put the needle in the same place”. CM stated P#1 had a large aneurysm that the physician had to address last year. The CM confirmed that treatment sheets did not show when patients had excessive bleeding from access site or if patient experienced bleeding around needle site after needle insertion. Also stated “I don’t think there is an area on the treatment sheet to indicate if topical medication was used to reduce pain during cannulation (insertion of needle)”. CM confirmed that the patient’s CIA and POC were not updated to reflect the patient has an AVG; the care plan dated 07/31/23 and POC dated 08/31/23 addressed catheter access, and not the AVG that has been active since 10/31/23. CM indicated that they do have topicals that can be used at the clinic, but a doctor’s order is needed. A review of policy titled, “Access Assessment and Cannulation” dated 7/5/22 showed: Step 4. ASK: complaints of pain, numbness, tingling, coldness and tenderness, fever. Document in treatment record. Step 5. LOOK: - Skin discoloration/Redness/Bruising/Lesion - Hematomas - Extremity or other swelling - New or change in aneurysm or pseudoaneurysm - Poor rotation of cannulation... - Any other unusual findings Document in treatment record. Anesthetic Consideration Peripheral needle sticks may cause patients to experience pain, anxiety, dissatisfaction, and discomfort. Using a local anesthetic may improve patient comfort and satisfaction. The staff should facilitate implementation of the patient’s anesthetic choice in accordance with physician orders and available items on the FKC formulary. Patient application of Topical Anesthetic Cream at Home: The medication is typically applied by the patient prior to coming to the facility for dialysis treatment. A review of policy titled, “CryoDose TA Topical Anesthetic Spray” dated 9/7/23 stated: Nursing Considerations You (Patient) will be given Cryodose cannister to take home and bring back to the clinic for your treatment... On 3/20/24 at 11:00 a.m., CM confirmed that P#1 did not have a physician order for any anesthetic for access site, to improve patient’s comfort and satisfaction.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 03383 Based on interviews and document review, it was determined that the facility failed to ensure that one of three patient grievances [filed by Patient (P) #1] pertaining to change in appointment time, was followed up on and resolved. Findings were: During an interview on 3/20/24 at 9:12 a.m., P#1 stated, I’ve been on dialysis for 10 years. I was given the shift that begins at 4:45 a.m. When all those people left about two years ago, my time was changed to 5:45 a.m. start time and I usually get here at 5:30 a.m.; they said corporate changed the time (to start patient’s dialysis), when the White people left is when it changed. I called the grievance line, but they never got back to me. They are late putting me on (starting dialysis treatment). They were late putting me on this morning, I didn’t go on until after 6:00 a.m., now I will be late coming off. A review of the Social Worker (SW) Notes for P#1 showed the following: 9/17/22: Pt (Patient) expresses concerns about change with his chair time 9/28/22: Pt expresses concerns about change with his chair time and feeling it is unfair that he does not have an earlier time and he has been here longer. 11/08/22: Pt expresses concerns about change with his chair time; has called clinical services and hasn’t gotten a response. 12/05/22: Pt expresses concerns about change with his chair time and calling to file grievance and getting no response. 01/23/23: SW did note that the patient has improved with missed treatments as he only missed one due to being in the hospital... Pt still expresses frustration with his chair time... Patient still wishes his time was what it was when he first started at the clinic seven years ago. 3/13/23: Patient is voicing concerns about change in chair time. 5/17/23: Patient is voicing concerns about change in chair time, other patient’s getting off before him, favoritism, and feeling staff do not care about him. SW Notes Continued: 1/17/24: Patient stated he was not well due to pain in a wound on his bottom and missing treatments because of it. 1/17/24: Patient stated he was not doing too well due to some pain in a wound on his bottom. Patient stated it has been real uncomfortable to be in the chair for this amount of time. No pillows, cushioning, or shifting is alleviating the pain according to the patient. Patient still mentioning frustration with change in chair time at this SW visit along with pain which is making it difficult to receive dialysis. 02/26/24: Did not mention chair time but did talk about wound. The SW notes showed that P#1 was advised to talk to the CM about the change in treatment time. SW Notes did not show the SW followed up with the patient’s complaints/concerns about the change in treatment time. A review of the Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) dated 8/31/23 did not address P#1’s unwaivering concerns and frustrations about change in scheduled appointment time since 9/7/22. There was a lack of documented evidence that the SW addressed P#1’s psychosocial needs. A review of Patient Grievance Reports showed the following: - P#1 filed a grievance to the Clinic Manager (CM) on 3/6/24 related to chair time being changed in 2022 and waiting too long to be brought back to the treatment floor. This was documented as resolved on 3/6/24. - The “Resolution/Corrective Actions” stated: We have discussed several times over the past year trying to explain the reason for the spacing of treatments out is for the safety and adequate time for staff to assess and perform all the necessary tasks. Patient does show up at 4:45 a.m. most days for chair time of 5:45 a.m. Upon review of his treatment times the patient has been getting on and started anywhere between 5:40 a.m. - 6:00 a.m. - The “Follow Up with Patient” stated: Explained to the patient again that we cannot put him on early so that there is adequate time between patients in the morning and at shift change. That all the schedules are subject to change based on prescription changes and safety aspects. - There was a lack of documented efforts made by the CM to meet P#1’s individual needs. - There were two patients (P#6 and P#7), who also complained about the change in their treatment times. P#6’s complaint was filed on 5/31/23 and was resolved on 7/6/23. P#7’s complaint was filed on 6/1/23 and was resoved on 7/6/23. Both P#6 and P#7 were able to keep their treatment times after threatening to leave for another facility. A review of facility’s Grievance policy showed the following: 1. FKC Staff promptly acknowledges and reports all patient grievances to the Nurse in Charge (or Team Leader) as soon as possible. 2. The Nurse in Charge (or Team Leader) meets with the patient to gather information and completes as many fields as possible on the Patient Grievance Status Report daily within 72 hours of being notified. 3. The CM reviews the Patient Grievance Status Report daily. For any new grievances, CM meets with the patient within 5 business days to acknowledge, investigate and address the grievance. Note: MSW or other staff may also assist in assessing and resolving patient grievances, as appropriate. 4. CM reports back to the patient when a resolution is attained or considered by the facility. The CM was notified of the above findings on 3/20/24 at approximately 2:00 p.m., and did not provide documentation that showed staff adhered to the facility’s grievance policy or that SW assisted in assessing and resolving P#1’s concerns.”