Fmc - Fresenius Medical Care Lake Lanier

“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 38 in-center hemodialysis (ICHD) patients who were dialyzing at this facility. Findings include: Cross Reference: 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, a review of the Centers for Disease Control and Prevention (CDC) guidelines, staff interviews, and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCTAA and PCT BB), and one of one patient (P) (P#8) observed, consistently performed hand hygiene (handwashing with soap and water or use of an alcohol-based hand sanitizer), after removing contaminated gloves, between glove changes, and after touching contaminated area/equipment. This breach in infection control techniques, such as hand hygiene, had the potential to increase the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. The facility had 38 in-center hemodialysis (ICHD) patients. Findings include: During an observation in the Patient Treatment Room on 8/13/25, between 9:38 a.m. and 10:40 a.m., the following was revealed: - At 9:52 a.m. after dialysis treatment, P#8 at Station (S) 10 was applying pressure to his arm access site with his gloved left hand, until hemostasis (stopping of bleeding) was achieved. After glove removal, P#8 did not sanitize his hands and instead he proceeded to the weighing scale to obtain his post-treatment weight. PCT BB did not remind or encourage P#8 to perform hand hygiene. At 9:57 a.m., P#8 exited the Patient Treatment Room where he touched the door handle (clean). This door handle was not disinfected after being touched by P#8 which had the potential for cross contamination. - At 10:01 a.m., PCT BB was charting chairside at S8 using the dialysis machine’s keyboard (dirty) with her gloved hands. After completing this task, she removed her gloves but did not sanitize her hands. She then picked up a clean stethoscope and placed it around her neck. Subsequently, PCT BB put on a new pair of gloves without first performing hand hygiene and continued with her task. - At 10:12 a.m., PCT AA touched and repositioned the dialysis chair (dirty) at S10 without wearing gloves. After this task, she did not sanitize her hands, then she put on a new pair of gloves. According to CDC, healthcare workers to wash their hands immediately before touching a patient, after glove removal, after touching a patient’s equipment or surface, and after contact with body, bodily fluids, or contaminated surfaces. Additionally, 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. - During an interview with PCT AA on 8/13/25, at 3:41 p.m., she stated that she forgot to wear gloves when she touched the dialysis chair at S10. She acknowledged the importance of performing hand hygiene between glove changes. Additionally, she mentioned that P#8 was aware of the significance of performing hand hygiene before leaving the Patient Treatment Room, but he was not doing it. - During an interview with PCT BB on 8/13/25, at 4:05 p.m., she acknowledged the previously mentioned observation and stated that she became nervous and unintentionally forgot to sanitize her hands after removing her gloves. - A review of facility P & P Reference #47664, titled, “Hand Hygiene”, published 11/6/23, stated: Responsibility All staff, patients, patient care givers, including physicians and non-physician practitioners . . . must follow the same requirement for hand hygiene. Hands will be: Decontaminated using alcohol-based hand rub or by washing hands with anti-microbial soap and water . . . When: - Entering and leaving the treatment area. - Immediately after removing gloves. - After contact with other objects within the patient station or treatment space. Patients Patients should perform hand hygiene if able, prior to and after each dialysis treatment. . . - A review of facility P & P Reference #47663, titled, “Personal Protective Equipment”, published 11/6/23, stated: Gloves Staff must remove gloves and wash hands after: . . . Touching any surfaces within the patient station If hands are not visibly soiled, an alcohol-based hand sanitizer may be used. Always perform hand hygiene after glove removal.”

“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: 52051 Based on observation, staff interviews, and a review of facility Policy and Procedures (P & P), 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. The facility had 38 in-center hemodialysis (ICHD) patients. Findings include: During a tour of the Dialysate Preparation Room on 8/12/25, at 8:47 a.m., the following was observed: - The Prefilter Housing had three to four dried trickles of flaky white substance on both sides, from top to bottom. - The ring pipe hanger on the backflow preventer showed severe corrosion and was covered in dark brown and rust-colored buildup. - There was a moderate amount of rust buildup at the base of the Domestic Water Heater Tank, which had spread to the cement flooring, creating a yellow to rust-colored coating. To the right of this tank was a vertical black pipe attached to the ground, which was moderately covered with a carbon-like, blackish, grainy substance that extended down to its base. - One of the two red valves at the bottom right side of the Granuflo Acid Concentrate had a thick buildup of white crystallized substance. - The floor beneath the Isopure MD440 (a system designed to purify water for dialysis), exhibited a rust-colored coating or stain. The stained floor area measured approximately 2 Feet in length and 1.5 Feet in width. Additionally, the base of the metal frames also showed a moderate amount of rust buildup. The Clinic Manager, who was present at the time of this observation on 8/13/25 at 8:49 a.m., acknowledged all the observations mentioned above, and stated that she would clarify and coordinate with the Biomedical Technician (BMT). On 8/13/25, at 10:29 a.m., this surveyor presented all the observations mentioned above to the Area Technical Operations Manager. He stated that he was aware of the rust buildup at the base of the Domestic Water Heater and stated that he was already addressing the issue. He also acknowledged all other observations made. A review of facility P & P Reference #47685, titled, “General Cleanliness and Infection Control Guidelines”, published 5/5/25, stated: - All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms.”

“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: 52051 Based on a review of medical records, staff interviews, and review of facility Policy and Procedures (P & P), it was determined that the facility failed to ensure that one of one patient (P), (P#4) sampled, who experienced elevated blood pressure (BP) readings, received medical care/interventions appropriate to P#4’s dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg (millimeters of mercury) before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. The facility had 38 in-center hemodialysis (ICHD) patients, two home hemodialysis (HHD) patients, and seven home peritoneal dialysis (PD) patients. Findings include: A review of P#4’s “Treatment Sheet” from 7/31/25 to 8/12/25, revealed the following: 1. On 7/31/25, P#4’s pre-treatment BP was 80/48 mmHg and pre-treatment assessment was performed by Registered Nurse (RN CC). - At 5:45 a.m., P#4’s Hemodialysis (HD) treatment was initiated by RN CC, with a BP reading of 204/86 mmHg. - At 6:31 a.m., BP was 214/80 mmHg. - At 7:02 a.m., BP was 187/83 mmHg, recorded by Patient Care Technician (PCT BB). There was no mention that RN CC had been notified of P#4’s high BP reading. - At 7:29 a.m., BP was 197/107 mmHg. - Between 7:29 a.m. and 8:16 a.m., there were no vital signs recorded, nor 30-minute check/monitoring by PCT BB or by RN CC (nor other PCTs and licensed nurses). - At 8:47 a.m., BP was 228/79 mmHg, and as per documentation, “treatment was discontinued without problem”. Signed by RN CC. - Post-treatment, P#4’s sitting BP reading was 205/89 mmHg. Throughout P#4’s hemodialysis (HD) treatment, there was no documented evidence that RN CC performed any nursing interventions regarding P#4’s low and high blood pressure readings. Additionally, there was no documentation of re-assessment or further evaluation, nor any record of physician notification. Furthermore, there was no documentary evidence of a doctor’s standing order for P#4’s high BP readings during HD treatment. 2. On 8/2/25, P#4’s BP readings ranged from 142/67 to 216/55 mmHg. - Between 5:41 a.m. and 6:33 a.m., there were no vital signs recorded, nor 30-minute check/monitoring by RN BB (nor other PCTs and licensed nurses). There was no documentary evidence that PCT BB notified RN BB of P#4’s high BP readings. There was no documentary evidence that the nephrologist was notified by RN BB of P#4’s high BP readings. Throughout P#4’s HD treatment, there was no documentation indicating whether any assessment or intervention was provided by RN BB to address P#4’s elevated BP readings. During an interview on 8/14/25, at 1:40 p.m., RN BB was asked how high BP readings were handled. RN BB stated that she typically would retake the BP to confirm the readings. She usually would not administer BP medications if the treatment had just begun. RN BB also confirmed that PCTs were supposed to notify the nurse of high BP readings. If the BP remained consistently high during treatment, the RN should notify the physician. When this surveyor inquired whether these interventions were applied for P#4’s treatment on 8/2/25, RN BB admitted that they were not. She also recognized the significance of accurate and complete documentation. RN CC was not available for an interview. A review of facility P & P, titled, “Hypertension”, published 9/7/21, stated: Treating Hypertension 1. Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg. 2. The RN will assess the patient and determine if further nursing interventions are needed. 4. If hypertension is not related to hypervolemia (a condition where there is too much fluid in the body), notify the physician for additional orders/interventions. 5. Document in patient’s treatment record. A review of facility P & P Reference #45265, titled, “Nursing Supervision and Delegation”, published on 11/6/23, stated: Daily Treatment - Prior discharge, the RN must review the treatment record to: *Confirm patients are stable for discharge. Record Review - The record must be reviewed for: Low or high blood pressure *Blood pressures less than (<) 100 systolic or greater than (>) 180 systolic addressed by registered nurse with documentation present. Documentation Document all findings in the patient’s medical record. Guidelines for PCT/LPN/LVN/RN: When to Refer a Patient to the Team Leader/Charge Nurse for Further Assessment: - The following criteria can be used as a guideline to identify when PCT/LPN/LVN/ or RN shall refer a patient to the Team Leader/ Charge Nurse for further assessment pre, or post treatment. The Team Leader/ Charge Nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. - Blood Pressure *A systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 100 mmHg at any time before, during or after the treatment. If BP less than or equal to 100 mmHg systolic during treatment. A systolic blood pressure less than 100 mmHg post treatment when standing. A review of facility P & P Reference #45284, titled, “Patient Assessment and Monitoring,” published on 5/1/23, stated: Data Collection If the PCT/LPN note any changes or abnormal findings in the patients’ condition . . . the registered nurse must assess the patient. - The RN will notify the patient’s physician/ physician extender of any abnormal findings, if necessary, based on clinical judgment for any additional instruction. Pre-treatment 1. Verify: Systolic blood pressures greater than 180 mmHg and/or diastolic pressures greater than 100 mmHg. 3. Document findings and interventions in the medical record. Contact the physician as needed for additional orders based on assessment findings and clinical judgment. During Treatment - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulation. - Blood pressure Report to the nurse: *Systolic blood pressures greater than 180 mmHg *Blood pressure less than or equal to 100 mmHg systolic”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 52051 Based on a review of Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track and trend, perform root cause analysis, develop and implement plans of action, evaluate its effectiveness and make changes to plans of action if necessary, to improve and sustain patient outcomes for the facility’s Hospitalization & Re-admission outcomes and management of patients with high Phosphorus (a mineral found in many foods, however during kidney failure, the kidneys cannot effectively regulate phosphorus, which may lead to bone problems if phosphorus levels become too high), for in-center hemodialysis (ICHD) patients, in six of six months (January 2025 - June 2025) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of all 38 in-center hemodialysis (ICHD) patients, two home hemodialysis (HHD) patients, and seven home peritoneal dialysis (PD) patients. Findings include: A comparison between the facility’s FY 2025 QDFR and the facility’s QAPI meeting minutes between (January 2025 - June 2025), revealed the following: 1. Hospitalization and Re-admission: - FY 2025 QDFR - none reported. - QAPI - percent of patients who were re-admitted to the hospital within 30 days, ranged from 19.5% - 26.5%. The US threshold was 1.04%. 2. Phosphorus >7.0 mg/dL: - FY 2025 QDFR - 20.9% of ICHD patients had Phosphorus >7.0 mg/dL. - QAPI - percent of patients with Phosphorus >7.0 mg/dL ranged from 20% - 35%. The US threshold was 16.3%. There was a lack of documentary evidence that the entire Interdisciplinary Team (IDT) was fully involved in tracking and trending hospitalizations/re-admissions and phosphorus levels. Additionally, there was also a lack of documentary evidence that the IDT performed root cause analysis, developed and implemented action plans, evaluated their effectiveness, or modified plans to improve and sustain patient outcomes. During an interview with Registered Dietitian (RD AA) on 8/14/25, at 1:13 p.m., she mentioned that a new medication, “Xphozah” (used to reduce phosphorus levels in dialysis patients) was being slowly adopted at the facility. Patients transitioned to this medication change between March and April 2025. During a discussion with the Director of Operations and the Clinical Manager on 8/14/25, at 2:30 p.m., both acknowledged that the IDT should have been more actively involved in tracking and trending facility outcomes. They also recognized that not only should root cause analysis and plans of correction be formulated, but should also be implemented, evaluated, and updated or revised if they were not effective in improving and sustaining outcomes.”

“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 and provide safe patient care, 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. 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 38 in-center hemodialysis (ICHD) patients who dialyzed at this facility. Findings include: During an interview with Patient Care Technician (PCT) (PCT BB) on 8/13/25, at 3:52 p.m., she stated that this facility was dependent on float-pool nurses and technicians. She mentioned that on Fridays and Saturdays, it was typically just her, PCT CC, and RN BB who were working. Station (S) 9 and S10 were usually assigned to the licensed nurse. During an interview with the Clinical Manager (RN AA) on 8/13/25, at 4:39 p.m., she stated that she occasionally helped out on the Treatment Floor (Patient Treatment Room), on Fridays. She confirmed that the facility was dependent on float-pool nurses and technicians. Additionally, she acknowledged that there were times, particularly on Saturdays, when they were short-staffed. During a discussion with the Director of Operations on 8/14/25, at 7:32 a.m., she mentioned that staffing had been a significant challenge in this facility which management had been addressing for the past three months. 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 Friday and Saturday schedules from July 5, 2025 to August 9, 2025, revealed the following: - The Patient Treatment Room was divided into three Pods (sections): - Pod #1 (consisted of S1, S2, S3 and S4) - Pod #2 (consisted of S5, S6, S7, and S8) - Pod #3 (consisted of S9 and S10) - Both the Friday and Saturday schedules had two shifts. During the first shift, there were a total of 10 ICHD patients. For the second shift, there were 10 ICHD patients on Friday and nine ICHD patients on Saturday. - The schedules for Friday and Saturday, except for August 1, 2025, indicated that the RN served as a dialysis care giver. During the first shift on both Friday and Saturday, the RN provided complete care to two patients in a Pod and to one patient during the second shift on 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 assigned as a dialysis care giver to two patients on the first shift and one patient on the second shift. A review of the “Employees’ Clock-ins and Clock-outs” for Fridays and Saturdays from July 5, 2025, to August 9, 2025, revealed that only two PCTs and one RN worked during this period, except for July 26, 2025, when there were two RNs and one PCT on duty. During an interview with RN BB on 8/14/25, at 1:37 p.m., she confirmed that on the Friday and Saturday schedule, she was responsible for the total care of patients on S9 and S10 during the first shift and second shift, on top of her nursing roles and responsibilities. RN BB also stated, “It can be very busy. I am constantly bouncing around.””