Fresenius Medical Care Toccoa

“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 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 all Direct Patient Care (DPC) staff (Registered Nurses - (RNs) and Patient Care Technicians - (PCTs), consistently followed prescribed hemodialysis treatment orders as evidenced by two of three Patients (P) (P#1 and P#3) sampled, had ultrafiltration rate (UFR - the speed at which excess fluid is removed during a dialysis treatment session), that exceeded the recommended maximum of 13 milliLiter per kilogram per hour (mL/kg/hr), which is considered the safe limit for fluid removal during hemodialysis. Excessive ultrafiltration (UF) during hemodialysis can lead to serious complications due to rapid fluid removal which can result in intradialytic hypotension (low blood pressure during dialysis), muscle cramping, dizziness, and potentially contribute to long-term cardiovascular complications and even mortality. Additionally, intradialytic (during dialysis)monitoring every 30 minutes were not consistent as required on three of three patients (P#1, P#2, and P#3), sampled. When blood pressure (BP) is not monitored at least every 30 minutes as recommended, episodes of hypotension (low blood pressure) or hypertension (high blood pressure), may go undetected, delaying necessary interventions such as but not limited to: fluid administration or adjustment of ultrafiltration goals. These deficient practices had the potential to negatively affect the health and safety of P#1, P#2, and P#3. The facility census was 66. Findings include: A review of P#1’s, P#2’s, and P#3’s “Treatment Sheets” between July 3, 2025 to July 31, 2025, revealed the following: P#1: - On 7/03/25: There was no 30-minute intradialytic monitoring between 7:44 a.m. and 8:47 a.m. = (63-minute gap) - On 7/10/25: Treatment started at 7:36 a.m. P#1’s first BP check was at 8:02 a.m. at 170/85 mmHg (millimeter of mercury) = (26-minute delay) - On 7/17/25: There was no 30-minute intradialytic monitoring between 8:36 a.m. (BP at 139/77 mmHg) and 9:34 a.m. (BP at 131/68 mmHg) = (57-minute gap) - On 7/19/25: P#1’s Estimated Dry Weight (EDW) or target weight was 160.5 kg. P#1’s Pre-Weight (pre-dialysis weight) was 165.5 kg. His Post-Weight (post dialysis weight) was: 154.1 kg (11.4 kg below P#1’s target weight or EDW. Fluid Removed: 11.1 kg | UFR was 20.7 mL/kg/hr. Under Recommendation note: “Adjust Target Weight Removal to 0.5 kg or below”. Under Recommendation Action: “Declined - patient refused”. - On 7/31/25: There was no 30-minute intradialytic monitoring between 8:36 a.m. (BP 125/72) and 9:33 a.m. (BP reading 109/56 mm Hg) = (57-minute gap with a significant drop in BP reading) P#2: - On 7/17/25: Hemodialysis treatment started at 8:10 a.m., and the first BP reading was recorded at 8:33 a.m. (BP 169/94 mmHg) = (23-minute delay) - On 7/22/25: There was no 30-minute intradialytic monitoring between 9:02 a.m. (BP reading 132/66 mmHg) and 10:04 a.m. (BP 180/77 mmHg = (62-minute gap with a significant BP reading increase). - On 7/24/25: There was a 38-minute gap in intradialytic monitoring between 8:02 a.m. (BP reading 116/55 mmHg) and 8:40 a.m. (BP reading 105/56 mmHg). - On 7/26/25: There was a 55-minute gap in intradialytic monitoring between 11:04 a.m. (BP reading120/62 mmHg) and 11:59 a.m. (BP reading 115/60 mmHg). - On 7/29/25: There was a 47-minute gap in intradialytic monitoring between 7:53 a.m. (BP reading 160/72 mmHg) and 8:40 a.m. (BP reading 140/73 mmHg). - On 7/31/25: There was a 41-minute gap in intradialytic monitoring between 8:03 a.m. (BP reading 125/59 mmHg) and 8:44 a.m. (BP reading 110/55 mmHg). And a 60-minute gap in intradialytic monitoring between 9:35 a.m. (BP reading 125/66 mmHg) and 10:35 a.m. (BP reading 141/58). P#3: - On 7/07/25: There was a 59-minute gap in intradialytic monitoring between 10:02 a.m. (BP reading 143/49 mmHg) and 11:01 a.m. (BP reading 114/45 mmHg, with a significant drop in BP reading). - On 7/09/25: There was a 55-minute gap in intradialytic monitoring between 11:30 a.m. (BP reading 136/63 mmHg) and 12:25 p.m. (BP reading 126/51 mmHg). - On 7/14/25: There was a 68-minute gap in intradialytic monitoring between 10:35 a.m. (BP reading 101/61 mmHg) and 11:43 a.m. (BP reading 98/55 mmHg, with a significant low BP reading). - On 7/16/25: There was a 43-minute gap in intradialytic monitoring between 10:33 a.m. (BP reading 136/62 mmHg) and 11:16 a.m. (BP reading 120/51 mmHg). - On 7/23/25: P#3’s EDW was 112.7 kg | Pre-Weight: 120.3 kg | Post-Wt: 114.4 kg UFR: 13.9 mL/kg/hr - Under Recommendation notes: Registered Nurse (RN AA) documented: “Following sequential/pure UF, adjust Target Weight removal to max hourly UFR not to exceed UFR of 13 mL/kg/hr. Increase today’s treatment duration by 15 minutes and utilize sequential or pure UF for the first 15 minutes of treatment”. Under Action note: “Declined - patient refused”, written by RN AA. - P#3’s BP reading at 11:37 a.m. on 7/23/25, was 129/66 mmHg then at 12:03 p.m., BP reading was 104/66 mmHg. RN AA re-checked P#3’s BP right after the first reading and it had dropped to 74/30 mmHg. - P#3’s dialysis treatment ended at 12:15 p.m., but there was no BP documented at termination of treatment. - At 12:45 p.m., P#3’s BP reading right before discharge was 102/48 mmHg (sitting BP). During an interview with the Clinical Manager on 8/5/25 at 12:30 p.m., the Clinical Manager stated that she was not aware that staff were not checking vital signs every 30 minutes and she didn’t realize that the UFRs were greater than 13 mL/kg/hr on the above mentioned patients. During an interview conducted on 8/5/25, at 1:58 p.m., RN AA, who provided care to P#3 on 7/23/25, stated that P#3 enjoyed eating watermelon and acknowledged that although she provided education to her patients, she did not always document the type or the topic of the education she provided nor the dates when education was provided. RN AA also stated that P#3’s BP readings were taken on the left leg above the ankle. A review of Policy #45284, titled, “Patient Assessment and Monitoring”, published 5/1/23 verson 4, stated: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes per state regulation. A review of policy titled, “Sequential Ultrafiltration”, version #4, published 3/2/20, stated: A physician’s order is required for Sequential Ultrafiltration Follow the steps below to run Sequential Ultrafiltration for a PORTION of the dialysis treatment Follow the steps below to run sequential Ultrafiltration for the ENTIRE dialysis treatment - During an interview on 8/5/25 at 3:00 p.m., the Medical Director was notified of the above findings. The Medical Director stated that the facility had standing orders for Sequential Ultrafiltration (excess fluid and salt are removed from the blood in two stages. The two-stage process helps avoid pulling too much fluid too quickly and bottoming out the patient’s blood pressure), for any patients that needed them so they do not have to exceed the UFR of 13 mL/kg/hr. The Medical Director also added that the staff should be re-educated regarding sequential ultrafiltration and intradialytic monitoring. - The Clinical Manager was not able to provide a documentary evidence of P#1’s and P#3’s standing order for Sequential Ultrafiltration.”