Fresenius Kidney Care Orange Park North

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 35966 Based on record review and staff interview, the facility failed to ensure the total chlorine level testing was performed at the beginning of each treatment day prior to patients initiating treatment for one day in July 2024. Findings include: Review of the facility report titled “Post Worker Carbon Tank - TCL - 1 (54637) showed on 7/22/24, total chlorine level testing was performed at 9:00, 12:25, and 15:26. The facility policy titled “Carbon Filtration Monitoring for Incenter Central Water Systems Policy” published 11/7/2022 states the Worker Carbon Filter must be tested “Prior to the initiation of the first patient treatment of the day and at a minimum of every 4 hours. Routine Total Chlorine Testing will be documented in the approved electronic documentation system.” The Clinic Manager confirmed during an interview on 9/17/24 at or around 10:30am that 7 patients started treatment between the hours of 5:28am and 7:33am on 7/22/24. During the interview with the Area Technical Operations Manager (ATOM) on 9/17/24 at or around 11:30am, it was confirmed the first morning total chlorine testing of the post worker carbon tank documentation was missing on 7/22/24. The ATOM confirmed that the water used for treatment prior to 9:00 was safe for patients by showing documentation of the Reverse Osmosis (RO) water total chlorine testing that had been performed prior to patients beginning treatment on 7/22/24.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 35966 Based on record review and staff interview, the facility failed to ensure patient care plans were signed by the patient for three of four patient care plans reviewed (Patient #1, Patient #3, and Patient #4). Findings include: 1. The review of Patient #1’s plan of care showed it was completed on 8/1/24 and had not been signed by the patient. There was no record indicating the patient had refused to sign the care plan or a note indicating why a signature was not provided. 2. The review of Patient #3’s plan of care showed it was completed on 11/29/23 and had not been signed by the patient. There was no record indicating the patient had refused to sign the care plan or a note indicating why a signature was not provided. 3. The review of Patient #4’s plan of care showed it was completed on 8/27/24 and had not been signed by the patient. There was no record indicating the patient had refused to sign the care plan or a note indicating why a signature was not provided. The interview on 9/17/24 at 12:30pm with the Clinical Manager confirmed the version of the care plan signed by the patients could not be located.”

“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: 35966 Based on patient treatment record review and staff interview, the facility failed to maintain complete and accurate medical records for 3 patients (Patient #1, Patient #3, Patient #4) out of 4 in-center patients sampled. Findings include: 1. The review of Patient #1’s physician orders starting 1/12/24 and ending 1/10/25 showed an order of Heparin Sodium (Porcine) Bolus 2000 units Intravenous push (IVP) every treatment. Review of the patient’s treatment sheet dated 9/2/24 showed no documentation of the patient receiving the ordered medication. 2. A review was conducted of Patient #3’s dialysis treatment record for 9/4/24. There was no nursing assessment documented prior to the initiation of the patient’s treatment. 3. The review of Patient #4’s physician orders starting 4/17/24 and ending 4/16/25 showed an order of Heparin Sodium (Porcine) Bolus 4000 units IVP every treatment. Review of the patient’s treatment sheet dated 9/2/24 showed no documentation of the patient receiving the ordered medication. The interview with the Clinic Manager on 9/17/24 at 12:35pm stated the documentation for the heparin was missing for patient #1 and #4 due to a computer glitch. She was unable to locate a nurse’s note indicating heparin was given. The Clinic Manager confirmed during the interview that the nurse assessment was missing for Patient #3 and was unable to locate any further documentation.”