Fresenius Kidney Care South Avenue

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to ensure that one out of one bottles of “Minncare Residual Test Strips” that were used for testing for clearance of the Minncare Disinfectant solution after disinfecting the reverse osmosis machine (RO) were not expired. This had the potential to affect all 47 in-center hemodialysis patients receiving care at the facility. Findings include: During an observation in the water room on 06/30/24 at 9:15 AM, revealed one bottle of opened “Minncare Residual Test Strips” manufactures expiration date was 03/20/25. During an interview with the Clinic Manager 3 and Biomedical Technician 6 on 06/30/25 at 9:15 AM, they confirmed the above findings. Review of the facility’s policy, titled: “Storage of Supplies and Supply Expiration Dates for Inpatient Service,” dated 07/01/24, indicated, “The purpose of this document is to provide guidance for storage of supplies, supply expiration dates, and removal of expired supplies. Supplies will be rotated First in first out. Any item that is expired, damaged, or has experienced loss of packaging integrity (tom, wet, punctured) will be removed from stock and disposed of appropriately.””

“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: 22676 Based on record review, interview, and policy review, the facility failed to conduct a nursing post assessment for one of five sampled in-center dialysis patients (Patient (P4). Failure to assess a patient could have a negative impact on the patient outcome on all 47 patients receiving in-center dialysis treatments at this facility. Findings include: Review of P4’s “Treatment Detail Report” in the electronic medical record (EMR) revealed on 06/24/25 that there was not a Registered Nurse (RN) assessment conducted. During an interview on 07/01/25 at 3:00 PM, Clinic Manager 3 confirmed the above findings, and that there was not an RN assessment completed. Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated 05/01/23, indicated, “The Registered Nurse will assess/reassess post treatment as indicated. Document findings in the patient’s record”.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 22676 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis plan (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) by following the physician prescription as determined by the medical provider for three of five sampled in-center dialysis patients (Patient (P1), P3 and P4). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 47 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s “Treatment Detail Report” in the electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 450 milliliters per minute (ml/min), and a Dialysate Flow Rate (DFR) of autoflow 1.5 ml/min or 675 ml/min. Review of two of six flowsheets from 06/17/25 through 06/28/25 indicated the following: a. On 06/24/25 from 8:07 AM until 10:07 AM, the BFR was documented at 350 ml/min and the DFR at 600 ml/min. b. On 06/26/25 from 10:13 AM until 11:27 AM, the BFR was documented at 300 ml/min and the DFR was documented at 500 ml/min. There was no documentation for the change to the prescribed BFR and DFR. 2. Review of P3’s “Treatment Detail Report” in the EMR revealed a prescribed BFR of 450 ml/min, and a DFR of autoflow 1.5 ml/min or 675 ml/min. Review of one of six flowsheets from 06/17/25 through 06/26/25 indicated the following: a. On 06/19/25 from 8:24 AM until 10:36 AM, the BFR was documented at 400 ml/min and the DFR at 600 ml/min. There was no documentation for the change to the prescribed BFR and DFR. 3. Review of P4’s “Treatment Detail Report” in the EMR revealed a prescribed BFR of 400 ml/min, and a DFR of autoflow 1.5 ml/min or 675 ml/min. Review of one of six flowsheets from 06/07/25 through 06/26/25 indicated the following: a. On 06/20/25 from 11:18 AM until 1:35 PM, the BFR was documented at 350 ml/min. There was no documentation for the change to the prescribed BFR. During an interview on 07/01/25 at 11:30 AM, Clinic Manager 3 confirmed the above findings, and that staff did not follow the physician’s order for dialysis treatment. Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated 05/01/23, states “Check that blood flow is being achieved or reason documented in medical record if unable to meet prescribed flow rate. Check Dialysis flow rate setting is correct, and prescribed flow is being delivered”.”

“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: 22676 Based on record review, policy review, document review, and interview, the facility failed to ensure Plan of Care (POC) participation, and that POC information was provided timely for one of five patients (Patient (P) 4) reviewed for care planning. This failure had the potential to negatively impact on the effectiveness of the dialysis treatments for the 47 patients receiving dialysis at the facility. Findings include: Review of the facility’s form titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed, “ ...the form required a patient signature and date when the plan was reviewed, and the patient understood the plan...” Review of P4’s 30-day POC, dated 03/18/25, located in the electronic medical record (EMR) under the “Plan of Care” section revealed, P4 did not sign the POC acknowledgement form. There was no documented evidence the patient received the POC information. In addition, the 90-day POC was completed on 06/25/25 P4 did not sign the POC form and there was no documented evidence the patient received the POC information. During an interview on 07/01/25 at 3:00 PM, Clinical Manager 3 confirmed the facility developed P4’s 30-day POC on 03/18/25 and the 90-day POC on 06/25/25 and there was no documented evidence that the patient was provided with the information. Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23 revealed, “ ...An interdisciplinary Comprehensive Assessment and Plan of Care must be completed by the interdisciplinary team members, per the frequency outlined in the Condition for Coverage ...The patient’s plan of care will be signed by all members of the IDT [Interdisciplinary Team].””