Fmc Bay Minette

“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: 22676 Based on interview, document review, policy review, and review of the manufacturer’s instructions, the facility failed to ensure the glucometer was in the control range as well as follow the manufacturer’s instructions for one of one glucometer used in the facility. This deficient practice had the potential to provide incorrect blood glucose results and could result in inaccurate glucose level results for all 44 patients receiving care at the facility. Findings included: Review of electronic “FKC [Fresenius Kidney Center] Log Reading Report” for the treatment unit, from 06/01/25 through 07/28/25 revealed the following: 1. The meter for the treatment unit labeled “Meter v3 81126” on 07/07/25 revealed the high range should be between 279 and 374. On 07/07/25 the recorded test result was 474. There was no recorded repeat of the abnormal control test. During an interview on 07/28/25 with Clinic Manager 3, confirmed the findings and agreed the staff did not repeat the high-level control as required by the manufacturer’s instruction. Review of the facility’s policy titled, “Blood Glucose Monitoring Device,” dated 11/06/23, revealed, under “Policy Training” section revealed, “Calibration and control testing shall be performed each operating day ...” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“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 one of five sampled in-center dialysis patients (Patient (P)1). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 44 patients receiving in-center dialysis treatments at this facility. Findings include: Review of P1’s electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) and a Dialysis Flow Rate of Auto flow of 1.5 the BFR which should be 600 ml/min. Review of two of six “Post Treatment” flowsheets from 07/14/25 through 07/25/25 in the EMR indicated the following: a. On 07/14/25 from 11:30AM until 2:09 PM, the BFR was documented at 350 ml/min. b. On 07/23/25 from 11:34 AM until 1:52 PM 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. During an interview on 07/30/25 at 10:15 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 revealed, “Check dialysate flow rate setting is correct, and the correct 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 three of five patients (Patient (P) 2, P4 and P5) reviewed for care planning. This failure had the potential to negatively impact the effectiveness of the dialysis treatments for the 44 patients receiving dialysis at the facility. Findings include: 1. Review of P2’s 30-day POC, dated 03/20/25, and the 90-day POC, dated 06/17/25, located in the electronic medical record (EMR) under the “Plan of Care” section revealed, P2 did not sign the POC acknowledgement form and there was no documented evidence the POC information was discussed with the patient as of 07/30/25. 2. Review of P4’s annual POC, dated 05/13/25, located in the EMR under the “Plan of Care” section revealed, P4 did not sign the POC acknowledgement form and there was no documented evidence that the POC information was discussed with the patient as of 07/30/25. 3. Review of P5’s annual POC, dated 12/09/24, located in the EMR under the “Plan of Care” section revealed, P5 did not sign the POC acknowledgement form and there was no documented evidence that the POC information was discussed with the patient as of 07/30/25. During an interview on 07/30/24 at 10:15 AM, Clinical Manager 3 confirmed the facility confirmed the above POC acknowledgement form had not been signed as required by the patients. 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 the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/03/23 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].””