Fmc - Village Oaks Kidney Disease Clinic

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 27438 Based on observation, interview, and review of the facility’s policy, the facility failed to ensure the staff removed expired medication from the medication storage cabinet. This deficient practice had the potential to affect the potency of the medication and could affect all 115 in-center hemodialysis patients receiving treatment at this facility. Findings include: Observation of the facility’s medication preparation area on 11/04/24 at 3:30 PM showed the following expired injectable medications: four single-use vials of diphenhydramine HCL (used to treat life-threatening allergic reactions) injection-50 mg/ml (measurement of dose) with an expiration date of 10/2024 stored adjacent to nonexpired medications. During an interview on 11/04/24 at 11:55 AM, the Registered Nurse (RN)2 stated the medications are monitored on a monthly basis and the expired medication should be removed prior to expiration. A review of the facility’s policy titled, “Medication Preparation and Administration,” revised 02/06/2023, indicated, “Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on the monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 26190 27438 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for three of ten in-center patients (Patient (P)7, P9, and P10). Failure to follow the medical providers dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 115 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P7’s “Treatment Sheet” forms, found in the electronic medical record (EMR), revealed one of six printed “Treatment Sheet” forms from 10/21/24 through 11/04/24, indicated the following: On 10/23/24, the staff failed to follow the dialysis prescription Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) when during the threehour treatment the BFR remained at 350 ml/min. There was no documented rationale for the change to the prescribed BFR. 2. Review of P9’s “Treatment Summary” forms, found in the EMR), revealed four of six printed “Treatment Data” forms from 10/21/24 through 11/01/24, indicated the following: a. On 10/21/24, the staff failed to follow the dialysis prescription Dialysis Flow Rate (DFR) of 800 ml/min when during the three-hour treatment the DFR remained at 700 ml/min. There was no documented rationale for the change to the prescribed DFR. b. On 10/23/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4-hour treatment the DFR remained at 700 ml/min. There was no documented rationale for the change in the prescribed DFR. c. On 10/28/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4.0-hour treatment the DFR remained at 700 ml/min. There was no documented rationale for the change to the prescribed DFR. d. On 10/30/24, the staff failed to follow the dialysis prescription Blood Flow Rate (BFR) of 450 ml/min and the DFR of 800 ml/min when during the 4.0-hour treatment the BFR remained at 375 ml/min and the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed BFR and DFR. 3. Review of P10’s “Treatment Sheet” forms, found in the EMR, revealed two of six printed “Treatment Sheet” forms from 10/21/24 through 11/04/24, indicated the following: a. On 10/21/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the treatment time from 8:16 AM until 10:35 AM (139 minutes) of the three hour and 45-minute treatment, when the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. b. On 10/23/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 3 hour and 45-minute treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. During an interview on 11/06/24 at 8:05 AM, the Clinical Manager reviewed and verified the discrepancy between the prescription and machine generated “Treatment Sheet” forms for P7, P9, and P10 forms revealed that he/she expects staff to monitor and document the DFR and BFR findings every 30 minutes and all treatment prescriptions for patients to be followed or have documentation on why the prescription was not followed. During an interview on 11/06/24 at 9:40 AM, the Registered Nurse (RN)3 reviewed the DFR findings for P10 and verified the discrepancy between the prescription and machine generated DFR and required staff observation documentation. The RN3 verified staff are required to document patient observations along with machine settings every 30 minutes and make corrections if needed. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/2023, indicated, “During Treatment...Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations ...Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.””