Fmc - Regency Park

“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: 39025 Based on observation, document review, and interview it was determined the facility failed to ensure medications were removed from and not available for patient care. The Findings Include: 1. During the observational tour on 03/18/25 at approximately 10:25 AM, the following medications at the nursing station were expired - 1) Nitroglycerin sublingual tablets, 0.4 mg (milligram) tablets, 100 count bottle. Expiration 01/2025. 2) 2 suture removal trays containing 1 each of forceps 3 x 3 gauze, prep pads, and scissors. Expiration 02/28. 3) 2 boxes of 50% (percent) Dextrose injection, 25 g (grams)/50 ml (milliliters) (0.5 g/ml). Expiration 03/01/25. 2. A facility policy titled, “Medication Preparation and Administration” dated 02/06/2023 included, “Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control ... Monitoring Expired Medications: 1. Expiration dates for all stored medications are to be monitored on a monthly basis. 2. Expired medications are to be discarded via (name of facility) off-site return program or in accordance with local and/or state law ...” 3. An interview was conducted on 03/18/25 at approximately 10:45 AM with E#5 (Registered Nurse - RN). E#5 observed and acknowledged the expired medications and stated, “We don’t have a set schedule or policy on when to check our medications for expiration dates, only a policy on patient rights when administerating medications.” 4. An interview was conducted on 03/18/25 at approximately 2:50 PM with E#1 (Clinic Manager). E#1 confirmed the facility did not have a schedule or policy to audit medications for expiration dates.”

“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: 39025 Based on document review and staff interview, it was determined for 3 (Pt#1, Pt#2, Pt#5) of 10 patient’s records reviewed for BFR (Blood Flow Rate) and DFR (Dialysis Flow Rate), the ESRD (End Stage Renal Disease) Facility failed to ensure the patient’s BFR and DFR was achieved and maintained in accordance with the dialysis prescription. Findings include: 1. On 3/19/25, Pt #1’s record was reviewed. Pt #1 was admitted for in-center hemodialysis on 4/11/22 with a diagnosis of Type 2 diabetes mellitus with diabetic CKD (chronic kidney disease). Pt #1’s clinical record contained a physician order that prescribed a DFR of 800 ml/min (milliliters/minute). Pt #1’s treatment sheet dated 3/15/25 failed to achieve the prescribed DFR of 800, running at 600 for the entire treatment course. The record lacked documentation of notification to the physician and a physician’s order to change DFR orders. 2. On 03/19/25, Pt #2’s record was reviewed. Pt #2 was admitted for in-center hemodialysis on 11/11/24 with a diagnosis of ESRD and CKD. Pt #2’s clinical record contained a physician’s order dated 11/11/24 that prescribed a BFR of 400. On 12/09/24 and 12/11, Pt #2’s treatment sheets document they were dialized at a BFR of 300 with the lowest dropping to 200, failing to achieve the prescribed BFR of 400. The record lacked documentation of notification to the physician and a physician’s order to change BFR orders. 3. On 03/19/25, Pt#5’s record was reviewed. Pt#5 was admitted for in-center hemodialysis on 02/19/19 with a diagnosis of ESRD. Pt #5’s clinical record contained a physician’s order dated 03/08/25 that prescribed a BFR of 450 and a DFR of 800 ml/min. On 03/13/25, Pt #5’s treatment sheet documents they were dialized with an average DFR of 500, failing to achieve the prescribed DFR of 800. On 03/15/25, Pt #5’s treatment sheet documents they were dialized at average BFR of 430, failing to achieve the prescribed BFR of 450. The record lacked documentation of notification to the physician and a physician’s order to change BFR and DFR orders. 4. On 03/19/25, the policy titled “Patient Assessment and Monitoring” (Published 05/01/23) was reviewed. The policy noted, “Purpose ... to provide guidance to (facility name) direct patient care staff on assessment and monitoring patients before, during, and after treatment. Responsibility: Direct patient care staff (RN (Registered Nurse), ..., PCT (Patient Care technician)) ... Data Collection: ... If the PCT ... note any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, ... the registered nurse must assess the patient. The RN will notify the patient’s physician ... of any abnormal findings ... 3. Machine parameters and Extracorporeal Circuit: Check machine settings and measurements: Check prescribed blood flow is being achieved or reason documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. ... 4. Document any findings and interventions in the medical record.” 5. On 03/19/25 at approximately 11:15 AM, an interview with the Clinic Manager (E #1) was conducted. E #1 reviewed Pt#1, Pt#2, and Pt#5’s treatment records and verbally agreed the BFR and DFR was not achieved and there was no documentation in the records indicating why.”