Fresenius Kidney Care-East Fort Walton Beach

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 29722 Based on observations, the facility faled to enssure the items considered clean, to incude patient wheelchairs, were stored in an area to prevent cross contamination. The findings include: On 07/22/2025 at approximately 9:16 AM, Staff C, a Patient Care Technician (PCT) was observed while discontinuing and removing fistula needles from the Patient at Station #14. The PCT was observed to walk the needles around the patient to the sharps container, passing over the clean oxygen concentrator positioned next to the Sharps container, to which he disposed of the needles. On 07/22/2025 at 9:41 AM observed between Stations #13 and #14, was a “clean” air concentrate positioned and touching the SharpSmart biomedical waste container which contained discarded arterial and venous catheter needles/lines. (Photo documenttion obtained) On 07/22/2025 at 11:35 AM observed was a patient’s walker parked directly in front of a Sharpsmart biomedial waste bin and alongside an open lid red biohazardous waste box. (Photo documenttion obtained) On 07/22/2025 at 11:56 AM observed was a patient’s walker parked directly beside an opened-lid red biohazardous waster container. (Photo documentation obtained)”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 29722 Based on observations, interviews and review of the facility’s policy and procedure, the facility failed to ensure the use of proper hand hygiene after removing gloves on numerous observations made. (Staff C) The findings include: On 07/21/2025 at approximately 11:40 AM, the process of cleaning and disinfection of the dialysis Station #16 was observed performed by Staff C, a Patient Care Technician.” While wearing a pair of gloves, Staff C was observed to remove and discard the bloodlines. He proceeded to the bleach wipe container, located in a central area. There were no wipes in the bleach container. While his hands remained gloved, he opened a drawer and retrieved a new package of wipes and placed them in the bleach solution. He removed his gloves and donned a new pair. He continued to wipe down the machine, failed to empty the prime receptable he unhooked the standard bath lines and connected to the machine. Without changing gloves Staff C went over to Station #14 and moved the dialysis machine. He then removed his gloves. Observed at 12:16 PM, the chair from Station #16 has still yet to be cleaned. Without wearing gloves, he removes the prime receptacle bin from Station #16 and empties into the “clean” sink. On 07/22/2025 at 9:00 AM, two patients who were seated next to each other at Stations #13 and #14 were interviewed. Both were asked if they had any concerns with the facility’s infection control practices. Both stated they did have concerns, in particular, with new staff not washing their hands after changing gloves. Neither patient voiced any hesitancy in speaking out with their concerns but indicated staff don’t like it and felt like staff needed to listen to them more, “we know our own bodies.” On 07/22/2025 at approximately 9:27 AM, Staff C, a Patient Care Technician (PCT) was observed to don on a pair of gloves and respond to a machine alarm at Station #4. Staff C then removed his gloves and failed to wash or sanitize his hands. He proceeded to walk around the treatment floor. Dons on a new pair of gloves and finishes machine set up at Station #11. This same technician then returns to Station #4 wearing gloves, removes his gloves. Does not sanitize his hand. Picks up a box of gloves and bring them to a central area. He dons on a new pair of gloves and proceeds to Station #3. Staff C then removes his gloves and sanitizes his hands at Station #2. While at Station #2, the PCT, while wearing gloves, visualizes the patient’s access by touching the patient. He removes the gloves and fails to sanitize his hands. Staff C dons on a new pair of gloves and goes to Station #1. He removes his gloves, fails to sanitize his hands then goes to Station #4. A review of the facility’s policy and procedure entitled “Hand Hygiene” published 11/06/2023, reference number 47664, indicates, “ All staff, patients, patient care givers, including physician and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. The policy indicates that “Decontamination using alcohol-based hand rub or by washing hands with antimicrobial soap and water” - “Before and after direct contact with patients; Entering and leaving the treatment area; Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medicals; Immediately after removing gloves; After contact wit body fluids or excretions, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled; after contact with inanimate objects near the patient; When moving from a contaminated body site to a clean body site of the same patient”

“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: 29722 Based on observation, interview and reviw of the facility’s policy and procedure, the facility failed to ensure staff demonstrated compliance with current aseptic techniques when accessing medicals from vials. The findings include: On 07/22/2025 at 10:44 AM, the LPN (Licensed Practical Nurse), Staff K, was observed to open a new vial of Venofer (an iron medication for treating anemia). The LPN failed to disinfect the rubber septum before withdrawing the medication from the vial. On 07/22/2025 at 11:05 AM an interview was conducted with the Charge Nurse, Staff F. She stated that newly opened vials should be disinfected after opening and before accessing medication. On 07/22/2025 at 11:10 AM an interview was conducted with the LPN, Staff K. She stated she was not aware that newly opened vials of mediation needed to be disinfected before accessing - stating, “I just learned something new.” A review of the facility’s policy entitled “5008X Medication Preparation and Administration”, published on 07/07/2025, reference number 64475, indicates on page 6 of 12 under the heading of Infection Control - “Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 29722 Based on observations and staff interviews, the facility failed to ensure the patient’s vascular access remained visible and uncovered during the course of treatment for 1 of 16 patients observed at Station 9. The findings include: On 07/22/2025 at 11:21 AM, the patient at Station #9 was observed to have a blanket pulled all the way up to the chin. The patient’s vascular access was not visible. On 07/22/2025 at 11:37 AM, the patient at Station #9 remained with the blanket pulled up to the chin. The patient’s vascular access was not visible. On 07/22/2025 at 11:48 AM, the patient at Station #9 remained with the blanket pulled up to the chin. The patient’s vascular access was not visible. On 07/22/2025 at 11:58 AM, the patient at Station #9 remained with the blanket pulled up to the chin. The patient’s vascular access was not visible. On 07/22/2025 at 11:58 AM an intrview was cndcuted with Staff F, the Charge Nurse, she stated the vascular access sites should remain uncovered. The patient at Station #9 was identified. The Charge Nurse informed the Patient Care Technician (PCT), who then lowered the patient’s blanket revealing the vascular access site.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 29722 Based on observations, interviews, review of the facility’s policy and procedure as well as online review of medication packaging information, the facility failed to ensure the proper administration of Venofer, an iron sucrose medication used to treat anemia, for 1 of 1 patients observed for medication administration ( Station #2). The findings include: On 07/22/2025 at 10:44 AM, the Licensed Practical Nurse (LPN)), was observed to draw up 100mg of Venofer in a luer-lock syringe. She proceeded over to Station #2. The patient at Station #2 had 10-minute left of trreatment. The LPN, disinfected the IV line port nearest the normal saline bag and in one swift motion injected the entire contents, Venofer 100mg, (milligrams) into the IV (intravenous) line. The LPN was asked when Venofer should be administered, she stated towards the end of treatment because it can cause clotting of the line. On 7/22/2025 at approximately 11:10 AM an interview was conducted with a visiting Facility Administrator, who was present during the survey, she was not aware of any particular indications as to when Venofer should be administered. On 07/22/2025 at approximately 11:20 AM a different visiting FA was asked about the administration of Venofer. She stated the medication should be administered over 3 - 5 minutes. She was not aware, at what point in the patient’s treatment the Venofer should be administered. A review of the facility’s policy entitled “Special Considerations: Venofer,” published 07/01/2024 reference number 47534, indicates “Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes...” Venofer should be administered ealry during the dialysis session generally within the first hour.” A review of the medication package insert, located online at Venofer.com, under “Full Prescribing Information,” indicates “DOSAGE AND ADMINISTRATION: 2.1 Mode of Administration, Administer Venofer only intravenously by slow injection or by infusion. The dosage of Venofer is expressed in mg (milligram) of elemental iron. Each mL contains 20 mg of elemental iron. 2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Administer Venofer early during the dialysis session (generally within the first hour).””

“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: 29722 Based on observations, interviews, patient treatment records reviews and review of the facility’s policy and procedure, the facility failed to ensure that the patient dialysis prescription was followed for 2 of 4 prescriptions verifications performed. (Station #9) The findings include: On 07/21/2025 at 10:48 AM, with the assistance of Staff F, the Charge Nurse, the dialysis prescription for the patient at Station #9 was verified. The patient was initiated for treatment at 10:18AM. A check of the patient’s currently running Blood Flow Rate (BFR) revealed a rate of 400 mL/min (mililiter/minutes). The patient’s physician prescribed BFR was 450 mL/min. A review of the treatment record failed to indicate why the prescriibed blood flow rate was not followed. The Charge Nurse stated that there should be a note. Staff F then attempted to increase the patient’s BFR, but due to high arterial pressures, the rate had to be lowered. A notation was then made into the record. On 07/21/2025 at 2:00 PM, with the assistance of Staff B, a Registered Nurse, the dialysis prescription for the patient at Station #7 was verified. The patient’s dialyzer was checked, the patient was currently dialyzing on a 180NRe Optiflux. A review of the physician prescribed prescription indicated a 160NRe Optiflux. The patient was dialyzing on the wrong dialyzer. On 07/21/2025 at approximately 2:40 PM an interview was conducted with the Charge Nurse, Staff F, she was asked about prescription verification process. She stated the prescription is verified by the person who sets up the machine and another check is done when the patient gets on the machine. She was asked to see if there had been a recheck of the prescription for the patient at Station #7. She was able to pull up the patients treatment record information and could see that Staff B, an RN, had set the machine up and the machine recheck had been commplted by Staff K, a Patient Care Technician. The Charge Nurse was informed that the patient had the wrong dialyzer. A review of the facility’s policy entitled “Pre-Treatment Safety Checks Procedure,” published on 02/06/2023 with a reference number 47798, indicates under the heading “Pre-Dialysis Safety Checks,” to “Verify the following elements by two direct patient care staff members prior to treatment initiation: ... Prescribed dialyzer””