Fresenius Kidney Care Sebastian

“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: 29151 Based on observation, policy review and interview, it was determined, the clinical staff failed to follow standard infection control practices to minimize the risk of cross contamination as evidenced by failure to follow guidelines to perform proper hand hygiene during discontinuation of treatment. This failure affected 1 of 2 observations of care affecting Station #5. Center of Disease Control guidelines state proper hand washing is the most important measure against cross contamination. The findings included: Observation of care conducted on 12/11/23 at 10:15 AM revealed Staff A, a Patient Care Technician, discontinuing treatment at Station #5. The staff performed hand hygiene, and don clean gloves, then proceeded to touch the machine, reinfused the extracorpeal circuit and disconnected the blood lines. With the same gloves the staff proceeded to remove the first needle, covered the site with a clean bandage and proceeded to remove the second needle. Interview with Staff A conducted on 12/13/23 at 8:23 AM revealed the staff acknowledges she should have use clean hands and gloves prior to removing the needle and after touching the dialysis machine. Facility policy titled “Post Treatment Fistula Needle Removal” dated 07/06/21 documents “To provide instructions for fistula and graft needle removal at the end of the dialysis treatment to minimize access trauma and achieve optimal hemostasis. Follow the following steps: Person removing needles perform hand hygiene and don clean gloves.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 29151 Based on observation, policy review and staff interview, the facility failed to follow standard infection control practices related to cleaning and disinfection of the dialysis station. This is evidenced by an observation of the staff disinfecting the dialysis machine, while the patient was still at the station (Station #8). The findings included: An observation of termination of treatment conducted on 12/11/23 at approximately 9:50 AM at Station #8 revealed Staff B, a Patient Care Technician (PCT), disinfecting the dialysis machine while the patient was observed sitting at the station and still holding his access site. After the patient left the station, Staff B proceeded to disinfect the dialysis chair. At approximately 10:05 AM, another patient was set up at Station #8 and the staff did not disinfect the dialysis machine after the previous patient vacated the station. Staff B failed to ensure at the end of the dialysis treatment, all surfaces were appropriately cleaned. Interview with Staff B conducted on 12/13/23 at 8:40 AM revealed the staff confirmed the observation and stated her understanding was that she could disinfect the machine while the patient was at the station, but she could not set up the machine until the patient had vacated the chair. Facility policy titled “Cleaning and Disinfection of the Dialysis Station” dated 09/05/23 documents “For patients dialyzing in a treatment area where multiple patients dialyze, the patient must completely vacate the dialysis station before the dialysis machine can be externally disinfected, allowed to dry and set up for the next treatment.””

“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: 22517 Based on observation, policy review and staff interview, the facility staff failed to adhere to their policy and procedure regarding current aseptic techniques for labeling of multi-dose vials of medications, as evidenced by, the Home Training Nurse failed to appropriately label medication vials when opened. The findings included: An observation in the Home Training Room 1 revealed a opened multi-dose vial of Heparin Sodium Injection 30,000 USP Units/30 ml stored in a unlocked drawer in the room. The vial did not have an open date on it. An interview was conducted on 12/11/23 at 11:02 AM with the Home Training Nurse who confirmed that the bottle was not labeled properly. Review of the facility’s policy and procedure for Medication Preparation and Administration documented, “When preparing medications if the vial is not used immediately in its entirety, the nurse must place the date and time the vial was opened on the medication label along with their initials. Note: to ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Label any open multi-dose vial that is not used immediately and store vial accordingly.””

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29151 Based on observation, policy review and interview, it was determined, the clinical staff failed to implement aseptic technique when providing catheter site care during 1 of 2 observations. The failure affected Station #6. The findings included: Observation of the initiation of treatment with a CVC (Central Venous Cathter) at Station #6 conducted on 12/11/23 starting at 10 AM with the Staff A, a Patient Care Technician, revealed the staff performed hand hygiene, don clean gloves, then removed the old CVC dressing and continued to cleanse the site without removing the dirty gloves and performing hand hygiene. The staff performed the site disinfection with the same gloves used to remove the dirty dressing. An interview conducted on 12/13/23 at 8:23 AM with Staff A, confirmed the above observation. Facility policy titled “Central Venous Catheter Dressing Change” dated 11/02/19 documents “Follow the steps below to remove a catheter dressing and inspect the exit site before initiating treatment. Perform hand hygiene, Don gloves, Remove the old dressing.... Discard the dressing and perform hand hygiene, Clean the catheter exit site.””

“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: 22517 Based on observation and staff interview, the facility staff failed to ensure all supplies were maintained and operated in accordance with the manufacturer’s recommendations, as evidenced by the failure of the staff to ensure supplies were not available for use beyond the manufacturer’s documented expiration date. The findings included: 1) Observations of the Home training rooms on 12/11/23 beginning at 9:30 AM revealed multiple Lab collection tubes, vacuette, which had expired as follows: a. In Room 2 , there were 9 green top vacuette stored in the plastic storage bin which had expired on 09/30/23. There were also 4 lavender top vacuettes which had expired on 08/31/23. b. In Room 1, there were multiple lab tubes stored in the plastic storage bin which had expired as follows: 9 lavender tops which had expired 08/31/23. It should also be noted that these tubes also had little white specks throughout the inside of the tube. one drawer contained 7 clear top tubes which had expired 10/31/23. 14 Goldenrod yellow tubes which had expired 08/31/23. These tubes also had noted white specks throughout the inner surface of the tubes. 20 Green Top which had expired on 09/30/23. An interview was conducted on 12/11/23 at 11:02 AM with the Home Training Nurse, who stated she was not aware that the lab tubes had expired. She stated that she just received those items from the lab on Friday and she restocked her drawers with them. Review of the facility’s policy regarding Expiration of Supplies, documented that the purpose of the policy provides guidance on “checking expiration dates to assure that supplies are taken out of circulation by the expiration date.””

“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: 29151 Based on record review and interview, it was determined, the clinical staff failed to ensure dialysis prescriptions were followed for 2 of 3 sampled in-center patients (Patient #5 and #6). This failure included deviation of the prescribed Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR) and failure to document the reason for the deviation of treatment. The findings included: 1) Clinical record review conducted on 12/12/23 revealed Patient #6 has physician’s orders for dialysis treatment as of 11/03/23 for Blood Flow Rate (BFR) of 350 and Dialysate Flow Rate (DFR) of autoflow 1.5 (DFR 525). Treatment Records dated 11/22/23, 11/20/23, 11/15/23, 11/10/23, 11/08/23 and 11/03/23 indicates the patient did not receive the prescribed BFR and DFR. The record does not provide an explanation for the deviation from the prescription. 2) Clinical record review conducted on 12/12/23 revealed Patient #5 has physician’s orders for dialysis treatment as of 11/01/23 for Blood Flow Rate (BFR) of 450 and Dialysate Flow Rate (DFR) of 800. Treatment records dated 11/03/23, 11/06/23, 11/29/23, 12/01 and 12/04/23 indicates the patient did not receive the prescribed BFR and treatment records dated 12/01/23 and 12/04/23 indicates the patient did not receive the prescribed DFR. The record does not provide an explanation for the deviation from the prescription. Interview with the Clinical Manager on 12/13/23 at 9:12 AM confirmed the staff failed to adhere to the prescription and failed to document the reason for the change in prescription for Patients #5 and #6.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 29151 Based on record review and interview, it was determined, the Medical Director and facility staff failed to ensure the initial nursing assessments had all required elements, including a fall risk assessment. This failure affected 1 of 1 newly admitted in-center patient (Patient #6). The findings included: Clinical record review conducted on 12/12/23 revealed Patient #6 was recently admitted to the facility on 11/01/23. The facility Initial Nurse Assessments, Treatment Flowsheets and Progress Notes failed to document the completion of a Fall Risk assessment. Interview with the Clinical Manager conducted on 12/13/23 at 2:20 PM confirmed the facility does not complete a fall risk assessment as part of the initial assessment. The fall risk assessment is completed as part of the comprehensive assessment, within thirty day of admission.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 22517 Based on clinical record review and staff interview, the home records failed to document accurately the administration of the medications administered by the patient at home for 1 of 1 Home Hemodialysis Patients, Patient # 1. The findings included: Review of the clinical record for Patient # 1 revealed that the patient was admitted to the facility on 04/03/23 and was prescribed to receive Hemodialysis at home via NxStage Pure Flow four times a week. On 10/13/23, the physician prescribed for the patient to self-administer Mircera 50 mcg subcutaneously (SQ) once. The physician again prescribed on 11/10/23 for the patient to self-administer Mircera 75 mcg SQ once. Review of the corresponding home records revealed that the patient failed to document the administration of the prescribed Mircera doses. An interview was conducted on 12/12/23 in the afternoon with the Home training Nurse. She stated that she noted the administration in the facility’s records but failed to ensure that the patient’s home records reflected the self-administration of the medication. Review of the facility’s policy and procedure regarding Administration of Intravenous Medication for the Home Hemodialysis Patient documented, “the patient and/or care partner will: Document all IV medications administered at home.””