Kidney Care Center of Winter Haven

“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: 42154 Based on the facility policy, observations and interviews the facility failed to perform hand hygiene while accessing and discontinue an arteriovenous (AV) fistula in one (Staff B) of three employees observed. Findings included: Review of the facility policy titled, “Access AVF- AVG cannulation & Initiation and termination of hemodialysis treatment patient care”, # 7067, reviewed 12/2024 ...Page 4 ...Locate and palpate the access to determine the needle cannulation sites prior to skin preparation ...With clean gloved hands, cleanse the access cannulation site cleanse the first cannulation site and allow to dry. With clean-gloved hands, cleanse the second cannulation site and allow to dry Do not touch the cleanse site again, if touched it must be disinfected again ... Review of facility policy title, “Infection prevention and control practices”, #2031, reviewed 12/2024 ...Hand Hygiene shall be performed after contact with the chair-side computer keyboards/ screens. All surface areas and equipment shall be cleaned and disinfected with a facility approved disinfected and according to manufactures instructions ... On 01/13/2025 at 9:35 AM Staff B, CCHT applied gloves and repositioned the Blood pressure cuff for Patient #1, then touched the dialysis computer. She then removed the dialysis needles from Patient #1 and performed post dialysis care for the AV fistula. No hand hygiene was completed. On 01/13/2025 at 10:58 AM Staff B, CCHT evaluated access and located cannulation site for Patient #4’s AV fistula, then applied antiseptic to the skin over the cannulation site and inserted the cannulation needles. No hand hygiene was completed. An interview with the Clinical manager on 01/14/2025 at 10:00 AM in which she stated that the Staff needs to change gloves after they find the fistula and to not touch it again. She also stated that they need to do everything for the patient first then go to the computer not back and forth.”

“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: 42154 Based on the facility policy, observation and interviews, the facility failed to disinfect all surfaces and equipment in patient stations in three (4, 6, 10) of twelve stations observed. Findings included: Review of the policy title, “Infection control & Prevention Cleaning and Disinfection of Medical Devices and Equipment”, #2032, reviewed 12/2024 ...Purpose ...Dialysis patients are at high risk for infection because the process of hemodialysis requires vascular access for prolonged periods. In an environment where multiple patients received dialysis repeatedly, opportunity exists for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel ... At the end of each dialysis treatment, all Surfaces should be cleaned using appropriate germicide. After each treatment, the staff shall clean and disinfect medical devices and equipment ...Any items taken to a patient’s dialysis station, including those placed on top of dialysis machines, shall either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used for other patients ... Review of facility policy title, “Infection prevention and control practices”, #2031, reviewed 12/2024 ...any item taken to a patients dialysis station, including those placed on top of dialysis machines, shall either be disposed of, dedicated for use only a single patient, or cleaned and disinfected before returned to a common clean area or used for others patients ...Hand Hygiene shall be performed after contact with the chair-side computer keyboards/ screens. All surface areas and equipment shall be cleaned and disinfected with a facility approved disinfected and according to manufactures instructions ... On 01/13/2025 at 9:00 AM a flash tour was conducted with observation of an oxygen concentrator located in station 4 and station 10 not being used with patients in those stations. Observed staff members moving the concentrator out of the patient station without disinfection being done. On 01/14/2025 at 10:35 AM Staff C, CCHT took an oxygen concentrator from station #4 to station #6 without disinfecting the equipment. In an interview with Staff C, CCHT on 01/14/2025 at 10:35 AM, they stated that the oxygen concentrator was in station #4 but she needed it in station #6 and the patient in station #4 did not use it. In an interview with the Clinical Manager on 01/14/2025 at 10:35 AM, she stated that the staff needs education on removing equipment from patient care areas and cleaning them.”

“CARTRIDGE FILTERS-CONFIG & MONITORING CFR(s): 494.40(a) 5.2.3 Cartridge filters: config and monitoring The cartridge is contained within an opaque filter housing with seals to separate the feed and product water streams. When the maximum [pressure drop] ?P recommended by the filter manufacturer is reached, the cartridge should be replaced according to the manufacturer ’ s instructions. 6.2.3 Cartridge filters Cartridge filters should be monitored on a periodic .... basis for a [pressure drop] ?P across the filter [that] can be used to determine when the filter is retaining particulate matter to the point that the filter will no longer allow the required water flow without an excessive reduction in pressure at the outlet of the filter. A marked decrease in ?P without a corresponding decrease in flow rate may indicate a loss of filter integrity. Follow the manufacturer ’ s recommendations concerning when to replace cartridge filters. Replacement of the cartridge will usually be indicated by an increase in ?P to some specified value. A log sheet should be developed to record the pressure drop measurements. This Standard is not met as evidenced by: 49691 Based on review of the facility machine repair and Preventative maintenance logs, policy review, and an interview the facility failed to maintain the (DFU) directions for use of 15 (1-15) of 15 of dialysis machines. Findings Included: A record review of the facility machine logs Showed that the DiaSafe filters (A filter that produces ultrapure dialysis fluid for dialysis machines) were not changed in a three-month period of time (last changed 10/14/2024); on 15 of the 15 machines the time between filter change extended beyond the three-month allotted time frame by 2 days. In an interview with the Biomedical Technician D on 1/13/2025 at 12:05 pm, he noted the lapse and concurred with the findings. A review of the Facility policy # 2032 E states: DiaSafe testing is to be performed biweekly. The DiaSafe filter must be changed every 90 days. The Fresenius 2008T make and model of the machines used in the facility, DFU Manual Chapter 6 page 277; states ,” The DiaSafe filter is intended for the preparation of ultra-pure dialysate. If the machine has a DiaSafe plus filter, it should be replaced at least every 90 days. You must also replace the filter if the DiaSafe tests fails or shows an external leak.””

“RO-CHEMICAL ANALYSIS-FREQUENCY CFR(s): 494.40(a) 6.2.7 Reverse osmosis: Chemical analysis: frequency Chemical analysis for the contaminants listed in 4.1.1 (Table 1) should be done when the RO system is installed, when membranes are replaced, and at not less than annual intervals thereafter to ensure that the limits specified in 4.1.1 are met (see Table 1). Chemical analyses should be done when seasonal variations in source water suggest worsening quality or when rejection rates fall below 90 %. This Standard is not met as evidenced by: 49691 Based on record review, Facility policy review, and an interview the facility failed to ensure that the RO (Reverse Osmosis) Water Quality (used for the purpose of Hemodialysis for Patients with ESRD End Stage Renal Disease) was performed to national AAMI (The Association for the Advancement of Medical Instrumentation) standards of at least yearly. Findings included: Based upon record review of water quality for the facility the last AAMI available in the logs was from January of 2023. Review of the Facility water quality policy, Policy # 2051- Water Purity referred to the AAMI water quality guidelines ...done at a minimum annually. In an Interview with Biomedical Staff D on 1/13/2025 at 12:15PM, Staff D stated that he just drew one yesterday but could not produce the test.”