Davita Lincoln City Dialysis

“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: 47148 Based on observation and review of documentation, it was determined that the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the facility. Findings: Observation of the facility on 03/24/2025 beginning at 1025 revealed: - Dried blood on the arm of the patient chair in station #1 - A tub labelled “1:100 bleach” dated “3/20/2025” - A tub labelled “1:10 bleach” dated “3/20/2025” - A tub labelled “1:100 bleach clamps” dated “3/20/2025” Review of facility policy titled, “Infection Control for Dialysis Facilities” dated as last revised April 2023, stipulated, “At the end of each treatment, the dialysis station will be cleaned and disinfected ... Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs).” Review of facility policy titled, “Preparation of One to Ten (1:10) Bleach Solution” and “Preparation of One to One Hundred (1:100) Bleach Solution,” dated as last revised October 2023, stipulated, “With indelible marking pen and label, label container with expiration date, time and initials. The solution is good for 24 hours only ... The solution must be changed when the maximum allowable time is exceeded (24 hours).” During an interview with the FA on 03/25/2025 at 1500, the above findings were confirmed.”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined that the facility failed to ensure the water system was monitored for endotoxins and bacterial contamination as required by facility policy, AAMI guidelines and CMS regulations on a monthly basis. Findings: Review of monthly bacterial and endotoxin water testing logs revealed that between 01/16/2024 and 02/11/2025, the facility failed to verify that cultures were reviewed by the Medical Director monthly. Examples include, but not limited to: - 01/16/2024 - Cultures were conducted but not reviewed by the MD until 03/22/2024 - 02/15/2024 - Cultures were conducted but not reviewed by the MD until 03/22/2024 - 03/14/2024 - Cultures were conducted but not reviewed by the MD at all - 04/09/2024 - Cultures were conducted but not reviewed by the MD until 05/17/2024 - 05/23/2024 - Cultures were conducted but not reviewed by the MD until 06/28/2024 - 06/20/2024 - Cultures were conducted but not reviewed by the MD until 07/25/2024 - 07/25/2024 - Cultures were conducted but not reviewed by the MD until 08/30/2024 - September 2024 - No documentation of cultures conducted or reviewed - 10/24/2024 - Cultures were conducted but not reviewed by the MD at all - 11/21/2024 - Cultures were conducted but not reviewed by the MD at all - November 2024 - lacked documentation of semi-annual AAMI analysis results. - 12/05/2024 - Cultures were conducted but not reviewed by the MD until 02/25/2025 - 01/16/2025 - Cultures were conducted but not reviewed by the MD until 02/25/2025 - 02/11/2025 - Cultures were conducted but not reviewed by the MD at all During review of the facility policy titled, “Water Culture Policy” dated April 2024, stipulated, “1. The Facility Administrator or designee is responsible for verifying that cultures are obtained, results recorded, reviewed and necessary actions taken, as applicable ... 2. The Medical Director documents a review of all water culture results monthly ... Monthly is defined within a calendar month.” During an interview with the BioMed Technician on 03/24/2025 at 1500, they stated that the culture results are reviewed during the monthly FHM meetings and sometimes the Medical Director attends by phone and not available to sign in person until a later date. During an interview with the FA on 03/25/2025 at 1515, the above findings were confirmed.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 31224 47148 Based on observation, interview, and review of documentation, it was determined that the facility failed to ensure that the building was constructed and maintained to ensure the safety of the patients, staff and the public. Findings: Observation of the facility on 03/24/2025 beginning at 1015 revealed: - 2 containers of RPC Water Hardness Test Strips that expired on 06/30/2024.. - 1 container of MinnCare 1% Indicator Test strips that expired on 05/02/2024. - An unsecured O2 canister located in a storage area off the main lobby. - The area under the “Dirty Sink” showed signs of a water leak that damaged the particle board and left a residue along with reddish brown staining of unknown origin. - The faucet for the “Dirty Sink” had a buildup of black residue around it’s base. - The area under the “Clean Sink” had yellow-brown staining/residue and had a package of clean, exposed paper towels stored underneath. - An open box of clean isolation gowns was found stored on the floor of the downstairs storage area. - Standing water on the floor of the water room around the acid concentration tanks and mixing container. - A water leak in the tubing between distribution pump #1 and #2. The facility had placed a red container to collect the water but it was overflowing onto the floor leaving standing water. - The area around the bottom shelving unit where the salt pellet bags are stored had a large amount of yellowish-brown precipitate on the floor. - Dark colored residue was found around the frame of the treatment floor scale. - White precipitate was found on wall boxes of several patient stations. Review of facility policy titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES,” dated 04/2023, stipulated: * “Supplies will be stored in a manner that maintains their integrity.” * “Soap and a supply of paper towels protected from contamination must be available at each clean sink.” During interview on 03/25/2025 at 1500, the FA and Biomed confirmed the above findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 31224 Based on interview, review of 2 of 2 patients’ plan of care (Patient #s 1 and 2) and review of documentation, it was determined that the facility failed to ensure that plans of care were signed by the patient and/or the patient’s designee or that a reason for refusal was documented. Findings: Review of medical records of Patient #1 included the following: - A Plan of Care dated 09/22/2023 had “Attended via WebEx” written in place of the Provider’s signature. The Plan of care also lacked the signature of the patient or patient’s designee. - A Plan of Care dated 09/27/2024 that lacked a signature page that indicates that the team members reviewed the Plan of Care and that the Plan of Care was reviewed with the patient or patient’s designee. Review of medical records of Patient #2 included a Plan of Care dated 03/25/2024 that lacked the signature of the IDT and the patient or patient’s designee. The Plan of Care also lacked documentation that showed if the patient chose not to sign the plan of care or why the signature was not provided. Review of the facility policy, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE,” dated as last revised in 10/2024, stipulated, “The patient’s plan of care will be completed by the facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.” During interview on 03/25/2025 at approximately 1100, the MSW confirmed the above findings.”