Davita E.a. Motto 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: 50072 Based on observations, facility policy review, and staff interviews, the facility failed to ensure items contained in the facility and intended for patient use were not expired. The facility reported a census of 67 in center hemodialysis patients at the time of the survey. Failure to monitor expired/outdates on items used in patient care can result in compromised quality of care to patients. Sterility, strength and stability of expired/outdated items cannot be guaranteed thus placing patients at risk of adverse outcomes. Findings include: 1. Observation of the treatment floor on 01/21/25 at 9:00 am showed the folowing: a. The lab area showed 2 packages containing 56 each of Blood Collection Tubes expired 12/31/24. b. The medication area showed 6 pressure bandages expired 11/28/24. c. A clean sink in the treatment area with foam hand soap expired 12/24. 2. Review of facility policy: 1-05-01 titled Incenter Hemodialysis Policies and Procedures, reads in part, “Supplies 8. Supplies will be stored in a manner that maintains their integrity...b. Expiration date and package integrity will be verified prior to use. 3. During an interview with the Facility Administrator on 01/22/25 at approximately 10 am, they acknowledged the expired items should be removed from the facility to prevent further use.”

“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: 44475 Based on observation, facility policy review, and staff interviews, the facility failed to ensure proper maintenance and cleanliness of the physical environment for water and dialysate to ensure quality and safety. The facility reported a census of 67 in center hemodialysis patients at the time of the survey. Failure to provide a clean, well maintained water room and equipment used in the water room to ensure safety of the water and dialysate used in the treatment of dialysis patients could affect the quality of the water and dialysate. Maintenance and cleanliness of equipment used to determine accurate specific gravity of acid solution used in dialysate is crucial to ensure the correct pH balance in the dialysate. Failure of a dialysis center to provide high quality water and dialysate could provide inadequate treatment of a dialysis patient which could lead to health complications. Findings include: 1. The facility’s policy titled, “Physical Environment”, with a revision date of April 2018 directed, in pertinent part, the dialysis facility will be maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. The dialysis facility will implement and maintain a program to verify that all equipment, including water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations. Refer to biomed policies for further instructions regarding dialysis delivery systems and the water treatment systems. 2. The facility’s policy titled, “Responsibilities of the Biomed department” last revision date October 2021, directed in pertinent part, the responsibilities of the Biomed Department include maintenance and monitoring of the facility’s water treatment system. 3. Observation of the water treatment room on 01/21/25 around 9:00 am, accompanied by the Facility Administrator, revealed a work station containing the chlorine and water hardness testing strip packages to be covered in a dry white substance. Package labeling was not legible due to the white substance caked on the packaging. The surface of the table and other items on it were covered in the same white caked on substance. The sink, floor and area around the acid holding tanks was covered in the same white substance. 4. In a concurrent interview and observation of the acid mixing area of the water room on 1/22/25 at 9:20 AM, accompanied byStaff G, Biomed Staff, and Staff H, Biomed Staff, revealed a two shelf wheeled cart covered in a dry white substance with large brown particles on the lower shelf, dry white substance covering the floor around the tanks folding acid solution, white dry substance on the tanks holding acid solution, and a clear hydrometer test cylinder (container with measurement markings used along with a hydrometer to measure the specific gravity [measurement of how dense a solution is] of the acid solution) with a dry white substance obscuring the unit markings on the outside of the test cylinder which made it difficult to read the measurement. Staff G and Staff H reported that they are not responsible for cleaning after clinical staff mix acid solution and they have reported the issue with cleanliness to the Facility Administrator. 5. In an interview on 1/22/25 at 2:52 PM, Staff C, Patient Care Technician (PCT) reported that the water room was clean when he was last in the room to mix acid on 1/9/25. Staff C reported that at staff meetings, the Facility Administrator has told staff to clean the water room after acid was mixed. 6. In an interview on 1/22/25 at 4:22 PM, Staff K, Manager of Clinical Services reported that she performed an audit of the water room on 1/17/25 that showed the acid mixing area of the water room was dirty.”