Davita Leesburg Dialysis Center

“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: 49777 Based on observations, record review and interviews, the facility failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis unit. Findings include: During an observation on 12/02/2024 at 9:40 am there were 32 treatment stations with 20 patients observed receiving dialysis Station #2 had a clear jug dated 12/2/24 with no jug cap secured on the bottle. The dialysis machine was running and in use on a patient at the time of the observation. During an observation on 12/02/2024 at 9:44 am Station #4 had a clear bottle labeled Citrapure (a citric based concentrate used in dialysis) with the jug cap unsecured. The dialysis machine was running and in use on a patient at the time of the observation. During an interview on 12/02/2024 at 10:00 am Staff E, Patient Care Technician ( PCT) stated “Out of the 32 wall units for water and acid (Chase Boxes) about 50% are not working. 15 stations have jugs. They should be capped. “ During an interview on 12/0220/24 at 10:45 am the Administrator stated, “ Bottles attached to tubing need to be capped while in operation. They should be capped, there are different size caps, and we need to have both sizes available.” Request for policy and procedure, none were provided. 2.On 12/2/2024 at 9:45 AM, during tour of treatment room, observed 32 treatment stations with 20 patients presently on dialysis. Some of the machines have jugs attached and some are attached to wall units (Chase Box). Two of the jugs (Station # 2 and Station # 4) did not have the jug caps secured and both dialysis machines are in operation. During an observation on 12/02/2024 at 9:45 am a dialysis machine at station # 21 was observed leaking from the inside of the dialysis machine. There was a clear fluid puddled around the machine on the floor surrounding the dialysis machine and on the back of the machine on a small ledge. The machine was not observed to be in use on a patient during this observation. During an interview on 12/02/2024 at 9:46 AM Staff E Patient Care Technician (PCT) stated, “ There have been issues with leakage from the machines . I notified the RN ( Registered Nurse) and Biomed ( Biomedical Services Specialist) about this machine and it is not to be used.” During an observation on 12/02/2024 at 12:00 PM, the same dialysis machine at Station # 21 was observed to be on and in use with a patient. A puddle of water was observed surrounding the dialysis machine and patient treatment chair and extended to under the computer on wheels and extending out toward other patient care areas. During an observation on 12/02/2024 at 12:02 PM the Registered Nurse ( RN) acknowledged that the dialysis machine was leaking from the front and the back of machine and was not aware if Biomed has looked at it this am.” During an interview on 12/02/2024 at 12:02 PM the Registered Nurse ( RN) stated. “ I was not aware of any leakage from the machine, the machines are old, and I would not take the patient off the machine for a moderate leak like that. I am not aware of whether biomed has looked at this machine this morning.” During an observation on 12/02/2024 at 12:03 PM the Administrator confirmed that there was fluid leakage from the dialysis machine, puddling water near the computer on wheels, which is to the right of the machine and water moving from the back of machine to aisle to the left of the machine. During an interview on 12/02/2024 at 12:03 PM the Administrator, stated “ We’re supposed to be getting new machines. I do not have a date yet.” During an interview on 12/02/24 at 2:00 PM Staff B Biomed Services Specialist, stated “ I was notified by staff this am that dialysis machine was leaking from the inside, and I told them not to use the machine. I had to leave to go to another facility for an emergency.” Requested policies and procedures , these were not provided.”

“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: 49777 Based on observations, record review and interviews, the facility failed to implement and maintain dialysis machines and equipment and water treatment systems are maintained and operated in accordance with manufacturer’s instructions to prevent leakage. Findings include: During an observation on 12/02/2024 at 9:45 am a dialysis machine at station # 21 was observed leaking from the inside of the dialysis machine. There was a clear fluid puddled around the machine on the floor surrounding the dialysis machine and on the back of the machine on a small ledge. The machine was not observed to be in use on a patient during this observation. During an interview on 12/02/2024 at 9:46 AM Staff E Patient Care Technician (PCT) stated, “ There have been issues with leakage from the machines . I notified the RN ( Registered Nurse) and Biomed ( Biomedical Services Specialist) about this machine and it is not to be used.” During an observation on 12/02/2024 at 12:00 PM, the same dialysis machine at Station # 21 was observed to be on and in use with a patient. A puddle of water was observed surrounding the dialysis machine and patient treatment chair and extended to under the computer on wheels and extending out toward other patient care areas. During an observation on 12/02/2024 at 12:02 PM the Registered Nurse ( RN) acknowledged that the dialysis machine was leaking from the front and the back of machine and was not aware if Biomed has looked at it this am.” During an interview on 12/02/2024 at 12:02 PM the Registered Nurse ( RN) stated. “ I was not aware of any leakage from the machine, the machines are old, and I would not take the patient off the machine for a moderate leak like that. I am not aware of whether biomed has looked at this machine this morning.” During an observation on 12/02/2024 at 12:03 PM the Administrator confirmed that there was fluid leakage from the dialysis machine, puddling water near the computer on wheels, which is to the right of the machine and water moving from the back of machine to aisle to the left of the machine. During an interview on 12/02/2024 at 12:03 PM the Administrator, stated “ We’re supposed to be getting new machines. I do not have a date yet.” During an interview on 12/02/24 at 2:00 PM Staff B, Biomed Services Specialist, stated “ I was notified by staff this am that dialysis machine was leaking from the inside and I told them not to use the machine. I had to leave to go to another facility for an emergency.” Requested policies and procedures, these were not provided.”