Fmc - Humboldt Park

“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: 39802 Based on document review, observation, and interview, it was determined that for 1 of 6 pH calibration solutions observed, the Facility failed to ensure that expired solutions were discarded. This had the potential to affect all in-center dialysis patients on census. Findings include: 1. The Facility’s “Myron L D6 Meter Maintenance Procedure” (dated 9/1/2022), “...Materials Required: ...Calibration Solutions: ...4.0, 7.0 and 10.0 pH buffer solution... At the beginning of the day, check... pH solution expiration dates. Discard expired solutions... Use unexpired solutions for meter verification...” 2. During an observational tour of the dialysis treatment area on 12/27/2023, at approximately 9:15 AM, one bottle of pH 10.0 buffer (calibration) solution at the meter station was noted to have an opened date of 10/24/2023 and a written discard date of 1/24/2024; however, the manufacturer’s expiration date was 10/20/2023. 3. An interview was conducted with Patient Care Technician (E#2) on 12/27/2023, at approximately 12:15 PM. E#2 stated that they verify the meters every morning with the buffer solutions. E#2 stated that they stopped using the 10.0 pH buffer solution and haven’t used it for a while. 4. An interview was conducted with the Area Technical Operations Manager (E#3) on 12/27/2023, at approximately 1:00 PM. E#3 stated that the clinical staff should be checking the expiration dates of the meter buffer solutions every morning when they are calibrating the meters. E#3 stated that three solutions for calibrating pH are used including 4.0, 7.0, and 10.0.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 7 of 20 patients (Pts. #11 and #13-18) observed, the Facility failed to ensure that access sites were uncovered and visible throughout dialysis treatment. Findings include: 1. The Facility’s policy titled, “Patient Assessment and Monitoring” (dated 05/01/2023), was reviewed and required, “...During Treatment: ...Observe connections are secure and visible... Ensure access remains uncovered throughout the treatment...” 2. During a tour of the dialysis treatment area on 12/27/2023, the following were observed: - At approximately 9:05 AM, Pts. #11 and #13-#17 had their access sites covered by blankets or clothing and their access sites and/or connections were not visible. The access sites remained covered throughout treatment/tour, ranging from 1-3 hours later. During this time, multiple staff (nurses and patient care technicians) were observed at the patients’ stations multiple times; however, staff did not uncover the access sites before leaving the stations. - At approximately 12:13 PM, Pt. #18 had their access site covered by a black blanket. A Patient Care Technician (E#4) was at the station documenting on the machine and did not uncover the access site before leaving the station. 3. An interview was conducted with the Clinical Manager (E#1) on 12/28/2023, at approximately 2:45 PM. E#1 stated that access sites should be uncovered and visible at all times so that staff can monitor for dislodgement or disconnections.”