Innovative Renal Care Roseburg

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 37237 Based on interview and review of documentation, it was determined that the facility failed to ensure that the chlorine test was performed according to facility policy and that the RO was running for at least 15 minutes prior to chlorine testing. Findings: Review of the “Total Chlorine Log” for November 2024 revealed: - On 11/04/2024 chlorine tests were documented as completed at 0715 and 1035. It could not be determined if the “3rd Chlorine Check” test was completed within the 4-hour timeframe due to an illegibly written time. * During interviews with the Clinic Manager on 11/20/2024 at 1225 and with the Biomed tech at 1255, neither could verify what time the test was completed. - On 11/18/2024 there was no documentation that the RO was turned on and running for 15 minutes before the first test of the day. The column was blank for “RO on for 15 min.? Y/N.” - On 11/19/2024 the “1st Chlorine Check ... 2nd Chlorine Check ... 3rd Chlorine Check” lacked documentation that the checks were verified by a second staff. The box for “2nd check Initials” for all three checks was blank. - On 11/20/2024 the “2nd Chlorine Check” lacked documentation that the check was verified by a second staff. The box for “2nd check Initials” was blank. Similar findings were identified for the “2nd Chlorine Check” on 10/25/2024. Review of the facility policy, “IC23 Total Chlorine Testing” dated as last revised 04/2023 stipulated: - “Chlorine/chloramine levels must be tested at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift or every 4 hours; whichever comes first.” - “Two trained personnel, one of whom must be a direct care staff member, will verify Total Chlorine Test results.” During interview with the CM on 11/20/2024 at 1225 the above findings were confirmed. Should the carbon tanks become exhausted, chlorine breakthrough could occur potentially exposing patients to chloramine in the water used to prepare dialysate. Patient safety can only be ensured by monitoring the performance of the carbon adsorption bed at least every 4 hours. Exposure of patients to chloramine levels > 0.1 could potentially have an adverse affect on their health including but not limited to hemolysis and/or death.”

“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: 37237 Based on interview and review of documentation, it was determined the facility failed to ensure that that all equipment was maintained in accordance with manufacturer’s recommendations. Findings: * Review of the “TDS Meter Calibration Log” for November 2024 revealed the following instructions listed on the bottom of the form: - “Daily Requirement: Check against internal Standard.” - “Weekly Requirement: Perform FULL Calibration.” - “Weekly Requirement: Verify Calculated Percent Rejection against RO Displayed Value.” Daily checks were missed on 11/04/2024, 11/13/2024, 11/15/2024, 11/18/2024 and 11/20/2024. Three weekly calibrations were completed between 11/07/2024 and 11/13/2024. No data was documented after 11/13/2024. During interview with the Clinic Manager on 11/20/2024 at 1225, they stated that they were not completely sure how often the TDS Meter Calibration log needed to be completed. They stated they thought the log was to be done weekly and that the calibration was being done too often. During interview with the Biomed tech on 11/20/2024 at 1255, they verified that some daily checks were missed and that daily checks and weekly calibrations were required. * Review of the “RO #1 Water System Log Sheet” revealed that staff failed to initial the “Operator” row on 11/19/2024. * Review of the “Pretreatment Water System Log” revealed: - On 11/18/2024 staff failed to document the value for “No Post Softener Hardness PM” and failed to initial the log was complete for the day. - On 10/31/2021 staff failed to document the value for “No Post Softener Hardness PM” and failed to initial the log was complete for the day. The Clinic Manager confirmed the above findings on 11/20/2024 at 1225.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 37237 Based on interview, medical record review for 1 of 2 patients (Patient #1) and review of documentation, it was determined the facility failed to ensure all patient assessments were documented every 30 minutes according to facility policy Findings: Review of Patient #1’s treatment flowsheets revealed that documentation visual checks for assessment of the patient’s access and face are only documented within the “Notes” section of the flowsheets. The dialysis machine automatically documents the patient’s VS (including BP and Pulse). Review of the treatment flowsheet dated 11/15/2024 revealed that at 1137, staff documented “Patient denies any complaints, access visible.” At 1229, staff documented “Patient denies any complaints, access visible.” Between 1137 and 1229 (52 minutes), staff documented notes, but failed to document the access or face was visualized. Review of the treatment flowsheet dated 11/20/2024 revealed that at 1031 staff documented “pt awake and alert, denies any complaints, access visible, will cont to monitor.” At 1100 staff documented “pt awake and alert with no concerns or complaints. bp is stable pt awake and playing on phone.” At 1130 staff documented pt resting, alert and awake, no complaints.” Treatment was terminated at 1136. Visualization of face and access failed to be documented between 1031 and 1136 (65 minutes). Similar findings were identified for treatment flowsheets dated: 11/18/2024, 11/15/2024, 11/11/2024, 11/08/2024, 11/06/2024, 11/04/2024, 11/01/2024, 10/25/2024, and 10/23/2024. Review of the facility policy, “IC08 Monitoring & Documentation of Patient Care During Treatment,” dated as last revised 11/29/2022 stipulated “10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every 30 minutes and PRN depending on the patient’s condition includes, but is not limited to ... Visibility of the vascular access and interventions taken to address non-visibility of the access.” On 11/20/2024 at 1530, the CM confirmed that visualization of the access and face are put in the EHR directly by staff and should be documented every 30 minutes.”