Fresenius Kidney Care North Idaho

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 39430 Based on observation, staff interview, and medical records, it was determined the facility failed to ensure the Medical Director provided necessary monitoring and oversight to ensure the delivery of quality patient care. This failure created the potential for negative patient outcome for all patients dialyzing at the facility. Findings include: 1. Refer to V715 as it relates to the Medical Director’s failure to ensure all patient care and safety policies were adhered to by all individuals who treated patients in the facility.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 39430 Based on observations, staff interviews, policy review, and clinical record review, the governing body failed to provide effective oversight of the dialysis facility’s operations to ensure patient health and safety. The facility failed to correct a previously identified and ongoing issue involving the registered nurse’s (RN A) failure to perform critical patient care duties during dialysis treatments. Additionally the facility failed to ensure Patient prescriptions were being followed, and facility policies were being adhered to. These failures directly impacted the health and safety of multiple patients and placed all patients in the facility at risk for harm. Refer to V-0463 as it relates to the facility’s failure to ensure patients received service outlined in their POC. Refer to V-0640 as it relates to the facility’s failure to ensure identified issues regarding patient safety were immediately corrected. Refer to V-0710 and it’s associated standard level deficiencies as it relates to the facilities failure to ensure all patient care and safety polices were adhered to by all individuals who treated patients in the facility. These systemic issues had the potential to compromise patient safety for all patients receiving treatment at the facility.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 51906 Based on record review and staff interview, it was determined the facility failed to ensure services were provided in accordance with the POC for 2 of 6 ICHD patients (Patient #1, and #5) whose records were reviewed. Not meeting the prescribed BFR had the potential for inadequate dialysis treatment. Findings include: 1. Patient #5 was an 85 year old male who received ICHD. His treatment sheets were reviewed for 13 treatments between 5/5/25 and 4/7/25. His ordered BFR was 350. He did not meet his prescribed BFR for 5 of 13 treatments as follows: - 5/5/25: The BFR throughout treatment was 400. There was no documentation as to why the BFR was not set to the prescribed BFR. - 4/30/25: The BFR throughout treatment was 400. There was no documentation as to why the BFR was not set to the prescribed BFR. - 4/28/25: The BFR throughout treatment was 400. There was no documentation as to why the BFR was not set to the prescribed BFR. - 4/18/25: The BFR throughout treatment was 400. There was no documentation as to why the BFR was not set to the prescribed BFR. - 4/7/25: The BFR throughout treatment was 400. There was no documentation as to why the BFR was not set to the prescribed BFR. The CM was interviewed on 5/7/25 beginning at 8:17 AM. Patient #5’s record was reviewed in his presence. He confirmed that the patient’s BFR did not meet the prescribed flow rate. He confirmed that there should have been documentation why the prescribed BFR was not met. 2. Patient #1 was an 82 year old male who received ICHD. His treatment sheets were reviewed for 13 treatments between 3/19/25 and 5/5/25. His ordered BFR was 400. He did not meet his prescribed BFR for 2 of 13 treatments as follows: - 4/9/25: The BFR throughout treatment was 300. There was no documentation why the BFR was not set to 400 per the prescription. - 3/28/25: The BFR at the beginning of treatment, at 11:05 Am was correctly set to 400. From 1:02 PM to the completion of therapy at 2:54 PM the BFR was set to 350. There was no documentation why the BFR was not set to 400 per Patient#1’s prescription. The CM was interviewed on 5/7/25 beginning at 8:17 AM. Patient #1’s record was reviewed in his presence. He confirmed that Patient #1’s BFR did not meet the prescribed flow rate. He confirmed that there should have been documentation why the prescribed BFR was not met. The facility failed to ensure patients received their prescribed treatment as outlined in their plan of care.”

“QAPI-QAPI-IMMEDIATELY CORRECT ANY IJ ISSUES CFR(s): 494.110(c) The facility must immediately correct any identified problems that threaten the health and safety of patients. This Standard is not met as evidenced by: 39430 Based on observations, staff interviews, and clinical record review, the facility failed to immediately correct a previously identified problem that posed a threat to the health and safety of patients. Specifically, the facility failed to ensure that a registered nurse (RN A) performed assigned patient care duties as required during dialysis treatments, despite prior awareness of the issue. This directly affected 2 patients (Patient #1, #6) whose care was observed, and had the potential to affect all patients dialyzing at the facility. Findings include: Observations were conducted on the facility treatment floor on 5/05/25 beginning at 1:30 PM. The following issues were identified. 1. Patient #6’s care was observed on the treatment floor on 5/05/25 beginning at 1:30 PM. Patient #6 experienced a hypotensive episode during dialysis, becoming unresponsive. The PCTs on duty placed Patient#6 in the Trendelenburg position (reclined with feet elevated), initiated oxygen therapy, and administered a normal saline bolus per standing orders, and Patient #6 was stabilized and returned to baseline after approximately 10 minutes. Despite being called to the treatment station for Patient #6 by the PCTs who were attending to Patient #6, RN A, who was the sole RN on duty, did not respond to Patient #6’s treatment station area during the hypotensive episode. This surveyor observed several minutes elapse between notification by the PCT that RN A’s assistance was needed, to RN A responding the Patient #6’s treatment station. RN A was observed sitting at a computer in the nurse’s station. Patient #6 was stabilized prior to RN A responding to Patient #6’s treatment area. Patient #6’s medical record was reviewed and there was no evidence of a nursing assessment or documentation by the RN regarding the patient’s condition during or following the hypotensive event. The RN post assessment included, “pt tolerated tx [treatment] well today.” 2. An observation on 5/05/25 at approximately 2:00 PM showed that Patient #1’s dialysis machine lost power after the power cord was inadvertently unplugged by RN A. This caused the machine to shut down, leaving Patient #1’s blood stagnant in the extracorporeal circuit. RN A approached the machine as it began to power back on but did not remain at the station to ensure the machine fully restarted, that the patient’s blood was returned, or dialysis resumed. Instead, RN A instructed a PCT, who was actively assisting another patient, to “fix it” and walked away while the machine was still booting up and the treatment screen remained blank. Patient #1’s dialysis treatment was resumed and machine settings reverified by the PCT. Patient#1’s treatment sheet for 5/05/25 was reviewed after it was completed. There was no documentation Patient #1’s machine became unplugged and paused his treatment. Additionally there was no documentation of an adverse event entered. Interview with Staff A on 5/06/25 beginning at 10:30 AM revealed additional concerns regarding RN A’s performance. Staff A stated, she has noticed that the nurse often seems overwhelmed and doesn’t respond quickly in emergency situations. Additionally, she has been concerns about RN A’s ability to manage the patient load and respond when things go wrong. Staff A stated she had voiced her concerns to facility leadership. An interview with a PCT A on 5/07/25 at 10:10 AM revealed concerns that RN A often responded slowly, if at all, during patient emergencies or urgent situations. PCT A reported having to intervene on multiple occasions due to delayed nursing response and expressed concern that this created a patient safety risk. PCT A also stated that staff and patients frequently approached him directly with medical concerns instead of going to RN A, and that he routinely had to redirect them to the nurse because the issues were outside his scope of practice. PCT A indicated that these concerns had been communicated to supervisory staff. An interview with PCT B was conducted on 5/07/25 beginning at 9:00 AM. When asked about appropriately trained staff relating to patient safety, PCT B stated she had concerns with RN A. She stated that RN A’s response was slow and often must tell her multiple times if an assessment is needed for patients. PCT A stated that patient safety is a current concern. An interview with the Clinical Manager on 5/06/25 at 1:00 PM confirmed that the above identified issues with RN A had been previously identified, and that the RN has been educated and retrained multiple times, and had been placed on performance improvement plans historically. However, the Clinical Manager acknowledged that the same issues identified by the surveyors, were identified previously multiple times. The facility failed to ensure identified issues affecting patient safety were immediately corrected.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51906 Based on record review, policy review, and staff interview it was determined the facility failed to ensure all policies and procedures were adhered to by facility staff. This directly impacted 3 out of 6 patients (Patient #1, #2, and #5) whose treatment records were reviewed. This resulted in high blood pressures, low blood pressures, low heart rates, and changes in patient conditions not being reported to the Charge Nurse / Team Leader for further evaluation. Additionally, there was missing documentation of the Charge Nurse / Team Leader following up on reports of low blood pressure, high blood pressure, low heart rates, and changes in patient condition. Patient’s vitals were also not monitored at least every 45 minutes while receiving dialysis per policy. This directly affected 1 of 6 patients (Patient #1) whose treatment sheets were reviewed. This had the potential for negative outcomes for all patients receiving ICHD. Findings include: 1. A facility policy titled, “Nursing Supervision and Delegation” dated 11/06/2023, was reviewed. It stated the following: - “Guidelines for PCT/LPN/LVN/RN: When to Refer a Patient to the Team Leader/ Charge Nurse for Further Assessment: -Blood Pressure A Systolic [sic] blood pressure greater than 180 mm/Hg and / or diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the treatment. If B/P less than or equal to 100mm/hg [sic] systolic during treatment. A systolic blood pressure less than 100 mm/Hg post treatment when standing. A drop in systolic BP of 20 mmHg [sic] between sitting and standing.” - “Heart Rate/Cardiac A heart rate that is new onset and is below 60 beats per minute or greater than 100 beats per minute or an irregular heart rate that is new onset ... ....” - “Patient Complaints Any patient complaint at any time before, during, or after the treatment ...,” This policy was not followed. Examples include: a. Patient #1 was an 82 year old male who received ICHD. Patient #1 ’ s medical record included treatment sheets. The treatment sheets included documentation of low and high blood pressures, low and high heart rates, and patient complaints that were not reported to the Charge Nurse /Team Leader. Patient #1 ’ s record included a treatment sheet dated 5/02/25. At 12:34 PM, Patient #1 ’ s blood pressure was documented as 97/54 mmHg. There was no documentation Patient #1 ’ s low blood pressure was reported to the Charge Nurse / Team Leader. Patient #1 ’ s record included a treatment sheet dated 5/02/25. At 1:48 PM, Patient #1 ’ s heart rate was documented as 32 beats per minute. There was no documentation Patient #1 ’ s low heart rate was reported to the Charge Nurse / Team Leader. Patient #1 ’ s record included a treatment sheet dated 4/30/25. At 11:34 AM, Patient #1 ’ s blood pressure was documented as 75/41 mmHg. There was no documentation Patient #1 ’ s low blood pressure was reported to the Charge Nurse / Team Leader. Patient #1 ’ s record included a treatment sheet dated 4/30/25. At 2:02 PM, Patient #1 ’ s blood pressure was documented as 86/56 mmHg. There was no documentation Patient #1 ’ s low blood pressure was reported to the Charge Nurse / Team Leader. b. Patient #5 was an 85 year old male who received ICHD. Patient #5 ’ s medical record included treatment sheets. The treatment sheets included documentation of low blood pressure that was not reported to the Charge Nurse / Team Leader per policy. Patient #5 ’ s record included a treatment sheet dated 4/30/25. At 7:12 am Patient #2 ’ s blood pressure was documented as 72/45 mmHg. There was no documentation the low blood pressure was reported to the Charge Nurse/ Team Leader per policy. Patient #5 ’ s record included a treatment sheet dated 4/30/25. Between 8:01 AM and 9:00 AM the following blood pressures were not documented as having been reported to the Charge Nurse/ Team Leader per policy: 08:01 AM - 85/53 mmHg. 08:31 AM -84/58 mmHg. 09:00 AM - 82/64 mmHg. The CM was interviewed on 5/07/25 beginning at 8:17 AM and Patient #1 and #5 ’ s records were reviewed in his presence. He confirmed that the Charge Nurse/Team Leader not being notified of the findings did not follow facility policy. The facility failed to follow policy related to notification of Charge Nurse/Team Leader. 2. A facility policy titled, “Patient Assessment and Monitoring” dated 5/01/2023 with titled section “Data Collection....If the PCT/LPN note any changes or abnormal findings in the patient’s condition.... or reported by the patient.... the registered nurse must assess the patient.” In the titled section “Pre-treatment” the following is listed: - “Blood Pressure....Verify: Systolic blood pressures greater than 180 mm/Hg and / or diastolic blood pressures greater than 100 mm/Hg. Systolic blood pressures less than or equal to 100 mm/hg [sic] systolic during treatment. - “Pulse.... Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute...” - “Reported by the patient...Record new complaints” This policy was not followed. Examples include: a. Patient #1 was an 82 year old male who received ICHD. Patient #1 ’ s medical record included treatment sheets. The treatment sheets included documentation of low and high blood pressures, low heart rates, and patient complaints. There was documentation that the Charge Nurse/ Team Leader was notified of these findings. There was no documentation the Charge Nurse/ Team Leader assessed patient after being notified of findings. Patient #1 ’ s record included a treatment sheet dated 4/30/25. At 11:23 AM, Patient #1 ’ s blood pressure was documented as 70/37 mmHg. There was no documentation the Charge Nurse / Team Leader assessed this patient per policy after being notified of the low blood pressure. Patient #1 ’ s record included a treatment sheet dated 4/30/25. At 12:05 PM, Patient #1 ’ s blood pressure was documented as 90/42 mmHg. There was no documentation the Charge Nurse / Team Leader assessed this patient after being notified of the low blood pressure. Patient #1 ’ s record included a treatment sheet dated 4/07/25. At 12:00 PM, Patient #1 ’ s blood pressure was documented as 98/55 mmHg with a heart rate of 54 and complaints of cramping. There was no documentation the Charge Nurse / Team Leader assessed this patient per policy after being notified of low blood pressure, low heart rate, and complaints of cramping. Patient #1 ’ s record included a treatment sheet dated 4/02/25. At 11:03 AM, Patient #1 ’ s blood pressure was documented as 186/65 mmHg with complaints of cramping. There was no documentation the Charge Nurse / Team Leader assessed this patient after being notified of the high blood pressure and patient ’ s complaints of cramping. b. Patient #2 was an 85 year old female who received ICHD. Patient #2 ’ s medical record included treatment sheets. The treatment sheets included documentation of drops in systolic blood pressure between sitting and standing greater than 20 mmHg that were not assessed by the Charge Nurse / Team Leader as required per policy. Patient #2 ’ s record included a treatment sheet dated 5/05/25. At 7:16 PM, Patient #2 ’ s blood pressure was documented as 157/109 mmHg sitting and documented as 183/75 mmHg standing, which was a 26 mmHg difference between sitting and standing systolic blood pressure. There was no documentation the Charge Nurse / Team Leader assessed this patient as required per policy. Patient #2 ’ s record included a treatment sheet dated 4/30/25. At 6:49 PM, Patient #2 ’ s blood pressure was documented as 178/61mmHg sitting and 144/58 mmHg standing, which was a 32 mmHg difference between sitting and standing systolic blood pressure. There was no documentation the Charge Nurse / Team Leader assessed this patient after documentation of a 32 mmHg difference in systolic blood pressure. Patient #2 ’ s record included a treatment sheet dated 4/23/25. At 6:23 PM, Patient #2 ’ s blood pressure was documented as 139/105 mmHg sitting and documented as 165/98 mmHg standing which was a 26 mmHg difference in systolic blood pressure. There was no documentation the Charge Nurse / Team Leader assessed this patient after documentation of a 26 mmHg in systolic blood pressure as required per facility policy. The CM was interviewed on 5/07/25 beginning at 8:17 AM and Patient #1 and #2 ’ s records were reviewed in his presence. He stated that the low and high blood pressures, low heart rate, differences of 20 mmHg systolic blood pressure between sitting and standing, and patient complaints should have been assessed and documented by the Charge Nurse/Team Lead. Further he agreed that not documenting or completing an assessment was not following facility policy. The facility failed to follow policy regarding patient assessment and monitoring. 3. A facility policy titled, “Patient Assessment and Monitoring” dated 5/01/2023 with titled section, “Data Collection” the following instructions are listed, “Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” Blood pressures and pulse rates were not obtained per policy. Examples include: Patient #1 was an 82 year old male who received ICHD. Patient #1 ’ s medical record included treatment sheets that included blood pressure and pulse checks not being completed at least every 45 minutes per policy: -Patient #1’s record included a treatment sheet dated 5/05/25 at 12:40 PM, Patient #1’s blood pressure was documented as 116/70, and his pulse rate was documented as 78. There was not another blood pressure or pulse rate documented until 1:35 PM, 55 minutes later. - Patient #1’s record included a treatment sheet dated 4/04/25 at 11:15 AM, Patient #1’s blood pressure was documented as 190/72, and his pulse rate was documented as 73. There was not another blood pressure or pulse rate documented until 12:35 PM, 1 hour and 20 minutes later. - Patient #1’s record included a treatment sheet dated 4/04/25 at 2:11 PM, Patient #1’s blood pressure was documented as 118/57, and his pulse rate was documented as 79. There was not another blood pressure or pulse rate documented until 3:10 PM, 1 hour and 1 minute later. - Patient #1’s record included a treatment sheet dated 4/02/25 at 11:32 AM, Patient #1’s blood pressure was documented as 143/94, and his pulse rate was documented as 57. The treatment sheet indicated at12:27 PM patient requested to stop treatment and EMS was called. There was not another blood pressure or pulse rate documented as the patient left with EMS at 12:45 PM with no further vitals documented, leaving a gap of 1 hour and 3 minutes that the patient was in the facility without documented vital signs. - Patient #1’s record included a treatment sheet dated 3/31/25 at 11:11 AM, Patient #1’s blood pressure was documented as 91/54 and his pulse rate was documented as 69. There was not another blood pressure or pulse rate documented until 12:31 PM, 1 hour and 20 minutes later. The CM was interviewed on 5/07/25 beginning at 8:20 AM and Patient #1’s treatment sheets were reviewed in his presence. He confirmed that greater than 45 minutes had passed between blood pressure and pulse rate readings on the above incidences. He confirmed this did not follow facility policy. The facility failed to follow their policy regarding patient monitoring during dialysis treatment.”