Fmc - Dialysis of Murray

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 35697 Based on observation, interview, and facility policy review, the facility failed to ensure all environmental surfaces in the dialysis treatment stations were disinfected at the end of each dialysis treatment during 4 of 4 observations of the cleaning and disinfection of the dialysis treatment stations. Failure to thoroughly disinfect all environmental surfaces in the dialysis treatment stations had the potential to serve as a vehicle for transmission of infectious disease and negatively impact the safety and wellbeing of the 52 patients who received dialysis treatments at the facility. The findings include: A facility policy titled, Cleaning and Disinfecting the Dialysis Station, dated 09/05/2023, indicated, “Definition: Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV [intravenous] pole, BP [blood pressure] cuff and hand sanitizer/holder, organizer; Chair/bed; Pureflow SL; Individual television and remote.” Under the section, “General Cleaning,” the policy indicated, “The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station (ex [example] Stethoscope) must be disinfected with 1:100 bleach or EPA [Environmental Protection Agency] registered disinfectant before removed from the dialysis station.” 1. Observation of the hemodialysis treatment area on 11/12/2024 revealed the following: At 9:58 AM, Patient Care Technician (PCT) #19 was observed disinfecting station 11. PCT failed to disinfect the sharps container, which was attached to the dialysis machine, and the trash receptacle, which was placed under the arm table of the dialysis chair. During an interview at 10:02 AM, PCT #19 acknowledged the trash receptacle was cleaned at the end of the day and not after each patient. 2. Observation of the hemodialysis treatment area on 11/12/2024 revealed the following: At 10:55 AM, Certified Clinical Hemodialysis Technician (CCHT) #10 was observed disinfecting station 10. CCHT failed to disinfect the sharps container, which was attached to the dialysis machine, and the trash receptacle, which was placed under the arm table of the dialysis chair. During an interview on 11/12/2024 at 11:17 AM, Clinic Manager (CM) #1 stated, “Honestly, we don’t touch the sharps container that is attached to the dialysis machine.” During an interview on 11/12/2024 at 11:54, CM #1 stated it was expected for staff to clean the sharps container as it was attached to the machine, and the trash receptacle should be wiped and the liner replaced after each patient. 3. Observation of the hemodialysis treatment area on 11/13/2024 revealed the following: At 10:55 AM, In Center Registered Nurse (ICRN) #8, was observed disinfecting station 11. ICRN failed to disinfect the sharps container, which was attached to the dialysis machine. During an interview at 9:56 AM, ICRN #8 acknowledged she did not remember if she had cleaned and disinfected the sharps container that was attached to the dialysis machine. 4. Observation of the hemodialysis treatment area on 11/13/2024 revealed the following: At 10:12 AM, Certified Clinical Hemodialysis Technician (CCHT) #10 was observed disinfecting station 11. CCHT failed to disinfect the trash receptacle, which was placed under the arm table of the dialysis chair. During an interview at 10:12 AM, CCHT #10 acknowledged the trash receptacle was part of the dialysis station, and she should have emptied and cleaned it and replaced the liner. During an interview on 11/14/2024 at 3:30 PM, Clinic Manager #1 confirmed staff should clean the sharps container and the trash receptacle because it was placed in the dialysis treatment area.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to provide the necessary care and services to manage the patient’s volume status when they failed to report out-of-range vital signs to the registered nurse (RN) and failed to monitor vital signs per facility policy. This affected 5 (Patients #1, #2, #3, #4, and #5) out of 7 patients in the medical record review sample. The findings include: The facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023 indicated, “The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed.” The policy outlined monitoring expectations including, “During Treatment, Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” Further, the policy indicated “Follow the steps below for monitoring patient and machine parameters during treatment: Step 1, Blood Pressure, Record Blood Pressure.” “Report to the nurse: Systolic blood pressures greater than 180 mm/Hg [millimeters of mercury], Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic.” “Pulse. Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular.” 1. Patient #1: A review of the Treatment Sheet dated 10/21/2024, indicated there was no evidence of vital signs being taken from 1:05 PM to 2:02 PM (57 minutes) while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 10/21/2024, indicated an out-of-range pre-treatment blood pressure of 182/112 at 11:11 AM, taken by Patient Care Technician [PCT] #19. There was no evidence the RN was notified of the out-of-range vital signs. A review of the Treatment Sheet dated 10/30/2024, indicated there was no evidence of vital signs being taken from 10:33 AM to 11:32 AM (59 minutes) while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 11/01/2024, indicated Patient #1’s blood pressure was 44/30 and heart rate was 57 at 12:07 PM, which had been taken by PCT #14 while the patient was receiving dialysis treatment. There was no evidence the RN was notified of these out-of-range vital signs. A review of the Treatment Sheet dated 11/08/2024, indicated there was no evidence of vital signs being taken from 3:03 PM to 4:06 PM (1 hour and 3 minutes) while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 11/08/2024, indicated at 3:03 PM, Patient #1’s heart rate was 55, which had been taken by Certified Clinical Hemodialysis Technician [CCHT] #11 while the patient was receiving dialysis treatment. There was no evidence of RN notification of the out-of-range vital signs. In an interview on 11/14/2024 at 10:38 AM, the Incenter Hemodialysis Clinic Manager confirmed the findings above. She indicated the low blood pressure reading on 11/01/2024 at 12:07 PM should have been verified, documented, and the RN should have been notified if the blood pressure had not improved. 2. Patient #2: A review of the Treatment Sheet dated 10/29/2024, indicated there was no evidence of vital signs being taken from 10:36 AM to 11:34 AM (58 minutes) while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 11/09/2024, indicated at 11:04 AM, Patient #2’s blood pressure was 172/102, which had been taken by Patient Care Technician [PCT] #14. At 11:36 AM, Patient #2’s blood pressure was 166/102, which was taken by PCT #14 while the patient was receiving dialysis treatment. There was no evidence of RN notification of the out-of-range vital signs. In an interview on 11/13/2024 at 3:02 PM, the Incenter Hemodialysis Clinic Manager confirmed the findings above. 3. Patient #3: A review of the Treatment Sheet dated 10/21/2024, indicated at 9:33 AM, Patient #3’s blood pressure was 86/49, which was taken by Certified Clinical Hemodialysis Technician [CCHT] #11. There was no evidence of RN notification of the out-of-range vital signs. A review of the Treatment Sheet dated 10/23/2024, indicated at 7:16 AM, Patient #3’s pre-treatment sitting blood pressure was 81/46 and standing blood pressure was 79/47. At 7:22 AM, Patient #2’s blood pressure at the initiation of dialysis was 87/56, which were all taken by CCHT #10. There was no evidence of RN notification of the out-of-range vital signs. A review of the Treatment Sheet dated 10/25/2024, indicated at 8:02 AM, Patient #3’s blood pressure was 97/56 and heart rate was 56 taken by PCT #14. There was no evidence of RN notification of the out-of-range vital signs. A review of the Treatment Sheet dated 10/28/2024, indicated at 10:01 AM, Patient #3’s blood pressure was 83/57, which was taken by PCT #19. There was no evidence of RN notification of the out-of-range vital signs. A review of the Treatment Sheet dated 10/30/2024, indicated at 9:03 AM, Patient #3’s blood pressure was 99/63 and heart rate was 55, which was taken by CCHT #11. At 9:32 AM, Patient #3’s blood pressure was 99/54 which was taken by CCHT #11. At 10:33 AM, Patient #3’s blood pressure was 106/57, which was taken by PCT #13. There was no evidence of RN notification of the out-of-range vital signs. A review of the Treatment Sheet dated 11/01/2024, indicated at 7:19 AM, Patient #3’s pre-treatment blood pressures was 87/52 sitting and 80/44 standing, which was taken by CCHT #10. At 8:34 AM, Patient #3’s blood pressure was 93/59, which was taken by CCHT #11. At 9:01 AM, Patient #3’s blood pressure was 90/54 and heart rate was 55, which was taken by CCHT #10. There was no evidence of RN notification of the out-of-range vital signs. In an interview on 11/14/2024 at 11:16 AM, the Incenter Hemodialysis Clinic Manager confirmed the findings above. 4. Patient #4: A review of the Treatment Sheet dated 11/06/2024, indicated at 6:32 AM, Patient #4’s blood pressure was 102/57, which was taken by Certified Clinical Hemodialysis Technician [CCHT] #11. At 7:08 AM, Patient #4’s blood pressure was 93/50, which was taken by Patient Care Technician [PCT] #13. At 7:31 AM, Patient #4’s blood pressure was 92/49, which was taken by PCT #19. At 8:04 AM, Patient #4’s blood pressure was 93/55, which was taken by PCT #19. At 8:23 AM, Patient #4’s blood pressure was 98/53, which was taken by CCHT #11. There was no evidence of registered nurse notification of the out-of-range vital signs. In an interview on 11/13/2024 at 4:17 PM, the Incenter Hemodialysis Clinic Manager confirmed the findings above. 5. Patient #5 A review of the Treatment Sheet dated 10/22/2024, indicated there was no evidence of vital signs being taken at the beginning of dialysis treatment. Pre-treatment assessment vital signs were documented at 7:42 AM. Treatment was initiated at 7:46 AM. No vital signs were taken until 8:02 AM (16 minutes after treatment initiation). A review of the Treatment Sheet dated 10/29/2024, indicated there was no evidence of vital signs being taken from 10:07 AM to 11:02 AM (55 minutes), while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 11/05/2024, indicated there was no evidence of vital signs being taken from 8:35 AM to 9:34 AM (59 minutes), while the patient was receiving dialysis treatment. A review of the Treatment Sheet dated 11/07/2024, indicated there was no evidence of vital signs being taken at the beginning of dialysis treatment. Pre-treatment assessment vital signs were documented at 7:46 AM. Treatment was initiated at 7:50 AM. No vital signs were taken until 8:33 AM (43 minutes after treatment initiation). In an interview on 11/13/2024 at 2:37 PM, the Incenter Hemodialysis Clinic Manager confirmed the findings above. She stated the facility’s expectation would be for vital signs to be taken immediately after putting the patient on the machine at the initiation of dialysis treatment. She confirmed that vital signs taken 15 minutes after the initiation of dialysis would be considered late. During an interview on 11/14/2024 at 10:00 AM, RN #7 stated the facility’s expectation was for patient care technicians (PCTs) to notify the nurses for out-of-range blood pressures but stated they did not always do it, so she made an effort to check on patients herself. During an interview on 11/14/2024 at 3:45 PM, RN #6 confirmed the expectation for PCTs to notify the RN of out-of-range vital signs. The RN stated then the nurse would recheck the vital signs and document the new blood pressure reading with any assessment findings. In an interview on 11/14/2024 at 2:45 PM, the Medical Director confirmed the facility’s expectation was for patient monitoring and vital signs at least every 45 minutes, per policy. He stated the staff were educated on the importance of blood pressure monitoring and confirmed the PCTs should report out-of-range vital signs and big changes in blood pressure to the nurses and that this notification should be documented.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50873 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis prescription as determined by the medical provider for 3 (Patients #1, #3, and #4) of 5 sampled in-center hemodialysis patients. The findings include: Facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, stated, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” 1. Review of the “Treatment Sheet” for Patient #1, dated 11/06/2024, showed hemodialysis orders that included a BFR [blood flow rate] of 450 mL/min [milliliters per minute]. The treatment sheet showed the patient treatment was run at a BFR of 350 ml/min from 11:03 AM to 2:34 PM (3 hours and 31 minutes). There was no evidence of a documented reason the blood flow rate was not able to be met. This finding was confirmed with the Incenter Hemodialysis Clinic Manager on 11/14/2024 at `10:38 AM, and she stated there should be a note with a rationale if the BFR is reduced, but this was not done. 2. Review of the “Treatment Sheet” for Patient #3 on 10/30/2024 showed hemodialysis orders that included a BFR [blood flow rate] of 450 mL/min [milliliters per minute]. The treatment sheet showed the patient treatment was run at a BFR of 330 ml/min from 7:31 AM to 9:32 AM (2 hours and 1 minute). There was no evidence of a documented reason the blood flow rate was not able to be met. This finding was confirmed with the Incenter Hemodialysis Clinic Manager on 11/14/2024 at 11:16 AM. 3. Review of the “Treatment Sheet” for Patient #4 on 10/30/2024 showed hemodialysis orders that included a DFR [dialysate flow rate] of 500 mL/min [milliliters per minute]. The treatment sheet showed the patient treatment was run at a DFR of 700 ml/min from 5:33 AM to 8:03 AM (2 hours and 30 minutes). There was no evidence of a documented reason the dialysate flow rate was not able to be met. This finding was confirmed with the Incenter Hemodialysis Clinic Manager on 11/13/2024 at 4:17 PM, who stated there was no reason for a patient to be run at a different DFR than ordered, unless the doctor ordered to change it. She confirmed there were no notes to indicate why the DFR was different than ordered. During an interview on 11/14/2024 at 3:45 PM, Registered Nurse (RN) #6 stated if the blood flow rate was unable to be run as prescribed, the facility expectation was that the reason for deviating from the prescription would be documented. During an interview on 11/14/2024 at 2:45 PM, the Medical Director confirmed the facility expectation was for the dialysis prescription to be followed and to document if any deviations were necessary, such as if the BFR was unable to be achieved.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the incenter hemodialysis Quality Assessment and Performance Improvement [QAPI] program failed to track, trend, and analyze quality indicator information, with a potential for negative impact to 52 out of 52 incenter hemodialysis patients receiving care at the clinic. The findings include: A facility policy titled, “Quality Assessment and Performance Improvement Program,” published 11/04/2024, indicated, “QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes.” Further, under the section “QAPI Committee Responsibilities” the policy indicated the responsibilities included, “Measuring, analyzing, and tracking quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations.” Review of the Crude Mortality Root Cause Trend Analysis (ICHD) from September 2024 revealed 13 patient deaths in the previous 11 months (August 2024 - October 2023). Of those deaths, nine showed a one-month average treatment time of less than four hours; and it revealed eight patients had a central venous catheter. There was no evidence of data analysis, creation of an action plan, or previous action plans. In an interview on 11/14/2024 at 12:00 PM, the Incenter Hemodialysis Clinic Manager stated that mortality analysis was not being conducted. She stated the facility was collecting mortality related data, with the exception of the patient’s cause of death. However, the data was not being analyzed. She stated the facility did note an upward trend in mortality, but the data analysis was not performed, and an action plan was not developed. In an interview on 11/14/2024 at 2:45 PM, the Medical Director confirmed the facility expectation to track, trend, and analyze QAPI data and to create an action plan for quality indicators that were outside of benchmarks or trending down.”

“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: 35697 Based on observation, interview, and facility policy review, the facility failed to discard expired supplies in accordance with facility policy and procedure for 1 of 2 medication rooms and 1 of 1 dialysis treatment area. The findings include: A facility policy titled, “Storage of Supplies,” published 04/05/2021, indicated, “Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date.” 1. An observation on 11/12/2024 at 9:36 AM, in the presence of Registered Dietitian (RD) #15 in the Medication Prep [Preparation] Room of the Home Dialysis Clinic area, revealed the following expired items: - Seven syringes of 10 milliliters (mL) saline solution were in one of the cabinet drawers with an expiry date of 05/31/2023. - The glucometer in one of the cabinet drawers had glucose test strips with an expiry date of 08/10/2022. - There was a glucometer contact solution (2.5 ml bottle) with an expiry date of 02/26/2021. - The control solution used for the glucometer (2.5 ml bottle) had an expiry date of 02/26/2021. During interview 11/12/2024 at 9:41 AM, RD #15 stated, “We don’t use this room.” The RD further stated the expired items should have been discarded. During an interview on 11/12/2024 at 11:52 AM, Clinical Manager (CM) #2 stated the expired saline syringes should have been removed from the medication room, and the glucometer should have been tagged, “Do not use.” 2. Observation of the hemodialysis treatment area on 11/12/2024 at 11:14 AM revealed the following expired supplies: - Two containers of pH (potential of hydrogen) test strips, with an expiry date of 08/01/2024. - One bottle of Myron-L TDS/Conductivity test solution, expired 03/29/2024. During an interview on 11/12/2024 at 11:14 AM, Certified Clinical Hemodialysis Technician (CCHT) #10 acknowledged the facility did not check pH and conductivity unless the machine test failed. CCHT discarded the expired items. During an interview on 11/12/2024 at 3:30 PM, CM #1 acknowledged the expired items should have been discarded as per facility policy.”