Davita Wyandotte Central Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 22676 Based on staff interview, review of facility documents, and policy review, the facility failed to meet the Conditions for Coverage (CfC ) for Water and Dialysate when the facility did not: 1. Ensure the “CWP” sic (Reverse Osmosis system (RO) was disinfected for one of 10 weeks reviewed and check for residual Minncare peracetic acid disinfectant for five of 10 weeks reviewed and 2. Ensure the “CitraPure “ acid solution was in the specific gravity range prior to transferring to the storage tank. The cumulative effects of this deficient practice resulted in and Immediate Jeopardy (IJ - a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death). On 03/22/24 at 7:10 PM, the Director of Operations and the Facility Administrator were notified of an Immediate Jeopardy at V219 under 42 CFR 494.40, Water and Dialysate quality. The facility provided an acceptable plan for removal of the Immediate Jeopardy on 03/23/24 at 2:00 PM. The plan of removal included the following: Wyandotte Central Dialysis takes the conditions of coverage very seriously; immediate steps taken to verify facility provides quality dialysis treatments to patients in a healthy and safe environment. Governing Body (GB) Meeting held 3/22/2024 to discuss immediate jeopardy status presented by CMS surveyor; immediate plan of correction developed, approved and initiated to verify system disinfection is performed and documented per policy. BOM (Biomedical Operations Manager) has reviewed and approved this POC on 3/23/2024. Facility Administrator or designee immediately began in-servicing all clinical teammates trained on water room duties: Nurses, PCT’s on the following Policies: Facility Specific Procedures for CWP RO Chemical Disinfect Procedure with emphasis on:.. This procedure will be performed on a weekly basis and may be performed in conjunction with the HW Circulation procedure for the disinfection of the distribution loop. On the CWP Operator’s panel, press the STOP touch pad. 1. Stops the flow of water through the distribution loop. 2. Ensure that, if applicable, DI tanks are bypassed, the Dry Acid mixer is disconnected from the distribution loop, and all Central Bicarbonate procedures have been completed. 2. Prevents damage to DI tanks, acid mixers and central bicarbonate mixers. Hot water in the loop can reach temperatures of 90 degrees Celsius and will cause extreme damage to these devices. 3. Verify that the cursor on the Operator’s panel display is in the upper left corner. 3. 4. Enter the Operator’s Code, 813, and press the Enter (f-) touchpad 4. Allows the operator to enter the disinfect mode 5. Press the DISINF (disinfect) touch pad on the Operator’s panel.5. Initiates the chemical disinfection procedure. 6. Press the DISINF touch pad again to confirm the disinfect process. 6. Confirms that the operator desires to complete a disinfection procedure. 7. Open the lower door of the CWP and move the solution connector to the disinfection position. 7. Allows the chemical to be drawn up from the Minncare chemical container. 8. Verify that the chemical uptake wand is correctly positioned in the chemical jug and that there is enough chemical present to complete the disinfection procedure. Close the door. 8. Ensures that enough chemical is present to complete the procedure. If there is not enough chemical present, the procedure will stop and generate a low chemical alarm. 9. Press the DISINFtouch pad. 9. Initiates the automated chemical uptake, dwell and rinse procedure. 10. Document the Chemical Disinfection start time on the Weekly Log. Facility Specific Procedure CWP Post Chemical Disinfect Start up and Daily Water Treatment Log with emphasis on: Open the lower door on the CWP and move the solution connector to the OPERATION position. 1. 2. Press the green START touch pad on the CWP Operator’s panel. 2. Allow the RO unit to flush and allow the operator to check the CWP RO unit for residual peracetic acid. 3. After approximately 1 minute, use a Minncare residual test strip and test the water flowing into the drain funnel on the right side of the CWP for the absence of PAA. 3. 4. Document that the water is free of disinfectant on the Weekly water log sheet. When the water is verified to be free of residual disinfectant, press the red STOP touch pad on the CWP Operator’s panel. 5. Stops the flow of water from the CWP RO unit. Policy 2-10-078 Residual MinnCare HD Testing Using Residual Minncare HD Acid Test strips with emphasis on: Put on PPE. 1. PPE is worn for teammate protection. 2. Verify that the test strip vial has been tightly capped and is not beyond the manufacturer’s expiration date. 2. Test strips stored in open vials or used beyond their expiration date may give inaccurate test results. 3. Collect a sample of the solution to be tested. 3. Note: Use a clean sample container 4. Remove a test strip from the bottle. Immediately recap bottle. 4. Tightly recapping the bottle will minimize moisture exposure of the remaining test strips. Dip the test in the solution to be tested such that the reaction zone is wetted. 5. The reagent pad contains the chemicals that will need to react to show the test result. 5. Remove test strip from the test water, gently shake off excess liquid and compare the reaction zone with the color scale between 5 and 10 seconds after exposure. 5. Delaying comparison of the reacted test strip with the color chart may cause test results to be reported inaccurately. 6. Read result: ACCEPTABLE: 1 ppm or less is safe for patient use UNACCEPTABLE: Greater than 1 ppm is unacceptable for patient use 6. If residual MINNCAREo HD testing is unacceptable, repeat rinse procedure and repeat residual MINNCAREo HD testing. 7. Results must be verified and recorded on appropriate disinfection log(s). Attendance of in-services are evidenced by TMs signature on clinical in-service form. Any teammate not present for today’s in-service will get in-service on their next scheduled workday before starting patient care. BSS will be on site on 3/23/2024 to re-educate teammates on above policies. As stated above, any teammate that is not present for this in-service, and performing water room tasks, will be re-inserviced on their next scheduled workday and no later than 3/28/2024. All teammates will complete CEC 4012 by end of day on 3/27/2024 and BSS will verify Skills checklists on 3/28/2024, prior to next disinfection on 3/28/2024. BSS will be present for next disinfection and negative verification to verify process is completed per facility specific policies. Skills checklists will be placed in Digital Teammate Files. 2 teammates will verify Thursday that the CWP was put into Chemical Disinfect. 2 PCT’s will verify Friday AM that chemical disinfection took place, chemical uptake verified and negative residual test was completed and documented. BSS (Biomedical Services Specialist) will audit water logs weekly x 4 weeks then monthly ongoing and evidence results in FHM (Facility Health Meeting). Facility Administrator (FA) will also complete observational audits of the water log each week on Friday to verify disinfection and post chemical residual is properly documented x 4 weeks, then minimum of monthly. Any instance of noncompliance will be addressed immediately. FA & Medical Director are responsible for compliance with this plan of correction. The surveyor validated the facility implementation of the plan for removal. The Director of Operations and the Facility Administrator were notified that the interventions identified in the removal plan were reviewed and verified as implemented, and the IJ was removed at 03/23/24 at 2:15 PM. Findings Include: 1. The facility failed to ensure the “CWP” Reverse Osmosis system (RO) was disinfected for one of 10 weeks reviewed and check for residual Minncare peracetic acid disinfectant for five of 10 weeks reviewed. (Refer to tag V219). 2. The facility failed to ensure the “CitraPure “ acid solution was in the specific gravity range prior to transferring to the storage tank. (Refer to tag V226). 3. The facility failed to conduct a thorough review of one of 10 dialysate “acid” mixing logs and two out of two months of the “CWP” Reverse Osmosis (RO) logs reviewed through the QAPI (Quality Assurance and Performance Improvement) process from December 2023 through March 15, 2024. (Refer to tag V628).”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to conduct a thorough review of one of 10 dialysate “acid” mixing logs and two out of two months of the “CWP “ Reverse Osmosis (RO) logs reviewed through the QAPI process from December 2023 through March 15, 2024. Failure to review to identify issues and develop corrective action plans had the potential to cause harm to all 72 in-center hemodialysis patients receiving care at the facility. Findings Include: 1. The facility failed to conduct a thorough review of one of 10 dialysate “acid” mixing logs and two out of two months of the “CWP” Reverse Osmosis (RO) logs reviewed through the QAPI process from December 2023 through March 15, 2024. (Refer to tag 628).”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to ensure the CWP Reverse Osmosis (RO) was disinfected for 1 of 10 weeks reviewed and check for residual Minncare peracetic acid disinfectant for 5 of 10 weeks reviewed. This had the potential to cause harm to all 72 in-center hemodialysis patients receiving care at the facility by failure to disinfect the “CWP” reverse osmosis system (RO) and test for the absence of the disinfectant. Findings Include: Review of facility’s policy titled, “CWP RO Chemical Disinfection Procedure” dated November 2019 states, “This procedure will be performed on a weekly basis ...Document the chemical disinfection start time on the weekly log ...refer to CWP post chemical start up procedure. Review of facility’s policy titled, “CWP RO post Chemical Disinfection start up procedure. “ indicated, “. . .open the lower door and press green start touch pad .... use a Minncare residual test strip and test the water flow. Document that the water is free of disinfectant on the weekly waterlog sheet. Document the verification of chemical uptake in the weekly waterlog.” 1 Review of the RO water logs from 01/12/24 through 03/20/24, revealed the facility failed to check for clearance of the Minncare peracetic acid disinfectant for on the following days: On 01/18/24 (No time documented) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 01/19/24. On 01/25/24 at 4:30 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 01/26/24. On 02/01/24 (No time documented) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 02/02/24. On 02/08/24 at 6:10 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 02/09/24. On 03/07/24 at 4:40 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 03/08/24. 2. Review of the water logs also revealed that the facility failed to disinfect the water system the week of 03/11/24 through 03/16/24. On 03/14/24 there is no evidence the regular “Thursday” disinfection was completed. The facility did not document the initiation of the disinfection and did not check for consumption of the disinfectant or check for clearance. Review of the logs also revealed that the disinfection process (initiation, consumption of the disinfectant and residual) was all documented-on Thursday on 02/01/24, 02/15/24, 02/22/24 and 03/21/24, and there was no evidence the amount of consumption and residual testing was completed on the following day. During an interview on 03/22/24 at 9:00 AM, the Administrator confirmed the above findings. The Administrator stated that he/she knew the RO was disinfected the week of 03/11/24 through 03/16/24. He/she could not explain why the initiation of the disinfectant on Thursday and the consumption, or residual clearance was not documented on Friday if disinfection did occur. During an interview on 03/23/24 at 1:15 PM, Certified Clinical Hemodialysis Technician (CCHT) 11 confirmed that he/she was the one who initiated the disinfection on 02/22/24 and that he/she did not know why he/she recorded the initiation, consumption, and residual testing all on the same day. CCHT11 confirmed that he/she only initiated the start of the chemical through the RO. CCHT11 also confirmed there was no evidence the consumption of the disinfectant or residual was tested the following morning on startup. CCHT11 stated “they always initiate the chemical on Thursday and record consumption and residual on Friday morning after the RO is started up and has run for 15 minutes.” During a telephone interview on 03/22/24 at 12:30 PM, the medical director confirmed that if the disinfection was not done and testing for chemical was not done there could be a risk of increase infection risk and exposure of the chemical to the patients. During an interview on 03/22/24 at 10:15 AM, the Biomed staff confirmed the above CWP disinfection initiation and clearance was not followed. Biomed 6 agreed if the staff failed to follow the procedure there could be an increased risk to the patients.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to ensure the “CitraPure “ acid solution was in the specific gravity range prior to transferring to the storage tank. This had the potential to cause harm to all 72 in-center hemodialysis patients receiving care at the facility by administering the acid to the patients during dialysis. Findings Include: Review of the facility’s policy titled, “Preparation of Rockwall CitraPure utilizing DAMX45 Dry acid Concentrate Mixer,” dated September 2015, indicated, “. . .20. Document the hydrometer reading on the CitraPure batch production record ...21. If test results for specific gravity are not within acceptable parameters, do not transfer and do not use the solution. Notify the Facility Administrator and the biomed team. If the hydrometer reading for the solution is not within acceptable range, the mixed solution may not have the correct composition and must not be used. The biomed team will be responsible for verifying appropriate disposal of the large batch non-transferable solution.” Review of the facility’s form titled, “CitraPure Batch Procedure Record,” dated revised April 2020, “ indicated, “Checking Specific Gravity values for CitraPure refer to manufactures instruction.” Review of CitraPure manufacture instruction limits for this batch state the acceptable specific gravity range was “1.187 to 1.214.” Review of the “CitraPure batch production record” dated 12/15/23 for the 3 Potassium (K) 2.5 Calcium (CA) revealed the manufacturers acceptable range for the low range was 1.187 and the high range was 1.214. The Hydrometer reading (a method used to determine the specific gravity) was recorded as being 1.220. Registered Nurse (RN) 3 documented that the “solution was within acceptable range and could be transferred to the storage tank on 12/15/23.” During an interview on 03/22/24 at 9:00 AM, the Administrator verified the staff did not follow the policy and the manufacturers’ instructions. He/She also verified the solution was out of range and it was transferred to the holding tank. During an interview on 03/22 24 at 10:15 AM, Biomed Staff 6 verified the staff did not follow the policy and the manufacturers’ instructions. He/She also verified the solution was out of range and it was transferred to the holding tank. During an interview on 03/23/24 at 1:15 PM, Biomed Staff 20 verified the staff did not follow the policy and the manufacturers’ instructions. He/She also verified the solution was out of range and it was transferred to the holding tank. He/she stated that he/she was not notified that the solution was out of range so that it could be neutralized and sent to the drainage system.”

“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: 22676 Based on review of glucometer (device used to test blood sugar levels) logs, interview, review of glucometer policy, and manufacturer’s instructions, the facility failed to ensure the glucometer was in the control range and follow manufacturer’s instructions for one of two glucometers used in the facility. This deficient practice had the potential to provide incorrect blood glucose results and could result in inaccurate glucose results causing mistreated blood glucose levels treatment to all 72 patients receiving incenter care at the facility. Findings Included: Review of the facility’s policy titled, “Blood Glucose Testing,” dated 12/19, revealed, under “Policy” section revealed, “. . .2. blood glucose monitor is used according to manufactures instructions. 6. Quality control is completed prior to the first use of the day when the DaVita approved blood glucose monitor id used for patient blood glucose testing ...” Calibration and control testing shall be performed each operating day ...” “Quality Control (QC)” 4. QC procedures are performed according to manufactures instructions ... Review of the “Embrace Pro” glucose monitoring system manufactures instruction revision date 09/20 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...” Review of electronic “Blood Glucose Logs” from 01/05/24 through 03/19/24 revealed the controls were not recorded every working day. The following controls revealed: On 01/16/24 the recorded acceptable high control range was 285-385, the recorded high control was 390. On 01/20/24 the recorded acceptable high control range was 285-385, the recorded high control was 396. On 01/23/24 the recorded acceptable high control range was 285-385, the recorded high control was 396. On 01/26/24 the recorded acceptable high control range was 285-385, the recorded high control was 394. On 01/27/24 the recorded acceptable high control range was 285-385, the recorded high control was 414. On 01/30/24 the recorded acceptable high control range was 285-385, the recorded high control was 407. On 01/31/24 the recorded acceptable high control range was 285-385, the recorded high control was 417. On 03/07/24 the recorded acceptable low control range was 94-126, the recorded low control was 128. On 03/09/24 the recorded acceptable low control range was 94-126, the recorded low control was 127. On 03/15/24 the recorded acceptable low control range was 94-126, the recorded low control was 129. During an interview on 03/21/24 12:15 PM, the Administrator confirmed the findings and agreed the staff did not repeat the high and low-level control as required by the manufacturer’s instruction.”

“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: 22676 Based on observation, interview, and review of the policy, the facility failed to ensure patients were visualized by the staff and the hemodialysis access sites were uncovered and visible for one of three days of the survey. The patient and the access site (faces, needle insertion sites and line connections) for all patients on treatment must always be visible to staff, to ensure the lines and needles do not become dislodged or disconnected. Excessive blood loss can result from needle dislodgement, resulting in dire consequences such as severe hypotension (low blood pressure), hospitalization, blood transfusions, and death, and could affect all 72 in-center hemodialysis patients receiving care at the facility. Findings Include: Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revision date April 2023, indicated, “The vascular access site, blood line connections and patient’s face should be visible throughout the dialysis treatment.” Observation on 03/21/24 from 10:30 AM to 10:37 AM revealed the patient at Stations 4 was sitting in treatment area (POD) 1 at Station 4 in the corner. The unidentified patient in Station 4 was assigned Registered Nurse (RN) 3 who was the only RN assigned to work in the unit on 03/21/24. RN3 was seen on the other side of the unit from 10:30 AM to 10:37 AM assessing another patient. There was no other staff in POD 1 at this time and the patient face and dialysis access (needles) could not be visualized by anyone. Observation on 03/21/24 from 10:35 AM to 10:45 AM revealed an unidentified patient in the corner of POD 2 Station 7 that was not observed from 10:35 AM to 10:45 AM. This patient was assigned to Certified Clinical Hemodialysis Technician (CCHT) 11. CCHT11 was seen at Station 15 assisting another patient. There was no other staff in POD 2 that could see the patient’s face and access. Review of the seating chart revealed the facility had 5 PODs for a total of 20 stations. RN3 was assigned to Stations 1-4 in POD 1. CCHT 11 was assigned to the patients in POD 2, Station 5-8. Patient Care Technician (PCT) 14 was assigned to the patients in POD 3 Stations 9-12. There were no staff assigned to the two patients in POD 4. Two patients were seen sitting in POD 5 waiting for dialysis to be initiated at 11:00 AM. During an interview on 03/21/24 at 11:00 AM, RN3 confirmed the patients’ faces and access could not always be visualized by the staff. RN3 confirmed he/she was the only RN assigned to work the unit on 03/21/24 and he/she was also assigned to the patients in POD 1. He/she also confirmed that he/she was assigned to give all medications, conducting the pre-treatment and post-treatment assessment and any other nursing needs that may arise during the shift. When asked who was assigned to the patient sitting in POD 4 and who would be assigned to POD 5, he/she stated they “ we [staff] all were”. During an interview on 03/21/24 at 11:15 AM, CCHT 11 confirmed he/she was providing care for the patients in POD 4 from 10:35 AM to 10:45 AM and the patient he/she was assigned to in POD 2 was not always being observed.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 22676 Based on interview, Quality assessment and performance improvement (QAPI) meeting minutes, technical audits, and policy review, the facility failed to conduct a thorough review of one of 10 dialysate “acid” mixing logs and two out of two months of the “CWP” (Reverse Osmosis) (RO) logs reviewed through the QAPI process from December 2023 through March 15, 2024. Failure to review to identify issues and develop corrective action plans had the potential to cause harm to all 72 in-center hemodialysis patients receiving care at the facility. Findings Include: Review of the facility’s policy titled, “Continuous Quality Improvement Program” dated April 2021, failed to specifically outline in the written plan what should be audited in the water and dialysate area. Bullet 7.0 stated, “The facility will analyze, track quality indicators or other aspects of performance. The program must include, but not limited to, the following. Other indicators as reflected the facility Health Record Application.” Each action plan will be evaluated with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority.” The facility Health Meeting documents list “Concentrate Mixing and RO disinfection complete without issue.” as indicators for monthly review. Review of the January 2024 QAPI Meeting Minutes, showed the December 2023 QAPI Technical Audit of the Concentrate mixing form, under the section “Biomed/Water/Dialysate” indicated that there were no identified issue with the “concentrate mixing” (CitraPure) Review of the “CitraPure batch production record” dated 12/15/23 for the 3 Potassium (K) 2.5 Calcium (CA) revealed the manufacturers acceptable range for the low range was 1.187 and the high range was 1.214. The Hydrometer reading (a method used to determine the specific gravity) was recorded as being 1.220. Registered Nurse (RN) 3 documented that the “solution was within acceptable range and could be transferred to the storage tank on 12/15/23.” Review of the RO water logs revealed the facility failed to check for clearance of the Minncare peracetic acid disinfectant for on the following days: On 01/18/24 (No time documented) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 01/19/24. On 01/25/24 at 4:30 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 01/26/24. On 02/01/24 (No time documented) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 02/02/24. On 02/08/24 at 6:10 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectant on 02/09/24. Review of the “QAPI Meeting Minutes” from 02/27/24 through 03/13/24, revealed the report for January and February showed there were no issues identified in the “CWP” (Reverse Osmosis Water system disinfection process). During an interview on 03/22/24 at 10:30 AM, the Facility Administrator confirmed that he/she was the one directly assigned to the auditing of the acid mixing and CWP RO disinfection process. He/she confirmed that from December 2023 through March 15, 2024, the QAPI minutes failed to identify any above issue with dialysis “acid” mixing in the month of December and failed to identify the above issues with disinfection in the months of January and February data collection.”