Davita Wenatchee Valley Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 22676 Based on staff interviews, review of facility documents, and policy review, the facility failed to meet the requirements of 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 2 of 14 weeks reviewed and check for residual Minncare peracetic acid disinfectant for 8 of 14 weeks reviewed and record the amount of consumption of the disinfectant for 9 of 14 weeks reviewed. 2. The facility failed to circle the correct number of the bath being made (a type of acid base used in dialysis treatments) for six of six baths made. This had the potential to cause harm to all 74 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: 1. The facility failed to ensure the CWP Reverse Osmosis (RO) was disinfected for two of 14 weeks reviewed and check for residual Minncare peracetic acid disinfectant for eight of 14 weeks reviewed and recorded the amount of consumption of the disinfectant for nine of 14 weeks reviewed. Refer to V219 2. The facility failed to circle the correct number of the bath being made (a type of acid base used in dialysis treatments) for six of six baths made. Refer to V226”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 22676 Based on staff interviews, review of facility documents, and policy review, the facility failed to meet the requirements of the Conditions for Coverage (CfC) for Quality Assessment & Performance Improvement (QAPI) when the facility failed to ensure it continuously monitored its performance, taking actions that result in performance improvement and track performance to ensure that improvements are sustained over time for five of six Quality Improvement minutes reviewed. Findings include: 1.The facility failed to ensure it continuously monitored its performance, taking actions that result in performance improvement and track performance to ensure that improvements are sustained over time for five of six Quality Improvement minutes reviewed. Refer to F638”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 52064 Based on document review, staff interview, and policy review the facility failed to ensure they conducted quarterly fire drills as per facility policy. Two of four fire drills were conducted in the past 12 months. Failure to ensure facility staff and patients are prepared for emergency situations puts all patients and staff at risk for harm in the event of an emergency. Findings include: Review of facility fire drill documentation for 2024 revealed fire drills were conducted with staff and patients in two of four quarters (Q): ...June 2024 on 06/24/24 and 06/25/24 (Q2) ...October 2024 on 10/02/24 and 10/03/24 (Q4) Interview with the Facility Administrator on 01/09/25 at 9:02 AM in the administrator’s office, he/she stated she was behind on quarterly fire drills last year and had only two fire drills in the past 12 months. He/she acknowledged the fire drills were to be performed on a quarterly basis and could not produce additional documentation for fire drill completion. Review of the facility’s policy titled, “Emergency Management Plan (ICHD, HOME),” revised April 2024, indicate, “...3. Fire Safety Drills:. . .b. Required on a quarterly basis...””

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure expired medication was removed from the emergency cart as to not be available for use. One of three vials of diphenhydramine in the emergency cart was expired. Failure to remove expired medication from the cart can lead to expired medications being given to the patient in case of an emergency. Findings include: During review of the emergency equipment cart and contents of the emergency cart on 01/08/25 at 6:20 AM one of three vials of diphenhydramine was found to expired. The expiration date was noted to be 2024-07. Interview with Registered Nurse (RN) 9 at 6:25 AM, in the patient treatment area at the medication preparation area he/she confirmed the vial was expired and was removed from the emergency cart. Review of facility’s policy titled, “Emergency Equipment Checks” revised April 2022, indicated, “...3. The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional. . .Weekly:...Emergency cart (crash cart) is clean, operational and supplies/medications have not expired.” Review of facility’s policy titled, “Medication Policy” revised November 2023, indicated, “...13. Do not use any medication that has been stored improperly or has expired...31. Medications are ordered and replaced prior to expiration.””

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and facility policy review, the facility failed to ensure staff followed their policy for infection control. One of five staff members (Patient Care Technician (PCT) 17) was observed wearing personal protective equipment (PPE) in the hallway by the employee lounge and office area of the facility. One of four staff members (Certified Clinical Hemodialysis Technician (CCHT) 17) was observed performing patient care that had the potential for exposure to body fluids without appropriate PPE as per facility policy. Findings include: Upon arrival at the facility on 01/07/25 at 8:02 AM the door to the lobby from the patient treatment area was opened by PCT17 in full PPE (gloves, gown, mask). After greeting the survey team, PCT 17 told us she would open another door to allow us into the conference room of the facility. PCT17 was still in full PPE when the other door was opened and PCT17 proceeded to walk through the hallway of the office area, employee lounge area, and conference room in full PPE and proceeded back into the patient treatment area. During observation of care in the patient treatment area on 01/07/25 at 10:45 AM and again at 11:27 AM, CCHT17 was observed wearing a gown, gloves, and goggles only during the discontinuation of dialysis process. He/she was not wearing a face shield or mask for protection of the mucous membranes of the nares or mouth from potential for contact with blood spurt or spatter during the dialysis process as per facility policy. In an interview with Registered Nurse (RN) 8 at 8:10 AM on 01/07/25 at the medication preparation desk, he/she stated the employee should not be wearing PPE outside the patient treatment area. In an interview with CCHT17 on 01/07/25 at 12:10 PM in the patient treatment area he/she acknowledged he/she was not wearing a mask or face shield to protect from inadvertent blood spatter to the mucous membranes. He/she stated, “I didn’t know I was supposed to be wearing a mask.” Review of the facility’s policy titled, “Infection Control for Dialysis Facilities Policy” Revised April 2023, indicated, “ ...PPE (i.e., gown, gloves, eye protection, face shield). . .5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids.... PPE is to be: a. Removed prior to leaving the patient treatment area. . . c. PPE is not to be worn in non-treatment areas, for example, teammate lounge, teammate offices.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure the hemostats used in patient care were disinfected as per facility policy and stored appropriately. The facility failed to ensure staff disinfected equipment that was used on patients before returning to a clean area. Failure to disinfect appropriately has the potential to cause harm to all 74 patients dialyzed in the facility. Findings include: 1. During a tour of the patient treatment area on 01/07/25 at 8:44 AM, four of 12 clamps laying on the countertop by Central Venous Catheter (CVC) packs were observed to be in the closed position. In a storage bin marked “clean clamps” 25 of 40 blue hemostat clamps were in the closed position. In an interview with CCHT11 on 01/07/25 at 8:44 AM, he/she acknowledged the blue clamps were in a closed position and he/she could not verify if they had been open when disinfected On 01/07/25 at 12:15 PM it was noted there were four of six blue hemostats in the clamped position in a container marked “dirty clamps” and four of 20 blue hemostat clamps in a closed position in another container marked “dirty clamps”. In an interview with CCHT13 on 01/07/25 at 12:15PM he/she acknowledged the clamps were in the closed position while being soaked in bleach solution. 2. During observation in the patient treatment area on 01/07/25 at 11:03 AM Certified Clinical Hemodialysis Technician (CCHT) 13 took the thermometer off the computer cart between Stations 1 and 2 and used to get the temperature of patient at Station 3 and returned the thermometer to the computer cart between Stations 3 and 4 without sanitizing or disinfecting the surface of the thermometer. In an observation on 01/07/25 at 12:20 PM CCHT14 took thermometer out of basket on computer cart between Stations 9 and 20 and used to get temperature of patient in Station 10. CCHT14 then placed the thermometer on computer cart basket between Stations 10 and 11 and did not clean or disinfect the surface of the thermometer. In an interview with CCHT13 on 01/07/25 at 11:32 AM he/she acknowledged the computer cart was considered clean and all equipment on it should be cleaned/disinfected or disposable and discarded after use. Review of facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023 indicated, “Disinfection...14. Non-disposable items are to be disinfected after each patient use.....b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution.15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 52064 Based on observation, staff interviews, and policy review, the facility staff failed to clean all non-disposable items in the patient treatment station between patients. A trash receptacle was shared by every two stations. The outside of the trash receptacle was never cleaned before moving between stations. This practice can lead to cross contamination between all patients who dialyze at the dialysis stations. Findings include: During observation in the dialysis treatment room on 01/07/25 between 9:50 AM-12:24 PM and 01/08/25 between 10:15 AM-12:30 PM it was noted the outside of trash receptacles were not sanitized and disinfected between patients at Stations 3/4, 5/6, and 10/11. These trash receptacles were shared between two side-by-side stations. Trash receptacles were placed at the legs of the chairside computer on wheels. Trash receptacles located and shared at Stations 3/4, 5/6, 7/8, 20/9, 10/11, 12/13, 14/15, and 16/17 were noted on 01/08/25 at 12:15 PM overflowing with trash from the previous patients dialyzed at the stations. In an interview with Certified Clinical Hemodialysis Technician (CCHT) 13 on 01/08/25 at 12:17 PM in the patient treatment room he/she acknowledged the outside of the trash receptacle is not cleaned between patients or treatments and the liner is not changed out between patients even though the trash receptacle is full and overflowing onto the floor. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised April 2023 indicated, “. . .14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses.””

“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: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure the policies for infection control were followed by all staff in the facility. Seven of seven computer carts were pushed back between hemodialysis machines in a blood splash/splatter area. Failure of staff to follow these infection control guidelines put all patients and staff in the facility at risk for cross contamination. Findings include: During observation in the patient treatment area on 01/07/25 from 9:50 AM -12:24 PM it was observed the computer cart with the monitor and keyboard was pushed back in between the dialysis machines in an area where blood and infectious matter could contaminate the cart and contents of the cart. The computer cart was shared between two stations. Seven of seven computer carts being used during patient treatments were pushed back into the splash/spatter zone of the patient station. The waste receptacle being used for patient trash from the stations was also located against the legs of the chairside computer cart. The trash receptacle exterior was not sanitized/disinfected between patient use. The computer cart also had boxes of gloves, hand sanitizer, and a thermometer in a small basket located on each cart that could all become contaminated in the splash/spatter zone with infectious matter. In an interview with Certified Clinical Hemodialysis Technician (CCHT)11on 01/07/25 at 10:45 AM he/she stated the computer on wheels is always pushed back between the patient hemodialysis machines. He/she further stated the computer and cart is considered clean and acknowledged the cart is in an area of potential blood contamination in the area they are currently being used. CCHT 11 acknowledged at this time the trash receptacle sits at the base of the computer cart wheels and the trash receptacle is considered “dirty”. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, indicated, “Hand Hygiene Supplies . . .8. Supplies will be stored in a manner that maintains their integrity. . . Disinfection . . .12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought to the station) ...15. The chair-side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas.””

“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 two of 14 weeks reviewed and check for residual Minncare peracetic acid disinfectant for eight of 14 weeks reviewed and recorded the amount of consumption of the disinfectant for nine of 14 weeks reviewed. This had the potential to cause harm to all 74 in-center hemodialysis patients receiving care at the facility by failure to disinfect the “CWP” RO system and test for the absence of the disinfectant. Findings include: 1. Review of the “CWP Daily Waterlog” from January 08/07/24 through 12/28/24, revealed the facility failed to check for clearance of the Minncare peracetic acid disinfectant for on the following days: On 08/13/24 at 5:15 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 08/14/24. On 08/27/24 there was no initiation of the disinfection recorded. There was no documented evidence that the RO system was checked for residual disinfectants on 08/28/24. On 09/10/24 at (no time recorded on log) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/11/24. On 09/17/24 at (no time recorded on log) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/18/24. On 09/24/24 at 4:14 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/25/24. On 10/08/24 at 4:28 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 10/09/24. On 11/09/24 at 4:41 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 11/10/24. On 11/26/24 there was no initiation of the disinfection recorded. There was no documented evidence that the RO system was checked for residual disinfectants on 11/27/24. 2. Review of the “CWP Daily Waterlog” also revealed that the facility failed to disinfect the water system the week of 08/27/24 through 11/26/24. On 08/27/24 and 11/26/24, there is no evidence that the regular “Tuesday” 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 disinfections did not record the consumption of the disinfectant on the following days. 08/13/24, 08/28/24, 09/04/24, 09/11/24, 09/18/24, 09/25/24, 10/09/24, 11/06/24, and 11/20/24 In an interview with Biomedical Technician 6 on 01/07/25 at 2:10 PM, confirmed the above findings. He/she stated the Administrator was responsible for auditing the waterlogs. He/she confirmed if the process were not followed the patient could be at risk of exposure to peracetic acid which could jeopardize their health. An interview with the Facility Administrator on 01/08/25 at 11:27 AM he/she confirmed that he/she was responsible for the audits of the waterlogs which included the disinfections, consumptions, and clearance of the chemical for the system. The Administrator also confirmed that he/she did not find the above issues. He/she stated similar issues were identified in June and July 2024 and the staff was educated on 08/01/24 and the Facility Administrator audited on the waterlogs on the weeks of 08/06/24, 08/15/24, and 08/22/24 and could not identify any issues. When asked about A the review of August 2024 waterlogs, which identified on 08/13/24 the consumption nor the residual check for peracetic acid was recorded. The Facility Administrator also stated he/she did not understand the log and how to review it. In an telephone interview with the Medical Director on 01/08/2025 at 3:30PM he/she stated the facility had made him/her aware of the issues found during the survey process this week. The Medical Director was sure they brought them up in Quality Assurance Review or Governing Body but they did so many policies and paper reviews he/she was not exactly sure of what they were. He/she further stated that he/she had not gone back to see the water system and he/she did not remember any materials on the water system being presented to him. 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.””

“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, review of manufacturer’s instructions, and policy review, the facility failed to circle the correct number of the bath being made (a type of acid base used in dialysis treatments) for six of six baths made. This had the potential to affect all 74 patients receiving in-center hemodialysis patients receiving care at the facility. Findings include: Review of the “Granuflo Mixing Log” for the month of October 2024 through 11/30/24 revealed the staff were not consistently marking the “Granuflo (132 Gallon) Batch Production Record,” appropriately to indicate what batch was mixed as evidenced by the following: Review of the batch mixed on 10/10/24 was marked as batch one and the batch mixed on 10/17/24 was marked as batch five. There were two baches made on 10/23/24, one was mixed at 7:30 AM mixed as batch three and one mixed at 12:00 PM was marked as batch four. The batch mixed on 10/29/24 was marked as batch five and the one mixed on 11/05/24 was marked as batch five. The inconsistence in marking the batch number could lead to the filter not being changed as required. During an interview on 01/0724 at 2:30 AM, Biomedical Technician 6 confirmed the records above were not numbered correctly for the batches that were made, and if not marked correctly the filter would not be changed correctly. Review of the facility’s policy titled, “Granuflo Concentrate Dissolution Unit: (132 Gallon) Mixing Procedure” dated October 2024, failed to include directions for the filter change although the form fused for mixing the acid stated, “replace filter after six batch. The form attached had a number sequence to mark the bath number made.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 52064 Based on observation and staff interviews, the facility was using power strips behind the patient stations to provide additional electrical outlets for their patient equipment. Three of five pods had a power strip plugged into the outlet behind a patient station. Extra electrical equipment plugged into existing outlets has the potential to overload the electrical circuit in the patient station. Findings include: During a tour of the patient treatment area of the facility on 01/07/25 at 9:52 AM it was noted there were power strips plugged into outlets between stations 2/3, 6/7, and 9/10. There was an additional three cords plugged into each power strip. The power strips were being used for cords from oxygen concentrators and power cords from the patient chairs. In an interview with Certified Clinical Hemodialysis Technician (CCHT) 11 in the patient treatment area on 01/07/25 at 9:52 AM he/she said someone from up above approved the power strip being used at the patient stations. In an interview with the Facility Administrator on 01/07/25 at 10:40 AM in the patient treatment area he/she stated he/she could not provide a policy for the use of the power strips and they used them for the additional outlets because they did not have enough outlets for the equipment.”

“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 logs, interview, review of facility’s 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 one glucometer used in the facility. This deficient practice had the potential to provide incorrect blood glucose results and could result in inaccurate glucose level results for all 74 patients receiving care at the facility. Findings included: Review of electronic “Blood Glucose Logs” for 11/04/24 through 1/07/24 revealed the following: On 11/20/24, the recorded acceptable low control range was 92-104, the recorded low control was 130. On 12/06/24, the recorded acceptable low control range was 92-124, the facility staff failed to record the low control. On 12/19/24, the recorded acceptable low control range was 91-123, the recorded low control was 127. On 12/24/24, the recorded acceptable low control range was 91-123, the recorded low control was 135. On 12/28/24, the recorded acceptable low control range was 91-123, the recorded low control was 124. On 01/07/25, the recorded acceptable high control range was not recorded. During an interview on 01/08/25 at 8:15 PM, the Facility Administrator confirmed the findings and agreed the staff did not repeat the low-level and record the low-level and the high-level control as required by the manufacturer’s instruction. Review of the facility’s policy titled, “Embrace-pro Blood Glucose Monito Quality Control,” dated 09/20, revealed, “Glucose controls checks should be performed....” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“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 interviews, document review, and policy review, the facility failed to ensure it continuously monitored its performance, taking actions that resulted in performance improvement and track performance to ensure that improvements are sustained over time for six of six Quality Improvement minutes reviewed. These findings have the potential to cause harm to all 74 patients receiving care at the facility. Findings include: Review of the RO system quality committee audits in the Quality Committee minutes for September 2024, October 2024, November 2024, and December 2024 reported no issues with the Waterlogs. There was no documentation that the above issue was identified through the quality improvement review that identified the issues found in the review of the “CWP daily Waterlogs.” The July Quality Committee minutes for the month of July show no issue with the waterlogs. August minutes showed only issues with the peracetic acid reagent temperature and missing signatures. Review of “CWP Daily Waterlog” for week of 10/29/24 revealed documentation of chemical disinfection on 10/29/24 at 4:13 PM with consumption noted on 10/30/24 and residual documented on 10/30/24 and disinfection. The log also recorded on 10/30/24 at 5:00AM and again on 10/31/24 at 5:00AM which would indicate the system was disinfected three days in a row. Review of the Quality Committee minutes failed to indicate the “CWP” sic (Reverse Osmosis system (RO) was disinfected for 2 of 14 weeks reviewed and check for residual Minncare peracetic acid disinfectant for 8 of 14 weeks reviewed and record the amount of consumption of the disinfectant for 9 of 14 weeks reviewed. 1 Review of the RO waterlogs from January 08/07/24 through 12/28/24, revealed the facility failed to check for clearance of the Minncare peracetic acid disinfectant for on the following days: On 08/13/24 at 5:15 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 08/14/24. On 08/27/24 there was no initiation of the disinfection recorded. There was no documented evidence that the RO system was checked for residual disinfectants on 08/28/24. On 09/10/24 at (no time recorded on log) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/11/24. On 09/17/24 at (no time recorded on log) the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/18/24. On 09/24/24 at 4:14 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 09/25/24. On 10/08/24 at 4:28 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 10/09/24. On 11/09/24 at 4:41 PM the system was put into disinfection mode. There was no documented evidence that the RO system was checked for residual disinfectants on 11/10/24. On 11/26/24 there was no initiation of the disinfection recorded. There was no documented evidence that the RO system was checked for residual disinfectants on 11/27/24. 2. Review of the waterlogs also revealed that the facility failed to disinfect the water system the week of 08/27/24 through 11/26/24. On 08/27/24 and on 11/26/24, there is no evidence that the regular “Tuesday” 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 disinfections did not record the consumption of the disinfectant on the following days. 08/13/24, 08/28/24, 09/04/24, 09/11/24, 09/18/24, 09/25/24, 10/09/24, 11/06/24, and 11/20/24 Quality Improvement process from August 2024 to December 2024 did not identify this in their log review. In an interview with the Biomedical Technician on 01/07/25 at 2:10PM he/she stated that the Facility Administrator was responsible for the Auditing of the waterlogs. He/she also confirmed they would not have disinfected the RO at the two times recorded as 5:00 AM, which is when the patients are going on treatment, and they would be unable to run the dialysis machines while in disinfection mode. In an interview with the Facility Administrator on 01/08/25 at 11:27AM confirmed that she/he was responsible for the audits of the waterlogs which include disinfection, consumption, and clearance of the chemical from the system. The Facility Administrator also confirmed that he/she did not find the above concerns with the logs. He/she stated similar issues were identified in June 2024 and July 2024 and the staff was educated on 08/01/24. The Facility Administrator audited on the waterlogs on the weeks of 08/06/24, 08/15/24, and 08/22/24 and did not identify any concerns. The Facility Administrator also stated he/she did not understand the log and how to review it. Further review of the August 2024 waterlogs identified that on 08/13/24 the consumption and the residual check for peracetic acid were not recorded, which was not found on the weekly audit by the Facility Administrator. Review of the CWP RO System manufacturer instructions required that disinfection of the system be completed at least weekly. Review of the policy titled, “CWP Post Chemical Disinfect Start UP Procedure” provided by the facility had an origin date of 03/01/13 and a revision date of 03/17/16. This policy states ...”Materials required: MINNCARE@ Residual Test strips ...This procedure will be performed after a chemical disinfect of the RO has been completed ...Verify the water is free of residual disinfectant using an approved test strip ...Mark the level of the disinfectant and the date on the Minncare@ disinfectant container, and that the disinfectant level is lower than the marking from the previous disinfection.” The CWP water system was installed in the facility in June 2023 ten years after the policy inception. Review of the facility’s policy titled, “Water Treatment System Disinfection” revision date October 2021 states “ ...The RO is disinfected at least weekly using peracetic acid (PAA) solution.” In an telephone interview with the Medical Director over the phone on 01/08/25 at 3:30PM he/she stated the facility had made him/her aware of the concerns found during the survey process this week and he/she was sure they brought them up in Quality Assurance Review or Governing Body but they did so many policies and paper reviews he/she was not exactly sure of what they were. He/she stated further that he/she had not gone back to see the water system and he/she did not remember any materials on the water system being presented to him/her.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 52064 Based on staff interviews, review of biomed monthly audits, and policy review, the facility failed to ensure the Medical Director was involved in the implementation and ongoing monitoring of the performance improvement plan for the identified issues with the water treatment log. Failure of the quality assessment program to ensure performance improvement plans are initiated and monitored on a continuous basis for identified deficient practices places all patients at risk for harm. Findings include: In an interview with the Manager of Clinical Services (MCS) on 01/08/25 at 10:43 AM revealed the Facility Administrator performed an audit of the daily water treatment logs on 08/01/24 and found deficient practices in June and July 2024 and put an action plan together. There was an inservice for staff and audits performed weekly for four weeks in August 2024 by the Facility Administrator. He/she performed an audit on 08/06/24 and found the same issues and did not change the plan from the one developed by the Facility Administrator. The Manager of Clinical Services stated the plan was to continue to audit weekly for four weeks and then monthly by the biomed. In the same interview with the Manager Clinical Services, when asked how the “Improvement Plans” are reviewed in their meeting, he/she explained if added as an “Improvement Plan” it will auto populate monthly for review and discussion. If placed under “Comments” it will show what happened and how it was fixed that month only. He/she further stated a “Comment” was done at the August quality meeting and was never put under “Improvement Plan” for ongoing monitoring to be discussed with the Medical Director at the meetings. He/she further stated the Facility Administrator and the Biomed said everything was okay and the Manager Clinical Services performed no follow-up audits. In an interview with the Facility Administrator on 01/08/25 at 11:07 AM the Facility Administrator stated, “He/she doesn’t remember ever taking the Medical Director to the water room or explaining the water logs to the Medical Director”. He/she said at the August quality assurance meeting the Medical Director was told about the discrepancies on the log and the audit process. The Facility Administrator said if an “Improvement Plan” is opened we will do a “Deep Dive and Root Cause” and we will have to explain what we are going to do about it. The Facility Administrator stated an “Improvement Plan” was not initiated in the quality program when first identified. Improvement Plans would carry over monthly until you clear it and will pop up at least for three months to see how trending. He/she further stated except for the monthly Biomed report in their meeting the log issue was not addressed with the Medical Director after the August meeting. The Facility Administrator further stated, “Did not understand the log and was inserviced today on how to audit the log”. In an interview with the Medical Director by phone on 01/08/2025 at 3:30PM he/she stated the facility had made him/her aware of the issues found during the survey process this week and he/she was sure they brought the issues up in Quality Assurance Review or Governing Body about the water log issues, but they did so many policies and paper reviews he/she was not exactly sure of what they discussed. The Medical Director further stated that he/she had not gone back to see the water system and did not remember any materials on the water system being presented to him/her. Review of the monthly biomed audits presented for October 2024 and November 2024 quality meetings, on 01/08/25 at 11:25 AM, revealed discrepancies noted in water and machine logs with no improvement plan discussed or initiated in the Quality Improvement meeting or with the Medical Director. Review of the facility’s policy titled, “Continuous Quality Improvement Program”, Revised April 2021, indicated, “...4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation.. . .8. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained”. Review of the facility’s policy titled, “Medical Director Qualifications and Responsibilities Policy,” revised December 2022, indicated, “...4.2. Medical Director Responsibilities 4.2.1. Medical Director responsibilities include, but are not limited to, the following...: ...(g) Oversight of patient care delivery and clinical outcomes in the center, including oversight of safety and quality of water used for patient treatments. (h) Oversight of the Quality Assurance (QA/Quality Improvement (QI) program.”