Fmc - Neenah

“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: 22198 Based on observations, interviews and policy review, the facility failed to ensure staff cleaned the wall box at dialysis stations (Stations 1 and 11) during two of two observations. Failure to perform complete dialysis station cleaning allows for the potential of cross contamination. Findings include: During an observation of the cleaning and disinfection process on 08/04/25 at 12:22 PM Registered Nurse (RN) 9 failed to clean the wall box at Station 1 as a part of the station cleaning. During an observation of the cleaning and disinfection process on 08/05/25 at 10:50 AM Certified Clinical Hemodialysis Technician (CCHT) 10 failed to clean the wall box at Station 11 as a part of the station cleaning. During an observation on 08/05/25 at 10:57 AM the wall boxes at Station’s 8, 12, and 13 had white crystals built up and were discolored. During an interview on 08/05/25 at 11:00 AM the Biomedical Technician (BMT) 5 confirmed that the wall boxes at Station’s 8, 12, and 13 had white crystals built up and were discolored and stated, “the staff must not have cleaned them at the end of the day yesterday.” During an interview on 08/05/25 at 11:03 AM, CCHT10 stated that the wall boxes are cleaned at the end of each day, not after each dialysis treatment. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” dated 09/05/23 revealed, “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 in the dialysis station may include (but is not limited to) the following ... Dialysis Wall Box A box designed to connect central distribution systems to a hemodialysis machine that is located in the chase wall behind the machine. ... Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood.” During an interview on 08/05/25 at 12:00 PM, after reviewing the dialysis station cleaning policy, the Facility Administrator 1 stated that the policy requires the wall boxes to be cleaned after each dialysis treatment as a part of the dialysis station and at the end of the day.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 22198 Based on observation, interviews, medical records and policy review, the facility failed to ensure one of one staff (Registered Nurse (RN) 9) followed the isolation for Hepatitis B Antigen (HBsAG+) protocol for one of one a HBsAG+ patient (Patient (P)1) when 1. RN9 failed to remove gloves donned in the isolation room prior to exiting, 2. failed to use an isolation room dedicated thermometer, and 3. failed to wipe down the common area thermometer and scaled after it was use by a HBsAG+ patient. These failures had the potential to place 13 of 55 patients that do not have immunity to Hepatitis B virus (HBV) at risk for exposure to HBV. Findings include: Review of P1’s medical record revealed P1 was admitted on 05/27/25 and his/her Hepatitis B titer was identified as HBsAG+. During an observation on 08/04/25 at 11:50 AM, after finishing discontinuation of the dialysis treatment for P1, RN9 removed his/her gloves, performed hand hygiene, then donned a new pair of gloves. RN9 then picked up P1’s personal belongings and assisted him/her to a standing position from the dialysis chair. Prior to exiting the isolation room, RN9 removed his/her gown touching the outside of the gown to get it over his/her head but kept the gloves on. RN9 then left the isolation room carrying P1’s personal belongs bag and walked P1 to the common area/corner of the dialysis treatment floor by the exit. While still wearing the gloves from the isolation room, RN9 picked up the common area thermometer and took P1’s temperature and then touched the scale to obtain P1’s weight. Without disinfecting the scale or thermometer and without changing gloves, RN9 assisted P1 out the dialysis treatment floor exit. After leaving the exit door area, RN9 removed gloves, discarded them in a common are garage can and performed hand hygiene on the dialysis treatment floor. Further observation on 08/04/25 at 11:53 AM revealed Certified Clinical Hemodialysis Technician (CCHT) 10 walked over to the common area, picked up the uncleaned thermometer with his/her bare hands and obtained P7’s temperature. CCHT10 then pushed the uncleaned scale button to obtain P7’s weight. CCHT10 cleaned the scale and the thermometer immediately after using the items with the container of general dialysis treatment floor disinfecting wipes. Reviews of the immunity status for both CCHT10 obtained for his/her personnel file and P7 obtained for his/her medical record, both were confirmed as immune. During an interview on 08/04/25 at 11:55 AM when asked if he/she should wear the gloves they put on while in the isolation room outside of the isolation room, RN9 stated “I changed my gloves” (after care). When asked if the scale and thermometer should be cleaned after being used on a HBsAG+ patient stated, “I did.” When the observation was reviewed with RN9, he/she agreed that the items should have been cleaned per the HBsAG+ policy. RN9 did not know if there was a dedicated thermometer in the isolation room. During interview on 08/04/25 at 12:15 PM with the Facility Administrator when asked if RN9 should wear gloves put on in the isolation room outside of the isolation room, the Facility Administrator confirmed staff are to remove all personal protective equipment (PPE) and perform hand hygiene prior to leaving the isolation room. During an interview on 08/04/25 at 12:45 PM when asked if there was a dedicated thermometer the Facility Administrator stated, “I will look into that.” The Facility Administrator provided no additional information by the time of exit. Review of the facility’s policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+) dated 06/04/25 revealed “Hand hygiene must be practiced when entering and leaving the isolation area. ... Personal protective equipment (PPE) must be removed and discarded or left in the isolation room/area if not soiled. ... Separated dedicated supplies and equipment, including blood glucose monitors, must be used to provide care to the HBsAg positive patient. ... Equipment cannot be used for HBV negative patients on other shifts or days due to the risk of cross contamination. Equipment used for HBsAg positive patients should be reserved for the HBsAg positive patient unless repair or maintenance is needed. ... All equipment, counter tops, chair etc. will be surface disinfected with a 1:100 bleach solution after the training session ends, and before use with another patient.””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22198 Based on observation, document review and interview, the facility failed to ensure that the water rooms that housed the dialysis acid mixing and holding tanks, and dialysis water purification system was secure from unauthorized users. This failure to secure the water room from unauthorized users has the potential to negatively affect all 55 incenter dialysis patients if the water becomes contaminated. Findings include: During an observation on 08/04/25 at 11:56 AM a delivery person walked out of the bulk storage/water room area unescorted onto the dialysis treatment floor to provide a delivery slip to Facility Administrator 1. The delivery person then entered the code to get back into the bulk storage and water room area and exited the facility. During an observation on 08/04/25 at 12:05 PM Certified Clinical Hemodialysis Technician (CCHT) 11 and Registered Nurse (RN) 8 entered the locked common bulk storage area which housed the dialysis water purification system through an accordion gate . In an interview at time of observation CCHT11 and RN8 confirmed the accordion gate was left open when the dialysis unit is open. The lock for accordion gate for dialysis acid mixing and holding tanks was also observed in the unlocked/opened position. The supply receiving door in the bulk storage/water room area allowed access to the unlocked water purification system and the acid mixing and storage area for anyone delivering supplies. During an observation on 08/04/25 between 9:05 AM and 12:00 PM the Administrative Assistant (AA) was observing entering and exiting the bulk storage/water room area multiple times. During an interview on 08/05/25 at 2:00 PM the Area Technical Operations Manager (ATOM) 12 stated he/she saw the Fresenius delivery truck, so ATOM 12 knew it was a Fresenius delivery person in the building. After discussing the observation of the delivery person and observations of the AA entering and exiting the bulk storage/water room area, ATOM 12 confirmed those accordion gates are to be locked. Review of the facility’s policy titled, “Physical Security and Facility Access” dated 09/05/23 revealed, “All visitors, including delivery drivers, sales representatives, ... or other non-FKC persons presenting themselves at a FKC facility need to check in with the appropriate facility personnel who will verify their identity. ... Water Treatment Area Security Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment. No exterior building door will be left unlocked unless under the continual supervision of a facility staff member.””

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 22198 Based on observation, interviews, policy review, and manufactures directions for use (MFR DFU), the facility failed to ensure that after educating staff on the new acid testing spigot and how to obtain the first sample after the acid was mixed; that they there were monitored to ensure they followed the testing process per MFR DFU and facility policy. The failure to follow the MFR DPU and facility policy places all 55 in-center dialysis patients at risk for delayed treatments. Findings include: During an observation on 08/04/25 at 12:10 PM Certified Hemodialysis Technician (CCHT) 11 was demonstrating the acid mixing, testing, and transferring to bulk storage tanks process. During the demonstration, CCHT11 pointed to the hydrometer cylinder and stated the cylinder was put into the acid mixer (pointed to the removable cover) to obtain the first acid test sample after the acid was completely mixed to ensure it was within parameters before transferring the acid to the bulk tank. In an interview during the observation, CCHT11 was asked if the spigot on the new neutralizing tank that was added to ensure testing was obtained per MFR DFU alongside the ACID mixer was ever used to obtain the first test sample, CCHT 11 stated “no, we did the cylinder inside the tank to get the sample.” CCHT 11 stated that “I am a Fresenius float tech, and every facility does it a little differently.” Interview on 08/05/25 at 8:00 AM with Biomedical Technician (BMT) 5, and two Area Technical Operations Managers (ATOM) (ATOM 12 and ATOM-Northern Region 13) all confirmed that dipping the hydrometer cylinder into the tank was not how the staff were supposed to take the first ACID test sample. ATOM 12 provided training documents dated December 2024 and confirmed CCHT 11 was present for the training. BMT5, ATOM’s 12 and 13 confirmed that dipping the hydrometer cylinder into the acid tank to obtain a sample does not follow the MFR DFU or the facility’s policy. When asked if monitoring d after the new training and change in the location of the first testing spigot was completed to ensure that staff understood the new system BMT5, ATOM’s 12 and 13 stated “no” we are not onsite at this location every day to do that. Review of the facility sign posted on the wall above the neutralizing tanks in the acid mixing area titled “Acid Neutralization Tank” (not dated) revealed “While the mixer is still transferring and the acid concentrate has just reached the 3-1/2 gallon mark, close the Neutralization Tank inlet valve and fill the hydrometer cylinder 2/3 full from the sample valve of the Neutralization Tank, Pause the transfer process and measure the specific gravity and temperature of the acid concentrate in the hydrometer cylinder. If the specific gravity is within limits, move the transfer hose to the correct acid concentrate storage tank and continue with the transfer process. Document the reading in TMs (the electronic. If the specific gravity is not within limits, reach out to the technical department for guidance. Empty the hydrometer cylinder into the Neutralization Tank and rinse the cylinder with RO water.” Review of the MFR DPU titled, “Dry Acid Dissolution Unit (DADU),” not dated but identified as “REV. F” revealed “Always handle the hydrometer with care. Always hold it vertically by the top, as finger marks lower down can affect the accuracy of the instrument. The hydrometer should never be held by the stem horizontally. Rinse the hydrometer and the hydrometer cylinder separately with purified water before checking solution for specific gravity. The purified water source must meet ANSI/AAMI or ISO standards for dialysis currently ANSI/AAMI RD62, or ISO 13959. ... Fill the Hydrometer Cylinder: Insert the Transfer Nozzle into the Hydrometer Cylinder slowly OPEN the Transfer Nozzle valve until solution starts to slowly accumulate into the Hydrometer Cylinder Allowing solution to fill down the side of the beaker minimizes the creation of bubbles within the solution (Figure 12, item B) Fill the hydrometer Cylinder approximately 2/3 rd (sic) full CLOSE Transfer Nozzle and then press PAUSE on the Display Panel. Place Transfer Nozzle onto a clean surface.” Review of the facility’s policy titled “Acid Concentrate Specific Gravity Testing Procedure” dated 07/05/22 revealed “Once hydrometer is clean place hydrometer onto a clean area while placing the clean hydrometer cylinder next to the filter housing. Remove the transfer hose from the top of the tank and connect to transfer nozzle with the valve closed (sic). Slightly open the main transfer valve next to the filter housing and press Dissolution START button, slightly open the Transfer Nozzle Valve and flush 3.5 gallons of solution in the Residual Solution Bucket and close Transfer Nozzle Valve. Fill hydrometer cylinder by inserting nozzle into cylinder and slowly opening transfer nozzle valve. As solution begins to fill tilt the cylinder to minimize bubbles while filling while filling the cylinder 2/3 full. Tum off Transfer Nozzle Valve and set on clean area. Place hydrometer cylinder on a level surface. Using the thermometer measure (sic) the temperature in degrees Celsius of the solution in the hydrometer cylinder. Record the measured temperature in degrees Celsius on the Batch Record in the ‘Measured Temp DADU’ (Dry Acid Dissolution Unit) box.””

“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: 22198 Based on observations, interviews, policy, and manufacturer’s directions for use (DFU) review, the facility failed to 1. follow the bloodline manufacturer’s DFU during dialysis treatments by not monitoring and maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at 85- 95% full during treatment for two of three survey days, and 2. Failed to follow the manufacture (MFR) expiration dates to ensure dialysis supplies were not used beyond their expiration date for two of three observation days when staff failed to removed expired supplies from immediate use dialysis floor supply cabinets and bins. The failure to follow the manufacturer’s DFU had the potential to negatively impact on the safety and wellbeing of all 55 patients receiving in-center hemodialysis treatments at this facility. Findings include: 1. During an observation on 08/04/25 at 10:22 AM the bloodline arterial chambers at Stations 7 and 9 were less than one half full, and the venous chambers were filled to the top. During an observation on 08/04/25 at 11:05 AM the bloodline arterial chamber at Station 1 was less than one half full. During an observation and interview on 08/04/25 at 11:05 AM, Registered Nurse (RN) 9 confirmed that the arterial chambers were not filled to the appropriate level. RN9 stated that checking the blood chambers was a part of their rounding. When asked how full the chambers should be, RN9 was not able to articulate the amount but stated there was a fill line. During an observation on 08/05/25 between 9:55 AM and 10:25 AM the arterial chamber at Station 6 was one half full and at Stations 13 and 14 the arterial chambers were less than one quarter full. During an interview on 08/05/25 at 10:25 AM with Certified Clinical Hemodialysis Technician (CCHT) 10 confirmed that the arterial chambers were not filled to the correct amount at Stations 6, 13, and 14. CCHT10 confirmed checking the blood chambers was a part of their rounding observation that occurred every 30 to 45 minutes. When asked how full the arterial chambers should be, CCHT could not articulate the amount but pointed to the chamber stating there was a fill line, however, confirmed he/she could not visualize the fill line. During an observation on 08/05/25 at 10:45 AM the arterial chamber at Station 17 was one half full. CCHT11 completed work at the Station and was walking away. During an interview on 08/05/25 at 10:45 AM CCHT11 confirmed that the arterial chamber at Station #7 was not filled to the correct level and returned to the correct level. Review of the undated manufacturer’s DFU for the “Combi Set SmartTech” “ revealed, under the title ‘WARNINGS. . .Always monitor the venous chamber with a level detector. ‘During Treatment: Maintain fluid level in arterial chamber at approximately 90% full and venous chamber at approximately 70% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. ... Maintain a proper fluid level in chambers to ensure that no air is returned to the patient.” Review of the facility’s policy titled “Patient Assessment and Monitoring” dated 05/01/23 revealed, “The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment. ... During Treatment ... Venous and arterial chambers are filled to the fill level.” Observation of the storage bin located on the dialysis treatment floor on 08/04/25 at 11:10 AM revealed threeavailable for use Optiflux F200 NR dialyzers which expired on 03/31/25. Further observation revealed one Optiflux F250 NR was observed in a bin of other dialyzers expited on 10/31/24. During an interview on 08/04/25 at 11:10 AM Facility Administrator 1 confirmed that the three Optiflux F200 NR dialyzers and the one Optiflux F250 NR which were on the dialysis floor and available for immediate use and were expired. Facility Administrator 1 confirmed that the dialysis staff are responsible for checking, rotating, and removing expired supplies from the dialysis floor. During an observation the Nurse’s station and medication preparation area on 08/05/25 at 9:20 AM revealed the following expired items: 1 box of 90 individually packaged “Providone Iodine” prep pads Five “Precision Glide” 21-gauge needles. Monofilament” foot screening tests; one package of 20-foot screening tests was sealed and one package of 20 contained five (5) remaining foot screening tests. 28 “Sol-Care” TB (tuberculin) safety needles with fixed needles. Two 100 milliliter (ml) bags of normal saline (0.9%) which were removed out of their original packaging and had not been labeled and rated with the new expiration date. Review of the MFR expiration date revealed, the “Providone Iodine” individually packaged prep pads expired 04/28/25. Review of the MFR expiration date revealed four of the five “Precision Glide” 21-gauge needles expired on 02/28/25, and one of the five had expired on 05/31/23. Review of the MFR expiration date revealed two packages (25 total) “Monofilament” foot screening tests both had an expiration date of 04/2025. Review of the MFR expiration date revealed the 28 “Sol-Care” TB (tuberculin) safety needles with fixed needle expired 04/15/25. During an interview on 08/05/25 at 9:55 AM Facility Administrator 1 confirmed the above items were expired and still available for immediate use supplies on the dialysis floor and should have been removed. Facility Administrator 1 confirmed the facility did have a policy regarding expired supplies but was unaware of a labeling policy for the 100 ml bags of normal saline. During an observation on 08/05/25 at 10:35 AM in the designated laboratory area 60 of a package of 100 red top laboratory tubes were expired. Review of the MFR date of expiration revealed, the 60 red top blood collection tubes expired 07/31/25. During an interview on 08/05/25 at 10:35 AM CCHT 11 confirmed the 60 red top blood collection tubes had expired on 07/31/25. Review of the facility’s policy titled “Expiration Dates Sterile Supplies” dated 07/04/12 revealed, “This policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date. ... Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date.” During an interview on 08/05/25 at 2:30 PM Facility Administrator 1 stated he/she had reached out to “Corporate” and the “Baxter” for help locating the MFR requirements for labeling or change of expiration date once the 100 ml bags are removed from their original package. Facility Administrator confirmed “Corporate” was not able to locate any guidance, and the facility had not received a return call from Baxter. Review of the Baxter MFR DFU for “MINI-BAG (Viaflex) Plastic Container obtained from the world wide web at https://www.baxter.ca/sites/g/files/ebysai1431/files/2019-04/0.9_Sodium_Chloride_Injection_USP_in_VIAFLEX_EN.pdf, dated 04/02/19, revealed “Do not remove unit from overwrap until ready to use. The overwrap is a moisture barrier.””

“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: 22198 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for three of seven) sampled current incenter dialysis patients (Patient(P)1, P2, and P5) reviewed. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for the 55 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s electronic medical record (EMR) “Treatment Sheet For Facility: Northeast Wisconsin \Neenah”, revealed a prescribed blood flow rate (BFR) 400 milliliters per min (ml/min) and the dialysate flow rate (DFR) was 800 ml/min. Review of three of the six “Treatment Sheet for Facility: Northeast Wisconsin\Neenah” 07/23/25 to 08/04/25 revealed the following: a. On 07/25/25 the dialysis treatment started correctly at 7:55 AM at 9:38 AM the prescription BFR was changed to 350 ml/min until 11:34 AM when the BFR was decreased to 300 ml/min at the end of the treatment. b. On 07/28/25 the dialysis treatment started correctly at 10:24 AM at 11:07 AM the prescription BFR was changed to 350 ml/min. At 11:32 AM the BFR was changed to 375 ml/min until the end of treatment at 2:01 PM. c. On 07/30/25 the dialysis treatment started correctly at 8:22 AM at 9:11 AM the prescription BFR was changed to 375 ml/min. At 9:31 AM the BFR was changed to 350 ml/min until 10:33 AM when it was changed to 375 ml/min until the end of treatment at 11:55 AM. There was no rationale documentation for the change to the prescribed BFR. 2. Review of P2’s electronic medical record (EMR) “Treatment Sheet For Facility: Northeast Wisconsin \Neenah”, revealed a prescribed blood flow rate (BFR) 400 ml/min and the DFR was Autoflow 2.0. Review of four of the six “Treatment Sheet for Facility: Northeast Wisconsin\Neenah” 07/23/25 to 08/04/25 revealed the following: a. On 07/23/25 the dialysis treatment started at 7:13 AM with the BFR at 350 ml/min and the DFR at 800 ml/min. At 7:34 AM the BFR was lowered to 300 ml/min with the DFR remaining at 800 ml/min for the remainder of the dialysis treatment (11:02 AM). b. On 07/25/25 the dialysis treatment started at 7:11 AM with the BFR at 260 ml/min and the DFR at 800 ml/min. At 8:03 AM the BFR increased to 350 ml/min and the DRF was changed to 700 ml/min. At 10:16 the BFR was set at the prescribed BFR (400 ml/min) and the DFR at 800 ml/min and at 10:31 was changed to 350 ml/min with a DFR to 700 ml/min until the end of treatment at 10:59 AM. c. On 07/28/25 the dialysis treatment started at 7:09 AM with a BFR at 350 ml/min and a DFR at 800 ml/min and was run at this rate for the entire dialysis treatment that ended at 10:56 AM. d. On 07/30/25 the dialysis treatment started at 7:12 AM with a BFR at 350 ml/min and a DFR at 800 ml/min and was run at this rate for the entire dialysis treatment that ended at 11:01 AM. e. On 08/04/25 the dialysis treatment started at 7:17 AM with the BFR at 300 ml/min and the DFR at 600 ml/min. At 8:01 AM the BFR was changed to 400 ml/min and the DFR at 800 ml/min. At 9:02 AM the BFR was changed to 375 ml/min and the DFR remained at 800 ml/min and remained at this rate until the end of the dialysis treatment 11:05 AM. There was no rationale documentation for the change to the prescribed BFR or why the DFR was manually changed and not entered as an Autoflow 2.0. Review of the facility’s policy titled, “Auto Flow Dialysate,” dated 04/05/21, revealed “Depending on the auto flow rate selected the dialysate flow rate will be either 1.5 or 2.0 times the blood flow rate. The dialysate flow (DFR) rate will change when the user changes the blood flow rate (BFR). 3. Review of P5’s electronic medical record (EMR) “Treatment Sheet For Facility: Northeast Wisconsin\Neenah”, revealed a prescribed BFR 450 ml/min and the DFR was 700 ml/min. Review of two of six nonconsecutive treatments titled “Treatment Sheet for Facility: Northeast Wisconsin\Neenah” 07/09/25 to 08/02/25 revealed the following: On 07/09/25 the dialysis treatment started at 11:51 AM with a BFR of 400 ml/min and at 400 ml/min until the end of treatment 3:54 PM. On 07/11/25 the dialysis treatment started at 12:04 PM with the DFR set to run at 800 ml/min, remained at 800 ml/min until 2:00 PM. There was no rationale documentation for the change to the prescribed DFR. On 08/06/25 at 2:30 PM during an interview with the Facility Administrator 1 and the Director of Operations (DOO) 14 confirmed the above prescription was not run and prescribed the documentation did not include a special order or justification for the change to the physician’s prescribed dialysis treatment. Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated 05/01/23 revealed, “Check machine settings and measurements: 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. Document any findings and interventions in the medical record.””