Fmc - Ripon South

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure that for one of two patient (Patient (P) 6) arteriovenous fistula (AVF) and an arteriovenous graft (AVG) discontinuation that staff reminded patients to perform hand hygiene or offer hand sanitizer after holding their access site to achieve hemostasis (stop the bleeding). The failure to have patients perform hand hygiene after holding their access site to stop the bleeding could potentially lead to cross contamination. Findings include: During an observation of dialysis discontinuation on 06/23/25 at 9:55 AM P6 held both the top and bottom needled insertion site to help stop the bleeding with pressure dressing during the discontinuation of dialysis. After hemostasis was achieved and Certified Clinical Hemodialysis Technician (CCHT) 11 placed on new cleaning dressing, Registered Nurse (RN) 9 was there to assess patients blood pressure (BP). Once P6’s BP was under control RN9 discharged P6 without a reminder to perform hand hygiene of offering P6 hand sanitizer. P6 left the dialysis unit without performing hand hygiene. During an interview of 06/23/25 at 10:30 AM RN9 confirmed that patients should be reminded to perform hand hygiene after holding the dialysis access site to stop the bleeding. Review of the facility policy titled “Hand Hygiene” dated 11/06/23 revealed that the policy referred to “All staff, patients, patient caregivers, including physicians and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. ...Hands will be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ...Entering and leaving the treatment area. ... Immediately after removing gloves ... Patients should perform hand hygiene if able, prior to and after each dialysis treatment. ... As needed, direct patient care staff will demonstrate how to operate the sinks, demonstrate hand washing to patients who are able to perform hand washing, and explain risk of contamination with regard to their vascular access and hands to all patients.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure that it had clearly marked a dedicated clean storage area for two of two observation days (06/23/25 and 06/25/25) during this three-day survey. The failure to clearly define and mark clean areas has the potential for cross contamination to occur. Findings include: During an observation on 06/23/25 from 9:30 AM to 12:00 PM, 06/23/25 from 1:30 PM to 3:00 PM and 06/25/25 from 9:30 AM to 10:45 AM and on 06/25/25 from 1:30 PM to 2:00 PM the door to a room labeled “Clean Utility” was propped open. Inside the room were additional clean and sterile dialysis supplies, some still in their original shipping boxes (fistula and graft needles), and other clean supplies sitting on the shelves (alcohol pads, gauze pads, hand sanitizer). On 06/25/25 at 9:47 AM Certified Hemodialysis Technician (CCHT) 10 was observed entering the room labeled “Clean Utility” to obtain dialysis supplies wearing his/her dialysis treatment gown and eye/face shield. On 06/23/25 at 10:47 AM CCHT 11 was observed to enter the room labeled “Clean Utility” to obtain dialysis supplies wearing his/her dialysis treatment gown and eye/face shield. After sharing the above observations, during an interview on 06/24/25 at 3:00 PM Clinic Manager (CM) 3 confirmed that the room labeled “Clean Utility” was a clean storage room and the door was propped open so staff could access dialysis supplies. CM3 confirmed that the staff do have roller carts, drawers, metal racks, and cabinets on the floor containing dialysis supplies. CM3 confirmed that the door to the clean supply room that contained the dialysis clean and sterile supplies stayed propped open all the time during treatment, on non-dialysis treatment days and after clinic hours. CM3 confirmed that gowns and shields worn by staff are considered dirty and should not be worn when entering the clean storage room. During an interview on 06/25/25 at 9:50 AM CCHT10 confirmed that he/she was not aware that dialysis staff could not enter the “clean and sterile storage supply room with their treatment floor PPE (personal protective equipment) on. During an interview and observation occurring concurrently on 06/25/25 at 10:00 AM the Facility Administrator 4 walked through the two facilities storage areas and stated that the storage in the back by the biomedical and water treatment area was their clean storage. The large racks contained shipping boxes of bulk supplies for the facility (example: sealed boxes of dialyzer, boxes of bicarbonate bags, and hand sanitizer). When the large racks of shipping boxes of bulk supplies were pointed out, Facility Administrator 4 stated, yes, this would be the facility’s “bulk storage.” Walking back to dialysis treatment floor and the room labeled “Clean Utility”, the Facility Administrator 4 stated the room is not labeled correctly and the door should not be propped open. The Facility Administrator 4 also confirmed that the shipping boxes to hold supplies like the fistula and graft needles, should not be in the clean storage room. The Facility Administrator 4 confirmed that staff should not enter the clean supply room with the treatment PPE on.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 22198 Based on observations, interviews, review of the Centers for Disease Control and Prevention (CDC) protocol, and policies reviewed, the facility failed to ensure that central venous catheter (CVC-a thin, flexible tube inserted into a large vein, near the heart, to provide reliable access for administering dialysis) policies and procedures were followed for two of six CVC observations. The failure to disinfect the CVC hub has the potential to increase the risk of Catheter-related Bloodstream Infections (CRBSIs). Findings include: During an observation of CVC initiation of dialysis treatment for P1 on 06/23/25 at 10:47 AM the Patient Care Technician (PCT) 12 tossed the alcohol pad used to scrub one leg of the CVC port onto the clean supplies on the chair side table that had the supplies to initiate dialysis for P1 including sterile syringes and additional alcohol pads. PCT 12 then took an alcohol pad from below the used red tinged alcohol pad and cleaned the other leg/port tossed that on the chair table on top of the sterile syringes before testing the CVC legs for patency with the sterile syringes. Directly under the chairside table during the dialysis initiation was a lined waste bin for garbage. During an interview on 06/23/25 at 10:55 AM PCT12 confirmed he/she was not aware he/she should not do that. During an observation on 06/23/25 at 2:35 PM Certified Clinical Hemodialysis Technician (CCHT) 11 was removing P1 from dialysis treatment and after cleaning one leg of the CVC placed the red tinged alcohol pad on the tray table, injected heparin into the port and left the syringe attached. CCHT11 picked up the red tinged alcohol pad from the chairside table and cleaned the second leg of the CVC and injected heparin removing. CCHT11 then reused the same alcohol pad to scrub the hub of one leg of the CVC then capped the port to close the connect, then wiped the second leg of the CVC with the same syringe and capped the second leg. During an interview on06/23/25 at 10:55 AM, CCHT11 stated he/she thought it was an acceptable practice to reuse the alcohol pad if it was flipped over. During a review of Quality Assurance and Performance Improvement (QAPI) it was revealed that for the past 12 months the facility has had no blood stream infection (BSI). During an interview on 06/24/25 at 2:41 PM with the Clinical Manager (CM) 3 after reviewing the QAPI data on BSI’s and the observation from 06/23/25 of CVC initiation and discontinuation stated the staff have been educated and audited on CVC care, initiation and discontinuation and know it is not acceptable to reuse alcohol pads or use the chair side table as the garage for used supplies, that is why we have the garbage bins chairside. CM3 stated, “I think they were just nervous.” Review of the facility’s policy titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” dated 05/05/25 revealed, “Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heparin Administration ... Using a sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) scrub the sides (threads) and end of the hub thoroughly with friction, making sure any to remove residue (e.g., blood) ... Using the same sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. (Steps 3 and 4 should take 10-15 seconds.) ... Repeat steps 9 and l0 for the venous catheter limb. Review of the facility’s policy titled, “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer” dated 11/04/24 revealed “Follow the steps below to disinfect the catheter and to disconnect the patient from the extracorporeal system: Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other appropriate antiseptic product such as chlorhexidine or povidone if required by the hospital) for 10-15 seconds any time caps are removed, or bloodlines are disconnected (i.e. End of treatment or treatment interruption) to reduce risk of contamination. ... Using a sterile alcohol pad, (or other appropriate antiseptic product such as chlorhexidine or povidone if required by the hospital) scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood). Repeat steps 5 through 8 for the venous end of the catheter limb.” Review of the Centers for Disease Control and Prevention (CDC) protocol for CVC care found at https://www.cdc.gov/dialysis-safety/media/pdfs/Hemodialysis-Central-Venous-Catheter-STH-Protocol-P.pdf not dated used for “National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. Am J Kidney Dis 2006; 48 (suppl 1):S1-S322, and the O’Grady NP, Alexander M, Burns LM, et al. Guideline for the prevention of intravascular catheter-related infections. Clin Infect Dis 2011; 52:e162-e193” for two of their three references quoted in the recommended protocol titled “Hemodialysis Central Venous Catheter Scrub-the-Hub Protocol”, that revealed “This protocol outlines a suggested approach to preparing catheter hubs prior to accessing the catheter for hemodialysis. It is based on evidence where available and incorporates theoretical rationale when published evidence is unavailable. .... Connection Steps Disinfect the hub with caps removed using an appropriate antiseptic. a. (Optional) Prior to cap removal, disinfect the caps and the part of the hub that is accessible and discard the antiseptic pad (i.e., use a separate antiseptic pad for the next step). b. Remove the caps and disinfect the hub with a new antiseptic pad for each hub. Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood). c. Using the same antiseptic pad, apply antiseptic with friction to the catheter, moving from the hub at least several centimeters towards the body. Hold the limb while allowing the antiseptic to dry. d. Use a separate antiseptic pad for each hub/catheter limb. Leave hubs “open” (i.e., uncapped and disconnected) for the shortest time possible. ... 4. Always handle the catheter hubs aseptically. Once disinfected, do not allow the catheter hubs to touch nonsterile surfaces. ... 6. Repeat for other limb (this might occur in parallel). ... Disconnection Steps: ... Use a separate antiseptic pad for each hub. Leave hubs “open” (i.e., uncapped and disconnected) for the shortest time possible. 4. Always handle the catheter hubs aseptically. Once disinfected, do not allow the catheter hubs to touch nonsterile surfaces. Hold the catheter until the antiseptic has dried.””

“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, interviews, and policy review, the facility failed to ensure all elements of the dialysis water system were secure from unauthorized personnel for two of two dialysis treatment days (06/23/25 and 06/25/25) of this three-day survey. The failure to ensure that the acid mixing, testing, places all 19 dialysis patients at risk should the Acid mixing system be entered and contaminated by an unauthorized user. Findings include: During an observation of the water treatment system on 06/23/25 at 1:48 PM Certified Clinical Hemodialysis Technician (CCHT) 10 left the treatment floor and walked in the area where biomedical had their office, their bulk storage. This space also included the facility’s Acid Mixing, testing and storage tanks located in an alcove of the room but was not secured to prevent unauthorized users from entering that portion of the water system. During a walk through the Area Technical Operation Manager (ATOM) 7 on 06/25/25 at 2:00 PM, ATOM7 confirmed that the Acid mixer, testing equipment, and the two bulk storage tanks were not secure. Review of the door from the treatment floor that led directly into this area did not have a keypad lock securing it from unauthorized access. The door did have a key lock but that was not safe if the staff needed emergency access to the area. ATOM 7 confirmed that there was no door or security system currently in place to prevent delivery staff and dialysis visitors or patients from the ACID mixing, testing or bulk storage. Review of the facility’s policy titled, “Physical Security and Facility Access,” dated 09/05/23 revealed, “ 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. ...””

“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 staff were following the MFR DFU for testing of Acid from the mixing tank for one of one (Acid Mixing System). The failure to follow the MFR DPU and facility policy places all 19 in-center dialysis patients at risk for delayed treatments. Findings include: During an observation on 06/23/25 at 1:48 PM Certified Hemodialysis Technician (CCHT) 10 was demonstrating the ACID mixing, testing, and transferring to bulk storage tanks. During the demonstration, CCHT10 pointed to the hydrometer cylinder and in a swooping motion used his/her hand over the mixing tank’s removable cover in a downward fashion to show how the ACID mixture would be tested. During an interview concurrently with the observation and demonstration of the Acid mixing, testing and transferring on 06/23/25 at 1:48 PM, CCHT10 confirmed that he/she takes the hydrometer and dips it into the mixing tank, and again performed the downward swooping motion over the mixing tank removable cover to show how the first ACID mixture test would be performed and were the sample would be taken from. CCHT10 confirmed that the first Acid test would be taken out of the Acid missing tank. When asked if there was a spigot on the ACID mixer to remove the mixed Acid solution for testing, CCHT10 stated “no” and again stated they dip the hydrometer into the mixed ACID solution by removing the top cover and putting the hydrometer into the mixer to retrieve the first ACID testing solution. During an interview on 06/23/25 at 3:13 PM Biomedical Technician II (BMT II) 6, and two Area Technical Operations Managers (ATOM) (ATOM 7 and ATOM-Northern Region 8) all confirmed that dipping the hydrometer cylinder into the tank was not acceptable and “the policy also states that.” BMT II 6 stated that all staff that perform ACID mixing were recently trained on how to perform the Acid testing and the spigot that was added so that staff could perform the task without dipping the hydrometer cylinder into the mixing tank to follow the MFR DFU. A tour and second observation of the Acid mixing, testing, transferring and bulk storage was conducted with BMTII6, ATOM7, and ATOM8 on 06/23/25 at 4:11 PM, and BMTII6 pointed out the newly added PVC cylindrical bucket over the drain that also contained a spigot coming off the ACID mixer. During an interview on 06/23/25 at 4:11 PM concurrent with the observation, BMT II 6 pointing at the spigot stated, that is where the first sample from the Acid mixer is to be taken from. BMT II 6 pointed to the cylindrical PVC (polyvinyl chloride) bucket with the direction posted and stated, “I even added the directions for testing and disposing of the Acid right on it.” Review of the facility’s policy titled “Acid Concentrate Mixing and Handling: Acid Dissolution Unit” dated 09/05/23 revealed Prior to being allowed to operate the DADU the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include one or more of the following areas: ... Performing specific gravity tests ...” During an interview 06/23/25 at 4:30 PM BMT II 6 and ATOM7 confirmed the policy did not include the MFR DFU that prohibits dipping the hydrometer directly into the ACID mixer to obtain a sample. The MFR DFU was requested at this time. BMT II 6 confirmed that after the new system was put in and the staff were trained, he/she did not perform any audits after the training to ensure staff perform the testing correctly with the new system. Review of the training for CCHT 10 confirmed that on 01/31/35 CCHT 10 had been trained and performed a return demonstration on the “Dry Acid Dissolution System” that included testing of ACID and signed off by BMT II 6. Review of the DMFR 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.””

“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 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 two treatment days (06/23/25 and 06/25/25). Failure to follow the manufacturer’s DFU had the potential to negatively impact the safety and wellbeing of the 19 patients receiving in-center hemodialysis treatments at this facility. Findings include: 1. Observations on 06/23/25 between 9:30 AM and 11:00 AM revealed at dialysis Stations 2, 4, 6, 7, and 8 the arterial chambers were less than one half full however they failed to adjust the arterial drip chamber to the manufacturer’s DFU of 85-95%. At Station 2 the Venous chamber was filled and the blood was backing up filling half the line before reaching the machine and filter. During an interview on 06/23/25 at 945 AM when asked if he/she was performing safety checks on the arterial and venous chambers to ensure they were filled correctly as a part of their 30/45-minute dialysis assessment and safety checks, Patient Care Technician (PCT) 12 stated “I don’t know.” During an interview on 06/23/25 at 10:15 AM pointing out Stations 2, 4, 6, 7, and 8 arterial chambers and the at Station 2 the venous chamber backing up into the line to the machine, Certified Clinical Hemodialysis Technician (CCHT) 11 confirmed dialysis staff should be checking as a part of their 30/45-minute assessment and safety checks. During an observation on 06/23/25 from 12:42 PM to 2:55 PM the arterial chambers at Stations 3, 4, and 8 were half or less than one half full, not the manufacturer’s DFU of 85-95% for arterial chambers. These findings were confirmed during an interview with CCHT 11 on 06/23/25 at 1:30 PM. 2. During an observation on 06/25/25 between 9:30 AM and 10:45 AM the atrial chambers at Station 10 was half full, not the manufacturer’s DFU of 85-95% for arterial chambers. This finding was confirmed by CCHT 10 on 06/25/25 at 10:00 AM who stated, “the arterial chamber should be to the fill line” (pointing to the line on the arterial chamber). Review of the facility’s policy titled “Patient Monitoring and Safety Checks During Hemodialysis Treatment” dated 09/05/23 revealed, “Monitor and document Safety Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the FKC [Fresenius Kidney Care] Treatment Record. ... Monitor pressure changes in arterial & venous chambers to ensure adequate blood flow. Confirm the arterial and venous chambers are filled to level line and pigtails are clamped.” Review of the manufacturer’s DFU for the “Combi Set SmartTech” not dated but identified as “Rev A” revealed, under the title ‘WARNINGS’ “Always monitor the venous chamber with a level detector. Lack of detection may allow air to enter the Blood Tubing Set resulting in patient injury or death. ... ‘FEATURES’ The bloodline contains interfaces to the hemodialysis machine safety mechanism to ensure proper operation. These include monitor lines for the monitoring of the arterial and venous pressures, as well as a venous chamber for the detection of air in the blood path. ‘PRIMING PRECAUTIONS” Prime arterial chamber approximately 90% full and venous chamber to approximately 70% full. ... 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. Air leaks will also cause the chamber levels to fluctuate. Monitor arterial and venous pressures. Pressure readings which are clinically inappropriate for treatment must be addressed immediately and may indicate a clamped, loose, kinked or disconnected monitor line or wet Transducer Protector (TP). ... Maintain a proper fluid level in chambers to ensure that no air is returned to the patient.””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 22198 Based on observation, interview, record review, and review of the facility’s policies, the facility failed to ensure that blood pressures (BP) were documented per policy for two of five current inpatients (Patient P)1 and P2) records reviewed to ensure the management and treatment of BP concerns were addressed out of a total of six records reviewed. The failure to ensure blood pressures were taken and recorded in the time frame set by the facility had the potential to cause a delay in the treatment of hypertension or hypotension for all 19 in center dialysis patients during dialysis treatment. Findings include: 1. Review P1’s dialysis treatment sheets titled, “Treatment Sheet For Facility: Ripon South” from 06/11/25 to 06/23/25 revealed that for three of the six treatment BPs were not documented every 30 to 45 minutes as follows: a. On 06/11/25 P1’s BP was within normal limits (WNL) at 11:04 AM and not retaken again until 12:06 PM (one hour and two minutes). At 1:30 PM BP was taken at 1:30 PM and was low 94/68 millimeters of mercury (mm/Hg) and not retaken until 2:24 PM (54 minutes) and remained low at 90/72 mm/Hg. There was documentation that the Registered Nurse (RN) was notified of the low BPs at 1:30 PM and 2:24 PM. b. On 06/13/25 P1’s BP was WNL at 2:02 PM. However, the BP was not retaken until 2:58 PM (56 minutes). c. On 06/16/25 P1’s BP was elevated 168/106 mm/Hg at 12:32 PM but not retaken until 1:22 PM (50 minutes) and the BP was recorded as 163/127 mm/Hg (remained elevated). No BP was taken between 1:22 PM and 3:04 PM (one hour and 42 minutes later). 2. Review of P2’s dialysis treatment sheets titled, “Treatment Sheet For Facility: Ripon South” from 06/11/25 to 06/23/25 revealed that for two of the six treatment BPs were not documented every 30 to 45 minutes as follows: a. On 06/13/25 BP was taken at 7:34 AM and was 105/56 mm/Hg (low) and not retaken 8:34 AM (one hour) and was lower at 107/47 mm/Hg. There was no documentation that the RN was notified. The RN assessment was documented at 9:37 AM (2 hours and three minutes after the first low BP). b. On 06/20/25 BP was taken at 9:05 AM and was 88/50 mm/Hg (low) and no BP was recorded through the end of the treatment. The treatment ended at 10:55 AM with no documentation that BPs were monitored for the one hour and 50-minute period. During an interview on 06/24/25 at 1:55 PM the Clinical Manager (CM) 3 confirmed the above findings did not follow the facility policy. CM 3 confirmed there was no additional documentation. Review of the facility policy titled “Patient Assessment and Monitoring” dated 05/01/23 revealed “Direct patient care staff may collect data such ass weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. ... The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. ... Record blood pressure. During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed: Review data collected above. Determine if any clinical interventions are necessary. ... During Treatment Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. ... Follow the steps below for monitoring patient and machine parameters during treatment: Record blood pressure. Recheck blood pressures after a drop that requires interventions such as administering normal saline. Reposition electronic cuff or use a manual cuff for aberrant, blood pressure readings. Report to the nurse: Systolic (top number) blood pressures greater than 180 mm/Hg Diastolic (bottom number) blood pressure greater than 100 mm/Hg. Blood Pressure less than or equal to 100 mm/Hg systolic”

“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 five current incenter dialysis patients (Patient(P)1, P3, and P5) reviewed out of a total of six records reviewed. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 19 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s electronic medical record (EMR) “Treatment Sheet For Facility: Ripon South”, 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 one of the six “Treatment Sheet for Facility: Ripon South” 06/11/25 to 06/23/25 revealed the following: a. On 06/13/25, the dialysis treatment started at 10:40 AM. The dialysis treatment BFR was set at 300 ml/min and runs the entire treatment until 2:58 PM at 300 ml/min. There was no rationale documentation for the change to the prescribed BFR. 2. Review of P3’s EMR “Treatment Sheet For Facility: Ripon South”, revealed a prescribed BFR 400 ml/min and the DFR was 700 ml/min. Review of one of the six “Treatment Sheet for Facility: Ripon South” 06/11/25 to 06/23/25 revealed the following: a. On 06/18/25, the dialysis treatment started at 6:24 AM. The dialysis treatment DFR was set at 800 ml/min and runs the entire the hour and 30-minute treatment at 800 ml/min. There was no rationale documented for the change to the prescribed DFR. During an interview on 06/24/25 at 1:55 PM the Clinical Manager (CM) 3 confirmed the above findings and that there was no additional documentation to explain why P1 and P3’s prescriptions were not followed or that the physician was notified. 3. Review of P5’s EMR “Treatment Sheet for Facility: Ripon South”, revealed a prescribed BFR 350 ml/min and the DFR 1.5 Autoflow. Review of two of the six “Treatment Sheet for Facility: Ripon South” 06/11/25 to 06/23/25 revealed the following: a. On 06/13/25, the dialysis treatment started at 8:37 AM and for the entire three-hour and 30-minute dialysis treatment the DFR was programed at 800 ml/min. b. On 06/20/25, the dialysis treatment started at 9:45 AM and for the entire three-hour and 30-minute dialysis treatment the DFR was programed at 700 ml/min. There was no rational documentation for why the staff had not entered the 1.5 Autoflow rate for P5. During an interview on 06/25/25 at 1:50 PM the Clinic Manager 4 provided the Dialysis Autoflow policy and confirmed that P5’s dialysis prescription must have been entered as a manual run for the above rates. Clinic Manager 4 indicated that if the machine is set at an “Autoflow” rate the machine will run between the set parameters and provided an example “for a 350 BFR with an Autoflow of 1.5 the parameters on the dialysis machine would keep the DFR between 500 and 600 and pointed to the policy. Clinic Manager 4 stated that Clinic Manager 4 confirmed that for the two days identified above the dialysis machine had not been programmed correctly as a 1.5 Autoflow because the machine DFR would have stayed between 500 and 600 ml/min. Clinic Manager 4 stated that most likely the two treatments were probably programed manually to run the DFR at either 700 or 800 ml/min. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations. ... Check machine settings and measurements: Check prescribed blood flow is being achieved (sic) or reason is documented in the medical record if unable to meet the prescribed blood flow rate. Check dialysate flow rate setting is correct, and the prescribed flow rate is being delivered.” 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 rate will change when the user changes the blood flow rate. The following chart details the approximate transition point where the dialysate flow will change.” The flow chart defined a blood flow rate entered in between “316 and 416 at a 1.5 autoflow” “Option selection for Minimum Dialysate Flow 500 Dialysate Flow Rate 600. To select autoflow touch the dialysate flow indicator pad on the HOME screen and scroll up past 800 until either the A1.5 or the A2.0 is visible. Press confirm.””