Fkc Liberty Dialysis Chippewa

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 31759 Based on review of facility policy and procedure, observation, and staff interviews, the facility failed to adhere to infection control precautions specifically designed to prevent transmission of bloodborne pathogens between patients and staff (V111, V115, V116, V117, &V142); and failed adhere to procedures for medication vial asepsis (V143). This condition was not met as evidenced by the above non-compliance but did not result in immediate jeopardy. Findings include: Facility failed to provide a sanitary environment to minimize the transmission of infectious agents within and between the unit and other public areas when patients stored personal belongings directly on the treatment floor. Cross reference V111 for additional information. Facility failed to ensure staff wore a gown and mask during intravenous medication administration. Cross reference V115 for additional information. Facility failed to ensure an item taken to the dialysis station was disinfected before being returned to a common clean area. Cross reference V116 for additional information. Facility failed to ensure clean items and supplies were clearly separated from areas designated as contaminated. Cross reference V117 for additional information. Facility failed to monitor and implement infection control policies and activities to ensure staff disinfected equipment appropriately. Cross reference V142 for additional information. Facility failed to ensure staff timed, dated, and initialed multi-dose vials after opening. Cross reference V143 for additional information.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, and staff (EMP) interviews, the facility failed to provide a sanitary environment to minimize the transmission of infectious agents within and between the unit and other public areas. Specifically, the facility permitted patients to store belongings (coats and bags taken to and from dialysis, private residences, and public transportation) directly on the treatment floor for eight (8) of 13 patients who brought personal belongings to the dialysis treatment station (ST4, ST6, ST7, ST9, ST13, ST14, ST16, and ST23). Findings include: Review of “Infection Control Overview” policy on October 29, 2024, at 8 a.m. showed, “The purpose of this policy is to provide an overview of the bloodborne pathogen/infection control requirements that each Fresenius Kidney Care (FKC) facility shall meet. ... The nature of dialysis, with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients, makes a dialysis clinic a high risk for spreading infectious disease. The Centers for Disease Control (CDC) has recommended specific infection control practices for dialysis centers that have been shown to reduce and prevent the spread of infectious disease.” Review of “Cleaning and Disinfecting the Dialysis Station”on October 29, 2024, at 2 p.m. showed, “The dialysis station could become contaminated with blood and other body fluids during treatment. ... Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. ... Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease.” Observations on the treatment floor on October 23, 2024, at 1:10 p.m. revealed 14 patients had brought bags/totes containing personal items with them to the dialysis station. The patients used these bags/totes to transport their belongings to and from their homes to the facility. Eight (8) of these 14 patients stored their items directly on the facility’s treatment floor. For instance, patients at stations 4, 6, 7, 9, 13, 14, and 16 stored their bags/totes on the floor; and a patient at station 23 had placed his coat directly on the floor next to his dialysis chair with his shoes placed on top of his coat. Interviews with EMP7 (administrator) and EMP6 (acting clinic manager) confirmed findings and noted patients should not store their belongings on the floor of the treatment area.”

“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: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure staff wore a gown and mask during intravenous (IV) medication administration for one (1) of one (1) IV medication administration observation. Findings include: Review of facility policy on October 25, 2024, at 10:30 a.m. showed, “Medication Preparation and Administration Procedure ... To provide direction for safely, ... and aseptically administering medications ... Medication Administration Procedure ... Follow the steps in the table below to prepare for administration of medication. ... PPE: Gloves, gown, safety glasses and, a mask or full-face shield for IV medication administration into extracorporeal circuit or peripheral site.” Observation of medication administration on October 25, 2024, at 9:32 a.m. revealed EMP8 draw up an IV medication in a clean area. EMP8 then walked to station 10 and administered the medication to the patient through the patient’s extracorporeal circuit. EMP8 wore safety glasses but no mask or gown. Interview with EMP8 after the observation at approximately 9:40 a.m. confirmed findings.”

“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: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure an item (clinic’s portable landline phone) was disinfected before being returned to a common clean area for one (1) of one (1) observation of medication administration. Findings include: Review of facility policy on October 25, 2024, at 11:40 a.m. showed, “Dialysis Precautions ... Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where this [sic] is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored.” Observation of medication administration on October 25, 2024, at 9:32 a.m. revealed EMP8 draw up an IV medication in a clean area while wearing the facility’s portable landline phone clipped to his/her left scrub pants pocket. EMP8 then walked to station 10 wearing the phone and administered a medication to the patient through the patient’s extracorporeal circuit. EMP8 returned to the same clean area while still wearing the phone, but he/she did not disinfect the phone. EMP8 confirmed findings after the observation at approximately 9:40 a.m. He/she noted he/she wears the phone in the clinic in case front-office personnel are not available to answer incoming calls. Further observation on the treatment floor on October 25, 2024, at approximately 12:30 p.m. revealed the same phone EMP8 had been wearing was now resting on the counter at the nurses’ station (clean area).”

“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: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure clean items and supplies were clearly separated from areas designated as contaminated for three (3) of three (3) biohazard bins containing regulated waste. Findings include: Review of policy on October 25, 2024, at 11:40 a.m. showed, “Dialysis Precautions ... The components of dialysis precautions are described below and apply during care of all dialysis patients at all times or while performing related activities to prevent disease transmission from exposure to the following: 1. Blood 2. Body fluids with visible blood ... Clean area: an area designated for the clean and unused equipment, supplies and medications. Dirty area: an area where this [sic] is a potential for contamination with blood or body fluids and where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. ... Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples area handled and stored.” Observation on the treatment floor revealed three (3) red biohazard bins designated for the storage of regulated waste. Each bin was stored up against a half wall. The half wall was topped with molding or counter-top like surface that acted as a shelf where items could be placed/stored. The top molding shelf where each bin was located was only 16 inches above the bins and had a sign that read, “BIO-HAZARDS BELOW.” Two (2) of the three (3) locations had unused patient-care supplies stored on the molding shelf directly above the biohazard bins to include unused (designated clean) blood lines, bags of saline (medication), cannulation sets, hemostats, gauze dressings, tape, and clamps (supplies necessary to initiate dialysis). One (1) of these two (2) locations had the lid partially opened and the “BIO-HAZARDS BELOW” sign located above it, and portions of the wall, had several small red spots on them of an unknown substance. One location had five (5) small jugs of disinfectant (used to disinfect the machines once patients are off dialysis) and a face shield (staff personal protective equipment). Interviews with EMP6 (acting clinic manager) and EMP13 (nurse educator) on October 25, 2024, at 10:07 a.m. confirmed findings. Once alerted, staff promptly removed the patient care supplies that were located above biohazard bins.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to monitor and implement infection control policies and activities to ensure staff disinfected equipment appropriately for one (1) of one (1) registered nurse observed assessing patients entering and exiting the facility before and after treatment (EMP1). Findings include: Review of facility policy on October 25, 2024, at 10:45 a.m. showed, “General Cleanliness and Infection Control Guidelines ... Noncritical medical equipment, which includes equipment that touches only intact skin (e.g., stethoscope, blood pressure cuffs) surfaces shall be cleaned with a low-level disinfectant.” Observation of EMP1 on October 23, 2024, at 11 a.m. was conducted by the patient scale and nurses’ station. Patients would enter and exit the facility near the nurses’ station and patient scale area. Prior to patients going to their stations or leaving the facility once treatment was completed, EMP1 would use a stethoscope on the patient for assessment. Once EMP1 was finished with his/her assessment, he/she would squirt hand sanitizer onto his/her hands while simultaneously wiping the stethoscope with his/her now wet hands. This was observed for three (3) patients leaving the facility (treatment completed) and five (5) patients entering the facility. During an interview with EMP1 on October 23, 2024, at 11:36 a.m. he/she noted that he/she was disinfecting the stethoscope with the hand sanitizer that was on his/her hands. When asked if it was necessary to disinfect the stethoscope in this manner, he/she said, “Should absolutely disinfect between patients. You never know what someone has on their clothes.” After the interview with EMP1, the bottle of hand sanitizer that he/she used was reviewed, “ANIOSGEL 85 NPC ... Purpose Antiseptic Hand Rub ... Uses ... A hand rub to decrease bacteria on the skin. ... Directions ... Apply product onto hands, spread thoroughly and rub until dry.” There was no mention on the bottle concerning using it on hands to disinfect equipment. Interview with EMP7 (administrator) on October 24, 2024, at approximately 1 p.m. confirmed EMP1 should have used a low-level disinfectant on the stethoscope.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure staff timed, dated, and initialed multi-dose vials after opening for one (1) of one (1) medication preparation observation involving a multi-dose medication vial. Findings included: Review of facility policy on October 25, 2024, at 12 p.m., “Medication Preparation and Administration ... Labeling Vials ... When preparing medications if not used immediately in its entirety, the nurse or PCT ..., must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Label any open multi-dose vial that is not used immediately and store vial accordingly. ... Any open multi dose vial must be discarded 28 days after opening or per manufacturer’s expiration date.” Observation of medication preparation was conducted on October 25, 2024, at 12:46 p.m. with EMP12 (patient care technician). EMP12 removed a vial of Heparin (medication) from a drawer and drew some of it up into a syringe but the vial was not timed, dated, or initialed. EMP12 was asked if he/she knew when the vial was opened and he/she remarked it was probably opened sometime between 9:50 a.m. and 10 a.m. EMP11 then approached the medication preparation area and noted that he/she opened the vial 15 minutes ago. EMP12 and EMP6 (acting clinic manager) where shown the vial of Heparin on October 25, 2025, at 1 p.m. confirmed above findings.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 31759 Based on review of facility documentation, and staff (EMP) interview, the facility failed to ensure the training for operators of water/dialysate system equipment included actual observation of the work performed for nine (9) of nine (9) direct patient care staff (EMP1, EMP2, EMP4, EMP5, & EMP8-EMP12). Findings include: During interview with EMP13 on October 25, 2024, at 10:40 a.m. he/she noted that the facility has no policy to ensure this standard is met but provided an outline of a “Workbook” document. Review of this document showed, “About this Workbook ... The water training and Skills validation workbook has been developed to document training and skills validation for water room tasks. The water room is defined as any location where water is being processed to meet FKC water safety standards [conductivity of final dialysate]. Direct Patient Care (DPC) staff performing any tasks related to equipment used in the water treatment process will be called a Water Room Expert ... Section 2 - Training records: Contains forms to document training for each individual task. The ‘DPC Water Room Expert’ will print all applicable training records to be used during training and return demonstration by the employee.” Review of “DPC Water Room Skills Validation” on October 25, 2024, at 10:40 a.m. showed it contained the previous process for conductivity testing “pHoenix Meter ... Use ... Calibration,” which required direct observation of work performed to validate the staff member. The facility implemented a new process for conductivity testing of dialysate on September 29, 2023. Review of spread sheet provided by EMP13 (nurse educator), on October 29, 2024, at 8 a.m., showed staff who completed BlueStar LMS module. EMP1, registered nurse (RN), was transferred on 9/30/2024, and completed LMS module on 3/8/2024 (at another facility). EMP2 patient care technician (PCT) was hired on 7/23/2013 and completed LMS module on 7/12/2023. EMP4, RN, was borrowed during the survey, and completed LMS module on 10/12/2023. EMP5, RN, was hired on 12/23/2012 and completed LMS module on 3/7/2024. EMP8, RN, was hired on 8/5/2024 and completed LMS module on 12/15/2023 (at another facility). EMP9, PCT, was hired on 4/1/2024 and completed LMS module on 5/2/2024. EMP10, PCT, was hired on 4/28/2024 and completed LMS module on 6/28/2024. EMP11, PCT, was hired on 4/28/2024 and completed LMS module on 7/16/2024. EMP12, PCT, was hired on 4/23/2018 and completed LMS module on 6/13/2023. Review of course description for above completed module, “LMS Educational Program/Course Approval Request” on October 25, at approximately 10 a.m. showed, “Purpose Train DPC staff on 2088T [sic] BlueStar Hemodialysis Machine ... Short Description ... Course will identify special features of the BlueStar machine and introduce staff to the procedures for using the machine. ... How many components ... are there? ... Screen changes ... Auto Start ... Auto Prime ... Assisted Reinfusion ... Alarms ... Upon Completion of the course the learner will be able to: Identify special features of the 2008T BlueStar Hemodialysis Machine ... Utilize auto start and auto prime features ... Attach bloodlines ... Complete machine testing and recirculation process ... State the testing procedures for independent conductivity testing and pH levels [EMPHASIS] ... Discontinue treatment using assisted reinfusion with blood return accuracy.” During an interview with EMP13 on October 25, 2024, at 10:40 a.m., he/she confirmed that facility employees who operate the BlueStar Hemodialysis Machines for the new conductivity testing procedure had not been signed off by direct observation of the actual work performed (skills validation) concerning the new conductivity testing method as outlined in the LMS module. There was no skills validation checklist for above mentioned employees.”

“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: 31759 Based on review of policy, manufacturer’s directions for use, observation, and staff (EMP) interview, the facility failed to ensure the chlorine test was conducted in accordance with the manufacturer’s direction for use for one (1) of one (1) employee observed (EMP8); and failed to ensure conductivity safety checks and machine parameters were documented and verified as in range prior to treatment for five (5) of five (5) active in-center hemodialysis clinical records reviewed (CR1, CR2, & CR4-CR6). Findings included: Review of facility policy on October 29, 2024, at 8 a.m. showed, “Checking Conductivity and pH of Final Dialysate ... BlueStar Independent Conductivity/pH Test Option ... Policy Two staff members will verify the conductivity and pH prior to each patient’s treatment. When replacing the concentrate to same or new formula or replacing bicarbonate (except if using BiBag) pH must be checked. If any of the following scenarios occur the reason must be investigated and reported to the Clinical Manager, Program Manager, Charge Nurse, Team Leader or Home Therapies Nurse as applicable. Treatments may not be initiated, or current treatment must be stopped if: The displayed conductivity falls outside of the +/- 0.5 mS/cm of TCD. The conductivity displayed on the dialysis machine is not within +/- 0.3 mS/cm of the reading taken with the handheld conductivity meter. ... Record conductivity ... readings in the FKC treatment record.” Review of manufacturer’s directions for use for facility’s hemodialysis machines on October 29, 2024, at 8 a.m. showed, “2008T Hemodialysis Machine Operator’s Manual ... 490122 Rev AB ... Final Setup when using Auto Prime Method At this point, all self-tests should have been successfully completed and the saline should be recirculating in the bloodlines. If the ‘Independent Conductivity’ test (functional software version 2.72 or later with 2008T BlueStar Premium) was run as part of the self-tests and a bibag disposable is the bicarbonate source, the conductivity and approximate pH have already been independently verified by the Independent Conductivity/pH test. ... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means before initiating each dialysis treatment. Independent means could be by using an external conductivity meter, pH meter, pH paper or by using the machine ’ s independent conductivity test. ... Verify that the conductivity is within 0.4 mS/cm of the theoretical conductivity value (TCD) ... If conductivity and pH are not within these limits, do not initiate dialysis. The machine ’ s independent conductivity test relies on the use of prequalified manufactured acid concentrates or verified batch concentrates.” Review of manufacturer’s directions for use on October 23, 2024, at 1 p.m. showed, “RPC ... Ultra-Low Total Chlorine Test Strips ... Important Tips for Using E-Z Chek Sensitive and Ultra-Low Total Chlorine Test Strips ... 2) ... Proper test sample exposure time and wait time are critical for test strip accuracy. ... Test Procedure ... 4) Wait 20 seconds for the test strip to develop. ... 5) After the 20 second wait period, immediately compare the strip color to the ... color chart to determine the Total Chlorine level in sample.” Observation of chlorine testing in facility water room with EMP8 was conducted on October 23, 2024, at 12:45 p.m. During the observation, EMP8 swished the test strip in the water sample then removed test strip and immediately took the reading without waiting the required 20 seconds. Interview with EMP8 after the observation at 12:50 p.m. confirmed findings. Review of clinical records on October 24, 2024, at 10 a.m. CR1 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR1’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR2 received nine (9) incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR2’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR4 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR4’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR5 received 10 incenter hemodialysis treatment sheet from 10/2 to 10/23/2024. Review of CR5’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR6 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR6’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. Interview with EMP13 on October 25, 2024, on 10 a.m., while on the treatment floor observing conductivity and machine preparation, confirmed findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 31759 Based on review of facility policy, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the plan of care included a goal to achieve the prescribed dose of dialysis and adequacy for one (1) of one (1) patient admitted for less than 90 days (CR2). Findings include: Review of facility policy on October 24, 2024, at 12:47 p.m. showed, “Comprehensive Interdisciplinary Assessment and Plan of Care ... Components of the patient comprehensive interdisciplinary assessment ... Evaluation of appropriateness of dialysis prescription (including at least a monthly Kt/V [adequacy] or equivalent measure on HD patients [...]).” Review of facility policy on October 25, 2024, at 12:20 p.m. showed, “Patient Monitoring and Assessment ... Machine Parameters and Extracorporeal Circuit ... Check machine settings and measurements ... Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate.” Review of CR2 on October 24, 2024, at 11 a.m. showed patient was admitted to facility on 8/5/2024. The patient’s dialysis prescription included a blood flow rate (BFR) of 450. Review of CR2’s treatment sheets from 10/2/2024 to 10/23/2024 showed nine (9) treatments. The patient did not run as ordered for seven (7) of those nine (9) treatments: 10/7 BFR 350; 10/11 BFR 410; 10/14 BFR 250; 10/16 BFR 250; 10/18 BFR 250; 10/21 BFR 300; and 10/23/2024 BFR 300 There was no indication for why the patient did not run as ordered and no evaluation or action by the interdisciplinary team related to the appropriateness of the patient’s dialysis prescription as to why the patient could not be dialyzed as ordered. Interview with EMP6 on October 25, 2025, at approximately 10 a.m. confirmed findings.”

“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: 31759 Based on review of facility policy, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the plan of care included a goal to achieve the prescribed dose of dialysis and adequacy for one (1) of one (1) patient admitted for less than 90 days (CR2). Findings include: Review of facility policy on October 24, 2024, at 12:47 p.m. showed, “Comprehensive Interdisciplinary Assessment and Plan of Care ... Components of the patient comprehensive interdisciplinary assessment ... Evaluation of appropriateness of dialysis prescription (including at least a monthly Kt/V [adequacy] or equivalent measure on HD patients [...]).” Review of CR2 on October 24, 2024, at 11 a.m. showed patient was admitted to facility on 8/5/2024. The patient’s dialysis prescription included a blood flow rate (BFR) of 450. The interdisciplinary team completed the initial plan of care on 8/28/2024. The plan of care contained no goal for adequacy. Review of CR2’s treatment sheets from 10/2/2024 to 10/23/2024 showed nine (9) treatments. The patient did not run as ordered for seven (7) of those nine (9) treatments: 10/7 BFR 350; 10/11 BFR 410; 10/14 BFR 250; 10/16 BFR 250; 10/18 BFR 250; 10/21 BFR 300; and 10/23/2024 BFR 300 Review of a physcian rounding note from 8/5/2024 showed, “Dialysis Dose Goal ... spKt/V => 1.4 (HD).” Review of CR2’s lab results showed his spKt/V: 8/5 1.26; 8/14 1.38; 9/4 1.36; and 10/2/2024 1.37. There was no indication for why the patient did not run as ordered and no evaluation or action by the interdisciplinary team related to the appropriateness of the patient’s dialysis prescription or the patient’s progress towards their goal. Interview with EMP6 on October 25, 2025, at approximately 10 a.m. confirmed findings.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 31759 Based on review of policy, National Kidney Foundation (NKF) Guidelines, observation (OBS), and staff (EMP) interview, the facility failed to ensure two (2) of two (2) patients with an arteriovenous fistula (AVF) washed their access prior to disinfection and initiation of dialysis. Findings included: Review of facility policy on October 25, 2024, 10:32 a.m. showed, “Access Assessment and Cannulation ... Assessment of Vascular Access Follow the steps below to assess the vascular access Step 1 Action Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure.” According to NKF Guidelines, “Tips for Everyday Care of Your AV Fistula or Graft Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and antimicrobial soap.” Retrieved from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf Observation on treatment floor on October 23, 2024, at 11 a.m. revealed patient arrive to dialysis. The patient was weighed and assessed and proceeded to station 17 without washing his access in the sink. EMP4 wiped the patient’s AVF with a disinfectant wipe, inserted both needles, and initiated dialysis. An interview with EMP4 and the patient, after dialysis was underway, confirmed patient did not wash his access in the sink with soap and water prior to treatment. The patient exclaimed, “No one has ever told me to do that and I have been here for two years. No one has ever told me to do that.” Continued observation revealed another patient arrive for treatment on October 23, 2024, at 11:30 a.m. The patient was weighed and assessed and proceeded to station 15 without washing his access. EMP2 wiped the patient’s AVF with a disinfectant wipe, inserted both needles, and initiated dialysis. An interview with EMP5 (registered nurse present at chairside when EMP2 initiated dialysis) and the patient confirmed the patient did not wash their access in the sink with soap and water prior to treatment.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 31759 Based on review of facility policy and procedure, facility QAPI (quality assurance performance improvement), clinical records (CR), hospitalization logs, and staff (EMP) interview, the facility failed to record and follow up on all patient infections in order to analyze and document the incidence of infections to identify trends and establish baseline information on infection incidence; develop recommendations and action plans to minimize infection transmission, promote immunization; and take actions to reduce future incidents for two (2) of two (2) records hospitalized for covid-19 (CR3, & CR6). Findings included: Review of facility policy on October 29, 2024, at 8 a.m. showed, “Infection Control Overview ... The nature of dialysis, with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients, makes a dialysis clinic a high risk for spreading infectious disease. ... Policy: General ... The facility will monitor the effectiveness of the infection control program through the Quality Assessment and Performance Improvement Program. ... Mandatory Components of Program ... Surveillance program of specific measures for prevention, early detection, control and investigation of infectious and communicable diseases.” Review of facility policy on October 25, 2024, at 10:35 a.m. showed, “Quality Assessment and Performance Improvement Program ... QAPI Meeting Objectives ... Elements to be reviewed will include: ... Infection Surveillance.” Review of “Absence and Hospitalization” report on October 24, 2024, at 10 a.m. showed showed CR3 was hospitalized for “Covid-19” from 1/31/2024 to 2/2/2024; and CR6 was hospitalized for “Covid-19” from 12/11/2023 to 12/15/2023. Review of CR3 on October 24, 2024, at 11 a.m. showed, “PROVIDER ROUNDING NOTE COMP HD ... Entry Date 2/7/2024 ... Comments: Seen at first shift. In COVID isolation.” Review of CR6 on October 24, 2024, at 12 p.m. showed a hospital discharge note from 12/15/2023, “Admit/Discharge Diagnosis: Admitting Dx: Covid.” Review of “Infection Logs” on October 24, 2024, at 1 p.m., that were part of QAPI review from December 2023 to October 2024, did not show that CR3’s or CR6’s covid-19 infections had been logged for tracking purposes. Interview with EMP6 (clinic manager) on October 24, 2024, at approximately 1 p.m. confirmed above findings.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 31759 Based on review of facility documentation, and staff (EMP) interview, the medical director failed to develop, review, and approve policies and procedures for staff training to ensure skills validation was completed for a new process and technology; and failed to ensure staff operated water room equipment in accordance with manufacturer’s directions for use. Findings include: Review of facility policy on October 29, 2024, at 2 p.m. showed, “MEDICAL DIRECTOR DUTIES ... Medical Director responsibilities are those administrative duties associated with the overall functioning of the dialysis facility, with the primary goal of providing safe and effective dialysis services, while maintaining the highest standards of quality patient care. This document outlines those duties that the Medical Director may perform frequently as well as occasionally. Clinical Management: Development, implementation, monitoring, review and update of policies and procedures in relation to: Patient care and the delivery of high-quality, safe and effective dialysis. ... Facility Staff Management: Serve as an educational resource for facility staff including: Periodic review and revision of staff training materials. Sign-off annual staff training and competency testing. Development of inservice or other educational programs and actual staff training. ... Facility Management: Oversight of facility operations, including participation in budget development and cost containment efforts. Assuring dialysis equipment and other technical component services meet clinical standards. Oversight of water analysis, including monitoring routine cultures and implementing remedial actions if necessary.” Review of facility policy on October 29, 2024, at 2 p.m. showed, “FKC Policy and Procedure Guidelines ... The purpose of this document is to provide guidance for amending existing policies or procedures or to request new policies and procedures. ... Background Policies and procedures are generally developed by FKC Corporate Clinical Services and Biomedical Services to ensure that the quality of care and service provided to our patients meet the highest clinical standards of care. ... In the course of facility operations, there may be individual facility circumstances when it is necessary for the facility Governing Body to consider amending Corporate policies or procedures, in order to meet state specific laws, regulatory/licensure or individual facility requirements such as physical plant or equipment related differences. ... The facility Governing Body may submit a request to change an existing policy or procedure or create a new policy or procedure using the process outlined in this policy. To begin the process, managers may submit the FKC Policy and Procedure Request form outlining the requested changes in addition to the reason for an amended or new policy.” The facility implemented new dialysate testing technology sometime in August or September 29, 2023. A review of facility documentation on October 29, 2024, at 8 a.m. and interviews with staff on October 25, 2024, at 10:40 a.m., confirmed there was no skills validation for new dialysate testing technology. The facility had no policy to ensure compliance with this requirement. Cross reference V260 for additional information. A review of patient treatment sheets was conducted on October 24, 2024, at 10 a.m. and a review of facility policy and manufacturer’s directions for use revealed the facility did not verify and document conductivity range in accordance with policy and manufacturer’s directions for use. Cross reference V403, and V730 for additional information. Observation of chlorine testing in facility water room was conducted on October 23, 2024, at 12:45 p.m. During the observation staff failed to follow manufacturer’s directions for use concerning chlorine test strips. Cross reference V403 for additional information.”

“MR-CENTRALIZE ALL INFO;IDT HAS ACCESS CFR(s): 494.170(b)(2) (2) All clinical information pertaining to a patient must be centralized in the patient’s record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient’s condition and prescribed treatment. This Standard is not met as evidenced by: 31759 Based on review of facility policy, manufacturer’s directions for use, a memo from the Department to facilities, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the patient (treatment) flow sheets contained documentation of conductivity safety checks and machine parameters to show conductivity was verified as in range for five (5) of five (5) active in-center hemodialysis clinical records reviewed (CR1, CR2, & CR4-CR6). Findings included: Review of facility policy on October 29, 2024, at 8 a.m. showed, “Checking Conductivity and pH of Final Dialysate ... BlueStar Independent Conductivity/pH Test Option ... Policy Two staff members will verify the conductivity and pH prior to each patient’s treatment. When replacing the concentrate to same or new formula or replacing bicarbonate (except if using BiBag) pH must be checked. If any of the following scenarios occur the reason must be investigated and reported to the Clinical Manager, Program Manager, Charge Nurse, Team Leader or Home Therapies Nurse as applicable. Treatments may not be initiated, or current treatment must be stopped if: The displayed conductivity falls outside of the +/- 0.5 mS/cm of TCD. The conductivity displayed on the dialysis machine is not within +/- 0.3 mS/cm of the reading taken with the handheld conductivity meter. ... Record conductivity ... readings in the FKC treatment record.” Review of manufacturer’s directions for use for facility’s hemodialysis on October 29, 2024, at 8 a.m. showed, “2008T Hemodialysis Machine Operator’s Manual ... 490122 Rev AB ... Final Setup when using Auto Prime Method At this point, all self-tests should have been successfully completed and the saline should be recirculating in the bloodlines. If the ‘Independent Conductivity’ test (functional software version 2.72 or later with 2008T BlueStar Premium) was run as part of the self-tests and a bibag disposable is the bicarbonate source, the conductivity and approximate pH have already been independently verified by the Independent Conductivity/pH test. ... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means before initiating each dialysis treatment. Independent means could be by using an external conductivity meter, pH meter, pH paper or by using the machine’s independent conductivity test. ... Verify that the conductivity is within 0.4 mS/cm of the theoretical conductivity value (TCD) ... If conductivity and pH are not within these limits, do not initiate dialysis. The machine’s independent conductivity test relies on the use of prequalified manufactured acid concentrates or verified batch concentrates.” Review of memo from the Department was shown to the facility administrator on October 24, 2024, at approximately 12:30 p.m. The memo was dated May 9, 2024, and distributed to facilities on May 13, 2024, “Dear Provider: As newer technology develops, both facilities and state agencies are encountering new methods of adaptation in order to remain in compliance with 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services. Many providers are currently using the Fresenius 2008T Machine with BlueStar technology that has changed the method of conductivity testing. ... From a patient safety aspect, the Department of Health surveyors will be ensuring that documentation that the TCD and alarm limits is verified on the treatment sheets when conducting Medicare Recertification surveys.” Review of clinical records on October 24, 2024, at 10 a.m. CR1 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR1’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR2 received nine (9) incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR2’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR4 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR4’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR5 received 10 incenter hemodialysis treatment sheet from 10/2 to 10/23/2024. Review of CR5’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. CR6 received 10 incenter hemodialysis treatment sheets from 10/2 to 10/23/2024. Review of CR6’s treatment sheets for above dates did not show that the hemodialysis machine’s conductivity and TCD was documented to show the range verified as within normal safe limits to before initiating treatment. Interview with EMP13 on October 25, 2024, on 10 a.m., while on the treatment floor observing conductivity and machine preparation, confirmed findings.”