032530 Desert Valley Dialysis (Fmc)

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 52534 Based on document review and interview, it was determined that the facility failed to ensure: 1. Discharge summaries were completed within 30 days for (3) of (4) patients (Patients #7, #8, and #10) according to applicable state laws, which has the potential risk of impeding the patient’s continuity of care; and 2. Fire inspections were completed annually according to applicable state laws, which has the potential risk that patients, visitors and staff could suffer harm in case of a fire. Findings include: 1. The Arizona Administrative Code (A.A.C.) requires” ... R9-10-1018 Dialysis Services ... L. For a patient who receives dialysis services, an administrator shall ensure that after the patient’s discharge from an outpatient treatment center that is authorized to provide dialysis services, the nephrologist responsible for the dialysis services provided to the patient documents the patient’s discharge in the patient’s medical record within 30 calendar days after the patient’s discharge ...” Facility policy regarding discharge summaries was requested but not provided. Patient #7’s medical record review on 04/21/2025 revealed the patient was discharged on 03/12/2025 and the physician signed the discharge summary on 04/21/2025, outside of the 30 day period. Patient #8’s medical record review on 04/21/2025 revealed the patient was discharged on 01/22/2025 and the physician signed the discharge summary on 03/24/2025, outside of the 30 day period. Patient #10’s medical record review on 04/21/2025 revealed the patient was discharged on 01/02/2025 and the physician signed the discharge summary on 02/27/2025, outside of the 30 day period. Employee #9 confirmed on 04/21/2025 that the discharge summaries were not completed within the 30 day period according to state law for Patients #7, #8, and #10. 2. The Arizona Administrtive Conde (A.A.C.) requires “... R9-10-1029 Emergency and Safety Standards ... D. An administrator shall ensure that an outpatient treatment center has either: 1. Both of the following that are tested and serviced at least once every 12 months: a. A fire alarm system installed according to the National Fire Protection Association 72: National Fire Alarm and Signaling Code, incorporated by reference in R9-10-104.01, that is in working order ...” Review of Fire Panel Inspection Report on 04/21/2025 revealed it was last inspected on 02/20/2024. Employee #3 confirmed on 04/22/2025 there was no fire panel inspection completed since then, making the inspection overdue.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview, the Department determined that the administrator failed to ensure staff aseptically cannulated (3) of (6) patients’ (Patients #12, 13, and 14) vascular access prior to cannulation with fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access and using clean tapes increases the risk for vascular access and blood stream infection. Findings include: The policy titled “Access and Cannulation” requires: “...Skin Disinfection ...disinfect cannulation site as follows ...70% isopropyl alcohol pad ...Using gently friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating ....” Patient #12 Observation on 04/22/2025 revealed Employee #19 preparing to cannulate Patient #12 ’ s vascular access. Employee #19 used an alcohol prep pad to disinfect the arterial cannulation site for 27 seconds prior to cannulating the site with a fistula needle. Employee #19 then used an alcohol prep pad to disinfect the venous cannulation site for 21 seconds prior to cannulating the site with a fistula needle. Patient #13 Observation on 04/22/2025 revealed Employee #14 preparing to cannulate Patient #13 ’ s vascular access. Employee #19 used an alcohol prep pad to disinfect the arterial cannulation site for 9 seconds prior to cannulating the site with a fistula needle. Employee #19 then used an alcohol prep pad to disinfect the venous cannulation site for 18 seconds prior to cannulating the site with a fistula needle. Patient #14 Observation on 04/22/2025 revealed Employee #19 preparing to cannulate Patient #14 ’ s vascular access. Employee #19 used an alcohol prep pad to disinfect the arterial cannulation site for 19 seconds prior to cannulating the site with a fistula needle. Employee #19 then used an alcohol prep pad to disinfect the venous cannulation site for 17 seconds prior to cannulating the site with a fistula needle. Employee #1 and 20 confirmed on 04/22/2025, that Employee #19 did not apply disinfectant for 30 seconds to Patient #12 and 14 ’ s vascular access prior to cannulation as required by policy, and Employee #14 did not apply disinfectant for 30 seconds to Patient #13 ’ s vascular access prior to cannulation as required by facility policy.”

“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: 37489 Based on review of policy/procedure, the Centers for Disease Control and Prevention (CDC) guidelines, observation, and interview, it was determined that the facility failed to ensure: 1. staff changed gloves and performed hand hygiene between clean and dirty tasks, and between multiple dialysis stations, patients, and patients’ machines; and 2. staff did not wear artificial fingernails while providing patient care services. Failure to follow established standard and infection control precautions poses an increased risk of infections for immunocompromised patients through contact transmission and cross contamination. Findings include: 1. and 2. The facility policy titled “Hand Hygiene” requires: “...The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination...Hands Will Be...Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...Before and after direct contact with patients...Immediately after removing gloves...After contact with inanimate objects near the patient...When moving from a contaminated body site to a clean body site of the same patient...All staff, patients, patient care givers, including physicians and non-physician practitioners, social workers, dietitians and any other indirect patient care staff must follow the same requirements for hand hygiene...Caution Regarding Fingernails...Do not wear artificial fingernails, extenders or nail wraps when having direct contact with patients. Natural fingernail length shall be kept to ¼ inch or less....” Observation on 04/22/2025 revealed Provider #22 providing patient care and assessment between first and second shift patients at stations #1, #4, #5, and #13; and between second and third shift patients at stations #2, #10, and #14. Provider #22 did not wash their hands or use hand sanitizer to perform hand hygiene before donning gloves to conduct patient assessments, nor after removing gloves and leaving the patient station to document on paperwork at a desk at the far end of the clinic. Observation on 04/22/2025 revealed Employee #14 use bare hands to replace and adjust a patient’s blanket that had fallen to the floor next to the dialysis chair at station #12, walked a couple steps to station #11 picked up a dirty glove on the tile floor at the station and discarded the glove, then walked to station #9 and retrieved gloves from the box located at the dialysis station. Employee #14 then returned to the workstation and sat down holding the gloves in hand. Employee #14 retained the gloves until donning them a few minutes later at station #9 without performing hand hygiene. Observation on 04/22/2025 revealed Employee #15 don gloves and start disinfecting station #4. Employee #15 wiped down the dialysis machine, then retrieved a hemostat and fistula clamp from the chairside table and another hemostat from the tile floor, walked to the dirty sink, dropped the equipment in the sink then used the same dirty gloves to retrieve a large handful of clamps and hemostats that had been soaking in the bleach solution, wash them with water, then walk to the clean supply utility cart and place them in the appropriate bin. Employee #15 then repeated the same action with an additional handful of bleached clamps and hemostats, picked up the two hemostats and clamp previously placed in the dirty sink, dropped them in the bleach solution, and walked back to station and continued cleaning the dialysis station chair without changing gloves. Observation on 04/22/2025 revealed Employee #14 take CVC take off supplies to station #12. Employee #14 did not don gloves to unwrap saline flushes and prepare tape and gauze along with syringes and other disposable items at the patient’s chairside table. Employee #14 returned to the technician workstation sat down a few minutes, then walked back to the station when the patient’s treatment finished. Employee #14 donned gloves and performed the CVC take off procedures without performing hand hygiene. Employees #1 and #20 confirmed on 04/22/2025 that staff did not follow hand hygiene practices as required by facility policy. 2. The CDC “Morbidity and Mortality Weekly Report, October 25, 2002 / Vol. 51 / No. RR-16, Guideline for Hand Hygiene in Health-Care Settings Recommendations” revealed: “...HCWs who wear artificial nails are more likely to harbor gram-negative pathogens on their fingertips than are those who have natural nails, both before and after handwashing...Personnel wearing artificial nails also have been epidemiologically implicated in several other outbreaks of infection caused by gram-negative bacilli and yeast...These recommendations are designed to improve hand hygiene practices of HCWs and to reduce transmission of pathogenic microorganisms to patients and personnel in healthcare settings...Do not wear artificial fingernails or extenders when having direct contact with patients at high risk....” Observation on 04/21/2025 revealed Employee #18 providing patient care for patients receiving dialysis treatment at stations #9 - #12. Employee #18’s hands revealed s/he had iridescent pearl colored artificial nails that were grown out approximately 1/4 inch or slightly less noted during glove changes, preparing IV medication, and while providing care to patients on dialysis treatment. Employee #20 confirmed on 04/21/2025 that staff are not allowed to wear artificial nails per facility policy as it is an infection control hazard.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure the staff properly disinfected their stethoscope after patient assessment. This deficient practice poses an increased risk of the spread of infectious diseases. Findings include: Facility Policy titled “General Cleanliness and Infection Control Guidelines” requires “... Noncritical medical equipment, which includes equipment that touches only intact skin (e.g., stethoscope, blood pressure cuffs), must be disinfected with 1:100 bleach or an EPA registered disinfectant. ...” Observation on 04/21/2025 revealed Provider #23 conducting an assessment on the patient at station #11. Provider #23 used their stethoscope for the assessment and placed it in a basket attached to the front of the “rounding cart” without disinfecting the stethoscope and returned to a desk to document the event. Employee #1 confirmed on 04/21/2025 that the stethoscope was not disinfected according to facility policy. Observation on 04/22/2025 revealed Provider #22 wearing their stethoscope around their neck and taking it off to assess the patient at station #14. Provider #22 then reached into their pants pocket, through a tear in their gown, to retrieve an alcohol pad, then cleaned the diaphragm of their stethoscope with the alcohol pad, and placed it back around their neck. Provider #22 returned to the nurses station to chart with the stethoscope still around their neck. Further observation on 04/22/2025 revealed Employee #14 picking up their stethoscope from a clean sink area and placing it around their neck. Employee #14 then went to the lobby to escort a patient to the treatment area. Employee #14 returned from the lobby with the stethoscope around their neck and escorted a patient to Station #10. Employee #14 was then observed assessing the patient ‘s access with their stethoscope and bare hands. Employee #14 then left Station #10 and placed their stethoscope down on the clean sink area and returned to Station #10 without disinfecting the stethoscope. Employee #20 confirmed on 04/22/2025 that Provider #22 and Employee #14 did not disinfect their stethoscope according to facility policy, and that Provider #22 should have disinfected the entire stethoscope, not just the diaphragm.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately disinfected the dialysis stations. This deficient practice poses an increased risk of the spread of infectious diseases. Findings include: Facility Policy titled “Cleaning and Disinfecting the Dialysis Station” requires “ ... 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 dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer. Chair/bed. Pureflow SL. Individual television and remote. ... Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or a s soon as feasible. ...” Observation on 04/22/2025 revealed Employee #15 cleaning and disinfecting station #2. Employee #15 did not clean and disinfect the IV pole on the machine, the laminated “RN Notification” card hanging on the IV pole, or the TV remote. Additionally, Employee #15 moved a glove dispenser mounted to an IV pole from the station with dirty gloved hands out to the station, then continued on with the station disinfection before returning the glove dispenser back to the original placement between stations. The pole was not disinfected. Additionally, Employee #15 did not disinfect the BP basket or YubiKey scanner on the side of the dialysis machine. Employee #15 then set up the station with new supplies to be used for the next patient. Observation on 04/22/2025 revealed Employee #14 cleaning and disinfecting station #9. Employee #14 did not clean and disinfect the IV pole, the top or back of the machine. Employee #14 then set up the station with new supplies to be used for the next patient. Observation on 04/22/2025 revealed Employee #19 cleaning and disinfecting station #14. Employee #19 did not disinfect the IV pole, BP cuff basket or YubiKey scanner on the side of the machine, or the laminated card and remote hanging on the IV pole. Employee #14 then set up the station with new supplies to be used for the next patient. Observation on 04/22/2025 revealed Employee #15 cleaning and disinfecting station #4. Employee #15 did not disinfect the laminated card hanging on the IV pole or the section of the machine above the sharps container including the YubiKey scanner. Employee #15 then set up the station with new supplies to be used on the next patient. Observation on 04/22/2025 revealed Employee #12 cleaning and disinfecting station #8. Employee #12 did not disinfect the IV pole or laminated card hanging from the IV pole, missed the side of the machine above the sharps container and the YubiKey scanner and the BP basket, and the hansen hoses. Observation on 04/22/2025 revealed Employee #14 taking bleach soaked rags to Station #11. The employee placed the rags on the top of the machine and on the chair. Employee #14 then wiped down the entirety of the Station #11 chair and disposed of the rags. Employee #14 then took the rags that were placed on top of the machine and wiped the screen and keyboard of the dialysis machine and disposed of the rags. Employee #14 did not disinfect the BP cuff, BP cuff basket, IV pole, or the TV remote. Employee #14 was then observed leaving Sation #11 to retrieve a bicarb bag from the nurses station. Employee #14 then returned to Station #11 and placed the bicarb bag into the dirty machine. Employee #14 removed the dirty prime bucket from the side of the machine, emptied it at a dirty sink, wiped the bucket with a bleach cloth, then returned the prime bucket to the machine. Employee #14 then left Station #11 and sat in a chair at the nurses station. Employees #1 and #20 confirmed on 04/22/2025 that staff did not properly disinfect dialysis stations according to facility policy, and should not have brought the clean supplies to the stations if not properly disinfected.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1.Tubersol vials were appropriately labeled when opened which has the potential risk that patients may receive expired, ineffective or contaminated medication; and 2.The diaphragm of multi-dose medication vials was disinfected before access. These deficient practices have the potential risk for patients to receive expired medications which can have adverse effects on the patient ’ s health. Findings include: 1. And 2. Facility policy titled “Medication Preparation and Administration” requires “ ... When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials. ... Cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. ...” 1. Observation on 04/21/2025 revealed an opened multidose-vial of Tubersol in the medication refrigerator in the medication preparation area that was not labeled with the date it was opened. Employee #1 confirmed on 04/21/2025 that the vial was not labeled according to facility policy. 2. Observation on 04/21/2025 revealed Employee #13 accessing a multi-dose vial of Heparin without disinfecting the diaphragm. Observation on 04/21/2025 revealed Employee #12 placed an alcohol pad on top of the diaphragm of the medication vial and left it there while preparing an empty syringe, then removed the alcohol pad from the diaphragm without using friction to clean it, then accessed the multidose vial to draw up the medication. Observation on 04/21/2025 revealed Employee #18 placed an alcohol pad on top of the diaphragm of the medication vial and left it there while preparing an empty syringe, then removed the alcohol pad from the diaphragm without using friction to clean it, then accessed the multidose vial to draw up the medication. Employee #1 and #20 confirmed on 04/21/2025 that the diaphragm was not disinfected according to facility policy.”

“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: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff followed facility policy and procedure of termination of treatment for (1) of (1) patients (Patient #11) with a Central Venous Catheter (CVC). This deficient practice poses the potential risk of patients to contract Central Line-Associated Bloodstream Infections. Findings include: Facility policy titled “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyser” requires “ ... Place mask on patient ... 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 ...” Observation on 04/22/2025 revealed Employee #14 terminating treatment for Patient #11. Patient #11 wore a mask that was covering their mouth but did not cover their nose. Employee #14 did not ask the patient to cover their nose with the mask prior to accessing their CVC. Employee #14 disconnected the bloodline from the arterial limb of Patient #11 ’ s CVC then, immediately attached a saline syringe and flushed the CVC, removed and attached another syringe containing heparin locking solution and instilled the heparin. Employee #14 then retrieved a large alcohol prep pad, removed the empty heparin syringe, disinfected the threads on the catheter hub, and capped the line. Employee #14 completed the same sequence/procedure with the CVC venous limb. Employees #1 and #20 confirmed on 04/22/2025 that the patient should be instructed to properly wear the face mask, covering their mouth and nose, and that the CVC hub and threads were not properly disinfected according to facility policy.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, the Department determined that the administrator failed to ensure bleach and Naturalyte acid were not stored next to each other on the treatment floor which has the potential for chemical reactions that may result in harmful vapors and chemical reactions. Findings include: The facility policy titled “Acid Concentrate Storage and Handling” requires: “...Do not store acid concentrates adjacent to bleach/bleach products ....” Observation on 04/21/2025 revealed two utility carts with supplies in use on the treatment floor. The carts were placed side by side. One cart contained a gallon bottle of bleach and a cardboard box with dry bleach cloth packages on the lower shelf and more dry cloth packages and two bleach solution (1:10 and 1:100 bleach concentrate) containers on the top shelf.. The second utility cart contained gallon jugs of Bicarbonate and Naturalyte acid concentrate solutions on all three shelves of the utility cart. Staff were observed pulling soaked bleach cloths out of the bleach solution containers which splashed the immediate and adjacent area with the bleach solution and opening/inserting wands into the acid concentrate jugs before taking them to patient stations.. Employee #3 confirmed on 04/21/2025 that staff did not store the acid concentrate and bleach solutions safely as required by policy.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 52534 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications were locked or otherwise secured when not in use in a medication storage cabinet on the treatment floor. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings include: The facility policy titled “Medication Preparation and Administration” requires: “...Securement ...All medications will be kept in a locked cabinet except when in use ....” Observation on 04/21/2025 revealed a metal storage cabinet with an unlocked metal shackle padlock hanging on the hasp latch on the unlocked cabinet door. The cabinet contained various packages of oral and IV medications, an individual patient ’ s medications, oral supplements, and emergency medications in a plastic box. There were no staff in the immediate area and both nurses were at patient stations providing patient care. Employee #7 confirmed on 04/21/2025, that the medications were not locked when not in use.”

“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: 52534 Based on document review and interview, it was determined that the facility failed to ensure biomedical technical staff accurately documented in the dialysis equipment maintenance records and performed annual preventive maintenance as required in the manufacturer’s directions for use (DFU) which has the potential for patient injury or harm if dialysis machines are not maintained and normal operation is not verified. Findings include: The document titled “2008T Machine Operator ’ s Manual” referenced preventive maintenance in the “”2008T Hemodialysis System Preventive maintenance Procedures” document as follows. The document titled “2008T HEMODIALYSIS SYSTEM PREVENTIVE MAINTENANCE PROCEDURES” requires: “...Preventive Maintenance for the 2008T Hemodialysis System...Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hours intervals are as follows: ...Machines without...with Extended Life Pump Components...Six (6) months...Annually or after 4000 hours of operation...Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause injury or death to the patient or the operator...Included in the Preventive Maintenance procedures are tests to verify normal machine operation....” The “FKC EQUIPMENT RECORD” for preventive maintenance and work orders for the last 12 months for dialysis machines was reviewed and found to have discrepancies in record keeping for tracking machine hours and corresponding maintenance, as well as preventive maintenance not performed in the required interval according to the manufacturer’s DFU. The following dialysis machine records contained inaccurate documentation of hours in operation and that preventive maintenance was not performed within the manufacturer’s DFU. Dialysis machine 6T0S-160050 05/21/2024: clock hours 22,003 07/24/2024: clock hours 24,155 07/15/2024: clock hours 23,016 09/25/2024: clock hours 24,000 11/29/2024: clock hours 24,909 Dialysis machine 3T0S-268750 05/22/2024: clock hours 3,513 07/18/2024: clock hours 4,293 07/15/2024: clock hours 4,249 07/24/2024: clock hours 24,155 09/25/2024: clock hours 5,243 11/29/2024: clock hours 6,039 Dialysis machine 9T0S-241739 05/22/2024: clock hours 15,620 07/15/2024: clock hours 16,089 09/25/2024: clock hours 17,094 12/04/2024: clock hours 17,495 11/29/2024: clock hours 9,351 12/04/2024: clock hours 17,495 Employee #3 confirmed on 04/22/2025 that clock hours used to determine timeframes for performing dialysis machine preventive maintenance were not logged accurately in the facility equipment record; therefore, it would be difficult to determine if the DFU for machine maintenance was followed.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 52534 Based on document review, and interview, it was determined that the facility failed to ensure staff followed the hemodialysis treatment order for prescribed Blood Flow Rate (BFR) for (4) of (6) patient (Patients #2, 3, 4, and 5). Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings include: Facility policy titled “Patient Assessment and Monitoring” requires “... Check machine settings and measurements: ... Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. ... Document any findings and interventions in the medical record. ...” Patient #2 Patient #2 ’ s medical record review on 04/21/2025 revealed the prescribed BFR of 350mL/min. The following dialysis treatments were not delivered as prescribed. 04/18/2025 BFR ranged from 200 to 350 throughout treatment No documentation of the changes or rationale were found in the treatment record. Patient #3 Patient #3 ’ s medical record review on 04/21/2025 revealed the prescribed BFR of 400mL/min. The following dialysis treatments were not delivered as prescribed. 04/19/2025 BFR ranged from 300 to 400 throughout treatment 04/17/2025 BFR was 350 for the entire treatment 04/12/2025 BFR was 350 for the entire treatment 04/10/2025 BFR ranged from 350 to 400 throughout treatment No documentation of the changes or rationale were found in the treatment record. Patient #4 Patient #4 ’ s medical record review on 04/21/2025 revealed the prescribed BFR of 400mL/min. The following dialysis treatments were not delivered as prescribed. 04/07/2025 BFR ranged from 350 to 400 throughout treatment No documentation of the changes or rationale were found in the treatment record. Patient #5 Patient #5 ’ s medical record review on 04/21/2025 revealed the prescribed BFR of 450mL/min. The following dialysis treatments were not delivered as prescribed. 04/10/2025 BFR ranged from 400 to 450 throughout treatment 04/08/2024 BFR ranged from 400 to 450 throughout treatment No documentation of the changes or rationale were found in the treatment record. Employee #9 confirmed on 04/21/2025 the BFRs for Patients #2, #3, #4, and#5 were not as prescribed and did contain documentation of the rationale for the changes throughout the treatment.”