032542 Arcadia Dialysis Center (Fmc)

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 37489 Based on review of the facility’s Emergency Plan Requirements, record review, and interview, it was determined the facility failed to participate in and document two cycles of EP drills as required. Failure to participate in drills may lead to untrained staff in an emergency situation and may result in harm to the patients during an emergency. Findings include: The facility Emergency Plan requires: “...Conduct at least one Table Top Mock drill annually with the entire IDT involvement. Participate in at least one community-based drill sponsored by the EOC, Healthcare alliance or local hospital. If a community-based drill is not completed each year, the DO must document who they contact, what was the reason given on why the drill could not be completed. If no community (sic) based drill the DO should conduct a mock drill with the Area facilities and attempt to engage the local hospital and transportation companies, volunteer groups, etc ....” Document review on 05/07/2025 revealed that the facility was missing documents demonstrating participation in a full-scale exercise (FSE) that was community-based or a facility-based exercise or table top drills were conducted for the year 2022. A community-based drills were conducted on 08/21/2023 and 12/10/2024, with a table top exercise conducted on 03/21/2025. Employee #1 confirmed on 05/07/2025 that the facility was not able to locate documentation of participation in either a full-scale exercise that was community-based or a facility-based exercises in 2022 and did not alternate community and facility-based drills in subsequent years.”

“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: 37489 Based on document review and interview, it was determined that the facility did not ensure the nephrologist completed a discharge document in (2) of (4) patient’s medical record (Patients #6 and 7) within 30 days of the patient’s discharge which has the potential risk of affecting the continuity of patient care. Findings include: A discharge summary policy was requested but not provided. The policy titled “Standard Discharge Policy” was the document provided but did not address the state licensure requirement for a discharge to be documented within 30 days after a patient’s discharge from the facility. Arizona Administrative Code requires: “...R9-10-1018.L.1-2 - . Dialysis Services...L. For a patient who received 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 days after the patient’s discharge and includes: ...1. A description of the patient’s medical condition and the dialysis services provided to the patient, and 2. The signature of the nephrologist....” Patient #6 The patient was discharged from the facility on 02/03/2025. There was not discharge summary document in the patient’s medical record. Patient #7 The patient was discharged form the facility on 02/06/2025. The discharge summary document was completed on and signed by the nephrologist on 03/25/2025. Employee #1 confirmed on 05/07/2025 that Patients #6 and 7 did not have a discharge summary document completed within 30 days.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to maintain the environment in a clean and sanitary manner which has the potential risk of increased infection for immunocompromised patients. Findings include: The policy titled “ General Cleanliness and Infection Control Guidelines “ requires: “ ...All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms ...Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff .... “ Observation on 05/07/2025 revealed items/areas had not been maintained in a clean and sanitary manner as follows. 1. A utility cart on the treatment floor with a combination of open, used and new one-gallon and 2 1/2-gallon reusable acid concentrate jugs stored on the two cart selves. Underneath the jugs the shelves were lined with dirty chux under pads that were completely saturated with yellowish brown liquid and caked with crystalline build up in the drier areas of the chux pads. 2. A second utility cart contained multiple citric acid bottles and jugs on two shelves lined with chux pads that were also saturated with a yellowish-brown liquid and scattered unidentifiable debris. 3. A refrigerator at the nurse ’ s station was dirty with debris and sticky substances on the bottom the refrigerator and in the shelf on the door was a urine sample cup filled with an unidentified/unlabeled liquid. 4. Two utility carts in the hallway between the treatment floor and a storeroom were found dirty with pieces of torn blue plastic chux backing, dialyzer caps, and various unidentifiable black/brown grime and debris. 5. Blood splattered gown with small pattern splatter and also a larger area of blood greater than the diameter of a quarter had been placed in regular trash and the bloody portion of the gown was hanging over the top and side of the trash can directly beside and within 6 inches a utility cart stacked with Naturalyte one-gallon acid concentrate jugs. 6. Four (4) of (6) hand washing sinks on the treatment floor did not have hand soap for hand washing. Two (2) sinks in the lab processing area and (1) sink at the nurse’s station did not have either hand soap or hand sanitizer to perform hand hygiene. Employees #11, 30 and 31 confirmed on 05/07/2025 that the above observed areas were not maintained in a clean and sanitary manner.”

“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 wore gloves and performed hand hygiene between clean and dirty tasks, and between multiple dialysis stations, patients, and patients’ machines and a dialysis patient hold their access after treatment without wearing gloves; 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 05/07/2025 revealed Employee #11 retrieved a set of clean gloves without performing hand hygiene, walk to a dialysis station, set the contaminated gloves on a box of clean gloves, perform hand hygiene, then don the dirty gloves and provide patient care. Observation on 05/07/2025 revealed staff required the patient at Station #4 to hold pressure with gauze on his/her vascular access to achieve hemostasis without providing the patient a glove. Employee #1 confirmed on 05/07/2025 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 05/07/2025 revealed Employee #11 providing patient care for patients receiving dialysis treatment at the facility. Employee #11 was noted to have unkempt, grown out white artificial nails. Employee #11 confirmed on 05/07/2025 that she had artificial nail overlays. Observation on 05/07/2025 revealed Employee #19 providing patient care for patients receiving dialysis treatment at the facility. Employee #19 was noted to have artificial nails that were partially grown out. Employee #19 confirmed on 05/07/2025 that she had artificial nail overlays. Employee #1 confirmed on 05/07/2025 that staff are not allowed to wear artificial nails per facility policy as it is an infection control hazard.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff wore PPE (personal protective equipment) on the treatment floor. Failure of dialysis staff to wear a gown as a standard practice on the treatment floor poses an increased risk of exposure to pathogenic agents, blood, and body fluids which may increase the risk of infection for patients. Findings include: The policy titled “ Personal Protective Equipment “ requires: “ ...The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use ...Employees with potential exposure to hazardous chemicals, blood, or other potentially infectious material .... “ The policy titled “ Infection Control Overview “ requires: “ ...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 .... “ Observation on 05/07/2025 revealed Employee #7 at dialysis station #23 talking with the patient receiving treatment. Employee #7 was not wearing a fluid resistant gown while having a discussion with the patient on dialysis. Observation on 05/07/2025 revealed Employee #2 use the treatment floor as a pass though from her office to the facility ’ s back offices. Employee #2 was noted out on the treatment floor on five separate occasions when she stopped to talk to patients on dialysis treatment at the dialysis station; and also stopped several times to have a discussion with other employees on the treatment floor. Employee #2 wore scrubs and a hoodie style zip up jacket but did not wear a fluid resistant gown when at dialysis stations or lingering on the treatment floor talking with staff. Observation on 05/08/2025 revealed Employee #6 use the treatment floor as a pass through to her office. Employee #6 was not wearing a fluid resistant gown and stopped to talk to several patients at their stations while they were receiving treatment. Employees #1 confirmed on 05/08/2025 that staff are required to wear a fluid resistant gown when on the treatment floor.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure dialysis stations were cleaned and disinfected after use which posed a potential risk of increased infection for dialysis patients. Findings include: The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors...a dialysis station must be cleaned and disinfected between dialysis patients...Dialysis station...Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment...The dialysis station could become contaminated with blood and other body fluids during treatment...Follow the steps below to disinfect the dialysis station after each dialysis treatment...Use a cloth wetted with...disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine...)...Place the chair in Trendelenburg...so all surfaces of the chair are accessible. Clean all surfaces...Give special attention to the cleaning control panel on the dialysis machine and other surfaces that are frequently touched and potentially contaminated with patient’s blood and/or body fluids...Pick up all trash or visible medical debris from around the patient chair....” Observation on 05/07/2025 revealed Employee #18 cleaning and disinfecting station #14 after the patient vacated the station. Employee #18 did not clean the chair in its entirety missing sections on the arm of the chair that were still splattered with dialysate build up when the station was set up with supplies for the next patient. Observation on 05/07/2025 revealed Employee #30 cleaning and disinfecting station #4 after the patient vacated the station. Employee #30 did not clean the chair or front and sides of the dialysis machine in its entirety missing sections on the arm of the chair that were still splattered with dialysate build up when the station was set up with supplies for the next patient and missing sections of the side of the machine above the sharps container, around the BP cuff basket, and the YubiKey scanner. Employee #1 and 13 confirmed on 05/07/2025 that staff did not clean and disinfect the dialysis station as required by policy.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately labeled multi-dose medication vials when opened. Failure to label medication vials when opened with an appropriate expiration date prevents staff from knowing when to discard the vial which increases the risk a patient will receive a medication that is no longer stable, and that may be contaminated due to reduction of preservative efficacy as well as an increased exposure to pathogens from accessing a vial multiple times. 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. ...” Policy titled “Medication Preparation and Administration” requires “... Any open multidose vials must be discarded 28 days after opening or per manufacturer ’ s expiration date. ...” Observation on 05/07/2025 revealed the following medication vial that were either not discarded upon expiration or labeled legibly. Sodium Citrate 4% Injection 30 mL multidose vial; illegibly labeled with an incomplete date of 4/2 (3) Lidocaine HCL 1% Injection 10 mL multidose vial; open and labeled with an incomplete date of 12/02 Employee #11 confirmed on 05/07/2025 that the above listed medication vials were not labeled and discarded appropriately according to policy.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff label open 1-gallon jugs of Naturalyte acid concentrate solution and did not combine multiple open 1-gallon jugs together which has the potential risk of patients receiving contaminated or wrong acid concentrate solutions during treatment. Findings include: The facility policy titled “Acid Concentrate Storage and Handling” requires: “...Concentrating Container Labeling....will occur when...1-gallon: ...if unused acid will be stored for further use, record the date and time it was opened and the initials of the staff member that opened the container...Post treatment...If concentrate will be stored for future use...Open, labeled concentrate must be stored separately on a properly labeled location...Do not return the opened acid to the same shelf as the unopened acid concentrate...If not able to meet requirements, acid concentrate must be discarded after treatment....” Observation on 05/07/2025 revealed two utility carts on the treatment floor that contained opened used and unopened new 1-gallon jugs of acid concentrate. Jugs of open and unopened concentrate were stored side by side on the same shelves. Each utility cart contained an, open jug of concentrate that had not been labeled when opened and had been combined with another concentrate over the fill line to the neck of the jug all the way to the cap. Neither jug was sealed. Employee #16 confirmed on 05/07/2025 that the opened and sealed jugs were stored adjacent to each other. Additionally, that opened jug of acid concentrate were not labeled when opened and leftover acid concentrate had been combined in 1-gallon containers.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure staff documented conductivity test results for testing of bicarbonate solution mixing which has the potential risk of a solution not meeting specific parameters for appropriate dialysate used for patient treatments. Findings include: The facility log titled “6231 Bicarb Mixing Logs” revealed not test results for conductivity were documented for batches mixed on 03/11/2025, 03/25/2025, and 04/11/2025. Employee #5 confirmed on 05/06/2025 that the bicarb mix logs were missing conductivity testing on the above listed days.”

“MICROB MONITOR-REPEAT CULTURES CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: repeat cultures Cultures should be repeated when bacterial counts exceed the allowable levels. If culture growth exceeds permissible standards, the water system and dialysis machines should be cultured weekly until acceptable results are obtained. Additional samples should be collected when there is a clinical indication of a pyrogenic reaction or septicemia, and following a specific request by the clinician or the infection control practitioner. If repeat cultures are performed after the system has been disinfected (e.g., with formaldehyde, hydrogen peroxide, chlorine, or peracetic acid), the system should be flushed completely before collecting samples. Drain and flush storage tanks and the distribution system until residual disinfectant is no longer detected before collecting samples. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure staff disinfected dialysis machines and repeated culture and endotoxin testing to ensure the result was below action level before returning dialysis machines to the treatment floor for use which has the potential increased risk of infection for patient’s receiving treatment at the facility in machines are not disinfected and tested for microorganisms. Findings include: The facility policy titled “Microbiological Monitor of Dialysate” requires: “...Idle Dialysis Machine...When a machine has not been disinfected for 7 days or longer the machine must be: ...Removed form services...Disinfected in accordance with company policy...Sampled in accordance with baseline sampling, with the first sample collected following disinfection...Machine may be returned to service, with Medical Director’s approval, once a culture and endotoxin result below action level has been obtained. Baseline sampling must continue per policy....” Review of HD machine disinfection logs and the facility quality meeting minutes revealed that machines #3T0S-121073, 5T0S-145965, and 5T0S-146002 had not been disinfected for more than seven (7) days in January 2025. Documentation related to disinfection, repeat culture and endotoxin testing below action level, and medical director approval to return the machines to service was requested. The documentation revealed machine 3T0S-121073 and 5T0S-145965 had been without disinfection for 12 days; and machine 5T0S-146002 had been without disinfection for 14 days. Employee #5 and 28 confirmed on 05/06/2025, that the facility did not maintain documentation to demonstrate appropriate disinfection and repeat culture and endotoxin testing with medical director approval to return the machines to service for the above listed machines that had not been disinfected at least once every seven days as required.”

“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 a review of facility policies and procedures, observation on tour, and an interview with staff, it was determined that the facility failed to require that. 1. Staff monitor and keep the arterial drip chamber 85-95% full, which has the potential for air entering the bloodlines, which can lead to a patient’s injury or death, due to an air embolism; 2. Medications, supplies, and equipment have not expired. Failure of staff to follow facility policy regarding equipment and supply expiration dates has the potential risk of using expired supplies and equipment for patients, which could lower the efficacy of the equipment or supplies and could expose patients to a risk of infection; and 3. Bleach and citric acid were not stored appropriately which has the potential for harmful vapors and chemical reactions that may harm patients and staff. Findings include: 1. A review of facility policy titled, “ Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer” revealed: “...The arterial chamber is 85-95% full ... monitor pressure changes in the arterial chamber to ensure adequate blood flow ... ensure that arterial chamber is filled to 85-95%....” Observation on a tour of the facility on 05/07/2025 revealed that the arterial drip chambers on the dialysis machines at stations #21, #1 were filled less than 50% full. Observation on a tour of the facility on 05/08/2025 revealed the arterial drip chambers on the dialysis machines at stations #1 and #4. At station number four, employee #18 did a patient safety check at 09:00 and did not fill the arterial chamber, and again at 09:23, did the patient safety check and did not fill the arterial chamber. Employee #1 confirmed during an interview on 05/07/2025, that the drip chambers should be filled to 85-95 % full. 2. Facility Policy titled, “ Expiration Dates Sterile Supplies” states, “...Expired supplies will be removed from stock and/or disposed of appropriately....” Observation on tour conducted on 05/07/2025, revealed the following expired supplies: (3) three boxes of Embrace Pro glucose meter high and low calibration solutions; expired 03/27/2025 (1) 28-gram tube Triple Antibiotic Ointment; expired 03/25 Male to Male Lure Adapters- 1 expired 02/07/2021, 6 expired 12/18/2022, 17 expired 03/01/2024 Path Tech Cultures- 5 expired 02/15/2024, 299 expired 05/02/2024 Yankauer- 1 expired 01/06/2024 (2) expired vacutainer blood collection tubes; expired 04/30/2025 Employee #1 and 11 visually verified that the stocked supplies were expired during the tour on 05/07/2025. Employee #1 acknowledged on 05/08/2025, that the supplies had expired and were not removed and/or disposed of per facility policy. 3. The policy titled “Acid Concentrate Storage and Handling” requires “... Do not store acid concentrates adjacent to bleach/bleach products....” Observation on 05/05/2025 revealed three (3) partially filled bleach containers for machine disinfection on a utility cart with (27) empty containers. Employee #5 confirmed on 05/05/2025 that bleach disinfection bottles should have been emptied and rinsed after use and not returned to the utility cart. Observation on 05/07/2025 revealed two utility carts side by side in the store room. One cart contained bleach disinfection bottles and a 1-gallon jug of open vinegar. The second cart contained an open jug of bleach. Employee #5 confirmed on 05/07/2025 that bleach and vinegar are not to be stored adjacent to each other for safety. Observation on 05/05/2025 revealed Minncare (peracetic acid-based disinfectant) solution jugs and bleach jugs stored side by side in the store room. The Centers for Disease Control and Prevention (CDC) document titled “Health Hazards and Protective Measures” revealed: “ ... Toxic gas chlorine can be released if you mix sodium hypochlorite (bleaching solutions) and acidic cleaning agents ....” Employees #5 and 28 confirmed on 05/06/2025, that the facility does not have a specific policy addressing the storage of bleach and Minncare adjacent to each other; however, the facility policy for storage of acid solutions and bleach together prohibit the practice as it can create toxic fumes if mixed.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure: 1. annual preventive maintenance was performed on the facility backflow prevention devices; and 2. staff accurately documented dialysis machine hours to perform annual preventive maintenance. Failure to accurately document time intervals for maintenance and perform routine preventive maintenance according to manufacturer’s recommendations poses a potential risk of patient harm or injury if equipment if not functioning per specifications. Findings include: Based on document review and interview, it was determined that the facility failed to ensure: 1. annual preventive maintenance was performed on the facility backflow prevention devices; and 2. staff accurately documented dialysis machine hours to perform annual preventive maintenance. Failure to accurately document time intervals for maintenance and perform routine preventive maintenance according to manufacturer’s recommendations poses a potential risk of patient harm or injury if equipment if not functioning per specifications. Findings include: 1. Documentation for annual testing and preventive maintenance was requested for the backflow prevention devices located in the facility water room. No reports or documentation was provided. Employee #28 confirmed on 05/07/2025, that no records were available for review. 2. The document titled “2008T HEMODIALYSIS SYSTEM PREVENTATIVE 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 facility policy titled “Equipment Installation - Operation - Maintenance - Repair - and Disposal” requires: “...Unless otherwise directed by company policy and procedures, all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions for use (IFU)....” The “FKC EQUIPEMENT 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. Dialysis machine 3T0S-120762 07/24/2024: clock hours 35,006; diasafe 08/20/2024: clock hours 15,217; annual preventive maintenance 09/20/2024: clock hours 35,363; diasafe Dialysis machine 3T0S-120799 07/24/2024: clock hours 21,639; diasafe 09/20/2024: clock hours 29,999; diasafe 09/20/2024: clock hours 22,126; annual preventive maintenance Dialysis machine 3T0S-121029 09/17/2024: clock hours 35,761; annual preventive maintenance 11/14/2024: clock hours 40,345; diasafe 01/11/2024: clock hours 36,989; diasafe 03/04/2025: clock hours 37,458; preventive maintenance 03/04/2025: clock hours 29,885; electrical leakage test 03/27/2025: clock hours 37,620; diasafe Dialysis machine 3T0S-121073 11/14/2024: clock hours 38,954; diasafe 11/14/2024: clock hours 24,765; annual preventive maintenance 01/11/2025 clock hours 20,642; diasafe 03/27/2025: clock hours 39,667; diasafe Dialysis machine 5T0S-145861 01/11/2025: clock hours 27,105 diasafe 03/27/2025: clock hours 24,312 diasafe Employees #5 and 28 confirmed on 05/06/2025 that clock hours documented in the equipment record were inaccurate and were unable to determine the appropriate timeframe for annual preventive maintenance.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. staff followed the physician’s prescribed hemodialysis (HD) order for machine temperature and Ultrafiltration (UFR) Profile for (3) of (5) patients (Patients #29, 58, and 59) receiving dialysis treatment on 05/07/2025; and 2. staff followed the physician’s prescribed HD order for blood flow rate (BFR). Failure to follow physician orders and not reporting abnormalities poses the potential risk of inadequate dialysis, decreased clearances, and hospitalizations. Findings include: 1. Patient #29 Observation on 05/07/2025 revealed the patient receiving dialysis treatment. The machine settings were compared to the patient’s HD order. The machine was set at a temperature of 37° Celsius. Patient #29’s HD ordered machine temperature was 36° C. Patient #58 Observation on 05/07/2025 revealed the patient receiving dialysis treatment. The machine settings were compared to the patient’s HD order. The machine was set at a temperature of 36° C and the machine was not set to for a UFR Profile #1. Patient #58’s HD ordered machine temperature was 37° C and had a UFR Profile #1 ordered. Patient #59 Observation on 05/07/2025 revealed the patient receiving dialysis treatment. The machine settings were compared to the patient’s HD order. The machine was set at a temperature of 36° Celsius. Patient #59’s HD ordered machine temperature was 37° C. Employee #13 confirmed on 05/07/2025 that Patients #29, 58, and 59’s machines were not set according to their HD prescription orders. 2. The facility policy titled “Patient Assessment and Monitoring” requires: “...Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow....” Patient #1 A treatment sheet dated 04/24/2025 revealed that a blood flow rate was prescribed at 450ml/min. At 06:01 the blood flow was set to 400ml/min, then set to 400ml/min at 06:24, with no documentation alerting the RN. A treatment sheet dated 04/26/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 06:40, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 05/03/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 07:02, the blood flow rate was set to 300ml/min, with no documentation alerting the RN. Patient #2 A treatment sheet dated 04/14/2024 revealed that a blood flow rate of 400ml/min was prescribed. At 14:50, the blood flow was set to 450ml/min, with no documentation alerting the RN. A treatment sheet dated 04/18/2025 revealed that a blood flow rate of 400ml/min was prescribed. At 14:43, the blood flow rate was set to 300ml/min, with no documentation alerting the RN. Patient #3 A treatment sheet dated 03/26/2025 revealed that a blood flow rate was prescribed at 600ml/min. At 15:39, the blood flow was set to 500ml/min. At 16:24, the blood flow rate was set to 450ml/min. At 17:08, the blood flow rate was set to 400ml/min. At 18:10, the blood flow rate was set to 350ml/min. At 18:28, the blood flow rate was set to 350ml/min. At 18:43, the blood flow rate was set to 400ml/min. At 19:09, the blood flow rate was set to 300ml/min, with no documentation alerting the RN. A treatment sheet dated 03/28/2025 revealed that a blood flow rate of 600ml/min was prescribed. At 16:24, the blood flow rate was set to 450ml/min. At 16:58, the blood flow rate was set to 500ml/min, with no documentation alerting the RN. A treatment sheet dated 03/29/2025 revealed that a blood flow rate of 600ml/min was prescribed. At 12:23, the blood flow rate was set to 550ml/min, with no documentation alerting the RN. A treatment sheet dated 03/31/2025 revealed that a blood flow rate of 600ml/min was prescribed. At 16:45, the blood flow rate was set to 500ml/min, with no documentation alerting the RN. A treatment sheet dated 04/02/2025 revealed that a blood flow rate of 600ml/min was prescribed. At 17:03, the blood flow rate was set to 500ml/min, with no documentation alerting the RN. A treatment sheet dated 04/04/2025 revealed that a blood flow rate of 600ml/min was prescribed. At 18:09, the blood flow rate was set to 500ml/min, with no documentation alerting the RN. Patient #4 A treatment sheet dated 04/22/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 13:01, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 04/29/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 11:23, the blood flow rate was set to 400ml/min, with no documentation alerting the RN. A treatment sheet dated 05/01/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 12:21, the blood flow rate was set to 350ml/min, with no documentation alerting the RN. Patient #10 A treatment sheet dated 04/03/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 07:03, the blood flow rate was set to 460ml/min, with no documentation alerting the RN. A treatment sheet dated 04/08/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 07:55, the blood flow rate was set to 300ml/min, with no documentation alerting the RN. A treatment sheet dated 04/10/2025 revealed that a blood flow rate of 450ml/min was prescribed. At 06:40, it was set to 400ml/min. At 07:01, it was set to 300ml/min, and then at 07:21, it was set to 400ml/min, with no documentation alerting the RN. Employee #1 confirmed during an interview on 05/07/2025 that this practice did not follow facility policy and procedures or physician orders.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 45999 Based on a review of facility policy, medical records, and staff interviews, it was determined that the facility failed to require clinical staff to notify the nurse and provide a documented intervention for (5) five out of (6) patients reviewed when the patient’s blood pressure (BP) and/or heart rate (HR) were out of range per the facility policy, which poses the potential risk of cardiovascular compromise and hospitalization. Findings include: The facility policy titled “Patient Assessment and Monitoring....” was published on May 1, 2023, revealed:” ...Report to the nurse: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic...Heart rates that have dropped below 60 or risen above 100 ...Report to the nurse any significant findings....” A facility document titled “2024 AZ Hemodialysis Standing Orders” revealed, “ ...Intra HD for a significant drop in systolic BP >40mm/Hg ...Notify nurse ....” “...Treatment Sheets....” revealed: Patient #1 04/24/2025 revealed: 07:44 BP:184/97 09:23 BP:194/100 09:41 BP:187/103 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Patient # 2 04/11/2025 revealed: Pre-sitting HR 59 15:22 HR:50 15:40 HR:53 16:02 HR:51 16:44 HR:52 17:03 HR:57 17:22 HR:52 04/14/2025 revealed: Pre-sitting HR 54 14:50 HR:53 15:01 HR:53 15:21 HR:54 15:46 HR:53 16:03 HR:53 16:20 HR:51 16:43 HR:52 17:05 HR:53 17:29 HR:51 17:42 HR:57 17:56 HR:51 04/18/2025 revealed: Pre-sitting HR 54 14:43 HR:53 15:02 HR:48 15:49 HR:48 16:03 HR:50 16:24 HR:53 16:41 HR:52 17:05 HR:50 17:20 HR:54 17:43 HR:55 04/21/2025 revealed: Pre-sitting HR 51 14:49 HR:54 15:01 HR:50 15:14 HR:50 15:22 HR:42 15:41 HR:49 16:01 HR:48 16:24 HR:44 16:44 HR:49 17:02 HR:49 17:23 HR:42 17:50 HR:50 04/25/2025 revealed: Pre-sitting HR 51 14:42 HR:59 15:10 HR:51 16:02 HR:51 16:21 HR:49 16:43 HR:51 17:03 HR:51 17:23 HR:52 17:41 BP:181/80 HR:54 04/28/2025 revealed: Pre-sitting HR 57 14:44 HR:57 15:00 HR:55 15:40 HR:51 16:02 HR:51 17:06 HR:55 17:25 HR:55 17:44 HR:48 The facility administrator could not provide documentation of the RN being made aware of vital signs out of range and/or a change in vital signs. Patient #4 04/22/2025 revealed: Pre-sitting BP:205/87 10:53 BP:201/81 11:45 BP:213/91 12:05 BP139/72 (40 POINT DROP) 13:23 BP:188/84 04/24/2025 revealed: Pre-sitting BP:192/62 Pre-standing BP:203/122 10:51 BP:183/75 11:13 BP:192/76 04/29/2025 revealed: 11:03 BP:208/88 11:23 BP:195/78 11:42 BP:206/86 12:02 BP:183/59 12:24 BP:211/66 12:47 BP:181/73 13:03 BP:190/73 13:46 BP:197/78 05/01/2025 revealed: re-sitting BP:192/97 Pre-standing BP:195/83 13:24 BP:193/77 13:43 BP:143/85 (40 POINT DROP) 13:56 BP:205/87 05/03/2025 revealed: 12:22 BP:189/72 13:00 BP:182/61 13:24 BP:192/78 13:43 BP:191/61 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Patient #9 04/28/2025 revealed: 07:02 BP:181/75 09:01 HR:104 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Patient #10 03/13/2025 revealed: 10:00 HR:104 04/03/2025 revealed: 10:02 HR:102 The facility administrator was unable to provide documentation of the RN being made aware of vital signs out of range. Employee #1 confirmed during an interview on 05/07/2025 that no documentation of RN notification and/or intervention for out-of-range vitals was available as required per facility policy.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure the charge nurse had annual water skills validated within the last 12 months which poses a risk to the health and safety of patient receiving dialysis treatment if the charge nurse is not trained and qualified to perform all components of the dialysis treatment. Findings include: Personnel files were reviewed for Employees #1, 2, 3, 5, 6, 7, 8, 9, 10, 17, 19, and 22. The personnel file review covered a comprehensive cross section of staff, job descriptions and duties, and the requirements before performing in the role each individual was hired to perform. Personnel files for the staff listed above were complete and contained the required documentation of verification of skills and knowledge required in their job descriptions. Employee #13 ’ s personnel file revealed that the “ Fresenius Kidney Care DPC Water Skills Validation “ annual skills checklist was completed on 05/05/2025 which occurred the first day of the survey. An annual water skills validation completed within the last 12 months prior to the survey was requested but not provided. Additionally, the skill validation checklist had not been signed by the medical director as certifying that the employee demonstrated competency for the skills validated. Employee #13 ’ s job description for registered nurse requires annual validation of water skills. Employee #1 confirmed on 05/07/2025 that demonstration of annual water skills prior to the survey was not documented and could not be provided.”