Davita Vincennes Dialysis

“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: 48387 Based on record review and interview, the Facility failed to complete the required tabletop emergency preparedness exercise, affecting 1 of 1 facility Emergency Preparedness review. Findings include: A binder for Emergency Preparedness failed to evidence emergency preparedness exercise for 2023 During an interview on 04/04/2025, the FA indicated she could not locate an emergency exercise for 2023 in the binder or office.”

“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: 38262 Based on observation, record review, and interview, the facility staff failed to ensure hand hygiene and glove changes were performed before and after removing gloves, before caring for a patient, before preparing medication, and after touching dirty equipment and bloodlines and failed to provide education on infection control for 10 of 10 staff observations. (PCT 1, PCT 3, PCT 4, PCT 5, RN 1,RN 2, RN 3) Findings include: 1. A revised 04/2023 policy titled “Infection Control for Dialysis Facilities” indicated staff should perform hand hygiene before gloving and immediately after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery contact, and before leaving the treatment area. The policy indicated that staff should encourage patients to wash their hands after contact with infectious material and glove removal. 2. A revised 10/2023 policy titled “Medication Policy” indicated that staff must utilize aseptic techniques when preparing and administrating medications. 3. During a medication preparation and administration observation on 04/01/2025 at 10:10 AM, PCT 1 left Station #12 with gloved hands, went to the medication preparation counter, removed medication from the locked cabinet, prepared medication, and returned to Station #12. PCT 1 failed to remove gloves and perform hand hygiene before collecting and preparing medication, after preparing medication, and before returning to Station #12. 4. During an AV Fistula initiation observation on 04/01/2025 at 10:12 AM, PCT 1 touched the computer keyboard, donned gloves, and then cleaned Patient # 12’s AV fistula site. PCT 1 failed to perform hand hygiene after touching the computer keyboard and before gloving. PCT 1 with gloved hands, inserted cannulation needles, removed gloves, collected a thermometer, and gave it to a teammate. PCT 1 failed to hand hygiene after removing gloves and before touching the thermometer. During an interview on 04/01/2025 at 3:00 PM, PCT 1 indicated that staff should wear gloves while providing patient care. She indicated staff should practice hand hygiene before and after touching anything related to the patient. 5. During an observation on 04/01/2025 at 10:25 AM, RN 1 disinfected the treatment chair at Station #11 with gloved hands. She removed one glove and touched the dialysis machine screen to silence an alarm with her finger at Station #10. RN 1 failed to remove both gloves, perform hand hygiene, and apply clean gloves before touching another dialysis machine. During an interview on 04/01/2025 at 12:55 PM, RN 1 stated she received training on infection control. She stated staff should wear gloves to touch the dialysis machine screen. She stated staff should remove gloves and perform hand hygiene during patient care. 6. During an observation on cleaning and disinfecting of the dialysis station on 04/01/2025 at 10:34 AM, PCT 5 walked to Station #10 with disinfectant rags in hand, silenced the alarm on the dialysis machine with his elbow, and continued to Station # 4 to disinfect the station. PCT 5 left Station #4 with a used disinfectant rag in the gloved hand, went to Station #1, silenced the dialysis machine with his elbow, then returned to Station #4 to continue cleaning with the rag. PCT 5 failed to follow infection control procedure of removing gloves and disinfection hands before and after touching Station #10 and Station #1’s dialysis machine. 7. During a CVC initiation observation on 04/02/2025 at 11:55 AM, RN 2 completed CVC site care, and then cleaned CVC hubs on Patient #2. RN 2 failed to change gloves and hand hygiene after finishing CVC site care and before starting dialysis with CVC on Patient #2. 8. During an observation on 04/02/2025 at 9:50 AM, RN 2, with gloved hands, collected clean supplies, went to Station # 10, silenced the dialysis machine alarm using gloved hand, then went to the computer between Station #8 and Station #9, placed clean supplies on a computer cart, documented on a computer with gloved hands, then used clean supplies to discontinue Patient #21’s treatment. RN 2 failed to remove gloves and hand hygiene before collecting clean supplies, before and after silencing the dialysis machine alarm, and before touching Patient #21’s AV’s fistula. 9. During an observation on 04/02/2025 at 9:42 AM, Patient #17 applied a glove and held pressure to their AV site to stop bleeding after disconnecting from the bloodlines. RN 3 assisted Patient #17 in removing their glove but did not offer the Patient hand sanitizer before leaving the treatment area. 10. During an observation of a disconnect with a CVC on 04/02/2025 at 9:50 AM, PCT 3 removed the first bloodline from Patient #12, removed gloves, and touched the computer keyboard. PCT 3 failed hand hygiene after removing gloves and touching the community keyboard. PCT 3 removed Patient #12’s second bloodline, removed gloves, collected supplies from a clean area, returned to Patient #12, gloved and removed Patient #12’s first needle. PCT 3 failed to perform hand hygiene after removing gloves and before collecting supplies from a clean area and failed to perform hand hygiene before gloving to remove Patient #12’s first needle. 11. During an AV Fistula initiation observation on 04/02/2025 at 10:25 AM, PCT 3 removed dirty supplies from the side table with gloved hands and then touched the bloodline to reinfused blood on Patient # 13. PCT 3 failed to change gloves and hand hygiene after removing dirty supplies and before touching Patient #13’s bloodline. 12. During a medication preparation and administration observation on 04/02/2025 at 11:50 AM, PCT 2, with gloved hands, prepared medication, returned to Station #10, and attached a syringe to the dialysis machine. PCT 2 failed to remove gloves and hand hygiene after preparing medication before returning to Station #10. PCT 2 touched the computer keyboard between Station # 10 and Station #11, then the dialysis machine screen. PCT 2 failed to remove gloves and hand hygiene after attaching a syringe to the dialysis machine and before touching the computer keyboard; after the computer keyboard and before touching the dialysis machine screen. 13. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services stated that staff and patients are to remove gloves and perform hand hygiene after touching access sites and bloodlines, removing gloves, and leaving the treatment area.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 38262 Based on observation, record review, and interview, the facility staff failed to store Personal Protective Equipment (PPE) such as face shields, gowns, and gloves, and staff personal items in a designated area for 2 of 3 observation days. Findings include: 1. A revised 04/2023 policy titled “Infection Control for Dialysis Facilities” indicated staff should disinfect and store PPE and non-disposable items in a designated area. The policy indicated staff should store supplies in a manner that maintains their integrity and prevents cross-contamination. Food and drinks in the treatment area are limited to patients. Sharing and storage in the treatment area were not allowed. Staff should store disposable gloves and alcohol-based hand rub containers on the chair side cart. 2. During flash tour observation on 04/01/2025 at 9:33 AM, a drawer labeled “Needle Kits” had a used bottle of water lying on top of a drawer of prepared needle kits for AV fistula access sites. 3. During the flash tour on 04/01/2025 at 9:47 AM, the surveyor found two face shields with smear marks and fingerprints sitting on the counter at nurse’s station 1, a designated clean area. 4. During the flash tour on 04/01/2025 at 9:49 AM, the surveyor found two face shields with smear marks and fingerprints sitting on the counter at nurse’s station 2, a designated clean area. 5. During a random interview on 04/01/2025 at 10:16 AM, PCT 4 stated PPE should be placed on the wall hooks when not in use. 6. During a CVC site care observation on 04/02/2025 at 11:55 AM, RN 2 placed a community alcohol sanitizer container on Patient #2’s chair side table; RN 2 placed a community box of gloves on Patient #2’s lap. RN 2 picked up the alcohol container from the floor and placed it on the computer cart between Station #10 and Station #11. RN 2 failed to disinfect the alcohol container after picking it up from the floor and before placing it in a clean area. 7. During an interview on 04/01/2025 at 3:00 PM, PCT 1 indicated that staff are not allowed to have personal items such as water bottles and cell phones on the treatment floor. She indicated that these items are not to be placed with clean supplies. 8. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services stated staff should hang their face shields on a hook on the wall in a designated area for PPE. The Manager of Clinical Services indicated staff are not allowed to have water bottles on the treatment floor, and staff should not store personal water bottles with clean supplies. She indicated that the staff should not place community alcohol containers on the side table of the treatment chair, and they should not place the box of gloves on the patient’s lap.”

“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: 38262 Based on observation, record review, and interview, the facility staff failed to follow applicable infection control procedures when cleaning and disinfecting contaminated surfaces and equipment for 3 of 3 cleaning and disinfection of the dialysis station observations. (Stations 4, 8, 11) Findings include: 1. A revised 04/2023 policy titled “Infection Control for Dialysis Facilities” indicated staff should clean and disinfect the dialysis station at the end of each treatment. The policy indicated staff should clean and disinfect all surfaces of the dialysis chair, trays, wall box, TV, and countertops. 2. During an observation on 04/01/2025 at 10:20 AM, RN 1 failed to clean and disinfect the outside panels of the treatment chair, TV, wall box, and countertop behind the dialysis machine at Station #11. During an interview on 04/01/2025 at 12:55 PM, RN 1 stated staff should clean and disinfect the station’s treatment chair, TV, wall box, and countertops. 3. During an observation on cleaning and disinfecting of the dialysis station on 04/01/2025 at 10:34 AM, PCT 5 failed to clean the counter at the back of Station #4. PCT 5 failed to empty and disinfect the prime rinse container before setting the machine up for the next patient. 4. During an observation on 04/02/2025 at 11:00 AM, the chair side table at Station #8 had blood on it; PCT 3 prepared a dialysis machine at Station #8 for the next patient and was ready to place the new patient in the chair. During an interview on 04/02/2025 at 11:00 AM, PCT 3 confirmed that there was blood on the chair side table, and the station should be clean and free of blood before the next patient is allowed in a chair. She indicated she was not the one who had cleaned the chair. 5. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services indicated staff should clean the counter behind the station, television, and prime rise container before preparing the machine for the next patient. She indicated they should clean the outside of the chair. The Manager of Clinical Services indicated that staff should clean visible blood off surfaces.”

“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: 38262 During an observation, record review, and interview, the facility staff failed to place a clean field under a CVC port for 2 of 2 CVC initiation observations. (Patients #2, #14) Findings include: 1. A revised 10/2024 policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” indicated staff should hold the catheter(a thin, flexible tube inserted into a large vein near the heart) with the non-dominate hand, and use the other hand to place a sterile 4 X 4 gauze under the catheter limbs. The policy states that placing gauze under the catheter limbs provides a sterile surface. 2. During an observation on 04/02/2025 at 11:50 AM, PCT 3 failed to place a clean field under Patient #14’s CVC port before disinfecting the CVC hubs (the connector or port on a CVC where medications, fluids, or other interventions are accessed). 3. During a CVC initiation observation on 04/02/2025 at 11:55 AM, RN 2 completed CVC exit site care on Patient #2, then cleaned CVC hubs and laid hubs on dirty drapes from exit site care. RN 2 failed to remove or cover the dirty drape with sterile 4 X 4 gauze before disinfecting the CVC hubs on Patient # 2. 4. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services indicated staff should place a clean field under the CVC port before disinfecting the CVC hubs. She stated staff will need more education on this.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 38262 Based on observation, record review, and interview, the staff failed to follow manufacturer instructions on the wait time to obtain accurate pH test results for 2 of 2 preparations of the Hemodialysis Machine observations. (PCT 3, PCT 4) Findings include: 1. A document titled “E-Z Check 6.8 - 8.5 pH test Strips” indicates users should compare test results to the color scale on the bottle between 20 and 25 seconds after briskly shaking off excess solution. 2. During a random hemodialysis machine set-up observation on 04/01/2025 at 10:16 AM, PCT 4 removed the pH test strip (a test that measures the acidity or alkalinity of a substance) from the solution and read the pH strip immediately. PCT 4 failed to follow the manufacturer’s instructions to collect an accurate pH reading. During an interview on 04/01/2025 at 10:17 AM, PCT 4 stated she reads the pH test strip immediately because the solution runs down the strip quickly, causing the colors to bleed together. 3. During the preparation of the hemodialysis machine on 04/02/2025 at 10:15 AM, PCT 3 ran the solution over the pH strip and read the pH strip without looking at the clock or watch to allow for a 20-25-second test strip process time. PCT 3 failed to collect an accurate pH reading. During an interview on 04/02/2025 at 10:15 AM, PCT 3 indicated she was unsure of the required wait time before reading the pH test results.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 48387 Based on observation, record review, and interview, the agency failed to maintain confidentiality by locking the computer screen when left unattended for 2 of 2 observation days. Findings include: 1. A policy dated 06/2022 titled “ Administrative, Technical, and Physical Safeguards for Protected Health Information” states “ Teammates are required to log off terminals or use the lock workstation function prior to leaving the work area.” 2. During flash tour observation on 04/01/2025 at 9:55 AM, RN 4 failed to log out of the computer before leaving the nurse’s station. The facility failed to maintain confidentiality of patient health information (PHI). 3. During an observation on 04/02/2025 at 9:20 AM, RN 2 failed to log out of the computer before leaving the nurse’s station. The facility failed to maintain confidentiality of patient health information. 4. During an observation on 04/02/2025 at 9:20 AM, RN 3 failed to log out of the computer before leaving the nurse’s station. The facility failed to maintain confidentiality of patient health information. 5. During an observation on 04/02/2025 at 11:05AM, RN 2 failed to log out of the computer before leaving the nurse’s station. The facility failed to maintain confidentiality of patient health information. 6. During an observation on 04/02/2025 at 11:46 AM, PCT 4 failed to log out of the computer before leaving the nurse’s station. The facility failed to maintain confidentiality of patient health information. 7. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services indicated that staff are to lock their unattended computer.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 38262 Based on record review and interview, the medical director failed to ensure facility staff followed policy and procedures related to performing a pretreatment assessment within one hour of starting treatment for 6 of 7 records reviewed (Patients #1, #3, #4, #5, #6, #10) failed to follow policy and procedure related to completing a nursing assessment prior to starting a new patient’s dialysis treatment for 1 of 1 new admission record reviewed (Patient #3), failed to follow policy and procedure when assessing an atrioventricular (AV) access site for 2 of 2 access of an AV site observations (Patient #2, #8) failed to follow policy and procedure in regards to storing and labeling heparin syringes with a date, time, and initials when preparing medication for 2 of 2 nursing station observations (nurse station 1, nurse station 2) and for 1 of 2 rolling cart observations (rolling cart #1), and failed to follow policy and procedures regarding a Ultrafiltration rate (UFR) outside of safe parameters for 1 of 1 patients with an abnormal UFR record review. (Patient #3) Findings include: Patient Assessment 1. A 04/2024 revised policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” indicated that licensed nurses should confirm patients’ prescriptions and perform a nursing assessment on patients within one hour of treatment initiation. 2. A review of Patient #1’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 04/01/2025 indicated a treatment start time of 6:24 AM; RN 1 documented a pretreatment assessment time of 8:06 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. During an interview on 04/01/2025 at 12:50 PM, RN 1 stated nurses should perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/20/2025 indicated a treatment start time of 6:41 AM; RN 6 documented a pretreatment assessment time of 8:49 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/13/2025 indicated a treatment start time of 6:40 AM; RN 5 documented a pretreatment assessment time of 8:27 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 3. A review of Patient #3’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 04/01/2025 indicated a treatment start time of 6:10 AM; RN 1 documented a pretreatment assessment time of 8:04 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/20/2025 indicated a treatment start time of 6:17 AM; RN 6 documented a pretreatment assessment time of 8:48 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/15/2025 indicated a treatment start time of 6:43 AM; RN 7 documented a pretreatment assessment time of 8:33 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 4. A review of Patient #4’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 03/28/2025 indicated a treatment start time of 9:50 AM; RN 1 documented a pretreatment assessment time of 11:31 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/17/2025 indicated a treatment start time of 9:43 AM; RN 1 documented a pretreatment assessment time of 11:25 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/14/2025 indicated a treatment start time of 9:46 AM; RN 4 documented a pretreatment assessment time of 11:05 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 5. A review of Patient #5’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 03/12/2025 indicated a treatment start time of 2:23 PM; RN 5 documented a pretreatment assessment time of 4:09 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 6. A review of Patient #6’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 03/28/2025 indicated a treatment start time of 1:36 PM; RN 3 documented a pretreatment assessment time of 6:40 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/19/2025 indicated a treatment start time of 11:27 AM; RN 3 documented a pretreatment assessment time of 1:56 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/12/2025 indicated a treatment start time of 11:26 AM; RN 5 documented a pretreatment assessment time of 1:43 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 7. A review of Patient #10’s record failed to evidence timely assessments for the following dates: A Treatment Detail report dated 03/19/2025 indicated a treatment start time of 12:12 PM; RN 3 documented a pretreatment assessment time of 1:31 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Detail report dated 03/12/2025 indicated a treatment start time of 11:01 AM; RN 5 documented a pretreatment assessment time of 12:35 PM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. 8. During an interview on 04/03/2025 at 10:44 AM, the Manager of Clinical Services stated she knew staff were not completing their nursing assessments within the hour of starting the treatment. She was not able to provide documentation of staff education regarding the issue. New Patient Assessment A 04/2024 revised policy titled “Initial Patient Nursing Assessment for New Patients” indicated the RN should perform an initial pretreatment evaluation before their first dialysis treatment. A review of Patient #3’s record evidenced an Initial Patient Nursing Assessment dated 02/19/2025 at 4:46 PM. Patient #3’s first dialysis treatment was on 02/19/2025 at 3:32 PM. The facility staff failed to perform the initial pretreatment assessment before the first dialysis treatment. During an interview on 04/03/2025 at 1:30 PM, the Manager of Clinical Services stated that staff should have performed the pretreatment assessment before their first dialysis treatment. She stated staff should know how to do this. Assessing AV site 1. A policy titled “Arteriovenous Fistula (AF) and Arteriovenous Graft Vascular Access Care” indicates that the staff should determine the direction of access flow before accessing AF. 2. During an AV Fistula initiation observation on 04/01/2025 at 10:12 AM, PCT 1 failed to evaluate AV access (locate and palpate) after washing Patient #8’s skin over the access site and before initiating dialysis. During an interview on 04/01/2025 at 3:00 PM, PCT 1 indicated staff are to listen to AV fistula sites, but she was unsure if staff have to feel the site before accessing. 3. During an AV Fistula initiation observation on 04/01/2025 at 10:25 AM, PCT 4 failed to evaluate AV access after washing Patient #2’s skin over the access site and before initiating dialysis. 4. During an interview on 04/01/2025 at 1:50 PM, RN 1 indicated staff are to look, listen, and feel the AV fistula site before accessing the site for treatment. 5. During an interview on 04/03/2025 at 1:00 PM, the Manager of Clinical Services indicated that the staff must take 10 seconds to assess the AV fistula by listening to the fistula with a stethoscope before accessing the site. Labeling and storage of medications 1. A revised 10/2023 policy titled “Medication Policy” indicated that if staff prepares medication in a syringe, staff should label the syringe with the date, time, and initials of the person who prepared the medication if not used immediately. The policy indicated staff should store non-refrigerated medications in a locked cabinet if not supervised by a licensed nurse. 2. During a flash tour on 04/01/2025 at 9:40 AM, the surveyor found four pre-drawn Heparin (anti-clotting medication) syringes identifying the name of the medication on the counter unattended at nurse’s station 1. The staff failed to include the date, time, or initials of the person who prepared the medication and failed to lock up unsupervised medications. During an interview on 04/01/2025 at 9:41 AM, PCT 6 stated she did not know who prepared the Heparin syringes. She stated the syringes should include the date, time, and initials of the person who prepared the medication. 3. During a flash tour on 04/01/2025 at 9:43 AM, the surveyor found two pre-drawn Heparin syringes unattended at nurse’s station 2. The staff failed to lock up unsupervised medications. 4. During a flash tour on 04/01/2025 at 9:47 AM, the surveyor found four pre-drawn Heparin syringes sitting on top of two intravenous (IV) solution bags in an unattended rolling cart #1 near the isolation room. 5. During an interview on 04/01/2025 at 12:55 PM, RN 1 stated staff can store Heparin syringes on the counter or top of the patient’s dialysis machine. She stated they could draw the medication 4 hours before giving it. 6. During an interview on 04/02/2025 at 10:15 AM, PCT 3 indicated staff must keep medication in a locked drawer if they have not administered it immediately after pulling it from the vial. She state that team members should label medication not given immediately with the patient’s information, the time and date the medication staff removed from the vial, and the staff’s initials. 7. During an interview on 04/02/2025 at 3:00 PM, the Manager of Clinical Services stated staff must label the Heparin syringes with a date, time, and initials. She said staff must store the pre-drawn Heparin syringes in a locked drawer. UFR outside parameters A revised 04/2024 policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” indicated that staff should follow the prescribed UFR (the speed at which the dialysis machine would remove water during dialysis recommended below 13 mL/h/kg (milliliters/hour/kilogram)). The policy stated staff should report any abnormal findings or findings outside of physician-specific ordered parameters to the nurse. Staff should notify the physician of any concerns that may preclude the initiation of dialysis. The nurse assesses the patient’s needs to determine interventions and notifies the physician of abnormal findings. Staff should document any interventions and patient responses in the medical record. A review of Patient #3’s Treatment Details Reports evidenced a UFR greater than 13 mL/h/kg (above 13 is associated with a higher risk of death) for the following dates: 03/31/2025- UFR 15.5, 03/26/2025 - UFR 13.6, 03/24/2025 - UFR 13.9, 03/17/2025 - UFR 15.1, 03/14/2025 - UFR 13.4, 03/12/2025 - UFR 13.2, 03/10/2025 - UFR 14.5, 03/07/2025 - UFR 14.3, 03/05/2025 - UFR 14.2, and 03/03/2025 - UFR 15.2. A review of Patient #3’s Treatment Details Reports dated 03/03/2025 to 03/31/2025 failed to evidence staff offered Patient #3 an extra treatment, increased the treatment time, adjusted medications, or obtained a physician order to run the UFR higher than 13 mL/h/kg. During an interview on 04/03/2025 at 12:50 PM, the Manager of Clinical Services reviewed Patient #3’s Treatment Detail Reports, POC, and nursing and physician notes. She stated she could not find documentation of where staff addressed the high UFR by offering an extra treatment, increasing the treatment time, or adjusting medications. She stated staff assessed the patient’s weight, but there were no new orders, and the patient continued to run above 13 mL/h/kg, which was unacceptable without a physician order. She stated the staff should call to get an order from the physician to run the patient outside of parameters. She stated the facility does not have a specific UFR policy.”