Davita Kresge Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45246 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment and follow infection control and prevention processes resulting in the potential for the spread of infectious disease amongst all 87 patients receiving dialysis treatment at the facility. Findings include: See specific tags: V-111 The facility failed to provide a sanitary environment. V-113 The facility failed to ensure that staff changed disposable gloves and performed hand hygiene when caring for the patient. V-116 The facility failed to ensure that items taken into the dialysis station were cleaned and disinfected before being taken to a common clean area or used on another patient. V-117 The facility failed to ensure clean supplies were not in close proximity with dirty materials. V-122 The facility failed to disinfect dialysis stations after treatments. V-143 The facility failed to ensure that expired medications were not available for use.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 22960 Based on interview and record review, the facility failed to update their Emergency Preparedness plan biannually, resulting in the potential for less than optimal outcomes for all patients in the event of an emergency. Findings include: On 2/11/25 at 11:30 AM, the facility’s Emergency Plan was reviewed with the Facility Administrator (FA) “A”. It was noted that the policies located in the emergency binder were last revised April 2019. The title page for the corporate Emergency Plan located in the binder was blank. The Hazard Vulnerability Assessment (HVA) located in the binder was dated from 2019. There was no evidence that the Emergency Plan or the HVA had been updated within the last 2 years. When queried at that time about an updated Emergency Plan and HVA, FA “A” stated “We’re working on that.” Review of the Corporate “Facility Emergency Management Plan” revised April 2024 noted: “Facility Hazard Vulnerability Assessment...2. FA or designee will identify, evaluate and rate each hazard ANNUALLY...”.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 22960 Based on interview and record review, the facility failed to maintain emergency preparedness training for staff based on the emergency plan, resulting in the potential for inadequate staff response during an emergency. Findings include: On 2/11/25 at 11:30 AM, the facility’s Emergency Plan was reviewed with Facility Administrator (FA) “A”. When asked to provide documentation of the initial staff training on the facility’s Emergency Plan, as well as evidence that staff are provided emergency preparedness training at least every 2 years, FA “A” briefly looked through some files in a file cabinet and then stated, “I don’t have that.” Review of the “Facility Emergency Management Plan” revised April 2024 noted: “Training and Education Emergency Management Plan 1. The FA or designee, is responsible to provide training of EMP: a. Teammates i. ANNUALLY 1. Policy Facility Emergency Management Plan 2. Appropriate hazard policies, per HVA 3. Clinical emergency policies 4. Facility specific emergency response procedures.””

“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: 22960 Based on interview and record review, the facility failed to conduct the annual tabletop and community-based emergency preparedness training, resulting in the potential for inadequate facility response during an emergency event, endangering the health and safety of all patients and staff. Findings include: On 2/11/25 at 11:30 AM, the facility’s Emergency Preparedness Plan was reviewed with Facility Administrator (FA) “A”. There was no documentation of a full-scale community exercise, or communication with a local jurisdiction stating that they would excuse the facility’s participation in the community-based exercise. There was no documentation of an emergency scenario with a set of problem statements and questions designed to challenge the emergency plan, no analysis of the facility’s response and any revision to the facility’s emergency plan if needed. FA “A” confirmed that neither a full-scale community based exercise nor a table-top exercise had been completed. Review of the “Facility Emergency Management Plan” revised 04/2024 noted: “Emergency Drills 1. The FA or designee, will maintain the emergency preparedness training and testing based on the facility EMP...e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least ANNUALLY, conducted on OPPOSITE years (one year full-scale exercise, next year facility based/exercise of choice): 1. Full-scale exercise that is community-based...2. Individual facility-based exercise: a. Tabletop exercise that includes a group discussion led by the FA...”.”

“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: 45246 Based on observation, interview and record review, the facility failed to provide and maintain a safe and sanitary environment resulting in potential for infection transmission and negative outcomes for the 32 patients receiving dialysis treatment in the facility. Findings include: During the initial tour of the facility on 02/10/25 from 1030 to 1240, the floor around stations #22 and 23 was observed to be covered with white and dark gray sediment and crystals. Water boxes behind these stations had white crystalized sediment in them. Back ledge was dusty with a mouse trap sitting on top of it. Computer station base was covered with white sediment. There was a chair in a corner across from station #23 with multiple tears in the cushion and it was covered by white and gray sediment. Station # 17, 19 and 24 wall boxes had a large amount of white crystalized sediment in them. On 02/10/25 at 1123, during interview with Biomed technician, Staff D, he stated that it was the clinical staff’s responsibility to clean wall boxes after each patient treatment. Staff D acknowledged condition of the wall boxes and crystalized sediment in them. Further, on 02/10/25 at 1230, wall boxes behind stations #1, 2, 8, 7, and 30 were observed with solid white crystalized sediment in them and large areas of white residue around on the floor and wall cabinets. 50585 On 2/10/2025 at 1130, during a tour of the patient treatment area, a white sediment was observed present on the ledge and on the glass barrier above the sink labeled “clean.” A 5 liter oxygen concentrator was observed stored on the floor underneath the sink and the outside of the concentrator contained white sediment. An orange pylon labeled “Wet Floor” was observed on the floor next to the 5 liter oxygen concentrator and underneath the sink and the pylon contained white and gray sediment on the base of the pylon and on the sides of the pylon. PCT Staff C confirmed the findings at the time of discovery. Facility’s policy “Infection Control for Dialysis Facilities”, dated April 2023, was reviewed and revealed: “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area. Teammates will monitor and address wall box residue/build up and patency issues.” Facility’s policy “Physical Environmnet”, revised April 2018, was reviewed and revealed: “1. The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.””

“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: 15195 Based on observation, interview, and record review, staff failed to remove gloves and perform hand hygiene during initiation of dialysis with a central venous catheter for one of three observations, resulting in the potential for transmission of infectious agents to all 27 central venous catheter patients served by the facility. Findings include: On 2/10/25 at 1200, Staff F was observed initiating dialysis with a central venous catheter (CVC) at Station 14. After cleaning and upon initiation of dialysis, Staff F was observed going back and forth (approximately four times) to the clean supply station to get more supplies and syringes without removing gloves or performing hand hygiene. On 2/20/25 at approximately 1220, Staff F was queried about this practice, but he did not answer the question stating that “the patient wasn’t supposed to be here today (and more about the patient)...” Review of the facility policy titled “Infection Control For Dialysis Facilities, #1-05-01, dated April 2023” documented, “Hand Hygiene- All teammates... will perform hand hygiene... d. after patient and dialysis delivery system contact, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse...””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to disinfect a pH bottle (potential for hydrogen - used for measuring whether a solution was acidic or basic) after testing of the dialysis solution for 1 of 2 observations resulting in an increased likelihood for spreading disease to the 32 patients receiving treatment at the time of observation. On 2/11/2025 at 1045, Patient Care Technician Staff J was observed performing the pH testing at patient treatment station # 6. After testing, Staff J was observed transporting the pH bottle back to the common area and did not disinfect the pH vial after performing the test. Staff J was queried immediately after finishing their tasks on whether they disinfected the pH bottle, and they said “no.” According to the facility’s policy “Infection Control for Dialysis Facilities,” dated 4/2023, “Non-disposable items are to be disinfected after each patient use, prior to removal from the treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 45246 Based on observation, interview, and record review, the facility failed to ensure clean supplies were not in close proximity with dirty materials, resulting in the potential for the spread of infection to all patients receiving dialysis treatment at the facility at the time of observation. Findings include: During initial tour of the facility on 02/10/25 from 1030 to 1240, a large gray trash can was observed touching the clean supplies cart across from the station #19. Small black trash can under the dirty sink next to the nurses’ station was touching the clean supply cart next to it. On 02/11/25 at 0919 once again, the trash can was observed across from the station #19 touching the clean supply cart. At 02/11/25 at 1318, during observation with clinical coordinator, Staff B, the trash can was observed positioned in very close proximity (almost touching) to a clean supply cart. Staff B acknowledged the finding and stated that clinical staff responsible for maintaining separation between dirty and clean supplies. Review of the facility policy titled “Infection Control for Dialysis Facilities, #1-05-01, dated October 2021, revealed: “44. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.””

“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: 45246 Based on observation, interview, and record review, the facility failed to disinfect dialysis stations and surrounding surfaces following patients’ treatments, resulting in the potential for the spread of infection to the patients receiving dialysis treatment at the facility at the time of observation. Findings include: On 02/10/25 at 1115 dialysis technician, Staff C, was observed cleaning the station # 17. While wiping the patient chair, Staff C opened the wings, wiped them and closed them right away, and not allowing the surface to air dry. She did not wipe the footrest of the chair and did not clean the wall box behind the machine. On 02/11/25 at 0927 dialysis technician, Staff J, was observed cleaning the station # 16. Staff J did not wipe the wall box behind the dialysis machine. She cleaned the treatment chair, but did not wipe the foot stand. Facility’s policy “Infection Control for Dialysis Facilities”, dated April 2023, was reviewed and revealed: “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Disinfection. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area. Teammates will monitor and address wall box residue/build up and patency issues.””

“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: 45246 Based on observation, interview, and record review, the facility failed to ensure that IV (intravenous) medications and multi-dose vials of injectable medications were dated with expiration dates after they were pre-drawn or were accessed, resulting in the potential for negative outcomes for all patients receiving treatment at the time of observations. Findings include: During initial tour of the facility on 02/10/25 from 1030 to 1240, a syringe with Heparin 1:1000 was observed lying on a side table at station #18 next to clean supplies (station was ready for the next patient). Syringe did not have staff initials, date or time when medication was drawn. There was another syringe with Heparin 1:1000 observed lying on a side table at station #17. Syringe did not have staff initials, date or time when medication was drawn. On 2/10/25 at 1057 registered nurse, Staff B, confirmed observations of syringes without dates/times and initials. Staff B stated that technicians are required to date and initial Heparin syringes that were pre-drawn for treatments since syringes need to be used within 4 hours after preparation. Later, at 1120, another syringe with Heparin 1:1000 was observed lying on a side table at station #14. Syringe did not have staff initials, date or time when medication was drawn. On 2/11/25 at 0858 Heparin 1:1000 multidose vial (approximately 1/6 full) was observed on the clean cart across from stations # 15 and 16 with no date/initials when medication was open. 15195 On 2/10/25 at 1030, two vials of Heparin 30 milliliters solution were opened and undated in the supply/tech cart across from station 29. Interview with Tech G, on 2/10/25 at approximately 1040, revealed that she worked from that cart and had failed to date the vials. 50585 On 2/10/2025 at 1030, during a tour of the facility’s treatment area, a 4% lidocaine patch (medication) was observed to be stored in an unlabeled drawer. The drawer also contained a candy bar and five pieces of candy. Nurse Clinical Coordinator Staff B confirmed the presence of the 4% Lidocaine patch stored with food. On 2/10/2025 at 1037, during an inspection of the facility’s medication refrigerator, an injectable syringe was observed to contain 2.5 milliliters of fluid and contained a medication label revealing Parsabiv 12.5 mg. The label did not have any date and time prepared or expiration date or time present. A multidose vial of Epogen 20,000 units was observed to be previously accessed and stored in a box in the medication refrigerator. The vial did not have any expiration date or time on the vial. Staff B confirmed the findings at the time of discovery and stated, “that is on me” regarding the syringe (the preparation date and time should be there). For the vial, Staff B revealed that they draw up the syringe first and then come back and label the vial with the expiration date and time. According to the facility’s policy “Medication,” dated 11/2023, the policy revealed the following: - “If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. - “Medications containing a preservative must be discarded 28 days after opening or accessed unless the manufacturer specifies a different date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date. Epogen multidose vials must be discarded 21 days after opening or accessed.” - “Medications and needle/syringe storage are done in accordance with state regulations.””

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 50585 Based on interview and record review, the facility failed to verify whether staff passed the color vision evaluation testing for 1 (Staff F) of 2 staff members, resulting in the potential for adverse consequences for all patients. Findings include: On 2/12/2025 at 1130, Patient Care Technician Staff F’s personnel file was reviewed. Staff F’s color vision evaluation sheet was reviewed and the sheet revealed that the test was performed by Facility Administrator (FA) Staff A on 6/18/2024. The instructions for performing the color vision evaluation as listed on the sheet revealed “For each plate, write the teammate’s/patient/helper response and circle the correct response below.” Staff F’s color vision sheet documentation did not verify whether Staff F successfully passed the color vision evaluation. The decision columns “Normal” or “Color Vision Defect” were not circled for color plates 1 through 9. Color plate 9 initially had the number 11 present but the 11 was crossed out and the number 2 was documented. On 2/12/2025 at 1150, Staff A was queried whether Staff F successfully passed the color vision evaluation including the evaluation for color plate 9, and they said “yes.” On 2/12/2025 at 1210, the facility’s policy “Color Vision Evaluation,” dated 10/2017, was reviewed and the policy revealed that “Documentation of the color vision evaluation will be documented in the teammate’s file and/or patient’s medical record.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 22960 Based on observation, interview, and record review, the facility failed to provide backflow protection for the drain lines of 3 of 32 hemodialysis machines, resulting in the potential for contamination of the hemodialysis machines from backflow of contaminants. Findings include: On 2/11/25 at 9:30 AM, during an observation of the treatment floor with Biomed “D”, the drain lines for the machines at stations 2, 28, and 29 were observed without an air gap to prevent backflow of gas, liquid, or solid contaminants. When queried at that time, Biomed “D” stated the valve boxes for machines 2, 28, and 29 were scheduled to be replaced, so the drain lines had been detached from the boxes, and placed directly down into the floor drains. According to the 2021 Michigan Plumbing Code, incorporating the 2021 edition of the International Plumbing Code, Section 802 Indirect Waste. “802.1 Protection: Devices, appurtenances, appliances and apparatus intended to serve some special function, such as sterilization, humidification, distillation, processing, cooling, or storage of ice or foods, and that discharge to the drainage system, shall be provided with protection against backflow, flooding, fouling contamination and stoppage of the drain.””

“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: 45246 Based on observation, interview and record review, the facility failed to ensure that staff adhered to policy and procedures regarding bloodflow and dialysate flow rates running as prescribed by the physician for 6 patients (P-1, 2, 3, 4, 6, 7, and 8) of 8 in-center patients reviewed for flow rate orders, resulting in the potential for negative patient outcomes. Findings include: On 2/10/25 at 1125 dialysis treatment orders were checked with registered nurse, Staff B, for the patient who was receiving dialysis treatment at station # 18 (P-8). Provider’s order indicated BFR (blood flow rate)- 450 mL/minute and DFR (dialysate flow rate)- 800 mL/minute. Dialysis machine had BFR set at 400 and DFR at 600. Staff B was asked if the expectations were for clinical staff to document the reason for rate changes, she stated “yes”. Staff B checked the record and stated that there was no documentation explaining the change in the dialysate rate for this patient. On 2/11/25 P-3 and P-4’s treatment sheets were reviewed and revealed the following documentation. P-3’s dialysis treatment orders for 1/18/25 indicated: duration- 240 min, BFR- 350, DFR- 800. Treatment flowsheet for P-3, dated 1/18/25, indicated that dialysis treatment began at 0645 and was done at 0956. At 0646 BFR was recorded as 350 and DFR was 500. At 0931 BFR at 350, DFR was changed to 600. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. P-3’s dialysis treatment orders for 02/04/25 indicated: duration- 270 min, BFR- 350, DFR- 800. On 2/04/25 treatment flowsheet for P-3 revealed dialysis began at 0542 and was done at 1018. For the duration of the treatment patient’s BFR was documented as 350 and DFR at 500. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. P-3’s dialysis treatment orders for 02/08/25 indicated: duration- 270 min, BFR- 350, DFR- 800. P-3’s treatment dated 02/08/25 started at 0534 and was done at 1026. At 0534 BFR was recorded 200 and DFR was 600. At 0604 BFR was changed to 300, DFR- 600. At 0632 BFR was changed to 250, DFR at 600. At 0920 BFR was changed to 200, DFR at 600. At 1002 BFR at 200 and DFR changed to 500. No nursing progress/treatment note was found with explanation of BFR and DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. P-4’s dialysis treatment orders for 1/31/25 indicated: duration- 165 min, BFR- 400, DFR- 800. On 1/31/25 treatment flowsheet for P-4 revealed dialysis began at 0544 and was done at 0833. For the duration of the treatment patient’s BFR was documented as 400 and DFR at 500. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. P-4’s dialysis treatment orders for 2/07/25 indicated: duration- 165 min, BFR- 400, DFR- 800. On 2/07/25 treatment flowsheet for P-4 revealed dialysis began at 1039 and was done at 1331. For the duration of the treatment patient’s BFR was documented as 400 and DFR at 500. No nursing progress/treatment note was found with explanation of DFR being outside the provider’s order and no record of provider’s notification was found for that treatment day. On 2/12/25 at 1043, during interview with facility’s medical director, Staff I, he was asked if his expectations were that all staff followed facility’s policies and procedures. He stated yes. When asked if he expected nurses to notify him or covering provider regarding any changes in dialysis treatment (BFR, DFR, treatment duration), Staff I said yes. 50585 On 2/10/2025 at 1345, P-1’s treatment sheets were reviewed. On 2/3/2025 and 2/7/2025, P-1’s prescription revealed a dialysis flow rate (DFR) of 800 mL/minute and a blood flow rate (BFR) of 450 mL/minute. On 2/3/2025, P-1’s documented DFR for the entire treatment was 600 mL/minute (200 mL/minute less than the prescribed rate). On 2/7/2025, P-1’s documented DFR from 0946 (treatment start time) to 1001 was 800 mL/minute. From 1031 to 1410, the documented DFR was 600 mL/minute. According to the Events/Comments sections for both dates, there was no documentation explaining why the DFR was running 200 mL/minute below the prescribed (800 mL/minute) rate. On 2/10/025 at 1400, P-2’s treatment sheets were reviewed. P-2’s prescriptions for 1/29/2025 and 2/3/2025 revealed a Dialysis Flow Rate (DFR) of 800 mL/minute and a Blood Flow Rate (BFR) of 350 mL/minute. On 1/29/2025 and 2/3/2025, P-2’s documented DFR for the entire dialysis treatment was 500 mL/minute. There was no documentation in the Events/Comments section of treatment sheets that revealed the reason why P-2 was receiving a DFR 300 mL/minute less than the prescribed (800 mL/minute) rate for both dates. On 2/11/2025 at 1230 Nurse Staff K was asked if the DFR was running at a different rate than prescribed, where would that be documented in the medcal record, and they revealed in the Events/Comments section on the treatment sheets. 15195 Additionally, review of P-6’s medical record revealed that he had an order for the Blood Flow Rate (BFR) to run at 400 and the Dialysate Flow Rate (DFR) to run at 800. The patient’s last six flow sheets (1/24/25 - 2/5/25) revealed that the physician orders were not followed for the BFR or DFR as follows: On 1/29/25 the BFR was documented at 300 and DFR was 600 without an order change or note by the nurse. On 2/3/25 the DFR was documented at 600 without an order change or note by the nurse. This was confirmed by Staff A on 2/11/25 at approximately 1500. Review of patient #7’s medical record revealed that he had an order for the BFR to run at 450 and the DFR to run at 800. The last seven flow sheets (1/23/25 - 2/8/25) revealed that the physician orders were not followed for the BFR or DFR on multiple days as follows: On 1/23/25 the DFR rate was documented at 600. On 1/25/25 the BFR rate was documented at 300-350 and the DFR rate was at 600. On 1/28/25 the BFR rate was documented at 350 and the DFR rate was at 600. On 1/30/25 the BFR rate was documented at 300-350 and the DFR rate was 600. On 2/8/25 the BFR rate was documented at 200 and the DFR rate was 600. On 2/11/25 at approximately 1500, Staff A verified that there was no order change or note by the nurse or tech. On 2/11/25 at approximately 1530, Clinical Services Manager (Staff M), verified that if/when the BFR or DFR are changed, there should be a note by the nurse documenting the reason for the change and the physician should be contacted for an order change. Review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, # 1-03-08, dated April 2024” documented, “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed... The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in the patient status...” Interview with the Medical Director (Staff I), on 2/12/25 at 1100, revealed that he expected staff to follow the facility policies and procedures.”