Davita East China Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment to minimize the transmission of infectious agents which could result in an increased potential for infections, for all 28 in-center patients currently being treated by the facility. Findings include: 1. The facility failed to maintain a sanitary environment: debris on the floor, environmental repairs needed on counter-tops; dust & leftover adhesive observed on multiple areas of the treatment floor. (See Tag V-0111) 2. The facility failed to ensure that staff remove Personal Protective Equipment (PPE /gowns, masks & gloves) when leaving the treatment area. (See Tag V-0115) 3. The facility failed to ensure that items taken into the dialysis station were disinfected prior to being returned to a common clean area or designated for single patient use. (See Tag V-0116) 4. The facility failed to ensure cell phones remained at a sufficient distance from patient stations to avoid contamination. (See Tag V-0119) 5. The facility failed to disinfect dialysis stations after treatments. (See Tag V-0122)”

“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 2/3/25 at 2:00 PM, 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 a table-top exercise, 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’s policy “Emergency Preparedness Drills” dated 4/07/07 noted: “2. EMP training exercises: a. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least ANNUALLY. Each type of exercise is required but each will be conducted on opposite years. i. Full scale exercise that is community-based is required when available, either with: 1) Emergency management agency 2) Healthcare coalition 3) NOTE: If one is not available: a. Conduct an individual facility-based exercise b. Document why facility was unable to participate in community exercise c. Maintain with facility EMP ii. Individual facility-based exercise: 1) Tabletop exercise that includes a group discussion led by the FA 2) Scenario relevant to facility 3) Designed to challenge facility EMP 4) Actions taken will be simulated and not disrupt patient treatments.””

“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: 38269 Based on observation, interview, and record review, the facility failed to keep a sanitary environment in the dialysis treatment area resulting in the potential for the spread of infectious disease amongst 9 patients receiving dialysis treatment at the time of observation. Findings include: On 02/03/2025 at 0930 during the initial tour of the dialysis treatment area, the floor was observed to have debris scattered throughout the unit. The observed debris included; used gloves, caps from syringes, scraps of paper, rolls of tape, dead insects, old holiday decorations, spattered drops of a dark rust/deep red substance on the floor, and gray balls of fuzz. On 02/03/2025 at 0937 during the initial tour of the dialysis treatment area, 2 of 2 nursing stations were observed to be cluttered with supplies, sticky notes, pens, paperclips, scraps of paper, rolls of tape, and a Band-Aid wrapper. Additionally both nursing stations had an accumulation of dust behind and on all computer components. On 02/03/2025 at 0940 during the initial tour of the dialysis treatment area, two large travel drinking cups were observed on top of a clean supply cart located in the treatment room. On 02/03/2025 at 1000 an interview was conducted with the Facility Administrator, Staff A. Staff A was queried about the concerns of an unsanitary environment including open drinks stored in the treatment area. Staff A confirmed the findings. Staff A stated, “those are staff cups and they do not belong on the treatment floor. I am not sure why there is so much stuff on the floor, it is usually clean.” Policy 1-05-01 Title: Infection Control for Dialysis Facilities last revised 04/2023. Page 5 of 5, #17. Food and drinks in the treatment area will be limited to patients. Sharing and storage of food and drink in the treatment area is not allowed. 22960 On 2/3/25 between 10:15 AM-10:30 AM, during an observation of the treatment area, the following items were observed: The counter located across from station 11 was observed to be missing the laminate strip along the front edge of the counter. There was exposed rough particle board, which was not smooth and easily cleanable. At stations 9 and 11, the countertop back-splash was lifted up and away from the counter, leaving a large gap where contaminates could seep down into the gap. At station 7, the back-splash under the window was missing the laminate covering, and the front edge of the counter directly behind the chair had several large chunks of missing laminate, with exposed rough particle board. In addition, there was rough, exposed particle board on the counter behind the chair at station 5. On 2/3/25 at 10:45 AM, Biomedical Technician “J” was queried about the condition of the counters in the dialysis treatment area. Biomedical Technician “J” stated he was not aware of the extent of dis-repair to the counters. Review of the facility’s policy “Physical Environment” dated 8-04-01 noted: “1. The dialysis facility will be...maintained to provide dialysis patients, teammates and the public a safe, functional, and comfortable treatment environment.””

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 38269 Based on observation, interview, and record review, the facility failed to ensure that staff remove personal protective equipment (PPE) prior to leaving the treatment area, resulting in the potential to spread infectious disease, among the 9 patients receiving dialysis treatment at the time of observation. Findings include: On 02/03/2025 at 0905, upon survey entrance, Staff H was observed in the front lobby (waiting area) wearing a white impervious gown, gloves and a mask (Personal Protective Equipment/PPE). On 02/03/2025 at 0906, Staff H was asked if this was an acceptable practice, she stated “oh, I guess I didn’t know.” On 02/05/2025 at 0805 Staff M was observed retrieving a patient from the lobby while wearing full PPE. On 02/05/2025 at 0815 an interview was conducted with the Facility Administrator (Staff A). Staff A was queried regarding PPE being worn outside of the treatment room area. Staff A stated, “I thought it was ok to wear PPE in the lobby if staff were picking up a patient.” Policy 1-05-01 Title: Infection Control for Dialysis Facilities last revised 04/2023. Page 2 of 5, “#5. PPE (gown, gloves, eye protection, face shield). a. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient areas. PPE is to be: a. Removed prior to leaving the treatment area.””

“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: 38269 Based on observation, interview, and record review, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common clean area or used on another patient, resulting in the potential to spread infectious diseases to all 9 patients receiving dialysis treatment at the time of observation. Findings include: On 02/03/2025 at 0946, aerosol spray cans (cooling spray used to decrease or alleviate pain during a needle stick) were observed placed on the chair side tables at stations #13, #12, #10, and #4. The observed cans were not labeled with patient identification to ensure single patient use. On 02/03/25 at 0955, Certified Clinical Hemodialysis Technician (Staff H) was queried regarding the above described spray. Staff H, shared that each patient was given a can to be used on a specific patient. Staff H further shared that the patients forget to bring the spray with them, so staff use common cans housed at the facility. Staff H confirmed that the cans are not labeled and that they should not be used on multiple patients, nor be placed on clean surfaces after being in the treatment bubble. On 02/05/2025 at 0835, 3 of 9 “clean” computer tables were observed to have unlabeled aerosol cooling spray cans sitting on the “clean” computer cart next to the “clean” keyboards used for charting on patients: On 02/05/25 at 1245, findings were reviewed with, and acknowledged by the Facility Administrator (Staff A) and the Regional Operations Director (Staff N ) . Policy 1-05-01 title: Infection Control for Dialysis Facilities, last revised 04/2023. Page 3 of 5, 10. Unused supplies (syringes, alcohol swabs, tape,, etc) or medication (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients. Page 5 of 5, #16. 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: 27408 Based on observation, interview, and record review, the facility staff failed to disinfect the patient’s entire dialysis machine and surrounding surfaces following a patient’s treatment for 5 of 5 station cleanings observed, resulting in the potential for less than optimal outcomes. Findings include: On 02/03/25 at 1015, observation of Patient Care Technician (PCT), Staff G, was disinfecting stations #5 & #6. Staff G did not disinfect the interior of the prime container (intravenous fluid waste bucket on the dialysis machine) or disinfect the back shelf of the station at station #5 and did not disinfect the interior of the prime container (intravenous fluid waste bucket on the dialysis machine), the chair’s footrest or disinfect the back shelf of the station at station #6. During an interview with Staff G, they revealed that she had forgot to disinfect those areas at each station. Staff G stated she “was a little nervous”. On 02/03/25 at 1130, Patient Care Technician (PCT), Staff H, was observed disinfecting stations #11 & #12. Staff H failed to disinfect the back shelf, and failed to clean the reusable patient blood pressure cuff when removing it from the contaminated chair at station #11, and failed to clean the chair’s footrest or disinfect the back shelf of the station at station #12. Staff H was queried about these observations, and she verified that she hadn’t cleaned the shelf, the blood pressure cuff or the footrest. On 02/03/25 at 1230, Patient Care Technician (PCT), Staff I, was observed disinfecting station #5. Staff I failed to disinfect the chair’s footrest or the back shelf at station #5. Staff I was queried about these observations, and she stated that she forgot to disinfect the back shelf or the chair’s footrest. On 02/03/25 at 1530 during review of the facility’s policy titled “Infection Control for Dialysis Facilities, #1-05-01, revised 4/2023” documented, “#13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tables, blood pressure cuffs). ii. Priming containers are to be emptied prior to disinfection.” On 02/03/25 at 0945, Patient Care Technician (PCT) Staff I, was observed wiping down the chair at station #12. When queried as to whether the station was clean or dirty, Staff I stated that the chair was dirty, but that the machine was already set up for the next patient. Staff I was also queried as to if it was the same situation as observed at station #9. Staff I stated “yes”. Staff I stated that the machines are cleaned, strung with new lines (for the next patient) and then turned away from the current patient who was “holding their sites”. Staff I stated, “I guess it would still be a dirty station if the patient is still there, or if they left and the chair is not cleaned.” On 02/03/25 at 1400 during review of policy #1-05-01, titled “Infection Control for Dialysis Facilities, #1-05-01, dated April 2023” documented, #13. At the end of each treatment, the dialysis station will be cleaned and disinfected. b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station to clean or disinfect the station and set up for the next patient.” On 02/05/25 at 0915, interview with the Medical Director, Staff B, revealed that it was his expectation that all “staff follow the policies and procedures of the facility”. 38269 On 02/03/2025 at 1500 during observation of the hemodialysis treatment area, 13 of 13 blood pressure cuffs were observed hanging on the sides of patient ready stations. The blood pressure cuffs at stations #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, and #13 were observed to be filled with multiple colors of; hair, debris, strings, yarn, and lint. At the time of observation Certified Clinical Hemodialysis Technician (Staff H) was queried regarding whether the cuffs had been cleaned, Staff H stated, “yes, those stations are clean. The blood pressure cuffs are clean.” On 02/04/2025 at 1338 Staff A (Facility Manager) was queried regarding a policy and procedure for cleaning blood pressure cuffs. Staff A stated, The Blood pressure cuffs should be either cleaned of lint or new cuffs ordered.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 38269 Based on observation, interview, and record review, the facility failed to monitor 2 of 13 patients receiving dialysis treatments, resulting in the potential for unidentified exsanguination. Findings include: On 02/05/2025 at 1115, while touring the treatment room floor 2 patients seated at station #1 and station #12 were observed to have dialysis access sites that were not visible (covered by personal blankets). On 02/05/2025 at 1115 at the time of observation both the Facility Administrator (Staff A) and the Regional Operational Director (Staff N) confirmed the above findings. Policy 1-03-08 1-03-08 Title: last revised April 2024 “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” Page 3 of 7, #9 c. The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment.”

“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: 27408 Based on observation, interview and record review, the Medical Director failed to ensure staff followed the facility policy and procedures for expired supplies and employee cell phone use, resulting in the potential for less optimal outcomes for the 9 in-center patients being treated at time of finding. Findings include: On 02/03/25 at 1030, during observations, Patient Care Technician (PCT), Staff H, was observed entering dialysis station #2, reaching beneath her protective gown with soiled gloves. She then proceeded to take out her phone, to silence the phone from ringing. Staff H was queried when she left the station, if employees could have cell phones while out on the floor. She replied, “we aren’t supposed to have anything, supplies or phones in our pockets while out on the floor.” On 02/04/25 at 1115, during review of the policy titled “Physical Environment” #8-04-01 dated “April 2018” revealed “#3 While in the treatment area where patient care remains the primary focus, personal use of pagers, cell phones, iPods, MP3 players, etc. by teammates is not permitted.” On 02/05/25 at 0915, an interview with the Medical Director Staff B, revealed that it was his expectation that all “staff follow the policies and procedures of the facility”. 38269 On 02/03/2025 at 1440 while reviewing the content of the emergency evacuation kit, the following was observed: 1. 14 of 15 liter bags of saline had an expiration date July 2024. 2. 4 of 4 mini-cap povidine/iodine solution caps had an expiration date October 2024. 3. Antibacterial skin and wound cleanser spray had an expiration date November 2024. On 02/03/2025 at 1450 During an interview, the above findings were reviewed with and acknowledged by the Facility Administrator (Staff A). On 02/05/2025 at 0915 an interview was conducted with the Medical Director (Staff B) who stated his expectation is that facility staff follow facility policies.”