Davita Alexandria Dialysis

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 42929 Based on interviews and facility document review, it was determined the facility staff failed to ensure the community-based risk assessment was updated every two (2) years as per the regulation. Findings: On 03/26/2024, the surveyor reviewed the facility’s emergency preparedness binder provided by Staff Member #1. There was only one community-based risk assessment or hazard vulnerability assessment (HVA) in the binder and it was not dated as when it was completed. A review of governing body meeting minutes from 2023 stating that the emergency preparedness plan was reviewed, contained no evidence that the HVA was reviewed or updated at that time. A review of the facility’s policy titled “Emergency Management Plan” with a revision date of April 2024 states in part: ... Facility Hazard Vulnerability Assessment (HVA).... 2. FA, or designee, will identify, evaluate and rate each hazard ANNUALLY ... On 03/27/2024, the surveyor discussed the community-based risk assessment/HVA with Staff Member #1, Staff Member #7, and Staff Member #10. Staff Member #7 stated that the HVA should have been updated in October 2023, but no documentation was provided. There was no documentation of community-risk assessments/HVAs from previous years provided. The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 42929 Based on interviews and facility document review, it was determined the facility staff failed to provide documentation of contact with the local emergency preparedness agency at least annually. Findings: On 03/26/2024 the surveyor reviewed the facility’s emergency preparedness binder provided by Staff Member #1. There was no documentation of contact with the local emergency preparedness agency in the binder. In the morning on 03/27/2024, the surveyor met with Staff Member #1, Staff Member #7, and Staff Member #10 and notified them of the lack of documentation of contact with the local emergency preparedness agency. No additional documentation was provided. The facility’s policy titled “Emergency Management Plan” with a revision date of April 2024 states in part: ... 11. The FA, or designee, shall have communication at least on an ANNUAL basis with the following local agencies regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility, and reviewing agency’s emergency plan. Communication template available on the DEM webpage. NOTE: documentation of contact is important: a. Local Emergency Management agency i. Additional follow-up contact required to include: 1. Phone contact 2. Attending meeting 3. Participation in collaborative and cooperative planning efforts... The above concerns were discussed again with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 42929 Based on interviews and facility document review, it was determined the facility staff failed to provided documentation of staff emergency preparedness training and education annually as per the facility’s policy. Findings: On 03/26/2024 the surveyor reviewed the facility’s emergency preparedness and fire drills binders provided by Staff Member #1. There was no documentation of staff emergency preparedness training and education in the binder provided. In the morning on 03/27/2024, the surveyor met with Staff Member #1, Staff Member #7, and Staff Member #10 and notified them of the lack of documentation of staff emergency preparedness training and education. Staff Member #7 stated that the training was completed in October of 2023, but no documentation was provided. The facility’s policy titled “Emergency Management Plan (EMP)” last revised April 2024 states in part: ... Training and Education. 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 ii. Quarterly 1. Fire Safety Preparedness iii. Upon Hire iv. Any changes and/or updates to EMP or facility specific emergency procedures v. Document training in teammate file 1. Training/In-service Documentation form ... The above concerns were discussed again with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“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: 42929 Based on interviews and facility document review, it was determined the facility staff failed to provide documentation of exercises to test the emergency plan annually. Findings: On 03/26/2024 the surveyor reviewed the facility’s emergency preparedness and fire drills binders provided by Staff Member #1. There was no documentation of exercises to test the emergency plan annually. In the morning on 03/27/2024, the surveyor met with Staff Member #1, Staff Member #7, and Staff Member #10 and notified them of the lack of documentation of exercises to test the emergency plan annually. Staff Member #7 stated that there was an exercise completed in October of 2023, but no documentation was provided. A review of the facility’s policy titled “Emergency Management Plan” last revised April 2024 states in part: ... Emergency Drills 1. The FA, or designee, will maintain the emergency preparedness training and testing based on the facility EMP 2. EMP training exercises: a. The purpose is to test effectiveness of the facility’s emergency plan, emergency response, hazard and risk assessment, and the support of the patient population served. b. Testing exercises should vary, based on the facility’s requirements, by cycles and frequency of testing. c. The intent is that testing exercise provide a comprehensive testing and training for teammates, volunteers, and individuals providing services under arrangement as well community partners. d. Testing exercise must be based on the facility’s identified hazards, to include natural or manmade disasters. 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: a. Required when available b. Defined as an operations-based exercise that typically involves multiple agencies, jurisdictions, and disciplines performing functional (for example, joint field office, emergency operation centers, etc.) and integration of operational elements involved in the response to a disaster event, i.e. “boots on the ground” response activities. c. Participation with any of the following: i. Emergency management agency ii. Local, state, and/or federal emergency response agencies iii. Healthcare coalition 2. Individual facility-based exercise: a. Tabletop exercise that includes a group discussion led by the FA b. Scenario situation must be based on hazards relevant to facility c. Designed to challenge facility EMP d. Actions taken will be simulated and not disrupt patient treatments e. Facility may choose to participate instead in a full-scale community based exercise f. If the facility experiences an actual emergency event or response of sufficient magnitude that requires activation of the relevant emergency plans meets the full-scale exercise requirement and exempts the facility for engaging in their next required community-based full-scale exercise or individual, facility-based exercise for following the actual event. i. Documentation is required 1. Utilize Facility Emergency Plan Activation template and document: a. Event that occurred b. Plan and policies activated c. Evaluation of plan d. Plan revisions required e. Governing Body review ii. Maintain copy with facility EMP... The above concerns were discussed again with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“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: 42725 Based on eight (8) infection control observations and facility policy review, it was determined the facility staff failed to follow required infection control and prevention practices related to hand hygiene. Findings: On 3/25/24, the surveyors conducted observations on the treatment floor from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m. At 1:17 p.m. while performing discontinuation of treatment from an arteriovenous (AV) fistula, Staff Member #18 did not perform hand hygiene between two (2) glove changes during the procedure. At 1:20 p.m. and 1:24 p.m., Staff Member #13 was observed removing and discarding gloves without performing hand hygiene prior to donning a new pair. At 1:50 p.m., while performing discontinuation of treatment from an AV fistula or graft site, Staff Member #13 did not perform hand hygiene between two (2) glove changes during the procedure. At 2:16 p.m. while performing discontinuation of treatment from a central venous catheter (CVC) site, Staff Member #13 did not perform hand hygiene between six (6) glove changes during the procedure. At 2:50 p.m., Staff Member #18 removed the used bloodlines from station #24 and placed them in the biohazard bin, then proceeded to touch machine #2 to cancel the alarm with the same gloves, then grabbed cloth wipes and put them in the bleach bin, then returned to station #24. At 3:29 p.m., Staff Member #13 was observed removing and discarding gloves without performing hand hygiene prior to donning a new pair. At 3:35 p.m., while performing the tasks for initiating a treatment for an AV fistula or graft site, Staff Member #13 did not perform hand hygiene between four (4) glove changes. Between 4:21 p.m. and 4:26 p.m., Staff Member #13 was observed providing CVC exit site care and initiating treatment for a CVC site. Staff Member #13 did not perform hand hygiene between seven (7) glove changes. At 5:00 p.m., the observations were discussed with Staff Members #1, #7, #8 and #10. The surveyors requested to review a policy related to hand hygiene. On 3/26/24, a review was conducted of the facility’s policy titled, Infection Control for Dialysis Facilities. The policy reads, in part: “HAND HYGIENE 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... ... b. prior to gloving and immediately after removal of gloves, ... ... d. after patient and dialysis delivery system contact, ... ... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse... PPE... ... 7. ... a. Gloves should be changed when: ... ... ii. When going from a “dirty” area or task to a “clean” area or task... ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“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: 40084 Based on observations and facility policy review, it was determined the facility staff failed to clean and disinfect equipment brought into the dialysis station during two (2) observations. Findings: During observations conducted on 3/25/24 from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m., the following was observed on the treatment floor: At 2:20 p.m., Staff Member #14 was observed using a thermometer on the patients at station #19 and #20. Staff Member #14 did not clean the thermometer between stations and after using, placed the thermometer on the “clean” chair side cart. At 3:35 p.m., Staff Member #13 was observed laying a “dirty” stethoscope down on top of the “clean” chair side cart. At 5:00 p.m., the observations were discussed with Staff Members #1, #7, #8 and #10. The surveyors requested to review a policy related cleaning and disinfecting stations and equipment. On 3/26/24, a review was conducted of the facility’s policy titled, Infection Control for Dialysis Facilities. The policy reads, in part: “... DISINFECTION... ... b. ... i. Disinfection should be completed by using a wiping motion with friction... ii. Sufficient disinfectant should be applied so that surfaces are visibly wet... 13. At the end of 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... ii. Priming containers are to be emptied prior to disinfection... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses... a. Stethoscopes will be disinfected with alcohol prep pad...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“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: 42725 Based on staff interview, observation, and document review, it was determined the facility staff failed to ensure clean areas/supplies were clearly separated from contaminated areas where supplies and equipment are handled. Findings: During the observations conducted on 3/25/24 from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m., the surveyors observed a large trash can on wheels and a large biohazard bin on wheels placed right up against an area containing clean supplies. Additionally, the facility uses station #16 for patient treatment. This station is located right against a counter/cabinet area that contains clean supplies. When a treatment is being conducted, there is an increased risk for contamination of the clean area and supplies. During the water room inspection and interview with Staff Member #2 on 3/26/24, the surveyor inquired about the stations in use by the staff. Staff Member #2 said staff do not use all the stations in the facility. Staff Member #2 keeps the extra machines connected to the wall boxes at the empty stations so the machines are routinely cleaned and can be “added into the rotation and used”. Staff Member #2 acknowledged that station #16 (which is used by staff) is too close to the clean supply area. At the exit conference on 3/27/24 at 6:00 p.m. with Staff Members #7 and #10, the surveyors discussed the placement of the trash cans and biohazard bins on the floor. Additionally, the surveyors discussed the use of station #16 and the risk it poses to the clean supply area located right against the station. On 3/26/24, a review was conducted of the facility’s policy titled, Infection Control for Dialysis Facilities. The policy reads, in part: “... SUPPLIES... 9. If a common supply cart is used to store clean supplies in the patient treatment area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood... FACILITY HYGIENE... 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: 42725 Based on observations and facility policy review, it was determined the facility staff failed to appropriately clean and disinfect the dialysis station during eight (8) observations. Findings: During observations conducted on 3/25/24 from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m., the following was observed on the treatment floor: At 1:36 p.m., the surveyor observed Staff Member #18 obtain cleaning cloths and soak them in the bleach containing dirty hemostats and clamps, then proceed to clean station #21 with those cloths. Staff Member #18 proceeded to clean the dialysis chair, but failed to wipe the footrest, the outside of the chair arms, and to thoroughly wipe the seat back of the chair and the inside arms of the chair. Staff Member #18 proceeded to remove the used bloodlines from the machine after cleaning the chair. Staff Member #18 failed to wipe the emergency kit bag hanging from the intravenous (IV) pole, the television including the television arm, the counter behind the dialysis station, the sharps container, and the wall box. The prime waste container was emptied in the dirty sink, rinsed with sink water, then dried with a dry cloth, and not disinfected with bleach. At 2:15 p.m., Staff Member #12 was observed cleaning station #12. Staff Member #12 failed to wipe the television monitor and the television arm. Staff Member #12 wiped the blood pressure cuff and tubing and then hung it over the “dirty” television arm. Staff Member #12 failed to wipe the emergency kit bag hanging from the intravenous (IV) pole, the counter behind the dialysis station, the sharps container, and the wall box. The prime waste container was emptied in the dirty sink, rinsed with sink water but not disinfected with bleach. While returning the prime waster container to the machine, Staff Member #12 dropped the container on the floor. The container was picked up off the floor and put on the machine without disinfection. At 2:51 p.m. while cleaning and disinfecting dialysis station #24, Staff Member #18 failed to wipe the outside of the prime waste container, the inside of the right chair arm and the outside of both chair arms, wiped the back rest of the chair in only an “S” motion. Staff Member #18 did not wipe the television monitor or television arm, wall box, and sharps container. At 2:58 p.m., Staff Member #13 was observed cleaning station #20. Staff Member #13 started cleaning the chair prior to disposing the used bloodlines hanging on the machine. Staff Member #13 wiped the blood pressure cuff and tubing and then placed it in the “dirty” basket on the “dirty” machine as neither had been cleaned yet. Staff Member #13 emptied the prime waste container, rinsed it with sink water, did not wipe it with bleach and returned it to hanging position on the “dirty” machine. Staff Member #13 failed to wipe the emergency kit bag hanging from the intravenous (IV) pole, the counter behind the dialysis station, the sharps container, and the wall box. The trash can at the station was overflowing and was not emptied. At 3:09 p.m., the surveyor observed Staff Member #13 dunk the prime waste bucket into the 1:10 bleach container at the dirty sink, swirl the bleach in the container, empty the container, then place the bucket back on the machine. At 3:26 p.m., the surveyor observed a patient care technician empty the prime waste bucket into the dirty sink, then fill it with tap water, swirl the water in the bucket, empty the bucket, then place the bucket back onto the machine. At 5:00 p.m., the observations were discussed with Staff Members #1, #7, #8 and #10. The surveyors requested to review a policy related cleaning and disinfecting stations and equipment. On 3/26/24, a surveyor conducted additional observations on the treatment floor from approximately 10:55 a.m. to 12:15 p.m. The following was observed: At 11:30 a.m., Staff Member #21 was observed cleaning station #20. Staff Member #21 failed to thoroughly wipe the chair, only “swiping” the chair with the cloth wipes. On 3/26/24, a review was conducted of the facility’s policy titled, Infection Control for Dialysis Facilities. The policy reads, in part: “... DISINFECTION... ... b. ... i. Disinfection should be completed by using a wiping motion with friction... ii. Sufficient disinfectant should be applied so that surfaces are visibly wet... 13. At the end of 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... ii. Priming containers are to be emptied prior to disinfection... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses... a. Stethoscopes will be disinfected with alcohol prep pad...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 42725 Based on interview and document review, it was determined the facility staff failed to provide documentation that two (2) of four (4) staff members were tested for hepatitis B or offered the vaccine. Findings: Four (4) personnel files were reviewed in the facility on 3/27/24. The personnel files for Staff Members #13 and #17 did not contain documentation that Hepatitis B testing was performed, the vaccination was offered and/or administered or that the employee declined vaccination. The surveyor requested the information on both staff members from Staff Member #7. No additional documentation was provided for Staff Member #13. Staff Member #7 said that Staff Member #17’s “specimen hemolyzed and [Staff Member #17] didn’t have a copy from their previous job”. A policy referencing the health testing for staff members was requested.. The surveyor was provided with a document titled, Teammate Health Monitoring. The document reads, in part: “... Per policy. At no cost to teammates, [name of facility] will regularly monitor teammates for infectious diseases according to current guidelines and/or recommendations... Hepatitis B - New hire situation... A. Evidence of antibodies greater than 10 from any time in the past; Draw NA... Follow-up None, no further testing... B. Previously vaccinated with response but unable to provide documentation of response; Draw HBsAG, HBsAB; HBsAB Result equal or greater than 10... Follow-up None, no further testing... less than 10... Offer booster... C. No history of vaccination... Draw HBsAG, HBsAB... less than 10... Offer vaccine series...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“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: 42929 Based on two (2) observations, interviews, and document review, it was determined the facility staff failed to maintain a safe environment for dialysis patients, staff, and the public by not including all of the necessary components of medication labeling. Findings: On 03/25/2024 at 11:38 a.m., the surveyor observed a heparin filled syringe for Patient #11 on the dialysis station chairside table that did not contained the time the medication was drawn or the initials of the staff drawing up the medication. The station was vacant as the patient had not yet arrived for treatment. On 03/25/2024 at 11:48 a.m., the surveyor observed an open vial of heparin in the medication drawer that was not dated or initialed. The above concerns were discussed with Staff Member #1, Staff Member #7, Staff Member #8, and Staff Member #10 on 03/25/2024 at 5:00 p.m. The facility’s policy titled “Medication Policy” with a revision date of October 2023 states in part: ... 20. ... if the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication.... 29. ... Each vial is labeled with the initials of the person opening the vial and the expiration date.... A review of the facility’s policy titled “Anticoagulation” with a revision date of October 2023 states in part: ... 4. Heparin is prepared/administered by licensed nurse teammates or patient care technicians (PCTs), if allowed by state regulations. The syringe is labeled with: Patient name, Medication name and dosage, Route, Date and time prepared, Initials of teammate preparing/administering the medication ... 9. Each vial is labeled with the initials of the person opening the vial and the expiration date.... The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“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: 42929 Based on observations, interviews, and facility document review, it was determined the facility staff failed to maintain aseptic technique when accessing the central venous catheter (CVC) for two (2) of two (2) patients observed. Findings: On 03/25/2024 at 2:16 p.m. while performing discontinuation of treatment from a CVC catheter, Staff Member #13’s mask and the patient’s mask at station 17 were not covering their noses during the procedure. Staff Member #13 did not perform hand hygiene between six (6) glove changes during the procedure. On 03/25/2024 at 3:23 p.m. while performing central venous catheter (CVC) care and treatment initiation at station #22, Staff Member #19 did not pull the patient’s shirt completely away from the CVC exit site, so the patient’s shirt was up against the exit site after the dressing was removed. Staff Member #19 removed the dressing, then cleaned the exit site with swabs, then removed gloves and performed hand hygiene. Staff Member #19 placed the dirty dressing on the chair side table with the clean supplies used for CVC care and initiation of treatment. Staff Member #19 wiped the CVC lumens, then removed the cap and immediately attached a syringe without cleaning the hub threads. Staff Member #19 removed the syringe, then scrubbed the hub threads for only seven (7) seconds, not fifteen (15) as per the facility’s policy. A review of the treatment flow sheets for Patient #2 from 03/11/2024, 03/15/2024, and 03/20/2024 contained evidence that the ancillary order for “CVC Cap-Clearguard” was “Not Fulfilled”. A review of the treatment flow sheets for Patient #5 from 03/13/2024, 03/15/2024, and 03/20/2024 contained evidence that the ancillary order for “CVC Cap-Clearguard” was “Not Fulfilled”. During an interview on 03/27/2024, Staff Member #7 and Staff Member #10 confirmed that the ancillary order for the CVC Cap-Clearguard confirms/documents that the staff member added a new CVC cap to the end of the CVC lumen at the end of treatment, and the staff should document on the flow sheet that it was completed. The above concerns were discussed with Staff Member #1, Staff Member #7, Staff Member #8, and Staff Member #10 on 03/25/2024 at 5:00 p.m. The facility’s policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” with a revision date of October 2023 states in part: ... Perform a [fifteen] 15 second hub scrub of the CVC during the process of connecting or disconnect from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason. ... 1. Procedure: ... Put on PPE and provide a mask to the patient. Rationale: PPE is worn to protect the teammate. Teammate and patient will wear masks covering the nose and mouth during this procedure. Rationale: These measures are vital to preventing the exposure of the catheter and exit site to nasal droplets and infectious bacteria such as methicillin-resistant Staphlyococcus aureus (MRSA). ... 3. ... Verify patient’s clothing is secured away from the exit site/work area. Rationale: Securing the patient’s clothing away from the work area minimizes the risk of cross-contamination. 4. Remove the old dressing and discard. ... 7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. 8. Holding catheter with the non dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of [thirty] 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab.... Then wait [sixty] 60 seconds for air dry time. 9. Clean each CVC limb/cap with a new large alcohol prep pad, staying close to the exit site and finishing with the cap. 10. Remove gloves and discard, perform hand hygiene per procedure and re-glove. ... 16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for [fifteen] 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried. Rationale: Allowing the hubs to air dry after disinfection prevents the alcohol from acting as an adhesive. Verify open lumen is not placed on a non sterile surface and minimize the time it is open. 17. Attach sterile 10 ml syringe to the arterial and venous limbs. ... Upon Completion of Dialysis ... 27. ... Remove the pair of ClearGuard HD caps that are contained in the shield from the foil pouch. 28. Discard used barrier that was used during treatment and place a new clean, moisture proof barrier under catheter to prevent contamination. ... 33. Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for [fifteen] 15 seconds, making sure to remove any residue for example blood. Hold the catheter until the antiseptic has dried. 34. While holding the shield and catheter hub in one hand, remove the single ClearGuard HD cap (red or blue), by rotating the lock ring counterclockwise, taking care to only handle the lock ring, do not touch the rod. Carefully insert the Clear Guard HD rod into the catheter hub and using a simultaneous push and twist motion, tighten by rotating clockwise. Repeat with the other ClearGuard HD cap and dispose of the shield and foil pouch. ... 37. Document findings and procedure in patient’s electronic health record. The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“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: 42725 Based on observations and facility policy review, it was determined the facility staff failed to ensure the access site for three (3) patients remained visible throughout the dialysis treatment. Findings: During the observations conducted on 3/25/24 from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m., the following was observed on the treatment floor: At 11:55 a.m., the surveyor observed a patient receiving treatment at station #6; the access site was covered with a blanket. At 1:10 p.m., the surveyor observed the site was still covered by a blanket. At 12:10 p.m., the patient receiving treatment at station #2 had their access site covered with a blanket. At 3:52 p.m., the patient receiving treatment at station #15 had their access site covered with a blanket. At 3:58 p.m., Staff Member #10 walked over, uncovered the site and provided education. At 4:10 p.m., that patient at station #14 receiving treatment had their access site covered with a blanket. At 4:20 p.m., Staff Member #10 had Staff Member #19 walk over and uncover the site. At 5:00 p.m., the observations were discussed with Staff Members #1, #7, #8 and #10. On 3/26/24 and 3/27/24, the facility’s policy titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, was reviewed and reads, in part: “... INTRADIALYTIC DATA COLLECTION/ASSESSMENT... ... b. ... v. Vascular access visible and line connections intact...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“PR-RECEIVE UNDERSTANDABLE INFORMATION CFR(s): 494.70(a)(2) The patient has the right to- (2) Receive all information in a way that he or she can understand; This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility staff failed to document in the patient’s medical record how forms requiring a signature were explained to those who do not speak or read English for one (1) of ten (10) patients sampled, Patient #3. Findings: On 03/26/2024, the surveyor reviewed the medical records for ten (10) patients. A review of the medical records contained evidence that one (1) of ten (10) patients, Patient #3, were documented as “Primary Language: Spanish” and no secondary language documented. All consents signed by Patient #3 were in English. The plan of care for Patient #6 dated 10/31/2023 was printed in English and Patient #6 was designated as Spanish as primary language. On 03/27/2024, the surveyor notified Staff Member #1, Staff Member #7, Staff Member #8, and Staff Member #10 of the above information. Staff Member #7 confirmed that a patient who’s primary language is documented as Spanish should receive consents in Spanish. The facility’s policy titled “Communication with Persons with Limited English Proficiency” with a revision date of October 2023 states in part: ... Policy: A. [The facility] will facilitate meaningful communication with LEP [Limited English Proficiency] patients and the Responsible Parties who are involved in a patient’s medical care and treatment. This includes communication of information contained in Vital Documents, including but not limited to, waivers of rights, consent to treatment forms, and financial and insurance benefit forms.... The above concern was discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 42929 Based interviews, medical record review, and facility document review, it was determined the facility staff failed to document notification to the charge nurse or physician of post treatment weight greater than 1 kg above or below the target weight for five (5), Patient #1, Patient #2, Patient #4, Patient #5, Patient #10, of eight (8) in-center patient’s flow sheets reviewed. Findings: On 03/26/2024, the surveyor reviewed the treatment flow sheets for eight (8) in-center hemodialysis patients, Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, Patient #8, Patient #9 and Patient #10. There was no documentation that the post treatment weight greater than 1 kg above or below the target weight was reported to the licensed nurse or physician for: Patient #1 03/15/2024 post treatment weight was 85 kg, 1.3 kg above the target weight of 83.5 kg; 03/20/2024 post treatment weight was 85.1 kg, 1.6 kg above the target weight of 83.5 kg. Patient #2 03/11/2024 post treatment weight was 62.4 kg, 1.9 kg above the target weight of 60.5 kg; 03/15/2024 post treatment weight was 63.6 kg, 3.1 kg above the target weight of 60.5 kg; 03/20/2024 post treatment weight was 64.3 kg, 3.8 kg above the target weight of 60.5 kg;. Patient #4 03/14/2024 post treatment weight was 82 kg, 2 kg below the target weight of 84 kg. Patient #5 03/11/2024 post treatment weight was 59.1 kg, 2.6 kg above the target weight of 56.5 kg; 03/18/2024 post treatment weight was 59 kg, 1.5 kg above the target weight of 57.5 kg; 03/20/2024 post treatment weight was 59 kg, 1.5 kg below the target weight of 57.5 kg; 03/22/2024 post treatment weight was 59.3 kg, 1.8 kg below the target weight of 56.5 kg. Patient #10 12/27/2023 post treatment weight was 80.9 kg, 3.9 kg above the target weight of 77 kg; 12/29/2023 post treatment weight was 79.4 kg, 2.4 kg above the target weight of 77 kg; 12/31/2023 post treatment weight was 79.2 kg, 2.2 kg above the target weight of 77 kg; 01/03/2024 post treatment weight was 81.4 kg, 4.4 kg above the target weight of 77 kg; 01/08/2024 post treatment weight was 82.3 kg, 5.3 kg above the target weight of 77 kg; The above concerns were discussed with Staff Member #1, Staff Member #7, and Staff Member #10 during a review of the medical records on 03/27/2024. The facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised October 2023 states in part: ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ... c. Target weight ... 13. All findings, interventions and patient response will be documented in the patient’s medical record. ... Abnormal Findings Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record ... In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. ... Fluid Status: ... Post-treatment: IF patient is above or below 1 kg from target weight... The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility staff failed to follow the dialysis treatment orders, specifically for blood flow rate (BFR) for five (5) of eight (8) patients’ flow sheets reviewed. Findings: The six (6) most recent dialysis treatment flow sheets for eight (8) in-center hemodialysis patients were reviewed on 03/26/2024. Dialysis orders for blood flow rate (BFR) were not followed in five (5) of the eight (8) patients’ flow sheets reviewed. There was no documentation of the reason or of notification to the charge nurse of the change in blood flow rate from the prescribed rate. Patient #1 3/11/2024 BFR documented at 300 ML/min, when the prescribed rate was 350 ML/min; 3/13/2024 BFR documented at 330 ML/min, when the prescribed rate was 350 ML/min; 3/20/2024 BFR documented at 320 ML/min, when the prescribed rate was 350 ML/min. Patient #4 3/21/2024 BFR documented at 350 ML/min, when the prescribed rate was 400 ML/min. Patient #5 3/13/2024 BFR documented at 250 and 280 ML/min, when the prescribed rate was 350 ML/min; 3/18/2024 BFR documented at 300 ML/min, when the prescribed rate was 350 ML/min; 3/20/2024 BFR documented at 200 ML/min, when the prescribed rate was 350 ML/min. Patient #8 3/11/2024, 3/13/2024, 03/15/2024, 03/20/2024, 03/22/2024 BFR documented at 400 ML/min, when the prescribed rate was 450. Patient #10 12/27/2023, 12/29/2023, 12/31/2023, 01/08/2024 BFR documented at 400 ML/min, when the prescribed rate was 450. A review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised October 2023 states in part: ... 2. The Nursing Assessment will be performed and documented by a licensed nurse ... a. The assessment includes the following components: ... ii. Verification of prescription including machine parameters ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ... f. Blood flow rate Intradialytic Data Collection/Assessment b. At a minimum, obtain and document the following: ... iii. Blood and dialysate flows, arterial and venous pressures ... 10. 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. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings: section in this policy). ... 13. All findings, interventions and patient response will be documented in the patient’s medical record.... The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, the facility staff failed to ensure the Plan of Care (POC) was signed by all interdisciplinary team members and the patient for six (6), Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, and Patient #7, of ten (10) POCs reviewed. Findings: On 03/26/2024 the surveyor reviewed the plan of care for ten (10) patients. Patient #2: There was no signature page to include the signature of the interdisciplinary team and the patient for the plan of care dated 03/12/2024 provided by the facility. The POC stated “patient not present at meeting”. Patient #3: The plan of care dated 10/11/2023 was not signed by the patient. Patient #4: There was no signature page to include the signature of the interdisciplinary team and the patient for the plan of care dated 10/04/2023 provided by the facility. The POC states “patient not present at meeting”. Patient #5: There was no signature page to include the signature of the interdisciplinary team and the patient for the plan of care dated 03/12/2024 provided by the facility. The POC states “patient not present at meeting”. Patient #6: The plan of care dated 10/31/2023 was not signed by the patient. Patient #7: The plan of care dated 12/22/2023 was not signed by the patient. The facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” with a revision date of October 2020 states in part: ... 14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’ personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.... The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility failed to implement the initial plan of care (POC) within the latter of thirty (30) calendar days after admission to the dialysis facility or thirteen (13) outpatient hemodialysis sessions beginning with the first outpatient dialysis session for four (4), Patient#1, Patient #2, Patient #3, and Patient #5, of ten (10) patient’s medical records reviewed. Findings: On 03/27/2024 the surveyor reviewed the plan of care for ten (10) patients. Patient #1 started dialysis treatment on 08/04/2024 and the patient’s initial plan of care meeting was dated 10/04/2023. There was no documentation of a plan of care completed by ninety (90) days from the start of treatment, and no ninety (90) plan of care provided after the surveyor’s request. Patient #2 started dialysis treatment on 02/02/2024 and the patient’s initial plan of care meeting was 3/12/2024. The surveyor reviewed the patient’s treatment log and Patient #2 completed thirteen treatments on 03/04/2024. Patient #3 started dialysis treatment on 08/29/2023 and the patient’s initial plan of care meeting was dated 10/1/2023. Patient #5 started dialysis treatment on 01/31/2024 and the patient’s initial plan of care meeting was dated 3/12/2024. The facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” with a revision date of October 2020 states in part: ... 4. A comprehensive assessment will be conducted on all new patients within [thirty] 30 calendar days (or [thirteen] 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 5. A follow up [ninety] 90 day re-assessment will be completed to evaluate patient’s status and provide information to adjust the patient’s plan of care.... The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 40084 Based on interview and record review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues related to Infection Control. The findings include: Current Recertification Survey Based on the scope and severity of deficiencies related to infection control, the facility failed to substantially comply with this condition. See Tags: V-0113 V-0117 V-0122 V-0126 V-0143 V-0147 V-0681 Recertificaton Survey Ending September 14, 2022 Based on the scope and severity of deficiencies related to infection control, the facility failed to substantially comply with this condition. See Tags: V-0113 V-0114 V-0116 V-0119 V-0122 V-0143 V-0146”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 42725 Based on observations, interviews, and document review, it was determined the facility staff failed to ensure a tuberculosis evaluation was completed as per the facility’s policy for two (2) of four (4) staff members and to provide evidence to support that annual competencies were completed for one (1) of four (4) staff members reviewed. Findings: Four (4) personnel files were reviewed in the facility on 3/27/24. The personnel files for Staff Members #14 and #16 did not contain documentation that a tuberculosis evaluation had been completed annually. Staff Member #14’s file did not contain documentation that annual competencies had been completed. The surveyor discussed the missing information with Staff Member #7. A current tuberculosis evaluation was not provided for Staff Member #14 or Staff Member #16. Staff Member #7 said that Staff Member #14’s annual competency training “did not get auto-populated” and had to be manually assigned, but “that was not done”. The policies referencing the health testing and competency requirements for staff was requested. The surveyor was provided with a document titled, Teammate Health Monitoring. The document reads, in part: “... Per policy. At no cost to teammates, [name of facility] will regularly monitor teammates for infectious diseases according to current guidelines and/or recommendations... TB... Follow-up, Annual TBRAQ [Tuberculosis Risk Assessment Questionnaire]...”. The surveyor was provided with a document titled, Annual Competency Certification Course List In-Center. The document reads, in part: “... CLED9001A-2024: ICHD RN Competency Exam & Attestation... DVU2062: Annual Nurse Competency Exam. SKLINV1000: Nurse Chronic Hemodialysis Skills Checklist Attestation”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“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: 42725 Based on observation, interview, and facility document review, it was determined the facility staff failed to follow facility policy when using vascular access clamps for one (1) patient. Findings: During the observations conducted on 3/25/24 from approximately 11:30 a.m. to 12:15 p.m. and again from approximately 1:10 p.m. to 4:20 p.m., the following was observed on the treatment floor: At 1:50 p.m., the surveyor observed the discontinuation of treatment for a patient with an AV fistula or graft at station #20. At 1:59 p.m., after removal and disposal of the first fistula needle, Staff Member #13 applied a vascular clamp to the access site. The first site check was performed at 2:34 p.m. by Staff Member #14. At 2:37 p.m., the clamp was removed. At 5:00 p.m., the observation was discussed with Staff Members #1, #7, #8 and #10. The surveyors requested to review a policy related to the usage of vascular clamps. On 3/26/24, a review was conducted of the facility’s procedure titled, Utilizing Vascular Access Clamp Procedure. The procedure reads, in part: “... 5. After placement of the clamp, check for thrill and bruit above and below clamp... ... 8. Clamp may remain in place for 5-10 minutes before checking to see if bleeding has stopped. 9. Bruit and thrill must be re-checked a minimum of every 10 minutes while using access clamps and documentation performed in the patient’s treatment record... ... 11. If bleeding has not stopped, reapply clamp checking for thrill and bruit above and below the clamp. 12. Clamp may remain in place for an additional 5-10 minutes before checking to see if bleeding has stopped. Access clamp should not be left on longer than 20 minutes...”. At the exit conference on 3/27/24 at 6:00 p.m., the findings were reviewed with Staff Members #7 and #10.”

“MD RESP-ENSURE IVD P&P FOLLOWED CFR(s): 494.150(c)(2)(ii) The medical director must- (2) Ensure that- (ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in §494.180(f). This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility’s medical director failed to ensure the interdisciplinary team adhered to the discharge and transfer policies and procedures for one (1) of one (1) discharged patient reviewed, Patient #10. Findings: A review of the facility’s policy titled “Discharge Summary” with last revision date October 2022 states in part: Purpose: To verify that a Discharge Summary is completed for all patients that expire, transfer, or transplant including voluntarily or involuntarily terminated dialysis care from [the dialysis facility] and the requirements for documentation of the discharge. Policy: 1. A Discharge Summary will be completed in a maximum of [thirty] 30 days from a patient’s discharge date or sooner according to state regulations. 2. All discharge summaries will be signed and dated by the attending nephrologist and nurse... On 03/26/2024 the surveyor reviewed the medical record documentation provided for Patient #10 to include five (5) treatment flow sheets. There was no documentation from the nurse, nephrologist, or any other staff member regarding the patient’s discharge from the facility and there was no discharge summary for the patient. On 03/27/2024, Staff Member #1 and Staff Member #10 provided the surveyor with the “Admit/Discharge History” form for Patient #10 that contained the only documented discharge related documentation of “... Discharge Date: 01/24/2024. Patient Discharge Reason: Regained Renal Function ... Last Treatment Date: 01/08/2024 ...” During an interview on 03/26/2024, Staff Member #6 stated that the nurse practitioner saw this patient and Staff Member #6 does not know what has happened to the patient. During an interview on 03/26/2024 at 2:15 p.m., Staff Member #3 stated that Staff Member #3 was notified verbally that Patient #10 regained kidney function and no longer needed dialysis. There was no documentation from Staff Member #3 in the medical record regarding this notification. During an interview on 03/27/2024, Staff Member #10 stated that Staff Member #3 had received a call from a doctor that Patient #10 regained kidney function. Staff Member #10 confirmed that Staff Member #3 did not write a note in Patient #10’s medical record about the patient regaining kidney function, but a note should have been written. Staff Member #10 confirmed that the facility did not have any discharge medical records from Patient #10’s hospital visit documenting that the patient no longer required dialysis. The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”

“GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS CFR(s): 494.180(i) The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network’s current statement of work. Each facility must participate in ESRD network activities and pursue network goals. This Standard is not met as evidenced by: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility staff failed to follow up with the ESRD network about Patient #10, who was missing treatments and with whom the facility staff were unable to locate. Also, the staff failed to log in to the Network monthly for the past nine (9) months. Findings: On 03/26/2024 the surveyor reviewed the medical record for Patient #10. A nursing note contained the documentation that the clinical coordinator called the network and the patient’s nephrologist for permission to contact the patient’s emergency contact list as “Do Not Contact” in the medical record, and to “initiate a wellness check.” The note states that the social worker contacted the police department to do a wellness check and the patient was located and taken to the hospital. The note states that the facility was waiting to find out where the patient was taken. There was no other/additional documentation of any contact or follow up with the ESRD Network. During an interview on 03/26/2027 at 2:15 p.m., Staff Member #3 confirmed that Staff Member #3 contacted “someone” at the network and was told to notify the social worker to initiate a wellness check for Patient #10. Staff Member #3 stated that the wellness check was done and the patient went to the hospital, then Staff Member #3 was notified by phone that the patient regained kidney function and no longer required dialysis. Staff Member #3 confirmed having no further contact or follow up with the ESRD Network regarding Patient #10. During an interview on 03/27/2024 at 11:54 a.m., Staff Member #5 stated that the ESRD Network notified the social worker that a welfare check should have been initiated after the patient missed the first treatment and for the social worker to initiate the welfare check at this time. Staff Member #5 contacted the police and the welfare check was completed. Staff Member #5 confirmed having no further contact or follow up with the ESRD Network regarding Patient #10. On 03/27/2024, Staff Member #1 and Staff Member #10 provided the surveyor with the “Admit/Discharge History” form for Patient #10 that contained the only documented discharge related documentation of “... Discharge Date: 01/24/2024. Patient Discharge Reason: Regained Renal Function ... Last Treatment Date: 01/08/2024 ...” On 03/27/2024 the facility was unable to provide any additional documentation of contact with the ESRD Network, any interdisciplinary team notes related to the patient discharge or follow up with the ESRD Network, and any documentation that the patient no longer required dialysis treatment, as per the surveyors request. On 03/26/2024, the ESRD Network provided documentation that the facility had not logged into the ESRD Network since 08/31/2023. On 03/27/2024, Staff Member #10 stated that either the facility administrator or the administrative assistant is usually the user that should log in, but was unsure who that user was at this facility. Staff Member #10 confirmed that the facility is supposed to log into the ESRD Network monthly. The above concerns were discussed with Staff Member #7 and Staff Member #10 at the exit conference on 03/27/2024 at 6:00 p.m.”