Dialysis Centers of Michigan

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 46476 Based on observation, record review, and interview, the facility failed to ensure staff performed infection control techniques in accordance with facility policies and procedures resulting in the potential for the spread of infectious agents to all 67 patients receiving services at this facility. Findings include: See specific tag: V-0113- Failure perform hand hygiene when indicated. V-0115- Failure to wear/change personal protective equipment. V-0116- Failure to cleanse/disinfect items taken into the dialysis station. V-0122-Failure to clean/disinfect shared equipment. V-0147- Failure to maintain aseptic technique when providing care to patients with intravascular catheters.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 38304 Based on observation, record review and interview, the Facility failed to maintain an updated patient census and patient emergency contacts in the emergency preparedness program, resulting in the potential for inadequate Facility response during an emergency event, and potentially endangering the safety of all in-center patients receiving treatment in the facility in the event of an emergency. Findings include: During dialysis floor observation on 1/14/25 at 1015, the contents of three emergency “to go” tote/containers were inspected. No patient list was observed in any of the patient care supplies found within the containers. This finding was reviewed with the Facility Administrator (Staff A) at 1135. Staff A noted the patient list (updated on 1/13/25) was kept at the nurse’s station on the treatment floor. Further review of this list revealed only 3 of 8 patients admitted within the last 90 days were found. This finding was reviewed and acknowledged by Staff A at 1242. The Facility failed to ensure an up to date and accurate patient list was available for use in the event of an emergency to account for the safety of all patients involved.”

“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 1/15/25 at 11:00 AM, the facility’s Emergency Preparedness Plan was reviewed with Facility Administrator (FA) “A”. There was no documentation of a full-scale community exercise, or communication with a local jurisdiction stating that they would excuse the facility’s participation in the community-based exercise. There was no documentation of an emergency scenario with a set of problem statements and questions designed to challenge the emergency plan, no analysis of the facility’s response and any revision to the facility’s emergency plan if needed. FA “A” confirmed that neither a full-scale community based exercise nor a table-top exercise had been completed. Review of the facility’s policy “Emergency Testing” revised 05/2022 noted: “4. The dialysis facility must complete all of the following: A. A Full Scale Community-Based Exercise...B. In addition to a full-scale community-based exercise, the dialysis facility will conduct a second exercise every two years...The second exercise can be...3. A table-top exercise or workshop that is led by a facilitator...”.”

“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: 47976 Based on observation, record review and interview, the facility failed to ensure staff performed hand hygiene per facility policy, resulting in the potential for spread of infectious agents to all 24 patients being served by this facility at the time of observations. Findings include: **Policy titled “G40 Infection Control” (revised 11/29/2022) stated, “8. Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items.” The policy also stated, “11 ....When soap and water are used, hands are first wetted with water, then soap is applied. Hands are rubbed together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. Hands are then rinsed with water and dried with a clean disposable towel.” During dialysis floor observation on 1/14/25 from 1030 to 1430 and 1/15/25 from 1030 to 1230, the following was noted: On 1/14/25 at 1045, Staff F (Certified Clinical Hemodialysis Technician) was observed taking her gloves off near station #19, discarding them in the trash can, then going to assist a patient at the scale without performing hand hygiene first. Staff F then returned to the treatment area and put on clean gloves to go assist the next patient without performing hand hygiene. On 1/14/25 at 1050, Staff F was observed using the computer on wheels while wearing a glove on her right hand in front of station #7. After discarding the glove, Staff F was observed putting on clean gloves before assisting the patient at station #19 without performing hand hygiene first. Staff F was also observed missing 2 more opportunities for hand hygiene after taking off dirty gloves while going between station #7 and station #19 to assist patients. Staff F was then observed pushing her computer on wheels with gloved hands after finishing assisting the patient at station #19. Staff F then went to station #21 with her computer, took off her dirty gloves, and put on clean gloves to assist the patient at station #21 without performing hand hygiene first. On 1/14/25 at 1130, Staff F was observed initiating dialysis on the patient at station #8. During the procedure, Staff F was observed removing a dirty glove and placing it on top of clean supplies on the side table at station #8. Staff F was then observed putting on new gloves without performing hand hygiene first. After removing these gloves, Staff F was observed using the computer again, going over to the nurse’s station for supplies, then returning to station #8 with clean gloves without performing hand hygiene first. On 1/14/25 at 1413, Staff H (Certified Clinical Hemodialysis Technician) was observed disconnecting the patient from dialysis at station #1 from dialysis treatment. During the procedure, Staff H missed 3 opportunities for hand hygiene following the removal of dirty gloves. Upon completing the procedure, Staff H was observed discarding trash from station #1, removing her gloves, and putting on clean gloves on her way to assist another patient without performing hand hygiene first. On 1/14/25 at 1425, Staff G (Certified Clinical Hemodialysis Technician) was observed wearing her dirty gloves while using the computer keyboard and mouse on her computer on wheels near station #12. After removing her gloves, Staff G failed to perform hand hygiene. This was again observed at 1436. After removing the second set of gloves, Staff G was observed using ungloved hands on the keyboard and mouse, which was now dirty. Staff G failed to perform hand hygiene after the computer and before putting on new gloves to assist the patient at station #12 again. On 1/15/25 at 1130, Staff J (Certified Clinical Hemodialysis Technician) was observed initiating dialysis on the patient at station #19. Staff J missed 3 opportunities for hand hygiene following the removal of dirty gloves. On 1/15/25 at 1145, Staff J was observed washing her hands with soap and water at the sink near station #19. During the observation, it was noted Staff J briefly rubbed her hands together and rinsed them under a weak stream of water for a total of 8 seconds. On 1/15/25 at 1429, Staff I (Certified Clinical Hemodialysis Technician) was observed removing her gloves and pushing her computer cart on wheels with dirty gloves in one hand touching the cart until she could throw them away to perform hand hygiene. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950. 38304 On 1/14/25 at 1419, Staff G (Certified Clinical Hemodialysis Technician) was observed at station #12 documenting on the MWS (mobile workstation) with dirty patient care gloves on. Staff G was then observed at 1423 standing up from the MWS to gather patient supplies needed to perform CVC care after a dialysis treatment was completed with no glove exchange or hand hygiene performed. The supplies were brought over to station #12 and placed on the side table of the patient’s chair. At 1428, Staff G helped adjust the patient’s footrest and then proceeded to perform CVC care. No glove exchange or hand hygiene was observed between 1419 and 1428. On 1/14/25 at 1444, Staff F was observed making dialysis machine adjustments at station #7 using the end of her index finger which was partially covered with a section glove with no hand hygiene observed prior to touching the dialysis machine. At 1450, Staff F was observed touching a patient at station #6 with no gloves on and adjusting the patient’s footrest with no hand hygiene observed prior to touching the patient. Staff F then went back to her chair and rested her hand over her mouth for 3 minutes. At 1454, Staff F put on a pair of gloves without performing hand hygiene first. Staff F then performed post-dialysis CVC care in its entirety with the same pair of gloves donned (put on) at 1454. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1224.”

“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: 47976 Based on record review and interview, the facility failed to ensure staff changed personal protective equipment (PPE) after coming into contact with potentially hazardous materials and failed to ensure staff wore gloves at all times while touching the patient or patient’s supplies, resulting in the potential for spread of infectious agents to all 24 patients being served by this facility at the time of findings. Findings include: **Policy titled “G40 Infection Control” (revised 11/29/2022) stated, “7. Gloves are required whenever caring for a patient or touching the patient’s equipment or supplies.” During dialysis floor observation on 1/14/25 from 1030 to 1430 and 1/15/25 from 1030 to 1230, the following was observed: On 1/14/25 at 1050, Staff I (Certified Clinical Hemodialysis Technician) was observed discarding bloodlines in a biohazard waste bin with a top raised by stepping on a foot pedal. While trying to get the items into the bin, Staff I was noted using her right arm (covered in a gown) under the lid to hold it open. Staff I failed to change her gown after coming in contact with a “dirty” surface potentially contaminated with infectious agents. During an interview on 1/14/25 at 1115, Staff I stated the lids do not open very far, so she had to use her arm to hold it open to get the contents into the bin. Upon inspection of the biohazard bin, it was noted the lid only opens about halfway, making it difficult to safely place larger items in the bin. On 1/14/25 at 1130, Staff F (Certified Clinical Hemodialysis Technician) was observed using an ungloved hand to place tape over the needle going into the patient’s arm at station #8. On 1/14/25 at 1140, Staff D (Registered Nurse) was observed using ungloved hands to pick up the patient’s prescription paper off the top of the dialysis machine to read it, then returning it to the top of the dialysis machine. On 1/15/25 at 1135, Staff J (Certified Clinical Hemodialysis Technician) was observed picking up the patient’s prescription paper from on top of the patient’s dialysis machine without wearing gloves and then placing it back on top of the dialysis machine. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950.”

“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: 37411 Based on observation, record review, and interview, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, resulting in the potential to spread infectious agents to all 24 patients receiving in-center hemodialysis at this facility at the time of observation. Findings include: **Policy titled “Mobile Work Stations (MWS)” (Effective 01/2021) stated, “Policy: 1. MWS are to be kept out of the immediate patient treatment area and far enough away to minimize the risk that the MWS will be sprayed with blood or contaminated fluids. MWS will remain in the designated “clean” areas of the centers. Keyboards and all sections of the MWS are considered clean.” During dialysis floor observation on 1/15/25 at 1130, Staff J (Certified Clinical Hemodialysis Technician) was observed taking a Mobile Work Station (MWS) into the patient treatment area. Staff J rolled the MWS into the dialysis machine and the power cords hanging from the MWS were resting on the treatment chair side table. Staff J was then observed rolling the MWS out of the patient treatment area and left it unattended without sanitizing. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1055. 47976 During dialysis floor observation on 1/14/25 from 1030 to 1430 and 1/15/25 from 1030 to 1230, the following was observed: On 1/14/25 at 1036, Staff G (Certified Clinical Hemodialysis Technician) was observed documenting at a Mobile Workstation (MWS) within 1 foot of the patient and of the dialysis machine at station #12. The cart also contained a thermometer that was used to take the patient’s temperature. Upon leaving the station, it was noted the MWS and its contents were not disinfected. On 1/14/25 at 1429, Staff I (Certified Clinical Hemodialysis Technician) was observed documenting at a MWS within 1 foot of the patient and of the dialysis machine at station #22. Upon leaving the station, it was noted the MWS and its contents were not disinfected. On 1/15/25 at 1055, Staff I and Staff G were observed documenting at 2 separate MWS’s, both within 1 foot of the patient and of the dialysis machine at station #24. Upon leaving the station, it was noted the MWS and its contents were not disinfected. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950.”

“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: 38304 Based on observation and interview, the Facility failed to ensure the Registered Nurse had disinfected her stethoscope in between patient assessments in 1 of 2 observations, and failed to ensure all surfaces of the treatment station were cleaned in between patients in 2 of 3 observations, resulting in the potential for transmission of infectious agents to all 24 in-center patients currently receiving treatments at the time of observations. Findings include: On 1/14/25 at 1124, Registered Nurse (Staff D) was observed performing a patient assessment at Station #8, which noted the use of a stethoscope that touched the patient over her lung and abdominal fields. Afterwards at 1127, Staff D was observed performing another patient assessment at Station #21, which noted the use of a stethoscope that touched the patient over his lung and abdominal fields. It was observed at no time between Station #8 and #21 did Staff D disinfect her stethoscope in between patients. Staff D acknowledged this finding during surveyor interview at 1132. On 1/14/25 at 1145, Certified Clinical Hemodialysis Technician (CCHT) Staff F was observed disinfecting the dialysis chair after patient use at Station 19 without opening and wiping down the interior sides of the patient chair. In addition, the side tables were not lowered to disinfect the in between areas and the footrest was not opened to clean in between sections where the patient chair and footrest meet. At 1149, Staff F was made aware and then acknowledged the findings. Staff F then promptly proceeded to re-disinfect the patient treatment chair appropriately. On 1/15/25 at 1043, Certified Clinical Hemodialysis Technician (CCHT) Staff J was observed disinfecting the interior sides of the dialysis treatment chair and quickly closed the wings of the chair without allowing any time to dry. Staff J then was observed cleaning the rest of the treatment chair without lowering the side tables to clean in between or opening the footrest to clean in between where the patient chair and footrest meet. At 1147, Staff J was made aware and then acknowledged the findings. The above findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1218. Staff A noted the findings did not meet Facility expectations and would be addressed with staff.”

“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: 47976 Based on record review and interview, the Facility failed to ensure staff maintained aseptic technique when providing care to patients with intravascular catheters during 4 of 4 observations, resulting in an increased risk for infection and potential for poor patient outcomesfor all 24 in-center patients currently receiving services. Findings include: **Policy titled “IC05A CVC: Initiation & Discontinuation of Treatment” (revised 6/11/2024) stated under “Initiation of Treatment” on page 1, “5 ....remove the arterial cap, and disinfect the hub with a new antiseptic pad. Scrub the sides (threads) and end of the hub thoroughly with friction for 15 seconds, making sure to remove any residue (e.g. blood).” The steps are to be repeated with the venous cap. Under “Discontinuation of Treatment” on page 5, the policy stated, “25. Disinfect the venous hub with a new antiseptic pad. Scrub the sides (threads) and end of the hub thoroughly with friction for 15 seconds, making sure to remove any residue (e.g. blood) ....Apply sterile cap, ensuring it is securely attached.” The steps are to be repeated with the arterial hub. On 1/14/25 at 1413, Staff H (Certified Clinical Hemodialysis Technician) was observed disconnecting a patient’s central venous catheter (CVC, a port that goes into a large vein in the chest) at station #1. During the procedure, Staff H was observed using an alcohol pad to hold onto the catheter stem while disconnecting the blood line, Staff H then briefly wiped the end of the catheter hub (open end) with the alcohol pad before attaching the cap. She was observed doing the same on the other side. Upon completion of the procedure, Staff H was asked what the facility policy was for hub scrub time. Staff H stated it was 20 seconds. On 1/15/25 at 1130, Staff J (Certified Clinical Hemodialysis Technician) was observed initiating dialysis through a patient’s CVC at station #19. During the procedure, Staff J was observed using an alcohol pad to scrub one catheter hub for 4 seconds and the other catheter hub for 7 seconds. Upon completion of the procedure, Staff J was asked what the facility policy was for hub scrub time. Staff J stated it was between 10 and 30 seconds, but she wasn’t sure. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950. 38304 On 1/14/25 at 1455, Staff F (Certified Clinical Hemodialysis Technician) was observed donning (putting on) a pair of gloves without prior hand hygiene to perform post-dialysis CVC care (central venous catheter) at station #7. During the procedure, Staff F was observed using an alcohol pad to hold onto 1 of 2 catheter stems (arterial and venous) while disconnecting the blood line, Staff F then wiped the end of the catheter hub (open end) with an alcohol pad for 4 seconds before attaching the cap. Staff F then repeated the same procedure on the second catheter stem for 3 seconds without using a clock for time verification on either CVC catheter stem. On 1/15/25 at 1055, Staff H (Certified Clinical Hemodialysis Technician) was observed prepping for initiating dialysis through a patient’s CVC at station #1. During the procedure, Staff H was observed taking off the old CVC dressing and using disinfecting swabs times two to cleanse the CVC catheter and surrounding areas. Once Staff H completed the cleaning and let the patient’s collared shirt go while turning away, it was observed the shirt had moved back and touched the CVC catheter and surrounding area. Staff H then proceeded to pull the patient’s shirt away again and cover the CVC/surrounding area with a new dressing without disinfecting the recontaminated area. At 1103, Staff H was made aware of the finding and acknowledged that she should have taped or clamped the shirt first. The findings above were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1220.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 37411 Based on observation and interview, the facility failed to ensure the conductivity meter was cleaned properly prior to use, after use, and prior to storing, potentially resulting in unsafe treatment conditions for all 16 patients receiving in-center hemodialysis at this facility at the time of observation. Findings include: Facility policy titled “Checking Conductivity and pH of Dialysate - Fresenius Machines” (Revision Date: 6/2022) stated, “Policy: The external portion of the conductivity meter must be cleaned with a cloth soaked in 1:100 bleach solution after each use, prior to using at another station, and prior to storing in a clean designated area. During dialysis floor observation on 1/15/25 at 1110, Staff K (Certified Clinical Hemodialysis Technician) was observed taking a Pheonix pH meter with external portion to station 11 without cleaning with bleach solution. Staff K then rinsed the external portion with water and set on a rack to dry after testing conductivity. Staff K failed to properly clean the external portion of the conductivity meter prior and post use. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1055.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 38304 Based on observation, record review and interview, the Facility failed to maintain its emergency crash cart supplies, resulting in the potential for an inadequate response during an emergency event, endangering the health and safety of all 24 in-center patients currently receiving services. Findings include: During dialysis floor observation on 1/14/25 at 1020, review of the Facility’s crash cart AED (automated external defibrillator) device noted there was no defibrillator pad. This finding was inspected/reviewed by the Facility Administrator (Staff A) at 1133. Staff A then looked for the AED replacement pad in a supply cabinet behind the nurse’s station on the treatment floor. No replacement pad was found on the treatment floor. Later that day at 1430, Staff A acknowledged an AED pad was used during a recent full code and was never replaced. Staff A noted this did not meet Facility expectations or its policy referenced below. Facility Policy: “Crash Cart” EPM-17 (dated 09/2017) stated, “The crash cart is to be restocked and checked after every use. If the AED is used during the month, it must be checked after use.””

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to have Against Medical Advice (AMA) documentation per their policy concerning early termination of dialysis treatment for 2 (P-1, P-2) of 7 in-center records reviewed, out of a total sample of 7 records reviewed, resulting in the potential for the patients to not understand their right to refuse treatments or the possible consequences of early termination. Findings include: P-1: This 73-year-old male was admitted to the dialysis facility on 4/9/21, with diagnoses which included end stage renal disease, diabetes-type 2, and hypertensive heart disease without heart failure. P-1 was receiving treatments 3 times per week (Tues-Thurs-Sat) for an ordered duration of 195 minutes each treatment. On 1/15/25, record review of P-1’s six most recent in-center dialysis treatments (12/7/24 through 1/2/25; currently hospitalized) noted the following concerns: The treatment flow sheets dated 12/7/24 and 12/28/24, had an ordered run time of 3 hours and 15 minutes each. Treatment documentation on 12/28/24 noted it was shortened by 38 minutes with patient refusal to sign AMA. No AMA form which noted the patient’s refusal was found in the medical record that pre-dated the policy referenced below. The treatment flow sheet dated 12/10/24 documented the treatment it was shortened by 19 minutes with no AMA form found in the medical record. Further, both shortened treatments above had no physician notification or education provided which explained the cumulative harm to the patient when dialysis treatments are shortened. P-2: This 81-year-old female was admitted to the dialysis facility on 7/12/2019, with diagnosis which included end stage renal disease, diabetes-type 2, and anemia. P-2 was receiving treatments 3 times per week (Tues-Thurs-Sat) for an ordered duration of 210 minutes each treatment. On 1/15/25, record review of P-2’s six most recent in-center dialysis treatments (12/19/24 through 1/14/25) noted the following concerns: The treatment flow sheets dated 12/19/24, 12/23/24, and 1/11/25 had an ordered run time of 3 hours and 30 minutes each. Treatment documentation on 1/11/25 noted it was shortened by 32 minutes with no documented AMA form or patient refusal. The treatment flow sheet dated 12/23/24 documented the treatment it was shortened by 19 minutes with no documentation which acknowledged the treatment was cut short. The treatment flow sheet dated 12/19/24 documented the treatment was shortened by 21 minutes with no documentation which acknowledged the treatment was cut short. In addition, all the shortened treatments above had no physician notification or education provided which explained the cumulative harm to the patient when dialysis treatments are shortened. During an interview with the Facility’s Medical Director on 1/16/24 at 0852, it was noted that she would like to be notified whenever a treatment is shortened by 15 or more minutes. Facility Policy “Against Medical Advice” No. G26 (revised 1/13/2025) stated, “The AMA should NOT be used to document patient non-adherence for matters that are not likely to cause serious or immediate harm to the patient or others, such as the patient insisting on regularly signing off of treatment early. In these cases, there must be a detailed progress note entered on the patient’s treatment sheet that explains the situation each time it occurs. Each note must provide details of patient counseling of the potential risks to the patient of not following medical orders/advice and the patient’s response, and notification of the patient’s physician as applicable.” The Facility Administrator (Staff A) reviewed and acknowledged the above findings during an interview on 1/16/25 at 1240.”

“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: 38304 Based on record review and interview, the Facility failed to ensure staff reported a change in target weight which indicated potential fluid overload in 1 (P-2) of 7 records reviewed; and failed to accurately assess blood pressure data in 1 (P-4) of 7 records reviewed, resulting in the potential for unrecognized changes in volume status and blood pressure and poor patient outcomes. Findings include: On 1/15/25, record review of P-2’s 6 most recent treatment flow sheets revealed an increasing trend (treatment #’s 4, 5, and 6) where P-2’s post-dialysis weights increased over the specified dry target weight (TW), indicating potential fluid overload. They are as follow: Treatment #4 on 1/9/25 had pre-dialysis weight of 65.1 kg.; TW of 61.0 kg.; and post-dialysis weight 63.2 kg. Post dialysis symptoms were shortness of breath (2 Liters of oxygen administered) and trace lower extremity edema (swelling). Treatment #5 on 1/11/25 had pre-dialysis weight of 65.0 kg.; TW of 61.0 kg.; and post-dialysis weight 64.1 kg. Post dialysis symptoms were 1+ (minor) lower extremity edema and no shortness of breath. Treatment #6 on 1/14/25 had pre-dialysis weight of 67.6 kg.; TW of 61.0 kg.; and post-dialysis weight 64.5 kg. Post dialysis symptoms were shortness of breath (2 Liters of oxygen administered) and 1+ lower extremity edema. Physician communication concerning notification of the overall increasing post-dialysis weight trend with positive symptoms for potential interventions was not found in the medical record. The above findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1235. Further, when Staff A was queried for what the measurable safety parameters were to notify the physician for potential fluid overload (a common reason for hospitalization), Staff A responded she would refer to the Facility’s policy (see below). Facility Policy: No policy was provided 24 hours after request (1/16/25 at 1242). 47976 P-4: This 66-year-old patient was admitted to this dialysis facility on 9/17/19 with the diagnosis of end stage renal disease. During record review on 1/15/25, it was noted on the plan of care dated 5/9/24 that the parameters for pre-dialysis and post-dialysis systolic blood pressure (top number) were less than 160 millimeters of mercury (mmHg) and greater than 110 mmHg. Under this section on the plan of care, data collected regarding recent blood pressures pre- and post- dialysis indicated 4 of the 8 measurements were greater than or equal to 160 mmHg. However, the plan of care indicated the blood pressure goal was met. The information above was presented to the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950. Staff A stated she usually determines if the goal is met or not met based on what she knows the patient’s blood pressure typically runs during treatment. Staff A acknowledged this is confusing based on the data presented in the report and acknowledged the findings.”

“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: 38304 Based on record review and interview, the Facility failed to deliver the prescribed dose of dialysis for 4 (P-1, P-3, P-4, and P-5) of 7 in-center patient records reviewed resulting in the failure to achieve optimal effectiveness of dialysis treatments and the potential for poor patient care outcomes. Findings include: P-1: This 73-year-old male was admitted to the Facility on 4/9/21, with diagnoses which included end stage renal disease, diabetes-type 2, and hypertensive heart disease without heart failure. On 1/15/25, record review of P-1’s six most recent in-center dialysis treatments (12/7/24 through 1/2/25; currently hospitalized) noted the following concern: The treatment flow sheet dated 12/7/24, documented the physician ordered BFR (blood flow rate) and DFR (dialysate flow rate) were to be delivered at 400 milliliters/minute (mL/min) and 500 mL/min respectively throughout treatment. However, the 12/7/24 treatment sheet documented that 9 of 9 DFR entries had been delivered at 600 mL/min. Additional record review found no documented evidence why P-1’s DFR was run at a rate more than prescribed for the entire treatment. This finding was reviewed and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1227. Staff A noted the failure to document the reason for changing the ordered dialysis prescriptions above did not meet Facility expectations or its policy referenced below. Facility Policy: “Monitoring & Documentation of Patient Care During Treatment” No. IC08 (revised 11/29/2022) stated, “4. The following must be documented before “starting” the patient’s treatment in the electronic documentation system: Treatment RX - indicating caregiver review and verification of all patient treatment data and machine set-up information. 8. The patient caregiver must ensure that all patient data is being collected and recorded on the treatment record for each treatment. Any problem with data collection must be addressed immediately and corrected as soon as possible.” 37411 P-5: This 75-year-old female was admitted to the Facility on 3/1/23, with diagnoses which included end stage renal disease and hypertension. On 1/15/25, record review of P-5’s six most recent in-center dialysis treatments (1/2/25 through 1/14/25) noted the following concern: The treatment flow sheet dated 1/2/25 documented the physician ordered Dialysis Prescription as BFR (Blood Flow Rate) and DFR (Dialysate Flow Rate) were to be delivered at 400 milliliters/minute (mL/min) and 800 mL/min respectively throughout treatment. However, both the 1/4/25 and 1/11/25 treatment sheet documented that the DFR was ran at 500. This finding was reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1055 and stated, “There is no documentation or order for running a lower DFR”. 46476 P-3: This 37-year-old was admitted to facility on 5/24/24 with acute kidney injury; high blood pressure; and heart failure. The medical record was reviewed on 1/15/25 and included the last 6 hemodialysis treatment flowsheets between 11/4/24 and 11/18/24. Active physician orders for hemodialysis in the plan of care during the period of review included a blood flow rate (BFR) of 350 milliliters/minute (mL/min), and a dialysate flow rate (DFR) of 600 mL/min each treatment. During review of the hemodialysis flowsheets, the following were noted: On the flowsheet dated 11/4/24, the treatment was started at 1012 and ended at 1317 (3 hours and 5 minutes). At 1057 (45 minutes into the treatment), the BFR was increased from 350 mL/min to 400 mL/min (50 mL/min above the rate ordered) and stayed at that rate for the remainder of the treatment (2 hours and 20 minutes). There was no documentation indicating why the BFR was increased above the prescribed dose. On the flowsheet dated 11/13/24, the treatment was started at 1053 and ended at 1357 (3 hours and 4 minutes). At 1053, the BFR was recorded as “00” and the DFR was recorded at 500 mL/min. The next recording was at 1119 (26 minutes later) and the BFR was 200 mL/min (150 mL/min below prescribed), and the DFR was 500 mL/min (100 mL/min below prescribed). Both BFR/DFR remained at that rate until the next recording at 1219 (1 hour later) when the BFR was increased to 400 mL/min (50 mL/min above prescribed), and the DFR was increased to 600 mL/min. The BFR stayed at that rate for the remainder of the treatment (1 hour and 27 minutes). There was no documentation indicating why the BFR and DFR were run at a different rate than prescribed for periods throughout this treatment. On 1/16/25 at 1025, these findings were reviewed with the Facility Administrator (Staff A) and the Alternate Clinical Manager (Staff C). Staff C stated that staff should only be following the prescribed order for all treatments. Staff A reviewed the treatment and documentation and was not able to provide a reason for the differing BFR/DFR rates for the above treatments and acknowledged the findings. 47976 P-4: This 66-year-old patient was admitted to this dialysis facility on 9/17/19 with the diagnosis of end stage renal disease. During record review on 1/15/25, it was noted dialysis prescription ordered the blood flow rate (BFR) to be run at 400 milliliters per minute (mL/min) and the dialysate flow rate (DFR) to be run at 500 mL/min. Upon review of the last 6 treatment sheets, it was noted the BFR was run at 325 mL/min for the entire treatment (3 hours and 9 minutes). There was no documentation regarding the reason for decreasing the BFR. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 0950.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 37411 Based on record review and interview, the facility failed to document and update the “Dialysis Access” Plan of Care (POC) for the continued use of central venous catheter (CVC) for 1 (P-5) of 4 patients reviewed with a CVC for greater than 90 days, from a total sample of 7 patients, resulting in the extended use of central venous catheter, and increased potential for complications and/or infections. Findings include: P-5: This 75-year-old female was admitted to the facility on 3/1/23, with diagnoses which included end stage renal disease and hypertension. On 1/15/25, record review noted that the patient has had a central venous catheter (CVC) for greater than 90 days and had the CVC placed on 2/28/23. A review of the patient’s CA (Comprehensive Assessment)/POC dated 1/16/24 stated, “Goal: Access: No intervention necessary.” Additionally, the Patient Access Notes dated 4/20/24 state, “Abandoned - 10/13/2023 - Maturing / Left Upper Arm / AV Fistula. Note: Pt (Patient) has an appointment with Dr at St John Hospital for 2nd stage to the Hero graft on 5/9/2024.” The record contained no further documentation regarding the CVC or AV fistula. The facility failed to document the patient’s need to address the AV fistula and the CVC remaining placed for greater than 90 days. This finding was reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 1/16/25 at 1055.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure the patient’s psychosocial status was monitored to assist the patient in following the treatment plan to achieve the goals for dialysis in 1 (P-4) of 7 records reviewed, resulting in the potential for unidentified barriers to treatment and unmet care needs. Findings include: P-4: This 66-year-old patient was admitted to this dialysis facility on 9/17/19 with the diagnosis of end stage renal disease. During record review on 1/15/25, it was noted the registered dietician documented under “Patient Barriers” on the plan of care dated 5/9/24 that the patient had “Poor adherence with medications and/or dialysis treatment - pt misses tx often.” However, it was noted the social worked documented under “Goals” that the patient was “compliant with treatment”. Upon further review of the record, it was determined the patient missed 21 visits from 1/1/24 to 5/30/24 - indicating poor compliance. During an interview with the Facility Administrator (Staff A) on 1/16/25 at 0950, Staff A was asked about this patient. Staff A reported this patient was non-compliant with her treatments. After showing Staff A the documentation by the social worker and dietician, Staff A was asked to provide documentation of the social worker investigating reasons for the patient missing so many treatments. Staff A was unable to provide documentation and was unsure why the social worker marked this goal as met. Staff A acknowledged the findings.”

“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: 38304 Based on record review and interview, the Facility failed to ensure the QAPI (quality assessment and performance improvement) program implemented specific measures and interventions which could be tracked and trended for quality improvement concerning BSI (bloodstream infections), hospitalization rates, and long-term catheter rates for the last 7 months of QAPI meeting minutes reviewed, resulting in the potential for less than optimal outcomes for all patients served by the facility. Findings include: On 1/10/25, pre-survey review of the DFR (dialysis facility report) noted a significantly higher than average percentage of occurrences for the Facility’s BSI rates, hospitalization, and long-term catheter rates. Subsequently, special attention was given to these aspects when reviewing the Facility’s QAPI program on 1/15/25 at 1410. Comprehensive QAPI meeting minutes from June through December 2024 were reviewed. The QAPI section which detailed BSI for June of 2024 noted the following: “Root Cause(s)” was blank; “Action Plan(s)” was blank; “Goal Statement” was blank; “By When” was blank; and “Responsible Person(s)” was blank. Further, each month (June-December 2024) reviewed concerning BSI rates failed to have any specific interventions/action plans which could be measured and tracked for quality improvement. The goal for hospitalization rates was under 1 percent for all of 2024. Review of submitted documentation of hospitalization rates (January through December 2024) noted that none of the months in 2024 met the goal. Each month (June-December 2024) reviewed concerning hospitalization rates failed to have any specific interventions/action plans which could be measured and tracked for quality improvement. In addition, the goal for long-term catheter rates was under 10 percent for all of 2024. Review of submitted documentation of long-term catheter rates (January through December 2024) noted a high to low range of 44.93% on January and 35.38% on April 2024. Each month (June-December 2024) reviewed concerning long-term catheter rates failed to have any specific interventions/action plans which could be measured and tracked for quality improvement. During an interview with the Facility Administrator (Staff A) on 1/15/23 at 1450, the above findings were reviewed with and acknowledged by Staff A who noted this did not meet Facility expectations or its policy referenced below. Facility Policy: “Quality Assurance & Performance Improvement (QAPI) No. G09 (revised 1/13/2025) stated, “Regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes... QAPI outcomes will be continually monitored, and the IDT in each IRC center will meet monthly to discuss trends and develop action plans as necessary to improve outcomes.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure accurate records in 1 (P-4) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-4: This 66-year-old patient was admitted to this dialysis facility on 9/17/19 with the diagnosis of end stage renal disease. During record review on 1/15/25, it was noted the patient’s estimated dry weight (EDW) was ordered at 62 kilograms (kg). Upon review of the last 6 treatment sheets, it was determined the patient’s weight post-treatment on 12/28/24 was 62.5 kg. After missing a week of dialysis treatment, it was noted her weight prior to treatment on 1/4/25 was 56.8 kg - a 5.7 kg weight loss. After treatment on 1/4/25, the patient’s weight was recorded as 62 kg - a 5.2 kg weight gain. During an interview with the Facility Administrator (Staff A) on 1/16/25 at 0950, Staff A was asked about the findings above. Staff A stated the pre-treatment weight on 1/4/25 must have been a documentation error because the note indicated fluid was removed during treatment. Staff A acknowledged the findings.”