Fmc - Allegan

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 47976 Based on record review and interview, the governing body failed to ensure availability of a social worker to meet the needs of the patient in 1 (P-1) of 5 records reviewed; and failed to ensure staff followed the requirements for an immediate involuntary patient discharge for 1 (P-1) of 1 record reviewed with an immediate involuntary discharge resulting in the potential for less than optimal patient outcomes for all patients served by the facility. See specific tag V-0758 - Failure to ensure availability of a social worker for patient needs V-0767 - Failure to follow requirements for involuntary discharge”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 38905 Based on interview and record review, the facility failed to update their Emergency Preparedness Plan on a bi-annual basis. This has the potential to decrease the effectiveness of the Emergency Preparedness Plan by increasing the likelihood of outdated information that could hinder the response to protect and aid all patients and staff in the event of an emergency. Findings Include: A review of the Emergency Preparedness Binder, provided by Facility Administrator (FA) “A”, starting on 4/9/25 at 13:30, found no update as to when the emergency plan had been reviewed last. A review of the plan found outdated information regarding the Hazard Vulnerability Assessment, dated 3/11/2022, and the Facility Emergency Information Directory, dated 3/4/2022. Further review found no reports showing the facility carried out a table top or community based exercise in the last two years. During an interview with FA “A”, on 4/9/25 at 14:40, the surveyor asked if there was a cover sheet or document that shows when the plan was reviewed last, FA “A” stated that there was not.”

“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: 38905 Based on interview and record review, the facility failed to have an updated Hazard Vulnerability Assessment. This has the potential to decrease the effectiveness of the Emergency Preparedness Plan by not having up to date information to mitigate risks and prepare all patients and staff for an emergency. Findings Include: A review of the Emergency Preparedness Binder, provided by Facility Administrator (FA) “A”, starting on 4/9/25 at 13:30, found a document entitled, “The HVA Hazard Vulnerability Assessment tool”, dated 3/11/22. Further review of the document found it states “A key component of any comprehensive disaster preparedness plan is the completion of a hazard vulnerability assessment (HVA) per facility which helps ascertain the risks, probability and likely frequency of events in a particular territory. Any hazard has the potential to cause a disaster. It is intended that the HVA be utilized as an evolving document which is reviewed at least annually.” During an interview with Facility Administrator (FA) “A” and Director of Operations (DO) “B”, on 4/9/25 at 14:42, it was found that the last Hazard Vulnerability Assessment (HVA) completed by the facility was on “3/11/22”. When asked if there was an updated assessment, FA “A” and DO “B” stated they had updated it today.”

“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: 38905 Based on interview and record review it was found the facility failed to conduct and document exercises to test the emergency plan. This has the potential to decrease the effectiveness of the facility’s emergency preparedness which could affect all patients and staff in the event of an emergency. Findings Include: A review of the Emergency Preparedness Binder, provided by Facility Administrator (FA) “A”, starting on 4/9/25 at 13:30, found printed slides of presentations that could be presented to staff as emergency scenarios, but no documentation that showed the emergency scenarios were carried out by the facility in the form of a table top, work shop, or community based exercise. Further review found no reports showing how the facility carried out the events, what staff were involved, if any other area agencies were involved, or any after action reports on what the facility may be able to learn from the exercises. An interview with FA “A”, starting on 4/9/25, at 14:40, confirmed there was no additional documentation for table top exercises, work shops, or community-based exercises that the facility had performed.”

“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 gloves were worn when touching patient equipment at the dialysis station (#11) of 12 stations, resulting in the potential for spread of infectious agents to all patients receiving dialysis at this facility at the time of observation. Findings include: During dialysis floor observation on 4/9/25 at 1032, patient care technician (Staff E) was observed disinfecting station #11. After completing the task, Staff E removed her gloves, failed to do hand hygiene after glove removal, then used her ungloved “dirty” hands to close the “wings” on the dialysis chair and to lower the footrest. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454.”

“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: 47976 Based on observation, record review, and interview, the facility failed to ensure items taken into the dialysis station were cleaned and disinfected before being taken to a common clean area or used on a patient, resulting in the potential for the spread of infectious agents to all patients receiving dialysis at this facility. Findings include: During dialysis floor observation on 4/9/25 at 1241, certified clinical hemodialysis technician (Staff G) was observed getting ready to initiate dialysis on a patient at station #4. Staff G was then observed getting a stethoscope off the chase (counter behind the dialysis chairs) near station #2. At the time, there was a patient seated at station #2, so this area would have been considered “dirty” as it was located within the patient treatment area. Staff G was then observed using the stethoscope on the patient at station #4 without disinfecting it first. During dialysis floor observation on 4/10/25 at 1010, patient care technician (Staff I) was observed using a Hoyer lift (a mechanical device used to lift patients who cannot stand to transfer) with the patient at station #9. After the patient was safely in his chair, Staff I was observed rolling the Hoyer lift back to its storage location without disinfecting it. **Policy titled “Cleaning and Disinfecting the Dialysis Station” (revised 9/5/23) stated “After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.” Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454. 37411 During dialysis floor observation on 4/10/25 at 1015, Registered Nurse (Staff H) was observed getting a stethoscope from the tabletop within the nurse’s station, then assessed the patient prior to dialysis initiating in chair #9, then return stethoscope to the nurse’s station. At no time during observation did Staff H disinfect the stethoscope.”

“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: 46476 Based on interview and record review, the facility failed to document whether 4 clinical staff members (Staff E, F, O, P) of 12 were either susceptible, vaccinated, or declined to be vaccinated for Hepatitis B resulting in unidentified Hepatitis B infection susceptibility and/or vaccination status. Findings include: On 4/10/25 at approximately 1330, the acting Director of Operations (Staff B) and the Facility Administrator (Staff A) provided personnel file documentation for surveyor review as requested. Staff B stated that documentation for Hepatitis susceptibility, vaccination or declination of vaccination for 4 staff members was not found in the personnel files and immediately acknowledged this finding to be out of compliance with regulations. On 4/10/25, personnel files and employee vaccination records were reviewed. During the review, the following staff were noted to have no evidence of Hepatitis B susceptibility, vaccination, or vaccination declination in their personnel files: Staff E, a Patient Care Technician who was hired 12/11/23 Staff F, a Registered Nurse (RN) who was hired 1/16/25 Staff O, a Certified Clinical Hemodialysis Technician who was hired 8/13/21 Staff P, an RN who was hired on 11/26/18 On 4/11/25 at 1530, these findings were again reviewed and acknowledged by Staff A and Staff B during interview.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 38905 Based on observation and interview, the facility failed to maintain general sanitation and upkeep of premises. This resulted in an increased risk of contamination and bacterial harborage and a possible decrease in the satisfaction of patients. This deficient practice has the potential to affect all patients in the facility. Findings Include: During a tour of the treatment floor, with Bio-med “J”, on 4/9/25, at 12:15, observation of the water boxes behind stations two and three found heavy accumulation of dust and dirt debris along with the growth of a colored substance in and around the floor drains. One of the main water box waste lines, behind station three, was found to be off center of the floor drain and causing excess splash and deterioration of the wall and floor juncture in the corner of the treatment floor between stations two and three. Further observation found temporary devices to alleviate the humidity in this area and the odor caused by the excess humidity. At this time, a strong damp mildew odor was present coming from the water box in this area. An interview with Bio-Med “J”, on 4/9/25, at 12:24, found that the cleaning vendor would not clean the area encased in the water boxes behind treatment stations.”

“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: 37411 Based on observation, record review, and interview, the facility failed to ensure patient access sites were visible to staff at all times for 2 (#10, 12) of 47 patients currently receiving dialysis treatment, resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant bleeding to occur. Findings include: During dialysis floor observation 4/9/25, it was noted the access site for the patient at station #12 was completely covered by a blanket from 1020 to 1105. At 1105, Patient Care Technician (Staff E) was asked if she could see the access site on the patient at station #12. Staff I stated she could not and went to station #12 to uncover the patient. 47976 During dialysis floor observation on 4/10/25 at 0946, it was observed the patient at station #10 was completely covered by a blue blanket and the patient’s access site could not be seen. At 1014, registered nurse (Staff F) was asked if she could see the patient’s access site at station #10. Staff F stated the access site was not fully visible and went to station #10 to uncover it. **Policy titled “Patient Assessment and Monitoring” (revised 5/1/23) stated, “Ensure access remains uncovered throughout the treatment”. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure patients were treated with respect, dignity, and with sensitivity to psychological needs and abilities to cope with ESRD in 1 (P-1) of 5 records reviewed and 3 of 10 current patient interviews, resulting in a loss of patient rights and fear of retaliation. Finding include: P-1: This 38-year-old patient was admitted to this facility on 3/16/22 with the diagnoses of type I diabetes mellitus with diabetic chronic kidney disease and diabetic retinopathy (a complication of diabetes that affects the eyes and can lead to vision loss). During review of P-1’s record, the following was noted: On 5/8/23, the nephrologist (Staff D) documented he was “doing her a service” writing orders for her transplant process and he was “not obliged” to help her any longer if she was “testy” with the staff. Additionally, Staff D documented he confronted the patient about her behavior without evidence of asking the patient how a reported interaction went with the nurse involved (Staff P). The blame was placed only on P-1. On 5/10/23, Staff P documented a late entry that stated the patient “complained again that no one did anything for her” when the doctor explained that him writing her orders was a “courtesy” on 5/8/23. On 5/10/23, the Facility Administrator (Staff L) documented a late entry about a conversation with P-1 on 5/8/23 regarding the patient being upset and stating she needed help with the transplant process. Staff L told the patient, “the clinic typically does not get involved with the transplant unless they are in need of record.....the rest is up to the patient and transplant center.” Staff L reminded the patient again that they “have gone above and beyond as a clinic” for her and the doctor writing orders for her was a “courtesy.” Staff L also documented Staff P reported she told the patient the same thing, however, this is not reflected in the late entry by Staff P. Staff P indicated it was the doctor and reported the patient “complained again” about needing help with the transplant process. (The record is conflicting.) Additionally, Staff L documented on 5/12/23 that the patient called and yelled about needing her records sent to other clinics for treatment following an immediate involuntary discharge. Staff L then documented she told the patient “she was no longer a patient at this facility” after P-1 stated she needed to help her. Staff L also documented she told the patient,”.. I was done with the conversation and hung up the phone ...” Upon review of the policy titled, “Transplant Responsibilities and Guidelines” (revised 3/2/20) stated, “The nephrologist will .... Facilitate and oversee as necessary, based on the requirements of the transplant center, consultations to other healthcare providers.” It also stated, “The Social Worker will...Assist the patient as needed with the transplant referral and evaluation and address any problems causing delays in completing the transplant evaluation,” and “Facilitate referral for additional consultations as required by the transplant center and ordered by the nephrologist.” Therefore, it was the expectation that the facility would help the patient through the transplant process as needed. Additionally, during review of social work notes date 3/16/22 through 12/30/22, multiple psychosocial needs and difficulty dealing with ESRD were identified for P-1, including the transplant process, treatment adherence, work, transportation, and her son. The findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454. On 4/9/25 and 4/10/25, patient interviews were conducted on the treatment floor while patients received their dialysis treatments. Of the 10 patients interviewed, 3 reported a concern regarding being treated rudely by staff. All 3 patients requested to be anonymous and did not wish to reveal the identity of the staff they were referring to. On 4/10/25, the complaint log from 2022 through 2025 (current) was reviewed. During this time period, 14 complaints were logged between 1/31/22 and 5/11/23. Of the 14 complaints, 5 were noted to be regarding staff rudeness, including the complaint by P-1.”

“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: 37411 Based on record review and interview, the facility failed to ensure patient blood pressure (BP) monitoring and assessment was performed per facility policy in 2 (P-2 and P-4) of 5 sample records reviewed resulting in unmanaged fluid volume status and the potential for poor patient outcomes. Findings include: P-4: This 67-year-old began hemodialysis at the facility on 3/7/24 with a diagnosis of end stage kidney disease. The medical record was reviewed on 4/10/25 and included 6 in-center hemodialysis treatment sheets between the dates of 7/25/24 and 8/3/24. On the treatment sheet dated 7/25/24, the following BP measurements were documented by Staff M patient care technician (PCT): At 1302, BP was 90/44 mm/Hg. At 1332, BP was 94/61 mm/Hg. At 1432, BP was 84/52 mm/Hg. On the treatment sheet dated 7/25/24, the following BP measurements were documented by Staff N PCT: At 1338, BP was 97/52 mm/Hg. There were no notes entered at any time by Staff M or Staff N indicating nurse notification of the BP’s which were outside reportable parameters per policy. **Policy titled “Patient Assessment and Monitoring” (published 5/1/2023) stated under “During Treatment” on page 4 to, “...Report to the nurse: Blood Pressure less than or equal to 100mm/hg systolic.” These findings were reviewed and acknowledged by the Facility Administrator (Staff-A), and the acting Director of Operations (Staff-B) during interview on 4/11/25 at 1000. 46476 P-2: This 60-year-old was admitted to the facility on 2/17/24 with diagnoses including end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 4/10/25 and included 6 hemodialysis treatment sheets between the dates of 3/18/25 and 4/3/25. During review, the following were noted: On the treatment sheet dated 3/18/25, the following BP measurements were documented by Staff E, a patient care technician (PCT): At 0733, the BP was 191/75 millimeters of mercury (mm/Hg) At 0802, the BP was 140/107 mm/Hg The BP was not documented again until 0833 (1 hour after first recorded BP out of parameters) and there were no notes entered by Staff E at the time of the BP recordings which indicated the nurse was notified of the BP measurements. On the treatment sheet dated 3/20/25, the following BP measurements were documented by Staff G, a Certified Clinical Hemodialysis Technician (CCHT): At 0902, BP was 184/47 mm/Hg At 0902 recheck, BP was 205/184 mm/Hg The BP was not documented again until 0932 (30 minutes later) and there were no notes entered at the time of the above BP measurements indicating that the CCHT had made the nurse aware of the BP readings. On the treatment sheet dated 3/22/25, the following BP measurement was documented: At 0837, BP was 129/111 mm/Hg by Staff O (a PCT) The BP was not documented again until 0905 (28 minutes later) and there were no notes entered by Staff O indicating that the nurse was alerted to the BP measurement. Facility policy titled “Patient Assessment and Monitoring”; published 5/1/2023, was reviewed on 4/11/25. On page 4., it stated “During Treatment ... Report to the nurse: Systolic blood pressure greater than 180 mm/Hg ... Diastolic blood pressure greater than 100 mm/Hg ...” On 4/11/25 at 1530, these findings were reviewed and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during interview.”

“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: 37411 Based on record review and interview, the Facility failed to deliver the prescribed blood flow rate (BFR) for 1 (P-5) of 5 in-center patient records reviewed, out of a total sample of 5 records reviewed, resulting in failure to achieve optimal effectiveness of dialysis treatments provided and poor patient care outcomes. Findings include: P-5: This 56-year-old was admitted to the facility on 4/10/21, with diagnosis of end stage renal disease. On 4/10/25, record review of P-5’s six most recent in-center dialysis treatments (3/27/25 through 4/8/25) noted the following concern: The treatment flow sheet dated 3/18/25 documented the physician ordered Dialysis Prescription as BFR (Blood Flow Rate) was to be delivered at 500 milliliters/minute (mL/min) throughout treatment. However, the 4/1/25, 4/5/25 and 4/8/25 treatment sheet documented that the BFR was ran at 450. These findings were reviewed and acknowledged by the Facility Administrator (Staff-A), and the acting Director of Operations (Staff-B) during interview on 4/11/25 at 1010. Facility Policy: “Patient Assessment and Monitoring” Version 4 (Published 5/1/2023) stated, “Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.””

“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 agency failed to ensure social work provided the necessary monitoring and interventions in 1 (P-1) of 5 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Job description for a “Strategic Facility Master Social Worker” (4/7/21 version) stated under “Principal Duties and Responsibilities” that the social worker, “Provides monitoring and interventions for the patient to adjust do dialysis and achieve optimal psychosocial status and quality of life.” P-1: This 38-year-old patient was admitted to this facility on 3/16/22 with the diagnoses of type I diabetes mellitus with diabetic chronic kidney disease and diabetic retinopathy (a complication of diabetes that affects the eyes and can lead to vision loss). During a phone interview with the patient (P-1) on 4/10/25 at 1044, P-1 reported poor follow-up with a social worker regarding her transplant process following the retirement of her original social worker. P-1 stated after the first social worker left, the follow-up decreased significantly due to low coverage. P-1 was frustrated regarding this. During review of the record on 4/10/25, it was noted the first social worker documented her last visit with the patient on 12/30/22 - just prior to her retirement. Prior to 12/30/22, the record for P-1 indicated social work visits were done at least monthly and outlined many patient needs and barriers, including the transplant process, transportation, and mental health concerns. Upon further review of the record, it was noted the next social work visit was not documented until 4/7/23. This patient was not seen by social work for over 3 months. During an interview with the current social worker (Staff K, not involved in the visits mentioned above) on 4/9/25 at 1330, Staff K was asked about the expectation for meeting with the patients at the clinic. Staff K stated the goal is at least monthly and additionally as needed. The facility failed to ensure to social work provided necessary monitoring and interventions to support the identified needs of this patient. The findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454.”

“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: 37411 Based on record review and interview, the facility failed to ensure the patient care technician notified the nurse of heart rates outside of reportable parameters per facility policy in 1 (P-5) of 5 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-5: This 56-year-old was admitted to the facility on 4/10/21, with diagnosis of end stage renal disease. On 4/10/25, record review of P-5’s six most recent in-center dialysis treatments (3/27/25 through 4/8/25) noted the following heart rates were noted and recorded by the patient care technician (PCT) during treatment: On 3/27/25: 108 at 1334; 102 at 1401; 113 at 1433. There was no documentation the nurse had been notified of the heart rates recorded outside the reportable parameters per facility policy. On 3/29/25: 121 at 1502. There was no documentation the nurse had been notified of the heart rates recorded outside the reportable parameters per facility policy. On 4/1/25: 121 at 1146; 119 at 1237; 123 at 1335. There was no documentation the nurse had been notified of the heart rates recorded outside the reportable parameters per facility policy. On 4/5/25: 120 at 1333; 102 at 1405. There was no documentation the nurse had been notified of the heart rates recorded outside the reportable parameters per facility policy. On 4/8/25: 107 at 1143; 111 at 1204; 107 at 1439; 121 1534; 102 at 1603. These findings were reviewed and acknowledged by the Facility Administrator (Staff-A), and the acting Director of Operations (Staff-B) during interview on 4/11/25 at 1000. **Policy titled “Patient Monitoring” (published 5/1/2023) stated under “During Treatment” on page 4 to, “...Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular.””

“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: 47976 Based on record review and interview, the agency failed to ensure the interdisciplinary team followed the policy and procedure regarding State notification following an involuntary discharge in 1 (P-1) of 1 record reviewed with an involuntary patient discharge, resulting in the potential for poor patient outcomes. Findings include: **Policy titled “Immediate and Non-immediate Involuntary Patient Discharge” (revised 11/4/24) stated under “Required Notifications” that the Clinical Manager or Social Worker will, “Contact the State agency and Network to inform them of the immediate discharge.” P-1: This 38-year-old patient was admitted to this facility on 3/16/22 with the diagnoses of type I diabetes mellitus with diabetic chronic kidney disease and diabetic retinopathy (a complication of diabetes that affects the eyes and can lead to vision loss). During record review on 4/9/25, it was noted this patient was involuntarily discharged immediately on 5/11/23. During record review on 4/10/25, it was noted the involuntary discharge letter sent to the patient on 5/11/23, stated “The ESRD Network and State survey agency have been informed of this decision.” Additionally, a checklist completed by the social worker on 5/11/23 indicated, “Yes” to the question, “Notification made to ESRD Network and State Health Agency?” Notification to the State was also documented by the previous facility administrator (Staff L) on a note dated 5/15/23. The acting Director of Operations (Staff B) was asked for evidence this occurred during an interview on 4/10/25 at 1245. Staff B was able to provide evidence of the information being sent to the Midwest Kidney Network, however, he was unable to provide evidence of State agency notification. Staff B acknowledged the findings.”

“GOV-RN, MSW, & RD AVAIL TO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- The registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs; This Standard is not met as evidenced by: 47976 Based on record review and interview, the governing body failed to ensure a social worker was available to meet the needs of the patient in 1 (P-1) of 5 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-1: This 38-year-old patient was admitted to this facility on 3/16/22 with the diagnoses of type I diabetes mellitus with diabetic chronic kidney disease and diabetic retinopathy (a complication of diabetes that affects the eyes and can lead to vision loss). During record review on 4/10/25, it was noted a social work visit was documented on 12/30/22 and not again until 4/7/23 - more than 3 months after the last visit. During a phone interview with the patient (P-1) on 4/10/25 at 1044, P-1 stated she had a social worker that was helping her regularly when she first started dialysis. When that social worker retired, P-1 stated there wasn’t a lot of follow-up, and she was not receiving the assistance she needed. During an interview with the current social worker (Staff K) on 4/10/25 at 1303, Staff K was asked how social work coverage was handled after the previous social worker retired in December 2022 until she was hired to cover this facility full-time a few months ago. Staff K stated staff “floated” to cover the case load, however, admitted there were issues with coverage after a social worker was hired and then left prior to her taking over this clinic. The governing body failed to ensure a social worker was available to meet the needs of the patient. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1454.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure immediate involuntary discharge (IVD) policy and procedure was followed in 1 (P-1) of 1 record reviewed with an IVD, resulting in the potential for missed dialysis treatments and poor patient outcomes. Findings include: P-1: This 38-year-old patient was admitted to this facility on 3/16/22 with the diagnoses of type I diabetes mellitus with diabetic chronic kidney disease and diabetic retinopathy (a complication of diabetes that affects the eyes and can lead to vision loss). During record review on 4/9/25, it was noted this patient was immediately discharged involuntarily on 5/11/23. According to the letter of notice sent to the patient on 5/11/23 (and received via certified mail on 5/13/23), the patient was discharged immediately based on a “perceived threat” made towards dialysis staff on social medial as well as “disruptive behavior.” The paperwork faxed to notify the Midwest Kidney Network on 5/15/23 stated, “Patient made threat against Charge Nurse at clinic on social medial platform.” Policy titled “Immediate and Non-immediate Involuntary Patient Discharge” (revised 11/4/24) was reviewed on 4/11/25. The policy stated under “Immediate Involuntary Discharge (Immediate Discharge)” that, “An ‘immediate severe threat’ is a threat of physical harm, including a patient having a gun or knife or making credible verbal threats of physical harm.” It also stated, “Note: This is usually based on an immediate threat of harm to patients or staff.” The social medial “threat” was posted on 5/8/23 prior to P-1’s dialysis treatment that day and read as follows: “Really in a rampage mood today Losing it on my ex. About ½ a second from reporting him to the IRS, have the school board meeting tonight and have no idea how many negative things are going to come out of my mouth about that, had the worst day Friday at dialysis that had my nurse saying ‘I can’t deal with you, I’m going to shoot myself in my head’. So also have no idea how treatment will go bc I feel like my mouth is going to get me in trouble there. You don’t say that to me for specific and hurtful reasons. Pray for me guys ....may need bail money after today.”[sic] The post was brought to the attention of staff by another dialysis patient on 5/11/23. The information in the post was provided via screen shots the acting Director of Operations (Staff B) was able to obtain, however, they were not documented as a part of the facility record or P-1’s medical record. Upon review of the post above and based on the wording in the immediate discharge letter sent to the patient, this was considered a “perceived threat” instead of an actual, credible threat of physical harm as noted in the policy and regulations. The post stated stated her “mouth” could get her in trouble and did not show a credible threat of physical harm toward any person at the facility. Additionally, it was noted the post was made on 5/8/23 prior to treatment and the patient attended 2 dialysis treatments after (dated 5/8/23 and 5/10/23) at which it was documented the patient was “calm” when assessed by the nurse (Staff P). During review of the complaint log entry regarding P-1 and this incident, it was noted the facility would follow-up with “regulatory, compliance, and SW services” about the next steps regarding the social media threat. Documentation of this was requested for review during an interview with the Facility Administrator (Staff A) and the acting Director of Operations (Staff B) on 4/11/25 at 0855. Staff B was unable to locate documentation regarding these conversations. Additionally, the complaint log noted the facility filed a police report with Allegan County regarding the incident. Staff B was also unable to provide documented evidence of a police report being filed by the clinic and stated he was told it was done by Staff P independently in regard to the Personal Protection Order (PPO) she requested against P-1 on 5/12/23. During an interview with Staff B on 4/11/25, Staff B asked if the approved PPO would be enough evidence to support the reason for the immediate involuntary discharge, however, the PPO was not taken out until 5/12/23 - after the patient had been immediately involuntarily discharged and was not a part of the decision. Upon further review of the record, it was noted late entries were made by Staff P on 5/8/23 and 5/10/23 and by the Facility Administrator (Staff L) on 5/10/23 that documented yelling and disruptive behavior instead of when it when it occurred. This was also inconsistent with the nephrologist’s (Staff D) assessment of the patient’s behavior at that time. Staff D noted discussion with the patient regarding her behavior about an interaction with Staff P, however, there was no documentation of the patient yelling or being disruptive. Additionally, there was also no documentation of immediate intervention used to assist in conflict resolution per the policy noted below). The policy also stated under “Reason for Non-Immediate Involuntary Discharge (30-day notice required)” that for “Disruptive or Abusive Behavior”, the, “Facility staff should consult the Disruptive Patient Behavior and Use of Behavioral Agreement policy at the first sign of disruptive or abusive behavior that does not rise to the level of a severe and immediate threat to the health and safety of others. Before involuntary discharge can occur, there must be evidence in the patient’s medical record of the IDT’s efforts to help the patient resolve any conflict or psychological issues contributing to the behavior. Consultation with Social Worker Leadership, is advisable to prevent the likelihood of involuntary discharge. Social Worker Leadership will assess the situation to determine when additional assistance is needed from the Network or other parties.” There was no evidence of efforts to help the patient resolve the conflict contributing to the initial behavior between Staff P and P-1 on 5/5/23. Additionally, the policy stated under “Admission or Readmission of Patient Following Involuntary Discharge” that, “Patients who have been involuntarily discharged from one FKC facility may be admitted to another FKC facility.” P-1 stated during her interview on 4/10/25 at 1045 that she was “blacklisted” from going to other Fresenius clinics, therefore, she was admitted to a clinic over an hour away. As a result, she was unable to use the county transportation she needed due to her diabetic retinopathy. Upon review of the documentation sent to the patient following the IVD, it was confirmed the patient was only provided a list of clinics run by other dialysis companies. The facility failed to provide documented evidence to ensure immediate involuntary discharge policy, procedure and regulations were followed. As a result, P-1 was inappropriately discharged immediately without the facility following and documenting the appropriate steps. Findings were reviewed with and acknowledged by the Medical Director, Facility Administrator (Staff A) and the acting Director of Operations (Staff B) during an interview on 4/11/25 at 1345.”