Davita Renal Center of Carrollton

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 43999 Based on observation, interview, and record review, the facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patient health and safety. Failure to adhere to strict infection control practices in the facility puts all patients and visitors at risk for cross contamination. Findings: The staff failed to follow the facility’s policy titled, “ Infection Control for Dialysis Facilities.” A. Facility failed to ensure staff changed gloves when going between clean and dirty tasks. (Cross Refer to Tag V0113) B. The facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and public areas. (Cross Refer to Tag V0119)”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 43999 Based on record review and staff interview the facility and its staff failed to provide services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. Nursing staff failed to assess the patient when significant changes occurred during treatment and report significant changes to the attending physician. The Findings: Review of facility policy and procedure titled: “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT 1/03/08: Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately.The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician ( or NPP if applicable) as needed of changes in patient status. All findings, interventions and patient response will be documented in the patient’s medical record.” Review of the facility standing orders stated the following: “Clonidine oral; 0.1milligrams, every 4 hours as needed.” (The order did not give blood pressure parameters when to administer) Review of treatment sheets dated 2/13/2024 revealed the following: Patient # 1 Treatment initiated at 10:36 a.m. and completed at 2:00p.m. by patient care technician staff # 6. Initial blood pressure (bp) recorded as 191/66 at 10:36. At 12:27 pm, the blood pressure recorded was 202/63. The registered nurse, staff number # 7, documented, “BP high asymptomatic monitoring, patient forgot to take her bp meds.” The patient’s blood pressure on treatment ranged from 182/71 to 204/70. Review of the post assessment documentation completed for the treatment, the registered nurse did not address the on-going hypertension. The registered nurse did not document that Clonidine was offered or refused by the patient. No documentation found that the attending physician was notified of the hypertension and patient discharged with blood pressure 178/89. Patient # 7 Hemodialysis treatment initiated at 10:37a.m. and completed 1:31p.m. by patient care technician staff # 9. Blood pressure at 10:37 a.m. was 109/61 heart rate 74. The following changes were recorded on the treatment sheet by patient care technician staff # 9. At 1:06 p.m. blood pressure recorded 102/53 Heart rate 75. At 1:16 p.m. blood pressure recorded 82/44 Heart rate 79 At 1:17 p.m. blood pressure recorded 69/53 Heart rate 68. Ultra Filtration turned off. At 1: 31 p.m. blood pressure recorded 105/52 Heart rate 69. Treatment ended at this time. No documentation was found that the registered nurse addressed the drop in blood pressure at time of occurrence. Review of the post assessment documentation for the treatment, the registered nurse did not address the drop in blood pressure and the patient not reaching the ultra-filtration goal due to drop in blood pressure during treatment. No documentation found that the attending physician was notified of the severe hypotension. Patient # 8 Hemodialysis treatment initiated at 5:57a.m. and completed 10:04 a.m. by registered nurse staff # 7. Review of the treatment sheet revealed a one-hour gap (08:32a.m. to 09:32 a.m.) in vital documentation during treatment. Also the patient arrived to treatment 3.2 kilograms below his estimated dry weight with no documentation by the registered nurse to address. Review of the post assessment documentation completed for the treatment, the registered nurse did not address the patient discharged 3.6 kilograms below his estimated dry weight. No documentation found that the attending physician was notified. An interview with Staff member # 4 on 2/13/2024 at 1:05 p.m., following her own review of the findings, revealed that she was unaware of the discrepancies found. Staff member #4 was unable to confirm when Clonidine was to be administered based on how the standing order was written.”

“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: 43999 Based on observation, policy review, and staff interview the facility failed to ensure the staff followed the acceptable infection control standards in care of the patients with a central venous catheter (CVC) as an access for dialysis. This practice placed all patients and staff at risk for cross - contamination and/or infection. Findings : On 2/13/24 during observation on the facility treatment floor, Staff #7 placed two dirty normal saline syringes on the clean supply area at the chairside table after flushing the catheter with normal saline prior to initiation of treatment. There was no separation for the clean and dirty supplies during the initiation of the patient treatment. In an interview with Clinical Coordinator ,staff #4 verified the above deficiencies were acknowledged as not being performed as per facility policy and procedure.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 43999 Based on review of medical records and interview with staff the facility failed to ensure that Plans of Care were implemented within the latter of 30 calendar days after admission to the facility. Findings: Review of Comprehensive Assessments and Plan of Cares on 02/13/24 at 11:30 a.m. in the facility conference room revealed the following: Patient #8 admitted to clinic on 01/24/24. As of 2/13/2024 an initial care plan meeting had not been completed. Patient #9 admitted to clinic on 12/08/23. Initial Comprehensive Assessment completed by interdisciplinary team as followed: Social Worker: 1/25/2024, Dietitian: 1/20/2024, Registered Nurse: 1/29/2024, MD: Blank Date of Care Plan Meeting: No meeting had been completed at time of review. An interview with Staff member # 4 on 2/13/2024 at 1:15 p.m. following her own review of the findings revealed that she was aware of the discrepancies found. Staff member # 4 stated the care plans would be completed on the next physician round.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 43999 Based on observation, documentation and interviews the facility failed to ensure that the patient/staff ratio is appropriate to the level of dialysis care provided to meet the patient needs. Findings: During observation on the patient treatment floor on 2/13/24 , the assigned Charge Nurse Staff # 3 stated, “ I provide direct care to all the catheter patients as I am the only nurse scheduled with 3 PCTs. This this includes giving all medications to all patients, direct pt care for 6 catheter patients and all other charge nursing responsibilities for the pt shifts Tuesday, Thursday, and Saturday. “ Review of the staff/patient daily assignments for 2/13/24 and 2/6/24, revealed the Registered Nurse (RN) who was also the CN (charge nurse) was assigned all nursing responsibilities for all patients that included initiation and termination of six different catheter patients throughout the two shifts as well as administration of all patient ordered medications, assessments, and other CN duties. In an interview with the Group Facility Administrator (GFA) staff #1 on 2/13/24, it was confirmed they schedule only one RN in the facility on TTS and that RN is in charge, if they schedule another RN or LVN they are scheduled in the PCT role and they are responsible for care of their pts, leaving the CN to administer medications and provide direct pt care to catheter patients schedule in the other two PCTs area. The RN/CN duties include medication administration, catheter care, nurse assessments, and all other CN responsibilities.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 28297 Based on interview, review of the facility’s documents, medical record review, and review of facility policies, the facility failed to meet the Condition for Coverage (CfC) for V750 Governance. The Medical Director failed to ensure P16 was not discharged involuntary unless “. . .(1) The patient or payer no longer reimburses the facility for the ordered services; (2)The facility ceases to operate; and (3)The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient ’ s documented medical needs., and 2) The facility failed to ensure a patient was not Involuntary Discharged unless 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. The cumulative effects of deficient practices in Governance affected 1 out of 16 sampled patients (Patient(P)16) ability to receive outpatient hemodialysis in a timely manner that could result in harm or death. This failure had the potential to affect all 73 in-center patients who may be subject to an Involuntary Discharge. Findings include: 1. The Medical Director failed to ensure the Involuntary Discharge notice given to P16 on 12/13/23 was completed as required based on the Conditions for Coverage (CfC) for Governance. Refer to V766. 2. The facility failed to ensure P16 was reassessed to 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 and document the reassessments, ongoing problems(s), and efforts made to resolve the problem(s). Refer to V767.”

“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: 26190 Based on document review, interview and policy review, the facility staff failed to ensure that their Emergency Preparedness Plan was reviewed and updated bi-annually. Findings Include: Review on 01/05/24 of the facility’s “Emergency Management Plan Binder” indicated a “Facility Emergency Preparedness Plan” was dated 05/25/21. The Emergency Preparedness (EP) Plan had not been reviewed and updated on a bi-annual basis. During an interview on 01/05/23 at 7:10 PM with the Interim Facility Administrator, upon review of EP Plan Approval and Implementation section he/she stated, this was not the correct EP Plan and left the conference room to look for additional information. The Interim Facility Administrator stated he/she could not locate any additional information and confirmed the date on the EP Plan was 05/25/21. Review of the facility’s policy titled, “Facility Emergency Management Plan” revised 05/21 indicated, “Goal: The Governing Body shall establish and maintain a facility specific Emergency Management Program designed to manage the consequences of emergencies and disasters that may disrupt the facility’s ability to provide patient care ...Approval 1. Governing Body review and approval of the EMP is required: ...c. Annual basis ...””

“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: 26190 Based on document review, interview and policy review, the facility staff failed to conduct Emergency Preparedness (EP) exercises to test the emergency plan annually by holding a full scale exercise that was community based or a table top exercise on yearly basis. Findings include: Review of the facility’s “Emergency Management Plan” binder indicated no documentation of a full scale community based exercise, a tabletop exercise or workshop that was led by a facilitator, or a mock disaster drill since 05/05/22. During an interview on 01/05/24 at 7:10 PM with the Interim Facility Administrator, he/she confirmed there was no documentation of an EP exercise since 05/05/22. The Interim Facility Administrator did not know why the EP exercises had not been completed since he/she was covering for the Facility Administrator who was out of the country on vacation. Review of the facility’s policy titled, “Facility Emergency Management Plan” revised 05/21 indicated, “Goal The Governing Body shall establish and maintain a facility specific Emergency Management Program designed to manage the consequences of emergencies and disasters that may disrupt the facility’s ability to provide patient care ...Emergency Drills 1. The FA (Facility Administrator) of designee, will maintain the emergency preparedness training and testing based on the facility EMP (Emergency Management Plan) 2. EMP training exercises: ...e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least Annually, conducted on OPPOSITE years (one year full-scale exercise, next year facility based/exercise of choice): 1. Full-scale exercise that is community-based: ...b. Defined as an operations-based exercise that typically involves multiple agencies, jurisdictions, and disciplines ...c. Participation with any of the following: i. Emergency management agency, ii. Local, state, and/or federal emergency response agencies iii. Healthcare coalition 2. Individual facility-based exercise: a. Table top exercise that includes a group discussion led by the FA b. Scenario situation must be based on hazards relevant to facility c. Designed to challenge facility EMP d. Actions taken will be simulated and not disrupt patient treatments e. Facility may choose to participate instead in an full scale community based exercise ...””

“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: 28297 Based on observation, interview, and policy review the facility failed to ensure patients were encouraged to wash or sanitized their hands after holding their access sites (a vascular access is created so that blood can be drawn from the body and run through a dialysis machine) for two of four survey days. The failure for patients to wash or sanitize hands after holding access site had the potential for cross contamination and could affect 73 in-center patients. In addition, staff failed to complete hand hygiene between glove changes as required for one of four survey days. The failure to sanitize hands between glove changes had the potential for cross contamination that could affect 73 in-center patients. Findings include: 1. a. Observation on 01/02/24 at 3:00 PM revealed the patient at Station 7 applied pressure to the right upper arm access site until bleeding had stopped. When finished the patient removed his/her glove and Patient Care Technician (PCT) 6 taped up the patient’s arm, gathered the patient’s supplies, and escorted the patient to the scale. The patient did not wash or sanitize hands and PCT6 did not request or encourage patient to wash or sanitize hands prior to leaving facility. b. Observation on 01/05/24 at 9:25 AM the patient at Station 15 was holding left lower arm access site. PCT4 went over to the patient and assisted the patient with his/her personal belongings and the patient left the facility still holding his/her access site with a gloved hand. During an interview on 01/05/24 at 10:00 AM PCT4 stated the patient at Station 15 always leaves the facility still holding access site with gloved hand. c. Observation on 01/05/24 at 9:45 AM the patient at Station 14 revealed the patient held the left upper arm access site with a gloved hand. When finished holding his/her access site, the patient left the facility without washing or sanitizing hands. During an interview on 01/05/24 at 10:00 AM PCT4 stated he/she could not confirm that the patient at Station 14 had washed or sanitized hands after holding access and did not know that it was required for patients to wash or sanitize hands after holding access site and prior to leaving facility. During an interview on 01/05/24 at 6:30 PM the Registered Nurse Clinic Coordinator confirmed that patients were required to wash or sanitize hands after holding access sites to prevent cross contamination. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, revealed the following: “Patients and caregivers will be encouraged to: a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area.” 2. Observation on 01/05/24 at 10:45 AM Registered Nurse (RN) 2 was doing the initiation of the dialysis treatment with a Central Venous Catheter (CVC-are flexible tubes inserted into large veins, typically located in the neck, chest, or groin. These catheters serve as a direct pathway for blood flow during dialysis treatment.) at Station 9. During the dressing change, RN2 removed the old dressing, removed his/her gloves, and put on a new pair of gloves without sanitizing hands as required. After the dressing change was complete RN2 removed gloves and reapplied new gloves to complete disinfection of the CVC lumens. RN2 did not wash or sanitize hands between glove changes as required. During an interview on 01/05/24 at 11:00 AM, RN2 confirmed he/she did not wash or sanitize hands between glove changes as required during initiation of dialysis via CVC but should have to prevent cross contamination of the CVC. During an interview on 01/05/24 at 6:30 PM the Registered Nurse Clinic Coordinator confirmed that staff were required to wash or sanitize hands between glove changes to prevent cross contamination. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, indicated, “Hand Hygiene: All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid,/bicarb lines form dialysis machine, changing acid types, when exchanging a dialysis machine) f. between patients even if the contact is casual, g. before ouching clean areas such as supplies, supply cart and chairside keyboard/mouse ...””

“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: 28297 Based on observation, interview and policy review, the facility failed to ensure staff and patients wore Personal Protective Equipment (PPE), (Personal protective equipment, commonly referred to as “PPE”, is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses) appropriately during discontinuation of the Central Venous Catheter (CVC- are flexible tubes inserted into large veins, typically located in the neck, chest, or groin. These catheters serve as a direct pathway for blood flow during dialysis treatment) for two of four days of the survey. The failure to wear PPE appropriately had the potential for staff and patients to cross contaminate the CVC site and this could affect 11 in-center patients with CVC’s. Findings include: 1.Observation on 01/02/24 at 2:45 PM, Registered Nurse (RN) 1 was at Station 8 discontinuing the treatment via a CVC. The patient did not have on a mask covering the nose and mouth for the entire discontinuation procedure. During an interview on 01/02/24 at 2:50 PM, RN1 confirmed that the patient at Station 8 did not have on a mask during the discontinuation of the CVC procedure and should have to prevent contamination of the CVC. RN1 stated he/she just failed to notice the patient did not have a mask covering the nose and mouth. 2.Observation on 01/05/24 at 11:00 AM revealed RN2 was at Station 3 discontinuing the dialysis treatment via a CVC. During the entire takeoff procedure, RN2 did not have the mask covering his/her nose as required. During an interview on 01/05/24 at 11:15 AM RN2 confirmed he/she did not have the mask completely covering his/her nose as required and should prevent contamination of the CVC. During an interview on 01/05/24 at 6:30 PM RN Clinic Coordinator confirmed patients were required to wear mask during discontinuation of the CVC to prevent cross contamination of the access. RN Clinic Coordinator also confirmed staff were required to wear masks completely covering the nose during CVC discontinuation to prevent cross contamination. He/she stated that they have had a problem in the past with staff not wearing mask appropriately. Review of the facility’s policy titled, “Central Venous Catheter (CVC) with Clearguard HD [Hemodialysis] Antimicrobial End Caps Procedure,” revised October 2023, indicated, mask to the patient. Teammate and patient will wear masks covering the nose and mouth during the procedure ...””

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure that area’s designated for clean supplies was clearly separated from the dirty area, for one of four survey days. The failure to separate clean areas from dirty areas had the potential for contamination of clean supplies and could affect 73 in-center patients. Findings include: Observation on 01/05/22 at 9:20 AM revealed the trash container used to dispose of garbage, across from Station 14, was stored next to the clean supply cart that contained four packs of dialyzer lines, and six needle packs (contained, needles, gauze, and disinfection wipes) on top of the cart. Continued observation revealed the red biohazard container used to dispose of used infectious dialyzers and lines, across from Station 4, was stored next to the clean supply cart that contained two packs of dialyzer lines, three dialyzers, and three needle packs (contained, needles, gauze, and disinfection wipes) on top of the cart. During an interview on 01/05/24 at 9:20 AM Registered Nurse (RN) 2 confirmed the observation and that the clean supplies should not be stored next to garbage cans or biohazard containers as it could cause the clean supplies to be contaminated from splash, when staff disposed of used supplies and garbage throughout the day. During an interview on 01/05/24 at 6:30 PM the RN Clinic Coordinator acknowledged that trash cans and red biohazard containers should not be stored next to the clean supply cart as there was a risk of contamination from the trash, and soiled dialyzer and hemodialysis lines being disposed of in the red biohazard container. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised April 2023 indicated,” ...Facility Hygiene, Clean areas should be clearly separated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.””

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure the venous pressure transducer protector (which provide a protective barrier between dialysis bloodlines and the dialysis machine,) was not wet (with blood or other fluid) for two of four survey days. The failure to change the venous transducer protector had the potential for inaccurate reading of the venous pressure and contamination of blood into the dialysis machine and this could affect 73 in-center patients. Findings include: Observation on 01/02/24 at 11:15 AM revealed the machine at Station 1 was reading an arterial pressure of 40 and a venous pressure of 40 with a blood flow rate of 350 milliliters per minute. (Ideally, the arterial pressure should be no more than 250, and the venous no greater than 300.) During an observation and interview with Registered Nurse (RN) Clinic Coordinator on 01/02/24 at 11:15 AM he/she confirmed the arterial pressure and venous pressure were not reading correctly for a blood flow rate of 350 at Station 1. He/she confirmed the arterial transducer line was clamped and the venous transducer and line was filled with clear fluid that resulted in the inaccurate reading of the arterial pressure and venous pressure. During an observation on 01/05/24 at 9:15 AM at Station 14 the venous line transducer was saturated with blood. During an interview on 01/05/24 at 9:25 AM Patient Care Technician (PCT) 4 confirmed the venous transducer protector was wet with blood at Station 14. PCT 4 stated it should have been changed to ensure an accurate reading of the venous pressure and that no blood passes through the machine. During an interview on 01/05/24 at 6:30 PM the RN Clinic Coordinator confirmed the transducer protectors should be changed immediately when wet with any fluid to ensure the pressures were reading correctly and no blood passes through the machine. Review of the facility’s policy titled, “Pre-Intra-Post-Treatment Data Collection, Monitoring, and Nursing Assessment,” revised October 2023, indicated, “External transducer protectors will be inspected for presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. If blood or saline is observed in the external transducer protector, refer to policy: Changing Transducer Protectors.” Review of the facility’s policy titled, “Changing Transducer Protectors,” revised April 2021, indicated, “The external transducer protector will be replaced: Prior to each patient use. Whenever blood or saline is observed in contact with the patient side of the transducer protector ...””

“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: 28297 Based on observations, interview, and facility’s policy and procedure review, the facility failed to follow the facility policy for dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by not maintaining the arterial drip chambers (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at 85-95% full for two of four survey days. Failure to follow the facility policy had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 73 patients receiving dialysis treatments in this facility. Findings include: 1. Observation of the hemodialysis treatment area on 01/02/24 at 2:45 PM revealed the arterial drip chamber level was less than 25% full. 2.Observation on 01/05/24 at 9:10 AM revealed the arterial drip chamber level was less than 10% full. 3. On 01/05/24 at 9:15 AM the arterial drip chamber level was less than 10% at Station 15 and Station 16. During an interview on 01/05/24 at 9:25 AM Patient Care Technician (PCT) 4 confirmed he/she was responsible for Stations 13-16. He/she confirmed the arterial drip chamber levels at Station 15 and Station 16 were not at the appropriate level of 3/4th full. He/she stated the drip chambers were required to be ¾s full to prevent air from getting into the extracorporeal system. During an interview on 01/05/24 at 6:30 PM the Registered Nurse Clinic Coordinator confirmed that the arterial drip chambers were required to be at ¾’s full to prevent air from getting into the extracorporeal system. Review of the facility policy titled, “Pre-Intra-Post-Treatment Data Collection, Monitoring, and Nursing Assessment,” revised October 2023, indicated, “The arterial and venous drip chamber levels should be observed and adjusted as needed.” Review of the undated Manufacture Director for Use for “Combi Set Prue Flow Series,” indicated, “Maintain fluid level at pre-pump arterial chamber at 85 to 95% full, post-pump venous chamber at 65 to 75% full. Levels may rise or drop during treatment due to changes in pressure or flowrate. Readjust levels as needed. Air Leaks will also cause the chamber levels to fluctuate ...””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 28297 Based on interview, facility document review, and policy review, the facility failed to track and trend patient mortality for 12 of 12 months reviewed. The failure to track and trend patient mortality had the potential for the facility to miss opportunities for performance improvement and to determine if the patient deaths were dialysis related, and this could impact 73 -in-center patients. Findings include: Review of the “Facility Health Report” for patient deaths from December 2022 through November 2023 revealed that nine patient deaths, including Patients (P) 2 and P4 were recorded however there was no data available for the cause of death. During an interview on 01/05/24 at 7:25 PM, the Registered Nurse Clinic Coordinator and Interim Facility Administrator confirmed there were no comments reported on any patient deaths as required. Both confirmed there should be some documentation on patient deaths to determine if there was something the facility could do to improve and prevent other deaths. Review of the facility policy titled, “Continuous Quality Improvement Program,” revised April 2021, indicated, “Facility Administrator (FAs) conduct periodic Facility Heath Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly...The facility will measure, analyze, an track quality indicators or other aspects of performance. The program must include, but not be limited to, the following ...Mortality - review of deaths ...””

“GOV-ADM RESP FOR RESOURCES FOR QAPI CFR(s): 494.180(a)(4) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (4) Allocation of necessary staff and other resources for the facility’s quality assessment and performance improvement program as described in §494.110. This Standard is not met as evidenced by: 26190 Based on observations, interview, document review and policy review the facility’s governing body failed to ensure the grievance procedure was followed when the facility failed to ensure the patient parking area was well lit and safe. Findings include: Review of Patient (P) 16’s medical record indicated R16 began dialyzing at the facility on 06/13/17 with the diagnoses of end stage renal disease, diabetes, and diabetic retinopathy. P16 received dialysis on Monday, Wednesday and Fridays. Review of P17’s medical record indicated R17 began dialyzing at the facility on 05/01/18 with the diagnoses of end stage renal disease and glomerulonephritis. P17 received dialysis on Monday, Wednesday and Fridays. During observations on 01/05/24 at 9:15 PM on 01/04/24 at 7:00 PM revealed the patient parking lot lights were not working and the parking lot was very dark making it difficult to see. Review of the facility’s grievance logs indicated a facility form titled, “Grievance/Investigation Document” filed on 12/19/23 by P17, stated “ ...Describe the Complaint: Patient complaint of lights in parking lot are out and making it very difficult to see. Investigation Document Interview and Investigation: Notified FA [Facility Administrator] of this, staff was made aware of outside lights not working, staff tried to put in a ticket for service of lights but was told we had to reach out to landlord of facility. IDT [Interdisciplinary Team] Complaint Resolution Describe the Plan of Resolution: Communicated with FA about light issue, he/she will communicate with landlord and management team ...Describe the Resolution: FA has been communicating with facility landlord management team to have this issue resolved as soon as possible ...” There was an additional grievance filed on 05/09/23 regarding the parking lot lights not working. During an interview on 01/03/24 at 3:50 PM with P16, he/she stated, “At :00 AM in the parking lot, the lights don’t work, this is a big hazard ...” During an interview on 01/05/24 at 10:17 AM with P17, he/she stated he/she has been receiving dialysis treatment at the facility for eight years. P17 said he/she arrived for dialysis at approximately 5:00 AM and it was “pitch black dark.”. P17 stated the lights in the parking lot were not working and he/she can’t remember how long they have not worked, but it had been awhile. During an interview on 01/05/24 at 7:10 PM with the Director of Clinical Services, he/she confirmed that the parking lot lights were not working and he/she was unsure how long they had not been working. Review of information the facility staff provided regarding Facility Administrator’s requests for the lights to be repaired indicated an initial e-mail on 11/13/23, followed by emails on 12/11/23, 12/13/23, 12/15/23, 12/22/23 and 01/02/24. Also, the Facility Administrator submitted work orders, that stated the parking lot lights were not working which was a safety issue for the patients, on 11/16/23, 12/11/23 and 12/13/23. Review of the facility’s policy titled, “Patient Grievance” revised 10/21 stated, “Purpose: To provide guidance on the patient grievance process ...Internal Grievance Process: A. Grievances may be reported to a ...teammate either verbally or in writing ...C. The FA (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible ...If the patient’s grievance cannot be resolved by the FA, the ROD (Regional Operations Director) and Medical Director will be notified and a formal grievance conference will be coordinated ...D. If the patient grievance cannot be resolved by the ROD and/or Medical Director, the Divisional Vice President will be notified. E. The Divisional Vice President will discuss the grievance with the patient and take appropriate action towards a solution, if possible. The Divisional Vice President along with Group General Counsel will take the necessary steps to review and, if necessary, investigate the grievance ...””

“GOV-GB&MED DIR RESP STAFF FLW DC/TRANSFER P&P CFR(s): 494.180(f)(1)-(3) The governing body must ensure that all staff follow the facility’s patient discharge and transfer policies and procedures. The medical director ensures that no patient is discharged or transferred from the facility unless - (1) The patient or payer no longer reimburses the facility for the ordered services; (2) The facility ceases to operate; (3) The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient ’ s documented medical needs; This Standard is not met as evidenced by: 28297 Based on interview, medical record review, facility document review and facility policy review, the Medical Director failed to ensure one of 16 sampled patients (Patient (P) 16) were not give an improper 30-day notice of an Involuntary Discharge (IVD) based on ongoing disruptive and abusive behavior. The Medical Director failed to ensure efforts were made to complete a reassessment of the ongoing problem and that efforts were made to resolve the problem that led to the IVD. The failure to provide a proper Involuntary Discharge had the potential for harm or death for P16 and could affect all 73 in-center patients who may be at risk for an IVD. Refer to V767. Findings include: During the entrance conference interview on 01/02/24 at 9:00 AM the Facility Administrator stated they were in the process of an IVD with the patients last day of treatment effective 01/12/24. Review of the medical record for P16 revealed the facility admitted the patient on 06/13/17 with diagnosis of end stage renal disease (ESRD), Diabetes Type 1 and Diabetic Retinopathy. Review of the Patient Assessment and Plan of Care for P16, dated 10/12/23, revealed the facility deemed the patient unstable due to noncompliance with treatment. There was a Comprehensive Assessment and Plan of Care developed on 12/22/23 related to the IVD. There is no documentation that any mediation or a mitigation plan was initiated or implemented between P16 and the Physician. It is documented that the patient did not attend the meeting. Review of the P16’ “Nephrologist Notes” dated 12/08/23 documented by Nephrologist 1, indicated, “Informed the patient that due to his/her continued noncompliance with dialysis (skipping on Mondays for months), I would be changing his/her schedule to Wed [Wednesday] and Fri [Friday] only, so that the Monday spot can be used for other patients/treatments. He/she immediately became visibly upset and said that he/she was going to fire me as his/her doctor. He/she also said that he/she is going to sue me, and that he/she should have sued the dialysis clinic “a long time ago.” He/she used excessive profanity in a loud, threatening voice towards me in front of the staff and other patients. I told him/her to stop cursing at me, or I would call security/police. At that point, he/she stopped and asked to be immediately taken off the machine. His/her treatment was then terminated early.” Review of the “Governing Body Meeting minutes,” dated 12/13/23, indicated, “The governing body (GB) held a meeting to review and discuss the compliance and behavior challenges for [P16]. Primary Nephrologist and the Medical Director have chosen to terminate services for this patient, effective 30 days from 12/11/23. The ESRD Network was notified on 12/13/23. Facility will follow policy guidance in conjunction with the ESRD Network guidance to discharge the patient. Current facility rounding Physicians declined to accept the patient. Facility sent the official letter to the patient on 12/13/23. Patient will discharge effective from 01/12/24.” This meeting was attended by the Medical Director, Facility Administrator, Clinical Coordinator, and the Regional Operations Director. During an interview on 01/04/24 at 11:30 AM Nephrologist 1 stated P16 is a diabetic and very noncompliant and stopped coming on Mondays, cutting treatment short, and not following up with other Physicians as requested that were caring for the patient. He/she stated the patient was usually non-chalet about discussions about non-compliance and they had never argued in the past and the patient has never threatened him/her with physical violence. Nephrologist 1 stated he/she had a conversation with the patient on 12/08/23 that he/she was cutting the patient’s treatment to two days a week so they could free the Monday chair up for another patient. Nephrologist 1 stated the patient started yelling and cursing very loudly on the treatment floor and said, “I should fire you” and that the patient was aggressive and loud but did not physically threaten him/her. Nephrologist 1 stated he/she was very surprised by P16 response ...Nephrologist 1 stated he/she wrote an order to terminate care of the P16. During an interview on 01/04/24 at 2:00 PM with Interim Facility Administrator, Manager of Clinical Services, Lead Social Worker and Facility Social Worker revealed the Medical Director wrote an order to discharge the P16 from the facility and has made referrals to other centers and Nephrologists that provide care at the facility, and they have declined care for the patient. They stated all the other Physicians at the facility are in the same group as Nephrologist 1 except one and that nephrologist only has one patient at the facility. They stated they have made sure the patient has a list of other dialysis facilities in the area and Nephrologist numbers from the facility. During an interview on 01/04/24 at 4:55 PM the Medical Director stated Nephrologist 1 and most of the doctors at this facility were in the same practice. The Medical Director stated that he/she had a conversation with Nephrologist 1 about the altercation with P16. The Medical Director was told P16 was threatening, cursing, using profanity and raising his/her voice at Nephrologist 1 after the he/she was talking to the patient about non-compliance with treatments. The Medical Director stated P16 had lost the trust of the Nephrologist and that they could not wait to discharge the patient until the patient committed an act of violence before action was taken. The Medical Director confirmed that he/she had written an order to discharge the patients due to the altercation between P16 and Nephrologist 1 on 12/13/23. Review of the IVD letter and documents provided from the Facility Social Worker that was given to P16 revealed other dialysis facility including non-Davita facilities were listed however only the Nephologist that practice at this center were provided to the patient and not Nephrologist outside of current facility as required per policy. Review of the facility policy titled, “Patient Behavior Agreements, 30 DAY Discharge, Involuntary Discharge or Involuntary Transfer,” revised October 2023, indicated, “Purpose: To provide guidance on Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge or Involuntary Transfer. These may become necessary when a patient does not conform to the Patient’s Standards of Conduct and/or Patient’s Rights, Responsibilities and Facility Rules. When a facility is considering involuntary discharge, the patient is automatically designated as “unstable” and therefore requires an assessment. The Interdisciplinary Team (IDT) must assess the patient with an intent to identify any potential action or plan that could prevent the need to discharge or transfer the patient involuntarily. If the patient’s behavior is disruptive to the facility, but is non-threatening, a comprehensive patient assessment will be completed by the Interdisciplinary Team (IDT) in order to identify any potential action or plan of correction required. The assessment must focus on identifying the root causes of disruptive behavior and result in a plan of care aimed at addressing those causes and resolving disruptive behavior. This assessment may require a change in health status to unstable ... the patient’s behavior continues to be disruptive to the facility, but is non-threatening to others, the patient should receive a First Letter of Concern. This letter will be written in collaboration with your Risk Manager and will provide specific details of the patient’s behavior and concerns the facility has regarding the patient’s behavior ... Discharge for Lack of Physician Coverage:. . .20. If the reason for discharge is the physician’s determination to no longer care for a particular patient and there is no other physician available that is willing to accept the patient, generally, the state practice boards for physicians require the patient be given some notice to avoid a charge of patient abandonment. The facility will need to follow this regulation as to reassessment, 30-day notice of discharge, attempts for placement, etc. during the physician’s period of notice to the patient. The Facility Administrator/designee should follow state law requirements regarding notice.” Review of the facility document titled, “After Physician Discharge Directions,” revised 01/12/12, indicated “ ...4. include with the letter a list of physicians who have privileges in your center and all other nephrologists in the local area. Also provide the patient with a list of local facilities. include DaVita and non-DaVita facilities. www.dialysisfinder.com is an excellent resource for this list. You should ask all physicians who are credentialed in your facility to accept the patient and document in Falcon ...” Review of the “Summary of Duties of a Medical Director of an In-center (Redacted) Dialysis Facility,” indicated, “ ...Perform any duties required to be in compliance with 42 C.F.R. Part 494 Medicare conditions for Coverage for End-Stage Renal Disease Facilities, other applicable laws and regulations, DaVita’s Code of Conduct, Medical Staff Bylaws, Company’s and DaVita’s compliance program, initiatives, policies, training, and Privacy & Security Standards ...””

“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: 28297 Based on interview, medical record review, facility document review and facility policy review the facility failed to ensure one of 16 sampled patients (Patient (P)16 was reassessed to 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 and document the reassessments, ongoing problems(s), and efforts made to resolve the problem(s) to prevent an Involuntary Discharge (IVD). The failure to provide a proper IVD had the potential for harm or death for P16 and could affect all 73 in-center patients who may be at risk for an IVD. Findings include: During the entrance conference interview on 01/02/24 at 9:00 AM the Facility Administrator stated they were in the process of an IVD with a patient with the patients last day of treatment effective 01/12/24. During an email communication with the end stage renal disease (ESRD) Network 14 on 01/02/24 at 1:43 PM, the Deputy Director stated the facility was in the process of an IVD however he/she stated “the discharge reason (Medical Doctor termination of patient) is not included in the Conditions of Coverage as an acceptable reason for IVD. According to our Social Worker, the patient has some verbal outbursts towards the physician and staff, but he/she was unsure if it would meet criteria for ongoing disruptive behavior at this time.” Review of the medical record for P16 revealed the facility admitted the patient on 06/13/17 with diagnosis of ESRD, Diabetes Type 1 and Diabetic Retinopathy. Review of the Patient Assessment and Plan of Care, dated 10/12/23, revealed the facility deemed the patient unstable due to noncompliance with treatment. A Comprehensive Assessment and Plan of Care was developed on 12/22/23 related to the IVD. Nephrologist 1 There is no documentation that any mediation or mitigation plan was initiated or implemented between P16 and the Physician. It is documented that the patient did not attend the care plan meeting. Review of the facility document titled “Patient Events” from January 2022 through December 2023, the facility staff had documented that P16 had one occurrence of a threat of violence (01/14/22) and three occurrences of verbal abuse (08/08/22, 10/06/23, 12/08/23) against staff. In response to these occurrences, no documentation was provided regarding interventions implemented by facility staff to improve/mediate the situation. On 01/05/24 a request was made for the Lead Social Worker to find any documentation of follow-up to any behavior issues from P16 prior to 12/08/23. He/she was unable to provide any documentation. Review of “Nephrologist 1 Cinic Visit Notes,” dated 12/08/23, indicated, “I informed the patient that due to his/her continued noncompliance with dialysis (skipping on Mondays for months), I would be changing his/her schedule to Wed [Wednesday] and Fri [Friday] only, so that the Monday spot can be used for other patients/treatments. He/she immediately became visibly upset and said that he/she was going to fire me as his/her doctor. He/she also said that he/she is going to sue me, and that he/she should have sued the dialysis clinic “a long time ago.” He/she used excessive profanity in a loud, threatening voice towards me in front of the staff and other patients. I told him to stop cursing at me, or I would call security/police. At that point, he/she stopped and asked to be immediately taken off the machine. His/she treatment was then terminated early.” Review of the “Nurses Notes,” dated 12/08/23 at 7:22 PM, indicated, “During rounds with [Nephrologist 1] he/she discussed P16 (redacted) missing his/her Treatments every Monday. Suddenly [P16] got upset and started shouting at Dr [Nephrologist 1] saying ‘you are rude to me .l will change from this [expletive] unit to another one. I will sue you guys. L should have done this [expletive] long ago. Take me out of this [expletive] machine.’ So as per his/her demand treatment ended in treatment 30 minutes.” Review of the “Facility Social Workers Notes,” dated 12/11/23, indicated, “MSW [Master Social Worker] was informed by FA [Facility Administrator] on 12/08/23 that MD terminated pt [patient] and that he/she will no longer provide care d/t [due to] pt cursing doctor, using profanity and being loud on the treatment floor when MD addressed his/her missed treatment. MSW working with Divisional Lead Social Worker to address this issue.” Continued review from the “Facility Social Worker Notes,” dated 12/13/23, revealed the following, “Met with pt on the floor today. Pt reported he/she was having a bad day on Friday, 12/08/23, and MD had informed him/her about a change in his Rx [physician order] to 2 [sic] tx [times] week because pt missing tx on Monday. Pt reported facility is legally not allowed to give away his/her chair. Pt reported MD doesn’t really care about pt. Doesn’t spend enough time [with him/her]. Pt stated he/she is tired, and he/she would like to move to a facility closer to Plano. MSW notified the Network today regarding pt’s discharge. MSW is working on getting the 30-day letter sent out today because the facility has to give him 30 days’ notice. Will give the letter and let pt know verbally and also mail it certified. Network sent the IVD packet. . .. MSW will try to find placement somewhere else. Network SW notified that discharge orders have to be written and cannot be electronic. Throughout the 30 days MSW will touch base with network SW. MSW doesn’t need to send the IVD packet now; it can be done a week or so before pt’s 30-day mark is up. Facility hoping to get pt transferred to avoid involuntary discharge. MSW will make efforts to place pt somewhere else because IVD is technically non-supported. Everything facility sends to the network needs to be forwarded to the state via fax or email. All IVD have to be reported to the state and a report for involuntary discharge needs to be completed. FA aware.” During an interview on 01/03/24 at 3:50 PM, P16 stated, “ ... I came in on a Friday in December, a couple of weeks ago and I was in a bad mood. Nephrologist 1 said they are going to give up his/her chair on Mondays so I got pissed and snipped off. I do skip on Mondays because I have to work but I have been missing Mondays for the last four to five months. I told Nephrologist 1 he/she does not help me, he/she does not want to listen to what I say, so Nephrologist 1 sent me a paper that he/she was no longer my doctor, and I have until January 12th. I was told I have to go to hospital every other day for treatment. I called the receptionist and asked ‘did you find me anything’ and he/she said they all denied accepting me. I asked why and the receptionist said he/she could not tell me and I would have to call them myself. The doctor has black-listed me around the area.” P16 became tearful, and stated cursed at Doctor - I did not threaten him/her. I would not threaten anybody. He/she only writes a script and leaves. P16 stated I did tell a tech I will whip your [expletive] after the tech threatened to fight, said something to him/her. The tech was very negative that day. I have been written up one time and I don’t remember for what. It was the Lead Social Worker who wrote me up 2018-2019.” P16 stated the facility has not talked to him/her about behavioral contract. During an interview on 01/04/24 at 11:30 AM, Nephrologist 1 stated P16 is a diabetic and very noncompliant. P16 stopped coming to treatment on Mondays, cutting treatment short, and not following up with other physicians as requested. Nephrologist 1 stated the patient was usually non-chalet about discussions about non-compliance and they had never argued in the past and the patient had never threatened him/her with physical violence. Nephrologist 1 stated he/she had a conversation with the patient on 12/08/23 about cutting the patient’s treatment to two days a week so they could free the Monday chair up for another patient. Nephrologist 1 stated the patient started yelling and cursing very loudly on the treatment floor and said, “I should fire you” Nephrologist 1 stated P16 was aggressive and loud but did not physically threaten him/her. Nephrologist 1 stated he/she was very surprised by P16 response ...Nephrologist 1 stated he/she wrote an order to terminate care of the P16. During an interview on 01/04/24 at 2:00 PM, Interim Facility Administrator, Manager of Clinical Services, Lead Social Worker, and Facility Social Worker revealed the facility had made referrals to other centers and called all nephrologist that provide care at the facility, and they have declined care for the patient. They stated all the other physicians at the facility are in the same group as Nephrologist 1 except one and that nephrologist only has one patient at the facility. They stated they have made sure the patient has a list of other dialysis facilities in the area and Nephlogist numbers from the facility. Review of the IVD letter and documents provided from the Facility Social Worker to P16 revealed other dialysis facilities including non-corporate facilities were listed however only nephologist that practice at this center were provided to the patient. There was documentation that an outside nephrologist was referred to P16 as required per policy. During an interview on 01/04/24 at 4:55 PM the Medical Director stated Nephrologist 1 and most of the doctors at this facility were in the same practice. The Medical Director stated that he/she had a conversation with Nephrologist 1 about the incident with P16. The Medical Director was told P16 was threatening, cursing, using profanity and raising his/her voice at Nephrologist 1 after the he/she spoke to the patient about non-compliance with treatments. The Medical Director stated P16 has lost the trust of the Nephrologist and that they could not wait until the patient committed an act of violence before action was taken. During an interview on 01/05/24 at 3:50 PM the Facility Social Worker stated P16 worked on Monday’s causing the him/her to miss treatment. The patient has a history of Psychiatric issues. The Facility Social Worker stated he/she had talked to the patient about non-compliance and the patient gets upset and then just shuts down and won’t talk and wants to be left alone. P16 did uses foul language but never had at him/her. The Facility Social Worker stated he/she notified the Renal Network and was told the facility cannot discharge a patient for non-compliance. He/she stated he/she reported that to the Facility Administrator, but the facility continued with the IVD. The Facility Social Worker stated the patient has not been given a Letter of Concern regarding behaviors. An interview with the Facility Administrator could not be conducted because he/she was out of the country as of 01/03/24. Review of the facility policy titled, “Patient Behavior Agreements,30 DAY Discharge, Involuntary Discharge or Involuntary Transfer,” revised October 2023, indicated, “Purpose: To provide guidance on Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge or Involuntary Transfer. These may become necessary when a patient does not conform to the Patient’s Standards of Conduct and/or Patient’s Rights, Responsibilities and Facility Rules. When a facility is considering involuntary discharge, the patient is automatically designated as “unstable” and therefore requires an assessment. The Interdisciplinary Team (IDT) must assess the patient with an intent to identify any potential action or plan that could prevent the need to discharge or transfer the patient involuntarily. If the patient’s behavior is disruptive to the facility, but is non-threatening, a comprehensive patient assessment will be completed by the Interdisciplinary Team (IDT) in order to identify any potential action or plan of correction required. The assessment must focus on identifying the root causes of disruptive behavior and result in a plan of care aimed at addressing those causes and resolving disruptive behavior. This assessment may require a change in health status to unstable ... the patient’s behavior continues to be disruptive to the facility, but is non-threatening to others, the patient should receive a First Letter of Concern. This letter will be written in collaboration with your Risk Manager and will provide specific details of the patient’s behavior and concerns the facility has regarding the patient’s behavior ... Discharge for Lack of Physician Coverage: 20. If the reason for discharge is the physician’s determination to no longer care for a particular patient and there is no other physician available that is willing to accept the patient, generally, the state practice boards for physicians require the patient be given some notice to avoid a charge of patient abandonment. The facility will need to follow this regulation as to reassessment, 30-day notice of discharge, attempts for placement, etc. during the physician’s period of notice to the patient. The Facility Administrator/designee should follow state law requirements regarding notice.” Review of the facility’s document titled, “After Physician Discharge Directions,” revised 01/12/12 indicated, “ ...4. Include with the letter a list of physicians who have privileges in your center and all other nephrologists in the local area. Also provide the patient with a list of local facilities. Include DaVita and non-DaVita facilities. www.dialysisfinder.com is an excellent resource for this list. You should ask all physicians who are credentialed in your facility to accept the patient and document in Falcon ...””